USA > History > 2010 > Health (II)

Deal Would Provide Dialysis

to Illegal Immigrants in Atlanta

August 31, 2010
The New York Times
By KEVIN SACK
and CATRIN EINHORN

ATLANTA — Thirty-eight end-stage renal patients, most of them illegal immigrants, would receive the dialysis they need to stay alive at no cost under a rough agreement brokered Tuesday among local dialysis providers and Atlanta’s safety-net hospital, Grady Memorial.

The deal, if completed, would end a yearlong impasse that has come to symbolize the health care plight of the country’s uninsured immigrants and the taxpayer-supported hospitals that end up caring for them. The problem remains unaddressed by the new health care law, which maintains the federal ban on government health insurance for illegal immigrants.

Grady, which receives direct appropriations from Fulton and DeKalb Counties, ultimately agreed on Tuesday to help pay for continuing dialysis for most of the immigrants. Others would be distributed among local dialysis providers as charity cases.

Last fall, Grady’s new management closed its money-losing outpatient dialysis clinic in a move intended to demonstrate fiscal toughness to the city’s philanthropic community. The closing displaced about 60 uninsured illegal immigrants who depended on free thrice-weekly treatments at the clinic to survive.

Illegal immigrants, and legal immigrants newly in the country, are not eligible for Medicare, the federal program that covers most dialysis costs for American citizens with end-stage renal disease.

Grady volunteered to transport the patients to other states or their home countries and pay for three months of treatment. Thirteen accepted the offer. But in response to a patient lawsuit and news media scrutiny, the hospital eventually contracted with a commercial dialysis provider to treat the others in Atlanta for one transitional year.

That contract, with Fresenius Medical Services, expired on Tuesday.

Vital details of the agreement remain to be negotiated, including precisely how the patients will be distributed, how much Grady will pay and whether the arrangement will extend for patients’ lifetimes. But all parties said after meeting Tuesday morning that they were optimistic that they would reach an understanding and that patients would see no lapse in treatment.

“That would make me feel real happy because continuing with my dialysis, I need it to live,” said Ignacio Godinez Lopez, 24, who crossed into the United States illegally as a teenager and has been treated at Grady’s expense for four years. “I’m young, and without dialysis it would be taking my life.”

The patients in Atlanta have gambled that American generosity, even at a time of hostility toward illegal immigrants, would prove a surer bet than uncertain care in their home countries. Several said that the fates of those who returned home had reinforced their fears about leaving Atlanta.

Five of the 13 patients who left for Mexico with assistance from Grady or the Mexican government have died, according to Matt Gove, a Grady senior vice president. Most died while still receiving dialysis, although not always as regularly as recommended.

One patient, Fidelia Perez Garcia, 32, apparently succumbed in April to complications from renal failure after running out of Grady-sponsored treatments in Mexico. Patients with end-stage renal disease can die in as little as two weeks without dialysis, which filters toxins from their blood.

Ms. Perez’s mother, Graciela Garcia Padilla, said by telephone that her family was able to raise money for three additional dialysis sessions, at a cost of about $100 each. Ms. Perez then went 12 days without dialysis and persuaded a hospital to treat her only when she was close to death, Ms. Garcia said.

“They sent her to me just to die,” Ms. Garcia said. “Here, they let people die.”

At the same time, regular treatment in Atlanta has not guaranteed survival. Four of the 45 patients who were receiving dialysis at Fresenius clinics have also died, Mr. Gove said.

Nationally, about one in five dialysis patients die within a year of starting treatment, and about two in three die within five years, according to government figures.

The hospital, which has recently begun a financial turnaround after years of multimillion-dollar losses, has spent more than $2 million on repatriation and dialysis since closing its clinic, Mr. Gove said. As the expiration of Grady’s contract with Fresenius loomed, each sought to shift responsibility to the other. Larry L. Johnson, a DeKalb County commissioner who prodded and mediated the negotiations, said there was movement only when Grady agreed to contribute financially to the patients’ care.

Under the broad outlines of the agreement provided by Mr. Johnson and other participants, Fresenius, DaVita Inc. and Emory University’s health system would each treat a small number of patients — most likely three to five — as charity cases. Fresenius would care for the rest with financial assistance from Grady.

Fresenius and DaVita are the country’s largest commercial dialysis providers, with combined net income of more than $1.3 billion last year.

The agreement would not address the broader concern of how to care for illegal immigrants in the region who have developed renal disease since the Grady clinic’s closing, or those who will do so in the future. At the moment, their only option may be to wait until they are in distress and then visit hospital emergency rooms, which are required by law to provide dialysis to patients who are deemed in serious jeopardy.


Kevin Sack reported from Atlanta, and Catrin Einhorn from New York.

    Deal Would Provide Dialysis to Illegal Immigrants in Atlanta, NYT, 31.8.2010, http://www.nytimes.com/2010/09/01/health/policy/01grady.html

Drug Makers on the Trail of an Alternative to Steroids

August 30, 2010
The New York Times
By ANDREW POLLACK

The hunt is on for alternatives to anabolic steroids, which build muscle by mimicking the effects of the hormone testosterone but whose reputation has been tarnished by athletic doping scandals and side effects like liver damage.

A federally financed study showed that testosterone increased strength in the elderly. But the study was ended abruptly last year because those getting the hormone suffered far more cardiac problems than those getting a placebo.

Human growth hormone is also controversial because of side effects and questions about whether it can increase strength.

Companies like GTx and Ligand Pharmaceuticals are trying to develop drugs that possess the muscle-building ability of testosterone without its side effects, like the development of facial hair and other masculine features in women. These drugs are called selective androgen receptor modulators, or Sarms.

Pfizer, Amgen and Acceleron Pharma are separately pursuing drugs that block myostatin, a protein made by the body that acts as a brake on muscle formation.

Belgian Blue cattle, which do not make myostatin, have huge, rippling muscles and yet are otherwise apparently healthy. Several years ago, scientists reported that a German boy who lacked myostatin because of genetic mutations had abnormal strength and muscle mass.

Cytokinetics is testing a drug for Lou Gehrig’s disease that improves the ability of muscles to contract by, in effect, making them more sensitive to nerve signals.

Most of the drugs have been tested in only early-stage clinical trials so far, and there have been many setbacks.

Wyeth, now part of Pfizer, dropped a myostatin inhibitor that did not work well in a muscular dystrophy clinical trial. Amgen last month called off a trial to test its myostatin blocker for age-related muscle decline. Merck withdrew from a partnership to develop GTx’s drug.

But those companies all say they are not giving up on the quest.

    Drug Makers on the Trail of an Alternative to Steroids, NYT, 30.8.2010, http://www.nytimes.com/2010/08/31/health/research/31muscleside.html

Doctors Seek Way to Treat Muscle Loss

August 30, 2010
The New York Times
By ANDREW POLLACK

Bears emerge from months of hibernation with their muscles largely intact. Not so for people, who, if bedridden that long, would lose so much muscle they would have trouble standing.

Why muscles wither with age is captivating a growing number of scientists, drug and food companies, let alone aging baby boomers who, despite having spent years sweating in the gym, are confronting the body’s natural loss of muscle tone over time.

Comparisons between age groups underline the muscle disparity: An 80-year-old might have 30 percent less muscle mass than a 20-year-old. And strength declines even more than mass. Weight-lifting records for 60-year-old men are 30 percent lower than for 30-year-olds; for women the drop-off is 50 percent.

With interest high among the aging, the market potential for maintaining and rebuilding muscle mass seems boundless. Drug companies already are trying to develop drugs that can build muscles or forestall their weakening without the notoriety of anabolic steroids. Food giants like Nestlé and Danone are exploring nutritional products with the same objective.

In addition, geriatric specialists, in particular, are now trying to establish the age-related loss of muscles as a medical condition under the name sarcopenia, from the Greek for loss of flesh. Simply put, sarcopenia is to muscle what osteoporosis is to bone.

“In the future, sarcopenia will be known as much as osteoporosis is now,” said Dr. Bruno Vellas, president of the International Association of Gerontology and Geriatrics.

Researchers involved in the effort say doctors and patients need to be more aware that muscle deterioration is a major reason the elderly lose mobility and cannot live independently.

“A doctor sees old people who are shrinking and getting weak, but there is no medical terminology that’s been created and made uniform to allow the doctor to make a diagnosis, look at possible causes, and make a treatment plan,” said Dr. Stephanie A. Studenski, a professor of medicine at the University of Pittsburgh.

Of course, commercial interests are at play as well. “If you are trying to sell drugs, you want to have a very clear criterion for diagnosing the problem and for endpoints to treat it,” said Dr. Thomas Lang of the University of California, San Francisco, who is working on techniques for diagnosing sarcopenia.

A task force of academic and industry scientists met in Rome last November and in Albuquerque last month and has submitted a proposed definition of sarcopenia for publication in a medical journal. The meeting received financial support from several drug companies and food companies.

Underscoring the focus on sarcopenia, four European medical societies proposed a somewhat different definition, and Dr. Studenski is developing yet another.

Whatever the definition, experts say, sarcopenia affects about 10 percent of those over 60, with higher rates as age advances. One study estimated that disability caused by sarcopenia accounted for $18.5 billion in direct medical costs in 2000, equivalent to 1.5 percent of the nation’s health care spending that year.

Causes of the loss of muscle mass or strength might include hormonal changes, sedentary lifestyles, oxidative damage, infiltration of fat into muscles, inflammation and resistance to insulin. Some problems stem from the brain and nervous system, which activate the muscles.

Experts say the best approach to restoring or maintaining muscle mass and strength is exercise, particularly resistance training.

The National Institute on Aging is now sponsoring a controlled trial to test whether exercise can prevent disability in largely sedentary people, age 70 to 89. There is also some early evidence that nutrition, like vitamin D or high levels of protein, might help. “At this point, what we can say is that older people are at risk for eating too little protein for adequate muscle preservation,” said Dr. Elena Volpi of the University of Texas Medical Branch in Galveston.

Pharmaceutical companies are paying more attention to muscles, a part of the body they once largely ignored. A year ago, for instance, GlaxoSmithKline hired William Evans, a leading academic expert on sarcopenia, to run a new muscle research unit.

But with sarcopenia still not established as a treatable condition, “there is no real defined regulatory path as to how one would get approved in this area,” said R. Alan Ezekowitz, a research executive at Merck.

So for now, many companies are focusing on better defined illnesses like muscular dystrophy and cachexia, the rapid muscle wasting that can accompany cancer or other diseases.

One problem is that academic researchers and drug companies initially viewed sarcopenia as primarily a loss of muscle mass, a direct analogy to bone density in osteoporosis. Muscle mass can be measured by the same scans used for bone density.

But some studies have shown that strength, like gripping force, or muscle function, as measured, say, by walking speed, can be more important than mass in predicting problems seniors might have.

“There’s a lot more to the story than simply having a lot of muscle tissue,” said Brian C. Clark, an expert at Ohio University. “Most of the drug stuff has been targeting muscle mass.”

So the definition is shifting to include muscle strength and function. The academic-industry task force recommends testing whether a person can walk four meters, or about 13 feet, in four seconds.

That can be tested by any doctor, without the special equipment needed to measure muscle mass or strength, said Roger A. Fielding of Tufts University, a leader of the task force.

Experts say that to win approval from regulators and reimbursement from insurers, a drug must do more than merely improve mass or strength. It must, for example, improve walking ability or prevent people from falling.

Or perhaps it could restore mobility faster after a person is bedridden. Older people can lose so much muscle during a prolonged hospital stay that they have to move to a nursing home.

Demonstrating such benefits and cost savings would help counter criticism that doctors and drug companies are trying to turn a natural consequence of aging into a disease.

“If you can get out of a nursing home in three weeks instead of three months, wouldn’t we say it is a useful thing?” said Dr. Studenski, who consults for drug companies.

Efforts to develop muscle drugs are still in early stages, and there have been setbacks.

But for inspiration, researchers can look to the bears, though scientists have no definitive answer to the animals’ youthful secret.

Moreover, a study that has tracked 3,000 people for 50 years found that about 20 of them, now in their 80s, have not lost muscle mass.

“Maintaining the muscle is possible,” said Dr. Luigi Ferrucci of the National Institute on Aging, who directs the study, called the Baltimore Longitudinal Study of Aging. “We just don’t know the right formula yet.”

    Doctors Seek Way to Treat Muscle Loss, NYT, 30.8.2010, http://www.nytimes.com/2010/08/31/health/research/31muscle.html

Egg Farms Violated Safety Rules

August 30, 2010
The New York Times
By WILLIAM NEUMAN

Barns infested with flies, maggots and scurrying rodents, and overflowing manure pits were among the widespread food safety problems that federal inspectors found at a group of Iowa egg farms at the heart of a nationwide recall and salmonella outbreak.

Inspection reports released by the Food and Drug Administration on Monday described — often in nose-pinching detail — possible ways that salmonella could have been spread undetected through the vast complexes of two companies.

The inspections, conducted over the last three weeks, were the first to check compliance by large egg-producing companies with new federal egg safety rules that were written well before the current outbreak, but went into effect only last month.

“Clearly the observations here reflect significant deviations from what’s expected,” said Michael R. Taylor, deputy commissioner for food for the F.D.A.

Mr. Taylor said that in response to the outbreak and recall, F.D.A. inspectors would visit all of the 600 major egg-producing facilities in the country over the next 15 months. Those farms, with 50,000 or more hens each, represent about 80 percent of nationwide egg production.

The recall, which began Aug. 13, involves more than half a billion eggs from the Iowa operations of two leading egg producers, Wright County Egg and Hillandale Farms. About 1,500 reported cases of Salmonella enteritidis have been linked to tainted eggs since the spring — the largest known outbreak associated with that strain of salmonella.

The F.D.A. inspection reports portray areas of filth and poor sanitation at both operations, including many instances of rodents, wild birds or hens escaped from cages — all of which can carry salmonella — appearing to have had free run of the facilities.

It was difficult to gauge from the report how extensive the problems were. Both companies operate vast facilities housing seven million hens. Wright County Egg says inspectors visited 73 barns on its five egg farms.

Both companies said that they had acted quickly to correct problems and were continuing to cooperate with regulators. The reports cited numerous instances in which both companies had failed to follow through on basic measures meant to keep chickens from becoming infected with salmonella, which can cause them to lay eggs containing the bacteria.

“That is not good management, bottom line,” said Kenneth E. Anderson, a professor of poultry science at North Carolina State University. “I am surprised that an operation was being operated in that manner in this day and age.”

Inspection visits to Wright County Egg found barns with abundant rodent holes and gaps in doors, siding and foundations where rodents could enter. Inspectors spotted mice scampering about 11 laying houses.

Inspectors said that many of the barns lacked separate entrances, so that workers had to walk through one barn to get into another — conditions that could allow workers to track bacteria between barns. In addition, workers were seen moving from barn to barn without changing protective clothing or cleaning tools.

The report on Wright County Egg also described pits beneath laying houses where chicken manure was piled four to eight feet high. It also described hens that had escaped from laying cages tracking through the manure.

Officials last week said that they were taking a close look at a feed mill operated by Wright County Egg, after tests found salmonella in bone meal, a feed ingredient, and in feed given to young birds, known as pullets. The young birds were raised to become laying hens at both Wright County Egg and Hillandale.

The inspection report helped fill in the picture of the feed mill as a potential source of contamination, saying that birds were seen roosting and flying about the facility. (Officials said both wild birds and escaped hens were found at the mill.)

Nesting material was seen in parts of the mill, including the ingredient storage area and an area where trucks were loaded. The report also said that there were numerous holes in bins or other structures open to the outdoors. That included the bin containing meat and bone meal that provided the feed ingredient sample in which salmonella was found.

Officials said last week that they had found traces of salmonella similar to the strain associated with the outbreak in a total of six test samples taken from Wright County Egg facilities. That included the two feed tests and four tests taken from walkways or other areas.

On Monday, officials said for the first time that they had also found salmonella at a Hillandale facility. The bacteria was found in water that had been used to wash eggs.

The inspection report on Hillandale showed many problems similar to those found at Wright County Egg, including hens tracking through manure piles and signs of rodent infestation.

F.D.A. officials said they were not permitted to discuss possible enforcement actions. But, according to Mr. Taylor, the law allows for civil actions like injunctions as well as criminal prosecution.

“We are in the process of analyzing this evidence and considering what enforcement actions would be appropriate,” Mr. Taylor said.

Officials said their investigation was continuing and they were not yet able to say how the salmonella had gotten into the laying operations.

Wright County Egg is owned by Jack DeCoster, who has a long history of environmental, labor and immigration violations at egg operations in Maine, Iowa and elsewhere. The inspection report identified Mr. DeCoster’s son, Peter DeCoster, as the chief operating officer of the Iowa operation.

Both companies have stopped selling shell eggs to consumers from their Iowa facilities and instead are sending all their eggs to breaking plants where they are pasteurized, which kills the bacteria. The eggs would then most likely be sold in liquid form, possibly to food manufacturers.

Symptoms of salmonella include diarrhea, vomiting and stomach cramps. The bacteria is killed by pasteurization or by thoroughly cooking the eggs.

    Egg Farms Violated Safety Rules, NYT, 30.8.2010, http://www.nytimes.com/2010/08/31/business/31eggs.html

Years Later, No Magic Bullet Against Alzheimer’s Disease

August 28, 2010
The New York Times
By GINA KOLATA

BETHESDA, Md. — The scene was a kind of science court. On trial was the question “Can anything — running on a treadmill, eating more spinach, learning Arabic — prevent Alzheimer’s disease or delay its progression?”

To try to answer that question, the National Institutes of Health sponsored the court, appointing a jury of 15 medical scientists with no vested interests in Alzheimer’s research. They would hear the evidence and reach a judgment on what the data showed.

For a day and a half last spring, researchers presented their cases, describing studies and explaining what they had hoped to show. The jury also heard from scientists from Duke University who had been commissioned to look at the body of evidence — hundreds of research papers — and weigh it. And the jury members had read the papers themselves, preparing for this day.

The studies included research on nearly everything proposed to prevent the disease: exercise, mental stimulation, healthy diet, social engagement, nutritional supplements, anti-inflammatory drugs or those that lower cholesterol or blood pressure, even the idea that people who marry or stay trim might be saved from dementia. And they included research on traits that might hasten Alzheimer’s onset, like not having much of an education or being a loner.

It is an issue that has taken on intense importance because scientists recently reported compelling evidence that two types of tests, PET scans of Alzheimer’s plaque in the brain and tests of spinal fluid, can find signs of the disease years before people have symptoms. That gives rise to the question: What, if anything, can people do to prevent it?

But the jury’s verdict was depressing and distressing. So far, nothing has been found to prevent or delay this devastating disease, which ceaselessly kills brain cells, eventually leaving people mute, incontinent, unable to feed themselves, unaware of who they are or who their family and friends are.

“Currently,” the panel wrote, “no evidence of even moderate scientific quality exists to support the association of any modifiable factor (such as nutritional supplements, herbal preparations, dietary factors, prescription or nonprescription drugs, social or economic factors, medical conditions, toxins or environmental exposures) with reduced risk of Alzheimer’s disease.”

“I was surprised and, at the same time, very sad” about the lack of evidence, said Dr. Martha L. Daviglus, the panel chairwoman and a professor of preventive medicine and medicine at the Feinberg School of Medicine at Northwestern University. “This is something that could happen to any of us, and yet we are at such a primitive state of research.”

She said, “In the end, we concluded that the evidence is the evidence and we have to say what it is.”

The state of the evidence reflects in part the long time it took before researchers even realized that Alzheimer’s was a disease, said Dr. Richard J. Hodes, director of the National Institute on Aging. Until the mid-1980s, many thought dementia was a normal part of aging, and so serious studies of its causes and prevention did not really begin until then. Scientists have spent the years since searching for factors that might affect risk, checking data from other studies to see if, for example, diet or blood pressure or years of education might be associated with the disease.

In the meantime, doctors are in a bind. Should they tell people to do things like walk briskly or eat vegetables — activities that might someday be shown to protect against Alzheimer’s and that certainly cannot hurt? Or should they wait for absolute proof, confirmation that a diet or a drug or an exercise regimen prevents Alzheimer’s?

The Alzheimer’s Association tells people to exercise, challenge themselves mentally, remain socially engaged and keep their hearts healthy. Such measures can only help, says Dr. Maria C. Carrillo, a senior director of the organization.

But, she said, “The Alzheimer’s Association certainly agrees that there is not enough evidence to say anything definitive about the prevention of Alzheimer’s disease and any kind of intervention.”

Of course, Dr. Hodes said, there are many reasons to follow practices to improve general health. But, he said, researchers have to be careful about implying that any measures will protect against this degenerative brain disease.

“We don’t know that yet,” Dr. Hodes said.

 

Rating the Quality

Dr. John W. Williams Jr., head of the Duke group that evaluated the studies, thought the task would not be too arduous. He expected relatively few studies and clear results.

To its great surprise, the Duke group discovered a vast amount of literature on Alzheimer’s prevention. Instead of coming up empty on many topics, Dr. Williams said, “We came up empty on very few.”

The problem, the group wrote, was that “the quality of the evidence was typically low.”

Most studies observed people who happened to use or not use a possible preventive measure and then determined whether they got Alzheimer’s or not.

Such studies, known as observational ones, are not the gold standard, like those in which people are randomly assigned to take a pill or do something like exercise, or not. Observational studies are useful in generating hypotheses but are not proof. Still, if several well-done studies of this type come to the same conclusion, they can be valuable evidence.

In the case of Alzheimer’s prevention, though, the studies tended to have problems, Dr. Williams said.

Often it was not clear precisely what subjects were doing. They might have been using a drug or a supplement at the start of the study but the dose was not specified, nor was it clear whether subjects were taking the same doses, or for how long.

Some studies of drugs to lower blood pressure used self-reports as opposed to, for example, pharmacy data. A 12-year study asked participants about their use of cholesterol-lowering statins at the start of the study but never did again. A nine-year statin study used pharmacy records but included as users those who took the drugs at any time during the study period.

Definitions of conditions, like high blood pressure, tended to vary from study to study.

Descriptions of factors like “strong social support” were vague or idiosyncratic. For example, some studies classified married people as having strong social support for that reason alone, with no evaluation of whether the marriage was good or bad.

Often, there were vague assessments of Alzheimer’s disease. And often studies did not take into account other differences among subjects, like age or family history of Alzheimer’s, that might have independently led some to get the disease and others not.

Looking over the piles of studies, the group rated evidence as high, moderate or low, depending on how confident they were in the findings.

Low confidence did not necessarily mean the measures did not work — it meant the evidence was so faulty that there was no way of deciding.

In the end, it said it was highly confident in the findings for just one thing, the herb ginkgo biloba. But in that case the evidence pointed in only one direction: it did not prevent Alzheimer’s.

Moderate evidence, not totally convincing but not worthless, applied to only four factors studied.

Two were factors that increased risk. They were a particular gene, ApoE4, which, moderate evidence showed, increased risk about threefold, and menopause therapy with a combination of estrogens and progestins, which doubled risk.

The other moderate evidence indicated that certain things that had been hoped to be protective were not. For instance, there was moderate evidence that vitamin E, found in nuts, vegetable oils, green leafy vegetables and fortified cereals, had no effect on risk. There was also moderate evidence that cholinesterase inhibitors, drugs often used to treat Alzheimer’s symptoms, had no effect.

Other than that, evidence was poor.

There is only poor evidence, for example, that keeping your brain active, having a high level of education or exercising has a protective effect. There is also only poor evidence that eating a Mediterranean diet — high in fruits and vegetables, fish and olive oil — will help stave off Alzheimer’s.

There is only poor evidence that having poor social support or smoking increases risk.

In a way, it is not surprising that many thought the evidence was stronger than it was, says Dr. James R. Burke, a member of the Duke group and director of the Memory Disorders Clinic at Duke.

“You remember the positive studies,” Dr. Burke said. “The ones that are more marginal, you tend to put them out of your mind.”

And many things thought to protect against Alzheimer’s — a healthy diet, vigorous exercise and an active brain — just seem to be common sense. The science jury said it was still possible that those measures might be found to help and urged that better quality studies be done.

But that may not be so easy if studies have to follow people until they get the disease. Alzheimer’s seems to progress silently in the brain for a decade before the earliest symptoms of memory problems surface. It can take another decade until the distinctive signs of Alzheimer’s appear: profound memory loss and an inability to handle the normal activities of daily life like bathing and dressing.

“Once there is even minimal cognitive impairment, the brain is damaged, inflamed, burning like a bonfire,” said Dr. Caleb Finch, director of the Gerontology Research Institute at the University of Southern California.

As a result, high-quality studies of possible factors like diet and exercise or mental stimulation before the disease’s onset might have to last for decades.

In the meantime, patients, like those at Dr. Burke’s Memory Disorders Clinic, and their frightened family members want advice about things they can do now.

He tells them to do all they can to stay healthy: keep their heart disease risk factors under control, eat a good diet, exercise. He tells them that even if good health cannot prevent Alzheimer’s, it might delay its onset.

“We don’t have compelling evidence or proof that this will prevent Alzheimer’s disease,” he says. But those measures, he adds, “would improve quality of life.”

But Dr. Williams, head of the Duke group, said it was also important to keep an open mind; the measures may or may not affect a person’s chances of getting Alzheimer’s.

“Unfortunately, in medicine,” he said, “things that are logical and make good sense don’t necessarily work out.”

 

The Problem, Personified

Elise Schoux of Washington is facing the prevention problem. She is 53, an age when prevention might make sense — when Alzheimer’s strikes, people usually are in their 70s and 80s — and she is watching her 70-year-old husband’s slow decline into the dread disease.

Bill Schoux’s memory had been deteriorating for years, but in July 2009, when he got the diagnosis, Mrs. Schoux was devastated.

“For two weeks, we were at a loss, we would burst into tears,” she said. “How could this be?”

Mr. Schoux had been an athlete all his life, he ate a healthy diet, he was friendly and outgoing. He had been an expert on foreign aid, traveling around the world, and had certainly had a mentally stimulating career. Mrs. Schoux is not sure how much more her husband could have done to ward off Alzheimer’s. But she wants to do everything she can to protect herself from getting it and to slow the disease in him.

