Government concedes vaccine injury case
Thu, 06 Mar 2008 02:56:39 GMTBy MARILYNN MARCHIONE, AP Medical Writer
Government health officials have conceded that childhood vaccines worsened a rare, underlying disorder that ultimately led to autism-like symptoms in a Georgia girl, and that she should be paid from a federal vaccine-injury fund.
Medical and legal experts say the narrow wording and circumstances probably make the case an exception — not a precedent for thousands of other pending claims.
The government "has not conceded that vaccines cause autism," said Linda Renzi, the lawyer representing federal officials, who have consistently maintained that childhood shots are safe.
However, parents and advocates for autistic children see the case as a victory that may help certain others. Although the science on this is very limited, the girl's disorder may be more common in autistic children than in healthy ones.
"It's a beginning," said Kevin Conway, a Boston lawyer representing more than 1,200 families with vaccine injury claims. "Each case is going to have to be proved on its individual merits. But it shows to me that the government has conceded that it's biologically plausible for a vaccine to cause these injuries. They've never done it before."
A lawyer for the 9-year-old girl has scheduled a news conference in Atlanta on Thursday. Her parents have declined to comment in the meantime because the case is not final and the payment amount has not been set.
Nearly 5,000 families are seeking compensation for autism or other developmental disabilities they blame on vaccines and a mercury-based preservative, thimerosal. It once was commonly used to prevent bacterial contamination but since 2001 has been used only in certain flu shots. Some cases contend that the cumulative effect of many shots given at once may have caused injuries.
The cases are before a special "vaccine court" that doles out cash from a fund Congress set up to pay people injured by vaccines and to protect makers from damages as a way to help ensure an adequate vaccine supply. The burden of proof is lighter than in a traditional court, and is based on a preponderance of evidence. Since the fund started in 1988, it has paid roughly 950 claims — none for autism.
Studies repeatedly have discounted any link between thimerosal and autism, but legal challenges continue. The issue even cropped up in the presidential campaign, with Republican John McCain asserting on Friday that "there's strong evidence" autism is connected to the preservative.
The girl has a disorder involving her mitochondria, the energy factories of cells. The disorder — which can be present at birth from an inherited gene or acquired later in life — impairs cells' ability to use nutrients, and often causes problems in brain functioning. It can lead to delays in walking and talking.
Federal officials say the law bars them from discussing the case or releasing documents without the family's permission. However, The Associated Press obtained a copy of the concession by U.S. Department of Health and Human Services officials.
According to the document, five vaccines the girl received on one day in 2000 aggravated her mitochondrial condition, predisposing her to metabolic problems that manifested as worsening brain function "with features of autism spectrum disorder." In the 1990s, the definition of autism was expanded to take in a group of milder, related conditions, which are known as autism spectrum disorders.
The document does not address whether it was the thimerosal — or something else entirely in the vaccines — that was at fault.
The compensation fund lists problems with brain function as a rare side effect of certain vaccines. Such problems are enough on their own to warrant compensation, even without autism-like symptoms, and the fund has made numerous payouts in such cases.
The Health Resources and Services Administration, which is in charge of the fund, said: "HRSA has maintained and continues to maintain the position that vaccines do not cause autism."
A Portuguese study suggested that 7 percent of autistic children might also have the mitochondrial disorder, versus one in 5,000 people — or 0.02 percent — in the general population, said Dr. Marvin Natowicz, a Cleveland Clinic geneticist.
"Even if they're off by a factor of seven" and only 1 percent are afflicted, "it's still a striking statistic," he said.
Others said they doubt the Georgia case will have much effect.
"No link between mitochondrial disorders and autism spectrum disorder has been made in mainstream medicine," said Dr. Michael Pichichero of the University of Rochester in Rochester, N.Y., who has consulted for the government on vaccines and has received speaking fees from vaccine makers.
A decision is expected this spring on the first test case for a larger group of autism-vaccine claims, which are being heard in the U.S. Court of Federal Claims.
