History > 2007 > USA > Health (II)

Rhett Davis has a rare blood disorder

that has already destroyed his liver.

In December,

he began getting infusions

of the first drug developed to treat his disorder,

a drug that is not expected

to win FDA approval until March.

By Tim Dillon, USA TODAY

Unapproved drugs spark life-and-death debate

UT

2 April 2007

http://www.usatoday.com/news/nation/2007-04-02-unapproved-drugs_N.htm

Expensive Lesson for Maine

as Health Plan Stalls

April 30, 2007
The New York Times
By PAM BELLUCK

PORTLAND, Me., April 23 — When Maine became the first state in years to enact a law intended to provide universal health care, one of its goals was to cover the estimated 130,000 residents who had no insurance by 2009, starting with 31,000 of them by the end of 2005, the program’s first year.

So far, it has not come close to that goal. Only 18,800 people have signed up for the state’s coverage and many of them already had insurance.

“I think when we first started, in terms of making estimates, we really were kind of groping in the dark,” said Gov. John E. Baldacci, who this month proposed a host of adjustments.

The story of Maine’s health program — which tries to control hospital costs, improve the quality of health care and offer subsidized insurance to low-income people — harbors lessons for the country, as covering the uninsured takes center stage. States, including California, Massachusetts and Pennsylvania, have unveiled programs of their own, seeking to balance the needs and interests of individuals, employers, insurers and health care providers.

But as Maine tries to reform its reforms, it faces some particular challenges: It has large rural, poor and elderly populations with significant health needs. It has many mom-and-pop businesses and part-time or seasonal workers, and few employers large enough to voluntarily offer employees insurance. And most insurers here no longer find it profitable to sell individual coverage, leaving one carrier, Anthem Blue Cross Blue Shield, with a majority of the market, a landscape that some economists said could make it harder to provide broad choices and competitive prices.

Some parts of the state’s current program — named Dirigo after the state motto, which means “I lead” in Latin — are seen as promising. These include the creation of a state watchdog group to promote better health care, and an effort to control costs by asking hospitals to rein in price increases and spending, although experts and advocates said those cuts needed to be greater.

But a financing formula dependent on sizable payments from private insurers has angered businesses and is being challenged in court.

And while some people have benefited from the subsidized insurance, which provides unusually comprehensive coverage, others have found it too expensive. And premiums have increased, not become more affordable, because some of those who signed up needed significant medical care, and there are not enough enrollees, especially healthy people unlikely to use many benefits.

“It was broad-based reform that just never got off the ground,” said Laura Tobler, a health policy analyst with the National Conference of State Legislatures. “The way that they funded the program became controversial. And getting insurance was voluntary and it wasn’t that cheap.”

Governor Baldacci said in an interview that when the Legislature enacted the Dirigo Health Reform Act in 2003, it gave him less money and more compromises than he had wanted. He said his administration had now learned more about what works and what does not.

His new proposals include requiring people to have insurance and employers to offer it and penalizing them financially if they do not; making the subsidized insurance plan, DirigoChoice, more affordable for small businesses; creating a separate insurance pool for high-risk patients; instituting more Medicaid cost controls; and having the state administer DirigoChoice, which is now sold by Anthem Blue Cross.

“We’ve got a reform package that takes Dirigo to the next level,” Mr. Baldacci said. “It takes the training wheels off.”

The proposed overhaul seems to include something each of Maine’s constituencies can embrace and something each opposes, so there is no guarantee which changes will be adopted by the Legislature.

“It’s very hard politically to deal with the underlying costs of the system,” said Andrew Coburn, director of the Institute for Health Policy at the Muskie School of Public Service in Portland. “And Maine is just not wealthy enough to cobble together enough resources to fully cover the uninsured.”

The state’s current program, which has added 5,000 people to Medicaid and enrolled 13,800 people in DirigoChoice, has made progress. Even though the enrollment goal has not been met, the insurance plan has grown faster than any in Maine’s history, the governor said. And although about 60 percent of its enrollees were previously insured, some were paying what state officials deemed was too high a percentage of their income, said Trish Riley, director of the Governor’s Office of Health Policy and Finance.

The DirigoChoice benefits are impressive, said Hilary K. Schneider, policy director for Consumers for Affordable Health Care, a Maine advocacy group. The program completely covers preventive care, subsidizes premiums and deductibles, and unlike most insurance plans, covers treatment for mental illness and does not exclude people for pre-existing medical conditions.

Such coverage has caused critics to say DirigoChoice would be more affordable if it scaled back benefits.

“It’s a Cadillac policy, and we ought to be trying to fund a Ford Escort policy,” said Jim McGregor, executive vice president of the Maine Merchants Association.

One of DirigoChoice’s success stories, Jacquie Murphy, 63, of Westbrook, said, “It absolutely saved my life.” Ms. Murphy said she has fibromyalgia, chronic fatigue syndrome, back problems, an autoimmune disease and memory problems from a childhood brain injury. She said that a few years ago, when she left an abusive marriage and gave up her husband’s coverage, the fear of being unable to afford insurance that would accept someone with her illnesses “caused me to become clinically depressed.”

With DirigoChoice, which costs her just over $100 a month with the state paying a subsidy of about $250, she now has a walker, sees orthopedic surgeons for shoulder and ankle fractures, and takes medication for memory, cholesterol and thyroid problems. The relief of being insured lifted her depression, she said, and now, in her home with its Asian-themed pebbled backyard, she works as a career and life coach.

For others, like Leah Deragon, 34, DirigoChoice is too costly. Ms. Deragon, who runs a Portland nonprofit center that helps low-income families with new babies, said that although she and her husband, an engineering student, qualified for a subsidy, they could not afford the roughly $300 out-of-pocket cost each month. She remains uninsured, forgoing annual checkups and using student loan money when she needed dental work.

“For us it was very frustrating,” said Ms. Deragon, who shops at Goodwill and lives in her mother’s home in Gorham to save money. “We earned, I think, $16,000 last year. We can’t do $200 or $300 a month and still put gas in our car. Come the end of the month, we would be forced to hitchhike.”

And there is John Henderson, 42, of Auburn, who enrolled in DirigoChoice in 2006 for about $90 a month while working at an L. L. Bean warehouse, a job he kept to 20 hours a week so his income would qualify him for such a low rate.

But he dropped the plan this year when rates increased by 13.4 percent on average. Mr. Henderson, who has diabetes and is currently jobless, said he had stopped once-regular doctor’s appointments and some medications that “I have just no hope of affording.”

Ms. Schneider’s group is suing the state insurance commissioner for approving the rate increase.

An Anthem spokesman, Mark Ishkanian, said the increase was necessary because medical claims of DirigoChoice customers were “substantially higher” than anticipated, about double those of non-Dirigo plans. One reason for the higher expense was “pent-up demand” by enrollees who had been deferring visits to doctors while they were uninsured, Mr. Ishkanian said. Another was the richness of the coverage, which enrollees used for treating long-held conditions or mental illness, he said.

Ms. Riley said the state was surprised that more than half of DirigoChoice enrollees qualified for the highest subsidy, 80 percent, which meant the program has been more expensive for the state.

She said Maine also expected more small businesses to enroll in DirigoChoice. But many businesses found that the program requirements of enrolling 75 percent of a firm’s employees and paying 60 percent of the cost were too expensive.

“If they weren’t able to afford insurance before, they’re unlikely to be able to afford Dirigo,” said Kristine Ossenfort, senior governmental affairs specialist of the Maine State Chamber of Commerce.

Some health care advocates have accused Anthem of not marketing DirigoChoice enough to prospective customers, which Anthem denies.

Especially controversial was Maine’s financing formula for its program, which assumed that there would be savings because an increase in insured people would mean less charity care from hospitals, and that the cost-cutting measures would mean lower costs to insurers.

The state said it would charge insurers for those savings, rather than let insurers take the savings as profit. But when the state tried to charge insurers $43.7 million in 2005 and $34.3 million in 2006, the insurance industry and the chamber of commerce sued, saying the insurers owed much less.

A judge ruled for the state, but the case is being appealed. The governor’s new proposal would phase out this financing structure and impose lower-cost surcharges instead.

Among the state program’s biggest fans is Joan M. Donahue, 40, who was uninsured when she started a home care agency in Warren three years ago. She now has DirigoChoice for herself and her 17-year-old son, and three employees are enrolled. She also has two employees who cannot afford it and have not enrolled.

“I will absolutely stick with Dirigo,” said Ms. Donahue, who does not qualify for the subsidy. “This program needs healthy people who don’t get subsidized so it can prosper.”

The Dirigo program has already made one change that could attract people like Malvina Gregory, 31, a Spanish interpreter in Portland, who could not afford the subsidized insurance but may reconsider. Ms. Gregory was originally put off because it demanded full payment up front, and rebated the subsidy later; she went instead to a Portland program giving nearly free care, but is now afraid her income “will bump me over the limit” for that program.

DirigoChoice will now allow individuals to pay only their part up front. “The concept of Dirigo, I think, is phenomenal,” Ms. Gregory said. “I hope they are able to lower the premiums. There are a lot of folks like me that are in that bind.”

Expensive Lesson for Maine as Health Plan Stalls, NYT, 30.4.2007, http://www.nytimes.com/2007/04/30/us/30maine.html

States Expand

Children's Health Coverage

April 29, 2007
By THE ASSOCIATED PRESS
Filed at 2:27 a.m. ET
The New York Times

WASHINGTON (AP) -- Many states are making more children eligible for government-funded health insurance even as President Bush's health chief says families are relying too much on public money for the coverage.

The goal of the states is to allow more middle-class families to participate in the State Children's Health Insurance Program. The states are raising income limits so families once shut out because of their earnings now can qualify.

When the program began a decade ago, states could offer coverage to families whose income was not more than double the federal poverty level. Today, for example, that threshold is $41,300 for a family of four. A few states use a Medicaid-based formula that lets them insure more children than under the income limit.

Already, 18 states exceed the 200 percent level, with federal permission. Five more, plus the District of Columbia, could join the list this year, according to a survey by Georgetown University's Center for Children and Families.

New York lawmakers recently set an income limit of up to $82,600 for a family of four. Eligible families get some government help in buying insurance. The poorer they are, the greater the subsidy.

Other states considering significant expansions in eligibility include California, Ohio and Oklahoma. Florida and Oregon are considering modest expansions, the center reported.

Health and Human Services Secretary Mike Leavitt said if other states followed New York's proposal, it would mean that 71 percent of the nation's children would be on ''public assistance.''

''SCHIP is being proposed in the spirit of the expansion of health coverage. But that isn't the reality,'' Leavitt said last week. ''For every 10 people that go on a publicly funded plan, six of them leave a private plan.''

Jocelyn Guyer, deputy executive director of the university center, said states have determined that public health insurance is better than no insurance at all. She said a range of studies shows that most children entering the program would otherwise lack coverage.

''State leaders are moving in a very different direction than the Bush administration is talking about,'' Guyer said. ''They see that even moderate-income families increasingly find that coverage is simply unaffordable, and that it's appropriate to have some subsidy.''