So Mrs. Schoux now unfailingly goes to the gym with her husband several days a week, lifting weights and spending 30 minutes on a treadmill or an elliptical cross trainer.

Her husband always worked crossword puzzles. Now she does them, too. She and her husband have a subscription to a local theater. And they read the newspaper every day.

“It can’t hurt to keep the brain cells moving,” Mrs. Schoux said.

Mrs. Schoux also tries to eat blueberries, salmon, intensely colored fruits and dark leafy vegetables, in case that helps.

She knows that much of what she is trying is unproved but feels that it can, at worst, be harmless.

“I don’t know what the answers are,” Mrs. Schoux said. “I hope they find something. It is a seriously debilitating disease.”

    Years Later, No Magic Bullet Against Alzheimer’s Disease, 28.8.2010, http://www.nytimes.com/2010/08/29/health/research/29prevent.html

Digital Devices Deprive Brain of Needed Downtime

August 24, 2010
THe New York Times
By MATT RICHTEL

SAN FRANCISCO — It’s 1 p.m. on a Thursday and Dianne Bates, 40, juggles three screens. She listens to a few songs on her iPod, then taps out a quick e-mail on her iPhone and turns her attention to the high-definition television.

Just another day at the gym.

As Ms. Bates multitasks, she is also churning her legs in fast loops on an elliptical machine in a downtown fitness center. She is in good company. In gyms and elsewhere, people use phones and other electronic devices to get work done — and as a reliable antidote to boredom.

Cellphones, which in the last few years have become full-fledged computers with high-speed Internet connections, let people relieve the tedium of exercising, the grocery store line, stoplights or lulls in the dinner conversation.

The technology makes the tiniest windows of time entertaining, and potentially productive. But scientists point to an unanticipated side effect: when people keep their brains busy with digital input, they are forfeiting downtime that could allow them to better learn and remember information, or come up with new ideas.

Ms. Bates, for example, might be clearer-headed if she went for a run outside, away from her devices, research suggests.

At the University of California, San Francisco, scientists have found that when rats have a new experience, like exploring an unfamiliar area, their brains show new patterns of activity. But only when the rats take a break from their exploration do they process those patterns in a way that seems to create a persistent memory of the experience.

The researchers suspect that the findings also apply to how humans learn.

“Almost certainly, downtime lets the brain go over experiences it’s had, solidify them and turn them into permanent long-term memories,” said Loren Frank, assistant professor in the department of physiology at the university, where he specializes in learning and memory. He said he believed that when the brain was constantly stimulated, “you prevent this learning process.”

At the University of Michigan, a study found that people learned significantly better after a walk in nature than after a walk in a dense urban environment, suggesting that processing a barrage of information leaves people fatigued.

Even though people feel entertained, even relaxed, when they multitask while exercising, or pass a moment at the bus stop by catching a quick video clip, they might be taxing their brains, scientists say.

“People think they’re refreshing themselves, but they’re fatiguing themselves,” said Marc Berman, a University of Michigan neuroscientist.

Regardless, there is now a whole industry of mobile software developers competing to help people scratch the entertainment itch. Flurry, a company that tracks the use of apps, has found that mobile games are typically played for 6.3 minutes, but that many are played for much shorter intervals. One popular game that involves stacking blocks gets played for 2.2 minutes on average.

Today’s game makers are trying to fill small bits of free time, said Sebastien de Halleux, a co-founder of PlayFish, a game company owned by the industry giant Electronic Arts.

“Instead of having long relaxing breaks, like taking two hours for lunch, we have a lot of these micro-moments,” he said. Game makers like Electronic Arts, he added, “have reinvented the game experience to fit into micro-moments.”

Many business people, of course, have good reason to be constantly checking their phones. But this can take a mental toll. Henry Chen, 26, a self-employed auto mechanic in San Francisco, has mixed feelings about his BlackBerry habits.

“I check it a lot, whenever there is downtime,” Mr. Chen said. Moments earlier, he was texting with a friend while he stood in line at a bagel shop; he stopped only when the woman behind the counter interrupted him to ask for his order.

Mr. Chen, who recently started his business, doesn’t want to miss a potential customer. Yet he says that since he upgraded his phone a year ago to a feature-rich BlackBerry, he can feel stressed out by what he described as internal pressure to constantly stay in contact.

“It’s become a demand. Not necessarily a demand of the customer, but a demand of my head,” he said. “I told my girlfriend that I’m more tired since I got this thing.”

In the parking lot outside the bagel shop, others were filling up moments with their phones. While Eddie Umadhay, 59, a construction inspector, sat in his car waiting for his wife to grocery shop, he deleted old e-mail while listening to news on the radio. On a bench outside a coffee house, Ossie Gabriel, 44, a nurse practitioner, waited for a friend and checked e-mail “to kill time.”

Crossing the street from the grocery store to his car, David Alvarado pushed his 2-year-old daughter in a cart filled with shopping bags, his phone pressed to his ear.

He was talking to a colleague about work scheduling, noting that he wanted to steal a moment to make the call between paying for the groceries and driving.

“I wanted to take advantage of the little gap,” said Mr. Alvarado, 30, a facilities manager at a community center.

For many such people, the little digital asides come on top of heavy use of computers during the day. Take Ms. Bates, the exercising multitasker at the expansive Bakar Fitness and Recreation Center. She wakes up and peeks at her iPhone before she gets out of bed. At her job in advertising, she spends all day in front of her laptop.

But, far from wanting a break from screens when she exercises, she says she couldn’t possibly spend 55 minutes on the elliptical machine without “lots of things to do.” This includes relentless channel surfing.

“I switch constantly,” she said. “I can’t stand commercials. I have to flip around unless I’m watching ‘Project Runway’ or something I’m really into.”

Some researchers say that whatever downside there is to not resting the brain, it pales in comparison to the benefits technology can bring in motivating people to sweat.

“Exercise needs to be part of our lives in the sedentary world we’re immersed in. Anything that helps us move is beneficial,” said John J. Ratey, associate clinical professor of psychiatry at the Harvard Medical School and author of “Spark: The Revolutionary New Science of Exercise and the Brain.”

But all things being equal, Mr. Ratey said, he would prefer to see people do their workouts away from their devices: “There is more bang for your buck doing it outside, for your mood and working memory.”

Of the 70 cardio machines on the main floor at Bakar Fitness, 67 have televisions attached. Most of them also have iPod docks and displays showing workout performance, and a few have games, like a rope-climbing machine that shows an animated character climbing the rope while the live human does so too.

A few months ago, the cable TV went out and some patrons were apoplectic. “It was an uproar. People said: ‘That’s what we’re paying for,’ ” said Leeane Jensen, 28, the fitness manager.

At least one exerciser has a different take. Two stories up from the main floor, Peter Colley, 23, churns away on one of the several dozen elliptical machines without a TV. Instead, they are bathed in sunlight, looking out onto the pool and palm trees.

“I look at the wind on the trees. I watch the swimmers go back and forth,” Mr. Colley said. “I usually come here to clear my head.”

    Digital Devices Deprive Brain of Needed Downtime, NYT, 24.8.2010, http://www.nytimes.com/2010/08/25/technology/25brain.html

Wrong Direction on Stem Cells

August 24, 2010
The New York Times

In a huge overreach, a federal judge has decided that the legal interpretation that has governed federal support of embryonic stem cell research for more than a decade is invalid. If the ruling stands, it will be a serious blow to medical research.

The ruling by Judge Royce Lamberth would block President Obama’s expansion of federally funded research to include scores of new stem cell lines. It also appears to bar funding for research on the handful of lines that were approved by President George W. Bush in 2001. The Department of Justice has rightly announced that it will appeal.

Scientists hold high hopes that this research will lead to cures for devastating ailments like diabetes, Parkinson’s and spinal cord injuries. The stem cells are also useful for screening drugs to treat such diseases. Researchers who already have federal money in hand could likely continue their work. But those who need new funding for proposed or continuing research would have to find private sources or shut their experiments down.

The judge’s ruling came as he granted a preliminary injunction blocking President Obama’s 2009 executive order expanding this research to use stem cells derived from surplus embryos at fertility clinics that would otherwise be discarded or frozen in perpetuity.

Although the injunction is temporary, the ruling is ominous because it means that the judge believes the two plaintiffs — scientists who do research on adult stem cells — have a “strong likelihood of success” if this issue proceeds to trial.

The case involves an obscure rider, known as the Dickey-Wicker amendment, that has been attached to annual appropriations bills for the Department of Health and Human Services since 1996. It prohibits the use of federal funds to support research in which embryos are destroyed or discarded. It does not directly address research on stem cells derived from embryos, a field that developed later.

The Clinton administration and now the Obama administration drew a fine distinction: deriving the stem cells — which results in destruction of the embryos — could not be supported by the federal government but research on stem cells after they were derived with private funds could be financed.

The Bush administration also implicitly accepted this distinction by funding research on a handful of stem cell lines derived with private funds. At no time has Congress disputed this distinction or rewritten Dickey-Wicker to address stem cells directly.

Now Judge Lamberth has ruled that Dickey-Wicker prohibits funding of all research in which a human embryo is destroyed, even if the destruction occurs before the research begins. He claims that the Dickey-Wicker language “unambiguously” prohibits work on stem cells derived from embryos.

How can that be true if the federal government has interpreted it the other way for 11 years and Congress has not disputed that interpretation? If there is any ambiguity, the courts typically give deference to agency interpretations.

The judge also finds that the two adult stem cell researchers who brought the case would suffer imminent and irreparable harm without the injunction because they would have to compete with embryonic stem cell researchers for research funds. That is absurd. Adult stem cell research is funded far more generously than work with embryonic stem cells. And there is no firm limit on the amount of money that can be spent on each.

Scientists are hopeful that a relatively new field of research in which mature skin cells are reprogrammed back to an embryonic-like state will ultimately make it unnecessary to destroy embryos, but that day is not here. We need to pursue all avenues vigorously.

The Justice Department should quickly press its appeal. And Congress should settle this issue once and for all — by passing legislation that ensures continued federal funding to support research on stem cells derived from human embryos.

    Wrong Direction on Stem Cells, NYT, 24.8.2010, http://www.nytimes.com/2010/08/25/opinion/25wed1.html

A Choice of Two Cancer Screenings

August 24, 2010
The New York Times

To the Editor:

The American College of Gastroenterology agrees with your Aug. 17 editorial “Colon Cancer Prevention” that patients should not abandon colonoscopies based on the studies cited in this editorial. In fact, the available science demonstrates the clear superiority of colonoscopy in reducing colorectal cancer deaths when performed by a well-trained endoscopist.

Sigmoidoscopy does not view the entire colon, still requires that the patient take a prep, is often uncomfortable because of the lack of sedation and may not allow for polyp removal at the initial screening exam. These limitations could mean the difference between life and death — especially for high-risk groups, like African-Americans, who have a greater prevalence of right-sided polyps and cancer, which sigmoidoscopy cannot detect.

At a time when we are making tremendous progress in reducing colorectal cancer mortality because of more screening through colonoscopy, it would be misguided to change course, based on the available evidence.

Philip O. Katz
President
American College of Gastroenterology
Philadelphia, Aug. 17, 2010

•

To the Editor:

Your editorial questions the efficacy of colonoscopies and asserts that the less expensive sigmoidoscopy is “easier on the patient.”

In the past 10 years I have had two routine colonoscopies, one in which polyps were discovered and removed during the procedure. In both cases the experience was done with the aid of sedation drugs and not at all uncomfortable.

In contrast, the sigmoidoscopy involves being probed without the benefit of drugs. And then, if a polyp is discovered, you have to schedule a follow-up colonoscopy in order to remove the polyp — a second procedure that wouldn’t be necessary had the colonoscopy been the first choice.

Before we start the mad rush to save money at any cost, can we please have a full and honest assessment of the patient experience?

Don Bullick
San Francisco, Aug. 18, 2010

•

To the Editor:

I agree with your editorial suggesting that patients should not abandon screening colonoscopy. But patients should know that colonoscopy is a highly operator-dependent procedure. Recent guidelines establish clear quality targets for colonoscopists, but many doctors have not yet done the measurements of their polyp detection rates that define whether they are effective examiners.

It is fair for patients to ask colonoscopists for their detection rate for adenomas (pre-cancerous polyps) and other established measures of quality. High-quality colonoscopy can detect lesions that are relatively specific to the right colon, including flat and depressed lesions as well as serrated polyps, and can certainly provide much better protection against right-sided colon cancer than was seen in the recent studies that your editorial cites.

Douglas K. Rex
Indianapolis, Aug. 18, 2010

The writer, a doctor, is director of endoscopy at Indiana University Hospital and has played a major role in developing the clinical guidelines for colonoscopy.

•

To the Editor:

Your editorial about colon cancer prevention reminded me of my own experience with sigmoidoscopies versus colonoscopies. About 15 years ago, at age 55, I heard a lecture by someone recommending colonoscopies if one wanted to find all polyps on the colon. Since I had colon cancer in my family, I had been having sigmoidoscopies yearly since age 50.

No polyps had been discovered. I decided to have a colonoscopy, which my insurance company refused to pay for. I went ahead anyway. A large precancerous polyp was found on the lower part of my colon and removed. The sigmoidoscopy had not seen that part of my colon. I feel as if the colonoscopy saved my life. My insurance company did pay after the discovery of the polyp.

I now get regular colonoscopies and no more sigmoidoscopies. To me, it’s a no-brainer. An added advantage is that colonoscopies are painless and sigmoidoscopies cause severe cramping. (We all know that the worst part of the colonoscopy is the preparation.)

Ellen Shaffer Meyer
Wilmington, Del., Aug. 18, 2010

    A Choice of Two Cancer Screenings, NYT, 24.8.2010, http://www.nytimes.com/2010/08/25/opinion/l25colon.html

Colon Cancer Prevention

August 16, 2010
The New York Times

A provocative new analysis suggests that the colonoscopies many people get to detect and eliminate colon cancer before it can kill them may be no more effective than a less invasive (and cheaper) procedure would be. The analysis, more thought-provoking than conclusive, illustrates the kind of evidence scientists will need to develop as leaders of the American health care system struggle to define which treatments are more effective — and more cost-effective — than others.

Over the past two decades, colonoscopies have become the preferred method for trying to detect and remove cancers and precancerous polyps in the colon. They have largely supplanted their main rival, sigmoidoscopies. The sigmoidoscopy looks at only part of the colon; the colonoscopy inspects the whole length. For many patients and doctors, it seems only common sense that the more comprehensive exam is the safest choice.

Yet there is scant evidence to support that belief. A recent commentary by two Columbia University experts in the Journal of the American Medical Association suggested that colonoscopies may be no better at preventing cancer deaths than sigmoidoscopies, which are easier on the patient and have fewer complications.

Three studies conducted abroad over the past two years found that colonoscopies did indeed reduce colorectal cancer mortality or incidence — by essentially the same amount that sigmoidoscopies did in separate studies. The colonoscopies achieved their effect by eliminating only growths found in the part of the colon that sigmoidoscopies can also reach and identify, not by eliminating growths deeper inside.

Experts have been scrambling for explanations. Their theories include: a failure by many doctors abroad, who are often less experienced than American specialists, to inspect the entire colon; a failure by many patients to cleanse their bowels sufficiently; and molecular or anatomical differences that might make growths in the distant reaches of the colon more difficult to spot.

It would seem premature for patients to abandon colonoscopies based on these studies. The critical need now is for researchers to determine how well colonoscopies perform in the United States and to identify how to improve their effectiveness. Meanwhile, those who have shunned colonoscopies as too arduous may prefer a sigmoidoscopy. Either technique can substantially reduce the risk of colon cancer.

    Colon Cancer Prevention, NYT, 16.8.2010, http://www.nytimes.com/2010/08/17/opinion/17tue3.html

Two New Paths to the Dream: Regeneration

August 5, 2010
The New York Times
By NICHOLAS WADE

Two research reports published Friday offer novel approaches to the age-old dream of regenerating the body from its own cells.

Animals like newts and zebra fish can regenerate limbs, fins, even part of the heart. If only people could do the same, amputees might grow new limbs and stricken hearts be coaxed to repair themselves.

But humans have very little regenerative capacity, probably because of an evolutionary trade-off: suppressing cell growth reduced the risk of cancer, enabling humans to live longer. A person can renew his liver to some extent, and regrow a fingertip while very young, but not much more.

In the first of the two new approaches, a research group at Stanford University led by Helen M. Blau, Jason H. Pomerantz and Kostandin V. Pajcini has taken a possible first step toward unlocking the human ability to regenerate. By inactivating two genes that work to suppress tumors, they got mouse muscle cells to revert to a younger state, start dividing and help repair tissue.

What is true of mice is often true of humans, and although scientists are a long way from being able to cause limbs to regenerate, the research is attracting attention. Jeremy Brockes, a leading expert on regeneration at University College London, said the report was “an excellent paper.” Though there is a lot still to learn about the process, “it is hard to imagine that it will not be informative for regenerative medicine in the future,” he said.

In recent years, most research in the field of regenerative medicine has focused on the hope that stem cells, immature cells that give rise to any specific type of cell needed in the body, can somehow be trained to behave as normal adult cells do. Nature’s method of regeneration is quite different in that it starts with the adult cells at the site of a wound and converts the cells to a stemlike state in which they can grow and divide.

The Stanford team has taken a step toward mimicking the natural process. “What I like is that it’s built on what’s happening in nature,” Dr. Blau said. “We mammals lost this regenerative capacity in order to have better tumor suppression, but if we reawaken it in a careful way we could make use of it in a clinical setting.”

Dr. Pomerantz, a clinician, hopes the technique can be applied to people, though many more animal experiments need to be done first. “We have shown we can recapitulate in mammalian cells behavior of lower vertebrate cells that is required for regeneration,” he said. “We would propose using it in amputations of a limb or part of a limb or in cardiac muscle.” After a heart attack, the muscle cells do not regenerate, so any method of making them do so would be a possible treatment.

Interfering with tumor suppressor genes is a dangerous game, but Dr. Pomerantz said the genes could be inhibited for just a short period by applying the right dose of drug. When the drug has dissipated, the antitumor function of the gene would be restored.

Finding the right combination of genes to suppress was a critical step in the new research. One of the two tumor suppressor genes is an ancient gene, known as Rb, which is naturally inactivated in newts and fish when they start regenerating tissue. Mammals possess both the Rb gene and a backup, called the Arf gene, which will close down a cancer-prone cell if Rb fails to do so.

The Stanford team found that newts did not have the Arf backup gene, which mammals must have acquired after their lineage diverged from that of amphibians. This suggests that the backup system “evolved at the expense of regeneration,” the Stanford researchers say in Friday’s issue of Cell Stem Cell.

The Stanford team shut off both Rb and Arf with a chemical called silencing-RNA and found the mouse muscle cells started dividing. When injected into a mouse’s leg, the cells fused into the existing muscle fibers, just as they are meant to.

The Stanford researchers have learned how to block two genes thought to inhibit the natural regenerative capacity of cells, but it is somewhat surprising that the regenerative mechanism should still exist at all if mammals have been unable to use it for 200 million years. “One school of thought is that regeneration is a default mechanism and doesn’t require its own program,” Dr. Pomerantz said.

Dr. Brockes believes that this is true in part. Regeneration “depends on a largely conserved cellular machinery,” he said, meaning that it is present in all animals. The machinery comes into play in wound healing and tissue maintenance. But specific instances of regeneration, like regrowing a whole limb, are invoked by genes specific to various species. He has found a protein specific to salamanders that coordinates regrowth of a salamander limb.

If the regeneration of a whole limb is a special ability that salamanders have evolved, then humans would not have any inherent ability to do the same. “I would beware of suggesting that this sort of manipulation is capable of unlocking ‘the newt within,’ ” Dr. Brockes said.

A second, quite different approach to regenerating a tissue is reported in Friday’s issue of Cell by Deepak Srivastava and colleagues at the University of California, San Francisco. Working also in the mouse, they have developed a way of reprogramming the ordinary tissue cells of the heart into heart muscle cells, the type that is irretrievably lost in a heart attack.

The Japanese scientist Shinya Yamanaka showed three years ago that skin cells could be converted to embryonic stem cells simply by adding four proteins known to regulate genes. Inspired by Dr. Yamanaka’s method, Dr. Srivastava and his colleagues selected 14 such proteins and eventually found that with only three of them they could convert heart fibroblast cells into heart muscle cells.

To make clinical use of the discovery, Dr. Srivastava said he would need first to duplicate the process with human cells, and then develop three drugs that could substitute for the three proteins used in the conversion process. The drugs could be loaded into a stent, a small tube used in coronary bypass operations. With the stent inserted into a heart artery, the drugs would convert some of the heart’s tissue cells into heart muscle cells.

Some researchers hope that with Dr. Yamanaka’s method of turning skin cells into embryonic stem cells, those stem cells can be converted into usable heart muscle cells. One problem with this approach is that any unconverted embryonic stem cells may form tumors. Dr. Srivastava’s method sidesteps this problem by avoiding the stem cell stage.

    Two New Paths to the Dream: Regeneration, NYT, 5.8.2010, http://www.nytimes.com/2010/08/06/science/06cell.html

Dr. Robert M. Chanock, Prominent Virologist, Dies at 86

August 4, 2010
The New York Times
By LAWRENCE K. ALTMAN

Dr. Robert M. Chanock, a pediatrician whose discoveries of viruses led to far-reaching improvements in preventing and treating common respiratory illnesses, particularly among children, died Friday in Sykesville, Md. He was 86.

His death, at an assisted living facility, was caused by complications of Alzheimer’s disease, the National Institute of Allergy and Infectious Diseases said. He had worked at the institute, in Bethesda, Md., for 53 years and had lived in Bethesda.

“Dr. Chanock was one of the top 20 virologists in history and covered a broad range of infectious diseases with an amazing productivity,” Dr. Erling C. J. Norrby, a virologist and former secretary general of the Royal Swedish Academy of Sciences, said in an interview on Tuesday.

Dr. Chanock first gained wide attention in 1957 with the discovery of the human respiratory syncytial virus, one of the most common causes of illness in the world. It can cause bronchiolitis, an infection of the small airways in the lungs, especially among infants and young children.

As the head of research teams, he subsequently discovered four other infectious agents, called para-influenza viruses, which include the most important cause of severe croup in infants.

In 1962, a team led by Dr. Chanock showed that a bacterium, Mycoplasma pneumoniae, is a cause of atypical pneumonia, commonly known as walking pneumonia, in which even extensive lung infection may nonetheless not limit mobility. Additional studies showed that antibiotics can cure Mycoplasma infections.

In 1968, Dr. Chanock became chief of the national institute’s laboratory of infectious diseases, where his colleagues and trainees discovered still other viruses, including some that cause common colds.

In 1972, a colleague, Dr. Albert Z. Kapikian, used a technique known as immune electron microscopy to discover what caused outbreaks of a condition called explosive diarrhea, often occurring on cruise ships. The virus, then called the Norwalk agent and now known as a norovirus, each year affects an estimated 23 million Americans and causes about 220,000 deaths in developing countries.

Dr. Chanock also led teams of epidemiologists in deciphering how the viruses were transmitted and determining whom they most affected. And he pursued, unsuccessfully, the development of vaccines against respiratory syncytial virus and the para-influenza viruses.

“That turned out to be a very hard nut to crack,” said Dr. Kenneth McIntosh, a former colleague who is now professor of pediatrics at Harvard Medical School, “and so we still, 40 to 50 years later, do not have vaccines for these important viruses.”

But Dr. Chanock’s teams did develop a vaccine that the Food and Drug Administration licensed to prevent two types of adenovirus infection, a respiratory illness that often breaks out among troops living in close quarters.

The teams also played important roles in developing vaccines against the liver infection hepatitis A as well as against rotavirus, which is the most common cause of severe diarrhea among infants and which continues to be fatal to about half a million of them worldwide every year.

Further, the teams’ research was important in the licensing of the first nasal spray form of influenza vaccine. And their experimental immunizations against dengue fever, a mosquito-borne viral disease recently found to have infected people in Key West, Fla., are in clinical trials.

Dr. Chanock was elected to the National Academy of Sciences in 1973.

“Never in the history of infectious diseases has one person developed so much definitive information about the causes of so much human disease in so short a period of time,” Dr. Dorland Davis, another leading scientist, wrote of Dr. Chanock in 1967.

Some virus experts today question whether that comment was overstated, but few deny the significance of Dr. Chanock’s discoveries or fail to marvel at their rapid pace.

Robert Merritt Chanock was born July 8, 1924 in Chicago, where his father, Theodore, converted his lamp factory to produce artillery shells during World War II. After retiring in 1948, Theodore and his wife, Frances, moved to California, where he became successful in the hotel and early cable television businesses.

In high school, Dr. Chanock wanted to be a physicist. But after drafting him in 1943, the Army gave him a choice of going to the European front or, if he passed an examination, to medical school, with military support. He took the second option, attending the University of Chicago, where he received undergraduate and medical degrees. He interned at Highland Hospital in Oakland, Calif. (now part of the Alameda County Medical Center), before returning to the University of Chicago to complete his pediatrics training.

In 1952 he was drafted again. On a flight to Korea to work on the Japanese B virus, which causes encephalitis, an inflammation of the brain, Dr. Chanock’s appendix ruptured. Because of his condition, Army regulations prevented him from going to Korea, and so he did infectious-disease research in Tokyo.

After his discharge from the military, he worked with Dr. Albert B. Sabin at Children’s Hospital in Cincinnati. Dr. Sabin later developed the oral polio vaccine. Dr. Chanock went on to do research and teach at the University of Cincinnati and at Johns Hopkins University before joining the national institute in Bethesda.

Survivors include a son,. Stephen, of Potomac, Md., a doctor who is a researcher at the National Cancer Institute, and four grandchildren. His wife, the former Catherine Elizabeth Osgood, died last year; another son, Foster, died in 1980.

Dr. Chanock customarily swam a mile a day in his pool at home. After Alzheimer’s robbed him of the ability to count laps, a family member did it for him until he stopped swimming last October.

    Dr. Robert M. Chanock, Prominent Virologist, Dies at 86, NYT, 5.8.2010, http://www.nytimes.com/2010/08/05/health/05chanock.html

The Avandia Saga Continues

July 14, 2010
The New York Times

A panel of expert advisers to the Food and Drug Administration delivered a confusing verdict on Wednesday after two days of hearings on the safety of the diabetes drug Avandia. A majority of the 33-member panel expressed concern that Avandia raises the risk of heart attacks compared with other diabetes drugs. But a majority also voted to leave the drug on the market anyway, with various degrees of restrictions or warnings.

