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Rabu, 26 November 2008

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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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.

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

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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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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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