Guyer's organization conducts research but also advocates for more federal money for children's health insurance.

In 1997, Congress provided the children's insurance program with $40 billion over 10 years. The program now covers more than 6 million people, including about 640,000 adults. The families make too much to qualify for Medicaid, but not enough to afford private insurance.

Congress probably will renew the program this year, with a contentious debate expected over how much money to spend.

A large expansion of children's health insurance is a priority for Democrats. They want to spend $75 billion over five years; the Bush administration is seeking less than half that.

States match federal dollars with their own. On average, states spend $30 for every $70 from Washington.

The administration wants the insurance program to help just low-income families. Leavitt said all states should enact plans that would provide other families with access to more basic insurance policies.

Those policies may not be as comprehensive as some families would like. For example, he said, they may not cover treatments once the care reaches a certain expense, but the policies would provide some protection.

Leavitt noted that Michigan was working on a plan that would pay as much as $35,000 in a year for health costs and could serve as many as 1.1 million people. Tennessee is developing what Leavitt described as a ''very basic'' insurance plan. The plan would cost $150 a month -- $50 from the insured, $50 from the employer and $50 from the state.

Guyer said many states considering expansions will scrap them unless Congress acts this summer to provide more money.

She cited Ohio and Oklahoma. According to the center, both states are considering proposals that would increase eligibility limits so families of four with an income under $61,950 could participate.

''It just comes down to the reality that in the absence of federal money, they really can't do this,'' Guyer said.

The Senate Finance Committee may take up a children's health insurance bill as soon as next month.

Legislation introduced last week by Sens. Edward M. Kennedy, D-Mass., Jay Rockefeller, D-W.Va., and Olympia Snowe, R-Maine, would allow states to expand coverage to families earning less than triple the poverty level, or $61,950 for a family of four.

Kennedy said the program ''has been a great success, but 9 million children in the United States still lack health insurance. This bill will make a real difference in their lives.''

------

On the Net:

Georgetown University's Center for Children and Families: http://ccf.georgetown.edu

State Children's Health Insurance Program: http://www.cms.hhs.gov/home/schip.asp

    States Expand Children's Health Coverage, NYT, 29.4.2007, http://www.nytimes.com/aponline/us/AP-Health-Insurance-Children.html

Chemotherapy Fog

Is No Longer Ignored as Illusion

April 29, 2007
The New York Times
By JANE GROSS

On an Internet chat room popular with breast cancer survivors, one thread — called “Where’s My Remote?” — turns the mental fog known as chemo brain into a stand-up comedy act.

One woman reported finding five unopened gallons of milk in her refrigerator and having no memory of buying the first four. A second had to ask her husband which toothbrush belonged to her.

At a family celebration, one woman filled the water glasses with turkey gravy. Another could not remember how to carry over numbers when balancing the checkbook.

Once, women complaining of a constellation of symptoms after undergoing chemotherapy — including short-term memory loss, an inability to concentrate, difficulty retrieving words, trouble with multitasking and an overarching sense that they had lost their mental edge — were often sent home with a patronizing “There, there.”

But attitudes are changing as a result of a flurry of research and new attention to the after-effects of life-saving treatment. There is now widespread acknowledgment that patients with cognitive symptoms are not imagining things, and a growing number of oncologists are rushing to offer remedies, including stimulants commonly used for attention-deficit disorder and acupuncture.

“Until recently, oncologists would discount it, trivialize it, make patients feel it was all in their heads,” said Dr. Daniel Silverman, a cancer researcher at the University of California, Los Angeles, who studies the cognitive side effects of chemotherapy. “Now there’s enough literature, even if it’s controversial, that not mentioning it as a possibility is either ignorant or an evasion of professional duty.”

That shift matters to patients.

“Chemo brain is part of the language now, and just to have it acknowledged makes a difference,” said Anne Grant, 57, who owns a picture-framing business in New York City. Ms. Grant, who had high-dose chemotherapy and a bone marrow transplant in 1995, said she could not concentrate well enough to read, garbled her sentences and struggled with simple decisions like which socks to wear.

Virtually all cancer survivors who have had toxic treatments like chemotherapy experience short-term memory loss and difficulty concentrating during and shortly afterward, experts say. But a vast majority improve. About 15 percent, or roughly 360,000 of the nation’s 2.4 million female breast cancer survivors, the group that has dominated research on cognitive side effects, remain distracted years later, according to some experts. And nobody knows what distinguishes this 15 percent.

Most oncologists agree that the culprits include very high doses of chemotherapy, like those in anticipation of a bone marrow transplant; the combination of chemotherapy and supplementary hormonal treatments, like tamoxifen or aromatase inhibitors that lower the amount of estrogen in women who have cancers fueled by female hormones; and early-onset cancer that catapults women in their 30s and 40s into menopause.

Other clues come from studies too small to be considered definitive. One such study found a gene linked to Alzheimer’s disease in cancer survivors with cognitive deficits. Another, using PET scans, found unusual activity in the part of the brain that controls short-term recall.

The central puzzle of chemo brain is that many of the symptoms can occur for reasons other than chemotherapy.

Abrupt menopause, which often follows treatment, also leaves many women fuzzy-headed in a more extreme way than natural menopause, which unfolds slowly. Those cognitive issues are also features of depression and anxiety, which often accompany a cancer diagnosis. Similar effects are also caused by medications for nausea and pain.

Dr. Tim Ahles, one of the first American scientists to study cognitive side effects, acknowledges that studies have been too small and lacked adequate baseline data to isolate a cause.

“So many factors affect cognitive function, and the kinds of cognitive problems associated with cancer treatment can be caused by many other things than chemotherapy,” said Dr. Ahles, the director of neurocognitive research at Memorial Sloan-Kettering Cancer Center in New York.

The new interest in chemo brain is, in effect, a testimony to enormous strides in the field. Patients who once would have died now live long enough to have cognitive side effects, just as survivors of childhood leukemia did many years ago, forcing new treatment protocols to avoid learning disabilities.

“A large number of people are living long and normal lives,” said Dr. Patricia Ganz, an oncologist at U.C.L.A. who is one of the nation’s first specialists in the late side effects of treatment. “It’s no longer enough to cure them. We have to acknowledge the potential consequences and address them early on.”

As researchers look for a cause, cancer survivors are trying to figure out how to get through the day by sharing their experiences, and by tapping expertise increasingly being offered online by Web sites like www.breastcancer.org and www.cancercare.org.

There are “ask the experts” teleconferences, both live and archived, and fact sheets to download and show to a skeptical doctor. Message boards suggest sharpening the mind with Japanese sudoku puzzles or compensatory techniques devised to help victims of brain injury. There are even sweatshirts for sale saying “I Have Chemo Brain. What’s Your Excuse?”

Studies of cognitive effects have overwhelmingly been conducted among breast cancer patients because they represent, by far, the largest group of cancer survivors and because they tend to be sophisticated advocates, challenging doctors and volunteering for research.

Most researchers studying cognitive deficits say they believe that those most inclined to notice even subtle changes are high-achieving women juggling careers and families who are used to succeeding at both. They point to one study that found that complaints of cognitive deficits often did not match the results of neuro-psychological tests, suggesting that chemo brain is a subjective experience.

“They say, ‘I’ve lost my edge,’ ” said Dr. Stewart Fleishman, director of cancer supportive services at Beth Israel and St. Luke’s/Roosevelt hospitals in New York. “If they can’t push themselves to the limit, they feel impaired.”

Dr. Fleishman and others were pressed as to why a poor woman, working several jobs to feed her children, navigating the health care system and battling insurance companies, would not also need mental dexterity. “Maybe we’re just not asking them,” Dr. Fleishman said.

Overall, middle-class cancer patients tend to get more aggressive treatment, participate in support groups, enroll in studies and use the Internet for research and community more than poor and minority patients, experts say.

“The disparity plays out in all kinds of ways,” said Ellen Coleman, the associate executive director of CancerCare, which provides free support services. “They don’t approach their health care person because they don’t expect help.”

But approaching a doctor does not guarantee help. Susan Mitchell, 48, who does freelance research on economic trends, complained to her oncologist in Jackson, Miss., that her income had been halved since her breast cancer treatment last year because everything took longer for her to accomplish.

She said his reply was a shrug.

“They see their job as keeping us alive, and we appreciate that,” Ms. Mitchell said. “But it’s like everything else is a luxury. These are survivor issues, and they need to get used to the fact that lots of us are surviving.”

Among women like Ms. Mitchell, lost A.T.M. cards are as common as missing socks. Children arrive at birthday parties a week early. Wet clothes wind up in the freezer instead of the dryer. Prosthetic breasts and wigs are misplaced at the most inopportune times. And simple words disappear from memory: “The thing with numbers” will have to do for the word “calculator.”

Linda Lowen, 46, had a hysterectomy and chemotherapy for ovarian cancer 13 years ago, and says she still cannot recognize neighbors at the grocery store. “I had a mind like a steel trap, and I ended up with a colander for a brain,” said Ms. Lowen, a radio and television talk show host in Syracuse.

The other night, Ms. Lowen set out to find a good place to store her knitting supplies. She began emptying a cabinet of games that her teenage daughters no longer played. Meanwhile, she noticed a blown light bulb and went to find a replacement. That detour led to another, and five hours later she had scrubbed every surface and tidied the contents of eight drawers. But she still had no storage space for her knitting supplies.

“I have an almost childlike inability to follow through on anything,” Ms. Lowen said.

Solutions come in many forms for women whose cancer treatment has left them with cognitive deficits.

Sedra Jayne Varga, 50, an administrative assistant in family court in Manhattan, is part of a research study of the stimulant Focalin, which she said had helped. But Ms. Varga also plans to have laser surgery on her eyes so that losing her glasses will no longer be an issue.

Lu Ann Hudson, 44, a designer of financial databases in Cincinnati, relies on a key fob that sets off a beep in her car when she is looking for it in parking lots. Terry-Lynne Jordan, 43, who analyzes environmental incidents for an oil company in Calgary, Alberta, uses the calendar on her computer and voice mail messages to herself to remind her of meetings.

And Debbie Kamplain, a 32-year-old stay-at-home mother in Peoria, Ill., hired a $30-an-hour personal organizer to help her sell a house, buy another and get ready to move her family to Indiana next month.

But it is Ms. Kamplain’s 2 ½-year-old son, Daniel, who sees to it that she stays on task. Long before Daniel could talk, he would pull her over to the refrigerator if she got distracted while getting him a drink.

“Poor kid,” Ms. Kamplain said. “I say I’m going to do something, forget about it immediately, and he’s the one who has to remind Mommy about stuff.”

    Chemotherapy Fog Is No Longer Ignored as Illusion, NYT, 29.4.2007, http://www.nytimes.com/2007/04/29/health/29chemo.html

Editorial

The Abstinence-Only Delusion

April 28, 2007
The New York Times

Reliance on abstinence-only sex education as the primary tool to reduce teenage pregnancies and sexually transmitted diseases — as favored by the Bush administration and conservatives in Congress — looks increasingly foolish and indefensible.

