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.

___

On the Net:

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.

___

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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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FDA finds traces of melamine in US infant formula

Traces of the industrial chemical melamine have been detected in samples of top-selling U.S. infant formula, but federal regulators insist the products are safe. The Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, but a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it.

"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."

Melamine is the 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.

Previously undisclosed tests, obtained by The Associated Press under the Freedom of Information Act, show that the FDA has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.

Separately, a third major formula maker told AP that in-house tests had detected trace levels of melamine in its infant formula.

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

The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally.

The U.S. government quietly began testing domestically produced infant formula in September, soon after problems with melamine-spiked formula surfaced in China.

Sundlof said there have been no reports of human illness in the United States from melamine, which can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.

Melamine is used in some U.S. plastic food packaging and can rub off onto what we eat; it's also contained in a cleaning solution used on some food processing equipment and can leach into the products being prepared.

Sundlof told the AP the positive test results "so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine."

That's different from the impression of zero tolerance the agency left on Oct. 3, when it stated: "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns."

FDA scientists said then that they couldn't set an acceptable level of melamine exposure in infant formula because science hadn't had enough time to understand the chemical's effects on infants' underdeveloped kidneys. Plus, there is the complicating factor that infant formula often constitutes a newborn's entire diet.

The agency added, however, that its position did not mean that any exposure to a detectable level of melamine and melamine-related compounds in infant formula would result in harm to infants.

Still, the announcement was widely interpreted by manufacturers, the news media and Congress to mean that infant formula that tested positive at any level could not be sold in the United States.

The Grocery Manufacturers Association, for example, told its members: "FDA could not identify a safe level for melamine and related compounds in infant formula; thus it can be concluded they will not accept any detectable melamine in infant formula."

It was not until the AP inquired about tests on domestic formula that the FDA articulated that while it couldn't set a safe exposure for infants, it would accept some melamine in formula — raising the question of whether the decision to accept very low concentrations was made only after traces were detected.

On Sunday, Sundlof said the agency had never said, nor implied, that domestic infant formula was going to be entirely free of melamine. He said he didn't know if the agency's statements on infant formula had been misinterpreted.

In China, melamine was intentionally dumped into watered-down milk to trick food quality tests into showing higher protein levels than actually existed. Byproducts of the milk ended up in infant formula, coffee creamers, even biscuits.

The concentrations of melamine there were extraordinarily high, as much as 2,500 parts per million. The concentrations detected in the FDA samples were 10,000 times smaller — the equivalent of a drop in a 64-gallon trash bin.

There would be no economic advantage to spiking U.S.-made formula at the extremely low levels found in the FDA testing. It neither raises the protein count nor saves valuable protein, said University of California, Davis chemist Michael Filigenzi, a melamine detection expert.

According to FDA data for tests of 77 infant formula samples, a trace concentration of melamine was detected in one product — Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron. An FDA spreadsheet shows two tests were conducted on the Enfamil, with readings of 0.137 and 0.14 parts per million.

Three tests of Nestle's Good Start Supreme Infant Formula with Iron detected an average of 0.247 parts per million of cyanuric acid, a melamine byproduct.

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

And while the FDA said tests of 18 samples of formula made by Abbott Laboratories, including its Similac brand, did not detect melamine, spokesman Colin McBean said some company tests did find the chemical. He did not identify the specific product or the number of positive tests.

McBean did say the detections were at levels far below the health limits set by all countries in the world, including Taiwan, where the limit is 0.05 parts per million.

"We're talking about trace amounts right here, and you know there's a lot of scientific bodies out there that say low levels of melamine are always present in certain types of foods," said McBean.

Mead Johnson spokeswoman Gail Wood said her company's in-house tests had not detected any melamine, and that the company had not been informed of the FDA test results, even during a confidential agency conference call Monday with infant formula makers about melamine contamination.

The FDA tests also detected melamine in two samples of nutritional supplements for very sick children who have trouble digesting regular food. Nestle's Peptamen Junior medical food showed 0.201 and 0.206 parts per million of melamine while Nestle's Nutren Junior-Fiber showed 0.16 and 0.184 parts per million.

The agency said that while there are no established exposure levels for infant formula, pediatric medical food — often used in feeding tubes for very sick, young children — can have 2.5 parts per million of melamine, just like food products other than infant formula.

