Sunday, February 15, 2009

U.S. court rules vaccines “don’t cause autism”

Vaccines aren't to blame for autism, a special federal court declared Thursday in a blow to thousands of families hoping to win compensation and to many more who are convinced of a connection. The special masters who decided the case expressed sympathy for the families, some of whom have made emotional pleas describing their children's conditions, but the rulings were blunt: There's little if any evidence to support claims of a vaccine-autism link.

The evidence "is weak, contradictory and unpersuasive," concluded Special Master Denise Vowell. "Sadly, the petitioners in this litigation have been the victims of bad science conducted to support litigation rather than to advance medical and scientific understanding" of autism.

Science years ago reached the conclusion that there's no connection, but Thursday's rulings in a trio of cases still have far-reaching implications — offering reassurance to parents scared about vaccinating their babies because of a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise, and last fall a Minnesota baby who hadn't been vaccinated against meningitis died of that disease.

The special court represented a chance for vindication for families who blame vaccines for their children's autism. Known as "the people's court," the U.S. Court of Claims is different from many other courts: The families involved didn't have to prove the inoculations definitely caused the complex neurological disorder, just that they probably did. More than 5,500 claims have been filed by families seeking compensation through the government's Vaccine Injury Compensation Program, and Thursday's rulings dealt with the first three test cases to settle which if any claims had merit. The first cases argued that a combination of the measles-mumps-rubella vaccine plus other shots triggered autism.

"I must decide this case not on sentiment but by analyzing the evidence," said Special Master George Hastings Jr., writing specifically about Michelle Cedillo of Yuma, Ariz., who is disabled with autism, inflammatory bowel disease and other disorders that her parents blame on a measles vaccine given at 15 months. "Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment," Hastings concluded.

Attorneys for the families said they were disappointed and may appeal.... Worry about a vaccine link first arose in 1998 when a British physician, Dr. Andrew Wakefield, published a medical journal article linking a particular type of autism and bowel disease to the measles vaccine. The study was soon discredited, and British medical authorities now are investigating professional misconduct charges against Wakefield. Then came questions about thimerosal, a preservative that manufacturers began removing from all vaccines given to infants in 2001. Today it is present only in certain formulations of the flu shot.

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FDA approves medicine from engineered goats

Potentially opening a new era in farming and pharmaceuticals, the U.S. government has approved the first drug produced by genetically engineered livestock. The drug, meant to prevent fatal blood clots in people with a rare condition, is a protein extracted from the milk of goats that have been given a human gene. The same drug, which was approved in Europe in 2006 but has not been widely adopted, is the first to have been cleared by the U.S. Food and Drug Administration under guidelines the agency adopted only last month to regulate the use of transgenic animals in the nation's drug and food supply.

Made by GTC Biotherapeutics, the drug is produced by a herd of 200 goats that live under quarantine on a high-security farm in central Massachusetts. The animals have been bred to contain a human gene that causes their milk to produce a human blood protein that can be extracted and processed into the anti-clotting drug. Proponents say such animals could become a way of producing biotechnology drugs at lower cost or in greater quantities than with the existing methods, which involve extracting the drugs from donated human blood or growing genetically engineered cells in steel tanks. The protein in the goat milk, antithrombin, is sometimes in short supply or unavailable for pharmaceutical use because of a shortage of human plasma donations.

GTC Biotherapeutics said one of its goats can produce as much antithrombin in a year as can be derived from 90,000 blood donations. And if more drug is needed, the herd can be expanded. "If you need more, you breed more," said Thomas Newberry, a spokesman for GTC, which is based in Framingham, Massachusetts.

Other drugs produced in animals are under development. One company, Pharming, based in the Netherlands, plans to apply this year for U.S. approval of a drug produced in the milk of transgenic rabbits to treat hereditary angioedema, a protein deficiency that can lead to dangerous swelling of tissues.

Another company, PharmAthene, working under a U.S. Defense Department contract, is developing a treatment for nerve-gas poisoning in the milk of transgenic goats.

But turning animals into walking pharmaceutical factories does not sit well with some environmental advocates and animal rights activists. "It is a mechanistic use of animals that seems to perpetuate the notion of their being merely tools for human use rather than sentient creatures," the Humane Society of the United States says in its position paper on the practice.

There are also more concrete concerns - that the animals could be harmed, that animal germs might contaminate the drug, and that the milk or meat from genetically engineered drug-producing animals might enter the food supply. There is also a concern that such animals might escape and breed with other animals, spreading the gene, with unpredictable consequences.

Still, it is not clear to what extent the use of the animals will catch on. Established manufacturers might stick with the tried-and-true methods. "I think we have very good ways of making therapeutic proteins today," said Norbert Riedel, chief scientific officer at Baxter International, which makes proteins both from human plasma and in cell culture. One risk of using animals is that drug production can be lost if a disease wipes out the herd.

Still, the government's stance on the GTC drug, which was issued Friday, eliminates one barrier to producing drugs in animals: companies' uncertainty over whether the Food and Drug Administration would ever approve such a drug. "It really takes away one of the biggest issues that have always been on the table, which is how do regulatory agencies view this kind of technology," said Samir Singh, president of the U.S. operations of Pharming.

Indeed, showing that approval could be obtained is a major reason GTC developed its drug, ATryn. Sales of the drug are expected to be modest. It was approved in Europe in 2006, and sales there have been small. ATryn will be sold in the United States by Ovation Pharmaceuticals. It is not clear what the price will be and how that price will compare to that of the product from human plasma. The drug was approved for people born with a rare hereditary deficiency of antithrombin to prevent blood clots while they undergo surgery or childbirth.

People with the deficiency are vulnerable to blood clots. They can reduce that risk by taking blood thinners like warfarin. But during surgery or childbirth, blood thinners are usually not used because they increase the risk of excessive bleeding. The FDA determined ATryn was as effective as antithrombin derived from human plasma in preventing clots. However, the protein derived from plasma lasts longer in the body than the one from goats, probably because the sugars coating the protein are different.

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1 comment:

Anonymous said...

I have learned so much about pills that were supposed to be good for humans, and the effects were devastating.
When they start making pills for humans, not animals, maybe we will progress.
Personally, when my Dr. suggests a new pill, I say NO.