The abstinence-only campaign has always been driven more by ideology than by sound public health policy. The program’s tight rules, governing states that accept federal matching funds and community organizations that accept federal grants, forbid the promotion of contraceptive use and require teaching that sex outside marriage is likely to have harmful psychological and physical effects.

At least nine states, by one count, have decided to give up the federal matching funds rather than submit to dictates that undermine sensible sex education. Now there is growing evidence that the programs have no effect on children’s sexual behavior.

A Congressionally mandated report issued this month by the Mathematica Policy Research firm found that elementary and middle school students in four communities who received abstinence instruction — sometimes on a daily basis — were just as likely to have sex in the following years as students who did not get such instruction. Those who became sexually active — about half of each group — started at the same age (14.9 years on average) and had the same number of sexual partners. The chief caveat is that none of the four programs studied continued the abstinence instruction into high school, the most sexually active period for most teenagers, so it is not known whether more sustained abstinence education would show more effectiveness.

Supporters of abstinence-only education sometimes point to a sharp decline in teenage pregnancy rates in recent years as proof that the programs must be working. But a paper by researchers at Columbia University and the Guttmacher Institute, published in the January issue of The American Journal of Public Health, attributed 86 percent of the decline to greater and more effective use of contraceptives — and only 14 percent to teenagers’ deciding to wait longer to start having sex. At the very least, that suggests that the current policy of emphasizing abstinence and minimizing contraceptive use should be turned around.

As Congress prepares to debate further financing, it should either drop the abstinence-only program as a waste of money or broaden it to include safe-sex instruction. Abstinence deserves to be part of a comprehensive sex education effort, but not the only part.

    The Abstinence-Only Delusion, NYT, 28.4.2007, http://www.nytimes.com/2007/04/28/opinion/28sat1.html

Immigrants Seek

Mental Health Outreach

April 25, 2007
By THE ASSOCIATED PRESS
Filed at 4:50 a.m. ET
The New York Times

ANNANDALE, Va. (AP) -- The video manifesto Seung-Hui Cho mailed midway through his rampage at Virginia Tech revealed a bitter, vengeful and violent young man -- and raised questions about why he hadn't received counseling or treatment that might have averted the massacre that left 32 students and teachers dead last week.

But church officials in Cho's hometown in northern Virginia say the 23-year-old gunman's family tried for years to get him counseling. And experts say his parents, emigres from South Korea, may have been unsure what to make of Cho's disquieting isolation and held back by the stigma mental illness carries in their culture.

Cho, 8 when his family emigrated to the U.S., was already showing signs that worried his family in Korea: He was unresponsive, nearly mute and distant, relatives say. Cho struggled to fit in, but ''we never could have envisioned that he was capable of so much violence,'' his sister said in a statement Friday.

Gov. Timothy M. Kaine met Tuesday with Korean Americans and promised to reevaluate mental health outreach to immigrants after community leaders pleaded with him for more funding and resources.

Although mental health problems still carry a stigma in many cultures, they can be especially hard to identify in immigrant populations where people may not know if problems are internal or related to the stresses of adjusting to a new country.

Theodore Kim, of the Korean American Association of Greater Washington, said Korean Americans were rendered ''completely speechless'' by news that the gunman was from their community.

''Unfortunately, our diligence and helping hand failed to reach Seung-Hui Cho,'' he said tearfully. ''How could this happen?''

In the video sent to NBC, Cho exhibits clear signs of a serious mental disorder, said Dr. Damian Kim, a New York City psychiatrist and psychoanalyst. ''The main culprit here is mental disease -- schizophrenia, the paranoid type,'' he said.

Kim, who specializes in mental health among immigrants, acknowledged that there is no way to know Cho's true condition without having evaluated him. But he said Cho's sense of persecution and reports he had imaginary friends suggest schizophrenia.

''When it becomes chronic, they have a knack for hiding their pathology,'' he said, ''so the family may not have thought there was anything seriously wrong.''

The Rev. Dihan Lee of the Open Door Presbyterian Church in Herndon says many parents are unsure when their children are merely adjusting to U.S. life -- or need outside help.

''If you come to this country and your child has to deal with learning the language, fitting into the culture, and they show behavior problems or are socially awkward, you chalk it up to just trying to fit in,'' he said.

Even if the parents suspect a serious problem, they may hesitate to seek help, said Kim. ''Saving face'' is paramount to Koreans, who are fiercely proud and protective of their family name and reputation. The shame of one is shared by all, he said.

Church is the backbone of many Korean communities in the U.S., serving not only as a place of worship but also as a community center. But mental health is rarely addressed there.

''Koreans wouldn't want people to know their child is mentally unstable. Who would want that stigma to follow him?'' said Henry Pak, 32, of Rockville, Md.

One pastor said Cho's mother went from church to church looking for someone to counsel her troubled son.

''They went around seeking help for their son ever since he stopped talking 10 years ago,'' said Bong-han Kim, an assistant pastor at the One Mind Church of Washington in Springfield.

News that the gunman was Korean set off a torrent of discussion -- and reflection -- among Korean Americans, who debated whether pressures within the community may have contributed to Cho's isolation.

For many, the burden of fulfilling the ''American dream'' can be immense, said Josephine Kim, a Harvard lecturer who specializes in mental health issues among Asian Americans.

She cited a study showing that 76 percent of Asian Americans treated in emergency rooms for attempted suicide cite intergenerational conflicts with their parents.

''The pressure is unreal. Korean parents view their children as extensions of themselves, so if the children fail, they fail,'' she said.

John Lee, 22, a senior at George Mason University, said many of his Korean-American friends chafe under the pressure their parents place on them to get into a top-tier college.

''It's noble that they came all the way over here for our sake, and I really do appreciate it, but sometimes I wish they understood better that it's a different world -- and we have different sets of values and goals,'' he said.

It's hard to see any similarity between Lee -- outgoing, articulate and ambitious -- and Cho, a loner with few friends.

But John's father, Jonathan Lee, recalls a time when his son wasn't so well-adjusted. He was distant during middle school, and his grades dropped.

A psychologist assured him his son was fine -- and was only being teased at school. They eventually turned to a pastor for counseling.

Lee said he could've turned out angry like Cho, so he launched his own rampage, a ''love rampage.''

''I made sure I gave everybody around me an extra dose of goodness,'' he said. ''There is too much hate in this world... and I wanted to spread a message of peace and love.''

------

On the Net:

Open Door Presbyterian Church, http://www.opendoorpc.org

Korean American Family Counseling Center, http://www.kafcc.org

Korean Community Service Center of Greater Washington, www.kcscgw.org 

    Immigrants Seek Mental Health Outreach, NYT, 25.4.2007, http://www.nytimes.com/aponline/us/AP-Virginia-Tech-Shooting-Mental-Health.html

In Turnabout, Infant Deaths Climb in South        NYT        22.4.2007

http://www.nytimes.com/2007/04/22/health/22infant.html

In Turnabout,

Infant Deaths Climb in South

April 22, 2007
The New York Times
By ERIK ECKHOLM

HOLLANDALE, Miss. — For decades, Mississippi and neighboring states with large black populations and expanses of enduring poverty made steady progress in reducing infant death. But, in what health experts call an ominous portent, progress has stalled and in recent years the death rate has risen in Mississippi and several other states.

The setbacks have raised questions about the impact of cuts in welfare and Medicaid and of poor access to doctors, and, many doctors say, the growing epidemics of obesity, diabetes and hypertension among potential mothers, some of whom tip the scales here at 300 to 400 pounds.

“I don’t think the rise is a fluke, and it’s a disturbing trend, not only in Mississippi but throughout the Southeast,” said Dr. Christina Glick, a neonatologist in Jackson, Miss., and past president of the National Perinatal Association.

To the shock of Mississippi officials, who in 2004 had seen the infant mortality rate — defined as deaths by the age of 1 year per thousand live births — fall to 9.7, the rate jumped sharply in 2005, to 11.4. The national average in 2003, the last year for which data have been compiled, was 6.9. Smaller rises also occurred in 2005 in Alabama, North Carolina and Tennessee. Louisiana and South Carolina saw rises in 2004 and have not yet reported on 2005.

Whether the rises continue or not, federal officials say, rates have stagnated in the Deep South at levels well above the national average.

Most striking, here and throughout the country, is the large racial disparity. In Mississippi, infant deaths among blacks rose to 17 per thousand births in 2005 from 14.2 per thousand in 2004, while those among whites rose to 6.6 per thousand from 6.1. (The national average in 2003 was 5.7 for whites and 14.0 for blacks.)

The overall jump in Mississippi meant that 65 more babies died in 2005 than in the previous year, for a total of 481.

The toll is visible in Hollandale, a tired town in the impoverished Delta region of northwest Mississippi.

Jamekia Brown, 22 and two months pregnant with her third child, lives next to the black people’s cemetery in the part of town called No Name, where multiple generations crowd into cheap clapboard houses and trailers.

So it took only a minute to walk to the graves of Ms. Brown’s first two children, marked with temporary metal signs because she cannot afford tombstones.

Her son, who was born with deformities in 2002, died in her arms a few months later, after surgery. Her daughter was stillborn the next year. Nearby is another green marker, for a son of Ms. Brown’s cousin who died at four months, apparently of pneumonia.

The main causes of infant death in poor Southern regions included premature and low-weight births; Sudden Infant Death Syndrome, which is linked to parental smoking and unsafe sleeping positions as well as unknown causes; congenital defects; and, among poor black teenage mothers in particular, deaths from accidents and disease.

Dr. William Langston, an obstetrician at the Mississippi Department of Health, said in a telephone interview that officials could not yet explain the sudden increase and were investigating. Dr. Langston said the state was working to extend prenatal care and was experimenting with new outreach programs. But, he added, “programs take money, and Mississippi is the poorest state in the nation.”

Doctors who treat poor women say they are not surprised by the reversal.

“I think the rise is real, and it’s going to get worse,” said Dr. Bouldin Marley, an obstetrician at a private clinic in Clarksdale since 1979. “The mothers in general, black or white, are not as healthy,” Dr. Marley said, calling obesity and its complications a main culprit.

Obesity makes it more difficult to do diagnostic tests like ultrasounds and can lead to hypertension and diabetes, which can cause the fetus to be undernourished, he said.

Another major problem, Dr. Marley said, is that some women arrive in labor having had little or no prenatal care. “I don’t think there’s a lack of providers or facilities,” he said. “Some women just don’t have the get up and go.”

But social workers say that the motivation of poor women is not so simply described, and it can be affected by cuts in social programs and a dearth of transportation as well as low self esteem.

“If you didn’t have a car and had to go 60 miles to see a doctor, would you go very often?” said Ramona Beardain, director of Delta Health Partners. The group runs a federally financed program, Healthy Start, that sends social workers and nurses to counsel pregnant teenagers and new mothers in seven counties of the Delta. “If they’re in school they miss the day; if they’re working they don’t get paid,” Ms. Berdain said.