The head of manufacturing for Nestle Nutrition in North America, Walter Huber, said in an interview that the company took samples alongside FDA officials who visited a manufacturing plant, and that those samples showed similar results to what FDA found for the two pediatric medical foods. Huber added that Nestle didn't fund cyanuric acid in any of the samples.

The FDA shared its results with Nestle a few weeks ago, Huber said. He said he wasn't sure whether Nestle had tested other of its products beyond what it did related to the FDA.

Rep. Rosa DeLauro, D-Conn., who heads a panel that oversees the FDA budget, said the agency was taking a "marketplace first, science last" approach.

"The FDA should be insisting on a zero-tolerance policy for melamine in domestic infant formula until it is able to determine conclusively based on sound independent science that the trace levels would not pose a health risk to infants," DeLauro said.

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, said: "If no safe level of melamine has been established for consumption by children, then the FDA should immediately recall any formula that has tested positive for even trace amounts of the contaminant."

Several medical experts said trace concentrations would be diluted even in an infant, and are highly unlikely to be harmful.

"It's just a tiny amount, it's very unlikely to cause stones," said Stanford University Medical School pediatrics professor Dr. Paul Grimm.

Dr. Jerome Paulson, an associate professor of pediatrics at Children's National Medical Center in Washington, D.C., said he didn't think the FDA's decision was unreasonable. He added, however, that the agency should research the impacts of long-term, low-dose exposure, "and not just assume it's safe, and then 15 years from now find out that it's not."

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On the Net:

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

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Germ alert: Steer clear of flatbed chicken trucks

ATLANTA – You've heard about the chicken that crossed the road. But have you heard the one about the chickens traveling down the road? It's no laughing matter. Crates of chickens being trucked along the highway in the back of an open truck can shoot a bunch of nasty bacteria into the cars behind them, researchers have found.

Drivers stuck behind such a truck should "pass them quickly," advised study co-author Ana Rule, a researcher at Johns Hopkins University.

Even so, it's not clear that germy debris will make you sick. None of the scientists who studied this problem got sick. And the disease-causing bacteria in question are normally spread by food or water, not air.

Rule and her colleagues at the Bloomberg School of Public Health focused on the so-called Delmarva Peninsula, a coastal area that includes parts of Delaware, Maryland and Virginia. The region is a chicken mecca, with one of the highest concentrations of broiler chickens per acre in the nation.

The researchers chose a 17-mile stretch of highway connecting chicken farms in Maryland to a processing plant to the south in Accomac, Va. They rode in four-door cars with all the windows down and the air conditioning off.

They checked the cars for bacteria after driving when there were no chicken trucks around. And they checked for bacteria after 10 trips behind flatbed trucks carrying crates of broiler chickens.

They collected bacteria from air samples, door handles and soda cans inside the car.

In all the truck chases, they found high levels of certain bacteria, including some that are resistant to antibiotics.

The study, released this week, is being published in the first issue of the Journal of Infection and Public Health, and it's billed as the first to look at whether poultry trucking exposes people to antibiotic-resistant bacteria.

It was a casual conversation that inspired the effort.

"Somebody said, 'I went to the beach the other day and I got stuck behind a chicken truck, and boy, is that nasty,'" Rule said.

She said studies to determine if chicken trucks can make you sick are somewhere down the road.

Dr. Keith Klugman, an Emory University epidemiologist who was not involved in the research, said getting sick that way is unlikely. Most healthy people don't suffer serious illness from these bacteria even when exposed in more conventional ways.

"It was kind of an unnatural experiment, in that people were driving behind these trucks with the windows open and the air conditioning off — for 17 miles," he added. "If you were driving behind a truck that was spewing stuff out the back of it, the first thing you would probably do is close your windows."

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On the Net:

Journal of Infection and Public Health: http://www.elsevier.com/locate/jiph

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Encouraging dip in rate of new cancers, deaths

WASHINGTON – The rate of new cancer cases finally may be inching down — cautiously optimistic news but a gain that specialists worry could be derailed by economic turmoil. Death rates from cancer have been dropping slowly for years, thanks to earlier detection and better treatments. But preventing cancer is the ultimate goal, and Tuesday's annual "Report to the Nation" on cancer also shows a small but encouraging change: The rate of new diagnoses among men dropped 1.8 percent a year between 2001 and 2005.

For women, the dip was just over half a percent a year.

Also, the cancer death rate among men and women continued to drop, by an average of 1.8 percent a year through 2005, said the report published in the Journal of the National Cancer Institute.