Reported cases of autism have been rising in the U.S., even after thimerosal was removed from most childhood vaccines. However, some experts believe the rise is due to an expansion of the definition of autism and related conditions, and a desire to diagnose children so they qualify for special services and aid.
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Associated Press writer Kristen Gelineau in Richmond, Va., and medical writer Mike Stobbe in Atlanta contributed to this story.
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On the Net:
U.S. Court of Federal Claims: http://www.uscfc.uscourts.gov
Vaccine injury fund: http://www.hrsa.gov/vaccinecompensation
CDC autism page: http://www.cdc.gov/ncbddd/autism/index.htm
American Academy of Pediatrics autism reports:
http://www.aap.org/advocacy/releases/oct07autism.htm
New colon cancer screening guides issued
Thu, 06 Mar 2008 00:32:52 GMTBy MIKE STOBBE, AP Medical Writer
ATLANTA - Medical experts recommended Wednesday that a less invasive procedure known as a virtual colonoscopy and a stool DNA test join the arsenal of screenings for colon cancer in the hopes that more people would get checked out.
The recommendations bring to six the number of screening tests suggested for spotting signs of colon cancer, said Dr. Otis Brawley, national chief medical officer of the American Cancer Society, one of the groups that made the recommendations.
The tests range in price from a few dollars to several hundred. Which test is best for patients depend on several factors, including what their insurer covers and the preference of their primary care doctor, experts said.
Only one company has a stool DNA test on the market — EXACT Sciences Corp. of Marlborough, Mass. The medical groups delayed releasing the recommendations until markets closed Wednesday because they were concerned it would affect trading, Brawley said.
The recommendations may also mean more business for radiologists. There has been something of a turf battle between gastroenterologists, who perform colonoscopies, and radiologists, who handle virtual colonoscopies.
The new guidelines represent an agreement that both are valuable ways to diagnose and prevent colon cancer, Brawley said.
These first consensus guidelines were released by the Cancer Society, the American College of Radiology, and the U.S. Multi-Society Task Force on Colorectal Cancer.
The latter group comprises representatives from the American College of Gastroenterology, the American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy.
The recommendations came out the same day as a medical study that found that flat growths on the colon wall are more common in Americans than previously thought. Researchers concluded that the growths are more likely to be cancerous than the more familiar knobby masses known as polyps.
The study, published in the Journal of the American Medical Association, suggested that more careful colorectal cancer screening is necessary.
However, Brawley said the release of the new recommendations was coincidental and not driven by the study's findings.
Colorectal cancer is the nation's second leading cancer killer. It will kill about 50,000 people in the United States this year, the Cancer Society estimates. Screenings are designed to save lives by finding growths before they turn cancerous.
Traditional colonoscopies, long considered the gold standard test, are recommended every 10 years, starting at age 50. A doctor snakes a long, thin tube equipped with a small video camera through the large intestine to view the lining. The doctors also can use the device to cut away a tissue sample or even remove a polyp.
However, colonoscopies come with risks, including a chance that a doctor will accidentally puncture the colon. Also, many people have balked at getting screened because the test is expensive and they perceive it as unpleasant.
A virtual colonoscopy is a sort of super X-ray of the colon and rectum. Air is pumped into the colon to stretch it, and then a special CT scan is done. It is not invasive, but if a polyp is found, doctors will have to perform an optical colonoscopy in order to take a biopsy.
The biggest issue is not which screening a patient should get, but that patients come in for screening. All colon cancer deaths can be averted through screening and early treatment, but only 30 percent of people recommended to get screenings actually do, according to the Cancer Society.
"The challenge we have is getting people to participate in screenings," said Jack Mandel, an Emory University epidemiologist who has studied colon cancer screening tests. "We can prevent these deaths."
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Associated Press writer Carla K. Johnson in Chicago contributed to this report.