It will now be up to patients and their doctors to decide whether the risk is worth taking in particular cases.

The clearest lesson to emerge from the hearings and other recent revelations is that GlaxoSmithKline, the maker of Avandia, can’t be trusted to report adverse clinical results fairly. The company must be watched like a hawk as additional trials that it sponsors go forward.

Avandia is used to control blood sugar levels in diabetics, and it apparently does that well. Over the past three years, at least two major studies have suggested that it also increases the risk of cardiovascular problems, such as heart failure, heart attacks or strokes. The evidence, however, is mixed, and one recent study even suggested that Avandia might lower some cardiovascular risks. The F.D.A.’s own staff is sharply split over whether Avandia should be withdrawn; the outside experts were called upon to render independent advice before the agency makes a final decision.

The most troubling aspect of the Avandia saga is evidence — from internal company documents and investigations by a Senate committee and an F.D.A. investigator — that Glaxo sought to hide emerging indications of Avandia’s heart risks.

Glaxo failed to report the results of a 1999 study that showed Avandia might be riskier for the heart than a competing drug (“these data should not see the light of day,” cautioned an internal e-mail message). And Glaxo made Avandia look good in a major clinical trial by failing to include in its tally of adverse events at least a dozen patients who suffered serious heart problems. The company found reasons to drop them from the study or misreport their ailments.

In the crucial votes on Wednesday, the experts were asked to choose among five options for regulatory actions that the F.D.A. might take.

Twelve voted to remove Avandia from the market. Ten voted to leave it on the market while further beefing up warning labels and adding restrictions on use, such as allowing only certain physicians to prescribe it or requiring special education for doctors and patients. Another 10 would settle for the current or somewhat stronger warnings. (One expert abstained.)

Some analysts see a victory for Glaxo, in that 20 of the panelists voted to retain the drug. But it is hardly reassuring that 22 of the panelists voted either for severe restrictions or complete banishment.

The process doesn’t end here. The panel also voted to continue a large Glaxo-sponsored clinical trial to compare the cardiovascular risks of Avandia with those of Actos, its major rival, and with standard treatments for diabetes. Even if that trial is allowed to go forward, the results won’t be in for years. Right now, doctors and patients will have to think very hard before using a drug that a majority of these experts has deemed risky.

    The Avandia Saga Continues, NYT, 14.7.2010,k http://www.nytimes.com/2010/07/15/opinion/15thu1.html

Diabetes Drug Maker Hid Test Data on Risks, Files Indicate

July 12, 2010
The New York Times
By GARDINER HARRIS

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.

The heart risks from Avandia first became public in May 2007, with a study from a cardiologist at the Cleveland Clinic who used data the company was forced by a lawsuit to post on its own Web site. In the ensuing months, GlaxoSmithKline officials conceded that they had known of the drug’s potential heart attack risks since at least 2005.

But the latest documents demonstrate that the company had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public. In one document, the company sought to quantify the lost sales that would result if Avandia’s cardiovascular safety risk “intensifies.” The cost: $600 million from 2002 to 2004 alone, the document stated.

Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said that the company had not provided the results of its study because they “did not contribute any significant new information.”

The company said that Avandia was safe and that Dr. Freed no longer worked for GlaxoSmithKline.

A panel of experts will meet Tuesday and Wednesday to decide whether Avandia should still be sold and whether it is ethical to test Avandia directly against Actos.

Whether to withdraw Avandia is a question that has split the F.D.A., with some officials arguing that the drug is useful despite its risks and others insisting that it must be withdrawn.

According to the documents, Dr. John Jenkins, director of the agency’s office of new drugs, who has argued internally that Avandia should remain on the market, briefed the company extensively on the agency’s internal debate.

“It is clear the office of new drugs is trying to find minimal language that will satisfy the office of drug safety,” a top company official wrote in an e-mail message after he spoke with Dr. Jenkins, according to a sealed deposition obtained by The Times.

In the deposition, Dr. Rosemary Johann-Liang, a former supervisor in the drug safety office who left the F.D.A. after she was disciplined for recommending that Avandia’s heart warnings be strengthened, said of Dr. Jenkins’ conversations with GlaxoSmithKline, “This should not happen, and the fact that these kind of things happen, I mean, I think people have to make a determination about the leadership at the F.D.A.”

An F.D.A. spokeswoman said the agency would not comment on the contents of the deposition.

Members of Congress, where the Avandia case has led to legislative changes, said they were outraged at GlaxoSmithKline’s behavior.

“When drug companies withhold data regarding safety concerns about their medicines, they put patients at risk,” said Senator Max Baucus, Democrat of Montana, who is chairman of the Senate Finance Committee. Mr. Baucus and Senator Charles E. Grassley of Iowa, the committee’s ranking Republican, spent years investigating GlaxoSmithKline’s development of Avandia.

Besides the trial comparing Avandia with Actos, the company also conducted trials comparing Avandia with glyburide, a cheaper and older diabetes medicine.

When Rhona A. Berry, a company official, asked about publishing two of the trials, Dr. Freed responded in an e-mail message dated July 20, 2001, that referred to Avandia by the abbreviation of its generic name, rosiglitazone: “Rhona — Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm,” the message said. “It is a difficult story to tell and we would hope that these do not see the light of day.”

Hiding the results of negative clinical trials was once widespread in the drug industry.

But after GlaxoSmithKline was found in 2004 to have hidden data that showed that its antidepressant, Paxil, led children and teenagers to have more suicidal thoughts and behaviors, the company settled a lawsuit by agreeing to publicly post data from all of its trials. In 2007, Congress mandated such disclosures. But the postings are often little more than cryptic references, so the issue is far from resolved.

With Avandia, GlaxoSmithKline has done more than hide trial data. An F.D.A. reviewer who closely examined a landmark Avandia clinical trial called “Record,” found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.

The company’s conduct of the Record trial has received sharp criticism from medical leaders for other reasons as well. To compare Avandia and Actos in 1999, researchers at SmithKline measured Actos’s effects in patients in the same way that they had conducted earlier trials of Avandia so that the results for the two drugs could be compared.

When the results of the study suggested that Avandia was more dangerous than Actos, the company decided against further comparisons.

    Diabetes Drug Maker Hid Test Data on Risks, Files Indicate, NYT, 12.7.2010, http://www.nytimes.com/2010/07/13/health/policy/13avandia.html

Obama to Outline Plan to Cut H.I.V. Infections

July 11, 2010
The New York Times
By ROBERT PEAR

WASHINGTON — President Obama will unveil a new national strategy this week to curb the AIDS epidemic by slashing the number of new infections and increasing the number of people who get care and treatment.

“Annual AIDS deaths have declined, but the number of new infections has been static and the number of people living with H.I.V. is growing,” says a final draft of the report, obtained by The New York Times.

In the report, the administration calls for steps to reduce the annual number of new H.I.V. infections by 25 percent within five years. “Approximately 56,000 people become infected each year, and more than 1.1 million Americans are living with H.I.V.,” the report says.

Mr. Obama plans to announce the strategy, distilled from 15 months of work and discussions with thousands of people around the country, at the White House on Tuesday.

While acknowledging that “increased investments in certain key areas are warranted,” the report does not propose a major increase in federal spending. It says the administration will redirect money to areas with the greatest need and population groups at greatest risk, including gay and bisexual men and African-Americans. The federal government now spends more than $19 billion a year on domestic AIDS programs.

On average, the report says, one person is newly infected with H.I.V. every nine and a half minutes, but tens of thousands of people with the virus are not receiving any care. If they got care, the report says, they could prolong their own lives and reduce the spread of the virus to others. By 2015 the report says, the United States should “increase the proportion of newly diagnosed patients linked to clinical care within three months of their H.I.V. diagnosis to 85 percent,” from the current 65 percent.

The first-ever national AIDS strategy has been in the works since the start of the administration. It comes in the context of growing frustrations expressed by some gay rights groups. They say that more money is urgently needed for the AIDS Drug Assistance Program, and they assert that the White House has not done enough to secure repeal of the law banning military service by people who are openly gay or bisexual.

The report tries to revive the sense of urgency that gripped the nation in the first years after discovery of the virus that causes AIDS. “Public attention to the H.I.V. epidemic has waned,” the report says. “Because H.I.V. is treatable, many people now think that it is no longer a public health emergency.”

The report calls for “a more coordinated national response to the H.I.V. epidemic” and lays out specific steps to be taken by various federal agencies.

Mr. Obama offers a compliment to President George W. Bush, who made progress against AIDS in Africa by setting clear goals and holding people accountable.

The program begun by Mr. Bush, the President’s Emergency Plan for AIDS Relief, “has taught us valuable lessons about fighting H.I.V. and scaling up efforts around the world that can be applied to the domestic epidemic,” the report says.

Mr. Obama’s strategy is generally consistent with policies recommended by public health specialists and advocates for people with H.I.V. But some experts had called for higher goals, more aggressive timetables and more spending on prevention and treatment.

The report makes these points:

¶Far too many people infected with H.I.V. are unaware of their status and may unknowingly transmit the virus to their partners. By 2015, the proportion of people with H.I.V. who know of their condition should be increased to 90 percent, from 79 percent today.

¶The new health care law will significantly expand access to care for people with H.I.V., but federal efforts like the Ryan White program will still be needed to fill gaps in services.

¶Federal spending on H.I.V. testing and prevention does not match the need. States with the lowest numbers of H.I.V./AIDS cases often receive the most money per case. The federal government should allocate more of the money to states with the highest “burden of disease.”

¶Health officials must devote “more attention and resources” to gay and bisexual men, who account for slightly more than half of new infections each year, and African-Americans, who account for 46 percent of people living with H.I.V.

¶The H.I.V. transmission rate, which indicates how fast the epidemic is spreading, should be reduced by 30 percent in five years. At the current rate, about 5 of every 100 people with H.I.V. transmit the virus to someone in a given year.

If the transmission rate is unchanged, the report says, “within a decade, the number of new infections would increase to more than 75,000 per year and the number of people living with H.I.V. would grow to more than 1.5 million.”

The report finds that persistent discrimination against people with H.I.V. is a major barrier to progress in fighting the disease.

“The stigma associated with H.I.V. remains extremely high,” it says. “People living with H.I.V. may still face discrimination in many areas of life, including employment, housing, provision of health care services and access to public accommodations.”

The administration promises to “strengthen enforcement of civil rights laws” protecting people with H.I.V.

One political challenge for the administration is to win broad public support for a campaign that will focus more narrowly on specific groups and communities at high risk for H.I.V. infection.

“Just as we mobilize the country to support cancer research whether or not we believe that we are at high risk of cancer and we support public education whether or not we have children,” the report says, “fighting H.I.V. requires widespread public support to sustain a long-term effort.”

    Obama to Outline Plan to Cut H.I.V. Infections, NYT, 11.7.2010, http://www.nytimes.com/2010/07/12/health/policy/12aids.html

Robert Butler, Aging Expert, Is Dead at 83

July 6, 2010
The New York Times
By DOUGLAS MARTIN

Dr. Robert N. Butler, a psychiatrist whose painful youthful realization that death is inevitable prompted him to challenge and ultimately reform the treatment of the elderly through research, public policy and a Pulitzer Prize-winning book, died Sunday in Manhattan. He was 83 and had worked until three days before his death.

The cause was acute leukemia, his daughter Christine Butler said.

Dr. Butler’s influence was apparent in the widely used word he coined to describe discrimination against the elderly: “ageism.” He defended as healthy the way many old people slip into old memories — even giving it a name, “life review.”

In speech after speech, he pounded home the message that longevity in the United States had increased by 30 years in the 20th century — greater than the gain during the preceding 5,000 years of human history — and that this had led to profound changes in every aspect of society, employment and politics among them.

Dr. Christine Cassel, president of the American Board of Internal Medicine, said in an interview that Dr. Butler had in effect “created an entire field of medicine.” She said he had helped change attitudes so that aging could be perceived “a positive thing.”

Dr. Butler was the founding director of the National Institute on Aging at the National Institutes of Health and advocated for the aging before Congress and the United Nations. He helped start and led the American Association for Geriatric Psychiatry, the Alzheimer’s Disease Association and the International Longevity Center. President Bill Clinton named him chairman of the 1995 White House Conference on Aging.

“He really put geriatrics on the map,” Dr. David B. Reuben, chief of the division of geriatrics at the University of California, Los Angeles, said in an interview.

Dr. Butler challenged long-held conceptions about aging, calling it “the neglected stepchild of the human life cycle.” He helped establish, for example, that senility is not inevitable with aging. When the Heinz Family Foundation presented him with an award in 2003, it called him “a prophetic visionary.”

The most noted exposition of his vision was the 1975 book that earned him his Pulitzer, “Why Survive? Being Old in America.” It went from a bleak explication of the elderly’s condition to prescriptions to improve it.

“Human beings need the freedom to live with change, to invent and reinvent themselves a number of times through their lives,” Dr. Butler wrote.

Dr. Butler’s mission emerged from his childhood, he wrote in his book. His parents had scarcely named him Robert Neil Butler before splitting up 11 months after his birth on Jan. 21, 1927, in Manhattan. He went to live with his maternal grandparents on a chicken farm in Vineland, N.J.

He came to revere his grandfather, with whom he cared for sick chickens in the “hospital” at one end of the chicken house. He loved the old man’s stories. But the grandfather disappeared when Robert was 7, and nobody would tell him why. He finally learned that he had died.

Robert found solace in his friendship with a physician he identified only as Dr. Rose. Dr. Rose had helped him through scarlet fever and took him on his rounds by horse and carriage. The boy decided he could have helped his grandfather survive had he been a doctor. He also concluded that he would have preferred that people had been honest with him about death.

From his grandmother, he learned about the strength and endurance of the elderly, he wrote. After losing the farm in the Depression, she and her grandson lived on government-surplus foods and lived in a cheap hotel. Robert sold newspapers. Then the hotel burned down, with all their possessions.

“What I remember even more than the hardships of those years was my grandmother’s triumphant spirit and determination,” he wrote. “Experiencing at first hand an older person’s struggle to survive, I was myself helped to survive as well.”

Dr. Butler served in the United States Maritime Service before entering Columbia University, where he earned his bachelor’s and medical degrees. During his internship in psychiatry at St. Luke’s Hospital, he had many elderly patients and realized how little he had been taught about treating them. He began reading about the biology of aging.

After his residency at the University of California, San Francisco, he worked at the National Institute of Mental Health as a research psychiatrist. He studied the central nervous system in elderly people, work that became part of a large study of aging. He also helped Ralph Nader investigate problems in nursing homes.

The book that emerged from his experiences proposed many specific reforms to help old people, including a national service corps that would enlist the elderly as community volunteers.

In 1975 he succeeded in creating a National Institute on Aging and was its head for six years.

“Nobody thought research on aging was a legitimate field until Bob came along and convinced them to create a separate institute,” Dr. Cassel said.

In 1982, the Mount Sinai School of Medicine in Manhattan asked Dr. Butler’s advice on whom to hire for a new geriatrics chair. He proposed instead that the school create a department devoted solely to gerontology. It did, and was one of the first to do so.

He wrote numerous articles and several books, including the bestseller “Sex after Sixty,” which he wrote with his second wife, Dr. Myrna I. Lewis, in 1976.

Dr. Butler’s first marriage, to Diane McLaughlin, ended in divorce. Dr. Lewis died in 2005. Besides his daughter Christine, he is survived by three other daughters, Carole Butler Hall, Cynthia Butler and Alexandra Butler; and six grandchildren.

Dr. Butler acknowledged in an interview two years ago with The Saturday Evening Post that his views on his own aging had changed: he feared death less.

“I feel less threatened by the end of life than I perhaps did when I was 35,” he said.

    Robert Butler, Aging Expert, Is Dead at 83, NYT, 6.7.2010, http://www.nytimes.com/2010/07/07/health/research/07butler.html

Letters

Is There a Sexual Malaise in America?

July 2, 2010
The New York Times

To the Editor:

Re “No Sex Please, We’re Middle Class” (Op-Ed, June 27):

The sexual malaise described by Camille Paglia is just a symptom of a broader malady among the middle class: the confusion of “standard of living” with quality of life. My demographic is obsessed with work to the point that we don’t take the vacation we’re entitled to. We are willing to sacrifice hours each day to our commutes in order to live in big houses, where we paradoxically spend few of our waking hours.

And we often spend so much time on “activities” — ours and our children’s — that at the end of the day, we are too tired to enjoy one of the greatest benefits of a healthy marriage.

Ms. Paglia is quite correct that no drug will ever cure this ailment.

Happiness in life will always be reserved for those who care more about being happy than about being “successful.”

Daniel Dickinson
Mountain View, Calif., June 28, 2010

•

To the Editor:

Could it be that white middle-class women suffer from low libido not because they hope to be treated as equals in the workplace but because of the stress and exhaustion that accompany family-unfriendly work policies, the ceaseless task of finding adequate schooling for their children, the ever-present fear of losing one’s job in the “flexible work force” and men’s persistent reluctance to shoulder their share of the responsibility in the home?

By the way, does Camille Paglia have any evidence that working-class women and women of color are more sexually alive (and immune to the ravages of contemporary economic conditions) than white middle-class women?

Julia Rothenberg
New York, June 27, 2010

The writer is an assistant professor of sociology at St. Joseph’s College.

•

To the Editor:

While I admire Camille Paglia, I believe that she misses the culprit when she blames middle-class values for today’s sexual torpor in American society.

The underlying problem is not middle-class values, but rather that the middle class is the victim of politically correct American-style feminism, which is both overly legislated and utterly lacking in subtlety or humor of any kind.

Having successfully big-brothered flirtation out of practice, and legally erased any differences between the sexes, a result is what we have today: men who are terrorized into the self-ghettoed adolescence of sports bars, and women who are not entirely sure what their gender is.

J. J. Gross
Jerusalem, June 28, 2010

•

To the Editor:

I’m not sure if there is a sexual malaise gripping the country, as Camille Paglia asserts, but if there is, it has little to do with gender equality in the workplace — which, by the way, doesn’t exist. More likely causes would include declining testosterone levels in men (perhaps caused by rising obesity rates, or by increased toxins in the environment) and rising rates of narcissistic personality disorder and autism spectrum disorders.

Cultural trends come and go, but a decline in sexuality can be caused only by more serious biological, environmental and genetic problems.

Anne Rettenberg
New York, June 27, 2010

The writer is a psychotherapist.

•

To the Editor:

Recently you published two articles related to sexual expression in women: one from Kelly Blanchard cheering the birth control pill (Op-Ed, June 22) and the other by Camille Paglia on the subject of female lack of desire.

The hormonal manipulation of the birth control pill reduces sexual desire in women; this has been proved. When it is introduced in any relationship, a subtle change takes place. Now, we have a sort of stale situation where women are undervalued for a quality deemed passé: their fertility. Likewise men.

We can share within a relationship everything except our fertility, give everything to our spouse except our fertility. There is no communication about this; it falls to the woman to take the pill. In a more natural situation, both partners need to negotiate in this most intimate area, and sex becomes more appreciated.

Leaving to one side all the other things that can be said about this subject, I think that the only problem today is that we have divorced fertility from lovemaking. All for convenience and to have our own way.

Nandarani Evans
Honolulu, June 27, 2010

•

To the Editor:

We really are drenched in prurience, not sex. The difference is vital. The mass media have trivialized eroticism, and replaced it with titillation, and a kind of coarse, juvenile sensitivity, as the mass media do with everything.

Tom Tillinghast
San Francisco, June 27, 2010

•

To the Editor:

As much as I enjoyed Camille Paglia’s article, I think she has overanalyzed the sexual malaise of middle-class women. It is not caused by “bourgeois propriety,” the lack of mystery in men or representations in popular culture. We are just plain tired!

We work outside the home and inside, we are caring for children and aging parents, we are probably underpaid and most certainly overworked. When we get in bed at the end of the day? We sleep.

Kinnan O’Connell
Larchmont, N.Y., June 28, 2010

    Is There a Sexual Malaise in America?, NBYT, 2.7.2010, http://www.nytimes.com/2010/07/06/opinion/l06sex.html

No Sex Please, We’re Middle Class

June 25, 2010
The New York Times
By CAMILLE PAGLIA

Philadelphia

WILL women soon have a Viagra of their own? Although a Food and Drug Administration advisory panel recently rejected an application to market the drug flibanserin in the United States for women with low libido, it endorsed the potential benefits and urged further research. Several pharmaceutical companies are reported to be well along in the search for such a drug.

The implication is that a new pill, despite its unforeseen side effects, is necessary to cure the sexual malaise that appears to have sunk over the country. But to what extent do these complaints about sexual apathy reflect a medical reality, and how much do they actually emanate from the anxious, overachieving, white upper middle class?

In the 1950s, female “frigidity” was attributed to social conformism and religious puritanism. But since the sexual revolution of the 1960s, American society has become increasingly secular, with a media environment drenched in sex.

The real culprit, originating in the 19th century, is bourgeois propriety. As respectability became the central middle-class value, censorship and repression became the norm. Victorian prudery ended the humorous sexual candor of both men and women during the agrarian era, a ribaldry chronicled from Shakespeare’s plays to the 18th-century novel. The priggish 1950s, which erased the liberated flappers of the Jazz Age from cultural memory, were simply a return to the norm.

Only the diffuse New Age movement, inspired by nature-keyed Asian practices, has preserved the radical vision of the modern sexual revolution. But concrete power resides in America’s careerist technocracy, for which the elite schools, with their ideological view of gender as a social construct, are feeder cells.

In the discreet white-collar realm, men and women are interchangeable, doing the same, mind-based work. Physicality is suppressed; voices are lowered and gestures curtailed in sanitized office space. Men must neuter themselves, while ambitious women postpone procreation. Androgyny is bewitching in art, but in real life it can lead to stagnation and boredom, which no pill can cure.

Meanwhile, family life has put middle-class men in a bind; they are simply cogs in a domestic machine commanded by women. Contemporary moms have become virtuoso super-managers of a complex operation focused on the care and transport of children. But it’s not so easy to snap over from Apollonian control to Dionysian delirium.

Nor are husbands offering much stimulation in the male display department: visually, American men remain perpetual boys, as shown by the bulky T-shirts, loose shorts and sneakers they wear from preschool through midlife. The sexes, which used to occupy intriguingly separate worlds, are suffering from over-familiarity, a curse of the mundane. There’s no mystery left.

The elemental power of sexuality has also waned in American popular culture. Under the much-maligned studio production code, Hollywood made movies sizzling with flirtation and romance. But from the early ’70s on, nudity was in, and steamy build-up was out. A generation of filmmakers lost the skill of sophisticated innuendo. The situation worsened in the ’90s, when Hollywood pirated video games to turn women into cartoonishly pneumatic superheroines and sci-fi androids, fantasy figures without psychological complexity or the erotic needs of real women.

Furthermore, thanks to a bourgeois white culture that values efficient bodies over voluptuous ones, American actresses have desexualized themselves, confusing sterile athleticism with female power. Their current Pilates-honed look is taut and tense — a boy’s thin limbs and narrow hips combined with amplified breasts. Contrast that with Latino and African-American taste, which runs toward the healthy silhouette of the bootylicious Beyoncé.

A class issue in sexual energy may be suggested by the apparent striking popularity of Victoria’s Secret and its racy lingerie among multiracial lower-middle-class and working-class patrons, even in suburban shopping malls, which otherwise trend toward the white middle class. Country music, with its history in the rural South and Southwest, is still filled with blazingly raunchy scenarios, where the sexes remain dynamically polarized in the old-fashioned way.

On the other hand, rock music, once sexually pioneering, is in the dumps. Black rhythm and blues, born in the Mississippi Delta, was the driving force behind the great hard rock bands of the ’60s, whose cover versions of blues songs were filled with electrifying sexual imagery. The Rolling Stones’ hypnotic recording of Willie Dixon’s “Little Red Rooster,” with its titillating phallic exhibitionism, throbs and shimmers with sultry heat.

But with the huge commercial success of rock, the blues receded as a direct influence on young musicians, who simply imitated the white guitar gods without exploring their roots. Step by step, rock lost its visceral rawness and seductive sensuality. Big-ticket rock, with its well-heeled middle-class audience, is now all superego and no id.

In the 1980s, commercial music boasted a beguiling host of sexy pop chicks like Deborah Harry, Belinda Carlisle, Pat Benatar, and a charmingly ripe Madonna. Late Madonna, in contrast, went bourgeois and turned scrawny. Madonna’s dance-track acolyte, Lady Gaga, with her compulsive overkill, is a high-concept fabrication without an ounce of genuine eroticism.

Pharmaceutical companies will never find the holy grail of a female Viagra — not in this culture driven and drained by middle-class values. Inhibitions are stubbornly internal. And lust is too fiery to be left to the pharmacist.


Camille Paglia, a professor of humanities and media studies at the University of the Arts, is the author of “Sexual Personae.”

    No Sex Please, We’re Middle Class, NYT, 25.6.2010, http://www.nytimes.com/2010/06/27/opinion/27Paglia.html

Promise Seen for Detection of Alzheimer’s

June 23, 2010
The New York Times
By GINA KOLATA

Dr. Daniel Skovronsky sat at a small round table in his corner office, laptop open, waiting for an e-mail message. His right leg jiggled nervously.

A few minutes later, the message arrived — results that showed his tiny start-up company might have overcome one of the biggest obstacles in diagnosing Alzheimer’s disease. It had found a dye and a brain scan that, he said, can show the hallmark plaque building up in the brains of people with the disease.

The findings, which will be presented at an international meeting of the Alzheimer’s Association in Honolulu on July 11, must still be confirmed and approved by the Food and Drug Administration. But if they hold up, it will mean that for the first time doctors would have a reliable way to diagnose the presence of Alzheimer’s in patients with memory problems.

And researchers would have a way to figure out whether drugs are slowing or halting the disease, a step that “will change everyone’s thinking about Alzheimer’s in a dramatic way,” said Dr. Michael Weiner of the University of California, San Francisco, who is not part of the company’s study and directs a federal project to study ways of diagnosing Alzheimer’s.