The improvements are due to gains against some leading cancers — prostate, colorectal, breast and, for men, lung cancer. But numerous other types still are on the rise, including melanoma and kidney cancer.

Also, Tuesday's report highlights a disappointing missed opportunity: Huge state-by-state variations in anti-smoking policies that translate into big differences in lung cancer. Men in Kentucky die from lung cancer at twice the rate of men in California, for example. California, through higher cigarette taxes and other steps, has logged a 2.8 percent a year decline in that death rate, compared with less than a percent a year for Kentucky.

Nor is it clear that the drop in new cases represents a true decrease in cancer, or if some may be due to people skipping screenings that would have caught brewing disease, cautioned American Cancer Society epidemiologist Ahmedin Jemal, who led the report along with government scientists.

But NCI Director Dr. John Niederhuber said the decline seems steady enough to be real, a feat considering that cancer risk jumps with age and the U.S. is rapidly graying.

"This really is quite significant," Niederhuber said. "Some of the things we're doing, we're doing right."

Still, experts questioned if the good trends can survive the bad economy. Consider: The report credits a drop in colorectal cancer to a big increase in colonoscopies between 2000 and 2005. That screening can detect precancerous growths in time to remove them and avoid cancer — if people have insurance that pays.

Already the NCI has had a below-inflation budget for several years, cutting investment in research to prevent and treat cancer.

"I've had to find about $175 million to take out of our budget, just take it out," said Niederhuber. "It's hard to keep momentum. ... We're chipping away at the bone."

More recent rises in unemployment and poverty add to the concern, warned Dr. Louis Weiner, director of Georgetown University's Lombardi Comprehensive Cancer Center.

"We've had some hard-won gains," Weiner said. "To slow down progress when we're so close to a fundamental understanding of cancer biology that we need to really made advances is really tragic."

Among the report's other findings:

_New cases of lung cancer dropped about 1.8 percent a year among men but kept rising among women, about half a percent a year. That's because smoking rates fell for men before they did for women, so men reaped the benefits sooner. It remains the top cancer killer, but the death rate dropped 1.9 percent a year for men and 0.9 percent among women.

_The rate of new breast cancer dropped about 2.2 percent a year, due largely to millions of women abandoning hormone replacement therapy starting around 2002. The death rate dropped 1.8 percent a year.

_For colorectal cancer, the incidence rate dropped 2.8 percent a year among men and 2.2 percent among women, largely due to screening. Early detection and improved care also fueled a 4.3 percent a year drop in the death rate for both sexes.

_Prostate cancer turned a corner, with the incidence rate dropping 4.4 percent a year between 2001 and 2005 after rising in previous years. The change probably reflects a leveling of prostate screening that had surged in the late 1990s.

_Melanoma, the deadliest skin cancer, jumped 7.7 percent a year among men and by nearly 3 percent a year among women.

_Kidney cancer incidence is rising about 2 percent a year for both sexes.

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Livers go to sickest, access for blacks improves

CHICAGO – Blacks waiting for a liver transplant used to be more likely to die compared to whites. Now they have the same chance of getting a life-saving organ under a nationwide system that puts the sickest patients first, a new study found.

Racial differences disappeared when the old system was scrapped in 2002, according to the federally funded study, the first assessment of how blacks fared after the change.

"By design, we tried to make it race blind. It looks like we did," said Dr. Richard Freeman, a transplant surgeon at Tufts University School of Medicine in Boston, who helped create the new system and was not involved in the study.

But the research, in Wednesday's Journal of the American Medical Association, suggests the system may favor men over women. Dr. Cynthia Moylan, the study's lead author and a transplant fellow at Duke University Medical Center in Durham, N.C., called for more research on gender differences.

The nation faces a serious shortage of livers from deceased donors, with nearly 16,000 people now waiting. About 6,500 liver transplants were performed last year, but 1,602 people died waiting for a new one.

Under the old system, which relied heavily on how long a patient spent on an official waiting list, sicker patients were passed over in favor of those waiting longer.

The system favored whites because blacks join waiting lists when they are sicker. Why isn't clear, but blacks may get treatment later or have poor access to liver specialists.

Compared to whites, blacks on the waiting list had a 50 percent greater chance of dying or becoming too sick for transplant within three years, according to an analysis of five years of transplant records before the change. After the new system, called Model for End-Stage Liver Disease, or MELD, that difference disappeared.