Poverty has climbed in Mississippi in recent years, and things are tougher in other ways for poor women, with cuts in cash welfare and changes in the medical safety net.

In 2004, Gov. Haley Barbour came to office promising not to raise taxes and to cut Medicaid. Face-to-face meetings were required for annual re-enrollment in Medicaid and CHIP, the children’s health insurance program; locations and hours for enrollment changed, and documentation requirements became more stringent.

As a result, the number of non-elderly people, mainly children, covered by the Medicaid and CHIP programs declined by 54,000 in the 2005 and 2006 fiscal years. According to the Mississippi Health Advocacy Program in Jackson, some eligible pregnant women were deterred by the new procedures from enrolling.

One former Medicaid official, Maria Morris, who resigned last year as head of an office that informed the public about eligibility, said that under the Barbour administration, her program was severely curtailed.

“The philosophy was to reduce the rolls and our activities were contrary to that policy,” she said.

Mississippi’s Medicaid director, Dr. Robert L. Robinson, said in a written response that suggesting any correlation between the decline in Medicaid enrollment and infant mortality was “pure conjecture.”

Dr. Robinson said that the new procedures eliminated unqualified recipients. With 95 enrollment sites available, he said, no one should have had difficulty signing up.

As to Ms. Morris’s charge that information efforts had been curbed, Dr. Robinson said that because of the frequent turnover of Medicaid directors — he is the sixth since 2000 — “our unified outreach program was interrupted.” He said it has now resumed.

The state Health Department has cut back its system of clinics, in part because of budget shortfalls and a shortage of nurses. Some clinics that used to be open several days a week are now open once a week and some offer no prenatal care.

The department has also suffered management turmoil and reductions in field staff, problems so severe that the state Legislature recently voted to replace the director.

Oleta Fitzgerald, southern regional director for the Children’s Defense Fund, said: “When you see drops in the welfare rolls, when you see drops in Medicaid and children’s insurance, you see a recipe for disaster. Somebody’s not eating, somebody’s not going to the doctor and unborn children suffer.”

Visits with pregnant women and mothers in several Delta towns suggest that many poverty-related factors — including public policies, personal behaviors and health conditions — may contribute to infant deaths.

Krystal Allen, a cousin of Jamekia Brown’s, was 17 when she had her first baby. When he was 4 months old, she said, he developed breathing problems. Ms. Allen took the child to an emergency room, where he was put on a vaporizer and given an antibiotic and a prescription and they were sent home, where they slept for a few hours.

“When I woke up I thought he was sleeping, and I was getting ready for church,” Ms. Allen said. “But he was dead.”

Now 21, a mother of two with a third on the way, Ms. Allen lives in a sparsely furnished house in Hollandale with her unemployed boyfriend and his mother. Her children live with her parents.

Ms. Allen greeted visitors with breakfast in hand: a bottle of Mountain Dew and a bag of chips.

Janice Johnson, a social worker with Delta Health Partners, urged her to eat more healthily. “I’m going to change my diet one day,” Ms. Allen replied.

She had been to a doctor for one visit but had to sign up for Medicaid to get continued care. That required a 36-mile trip to an office in Greenville.

“Can’t you go this Friday?” Ms. Johnson asked.

“Well, if my mom is going to Greenville,” Ms. Allen replied, “and if she has gas in the car.”

As for Ms. Brown, having lost two babies and suffering from thyroid disease and hypertension, her latest pregnancy is considered high risk. Ms. Johnson has helped arrange for intensive medical monitoring.

Eunice Brown, 21, another of Ms. Johnson’s clients, was fortunate nothing went wrong with her first pregnancy. She was afraid to tell her mother. In the eighth month of her pregnancy, she went to the hospital with a stomach ache and delivered a healthy baby.

“I was 15 and I didn’t think prenatal care mattered that much,” she said in the one-bedroom home she shares with her mother, her three children and two nieces her mother is tending. Ms. Brown, who was three months’ pregnant with her fourth child, said she would apply for Medicaid “when I get the transportation.” The family has lived mainly off her welfare checks and her intermittent work, in elderly day care, which led her welfare check to be reduced from $194 a month to $26 a month. A father “sometimes helps with money,” she said.

In the past 10 years, the infant mortality rate for blacks in most of the Delta has averaged about 14 per thousand in some counties and more than 20 per thousand in others. But just to the south of Hollandale, Sharkey County, one of the poorest, has had a startlingly different record. From 1991 through 2005, the rate for blacks hovered at around 5 per thousand.

State officials say the county’s population is too small — it registers only 100 births a year — to be statistically significant. But many experts feel it is no coincidence that a steep drop in infant deaths followed the start of an intensive home-visiting system run by the Cary Christian Center, using local mothers as counselors.

“If this is a fluke it’s a 15-year fluke,” said Dr. Glick, the neonatologist.

The program, which is paid for with private money, buses nearly all pregnant blacks in Sharkey and a small neighboring county to pre- and postnatal classes.

Irma Johnson, who has worked for the Cary Center for 14 years, was a soothing presence as she visited Erica Moore, a 24-year-old with young twins. With Vaseline, warm water, a toothbrush and soft murmurs, she showed her how to combat cradle cap, a scaly buildup on the scalp.

But personal attention cannot always change ingrained attitudes.

Barbara Williams, another veteran counselor of the Cary center, made an unannounced visit to a cluster of trailers in Anguilla occupied by the extended Jackson family.

“I’ve been following this family for 18 years, and they’re in a bad cycle,” Ms. Williams said, noting that three generations of women had dropped out of high school.

As Ms. Williams entered one crowded trailer a young woman tried to hide, then stood defiantly. The woman, Victoria Jackson, 22, already has three small children and was five months pregnant.

No, she said, she has not signed up for Medicaid and she has not seen a doctor, and she brushed aside offers of help.

Ms. Williams, visibly upset, said later, “Victoria never gives a reason why she doesn’t see a doctor. I guess she thinks she’s gotten away with it three times already.”

    In Turnabout, Infant Deaths Climb in South, NYT, 22.4.2007, http://www.nytimes.com/2007/04/22/health/22infant.html

Shooting shows gaps

in mental health safety net

Thu Apr 19, 2007
8:46PM EDT
Reuters
By Julie Steenhuysen

CHICAGO (Reuters) - Mental health professionals complain their hands are tied in two ways when they try to help people like Virginia Tech gunman Cho Seung-Hui -- a lack of funding for mental health services in general, and laws that makes it tough to treat people against their will.

They say the 23-year-old student's shooting rampage sheds new light on flaws in the U.S. mental health system.

"Our mental health system failed this young man," said Jill Bolte Taylor, a brain researcher at Indiana University School of Medicine in Bloomington, Indiana.

Cho drew the attention of campus police in late 2005 amid complaints that he was annoying women students. He spent some time in a psychiatric hospital because of worries he was suicidal.

"Funding for mental health services in the United States has dropped in half over the past 25 years," Dr. Christopher Flynn, director of Virginia Tech's Thomas Cook Counseling Center, told a news conference.

"We have seen, every time there's a cut in public health funding, the first people that are cut are mental health providers, and we do our entire system a disservice by continuing to do that."

Dr. Steven Sharfstein, past president of the American Psychiatric Association, said the problems are both financial and legal.

"What was a red flag for me is that he was seen in a mental health facility and held for one day. That is a symptom of the dysfunction of our mental health system," said Sharfstein, who is president of Sheppard Pratt Health System in Baltimore.

"If someone isn't readily seen as imminently dangerous, there is no time and money set aside to do a more in-depth and effective diagnosis. He may have been hiding a paranoid psychosis that with a few days of observation might have come out."

PUBLIC HEALTH CRISIS

The National Alliance on Mental Illness in a 2006 report gave the U.S. mental health system the below-average grade of "D".

"Untreated mental health is the nation's No. 1 public health crisis," Michael Fitzpatrick, the group's executive director, said in a telephone interview.

"In recent years, states like the Commonwealth of Virginia have systematically reduced their funding for mental health services," he added.

"The reality is that in many communities, it is impossible to get mental health services unless you have been arrested," Fitzpatrick said.

Even if treatment is available, patients often are too sick to believe they need treatment. And unless a patient presents an imminent threat, many states prohibit involuntary treatment.

"Unfortunately, we live in a society that says as long as you are not a danger to yourself or someone else you can be as psychotic as you want to be," Taylor said.

Exceptions include states such as New York, which allow court-ordered treatment called assisted outpatient treatment for patients who cannot recognize their own need for care.

New York's law is named in memory of Kendra Webdale, a 32-year-old Buffalo woman pushed to her death in front of a subway train in 1999 by a man with severe mental illness who had a history of avoiding treatment.

Mental health advocates fear the shooting might produce a backlash against people with mental illness.

"Studies have shown that it is incredibly rare for someone with a mental illness to commit gross acts of violence, especially on such a scale as the Virginia Tech shootings," the U.S. Psychiatric Rehabilitation Association said in a statement.

    Shooting shows gaps in mental health safety net, R, 20.4.2007, http://www.reuters.com/article/idUSN1944150620070420

Agency Urges Change

in Antibiotics for Gonorrhea

April 13, 2007
The New York Times
By LAWRENCE K. ALTMAN

The rates of drug-resistant gonorrhea in the United States have increased so greatly in the last five years that doctors should now treat the infection with a different class of antibiotics, the last line of defense for the sexually transmitted disease, officials said yesterday.

The percentage of drug-resistant gonorrhea cases among heterosexual men jumped, to 6.7 percent in 2006 compared with 0.6 percent in 2001, officials from the Centers for Disease Control and Prevention said.

Standard monitoring of gonorrhea cases is conducted among men who go to S.T.D. clinics. New data from such sites in 26 cities show that rates of drug-resistant gonorrhea among heterosexual men at the clinics last year reached 26 percent in Philadelphia and more than 20 percent in Honolulu and four areas in California, Long Beach, Orange County, San Diego and San Francisco.

Among gay men at the clinics, the rates of the bacterial infection jumped, to 38 percent in the first half of 2006 from 1.6 percent in 2001.

For 14 years, most cases of gonorrhea have been treated with a class of antibiotics known as fluoroquinolones. Now, officials at the center are urging doctors to prescribe drugs in the cephalosporin class.

No new antibiotics for gonorrhea are in the pipeline, officials of the centers told reporters by telephone.

“Now we are down to one class of drugs,” said Dr. Gail Bolan, an expert in sexually transmitted diseases at the California Department of Health Services. “That’s a very perilous situation to be in.”

Dr. Bolan is a spokeswoman for the Infectious Diseases Society of America, a professional organization.

Health officials are also concerned about extremely drug-resistant tuberculosis and a number of other microbes like Pseudomonas aeruginosa, Klebsiella penumoniae and Acinetobacter species that are resistant to most antibiotics.

The United States has an estimated 700,000 new cases of gonorrhea a year, occurring among sexually active people of both genders at all ages. It is the second most commonly reported infectious disease, behind chlamydia, another sexually transmitted disease.

After a substantial decline from 1975 to 1997, the gonorrhea rates had leveled off in recent years.