Still, the long tale behind this finding shows just how difficult this disease is and why progress toward preventing or curing it has been so slow.

Ever since Alzheimer’s disease was described by a German doctor, Alois Alzheimer, in 1906, there was only one way to know for sure that a person had it. A pathologist, examining the brain after death, would see microscopic black freckles, plaque, sticking to brain slices like barnacles. Without plaque, a person with memory loss did not have the disease.

There is no treatment yet to stop or slow the progress of Alzheimer’s. But every major drug company has new experimental drugs it hopes will work, particularly if they are started early. The questions though, are who should be getting the drugs and who really has Alzheimer’s or is developing it?

Even at the best medical centers, doctors often are wrong. Twenty percent of people with dementia — a loss of memory and intellectual functions — who received a diagnosis of Alzheimer’s, did not have it. There was no plaque when their brains were biopsied. Half with milder memory loss, thought to be on their way to Alzheimer’s, do not get the disease. And with such a high rate of misdiagnosis, some who are mistakenly told that they have Alzheimer’s are not treated for conditions, like depression or low levels of thyroid hormone or drug side effects and interactions, that are causing their memory problems.

Brain scans that showed plaque could help with some fundamental questions — who has or is getting Alzheimer’s, whether the disease ever stops or slows down on its own and even whether plaque is the main culprit causing brain cell death.

Dr. Skovronsky thought he had a way to make scans work. He and his team had developed a dye that could get into the brain and stick to plaque. They labeled the dye with a commonly used radioactive tracer and used a PET scanner to directly see plaque in a living person’s brain. But the technology and the dye itself were so new they had to be rigorously tested.

And that is what brought Dr. Skovronsky, a thin and eager-looking 37-year-old, to his e-mail that recent day.

Five years ago, Dr. Skovronsky, who named his company Avid in part because that is what he is, had taken a big personal and professional gamble. He left academia and formed Avid Radiopharmaceuticals, based in Philadelphia, to develop his radioactive dye and designed a study with hospice patients to prove it worked.

Hospice patients were going to die soon and so, he reasoned, why not ask them to have scans and then brain autopsies afterward to see if the scans showed just what a pathologist would see. Some patients would be demented, others not.

Some predicted his study would be impossible, if not unethical. But the F.D.A. said it wanted proof that the plaque on PET scans was the same as plaque in a brain autopsy.

The Avid study was designed to provide that proof. And the full results, contained in the e-mail message sent that day, May 14, were the moment of truth. When he saw them, Dr. Skovronsky said they were everything he had hoped for.

“This is about as good as it gets,” he said that day.

He went into a rotunda that serves as Avid’s lunchroom to tell the company’s 50 employees. “This is a big day for us,” he continued. “I thought about what I would say, but I have totally forgotten it.”

His employees applauded. Then they had champagne in blue plastic cups.

A First Dye

The type of scans used in this study, PET scans, are expensive and patients have to go to a scanning center, get injected with a radioactive dye, wait for the dye to reach their brain and then have a scan.

Other tests are being studied — ones that look for amyloid in cerebrospinal fluid that bathes the brain; MRI scans that look for shrinkage of the brain in areas needed for memory and reasoning; PET scans that look for uptake of glucose, a cellular fuel, to show areas where the brain was active and where it was not. The tests, though, were not necessarily specific for Alzheimer’s and none had been studied to see if they accurately predicted plaque on autopsy.

Earlier this decade, two scientists at the University of Pittsburgh developed an amyloid dye that while not practical for widespread use, stunned scientists by showing it seemed possible to see amyloid in a living brain.

The researchers, Chester Mathis and William Klunk, began their work two decades ago, persevering even though they had no research money. In the first 10 years, they tested more than 400 compounds. When they finally found one that seemed promising, they tested more than 300 variations.

“On and on it went,” Dr. Mathis said.

Finally, in late 2001, they began working with collaborators in Sweden to test their dye in humans.

On Valentine’s Day 2002, the Swedish researchers injected the first Alzheimer’s patient with the dye, known as Pittsburgh Compound B, and scanned the patient’s brain.

It worked, the Swedish doctors told Dr. Mathis in an excited phone call.

A PET scan showed amyloid exactly where it would be expected. The Swedish doctors were convinced they were seeing actual plaque. They told Dr. Mathis it was time to celebrate.

But Dr. Mathis worried. What if the same pattern occurred in people without Alzheimer’s?

Two weeks later, he got another call from Sweden. His colleagues had scanned a person without Alzheimer’s. There was no sign of telltale plaques.

His sweet reward came in July 2002, when the scans were shown to an audience of 5,000 scientists at an international conference on Alzheimer’s.

“There was an audible gasp,” Dr. Mathis said. “The field was taken aback.”

“The rest is history,” he added.

Yet there was a problem. Pittsburgh Compound B used carbon 11 as its radioactive tracer. And its half-life is 20 minutes. Researchers have to make it in a cyclotron in the basement of a medical center, quickly attach it to the dye, dash over to a patient lying in a scanner, and inject it.

And a critical question remained: Was a PET scan with the Pittsburgh dye really equivalent to a brain autopsy?

Meanwhile, others, including Dr. Skovronsky, had another idea — use fluoride 18, with a half-life of about two hours. It could be made in the morning, and used that afternoon. And fluoride 18 is made routinely for two million cancer PET scans each year.

Dr. Skovronsky, starting at the University of Pennsylvania and then at Avid, worked with a University of Pennsylvania chemist, Hank Kung, for nine years to find and develop the radioactive dye. The university had the patent; Avid licensed it. Finally, on June 8, 2007, a patient at Johns Hopkins had a scan with their compound. Plaque lit up.

Most of the time, the scans were as expected — those with Alzheimer’s had lots of plaque, those with normal memories had little if any and those with mild memory impairment were in between.

But about 20 percent of people over 60 with normal memories had plaque.

“Then we looked more carefully,” Dr. Skovronsky said. “The 20 percent who had amyloid, though they were still statistically in the normal range, did worse on every memory test than the control group.”

What, Dr. Skovronsky asked, did that mean? Were they starting to develop Alzheimer’s? If so, could dementia be stalled if there were drugs to stop amyloid from accumulating?

The definition of Alzheimer’s is plaque plus memory loss and other symptoms of mental decline. But what is not known because no one could follow the development of plaque before a person died, was whether people with plaque and normal memories were developing Alzheimer’s.

“We’ve always assumed the pathology has been there, that the plaque has been there years before symptoms,” said Dr. Steven T. DeKosky, an Alzheimer’s researcher who is vice president and dean at the University of Virginia School of Medicine. “But we never had a way to detect plaque in living persons,” he said. And so plaque in the brains of people with normal memories has been a puzzle.

“Over the next couple of years, we will find out what it means.”

A Request of the Dying

On Oct. 23, 2008, Avid and two other companies, Bayer and General Electric, that are developing fluoride 18-based dyes for amyloid scans, got a pointed question from an advisory committee to the F.D.A.: How do you know that what you are seeing on scans is the same as the amyloid you see on autopsy?

It seemed impossible to answer. If researchers wait for their subjects to die before comparing scans with autopsies they can be waiting a long time.

But Avid had a plan, and the committee agreed in principle that it would work. Hospice patients would be study subjects, some with dementia, some without. All would have memory tests and brain scans. After death, their brains would be autopsied. Avid suggested that after the first 35 died, there should be enough data to know if the scans gave a true picture of the pathology. Then the F.D.A. could decide if the results were convincing enough to approve the dye for marketing.

Some doctors had misgivings, wondering how they could ask people who were sick and dying to be scanned just to help Alzheimer’s research. But, they found, most patients and their families agreed and said they were grateful to have been asked.

That was evident on May 19, when Dr. Skovronsky gave a lunch for patients’ families in Sun City, Ariz., to thank them for participating.

They thanked him.

“It really touched my heart to be in this,” said Dorothy Wall, whose husband, Claude E. Wall, died of liver cancer in Sun City on March 3.

“Something bad happens, and now something good happens.”

Answers

Late last year, Avid saw the initial results of its hospice study — data from the first six patients. Then, as more patients were studied, the data from them were held by a company that would analyze it. Avid did not see the results until the study was completed. But those first six were encouraging.

A man diagnosed with Alzheimer’s and cancer had a scan showing no plaque. His autopsy did not show it, either. The diagnosis was wrong. Another man with Parkinson’s disease and dementia had been diagnosed as having dementia solely due to Parkinson’s. His scan showed amyloid. So did the autopsy. He had Alzheimer’s. A woman with mild memory loss had a scan showing no amyloid. Her autopsy also found none. Three others had clinical diagnoses of Alzheimer’s, confirmed by scans and autopsies.

Finally, on May 14, 35 patients had been scanned and autopsied. The Avid study was complete, and the full data will be presented at the meeting next month. Other companies, still doing their studies, did not yet have data to examine.

And Dr. Skovronsky got that e-mail message.

“This is going to have a big impact on Alzheimer’s disease, guys,” he told his staff that day.

    Promise Seen for Detection of Alzheimer’s, NYT, 23.6.2010, http://www.nytimes.com/2010/06/24/health/research/24scans.html

Obama Says Health Law Shouldn’t Be Excuse to Raise Rates

June 22, 2010
The New York Times
By KEVIN SACK and SHERYL GAY STOLBERG

WASHINGTON — President Obama, whose vilification of insurers helped push a landmark health care overhaul through Congress, warned industry executives at the White House on Tuesday not to use the bill “as an opportunity to enact unjustifiable rate increases that don’t boost care and inflate their bottom line.”

Mr. Obama made his remarks in the East Room of the White House after a private meeting with executives of leading health insurance companies and with state insurance commissioners who regulate them. As the new law is being implemented, the White House wanted to issue a pointed reminder to insurers — and the public — that the president intends to monitor the industry’s behavior.

“There are genuine cost drivers that are not caused by insurance companies,” Mr. Obama said. “But what is also true is that we’ve got to make sure that this new law is not being used as an excuse to simply drive up costs.”

Mr. Obama convened the White House session mark the 90th day (Tuesday was actually the 91st) since he signed the health bill into law. He also used the occasion to unveil what his administration is calling “a new Patient’s Bill of Rights” — a set of regulations governing how the industry implements some of the most consumer-friendly provisions of the health care bill.

The rules, which take effect Sept. 23, prevent insurers from refusing to cover children with pre-existing conditions; impose strict limits on insurers’ ability to cap coverage during any given year; end lifetime coverage caps; and end the practice known as rescission, in which companies, citing minor paperwork mistakes, cancel coverage for people who get sick.

Under the new regulations, companies will be prohibited from rescinding coverage except in cases involving fraud or intentional misrepresentation of facts.

The White House is concerned that health insurers will blame the new law for increases in premiums that are intended to maximize profits rather than cover claims. The administration is also closely watching investigations by a number of states into the actuarial soundness of double-digit rate increases.

“Our message to them is to work with this law, not against it; don’t try and take advantage of it or we will work with state authorities and gather the authority we have to stop rate gouging,” David Axelrod, Mr. Obama’s senior adviser, said in an interview. “Our concern is that they not try and, under the cover of the act, get in under the wire here on rate increases.”

The law does not grant the federal government new authority to regulate health care premiums, which remains the province of state insurance departments. But with important provisions taking effect this summer and fall, the Obama administration has repeatedly reminded insurers — and the public — that it will expose industry pricing to what the health secretary, Kathleen Sebelius, has called a “bright spotlight.”

The White House meeting follows the release on Monday of a survey by the Kaiser Family Foundation, a nonprofit health policy research group, finding that premiums for the policies most recently bought by individuals had increased by an average of 20 percent.

“The survey shows that the steep increases we have been reading about over the last several months are not just extreme cases,” said Drew Altman, the foundation’s president.

Mr. Obama’s message to insurers puts the industry on notice and positions the White House politically in case voters start to link premium increases to the new law. With the law expected to play a significant role in the midterm elections, the president has been using his platform to sell the bill’s most immediate benefits and, by extension, to defend Democrats in Congress who risked their careers to vote for it.

The insurers have attributed this year’s increases to skyrocketing medical costs and to the economic downturn, which has prompted healthier consumers to forgo health insurance, leaving a sicker and costlier pool to cover.

“Our companies are receiving rate increase requests from hospitals across the country of 40, 50 and 60 percent,” said Robert Zirkelbach, a spokesman for America’s Health Insurance Plans, a trade group. “That has a direct impact on the cost of health care coverage.”

But a report released Monday by Health Care for America Now, a coalition that supports the new law, stressed that the growth in premiums in the first eight years of this decade had far exceeded medical inflation — 97 percent to 39 percent.

The new law requires the health secretary to work with states to establish a process for annual reviews of “unreasonable increases in premiums.” Administration officials said Monday that they were still writing regulations to define “unreasonable increases.”

Mr. Obama’s approach to the health insurance industry has rarely been subtle, starting with his campaign, when he spoke of his dying mother’s struggle to persuade her insurer to cover her cancer treatments.

In March, with his health bill hanging by a thread in Congress, Mr. Obama ducked into a White House meeting with insurance executives to deliver a letter from an Ohio cancer survivor who had dropped her coverage after learning her premiums were rising 40 percent.

But for all of Mr. Obama’s browbeating, the new health care law stopped short of giving the administration the power to reject or limit rate increases. Instead, it established the annual reviews, starting next year, and makes available $250 million in grants to states to implement the review process.

States that accept the grants must recommend whether insurers with patterns of excessive pricing should be allowed to market policies through newly created exchanges, which will help individuals and businesses shop for coverage starting in 2014. Insurers also will be required to justify increases deemed unreasonable on their Web sites.

In the closing weeks of the health care debate, the White House offered a proposal to give the health secretary authority to deny unreasonable increases. It did not make it into the final legislation, but Senate Democrats have reintroduced it as a standalone bill.

The regulatory clout of state insurance departments varies widely, with some having minimal power to block rate increases. But in recent months, several states have taken unusually assertive steps.

In California, state regulators announced that they would order independent reviews of increases being sought by four large health insurers. That move came after the department discovered miscalculations in rate requests by Anthem Blue Cross, prompting the company to withdraw its plan to raise premiums by as much as 39 percent.

In Massachusetts, the administration of Gov. Deval Patrick, a Democrat, used long-untapped power to deny 9 of 10 rate increases requested by the state’s insurers, provoking a lawsuit from the industry. A court in Maine recently upheld a smaller rate increase for that state’s largest insurer — 10.9 percent instead of 18.1 percent — that had been ordered by the insurance superintendent.

In New York, Gov. David A. Paterson, a Democrat, signed legislation this month giving the state power to block unreasonable rates. And in Pennsylvania, Gov. Edward G. Rendell, also a Democrat, announced two weeks ago that his insurance commissioner, Joel Ario, would investigate large increases by the state’s biggest insurers.

“The plans are cherry-picking the best risk,” Mr. Ario, who will attend the White House session, said in an interview.

The federal law, which will require that most Americans obtain insurance, includes a number of provisions intended to slow the growth of premiums. For instance, insurance companies soon will have to spend at least 80 percent of revenue from premiums on claims, as opposed to administration and profit.

Insurers have warned since early in the debate that the overhaul might result in increased premiums for many consumers. The Congressional Joint Committee on Taxation and the nonpartisan Congressional Budget Office found otherwise, projecting that it would have minimal effect on group premiums, which account for 83 percent of the market. Their analysis forecast that premiums for individual policies would rise faster than they would without the new law, but that the increases would largely be offset by government subsidies.

Whatever the law’s ultimate effect, many of this year’s most egregious rate increases were announced well before it was clear the bill would pass.


Reed Abelson contributed reporting from New York.

    Obama Says Health Law Shouldn’t Be Excuse to Raise Rates, NYT, 22.6.2010, http://www.nytimes.com/2010/06/23/health/policy/23health.html

As Law Takes Effect, Obama Gives Insurers a Warning

June 21, 2010
The New York Times
By KEVIN SACK and SHERYL GAY STOLBERG

WASHINGTON — President Obama, whose vilification of insurers helped push a landmark health care overhaul through Congress, plans to sternly warn industry executives at a White House meeting on Tuesday against imposing hefty rate increases in anticipation of tightening regulation under the new law, administration officials said Monday.

The White House is concerned that health insurers will blame the new law for increases in premiums that are intended to maximize profits rather than covering claims. The administration is also closely watching investigations by a number of states into the actuarial soundness of double-digit rate increases.

“Our message to them is to work with this law, not against it; don’t try and take advantage of it or we will work with state authorities and gather the authority we have to stop rate gouging,” David Axelrod, Mr. Obama’s senior adviser, said in an interview. “Our concern is that they not try and, under the cover of the act, get in under the wire here on rate increases.”

The law does not grant the federal government new authority to regulate health care premiums, which remains the province of state insurance departments. But with important provisions taking effect this summer and fall, the Obama administration has repeatedly reminded insurers — and the public — that it will expose industry pricing to what the health secretary, Kathleen Sebelius, has called a “bright spotlight.”

The White House meeting coincides with Monday’s release of a survey by the Kaiser Family Foundation, a nonprofit health policy research group, that found that premiums for the policies most recently bought by individuals had increased by an average of 20 percent.

“The survey shows that the steep increases we have been reading about over the last several months are not just extreme cases,” said Drew Altman, the foundation’s president.

Mr. Obama’s message to insurers will serve to put the industry on notice and position the White House politically should voters start to link premium increases to the new law. With the law expected to play a significant role in the midterm elections, the president has been using his platform to sell the bill’s most immediate benefits and, by extension, to defend Democrats in Congress who risked their careers to vote for it.

He will do so again Tuesday; after his private meeting, Mr. Obama will appear in the East Room, where he will highlight new regulations to protect consumers from discriminatory insurance practices, end lifetime limits on coverage and ban unjustified revocations of coverage.

Mr. Axelrod likened them to “essentially a patients’ bill of rights, the strongest in history.”

White House officials said Tuesday’s attendees will include top executives from 13 leading health insurers, as well as Karen M. Ignagni, the president of America’s Health Insurance Plans, the industry trade group. Five state insurance commissioners also are expected to attend.

The insurers have attributed this year’s increases to skyrocketing medical costs and to the economic downturn, which has prompted healthier consumers to forgo health insurance, leaving a sicker and costlier pool to cover.

“Our companies are receiving rate increase requests from hospitals across the country of 40, 50 and 60 percent,” said Robert Zirkelbach, a spokesman for the trade group. “That has a direct impact on the cost of health care coverage.”

But a report released Monday by Health Care for America Now, a coalition that supports the new law, stressed that the growth in premiums in the first eight years of this decade had far exceeded medical inflation — 97 percent to 39 percent.

The new law requires the health secretary to work with states to establish a process for annual reviews of “unreasonable increases in premiums.” Administration officials said Monday that they were still writing regulations to define “unreasonable increases.”

Mr. Obama’s approach to the health insurance industry has rarely been subtle, starting with his campaign, when he spoke of his dying mother’s struggle to persuade her insurer to cover her cancer treatments.

In March, with his health bill hanging by a thread in Congress, Mr. Obama ducked into a White House meeting with insurance executives to deliver a letter from an Ohio cancer survivor who had dropped her coverage after learning her premiums were rising 40 percent.

But for all of Mr. Obama’s browbeating, the new health care law stopped short of giving the administration the power to reject or limit rate increases. Instead, it established the annual reviews, starting next year, and makes available $250 million in grants to states to implement the review process.

States that accept the grants must recommend whether insurers with patterns of excessive pricing should be allowed to market policies through newly created exchanges, which will help individuals and businesses shop for coverage starting in 2014. Insurers also will be required to justify increases deemed unreasonable on their Web sites.

In the closing weeks of the health care debate, the White House offered a proposal to give the health secretary authority to deny unreasonable increases. It did not make it into the final legislation, but Senate Democrats have reintroduced it as a standalone bill.

The regulatory clout of state insurance departments varies widely, with some having minimal power to block rate increases. But in recent months, several states have taken unusually assertive steps.

In California, state regulators announced that they would order independent reviews of increases being sought by four large health insurers. That move came after the department discovered miscalculations in rate requests by Anthem Blue Cross, prompting the company to withdraw its plan to raise premiums by as much as 39 percent.

In Massachusetts, the administration of Gov. Deval Patrick, a Democrat, used long-untapped power to deny 9 of 10 rate increases requested by the state’s insurers, provoking a lawsuit from the industry. A court in Maine recently upheld a smaller rate increase for that state’s largest insurer — 10.9 percent instead of 18.1 percent — that had been ordered by the insurance superintendent.

In New York, Gov. David A. Paterson, a Democrat, signed legislation this month giving the state power to block unreasonable rates. And in Pennsylvania, Gov. Edward G. Rendell, also a Democrat, announced two weeks ago that his insurance commissioner, Joel Ario, would investigate large increases by the state’s biggest insurers.

“The plans are cherry-picking the best risk,” Mr. Ario, who will attend the White House session, said in an interview.

The federal law, which will require that most Americans obtain insurance, includes a number of provisions intended to slow the growth of premiums. For instance, insurance companies soon will have to spend at least 80 percent of revenue from premiums on claims, as opposed to administration and profit.

Insurers have warned since early in the debate that the overhaul might result in increased premiums for many consumers. The Congressional Joint Committee on Taxation and the nonpartisan Congressional Budget Office found otherwise, projecting that it would have minimal effect on group premiums, which account for 83 percent of the market. Their analysis forecast that premiums for individual policies would rise faster than they would without the new law, but that the increases would largely be offset by government subsidies.

Whatever the law’s ultimate effect, many of this year’s most egregious rate increases were announced well before it was clear the bill would pass.


Reed Abelson contributed reporting from New York.

    As Law Takes Effect, Obama Gives Insurers a Warning, NYT, 21.6.2010, http://www.nytimes.com/2010/06/22/health/policy/22health.html

Hallucinations in Hospital Pose Risk to Elderly

June 20, 2010
The New York Times
By PAM BELLUCK

No one who knows Justin Kaplan would ever have expected this. A Pulitzer Prize-winning historian with a razor intellect, Mr. Kaplan, 84, became profoundly delirious while hospitalized for pneumonia last year. For hours in the hospital, he said, he imagined despotic aliens, and he struck a nurse and threatened to kill his wife and daughter.

“Thousands of tiny little creatures,” he said, “some on horseback, waving arms, carrying weapons like some grand Renaissance battle,” were trying to turn people “into zombies.” Their leader was a woman “with no mouth but a very precisely cut hole in her throat.”

Attacking the group’s “television production studio,” Mr. Kaplan fell from his hospital bed, cutting himself and “sliding across the floor on my own blood,” he said. The hospital called security because “a nurse was trying to restrain me and I repaid her with a kick.”

Mr. Kaplan’s hallucinations lifted as doctors treated his pneumonia. But hospitals say many patients are experiencing such inexplicable disorienting episodes. Doctors call it “hospital delirium,” and are increasingly trying to prevent or treat it.

Disproportionately affecting older people, a rapidly growing share of patients, hospital delirium affects about one-third of patients over 70, and a greater percentage of intensive-care or postsurgical patients, the American Geriatrics Society estimates.

“A delirious patient happens almost every day,” said Dr. Manuel N. Pacheco, director of consultation and emergency services at Mount Auburn Hospital in Cambridge, Mass. He treated Mr. Kaplan, whom he described as “a very learned, acclaimed person,” for whom “this is not the kind of behavior that’s normal.” “People don’t talk about it, because it’s embarrassing,” Dr. Pacheco said. “They’re having sheer terror, like their worst nightmare.”

The cause of delirium is unclear, but there are many apparent triggers: infections, surgery, pneumonia, and procedures like catheter insertions, all of which can spur anxiety in frail, vulnerable patients. Some medications, difficult for older people to metabolize, seem associated with delirium.

Doctors once dismissed it as a “reversible transient phenomenon,” thinking “it’s O.K. for someone, if they’re elderly, to become confused in the hospital,” said Dr. Sharon Inouye, a Harvard Medical School professor. But new research shows significant negative effects.

Even short episodes can hinder recovery from patients’ initial conditions, extending hospitalizations, delaying scheduled procedures like surgery, requiring more time and attention from staff members and escalating health care costs. Afterward, patients are more often placed, whether temporarily or permanently, in nursing homes or rehabilitation centers. Older delirium sufferers are more likely to develop dementia later. And, Dr. Inouye found, 35 percent to 40 percent die within a year.

“It’s terrible, more dangerous than a fall,” said Dr. Malaz A. Boustani, a professor at the Indiana University Center for Aging Research, who found that elderly patients experiencing delirium were hospitalized six days longer, and placed in nursing homes 75 percent of the time, five times as often as those without delirium. Nearly one-tenth died within a month. Experts say delirium can contribute to death by weakening patients or leading to complications like pneumonia or blood clots.

Ethel Reynolds, 75, entered a Virginia hospital last July to have fluid drained that had been causing her feet to swell. She wound up hospitalized for weeks, sometimes so delirious that “she screamed constantly, writhed,” said her daughter, Susan Byrd. “I had to get in bed with her because she thought someone was coming and they were going to hurt us,” Ms. Byrd said.

Ms. Reynolds ended up needing dialysis and surgery after an infection, and she died in September.

“We got her death certificate, and the No. 1 cause of death was delirium,” said Ms. Byrd, an ophthalmology nurse. “I was just blown away. As a nurse, I was expecting a quote-unquote medical reason: kidneys, heart, lung, an organ that I could understand had failed, and it wasn’t. It was delirium.”

Other triggers involve disorienting changes: sleep interrupted for tests, isolation, changing rooms, being without eyeglasses or dentures. Medication triggers can include some antihistamines, sleeping pills, antidepressants and drugs for nausea and ulcers. Dr. Inouye said that many “doctors don’t know how to appropriately use meds in older people, in terms of dosing” and compatibility with other medications.

Earle Helton, 80, a retired chemist hospitalized after a stroke, ordered his family to “throw a rope over the hedge so he could escape,” said his daughter, Amanda. He tried removing his hospital gown, loudly sang “Lullaby and Goodnight,” and doctors had to tie down his hands to prevent him from leaving, said his wife, Ginnie. Only when Dr. Inouye stopped some medications that other doctors had prescribed did he become lucid.

Delirium is sometimes treated with antipsychotics, but doctors urge caution using such drugs.

Delirium can wax and wane, not always causing aggressive agitation.

