Report: Young doctors still too tired for safety

WASHINGTON – Doctors-in-training are still too exhausted, says a new report that calls on hospitals to let them have a nap. Regulations that capped the working hours of bleary-eyed young doctors came just five years ago, limiting them to about 80 hours a week.
Tuesday, the prestigious Institute of Medicine recommended easing the workload a bit more: Anyone working the maximum 30-hour shift should get an uninterrupted five-hour break for sleep after 16 hours.
At issue is how to balance patient safety with the education of roughly 100,000 medical residents, doctors fresh out of medical school who spend the next three to seven years in on-the-job training for their specialty. The long hours are in some ways a badge of the profession; doctors can't simply clock out if a patient is in danger.
But sleep deprivation fogs the brain, a problem that can lead to serious medical mistakes. So in 2003, the Accreditation Council for Graduate Medical Education issued the first caps. Before then, residents in some specialties could average 110 hours a week.
The government asked the IOM to study the current caps. Violations of current limits are common and residents seldom complain, the committee found. While quality of life has improved, there's still a lot of burnout.
And despite one study that found residents made more errors while working longer shifts, patient safety depends on so many factors that it's impossible to tell yet if the caps helped that problem, the report said.
So it also recommends:
_Experienced physicians should more closely supervise residents.
_Better overlap of schedules during shift changes to reduce chances for error as one doctor hands patients' care over to the next.
_Increase mandatory days off each month, and extend hours off between shifts depending on how long the resident worked, during day or night.
The accreditation council didn't immediately say if it would follow the recommendations.

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Doctors separating joined twins in London

LONDON – British doctors conducted surgery to separate twins joined at the chest on Tuesday, hospital officials said.
Stephen Cox, a spokesman for the Great Ormond Street Hospital for Children in London, said the decision to separate Faith and Hope Williams was brought forward, after concerns developed Monday night. Cox would not specify what the concerns were.
The twins were born last week to Laura and Aled Williams. Doctors originally said they would have preferred to wait to separate the twins until they were older. The final decision to operate was made by the family.
The baby girls are joined at the abdomen. They are said to share a liver and intestines.
There was no word Tuesday night on how the operation went. The BBC said the hospital would provide an update Tuedsay morning.
"I would be optimistic about their chances," said Dr. Charles Stolar, pediatric surgeon in chief at Morgan Stanley Children's Hospital of New York-Presbyterian. Stolar is not connected to the British case, but has performed similar operations in the past.
"In general, this is a very fixable problem," he said.
But Stolar said that without knowing the details of the case, there could be other variables that could complicate the twins' prognosis.
Twins who share an abdomen usually share the liver, bile ducts from the liver, and various parts of the intestines. Conjoined twins occur about once in every 50,000 live births in the United States.
Twins joined at the chest are easier to separate than those joined elsewhere, like at the head. Last month, doctors in Cleveland decided it would have been too risky to separate 4-year-old twins born in Italy, connected at the head.
There are at least 40 doctors, nurses and other health professionals involved in the separation of the Williams twins in London.
During the surgery, doctors will have to divide the liver and ensure that each baby has enough intestinal tract to digest food. Doctors might also have to deal with other issues, such as if the kidneys are not distributed evenly or if they share part of the pelvis.
Lastly, doctors will need to close up the babies' abdomens, which may be tricky if there is not enough skin and muscle.
Depending on how complicated the surgery is, separated twins usually need to spend several weeks in the hospital as their recovery is monitored.
Stolar said that if there were no other complications — like heart or lung problems — then the babies would likely have few long-term problems, apart from not having belly buttons.
Hospital spokesman Cox said an update would be issued later, but didn't say when.
(This version CORRECTS Corrects that girls are joined at the abdomen stead breastbone to navel, corrects hospital name to Morgan Stanley Children's Hospital of New York-Presbyterian. UPDATES with briefing expected Wednesday.)

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1 in 5 young adults has personality disorder

CHICAGO – Almost one in five young American adults has a personality disorder that interferes with everyday life, and even more abuse alcohol or drugs, researchers reported Monday in the most extensive study of its kind. The disorders include problems such as obsessive or compulsive tendencies and anti-social behavior that can sometimes lead to violence. The study also found that fewer than 25 percent of college-aged Americans with mental problems get treatment.
One expert said personality disorders may be overdiagnosed. But others said the results were not surprising since previous, less rigorous evidence has suggested mental problems are common on college campuses and elsewhere. Experts praised the study's scope — face-to-face interviews about numerous disorders with more than 5,000 young people ages 19 to 25 — and said it spotlights a problem college administrators need to address. Study co-author Dr. Mark Olfson of Columbia University and New York State Psychiatric Institute called the widespread lack of treatment particularly worrisome. He said it should alert not only "students and parents, but also deans and people who run college mental health services about the need to extend access to treatment." Counting substance abuse, the study found that nearly half of young people surveyed have some sort of psychiatric condition, including students and non-students. Personality disorders were the second most common problem behind drug or alcohol abuse as a single category. The disorders include obsessive, anti-social and paranoid behaviors that are not mere quirks but actually interfere with ordinary functioning. The study authors noted that recent tragedies such as fatal shootings at Northern Illinois University and Virginia Tech have raised awareness about the prevalence of mental illness on college campuses. They also suggest that this age group might be particularly vulnerable. "For many, young adulthood is characterized by the pursuit of greater educational opportunities and employment prospects, development of personal relationships, and for some, parenthood," the authors said. These circumstances, they said, can result in stress that triggers the start or recurrence of psychiatric problems. The study was released Monday in Archives of General Psychiatry. It was based on interviews with 5,092 young adults in 2001 and 2002. Olfson said it took time to analzye the data, including weighting the results to extrapolate national numbers. But the authors said the results would probably hold true today. The study was funded with grants from the National Institutes of Health, the American Foundation for Suicide Prevention and the New York Psychiatric Institute. Dr. Sharon Hirsch, a University of Chicago psychiatrist not involved in the study, praised it for raising awareness about the problem and the high numbers of affected people who don't get help. Imagine if more than 75 percent of diabetic college students didn't get treatment, Hirsch said. "Just think about what would be happening on our college campuses." The results highlight the need for mental health services to be housed with other medical services on college campuses, to erase the stigma and make it more likely that people will seek help, she said. In the study, trained interviewers, but not psychiatrists, questioned participants about symptoms. They used an assessment tool similar to criteria doctors use to diagnose mental illness. Dr. Jerald Kay, a psychiatry professor at Wright State University and chairman of the American Psychiatric Association's college mental health committee, said the assessment tool is considered valid and more rigorous than self-reports of mental illness. He was not involved in the study. Personality disorders showed up in similar numbers among both students and non-students, including the most common one, obsessive compulsive personality disorder. About 8 percent of young adults in both groups had this illness, which can include an extreme preoccupation with details, rules, orderliness and perfectionism. Kay said the prevalence of personality disorders was higher than he would expect and questioned whether the condition might be overdiagnosed. All good students have a touch of "obsessional" personality that helps them work hard to achieve. But that's different from an obsessional disorder that makes people inflexible and controlling and interferes with their lives, he explained. Obsessive compulsive personality disorder differs from the better known OCD, or obsessive-compulsive disorder, which features repetitive actions such as hand-washing to avoid germs. OCD is thought to affect about 2 percent of the general population. The study didn't examine OCD separately but grouped it with all anxiety disorders, seen in about 12 percent of college-aged people in the survey. The overall rate of other disorders was also pretty similar among college students and non-students. Substance abuse, including drug addiction, alcoholism and other drinking that interferes with school or work, affected nearly one-third of those in both groups. Slightly more college students than non-students were problem drinkers — 20 percent versus 17 percent. And slightly more non-students had drug problems — nearly 7 percent versus 5 percent. In both groups, about 8 percent had phobias and 7 percent had depression. Bipolar disorder was slightly more common in non-students, affecting almost 5 percent versus about 3 percent of students.