Action was taken yesterday because the level of resistance has exceeded the standard of 5 percent set by the centers and the World Health Organization. Although the centers’ recommendations are not binding, physicians generally follow them.

“We are running out of options,” said Dr. John M. Douglas Jr., who directs the division of sexually transmitted diseases prevention at the centers. Cephalosporins, like their cousin penicillin, thwart bacteria by damaging a microbe’s cell wall, not by attacking DNA as the fluoroquinolones do, Dr. Douglas said.

Gonorrhea has not shown resistance to the cephalosporins, which were first marketed in the United States in the 1980s, Dr. Douglas said. Now “increased vigilance is essential,” he said, because resistance could still develop at any time, particularly with increased usage.

The disease centers say doctors should now prescribe ceftriaxone, sold as Rocephin, which is injected once into a muscle. The centers also recommend the one-time use of cefixime, or Suprax, but tablets of cefixime are not available in the recommended 400-milligram dose.

These drugs are meant to substitute for the three currently recommended fluoroquinolones, ciprofloxacin, or Cipro; ofloxacin, or Floxin; and levofloxacin, or Levaquin.

For patients allergic to cephalosphins, the centers recommend one injection of spectinomycin, a drug not available in the United States.

Over the years, gonorrhea has become resistant to a number of antibiotic classes starting with sulfa, then penicillin and the tetracyclines before fluoroquinolones.

The disease centers have gradually cautioned against using fluoroquinolones because of the emergence of resistance in different regions.

In 2000, the centers recommended against fluoroquinolones for any patient who acquired gonorrhea in Hawaii, other Pacific Islands and Asia. The agency extended the recommendation to California in 2002. In 2004, the centers recommended that fluoroquinolones not be used among gay men with gonorrhea.

In 2005, Britain recommended against using fluoroquinolones for gonorrhea because of a resistance problem there.

The centers do not plan a letter to doctors on the recommendations. They are relying on news reports and state and local health departments to spread the information.

    Agency Urges Change in Antibiotics for Gonorrhea, NYT, 13.4.2007, http://www.nytimes.com/2007/04/13/health/13disease.html?hp

Massachusetts Offers Details on Health Coverage

April 12, 2007
The New York Times
By PAM BELLUCK

BOSTON, April 11 — Massachusetts is poised to become the first state to make it possible for 99 percent of its adults to be covered by health insurance, with an ambitious plan that sets limits for the premiums people would be expected to pay.

State officials said that under the plan, they expected that all but about 65,000 of the 328,000 adults who are currently uninsured would be able to get affordable coverage.

The proposal sets a sliding scale of affordability standards in which, for example, a single person earning $40,001 a year would be expected to pay no more than 9 percent of income, or about $300 a month, for health insurance; a single person earning $25,000 a year would be expected to pay a much smaller percentage, about 3.3 percent of income, or $70 a month.

The plan is expected to be approved by the Commonwealth Health Insurance Connector Authority on Thursday.

Jon Kingsdale, the executive director of the authority, the agency set up to administer the plan, said setting the affordability standards “was always the most difficult and innovative element” of the state’s groundbreaking health care law, passed a year ago.

The law required all residents to get health insurance or face a fine or tax penalty. But from the beginning, there was concern that available health plans might be too expensive for some people, or, that some affordable plans might provide skimpy coverage. Last month, the authority voted to require all plans to have substantial coverage, including prescription drug benefits, which raised further questions about how expensive the insurance would be.

“To do this right means we’re walking a tight rope,” Mr. Kingsdale said. “We don’t want to be too punitive, we don’t want to put too high a standard of affordability, but we don’t want to let too many people out of a universal requirement. We’ve been putting a lot of stakes in the ground, but this is the center pole that will allow us to put up the tent and get everybody covered.”

The plan, if approved Thursday, would still need to be presented at public hearings across the state and face a final vote in June. The proposal would cost the state $13 million more than the $200 million it was planning to spend.

This proposal changes premiums and subsidy rates that were established earlier. It would allow about 52,000 more low-income people to qualify for free or cheaper coverage. A person earning up to $15,315, one and half times the federal poverty level, would not have to pay anything under this proposal.

Individuals earning $30,630 to $50,001 would not be eligible for state subsidies, but they would not be penalized if they could not find health insurance priced at $150 to $300 a month. People who earn more than $50,001 would not be given a cap on insurance costs.

People who claim they cannot afford coverage under the new system could apply for a waiver.

The proposal represents a carefully hammered-out compromise. Business groups wanted to make sure that premiums for state-sponsored insurance would not be too much less than the employee contributions to an employer’s plan because they fear that people would flock to the government-sponsored plans, driving up the cost to the state. Advocates for poor people had wanted lower costs for more residents.

“It doesn’t go the whole way, but it’s good enough for today,” said John McDonough, executive director of Health Care for All, an advocacy group. “I know there’s a lot of trash talk around the country about, ‘Oh it’s falling apart in Massachusetts.’ It ain’t true. We are going to be far and away the state with the lowest number of uninsured by a country mile.”

Leslie A. Kirwan, the Massachusetts secretary of administration and finance, who is chairwoman of the authority’s board, said the support of advocates like Mr. McDonough was earned in part by action by Gov. Deval L. Patrick, who agreed to waive fees that more than 10,000 poor families were paying for their children to be covered by Medicaid.

“There were real doubts about whether we could forge a compromise that the advocates could embrace and also make sure that the business community embraced it,” Ms. Kirwan said.

An employers’ group gave the plan cautious support on Wednesday.

“It does seem that what the Connector is putting forth is reasonable, but I haven’t looked at all the details,” said Eileen P. McAnneny, vice president of government affairs for Associated Industries of Massachusetts, which represents 7,500 employers. “You have to be very careful — if you set up subsidies that are more generous than employer plans, that encourages employers to drop coverage. Health care costs are expensive for employers, too.”

Jonathan Gruber, an authority board member and economics professor at the Massachusetts Institute of Technology, had argued against expanded subsidies, saying they were unnecessary and costly to the state. Still, he said Wednesday that he would vote for the plan.

“If they’re going to throw money at an issue, they threw it in the right place,” he said. “That said, it is a lot of money, and going forward we’re going to have to be careful not to address all the problems by putting more money into it.”

For Andrea Peña, a single mother of three, the proposal would make possible better and more secure health care coverage. Ms. Peña, a 39-year-old dental assistant who lives in public housing in South Boston, has been receiving Medicaid, but the income from her two part-time jobs recently increased to above $20,000, threatening to disqualify her from state aid. Under the new plan, Ms. Peña would be eligible for free state-sponsored insurance that would provide better dental and vision coverage.

“Just imagine if something were to happen to me,” Ms. Peña said. “Thanks to this I don’t have to worry about that any more.”

    Massachusetts Offers Details on Health Coverage, NYT, 12.4.2007, http://www.nytimes.com/2007/04/12/us/12mass.html

Study: Major increase in morbidly obese

10.4.2007
USA Today
By Nanci Hellmich

The prevalence of American adults who are 100 or more pounds over a healthy weight has risen dramatically since 2000, a study released Monday shows.

About 3% of people, or 6.8 million adults, were morbidly obese in 2005, up from 2% or 4.2 million people in 2000, says Roland Sturm, an economist with the RAND Corp., a non-profit think tank.

The evidence of such a significant increase in the number of Americans who are extremely heavy "is mind-boggling," he says.

Sturm analyzed government data on about 1.5 million people who reported their own weights and heights. Participants were categorized as severely or morbidly obese if they had a body mass index (a height-weight ratio) of 40 or higher.

According to government data, about 66% of people in the USA are now either overweight or obese, which is defined as 30 or more pounds over a healthy weight. Obesity increases a person's risk of contracting numerous diseases, including diabetes, heart diseases and cancer.

Sturm's study, which was released Monday on the website of the journal Public Health, shows that 24.6% of people were obese in 2005, up from 20% in 2000. That's an increase of 24%.

People usually under report their weight, so the percentage of people who are morbidly obese is actually higher than 3%, Sturm says. A large government survey in which people are actually weighed and measured suggests that about 5% of U.S. adults are morbidly obese and a third are obese, Sturm says.

He says his analysis highlights the dramatic increase in the number of morbidly obese people over a relatively short period of time.

"Even though we've had an explosion of bariatric surgery in that time, it doesn't seem to have made a dent in these numbers," he says. Bariatric surgery often reduces the size of the stomach.

For years, some experts believed that severe obesity was a rare condition that affected a fixed percentage of the population that might be more predisposed to weight gain for genetic or metabolic reasons, Sturm says.

"But these numbers show the trend is really paralleling what is going on in our society," he says. To help reverse the numbers, "we need to move to a healthier environment with friendlier staircases and more walkable environments," Sturm says.

George Blackburn, associate director of nutrition at Harvard Medical School, calls the increase in the percent of severely obese people a catastrophe.

"It is an emergency because the disability, the discrimination and the health care costs for this population are enormous," he says.

    Study: Major increase in morbidly obese, UT, 10.4.2007, http://www.usatoday.com/news/health/weightloss/2007-04-10-morbidly-obese_N.htm

Elizabeth Cullen and Martin Lilienthal

hold up Elizabeth's old "fat jeans."

By Todd Plitt, USA TODAY

   Couple take off pounds and years, but they 'don't diet'

UT        10.4.2007

http://www.usatoday.com/news/health/weightloss/2007-04-08-wlc-cullen-lilienthal_N.htm

Couple take off pounds and years,

but they 'don't diet'

10.4.2007
USA Today
By Nanci Hellmich

Martin Lilienthal Jr., 38, and Elizabeth Cullen, 37, of Wallingford, Conn., love food.

The couple met in college and often enjoyed all-you-can-eat buffets and late-night pizza splurges. "I didn't gain the Freshman 15. It was more like the Freshman 30," Cullen says. When they got out of college and were married, they continued to enjoy delicious meals he prepared. Their weight crept up.

But in 2001, Cullen, who was on two blood pressure medications, went out the day before her birthday to buy a pair of jeans. She was shocked at the size she needed. "They were obscenely large jeans. It was the largest size in the store," she says.

Since then, Cullen and her husband have lost more than 200 pounds together while still enjoying good food.

The two are among more than a dozen readers profiled as part of the fourth annual USA TODAY Weight-Loss Challenge. This year's challenge, which appears every Monday through May, is focusing on people who have succeeded at weight loss and maintenance.

When Cullen decided to give Weight Watchers a try in 2001, "the first two weeks were a nightmare. I was the worst human being to be around."

She lost 5 pounds after a week on the program's Flex Plan, which assigns points to foods. Cullen gradually started doing a little physical activity, including using exercise DVDs.

"If I could lose weight and not exercise, I am all into that," she says. "But sooner or later, you realize it would be better to exercise."

Lilienthal began following the program with her, but he didn't go to the meetings until three years later. "We decided to lose weight gradually and slowly change the way we eat so that we could change our lifestyle and not just go on a diet," he says.

