Vioxx by Jon Barron

Vioxx

By Jon Barron


Ooops! I have to digress for a moment, once again. In our last issue, we talked about how the press has pretty much ignored the Vioxx scandal. However, that doesn't mean nothing's been happening. There's been some fascinating maneuvering going on in the background that you should be aware of -- and that may have profound implications in terms of your ability to access alternative health treatments.

Since the news about Vioxx raising the risks of heart attacks and strokes first broke, and since Merck "voluntarily" pulled their blockbuster drug from the market because they wanted to put "patient safety first," the share price of Merck has dropped in half, slicing some $30 billion off the value of the world’s fourth-largest drug company. And as bad as that is, Merck would be happy if that were their only problem. After the news on Vioxx broke, an article appeared in the New England Journal of Medicine on October 21st blasting Merck for putting “sales over safety.” It also lambasted the Food and Drug Administration (FDA) for sitting on its hands as evidence of health risks mounted.

The Chairman of the US Senate Finance Committee seconded that opinion when he said that the leaked memos indicate that the FDA silenced one of its drug experts who raised safety concerns weeks before Merck pulled Vioxx from the market. Dr. David Graham, associate director for Science in the FDA Drug Center's Office of Drug Safety, told Senate investigators he faced stiff resistance within the regulatory agency to his findings. Or to quote Senator Chuck Grassley of Iowa, in a statement after finance committee investigators interviewed the researcher, "Dr. Graham described an environment where he was 'ostracized, subjected to veiled threats' and 'intimidation,"'

Circling its wagons, the FDA responded by saying that it "values open discussion and frank exchange about scientific and medical issues" and subjects its scientists to "more rigorous" scrutiny than typical scientific peer reviews. Nevertheless, the Government Accountability Office, an investigative arm of Congress (which already had been asked to look into whether the FDA muzzled another staffer who linked antidepressants to raising the odds of children suffering suicidal tendencies) was asked to roll the FDA's handling of the Vioxx affair into their ongoing investigation.

It now appears that the FDA may be maneuvering to protect its back. It has asked the Institute of Medicine to study the way it monitors the safety of drugs on the market. And, to make a long story short, in an attempt to look proactive, on November 4th, the FDA announced three major regulatory initiatives designed to clamp down on the dietary supplement industry.

"These initiatives refine the direction the agency is taking to regulate dietary supplements," said FDA Acting Commissioner Lester M. Crawford. "We now have a clear roadmap to share with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling."

Is the timing of this announcement a coincidence? Would you like to buy a bridge?

The next few months could be very interesting for the alternative health community. After all, why throw a friend (the drug industry) to the lions, when you can offer up a sacrificial lamb (natural supplements) to satisfy the bloodlust of the mob?
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