___ On the Net: Archives of General Psychiatry: http://www.archgenpsychiatry.com/

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Depression leads to internal fat in 70-somethings

CHICAGO – Older people who are depressed are much more likely to develop a dangerous type of internal body fat — the kind that can lead to diabetes and heart disease — than people who are not depressed, a disturbing new study found.

The connection goes beyond obesity and suggests some biological link between a person's mental state and fat that collects around the internal organs, scientists said.

"For the depressed public, it should be another reason to take one's symptoms seriously and look for treatment," said study co-author Stephen Kritchevsky, director of the Sticht Center on Aging at Wake Forest University in Winston-Salem, N.C.

People with depression were twice as likely as others to gain visceral fat — the kind that surrounds internal organs and often shows up as belly fat. It raises the risk for heart disease and diabetes.

Previous research has linked depression with those same health problems. Some researchers believe depression triggers high levels of the stress hormone cortisol, which promotes visceral fat. The cortisol connection may explain the findings, Kritchevsky said.

The research, published in Monday's Archives of General Psychiatry, is the first large study to track people over time to see if those with depression were more likely to gain weight. Mostly federally funded, the study used data from 2,088 people in the ongoing Health, Aging and Body Composition study. That project is following healthy older Americans to find out how changes in bone, fat and lean body mass affect health.

The participants, all in their 70s, were recruited in and around Memphis, Tenn., and Pittsburgh in 1997 and 1998 and were followed for five years. Researchers screened for symptoms of depression at the start of the study and again at four follow-up visits.

They measured visceral fat with CT scans. They calculated body mass index, body fat percentage, waist size and the distance between the back and the biggest part of the belly.

There were 84 people with depression symptoms at the start of the study. They gained, on average, 9 square centimeters of visceral fat. In contrast, the 2,004 people who weren't depressed lost visceral fat — on average, 7 square centimeters.

That variation "could mean the difference between developing a cardiovascular disease or not," said lead author Nicole Vogelzangs of VU University Medical Center in Amsterdam, the Netherlands, in an e-mail.

Both groups, depressed and non-depressed, were overweight on average at the start of the study, with approximately the same average body mass index. When the researchers took into account other risk factors for obesity, including the depressed group's higher visceral fat levels in the beginning, they still found a connection between depression and visceral fat gain.

They also found a similar link to visceral fat gain in people with recurring depression over the years. Adjusting for antidepressant use didn't change the findings either.

Researchers didn't make adjustments for poor eating habits, but they found no link between depression and BMI or body fat percentage.

"Since such an increase in overall obesity was not clearly found, we believe a biological explanation is more likely" than poor diet, Vogelzangs said.

The researchers did find hints of a depression link with waist circumference and the back-to-belly measurement — two other gauges of visceral fat.

That suggests depression has a specific tie with fat gained around the organs in the abdomen. The good news is visceral fat is easier to lose than subcutaneous fat, Kritchevsky said.

Dr. David Baron of Philadelphia's Temple University School of Medicine praised the study, although he wanted to know more about the participants' family history of obesity. The connection between brain and body makes sense, he said.

"Depression is a physical illness," Baron said. "Maybe we should be even more aggressive in treating depression in this age group, whether through medication or talk therapy."

___

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Asthma inhalers to go 'green' on Dec. 31

WASHINGTON – Last warning: Asthma inhalers go "green" on Dec. 31, forcing patients still using the old-fashioned kind to make a pricey and even confusing switch. The medicine inside these rescue inhalers — the albuterol that quickly opens airways during an asthma attack — isn't changing. But the chemicals used to puff that drug into your lungs are.

No more chlorofluorocarbons, or CFCs, that damage Earth's protective ozone layer. By year's end, all albuterol inhalers must be powered by the more eco-friendly chemical HFA, or hydrofluoroalkane.

The down side: The new inhalers cost more, $30 to $60 compared to as little as $5 or $10 for the disappearing generic CFC inhalers.

And patients face a learning curve. HFA inhalers must be used differently than the old-fashioned kind. The medicine feels and tastes different, sometimes alarming new users despite doctors' assurances that it works just as well.

"There's still significant confusion," says Dr. Harvey Leo of the University of Michigan's C.S. Mott Children's Hospital. "Patients will tell you, 'I don't feel the puff anymore.'"

Calls from parents unsure how to use the new inhalers, or even what they are, have increased in the past two months as more drugstores run out of CFC-powered inhalers and automatically switch people who'd been expecting a mere refill, he adds.

The change shouldn't be a surprise. The Food and Drug Administration has long warned it was coming, and lung specialists have spent the past year easing many of the nation's 20 million asthma patients — as well as millions of emphysema sufferers who also use albuterol to ease breathing — into it.