The new system is based on three lab tests. Results are combined as a score that predicts a patient's risk of death within three months. Livers are allocated based on scores.

The change was made after the government ordered the United Network for Organ Sharing, which runs the transplant network, to make liver allocation less arbitrary.

Prior research has also found racial disparities in the allocation of kidneys. UNOS is currently evaluating its system for kidneys, which is now based on waiting time, blood type and tissue type.

North Carolina resident Sharon Dickens, 40, who is black, received a new liver in 2004 after five years on the waiting list. She suffered from a rare disease that blocks the bile ducts; transplant is the only cure.

Dickens wonders whether her transplant might have come sooner if the new system were in place in 1999 when she joined the waiting list. If so, she would have spent less time at home sick in bed.

"I lost a lot of weight. I couldn't eat. My eyes were yellow. I had pain in my abdomen," said Dickens of Scotland Neck, N.C. "Now I have a lot of energy. I can go to college and do something with my life."

The research compared adults on the waiting list during two periods: nearly 22,000 patients before the new system and nearly 24,000 patients after the scores were used. They took into account other risk factors for dying while on the waiting list.

Before the change, 810 blacks, or 49 percent of those on the waiting list, got transplants. Meanwhile, 10,202 whites, or 52 percent of those on the list, got transplants.

In the years after the change, 849 blacks, or 47 percent, got transplants compared to 8,492 whites, or 42 percent.

For women, MELD wasn't an improvement. The study found women had a 30 percent greater chance of dying or becoming too sick for transplant with the new scoring system. The gender difference wasn't significant before.

One of the lab tests in the score may underestimate the severity of illness in women because of their smaller average size, said Dr. David Axelrod of Dartmouth-Hitchcock Medical Center in Lebanon, N.H., who was not involved in the study, but wrote an accompanying editorial.

"With a relatively minimal change we can deal with that," Axelrod said, suggesting a different weight-adjusted measurement.

Earlier research showed MELD improved waiting list death rates overall without hurting post-transplant survival. The average wait time for a liver in 2006 was 16 months, according to the organ network.

Regional differences in waiting list times are still a big problem, said Dr. J. Michael Millis, head of transplantation at University of Chicago Medical Center. Donated organs are generally offered to local patients first. Some states with greater demand for organs have longer wait times.

"In Wisconsin, waiting time is approximately half that in Chicago 90 miles away," Millis said. "There's no rational way to justify that."

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On the Net:

JAMA: http://jama.ama-assn.org

United Network for Organ Sharing: http://www.unos.org/

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AP IMPACT: Govt pays millions for unapproved drugs

WASHINGTON – Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found. Millions of private patients are taking such drugs, as well.

The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.

The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.

The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold. The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market.

Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid — which may be the biggest purchaser — keeps paying.

"I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program — to make sure we are getting the right set of services for beneficiaries."

At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.

Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.

That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private insurance plans also cover them.

The roots of the problem go back in time, tangled in layers of legalese.

It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were "grandfathered" under earlier laws, and even under the 1962 bill.

Then, in the early 1980s, a safety scandal erupted over one of those medications. E-Ferol, a high potency vitamin E injection, was linked to serious reactions in some 100 premature babies, 40 of whom died.

In response, the FDA started a program to weed out drugs it had never reviewed scientifically. Yet some medications continued to escape scrutiny.

Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive a toxic dose leading to complications such as organ failure.

Critics say the FDA's case-by-case enforcement approach is not working.

"The FDA does not appear to have a systematic mechanism to report these drugs out," said Jon Glaudemans, senior vice president of Avalere Health, a health care industry information company, "and there doesn't seem to be a systematic process by which health insurance programs can validate their status. And everyone is pointing the finger at someone else as to why we can't get there."

In most cases, doctors, pharmacists and patients are not aware the drugs are unapproved.

"Over the years, they have become fully entrenched in the system," said Patti Manolakis, a Charlotte, N.C., pharmacist who has studied the issue. Only a few unapproved drugs are truly essential and should remain on the market, she added.

Tackling the problem is made harder by confusing — and sometimes conflicting — laws, regulations and responsibilities that pertain to different government agencies.

Medicaid officials said their program, which serves the poor and disabled, is allowed to pay for unapproved drugs until the FDA orders a specific medication off the market. But that can take years.

Compare that with Medicare, the health care program for older people.

