History > 2007 > USA > Health (III)

Advances Cited

in Research on Multiple Sclerosis

July 30, 2007
The New York Times
By NICHOLAS WADE

Medical researchers have made a significant advance in understanding multiple sclerosis, a common neurological disease that causes symptoms ranging from muscle weakness to paralysis.

The disease is one in which the body’s immune system mistakenly attacks the electrical insulation of nerve fibers. The cause is part genetic and part environmental, but researchers trying to identify the relevant genes have endured repeated frustration. Their approach has been to guess what genes might be involved and see if patients have abnormal versions.

This guesswork has produced more than 100 candidate genes in recent years, none of which could be confirmed except for long-known variants in the mechanism used by the immune system to recognize proteins that are foreign to the body.

In three articles published online yesterday in The New England Journal of Medicine, three teams of researchers say they have identified, by separate routes, new genetic variants that contribute to the disease.

One team used a new, advanced gene-hunting method called Whole Genome Association, which has racked up a string of successes with major diseases in the last few months. The other teams used the candidate gene approach, but because all three teams identified the same gene, the researchers say they are confident they have opened a new window into the cause and possible treatment of multiple sclerosis.

The gene makes a substance called the interleukin-7 receptor, a protein that enables cells of the immune system to respond to a control agent. Researchers believe the receptor is part of a biochemical pathway involving many genes; defects in any of these genes may lead to the disease. It is now possible to explore the pathway, they say, in the hope of devising treatments to correct the disease-causing process.

The new research is the product of several large teams at universities in the United States and abroad who have coordinated their publications and pooled their data for analysis.

The leaders of the Whole Genome Association Study include David A. Hafler of Brigham and Women’s Hospital in Boston; Stephen L. Hauser of the University of California, San Francisco; and Jonathan L. Haines of Vanderbilt University Medical Center in Nashville. The two candidate gene studies were headed by Dr. Haines and Jan Hillert of the Karolinska Institute in Stockholm.

Because the course of the disease is unpredictable, clinical trials are hard to conduct, said Dr. Kári Stefánsson, chief executive of Decode Genetics in Reykjavik, Iceland. “But once you have an ironclad discovery, as I believe the interleukin-7 receptor is,” Dr. Stefánsson said, “then you have the motivation to endure the expense of a long clinical trial.”

Advances Cited in Research on Multiple Sclerosis, NYT, 30.7.2007, http://www.nytimes.com/2007/07/30/health/30gene.html

Six Killers | Cancer

Cancer Patients,

Lost in a Maze of Uneven Care

July 29, 2007
The New York Times
By DENISE GRADY

The first doctor gave her six months to live. The second and third said chemotherapy would buy more time, but surgery would not. A fourth offered to operate.

Karen Pasqualetto had just given birth to her first child last July when doctors discovered she had colon cancer. She was only 35, and the disease had already spread to her liver. The months she had hoped to spend getting to know her new daughter were hijacked by illness, fear and a desperate quest to survive. For the past year, she and her relatives have felt lost, fending for themselves in a daunting medical landscape in which they struggle to make sense of conflicting advice as they race against time in hopes of saving her life.

“It’s patchwork, and frustrating that there’s not one person taking care of me who I can look to as my champion,” Ms. Pasqualetto said recently in a telephone interview from her home near Seattle. “I don’t feel I have a doctor who is looking out for my care. My oncologist is terrific, but he’s an oncologist. The surgeon seems terrific, but I found him through my own diligence. I have no confidence in the system.”

It was a sudden immersion in the scalding realities of life with cancer. This year, there will be more than 1.4 million new cases of cancer in the United States, and 559,650 deaths. Only heart disease kills more people.

Cancer, more than almost any other disease, can be overwhelmingly complicated to treat. Patients are often stunned to learn that they will need not just one doctor, but at least three: a surgeon and specialists in radiation and chemotherapy. Diagnosis and treatment require a seemingly endless stream of appointments. Doctors do not always agree, and patients may find that at the worst time in their lives, when they are ill, frightened and most vulnerable, they also have to seek second opinions on biopsies and therapy, fight with insurers and sort out complex treatment options.

The decisions can be agonizing, in part because the quality of cancer care varies among doctors and hospitals, and it is difficult for even the most educated patients to be sure they are receiving the best treatment. “Let the buyer beware” is harsh advice to give a cancer patient, but it often applies. Excellent care is out there, but people are often on their own to find it. Patients are told they must be their own advocates, but few know where to begin.

“Here it is, a country with such a great health system, with so many different breakthroughs in treatment, but even though we know things that work, not everybody who could benefit gets them,” said Dr. Nina A. Bickell, an associate professor of health policy and medicine at the Mount Sinai medical school in Manhattan.

Death rates from cancer have been dropping for about 15 years in the United States, but experts say far too many patients receive inferior care. Mistakes in care can be fatal with this disease, and yet some people do not receive enough treatment, while others receive too much or the wrong kind.

“It’s quite surprising, but the quality of cancer care in America varies dramatically,” said Dr. Stephen B. Edge, the chairman of surgery at the Roswell Park Cancer Institute in Buffalo. “It’s scary how much variation there is.”

Government and medical groups acknowledge that the quality of care is uneven. In 1999, a report by the Institute of Medicine in Washington said, “For many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of their experience with cancer care.” The institute noted that there was no national system to provide consistent quality.

In March, cancer organizations tried to address the problem by issuing the first set of quality measures that can be used to judge whether hospitals are giving patients up-to-date care for breast and colon tumors, two of the most common cancers.

The list of measures calls for treatments that seem so basic even to a layperson that it is shocking to think any hospital would skip them. For instance, it says that women under 70 who have lumpectomies for breast cancer should also have radiation, and that doctors should consider chemotherapy for people with colon cancer that has spread to their lymph nodes.

Dr. Edge, who worked on the measures, said, “While they’re fairly simple and straightforward, and they seem very basic, it’s quite surprising how many people do not get the care that’s recommended.”

Treatment guidelines approved by experts already exist for 70 to 80 types of cancer (http://www.nccn.org/), but the new measures are the first to be formally endorsed by cancer organizations to assess whether hospitals are performing up to par. The measures were developed by the American College of Surgeons’ Commission on Cancer, the American Society of Clinical Oncology and the National Comprehensive Cancer Network, and are available online at www.facs.org/cancer/qualitymeasures.html.

It took more than two years, Dr. Edge said, before experts even agreed on these basic principles. The first goal is to give doctors and hospitals a chance to see how they stack up to national standards. Eventually, the measures may be used by regulators and payers, including Medicare, he said.

First Sign of Trouble

Karen Pasqualetto is slight and dark-haired, with a soft voice that belies how tough she is. After giving birth by Caesarean section last July, she noticed a lump under her ribs. It was the size and shape of a banana. Doctors noticed it but did nothing. She was sent home and was told it was probably a bruise. Within a week she was back in the hospital, terribly ill — swollen with fluid, vomiting, so anemic she needed a transfusion and suffering from severe abdominal pain. Tests found colon cancer that had already spread, or metastasized, to her liver — stage 4, the final chapter of the disease.

“The doctor came in with a tear in his eye,” she recalled. “ ‘It’s bad.’ Those were his exact words. ‘You have maybe six months.’ ”

Surgery was not recommended because the liver tumors were too extensive. She was referred to an oncologist, who offered “palliative” chemotherapy, given strictly to ease symptoms, not to try for a cure.

“His attitude was that it wouldn’t really make a difference,” Ms. Pasqualetto said.

Palliative treatment was all her health plan would cover. But she had read enough about the disease to know that the proposed regimen did not include the full program of drugs typically recommended for stage 4.

Look for other opinions, her family urged. Her husband had a new job that provided better health coverage, and they switched to a different insurer.

“I think I’d be dead if I’d stayed with the first provider,” she said.

Ms. Pasqualetto, a self-described Type A go-getter, knew better than most how to find information. She has a law degree and worked for several technology start-ups. She had made enough money to quit that career and do something she loved, teaching sixth grade at a Catholic school in Seattle.

She rejected the first oncologist after one visit and consulted the well regarded Seattle Cancer Care Alliance and Swedish Cancer Institute. Both recommended aggressive chemotherapy. Surgery might be possible, they said, if the drugs would shrink the tumors enough. She chose an oncologist at the Swedish institute Dr. Philip Gold, who brushed aside her six-month death sentence and assured her that people with stage 4 colon cancer could live three to four times that long.

“His message to me as a patient was, ‘I have a lot of tricks up my sleeve, this is what we start with, and if it doesn’t work I have this, and then I have a clinical study,’ ” Ms. Pasqualetto said. “The feeling I got was, there was hope, and a plan of attack.”

Eleven months later, after 22 courses of treatment, she gave Dr. Gold credit for keeping her alive and giving her extra time with her daughter, Isabel.

Location, Location, Location

Where patients are treated can make all the difference. Some doctors and hospitals may not see enough cases to stay sharp, especially when it comes to rarer kinds of tumors, complicated operations or advanced stages of the disease — all areas in which studies have shown that experience counts. This factor may leave people in rural areas or smaller cities, and poor people, at a distinct disadvantage.

Communication also plays a crucial part: some patients may not understand that surgery alone is not enough and that they also need chemotherapy or radiation or both.

Even when treatment guidelines are based on solid evidence, hospitals or doctors may not stick to them. But sometimes, the science is not clear, and experts do not agree on the best course — or even on whether there is a best course.

“In cancer, there is frequently no one best doctor and no one best treatment,” said Dr. John H. Glick of the Abramson Cancer Center at the University of Pennsylvania.

When patients consult him for second opinions or to transfer their care to his center, Dr. Glick estimated that he and his colleagues concur completely with the original doctor in about 30 percent of cases. But in another 30 to 40 percent of cases, they recommend major changes in the treatment plan, like a totally different chemotherapy regimen or the addition of radiation. Sometimes his team makes a completely different diagnosis.

In about another 30 percent of cases, his team recommends minor changes in chemotherapy, or additional tests. “We interpret things differently, maybe because we have more experience,” Dr. Glick said. “We see hundreds of patients with Hodgkin’s disease. A community oncologist may see only a couple.”

Warning Signs Overlooked

Looking back, Karen Pasqualetto thinks she had cancer symptoms that were dismissed by doctors in 2003 or 2004 — at least two years before the disease became horribly obvious. She noticed blood in her stool, a classic warning sign of colon cancer. But it lasted only a few days, and such bleeding can also be caused by minor ailments like hemorrhoids. Many doctors do not even think of colon cancer in a young person with no family history of the disease, and her doctor said anal fissures had probably caused the bleeding. There is no way now to know whether that was correct. No sigmoidoscopy or colonoscopy was done to examine the inside of her colon or rectum. Other warning signs were also missed or ignored: anemia and blood in her stools during pregnancy and in the hospital after giving birth .

Ninety percent of colorectal cancers occur in people 50 and older — the reason screening generally starts at 50 — but that still leaves more than 15,000 new cases a year in younger people, some of whom have no symptoms.

The sad paradox of colon cancer is that it is often preventable — but not prevented. It is one of only two cancers (the other is cervical) for which screening tests can find cancers or precancerous growths early enough to cure the disease or even prevent it with surgery alone.

Only 39 percent of colon cancers are detected early. The disease is still the second leading cause of cancer death in the United States (lung cancer is first), with about 154,000 new cases and 52,000 deaths expected this year.

Doctors say the main reason the death toll remains so high is that not enough people are screened. Screening is unpleasant: it requires stool tests or scopes inserted into the rectum. It should start at age 50 for most people, earlier for those with risk factors like a family history of colon cancer. But many people refuse the tests or put them off. Some cannot afford colonoscopy, which costs $2,000 to $4,000; not all insurers cover it, even for people over 50.

Whatever the reason, only about half of those who should be tested actually are. Deaths could be cut in half, experts say — meaning 26,000 lives a year could be saved — if all those who need screening were to receive it. It is possible that screening tests have saved President Bush from developing cancer. He has had colon polyps removed on several occasions, including last Saturday, when five were snipped out. Most polyps do not become malignant, but they are removed when found because nearly every colon cancer starts out as a polyp.

Screening has no advocate like a patient who has been through it all — surgery, radiation and chemotherapy, or slash, burn and poison, as some people call it — for a tumor that might have been easily cured if it had only been found sooner.

“If people knew what they had to go through with colorectal cancer, they wouldn’t hesitate to have this silly little colonoscopy,” said Rebecca Michalovic, who has rectal cancer that was diagnosed in 2003. Ms. Michalovic, 60, has had the works: radiation, three operations and a half-dozen ferocious drugs. Despite it all, the cancer has spread to her lungs. Even so, she continues to work full time as a counselor and administrator at Daemen College in Amherst, N.Y. But one drug after another has stopped working, and she is down to the last two. She was 56 and had always been healthy when the disease was diagnosed, after she noticed a bit of rectal bleeding. She had never been checked for colorectal cancer.

“I should have done it,” Ms. Michalovic said.

Elation and Then a Setback

One aspect of Karen Pasqualetto’s care has particularly troubled her. She was told that the first few months of chemotherapy had shrunk the liver tumors enough to make them operable, and surgery was scheduled for last January. She was elated, figuring that removal of the tumors was her best shot at staying alive. But in December a hospital review panel known as the tumor board refused to approve the surgery.

“I was adamantly told it was off the table, and I don’t know why,” Ms. Pasqualetto said. Even she, the feisty patient, felt powerless.

“Who is this tumor board, and do they hold the keys to my life?” she asked.

“You feel a total lack of control when you’re in a position like mine,” she said.

Her oncologist, Dr. Gold, who is chairman of the tumor board, said it was a group of doctors who met informally to review cases and decide what treatment would help a patient most. In Ms. Pasqualetto’s case, the board thought chemotherapy would accomplish more than surgery.

“Patients don’t always hear what you’re telling them,” Dr. Gold said.

The decision haunts Ms. Pasqualetto because it soon became clear that her tumors had been at their smallest in January. By March, they were growing again, defying the chemotherapy. She feared she might have lost her best chance.

In May, she said: “I didn’t even think I’d make it to today. The baby is starting to talk. I feel happy to be here for that moment. Next thing, maybe I’ll get to see her walk.”

Last month, she watched her daughter take her first steps.

But she had a severe allergic reaction to a new cancer drug in which she had placed a great deal of hope. With that reaction, another opportunity was gone. It was a huge setback.

The same day she had the reaction, a surgeon who had reviewed her case said he thought he could help her.

“It was almost like life and death in one day,” she said. “I know my chances are dwindling.”

The surgeon was Dr. Michael Choti, at Johns Hopkins, whom her sister had found through a patients’ advocacy group, the Colon Cancer Alliance. He specializes in colon cancer that has spread to the liver. Though the surgery would be difficult and more than one operation might be needed, he told her that she seemed young and strong enough to withstand it.

She was torn. Her oncologist in Seattle hinted that it might be too late to operate, and that surgery could even make matters worse by spreading tumor cells around inside her body. She trusted him, and the thought of leaving his care frightened her.

But she clung to the hope of becoming “cancer free,” and though surgery offered only a slim chance of that, she believed it was her only chance.

“It would almost be easier if there was somebody telling me what to do,” she said. “But there’s nobody saying, ‘This is what you should do.’ ”

Missing the Right Treatment

Studies suggest that significant numbers of patients miss out on cancer treatments that could prevent recurrence, prolong survival or save their lives.

Among women with breast cancer, 15 to 25 percent who should have radiation do not receive it, and 20 to 30 percent do not take the anti-estrogen drugs that are a mainstay for most patients, Dr. Edge said.

Women miss out for various reasons.

“Because they don’t get referred to the right doctor,” he said. “Or the doctor doesn’t explain things well and they get afraid of side effects. Or they don’t have insurance and the drug costs $200 a month.”

Race and ethnicity come into play in ways that are not understood. A study published last year in the Journal of Clinical Oncology by Dr. Bickell and other researchers assessed how likely a woman who had surgery for breast cancer was to miss out on other needed treatments — drugs or radiation — at several high-quality teaching hospitals. If she was white, she had a 1 in 6 chance of failing to receive the treatment; black, 1 in 3; and Hispanic, 1 in 4.

A second study published last month by the same group suggested that breakdowns in communication played a part: a third who did not receive the recommended treatment had refused it, and another third missed out because of “system failures,” meaning it was recommended but, for some reason, never happened (and in another third, doctors ruled out the treatment for medical reasons).

With pancreatic cancer, one of the deadliest types, people at early stages have a chance of surviving only if they have surgery. But a study released in June by the American College of Surgeons found that 38 percent of patients who were eligible for surgery were not even offered it.

With ovarian cancer, a deadly disease for which inadequate surgery has been proved to shorten a woman’s life, many do not receive the correct operation, which may require the removal of tumors from the intestine, diaphragm, liver, spleen and bladder.

“A third of the women in the United States are not getting the right surgery, not even close,” said Dr. Barbara Goff, a gynecologic oncologist at the University of Washington in Seattle. “We have so many resources, but we still do so poorly with ovarian cancer.”

For complex operations, numerous studies have shown higher success rates if the hospital and doctor have a lot of experience. But Dr. Goff and other researchers have found that 25 percent of ovarian cancer patients are operated on by surgeons who see only one case a year, and 33 percent in hospitals that treat fewer than 10 cases a year. Too many women are operated on by gynecologists or general surgeons, Dr. Goff said, adding that ovarian cancer operations should be done by gynecologic oncologists, who train specifically in cancer surgery. But she also said that many women do not know what kind of surgeon they need, or they cannot get to that surgeon.

In addition, although a major study in 2006 showed that pumping chemotherapy directly into the abdomen, instead of dripping it into a vein, added an average of 16 months to women’s lives and the National Cancer Institute endorsed the technique, some oncologists still do not offer it.

Uneven quality persists even in colon cancer, one of the most common types. Dr. Jane Weeks, a professor of medicine at Harvard, said half a dozen studies had found that in stage 3, when tumor cells have spread to lymph nodes, only about 65 percent of patients are given chemotherapy — even though it has been proved beneficial and is recommended for about 80 percent of patients.

Numerous studies have suggested that men with prostate cancer face the opposite problem — too much treatment, which wastes resources and money and needlessly subjects men to the pain and risks of surgery or radiation.

Prostate cancer, particularly in older men, often grows so slowly that men can be treated with “watchful waiting,” which means monitoring the cancer and treating it only if it starts to grow rapidly or turns more aggressive.

But a study last year of records of men treated from 2000 to 2002 found that among 24,405 with cancers considered to be of relatively low risk, 10 percent were overtreated with radical surgery, and 45 percent with radiation.

The surgeon’s expertise is crucial in prostate cancer. A study published this month in The Journal of the National Cancer Institute found that the cancer was less likely to come back in patients whose doctors had performed 250 or more operations. Their recurrence rate was 10.7 percent, compared with 17.9 percent in men whose doctors had performed the operation only 10 times.

A Plan for Action

On June 17, a Sunday, Karen Pasqualetto, her husband and Isabel caught a red-eye flight to Baltimore. Ms. Pasqualetto made a point of bringing Isabel, 11 months, to her first appointment with Dr. Choti, hoping that the baby’s blue eyes and cheerful grin would remind him just how high the stakes were and inspire him to try even harder to save her.

She emerged from the meeting a bit wistful. Though Dr. Choti had not criticized her previous care, he did say he would have operated much sooner, after a few months of chemotherapy.

In an interview, Dr. Choti said that Ms. Pasqualetto was a borderline case because the liver tumors were so extensive, and he could understand why the doctors in Seattle had decided not to operate.

Laughing as Isabel tottered around a hotel room in Baltimore, Ms. Pasqualetto looked so healthy it was hard to believe she was not. Only her stubbled scalp, mostly hidden by a bright pink ball cap, gave her away.

“I have fears about dying and about getting sicker, but I don’t explore them, except maybe 10 percent of the time,” she said. “The rest of the time, I just think it will all work out. I don’t know what that really means.”

If all the tumors could be removed, she might not even need more chemotherapy.

“Think of what a perspective I’d have on life,” she said. “I don’t allow myself to go there.”

‘A Complex Operation’

“They got them all,” Ms. Pasqualetto’s husband, Chris Hartinger, said shortly after her operation ended on June 21. “It turned out to be five tumors.”

Four were in her liver. The one in her colon was the size of a tangerine. Dr. Choti operated for eight hours, removing 12 to 18 inches of intestine and about 70 percent of her liver.

The day after surgery, Dr. Choti said, “I think we got away with quite a complex operation.”

The tumors were gone, but metastatic disease can be tough to beat in the long run.

“Roughly a third of patients will remain cancer free for a long time,” Dr. Choti said. “About half will still be alive after five years. In a minority, there’s a long-term cure. In some, we turn it into a chronic disease, if you will. She may recur, and we might be able to reoperate. We can prolong survival significantly.”

A few days after surgery, Ms. Pasqualetto was walking laps around the hospital corridors, thinking about things she had not allowed herself to consider, plans she had not dared to make, like whether Isabel would someday like to have a horse.

“I can’t believe it,” she said. “This is pretty exciting.”

But weeks later, at home again, she found herself back in the trenches, unsure of what the next step in her care would be. Her oncologist refused to see her until he spoke with the surgeon, and yet neither of them had called the other. Meanwhile, she was trying to decipher a worrisome report indicating that a CT scan had found minute lesions on her spleen.

“It’s like I’m flapping in the wind,” she said.

Far From Typical

Karen Pasqualetto is exceptional not only for her determination and confidence in dealing with problems that would intimidate many other people, but also for her financial wherewithal. So far her treatment has cost more than $400,000, almost all of it covered by health insurance from Starbucks, where her husband works in disaster-response planning.

When she joined a cancer support group, she recalled, “It was amazing to me the different experiences people were having based on what they could afford or who their provider was. I was able to say, ‘If the provider won’t pay, my family will. I don’t care, I’m going for a second opinion.’ ”

In the support group, it saddened her to hear other patients with advanced disease take the word of a single oncologist, because she believes that if she had done that, she would already be dead. She has come to think that survival may depend on money and access, and, she said, on “your own drive and motivation — are you Type A? — your education and your ability to sort through the medical world and the insurance world terminology.”

Ms. Pasqualetto’s doctors have accepted her insurance payments, but if they had not, she said, “I would find resources. I would get people to pay. I do have resources. I have access to people who wouldn’t sit by and let me die because of $200,000.”

Cancer Patients, Lost in a Maze of Uneven Care, NYT, 29.7.2007, http://www.nytimes.com/2007/07/29/health/29Cancer.html

Agency Offers

AIDS Education to Elderly

July 25, 2007
By THE ASSOCIATED PRESS
Filed at 8:49 p.m. ET
The New York Times

NEW YORK (AP) -- While volunteers passed out cups of Jell-O to the white-haired lunch crowd at a senior center, another group was distributing something that didn't quite fit amid the card games and daily gossip: condoms. ''You're giving out condoms,'' 82-year-old Rose Crescenzo said with a wistful smile, ''but who's going to give us a guy?''

But this was no joke.

The condom giveaway is part of an effort by New York City's Department of Aging to educate older people about the risks of contracting the virus that causes AIDS. After the condom giveaway, free HIV testing was offered.

AIDS education of the elderly has become an important issue as antiretroviral drugs that can keep patients living into their golden years changes the face of AIDS. Experts warn that ignorance about HIV among seniors can lead to new infections.

And those infections are happening. A physician from Howard University Hospital in Washington recently diagnosed unsuspected HIV in an 82-year-old.

So HIV educators are taking their message of prevention to senior centers and other locales where older people meet. They also hope to create a welcoming environment for people who already have the virus.

New York City has the most HIV cases of any U.S. city -- nearly 100,000 -- and is considered a leader in the area of AIDS education for seniors, with the City Council having budgeted $1 million toward HIV education for older people.

But smaller-scale campaigns are also under way elsewhere.

Nancy Orel, a professor of gerontology at Bowling Green State University in Ohio, is organizing a workshop for seniors that will include free condoms and HIV tests.

''Unfortunately, most individuals have the perception that sex ends at, what, 32?'' Orel said. ''And many older adults report that when they go to see their physicians, the physicians don't ask if they're sexually active.''

The program at the Peter Cardella Senior Center would have been unthinkable back when AIDS was known as a disease that strikes its victims young and kills them in their prime. But the aging of America's AIDS population has changed that.

''Often older people do not concern themselves with HIV and AIDS because they assume that they are not at risk, and that can be a tragic mistake,'' said Edwin Mendez-Santiago, New York City's commissioner of aging.

Frank Garcia, 72, happily pocketed his supply of official New York City condoms, which are packaged with a subway logo.

''I think it's a great thing,'' he said. ''We used to go to the drugstore and wait for an hour or two before we got up the nerve to ask for them. Your parents didn't talk about it. Everything was street-taught.''

A study last year by the AIDS Community Research Initiative of America projected that within the next decade, the majority of HIV-infected New Yorkers will be over 50.

Dan Tietz, executive director of the AIDS research group, said HIV education is needed at senior centers, where the average age is more like 70, because ''we know that people are still having sex well past 65.''

Dorcas Baker, who directs an AIDS education center in Baltimore, said health officials there began HIV prevention programs at senior centers in 2005.

''We call it the silent epidemic because no one thinks seniors are sexual or that they're using drugs,'' she said.

Some seniors tell AIDS educators the disease doesn't affect them because they are not having sex.

''We challenge them by saying, 'You're a grandmother, you're a mother, you're a sister, you're a neighbor,''' Baker said. ''They can also help to raise awareness even if they're not active themselves.''

People aged 50 to 64 accounted for 14 percent of new HIV diagnoses in 2005, while those over 65 comprised only about 2 percent of HIV diagnoses, according to Dr. Bernard Branson, associate director for laboratory diagnostics in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention.

At the Peter Cardella Center in Queens, 66-year-old AIDS educator Edward Shaw recounted his own 1988 diagnosis and warned: ''If you're still having sex, you need to know about HIV/AIDS.''

Many of the seniors ignored him as they chatted with friends and settled in for pork chops and green beans.

''I think it should be done in areas where it's really needed,'' said Julia Karcher, 82. ''These ladies are all by themselves for years and years and years.''

But Marie Tarantino, who gave her age as ''39-plus,'' said lonely seniors might take unwise risks.

''They might pick somebody up on the street,'' she said. ''They just think that at a certain age they can't get pregnant. They don't think they could get a sexually transmitted disease.''

And Crescenzo, who lost her husband of 62 years last October, did take the condoms.