“It is often the person quietly in bed,” and the condition can linger for weeks or months, landing patients back in the hospital, said Dr. Julie Moran, a geriatrician at Beth Israel Deaconess Medical Center in Boston. “We would have to build 100 more floors to keep everybody until they cleared their delirium. There are times when we could be working round the clock seeing patients with delirium.”

Frequently, geriatricians say, delirium is misdiagnosed, or described on patient charts as agitation, confusion or inappropriate behavior, so subsequent doctors might not realize the problem. One study found “delirium” used in only 7 percent of cases; “confusion” was most common. Another study of delirious older emergency-room patients found that the condition was missed in three-quarters of them.

People with dementia seem at greater risk for delirium, but many delirious patients have no dementia. For some of them, delirium increases the risk of later dementia. In such cases, it is unclear if delirium caused the dementia, or was simply a signal that the person would develop it later.

Some hospitals are adopting delirium-prevention programs, including one developed by Dr. Inouye, which adjusts schedules, light and noise to help patients sleep, ensures that patients have their eyeglasses and hearing aids, and has them walk, exercise and do cognitive activities like word games.

Dr. Moran’s hospital removes catheters, intravenous lines and other equipment whenever possible because they can make patients feel trapped, leading to delirium. She said nurses repeatedly assess cognitive function so patients “don’t have smoldering symptoms of delirium for days before they end up yelling and screaming.”

Mr. Kaplan, a biographer of Mark Twain and Walt Whitman, later jotted notes about his hallucinations, including being in a police helicopter “tracking fugitives with enormous light.”

“Exhilarating until I become one of the fugitives,” he wrote. “End up cold and naked in some sort of subway passage.”

His fall bruised his elbow, leg and wrist, said his wife, the writer Anne Bernays. The next day, “he was gaga till about noon,” and even “looked me in the eye and said ‘I’m going to kill you,’ ” she said. “He didn’t know where he was and didn’t recognize me.”

Fortunately, his delirium was discovered very quickly and he made a very good recovery, Dr. Pacheco said. “But,” he said, “delirium is very disruptive for the patient, family, hospital caregivers.”

As Mr. Kaplan understated later, “It was a lot of unpleasantness.”

    Hallucinations in Hospital Pose Risk to Elderly, NYT, 20.6.2010, http://www.nytimes.com/2010/06/21/science/21delirium.html

Schools Struggle to Educate the Severely Disabled

June 19, 2010
The New York Times
By SHARON OTTERMAN

Donovan Forde was dozing when the teacher came around to his end of the table. Pale winter light filtered in through the grated classroom window, and the warm room filled softly with jazz. It fell to his teacher’s aide to wake him up from his mid-morning nap.

She shined a small flashlight back and forth in his eyes like a dockworker signaling a ship, and called his name. Then she put her hand on his cheek, steering his head forward as he focused his eyes.

The teacher, Ricardo Torres, placed a red apple against Donovan’s closed left hand, and then held it near his nose so he could smell it. “Donovan, the fruit holds the seeds of the plant,” he said.

Then Mr. Torres held a plastic container of apple seeds to Donovan’s ear, shaking it, and placed Donovan’s hand inside so he could feel them. “And these are the seeds,” Mr. Torres said.

He watched Donovan’s eyes and face for a sign he had understood, a smile, nod, a noise. Donovan gently pulled his hand away. No one knew if he had grasped it.

At a time when his peers are enrolled in college or earning money at jobs, Donovan, a handsome 20-year-old with a sliver of a mustache, is still in public school, being taught the most basic of facts. His vocabulary for this science unit, which lasted about two weeks, was three words: seeds, fruit and juice.

And yet, because of his cognitive disabilities brought on by a traumatic brain injury at nearly 6 months old, it is almost impossible to know what he comprehends and retains. After 15 years in the New York City school system, he is less reserved and more social, but otherwise has shown almost no progress, his mother said.

Once predominately isolated in institutions, severely disabled students have been guaranteed a free, appropriate public education like all children since the passage of federal legislation in 1975. In the years since, school districts across the country have struggled to find a balance between instruction in functional skills and academics while providing basic custodial care.

Donovan is part of a fraction of a fraction, classified as having “multiple disabilities,” a broad category under the federal Individuals With Disabilities Education Act that refers to children who have at least two disabilities and severe educational needs.

There are 132,000 such students in the United States, out of more than 6.5 million now receiving some kind of special education service at an estimated cost of $74 billion a year.

Students with multiple disabilities, like Donovan and his schoolmates, can have a wide range of diagnoses, including cerebral palsy, rare genetic disorders and problems that stem from conditions in utero or at birth, some of which have no name.

For many of these students, the post-school future holds day residential programs, nursing facilities or group homes, not college or jobs. The concepts of educational reform and standardized assessment have little meaning for them; they are among the most costly to educate and the least understood.

Donovan recognizes familiar voices, and can mimic their intonations. He communicates some needs; at lunch, he pulls off his bib to show when he is finished. When happy, he sings fragmented notes, his scratchy voice rising in triplets and quads.

But he cannot walk, does not speak and cannot feed himself or see much beyond shapes and shadows. On standardized assessments, he has trouble with tasks most children master in infancy, like opening and closing his eyes on command. Occupied much of the time by his own inner world, he does not respond consistently to his own name.

One year before he is to leave the school system, educating Donovan remains a search for ways to reach him.

A Question of Goals

Donovan’s mother, Michelle Forde, likes his special education high school, Public School 79, the Horan School, in East Harlem, where she feels he is welcome and cared for. But she wishes his teachers would spend more time working on his practical challenges, like his self-abusive habit of hitting himself in the face so hard that he has to wear thick white cotton mitts most of the time, even when he sleeps.

Instead of having him work on basic academic goals, like identifying shapes and coins, she wishes he had physical therapy more than 30 minutes, twice a week, because it is generally the only time during the day he is taken out of his wheelchair, except when an aide takes him to the bathroom to change him.

Rebecca Bravo, the principal of P.S. 79 and the mother of a 38-year-old severely disabled daughter, says that those things are important, but she also has broader aims. For example, Donovan will never be able to prepare breakfast, but he should be allowed to help stir a pot in cooking class, even if an aide must move his hand. He might not be able to call 911, but if he learns about firefighters in social studies, he might be able to recognize a siren when he hears one.

Ms. Bravo does not want to go back to the days when students like Donovan were given only art and music instruction, along with a narrow focus on practical skills.

“For too long, that’s where we kept them, in art and music, and we didn’t give them some of the other things they needed,” she said.

P.S. 79, following city and state mandates, has been moving toward more academic instruction for years. This year, her last before retirement, Ms. Bravo decided to add a twist.

Not only would she teach her severely disabled students adapted versions of science, social studies, English and math, but they would also switch classes almost every 50 minutes instead of remaining with the same teacher. The different environments would be stimulating, she reasoned, and give them a high school experience more like that of their general education peers.

The day starts at 8 a.m. The first hour is spent in the cafeteria, eating breakfast and waiting for children to arrive on dozens of buses from throughout the city.

Painted with colorful murals, the hallways bustle with activity. Upstairs are special classes for students with emotional disturbance, autism or learning disabilities. Some 170 adults — aides, therapists, teachers and administrators — work with 319 students. In 2009, the cost per student was $58,877, more than triple the citywide average of $17,696.

It is a Tuesday in late February, and Donovan’s first class is adaptive physical education. A line of teacher’s aides wheels and walks the students to a classroom that has primary-colored mats along one wall, as well as a few balls, cones and a floor-based basketball net.

“We are in GYM,” the teacher, Kenneth Toron, announces in a circus performer voice, slurring his words somewhat because his left side is partially paralyzed from a stroke. As a visual clue, he holds up a simple line drawing of a basketball and a net known as a Mayer-Johnson symbol. “We are going to EXERCISE.”

Mr. Toron sets up a few cones on the floor and starts up a music playlist on the classroom computer. “Surfin’ U.S.A.” by the Beach Boys is first up. The more advanced students begin walking, some hesitantly, others easily, around the cones.

Some students in Donovan’s classes are able to speak, master vocabulary, socialize and walk, and others appear to attend to even less than he does, engaging in near-constant self-stimulating behaviors, like repetitive jaw chomping, collapsing to the floor during class or reciting many times an hour descending notes that resemble a sad bird call. Ms. Bravo believes in mixing students with multiple disabilities of varying severity so they can learn from one another.

Donovan remains in his wheelchair, moving his head slightly back and forth to the music, his legs crossed at the knees.

A soft ball covered with yellow tape dangles from a rope in front of his wheelchair. A few times during the class, Mr. Toron walks over and gives the ball a tap into Donovan’s line of vision. Donovan swipes the ball weakly out of his way with his ungloved right hand, nodding his head in time to the music. Anissia Mack, Donovan’s one-to-one aide, stands nearby; she occasionally jangles the ball.

Aides lift another student, Darius Jenkins, 15, out of his wheelchair and place him on an inclined plane, where he lies quivering and drooling slightly for most of the class. He is given a squeeze ball to hold several times, but each time, he drops it.

Donovan looks as though he is resting, but when Michael Jackson’s “Beat It” comes on, he smiles and raises his chin. From the back of his throat, he sings a few rough, wordless refrains that loosely follow the beat.

Next, it is off to science. Mr. Torres, a first-year teacher, uses all of his creativity to adapt the lessons, writing his own books, using symbols, pictures and words. He circulates around the room, asking students to identify the vocabulary.

“Which is the fruit?” he asks an intense young student named Isatou, presenting her with a set of two electronic buttons, one marked with a fruit picture, the other with a seed.

Sitting on her own, she presses the correct image, evoking the words “fruit, las frutas” from the button. “Good job,” Mr. Torres said.

Working with the apple and the seeds, Ms. Mack, who is in charge of most of Donovan’s repetition and drilling, marks his responses on a worksheet. “As far as what he’s retaining, I couldn’t tell you,” Ms. Mack said later. She has worked with him for two years, assigned to him because he is prone to seizures, and said the main change she had noticed was that he seemed calmer. “But I do think he appreciates getting an education,” she said.
 

‘Something’s Happened’

Donovan was born healthy, except for clubbed feet. An operation to correct them had been scheduled when, on Aug. 15, 1990, Ms. Forde left Donovan, nearly 6 months old, with his father while she went to work cleaning offices at night.

She felt uneasy all evening, and when she returned to her parents’ house at 1 a.m., her father told her, “Something’s happened to the baby.”

Ms. Forde, then 18, found Donovan unconscious in the hospital, his head in a bandage. His father had been on the street and returned home to get a baby bottle, he told her, leaving Donovan in the arms of a female friend. An under-age driver in a stolen car hit them as they stood near Avenue I and East 23rd Street in Brooklyn.

The friend’s leg was broken, and Donovan landed on his head on the pavement so hard that his heart stopped. A bystander gave him mouth-to-mouth, reviving him before the ambulance came.

For six weeks Donovan remained in a coma, the swelling in his head damaging his optic nerves before a shunt was placed to drain the fluid. After a few months at a rehabilitation center upstate, he came home, forever changed.

His habit of hitting himself started when he was about 5, the same age when he began attending public school, leaving a Helen Keller early intervention program for the blind. Ms. Forde struggled to care for him while getting her bachelor’s degree and working; she and his father split, and despite various attempts, she received no settlement for the accident.

At home, she tried to stimulate him by constantly playing music, especially R&B. She thinks that when he sings, he remembers nursery rhymes he had heard as a baby, his intermittent “ba ba” a remnant of “Baa Baa Black Sheep.”

“He only knows sitting up and making noises, because he was only 5 months old,” she said of his current skills. But though he seemed frozen in infancy in some ways, his bad habits worsened. At elementary school in Coney Island, Donovan twice knocked out one of his teeth, arriving home with them in a bag. At home, he began reaching into his diaper and spreading around the mess.

Pregnant with her second child, and unable to afford private care, Ms. Forde made the wrenching decision nine years ago to move him to the nursing facility at Coler-Goldwater Memorial Hospital on Roosevelt Island, where he would get 24-hour attention and Medicaid would foot the bill. He still lives there today, sleeping in a high-walled bed in a room he shares with three other severely disabled youths.

A Plan, but Little Progress

Donovan’s individual education plan paints a picture of what he is expected to learn at P.S. 79.

By November, it says, he will identify directional concepts like top and bottom, left and right with 100 percent accuracy. He will identify four United States coins and common shapes with 100 percent accuracy. He will communicate a message, a desire or need, using an electronic button or tactile icon, five times a day. The problem is that after 15 years of education, he has not learned how to do most of those things reliably.

“Donovan has not yet demonstrated consistent functional communication to indicate purposeful needs,” his plan states.

“I don’t think he can identify shapes,” his mother said, calling the plan unrealistic. “He’s not identifying anything; he just is thinking, ‘O.K., you have something in front of me — what do you want me to do?’ ” Because they need intensive interventions, students like Donovan do not fit neatly into the paradigm for special education that has prevailed in the United States for more than a decade: inclusion. Congress ranks each state for its success in moving special education children into general education classrooms, addressing a core concern in the field — that too many children are not getting access to the regular curriculum.

But whether Donovan is best served in an academic-focused classroom is an uncomfortable question for many educators, because few better options are available, and inclusion “indicates a level of hope for parents, and the absence of hope is deadly,” said David Rose, the founder of CAST, a national organization that works to expand learning opportunities for students with disabilities.

“It’s an awkward period,” Mr. Rose said, in talking about the education of children with the most severe cognitive disabilities. “Because we know what we are doing is not right, and we often don’t talk about things when we don’t know what we are doing about them yet.”

Following federal No Child Left Behind guidelines, New York State standards, even for assessments of the kind Donovan takes, are framed around academic skills. Schools choose the test subjects from a state list that includes items like number awareness, basic geometry and distinguishing living from nonliving things.

Of the 1 percent of students statewide who take such assessments, about 90 percent score at a proficient or advanced level, limiting their usefulness as an accountability standard, said Rebecca H. Cort, the state deputy commissioner for special education. “It’s a problem,” she said.

But despite her son’s lack of academic progress, Ms. Forde is not dissatisfied. She is grateful that her son goes to school like a regular student, and says that he seems happy most of the time. “The only goal I had for him was when he was in the hospital after the accident, when the nurse told me he wasn’t going to live,” she said. “He’s here, and he’s 20 years old. So he surpassed his goal. He’s alive.”

A Resonant Connection

There are glimmers that greater communication and interaction with other people, a momentous goal for a student like Donovan, are possible.

One day in late March, Donovan sat alone in the cafeteria before dismissal, moving his head from side to side as if discerning rhythms from the busy room around him. He smiled as if he were remembering a secret. “Who is that, Ray Charles?” said Roosevelt Adams, gesturing across the room at Donovan. “Or Stevie Wonder?”

A tall, rangy man with 26 years on the job as a teacher’s aide at P.S. 79 (or, as he prefers to be known, an educational assistant), Mr. Adams holds in his mind a kind of Rosetta stone to Donovan’s physical language. “That’s his happy mood,” he said.

Donovan’s communications are hard to measure on assessments, and there is no glossary of them posted for teachers to see. So not everyone knows that a head butt, according to Mr. Adams, is how Donovan says no when he gets angry. Or that when Donovan does not want something, he turns his head. When he wants something, “he lets you give it to him,” Mr. Adams said, adding that when his head is down, “that’s his low.”

Mr. Adams was Donovan’s one-to-one aide for four years before Ms. Mack took over two years ago. It is an intimate position to be in; from nearly the moment Donovan gets off the bus to the moment he leaves, the aide feeds him, quizzes him, reads to him, changes him (if the aide is the same gender) and wakes him up when he is dozing.

Besides physical therapy at P.S. 79, Donovan receives an hour each of occupational and speech therapy each week, and a half-hour of vision therapy. His classroom teachers must divide their time with 11 other students with multiple disabilities. So more than anyone else at P.S. 79, the teacher’s aides may have the best shot at providing the intensive one-on-one time that many experts say it takes to make progress with a student like Donovan.

They are also among the lowest paid people in the system, earning between $21,000 and $36,000 a year, and requiring no specific training in special education beyond what they learn on the job.

Donovan’s love for music requires no translation. He sings in fragmented high-pitched tones, or in throaty notes that blossom into rhythmic phrases. But Mr. Adams got him to achieve more.

By getting Donovan into a really happy mood, by tickling him or giving him a head rub, he found he could get him to sing “Old MacDonald” with him. And though he does not speak, Donovan managed the “Old Mac” and then — his favorite part — a loud “E-I-E-I-O.”

“Singing, that’s a form of talking,” Mr. Adams said, adding that Donovan reminded him of his mother and brother, both of whom were blind. “He understands very well, quite as much as you and I do. If he could talk, and he could see, he could express himself a little bit better.”

Without knowing it, Mr. Adams’s efforts had touched on recent research in educating severely disabled children that focuses on using emotion and human connection to reach them. As higher functioning areas of their brains are underdeveloped, emotion moves them at a deeper level, lighting up the same part of their brain, the limbic system, as meaningful music, and possibly creating a bridge to greater intellectual cognition.

“We are so focused on teaching them skills, we don’t focus on the emotional part of the child,” said Rosanne K. Silberman, who coordinates graduate teacher preparation programs in severe disabilities and blindness at Hunter College. “You want them to be happy. You want to be about working on showing this kid that he’s a worthwhile human being.”

Since Mr. Adams was reassigned to other students, Donovan no longer sings “Old MacDonald,” aides in his class said. He also appears to have forgotten how to indicate, with a nod, which is more: one marker tapped against his arm or two, said Sharon Naftali, his former classroom teacher who works with him in a yoga class. “It wasn’t practiced,” she said.

But Ms. Bravo said she believed exposing Donovan to change would help him be more flexible in the face of whatever lay ahead for him, likely a residential day program where he will get less one-on-one support than he does now. His therapies are starting to be scaled back in preparation for the transition.

“We find that very often we do a disservice to our kids when they come to depend on just one person,” she said.

A Year to Go

Donovan is the only legally blind student in his class, and when teachers take that into account, he comes alive. One Thursday afternoon, Timothy Carton, his English teacher, filled his brightly colored classroom with choruses of bird calls, the chirps of cardinals and blue jays causing Donovan to sing back. An interactive smart board narrated a simple story.

“Donovan, this is the big nest,” Mr. Carton explained in a bright tone, holding a handmade nest of twigs next to Donovan’s hand. “It’s round. It goes round and round and round. And in the middle is the bird,” he said, putting a chirping red plastic cardinal in his hand. “Can you feel the bird? Can you pick the bird up? The bird flies around, and you put the bird back in its nest.” He put his hand over Donovan’s to guide him through the motions.

But in math class, Donovan was unable, as were most of his classmates, to distinguish a dollar from a quarter, or participate in an exercise in which he was told it would cost $1 to buy a plastic model of French fries and 25 cents for a plastic toy version of a doughnut. An aide working with him and another student could not get a clear response, and after a few minutes, stopped trying.

One morning in mid-March, there was an accomplishment. In a modified yoga class called Getting Ready to Learn, Donovan’s vision teacher slipped off both of his gloves and spent time massaging his stiff arms, which tend to stay bent at right angles. Calmed, he was able to keep them off for the rest of the day.

“If I have one issue with the Department of Education, it’s that one size doesn’t fit all,” said Barbara Levine, the vision teacher, who has worked in city special education schools for 25 years and who wants Donovan to have a music class.

“What I’m seeing is that what they are doing is a great fit for 15 to 20 percent of the kids, and the rest of them, we go well over their heads,” she said.

Ms. Bravo said her goal was to strike a balance between functional and academic instruction, focusing on what is really important: the skills that Donovan will need to help communicate to caregivers in the years ahead. Whether that actually took place, she said, will be looked at.

She is retiring this year, but will recommend that the school scale back its class-switching experiment next year, Donovan’s last. Although the teachers and many of the students seemed to relish the dynamism of the curriculum, it proved too much for a single teacher to learn the individual learning styles of dozens of highly challenged students.

But Ms. Bravo is confident the school is moving in the right direction. “I believe we are a special place,” she said. “Are we perfect? No. But no place is.”

    Schools Struggle to Educate the Severely Disabled, NYT, 19.6.2010, http://www.nytimes.com/2010/06/20/education/20donovan.html

Push to Market Pill Stirs Debate on Sexual Desire

June 16, 2010
The New York Times
By DUFF WILSON

Ever since Viagra met blockbuster success in 1998, the drug industry has sought a similar pill for women.

Now, a German drug giant says it has stumbled upon such a pill and is trying to persuade the Food and Drug Administration that its drug can help restore a depressed female sex drive. The effort has set off a debate over what constitutes a normal range of sexual desire among women, with critics saying the company is trying to turn a low libido into a medical pathology.

On Wednesday, an F.D.A. staff report recommended against approving the drug, saying the maker, Boehringer Ingelheim, had not made its case and that the benefits of the daily pill did not outweigh its side effects, which included dizziness, nausea and fatigue.

That staff report came ahead of a meeting Friday by an F.D.A. advisory panel of experts who are to vote on whether to recommend that the agency approve the pill, which would be the first drug aimed specifically at a low sex drive in premenopausal women.

F.D.A. staff reports carry weight but do not always sway how advisory panels vote, and advisory votes do not always predict what the F.D.A. might finally decide.

Some analysts forecast that if the drug does reach the market, it could have annual sales in this country of $2 billion — or about equal to the current combined annual American sales of the men’s drugs Viagra, Levitra and Cialis.

In the last month, Boehringer has been trying to lay the consumer groundwork with a promotional campaign about women’s low libido, including a Web site, a Twitter feed, a Discovery Channel documentary and a publicity tour by Lisa Rinna, a soap opera star and former Playboy model, who describes herself as someone who has suffered from a disorder that Boehringer refers to as a form of “female sexual dysfunction.”

There is no dispute that some women have a depressed level of sexual desire that causes them anguish. Boehringer cites a condition — hypoactive sexual desire disorder — that is included in the Diagnostic and Statistical Manual of Mental Disorders, a reference book for psychiatrists and insurers.

But many experts say that unlike sexual dysfunction in men — which has an obvious physical component — sexual problems in women are much harder to diagnose. And among doctors and researchers, there is serious medical debate over whether female sexual problems are treatable with drugs. Some doctors advocate psychotherapy or counseling, while others have prescribed hormonal drugs approved for other uses.

There is also debate over how widespread hypoactive sexual desire disorder actually is among women. The medical literature, including articles in the prestigious New England Journal of Medicine, indicate numbers above 10 percent, but such studies have been financed by drug companies.

Critics say Boehringer’s market campaign exaggerates the prevalence of the condition and could create anxiety among women, making them think they have a condition that requires medical treatment.

“This is really a classic case of disease branding,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University’s medical school who researches drug marketing and has studied the campaign. “The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient.”

Boehringer developed the drug, flibanserin, as an antidepressant, but it failed to lift depression. The company says it learned serendipitously that the pill, taken daily for weeks, could restore female libido.

Dr. Peter J. Piliero, Boehringer’s director of medical affairs in the United States, says the lack of libido to the point of distress is a serious problem for some women.

“This is a real disease,” Dr. Piliero said in an interview. “There’s an unmet medical need among premenopausal women to have a treatment.”

Boehringer says the drug reduces the brain chemical serotonin, which can blunt sexual desire, and increases dopamine and norepinephrine, which improve desire, the company said. By acting on a woman’s brain, it takes a different approach from hormonal drugs or the action of Viagra for men, which increases blood flow.

Boehringer’s application for F.D.A. approval said that its two key 24-month studies, of 1,323 premenopausal women who said they suffered distress over lack of libido, had found small but statistically significant improvements. The women lived in the United States or Canada, were mostly married, well-educated and found to have the sexual desire disorder but were otherwise healthy.

In results reported last fall at a medical conference in Europe, the drug was found to increase self-reported “sexually satisfying events” to 4.5 a month on average. The reported events, which did not have to include orgasm, compared with 3.7 a month by women taking a placebo and 2.7 by those who did not take any pills.

The F.D.A. staff report on Wednesday, though, said that Boehringer’s data had not sufficiently demonstrated a second criteria the agency had set for approving such a drug — specifically, that women also report an increased level of sexual desire. The F.D.A. required daily self-reporting by the women in the studies; Boehringer said it had provided monthly reports.

Lara Crissey, a spokeswoman for Boehringer, declined to comment on the F.D.A. staff report.

Other drug companies that have sought a drug to elevate women’s sexual desire have included Pfizer, which spent several years trying to show that its drug Viagra could work for women as well as men. When Pfizer ended that research in 2004, it said in a news release that female sexual disorders resulted “from a broad range of medical and psychological conditions.”

Procter & Gamble sought F.D.A. approval for a skin patch to raise the testosterone levels of women who had had their uterus and ovaries removed, but it was rejected in 2004 because of possible links to breast cancer and cardiovascular disease. In 2006, though, European regulators, saying the testosterone patch appeared safe at low doses, approved that drug to treat depressed sexual desire in women whose uterus and ovaries had been surgically removed.

BioSante Pharmaceuticals, a company in Illinois, is in late-stage testing of another testosterone patch product which it hopes to submit to the F.D.A. next year. And Vivus, a drug development company, is testing a testosterone-based daily abdominal spray for women which it says has proved effective in early trials. And other research is focusing on the antidepressant buproprion, better known as Wellbutrin or Zyban.

Dr. Steven E. Nissen, a Cleveland Clinic cardiologist and a member of the 2004 F.D.A. panel that unanimously rejected the testosterone patch, said that the depressed desire disorder was a real medical condition, especially for middle-age or older women, with both physiological and psychological causes.

“I got a lot of hate mail after that vote,” Dr. Nissen recalled. “People wrote me and said, ‘You men have your Viagra, why are you denying us this?’ I said hey, I’m just trying to do the right thing. It needs to be scientifically sound.”

Dr. Nissen said he had not studied the Boehringer drug.

Leonore Tiefer, a psychologist and professor at New York University who has researched the topic of female sexual desire for more than a decade and plans to testify to the F.D.A. panel on Friday, said Boehringer had gone too far with its publicity effort.

“Women’s sex lives are often a struggle, a disappointment, an archipelago of regret,” she said. “Is there a small group of women who could benefit from medical intervention — probably.”