Medicare's prescription program is not supposed to cover unapproved drugs. Medicare has purged hundreds of such medications from its coverage lists, but continues to find others.

It might be easier to sort things out if the FDA compiled a master list of unapproved drugs, but the agency hasn't. FDA officials say that would be difficult because many manufacturers do not list unapproved products with the agency. Yet, the AP found many that were listed — a possible starting point for a list.

Among the drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant, and ICAR Prenatal, a vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed products from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist products, and $900,000 for ICAR.

Grassley said the system is failing taxpayers and consumers.

"The problem I see is bureaucrats don't want to make a decision," Grassley said. "There is no reason why this should be such a house of mirrors when so much public money is being spent." Grassley is considering introducing legislation to ensure that consumers are told when a medication is unapproved.

FDA officials say they tell Medicaid and Medicare when the agency moves to ban an unapproved drug, so the programs can stop paying.

"The situation is complicated by the fact that Medicaid and Medicare have a different regulatory regime than FDA does," said FDA compliance lawyer Michael Levy. "There are products that we may consider to be illegally marketed that could be legally reimbursed under their law."

The FDA began its latest crackdown on unapproved drugs two years ago and has taken action against nine types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars' worth of medications. But federal law does not provide fines for selling unapproved drugs, and criminal prosecutions are rare.

Some manufacturers of unapproved drugs say their products predate FDA regulation and are "grandfathered in."

"These are drugs that don't require an FDA approval," said Bill Peters, chief financial officer of Hi-Tech Pharmacal in Amityville, N.Y. "These are products with active ingredients that have been on the market for a long time." The company is moving away from older products, Peters said, and its new market offerings are FDA-approved.

Levy said the FDA is skeptical that any drugs now being sold are entitled to "grandfather" status. To qualify, they would have to be identical to medications sold decades ago in formulation and other important aspects.

The agency is targeting drugs linked to fraud, ones that do not work and, above all, those with safety risks. While the crackdown has helped, it does not appear to have solved the problem.

The gout drug banned by the FDA this February is not the only recent case involving safety problems.

Last year, the FDA banned unapproved cough medicines containing hydrocodone, a potent narcotic. Some had directions for medicating children as young as age 2, although no hydrocodone cough products have been shown to be safe and effective for children under 6.

In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators banned all products that contained carbinoxamine in combination with other cold medicines.

"We as Americans have a belief that all the prescription drugs that are available to us have been reviewed and approved by the FDA," said Manolakis, the pharmacist. "I think the presence of these drugs shows we have a false sense of security."

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On the Net:

FDA's unapproved drugs page: http://tinyurl.com/4tv2sb

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Pill as good as chemo on lung cancer, but costlier

LONDON – Some advanced lung cancer patients already treated with chemotherapy might be able to skip some of the bad side effects of another series of chemo by taking a pill instead, a study suggests. An international study showed patients on Iressa, an expensive, newer targeted treatment, survived about as long as those on another course of chemotherapy.

"This will provide us with another drug in our armory," said Dr. Michael Seckl, head of Cancer Research UK's Lung Cancer Group at Imperial College in London. Seckl was not connected to the research, which was published Friday in the Lancet medical journal.

Few treatments for lung cancer exist, and most patients die within a few years of diagnosis. Lung cancer kills about 1.4 million people every year.

Iressa, made by AstraZeneca PLC, is one of several new targeted drugs that attack specific growth receptors on cancer cells, doing less harm to patients. But Iressa costs thousands of dollars every month, much more than standard chemotherapy.

It is sold in the United States, but is not licensed in Europe, although it has been available on a limited compassionate use basis.

Two other lung cancer drugs, Tarceva and Avastin, made by Roche Holding AG, are already on the market in the United Kingdom, and Tarceva works similarly to Iressa.

In the study, paid for by AstraZeneca, researchers studied 1,433 advanced lung cancer patients in 24 countries, who had already gone through chemotherapy. Roughly half were given Iressa, or gefitinib, once a day. The other half were on docetaxel, a chemotherapy drug given intravenously every three weeks.

Patients on Iressa survived about 7.6 months while those on chemotherapy survived about 8 months. After one year, 32 percent of patients on Iressa were still alive, versus 34 percent of chemotherapy patients.

The most common side effects in Iressa patients were rash, acne and diarrhea. The patients on chemo most often suffered from fatigue, a higher risk for infections, and hair loss.