''If I get a date,'' she said, ''I'm going to use one of these.''

    Agency Offers AIDS Education to Elderly, NYT, 25.7.2007, http://www.nytimes.com/aponline/us/AP-Condoms-for-Seniors.html

Texas Leads U.S. in Teen Birth Rate

July 25, 2007
By THE ASSOCIATED PRESS
Filed at 7:44 p.m. ET
The New York Times

HOUSTON (AP) -- Texas had the nation's highest birth rate among teenagers ages 15 to 19 in 2004, according to a newly released study of children's health. The Kids Count study, which is updated annually by the Annie E. Casey Foundation in Baltimore, said the Texas rate of 63 births per 1,000 teens remained the same from 2003 to 2004.

Texas tied New Mexico and Mississippi for the top spot in 2003, but both of those states saw their rates decline in 2004. The average rate nationally was 41 births per 1,000 teens in 2004.

Texas mirrored the rest of the nation in reporting a steep decline in teen births since at least 1990.

''Texas has been showing improvement, but other states are showing more improvement,'' said Frances Deviney, director of Texas Kids Count and a senior research associate for the Center for Public Policy Priorities in Austin.

According to the study, Hispanic teens are more than 3 1/2 times as likely as Anglos to have a baby. Blacks are more than twice as likely as their white peers to give birth.

Observers were divided on whether Texas' emphasis on abstinence in sex education contributes to the state's relatively high numbers. A 1995 law requires school districts to emphasize abstinence in sex education classes.

''It's a touchy subject,'' said Robert Sanborn, president of Children at Risk. ''We can preach abstinence quite a bit, and there is nothing wrong with that, but it doesn't affect some kids, and apparently it's really not working in Texas.''

Don McLeroy, president of the State Board of Education, noted that sex education is mainly a local issue, with state law requiring each district to have a local committee that decides what will be taught.

''The idea that just giving them a lot of information is going to solve it, I think, is kind of naive,'' he said. ''Certainly, it's more of a societal problem than it is a school problem.''

Christine Markham, an assistant professor for health promotion and behavioral science at the University of Texas Health Science Center in Houston, said her studies of sexually active middle schoolers showed that educators need to provide information to students about sexual health and development before they reach high school.

''A lot of parents want to talk to their child about sex and dating, but they don't know how to start the conversation,'' she said.

Information from: Houston Chronicle, http://www.houstonchronicle.com 

    Texas Leads U.S. in Teen Birth Rate, NYT, 25.7.2007, http://www.nytimes.com/aponline/us/AP-Teen-Births.html

Albert Ellis, 93, Influential Psychotherapist, Dies

July 25, 2007
The New York Times
By MICHAEL T. KAUFMAN

Albert Ellis, whose innovative straight-talk approach to psychotherapy made him one of the most influential and provocative figures in modern psychology, died yesterday at his home above the institute he founded in Manhattan. He was 93.

The cause, after extended illness, was kidney and heart failure, said a friend and spokeswoman, Gayle Rosellini.

Dr. Ellis (he had a doctorate but not a medical degree) called his approach rational emotive behavior therapy, or R.E.B.T. Developed in the 1950s, it challenged the deliberate, slow-moving methodology of Sigmund Freud, the prevailing psychotherapeutic treatment at the time.

Where the Freudians maintained that a painstaking exploration of childhood experience was critical to understanding neurosis and curing it, Dr. Ellis believed in short-term therapy that called on patients to focus on what was happening in their lives at the moment and to take immediate action to change their behavior. “Neurosis,” he said, was “just a high-class word for whining.”

“The trouble with most therapy is that it helps you to feel better,” he said in a 2004 article in The New York Times. “But you don’t get better. You have to back it up with action, action, action.”

If his ideas broke with conventions, so did his manner of imparting them. Irreverent, charismatic, he was called the Lenny Bruce of psychotherapy. In popular Friday evening seminars that ran for decades, he counseled, prodded, provoked and entertained groups of 100 or more students, psychologists and others looking for answers, often lacing his comments with obscenities for effect.

His basic message was that all people are born with a talent “for crooked thinking,” or distortions of perception that sabotage their innate desire for happiness. But he recognized that people also had the capacity to change themselves. The role of therapists, Dr. Ellis argued, is to intervene directly, using strategies and homework exercises to help patients first learn to accept themselves as they are (unconditional self-acceptance, he called it) and then to retrain themselves to avoid destructive emotions — to “establish new ways of being and behaving,” as he put it.

His methods, along with those of Dr. Aaron T. Beck, a psychiatrist who was working independently, provided the basis for what is known as cognitive behavior therapy. A form of talk therapy, it has been shown to be at least as effective as drugs for many people in treating anxiety, depression, obsessive-compulsive disorder and other conditions.

His admirers credited Dr. Ellis with adapting the “talking cure,” the dominant therapy in extended Freudian sessions, to a pragmatic, stop-complaining-and-get-on-with-your-life form of guidance later popularized by television personalities like Dr. Phil.

Dr. Ellis had such an impact that in a 1982 survey, clinical psychologists ranked him ahead of Freud when asked to name the figure who had exerted the greatest influence on their field. (They placed him second behind Carl Rogers, the founder of humanistic psychology.) His reputation grew even more in the next two decades.

In 1955, however, when Dr. Ellis introduced his approach, most of the psychological and psychiatric establishment scorned it. His critics said he misunderstood the nature and force of emotions. Classical Freudians also took offense at Dr. Ellis’s critical observations about psychoanalysis and its founder. Dr. Ellis contended that Freud “really knew very little about sex” and that his view of the Oedipus complex, as suggesting a universal law of human disturbance, was “foolish.”

A sexual liberationist, Dr. Ellis collaborated with Dr. Alfred C. Kinsey in his taboo-breaking research on sexual behavior, and his writings about sex drew complaints from members of the American Psychological Association.

As a base for his work he established the Institute for Rational Living, now the Albert Ellis Institute, in a townhouse on East 65th Street in Manhattan. He lived there on the top floor.

The article in The Times described Dr. Ellis at 90, hard of hearing and recovering from abdominal surgery, coming downstairs one day in the spring of 2004 to lead one of his Friday sessions, just as he had for 30 years.

“Do you know why your family is trying to control you?” he asked a volunteer who had joined him in front of the audience. “Because they are out of their minds!” he said, inserting an unprintable adjective.

Another participant recalled the murder of her sister years ago by a drug dealer. “Why can’t you understand that some people are crazy and violent and do all kinds of terrible things?” Dr. Ellis declared. “Until you accept it, you’re going to be angry, angry, angry.”

Some critics complained that his seminars were more stand-up comedy than serious lecture. Still, despite his iconoclasm, or perhaps because of it, rational emotive behavior therapy became one of the most popular systems of psychotherapy in the 1970s and ’80s. In 1985, the American Psychological Association presented Dr. Ellis with its award for “distinguished professional contributions.”

Dr. Ellis was the author or co-author of more than 75 books, many of them best sellers. Among them were “A Guide to Successful Marriage,” “Overcoming Procrastination,” “How to Live With a Neurotic,” “The Art of Erotic Seduction,” “Sex Without Guilt,” “A Guide to Rational Living,” and “How to Stubbornly Refuse to Make Yourself Miserable About Anything — Yes, Anything.”

He often went back to his own life experiences to help explain his positive frame of thinking. Albert Ellis was born on Sept. 27, 1913, in Pittsburgh, the oldest of three children. As a child, he wrote, he had a kidney disorder that turned him from sports to books. His parents moved to the Bronx and separated when he was 11. He once wrote that he had limited but amiable contacts with his father, a traveling salesman, and that his mother, an amateur actress, was not interested in domestic life.

He maintained that the experience had left no scars. “I took my father’s absence and my mother’s neglect in stride,” he wrote, “and even felt good about being allowed so much autonomy and independence.”

He did well in school, skipped grades, won writing contests and, he said, was pleased with his accomplishments.

But at 19 he was painfully shy and eager to change his behavior. In one exercise he staked out a bench in a park near his home, determined to talk to every woman who sat there alone. In one month, he said, he approached 130 women.

“Thirty walked away immediately,” he said in the Times article. “I talked with the other 100, for the first time in my life, no matter how anxious I was. Nobody vomited and ran away. Nobody called the cops.”

Though he got only one date as a result, his shyness disappeared, he said. He similarly overcame a fear of speaking in public by making himself do just that, over and over. He became an accomplished public speaker.

Dr. Ellis studied accounting at City College during the Depression and took up some entrepreneurial schemes after graduating. In one, he paired used men’s jackets and pants of similar colors and sold them as suits. He wrote fiction but found no publishers. He had read a good deal about sex and set up a bureau in which he counseled couples.

His first marriage, to Karyl Corper, an actress, in 1938, ended in annulment. His second, in 1956, to Rhoda Winter, a dancer, ended in divorce. For 37 years, from 1966 to 2003, he lived with a companion, Janet L. Wolfe, a psychologist who had been executive director of the institute. More recently he married Debbie Joffe-Ellis, a psychologist and former assistant, who survives him.

After receiving a doctorate in clinical psychology from Columbia in 1947, Dr. Ellis spent several years undergoing classical psychoanalysis while using its techniques in his job at a state mental hygiene clinic in New Jersey. He quit in 1950 to begin a private practice specializing in sex and marriage therapy and soon started drifting from Freudian orthodoxy, finding it, he said, a waste of time.

He turned to Greek, Roman and modern philosophers and considered his own experience. Out of this came rational emotive behavioral therapy, which he decided would focus not on excavating childhood but on confronting the irrational thoughts that lead to self-destructive feelings and behavior. He founded his Manhattan institute in 1959.

“I was hated by practically all psychologists and psychiatrists,” he recalled. They thought his approach was “superficial and stupid,” he said, and “they resented that I said therapy doesn’t have to take years.”

In 2005, Dr. Ellis sued the institute after it removed him from its board and canceled his Friday seminars. He and his supporters claimed that the institute had fallen into the hands of psychologists who were moving it away from his revolutionary therapy techniques.

The board said it had acted out of economic necessity, asserting that payouts to Dr. Ellis for medical and other expenses were jeopardizing the institute’s tax-exempt status. Dr. Ellis was by then hard of hearing and required daily nursing care. Some board members said they were uncomfortable with his confrontational style and eccentricities and saw him as a liability.

In January 2006, a State Supreme Court judge ruled that the board had been wrong in ousting Dr. Ellis without proper notice and reinstated him. But his friend Ms. Rosellini said Dr. Ellis’s relations with the board had remained strained afterward.

Despite his failing health, Dr. Ellis maintained a demanding schedule late into his life.

“I’ll retire when I’m dead,” he said at 90. “While I’m alive, I want to keep doing what I want to do. See people. Give workshops. Write and preach the gospel according to St. Albert.”

    Albert Ellis, 93, Influential Psychotherapist, Dies, NYT, 25.7.2007, http://www.nytimes.com/2007/07/25/nyregion/25ellis.html

Limited Capacity Is Seen in Flu Defenses

July 18, 2007
The New York Times
By GARDINER HARRIS

WASHINGTON, July 17 — More than a year after President Bush unveiled a plan for coping with a pandemic flu outbreak, the federal government still has limited capacity to detect a disease outbreak and track its progress across the country.

The government has also decided that it will not close the borders if a pandemic flu outbreak occurs somewhere in the world.

“The reality is that there are tremendous challenges to sealing our borders to begin with,” said Dr. Rajeev Venkayya, special assistant to the president for biodefense. “Secondly, we believe that if a pandemic virus emerges anywhere in the globe, it is inevitable that it will arrive here in the U.S. irrespective of the actions we take at the borders.”

The government will try to limit the number of arriving people who might be infected with the virus and detain those suspected of harboring the virus, Dr. Venkayya said. But it will also try to allow the flow of goods and people across the border to continue, he said.

In the coming weeks, officials will release the government’s priority list detailing who will get the first lots of flu vaccines in the event of an outbreak. Plans to coordinate with state and local governments about when to close schools are also still in the works, they said.

These updates were delivered Tuesday in a White House briefing on the government’s progress in preparing the nation for an outbreak of a deadly infectious disease. Top officials emphasized that significant planning and investment decisions had already been made, including a $1 billion investment in finding new ways to manufacture flu vaccines.

But, Dr. Venkayya said, “there is much work that remains to be done.”

Also Tuesday, the Department of Health and Human Services announced that it had released $897 million to states for emergency preparedness efforts. The money includes $175 million for pandemic flu preparedness.

A nationwide surveillance system to track the progress of an outbreak as it moves around the world and across the country still needs considerable work, officials said.

“Just to be brutally honest, we have a lot of trouble determining when we have an outbreak of disease in a community here in the U.S.,” Dr. Venkayya said. “We need to have uniform biosurveillance capability to prepare not only for a pandemic, but any outbreak of infectious disease.”

The nation also has little extra capacity in its hospitals and other health care facilities to deal with a huge surge in need that would accompany a mass disease outbreak, Dr. Venkayya said. And the government has little ability to ensure that during an outbreak, when many workers would stay home, limited Internet capacity would go to essential work and not to children playing video games, officials said.

Eighty-six percent of the tasks that were to be completed this year under the president’s flu plan have been finished, officials said. The remaining 14 percent of those should be done by the end of the year, Dr. Venkayya said.

A significant remaining challenge, officials said, is that the country has grown tired of pandemic flu warnings. They emphasized that the planning would help prepare for any disease outbreak, whether from natural causes or a terrorist attack.

Jeff Levi, executive director of Trust for America’s Health, a nonprofit organization dedicated to disease prevention, praised the administration’s flu preparations.

“This report demonstrates that the federal government has made major strides in preparedness for a pandemic,” Mr. Levi said. “But as the administration also recognizes, there is still a long way to go before all levels of government and all sectors of society are fully prepared.”

    Limited Capacity Is Seen in Flu Defenses, NYT, 18.7.2007, http://www.nytimes.com/2007/07/18/health/18flu.html

Marguerite Vogt, 94, Dies; Biologist and Researcher on Polio Virus

July 18, 2007
The New York Times
By JEREMY PEARCE

Dr. Marguerite Vogt, a biologist who helped shed light on the polio virus at a time, in the 1950s, when it was virulent in the United States, particularly among children, died on July 6 in San Diego. Dr. Vogt, who also helped explain how some viruses can lead to cancer, was 94.

Her death was confirmed by the Salk Institute for Biological Studies in San Diego, where Dr. Vogt had conducted research since 1963, the year it opened.

In the 1950s, while at the California Institute of Technology, Dr. Vogt examined how the polio virus forms in tissue, finding it produced plaques. Collaborating with Renato Dulbecco, a virologist at Caltech, she developed methods for determining the extent of polio-infected cells in a given sample of tissue.

Their work helped explain the physiology of poliomyelitis, a contagious disease that can cause paralysis and death.

In 1954, Dr. Jonas Salk and others independently began a clinical test for a polio vaccine involving about one million American children. The vaccine, employing the polio virus in a deactivated form to provoke an immune response from the recipient’s body, was proved safe in 1955, and reported cases of polio in the United States dropped to fewer than 1,000 a year in 1962 from 45,000.

Researchers say the influence of the work of Dr. Vogt and Dr. Dulbecco on the development of the vaccine is unclear. The vaccine was eventually used worldwide.

After both Dr. Vogt and Dr. Dulbecco joined the Salk Institute, they continued their research together, experimenting with animal viruses grown in cultures. In one project, they studied how the polyoma virus, when introduced to healthy tissue in mice, can change otherwise normal cells into cancer cells.

In 1975, for his work showing how DNA tumor viruses replicate and transfer a virus’s genetic material, Dr. Dulbecco shared the Nobel Prize for Physiology or Medicine. (The other recipients were David Baltimore and Howard M. Temin.)In an interview this week, Dr. Dulbecco, a former president of the Salk Institute, acknowledged Dr. Vogt’s contributions to the Nobel-winning research, saying she was “an expert and fantastic scientist” who was “interested in the physiology of cells and changes of cells under certain conditions.” He and a number of her other peers, at Salk and elsewhere, have said that aspects of her work should have received broader recognition.

Dr. Vogt went on to expand her studies of the genetic underpinnings of cancers and of telomeres, the DNA sequences at the ends of chromosomes that are believed to form a protective buffer during replication. Her earliest work had been on the genetics of fruit flies.

Marguerite Maria Vogt was born in Berlin, the daughter of Oskar Vogt, a neuroscientist who was director of the Kaiser Wilhelm/Max Planck Institute there. She received her medical degree from the University of Berlin in 1937.

At the Salk Institute, Dr. Vogt was a senior scientist and professor of molecular and cell biology. She became an American citizen in 1958. She never married and left no immediate survivors.

Dr. Vogt continued to conduct research into her 90s, aided by her close friend Dr. Martin Haas, a biologist and former student of hers. She was never known to have complained about her lack of formal recognition.

“I’m happy not to have been bothered,” she recalled in an interview with The New York Times in 2001. “When you get too famous, you stop being able to work.”

    Marguerite Vogt, 94, Dies; Biologist and Researcher on Polio Virus, NYT, 18.7.2007, http://www.nytimes.com/2007/07/18/science/18vogt.html

Few Minorities Use Hospice Care Services

July 15, 2007
By THE ASSOCIATED PRESS
Filed at 11:24 a.m. ET
The New York Times

MONTGOMERY, Ala. (AP) -- Unlike terminally ill patients who die in hospitals, attached to tubes and monitors, Marie Madison wants to die in the comfort of her home.

The 97-year-old woman, diagnosed with acute respiratory failure in January, is the first in her family to receive home hospice care, with nurses from New Beacon Hospice in Birmingham checking on her twice a week and on call 24 hours. She also is a black person who chose an end-of-life service that minorities have tended not to use as frequently as whites.

Blacks seek hospice care in disproportionately smaller numbers than whites partly because of cost, health insurance and cultural factors, including a sense of being denied medical care on the basis of race, according to health care specialists.

''Some people think that if a doctor wants them to stay home and not come into the hospital, that the medical system isn't truly concerned about them,'' said Jon Radulovic, vice president of communications for the National Hospice and Palliative Care Organization.

Many in the hospice industry are reaching out to blacks and the growing Hispanic population, but Madison said no one had ever approached her about it until January.

''A social worker told me about it at the hospital and I thought it was nice,'' Madison said in a recent phone interview from her home.

Along with help from nurses, the hospice care team includes a chaplain who goes to Madison's home to sing her favorite hymns and read scriptures with her.

''So far so good,'' she said.

In 2005, 82.2 percent of those receiving hospice care were white, while 7.5 percent identified themselves as black or African-American, according to the National Hospice and Palliative Care Organization. About 75 percent of the country is white, while about 12 percent is black, according to the Census Bureau.

The California HealthCare Foundation issued a report in March that found some minorities and immigrants view hospice care as a way for doctors to deny them the medical care they've been fighting to get.

New Beacon director Debbie Cox said one of her goals is to reassure minorities that hospices provide a service they should consider.

''Once they see that I'm here to help you take care of your loved one, then they warm up to you a little bit,'' Cox said.

Some hospices are trying to reach more blacks through church programs.

''While I hate to generalize, African-Americans tend to rely a great deal on their spirituality and faith communities when dealing with serious illness,'' Radulovic said. ''Further education to the faith leaders is an important part of outreach to that community.''

David Stone, executive director of the Alabama Hospice Organization, said hospices also are trying to get information to Hispanics, including Spanish-language materials and making contact in faith-based community settings and gathering places.

In addition to trying to gain more minority patients, hospices are working to hire more minority employees.

''Hospices are really trying to make sure they as hospice providers are actually more multicultural themselves,'' Stone said.

He said patients generally want to be cared for by people they can relate to. ''When you're dealing with someone at such a vulnerable time, it's understandable that you'd want someone you feel you have a connection with,'' Stone said.

    Few Minorities Use Hospice Care Services, NYT, 15.7.2007, http://www.nytimes.com/aponline/us/AP-Hospice-Care-Minorities.html

New Bill Key to a Safer Cigarettes

July 16, 2007
By THE ASSOCIATED PRESS
Filed at 4:21 a.m. ET
The New York Times

WASHINGTON (AP) -- The federal agency charged with keeping food and drugs from harming people may soon be asked to take a consumer product that kills more than 400,000 people a year and make it safer.

The product is the cigarette -- generally acknowledged as anything but safe. Smoking accounts for nearly one in five deaths in the United States.

That toll can be reduced, tobacco foes say, and they point to a bill widely expected to pass a key Senate committee Wednesday as the tool to make it happen.

The legislation would give the Food and Drug Administration the same authority over cigarettes and other tobacco products that the regulatory agency already has over countless other consumer products. It's an authority the Supreme Court ruled in 2000 that the FDA does not have. But neither is it something the agency necessarily wants, according to past comments by FDA commissioner Dr. Andrew von Eschenbach.

The bill would allow the FDA to regulate the levels of tar, nicotine and other harmful components of tobacco products. Cigarette smoke alone contains more than 4,000 chemicals, more than 40 of which are known to cause cancer.

New products would need FDA approval before they could be sold, according to the legislation. It also would authorize the FDA to set national standards for cigarettes and other tobacco products to control how they are made, as well as force the disclosure of their ingredients, including compounds and additives, and in what quantities. That, supporters claim, should help expose and ultimately limit the ways cigarettes are engineered to the detriment of the public's health.

''If the FDA only prevented tobacco companies from manipulating their products to make it easier to start and harder to quit, it will make a major contribution to reducing the number of people who die,'' said Matthew Myers, president of the National Center for Tobacco-Free Kids, a supporter of the legislation, which has faltered in previous Congresses.

No one among those for or against the Senate bill, mirrored by matching legislation in the House, believes it could result in a safe cigarette. There is consensus that there is no such thing. But those against the bill maintain it could create that impression.

''It would still be a deadly product. They are not going to make it a safe product by taking out particular smoke constituents. The problem is the public is going to perceive the product is safe because the FDA has assumed jurisdiction,'' said Dr. Michael Siegel, a Boston University School of Public Health professor.

But advocates say the bill would at a minimum give the FDA the authority to go where the scientific evidence takes it and only then make decisions based on that science to reduce the harm caused by tobacco.

''There is a broad range of actions that the FDA potentially could take, some of which we understand now and some we can only see dimly,'' said the University of California, San Diego's Dr. David Burns, scientific editor of several surgeon general's reports on tobacco. ''To say that there's nothing we can do is nihilistic in thinking and inconsistent with science.''

The bill also would keep tobacco companies from tinkering with their products in ways that would make them any more dangerous, supporters add.

''The tobacco industry would not be allowed to manipulate the ingredients -- like increase nicotine or decrease nicotine or whatever they do -- without disclosing it. The bill would put the burden of proof on industry to demonstrate to the FDA that what they're doing would not be more harmful,'' said M. Cass Wheeler, chief executive officer of the American Heart Association.

When asked for some likely targets that regulators could tackle, Centers for Disease Control and Prevention chemist David Ashley rattled off more than a half dozen compounds in tobacco and smoke that worry scientists, even though it's unclear just how beneficial removing or reducing their levels would be. They include:

--Nitrosamines, a potent carcinogen. The burley tobacco used in American cigarettes is especially high in nitrosamines.

--Acetaldehyde, a potential carcinogen that may make tobacco more addictive. It's produced when sugars, added to tobacco, are burned.

--Cadmium and lead, two heavy metals that are toxic. Their levels generally depend on the environmental conditions where the tobacco was grown.

The elegance of the bill, Myers said, is it wouldn't dictate to the FDA how to proceed.

''This bill wisely doesn't try to predict what a cigarette will look like once FDA begins to take action. Instead, it says to the scientists at the FDA, 'You have the power to require changes in tobacco products in whatever ways you believe,''' Myers said.

But Ashley, an expert in the constituents of tobacco and tobacco smoke, cautions that cigarettes are a very complex product, and have traditionally changed with time as manufacturers tinker with them.

''One problem from a scientific standpoint is the product changes so often but the health effects are long-term. The cigarettes people are smoking today aren't the cigarettes of 10 years ago,'' Ashley said, adding: ''It's hard to link a change in the products to a particular health end point because there's nothing you can get your hands around.''

Another expert called the task of figuring out how to reduce tobacco's harm basic ''bread-and-butter stuff'' for the FDA.

''This is what they do all the time: develop performance criteria for products,'' said Jack Henningfield, an addiction expert and former tobacco researcher at the National Institute on Drug Abuse. That in turn would act as an incentive for tobacco companies to create products that are less harmful, he added.

As for the FDA, commissioner von Eschenbach said recently he wouldn't want his agency put in the position where it had to determine a cigarette is safe.

Nor would it appear that the agency could approve any new cigarette, even if it were purportedly safer, under the legislation, said Sen. Richard Burr, R-N.C., who opposes the bill.

''It's an impossible pathway to understand at an agency tasked with a mission that is to prove safety and efficacy,'' said Burr, adding that could keep any new reduced-harm tobacco product from coming on the market.

Philip Morris USA, maker of Marlboro, the nation's top-selling cigarette brand, supports the bill. R.J. Reynolds Tobacco Co. and others oppose the legislation, saying its restrictions on advertising would help cement Philip Morris' No. 1 market position.

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The bill is S.625

For bill information: http://www.thomas.gov/

    New Bill Key to a Safer Cigarettes, NYT, 16.7.2007, http://www.nytimes.com/aponline/us/AP-Safer-Cigarettes.html

Enduring a Rare Disease With No Cure

July 14, 2007
By THE ASSOCIATED PRESS
Filed at 4:10 a.m. ET
The New York Times

ROCHESTER, N.Y. (AP) -- All three of Darlene Royalty's daughters began to go blind at age 8, victims of a rare and brutal brain disorder with no cure.

Against the odds, Amber, Sandy and Sarah have survived into their 20s. They cannot speak or see, rely on feeding tubes, spend most of their days in bed at their home in tiny Ursa, Ill., and take multiple drugs to control seizures, clear their lungs, and relieve the anxiety or pain that comes with Batten disease.

They were diagnosed within three months of each other in 1995.

''We've been doing this for 12 years -- 12 very painful and very wonderful, fulfilling years,'' their mother said. ''I know there's no hope right now for them. I'm a realist. But maybe down the road, somebody else may be spared all of this suffering.''

Batten disease is caused when defective genes fail to make enzymes needed to dispose of waste made by brain cells. The waste piles up in the brain and kills healthy cells until the patient dies. There are some 500 cases in the United States and most victims die before or during their teens.