But industry figures show that in mid-November, 20 percent of all albuterol prescriptions still were being filled with CFC versions.

Some patients may purposefully be buying up cheaper CFC inhalers before the sales ban. But many patients don't see a lung specialist, or their prescription may not expire until next year so they haven't been seen recently enough to be told.

Reaching the last fraction "is, as you can imagine, a very difficult task," says Dr. Bidrul Chowdhury, FDA's pulmonary drugs chief. "How to get to somebody who is not tuned in?"

The CFC-free options: GlaxoSmithKline's Ventolin HFA, Schering Plough's Proventil HFA and Teva Specialty Pharmaceuticals' ProAir HFA all contain albuterol. Also, Sepracor's Xopenex HFA contains the similar medication levalbuterol.

Albuterol inhalers are for emergencies, for quick relief of wheezing. Patients also need daily medication to control their asthma and prevent flare-ups. Someone who's using the albuterol inhaler more than a few times a month isn't well-controlled, and his or her doctor needs to determine why, stresses Dr. Paul Greenberger of Northwestern University, president-elect of the American Academy of Allergy, Asthma & Immunology.

Here's the rub: Recent research suggests only one in five children has their asthma under good control; no one knows how many adults do.

The last to go CFC-free will be the poor and uninsured whose asthma is less likely to be controlled, says Leo, who researches that issue at Michigan's Center for Managing Chronic Disease.

Albuterol manufacturers are providing free samples and posting coupons on their Web sites.

Still, specialists worry that some patients will try to save money with a decades-old nonprescription inhaler that contains a different drug, epinephrine, best known by the brand name Primatene Mist — inhalers that also contain ozone-harming CFCs. National asthma guidelines argue against such self-treatment as too risky and less effective than albuterol. The government will allow sale of those over-the-counter inhalers until December 2011 as manufacturers reformulate.

Leo has another concern: Only one of the new inhalers counts doses used. He's monitoring emergency-room statistics to see if cost-conscious patients trying to squeeze out last drops wind up using empty inhalers.

What do patients need to know as they switch?

_Expect a softer puff instead of the CFC version's cold blast of air in the back of the throat.

"They are getting their medicine," says Dr. David Rosenstreich of New York's Montefiore Medical Center. "They have to get used to it and be aware that it's working."

_The new inhalers clog more often because HFA makes the drug stickier. Clean the hole weekly, following the instructions unique to each brand.

_Never get the whole device wet.

The FDA says there's plenty of supply; it gave manufacturers several years to ramp up before the ban.

But don't wait until the last minute. When Eric Stoermer of Ann Arbor, Mich., made the switch in August, he waited a week for a new inhaler for his 11-year-old son Ethan. Their drugstore was temporarily out of stock.

"I ended up having to hunt around on an emergency basis," Stoermer says. "This is a bad thing to run out of."

___

EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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Some doctors may give up vaccines because of cost

ATLANTA – About one in 10 doctors who vaccinate privately insured children are considering dropping that service largely because they are losing money when they do it, according to a new survey.

A second survey revealed startling differences between what doctors pay for vaccines and what private health insurers reimburse: For example, one in 10 doctors lost money on one recommended infant vaccine, but others made almost $40 per dose on the same shot.

The survey was revealing even to some doctors. "Many physicians really weren't aware and that they were getting reimbursed so little," said Dr. Gary Freed of the University of Michigan, a co-author of both articles published in the December issue of the journal Pediatrics.

The studies are the first to attach numbers to doctors' long-simmering complaints that they are only breaking even — or even losing money — when they give shots.

"It's a pleasure to see a real study to show we're not just making this up," said Dr. Herschel Lessin, a pediatrician in Hopewell Junction, N.Y. who said his practice's spending on vaccines has more than doubled from 2006 to 2007.

Experts say there's no evidence that significant numbers of doctors are quitting the vaccination business yet because of financial concerns.

But health officials are worried. Reimbursement concerns were behind an exodus of doctors from vaccine programs in the 1980s, which contributed to a terrible resurgence of measles in 1989-91 that caused 11,000 hospitalizations and 123 deaths.

This year, U.S. measles cases rose to the highest level in more than a decade, mainly because some parents are opting out of getting their kids vaccinated.

Health officials fear that problem, along with doctor's economic concerns, could set the stage for bigger outbreaks in the future.

"This is a very important wake-up call," said Dr. Lance Rodewald of the U.S. Centers for Disease Control and Prevention, referring to the two new studies.

The first study was based on a mail-in survey last year of nearly 1,300 pediatricians and family physicians; nearly 800 responded.

About half said they had delayed buying at least one vaccine because of the cost. Roughly one in five said they felt strongly that reimbursement for the purchase and administration of vaccines was not adequate.

The second survey asked doctors what they paid for vaccines and how much they were reimbursed by private insurers. It was answered by 76 doctors in five states, representing about 20 percent of those asked to participate. Many contracts prevent doctors from talking about their spending and reimbursement for vaccinations, Freed said.

One example of the disparity was a vaccine that protects against pneumococcal disease. The per-dose difference ranged from a $40 profit to an $11 loss. A chickenpox vaccine netted some doctors $35 but cost others nearly $30 per dose.

The survey examined the cost of the vaccines and the expense of storage and related medical supplies. But it didn't look at administrative fees and staff time.

The studies did not look at the 50 percent or more of vaccinations paid for by government, which generally provides free vaccines to doctors and covers administrative fees.

In New York state, some doctors actually do better financially with the government vaccine program than they do on the private market, with the government's administrative fee double or triple what some private insurers pay. But some business-savvy doctors can still make at least a small profit on vaccines in the private market, said Lessin, who is vice president of a 24-physician pediatric practice.

Most pediatricians are likely to keep giving vaccinations to kids, partly because of altruism and partly because giving shots drives business. "For us to give up vaccines would hurt our core business because that's why kids come in," Lessin said.

But family practice doctors — who are not as dependent on vaccinations for patients — may decide the shots are too much of a financial headache, he added.

Indeed, the new studies reflected that schism: Overall 11 percent of physicians have seriously considered stopping vaccinations for privately insured patients. But 21 percent of family doctors felt that way, compared with just 5 percent of pediatricians.