He does all the grocery shopping and cooking, so he began adapting his recipes to create weight-loss-friendly chili cheese dogs, barbecue ribs, meatloaf and split pea soup. Eventually, this resulted in a cookbook, Recipes from Martin's Kitchen.

The couple became more active by biking, hiking and kayaking, he says. Lilienthal suggested that they start running. Cullen says she wasn't sure she could. "In my head I was still a 300-pound person," she says. "I may sashay. I may amble. But I don't run unless something big is chasing me."

But she overcame her reservations and managed to train and run a 5K. They ran a half-marathon in October 2006, and this fall, they want to run a marathon. "We've gone from couch potatoes to marathoners," she says.

There were plenty of ups and down. "You don't live in a bubble," she says. "You have to deal with holidays and food-pushers at work — these are well-meaning people in your life who want you to eat more. It's hard when you have to stand up against that and tell people you are trying to eat healthfully.

"It took me five years to lose 120 pounds. I was frustrated that it took me that long, but when you struggle is when you learn," she says.

Lilienthal says: "If it wasn't for my wife starting this journey back in 2001, we would still be heavy, inactive people. Her decision has added years to our lives. Our lives have changed dramatically, and we can never go back.

"We can't, because we only have clothes that fit us in our closet."

    Couple take off pounds and years, but they 'don't diet', UT, 10.4.2007, http://www.usatoday.com/news/health/weightloss/2007-04-08-wlc-cullen-lilienthal_N.htm

Lessons of Heart Disease, Learned and Ignored

April 8, 2007
The New York Times
By GINA KOLATA

Keith Orr thought he would surprise his doctor when he came for a checkup.

His doctor had told him to have a weight-loss operation to reduce the amount of food his stomach could hold, worried because Mr. Orr, at 6 feet 2 inches, weighed 278 pounds. He also had a blood sugar level so high he was on the verge of diabetes and a strong family history of early death from heart attacks. And Mr. Orr, who is 44, had already had a heart attack in 1998 when he was 35.

But Mr. Orr had a secret plan. He had been quietly dieting and exercising for four months and lost 45 pounds. He envisioned himself proudly telling his doctor what he had done, sure his tests would show a huge drop in his blood sugar and cholesterol levels. He planned to confess that he had also stopped taking all of his prescription drugs for heart disease.

After all, he reasoned, with his improved diet and exercise, he no longer needed the drugs. And, anyway, he had never taken his medications regularly, so stopping altogether would not make much difference, he decided.

But the surprise was not what Mr. Orr had anticipated. On Feb. 6, one week before the appointment with his doctor, Mr. Orr was working out at a gym near his home in Boston when he felt a tightness in his chest. It was the start of a massive heart attack, with the sort of blockage in an artery that doctors call the widow-maker.

He survived, miraculously, with little or no damage to his heart. But his story illustrates the reasons that heart disease still kills more Americans than any other disease, as it has for nearly a century.

Medical research has revealed enough about the causes and prevention of heart attacks that they could be nearly eliminated. Yet nearly 16 million Americans are living with coronary heart disease, and nearly half a million die from it each year.

It’s not that prevention doesn’t work, and it’s not that once someone has a heart attack there is little to be done. In fact, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute at the National Institutes of Health, age-adjusted death rates for heart disease dropped precipitously in the past few decades, and prevention and better treatment are major reasons why.

But the concern, Dr. Nabel and others say, is that much more could be done. In many ways, scientists’ hard-won and increasingly detailed understanding of what causes heart disease and what to do for it often goes unknown or ignored.

Studies reveal, for example, that people have only about an hour to get their arteries open during a heart attack if they are to avoid permanent heart damage. Yet, recent surveys find, fewer than 10 percent get to a hospital that fast, sometimes because they are reluctant to acknowledge what is happening. And most who reach the hospital quickly do not receive the optimal treatment — many American hospitals are not fully equipped to provide it but are reluctant to give up heart patients because they are so profitable.

And new studies reveal that even though drugs can protect people who already had a heart attack from having another, many patients get the wrong doses and most, Mr. Orr included, stop taking the drugs in a matter of months. They should take the drugs for the rest of their lives.

“We’ve done pretty well,” Dr. Nabel said. “But we could be doing much better. I’ve heard some people refer to it as the rule of halves. Half the people who need to be treated are treated and half who are treated are adequately treated.”

The result, heart researchers say, is a huge disconnect between what is possible and what is actually happening.

Crucial Miscalculations

Keith Orr’s story has themes that resonate with every cardiologist. He did many things right, but also made some crucial miscalculations that were so common that nearly every patient makes them, cardiologists say. But not everyone comes out as well.

Mr. Orr anticipated a pleasant day on Feb. 6, starting with a workout at his gym, then lunch with a friend before he went to work at Smith & Wollensky, a steakhouse where he is a manager.

He arrived at the gym around noon and lifted weights, concentrating on the pectoral muscles of his chest. Then he moved on to an elliptical cross-trainer for cardiovascular exercise.

After half an hour on the elliptical, Mr. Orr felt a tightness in his chest. “I attributed it to the weight training,” he said, but stopped exercising, showered, dressed and walked to his car.

“I felt really bad, out of sorts,” he said. The pressure in his chest would ease off and then intensify, and now he was sweating profusely and was nauseated. When he arrived at the restaurant, he told his friend Darrin Friedman that he would have to beg off from lunch. “I feel like hell,” he told Mr. Friedman.

He went home and lay on his bed.

“I knew at that point that it was not a pulled muscle,” Mr. Orr said. “It’s a completely different feeling of pressure and discomfort. You feel as though something is genuinely wrong.”

It was 3:15. And the pain was no longer intermittent. It was constant.

Mr. Orr called Mr. Friedman and asked him to drive him to an emergency room. A few minutes later, the two set off for Brigham and Women’s Hospital, about a 10-minute drive.

“Keith was hunched over and he didn’t put his seat belt on,” Mr. Friedman said. “I kept asking him, ‘Is it getting better or getting worse or staying the same?’ For the first 10 minutes he said, ‘It’s about the same.’ Then, when we were a block or so away, he said: ‘I’m not doing well. I think it’s getting worse.’ “

When they arrived at the hospital’s emergency department, Mr. Friedman explained that his friend was having chest pains. Immediately, Mr. Orr was wheeled off for an electrocardiogram, showing his heart’s electrical signals. It was ominous, including one pattern called the tombstone T wave because patients who had it died in the days before there were aggressive treatments to open arteries.

The next thing Mr. Orr knew, he was being rushed to the cardiac catheterization laboratory for a procedure to open his artery.

“They said: ‘We’re going now. We’re going now,’ ” Mr. Orr recalled. “That really scared me. Someone kept yelling: ‘Do you have his labs? Do you have his labs?’ Someone else said, ‘We’ll transfer them later.’ ”

The electrocardiogram was at 3:45 p.m., roughly 30 minutes after his symptoms changed from intermittent to constant and 5 minutes after he got to the hospital.

At 3:52 p.m., Dr. Ashvin Pande, a cardiology fellow, was chatting in the hallway when he was called to the catheterization lab.

“Big M.I. coming in,” a nurse told Dr. Pande, using the abbreviation for myocardial infarction, or heart attack. At the time, the room was occupied — a patient was lying on the table for an elective procedure. He was quickly wheeled out and Mr. Orr was wheeled in. It was 3:56 p.m.

Within minutes, Dr. James M. Kirshenbaum, director of acute interventional cardiology, assisted by Dr. Pande, threaded a thin tube, like a long and narrow straw, from an artery in Mr. Orr’s groin to his heart. They injected a dye to make Mr. Orr’s arteries visible to an X-ray and they saw the problem — a huge clot in his heart’s left anterior descending artery, blocking blood flow to most of his heart.

The quickest option was to open that artery with a balloon and keep it open with a stent, a tiny mesh cage, if possible.

It worked — the balloon shattered the clot and pushed the debris against the artery wall and the stent held the artery open. Then a different problem arose. When the large clot was pushed aside, the debris was shoved against the opening of a small artery that branched from the larger one, much as a snowplow clearing a street can block a driveway.

“We made a calculated decision that it would be worth sacrificing the branch to secure the main vessel,” Dr. Pande said. But, fortunately, they were able to insert another balloon through the stent and into the small artery, opening it too.

At 4:43, the procedure was over and Mr. Orr was wheeled to the coronary intensive care unit. He had been awake but sedated and experienced what he said was the amazing feeling of having his artery opened. “As soon as the balloon goes in, all the pain disappears,” he said. “You know immediately.”

The cardiologists who saved his life walked out of the room, grinning and exhilarated.

“This adrenaline rush is why people like me go into cardiology,” Dr. Pande said.

The First Call: An Ambulance

Mr. Orr was incredibly lucky, said Dr. Elliott Antman, director of the coronary care unit at Brigham and Women’s Hospital. He ended up with little or no damage to his heart, even though he teetered between lifesaving decisions and critical miscalculations in his moments of crisis.

The first lifesaving decision was to go to a hospital soon after his chest pain began. But the miscalculation was to call his friend for a ride. He should have called an ambulance.

Had his friend gotten caught in traffic, Mr. Orr might have been dead or sustained serious injury to his heart. He might have had to go to a rehabilitation center and learn special tactics for conserving energy, like sliding a coffeepot along a counter instead of lifting it.

What few patients realize, Dr. Antman said, is that a serious heart attack is as much of an emergency as being shot.

“We deal with it as if it is a gunshot wound to the heart,” Dr. Antman said.

Cardiologists call it the golden hour, that window of time when they have a chance to save most of the heart muscle when an artery is blocked.

But that urgency, cardiologists say, has been one of the most difficult messages to get across, in part because people often deny or fail to appreciate the symptoms of a heart attack. The popular image of a heart attack is all wrong.

It’s the Hollywood heart attack, said Dr. Eric Peterson, a cardiologist and heart disease researcher at Duke University.

“That’s the man clutching his chest, grimacing in pain and going down,” Dr. Peterson said. “That’s what people imagine a heart attack is like. What they don’t imagine is that it’s not so much pain as pressure, a feeling of heaviness, shortness of breath.”

Most patients describe something like Mr. Orr’s symptoms — discomfort in the chest that may, or may not, radiate into the arms or neck, the back, the jaw, or the stomach. Many also have nausea or shortness of breath. Or they break out in a cold sweat, or have a feeling of anxiety or impending doom, or have blue lips or hands or feet, or feel a sudden exhaustion.

But symptoms often are less distinctive in elderly patients, especially women. Their only sign may be a sudden feeling of exhaustion just walking across a room. Some say they broke out in a sweat. Afterward, they may recall a feeling of pressure in their chest or pain radiating from their chest but at the time, they say, they paid little attention.

Patients with diabetes might have no obvious symptoms at all other than sudden, extreme fatigue. It’s not clear why diabetics often have these so-called silent heart attacks — one hypothesis attributes it to damage diabetes can cause to nerves that carry pain signals.