Families cursed with the inherited degenerative disorder come together for a few days each year to sustain one another. They share a grueling ordeal that somehow fills their lives with dignity and purpose.

Their three-day ''family support'' convention in Rochester, which wraps up Saturday, coincided this year with a biennial summit of doctors who specialize in treating the disease and seeking a cure.

On Friday, researchers at the University of Rochester Medical Center presented test results on Batten-afflicted mice, hoping the results will hasten the first drug-based clinical trials aimed at alleviating the most common form of the disease, which typically shows up in children age 5 or older.

Gene-therapy treatments for younger victims with more aggressive types of the disease are already under way at Weill Cornell Medical College in New York. And stem-cell trials being conducted in Oregon could, if successful, open the door to treating a host of neural disorders.

''I think we have the scientific basis for a clinical trial,'' said David Pearce, an associate professor in biochemistry and biophysics who heads the Rochester school's 2-year-old Batten disease research center. ''But there's a lot of very limiting steps. One is I don't have half a million dollars to do it.

''When it comes to a clinical trial, usually there's a big drug company behind it,'' he said. ''This is a rare disease, so actually figuring out how to raise the resources is very difficult.''

''It's definitely ignored as far as diseases go because we don't have the numbers that AIDS or leukemia or cancer has,'' said Karen Upchurch, of St. Petersburg, Fla., whose daughters, Dorothy, 16, and Rose, 24, died a decade apart of Batten disease.

Peg Davis, of Balsam, Minn., who brought her stricken daughters, Holly, 28, and Hannah, 25, to the convention, said that devoting her life to their care is not a burden.

''You get so much joy from them,'' she said.

But Davis admits she's begun to worry about ''every little thing (being) the sign that it's the end'' since her eldest, Chad, died of the disease in May 2006 at age 30.

''The last four years of his life, he really went through a lot,'' she said tearfully. ''He had a (heart) pacemaker put in, he had septic shock, he had pneumonia. All those years you're grieving. But when they're not with you anymore, that's when your heart breaks. When they're gone, what is your purpose?''

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On the Net: www.bdsra.org

    Enduring a Rare Disease With No Cure, NYT, 14.7.2007, http://www.nytimes.com/aponline/us/AP-Batten-Disease.html

Report: Teen Birth Rate Hits Record Low

July 13, 2007
By THE ASSOCIATED PRESS
Filed at 5:31 a.m. ET
The New York Times

WASHINGTON (AP) -- Fewer high school students are having sex these days, and more are using condoms. The teen birth rate has hit a record low.

More young people are finishing high school, too, and more little kids are being read to, according to the latest government snapshot on the well-being of the nation's children. It's good news on a number of key wellness indicators, experts said of the report being released Friday.

''The implications for the population are quite positive in terms of their health and their well-being,'' said Edward Sondik, director of the National Center for Health Statistics. ''The lower figure on teens having sex means the risk of sexually transmitted diseases is lower.''

In 2005, 47 percent of high school students -- 6.7 million -- reported having had sexual intercourse, down from 54 percent in 1991. The rate of those who reported having had sex has remained the same since 2003.

Of those who had sex during a three-month period in 2005, 63 percent -- about 9 million -- used condoms. That's up from 46 percent in 1991.

The teen birth rate, the report said, was 21 per 1,000 young women ages 15-17 in 2005 -- an all-time low. It was down from 39 births per 1,000 teens in 1991.

''This is very good news,'' said Sondik. ''Young teen mothers and their babies are at a greater risk of both immediate and long-term difficulties.''

The birth rate in the 15-19 age group was 40 per 1,000 in 2005, also down sharply from the previous decade.

Education campaigns that started years ago are having a significant effect, said James Wagoner, president of Advocates for Youth, a Washington-based nonprofit group that focuses on prevention of teen pregnancy and sexually transmitted diseases.

''I think the HIV/AIDS epidemic and the efforts in the '80s and '90s had a lot to do with that,'' Wagoner said of the improved numbers on teen sex, condoms and adolescent births.

''We need to encourage young teens to delay sexual initiation and we need to make sure they get all the information they need about condoms and birth control,'' he said.

The report was compiled from statistics and studies at 22 federal agencies, and covered 38 key indicators, including infant mortality, academic achievement rates and the number of children living in poverty.

Other highlights:

--The percentage of children covered by health insurance decreased slightly. In 2005, 89 percent of children had health insurance coverage at some point during the year, down from 90 percent the previous year.

--The percentage of low birthweight infants (born weighing less than 5 pounds, 8 ounces) increased. It was 8.2 percent in 2005, up from 8.1 percent in 2004.

--More youngsters are getting reading time. Sixty percent of children ages 3-5 (and not in kindergarten) were read to daily by a family member in 2005, up from 53 percent in 1993.

--The percentage of children who had at least one parent working year round and full-time increased to 78.3 percent in 2005, up from 77.6 percent the previous year.

--More young people are completing high school. In 2005, 88 percent of young adults had finished high school -- up from 84 percent in 1980.

The report was released by the Federal Interagency Forum on Child and Family Statistics -- a consortium of federal agencies that includes the National Institute of Child Health and Human Development, the Census Bureau and the Administration for Children and Families.

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On the Net:

Report available after midnight: http://childstats.gov

    Report: Teen Birth Rate Hits Record Low, NYT, 13.7.2007, http://www.nytimes.com/aponline/us/AP-Teen-Sex.html

Surgeon General Sees 4-Year Term as Compromised

July 11, 2007
The New York Times
By GARDINER HARRIS

WASHINGTON, July 10 — Former Surgeon General Richard H. Carmona told a Congressional panel Tuesday that top Bush administration officials repeatedly tried to weaken or suppress important public health reports because of political considerations.

The administration, Dr. Carmona said, would not allow him to speak or issue reports about stem cells, emergency contraception, sex education, or prison, mental and global health issues. Top officials delayed for years and tried to “water down” a landmark report on secondhand smoke, he said. Released last year, the report concluded that even brief exposure to cigarette smoke could cause immediate harm.

Dr. Carmona said he was ordered to mention President Bush three times on every page of his speeches. He also said he was asked to make speeches to support Republican political candidates and to attend political briefings.

And administration officials even discouraged him from attending the Special Olympics because, he said, of that charitable organization’s longtime ties to a “prominent family” that he refused to name.

“I was specifically told by a senior person, ‘Why would you want to help those people?’ ” Dr. Carmona said.

The Special Olympics is one of the nation’s premier charitable organizations to benefit disabled people, and the Kennedys have long been deeply involved in it.

When asked after the hearing if that “prominent family” was the Kennedys, Dr. Carmona responded, “You said it. I didn’t.”

In response to lawmakers’ questions, Dr. Carmona refused to name specific people in the administration who had instructed him to put political considerations over scientific ones. He said, however, that they included assistant secretaries of health and human services as well as top political appointees outside the department of health.

Dr. Carmona did offer to provide the names to the committee in a private meeting.

Bill Hall, a spokesman for the Department of Health and Human Services, said that the administration disagreed with Dr. Carmona’s statements. “It has always been this administration’s position that public health policy should be rooted in sound science,” Mr. Hall said.

Emily Lawrimore, a White House spokeswoman, said the surgeon general “is the leading voice for the health of all Americans.”

“It’s disappointing to us,” Ms. Lawrimore said, “if he failed to use this position to the fullest extent in advocating for policies he thought were in the best interests of the nation.”

Dr. Carmona is one of a growing list of present and former administration officials to charge that politics often trumped science within what had previously been largely nonpartisan government health and scientific agencies.

Dr. Carmona, 57, served as surgeon general for one four-year term, from 2002 to 2006, but was not asked to serve a second. Before being nominated, he was in the Army Special Forces, earned two purple hearts in the Vietnam War and was a trauma surgeon and leader of the Pima County, Ariz., SWAT team. He received a bachelor’s degree, in biology and chemistry, in 1976 and his M.D. in 1979, both from the University of California, San Francisco. He is now vice chairman of Canyon Ranch, a resort and residential development company.

His testimony comes two days before the Senate confirmation hearings of his designated successor, Dr. James W. Holsinger Jr. Two members of the Senate health committee have already declared their opposition to Dr. Holsinger’s nomination because of a 1991 report he wrote that concluded that homosexual sex was unnatural and unhealthy. Dr. Carmona’s testimony may further complicate Dr. Holsinger’s nomination.

In his testimony, Dr. Carmona said that at first he was so politically naïve that he had little idea how inappropriate the administration’s actions were. He eventually consulted six previous surgeons general, Republican and Democratic, and all agreed, he said, that he faced more political interference than they had.

On issue after issue, Dr. Carmona said, the administration made decisions about important public health issues based solely on political considerations, not scientific ones.

“I was told to stay away from those because we’ve already decided which way we want to go,” Dr. Carmona said.

He described attending a meeting of top officials in which the subject of global warming was discussed. The officials concluded that global warming was a liberal cause and dismissed it, he said.

“And I said to myself, ‘I realize why I’ve been invited. They want me to discuss the science because they obviously don’t understand the science,’ ” he said. “I was never invited back.”

Dr. Carmona testified under oath at a hearing before the House Oversight and Government Reform Committee headed by Representative Henry A. Waxman, Democrat of California. The topic was strengthening the office of the surgeon general. Dr. C. Everett Koop, surgeon general in the Reagan administration, and Dr. David Satcher, surgeon general during the Clinton administration and the first year of the administration of George W. Bush, also testified.

Each complained about political interference and the declining status of the office. Dr. Satcher said that the Clinton administration discouraged him from issuing a report showing that needle-exchange programs were effective in reducing disease. He released the report anyway.

Dr. Koop, said he had been discouraged by top officials in the Reagan administration from discussing the AIDS crisis. He did so anyway.

All three men urged major changes in the way the surgeon general is chosen and the way the office is financed.

Dr. Carmona described being invited to testify at the government’s nine-month racketeering trial of the tobacco industry that ended in 2005. He said top administration officials discouraged him from testifying while simultaneously telling the lead government lawyer in the case that he was not competent to testify. Dr. Carmona testified anyway.

Sharon Y. Eubanks, director of the Justice Department’s tobacco litigation team, was in the audience during Dr. Carmona’s testimony.

“What he said is all correct,” she said. “He was one of the most powerful witnesses. His testimony was very important.”

Dr. Carmona said that he felt that the duty of the surgeon general, often called the “nation’s doctor,” was to tackle many of the nation’s most controversial health topics and to issue balanced reports about the studies underlying them.

When stem cells became a focus of debate, Dr. Carmona said he proposed that his office offer guidance “so that we can have, if you will, informed consent.”

“I was told to stand down and not speak about it,” he said. “It was removed from my speeches.”

The Bush administration rejected the advice of many top scientists on this subject, including that of the director of the National Institutes of Health, Dr. Elias Zerhouni.

Similarly, Dr. Carmona wanted to address the controversial topic of sexual education, he said. Scientific studies suggest that the most effective approach includes a discussion of contraceptives.

“However there was already a policy in place that did not want to hear the science but wanted to preach abstinence only, but I felt that was scientifically incorrect,” he said.

Dr. Carmona said drafts of surgeon general reports on global health and prison health were still being debated by the administration. The global health report was never approved, Dr. Carmona said, because he refused to sprinkle the report with glowing references to the efforts of the Bush administration.

“The correctional health care report is pointing out the inadequacies of health care within our correctional health care system,” he said. “It would force the government on a course of action to improve that.”

Because the administration does not want to spend more money on prisoners’ health care, the report has been delayed, Dr. Carmona said.

“For us, the science was pretty easy,” he said. “These people go back into the community and take diseases with them.” He added, “This is not about the crime. It’s about protecting the public.”

    Surgeon General Sees 4-Year Term as Compromised, NYT, 11.7.2007, http://www.nytimes.com/2007/07/11/washington/11surgeon.html?hp

2008 Candidates Vow to Overhaul U.S. Health Care

July 6, 2007
The New York Times
By ROBIN TONER

WASHINGTON, July 5 — There is no better measure of the power of the health care issue than this: Sixteen months before Election Day, presidential candidates in both parties are promising to overhaul the system and cover more — if not all — of the 44.8 million people without insurance.

Their approaches are very different, reflecting longstanding divisions between the parties on the role of government versus the private market in addressing the affordability and availability of health insurance. Republicans, by and large, promise to expand coverage by using a variety of tax incentives to empower consumers to buy it themselves, from private insurers. Conservatives warn, repeatedly, of Democrats edging toward the slippery slope of “government-controlled health insurance,” as former Mayor Rudolph W. Giuliani of New York puts it, and promote the innovation and choice offered by private insurers.

The major Democratic candidates propose strengthening the private-employer-based system, through which most working families get their coverage. But many Democrats also see a strong role for government, including, in some plans, new requirements that individuals obtain insurance and that employers provide it, along with substantial new government spending to subsidize coverage for people who cannot afford it.

Still, while they argue over solutions, both parties acknowledge the problems and their political urgency. Republicans, whose primaries usually turn on other issues, often wait until the general election to roll out detailed health plans; this time they are plunging into the debate far earlier. Democrats are competing furiously among themselves over who has the bigger, better plan to control costs and to approach universal coverage, a striking change from the party’s wariness on the issue a decade ago after the collapse of the Clintons’ health care initiative.

And both parties are closely watching the action in the states as potential blueprints for a centrist compromise, especially in Massachusetts, which just began a major plan intended to require that every individual have insurance.

In short, says Jonathan Gruber, an economist, health expert and Clinton administration veteran, the times are “radically different.”

In fact, when Senator Barack Obama of Illinois unveiled a plan intended to cover tens of millions of uninsured Americans, but not requiring coverage for all, some Democrats in rival campaigns argued that he had not gone far enough. Senator Hillary Rodham Clinton, once vilified as overreaching on health care, is now more often faulted in her party as moving too slowly. Mrs. Clinton’s 1994 plan, attacked at the time from the left, right and center, is presented in the new Michael Moore documentary, “Sicko,” as a tragic missed opportunity.

This amount of attention, this early, comes in response to the growing anxiety among voters — and much of American business — about the cost of health care. Premiums for family coverage have risen by 87 percent since 2000, according to the Kaiser Family Foundation. The number of Americans without insurance has grown steadily, to what the Census Bureau estimates as nearly 45 million, from 37 million when the Clintons first confronted the issue.

Businesses say that health costs are a huge liability in their struggles to compete in a global economy, most vividly in the auto industry. And health care is now rated the top domestic issue in some recent polls among Democrats, independents and voters over all. Among Republicans, it was surpassed only by immigration in June, according to the latest Kaiser survey. A Democratic pollster, Geoffrey Garin, says: “There are a bunch of issues that candidates can take a pass on. This is not one of them.”

On the Republican side, few candidates have been better prepared to deal with the issue than former Gov. Mitt Romney of Massachusetts, who helped push through that state’s health plan with bipartisan support. But Republican primary voters tend to be leery of new government requirements, and, arguably, of Massachusetts as a role model. Mr. Romney, on the campaign trail, talks generally about getting “everybody inside the health care system,” through “market reforms” state by state to make private insurance cheaper and more available. But not, he says, “with a government takeover.”

Sally Canfield, policy director for the Romney campaign, says that Mr. Romney is proud of his record, but “the Massachusetts plan was crafted for Massachusetts,” and that a national plan would be different. For example, aides said he did not support a federal version of the Massachusetts requirement that individuals obtain insurance.

Mr. Romney’s rivals are casting themselves as equally committed to improving the health care system, but even more determined to use free-market principles to do so, which they hope will prove them more attuned to the Republican base. Mr. Giuliani plans to produce a major proposal in the next month, aides say, that will elaborate on his commitment to “affordable and portable free-market solutions.”

Mr. Giuliani says he wants to give individuals more control over, and responsibility for, health insurance, encouraging them to buy their own coverage on the private market and giving them “a very big tax deduction” to do it. Right now, most Americans under 65 get their coverage through their employers, who have the benefit of significant tax advantages, pooled risk and group rates.

Mr. Giuliani’s approach echoes President Bush’s call for an “ownership society,” which was popular with economic conservatives but widely criticized as putting too much risk on individuals. “Every one of the Democrats wants government-mandated health insurance,” Mr. Giuliani said recently. “We have to go in exactly the opposite direction.”

Senator John McCain, Republican of Arizona, will also outline a health care plan this summer, aides said. They said it would be intended to make coverage “affordable and available,” using tax credits and the expansion of programs like the State Children’s Health Insurance Program, but would include no new mandates on individuals.

Analysts say the Democrats are clearly drawing lessons from the health care battles of 1993-4, when a similar public groundswell for change collapsed in a matter of months. The 1,342-page Clinton plan at that time was bewilderingly bureaucratic and easy for opponents to characterize as something that would actually worsen the status quo for many insured Americans.

This year, the major Democratic proposals — including Mr. Obama’s, one from former Senator John Edwards of North Carolina and a plan expected from Mrs. Clinton — are arguably ambitious and costly, but do not try the wholesale reinvention of the system, or move explicitly toward the government takeover Republicans so often predict.

“There’s not a lot of untested political ideas out there,” said Robert Blendon, a professor in health policy at Harvard.

The major Democratic plans announced so far try to cover nearly everyone by shoring up the employer-based system, creating new public insurance options and establishing new health insurance purchasing pools that offer a variety of private and public plans to people who cannot get coverage through work. People who could not afford coverage would get subsidies. Given those supports, some Democrats (including Mr. Edwards and — it is widely expected but not yet announced — Mrs. Clinton) back the idea of requiring every individual to obtain insurance.

Mr. Edwards and Mr. Obama call for financing their plans with revenue from ending the Bush tax cuts for the wealthiest Americans; those cuts are set to expire in 2010.

Diane Rowland, executive vice president of Kaiser, said candidates were responding not only to recent failures, but also to recent successes, notably in Massachusetts and potentially California.

“To get something enacted, you need a lot of people who think they will gain from it,” Ms. Rowland said. “It’s a new way of talking about health reform, because it shows people with health insurance what they could gain. These proposals are not just about the haves versus the have-nots.”

Few have taken that advice more to heart than Mrs. Clinton, who is rolling out her proposals to control costs and improve quality before her ideas for covering the uninsured, which are expected in the next few months. She recently, for example, proposed a “Best Practices Institute” to assess the most effective treatments and procedures.

Another hallmark of this year’s plans, in both parties, is a reliance on better health information technology and disease management to hold down costs — not the more rigorous regulatory structures proposed in 1994, which critics asserted would soon lead to rationing.

By the time Election Day rolls around, polls indicate that the issue will be front and center, setting the stage for another great battle to overhaul the system under the next president. Veterans of the Clinton administration say it all feels familiar.

“If the Democrats win, it will be very hard not to take this issue on,” said Mr. Gruber, who is helping to carry out the Massachusetts plan. “It will be as promising as it was in the early 1990s.”

    2008 Candidates Vow to Overhaul U.S. Health Care, NYT, 6.7.2007, http://www.nytimes.com/2007/07/06/us/politics/06health.html?hp

Exec Linked to Va. Tech Shooter Quits

July 5, 2007
By THE ASSOCIATED PRESS
Filed at 10:53 a.m. ET
The New York Times

BLACKSBURG, Va. (AP) -- The executive director of a mental health agency that had a role in treatment for the Virginia Tech student who killed 32 people and himself has quit after a year in the position.

Les Saltzberg resigned from New River Valley Community Services following a board meeting, agency officials confirmed Monday. The board was expected to consider renewing his one-year contract.

Board members said the resignation on Thursday was unrelated to the April 16 killings committed on the Virginia Tech campus by Seung-Hui Cho.

Saltzberg declined to comment.

At a commitment hearing for Cho in December 2005, a special justice determined he was a danger to himself and ordered him to undergo outpatient treatment. The community services board was required by law to recommend a treatment plan for him, but did not do so.

Saltzberg has said the agency did not know treatment had been ordered for Cho because budget constraints had prompted it to stop sending representatives to all commitment hearings. Since the shootings, the agency has resumed sending representatives to hearings.

A previous version of this story contained a headline that said ''Va. Tech mental health director resigns.'' This version clarifies that the director did not work for the university.

    Exec Linked to Va. Tech Shooter Quits, NYT, 5.7.2007, http://www.nytimes.com/aponline/us/AP-Virginia-Tech-Mental-Health.html

Psychiatrists Top List in Drug Maker Gifts

June 27, 2007
The New York Times
By GARDINER HARRIS

WASHINGTON, June 26 — As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty.

How this money may be influencing psychiatrists and other doctors has become one of the most contentious issues in health care. For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved.

Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.

Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.

The number most likely represents a small fraction of drug makers’ total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them.

“For the fourth year in a row, our analysis shows that there is a great deal of money being spent in our small state on marketing pharmaceutical products,” said William H. Sorrell, the Vermont attorney general.

Endocrinologists received the second largest amount, according to the Vermont analysis, earning an average of $33,730. Since the state identified the specialties of only the top 100 earners, these averages represent the money earned by only some of the state’s specialists. There were 11 psychiatrists and 5 endocrinologists in that top group of 100.

Still, a similar pattern was evident in a Minnesota database that was the subject of a series of articles in The New York Times this year. As in Vermont, psychiatrists earned on aggregate the most in Minnesota, with payments ranging from $51 to $689,000. The Times found that psychiatrists who took the most money from makers of antipsychotic drugs tended to prescribe the drugs to children the most often.

These and other stories have helped to fuel a growing interest among state and federal officials to document and restrict payments to doctors from drug makers. At a gathering last month at Columbia Law School in New York, state attorneys general from across the country discussed ways to get similar data for their states.

And today, the Senate Special Committee on Aging, which is led by Senator Herb Kohl, Democrat of Wisconsin, will hold the first of a series of hearings on the issue, which could lead to legislative proposals to restrict and require disclosure of payments and gifts to doctors from drug companies nationwide.

Several lawmakers on Capitol Hill have expressed interest in such legislation, including Senator Charles E. Grassley, Republican of Iowa. “A federal law requiring public disclosure of payments to doctors could be very effective if it was carefully monitored and consistently applied,” Mr. Grassley said.

Efforts to require disclosure of payments to doctors began almost by happenstance in 1993, when The Minnesota Legislature passed a law that restricts drug companies from giving doctors gifts valued at more than $100 in any given year. The legislation also required companies to report and make public any consulting fees paid to doctors.

Lee Greenfield, a former state representative in Minnesota and one of the law’s authors, said it passed with little fanfare or debate after legislators heard stories about doctors accepting gifts of great value from drug makers.

“Why do we want them bribing doctors to use what may not be the best or most cost-effective drug for the patient purely to get some hand-held TV, we all asked,” Mr. Greenfield said.

Still, compliance with the law has been spotty. Some companies never responded to the board’s requests for disclosures. Others did so fitfully. A few sent letters saying they did not collect that information and thus could not provide it.

Minnesota officials never cracked down. Such reports were put in file drawers and largely forgotten until this past year, said Cody Wiberg, executive director of the Minnesota Board of Pharmacy. Mr. Wiberg said he planned this year to pursue companies that fail to report.

Besides Vermont and Maine, more than a dozen other states have or are now considering similar legislation, said Sharon Anglin Treat, executive director of the National Legislative Association on Prescription Drug Prices.

Officials in Maine and Vermont said they would try to compare reports of payments to doctors with Medicaid records to explore how marketing practices might influence prescribing by doctors in ways that increased costs to taxpayers.

“What we want to be able to do is overlay the prescribing information that we have with the drug detailing information,” said Jude Walsh, special assistant to the governor of Maine, John E. Baldacci. “If we see that doctors in a certain southern county in the state are prescribing a lot of a drug and getting a lot of detailing for that drug, that could lead to some record reviews to see what’s happening.”

    Psychiatrists Top List in Drug Maker Gifts, G, 27.6.2007, http://www.nytimes.com/2007/06/27/health/psychology/27doctors.html

Survey Finds 43.6 Million Uninsured in U.S.

June 26, 2007
The New York Times
By REUTERS

WASHINGTON, June 25 (Reuters) — About 43.6 million people in the United States, or 14.8 percent of the population, had no health insurance in 2006, according to a survey by the Centers for Disease Control and Prevention released Monday.

The finding, based on a survey of 100,000 people, is lower than previous federal estimates of 46 million.

The estimate is based on those who did not have insurance at the time of the interview. About 54.5 million people in the country, or 18.6 percent of the population, had no insurance for at least part of 2006.

The survey, by the National Center for Health Statistics, found that about 9.3 percent of children under 18 did not have health insurance, a decrease from 13.9 percent in 1997.

Texas had the largest percentage of people without health insurance, with 23.8 percent of the population not covered, the report said. Michigan had the lowest, at 7.7 percent.

    Survey Finds 43.6 Million Uninsured in U.S., NYT, 26.6.2007, http://www.nytimes.com/2007/06/26/washington/26insure.html

Bush Vetoes Measure on Stem Cell Research

June 21, 2007
The New York Times
By SHERYL GAY STOLBERG

WASHINGTON, June 20 — President Bush on Wednesday issued his second veto of a measure lifting his restrictions on human embryonic stem cell experiments. The move effectively pushed the contentious scientific and ethical debate surrounding the research into the 2008 presidential campaign.

“Destroying human life in the hopes of saving human life is not ethical,” Mr. Bush said in a brief ceremony in the East Room of the White House. He called the United States “a nation founded on the principle that all human life is sacred.”

At the same time, Mr. Bush issued an executive order intended to encourage scientists to pursue other forms of stem cell research that he does not deem unethical. But that research is already going on, and the plan provides no new money.

Advocates for embryonic stem cell research called the new plan a ploy to distract from Mr. Bush’s opposition to the studies.

“I think the president has issued a political fig leaf,” said Sean Tipton, spokesman for the Coalition for the Advancement of Medical Research, an advocacy group. “He knows he’s on the wrong side of the American public.”

The veto, only the third of Mr. Bush’s presidency, puts him at odds not only with the majority of voters, according to polls, but also with many members of his own political party. Republicans sent him a similar measure last year when they controlled Congress. But even with considerable support from the Republican minority this year, Democrats concede they do not have enough votes for a veto override.

That means decisions about federal financing for the experiments are likely to fall into the hands of the next occupant of the White House. Even before Mr. Bush could put his veto pen to the bill, two leading contenders for the Democratic presidential nomination in 2008 — Senators Hillary Rodham Clinton of New York and Barack Obama of Illinois — were weighing in.

Mrs. Clinton, speaking at a conference in Washington, vowed to “lift the ban on stem cell research” if elected. Mr. Obama issued a statement saying Americans deserved a president who “will make this promise real for the American people.”