In the U.S., Iressa is approved for use in patients who failed chemotherapy. The drug tends to work better in patients who have never smoked, Asians, women and those with a certain genetic profile.

"In the patients that respond, it is very dramatic," said Seckl, who has seen patients live years on the drug. He did not work with AstraZeneca on Iressa, but has consulted with them on other drugs.

"Though the benefits of prolonging life are modest, patients on (Iressa) get a higher quality of life," said Chris Twelves, a professor of clinical cancer oncology at Leeds University. "That should swing the pendulum in its favor."

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Teen lives 4 months with no heart, leaves hospital

MIAMI – D'Zhana Simmons says she felt like a "fake person" for 118 days when she had no heart beating in her chest. "But I know that I really was here," the 14-year-old said, "and I did live without a heart."

As she was being released Wednesday from a Miami hospital, the shy teen seemed in awe of what she's endured. Since July, she's had two heart transplants and survived with artificial heart pumps — but no heart — for four months between the transplants.

Last spring D'Zhana and her parents learned she had an enlarged heart that was too weak to sufficiently pump blood. They traveled from their home in Clinton, S.C. to Holtz Children's Hospital in Miami for a heart transplant.

But her new heart didn't work properly and could have ruptured so surgeons removed it two days later.

And they did something unusual, especially for a young patient: They replaced the heart with a pair of artificial pumping devices that kept blood flowing through her body until she could have a second transplant.

Dr. Peter Wearden, a cardiothoracic surgeon at Children's Hospital of Pittsburgh who works with the kind of pumps used in this case, said what the Miami medical team managed to do "is a big deal."

"For (more than) 100 days, there was no heart in this girl's body? That is pretty amazing," Wearden said.

The pumps, ventricular assist devices, are typically used with a heart still in place to help the chambers circulate blood. With D'Zhana's heart removed, doctors at Holtz Children's Hospital crafted substitute heart chambers using a fabric and connected these to the two pumps.

Although artificial hearts have been approved for adults, none has been federally approved for use in children. In general, there are fewer options for pediatric patients. That's because it's rarer for them to have these life-threatening conditions, so companies don't invest as much into technology that could help them, said Dr. Marco Ricci, director of pediatric cardiac surgery at the University of Miami.

He said this case demonstrates that doctors now have one more option.

"In the past, this situation could have been lethal," Ricci said.

And it nearly was. During the almost four months between her two transplants, D'Zhana wasn't able to breathe on her own half the time. She also had kidney and liver failure and gastrointestinal bleeding.

Taking a short stroll — when she felt up for it — required the help of four people, at least one of whom would steer the photocopier-sized machine that was the external part of the pumping devices.

When D'Zhana was stable enough for another operation, doctors did the second transplant on Oct. 29.

"I truly believe it's a miracle," said her mother, Twolla Anderson.

D'Zhana said now she's grateful for small things: She'll see her five siblings soon, and she can spend time outdoors.

"I'm glad I can walk without the machine," she said, her turquoise princess top covering most of the scars on her chest. After thanking the surgeons for helping her, D'Zhana began weeping.

Doctors say she'll be able to do most things that teens do, like attending school and going out with friends. She will be on lifelong medication to keep her body from rejecting the donated heart, and there's a 50-50 chance she'll need another transplant before she turns 30.

For now, though, D'Zhana is looking forward to celebrating another milestone. On Saturday, she turns 15 and plans to spend the day riding in a boat off Miami's coast

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Doctors transplant windpipe with stem cells

LONDON – Doctors have given a woman a new windpipe with tissue grown from her own stem cells, eliminating the need for anti-rejection drugs. "This technique has great promise," said Dr. Eric Genden, who did a similar transplant in 2005 at Mount Sinai Hospital in New York. That operation used both donor and recipient tissue. Only a handful of windpipe, or trachea, transplants have ever been done.

If successful, the procedure could become a new standard of treatment, said Genden, who was not involved in the research.

The results were published online Wednesday in the medical journal, The Lancet.

The transplant was given to Claudia Castillo, a 30-year-old Colombian mother of two living in Barcelona, suffered from tuberculosis for years. After a severe collapse of her left lung in March, Castillo needed regular hospital visits to clear her airways and was unable to take care of her children.

Doctors initially thought the only solution was to remove the entire left lung. But Dr. Paolo Macchiarini, head of thoracic surgery at Barcelona's Hospital Clinic, proposed a windpipe transplant instead.