The financial problem has been getting worse in recent years, as more vaccines have come on the market, experts say. Some have been unusually expensive, including Gardasil, a vaccine for girls against cervical cancer which is given in three doses over six months and is priced at about $375 for the series.

A government advisory panel studying the financial burden of vaccines is expected to submit proposals for changes in reimbursement practices to federal health officials next year.

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Swiss approve pioneering legal heroin program

GENEVA – The world's most comprehensive legalized heroin program became permanent Sunday with overwhelming approval from Swiss voters who simultaneously rejected the decriminalization of marijuana.
The heroin program, started in 1994, is offered in 23 centers across Switzerland. It has helped eliminate scenes of large groups of drug users shooting up openly in parks that marred Swiss cities in the 1980s and 1990s and is credited with reducing crime and improving the health and daily lives of addicts.
The nearly 1,300 selected addicts, who have been unhelped by other therapies, visit one of the centers twice a day to receive the carefully measured dose of heroin produced by a government-approved laboratory.
They keep their paraphernalia in cups labeled with their names and use the equipment and clean needles to inject themselves — four at a time — under the supervision of a nurse, and also receive counseling from psychiatrists and social workers.
The aim is to help the addicts learn how to function in society.
The United States and the U.N. narcotics board have criticized the program as potentially fueling drug abuse, but it has attracted attention from governments as far away as Australia and Canada, which in recent years have started or are considering their own programs modeled on the system.
The Netherlands started a smaller program in 2006, and it serves nearly 600 patients. Britain has allowed individual doctors to prescribe heroin since the 1920s, but it has been running trials similar to the Swiss approach in recent years. Belgium, Germany, Spain and Canada have been running trial programs too.
Sixty-eight percent of the 2.26 million Swiss voters casting ballots approved making the heroin program permanent.
By contrast, around 63.2 percent of voters voted against the marijuana proposal, which was based on a separate citizens' initiative to decriminalize the consumption of marijuana and growing the plant for personal use.
Olivier Borer, 35, a musician from the northern town of Solothurn, said he welcomed the outcome in part because state action was required to help heroin addicts, but he said legalizing marijuana was a bad idea.
"I think it's very important to help these people, but not to facilitate the using of drugs," Borer said. "You can just see in the Netherlands how it's going. People just go there to smoke."
Sabina Geissbuehler-Strupler of the right-wing Swiss People's Party, which led the campaign against the heroin program, said she was disappointed in the vote.
"That is only damage limitation," she said. "Ninety-five percent of the addicts are not healed from the addiction."
Health insurance pays for the bulk of the program, which costs 26 million Swiss francs ($22 million) a year. All residents in Switzerland, which has a population of 7.5 million, are required to have health insurance, with the government paying insurance premiums for those who cannot afford it.
Parliament approved the heroin measure in a revision of Switzerland's narcotics law in March, but conservatives challenged the decision and forced a national referendum under Switzerland's system of direct democracy.
Jo Lang, a Green Party member of parliament from the central city of Zug, said he was disappointed in the failure of the marijuana measure because it means 600,000 people in Switzerland will be treated as criminals because they use cannabis.
"People have died from alcohol and heroin, but not from cannabis," Lang said.
The government, which opposed the marijuana proposal, said it feared that liberalizing cannabis could cause problems with neighboring countries.
On a separate issue, 52 percent of voters approved an initiative to eliminate the statute of limitations on pornographic crimes against children before the age of puberty.
The current Swiss statute of limitations on prosecuting pedophile pornography is 15 years. The initiative will result in a change in the constitution to remove that time limit.

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Global AIDS crisis overblown? Some dare to say so

LONDON – As World AIDS Day is marked on Monday, some experts are growing more outspoken in complaining that AIDS is eating up funding at the expense of more pressing health needs. They argue that the world has entered a post-AIDS era in which the disease's spread has largely been curbed in much of the world, Africa excepted.
"AIDS is a terrible humanitarian tragedy, but it's just one of many terrible humanitarian tragedies," said Jeremy Shiffman, who studies health spending at Syracuse University.
Roger England of Health Systems Workshop, a think tank based in the Caribbean island of Grenada, goes further. He argues that UNAIDS, the U.N. agency leading the fight against the disease, has outlived its purpose and should be disbanded. "The global HIV industry is too big and out of control. We have created a monster with too many vested interests and reputations at stake, ... too many relatively well paid HIV staff in affected countries, and too many rock stars with AIDS support as a fashion accessory," he wrote in the British Medical Journal in May. Paul de Lay, a director at UNAIDS, disagrees. It's valid to question AIDS' place in the world's priorities, he says, but insists the turnaround is very recent and it would be wrong to think the epidemic is under control. "We have an epidemic that has caused between 55 million and 60 million infections," de Lay said. "To suddenly pull the rug out from underneath that would be disastrous." U.N. officials roughly estimate that about 33 million people worldwide have HIV, the virus that causes AIDS. Scientists say infections peaked in the late 1990s and are unlikely to spark big epidemics beyond Africa. In developed countries, AIDS drugs have turned the once-fatal disease into a manageable illness. England argues that closing UNAIDS would free up its $200 million annual budget for other health problems such as pneumonia, which kills more children every year than AIDS, malaria and measles combined. "By putting more money into AIDS, we are implicitly saying it's OK for more kids to die of pneumonia," England said. His comments touch on the bigger complaint: that AIDS hogs money and may damage other health programs. By 2006, AIDS funding accounted for 80 percent of all American aid for health and population issues, according to the Global Health Council. In Ethiopia, Rwanda, Uganda and elsewhere, donations for HIV projects routinely outstrip the entire national health budgets. In a 2006 report, Rwandan officials noted a "gross misallocation of resources" in health: $47 million went to HIV, $18 million went to malaria, the country's biggest killer, and $1 million went to childhood illnesses. "There needs to be a rational system for how to apportion scarce funds," said Helen Epstein, an AIDS expert who has consulted for UNICEF, the World Bank, and others. AIDS advocates say their projects do more than curb the virus; their efforts strengthen other health programs by providing basic health services. But across Africa, about 1.5 million doctors and nurses are still needed, and hospitals regularly run out of basic medicines. Experts working on other health problems struggle to attract money and attention when competing with AIDS. "Diarrhea kills five times as many kids as AIDS," said John Oldfield, executive vice president of Water Advocates, a Washington, D.C.-based organization that promotes clean water and sanitation. "Everybody talks about AIDS at cocktail parties," Oldfield said. "But nobody wants to hear about diarrhea," he said. These competing claims on public money are likely to grow louder as the world financial meltdown threatens to deplete health dollars. "We cannot afford, in this time of crisis, to squander our investments," Dr. Margaret Chan, WHO's director-general, said in a recent statement. Some experts ask whether it makes sense to have UNAIDS, WHO, UNICEF, the World Bank, the Global Fund plus countless other AIDS organizations, all serving the same cause. "I do not want to see the cause of AIDS harmed," said Shiffman of Syracuse University. But "For AIDS to crowd out other issues is ethically unjust." De Lay argues that the solution is not to reshuffle resources but to boost them. "To take money away from AIDS and give it to diarrheal diseases or onchocerciasis (river blindness) or leishmaniasis (disfiguring parasites) doesn't make any sense," he said. "We'd just be doing a worse job in everything else."
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China pledges to fight AIDS discrimination