But she said that if the drug were approved, she worried that “the much larger group of women without any medical reason for their sexual distress will inevitably be misinformed and misled into thinking that there is a pill that can get them the sex life they read about, the one they think everyone else is having.”

Boehringer has also sponsored medical education classes for doctors and nurses about hypoactive sexual desire disorder.

In one course, released online in May, a quiz asked doctors to diagnose the condition of a 42-year-old working mother who takes care of three children and her own sick mother, and who had no desire for sex. (Her husband is mentioned only in passing.)

The correct answer? Schedule a follow-up visit to evaluate whether she has diagnosable hypoactive sexual desire disorder.

    Push to Market Pill Stirs Debate on Sexual Desire, NYT, 16.6.2010, http://www.nytimes.com/2010/06/17/business/17sexpill.html

In Florida, a Lifeline to Patients With TB

June 12, 2010
The New York Times
By DAMIEN CAVE

LANTANA, Fla. — The last of the nation’s original tuberculosis sanitariums sits, improbably, just off Interstate 95, near a Dunkin’ Donuts and a Motel 6, and just behind fields of children playing soccer. The fading signs out front simply say A.G. Holley State Hospital. There is nothing to suggest that one of history’s greatest killers lurks inside.

Florida lawmakers have tried for years to shut the place down. History, it seems, should be on their side. Holley’s counterparts, like the Trudeau Sanatorium in upstate New York, closed decades ago, after antibiotics nearly scrubbed the disease from the United States. These days, TB treatment usually takes place at home or in a handful of large research centers.

And yet somehow Holley remains. Sixty years after it opened, it is both a paragon of globalized public health and a health care anachronism, where strangers live together for months with boredom, pills, pain, contemplation and the same ancient disease that killed George Orwell, Franz Kafka and Eleanor Roosevelt. There used to be 500 patients here, surrounded by brush, with nursing quarters segregated by race. Now, no more than 50 live in the main building, above echoing, empty floors sometimes rented out as a location for filming horror movies.

They have all moved in, like generations past, because they are unable to control their illnesses. Some have traditional TB, the airborne contagion carried by one-third of the world’s population, which becomes a lung-wasting menace in only about 10 percent of the infected. A growing number of others arrive with drug-resistant mutations that can cost hundreds of thousands of dollars to treat.

Just keeping Holley air-conditioned costs hundreds of thousands of dollars a year, according to administrators, which partly explains the state’s interest in moving and privatizing the program.

Employees and patients, however, argue that the specialized care at Holley is a bargain for public health. Holley is a leader in research on drug resistance, and 93 percent of those who enter end up completely cured.

Patients also leave with more than just stronger lungs. Maintaining old sanitarium ideals, Holley offers care beyond TB, whether dentures and eyeglasses or cultural activities, including outdoor classical music concerts for the noncontagious. Many Holley residents who hated arriving end up leaving profoundly changed.

“It’s not uncommon, as patients get better, for them to see this as a second chance at life,” says Dr. David Ashkin, Holley’s medical director, a Brooklynite with a hard-rock ’80s mullet. “It’s very spiritual and life changing to go from nearly dead to alive.”

Most days in fact are a mix of profound appreciation for life, and gnawing sadness at the limits of institutionalized existence.

6 A.M.: Sunrise Sadness

Jean Barreau has lived on Holley’s fourth floor for 23 months, and there is nothing he misses more than work — construction, odd jobs, anything to provide for his family in Haiti. In its absence, he gets up early and walks the halls. He passes a television in the room everyone still calls a solarium. He picks up coffee by the wooden phone booth. He walks some more.

“It’s my therapy,” he says. “I have to get up and do something.”

Compact and contemplative, Mr. Barreau usually ends with reading the Bible. It is practically a miracle that he can stand.

When he first arrived from southwest Florida in June 2008, tuberculosis had chewed not only through his lungs, but also his spine. He spent months in a back brace that squeezed him as tightly as a Victorian corset. On this morning, it sits in his corner room — a benefit of his having been here the longest — where the walls hold photos of Barack and Michelle Obama cut from magazines.

He says the clips are just decoration, to fight the boredom and the sadness. Eight months after he arrived, his wife died in Haiti. He is not sure of the cause, though it could have been TB.

Even as the rates of infection in the United States continue to decline — there were 12,904 reported cases in 2008, down 3 percent from the year earlier, according to the Centers for Disease Control and Prevention — tuberculosis is on the march worldwide. Every year, about two million people die of it, mostly in underdeveloped countries where AIDS is prevalent. (The chances of becoming sick with TB are greater in those with suppressed immune systems.)

Not that his wife’s diagnosis matters much. Asked how he coped with her death, Mr. Barreau, 50, turned silent as his nurses said he had stopped eating and stopped talking. His TB kept him from the funeral, too. He still has not had a chance to comfort his youngest three children, who are 16, 11 and 10.

“There are two types of crying,” Mr. Barreau says. “One is for the life lost; the other is for missing her burial.”

10 A.M.: Treatment

The pills are huge, and mostly red and white. “I want you to look at your medications and make sure they’re correct,” says Wayne Medema, a tall, bearded nurse who has worked at Holley for 15 years. He is at the room of William Hobrock, a sweet-tempered former janitor from outside Tampa who seems to have caught TB at the hospital where he worked.

Mr. Hobrock grabs two pills at a time. He swallows 10 in all.

Others deal with many more. Of the 31 patients at Holley in mid-May, seven were multidrug resistant, meaning that the usual cocktail of antibiotics and vitamins no longer worked, either because the patients did not properly take their first course of medication or because they caught a strain with that resistant mutation.

Of those seven, one had extremely drug resistant TB, which requires treatment with even harsher side effects and higher costs. While the average TB case around the world can be cured in six months with less than $40 worth of pills, the drugs used to battle extreme resistance cost about $150,000 for a full cycle — a hefty bill for Holley, which is financed mostly through state and federal programs like Medicaid.

Worldwide and in the halls here, these stubborn infections are on the rise. A recent World Health Organization report found that drug resistance has reached an all-time high, affecting 3.6 percent of reported TB cases.

“It’s a big concern for the future,” Mr. Medema says. “Can we really get a handle on it?”

Noon: Side Effect

Lunch comes early at Holley, and patients fill their plates with cafeteria cuisine in a room with a rounded wall of windows and a half-dozen tables.

Eating matters. In the era of the Romantic poets — “a fading rose fast withereth too,” John Keats wrote before dying of TB at 25 — tuberculosis was called consumption because it appeared to slowly devour its victims. Indeed, the patients who reach Holley after struggling against TB on their own are often most amazed by one side effect: their guts.

Willie Bennett, who stands about 6-foot-3, came in at 150 lbs; he is about to leave at 205. Barbara Unkelbach, another patient, weighed 129 pounds before being transferred here; now, a few months later, the scale says 164.

The added girth is a sign of health and renewed energy. Generations ago, sanitariums offered classes in metalwork. Holley now teaches patients about computers. There are also arts and crafts classes that yield flashes of beauty — like the bird feeders hanging from a tree in the recreation yard, painted blue and green, miraculously transformed to look nothing like two-liter bottles.

Jeffrey Brown, 46, of Savannah, Ga., considers the yard his own. He worked in landscaping before coming to Holley, and every afternoon he rakes or plants. As a result, flowers now wave where weeds once grew. Mulch lines the walkways, its pungent scent blowing in the breeze with ... cigarette smoke.

Bad habits, it seems, are especially hard to kick.

3 P.M.: When to Go

Fortunately, Ms. Unkelbach stopped drinking. She had a blood-alcohol level of 0.44 percent when she arrived at a nearby hospital with TB, and since coming to Holley, she has addressed both her alcoholism and her physical health.

Her doctors are amazed. Sitting in a chilled conference room to discuss when she might be going home, Dr. Ashkin and his deputy, Dr. Elena Hollender, begin with compliments.

“You look like a million bucks,” Dr. Hollender says. “Do you remember what you looked like when you came in here?”

Ms. Unkelbach, 44, blond, raspy and self-deprecating, nods and smiles. “Wow, it was a long time ago,” she says.

She really wants to leave. June 10 is the date she has been repeating for a week, the day she would like to start over again in her hometown, Hollywood, Fla. She plans to find a job and an apartment that Mr. Hobrock can move into as well (though she says the relationship is not romantic).

In her view, there are just a few more steps. In a few days, she will receive dentures, filling what is now a mostly toothless mouth. Holley’s doctors will also provide her with a cosmetic contact for the left eye that was blinded eight years ago when, she says, a friend accidentally hit her in the temple.

Dr. Ashkin says the improvements will help her find work. “We try to get them to a point where they can go out and be productive citizens again,” he says.

He clicks through several scanned images of Ms. Unkelbach’s lungs. He points to the decrease in TB bacteria, but also identifies a problem.

The bad news hits like thunder.

“You need to be treated until Sept. 11,” Dr. Ashkin says.

“Aw, hell no,” comes the reply. Ms. Unkelbach stiffens and pushes back from the table. “I’ll take the meds on the outside.”

“Just listen,” Dr. Ashkin says.

The next half hour is tense, as doctors lay out the risks. Missed medication or more drinking could make Ms. Unkelbach drug resistant and contagious. Leaving now may mean coming back — under a court order. Eventually, Ms. Unkelbach leaves, apologizing for her overreaction. A week later, she decides to stay.

8 P.M.: Cycling In and Out

Outside, a few hundred yards from boys kicking soccer balls on the other side of the fence, the patients gather. A group of Haitian men snap dominoes down against a plastic table. Ms. Unkelbach sits under a banyan tree reading a novel titled “Run for Your Life,” while Willie Bennett is enjoying his last night of cards. His second stay at Holley is coming to an end.

The next morning, he will leave and take a Greyhound bus home to the other side of the state. He arrived with one small suitcase and a fiancée nine months ago; three bags are now packed beside his bed upstairs, and he is single.

The anticipation has him jittery. “I’m probably going to be up all night,” he says, as he arranges his cards by suit. “It’s time to go home.”

Dr. Ashkin has more patients on the way. Every week one or two come in. Some are sicker than others — a 62-year-old man in central Florida died before he made it — but the routine stays the same. State lawmakers are still looking for ways to change the hospital, or at least cut costs.

But as a Holley resident once told a reporter, at A.G. Holley, “the principal thing is to get well and get out of here.”

That was in 1959.

    In Florida, a Lifeline to Patients With TB, NYT, 12.6.2010, http://www.nytimes.com/2010/06/13/health/13tuberculosis.html

Scientists Cite Advances on Two Kinds of Cancer

June 5, 2010
The New York Times
By ANDREW POLLACK

CHICAGO — Using two opposite strategies, scientists say they have made significant progress in taming two of the most intractable types of cancer.

One approach, highly focused on specific types of tumors, shrank them significantly in 57 percent of patients with a lung cancer marked by a specific genetic abnormality.

Even though the clinical trial was small (just 82 people, with no control group), the results were considered so striking for such sick patients that the study will be featured Sunday at the main session of the annual meeting of the American Society of Clinical Oncology here.

“This is a phenomenal example of finding the right patient and the right drug very early on,” said Dr. Pasi A. Janne of the Dana-Farber Cancer Institute in Boston, who was involved in the trial.

The other strategy is a potentially universal treatment for all types of cancer that works by releasing a brake on the body’s immune system, letting the immune system attack the cancer more vigorously.

In a study of patients who had advanced melanoma, those who got an experimental drug lived a median of about 10 months, compared with 6.4 months for those in a control group. After two years, about 23 percent of those who got the drug were alive, compared with 14 percent in the control group.

Lung cancer and melanoma are among the hardest cancers to treat. So the studies are being viewed as significant advances, though far from cures.

Dr. Steven J. O’Day of the Angeles Clinic and Research Institute in Santa Monica, Calif., a lead investigator in the melanoma trial, called the result “historic,” and added, “This is the first randomized placebo-controlled trial ever to show a survival benefit in Stage 4 melanoma.”

Bristol-Myers Squibb, which sponsored the trial, is planning to apply for regulatory approval to sell the drug, ipilimumab.

The lung cancer drug, by contrast, blocks an aberrant protein called ALK that is found in only about 5 percent of non-small-cell lung tumors. But in patients whose tumors have this aberration, the drug seems to work wonders. Not only did the tumors shrink significantly in 57 percent of the 82 patients, they remained stable in 30 percent more.

Beverly Sotir, 71, of Belmont, Mass., who has been taking the pills as part of the trial since July, said her tumors had shrunk without debilitating side effects. “For someone who’s been on chemo before, this is like a miracle drug,” she said. “You feel yourself. You look yourself.”

Pfizer, which sponsored the study, has started a more definitive trial aimed at winning approval of the drug, crizotinib.

There are caveats. The effects of crizotinib can eventually wear off, though 72 percent of the patients in the trial were free of cancer progression for six months.

As for the melanoma drug, because it removes checks on the immune system, 10 percent to 15 percent of patients who took it in the study suffered severe side effects that had to be treated with immune-damping steroids. Seven patients out of 540 who got ipilimumab died from these immune effects, according to a report of the study published online Saturday by The New England Journal of Medicine.

Efforts to harness the immune system to fight cancer have suffered setback after setback. Because tumor cells are mutated forms of the body’s own cells, not an invading pathogen, they do not usually elicit a strong immune response.

But the Food and Drug Administration this year approved a “cancer vaccine” for prostate cancer called Provenge, so-called because it trains the immune system to attack the patient’s tumors. Most such vaccines focus on a single type of cancer, or are even tailored to individual patients.

Ipilimumab, by contrast, is a more general immune booster. It blocks a protein called CTLA-4 that acts as a brake on T cells, the soldiers of the immune system. It is already also being tested against lung and prostate cancer.

Still, if a tumor does not elicit a strong immune response to begin with, then just keeping the response going longer would not help much, just as lifting one’s foot from the brake usually will not make a car go faster if the accelerator is not pressed.

In at least one other melanoma trial, conventional chemotherapy drugs achieved median survival of about 10 months, the same as ipilimumab.

Dr. Charles M. Balch, a melanoma expert at Johns Hopkins who was not involved in the trial, called the results “a single, not a home run,” though he added that for this disease even a single was important.

About 68,000 Americans are expected to get melanoma this year, with 8,700 deaths, according to the American Cancer Society. The numbers have been increasing, probably because of sun exposure decades ago.

The trial involved 676 patients in the United States and abroad with previously treated metastatic melanoma. They received either ipilimumab or an experimental cancer vaccine or both. Those who got ipilimumab alone did as well as those who got both, suggesting the vaccine had little effect.

Dr. Petra Rietschel of the Montefiore-Einstein Center for Cancer Care in the Bronx said melanoma experts were equally or even more excited about a drug being developed by Plexxikon and Roche that blocks a particular protein called B-RAF that is aberrant in more than half of all cases of the disease. That is similar to the approach of crizotinib, Pfizer’s lung cancer drug. They are part of a trend to genetically analyze a patient’s tumor and find drugs that block the particular genetic anomaly that drive that tumor’s growth.

Pfizer developed crizotinib to block another protein called MET. The fact that the drug also blocked ALK was considered unimportant.

But in 2007, after the clinical trial had started, Dr. Hiroyuki Mano and colleagues at Jichi Medical University in Japan reported that in a small number of lung cancers, there was a chromosome dislocation that brought the gene for ALK together with the gene for another protein called EML4. That created a fusion protein that spurred tumor growth. Dr. Mano had discovered this by systematically testing all the active genes in a tumor removed from a lung cancer patient.

Pfizer turned on a dime and began enrolling lung cancer patients with this fusion protein in the trial. Japanese patients began flying to South Korea, the nearest place with trial sites.

Dr. Mano said the first Japanese patient who went was so sick — heavily dependent on oxygen tanks and unable to swallow — that he had to be taken to the airport by medical helicopter and met by an ambulance at the airport in Seoul.

Two weeks later, Dr. Mano said, he went to Seoul to check on the patient. The man no longer needed oxygen and was walking in the neighborhood each day looking for good restaurants. The patient returned to Japan and lived for several more months.

Scientists said the ALK gene aberration tends to be more frequent in younger patients and nonsmokers. Experts say that even though the drug might be useful for only 5 percent of non-small-cell lung cancer patients, that would still be about 10,000 people a year in the United States and 40,000 worldwide.

Finding drugs for each subset of tumors will take years. And cancers can mutate and become resistant to drugs blocking particular abnormalities.

Dr. James Allison, who developed the idea for ipilimumab while at the University of California, Berkeley, said the immune therapies might be helped by such mutations. So the targeted drugs and the immune boosting ones might work best together.

“It’s the ultimate personalized treatment for cancer,” said Dr. Allison, who is now chairman of immunology at the Memorial Sloan-Kettering Cancer Center.

    Scientists Cite Advances on Two Kinds of Cancer, 5.6.2010, http://www.nytimes.com/2010/06/06/health/research/06cancer.html

The Doctor Payment Follies

June 4, 2010
The New York Times

The formula that is used to pay doctors who treat Medicare patients is producing increasingly absurd results. If it were to be followed this year, doctors would face a 21 percent cut in payments for the tests, procedures, office visits and other services they provide to elderly Americans.

That would be a disaster, driving many doctors to stop accepting Medicare patients. Luckily, nobody is seriously contemplating that. As it has done repeatedly in recent years, Congress is readying a short-term fix that would provide a modest increase in physician fees for the next 19 months.

There will likely be no real solution until the American health care system moves away from unfettered fee-for-service payments that encourage doctors to perform unnecessary and costly tests and procedures and pays them instead for better management of a patient’s care over time.

The flawed reimbursement formula predates the new health care reform law by more than a decade. But its problems are a reminder that even with reform there is a lot of work ahead to rein in the cost of health care.

When first enacted in 1997, the “sustainable growth rate” formula looked liked a reasonable way to restrain Medicare spending. It set annual limits for the total amount of money to be paid to doctors in the traditional Medicare program. It also included allowances for inflation in the cost of operating a medical practice, for growth in the elderly population, and even a little extra money to pay for increases in the volume and complexity of services performed.

It worked well for the first five years. Starting in 2002 it began to hit a variety of problems. The fatal flaw in the formula was that it had no way to limit the array of services doctors provided or distinguish between valuable and needless treatments.

If doctors in the aggregate drove expenditures above the limit, the formula called for fees in the following year to grow more slowly than medical inflation or be reduced. That aggregate punishment was not enough to persuade individual doctors to change behavior.

When Medicare doctors were faced with the prospect of actual rate cuts, they screamed for help. Congress provided repeated relief. Each time it postponed a scheduled cut, the meter kept ticking and the required cuts accumulated. That is why the system was due to cut doctors’ reimbursement by 21 percent on June 1.

The Obama administration is holding off, the House has approved a 19-month fix, and the Senate is expected to concur this week. The bill would raise doctors’ payments, in the aggregate, by about $1 billion over current rates — and $23 billion over what they would get if the required cuts were imposed. That is probably the best that can be done for now.

Meanwhile, the experience suggests that there could be problems with at least one key element of the new health care reform law. To hold down the cost of Medicare, it sets target levels for per capita Medicare spending beginning in 2015.

Once again the formula sets targets that may be hard to reach — and will require Medicare to find savings in the following year if they are not. The encouraging news is that a new independent board will have the power to recommend a much broader range of potential savings, not just cuts in doctor payments, to make up the difference. Congress will have the final say.

The reform law also tries to cut costs by emphasizing primary care and setting up pilot programs to find better ways to organize and deliver high-quality care at lower cost and move the system away from fee-for-service payments. If these work well, they could finally put a real brake on Medicare spending.

    The Doctor Payment Follies, NYT, 4.6.2010, http://www.nytimes.com/2010/06/06/opinion/06sun1.html

The Doctor Will See You Now. Please Log On

May 28, 2010
The New York Times

By MILT FREUDENHEIM

ONE day last summer, Charlie Martin felt a sharp pain in his lower back. But he couldn’t jump into his car and rush to the doctor’s office or the emergency room: Mr. Martin, a crane operator, was working on an oil rig in the South China Sea off Malaysia.

He could, though, get in touch with a doctor thousands of miles away, via two-way video. Using an electronic stethoscope that a paramedic on the rig held in place, Dr. Oscar W. Boultinghouse, an emergency medicine physician in Houston, listened to Mr. Martin’s heart.

“The extreme pain strongly suggested a kidney stone,” Dr. Boultinghouse said later. A urinalysis on the rig confirmed the diagnosis, and Mr. Martin flew to his home in Mississippi for treatment.

Mr. Martin, 32, is now back at work on the same rig, the Courageous, leased by Shell Oil. He says he is grateful he could discuss his pain by video with the doctor. “It’s a lot better than trying to describe it on a phone,” Mr. Martin says.

Dr. Boultinghouse and two colleagues — Michael J. Davis and Glenn G. Hammack— run NuPhysicia, a start-up company they spun out from the University of Texas in 2007 that specializes in face-to-face telemedicine, connecting doctors and patients by two-way video.

Spurred by health care trends and technological advances, telemedicine is growing into a mainstream industry. A fifth of Americans live in places where primary care physicians are scarce, according to government statistics. That need is converging with advances that include lower costs for video-conferencing equipment, more high-speed communications links by satellite, and greater ability to work securely and dependably over the Internet.

“The technology has improved to the point where the experience of both the doctor and patient are close to the same as in-person visits, and in some cases better,” says Dr. Kaveh Safavi, head of global health care for Cisco Systems, which is supporting trials of its own high-definition video version of telemedicine in California, Colorado and New Mexico.

The interactive telemedicine business has been growing by almost 10 percent annually, to more than $500 million in revenue in North America this year, according to Datamonitor, the market research firm. It is part of the $3.9 billion telemedicine category that includes monitoring devices in homes and hundreds of health care applications for smartphones.

Christine Chang, a health care technology analyst at Datamonitor’s Ovum unit, says telemedicine will allow doctors to take better care of larger numbers of patients. “Some patients will be seen by teleconferencing, some will send questions by e-mail, others will be monitored” using digitized data on symptoms or indicators like glucose levels, she says.

Eventually, she predicts, “one patient a day might come into a doctor’s office, in person.”

Although telemedicine has been around for years, it is gaining traction as never before. Medicare, Medicaid and other government health programs have been reimbursing doctors and hospitals that provide care remotely to rural and underserved areas. Now a growing number of big insurance companies, like the UnitedHealth Group and several Blue Cross plans, are starting to market interactive video to large employers. The new federal health care law provides $1 billion a year to study telemedicine and other innovations.

With the expansion of reimbursement, Americans are on the brink of “a gold rush of new investment in telemedicine,” says Dr. Bernard A. Harris Jr., managing partner at Vesalius Ventures, a venture capital firm based in Houston. He has worked on telemedicine projects since he helped build medical systems for NASA during his days as an astronaut in the 1990s.

Face-to-face telemedicine technology can be as elaborate as a high-definition video system, like Cisco’s, that can cost up to hundreds of thousands of dollars. Or it can be as simple as the Webcams available on many laptops.

NuPhysicia uses equipment in the middle of that range — standard videoconferencing hookups made by Polycom, a video conferencing company based in Pleasanton, Calif. Analysts say the setup may cost $30,000 to $45,000 at the patient’s end — with a suitcase or cart containing scopes and other special equipment — plus a setup for the doctor that costs far less.

Telemedicine has its skeptics. State regulators at the Texas Medical Board have raised concerns that doctors might miss an opportunity to pick up subtle medical indicators when they cannot touch a patient. And while it does not oppose telemedicine, the American Academy of Family Physicians says patients should keep in contact with a primary physician who can keep tabs on their health needs, whether in the virtual or the real world.

“Telemedicine can improve access to care in remote sites and rural areas,” says Dr. Lori J. Heim, the academy’s president. “But not all visits will take place between a patient and their primary-care doctor.”

Dr. Boultinghouse dismisses such concerns. “In today’s world, the physical exam plays less and less of a role,” he says. “We live in the age of imaging.”

ON the rig Courageous, Mr. Martin is part of a crew of 100. Travis G. Fitts Jr., vice president for human resources, health, safety and environment at Scorpion Offshore, which owns the rig, says that examining a worker via two-way video can be far cheaper in a remote location than flying him to a hospital by helicopter at $10,000 a trip.

Some rigs have saved $500,000 or more a year, according to NuPhysicia, which has contracts with 19 oil rigs around the world, including one off Iraq. Dr. Boultinghouse says the Deepwater Horizon drilling disaster in the Gulf of Mexico may slow or block new drilling in United States waters, driving the rigs to more remote locations and adding to demand for telemedicine.

NuPhysicia also offers video medical services to land-based employers with 500 or more workers at a site. The camera connection is an alternative to an employer’s on-site clinics, typically staffed by a nurse or a physician assistant.

Mustang Cat, a Houston-based distributor that sells and services Caterpillar tractors and other earth-moving equipment, signed on with NuPhysicia last year. “We’ve seen the benefit, ” says Kurt Hanson, general counsel at Mustang, a family-owned company. Instead of taking a half-day or more off to consult a doctor, workers can get medical advice on the company’s premises.

NuPhysicia’s business grew out of work that its founders did for the state of Texas. Mr. Hammack, NuPhysicia’s president, is a former assistant vice president of the University of Texas Medical Branch at Galveston, where he led development of the state’s pioneering telemedicine program in state prisons from the mid-1990s to 2007. Dr. Davis is a cardiologist.

Working with Dr. Boultinghouse, Dr. Davis and other university doctors conducted more than 600,000 video visits with inmates. Significant improvement was seen in inmates’ health, including measures of blood pressure and cholesterol, according to a 2004 report on the system in the Journal of the American Medical Association.

In March, California officials released a report they had ordered from NuPhysicia with a plan for making over their state’s prison health care. The makeover would build on the Texas example by expanding existing telemedicine and electronic medical record systems and putting the University of California in charge.

California spends more than $40 a day per inmate for health care, including expenses for guards who accompany them on visits to outside doctors. NuPhysicia says that this cost is more than four times the rate in Texas and Georgia, and almost triple that of New Jersey, where telemedicine is used for mental health care and some medical specialties.

“Telemedicine makes total sense in prisons,” says Christopher Kosseff, a senior vice president and head of correctional health care at the University of Medicine and Dentistry of New Jersey. “It’s a wonderful way of providing ready access to specialty health care while maintaining public safety.”