Though Democrats appear united in support of the stem cell studies, the issue divides the Republican contenders. Senator John McCain of Arizona and Rudolph W. Giuliani, the former mayor of New York, are generally supportive. But Mitt Romney, who supported federal financing for the research while governor of Massachusetts, now opposes it, saying he turned against it when he learned the details. The questions are personal for him because his wife, Ann, has multiple sclerosis, which doctors hope could be treated more effectively with the benefit of the research.

Embryonic stem cells are of great interest to scientists because they have the potential to give rise to any type of cell or tissue in the body, and might therefore be used to treat disease. But religious conservatives and abortion opponents oppose the studies because they destroy human embryos.

The opponents make up an important part of Mr. Bush’s political base, and they praised his veto.

“President Bush was forceful in his defense of the tiniest human beings at the beginning of his administration,” said Marjorie Dannenfelser, president of the Susan B. Anthony List, which represents women who oppose abortion. “He is equally forceful now.”

In August 2001, Mr. Bush announced the current rules: tax dollars could be used to study colonies, called lines, of embryonic stem cells, if the embryos themselves had already been destroyed. The bill he vetoed Wednesday would have allowed research on fresh lines drawn from surplus embryos destined to be destroyed by fertility clinics.

Advocates for the research say they have not given up trying to turn the vetoed measure into law. They are now considering trying to attach the bill to legislation Mr. Bush would be reluctant to reject, like an appropriations bill for the National Institutes of Health. And Representative Rahm Emanuel of Illinois, chairman of the House Democratic Caucus, said Democrats might well hold an override vote, if only to redraw attention to Mr. Bush’s opposition to the studies.

“He’s put America in his own political straitjacket on this research,” Mr. Emanuel said.

But proponents are also clearly looking to 2008.

“Beyond trying to do this in a must-pass, must-sign type piece of legislation,” said Representative Michael N. Castle of Delaware, lead Republican sponsor of the bill, “we’re going to have to wait either for a change of mind at the White House, which seems unlikely unless there are some major medical breakthroughs, or the next president.”

    Bush Vetoes Measure on Stem Cell Research, NYT, 21.6.2007, http://www.nytimes.com/2007/06/21/washington/21stem.html

U.S. Circumcision Rate Drops

June 18, 2007
By THE ASSOCIATED PRESS
Filed at 2:43 p.m. ET
The New York Times

SAN FRANCISCO (AP) -- On the eighth day of her son's life, Julia Query welcomed friends and family to celebrate his birth and honor their Jewish heritage.

But there was no crying, no scalpel, no blood, no ''mohel'' -- the person who traditionally performs ritual circumcisions in the Jewish faith. In fact, Elijah Rose's ''bris'' differed markedly from the ceremony long used to initiate Jewish boys into a covenant with God: There was no circumcision.

''I knew before I was even pregnant that I would not circumcise,'' said Query, 39, a San Francisco filmmaker whose son was born in 2002. ''It's not like you're just cutting a piece of paper off a pad -- there's no `cut here' line. It's not made to be cut off, and I would never, ever do that to my baby.''

Query is among a growing number of American parents refusing circumcision, in which the foreskin is removed from the penis.

According to a study by the National Health and Social Life Survey, the U.S. circumcision rate peaked at nearly 90 percent in the early 1960s but began dropping in the '70s. By 2004, the most recent year for which government figures are available, about 57 percent of all male newborns delivered in hospitals were circumcised. In some states, the rate is well below 50 percent.

Experts say immigration patterns play the biggest role in the decline, which is steepest in Western states with big populations from Asian and Latin American countries where circumcision is uncommon. The trend has also accompanied a change in Americans' attitudes toward medicine and their bodies.

''The rates of drug-free labor and breast-feeding all rose during the 1980s, while the initial declines in male circumcision rates began during the 1980s as well,'' said Katharine Barrett, an anthropology lecturer at Stanford University. ''It may have been part and parcel of the wider effort to reclaim bodies -- adult female and infant male -- from unnecessary and potentially harmful medical interventions.''

Circumcision remains the nation's most common surgery, and the United States is still one of the few developed countries where a majority of baby boys are circumcised. But circumcision is a heated issue and the subject of vehemently pro and anti Web sites.

''We were all circumcised when I was born,'' said R. Louis Schultz, a 79-year-old New Yorker and author of ''Out in the Open: The Complete Male Pelvis.'' ''People thought it could ward off masturbation or disease, and those funny attitudes have really changed. Now people are saying, `Why do it?'''

Many doctors still recommend circumcision because of some evidence that it reduces the risk of penile cancer, urinary tract infections, HIV and perhaps other sexual transmitted diseases. Many major insurance companies still cover it, and many hospitals offer it free for newborns.

But circumcision opponents say the medical benefits are dubious. Penile cancer, for example, is extremely rare. Since 1999, the American Academy of Pediatrics has not endorsed routine circumcision.

The debate escalated in February, when studies found that heterosexual men in Africa who were circumcised had HIV infection rates up to 60 percent lower than uncircumcised men. Because of those studies, the American Academy of Pediatrics is taking another look at its policy.

About one in three males worldwide is circumcised. In the United States, the rates vary widely by region.

It is most prevalent in the upper Midwest. In 2004, according to data compiled by the federal Agency for Healthcare Research and Quality, more than 79 percent of newborn boys in the Midwest were circumcised before leaving the hospital. Michigan and Kentucky had the highest rates, at 85 percent.

In the fast-growing West, the rate declined dramatically -- from 64 percent in 1979 to just under 32 percent in 2004.

In California, the rate of hospital circumcisions among newborns was 21 percent. California -- which has more immigrants than any other state -- had the lowest circumcision rate in the study, which had comprehensive data on only 27 states.

The decline coincides with rising immigration from Asia and Latin America.

''If you have a solid Victorian, American background, routine circumcision is not unusual,'' said Carol A. Miller, clinical professor of pediatrics at University of California at San Francisco.

Circumcision was uncommon in 35-year-old Usha Toland's family, which has roots in India, Sri Lanka and Malaysia. When her son, Reynick, was born in 2005 in San Francisco, her husband, Chris, a white man from Southern California, assumed his son would be circumcised. But after the couple read Web sites and medical literature, they decided against the surgery.

''Usha probably would have understood if I really wanted to have Reynick circumcised,'' said Chris, a 42-year-old advertising executive. ''But ultimately I didn't want to bring pain to the child unnecessarily. We wanted to do things the way God or the universe meant them to be.''

Many parents fear their boys would feel awkward in the locker room if they were not circumcised.

''I like the idea of him looking like his dad -- that's the most important thing for me,'' said Denise Milito Stockwell, 40, an artist in Chicago who had her 15-month-old son, Harlan, circumcised. ''It wasn't traumatic for him in any way. He came back from the event sleeping.''

Circumcision is still common in many Jewish and Muslim communities.

Ruth Katz, 38, of San Francisco had both her sons circumcised at brises. She and her husband, Michael Rapaport, were astonished when the teacher in their birthing class described circumcision as ''immoral'' and ''not consensual.''

''The edict to have your son circumcised was the first covenant with God -- the first challenge to being Jewish,'' said Katz, pursuing a master's degree in business administration. ''I am a progressive person and think a lot about human rights issues, but I have never questioned this.''

    U.S. Circumcision Rate Drops, NYT, 18.6.2007, http://www.nytimes.com/aponline/us/AP-Circumcision-Decline.html

Editorial

Two Cheers on Global AIDS

June 18, 2007
The New York Times
 

Now that the Group of 8 industrialized nations has pledged to commit $60 billion to combat AIDS and other diseases around the world in coming years — a substantial sum by any reckoning — Congress and other national legislatures ought to look hard for additional funds to close a looming gap between the funds committed and the needs of desperate patients.

The advanced nations — both the G-8 countries and other donor nations — have greatly increased their funding for AIDS programs in recent years in belated recognition that the epidemic threatens to destroy not just its victims, but also the social and economic fabric of many countries in sub-Saharan Africa. We are pleased that President Bush has proposed spending some $30 billion to combat AIDS abroad over a five-year period, from 2009 to 2013, but in truth that represents only a modest increase from the spending trajectory we were already on. At its recent summit meeting, the Group of 8 pledged to commit $60 billion to fight AIDS, tuberculosis and malaria “over the coming years,” including the American contribution.

Yet even these pledges will not be enough to keep up with the devastating epidemics. Tens of billions of dollars more will be needed to provide treatment, care and preventive services for AIDS alone over the next five years.

Although the Group of 8 pledges are welcome, they actually represent a retreat from previous goals. In 2005, at its meeting in Gleneagles, Scotland, the group pledged to provide “as close as possible to universal access to treatment” for all people suffering from AIDS by 2010. That should mean at least 10 million people in treatment by then, judging from estimates by United Nations AIDS experts. Yet at the recent meeting, the G-8 said it was aiming to treat only some five million patients in Africa by an unspecified date. That sounds like consigning millions of untreated people to death and disability.

To its credit, the United States has been by far the largest AIDS donor in recent years, providing almost half of the funding commitments made by donor governments. But when measured against the size of the national economy, the American donations rank only fifth. There is room to do more.

As Congress wrestles with the fiscal 2008 appropriations bills this year, it ought to provide the full $1.3 billion being sought by Congressional health advocates as the American contribution to a global fund to combat the three diseases — not just $300 million as proposed by the administration or the $850 million approved by the House Appropriations Committee. Congress should also set the nation — and by its example, the world — on course toward universal access to AIDS treatment by 2010.

    Two Cheers on Global AIDS, NYT, 18.6.2007, http://www.nytimes.com/2007/06/18/opinion/18mon1.html

Autism Debate Strains a Family and Its Charity

June 18, 2007
The New York Times
By JANE GROSS and STEPHANIE STROM

A year after their grandson Christian received a diagnosis of autism in 2004, Bob Wright, then chairman of NBC/Universal, and his wife, Suzanne, founded Autism Speaks, a mega-charity dedicated to curing the dreaded neurological disorder that affects one of every 150 children in America today.

The Wrights’ venture was also an effort to end the internecine warfare in the world of autism — where some are convinced that the disorder is genetic and best treated with intensive therapy, and others blame preservatives in vaccinations and swear by supplements and diet to cleanse the body of heavy metals.

With its high-powered board, world-class scientific advisers and celebrity fund-raisers like Jerry Seinfeld and Paul Simon, the charity was a powerful voice, especially in Washington. It also made strides toward its goal of unity by merging with three existing autism organizations and raising millions of dollars for research into all potential causes and treatments. The Wrights call it the “big tent” approach.

But now the fissures in the autism community have made their way into the Wright family, where father and daughter are not speaking after a public battle over themes familiar to thousands of families with autistic children.

The Wrights’ daughter, Katie, the mother of Christian, says her parents have not given enough support to the people who believe, as she does, that the environment — specifically a synthetic mercury preservative in vaccines — is to blame. No major scientific studies have linked pediatric vaccination and autism, but many parents and their advocates persist, and a federal “vaccine court” is now reviewing nearly 4,000 such claims.

The Wright feud has played out in cyberspace and spilled into Autism Speaks, where those who disagree with Katie Wright’s views worry that she is setting its agenda. And the family intent on healing a fractured community has instead opened its old wounds and is itself riven.

The rift began in April when Katie put herself squarely on the side of “The Mercurys,” as that faction is known, on Oprah Winfrey, where she described how her talkative toddler turned unresponsive and out-of-control after his vaccines and only improved with unconventional, and untested, remedies.

In a Web interview with David Kirby, author of the controversial book, “Evidence of Harm: Mercury in Vaccines and the Autism Epidemic,” Ms. Wright lashed out at the “old guard” scientists and pioneering autism families. If the old-timers are unable to let go of “failed strategies,” she said, they should “step aside” and let a new generation “have a chance to do something different with this money” that her parents’ charity was dispensing.

Complaints poured in from those who said Ms. Wright’s remarks were denigrating.

So, in early June, Bob and Suzanne Wright repudiated their daughter on the charity’s Web site. “Katie Wright is not a spokesperson” for the organization, the Wrights said in a brusque statement. Her “personal views differ from ours.” The Wrights also apologized to “valued volunteers” who had been disparaged. Told by friends how cold the rebuke sounded, Mrs. Wright belatedly added a line saying, “Katie is our daughter, and we love her very much.”

Ms. Wright called the statement a “character assassination.” She said she had not spoken to her father since. Ms. Wright continues to spend time with her mother, but said they had not discussed the situation.

“I totally respect if her feelings were hurt,” Mrs. Wright said. “But a lot of feelings were hurt. A lot.”

Now other autism families who hoped to put their differences aside are shouting at each other in cyberspace. “Our struggle is not and should not be against each other,” said Ilene Lainer, the mother of an autistic child and the executive director of the New York Center for Autism.

The big tent approach of Autism Speaks appealed to Mel Karmazin, chief executive of Sirius Radio and an early board member and contributor. “If you look at what projects Autism Speaks has funded, we are agnostic,” he said.

Mr. Karmazin, who also has an autistic grandson, added, “I never wanted to look my grandson in the eye and tell him I’m taking just one viewpoint or that I think it had to be genetic.”

Bob and Suzanne Wright are sympathetic to Katie’s plight, having witnessed Christian’s sudden regression and his many physical ailments, mostly gastrointestinal, which afflict many autistic children.

The boy did not respond to behavioral therapies, the Wrights said, leading to their daughter’s desperate search for anything that might help. “When you have that sense of hopelessness, and don’t see results, you do things that other people think is too risky,” Mr. Wright said. “The doctors say, ‘Wait for the science.’ But you don’t have time to wait for the science.”

The Wrights agreed to disagree with most of Katie’s views. But her public attack on other parents crossed a line, Mr. and Mrs. Wright said in separate telephone interviews.

“I know my daughter feels deeply that not enough is being done,” Mr. Wright said. “The larger issue is we want to be helpful to everyone, and to do that we need information, data, facts.”

Some in the traditional scientific community worry that Autism Speaks has let Ms. Wright’s experience shape its agenda. She scoffs at the notion. Her parents, she said in a telephone interview, are “courageous” and “trying very hard,” but have been slow to explore alternative approaches.

“You can say it and say it and say it,” she said. “Show me evidence that they’re actively researching vaccines.”

The Wright family’s fight has captured the attention of the bloggers, who are now questioning everything from its office lease to how it makes grants. The charity rebutted the bloggers’ accusations of improprieties in interviews with The New York Times, which examined its IRS forms and read relevant sections to Gerald A. Rosenberg, former head of the New York State attorney general’s charities bureau. He said nothing he reviewed was untoward.

The most distinctive aspect of Autism Speaks is its alliance with Autism Coalition for Research and Education, an advocacy group; the National Alliance for Autism Research, devoted to scientific research into potential genetic causes, with high standards for peer review; and Cure Autism Now, which has championed unconventional theories and therapies.

Which wing of the merged charity is ascendant? Some establishment scientists and parents now fear it is The Mercurys. They point to Cure Autism Now’s having more seats than the National Alliance does on the board of directors and the growing number of research projects that focus on environmental causes.

At a recent benefit gala, featuring Bill Cosby and Toni Braxton, some in the audience were surprised when Mr. Wright announced that all proceeds would go toward environmental research, which generally includes vaccines.

But a list of current research grants on the Autism Speaks Web site suggests that the Wrights, while walking a fine line, are leaning toward genetic theories.

From 2005 to 2007, the charity sponsored $11.5 million in grants for genetic research (compared with $5.9 million by all its partners between 1997 and 2004). It sponsored $4.4 million in environmental research (down from $6 million granted by the partners in the previous seven years). And many of the environmental studies explore what is known as the double-hit hypothesis: That the genes for autism may be activated in some children by exposure to mercury or other neuro-toxins.

Bob and Suzanne Wright say their two-year immersion into the world of autism has been an eye-opener, especially the heated arguments worthy of the Hatfields and McCoys.

Mrs. Wright is aware that the marriage of the Alliance and Cure Autism Now, for instance, could fall apart over opposing ideologies. “I’m not going to let it,” she said. “The truth will rise to the top.”

She is also aware that the rift in her own family needs repair: On Friday, her daughter posted a message on an autism Web site questioning their “personal denouncement of me.”

Yet Mrs. Wright is confident that “we’ll work our way through this.” Autism, she said “has done enough damage to my family. I’m not letting it do any more.”

    Autism Debate Strains a Family and Its Charity, NYT, 18.6.2007, http://www.nytimes.com/2007/06/18/us/18autism.html?hp

In Health Care, Cost Isn’t Proof of High Quality

June 14, 2007
The New York Times
By REED ABELSON

Stark evidence that high medical payments do not necessarily buy high-quality patient care is presented in a hospital study set for release today.

In a Pennsylvania government survey of the state’s 60 hospitals that perform heart bypass surgery, the best-paid hospital received nearly $100,000, on average, for the operation while the least-paid got less than $20,000. At both, patients had comparable lengths of stay and death rates.

And among the 20 hospitals serving metropolitan Philadelphia, two of the highest paid actually had higher-than-expected death rates, the survey found.

Hospitals say there are numerous reasons for some of the high payments, including the fact that a single very expensive case can push up the averages.

Still, the Pennsylvania findings support a growing national consensus that as consumers, insurers and employers pay more for care, they are not necessarily getting better care. Expensive medicine may, in fact, be poor medicine.

“For most consumers, the fact that there is no connection between quality and cost is one of the dirty secrets of medicine,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that provide health care coverage for workers.

Some Pennsylvania employers said the state’s findings, based on data from 2005, might put more pressure on insurance carriers and hospitals to start demonstrating the value of care. “It now provides us a tool to have a serious dialogue with our carriers,” said Mark Dever, a benefits consultant for Duquesne Light, a regional utility in Pittsburgh.

“We have to question,” he said. “There’s a big difference in price — why?”

The report by the Pennsylvania Health Care Cost Containment Council, a state agency, provides a rare public glimpse of detailed information about hospital payments and patient outcomes. And the seemingly random nature of the payments is striking.

Although federal Medicare payments are largely fixed, they varied somewhat among the Pennsylvania hospitals surveyed. The far greater disparity involved commercial insurers, which must negotiate their rates hospital by hospital.

And the survey found that good care can go unrewarded. One Philadelphia area hospital, Main Line Health’s Lankenau center, which performs a large number of bypass surgeries and has a high success rate, according to the survey, was paid an average of $33,549 by private insurers. That was less than half the nearly $80,000 in average payments received by the other hospitals, with poorer track records.

“It doesn’t make sense,” said Marc P. Volavka, the executive director of the Pennsylvania Health Care Cost Containment Council. “Certain payers are paying an awful lot for poor quality.”

He points to some of the experiments to change how hospitals are paid, like Geisinger Health System in central Pennsylvania, which is trying to demonstrate its commitment to high-quality care by offering a 30-day warranty on its cardiac surgery.

“The current reimbursement paradigm is fundamentally broken,” said Dr. Ronald Paulus, an executive with Geisinger, who says there is no current financial incentive for a hospital to provide the kind of care that leads to better outcomes and lower payments.

Pennsylvania is the first state to make such information, normally closely guarded by the hospitals and the insurers, available to everyone — including patients who may never see their hospital bills or be aware of how their hospitals compare with others in the state.

The council collected the payment data from the insurers and calculated averages of the payments to each hospital. So each hospital’s average includes small numbers of extraordinarily high-cost cases, where patients may have developed complications and had lengthy hospital stays.

As a result, a hospital with a relatively low number of surgeries but a high number of costly cases, could wind up with a high average payment. In the Philadelphia area, for example, Lower Bucks Hospital says its average of nearly $100,000 paid by commercial insurers for a bypass patient was skewed by a single very expensive case. Without that case, its average would be closer to $40,000, the hospital said.

But fully explaining the discrepancies in payments and quality of care is difficult.

In Philadelphia, heart patients have a choice among several academic medical centers. Two, Albert Einstein and Hahnemann University, were paid nearly $80,000, on average, for treating a bypass patient. The hospitals at the University of Pennsylvania and Thomas Jefferson University, whose patients did as well or better, were paid much less.

Both Albert Einstein and Hahnemann disputed the survey’s findings, saying payments they receive are lower than the state is reporting.

Hahnemann says its calculations show the average to be significantly lower — $23, 420 — rather than the $78,312 reported in the survey.

The council conceded that the pool of Hahnemann patients it used for its calculations was different from the patients the hospital might count. The council defended its conclusions, saying it used the same methodology for all the hospitals surveyed.

As for the quality measures, Hahnemann says its higher-than-expected mortality rates might reflect the hospital’s own poor record-keeping, which it says did not give the state an accurate picture of how sick some of its patients were before their surgeries. As eye-opening as the Pennsylvania report may be to the public, insurers have already been aware that their payment practices do not necessarily encourage hospitals to provide better care. Medicare, for example, pays essentially a flat fee, which varies depending on location and type of hospital, for the same surgery, regardless of outcome. Complications tend to simply mean additional payments. And many insurers follow the government’s lead.

And so hospitals are rewarded for providing more care, not better care.

“The Medicare program pays for services,” said Leslie Norwalk, the acting administrator for the federal program, who says hospitals are reimbursed even if the care they are providing is a result of a mistake or avoidable hospital infection.

Independence Blue Cross, which is Philadelphia’s largest private insurer, says the difficulty lies in finding the right measures to use to pay for quality care.

“Philosophically, you’re not going to get an argument from us,” said Dr. Richard Snyder, a senior executive at Independence. “We believe we should pay more for high quality than poor quality.”

He says hospitals that are poor performers do risk being excluded from its network, as happened in one case with a hospital — which he would not identify — that was not allowed to deliver cardiac care to the plan’s members for a year until the hospital improved its performance.

    In Health Care, Cost Isn’t Proof of High Quality, NYT, 14.6.2007, http://www.nytimes.com/2007/06/14/health/14insure.html?hp

South lags in report card on health care

13.6.2007
USA Today
By Julie Appleby

Where you live may help determine how long you live, with residents of the lowest-ranking five states dying prematurely at a rate twice that of those in the top-ranked five.

The rate of premature death in Minnesota, Utah, Vermont, Wyoming and Alaska is half of that of the lowest-performing states, South Carolina, Tennessee, Arkansas, Louisiana and Mississippi. Premature death is defined as dying before age 75 from conditions that could be delayed or prevented by appropriate medical care.

That kind of tremendous variation among states cuts across more than just premature death, says The Commonwealth Fund in a report out today that details 32 measures of cost, insurance coverage and medical quality, ranking states by how well they perform on each of the measures.

"Where you live matters for getting care when you need it, getting the right care and the opportunity to live a long and healthy life," says Cathy Schoen, a senior vice president at the fund and one of the report's co-authors. The New York-based Commonwealth Fund is a private foundation that studies health issues.

The report, "Aiming Higher: Results from a State Scorecard on Health System Performance," is one of the first to compile in one place a broad array of measures for each state. It comes amid a growing focus on efforts to rate and report on medical quality, from hospital death and infection rates tracked by Medicare to efforts by insurers to measure the performance of doctors and hospitals.

Using data mainly gleaned from government agencies, such as Medicare, the Census Bureau and the Centers for Disease Control and Prevention, the report concludes that all states could do better. But even lower-ranking states do some things right.

Across all measures, the top-performing five states are Hawaii, Iowa, New Hampshire, Vermont and Maine. The lowest-performing states were Kentucky, Louisiana, Nevada, Arkansas, Texas, with Mississippi and Oklahoma tying for last place.

Most of the findings have been reported separately in other places, but Schoen says she hopes that compiling the data into one report, which is available online at www.commonwealthfund.org, will spur states to take action. The Commonwealth Fund backs efforts to cover more residents with insurance.

"One purpose of the state scorecard is to stimulate discussion and action," Schoen says. Part of that discussion, she says, needs to revolve around expanding insurance. "The country needs to take a big step forward on health insurance: start insuring the entire population."

Possibly controversial but still useful

Efforts to measure and compare quality can be controversial. Medical providers often question whether the data were adjusted properly to account for variations in age or sickness or whether the items measured are an accurate reflection of performance.

The Commonwealth Fund report will likely garner the same kind of concern, but observers say that the report will prove useful.

"It's part of the entire movement toward measurement," says Hoangmai Pham, senior health researcher at the Center for Studying Health System Change, a non-partisan think tank in Washington. "It's an important first step. What happens from here on out is really hard work."

The highest-ranked states, the report says, often have policies designed to improve access to health insurance.

Hawaii, for example, gets top marks due, in large part, to a 1974 law requiring employers to offer health insurance to employees who work more than 20 hours a week, the report concludes. Eighty-seven percent of adults in the state are insured, as are 94.7% of children, according to the report.

States that generally had more people covered by health insurance also tended to score higher on quality measures, the report says.

On the other end, Mississippi and Oklahoma — which tied for last place in the overall ranking of 50 states — generally have high levels of uninsured and restrictive limits on who is eligible for state-sponsored care through Medicaid, the report says.

"The report does provide an opportunity for states to look at where they rank as compared to others and take it as a challenge to improve," says Mike Crutcher, Oklahoma's commissioner of health. Some things, he says, need a national solution.

Pham says she is cautious about drawing conclusions from the report about what causes the states to vary so much.

"It raises a lot of questions about the underlying causes and those questions are not easy to answer," she says. "It is difficult to draw any one conclusion about what one state did that affected its performance."

Diane Rowland of the Kaiser Family Foundation says that having insurance has clearly been demonstrated as better than not having insurance. But she, too, says that it is just one variable in overall health of residents.

"We also know that quality of people's health is dependent on the environment, whether they live in an area with clean or dirty air, for example," Rowland says.

Many ways to assess performance

Insurance coverage rates are just one measure of performance of a state, and the report includes many others, such as how many Medicare patients are readmitted to a hospital within 30 days of discharge, infant mortality rates, the percentage of children who receive recommended vaccinations and how much it costs to buy health insurance.

"This does as good a job as any report I've seen in bringing in a range of both acute and preventative measures in trying to assess the performance of the health services system for the state," says Christopher Atchison, associate dean of the College of Public Health at the University of Iowa.

Iowa scored high, he suspects, for a variety of reasons, including efforts by hospitals and doctors in the state to work together to promote quality efforts. He also says most residents are within 25 miles of a hospital and that the state is fairly homogenous. It also has a high percentage of residents who have health insurance coverage.

The Iowa health care Collaborative, a partnership between the state's hospital association and the state's physicians' association, works together to promote quality guidelines, improve safety and publish data on how well doctors and hospitals are doing in meeting quality goals.