“I say to patients, ‘Be alert to the possibility that you may be short of breath,’ ” Dr. Antman said. “Every day you walk down your driveway to go to your mailbox. If you discover one day that you can only walk halfway there, you are so fatigued that you can’t walk another foot, I want to hear about that. You might be having a heart attack.”

Other times, said Dr. George Sopko, a cardiologist at the National Heart, Lung and Blood Institute, symptoms like pressure in the chest come and go. That is because a blood clot blocking an artery is breaking up a bit, reforming, breaking and reforming. It was what happened to Mr. Orr when he was at the gym and meeting his friend afterward.

“It’s a pre-heart attack,” Dr. Sopko said. A blood vessel is on its way to being completely blocked. “You need to call 911.”

But most people — often hoping it is not a heart attack, wondering if their symptoms will fade, not wanting to be alarmist — hesitate far too long before calling for help.

“The single biggest delay is from the onset of symptoms and calling 911,” said Dr. Bernard Gersh, a cardiologist at the Mayo Clinic. “The average time is 111 minutes, and it hasn’t changed in 10 years.”

‘Time Is Muscle’

At least half of all patients never call an ambulance. Instead, in the throes of a heart attack, they drive themselves to the emergency room or are driven there by a friend or family member. Or they take a taxi. Or they walk.

Patients often say they were embarrassed by the thought of an ambulance arriving at their door.

“Calling 911 seems like such a project,” Mr. Orr said. “I reserve it for car accidents and exploding appliances. I feel like if I can walk and talk and breathe I should just get here.”

It is an understandable response, but one that can be fatal, cardiologists say.

“If you come to the hospital unannounced or if you drive yourself there, you’re burning time,” Dr. Antman said. “And time is muscle,” he added, meaning that heart muscle is dying as the minutes tick away.

There may be false alarms, Dr. Sopko said.

“But it is better to be checked out and find out it’s not a problem than to have a problem and not have the therapy,” he said.

Calling an ambulance promptly is only part of the issue, heart researchers say. There also is the question of how, or even whether, the patient gets either of two types of treatment to open the blocked arteries, known as reperfusion therapy.

One is to open arteries with a clot-dissolving drug like tPA, for tissue plasminogen activator.

“These have been breakthrough therapies,” said Dr. Joseph P. Ornato, a cardiologist and emergency medicine specialist who is medical director for the City of Richmond, Va. “But the hooker is that even the best of the clot buster drugs typically only open up 60 to 70 percent of blocked arteries — nowhere close to 100 percent.”

The drugs also make patients vulnerable to bleeding, Dr. Ornato said.

One in 200 patients bleeds into the brain, having a stroke from the treatment meant to save the heart.

The other way is with angioplasty, the procedure Mr. Orr got. Cardiologists say it is the preferred method under ideal circumstances.

Stents have recently been questioned for those who are just having symptoms like shortness of breath. In those cases, drugs often work as well as stents. But during a heart attack or in the early hours afterward, stents are the best way to open arteries and prevent damage. That, though, requires a cardiac catheterization laboratory, practiced doctors and staff on call 24 hours a day. The result is that few get this treatment.

“We now are seeing really phenomenal results in experienced hands,” Dr. Ornato said. “We can open 95 to 96 percent of arteries, and bleeding in the brain is virtually unheard of. It’s a safer route if it is done by very experienced people and if it is done promptly. Those are big ifs.”

The ifs were not a problem for Mr. Orr. His decision to go to Brigham and Women’s Hospital proved exactly right. But he did not know that when he chose the hospital — he chose it because his doctor was affiliated with Brigham.

A Need for More Angioplasty

Currently, 30 percent of patients who are candidates for reperfusion do not receive it, and of those who do, only 18 percent are treated with angioplasty, said Dr. Alice Jacobs, director of the cardiac catheterization laboratory at Boston University School of Medicine and a past president of the American Heart Association. Of the nation’s 5,000 acute care hospitals, Dr. Jacobs said, only 1,200 provide angioplasty.

Most hospitals, she said, cannot offer angioplasty because they do not have enough patients for a team of doctors to maintain their skills. An obvious solution would be to make heart attack care more like trauma care — sending patients to the nearest hospital that can provide angioplasty as quickly as possible. But that is not always easy, Dr. Jacobs said, because hospitals do not want to lose cardiac patients.

A major reason, she said, is financial. Hospitals are reimbursed by Medicare according an index that measures the acuity of medical conditions they treat.

“If your cardiac patients are transferred, your acuity index goes down, which lowers overall Medicare reimbursement for other problems like pneumonia and renal disease,” Dr. Jacobs said.

It is also difficult for patients who live in rural areas, where community hospitals are too small to offer angioplasty and larger hospitals that do offer it are hours away. Minnesota is experimenting with a program using helicopters to transport patients quickly. But for most rural patients elsewhere, angioplasty is almost an impossibility.

Dr. Antman suggests that heart disease patients ask their doctor if there is a hospital nearby that does angioplasty around the clock. If so, they might want to discuss with their doctor whether to ask that an ambulance take them there if they are having a heart attack.

It is the sort of advice that makes cardiologists nervous — they do not want to encourage patients to dictate treatment. But, Dr. Antman said, if it is feasible to get to an angioplasty-providing hospital within an hour, “in most cases that would be preferable.”

Getting the Proper Therapy

Opening an artery is only the start of treatment. The next part is at least as problematic: Patients have to get the right drugs, in the right doses, and have to take them for the rest of their lives.

“Care is getting a lot better,” Dr. Peterson said. “But the only caveat is that they are only really looking at, Did you get therapy? No one is looking too closely at, Did you do it right?”

For example, he said, a recent study found that heart attack patients were getting blood-thinning prescription drugs to prevent clots, as they should, but up to 40 percent were getting the wrong dose, usually one too high.

And even if every prescription were exactly right, as many as half of all patients do just what Mr. Orr did after his first heart attack. They stop taking many or all of their drugs.

Sometimes it is a matter of communication.

“The information did not get to the primary doctor and the primary doctor did not know to renew the prescription,” Dr. Peterson said. “When we talk to patients, they say: ‘No one communicated to me the importance of being on the medications long term. I thought I would only need them for three months, I thought it would be like an antibiotic. I thought they put in a stent so why do I need a drug?’ ”

But there may be more to it than ignorance. There also is the image those pills convey of a sick person.

Mr. Orr said he did not like to think of himself as someone who had to take a fistful of pills every day. Even the recommended daily aspirin seemed superfluous, he thought.

“I think I sort of pooh-poohed the notion that one tablet of aspirin each day would do anything,” Mr. Orr said.

What it does is make blood less likely to clot. In Mr. Orr’s case, Dr. Antman said, it is likely that when Mr. Orr was exercising on the cross-trainer, an area of plaque ruptured. Then a clot began to form in the area, eventually blocking the artery.

The problem was not exercise, which is good for people with heart disease, but Mr. Orr’s decision not to take his medications, Dr. Antman said. If he had been taking aspirin that clot would have had more difficulty forming and growing.

Dr. Antman has a message for patients: With a disease as serious as heart disease, those who take responsibility are often the ones who survive.

Having a heart attack, even if it turns out well, as his did, is a life-altering experience, Mr. Orr said.

His first heart attack, Mr. Orr said, “came out of the blue.” When he was discharged from the hospital, he was terrified that it would happen again when he was alone and unable to call for help. “I had a really hard time with it,” he said. “I only stayed in my own house for one night and then I moved to a friend’s house for two weeks.”

Now Mr. Orr plans to be serious about taking his medication and getting back to his diet and exercise program. He will call an ambulance if he ever has symptoms again. Still, he hates to think of himself as a patient. “I’m a little freaked out that I will have to take medication for the foreseeable eternity,” Mr. Orr said.

But the day after he got home from the hospital, he thought about what had happened.

“The gravity of the situation just sort of clicked,” Mr. Orr said. “I started to cry.”

    Lessons of Heart Disease, Learned and Ignored, NYT, 8.4.2007, http://www.nytimes.com/2007/04/08/health/08heart.html?hp

$500 Million Pledged to Fight Childhood Obesity

April 4, 2007
The New York Times
By STEPHANIE STROM

The Robert Wood Johnson Foundation plans to spend more than $500 million over the next five years to reverse the increase in childhood obesity. It is one of the largest public health initiatives ever tried by a private philanthropy.

“This is an epidemic that is going to cost the country in terms of morbidity and mortality and economically,” said Dr. Risa Lavizzo-Mourey, the foundation’s president and chief executive. “The younger generation is going to live sicker and die younger than their parents because of obesity.”

The foundation estimates that roughly 25 million children 17 and under are obese or overweight, nearly a third of the 74 million in that age group, according to Census Bureau data and a 2006 study published in The Journal of the American Medical Association.

Many of those children are poor and live in neighborhoods where outdoor play is unsafe and access to fresh fruits and vegetables is limited. “In many cases, the environment makes it almost impossible for them to choose healthy lifestyles,” Dr. Lavizzo-Mourey said. “We’re going to try to change that.”

The foundation plans to invest in programs to improve access to healthy food, encourage the development of safe play spaces, increase research to enhance understanding of obesity and prod governments into adopting policies to address the problem, among other things.

Experts on childhood obesity welcomed the foundation’s plans.

“Government grants for biomedical research in general, including obesity research, are being funded at the lowest levels I’ve seen in my career,” said Dr. David Ludwig, director of the Optimal Weight for Life Clinic at Children’s Hospital Boston and author of a new book, “Ending the Food Fight.” “So we are especially dependent on philanthropic support.”

Philanthropy has long fueled improvements in health, from John D. Rockefeller, whose money produced a yellow fever vaccine, to Bill and Melinda Gates, who are underwriting new health technologies and vaccines to address a variety of global problems.

Robert Wood Johnson, who built Johnson & Johnson into one of the world’s largest health and medical care products companies, established his foundation at his death in 1968 with 10,204,377 shares of the company’s stock. He committed it to improving the health of Americans.

The foundation played a major role in curbing tobacco use in this country, spending $446 million from 1991 to 2003 toward that goal, and it plans to use those experiences to shape its attack on childhood fat.

Since 1995, the number of adult and teenage smokers has declined 12.6 percent and 18 percent, respectively.

“It was a very carefully thought-out strategic initiative,” said Joel L. Fleishman, a professor of law and public policy at Duke University. The foundation underwrote research, prevention and smoking-cessation programs, and increased awareness of smoking’s dangers.

Over the last few years, the foundation has pledged $80 million to childhood obesity programs, like grants to the Food Trust to persuade supermarket operators to return to poor neighborhoods.

Its new effort intends to capitalize on and enhance efforts by the food industry and school districts and governments to address the problem, Dr. Lavizzo-Mourey said. Several snack food producers are making changes in their packaging and ingredients, and three soft-drink companies said they would no longer supply sweetened drinks to school cafeterias and vending machines.

Several states have mandated changes in school menus, increased physical education requirements and begun reporting students’ body mass index scores to parents.

In Arkansas, which has one of the most comprehensive programs aimed at the problem, obesity among the 450,000 children in 1,300 public schools has plateaued.