Contaminant found in blood thinner
Wed, 05 Mar 2008 23:24:41 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Some of Baxter International's recalled blood thinner heparin contained large amounts of a contaminant that might explain hundreds of serious side effects. And the government said Wednesday it's investigating whether what appears to be a fake ingredient got there by accident or by fraud.
The Food and Drug Administration said 19 deaths from allergic-type reactions are now associated with the recalled drug, up from four.
Baxter insisted the contaminant further points suspicion at ingredient suppliers in China, which are under increasing scrutiny after a wave of recalls involving food, drug and toy imports.
The FDA stopped short of ruling out a U.S. connection and cautioned that while the contaminant is a prime suspect, officials haven't yet proved it harmed patients.
"We still don't know whether this inadvertently got into the supply or whether it was actually added," said FDA drug chief Dr. Janet Woodcock. "We can't tell you where the contamination originated."
High-tech testing by Baxter and other groups uncovered a heparin-like compound in batches of the problem drug — a substance not found in batches of problem-free heparin.
The contaminant accounted for between 5 percent and 20 percent of some of the samples tested, what FDA's Woodcock called "significant quantities."
At those amounts, batches of heparin should have been flagged as subpotent in Baxter's routine quality tests — but they didn't, because the contaminant is so chemically close to real heparin that standard testing couldn't tell the difference, Woodcock said.
The FDA is so concerned that later this week it will give manufacturers and other regulatory agencies worldwide instructions on how to check other heparin supplies to be sure the contaminant isn't sneaking in.
Remaining U.S. supplies of heparin, made by Baxter competitor APP Pharmaceuticals, do not show contamination, the FDA stressed.
Heparin is derived from pig intestines, and the heparin-like contaminant is related to a complex group of chemicals also in those intestines, FDA officials said. That's part of the difficulty in determining how the contaminant got into bulk ingredients used to make vials of the injected blood thinner, which are used in patients undergoing dialysis and heart surgery.
Counterfeit ingredients from China are a perennial headache for the FDA. If the heparin contamination turns out to be deliberate, it would be reminiscent of last year's scandal when a Chinese company was charged with adding the toxic chemical melamine to an ingredient used in U.S. pet food, killing thousands of dogs and cats. The melamine let the ingredient pass chemical inspections for protein content.
But Baxter referred to the heparin-like compound as "naturally derived," and FDA said it would take more specific identification of the contaminant, among other things, to tell if it could have slipped into the bulk ingredient accidentally, during processing of the pig intestines.
Baxter, which had provided about half the nation's supply, halted production last month after its brand was linked to hundreds of reports of allergic-style reactions, including vomiting, nausea and difficulty breathing. Baxter purchases bulk heparin from Wisconsin-based Scientific Protein Laboratories, or SPL, which in turn owns a Chinese factory and buys additional crude heparin from other Chinese suppliers.
Baxter said it found the contaminant in samples of the ingredient from the China plant, Changzhou SPL, and in samples processed at the Wisconsin factory that came from Chinese-made crude heparin.
"These results suggest that the root cause may be associated with the crude heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter," the company said.
The vast majority of the world's heparin comes from Chinese ingredients, Baxter officials noted.
"It is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by SPL to Baxter is responsible for these adverse events," the Wisconsin-based SPL said in a statement.
FDA inspectors last week found quality-control problems at the Changzhou factory, a facility the agency had never before inspected — in violation of its own rules — because of a mix-up with the company's name. But the FDA isn't yet sure if those problems are linked to the allergic-style reactions.
The FDA now has 785 reports of side effects among patients taking heparin from any manufacturer, but can't yet say how many are the complications of concern. Last week, the agency put that number at 215. FDA also has a total of 46 reports of deaths, but ruled out a link with many of them and concluded that 19 deaths since January 2007 appear related to allergic-type reactions that triggered Baxter's recall.
House approves mental health bill
Thu, 06 Mar 2008 01:42:59 GMTBy ANDREW MIGA, Associated Press Writer
WASHINGTON - The House voted Wednesday to require equal health insurance coverage for mental and physical illnesses when policies cover both.