Once doctors had a donor windpipe, scientists at Italy's University of Padua stripped off all its cells, leaving only a tube of connective tissue.

Meanwhile, doctors at the University of Bristol took a sample of Castillo's bone marrow from her hip. They used the bone marrow's stem cells to create millions of cartilage and tissue cells to cover and line the windpipe.

Experts at the University of Milan then used a device to put the new cartilage and tissue onto the windpipe. The new windpipe was transplanted into Castillo in June.

"They have created a functional, biological structure that can't be rejected," said Dr. Allan Kirk of the American Society of Transplantation. "It's an important advance, but constructing an entire organ is still a long way off."

So far, Castillo has shown no signs of rejection and is not taking any immune-suppressing drugs, which can cause side effects like high blood pressure, kidney failure and cancer.

"I was scared at the beginning," Castillo said in a press statement. "I am now enjoying life and am very happy that my illness has been cured."

Her doctors say she is now able to take care of her children, and can walk reasonable distances without becoming out of breath. Castillo even reported dancing all night at a club in Barcelona recently.

Genden said that Castillo's progress needed to be closely monitored. "Time will tell if this lasts," he said. Genden added that it can take up to three years to know if the windpipe's cartilage structure is solid and won't fall apart.

People who might benefit include children born with defective airways, people with scars or tumours in their windpipes, and those with collapsed windpipes.

Martin Birchall, who grew Castillo's cells at the University of Bristol, said that the technique might even be adapted to other organs.

"Patients engineering their own tissues is the key way forward," said Dr. Patrick Warnke, a surgeon at the University of Kiel in Germany. Warnke is also growing patients' tissues from stem cells for transplants.

Warnke predicted that doctors might one day be able to produce organs in the laboratory from patients' own stem cells. "That is still years away, but we need pioneering approaches like this to solve the problem," he said.

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On the Net:

http://www.lancet.com/

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Tiny, long-lost primate rediscovered in Indonesia

WASHINGTON (Reuters) – On a misty mountaintop on the Indonesian island of Sulawesi, scientists for the first time in more than eight decades have observed a living pygmy tarsier, one of the planet's smallest and rarest primates.

Over a two-month period, the scientists used nets to trap three furry, mouse-sized pygmy tarsiers -- two males and one female -- on Mt. Rore Katimbo in Lore Lindu National Park in central Sulawesi, the researchers said on Tuesday.

They spotted a fourth one that got away.

The tarsiers, which some scientists believed were extinct, may not have been overly thrilled to be found. One of them chomped Sharon Gursky-Doyen, a Texas A&M University professor of anthropology who took part in the expedition.

"I'm the only person in the world to ever be bitten by a pygmy tarsier," Gursky-Doyen said in a telephone interview.

"My assistant was trying to hold him still while I was attaching a radio collar around its neck. It's very hard to hold them because they can turn their heads around 180 degrees. As I'm trying to close the radio collar, he turned his head and nipped my finger. And I yanked it and I was bleeding."

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Family history can trump breast cancer gene test

WASHINGTON – If breast cancer runs in the family, women can be at high risk even if they test free of the disease's most common gene mutations, sobering new research shows. The genes BRCA1 and BRCA2 are linked with particularly aggressive hereditary breast cancer, and an increased risk of ovarian cancer, too.

When a breast cancer patient is found to carry one of those gene mutations, her relatives tend to breathe a sigh of relief if they test gene-free.

But those headline-grabbing genes account for only about 15 percent of all breast cancer cases. Even in families riddled with breast cancer, a BRCA gene is the culprit only in roughly one family of every five that gets tested, said University of Toronto cancer specialist Dr. Steven Narod.

So clearly members of those families remain at risk from other yet-to-be-found genes, but how much risk?

Narod tracked nearly 1,500 women from 365 breast cancer-prone families, who tested negative for BRCA1 and BRCA2 mutations.

After five years, those women had a fourfold higher risk than average women of developing breast cancer, Narod reported Monday at a meeting of the American Association for Cancer Research.

This is crucial information for women considering gene testing, said Georgetown University genetics counselor Beth Peshkin, who wasn't part of the study.

"This is contrary to what I think the common perception is," Peshkin said. "Unless a mutation is identified in the family, a negative test result doesn't provide reassurance."

The good news: Narod's study showed these women didn't have an increased risk of ovarian cancer, like BRCA1- and BRCA2-carriers do.