Georgia state prisons save an average of $500 in transportation costs and officers’ pay each time a prisoner can be treated by telemedicine, says Dr. Edward Bailey, medical director of Georgia correctional health care.

With data supplied by the California Department of Corrections and Rehabilitation, which commissioned the report, NuPhysicia says the recommendations could save the state $1.2 billion a year in prisoners’ health care costs.

Gov. Arnold Schwarzenegger wants the university regents and the State Legislature to approve the prison health makeover. After lawsuits on behalf of inmates, federal courts appointed a receiver in 2006 to run prison medical services. (The state now runs dental and mental health services, with court monitoring.) Officials hope that by putting university doctors in charge of prison health, they can persuade the courts to return control to the state.

“We’re going to use the best technology in the world to solve one of our worst problems — the key is telemedicine,” the governor said.

WITHOUT the blessing of insurers, telemedicine could never gain traction in the broader population. But many of the nation’s biggest insurers are showing growing interest in reimbursing doctors for face-to-face video consulting.

Starting in June, the UnitedHealth Group plans to reimburse doctors at Centura Health, a Colorado hospital system, for using Cisco advanced video to serve UnitedHealth’s members at several clinics. And the insurer plans a national rollout of telemedicine programs, including video-equipped booths in retail clinics in pharmacies and big-box stores, as well as in clinics at large companies.

“The tide is turning on reimbursement,” says Dr. James Woodburn, vice president and medical director for telehealth at UnitedHealth.

Both UnitedHealth and WellPoint, which owns 14 Blue Cross plans, are trying lower-cost Internet Webcam technology, available on many off-the-shelf laptops, as well as advanced video.

UnitedHealth and Blue Cross plans in Hawaii, Minnesota and western New York are using a Webcam service provided by American Well, a company based in Boston. And large self-insured employers like Delta Air Lines and Medtronic, a Blue Cross Blue Shield customer in Minneapolis, are beginning to sign up.

Delta will offer Webcam consultations with UnitedHealth’s doctor network to more than 10,000 Minnesota plan members on July 1, says Lynn Zonakis, Delta’s managing director of health strategy and resources. Within 18 months, Webcam access will be offered nationally to more than 100,000 Delta plan members.

Dr. Roy Schoenberg, C.E.O. of American Well, says his Webcam service is “in a completely different domain” than Cisco’s or Polycom’s. “Over the last two years, we are beginning to see a side branch of telemedicine that some call online care,” he says. “It connects doctors with patients at home or in their workplace.”

Doctors “are not going to pay hundreds of thousands of dollars for equipment, so we have to rely on lower tech,” he adds. The medical records are stored on secure Web servers behind multiple firewalls, and the servers are audited twice a year by I.B.M. and other outside computer security companies, Dr. Schoenberg says.

In Hawaii, more than 2,000 Blue Cross plan members used Webcams to consult doctors last year, says Laura Lott, a spokeswoman for the Hawaii Medical Service Association. Minnesota Blue Cross and Blue Shield started a similar Webcam service across the state last November.

Doctors who use the higher-tech video conferencing technology say that Webcam images are less clear, and that Webcams cannot accommodate electronic scopes or provide the zoom-in features available in video conferencing. “If they are not using commercial-grade video conferencing gear, the quality will be much lower,” says Vanessa L. McLaughlin, a telemedicine consultant in Vancouver, Wash.

Last month, Charlie Martin, the crane operator, was back in the infirmary of the Courageous for an eye checkup. In Houston, his face filled the big screen in NuPhysicia’s office.

After an exchange of greetings, Chris Derrick, the paramedic on the oil rig, attached an ophthalmological scanner to a scope, pointed it at Mr. Martin’s eye, and zoomed in.

“Freeze that,” Dr. Boultinghouse ordered, as a close-up of the eye loomed on the screen. “His eyes have been bothering him. It may be from the wind up there on the crane.”

    The Doctor Will See You Now. Please Log On, NYT, 29.5.2010, http://www.nytimes.com/2010/05/30/business/30telemed.html

Researchers Say They Created a ‘Synthetic Cell’

May 20, 2010
The New York Times
By NICHOLAS WADE

The genome pioneer J. Craig Venter has taken another step in his quest to create synthetic life, by synthesizing an entire bacterial genome and using it to take over a cell.

Dr. Venter calls the result a “synthetic cell” and is presenting the research as a landmark achievement that will open the way to creating useful microbes from scratch to make products like vaccines and biofuels. At a press conference Thursday, Dr. Venter described the converted cell as “the first self-replicating species we’ve had on the planet whose parent is a computer.”

“This is a philosophical advance as much as a technical advance,” he said, suggesting that the “synthetic cell” raised new questions about the nature of life

Other scientists agree that he has achieved a technical feat in synthesizing the largest piece of DNA so far — a million units in length — and in making it accurate enough to substitute for the cell’s own DNA.

But some regard this approach as unpromising because it will take years to design new organisms, and meanwhile progress toward making biofuels is already being achieved with conventional genetic engineering approaches in which existing organisms are modified a few genes at a time.

Dr. Venter’s aim is to achieve total control over a bacterium’s genome, first by synthesizing its DNA in a laboratory and then by designing a new genome stripped of many natural functions and equipped with new genes that govern production of useful chemicals.

“It’s very powerful to be able to reconstruct and own every letter in a genome because that means you can put in different genes,” said Gerald Joyce, a biologist at the Scripps Research Institute in La Jolla, Calif.

In response to the scientific report, President Obama asked the White House bioethics commission on Thursday to complete a study of the issues raised by synthetic biology within six months and report back to him on its findings. He said the new development raised “genuine concerns,” though he did not specify them further.

Dr. Venter took a first step toward this goal three years ago, showing that the natural DNA from one bacterium could be inserted into another and that it would take over the host cell’s operation. Last year, his team synthesized a piece of DNA with 1,080,000 bases, the chemical units of which DNA is composed.

In a final step, a team led by Daniel G. Gibson, Hamilton O. Smith and Dr. Venter report in Thursday’s issue of the journal Science that the synthetic DNA takes over a bacterial cell just as the natural DNA did, making the cell generate the proteins specified by the new DNA’s genetic information in preference to those of its own genome.

The team ordered pieces of DNA 1,000 units in length from Blue Heron, a company that specializes in synthesizing DNA, and developed a technique for assembling the shorter lengths into a complete genome. The cost of the project was $40 million, most of it paid for by Synthetic Genomics, a company Dr. Venter founded.

But the bacterium used by the Venter group is unsuitable for biofuel production, and Dr. Venter said he would move to different organisms. Synthetic Genomics has a contract from Exxon to generate biofuels from algae. Exxon is prepared to spend up to $600 million if all its milestones are met. Dr. Venter said he would try to build “an entire algae genome so we can vary the 50 to 60 different parameters for algae growth to make superproductive organisms.”

On his yacht trips round the world, Dr. Venter has analyzed the DNA of the many microbes in seawater and now has a library of about 40 million genes, mostly from algae. These genes will be a resource to make captive algae produce useful chemicals, he said.

Some other scientists said that aside from assembling a large piece of DNA, Dr. Venter has not broken new ground. “To my mind Craig has somewhat overplayed the importance of this,” said David Baltimore, a geneticist at Caltech. He described the result as “a technical tour de force,” a matter of scale rather than a scientific breakthrough.

“He has not created life, only mimicked it,” Dr. Baltimore said.

Dr. Venter’s approach “is not necessarily on the path” to produce useful microorganisms, said George Church, a genome researcher at Harvard Medical School. Leroy Hood, of the Institute for Systems Biology in Seattle, described Dr. Venter’s report as “glitzy” but said lower-level genes and networks had to be understood first before it would be worth trying to design whole organisms from scratch.

In 2002 Eckard Wimmer, of the State University of New York at Stony Brook, synthesized the genome of the polio virus. The genome constructed a live polio virus that infected and killed mice. Dr. Venter’s work on the bacterium is similar in principle, except that the polio virus genome is only 7,500 units in length, and the bacteria’s genome is more than 100 times longer.

Friends of the Earth, an environmental group, denounced the synthetic genome as “dangerous new technology,” saying that “Mr. Venter should stop all further research until sufficient regulations are in place.”

The genome Dr. Venter synthesized is copied from a natural bacterium that infects goats. He said that before copying the DNA, he excised 14 genes likely to be pathogenic, so the new bacterium, even if it escaped, would be unlikely to cause goats harm.

Dr. Venter’s assertion that he has created a “synthetic cell” has alarmed people who think that means he has created a new life form or an artificial cell. “Of course that’s not right — its ancestor is a biological life form,” said Dr. Joyce of Scripps.

Dr. Venter copied the DNA from one species of bacteria and inserted it into another. The second bacteria made all the proteins and organelles in the so-called “synthetic cell,” by following the specifications implicit in the structure of the inserted DNA.

“My worry is that some people are going to draw the conclusion that they have created a new life form,” said Jim Collins, a bioengineer at Boston University. “What they have created is an organism with a synthesized natural genome. But it doesn’t represent the creation of life from scratch or the creation of a new life form,” he said.

    Researchers Say They Created a ‘Synthetic Cell’, NYT, 20.5.2010, http://www.nytimes.com/2010/05/21/science/21cell.html

Health Insurance Companies Try to Shape Rules

May 15, 2010
The New York Times
By ROBERT PEAR

WASHINGTON — Health insurance companies are lobbying federal and state officials in an effort to ward off strict regulation of premiums and profits under the new health care law.

The effort is, in some ways, a continuation of the battle over health care that consumed Congress last year.

Insurance lobbyists are trying to shape regulations that will define “unreasonable” premium increases and require them to pay rebates to consumers if the companies do not spend enough on patient care.

For their part, consumer groups say they worry that their legislative victories could be undone or undercut by the rules being written by the federal government and the states.

The health care overhaul provides a classic example of how the impact of a law depends on regulations needed to interpret it. The rules deal with relatively technical questions but go to the heart of the law, pushed through Congress by President Obama and Democratic leaders with no Republican support.

More than 40 provisions of the law require or permit agencies to issue rules.

Lobbyists are focusing on two provisions whose stated purpose is to ensure that consumers “get value for their dollars.”

One provision bars insurers from carrying out an “unreasonable premium increase” unless they first submit justifications to federal and state officials. Congress did not say what is unreasonable, leaving that task to rule-writers.

Another provision, effective Jan. 1, requires that a minimum percentage of premium dollars be spent on true medical costs related to patient care — not retained by insurers as profits or used to cover administrative expenses. Insurers must refund money to consumers if they do not meet the standards, known as minimum loss ratios.

Michael W. Fedyna, vice president and chief actuary of Aetna, underlined the importance of this issue, saying no other aspect of the law would be so “influential in shaping the future of the health care marketplace in the United States.”

The definition of medical loss ratio will “determine the willingness of health plans to enter new markets and remain in existing markets,” Mr. Fedyna said.

Joshua R. Raskin, who follows the industry as a managing director of Barclays Capital, said, “The definition of medical loss ratios for the purpose of health care reform will be one of the most important events of the year for managed care stocks.”

Senator John D. Rockefeller IV, Democrat of West Virginia, said the definition would be just as important for consumers and small businesses.

“The health insurance industry has shifted its focus from opposing health care reform to influencing how the new law will be implemented,” Mr. Rockefeller said.

The law requires insurers to spend a minimum percentage of premiums on health care services and “activities that improve health care quality” for patients.

Insurers are eager to classify as many expenses as possible in these categories, so they can meet the new test and avoid paying rebates to policyholders.

Thus, insurers are lobbying for a broad definition of quality improvement activities that would allow them to count spending on health information technology, nurse hot lines and efforts to prevent fraud. They also want to include the cost of reviewing care by doctors and hospitals, to determine if it was appropriate and followed clinical protocols.

Some consumer advocates, like Carmen L. Balber of Consumer Watchdog, favor a strict, narrow definition of quality improvement activities, limited to those activities that produce measurable benefits to individual patients.

But Alissa Fox, a senior vice president of the Blue Cross and Blue Shield Association, said that if the definition was too narrow, “health plans will come under enormous pressure to cut back quality improvement activities, including highly effective programs to reduce hospital infection rates.”

Another lobbying group, America’s Health Insurance Plans, said efforts to curb fraud directly benefited patients. “If fraud could be eliminated, billions more dollars would be available to pay for care,” said Randi Reichel, a lawyer who works for the insurers.

But Charles N. Kahn III, president of the Federation of American Hospitals, a trade group, said he feared that the quality improvement category would become a “catchall for a wide variety of expenses not directly related to patient care.”

Timothy S. Jost, a law professor at Washington and Lee University in Lexington, Va., said insurers wanted to include costs they incurred in deciding whether to pay claims. A major function of such activities, he said, is to “deny services to enrollees and to contest their claims.”

“It is inconceivable that Congress intended these costs to figure into the formula used to calculate rebates,” Mr. Jost said. “On the other hand, Congress did want to protect activities that demonstrably improve the quality of care.”

Under the law, insurers in the large group market are generally supposed to spend 85 percent of customers’ premiums on “clinical services” and quality-enhancing activities. The minimum is 80 percent for coverage sold to individuals and small groups.

Insurers and insurance regulators say that some companies will be unable or unwilling to meet the new standards.

The American National Insurance Company, based in Galveston, Tex., announced recently that it would discontinue the sale of most individual health plans on June 30 because it knew they would not meet the requirements of the new law.

Ronald J. Welch, senior executive vice president of the company, said the medical loss ratios were a factor.

    Health Insurance Companies Try to Shape Rules, NYT, 15.5.2010, http://www.nytimes.com/2010/05/16/health/policy/16health.html

The Wavering War on AIDS

May 13, 2010
The New York Times

The global war on AIDS has racked up enormous successes over the past decade, most notably by providing drugs for millions of infected people in developing countries who would be doomed without this life-prolonging treatment. Now the campaign is faltering.

Donations from the United States and other wealthy countries have leveled off while the number of people infected with H.I.V., the AIDS virus, grows by a million a year. By one informed estimate, only $14 billion will be available of some $27 billion needed this year to fight the disease in the developing world. Fewer than 4 million of the 14 million people infected with the AIDS virus are getting drug treatment — far short of the goal of universal access set by the United States and others.

Donor nations cite the economic crisis and tight budgets as reasons to slow their contributions to the global fight against AIDS. The Obama administration and many donor nations apparently believe that more lives could be saved by fighting other cheaper diseases, such as respiratory illnesses, diarrhea, malaria and measles.

The results of those decisions can be seen in Uganda and other countries where, as Donald G. McNeil Jr. recently reported in The Times, the campaign against AIDS seems to be falling apart.

Although the number of Ugandans receiving drug treatments jumped from fewer than 10,000 a decade ago to nearly 200,000 today, hundreds of thousands more Ugandans need the drugs and likely can’t get them because clinics now routinely turn new patients away.

That is partly because American funds have been frozen and clinics were told to stop enrolling new patients unless the government has a plan to pay for their treatment. It is also because Uganda has badly skewed its own priorities, such as negotiating to buy a squadron of fighter-bombers from Russia for $300 million.

The United States has been a leader in providing financing for the war on AIDS through bilateral programs and a multilateral global fund. Now, instead of a sharp increase in donations, as once planned, the administration proposes only a slight increase in bilateral financing and a modest reduction in its multilateral contribution.

It has shifted its focus to childhood diseases, keeping young mothers alive, and interrupting the transmission of H.I.V. between mother and child. It is pushing countries to improve their medical delivery systems, manage their own AIDS programs and contribute more of their own funds.

Those are good goals. But the AIDS pandemic is still spreading. And the goal of universal access to treatment remains a distant dream.

    The Wavering War on AIDS, NYT, 31.5.2010, http://www.nytimes.com/2010/05/14/opinion/14fri2.html

Editorial

The Anthem Saga

9 May 2010
The New York Times

Health insurers in many states have been seeking double-digit premium increases from people who buy their own policies directly from the companies rather than obtaining group coverage at work. In states where regulators have the power to curb excessive rate hikes, the increases are often rejected or negotiated down. In those where the regulatory laws are weak not much can be done beyond jawboning.

This hodgepodge of controls over premiums needs to be backstopped by a national law that would allow the federal government to block unjustified rate increases where state officials lack the authority to do so. Attempts to include such powers in the newly enacted health care reform law failed. And while the reform law does have provisions that should help restrain premiums, they lack the necessary teeth.

The story of Anthem Blue Cross’s effort to impose big premium hikes on people who buy their own policies in California, a state with weak regulations, shows why that is so necessary. It also shows how difficult it is to measure what’s reasonable and how a confusing mélange of factors can affect the setting of premiums.

Anthem outraged its enrollees and much of the public in February with a plan to raise premiums for individuals by an average of 25 percent. The company argued that it lost money on the individual market in California last year, that medical costs were escalating far faster than inflation, and that the recession was causing relatively healthy individuals to drop coverage, driving up average costs for the remaining, less healthy enrollees.

Anthem could have spread its losses more broadly to protect its individual buyers. The only reason the company lost money on the individual market is that it lost heavily on policies issued to participants in two state programs that required Anthem to cover people with pre-existing conditions and capped the premiums it could charge. It chose to offset further losses by imposing big hikes on other individual purchasers. For competitive reasons, it is unwilling to pass the costs on to employer-based group plans.

Meanwhile, an actuarial review commissioned by the state’s Department of Insurance found that Anthem also miscalculated the costs it would face in the individual market and the premiums it would need to offset them. Had the calculation been done correctly, Anthem would have needed an average increase in the individual market of only 15 percent, not the 25 percent it proposed.

There is no evidence that Anthem deliberately cooked the books. The errors were not detected by an internal company review or by an outside consultant hired by the company. They were found only when an independent firm hired by the state, Axene Health Partners, assigned four actuaries who spent 500 hours over 10 weeks analyzing calculations that it described as “extremely complex.”

It is daunting how much effort was required to dig out these discrepancies, and it’s revealing that it required a truly independent review to find them. Regulators everywhere are now on notice that they can’t assume company calculations are accurate and that they may need to hire their own consultants to probe deeply.

Anthem and its parent company, WellPoint, are scurrying to make amends. WellPoint has announced additional layers of internal review and will commission outside reviews of all of its 2010 rate filings in 14 states. Anthem is revising its rate proposals. But regulators won’t have a lot of power to force reductions beyond the rhetorical threat of further embarrassment.

Meanwhile, it is important to realize that the prime culprit in rising premiums is the escalating cost of medical care; the prices charged by health care providers and drug companies; and the ever-wider use of medical services, much of it unnecessary. Until those costs are contained, it will be hard to truly restrain premiums.

    The Anthem Saga, NYT, 9.5.2010, http://www.nytimes.com/2010/05/10/opinion/10mon1.html

More Wander Off in Fog of Age

May 4, 2010
The New York Times
By KIRK JOHNSON

ASHBURN, Va. — For generations, the prototypical search-and-rescue case in America was Timmy in the well, with Lassie barking insistently to summon help. Lost children and adolescents — from the woods to the mall — generally outnumbered all others.

But last year for the first time, another type of search crossed into first place here in Virginia, marking a profound demographic shift that public safety officials say will increasingly define the future as the nation ages: wandering, confused dementia patients like Freda Machett.

Ms. Machett, 60, suffers from a form of dementia that attacks the brain like Alzheimer’s disease and imposes on many of its victims a restless urge to head out the door. Their journeys, shrouded in a fog of confusion and fragmented memory, are often dangerous and not infrequently fatal. About 6 in 10 dementia victims will wander at least once, health care statistics show, and the numbers are growing worldwide, fueled primarily by Alzheimer’s disease, which has no cure and affects about half of all people over 85.

“It started with five words — ‘I want to go home’ — even though this is her home,” said Ms. Machett’s husband, John, a retired engineer who now cares for his wife full time near Richmond. She has gone off dozens of times in the four years since receiving her diagnosis, three times requiring a police search. “It’s a cruel disease,” he said.

Rising numbers of searches are driving a need to retrain emergency workers, police officers and volunteers around the country who say they throw out just about every generally accepted idea when hunting for people who are, in many ways, lost from the inside out.

“You have to stop thinking logically, because the people you’re looking for are no longer capable of logic,” said Robert B. Schaefer, a retired F.B.I. agent who cared for his wife, Sarah, for 15 years at home through her journey into Alzheimer’s. He now leads two-day training sessions for the Virginia Department of Criminal Justice Services.

Mr. Schaefer told his class of mostly police officers here in northern Virginia that unlike the ordinary lost child or hiker, a dementia wanderer will sometimes take evasive action to avoid detection, especially if the disease has made them paranoid about authority figures.

“We’ve found them in attics and false ceilings, in locked closets — you name it,” said Gene Saunders, a retired police officer from Chesapeake, who started a nonprofit company called Project Lifesaver 11 years ago to help find wanderers or people with other cognitive impairments. The group’s technology, fitting patients with wristbands that can be tracked by police officers with radio devices, is in use in 45 states, but its widest use is here in Virginia.

Wanderers often follow fence or power lines, and tend to be drawn toward water, Virginia state rescue officials said, bound on a mission that only they — and sometimes perhaps not even they — can imagine. (A search trick: try to figure what door they exited from, then concentrate first in that direction. But don’t bother calling out the person’s name, which he or she has often forgotten.)

Searching for them often also means learning a patient’s life story as well, including what sort of work they did, where they went to school and whether they fought in war. Because Alzheimer’s disease, the leading cause of dementia, works backward, destroying the most recent memories first, wanderers are often traveling in time as well as space.

Some World War II veterans, for example, have gone huge distances believing they needed to report to base or the front lines. A man in Virginia was lost for days until searchers, in interviews with his family, learned he had long ago been a dairy farmer, rescue officials said. It turned out he had headed for a cow pasture not far from his home, believing it was time for the morning milking.

The all-too-human stories of exhausted family members caring for Alzheimer’s sufferers must be taken in account as well, searchers say. The son or daughter or spouse who nodded off or was briefly inattentive, allowing a loved one to slip out, might feel guilty, and so understate, sometimes by many hours, how long the person has been gone — a crucial variable because time on the run in turn hugely increases the potential size of the search area.

Meanwhile, cold cases are piling up.

In Arizona, James Langston, the state’s search and rescue coordinator at the Division of Emergency Management, is haunted by the stories of people who simply stride out into the desert in high summer and vanish. A few years ago, a 20,000-square-mile area was searched after an Alzheimer’s patient’s car was found on a dirt road at the desert’s edge, he said. No trace of the person was ever found.

Advanced age, meanwhile, can compound health risks of exposure.

“We’ve had them die in as little as seven hours because they just keep going and don’t recognize they’re getting dehydrated,” Mr. Langston said.

Many states do not collect or fully categorize local data on search-and-rescue cases, so it is impossible to gauge the full impact of dementia wandering on law enforcement. But in Oregon, for example, the number of searches for lost male Alzheimer’s patients nearly doubled just last year, to 26 from 14 in 2008, and has more than tripled since 2006, according to emergency management officials.

For many people involved in those searches — or in training rescuers for the demographic tsunami to come — the turbulent emotions and grief that swirl around Alzheimer’s disease and dementia are simply part of the terrain. In the middle of his training courses, Mr. Schaefer sometimes pauses, choked up by memories of his wife, who received her Alzheimer’s diagnosis at age 50. She died 17 years later, having forgotten how to swallow, he said, and then finally, even how to breathe.

On a recent afternoon at the Northern Virginia Criminal Justice Training Academy, Mr. Schaefer told his class about the day he asked her if she knew who he was. He had taken steps by then to keep Ms. Schaefer from wandering away, disguising their home’s doors, for one thing, covering them with posters that looked like bookshelves.

But now he could see the panic and horror in her eyes, he said, that she could not find the right answer to his question. Could she recognize her own husband?

“No,” she answered. “But you take very good care of me.”

For John McClelland, 57, a retired volunteer fire and rescue officer who now leads training courses in Colorado, the story is even more personal: He has a diagnosis of Alzheimer’s himself. The disease killed his grandfather and three other people on that side of the family. He said he has already lost the ability to remember the faces of new acquaintances, even a day after meeting them.

Knowing what is coming for him as the fatal disease takes its course has made his training work all the more important and urgent, he said.

“The mission I’m on is that I’m willing to talk about Alzheimer’s as long as I’m articulate,” he said. “The hell of the disease is that I know what’s coming.”

    More Wander Off in Fog of Age, NYT, 4.5.2010, http://www.nytimes.com/2010/05/05/us/05search.html

A Mother’s Loss, a Daughter’s Story

April 21, 2010
The New York Times
By ROBIN POGREBIN

ANDREW AVRIN sits on a beige couch in a nondescript room, a fruit still-life partly visible on the wall behind him, twisting his fingers while, off-camera, an unseen interviewer prompts him to talk about his sister, Melissa, who died last year at the age of 19 after a long battle with bulimia.

“There was no food in the house,” he says, looking off to the side as his eyes fill. “If I went out with friends, I could not bring leftovers home because they would be gone by the next morning.”

Once, he explains, in the middle of a bitterly cold night, he looked out the window and saw Melissa on the curb, going through the garbage. “I went outside and I yelled her name,” he recounts in the interview, his voice breaking. “Just the way she looked back at me — it was so empty, vacant. It was a deer in the headlights, but that doesn’t even explain it.”

It is a hard scene for anyone to watch, but even more so for the film’s producer — Judy Avrin, Melissa’s mother, who decided to make a documentary about her daughter’s life and, ultimately, her death.

People deal with grief in their own ways, and those who have been spared the loss of a daughter or a son can only imagine how they would choose to try to cope. For Ms. Avrin, coping meant confronting her anguish and trying to make something good come out of it.

The idea for a film didn’t occur to her immediately. In the weeks following Melissa’s death, Ms. Avrin mostly avoided her daughter’s bedroom, and tried to resume some semblance of normalcy, going back to work three days a week as the coordinator for a consortium of academic libraries in New Jersey. But one day she sat down to read Melissa’s leather-bound journal.

Someday ...

I’ll eat breakfast.

I’ll keep a job for more than 3 weeks.

I’ll have a boyfriend for more than 10 days.

I’ll love someone.

I’ll travel wherever I want.

I’ll make my family proud.

I’ll make a movie that changes lives.

The film, called “Someday Melissa” and now in the editing stages, has become for Ms. Avrin salve, distraction and cause — a way to get the word out to other families grappling with eating disorders that they are not alone; to sound the alarm that eating disorders have the highest mortality rate of any mental illness; to help make sense of the senseless event that was losing her teenage daughter.