BEIJING – Chinese health authorities and the U.N. AIDS agency pledged to fight discrimination against people with the disease in China with the unveiling Sunday of a massive red ribbon, the symbol of AIDS awareness, at the Olympic Bird's Nest stadium in Beijing.

Organizers said the fear of being stigmatized at work or in their communities is discouraging many people at risk of HIV infection from being tested. HIV is the virus that causes AIDS.

After years of denying that AIDS was a problem, Chinese leaders have shifted gears in recent years, confronting the disease more openly and promising anonymous testing, free treatment for the poor and a ban on discrimination against people with the virus.

State television Sunday showed Chinese Premier Wen Jiabao visiting a village hit particularly hard by AIDS in eastern China's Anhui province. Wen, who makes such annual visits to mark World AIDS Day, observed Monday, held hands with children orphaned by AIDS and spoke to patients in beds.

The topic, however, still remains very sensitive and authorities regularly crack down on activists and patients seeking more support and rights.

"About half of all Chinese would not want to share a meal with a person with HIV/AIDS, and a quarter would not want to shake hands," said Dr. Bernhard Schwartlander, country coordinator of UNAIDS in China. "People will not come forward to be tested. They won't benefit from treatment. They won't talk to their partners and colleagues about HIV/AIDS — putting themselves and others potentially at risk for HIV."

Schwartlander was speaking at the Bird's Nest stadium, a main Olympic venue, during the unveiling of a 66-foot by 50-foot (20-meter by 15-meter) banner on which the red AIDS awareness ribbon was printed.

"Stigma and discrimination are major obstacles in an effective response to AIDS. We need to engage all sectors of society in China to combat these issues and work together to stop the disease," said Minister of Health Chen Zhu. He did not specify any steps they would take.

Official estimates put the number of people living with HIV in China at about 700,000, with around 85,000 people with full-blown AIDS, UNAIDS said in a statement. But the number of officially reported HIV cases remains only 264,302 — far lower than the estimated total, in part because of reluctance to seek testing.

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FTC tosses guidance on tar, nicotine in cigarettes

WASHINGTON – The cigarette industry for 42 years has made factual claims about tar and nicotine levels based on machine testing blessed by the Federal Trade Commission.

Now the FTC has dropped the test, known as the Cambridge Filter Method, like a hot rock.

The commission has rescinded guidance it issued 42 years ago, saying the test method is flawed. It also said the resulting marketing touting tar and nicotine levels could cause consumers to believe that lighter cigarettes were safer.

As a result, future advertising that lists tar levels for cigarettes won't be able to use terms such as "by FTC method."

"Our action today ensures that tobacco companies may not wrap their misleading tar and nicotine ratings in a cloak of government sponsorship," said Commissioner Jon Leibowitz. "Simply put, the FTC will not be a smokescreen for tobacco companies' shameful marketing practices."

The commission rescinded the guidance by a 4-0 vote.

Under the current system, cigarettes with a tar rate above 15 milligrams per cigarette are commonly referred to by the industry as "full flavor." Cigarettes with a tar rating of less than 15 milligrams are referred to as "low" or "light." Cigarettes with a tar rate below 6 are described as "ultra low" or "ultra light."

The National Cancer Institute found that changes in cigarette design reduced the amount of tar and nicotine measured by smoking machines using the Cambridge Filter Method. However, there was no evidence those changes reduced disease for smokers. The machine doesn't take into account the way smokers adjust their behavior, such as taking more or deeper puffs to maintain nicotine levels.

"The most important aspect of this decision is that it says to consumers that tobacco industry claims relating to tar and nicotine are at best flawed and most likely misleading," said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

The commission said it originally believed in the 1960s that giving consumers uniform, standardized information about tar and nicotine yields of cigarettes would help them make informed decisions about cigarettes. At the time, most public health officials believed that reducing the amount of tar in a cigarette could reduce a smoker's risk of lung cancer. However, that premise is no longer valid.

Sen. Frank Lautenberg, D-N.J., introduced legislation this year that would prohibit companies from making claims based on data derived from the FTC's testing method, but the bill did not make it to the full Senate for a vote.

"Tobacco companies can no longer rely on the government to back up a flawed testing method that tricks smokers into thinking these cigarettes deliver less tar and nicotine," Lautenberg said.

One FTC commissioner, Pamela Jones Harbor, urged Congress to approve the regulation of tobacco by the Food and Drug Administration. The bill would authorize government scientists to track, analyze and regulate the components of cigarettes.

Tobacco companies have stated clearly over the years that there is no such thing as a safe cigarette. In a statement, Philip Morris USA, the nation's largest tobacco company, said it remains committed to working with the FTC and other federal authorities to identify and adopt testing that improves on the Cambridge method.

The FTC noted that all four major domestic cigarette makers told commissioners the 1966 guidance should be retained until a replacement test method was approved.

Philip Morris warned commissioners that elimination of the guidance could lead to a new "tar derby" in which cigarette makers would use different methods of measuring the yields in their cigarettes, thereby leading to greater consumer confusion.

___

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Federal Trade Commission: http://www.ftc.gov


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Calls for national infant formula recall spread

Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer's group and the Illinois attorney general demanding a Food and Drug Administration recall and the federal agency saying it had released inaccurate information on what chemicals were found in which top selling products.

