Texas Personal Injury Lawyers – Jim Adler & Associates – Blog

What’s up with the FDA?

A lot of criticism, that’s what. The consumer watch dog is taking a beating for a process of drug approval that has ended up killing Americans. The FDA failure has attracted harsh attacks from the press. The Boston Globe, USA Today and The Reader’s Digest, among others, have published articles slamming the federal watch dog. The April 2008 edition of The Digest features a scathing assessment of the agency that is supposed to protect Americans from bad drugs, devices and products.

Spreading the bad word

The Reader’s Digest has 38 million U.S. readers and 100 million worldwide. But foreigners are no strangers to media criticism of the FDA. In 2005, The Lancet, a highly respected British medical journal, called the federal agency “ruthless and irresponsible” because it failed to take VIOXX off the market in 2000 despite evidence that long term use of the painkiller was risky for cardiac patients.

Internal critics slam the FDA

In early 2004, the white hot light of publicity caused headlines around the world when an FDA scientist testifying before congress attacked the agency for its handling of VIOXX.   Dr. David Graham, a senior FDA scientist accused it of “ignoring its own safety experts.” Its manufacturer pulled the drugg off the market voluntarily after that. By then, the highly touted drug had been sold in the U. S. for more than five years and experts had linked it to more than 27,000 heart attacks or sudden cardiac deaths nationwide between 1999, when it appeared on the market, through 2003.

Where there is smoke, is there fire?

The Reader’s Digest assessment of the FDA is damning. As the April edition of the magazine reports: “The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy  – and, sniff out any food borne terrorist plot” on the budget of a large school district!  Pressures on the FDA by patients who want to speed up the approval process for life-saving drugs; by drug manufacturers interested in profits, some of whom have hidden evidence of defects from the FDA; and by the FDA’s own sloppy record keeping and sometimes deliberate suppression of evidence that a drug is bad, is a recipe for continuing trouble.

Is the public helpless against killer drugs?

What can the public do? That’s a tough question since defective drugs and devices could be on the market for years before there’s enough evidence to recall them. Meanwhile, a new federal law gives FDA staffers the right to publish critiques of the agency; Congress has “created a new office within the FDA to improve the quality of research” and increased its budget. But lawsuits against drug manufacturers, and the media coverage they generate about the continuing FDA failure to properly regulate drugs, are crucial to protecting the public. VIOXX victims have won millions, keeping the story in the headlines, as crusading lawyers teach this malfunctioning federal agency a well deserved lesson.