“I kept saying, ‘This is an amazing way for me to channel my grief,’ ” Ms. Avrin said. “But it also allowed me to put off grieving.”

Ms. Avrin, 56, got the idea for the film from one of Melissa’s therapists, Danna Markson, who introduced her to Jeffrey Cobelli, 27, a filmmaker. Over the last several months of working on the project, Ms. Avrin has come to know more than she ever intended to about eating disorders — how their seriousness has been underestimated, their treatment underinsured, their deaths underreported.

The process hasn’t been easy, and some, like her ex-husband, initially questioned the impulse to do it at all. Melissa’s best friend since first grade, Nicole Kendrick, who also suffers from an eating disorder, said she was incredulous when she first learned that Ms. Avrin was making the film. “I thought she was crazy,” Ms. Kendrick said. “I guess I didn’t realize how deep a mother’s love can run.”

But Ms. Avrin said that making the film has been easier than doing nothing at all. “I’ve never once thought this was more than I could bear,” she said, in an interview at her home in Totowa, N.J. “If anything, the more I continue, the more I know it’s the right thing to do.”

The difficulty of reliving her daughter’s decline has been mitigated by the public response. “Sometimes I think: ‘I’m a suburban mom. Who am I to think I could make a difference in the world?’ ” Ms. Avrin said. “But then I read the messages that keep coming in from people I know and people I don’t know who say Melissa’s story has motivated them to fight one more day.”

On Melissa’s Facebook page and on the film’s Web site — somedaymelissa.com — Ms. Avrin continues to get feedback. “Thank you,” says one entry posted on the Web site’s guestbook page. “This could save one person’s life. That life may be mine.”

Ms. Avrin and Mr. Cobelli have interviewed Melissa’s family members, doctors and friends, along with prominent experts in the field, like Dr. Thomas R. Insel, the director of the National Institute of Mental Health; and Dr. B. Timothy Walsh, the founding director of the Eating Disorders Research Unit at the New York State Psychiatric Institute, and Dr. Evelyn Attia, the director of the Columbia Center for Eating Disorders, both at Columbia University Medical Center.

“I get a lot of requests, but there was something about this one I thought was particularly striking,” said Dr. Insel of the mental health institute. “I wanted to hear more of the story.”

“It was such an extraordinary expression of love,” he said, “a powerful way of honoring and remembering the daughter she lost.”

Although those closest to Melissa agreed to be interviewed for the film, participating wasn’t easy. William Avrin, Melissa’s father, said that he might have preferred to keep his experience to himself and that he was in no hurry to revisit his memories of Melissa. “I have a hole in my heart and it will be there forever,” he said in a telephone interview. “I don’t really try to describe what it’s like to lose a child.”

But he felt he had to do it for the film. “Clearly, Judy’s a champion of this project,” he said. “I’m a little bit more personal and inward. I’m still struggling with the whole thing. This is her way of dealing with it, and I respect that.”

In the documentary interview, filmed at his home in Hamburg, N.J., Mr. Avrin visibly struggles to describe what it was like to be thousands of miles away in Japan on business when he found out his daughter had died. At first he appears almost devoid of emotion, delivering his words in flat, deliberative sentences as he sits in a blue button-down shirt in front of his fireplace mantel. But then you can see tears trickling down into his salt-and-pepper mustache. “What was I thinking?” he says, repeating the question. “I was thinking my daughter is dead. That’s not supposed to happen. I couldn’t believe it. I didn’t — didn’t know what to think. I was in shock.”

Upon returning from Japan, Mr. Avrin decided not to view his daughter’s body. “Judy thought it would be better if I didn’t,” he said, “that I’d remember her like the last time that I saw her.”

Melissa died on May 6, 2009. Cause of death: heart attack due to complications from an eating disorder. Just a few days before, Melissa learned she had been admitted to Emerson College. The official letter of acceptance arrived a week after she died and sits unopened.

Melissa’s brother, Andrew, who is completing his Master of Science degree in engineering, said he believes the documentary has become essential to his mother’s emotional resilience. “It’s the only way she knows how to move forward,” he said.

At the same time, Andrew said he worried that the documentary would ultimately prove to be just a Band-Aid, postponing the heartbreak that is bound to rear its head when the film is completed. “The trick becomes moving forward with life but not letting everything this project is fill the void completely,” he said, “so the second this project finishes, you don’t crash.”

To be sure, Ms. Avrin doesn’t always hold it together. She did not conduct the interviews with her ex-husband or with her son (her collaborator, Mr. Cobelli, did). “We would have just sat there and cried,” she said.

In the interviews she did do, there have been times when she has broken down during or afterward. In concluding her discussion with Dr. Leslie Sanders, one of Melissa’s doctors, for example, Ms. Avrin starts to cry, and the cameras keep rolling. “I still remember being in your office and — I think her potassium was off — and you said, ‘I’ll be your quarterback,’ ” Ms. Avrin tells Dr. Sanders. “I didn’t know who to turn to next and I felt like I was in such good hands with you.”

Dr. Sanders responds: “I think what I remember about that first visit is just being struck at how little her life had become — I think at that point she was barely in school — and how much she was struggling, not just physically, I think physically was the least of it, but just emotionally and how we needed to do something intensive, and quickly, to get her life back.”

BORN Dec. 21, 1989, Melissa seemed in her early years to be a happy little girl. Her family lived in Wayne, N.J., and then in Pine Brook, N.J., spending two years in Coral Gables, Fla., in between, where Mr. Avrin was transferred for his work with a specialty chemical company. Melissa did well in school — producing A’s and short stories.

But at age 13, thing started to change. Melissa’s mood darkened; she didn’t want to go to school or do extracurricular activities. She developed stomach problems and constipation. Ms. Avrin took her to a pediatric gastroenterologist who said Melissa probably had an eating disorder. “I reacted the way most parents do: ‘That’s not possible,’ ” Ms. Avrin said. “We didn’t go back to him.”

In the early stages, the Avrins did not really see what was going on, in part because Melissa wasn’t visibly underweight, in part because they didn’t want to. But clues started to show up that were too stark to ignore — logs of cookie dough that disappeared from the freezer along with whole boxes of cookies from the cabinet. Empty pizza boxes. “I found containers with chewed and spit-out food and I’d never heard of that before,” Ms. Avrin tells Dr. Sanders during their filmed interview. “Is that very common?”

Ms. Avrin wrapped the fridge in locks and chains, hid her purse and made sure never to leave money lying around. “It didn’t have to be good junk food — if she wanted to go on a binge, it could be a dozen eggs,” Ms. Avrin said of Melissa. “Anything that wasn’t nailed down, she would eat.”

Ms. Kendrick, in her own interview for the film, alternates between smiling recollections of her childhood friend and sad eyes as she recalls Melissa’s downward spiral. “People who knew her in the last two years never really saw who she really was,” she says. “She was so energetic and funny and just ridiculous but not, like, in an obnoxious way. And then, as she started to worry about what other people thought, that’s when it started to be in more of an attention-getting way. When things got really bad, that kind of all just slowly disappeared and it just became very monotone — down. And we didn’t really see that energetic, fun Melissa anymore.”

Eventually, Melissa was sent away for professional help against her will and thus began a series of programs over the next few years that had varying degrees of success. It wasn’t until Melissa’s third round of in-patient treatment — when she and other young women testified about their eating disorders in front of their families — that her father began to fully understand. “I really said, ‘Wow this is almost like heroin addiction,’ ” he says in his film interview. “They need to purge because it makes them feel high and it’s something they need to do. I never appreciated that.”

In the course of making the film, Ms. Avrin has become something of a public service announcement on eating disorders. She was a featured speaker last October at the first walk to raise money for the National Eating Disorders Association. At its benefit dinner in March in New York, the evening opened with a clip from Ms. Avrin’s film. She is due to be in Washington in late April to lobby Congress as part of an Eating Disorders Coalition.

She said she is happy to play the role of advocate, to help try to remove the stigma that still cloaks eating disorders and keeps people from acknowledging the disease as the cause of death in obituaries. “I want it to come out of the shadows,” Ms. Avrin said. “I want people to talk about it, for people to get treatment faster, to reach doctors on the front lines. I want parents to open their eyes and not be swayed by being glad that their kid fits into size 4 jeans — to stop focusing on looks.”

Ms. Avrin is aiming to finish her documentary project by June, in time for summer film festival deadlines, and she said she is determined to get theatrical distribution. It would seem the ultimate act of acceptance. Yet in her film interview with Dr. Sanders, Ms. Avrin sounds like a mother still wrestling with remnants of denial.

“I’ve always been the glass half-full — I’ve always been an optimist,” she says, reaching under her eyeglasses to wipe away tears. “I always believed that she really would be somebody who could recover, even though, looking back, I realized the odds were stacked against her because of the level of her illness.”

“But I never lost hope and, you know,” she adds, “I still believe that she could have beaten it.”

    A Mother’s Loss, a Daughter’s Story, NYT, 22.4.2010, http://www.nytimes.com/2010/04/22/fashion/22Melissa.html

Obama Health Team Turns to Carrying Out Law

April 18, 2010
The New York Times
By ROBERT PEAR

WASHINGTON — The success of the new health care law depends to a large degree on a handful of Obama administration officials, who are scrambling to make the transition from waging political war on Capitol Hill to managing one of the most profound changes in social policy in generations.

For these officials, the task of carrying out the law may be as much of a challenge as getting it enacted.

Jay Angoff, a longtime consumer advocate and nemesis of the insurance industry, will lead efforts to regulate insurers and insurance markets.

Jeanne M. Lambrew, an idealistic veteran of the Clinton White House, is carrying out provisions of the law aimed at expanding coverage.

And Phyllis C. Borzi, a top Labor Department official, will police the conduct of employers, who provide health benefits to more than 150 million Americans.

Their task is to translate the promise of the law into reality, with help from the private sector, if possible.

Joseph R. Antos, an economist at the American Enterprise Institute, asked: “After spending so many months trashing the health insurance industry, will officials be able to calm down enough to be able to talk to the industry and the experts who will be running the new system? You need their input. It’s essential to get technical insights from people in the industry who were largely ignored in the political process.”

Here are profiles of three top members of the Obama team.

 

Jay Angoff

After graduating from Oberlin College in 1973 and Vanderbilt Law School in 1978, Mr. Angoff began his career as an antitrust lawyer at the Federal Trade Commission and then worked as a lobbyist at Congress Watch, a Ralph Nader organization.

Michael Pertschuk, a former chairman of the trade commission, wrote admiringly of Mr. Angoff in “Giant Killers,” his 1986 book about public interest lobbyists. He described Mr. Angoff as “tough, prickly, righteous, slow to compromise.”

Mr. Angoff worked for a nonprofit group, the National Insurance Consumer Organization, before moving to New Jersey, where he was a deputy insurance commissioner and health policy adviser to Gov. Jim Florio, a Democrat.

As director of the Missouri Insurance Department from 1993 to 1998, Mr. Angoff got to know Kathleen Sebelius, who was the insurance commissioner and then the governor of Kansas.

Ms. Sebelius, now the secretary of health and human services, recruited him to be director of a new Office of Consumer Information and Insurance Oversight.

Mr. Angoff said effective regulation of insurers “could have a greater impact on costs and coverage” than the public insurance option liberals championed unsuccessfully.

And Mr. Angoff has made it clear that he means to be aggressive in setting “marketplace rules.” He will enforce a section of the law that requires insurers to file detailed justifications for any “unreasonable increases in premiums.” One of his first tasks is to define “unreasonable.”

A former law partner, Cyrus Mehri, said: “Having been a state insurance commissioner, Jay can see through the games insurance companies play. He will put teeth into the law. He will create a whole new federal regulatory regime to rein in the abuses and excesses of the industry.”

As a Missouri official, Mr. Angoff won a legal battle with the state’s Blue Cross and Blue Shield plan, which agreed to help set up an independent charitable foundation after it switched from nonprofit to for-profit status. As a lawyer in private practice, he secured tens of millions of dollars for consumers in class-action lawsuits against insurers.

Calvin W. Call, executive director of the Missouri Insurance Coalition, a trade association, said Mr. Angoff’s appointment did not bode well for health insurers.

“The industry’s survival is probably limited in time, and Jay will be right there to watch it perish,” Mr. Call said. “Here in Missouri, Jay seemed to be a proponent of confrontation and almost invited litigation to decide issues that could have been resolved in the General Assembly or through compromise.”

On the other hand, Mr. Call said: “Jay kept us challenged every day. He may have made the industry better, more attuned to detail.”

 

Jeanne M. Lambrew

When President Bill Clinton’s plan for universal health insurance collapsed in 1994, many Democrats, exhausted and disillusioned, turned to other issues. Ms. Lambrew never wavered. She kept plugging away at efforts to expand coverage.

In Mr. Clinton’s second term, she worked at the White House, as senior health analyst at the National Economic Council and as an associate director of the Office of Management and Budget. In those roles, she was an architect of the Children’s Health Insurance Program.

During the Bush administration, Ms. Lambrew refined her ideas as a senior fellow at the Center for American Progress, a sort of government in exile for liberal policy experts. She became an associate professor at the University of Texas and collaborated with former Senator Tom Daschle on a book that laid out many ideas incorporated in the new health care law.

Ms. Lambrew is leading efforts to expand coverage as director of the Office of Health Reform established by Ms. Sebelius. Ms. Lambrew is racing to meet a deadline set by the new law: Within 90 days, every state must have an insurance pool where uninsured people with medical problems can buy coverage at reduced rates.

Even people who disagree with her politics say Ms. Lambrew is a pragmatist, focused on results, not ideological purity.

Ms. Lambrew picked up her interest in health care from her father, Dr. Costas T. Lambrew, a cardiologist in Maine; her mother, Patricia, a nurse; and her maternal grandfather, Dr. James Travers, a family doctor in New York.

While working at academic medical centers, her father said, “I ran clinics for people who could not afford private care.”

In 2003, Ms. Lambrew helped local officials overhaul the health care system in Maine, her home state. “Jeanne has a passion for the uninsured,” said Trish Riley, director of the Office of Health Policy and Finance in Maine.

 

Phyllis C. Borzi

Ms. Borzi, an assistant secretary of labor, has been working on employee benefits for 35 years, since she answered a job advertisement on a bulletin board at Catholic University while attending law school.

For 16 years, from 1979 to 1995, she worked for House Democrats on the subcommittee responsible for pensions and employee health benefits. She was a research professor at George Washington University and has extensive practical experience as a lawyer advising multiemployer health benefit plans.

Ms. Borzi said her goal now was to write regulations that provide clear guidance to employers without being “overly prescriptive.”

“I am committed to preserving the employment-based system and encouraging employers to keep their health plans in place,” Ms. Borzi said.

Though she is a Democrat with pro-employee sympathies, Ms. Borzi is respected by Republicans and employer groups like the United States Chamber of Commerce. They describe her as one of the nation’s leading experts on the law that governs workplace benefits, the Employee Retirement Income Security Act of 1974, known as Erisa.

Mark J. Ugoretz, president of the Erisa Industry Committee, a trade association of big companies, said Ms. Borzi knew as much about employee health benefits as anyone in the field. But he said he worried that her agency would be tempted to over-regulate health plans.

“If the regulations become too stringent, too burdensome, too costly, it could strangle the system,” Mr. Ugoretz said. “Employers would retreat from providing innovative, comprehensive health benefits, just as many companies have dropped traditional pension plans in favor of 401(k) plans.”

    Obama Health Team Turns to Carrying Out Law, NYT, 18.4.2010, http://www.nytimes.com/2010/04/19/health/policy/19health.html

Faces of Health Care Debate Point to New Law’s Complexity

April 16, 2010
The New York Times
By DAVID M. HERSZENHORN

WASHINGTON — They were the human faces of the nation’s wrenching, yearlong health care debate.

Natoma Canfield of Medina, Ohio, sent a letter to President Obama about no longer being able to afford her health coverage, and he read it aloud to a group of insurance executives at the White House. Then Ms. Canfield learned she had leukemia, helping Mr. Obama illustrate the life-and-death stakes of the often mind-numbing policy fight.

Marcelas Owens, an 11-year-old boy from Seattle, whose mother could not get some treatment for lack of insurance and died at age 27 from pulmonary hypertension, met Senator Patty Murray, Democrat of Washington, at a rally and ended up by the president’s side at the bill-signing ceremony. “I don’t want any other kids to go through the pain our family has gone through,” Marcelas said.

And Molly Secours, a filmmaker from Nashville, who battled uterine cancer, nearly lost her home because of medical bills — even though she had health insurance. Told that she would need a radical hysterectomy, chemotherapy and radiation treatment, Ms. Secours said, “I was consumed with the fear that I’ll have to declare bankruptcy.”

But if their stories helped the Democrats pass the health care overhaul, a more complicated question is: What will the health care law do for them?

Revisiting their cases illustrates both the enormous potential benefits of the new law, which seeks to insure some 32 million people, and also how the complexity of the health system will continue to pose a formidable challenge for patients and health care providers in the months and years ahead.

Of the cast of Americans who made appearances in the health care debate, Ms. Canfield, who is undergoing chemotherapy and preparing for a bone marrow transplant at the Cleveland Clinic, may have had the biggest role.

Her story led Mr. Obama to hold a rally in Ohio, not far from her home, which helped secure the vote of Representative Dennis J. Kucinich, a Democrat who had opposed the bill. Then, Ms. Canfield’s congressman, Representative John Boccieri, a freshman Democrat, cited her in announcing that he, too, would support the bill.

As it turns out, Ms. Canfield’s grave illness means that her time as one of the roughly 50 million uninsured Americans was brief. In recent days, she was approved for Social Security disability benefits and Medicaid, the federal-state insurance program for low-income people.

“She is no longer able to work,” said her sister, Connie Anderson. “She has kind of dropped down into a different category.”

Supporters of the legislation say that proves one of their main points — the existing system provides little help until catastrophe strikes and, even then, it entails a maze of bureaucracy.

But for some critics, the Cleveland Clinic’s quick reassurance that Ms. Canfield need not worry about losing her home to medical costs showed that Mr. Obama exaggerated her case. On Fox News, Sean Hannity accused Mr. Obama of lying about Ms. Canfield’s situation.

Ms. Canfield got a break. Her local hospital, Medina General, was taken over last year by the Cleveland Clinic, a prominent hospital system with a sophisticated patient-support structure.

In interviews, Ms. Canfield and her sister credited the hospital with helping secure government aid. Leukemia is on Social Security’s list of “compassionate allowances” for an expedited disability ruling. Were she not disabled, Ms. Canfield could not qualify for Medicaid in Ohio under current rules even though she earned well below the federal poverty limit.

That will change as a result of the new law, which will expand Medicaid in 2014. Between now and then, Ohio residents may benefit from the creation of a high-risk insurance pool, either at the state or national level. While other states already have such programs, Ohio does not.

But while the bill provides $5 billion to create or expand such programs, it is not clear how they will work. Premiums are often expensive, and payment rates for providers have not been set. That makes it impossible for a hospital to know if it would be paid more by a high-risk policy or by the state’s existing Hospital Care Assurance Program, which reimburses for care of the uninsured.

In the current system, Lyman Sornberger, the executive director of patient financial services at the Cleveland Clinic, said that Ms. Canfield had good reason to worry about being forced to sell her home to pay medical bills.

“Facilities or health care systems have an option to decide what their charity care is,” Mr. Sornberger said. “They could put a lien against her home. They could harm her credit. They could ask her to sell all of her assets and sell her home and pay that bill off to that health care system before they agree to give her any charity.”

Even with Medicaid paying the hospital bills, Ms. Canfield’s sister said she was worried about how she would pay her basic expenses, like property taxes and utility bills. Her disability payments do not begin until July, and even then will not cover all her expenses, Ms. Anderson said.

In the case of Marcelas Owens’s mother, Tiffany Owens, it is unclear that the health care legislation would have prevented her from falling into a gap in coverage that prompted her to forgo treatment and may have contributed to her death.

Ms. Owens briefly had private insurance through her restaurant management job. But in October 2006, when she could no longer work because she was sick, she lost both her job and her benefits.

She applied for Medicaid but was rejected because she had earned too much earlier in the year. She was told to reapply in January, but by then she was hospitalized. Six months later, she was dead.

“There was that lapse of time where the sickness was still progressing and there was nothing she could do until she could go back and reapply again,” said Gina Owens, her mother. “It’s just crazy that people fall through the cracks.”

It is not clear if the new health care law will help when a person’s employment, insurance and health status change so rapidly.

Beginning in 2014, low-income Americans who do not qualify for Medicaid could get subsidies to help buy private insurance. But a new system could have pitfalls.

For Marcelas himself, the most immediate benefit of the new law may be a provision barring states from cutting Medicaid rolls. Even when his mother was alive, Marcelas and his two sisters were on Medicaid.

Under the new law, primary care doctors will be paid higher rates to treat Medicaid patients for at least two years. The bill will also provide billions of dollars in additional aid to community health centers, like the Seattle Indian Health Board, where Marcelas gets his pediatric care.

In Nashville, Molly Secours thought she had the system figured out. She had health insurance from Blue Cross, a house and a film company. But after uterine cancer left her with huge bills, she nearly lost her home.

Congress came to the rescue, not with legislation but in the form of Representative Jim Cooper, Democrat of Tennessee, who helped her negotiate a new mortgage. Ms. Secours joined Speaker Nancy Pelosi at a news conference at the Capitol in July.

She is still paying off some bills to Baptist Hospital, but her home is secure. As someone with a pre-existing medical condition, Ms. Secours, under the new law, is assured of being able to find coverage. And as someone who buys her policy on the individual market, she may find better insurance or at least more options.

“People like me who have a major diagnosis aren’t going to get turned down because they had cancer,” she said.

Ms. Secours said she hoped to one day be able to take advantage of tax credits that the new health care law will give to small businesses to help them provide insurance to employees. “A couple of years from now I might be able to hire people and offer them something,” she said.

    Faces of Health Care Debate Point to New Law’s Complexity, NYT, 16.4.2010, http://www.nytimes.com/2010/04/17/health/policy/17health.html

Obama Widens Medical Rights for Same-Sex Partners

April 15, 2010
The New York Times
By SHERYL GAY STOLBERG

WASHINGTON — President Obama on Thursday ordered his health secretary to issue new rules aimed at granting hospital visiting rights to same-sex partners.

The White House announced the rule changes, which will also make it easier for gay men and lesbians to make medical decisions on behalf of their partners, in a memorandum released Thursday night. In it, the president said the new rules would affect any hospital that participates in Medicare or Medicaid, the government programs to cover the elderly and the poor.

“Every day, all across America, patients are denied the kindness and caring of a loved one at their sides,” Mr. Obama said in the memorandum, adding that the rules could also help widows and widowers who rely on friends and members of religious orders who care for one another. But he says gay men and lesbians are “uniquely affected” because they are often barred from visiting partners with whom they have spent decades.

Richard Socarides, who advised President Bill Clinton on gay rights issues, said that while the memorandum on its own did not grant any new rights, it did “draw attention to the very real and tragic situations many gays and lesbians face when a partner is hospitalized.”

Ordering the Department of Health and Human Services to find a better way to handle such situations, Mr. Socarides said, is “the kind of thing the gay community was hoping Obama would do right after he was inaugurated.”

Several states have tried to put an end to discrimination against same-sex couples, and Mr. Obama said he intended to build on those efforts. He said the new rules would make clear that designated visitors should enjoy visiting privileges that are no more restrictive than those enjoyed by immediate family members.

The rules will take time to draft and put in place, and so Mr. Obama’s order will have no immediate effect. Even so, gay rights groups called it a major advance for the families of lesbians, gay men, bisexuals and transgender individuals.

“It’s a huge deal,” said David Smith, vice president of policy for the Human Rights Campaign, which worked with the White House to develop the memorandum, in an interview Thursday night. “Nearly every hospital in the country will now be required to provide hospital visitation rights to LGBT families. It’s an enormous step. In the absence of equal marriage rights in most jurisdictions, this step provides an essential right to LGBT families for a gay person or a lesbian person to spend time with their partner in a critical situation.”

In some instances in the past, hospitals have barred bedside visits by the person who held the medical power of attorney for a patient.

Gay rights advocates said the rules change was inspired by one of those cases involving a same-sex couple, Janice Langbehn and Lisa Pond, who were profiled in The New York Times last year. After Ms. Pond was stricken with a fatal brain aneurysm, Ms. Langbehn was denied visiting rights in 2007 by a Florida hospital. Although Ms. Langbehn had power of attorney and she and Ms. Pond were parents to four children they had adopted, the hospital refused for eight hours to allow her and the children to see Ms. Pond, her partner for 18 years. Ms. Pond died as Ms. Langbehn tried in vain to get to her side.

Ms. Langbehn, represented by Lambda Legal, a legal advocacy organization, brought suit against the hospital, Jackson Memorial in Miami, but lost. On Thursday night, Mr. Obama called her from Air Force One to say that he had been moved by her case.

“I was so humbled that he would know Lisa’s name and know our story,” Ms. Langbehn said in a telephone interview. “He apologized for how we were treated. For the last three years, that’s what I’ve been asking the hospital to do. Even now, three years later, they still refuse to apologize to the children and I for the fact that Lisa died alone.”

Mr. Obama campaigned saying he would fight for the rights of gay men and lesbians, but he has been under pressure since the beginning of his presidency to be a stronger advocate for their issues.

Many gay men and lesbians grew disenchanted with what they viewed as his foot-dragging on reversing “don’t ask, don’t tell,” the policy that bars them from serving openly in the military. The president said in his State of the Union address this year that he intended to move to overturn the policy, and his administration has been taking steps to do so.

The memorandum is intended to “help ensure that patients will be able to face difficult times in hospitals with compassion, dignity and respect,” a White House spokesman, Shin Inouye, said Thursday night. “By taking these steps, we can better protect the interests and needs of patients that are gay or lesbian, widows and widowers with no children, members of religious orders, or others for whom their loved ones are not always immediate relatives. Because all Americans should be able to have loved ones there for them in their time of need.”

    Obama Widens Medical Rights for Same-Sex Partners, NYT, 15.4.2010, http://www.nytimes.com/2010/04/16/us/politics/16webhosp.html