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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