The 268-148 roll call was cheered by advocates who have been fighting more than a decade for what has come to be called mental health parity.
Supporters said the measure would help end the stigma of mental illness and create greater access for people needing mental health and addiction treatment.
Opponents warned it could drive up health care costs and force some employers to drop insurance coverage.
The "Paul Wellstone Mental Health and Addiction Equity Act of 2007" was named for the late Minnesota Democratic senator who championed the issue for years and who was killed in a 2002 plane crash.
"It's a historic step," said the late senator's son, David, 42. "It's a civil rights bill for people with mental illnesses and chemical addiction. It forces insurance companies to treat them as they treat others."
Forty-seven Republicans joined 221 Democrats in voting for the bill. Three Democrats voted against it.
The House vote sets the stage for talks with the Senate, which passed a narrower version of the bill last September with support from business and insurance groups.
The White House said it favors the Senate bill because it addresses the need to treat mental illnesses with the same urgency as physical illnesses but wouldn't significantly raise health care costs.
The House bill was sponsored by Reps. Patrick Kennedy, D-R.I., who has battled depression, alcoholism and drug abuse, and Jim Ramstad, R-Minn., a recovering alcoholic who is Kennedy's Alcoholics Anonymous sponsor.
"It's about opening up the doors and ending the shadow of discrimination against the mentally ill," said Kennedy.
Former first lady Rosalynn Carter, a longtime mental health advocate, said the bill would help erase the stigma of mental illness that prevents many people from seeking treatment.
The Senate bill was sponsored by Kennedy's father, Massachusetts Democrat Edward Kennedy, along with GOP Sens. Pete Domenici of New Mexico and Mike Enzi of Wyoming.
The younger Kennedy will negotiate with his father on a compromise measure.
"We've discussed strategies and ways we can try to move this," the congressman said.
The House measure specifies that if a plan provides mental health benefits, it must cover mental illnesses and addiction disorders listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, which is used by mental health professionals.
The Senate bill gives insurers more leeway on the types of mental disorders they would have to cover.
Rep. Phil Gingrey, R-Ga., complained the House bill would mandate coverage for such conditions as jet lag and sexual dysfunction that are listed in the psychiatric association's manual.
"Can you imagine any employer being willing to cover things like that?" said Gingrey, a doctor.
Opponents said because the House bill requires much broader coverage than the Senate bill, it would prevent some businesses from providing any mental health coverage at all.
"The House bill will put us in the awkward position of either covering everything in the professional manual — or covering nothing at all," said Neil Trautwein, the National Retail Federation's health care lobbyist.
The federation, a trade association for the retail industry, favors the Senate version.
The Senate bill was a compromise reached after negotiations with businesses, the insurance industry and mental health advocates. Business and insurance groups had fought previous versions, arguing the proposals would drive up insurance costs.
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On the Net:
Information on the bills, H.R. 1424 and S. 558, can be found at http://thomas.loc.gov
Protein that could fight obesity discovered Swedish study
Wed, 05 Mar 2008 15:18:23 GMTSTOCKHOLM - Researchers in Sweden have discovered a protein that stimulates the formation of fat cells, a finding that could potentially be used to treat obesity, the Karolinska Institute said Wednesday.
The protein, called TRAP , "stimulates the formation of new fat cells and can thus precipitate the development of obesity," the Institute said in a statement.
The research was based on cell cultures and mice studies, and showed that patients with obesity have excessive levels of the protein.
"This protein is potentially useful in the treatment of conditions involving morbid cachexia , such as cancer diseases," professor Goeran Andersson, who led the study, said.
"The discovery can also lead to new ways of treating obesity based on the inhibition of this protein's effect," he said.
The study lasted four years and followed 14 obese women, Andersson told AFP.
The results were published Wednesday in the US online journal Public Library of Science.