"When we look at these numbers in the Commonwealth report, we think it's great, but you ain't seen nothing yet," says Tom Evans, president of the collaborative. "We're proud of where we are and excited about the future."

What do you think of your state's ranking? Do you buy into the rankings enough to consider moving?

    South lags in report card on health care, UT, 13.6.2007, http://www.usatoday.com/money/industries/health/2007-06-13-health-states-usat_N.htm

House Passes Stem Cell Bill Despite Bush Veto Threat

June 7, 2007
The New York Times
By JEFF ZELENY

WASHINGTON, June 7 — The House gave final Congressional approval today to legislation intended to ease restrictions on federal financing of embryonic stem cell research, sending a bipartisan measure to the White House that President Bush has pledged to veto.

On a vote of 247 to 176, the House overwhelmingly passed the bill, with Republicans and Democrats forging a coalition to authorize federal support for research using stem cells derived from spare embryos that fertility clinics would otherwise discard. The Senate approved the legislation in April.

“Science is a gift of God to all of us and science has take us to a place that is biblical in its power to cure,” said Speaker Nancy Pelosi, Democrat of California. “And that is the embryonic stem cell research.”

The president has repeatedly vowed to veto the bill, following through on the first veto of his presidency when he rejected a similar stem cell proposal last year, which was passed by the Republican-controlled Congress. Democrats were not certain whether they had the votes to override a veto.

“I am disappointed the leadership of Congress recycled an old bill that would simply overturn our country’s carefully balanced policy on embryonic stem cell research,” Mr. Bush said in a statement. “If this bill were to become law, American taxpayers would for the first time in our history be compelled to support the deliberate destruction of human embryos. Crossing that line would be a grave mistake.”

Critics of the legislation said taxpayer dollars should not be used to increase spending on embryonic stem cell research, particularly in the wake of a new scientific advance reported Wednesday in which biologists believe they can use skin to generate new heart, liver or kidney cells. Such a technique, if proven successful, could sidestep the ethical debates surrounding stem cell research.

Throughout the Congressional debate, several Republicans who oppose the legislation seized upon reports of the new scientific advance.

“How many more advancements in noncontroversial, ethical, adult stem cell research will it take before Congress decides to catch up with science?” said Representative Joseph Pitts, a Pennsylvania Republican, holding up a front-page newspaper account of the scientific discovery. “These have all of the potential and none of the controversy.”

While those who support increasing the federal financing of embryonic stem cell research also hailed the development, they said such advances should not replace expanding research to press for a litany of diseases, including Alzheimer’s and juvenile diabetes.

“We welcome these advances as we welcome all advances in ethical life-saving research,” said Representative Diana L. DeGette, a Colorado Democrat and leading sponsor of the legislation. “However, this new scientific research should not be used as an excuse to say that it is a substitute for embryonic stem cell research.”

While Democrats urged the president to change his mind and sign the legislation into law, they said they would try to build support to override the presidential veto. Their campaign began today, only hours after the bill was passed, when Ms. Pelosi and Senator Harry Reid of Nevada, the majority leader, staged a rare public enrollment ceremony to send the legislation to the White House.

The attempt to override the president’s veto would begin in the Senate, where the bill passed April 11 on a vote of 63 to 34. Even counting the three Democrats who were not present for the vote, the legislation fell one vote shy of reaching the plateau to override a veto.

Senator Charles E. Schumer of New York, who leads the Democratic Senatorial Campaign Committee, began circulating a petition today to push for the expansion of the federal financing for the embryonic stem cell research. “Tell President Bush: Stop being stubborn, sign the stem cell bill,” the petition read.

A senior administration official said Mr. Bush, who is traveling in Europe, was not expected to veto the bill until his return to Washington next week.

Representative John A. Boehner of Ohio, the Republican leader, said Democrats who pushed the legislation were simply trying to turn the stem cell debate into a political opportunity.

“This is politics. This is not about expanding research,” Mr. Boehner said today. “They understand clearly that the president has vetoed this bill in the past and will veto it again. This is Washington being Washington, trying to score a political points, one party opposed to another.”

    House Passes Stem Cell Bill Despite Bush Veto Threat, NYT, 7.6.2007, http://www.nytimes.com/2007/06/07/washington/07cnd-stem.html?hp

Democrats Push Veto Fight on Stem Cells

June 7, 2007
By THE ASSOCIATED PRESS
Filed at 7:57 a.m. ET
The New York Times

WASHINGTON (AP) -- Congressional Democrats are spoiling for their second veto fight of the spring with President Bush, this one centered on embryonic stem cell research and its disease-fighting potential.

House supporters of legislation to loosen restrictions on the use of federal funds for the high-tech research claim more than enough votes to send the measure to the White House on Thursday.

Less clear is whether they also will have the votes to override the veto the president has pledged. Bush made his position clear weeks ago when he said the legislation, which involves the destruction of human embryos, ''crosses a moral line that I and many others find troubling.''

Public polls show strong support for the research, which supporters say could lead to treatment of diseases including Alzheimer's and juvenile diabetes. Democratic congressional leaders arranged to dispatch the measure to the White House with a flourish.

Democratic aides said House Speaker Nancy Pelosi and Senate Majority Leader Harry Reid intended to stage a ceremony to dramatize the passage of the bill.

They held a similar event earlier in the year when Congress approved legislation containing a troop withdrawal timetable for the Iraq war.

Bush vetoed that bill on May 1, and as expected, the House failed to override his veto.

Democrats made the legislation a top priority when they took control of the House and Senate in January.

The House approved an initial stem cell measure within days of convening on a 253-174 vote that was short of a veto-proof majority. The Senate passed a slightly different measure in April, 63-34. The House needed to vote on the bill again to send it to the president.

There was no federal money for embryonic stem cell research until Bush announced on Aug. 9, 2001, that his administration would make it available for lines of stem cells that were in existence. Elected with the strong support of abortion foes and other conservatives, he said at the time his decision was designed to balance concerns about ''protecting life and improving life.''

He also limited the funds to cell lines derived from embryos that were surplus at fertility clinics, and that had been donated from adults who had given informed consent.

Advocates of the veto-threatened legislation argue that the number of stem cell lines available for research is smaller than needed, and that some of the material has become contaminated over time by mouse embryonic skin cells that typically are placed at the bottom of culture dishes used in the research.

The bill would permit funding for research on embryonic stem cells regardless of the date of their creation, as long as they were donated from in-vitro fertilization clinics, they would ''otherwise be discarded'' and donors gave their approval.

Separately, three teams of researchers reported Wednesday they had found a way to produce embryonic stem cells without destroying embryos -- but in mice. They got ordinary skin cells to act like the embryonic cells, which can develop into all types of tissue.

In a prelude to the stem cell vote in Congress, House Republicans engineered the defeat of legislation to ban human reproductive cloning. The 213-204 vote against the measure was well short of the two-thirds majority needed for passage.

Critics said it would facilitate the creation of cloned human embryos to be used in research and then destroyed.

    Democrats Push Veto Fight on Stem Cells, NYT, 7.6.2007, http://www.nytimes.com/aponline/us/AP-Stem-Cells.html

Scientists Move Closer to Turning Skin Cells Into Tissues

June 6, 2007
The New York Times
By NICHOLAS WADE

In a surprising advance that sidesteps the ethical debates surrounding stem cell biology, researchers have come much closer to a major goal of regenerative medicine, the conversion of a patient’s cells into specialized tissues that might replace those lost to disease.

The advance is an easy-to-use technique for reprogramming a skin cell of a mouse back to the embryonic state. Embryonic cells can be induced in the laboratory to develop into many of the body’s major tissues.

If the technique can be adapted to human cells, it would let scientists use a patient’s skin cell to generate new heart, liver or kidney cells that might be transplantable and would not be rejected by the patient’s immune system.

Previously, the only way scientists knew they were likely to get such cells is by nuclear transfer, the insertion of an adult cell’s nucleus into an egg whose own nucleus has been removed. The egg somehow reprograms the nucleus back to embryonic state.

The new technique, developed by Shinya Yamanaka of Kyoto University, depends on inserting just four genes into a skin cell. These accomplish the same reprogramming task as the egg, or at least one very similar.

The technique is much easier to apply than nuclear transfer, does not involve the expensive and controversial use of human eggs, and should avoid all or almost all of the ethical criticism directed at the use of embryonic stem cells.

“From the point of view of moving biomedicine and regenerative medicine faster, this is about as big a deal as you could imagine,” said Irving Weissman, a leading stem cell biologist at Stanford University.

David Scadden, a stem cell biologist at the Harvard Medical School, said the finding that cells could be reprogrammed with simple biochemical techniques “is truly extraordinary and frankly something most assumed would take a decade to work out.”

The new technique seems likely to be welcomed by many who have opposed human embryonic stem cell research. It “raises no serious moral problem, because it creates embryonic-like stem cells without creating, harming or destroying human lives at any stage,” said Richard Doerflinger, a spokesman on stem cell issues for the United States Conference of Catholic Bishops. In themselves, embryonic stem cells “have no moral status,” and the bishops’ objections to embryonic stem cell research rest solely on the fact that human embryos must be harmed or destroyed to obtain them, he said.

Ronald Green, an ethicist at Dartmouth College, said it would be “very hard for people to say that what is created here is a nascent form of human life that should be protected.” The new technique, if adaptable to human cells, “will be one way this debate could end,” he said.

Ever since the creation of Dolly, the first cloned mammal, scientists have sought to lay hands on the mysterious chemicals with which an egg will reprogram a mature cell nucleus injected into it and set the cell on the same path of embryonic development as when egg and sperm combine.

Years of patient research have identified many of the genes that are active in the embryonic cell and maintain its pluripotency, or ability to morph into many different tissues. Last year Dr. Yamanaka and his colleague Kazutoshi Takahashi, both at Kyoto University, published a remarkable report relating how they had guessed at 24 genes that seemed responsible for maintaining pluripotency in mouse embryonic stem cells.

When they inserted all 24 genes into mouse skin cells, the cells showed signs of pluripotency. The Kyoto team then subtracted genes one by one until they had a set of four genes that were essential. The genes are inserted into viruses that infect the cell and become active as the virus replicates. The skin cell’s own copies of these genes are repressed since they would interfere with its function. “We were very surprised” that just four genes are sufficient to reprogram the skin cells, Dr. Yamanaka said.

Dr. Yamanaka’s report riveted the attention of biologists elsewhere. Two teams set out to repeat and extend his findings, one led by Rudolf Jaenisch of the Whitehead Institute and the other by Kathrin Plath of the University of California, Los Angeles, and Konrad Hochedlinger of the Massachusetts General Hospital. Dr. Yamanaka, too, set about refining his work.

In articles being published in Nature and a new journal, Cell-Stem Cell, the three teams show that injection of the four genes identified by Dr. Yamanaka can make mouse cells revert to cells that are indistinguishable from embryonic stem cells. Dr. Yamanaka’s report of last year showed that only some properties of embryonic stem cells were attained.

This clear confirmation of Dr. Yamanaka’s recipe is exciting to researchers because it throws open to study the key process of multicellular organisms, that of committing cells to a variety of different roles, even though all carry the same genetic information.

Recent studies have shown that the chromatin, the complex protein material that clads the DNA in chromosomes, is not passive packaging material but highly dynamic. It contains systems of switches that close down large suites of genes but allow others to be active, depending on the role each cell is assigned to perform.

Dr. Yamanaka’s four genes evidently reset the switch settings appropriate for a skin cell to ones that specify an embryonic stem cell. The technique is easy to use and “should revolutionize the field since every small lab can work on reprogramming,” said Alexander Meissner, a co-author of Dr. Jaenisch’s report.

An immediate issue is whether the technique can be reinvented for human cells. One problem is that the mice have to be interbred. Another is that the cells must be infected with the gene-carrying virus, which is not ideal for cells to be used in therapy. A third issue is that two of the genes in the recipe can cause cancer. Indeed 20 percent of Dr. Yamanaka’s mice died of the disease. Nonetheless, several biologists expressed confidence that all these difficulties will be sidestepped somehow.

“The technical problems seem approachable — I don’t see anyone running into a brick wall,” said Owen Witte, a stem cell biologist at the University of California, Los Angeles. In a Web cast about the research, Dr. Jaenisch predicted that the problems of adapting the technique to human cells will be solvable but he did not know when.

If a human version of Dr. Yamanaka’s recipe is developed, one important research use, Dr. Weissman said, will be to reprogram diseased cells from patients so as to study the molecular basis of how their disease develops.

Beyond that is the hope of generating cells for therapy. Researchers have learned how to make embryonic cells in the laboratory develop into neurons, heart muscle cells and other tissues. In principle these might be injected into a patient to replace or supplement the cells of the diseased tissue, without fear of immune rejection. No one really knows if the new cells would succumb to the same disease process, or if they would be well behaved, given that they developed in a laboratory dish without recapitulating the exact succession of environments they would have experienced in the embryo.

Still, repairing the body with its own cells should in principle be a superior form of medicine to the surgeon’s knife and the oncologists’ poisons.

But the first fruit of the new technique will be in figuring out how cells work.

This and other methods will lead to an explosion of information that will “open the door for understanding how cells program and re-program their fate,” Dr. Scadden predicted. If and when applicable to human cells, he said, the four-gene approach “will have profound implications for new biology, regenerative medicine and will change the ethical debate around stem cells.”

    Scientists Move Closer to Turning Skin Cells Into Tissues, NYT, 6.6.2007, http://www.nytimes.com/2007/06/06/science/06cnd-cell.html?hp

Bush Requests $30 Billion to Fight AIDS

May 31, 2007
The New York Times
By SHERYL GAY STOLBERG

WASHINGTON, May 30 — President Bush called Wednesday for Congress to spend $30 billion to fight global AIDS over the next five years, a near doubling of financing that is part of a White House effort to burnish Mr. Bush’s humanitarian credentials before he meets leaders of the Group of 8 industrialized nations next week.

The initiative, if approved, would build on a program that grew out of the president’s 2003 State of the Union address, when he asked for $15 billion over five years for prevention, treatment and care of AIDS patients in developing countries. Congress approved more than $18 billion, but the program is set to expire next year.

Mr. Bush’s announcement, delivered in the White House Rose Garden, adds to what has become an unexpectedly high priority for the White House. AIDS was not a signature issue for Mr. Bush when he ran for office in 2000. But it has become one in part because the Christian conservatives who make up his political base have embraced it, and in part because Mr. Bush wants to build a legacy for the United States and a more compassionate image abroad to counter international criticism of American policies in the wake of the Sept. 11, 2001, attacks.

That sentiment was reflected in Mr. Bush’s remarks on Wednesday.

“Once again, the generosity of the American people is one of the great untold stories of our time,” he said. “Our citizens are offering comfort to millions who suffer, and restoring hope to those who feel forsaken.”

AIDS advocacy organizations praised Mr. Bush for proposing the additional money, but said the plan — which he said would provide drugs for 2.5 million patients — did not go nearly far enough toward meeting the international community’s stated goal of treating the estimated 10 million patients in developing nations.

“It’s a modest increase, it’s important that he reaffirmed it, but we will need the next president to do more,” said Paul Zeitz, executive director of the Global AIDS Alliance, a nonprofit advocacy group. “We’re not getting ahead of the AIDS crisis. We’re tempering it.”

Administration officials concede that point and say the White House is hoping Mr. Bush’s announcement will prod other Group of 8 countries, as well as nations that have growing economies, to make spending commitments of their own.

“The goal of universal access isn’t a United States goal, it’s a global goal,” said Mark R. Dybul, the administration’s global AIDS coordinator. “The rest of the world is going to need to respond if we are going to achieve these goals.”

International development and human rights issues will be high on the agenda of next week’s summit, but so will climate change — an issue on which Mr. Bush finds himself at odds with his fellow Group of 8 leaders, notably the meeting’s host, Chancellor Angela Merkel of Germany. Dan Bartlett, counselor to Mr. Bush, said the president intended to address climate change in a speech on Thursday at the United States Agency for International Development.

But so far this week, Mr. Bush has been devoting most of his attention to human rights and poverty, issues that draw him less criticism than his stance on climate change. In an interview Monday night, a senior administration official said Mr. Bush planned to spend the week in advance of the Group of 8 conference spotlighting humanitarian issues and “demonstrating U.S. leadership around the world.”

On Tuesday, Mr. Bush announced he was imposing stiff economic sanctions on Sudan to press its government into cooperating with a United Nations peacekeeping force that is trying to end the violence in Darfur.

On Wednesday, in addition to the AIDS announcement, Mr. Bush named Robert B. Zoellick, his former trade representative, as his candidate to head the World Bank, calling the nominee “a committed internationalist” who “wants to help struggling nations defeat poverty.” In Thursday’s speech, Mr. Bush also intends to talk about education programs in the developing world, and his initiative to combat malaria.

The AIDS initiative, which is likely to generate bipartisan support in Congress, would cover federal spending for the 2009 to 2013 fiscal years, meaning the vast majority of the money would be spent after Mr. Bush left office. To promote it, the White House is sending Laura Bush to Africa next month.

“She and I share a passion,” Mr. Bush said. “We believe that to whom much is given, much is required.”

The United Nations reports that there are nearly 40 million people worldwide living with H.I.V., the virus that causes AIDS; last year three million died from their infections. In his announcement in 2003, Mr. Bush said he was committed to offering treatment for two million H.I.V. patients by 2008. But so far, he said, the program, called the President’s Emergency Plan for AIDS Relief, has paid for treatment for just 1.1 million people in 15 nations.

Advocates complain that the new goal, bringing the number of patients treated to 2.5 million, is not that much more ambitious than the old one. “By 2013 there will be 12 million people that urgently need medicines,” Mr. Zeitz said.

The White House, however, said that in addition to providing treatment for 2.5 million, the new money would prevent 12 million new infections and provide care for more than 12 million people.

Mr. Bartlett said the president was convinced America’s image in the world would improve because of it.

“I’ve heard him talk about this is a part of America that gets overlooked,” he said, “and that over time, people will look back and say, ‘At a point in time where America may have been under scrutiny for other reasons, look at the significant contribution they have made. They saved more lives than anybody could have imagined.’ ”

    Bush Requests $30 Billion to Fight AIDS, NYT, 31.5.2007, http://www.nytimes.com/2007/05/31/washington/31prexy.html

TB Patient Is Isolated After Taking Two Flights

May 30, 2007
The New York Times
By LAWRENCE K. ALTMAN

Federal and international officials are tracking down passengers and crew members on two trans-Atlantic flights earlier this month who may have been exposed to a man infected with an exceptionally dangerous form of tuberculosis.

The male passenger flew to Paris from his home in Atlanta on May 12 on Air France 385 and arrived in Paris on May 13. He returned to the United States on May 24 after taking Czech Air 104 to Montreal from Prague. The man drove into the United States that day and entered a hospital in New York City on May 25.

The man is now in an Atlanta hospital under federally enforced isolation after he was flown there from New York City on Monday in a plane owned by the Centers for Disease Control and Prevention in Atlanta.

Dr. Martin S. Cetron , an agency official, said he reached the man on his cellphone while he was in Italy to inform him that tests performed before he left for Europe showed that he had a form of tuberculosis that was extremely resistant to standard antibiotics. Dr. Cetron said that he advised the man not to take commercial flights home from Europe and that a United States Embassy would provide assistance, including examination by a tuberculosis expert.

While the agency began to explore ways to bring the man home, he flew to Montreal and drove into the United States. Then, after agency officials made contact with him, he followed their instructions to drive safely into New York without risk to the public.

The New York City health department said the man spent 72 hours in a hospital in isolation and did not interact with anyone other than trained medical workers.

The disease control agency said that because it was the first airline contact investigation for extremely drug resistant tuberculosis, it was not sure that current recommendations were adequate to determine the possible range and risk of transmission on infection.

Dr. Julie L. Gerberding, director of the C.D.C., said her agency was advising passengers on the commercial flights to be tested for tuberculosis even though they are believed to have a low risk of infection.

That appraisal was based on tests showing that the number of tuberculosis bacteria in the man’s sputum were too low to be detected but still enough to infect others. Dr. Gerberding said her agency was erring on the side of caution because the form of tuberculosis, known as XDR TB, was often fatal and a growing public health threat in many countries.

The advisory applies only to the crew members on the man’s flight and to his fellow passengers, particularly those who were seated next to him and in the two rows behind him and the two rows in front of him.

“We’re not concerned about a generic threat to travelers,” Dr. Gerberding said.

Drug-susceptible, or regular, TB and XDR TB are thought to be spread the same way. The TB bacteria become aerosols when a person coughs, sneezes, speaks or sings. The bacteria can float in the air for several hours, depending on the environment. People who breathe air containing these bacteria can become infected.

The risk of acquiring any type of TB appears to depend on several factors, such as the extent of disease in the person who is the source of the bacteria, the duration of exposure and ventilation.

People who become infected have usually been exposed for several hours or days in poorly ventilated or crowded environments. An important way to prevent the spread and transmission is by limiting an infectious person’s contact with other people. People who have a confirmed diagnosis of TB or XDR TB are placed on treatment and kept isolated until they are no longer infectious.

Contact passengers will be advised to undergo a medical evaluation and testing and then have follow-up tests 8 to 10 weeks later.

Dr. Gerberding said doctors had not determined the source of the man’s infection. Molecular fingerprints used to distinguish among bacterial strains so far do not match that of any other known case, she said. People who think they may have been exposed to TB or XDR TB can call (800) CDC-INFO for more information.

    TB Patient Is Isolated After Taking Two Flights, NYT, 30.5.2007, http://www.nytimes.com/2007/05/30/us/30tb.html?hp

Federal Quarantine for TB Traveler

May 30, 2007
By THE ASSOCIATED PRESS
Filed at 7:48 a.m. ET
The New York Times

ATLANTA (AP) -- A man with a form of tuberculosis so dangerous he is under the first U.S. government-ordered quarantine since 1963 told a newspaper he took one trans-Atlantic flight for his wedding and honeymoon and another because he feared for his life.

Health officials have questioned his decision to fly from Atlanta to Paris, and later from Prague to Montreal, citing the possibility that he could expose other passengers. The man told the Atlanta Journal-Constitution that while doctors told him they preferred that he put off his long-planned wedding in Greece, they didn't order him not to fly.

He knew that he had tuberculosis, but didn't think he was a danger, he said.

''We headed off to Greece thinking everything's fine,'' said the man, who declined to be identified in the newspaper because of the stigma attached to his diagnosis.

Dr. Steven Katkowsky, director of the Fulton County Department of Health & Wellness, said the man was told traveling was not advised.

The man flew from Atlanta to Paris on May 12 aboard Air France Flight 385. He returned to North America on May 24 aboard Czech Air Flight 0104 from Prague to Montreal, then drove into the United States at the Champlain, N.Y., border crossing.

The man, whom officials also did not identify, is at Atlanta's Grady Memorial Hospital in respiratory isolation.

He told the newspaper he flew into Canada to avoid U.S. authorities after they told him when he was in Italy to turn himself over to officials there due to the seriousness of the disease. He said he believed he had to return to the U.S. to get the treatment he needed to survive.

Officials at the Centers for Disease Control and Prevention have recommended medical exams for cabin crew members and passengers who sat within two rows of the man.

''This is a bacteria that is really transmitted through the air, and generally to people who are in closed spaces for very long periods of time,'' Dr. Julie Gerberding, director of CDC, told ABC's ''Good Morning America'' on Wednesday.

''So long air flights can pose a risk to some passengers, but short flights, or people who go onto an aircraft after a patient has left, are not at risk,'' she said.

The man told health officials he was not coughing during the flights. Other passengers are not considered at high risk of infection because tests indicated the amount of TB bacteria in him was low, said Dr. Martin Cetron, director of the CDC's division of global migration and quarantine.

CDC officials said the airlines were working with health officials to contact passengers. Those who should be tested will be contacted by health officials from their home countries.

Dr. Howard Njoo of the Public Health Agency of Canada said there appeared to be little chance that the man spread the disease on the flight into Canada. Still, the agency was working with U.S. officials to contact passengers who sat near him.

Air France-KLM has been asked by French health authorities to provide lists of all passengers seated within two rows of the infected man, a spokeswoman said Wednesday.

Daniela Hupakova, a spokeswoman for the Czech airline CSA, said the airline was informed about the man by U.S. officials. The crew of the flight underwent medical checks and all are fine, she said.

The airline was contacting passengers to recommend they undergo testing, and was cooperating with Czech and foreign authorities, she said.

The man told the Journal-Constitution the CDC contacted him in Rome during his honeymoon, telling him that he had to turn himself in to Italian authorities to be isolated and be treated. The CDC told him he couldn't fly aboard commercial airliners.

''I thought to myself: You're nuts. I wasn't going to do that. They told me I had been put on the no-fly list and my passport was flagged,'' the man said.

He told the paper he and his wife decided to sneak back into the U.S. via Canada. When he arrived back in the United States, he voluntarily went to a New York hospital, then was flown by the CDC to Atlanta. He is not facing prosecution, health officials said.

''I'm a very well-educated, successful, intelligent person,'' he told the paper. ''This is insane to me that I have an armed guard outside my door when I've cooperated with everything other than the whole solitary-confinement-in-Italy thing.''

CDC officials told The Associated Press they could not immediately comment on the interview.

The man's wife tested negative for TB before the trip and is not considered a public health risk, health officials said. Health officials said they don't know how the Georgia man was infected.

The quarantine order was the first since the government quarantined a patient with smallpox in 1963, according to the CDC.

Tuberculosis is a disease caused by germs that are spread from person to person through the air. It usually affects the lungs and can lead to symptoms such as chest pain and coughing up blood. It kills nearly 2 million people each year worldwide.

Because of antibiotics and other measures, the TB rate in the United States has been falling for years. Last year, it hit an all-time low of 13,767 cases, or about 4.6 cases per 100,000 Americans.

Health officials worry about ''multidrug-resistant'' TB, which can withstand the mainline antibiotics isoniazid and rifampin. The man was infected with something even worse -- ''extensively drug-resistant'' TB, also called XDR-TB, which resists many drugs used to treat the infection.

There have been 17 U.S. XDR-TB cases since 2000, according to CDC statistics.

The CDC's statement that the patient is at the low end of communicability ''provides some reassurance,'' said Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University.

The highly dangerous form is ''expanding around the world,'' particularly in South Africa, eastern Europe and the former states of the Soviet Union, he said.