While the $3,000 BRCA tests are well-accepted, newer tests for other genes linked to breast cancer are coming on the market.

But "the family history is a much stronger predictor," stressed Narod. He recommends that such women take the anti-cancer drug tamoxifen and undergo MRI cancer checkups instead of easier mammograms "regardless of what other gene tests showed."

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Doctors hoping for new era of artificial ankles

WASHINGTON – What was left of Dan Sivia's ankle simply didn't work. He limped through his 30s by sheer force of will, one foot almost completely immobile from repeated broken bones and surgeries. Then a doctor offered his last hope: An ankle replacement. A what? Sivia knew about hip, knee, even shoulder replacements. But ankles?

His confusion is understandable: The first ankle replacements of the 1970s were abandoned when they couldn't withstand the pounding of daily life. A second generation in the '90s lasted longer but never became really popular.

Now the nation is embarking on a new generation of artificial ankles designed to work more like the joint you're born with, a move specialists hope finally will offer less pain and more function to thousands who hobble — although it's too soon to be sure.

"These third-generation prostheses really mimic a natural ankle, which is really what makes them different," says ankle specialist Dr. Steven L. Haddad of the Illinois Bone and Joint Institute and an orthopedic surgery professor at Northwestern University.

If the newer implants pan out, it's a market ripe for growth. More than 200,000 people seek care for ankle pain annually, with few options for the severely damaged. More than 8,000 a year get their ankle bones fused, a last-ditch treatment after years of suffering, while surgeons perform between 2,000 and 2,500 ankle replacements.

While Medicare pays for ankle replacements, which Haddad says can reach $50,000 including a three- to five-day hospital stay, many other insurers don't. And a review in September's Journal of the American Academy of Orthopedic Surgeons cautions that so far, there is little research to tell how long newer versions will last — and that few hospitals have much practice in implanting them.

But for Sivia, the surgery restored an ability to walk that the 39-year-old thought he'd forever lost. His leg was crooked from a series of breaks that began in childhood and included a crushing ankle fracture at 28. A decade of pain later, he sought out Haddad. Then he spent 17 months on crutches, with external pins holding bones in place, as Haddad rebuilt his leg. The last surgery, the ankle implant, came in July.

"When I got to rake my own lawn — I've done it three times just because I can," the Waukegan, Ill., man said with a laugh. "I'm riding my bike, I'm doing all the things everybody else is doing."

Haddad says ankle sufferers tend to move like a sidewinder snake, one foot gingerly turned out to the side while the other foot does the heavy pushing to walk. They might have standard arthritis. But usually, fractures from years earlier — sometimes broken ankles, but often broken legs that left the entire lower limb out of alignment — simply made the ankle and its cushioning cartilage wear out.

Fusion — eliminating the pain-causing friction by permanently connecting ankle bones so they won't move — is usually an easy operation, with about 5 percent who fail to heal. The disadvantage is a stiff ankle that limits the foot's range of motion and eventually causes a domino effect, wearing out smaller joints in the foot to cause more pain until they, too, are fused.

Hence the quest for artificial ankles that would allow a fully flexible foot and normal gait.

That's not an easy task. The ankle joint is smaller than the hip and knee and must absorb more force than its sister joints, Dr. Keith Wapner of the University of Pennsylvania told a recent American Academy of Orthopedic Surgeons meeting.

The Food and Drug Administration began clearing so-called third-generation ankle implants in 2005, versions that Wapner expects to last longer. Each model is slightly different but consists of two attached parts. Surgeons drill a tunnel into the lower leg bone and slide in the stem of the artificial joint. A bottom piece connects to the top of the foot. Thin plastic hooked to one side functions as cartilage. Bone then grows into the implant, holding it in place.

In Europe, doctors also can use a similar but three-piece artificial ankle, where the plastic cushion is free-floating. Amid questions about whether that approach is better or worse, the FDA is evaluating whether to allow it here.

So which is better, fusion or replacement?

It all depends on age and activity. Even if these new ankles last more than a decade as Haddad expects, someone who jogs or mountain climbs will wear theirs out faster than someone who is sedentary. Also, different patients have different risks of wound infections.

"If you're someone that does not mind having additional surgeries on your ankle in the future as a trade-off to get better function, then a replacement is a better option," Haddad tells patients. "If you want to take care of it once, you have to opt for a fusion."

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