As worried parents called manufacturers looking for guidance about the presence of melamine and a key byproduct in U.S.-made formula, the FDA reiterated its position that the baby food is safe and parents should continue feeding it to their babies, contending the extremely low levels of contamination do not present a health danger.

Also, a spokesman for one major manufacturer criticized the FDA for its release of the inaccurate information.

"We're getting inundated by calls from moms confused about the situation," said Pete Paradossi, a spokesman for Mead Johnson, one of the three major manufacturers of U.S.-made formula involved in the problem detections.

Melamine is the industrial chemical found in Chinese infant formula — in far larger concentrations — that has been blamed for killing at least three babies and making at least 50,000 others ill.

The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally as was done in Chinese production. The manufacturers insist their products are safe.

"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."

Part of the confusion Wednesday stemmed from the FDA's own statements.

While proclaiming that the very low concentrations detected of melamine and a similar compound called cyanuric acid pose no health danger to infants, the FDA has maintained it is unable to identify any exposure level of melamine in infant formula "that does not raise public health concerns."

Further complicating the situation was inaccurate data that FDA released to The Associated Press, which was first to disclose the formulas' brand names and other details in an investigative report Tuesday.

A spreadsheet the AP obtained from the FDA under a Freedom of Information Act request stated that Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron contained traces of melamine.

On Wednesday, FDA spokeswoman Judy Leon said that spreadsheet contained an error — that the FDA had incorrectly switched the names of the Mead Johnson product with Nestle's Good Start Supreme Infant Formula with Iron. That meant, Leon said, that the Nestle's Good Start had melamine while Mead Johnson's Enfamil had traces of cyanuric acid.

The FDA said last month that the toxicity of cyanuric acid is under study, but that in the meantime it is "prudent" to assume that its potency is equal to that of melamine.

Problems with melamine-spiked formula surfaced this fall in China, where unscrupulous manufacturers intentionally dumped it into watered-down milk to falsely elevate protein levels. The concentrations in China were as much as 2,500 parts per million — about 10,000 times greater than what the FDA found in the U.S.

The FDA said there have been no reports in the United States of human illness from melamine. The chemical, which legally can be used in product packaging and a solution to clean manufacturing equipment, can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.

Mead Johnson spokesman Paradossi said he was frustrated that the FDA had provided inaccurate information for worldwide distribution by the AP. He said the FDA informed his company of the test results, as well as the inaccurate disclosures only Wednesday, during an emergency conference call the agency staged with major manufacturers and the industry's trade group. During a similar call Monday, the FDA told the industry about the upcoming AP investigative report.

Nestle did not returns calls seeking comment Wednesday.

At the same time, Illinois Attorney General Lisa Madigan called on the state's public health department and the FDA to recall both the Nestle and Mead Johnson products — and urged the companies to take that step regardless of what any government agency does.

Madigan also criticized the FDA's handling of its test results.

"The agency apparently withheld the results of its testing from the public for over three weeks, and then only disclosed the information in response to a FOIA request by The Associated Press," she wrote in a letter to Michael Leavitt, the secretary of the U.S. Department of Health and Human Services, which oversees the FDA.

As for possible consideration of a recall, the FDA's Leon said: "The agency would only seek to remove a product on the basis of a risk, based on scientific evidence. That's not what we're talking about here."

Consumers Union said that the FDA's assurances are of small comfort to parents and caregivers.

"The FDA originally said there was no safe level for these contaminants in infant formula. So this formula is contaminated," said Jean Halloran, the group's director of Food Policy Initiatives. "It is very disturbing to us that no recall has been requested."

She urged the FDA "to immediately make public all of the results of its tests for melamine contamination in food," even those with levels below what would trigger agency action."

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, also has called for recalls.

During a series of calls with formula manufacturers starting Monday — put together hurriedly, according to several participants, as the AP was preparing to publish its story — the FDA has told manufacturers it has taken 230 samples of various products, including pediatric supplements and ingredients used in infant formula. Leon said that 87 of those samples are of infant formula, and that 77 of those have been analyzed.

Under the corrected information she relayed Wednesday, the results were:

• Nestle's Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample, with readings of 0.137 and 0.14 parts per million.

• Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests for cyanuric acid, at an average of 0.247 parts per million.

Separately, a third major formula maker — Abbott Laboratories, whose brands include Similac — told AP that in-house tests had detected trace levels of melamine in its infant formula. Those levels were below what FDA found in the other formulas, an Abbott spokesman said, and below any nation's safety guidelines.

The three firms — Abbott Laboratories, Nestle and Mead Johnson — manufacture more than 90 percent of all infant formula produced in the United States.

___

Associated Press Writer Ricardo Alonso-Zaldivar contributed to this report from Washington, D.C.

___

On the Net:

The FDA's melamine guidance: http://www.fda.gov/oc/opacom/hottopics/melamine.html


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Brain scans show root of memory glitch with aging

NEW YORK – Brain scans of older people in a noisy lab machine give biological backing to the idea that distraction hampers memory with aging, researchers reported Wednesday.

The finding bolsters a theory about one reason why memory weakens with age: older people have more trouble remembering some things because they're more easily distracted when they try to learn them.

The memory exercise reported in the latest issue of the Journal of Neuroscience dealt with recognizing faces, but the findings apply to the more general task of trying to remember something a person sees or hears, said lead author Dale Stevens.

Stevens, a postdoctoral researcher at Harvard University, did the work while at the Rotman Research Institute at Baycrest, which is affiliated with the University of Toronto.

Older people who have to learn something should do all they can to focus on that task and eliminate potential distractions, he advised.

The study compared 10 healthy people in their 60s and 70s to a dozen younger volunteers, ages 22 to 36. Their brains were scanned while they looked at photographs of people they did not know. As each photograph was displayed for one second, the volunteers were asked if they'd seen it before in the study.

In all they saw 180 different faces, of which 120 showed up a second time. The older participants failed to recognize a face they'd already seen 43 percent of the time, compared to 26 percent for the younger volunteers.

Researchers went back to see what was going on in the brains of the volunteers when they first saw a face that they later failed to recognize. Why didn't those faces get planted in memory?