Associated Press writers Malcolm Ritter in New York and Rob Gillies in Toronto contributed to this report.

------

On the Net:

Centers for Disease Control and Prevention: http://www.cdc.gov/

Public Health Agency of Canada: http://www.phac-aspc.gc.ca/ 

    Federal Quarantine for TB Traveler, NYT, 30.5.2007, http://www.nytimes.com/aponline/us/AP-Tuberculosis-Infection.html

Obama Offers Universal Health Care Plan

May 29, 2007
By THE ASSOCIATED PRESS
Filed at 12:18 p.m. ET
The New York Times

IOWA CITY, Iowa (AP) -- Democratic presidential candidate Barack Obama on Tuesday offered a sweeping health care plan that would provide every citizen a means for coverage and calls on government, businesses and consumers to share the costs of the program.

Obama said his plan could save the average consumer $2,500 a year and bring health care to all. Campaign aides estimated the cost of the program at $50 billion to $65 billion a year, financed largely by eliminating tax cuts for the wealthy that are scheduled to expire. President Bush wants to make those cuts permanent.

''The time has come for universal, affordable health care in America,'' Obama said in a speech in Iowa City, at the University of Iowa's medical school.

While Obama's plan is aimed at expanding coverage, he said cutting costs was also essential.

''We have reached a point in this country where the rising costs of health care has put too many families and businesses on a collision course with financial ruin and left too many with no coverage at all,'' Obama said. ''This cost crisis is trapping us in a vicious cycle.''

Obama's plan retains the private insurance system but injects additional money to pay for expanding coverage. It would also create a National Health Insurance Exchange to monitor insurance companies in offering the coverage.

Those who can't afford coverage would get a subsidy on a sliding scale depending on their income, and virtually all businesses would have to share in the cost of coverage for their workers. The plan is similar to the one covering members of Congress.

Obama's package would prohibit insurance companies from refusing coverage because of pre-existing conditions.

The plan doesn't have the mandate that rival Democratic candidate John Edwards is proposing to ensure that all Americans get coverage. The 2004 Democratic vice presidential nominee would require everyone to have health insurance, much like state requirements for auto insurance for every driver. Both candidates would require businesses to help cover their workers.

New York Sen. Hillary Rodham Clinton, who oversaw a massive but unsuccessful project to overhaul the nation's health care system while she was first lady, has promised universal health care but has yet to provide specifics.

''My plan begins by covering every American. If you already have health insurance, the only thing that will change for you under this plan is that the amount of money you will spend on premiums will be less,'' Obama said. ''If you are one of 45 million Americans who don't have health insurance, you will after this plan becomes law.''

Obama also called for a series of steps to overhaul the current health care system. He would spend more money boosting technology in the health industry such as electronic record-keeping, put in place better management for chronic diseases and create a reinsurance pool for catastrophic illnesses to take the burden of their costs off of other premium payers.

His plan also envisions savings from ending the expensive care for the uninsured when they get sick. That care now is often provided at emergency rooms. The plan also would put a heavy focus on preventing disease through lifestyle changes.

Obama conceded that the overall cost of the program would be high.

''To help pay for this, we will ask all but the smallest businesses who don't make a meaningful contribution to the health coverage of their workers to do so to support this plan,'' said Obama. ''And we also will repeal the temporary Bush tax cut for the wealthiest taxpayers.''

Unveiling the proposal marks a crucial step for Obama. Serving in his first term as a senator, Obama often is criticized as not having the experience to be a serious candidate for the party's nomination.

Some also see him as offering more style than substance, and he's clearly hoping that spelling out a detailed plan to offer health care for all will deflect those criticisms. Polls also have shown that voters rank health care as among their top concerns.

    Obama Offers Universal Health Care Plan, NYT, 29.5.2007, http://www.nytimes.com/aponline/us/AP-Obama-Health.html

New York Prison Creates Dementia Unit

May 29, 2007
By THE ASSOCIATED PRESS
Filed at 11:57 a.m. ET
The New York Times

FISHKILL, N.Y. (AP) -- In the day room, white-haired men in robes watch ''The Price is Right.'' Out on the balcony, another looks through bars as he fidgets from side to side.

Prisons have been dealing with the special needs of older prisoners for years, but the one here in Fishkill state prison is considered unique because it specializes in dementia-related conditions.

The unit -- 30 beds on the third floor of the prison's medical center -- is a first for New York and possibly the nation, though experts say it likely won't be the last as more people grow old behind bars.

The unit has the clean-white-wall feel of a nursing home -- but for the prison bars. A marker board in the day room includes a picture of a sun with a smiley face and a reminder to ''Have a great day.'' The activity calendar lists puppies on Thursday and bingo on Friday. As long as they behave, patients can wander from their rooms to the day room.

''They're still in prison,'' said Fishkill superintendent William Connolly. ''This is just a unique environment within a prison environment.''

Connolly said the men's crimes are not considered in the screening process, though their prison record matters. The idea is to provide proper care and a safe environment.

''A lot of guys, when they were confined to the general population, they stayed in their rooms, they wouldn't come out,'' said nursing director Angela Maume. ''They were in a cocoon.''

The average age of patients here is 62, or 26 years above the systemwide average. All have been diagnosed with some level of dementia, which in the case of some patients is related to Alzheimer's or AIDS. One has Parkinson's disease and another has Huntington's disease. Some have additional psychiatric or medical disorders.

''Some of them don't even remember their crimes,'' said Dr. Edward Sottile, medical director for the Hudson Valley prison.

The average age of New York's prisoners is climbing. Inmates 50 and over accounted 3 percent of the prison population two decades ago, compared to 11 percent last year.

Like society as a whole, inmates are getting older as health care improves and baby boomers hit retirement age. But researchers also note that inmates are staying behind bars longer thanks to ''three strikes'' and other tough-on-crime laws.

Nationwide, the number of prisoners over age 50 in state and federal prisons is rising at about 8 percent a year, said sociologist Ronald Aday, author of ''Aging Prisoners: Crisis in American Corrections.''

''This group is going to mirror what's going on in our nursing homes. You have the terminally ill, you have people who have strokes in this population, you have people who have dementia,'' said Aday, of Middle Tennessee State University.

Fishkill, a 1,700-inmate, medium-security prison some 70 miles north of New York City, serves as a regional medical hub for the system. Inmates can get everything from throat cultures to long-term nursing care at the modern medical center built inside the prison's accordian-wired perimeter.

The dementia unit opened in October and is still getting up to speed. Twenty inmates from state prisons around the state -- Attica, Midstate, Coxsackie, Orleans -- are now patients.

Neither the American Correctional Association nor several experts in prison geriatrics were aware of any other special prison units for inmates with dementia.

Prison health care consultant Dr. Robert Greifinger said the idea makes sense because staff can be trained to deal with the special cases.

All workers on the Fishkill unit -- nurses, corrections officers, housekeepers -- go through a 40-hour training course to learn how to work with the cognitively impaired.

The job can be especially tricky for corrections officers, who usually must fill out a report every time they touch an inmate. Here, contact comes with the territory. Officers are trained to know that, on this ward, an outburst by an inmate could be a symptom of a troubled mind instead of a hostile act.

''A lot of times it would be construed as bad behavior,'' Sottile said, ''but they have no idea what they're doing.''

------

On the Net:

http://www.docs.state.ny.us

    New York Prison Creates Dementia Unit, NYT, 29.5.2007, http://www.nytimes.com/aponline/us/AP-Prison-Dementia-Unit.html

4 in Britain Test Positive for Bird Flu

May 29, 2007
By THE ASSOCIATED PRESS
Filed at 6:45 a.m. ET
The New York Times

LONDON (AP) -- Four people in Britain who tested positive for a mild strain of bird flu should serve as a reminder that a virus other than the feared H5N1 strain could also provoke a flu pandemic, experts say.

Health officials in recent years have focused on the threat from H5N1, which has killed at least 186 people worldwide since 2003. But some experts worry that seemingly less dangerous bird flu subtypes like H7 aren't getting enough attention.

''There may be a bit of complacency when it comes to recognizing the pandemic potential of H7 viruses,'' said Dr. Michael Perdue, a World Health Organization expert.

Last week, British authorities confirmed that four people tested positive for H7N2, a mild strain of bird flu. The four were tested in connection with a small farm in Wales where chickens died recently. Health officials were checking 142 other people for infection, including 11 reporting symptoms of flu or conjunctivitis.

More test results are pending, and officials said the number of confirmed human cases could increase. Those who are thought to have had contact with H7N2 are being offered antivirals by health authorities.

Having so many human cases at once is a potential concern. In Asia, where H5N1 has circulated most widely, millions of people have been exposed to millions of infected birds, resulting in about one new infection per week.

''Here, we're talking about a small number of birds and yet we still have four cases,'' Perdue said. ''Unless there's something unusual about the contact with birds, that suggests the virus is finding new ways of getting into humans.''

The H7 subtype has previously sparked human outbreaks. In a large outbreak in the Netherlands in 2003, 89 human cases were reported, mostly of conjunctivitis, as well as one death. There were also at least three likely instances of human-to-human transmission involving family members of poultry workers. In the case of the single fatality, officials noticed that particular virus had about 10 mutations.

British officials have been quick to reassure the public that the ''low pathogenic'' H7N2 virus -- in comparison to the ''highly pathogenic'' H5N1 virus -- poses little risk to the population. Indeed, H7N2 appears to cause only mild symptoms such as eye infections.

But low pathogenic viruses can quickly morph into highly pathogenic ones, sometimes within weeks. Too little is known about flu viruses to predict with any certainty which ones are most lethal for humans.

''The pandemic risk from low pathogenic avian viruses is almost as bad as that from highly pathogenic avian viruses,'' said Dr. Angus Nicoll, an influenza expert at the European Centre of Disease Prevention and Control.

''When people say low pathogenic or highly pathogenic, that only refers to how unpleasant the disease is for birds,'' Nicoll explained. ''That's almost irrelevant for humans.''

Like all flu viruses, low pathogenic viruses mutate rapidly, and could theoretically transform into a pandemic strain without the warning signals of a more virulent strain, which would leave many dead chickens -- and perhaps humans -- in its wake. Experts also worry about the possibility of a bird flu virus mixing with a human flu virus to create a new pandemic strain.

''If you have an H7 virus causing mild symptoms, that might give the virus the chance to reassort into a more dangerous virus before anybody notices,'' Perdue said. And for health officials hoping to quash a pandemic in its emerging stages, it might be too late to contain a global outbreak without an early warning.

Most experts believe that the preoccupation with H5N1 as the most likely pandemic candidate is justified.

''The situation with H5N1 is very intense,'' said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States. ''We know that H7 can cause outbreaks in chickens and that it can occasionally jump the species barrier, but it has not done it nearly to the extent of the H5N1 virus.''

Unlike many other bird flu subtypes, which disappear off the radar after a short period, H5N1 has remained entrenched in the environment, and continues to spread to new areas.

Still, while no bird flu virus can be ruled out when it comes to igniting the next pandemic, some clues may exist. Though H5N1 has several worrying characteristics, other flu subtypes are also in the running for the pandemic title.

''The last two flu pandemics were the result of a human flu virus recombining with low pathogenic avian viruses,'' said Perdue. The H7N2 recently detected in Britain would fall into that category. ''Given that historical context, perhaps we should concentrate our efforts a little more in that direction.''

    4 in Britain Test Positive for Bird Flu, NYT, 29.5.2007, http://www.nytimes.com/aponline/world/AP-Britain-Bird-Flu.html

Lost Chances for Survival, Before and After Stroke

May 28, 2007
The New York Times
By GINA KOLATA

Dr. Diana Fite, a 53-year-old emergency medicine specialist in Houston, knew her blood pressure readings had been dangerously high for five years. But she convinced herself that those measurements, about 200 over 120, did not reflect her actual blood pressure. Anyway, she was too young to take medication. She would worry about her blood pressure when she got older.

Then, at 9:30 the morning of June 7, Dr. Fite was driving, steering with her right hand, holding her cellphone in her left, when, for a split second, the right side of her body felt weak. “I said: ‘This is silly, it’s my imagination. I’ve been working too hard.’ ”

Suddenly, her car began to swerve.

“I realized I had no strength whatsoever in my right hand that was holding the wheel,” Dr. Fite said. “And my right foot was dead. I could not get it off the gas pedal.”

She dropped the cellphone, grabbed the steering wheel with her left hand, and steered the car into a parking lot. Then she used her left foot to pry her right foot off the accelerator. She pulled down the visor to look in the mirror. The right side of her face was paralyzed.

With great difficulty, Dr. Fite twisted her body and grasped her cellphone.

“I called 911, but nothing would come out of my mouth,” she said. Then she found that if she spoke very slowly, she could get out words. So, she recalled, “I said ‘stroke’ in this long, horrible voice.”

Dr. Fite is one of an estimated 700,000 Americans who had a stroke last year, but one of the very few who ended up at a hospital with the equipment and expertise to accurately diagnose and treat it.

Stroke is the third-leading cause of death in this country, behind heart disease and cancer, killing 150,000 Americans a year, leaving many more permanently disabled, and costing the nation $62.7 billion in direct and indirect costs, according to the American Stroke Association.

But from diagnosis to treatment to rehabilitation to preventing it altogether, a stroke is a litany of missed opportunities.

Many patients with stroke symptoms are examined by emergency room doctors who are uncomfortable deciding whether the patient is really having a stroke — a blockage or rupture of a blood vessel in the brain that injures or kills brain cells — or is suffering from another condition. Doctors are therefore reluctant to give the only drug shown to make a real difference, tPA, or tissue plasminogen activator.

Many hospitals say they cannot afford to have neurologists on call to diagnose strokes, and cannot afford to have M.R.I. scanners, the most accurate way to diagnose strokes, for the emergency room.

Although tPA was shown in 1996 to save lives and prevent brain damage, and although the drug could help half of all stroke patients, only 3 percent to 4 percent receive it. Most patients, denying or failing to appreciate their symptoms, wait too long to seek help — tPA must be given within three hours. And even when patients call 911 promptly, most hospitals, often uncertain about stroke diagnoses, do not provide the drug.

“I label this a national tragedy or a national embarrassment,” said Dr. Mark J. Alberts, a neurology professor at the Feinberg School of Medicine at Northwestern University. “I know of no disease that is as common or as serious as stroke and where you basically have one therapy and it’s only used in 3 to 4 percent of patients. That’s like saying you only treat 3 to 4 percent of patients with bacterial pneumonia with antibiotics.”

And the strokes in the statistics are only the beginning. For every stroke that doctors know about, there are 5 to 10 tiny, silent strokes, said Dr. Vladimir Hachinski, the editor of the journal Stroke and a neurologist at the London Health Sciences Centre in Ontario.

“They are only silent because we don’t ask questions,” Dr. Hachinski said. “They do not involve memory, but they involve judgment, planning ahead, shifting your attention from one thing to another. And they also may involve late-life depression.”

They are also warning signs that a much larger stroke may be on the way.

Most strokes would never happen if people took simple measures like controlling their blood pressure. Few do. Many say they forget to take medication; others, like Dr. Fite, decide not to. Some have no idea they need the drugs.

Still, there is much more hope now, said Dr. Ralph L. Sacco, professor and chairman of neurology at the Miller School of Medicine at the University of Miami. Like most stroke neurologists, Dr. Sacco entered the field more than a decade ago, when little could be done for such patients.

Now, Dr. Sacco said, there is a device, an M.R.I. scanner, that greatly improves diagnosis, there is a treatment that works and there are others being tested. “Medical systems have to catch up to the research,” he said.

In medicine, Dr. Sacco said, “stroke is a new frontier.”

Promise Unfulfilled

One Tuesday morning in March, Dr. Steven Warach, chief of the stroke program at the National Institute of Neurological Disorders and Stroke, met with a team from Washington Hospital Center, the largest private hospital in Washington, to review M.R.I. scans of recently admitted patients. They were joined in a teleconference by neurologists at Suburban Hospital in Bethesda, Md., the only other stroke center in the Washington and suburban Maryland area.

The images were mementos of suffering.

There was a 66-year-old woman with a stroke so big the scan actually showed degenerating fibers that carry nerve signals across the brain.

There was a 75-year-old who had trouble moving her right arm and right side in the recovery room after heart surgery. At first doctors thought she was just slow to wake up from the anesthesia. Now, though, it was clear she had suffered a stroke. She had lost the right half of her vision in both eyes and her right side was weak.

There was an 88-year-old who slumped forward at lunch, losing consciousness. When he came to, he had trouble forming words.

There was a middle-age man whose stroke was unforgettable. When Dr. Warach saw his initial M.R.I. scan, in his basement office at his home, he cried out in astonishment so loudly his wife ran downstairs. “I have never seen anything so severe,” Dr. Warach said. None of the three arteries that supplied the man’s right hemisphere were getting any blood.

Now the man lay in a coma, twitching on his left side, paralyzed on his right, breathing with the help of a ventilator. If he survived, he would have severe brain damage.

There was Michael Collins, a 49-year-old police officer who had had a stroke in his police car in Takoma Park, Md. Unlike the others, Mr. Collins seemed mostly recovered. The next few days, though, would determine whether he was among the lucky 10 percent of stroke patients who escape unscathed or whether he would always be weaker on his left side. If that happened, Mr. Collins said, he could never return to his job.

“You have to be able to shoot a gun with either hand,” he explained. But as time passed, Mr. Collins continued to be plagued by numbness in his left hand and on the left side of his face. He wanted to return to work — “I’m doing great,” he said this month — but the Police Department insisted that he retire, telling him, he said, “it’s an officer safety issue.”

The rest of the patients in the stroke units at the two hospitals that day were less fortunate: almost certain to live, but also almost certain to end up with brain damage. Some would have to spend time at a rehabilitation center.

On average, said Dr. Brendan E. Conroy, medical director of the stroke recovery program at the National Rehabilitation Hospital, which is attached to the Washington Hospital Center, a third of the Washington hospital’s stroke patients die, a third go home and a third come to him.

Those whose balance is affected typically spend 20 days learning to deal with a walker or a cane; those who are partly blind or paralyzed must learn to care for themselves. Many functions return, Dr. Conroy said, but rehabilitation also means learning to live with a disability.

But what was perhaps saddest to the neurologists viewing the M.R.I. scans that morning was that tPA, which only recently appeared to be a triumph of medicine, had made not a whit of difference to these patients. They either had not arrived at the hospital in time or had been considered otherwise medically unsuitable to receive it.

Few would have predicted that fate for the drug. In 1995, after 40 years of trying to find something to break up blood clots in the brain, the cause of most strokes, researchers announced that tPA worked. A large federal study showed that, without it, about one patient in five escaped serious injury. With it, one in three escaped.

The drug had a serious side effect — it could cause potentially life-threatening bleeding in the brain in about 6 percent of patients. But the clinical trial demonstrated that the drug’s benefits outweighed its risks.

When the study’s results were announced, Dr. James Grotta of the University of Texas Medical School at Houston expressed the researchers’ elation. “Until today, stroke was an untreatable disease,” Dr. Grotta said.

But the expected sea change did not occur.

One problem was that patients showed up too late. Many had no choice. Strokes often occur in the morning when people are sleeping. They awake with terrifying symptoms, paralyzed on one side or unable to speak.

“That’s the challenge — we have to ask the patient” when the stroke began, said Dr. A. Gregory Sorensen, a co-director of the Athinoula A. Martinos Center for Biomedical Imaging at Massachusetts General Hospital. “If they don’t know or can’t talk, we’re out of luck.”

Another problem is deciding whether a patient is really having a stroke. A person who has trouble forming words could just be confused. Or what about someone whose arm or leg is weak?

“A lot of things can cause weakness,” Dr. Warach said. “A nerve injury can cause weakness; sometimes brain tumors can be suddenly symptomatic. Sometimes people have migraines that can completely mimic a stroke.”

In fact, he said, a quarter of emergency room patients with symptoms suggestive of a stroke are not actually having one.

Most get CT scans, which are useful mostly to rule out hemorrhagic strokes, the less common type that is caused by bleeding in the brain and should not be treated with tPA. Stroke specialists can usually then decide whether the patient is having a stroke caused by a blocked blood vessel and whether it can be treated with tPA.

But most stroke patients are handled by emergency room physicians who often say they are not sure of the diagnosis and therefore hesitate to give tPA.

Dr. Richard Burgess, a member of Dr. Warach’s stroke team, explained the situation: There is no particular penalty for not giving tPA. Doctors are unlikely to be sued if the patient dies or is left with brain damage that could have been avoided. But there is a penalty for giving tPA to someone who is not having a stroke. If that patient bleeds into the brain, the drug not only caused a tragic outcome but the doctor could also be sued. Few emergency room doctors want to take that chance.

Treatment Barriers

There is a way to diagnose strokes more accurately — with a diffusion M.R.I., a type of scan that shows water moving in the brain. During a stroke, the flow of water slows to a crawl as dead and dying cells swell. In one recent study, diffusion M.R.I. scans found five times as many strokes as CT scans, with twice the accuracy.

A diffusion M.R.I. “answers the question 95 percent of the time," Dr. Sorensen said.

It seemed the perfect solution, but it was not.

Most hospitals say they cannot provide such scans to stroke patients. They would need both an M.R.I. technician and an expert to interpret the scans around the clock. They would need an M.R.I. machine near the emergency room. Most hospitals have the huge machines elsewhere, steadily booked far in advance for other patients.

It is simply not practical to demand the scans at every hospital or even every stroke center, said Dr. Edward C. Jauch, an emergency medicine doctor at the University of Cincinnati and a member of the Greater Cincinnati/Northern Kentucky Stroke Team.

“If you made M.R.I. the standard of care before giving tPA, most centers would not be able to comply,” Dr. Jauch said. And if it takes more time to get a scan — as it often does — it might be better to forgo it and give tPA immediately if the patient’s symptoms seem unambiguous.

Doctors do not need an M.R.I. to diagnose and treat stroke, said Dr. Lee H. Schwamm, vice chairman of the department of neurology at Massachusetts General Hospital. But, Dr. Schwamm added, if the question is whether it helps, there is one reply: “By all means.”

It has still not been shown, though, that M.R.I. scans actually improve outcomes. It might depend on the circumstances and the hospital, said Dr. Walter J. Koroshetz, deputy director of the National Institute of Neurological Disorders and Stroke.

But some who use M.R.I. scans, and who have studied them in research, say the system has to change. They say enough is known about the scans to advocate having them at every major medical center that will treat stroke patients.

“All these problems could be solved if there was a will to do it,” Dr. Sorensen said. In his opinion, it comes down to old and outdated assumptions that there is not much to be done for a stroke, to financial considerations and to a medical system that resists change. But the most significant barriers, he said, are financial.

Another approach, stroke specialists say, is to direct all patients with stroke symptoms to designated stroke centers. There, stroke patients would be treated by experienced neurologists and admitted to stroke units for additional care. For the first time, in its newly published guidelines, the American Stroke Association recommended the routing of patients to stroke centers.

But even with such a system in place, many patients end up at hospitals that are not prepared to treat them, as Dr. Grotta discovered in Houston.

He thought he could change stroke care in Houston with the stroke center idea. The first step went well — the city’s ambulance services agreed to take all patients with stroke symptoms to designated stroke centers.

Then, Dr. David E. Persse, the city’s director of emergency medical services, asked every one of Houston’s 25 hospitals if it wanted to be a stroke center. While seven have said yes, others have declined.

Stroke patients, unlike heart attack patients, are not moneymakers. Because of the way medical care is reimbursed, most hospitals either lose money or do little more than break even with stroke care but can often make several thousand dollars opening the arteries of a heart attack patient. And being a stroke center means finding and paying stroke specialists to be available around the clock.

Soon another problem emerged. As many as a third of the patients refused to let the ambulance take them to a stroke center, demanding to go to their local hospital.

“By law in Texas, we cannot take that man to another hospital against his will,” Dr. Persse said. “We could be charged with assault and battery and kidnapping and unlawful imprisonment.”

The Joint Commission, which accredits hospitals, recently started certifying stroke centers, requiring that the hospitals be willing to treat stroke patients aggressively. But only 322 of the 4,280 accredited hospitals in the nation qualify, and most patients and doctors have no idea whether a hospital nearby is among them. (The list is available on the site http://www.jointcommission.org/CertificationPrograms/Disease-SpecificCare/DSCOrgs/ under “primary stroke centers.”) Some states, like New York, Massachusetts and Florida, do their own certifying of stroke centers.

Nonetheless, most ambulances do not consider stroke center designations when they transport patients. And, said John Becknell, a spokesman for the National Association of Emergency Medical Technicians, national programs can be difficult because every community has its own rules for which ambulances pick up patients and where they take them.

As a result, most stroke patients have no access to the recommended care and even fewer get M.R.I.’s, a situation Dr. Warach said he found appalling.

“How can it ever be in the patient’s best interest to have an inferior diagnosis?” he asked. “It borders on malpractice that given a choice between two noninvasive tests, one of which is clearly superior, the worse test is the one that is preferred.”

Averting Catastrophe

In those awful moments when she realized she had had a stroke, Dr. Fite, unlike most patients, knew what to do. She told the ambulance crew to take her to Memorial Hermann Hospital, even though it was about an hour away. She knew that it was one of the Houston stroke centers, that Dr. Grotta worked there, and that its doctors had experience diagnosing strokes and giving tPA.

When she arrived, Dr. Grotta asked if she was sure she wanted the drug. Did she want to risk bleeding in the brain? Dr. Fite did not hesitate. The stroke, she said, “was just so devastating that I would rather die of a hemorrhage in the brain than be left completely paralyzed in my right side.”

“In my horrible voice, I said, ‘Yes, I want the tPA,’ ” Dr. Fite said.

Within 10 to 15 minutes, the drug started to dissolve the clot.

“I had weird spasms as nerves started to work again,” Dr. Fite said. “An arm would draw up real quick, a leg would tighten up. It hurt so bad I was crying because of the pain. But it was movement, and I knew something was going on.”

Now, she looks back with dismay on her cavalier attitude toward high blood pressure. She knew very well how to prevent a stroke but, like many patients and despite her medical training, she found it all too easy to deny her own risk.

Researchers have known for years the conditions that predispose a person to stroke — smoking, diabetes, high cholesterol and an irregular heartbeat known as atrial fibrillation. But the major one is high blood pressure.

“Of all the modifiable risk factors, high blood pressure leads the list,” Dr. Sacco said. “With heart disease, you think more of cholesterol; with stroke you think of high blood pressure.”