Rhonda Sanders of Bryant, Ark., said learning that her daughter, Samantha, had a body mass index in the 95th percentile “was a wake-up call, really.”

Samantha, a 5-foot-tall, 137-pound third grader at the time, started jumping rope and bouncing on the trampoline, and the family banned eating in front of the television.

“We didn’t do anything life-changing, we didn’t take away every bit of candy and chips, we just put some limits on it,” Ms. Sanders said. Three years later, Samantha’s B.M.I. score is in the 50th percentile. She favors fruits and vegetables and is on the school dance team.

“I know it’s not as simple for every child,” Ms. Sanders said, “but because children’s bodies are changing so rapidly, a few changes in the way they eat and their activity level can really make a huge difference.”

    $500 Million Pledged to Fight Childhood Obesity, NYT, 4.4.2007, http://www.nytimes.com/2007/04/04/health/04obesity.html?hp

Unapproved drugs spark life-and-death debate

2.4.2007
USA Today
By Rita Rubin

BALTIMORE — On a blustery January day, Rhett Davis relaxes in a recliner at Johns Hopkins Hospital as clear fluid drips from a hanging bag, through a tube and into a vein in his left arm. The 30-minute process is anticlimactic, considering what his family and his doctor went through to get the drug for him.

Davis, 32, was diagnosed with a rare blood disorder called paroxysmal nocturnal hemoglobinuria, or PNH, when he was 17, but his health didn't begin to deteriorate until about two years ago. The blood clots that kill nearly half of PNH patients destroyed his liver. His kidneys failed.

Since the week after Thanksgiving, though, Davis had been making six-hour round trips from his home in Kingston, Pa., to Baltimore for intravenous doses of eculizumab, the first drug shown to work against PNH. It wasn't approved by the Food and Drug Administration until March 16. Without the drug, Davis might have died by then, says his doctor, Robert Brodsky.

Every day, patients with life-threatening illnesses run out of FDA-approved treatments. In desperation, some seek drugs that have not yet been approved by the agency and, in some cases, have not even been widely tested. These patients argue they have nothing to lose and are willing to risk taking even a little-studied drug that offers a glimmer of hope.

But FDA officials, as well as many doctors, are concerned that even terminal patients are as likely to be harmed as helped by such drugs. And manufacturers and researchers worry that easy access to experimental drugs could stifle the development of new treatments by shrinking the pool of patients available for clinical trials.

Davis is typical of patients with life-threatening diseases who have been able to obtain experimental drugs outside of clinical trials. He didn't have time to wait for a new drug to arrive on the market, and he didn't meet the strict eligibility criteria for trials of drugs not yet approved.

Frustrated with the cumbersome process for obtaining experimental drugs — which requires dealing with the FDA bureaucracy as well as drugmakers and research institutions — a patient advocacy group has taken the FDA to court. The group argues that mentally competent terminally ill patients have a right to get such drugs.

Howard Fine, chief of the brain cancer branch at the National Cancer Institute, says he understands both sides of the debate over experimental drugs.

"Ethically speaking," Fine says, noting that he's talking only for himself, "who has the right to say to a patient: You have no right to try this medicine even though you're dying, even though you're well informed?"

On the other hand, he says, giving unapproved drugs to anyone who wants them would be a logistical nightmare: "Where are (drugmakers) going to send these drugs? The local doc down the street? And who's going to educate the doctor?"

Fine says he sees 2,000 to 3,000 brain tumor patients a year, the "vast majority" of whom will die within the next year. Sometimes they don't qualify for a clinical trial. Sometimes they can't deal with the hassle of it, especially if they live far from the National Institutes of Health's campus in Bethesda, Md. Fine says he gets calls from parents of dying children who plead: "Just give me this drug. What have we got to lose?"

A verdict in favor of the plaintiffs in the lawsuit against the FDA could eliminate patients' need to get the agency's permission to take experimental drugs. But many patients might still find roadblocks in cost, limited supplies and manufacturers' liability concerns.

On March 1, the U.S. Court of Appeals for the District of Columbia Circuit heard oral arguments in the case. Judge David Tatel got right to the point: "Who decides what's terminal, and how do you decide what lifesaving is? Suppose someone has a disease that will result in death in five or 10 years. Is that terminal?"

The court isn't likely to rule for several months, but the case already has divided doctors and patient-advocacy groups.

No 'slam-dunk' decision

"There are some good arguments on both sides," says Frank Palumbo, a lawyer and pharmacist who heads the University of Maryland School of Pharmacy Center on Drugs and Public Policy. "It's clearly not a slam-dunk for anybody."

The lawsuit over the FDA's barriers to the use of experimental drugs comes at a time when the agency also is under fire from critics who say it doesn't do enough to keep unsafe drugs off the market.

Opponents of easier access to experimental drugs argue that the drugs' early promise might not hold up. (For example, fewer than 10% of cancer drugs evaluated in Phase I trials, the first human tests, make it to market, the FDA says.) Instead of saving lives, some analysts say, drugs early in the developmental pipeline could end up shortening them.

"You don't want to put more weight than is appropriate into what a Phase I study shows," says bioethicist Arthur Caplan of the University of Pennsylvania. "Phase I studies are basically just trying to make sure you don't poison anybody by exposing them to stuff."

At best, dying patients might gain a few months of life from drugs that have undergone only Phase I testing, says Caplan, who supports making it simpler for patients to seek FDA permission to use experimental drugs.

"I'm not arguing that six months isn't good," Caplan says. But "just as it's good to live six more months, it's also good not to lose six months."

If the FDA loses the lawsuit, "companies could come along and sell false hope to patients," says Allen Lichter, CEO of the American Society of Clinical Oncology (ASCO), which submitted a "friend of the court" brief in February siding with the FDA.

The brief was co-signed by the American Academy of Medical Colleges and the National Coalition for Cancer Survivorship, which describes itself as the nation's "oldest survivor-led cancer advocacy organization."

"Yes, it's a little bit hard to get these drugs," Lichter says. "And to some extent, that's the way it should be. This shouldn't be as easy as walking down to the drugstore and buying a package of Tylenol."

Providing experimental drugs to all comers could hamper clinical trials, says Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America (PhRMA), the prescription drug industry's main trade group.

"Companies must be careful to make sure that after making experimental drugs available to more patients, they are able to find enough volunteer patients willing to abide by the restrictions and rules of a clinical trial," Goldhammer said in a statement.

But proponents of easier access to experimental drugs say patients are dying because they don't meet clinical trials' strict criteria.

Abigail's story

Abigail Burroughs was one of them, says her father, Frank Burroughs. Abigail had tumor cells that contained an enzyme called the epidermal growth factor receptor, or EGFR, which acts as an "on" switch, triggering cells to divide and spread without dying.

At the time, Erbitux and Iressa were being tested against tumors with EGFR in the colon and lung, respectively. But her tumor was in the head and neck, so she was ineligible.

Both drugs eventually won FDA approval.

After Abigail died in June 2001 at age 21, Frank Burroughs co-founded the Abigail Alliance for Better Access to Developmental Drugs. The Fredericksburg, Va.-based organization and the non-profit Washington Legal Foundation brought the lawsuit against the FDA that seeks increased access to experimental drugs.

"The point we make in our lawsuit is really an important one: The decision should be made by the patient in consultation with their doctor," Burroughs says. "We feel the FDA should not be overly paternalistic."

Emil Freireich, director of adult leukemia research at the University of Texas M.D. Anderson Cancer Center, agrees. When Freireich heard that ASCO, which he co-founded, had filed its court brief supporting the FDA's limits on experimental drugs, "I almost cried," he says.

"It's a really sad, sad day when an organization that represents all the oncology physicians in the world sides with the FDA over the interest of patients," Freireich says.

"I asked five leading (scientific) investigators to side with Abigail," Freireich says. "They all demurred, because they're scared the FDA is going to kick them in the butt."

'Compassionate use'

Rhett Davis obtained eculizumab through a treatment "IND" — short for investigational new drug — which is like a clinical trial for a single patient.

Just before it approves drugs, the FDA sometimes makes them available to groups of patients. The two-decade-old practice, known as "compassionate use," resulted from pressure by AIDS activists who demanded access to experimental drugs to treat what was then an imminent death sentence.

Brodsky, Davis' doctor and chief of hematology at Johns Hopkins, co-wrote a New England Journal of Medicine report in September on a Phase III trial that found eculizumab reduced the destruction of red blood cells in PNH patients and their need for transfusions.

Only those who were dependent on blood transfusions could enroll in the trial. When it was open for enrollment, Davis didn't qualify because he wasn't dependent on transfusions. By the time he required transfusions and became eligible for the trial, it was full.

As Davis lay in a hospital in Wilkes-Barre, Pa., last November — his skin tinged yellow because of his failing liver, fluid accumulating in his abdomen because of his failed kidneys — his family pressed their senator and congressman to help them obtain eculizumab.

Meanwhile, Brodsky applied to Alexion, the drug's maker, the FDA and the Johns Hopkins institutional review board, which must approve all human research at the hospital, so Davis could get the drug.

Davis could be considered for a lifesaving liver transplant only if he received the drug and it worked, Brodsky says. The day before Thanksgiving, Davis learned he would get his eculizumab.

Even if the Abigail Alliance wins its lawsuit against the FDA, the case might have a minimal effect on patients, Palumbo says. "It might be that (only) people with money and access to other professionals might be the real winners."

The lawsuit asks that terminally ill patients be allowed to pay for promising drugs that are not yet on the market. In December, the FDA proposed revisions to rules about how drugmakers can charge for experimental drugs. The ability to recoup costs might spur smaller companies to provide more drugs outside trials, FDA Deputy Commissioner Janet Woodcock says.

Still, no matter the verdict, even patients who could pay for experimental drugs might find makers unwilling to provide such drugs.

"Often, we are given as the reason" why patients can't get an investigational drug, Woodcock says. "But, if really questioned, the companies will say, 'We're not giving it out.' "

PhRMA's Goldhammer notes that companies often make just enough of such drugs to use in clinical trials.

Liability concerns loom large, because the FDA prohibits patients who get an experimental drug outside a clinical trial from waiving their right to sue the drugmaker if they have adverse effects, Baltimore lawyer Mark Gately says.

Gately spoke last month in Washington at a forum on the Abigail Alliance lawsuit. "The very risk of being sued," he says, "is a major disincentive to providing drugs in this situation."

A success story

Davis could be considered an example of what can go right when a desperately ill patient gets a drug before it goes on the market.

The call came Feb. 6, more than two months after Davis began taking eculizumab and began to show improvement.

By that night, Davis was having liver transplant surgery at Johns Hopkins. He left the hospital nine days later. Now, he's planning to return to work as an auditor by summer.

"He is perfect," Brodsky says. "His PNH, you wouldn't even know he has it anymore. His kidneys are fine. His liver is fine. No more fluid on him. He's not that horrible color he was.

"It was really the drug that made this possible."

    Unapproved drugs spark life-and-death debate, NYT, 2.4.2007, http://www.usatoday.com/news/nation/2007-04-02-unapproved-drugs_N.htm