In both groups, a brain area called the hippocampus, which is involved in memory, was less active when a face failed to stick in the memory than when it did. That was no surprise. More interestingly, the older group also showed heightened activity in certain other brain areas while the younger volunteers did not.

Those areas included the auditory cortex, which plays a role in analyzing sound, and several areas involved in directing attention, Stevens said.

So what was going on? The brain-scanning machine was noisy, with lots of knocking, buzzing and banging like a jackhammer, Stevens said. Even with the earplugs the volunteers wore, "it's a little distracting," he said.

The brain activity in the older volunteers shows that the noise was more distracting to them than to the younger participants, and reveals the brain circuits involved, researchers concluded.

The study could not address when a person's brain starts to act up this way. But Cheryl Grady of the Rotman institute, another author, said she suspects it may begin between ages 40 and 60.

Dr. Barry Gordon, a neurology professor and memory expert at The Johns Hopkins Medical Institutions in Baltimore, called the work "an appreciable advance." A next step could be seeing whether older people will do better on a memory test if they're warned about the distraction problem, said Gordon, who wasn't involved in the new study.

In any case, he said, "if you want to remember something, it's more important if you're older than younger not to be listening to your iPod."

___

On the Net:

The Journal of Neuroscience: http://www.jneurosci.org/

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Plumes spewing from Saturn moon may contain water

WASHINGTON – Astronomers looking at the spectacular supersonic plumes of gas and dust shooting off one of Saturn's moons say there are strong hints of liquid water, a key building block of life.

Their research, appearing in Thursday's issue of the journal Nature, adds to the growing push to explore further the moon Enceladus, as one of the solar system's most compelling places for potential life.

Using images from NASA's Cassini probe, astronomers had already figured that the mysterious plumes shooting from Enceladus' icy terrain contain water vapor. New calculations suggesting the gas and dust spew at speeds faster-than-sound make the case for liquid, said study lead author Candice Hansen of NASA's Jet Propulsion Lab in California. Her team calculated the plumes travel more than 1,360 mph.

Reaching that speed "is hard to do without liquids," Hansen said. While her paper offers more evidence building on what others have found, she added that her research is not the final proof of liquid water on Enceladus (pronounced en-SELL-ah-dus).

Other planetary scientists, such as Andrew Ingersoll at the California Institute of Technology, said the research is good, but that it is possible to achieve such speeds with ice particles and at cooler temperatures. So Hansen hasn't proven her case yet, he and other scientists said.

Carolyn Porco, the head of the Cassini camera team and an astronomer who didn't take part in Hansen's research, said "the evidence in my mind is building on liquid water." That moon, one of 60 circling Saturn, "has become the go-to place" for exploration in the outer planets, she said.

Europa, a moon of Jupiter, may have a liquid ocean beneath its frozen surface. But Enceladus, thought responsible for producing one of Saturn's rings, is more accessible, Hansen said. "Enceladus is sort of helpfully spewing out its innards," she said.

___

On the Net:

Nature: http://www.nature.com/nature

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Calls for national infant formula recall spread

Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer's group and the Illinois attorney general demanding a Food and Drug Administration recall and the federal agency saying it had released inaccurate information on what chemicals were found in which top selling products.

As worried parents called manufacturers looking for guidance about the presence of melamine and a key byproduct in U.S.-made formula, the FDA reiterated its position that the baby food is safe and parents should continue feeding it to their babies, contending the extremely low levels of contamination do not present a health danger.

Also, a spokesman for one major manufacturer criticized the FDA for its release of the inaccurate information.

"We're getting inundated by calls from moms confused about the situation," said Pete Paradossi, a spokesman for Mead Johnson, one of the three major manufacturers of U.S.-made formula involved in the problem detections.

Melamine is the industrial chemical found in Chinese infant formula — in far larger concentrations — that has been blamed for killing at least three babies and making at least 50,000 others ill.

The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally as was done in Chinese production. The manufacturers insist their products are safe.

"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."

Part of the confusion Wednesday stemmed from the FDA's own statements.

While proclaiming that the very low concentrations detected of melamine and a similar compound called cyanuric acid pose no health danger to infants, the FDA has maintained it is unable to identify any exposure level of melamine in infant formula "that does not raise public health concerns."

Further complicating the situation was inaccurate data that FDA released to The Associated Press, which was first to disclose the formulas' brand names and other details in an investigative report Tuesday.

A spreadsheet the AP obtained from the FDA under a Freedom of Information Act request stated that Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron contained traces of melamine.

On Wednesday, FDA spokeswoman Judy Leon said that spreadsheet contained an error — that the FDA had incorrectly switched the names of the Mead Johnson product with Nestle's Good Start Supreme Infant Formula with Iron. That meant, Leon said, that the Nestle's Good Start had melamine while Mead Johnson's Enfamil had traces of cyanuric acid.

The FDA said last month that the toxicity of cyanuric acid is under study, but that in the meantime it is "prudent" to assume that its potency is equal to that of melamine.

Problems with melamine-spiked formula surfaced this fall in China, where unscrupulous manufacturers intentionally dumped it into watered-down milk to falsely elevate protein levels. The concentrations in China were as much as 2,500 parts per million — about 10,000 times greater than what the FDA found in the U.S.

The FDA said there have been no reports in the United States of human illness from melamine. The chemical, which legally can be used in product packaging and a solution to clean manufacturing equipment, can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.

Mead Johnson spokesman Paradossi said he was frustrated that the FDA had provided inaccurate information for worldwide distribution by the AP. He said the FDA informed his company of the test results, as well as the inaccurate disclosures only Wednesday, during an emergency conference call the agency staged with major manufacturers and the industry's trade group. During a similar call Monday, the FDA told the industry about the upcoming AP investigative report.

Nestle did not returns calls seeking comment Wednesday.

At the same time, Illinois Attorney General Lisa Madigan called on the state's public health department and the FDA to recall both the Nestle and Mead Johnson products — and urged the companies to take that step regardless of what any government agency does.

Madigan also criticized the FDA's handling of its test results.

"The agency apparently withheld the results of its testing from the public for over three weeks, and then only disclosed the information in response to a FOIA request by The Associated Press," she wrote in a letter to Michael Leavitt, the secretary of the U.S. Department of Health and Human Services, which oversees the FDA.