The reason, Dr. Sacco said, is that with high blood pressure, the tiny blood vessels in the brain clamp down so much and so hard to protect the brain that they can become rigid. Then they get blocked. The result is a stroke.

Often, people decide they do not need their blood pressure medication or simply forget to take it because they feel well. But, Dr. Sacco said, patients are not solely to blame. Doctors may not have time to work with patients, monitoring blood pressure, telling them about changes in their diet and exercise that might help, or trying different drugs and combining them if necessary.

And it is not so simple for people to keep track of their blood pressure. Machines in drugstores and supermarkets are not always accurate. Doctors may require appointments to check blood pressure.

Even when people do try to control their pressure, doctors may not prescribe enough drugs or high enough doses.

“They’re on a couple of drugs, and the doctor doesn’t want to push it,” said Dr. Jeffrey A. Cutler, a consultant to the National Heart, Lung and Blood Institute and a retired director of its clinical applications and prevention program.

The result is that no more than half the people with high blood pressure have it under control, Dr. Cutler said. He estimated that half of all strokes could be prevented if people kept their blood pressure within the recommended range.

Another lost opportunity to prevent strokes is the undertreatment of atrial fibrillation, in which the two upper chambers of the heart quiver. Blood can pool in the heart and clot, and those clots can be swept into the brain, lodge in a small blood vessel and cause a stroke.

Strokes from atrial fibrillation can largely be prevented with anticlotting drugs like warfarin. Yet many who have the condition do not know it and many who know they have it were never given or do not take an anticlotting drug.

Some strokes can also be prevented by procedures to open obstructed arteries in the neck that supply blood to the brain.

As for Dr. Fite, she completely recovered. And she has changed her ways.

She was sobered by the cost of her treatment and brief hospital stay — $96,000, most of which was paid by her insurance company. But she was even more sobered by how close she came to catastrophe.

Now, Dr. Fite takes three blood pressure pills, a drug to prevent blood clots and a cholesterol-lowering drug. She plans to take those drugs every day for the rest of her life.

“I was so stupid,” she said. “Boy, when you go through this, you never want to go through it again.”

“I have been given that precious second chance,” she said. “I was so blessed.”

    Lost Chances for Survival, Before and After Stroke, NYT, 28.5.2007, http://www.nytimes.com/2007/05/28/health/28stroke.html?hp

Blue Light Aids Ill Mennonite Children

May 20, 2007
By THE ASSOCIATED PRESS
Filed at 5:28 a.m. ET
The New York Times

EAST EARL, Pa. (AP) -- Across the moonless dark of Lancaster County, where horse-drawn buggies clatter along dusty country roads and many families shun electricity, a strange blue light cuts harshly through the night.

Over the cornfields it beckons, like some otherworldly force, beaming from the bedroom window of a 100-year-old Mennonite farmhouse.

Downstairs, flaxen-haired girls with braids read to younger children ... a mother in a traditional long print dress and white organdy cap rocks a slumbering child ... a father returning from the fields pulls up a chair to the coal-fired stove.

The scene is bathed in the glow of a single gas lamp.

Upstairs, a baby sleeps in another kind of light, in a very different world.

High-intensity blue electric rays burn down upon his crib, creating an iridescent haze that envelops the room. The lights are suspended from a heavy stainless steel canopy just inches above the child.

The baby wears only a diaper and has no blankets, just starched white sheets. Mirrors are built into one side of the crib. Fans hum loudly to keep him cool.

With his chubby cheeks and bleached blonde hair, 15-month old Bryan Martin looks like an angel in his luminous cocoon.

But Bryan is a very sick child.

The whites of his eyes are yellow and his skin is an unnatural gold.

The blue lights are saving his life.

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In the lush, green pastures of Pennsylvania Dutch country, where life revolves around the one-room schoolhouse, the farm and the church, and locals speak a distinctive German dialect, the strange blue lights beam from a handful of homes.

To the Amish and Mennonites they mean one thing -- the presence of an extraordinarily rare disease that seems to cruelly target their communities, forcing afflicted children to spend 10 to 12 hours a day, undressed, under lights.

The children suffer from a genetic disorder that causes high levels of a toxin called bilirubin to build up in their bodies, resulting in severe jaundice that, if untreated, causes brain damage and death.

Bilirubin, a natural waste product from worn-out red blood cells, is normally broken down by an enzyme in the liver. If the enzyme is missing, bilirubin can be checked only by the wavelengths of blue lights. Levels must be monitored constantly. Even minor injuries or infections can cause them to rise dramatically.

The disease is Crigler-Najjar syndrome, named for two doctors who identified it 55 years ago. There are about 110 known cases of Crigler's worldwide, including about 35 in the U.S. About 20 are among the Amish and Mennonite in Pennsylvania.

There is no cure; Bryan's only hope for long-term survival is a liver transplant.

------

As a Mennonite, Katie Martin embraces the teaching of her church, that sick children are gifts from God, born to foster compassion and understanding.

But nothing prepared her for the news that her firstborn, Derick, had Crigler's. Several years earlier, a nephew had suffered brain damage and died of the disease at age 3.

''I thought it was a death sentence,'' she said.

In the past, it usually was. But in 1990 a new clinic had just opened in Strasburg specializing in children with rare diseases. There, the Martins met a doctor who had once studied with Dr. John Crigler, who first described the disease with Dr. Victor Najjar in 1952. The doctor told them about bilirubin levels and the dangers of kernicterus, the brain disorder that killed their nephew.

Bring the baby back for blood tests every month, the doctor told them.

And keep him under blue lights.

So the Martins -- who are unrelated to Bryan Martin -- took their yellow baby back to their 140-acre dairy farm in Mifflinberg and embarked on a life of testing, monitoring and lights.

Floyd, who also works as a welder, fashioned a stainless steel-framed canopy to hold the lights over his son's bed. He learned all he could about phototherapy, as the blue light treatment is called. As the boy grew, Martin made bigger, more sophisticated frames. When his next child, Amy, was born, he made another set of lights. When their three cousins across the hill were stricken, he made more.

Today, Floyd Martin's blue light beds, which cost about $1,000, are sought by Crigler families all over the world.

The Martins, old-order Mennonites, have electricity and a phone, but there is no computer, television or radio in their house. They travel by horse and buggy, except for emergencies when they hire a driver.

They had no moral qualms about using electric lights, as some more conservative families do.

But the disease forced other compromises, like accepting state insurance for their sick children, even though church rules forbid any form of government help. Generally, the church pays for all medical care.

''The hardest thing,'' says Katie Martin, a slender woman of 37 with a pale, thin face and dark brown eyes, ''was to hear them cry on cold winter nights and not just be able to wrap them in a blanket or curl up in our bed.''

She is standing in the brightly lit cow barn, overseeing the noontime milking of 65 Holsteins. Derick, now a strapping young man of 17, hauls long milking tubes along a motorized pulley. Amy, 15, attaches them to the cows.

The teenagers radiate sturdiness and health. Still, their mother eyes them nervously.

For years she has worried about bilirubin levels. She has cajoled her children back under the lights on the nights they crawled out, complaining about the heat. She has nursed them through gallbladder operations, and debilitating fatigue and other side-effects of Crigler's. She has made countless emergency visits to the clinic.

Now she has another worry: liver rejection. Both children have had transplants in the past three years and for Amy recovery was complicated. Ulcers. Lesions. Diabetes. High doses of steroids and anti-rejection therapy. Months of hospitalization. Martin estimates that Amy's total medical costs have amounted to over $1 million.

And yet, Martin knew her daughter had no choice. Bilirubin builds up dangerously in adolescence as skin gets more dense. And the psychological toll can be devastating.

For years, Martin received sad, lonely letters from a woman in England who survived Crigler's into early adulthood. In 2004, at the age of 30, she smashed her bed of lights. The disease killed her within a few weeks.

Martin tells this story to panicked parents who call from around the world when they have a yellow baby and they don't know where to turn.

She tells them exactly how to set the lights. She tells them what drugs to use and what to avoid. And she tells them about a special place and a doctor who is an expert on the disease.

''Go to Dr. Morton,'' she says. ''He can save your child.''

------

On a dewy spring morning in Strasburg, strains of Bach drift from a post-and-beam building on a hill overlooking an alfalfa field. Inside, rays of light wash down from rafters, silhouetting the doctor-musician as he cradles his cello.

For Holmes Morton, his daily dawn ''concert'' is a rare escape from the sadness of sick children and the desperation of parents who come to him for miracles.

There are no miracles, he tells them. For many rare diseases there are no cures.

To the families who travel from miles around, Morton's Clinic for Special Children is itself a miracle.

Here, on what was once an Amish farmer's field, in a building erected in traditional barn-raising fashion by 70 local men, some of the world's rarest diseases are identified. Children who would never have survived in the past are treated with special formulas and dietary regimens tailored solely to their needs. And because the local community helps pay for the nonprofit clinic through annual auctions, costs are far less than at a regular doctor's office.

Geneticists have long studied the Amish and Mennonites, descendants of Swiss and German Anabaptists who settled in Pennsylvania in the 1700s. Forbidden to marry outside their religion, the Plain People, as they are known, have a relatively high risk of being carriers of a rare disease.

But research generally takes place in university laboratories, far from actual patients and their illnesses.

At the Clinic for Special Children, laboratory director Erik Puffenberger studies a mass spectrometer and DNA sequencing machine in one room, while across the corridor an Amish family clusters around Morton to discuss their sick child. Heirloom quilts decorate the walls. A horse and buggy is tethered to a hitching post outside.

And new genes are being identified all the time.

''The real frontier of genetic medicine is in the everyday practice,'' Morton says, as he bounces over hilly back roads in his silver Jetta, waving at bearded farmers and straw-hatted boys.

With his thinning hair, walrus mustache, starched white shirt and bow-tie, Morton looks every inch the genial country doctor. But the 56-year-old, Harvard-trained pediatrician is far more. In 1989 he gave up a promising academic career to pursue his vision of the clinic, believing that the only way to understand rare diseases was to live in the communities where they occurred. Today, the clinic, which is run by Morton's wife Caroline, treats about 600 Amish and Mennonite children. Morton's work is recognized around the world.

''These children living with the sword of Damocles,'' Morton says. ''They need treatment, not just research.''

Morton is speaking not just of Crigler-Najjar syndrome, but of the many other rare disorders seen in the clinic. Maple syrup urine disease. Glutari aciduria. Pigeon breast disease. Pretzel syndrome.

Many of the disorders can be fatal -- or cruelly disfiguring -- if undetected. Like Crigler's, many are so unusual they are simply not recognized by general pediatricians.

The clinic now recommends all Amish and Mennonite newborns be routinely screened for more than 35 genetic diseases. In 2004 it discovered a gene implicated in some cases of sudden infant death syndrome. It has established links between rare metabolic disorders like glutari aciduria and diseases that are more common in the general population, like cerebral palsy.

''God sent Dr. Morton to us,'' says Norman Burkholder, after leaving his mules and plow one day to bring in his 9-year-old son. The child is dizzy and coughing and he complains, in Pennsylvania Dutch, that his stomach hurts.

Later the boy will be admitted to Lancaster General Hospital where he will spend days on a special formula prepared by Morton's clinic. The child has maple syrup urine disease, a rare enzyme deficiency that causes his urine and ear wax to smell like maple syrup. If he had not been properly diagnosed and the formula had not been available, he could have slipped into a coma and died.

Like Crigler-Najjar, there is no cure. The boy will eventually need a liver transplant.

------

John Crigler remembers being baffled by the jaundice disease he encountered among Amish newborns when he was a young pediatrician working with Najjar at Johns Hopkins Hospital in Baltimore. The babies all died.

''There wasn't any treatment, any hope, any cure,'' said Crigler, now 87. ''We were just spectators. There was nothing we could do.''

Patients began living longer in the 1970s when doctors realized that the wavelength and energy of blue light changes the nature of the bilirubin, allowing it to be excreted from the body.

There was even a brief time, in the late 1990s, when a cure seemed imminent. Experiments in rats suggested that chimeraplasty, a form of gene therapy, could also succeed in humans. The therapy is based on the use of a molecule called a chimeraplast, a synthetic blend of DNA and the related molecule RNA, that would enduce a patient's own cells to repair themselves.

At a conference of Crigler families in July 1999 Morton announced that the first human trials would begin on three of his patients in Lancaster General Hospital that fall.

''There was such excitement,'' recalls Katie Martin, who was pregnant with her third child at the time. ''We thought that soon we would get rid of the blue lights forever.''

Two months later an 18-year-old Arizonan named Jesse Gelsinger died during an unrelated gene-therapy trial at the University of Pennsylvania. Funding for human trials dried up.

So did hope for Derick and Amy Martin.

Liver transplants are expensive and invasive and bring their own share of heartache and fear. Rejection can be especially hard for teenagers like Amy, craving normality after years under lights.

Amy has a smattering of freckles over pink cheeks and expressive eyes that light up when she boasts about her horse, Paintball, or the two bucks she shot when she went hunting with her Dad. She is proud of her transplant, despite her long recovery and all the anti-rejection medicine she must take.

She will even lift her long white dress to show off the scar that snakes down her chest and around her stomach.

Amy hated the lights, hated having to sleep without a blanket, hated the flies that crawled under the glass. Most of all she hated her eyes.

When she woke up after her transplant, she begged for a mirror.

Carefully, she scanned the whites for any trace of yellow.

''Wow,'' she thought. ''They're so blue.''

And then she thought, ''I'm not a Crigler's child anymore.''

Amy's uncle and aunt, John and Miriam Martin, have witnessed her trials even as they contemplate three transplants in their own family.

John is Katie Martin's brother; he has the same warm brown eyes and kind smile. His three eldest children have yellow eyes and honeyed skin.

Dawn, 12, is the eldest, a serious child with a mothering streak. Nine-year-old Eric is lanky and shy. Joyce, 8, is the mischievous one with the big imagination.

At their Mifflinburg farmhouse, Martin has built them a huge sunroom, all windows and light. He has fixed up one of Floyd Martin's inventions in the living room -- a 6-foot-high box of blue lights and mirrors with a door that the children climb into after school, their heads popping out of the top. They call it ''the shuttle'' He has taken them on vacation to Florida, to a family with a Crigler's child who let them borrow blue lights.

But the 33 year-old father cannot escape the agony of having cursed his children with his genes.

The new baby, Joel, doesn't have Crigler's. Nor does 20-month-old Johnny. When they were born, John says, it seemed like a miracle.

Now the family prays for another miracle -- a cure.

''Now I lay me down to sleep ... I pray the Lord my soul to keep ...''

Lying on their stomachs on their double bed, Dawn and Joyce chant their prayers in singsong unison. They are in their underwear, covered by a sheet. A heavy stainless steel canopy of lights hangs above them.

Their father kisses them goodnight in the dark. He cannot bear to turn on the blue lights or pull off their cover while they are still awake.

Later, he will creep back into their room and press a switch.

Outside, from far across the fields, a strange blue light will beckon in the dark.

    Blue Light Aids Ill Mennonite Children, NYT, 20.5.2007, http://www.nytimes.com/aponline/us/AP-Blue-Light-Kids.html

FDA Set to OK Period Suppression Pill

May 18, 2007
By THE ASSOCIATED PRESS
Filed at 11:32 p.m. ET
The New York Times

TRENTON, N.J. (AP) -- Women looking for a simple way to avoid their menstrual period could soon have access the first birth control pill designed to let women suppress monthly bleeding indefinitely.

The U.S. Food and Drug Administration is expect to announce approval Tuesday for Lybrel, a drug from Wyeth which would be the first pill to be taken continuously.

Lybrel, a name meant to evoke ''liberty,'' would be the fourth new oral contraceptive that doesn't follow the standard schedule of 21 daily active pills, followed by seven sugar pills -- a design meant to mimic a woman's monthly cycle. Among the others, Yaz and Loestrin 24 shorten monthly periods to three days or less and Seasonique, an updated version of Seasonale, reduces them to four times a year.

Gynecologists say they've been seeing a slow but steady increase in women asking how to limit and even stop monthly bleeding. Surveys have found up to half of women would prefer not to have any periods, most would prefer them less often and a majority of doctors have prescribed contraception to prevent periods.

''I think it's the beginning of it being very common,'' said Dr. Leslie Miller, a University of Washington-Seattle obstetrician-gynecologist who runs a Web site focused on suppressing periods. ''Lybrel says, 'You don't need a period.'''

While that can be done easily -- sometimes more cheaply -- by skipping the sugar pills or replacing birth-control patches or vaginal rings sooner, doctors say the trend is fueled mainly by advertising for the new options. They expect plenty for Lybrel's July launch, although Madison, N.J.-based Wyeth says it will market to doctors first.

Analysts have estimated Lybrel sales could reach $40 million this year and $235 million by 2010. U.S. sales of Seasonique, launched last August, hit $6.1 million in the first quarter of 2007. Predecessor Seasonale, which got cheaper generic competition in September, peaked at about $100 million. Yaz, launched last August, had first-quarter sales of $35.6 million; Loestrin 24, launched in April 2006, hit $34.4 million in the first quarter.

Still, some women raise concerns about whether blocking periods is safe or natural. Baltimore health psychologist Paula S. Derry wrote in an opinion piece in the British Medical Journal two weeks ago that ''menstrual suppression itself is unnatural,'' and that there's not enough data to determine if it is safe long-term.

Sheldon J. Segal, a scientist at the nonprofit research group Population Council, wrote back that a British study found no harm in taking pills with much higher hormone levels than today's products for up to 10 years.

''Nothing has come up to indicate any unexpected side effects,'' said Segal, who co-authored the book ''Is Menstruation Obsolete?''

Most doctors say there's no medical reason women need monthly bleeding and that it triggers health problems from anemia to epilepsy in many women. They note women have been tinkering with nature since the advent of birth control pills and now endure as many as 450 periods, compared with 50 or so in the days when women spent most of their fertile years pregnant or breast-feeding.

Dr. Mindy Wiser-Estin, an obstetrician-gynecologist in Little Silver, N.J., has long advocated menstrual suppression.

She has seen a big increase in the last year in patients asking about it, but has one concern that leads her to encourage younger women to take a break every 12 weeks. About 1 percent of oral contraceptive users become pregnant each year, and young women taking continuous pills who have never been pregnant may not recognize the symptoms, she said.

''They may not know it in time to do something about it,'' Wiser-Estin said.

Barr Pharmaceuticals of Woodcliff Lake, N.J., whose subsidiary Duramed already is developing a lower-estrogen version of Seasonique, said its research with consumers and health care providers indicates they feel four periods a year is optimal, said spokeswoman Amy Niemann.

Wyeth obviously thinks otherwise.

''It allows women to put their menstrual cycle on hold'' and reduces 17 related symptoms, from irritability to bloating, based on one small study, said Dr. Amy Marren, director of clinical affairs for Wyeth Pharmaceuticals.

Marren said Lybrel contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

That might cause too much breakthrough bleeding, already a problem with some newer pills with low hormone doses, said Dr. Lee Shulman, a Chicago obstetrician-gynecologist who chairs the board of the Association of Reproductive Health Professionals.

In testing of Lybrel, 59 percent of women ended up with no bleeding after six months, but 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth.

''You're now basically trading scheduled bleeding for unscheduled bleeding, and I don't know whether American women will buy into that,'' Shulman said.

------

On the Net:

www.wyeth.com

Association of Reproductive Health Professionals menstruation site: www.arhp.org/healthcareproviders/resources/menstruationresources

Dr. Miller's Web site: www.noperiod.com

    FDA Set to OK Period Suppression Pill, NYT, 18.5.2007, http://www.nytimes.com/aponline/health/AP-No-More-Periods.html

U.S. healthcare expensive, inefficient: report

Tue May 15, 2007
1:25AM EDT
Reuters
By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - Americans get the poorest health care and yet pay the most compared to five other rich countries, according to a report released on Tuesday.

Germany, Britain, Australia and Canada all provide better care for less money, the Commonwealth Fund report found.

"The U.S. health care system ranks last compared with five other nations on measures of quality, access, efficiency, equity, and outcomes," the non-profit group which studies health care issues said in a statement.

Canada rates second worst out of the five overall. Germany scored highest, followed by Britain, Australia and New Zealand.

"The United States is not getting value for the money that is spent on health care," Commonwealth Fund president Karen Davis said in a telephone interview.

The group has consistently found that the United States, the only one of the six nations that does not provide universal health care, scores more poorly than the others on many measures of health care.

Congress, President George W. Bush, many employers and insurers have all agreed in recent months to overhaul the U.S. health care system -- an uncoordinated conglomeration of employer-funded care, private health insurance and government programs.

The current system leaves about 45 million people with no insurance at all, according to U.S. government estimates from 2005, and many studies have shown most of these people do not receive preventive services that not only keep them healthier, but reduce long-term costs.

Davis said the fund's researchers looked at hard data for the report.

"It is pretty indisputable that we spend twice what other countries spend on average," she said.

Per capita health spending in the United States in 2004 was $6,102, twice that of Germany, which spent $3,005. Canada spent $3,165, New Zealand $2,083 and Australia $2,876, while Britain spent $2,546 per person.

KEY MEASURES

"We focus primarily on measures that are sensitive to medical care making a difference -- infant mortality and healthy lives at age 60," Davis said. "Those are pretty key measures, like how long you live and whether you are going to die before age 75."

Measures of other aspects of care such as cataract surgery or hip replacements is harder to come by, she said.

They also looked at convenience and again found the United States lacking -- with a few exceptions.

"We include measures such as waiting more than four months for elective, non-emergency surgery. The United States doesn't do as well as Germany but it does a lot better than the other countries on waiting time for surgery," Davis said.

"We looked at the time it takes to get in to see your own doctor ... (or) once you go to the emergency room do you sit there for more than two hours, and truthfully, we don't do well on those measures," Davis said.

According to the report, 61 percent of U.S. patients said it was somewhat or very difficult to get care on nights or weekends, compared with 25 percent to 59 percent in other countries.

"The area where the U.S. health care system performs best is preventive care, an area that has been monitored closely for over a decade by managed care plans," the report reads.

The United States had the fewest patients -- 84 percent -- reporting that they have a regular doctor.

And U.S. doctors are the least wired, with the lowest percentage using electronic medical records or receiving electronic updates on recommended treatments.

    U.S. healthcare expensive, inefficient: report, R, 15.5.2007, http://www.reuters.com/article/domesticNews/idUSN1430711120070515

Industry’s Role in Childrens’ Antipsychotics

May 10, 2007
The New York Times
By GARDINER HARRIS, BENEDICT CAREY and JANET ROBERTS

When Anya Bailey developed an eating disorder after her 12th birthday, her mother took her to a psychiatrist at the University of Minnesota who prescribed a powerful antipsychotic drug called Risperdal.

Created for schizophrenia, Risperdal is not approved to treat eating disorders, but increased appetite is a common side effect and doctors may prescribe drugs as they see fit. Anya gained weight but within two years developed a crippling knot in her back. She now receives regular injections of Botox to unclench her back muscles. She often awakens crying in pain.

Isabella Bailey, Anya’s mother, said she had no idea that children might be especially susceptible to Risperdal’s side effects. Nor did she know that Risperdal and similar medicines were not approved at the time to treat children, or that medical trials often cited to justify the use of such drugs had as few as eight children taking the drug by the end.

Just as surprising, Ms. Bailey said, was learning that the university psychiatrist who supervised Anya’s care received more than $7,000 from 2003 to 2004 from Johnson & Johnson, Risperdal’s maker, in return for lectures about one of the company’s drugs.

Doctors, including Anya Bailey’s, maintain that payments from drug companies do not influence what they prescribe for patients.

But the intersection of money and medicine, and its effect on the well-being of patients, has become one of the most contentious issues in health care. Nowhere is that more true than in psychiatry, where increasing payments to doctors have coincided with the growing use in children of a relatively new class of drugs known as atypical antipsychotics.

These best-selling drugs, including Risperdal, Seroquel, Zyprexa, Abilify and Geodon, are now being prescribed to more than half a million children in the United States to help parents deal with behavior problems despite profound risks and almost no approved uses for minors.

A New York Times analysis of records in Minnesota, the only state that requires public reports of all drug company marketing payments to doctors, provides rare documentation of how financial relationships between doctors and drug makers correspond to the growing use of atypicals in children.

From 2000 to 2005, drug maker payments to Minnesota psychiatrists rose more than sixfold, to $1.6 million. During those same years, prescriptions of antipsychotics for children in Minnesota’s Medicaid program rose more than ninefold.

Those who took the most money from makers of atypicals tended to prescribe the drugs to children the most often, the data suggest. On average, Minnesota psychiatrists who received at least $5,000 from atypical makers from 2000 to 2005 appear to have written three times as many atypical prescriptions for children as psychiatrists who received less or no money.

The Times analysis focused on prescriptions written for about one-third of Minnesota’s Medicaid population, almost all of whom are disabled. Some doctors were misidentified by pharmacists, but the information provides a rough guide to prescribing patterns in the state.

Drug makers underwrite decision makers at every level of care. They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow.

But studies present strong evidence that financial interests can affect decisions, often without people knowing it.

In Minnesota, psychiatrists collected more money from drug makers from 2000 to 2005 than doctors in any other specialty. Total payments to individual psychiatrists ranged from $51 to more than $689,000, with a median of $1,750. Since the records are incomplete, these figures probably underestimate doctors’ actual incomes.

Such payments could encourage psychiatrists to use drugs in ways that endanger patients’ physical health, said Dr. Steven E. Hyman, the provost of Harvard University and former director of the National Institute of Mental Health. The growing use of atypicals in children is the most troubling example of this, Dr. Hyman said.

“There’s an irony that psychiatrists ask patients to have insights into themselves, but we don’t connect the wires in our own lives about how money is affecting our profession and putting our patients at risk,” he said.

The Prescription

Anya Bailey is a 15-year-old high school freshman from East Grand Forks, Minn., with pictures of the actor Chad Michael Murray on her bedroom wall. She has constant discomfort in her neck that leads her to twist it in a birdlike fashion. Last year, a boy mimicked her in the lunch room.

“The first time, I laughed it off,” Anya said. “I said: ‘That’s so funny. I think I’ll laugh with you.’ Then it got annoying, and I decided to hide it. I don’t want to be made fun of.”

Now she slumps when seated at school to pressure her clenched muscles, she said.

It all began in 2003 when Anya became dangerously thin. “Nothing tasted good to her,” Ms. Bailey said.

Psychiatrists at the University of Minnesota, overseen by Dr. George M. Realmuto, settled on Risperdal, not for its calming effects but for its normally unwelcome side effect of increasing appetite and weight gain, Ms. Bailey said. Anya had other issues that may have recommended Risperdal to doctors, including occasional angry outbursts and having twice heard voices over the previous five years, Ms. Bailey said.

Dr. Realmuto said he did not remember Anya’s case, but speaking generally he defended his unapproved use of Risperdal to counter an eating disorder despite the drug’s risks. “When things are dangerous, you use extraordinary measures,” he said.

Ten years ago, Dr. Realmuto helped conduct a study of Concerta, an attention deficit hyperactivity disorder drug marketed by Johnson & Johnson, which also makes Risperdal. When Concerta was approved, the company hired him to lecture about it.

He said he gives marketing lectures for several reasons.

“To the extent that a drug is useful, I want to be seen as a leader in my specialty and that I was involved in a scientific study,” he said.

The money is nice, too, he said. Dr. Realmuto’s university salary is $196,310.

“Academics don’t get paid very much,” he said. “If I was an entertainer, I think I would certainly do a lot better.”

In 2003, the year Anya came to his clinic, Dr. Realmuto earned $5,000 from Johnson & Johnson for giving three talks about Concerta. Dr. Realmuto said he could understand someone’s worrying that his Concerta lecture fees would influence him to prescribe Concerta but not a different drug from the same company, like Risperdal.

In general, he conceded, his relationship with a drug company might prompt him to try a drug. Whether he continued to use it, though, would depend entirely on the results.

As the interview continued, Dr. Realmuto said that upon reflection his payments from drug companies had probably opened his door to useless visits from a drug salesman, and he said he would stop giving sponsored lectures in the future.

Kara Russell, a Johnson & Johnson spokeswoman, said that the company selects speakers who have used the drug in patients and have either undertaken research or are aware of the studies. “Dr. Realmuto met these criteria,” Ms. Russell said.

When asked whether these payments may influence doctors’ prescribing habits, Ms. Russell said that the talks “provide an educational opportunity for physicians.”

No one has proved that psychiatrists prescribe atypicals to children because of drug company payments. Indeed, some who frequently prescribe the drugs to children earn no drug industry money. And nearly all psychiatrists who accept payments say they remain independent. Some say they prescribed and extolled the benefits of such drugs before ever receiving payments to speak to other doctors about them.

“If someone takes the point of view that your doctor can be bought, why would you go to an E. R. with your injured child and say, ‘Can you help me?’ ” said Dr. Suzanne A. Albrecht, a psychiatrist from Edina, Minn., who earned more than $188,000 from 2002 to 2005 giving drug marketing talks.

The Industry Campaign

It is illegal for drug makers to pay doctors directly to prescribe specific products. Federal rules also bar manufacturers from promoting unapproved, or off-label, uses for drugs.

But doctors are free to prescribe as they see fit, and drug companies can sidestep marketing prohibitions by paying doctors to give lectures in which, if asked, they may discuss unapproved uses.

The drug industry and many doctors say that these promotional lectures provide the field with invaluable education. Critics say the payments and lectures, often at expensive restaurants, are disguised kickbacks that encourage potentially dangerous drug uses. The issue is particularly important in psychiatry, because mental problems are not well understood, treatment often involves trial and error, and off-label prescribing is common.

The analysis of Minnesota records shows that from 1997 through 2005, more than a third of Minnesota’s licensed psychiatrists took money from drug makers, including the last eight presidents of the Minnesota Psychiatric Society.

The psychiatrist receiving the most from drug companies was Dr. Annette M. Smick, who lives outside Rochester, Minn., and was paid more than $689,000 by drug makers from 1998 to 2004. At one point Dr. Smick was doing so many sponsored talks that “it was hard for me to find time to see patients in my clinical practice,” she said.

“I was providing an educational benefit, and I like teaching,” Dr. Smick said.

Dr. Steven S. Sharfstein, immediate past president of the American Psychiatric Association, said psychiatrists have become too cozy with drug makers. One example of this, he said, involves Lexapro, made by Forest Laboratories, which is now the most widely used antidepressant in the country even though there are cheaper alternatives, including generic versions of Prozac.

“Prozac is just as good if not better, and yet we are migrating to the expensive drug instead of the generics,” Dr. Sharfstein said. “I think it’s the marketing.”

Atypicals have become popular because they can settle almost any extreme behavior, often in minutes, and doctors have few other answers for desperate families.

Their growing use in children is closely tied to the increasingly common and controversial diagnosis of pediatric bipolar disorder, a mood problem marked by aggravation, euphoria, depression and, in some cases, violent outbursts. The drugs, sometimes called major tranquilizers, act by numbing brain cells to surges of dopamine, a chemical that has been linked to euphoria and psychotic delusions.

Suzette Scheele of Burnsville, Minn., said her 17-year-old son, Matt, was given a diagnosis of bipolar disorder four years ago because of intense mood swings, and now takes Seroquel and Abilify, which have caused substantial weight gain.

“But I don’t have to worry about his rages; he’s appropriate; he’s pleasant to be around,” Ms. Scheele said.

The sudden popularity of pediatric bipolar diagnosis has coincided with a shift from antidepressants like Prozac to far more expensive atypicals. In 2000, Minnesota spent more than $521,000 buying antipsychotic drugs, most of it on atypicals, for children on Medicaid. In 2005, the cost was more than $7.1 million, a 14-fold increase.

The drugs, which can cost $1,000 to $8,000 for a year’s supply, are huge sellers worldwide. In 2006, Zyprexa, made by Eli Lilly, had $4.36 billion in sales, Risperdal $4.18 billion and Seroquel, made by AstraZeneca, $3.42 billion.

Many Minnesota doctors, including the president of the Minnesota Psychiatric Society, said drug makers and their intermediaries are now paying them almost exclusively to talk about bipolar disorder.

The Diagnoses

Yet childhood bipolar disorder is an increasingly controversial diagnosis. Even doctors who believe it is common disagree about its telltale symptoms. Others suspect it is a fad. And the scientific evidence that atypicals improve these children’s lives is scarce.

One of the first and perhaps most influential studies was financed by AstraZeneca and performed by Dr. Melissa DelBello, a child and adult psychiatrist at the University of Cincinnati.

Dr. DelBello led a research team that tracked for six weeks the moods of 30 adolescents who had received diagnoses of bipolar disorder. Half of the teenagers took Depakote, an antiseizure drug used to treat epilepsy and bipolar disorder in adults. The other half took Seroquel and Depakote.

The two groups did about equally well until the last few days of the study, when those in the Seroquel group scored lower on a standard measure of mania. By then, almost half of the teenagers getting Seroquel had dropped out because they missed appointments or the drugs did not work. Just eight of them completed the trial.

In an interview, Dr. DelBello acknowledged that the study was not conclusive. In the 2002 published paper, however, she and her co-authors reported that Seroquel in combination with Depakote “is more effective for the treatment of adolescent bipolar mania” than Depakote alone.

In 2005, a committee of prominent experts from across the country examined all of the studies of treatment for pediatric bipolar disorder and decided that Dr. DelBello’s was the only study involving atypicals in bipolar children that deserved its highest rating for scientific rigor. The panel concluded that doctors should consider atypicals as a first-line treatment for some children. The guidelines were published in The Journal of the American Academy of Child and Adolescent Psychiatry.

Three of the four doctors on the panel served as speakers or consultants to makers of atypicals, according to disclosures in the guidelines. In an interview, Dr. Robert A. Kowatch, a psychiatrist at Cincinnati Children’s Hospital and the lead author of the guidelines, said the drug makers’ support had no influence on the conclusions.

AstraZeneca hired Dr. DelBello and Dr. Kowatch to give sponsored talks. They later undertook another study comparing Seroquel and Depakote in bipolar children and found no difference. Dr. DelBello, who earns $183,500 annually from the University of Cincinnati, would not discuss how much she is paid by AstraZeneca.

“Trust me, I don’t make much,” she said. Drug company payments did not affect her study or her talks, she said. In a recent disclosure, Dr. DelBello said that she received marketing or consulting income from eight drug companies, including all five makers of atypicals.

Dr. Realmuto has heard Dr. DelBello speak several times, and her talks persuaded him to use combinations of Depakote and atypicals in bipolar children, he said. “She’s the leader in terms of doing studies on bipolar,” Dr. Realmuto said.

Some psychiatrists who advocate use of atypicals in children acknowledge that the evidence supporting this use is thin. But they say children should not go untreated simply because scientists have failed to confirm what clinicians already know.

“We don’t have time to wait for them to prove us right,” said Dr. Kent G. Brockmann, a psychiatrist from the Twin Cities who made more than $16,000 from 2003 to 2005 doing drug talks and one-on-one sales meetings, and last year was a leading prescriber of atypicals to Medicaid children.

The Reaction

For Anya Bailey, treatment with an atypical helped her regain her appetite and put on weight, but also heavily sedated her, her mother said. She developed the disabling knot in her back, the result of a nerve condition called dystonia, in 2005.

The reaction was rare but not unknown. Atypicals have side effects that are not easy to predict in any one patient. These include rapid weight gain and blood sugar problems, both risk factors for diabetes; disfiguring tics, dystonia and in rare cases heart attacks and sudden death in the elderly.

In 2006, the Food and Drug Administration received reports of at least 29 children dying and at least 165 more suffering serious side effects in which an antipsychotic was listed as the “primary suspect.” That was a substantial jump from 2000, when there were at least 10 deaths and 85 serious side effects among children linked to the drugs. Since reporting of bad drug effects is mostly voluntary, these numbers likely represent a fraction of the toll.

Jim Minnick, a spokesman for AstraZeneca, said that the company carefully monitors reported problems with Seroquel. “AstraZeneca believes that Seroquel is safe,” Mr. Minnick said.

Other psychiatrists renewed Anya’s prescriptions for Risperdal until Ms. Bailey took Anya last year to the Mayo Clinic, where a doctor insisted that Ms. Bailey stop the drug. Unlike most universities and hospitals, the Mayo Clinic restricts doctors from giving drug marketing lectures.

Ms. Bailey said she wished she had waited to see whether counseling would help Anya before trying drugs. Anya’s weight is now normal without the help of drugs, and her counseling ended in March. An experimental drug, her mother said, has recently helped the pain in her back.

This article is by Gardiner Harris, Benedict Carey and Janet Roberts.

    Industry’s Role in Childrens’ Antipsychotics, NYT, 10.5.2007, http://www.nytimes.com/2007/05/10/health/10psyche.html?hp

Doctors Reap Millions for Anemia Drugs

May 9, 2007
The New York Times
By ALEX BERENSON and ANDREW POLLACK

Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.

Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.

Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year.

Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients’ lives when used at high doses. Yesterday’s report followed the F.D.A.’s decision in March to strengthen warnings on the drugs’ labels.

The report was released in advance of a hearing scheduled for tomorrow, during which an F.D.A. advisory panel will consider whether the drugs are overused.

The medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — are among the world’s top-selling drugs, with combined sales of $10 billion last year. In this country, they represent the single biggest drug expense for Medicare and are given to about a million patients each year to treat anemia caused by kidney disease or cancer chemotherapy.

Dr. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit from fuller disclosure about the payments and the profits that doctors can make from them. “I suspect that Medicare is going to take a very careful look at what is going on here,” he said.

Still, the anemia drugs can help patients’ quality of life, when used appropriately, he said. “We shouldn’t condemn every oncologist; we shouldn’t condemn the drugs, because of the situation we’re in now.”

Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.

Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients.

The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company’s drugs exclusively typically receive higher rebates.

Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates “reflect intense competition” in the market for the drugs, the company said.

Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs.

“Amgen is dedicated to patient safety,” said David Polk, a spokesman. “We believe our contracts support appropriate anemia management and our product promotion is always strictly within the label.”

Both companies’ stocks fell yesterday after release of the F.D.A. report. Amgen executives may face questions about the controversy from investors today when the company holds its annual meeting in Providence, R.I.

Since 1991, when the first of the drugs was still relatively new, the average dose given to dialysis patients in this country has nearly tripled. About 50 percent of dialysis patients now receive enough of the drugs to raise their red blood cell counts above the level considered risky by the F.D.A.

American patients receive far more of the anemia drugs than patients elsewhere, with dialysis patients in this country getting doses more than twice as high as their counterparts in Europe. Cancer care shows a similar pattern. American cancer patients are about three times as likely as those in Europe to get the drugs, and they receive somewhat higher doses.

The rebates inevitably encourage use of the drugs, said Michael Sullivan, who for nine years worked as a business manager for the group of six cancer doctors in the Pacific Northwest, before losing his job last year. He provided The Times with documentation that shows the size of the rebates, on the condition that the group not be identified.

“Personally, I think rebates should go away,” said Mr. Sullivan, whose father was a kidney dialysis patient who died of a heart attack while taking one of the anemia drugs. “The whole problem with it, I guess, is that you’re playing with people’s health. It’s not the same as buying widgets.”

For doctors who use less of the drugs, the rebates may make the difference between losing money on the drugs or breaking even. Mr. Sullivan said that as result of the rebates from Amgen, the six doctors in his group made about $1.8 million in net profit on the drugs they prescribed.

Unlike most drugs, the anemia medicines do not come in fixed doses. Therefore, doctors have great flexibility to increase dosing — and profits. Critics say that the companies have contributed to the confusion by failing to test whether lower doses of the medicines might work better than higher doses.

“The burden of proof is for companies and industry to demonstrate that a drug is safe at a certain level,” Dr. Ajay Singh, an associate professor at Harvard Medical School. Dr. Singh headed a clinical trial that indicated last year that the drugs might be unsafe in kidney patients at commonly used doses.

Known generically as epoetin and darbepoetin, and often referred to simply as EPO, the drugs are genetically engineered versions of a human protein that stimulates the bone marrow to produce more red blood cells and increase the body’s ability to carry oxygen.

Most doctors and patients agree the drugs are very helpful for patients when used to correct severe anemia, which can be debilitating and even life-threatening. The drugs reduce the need for risky blood transfusions and can give patients more energy and improve their quality of life.

“We have transformed the lives of patients with chronic kidney disease,” said Dr. Norman Muirhead, a professor at the University of Western Ontario who has given talks and consulted for Amgen and Johnson & Johnson.

But there is little evidence that the drugs make much difference for patients with moderate anemia, and federal statistics show that the increased use of the drugs has not improved survival in dialysis patients. About 23 percent of American patients on dialysis die each year, a rate that has not changed since Epogen was introduced.

Anemia is measured by a patient’s level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around 14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10 as moderately or severely anemic.

The labels on the drugs, as currently approved by the F.D.A., encourage doctors to aim for a hemoglobin level of 10 to 12. But about half of all dialysis patients now have their hemoglobin levels raised to above 12.

Critics of the drugs say their increased use has been driven by profit. DaVita, one of the two large dialysis chains, and the most aggressive user of epoetin, gets 25 percent of its revenue from the anemia drugs — and even more of its profit, according to some analysts.

Dr. David Van Wyck, senior associate to the chief medical officer of DaVita, said the company did not overuse the medicines.

Doctors determine how much to use, Dr. Van Wyck said. “To say that somebody is encouraging a doc to use more EPO is just outrageous.”

Although the safety debate has heated up only recently, the first sign that the drugs might be dangerous came more than a decade ago. That evidence emerged in a trial sponsored by Amgen that was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14, the level in a healthy person.

But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a hemoglobin goal of 10.

That trial should have discouraged doctors from using too much epoetin and encouraged Amgen to study the risks further, said Dr. Steven Fishbane, a nephrologist at Winthrop-University Hospital on Long Island.

Instead, use of epoetin continued to soar. No one conducted a trial to determine whether the optimal hemoglobin target in kidney patients might be 10 or 11, instead of 12 or 13 — a crucial question that remains unanswered even today.

Dr. Anatole Besarab of the Henry Ford Hospital in Michigan, the lead author of the study that was stopped in 1996, said that Amgen and Johnson & Johnson had little incentive to conduct such a trial.

Dr. Robert M. Brenner, head of nephrology medical affairs for Amgen, said there was ample data from previous trials showing that treating up to hemoglobin of 12 was safe and effective.

Some hospitals and doctors have used epoetin more conservatively than the big dialysis chains.

Dr. Ronald A. Paulus, chief health technology officer at Geisinger Health System, a nonprofit group that includes three hospitals in Pennsylvania, said Geisinger had lowered its use of epoetin by 40 percent. Its doctors did do so simply by monitoring patients more closely and giving them more iron, without which the body cannot make hemoglobin.

Dr. N. D. Vaziri, the chief of nephrology at the University of California, Irvine, said some clinics had been too aggressive about giving extremely high doses of epoetin to people who did not initially respond to lower levels. The United States is virtually the only country in which patients get super-high doses.

“You create a toxicity situation,” said Dr. Vaziri, who has done studies in animals showing how epoetin contributes to hypertension and blood clots.

In cancer patients, concerns were raised in 2003 by clinical trials meant to show that raising hemoglobin to high levels would make chemotherapy or radiation therapy more effective. Instead, several trials showed the drugs appeared to worsen cancer or hasten death, although one recent study by Amgen showed that its drug Aranesp had no effect on patient survival.

The conflicting studies are among the issues the F.D.A. advisory committee is expected to discuss tomorrow. Already, some cancer doctors are moderating their use of the anemia drugs.

Dr. Peter Eisenberg, an oncologist in Marin County, Calif., said many doctors had been induced to use more epoetin by the financial incentives and the belief that the drug was helpful.

“The deal was so good,” he said. “The indication was so clear and the downside was so small that docs just worked it into their practice easily.

“Now it’s much scarier than that,” he said. “We could really be doing harm.”

    Doctors Reap Millions for Anemia Drugs, NYT, 9.5.2007, http://www.nytimes.com/2007/05/09/business/09anemia.html?hp

U.S. hospitals charge uninsured more, study says

Tue May 8, 2007 12:11AM EDT
Reuters
By Kim Dixon

CHICAGO (Reuters) - U.S. hospitals are charging uninsured patients about two-and-a-half times more than those with health insurance, a mark-up that has been steadily rising despite pressure to level prices, a study released on Tuesday found.

In 2004, the most recent year for which data was available, hospital patients without health insurance and others who pay for medical care out of their own pockets were charged an average 2.57 times more than those with health insurance, according to the study published in the May-June issue of the journal Health Affairs.

That number has been rising steadily since 1984, but has jumped more quickly since 2000, the analysis of government data said.

Hospitals in the United States have come under fire from patient groups and lawmakers for marking up prices for those lacking the negotiating clout of a health insurer. But the price discrepancies are steadily worsening despite some reform efforts, the article said.

"The mark-up on hospital care for these individuals, especially for those who can afford it least, is unjustifiable," said Gerard Anderson, director of the center for hospital finance and management at Johns Hopkins University's school of public health, and study author.

The American Hospital Association (AHA), which represents most of the nation's 5,000 or so hospitals, said the report was out-of-date and methodologically flawed.

The group said it is misleading because the study predates U.S. Centers for Medicare and Medicaid guidance, which hospitals say they needed before they could give discounts to uninsured patients.

"Before that, there was a lack of clarity as to whether hospitals could charge differentially," AHA policy analyst Carmela Coyle said.

Hospitals set rates based on a list called the chargemaster, which is generally believed to inflate prices substantially, in the belief that prices will come down during a negotiation process.

For-profit hospitals had the highest discrepancy between costs estimated by Medicare and prices charged, the study found.

UNINSURED WEIGH

But patients without health insurance, about 45 million people in the U.S., lack the ability to negotiate. As it stands, hospitals only collect about 10 cents on the dollar charged to uninsured patients, Anderson said.

"When a hospital presents a bill that has charges on it, those charges are the same for everyone. What is different is how much insurers may negotiate in terms of discounts with hospitals," Coyle said.

More than 60 class-action lawsuits have been filed against U.S. hospitals over the issue. Anderson has been an adviser on some of them. About a year ago, the American Hospital Association enacted a voluntary policy for poor and uninsured patients.

But that policy has yet to show an impact and it is unclear how many hospitals are abiding by the price suggestions, Anderson said.

Anderson recommends pursing the ongoing class-action lawsuits and having the government set a maximum amount that hospitals can charge as prescriptions to remedy the problem.

Several states are exploring the issue, including Illinois and Ohio, Anderson said.

There is one element in the debate in which Anderson and Coyle agree. Both say efforts to provide health insurance to greater numbers of people would ease the problem.

"The real problem of course, is that we live in a country where we don't guarantee coverage for everybody," Coyle said.

    U.S. hospitals charge uninsured more, study says, R, 8.5.2007, http://www.reuters.com/article/domesticNews/idUSN0737585520070508

FDA Seeks Antidepressant Suicide Warning

May 4, 2007
By THE ASSOCIATED PRESS
Filed at 8:00 p.m. ET
The New York Times

WASHINGTON (AP) -- Young adults face an increased risk of suicidal thoughts and behavior when they first begin taking antidepressants and should be warned about the danger, federal health officials said Wednesday.

The Food and Drug Administration asked makers of the drugs to expand its warning labels to include adults age 18-24. The labels already include similar warnings for children and adolescents.

Eli Lilly and Co., the maker of Prozac, Zoloft manufacturer Pfizer Inc. and other pharmaceutical companies said they would comply with the FDA's request.

''We believe this step will help ensure that the millions of people with depression who are young adults age 24 and under and their families can make informed treatment decisions while minimizing the fear and stigma associated with depression,'' Eli Lilly said in a statement.

Pfizer spokeswoman Shreya Prudlo said the company would update its label, which she said already calls for close monitoring of patients when they begin taking Zoloft. She added, however, ''There is no established causal link between Zoloft and suicide in adults, young adults or children.''

The proposed labeling changes would note that studies have not shown this increased risk in adults older than 24 and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior.

The expanded warnings would emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

''Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks,'' said Dr. Steven Galson, the FDA's drugs chief.

The FDA advises that patients of all ages starting on antidepressants should be ''monitored appropriately and observed closely'' for worsening symptoms, suicidal thoughts or behaviors or unusual changes in behavior.

Still, any risks are small. For every 1,000 patients 18-24 treated with antidepressants, the FDA would expect there would be five additional patients who have suicidal thoughts or exhibit suicidal behavior, said Dr. Thomas Laughren, who oversees psychiatric drugs for the FDA. The FDA analysis was based on studies of 11 antidepressants in more than 77,000 patients.

The proposed changes came with the endorsement of FDA expert advisers. Some experts have argued that the changes are overdue while others maintain they could keep drugs from those who need them.

Last month, a comprehensive analysis of antidepressants for children and teenagers found the benefits of treatment trump the small risk of increasing suicidal thoughts and behaviors in some patients. The Journal of the American Medical Association study also found that risk is lower than what the FDA identified in 2004, the year the agency warned the public about the risks of the drugs in children.

After that warning, doctors wrote children fewer prescriptions for antidepressants, and U.S. youth suicides increased.

That suggests the warnings could have a net effect that is harmful if they keep the drugs from patients who would benefit from them, said Dr. David Brent, a University of Pittsburgh School of Medicine psychiatry professor and co-author of the JAMA study.

''When you have a black-box warning and within it you caution people that the biggest risks are from the disease and not being treated, people will still pay attention to the headline and not the small print,'' Brent said.

Laughren said the FDA's doesn't know if the previously strengthened warnings led to the decrease in prescriptions or the increase in youth suicides.

''These are data that are hard to reach any conclusion about in terms of causality, but obviously it is something we are concerned about,'' Laughren said.

------

On the Net:

Food and Drug Administration antidepressant information:

http://www.fda.gov/cder/drug/antidepressants/default.htm

    FDA Seeks Antidepressant Suicide Warning, NYT, 4.5.2007, http://www.nytimes.com/aponline/us/AP-Antidepressants-Suicide.html

Mentally ill die 25 years earlier,

on average

3.5.2007
USA TODAY
By Marilyn Elias

Adults with serious mental illness treated in public systems die about 25 years earlier than Americans overall, a gap that's widened since the early '90s when major mental disorders cut life spans by 10 to 15 years, according to a report due Monday.

"We're going in the wrong direction and have to change course," says Joseph Parks, director of psychiatric services for the Missouri Department of Mental Health. He's lead author of the report from eight states — Maine, Massachusetts, Rhode Island, Oklahoma, Missouri, Texas, Utah and Arizona — that will be released at a meeting of state hospital directors in Bethesda, Md.

About 60% of the 10.3 million people with serious mental illness get care in public facilities, 90% as outpatients, Parks says. They have illnesses such as schizophrenia, bipolar disorder and major depression. Although the mentally ill have high accident and suicide rates, about 3 out of 5 die from mostly preventable diseases, he says.

Obesity is a serious problem. These patients often get little exercise, and many take a newer type of anti-psychotic, on the market for 18 years, that can cause drastic weight gains, promoting diabetes and heart disease, Parks says. He thinks these drugs are contributing to deaths from cardiovascular disease.

Recent studies question the advantage of the newer drugs. "Many could be switched to safer medicines," Parks says. Schizophrenics are thought to have a higher risk for diabetes already, he says.

Mentally ill adults also are more likely than others to have alcohol and drug-abuse problems, and to smoke.

Because of their mental disorder, patients often aren't good health advocates for themselves, says Andrew Leuchter of the UCLA School of Medicine. When patients do seek help, "I hear of great difficulty getting appointments even for simple problems like high blood pressure. … The public health system is underfunded, and it's gotten worse over the years."

Medical needs of the mentally ill are least likely to fall through the cracks when psychiatrists and primary care doctors practice in the same facility, according to a 2003 report from the Bazelon Center for Mental Health Law. But integrated clinics are "quite rare," says Bazelon policy director Chris Koyanagi.

Sometimes internists disregard medical symptoms of the mentally ill, chalking them up to the patient's disorder, says Kenneth Duckworth of the National Alliance on Mental Illness. And needed treatment may be harder to get. He points to a study showing that after the mentally ill suffer heart attacks, they're less likely than other patients to get state-of-the-art care.

Parks thinks agencies such as the Centers for Disease Control and Prevention should track the health of adults with mental illness, just as they do other vulnerable groups, to identify problems and solutions. "Many struggle for decades to overcome mental illness," he says, "and after all that struggle, it's particularly cruel to think that you would die young."

Mentally ill die 25 years earlier, on average, UT, 3.5.2007, http://www.usatoday.com/news/health/2007-05-03-mental-illness_N.htm