As for possible consideration of a recall, the FDA's Leon said: "The agency would only seek to remove a product on the basis of a risk, based on scientific evidence. That's not what we're talking about here."

Consumers Union said that the FDA's assurances are of small comfort to parents and caregivers.

"The FDA originally said there was no safe level for these contaminants in infant formula. So this formula is contaminated," said Jean Halloran, the group's director of Food Policy Initiatives. "It is very disturbing to us that no recall has been requested."

She urged the FDA "to immediately make public all of the results of its tests for melamine contamination in food," even those with levels below what would trigger agency action."

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, also has called for recalls.

During a series of calls with formula manufacturers starting Monday — put together hurriedly, according to several participants, as the AP was preparing to publish its story — the FDA has told manufacturers it has taken 230 samples of various products, including pediatric supplements and ingredients used in infant formula. Leon said that 87 of those samples are of infant formula, and that 77 of those have been analyzed.

Under the corrected information she relayed Wednesday, the results were:

• Nestle's Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample, with readings of 0.137 and 0.14 parts per million.

• Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests for cyanuric acid, at an average of 0.247 parts per million.

Separately, a third major formula maker — Abbott Laboratories, whose brands include Similac — told AP that in-house tests had detected trace levels of melamine in its infant formula. Those levels were below what FDA found in the other formulas, an Abbott spokesman said, and below any nation's safety guidelines.

The three firms — Abbott Laboratories, Nestle and Mead Johnson — manufacture more than 90 percent of all infant formula produced in the United States.

___

Associated Press Writer Ricardo Alonso-Zaldivar contributed to this report from Washington, D.C.

___

On the Net:

The FDA's melamine guidance: http://www.fda.gov/oc/opacom/hottopics/melamine.html.

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Patient-led drug trials defy medical establishment

CLAREMONT, Calif. – Until last year, Alan Felzer was an energetic engineering professor who took the stairs to his classes two steps at a time. Now the 64-year-old grandfather sits strapped to a wheelchair, able to move little but his left hand, his voice a near-whisper.

Felzer suffers from ALS, also known as Lou Gehrig's disease. The fatal neurological disorder steals the body's ability to move, speak and ultimately to breathe. But rather than succumb to despair along with his illness, Felzer turned to the Web to become his own medical researcher — and his own guinea pig.

Dozens of ALS patients are testing treatments on their own without waiting on the slow pace of medical research. They are part of an emerging group of patients willing to share intimate health details on the Web in hopes of making their own medical discoveries.

Some doctors caution that such patient-led research lacks rigor and may lead to unreliable results, false hopes and harm to patients.

"The Internet is a wonderful tool, but you know, it's buyer beware," said Dr. Edward Langston, immediate past chairman of the American Medical Association's board.

In Felzer's case, the experiment's results illustrate the obstacles that stand between patients and self-discovered breakthroughs. The drug he tried did no good. But he and his family felt they had little time and little to lose in trying.

"ALS is such a short illness," said Felzer's wife, Laura. She helps her husband communicate using sign language with his one good hand when his slow, halting words become difficult to understand. "You want to do what you can as fast as you can."

The U.S. Food and Drug Administration has approved only one drug to treat ALS symptoms. It only works for some patients, and its effects are limited. As a result, Internet forums for ALS patients brim with links to the latest research offering any hint of promise. After Alan Felzer was diagnosed last year, his 33-year-old daughter, Karen, dived into the forums and found new hope.

In a recent small study, Italian scientists reported that every ALS patient given the drug lithium, commonly used to treat bipolar disorder, saw the disease's progress slow substantially.

Many ALS patients began trying lithium on their own. They persuaded their doctors to prescribe it "off-label" — a use not approved by federal drug regulators. Off-label prescribing is a common practice, researchers say, when patients are facing a terminal illness.

Despite the risks, Langston of the AMA pointed out that doctors often stumble upon treatments, and patients could possibly do the same. "If patients are willing to share their experiences, that may in fact occur," he said.

Felzer began taking lithium in January, and his scientifically minded family reached out to other ALS patients. "All those people are taking it anyway," said Alan Felzer, whose smile remains bright and his gaze sharp even as the rest of his body fails him. "So it only made sense to keep track of what was happening."

The task of leading the ALS-lithium project fell to Felzer's daughter, Karen, a U.S. Geological Survey earthquake researcher. Her partner in the effort was Humberto Macedo, a 42-year-old computer systems analyst, father of six and ALS patient in Brasilia, Brazil.

The study grew naturally out of the strong reliance of ALS patients on one another for information, Macedo said.

Working online, Karen Felzer and Macedo recruited nearly 200 patients worldwide to take a specific lithium dosage and answer standard surveys to gauge their symptoms. They began running their study through a Web site called PatientsLikeMe.com, using it to attract volunteers and track their progress.

On the site, patients share detailed information about their symptoms and the drugs they are taking. The site focuses on conditions that have stubbornly resisted medical science, such as ALS, Parkinson's and multiple sclerosis.

The site's founders hope professional and amateur researchers alike will dip into the resulting pool of data and emerge with insights that lead to better treatments.

"My ultimate frustration that drove this site into existence was an overall feeling that there was a lack of transparency and speed or urgency" by the medical system, said Jamie Heywood, who co-founded PatientsLikeMe months before his own brother died of ALS.

Heywood too hoped that lithium was the breakthrough he and others had been seeking.

But after six months, none of the 87 people who stuck with the study showed any letup in the disease's progress, said Karen Felzer. She now doubts the Italian study's results.

"It's obvious to everyone it's not the miracle drug we thought at first," she said. She also thinks other tests of lithium for ALS should be halted to spare patients the drug's possible side effects, such as tremors, weakness and difficulty breathing. Her father stopped taking the drug, though Macedo is continuing.

However, other reseachers say professional lithium studies should go forward. Dr. Merit Cudkowicz, a Harvard Medical School professor, is set to begin one in December with 84 patients. Her study will stick to the so-called gold standard of research, in which each patient will be randomly chosen to take the drug in question or a placebo. Neither patients or researchers will know who got the drug to avoid introducing bias.

Because the patient-led lithium study lacked those tight controls, it is unreliable as a measure of safety and effectiveness, Cudkowicz said. With an incurable disease, she said, "You don't want to be throwing something away that works because of a bad study."

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