Medical Progress Today
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Volume 3, Number 1
January 6, 2006


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Commentary

Vexing Vioxx
Washington Post, 1-2-06

The New England Journal of Medicine recently issued a clarification of an article on Vioxx that was published in 2000, setting off yet another firestorm of controversy on the data that companies supply to medical journals in support of drug studies. While noting that doctors and medical journals should view those studies with some healthy skepticism, the Washington Post reaffirms its commitment to drug regulation through federal agencies—not the courts.

It is true that Merck disclosed the existence of the three heart attacks to physicians who were sent a copy of the original article, the main purpose of which was to establish that Vioxx caused fewer stomach problems than other leading painkillers. More important, Merck revealed the three additional heart attacks to the Food and Drug Administration, well before the journal article appeared. Had Merck not done so, the company would have been liable for criminal prosecution: The government does have the tools to prosecute companies that lie or withhold information from the FDA, and it does use them.
In other words, this revelation raises legitimate questions about the relationship between scientists, who are often paid by drug companies, and medical journals, which should do a better job of stating authors' conflicts of interest. It should also lead doctors who prescribe drugs and are ultimately responsible for understanding their side effects to read such journals with greater skepticism.
It does not, however, alter our view that the courts are the wrong place to resolve disputes about drug safety. The New England Journal of Medicine's retraction is expected to have an enormous impact on the thousands of lawsuits against Merck. But it is still not clear that doctors prescribing Vioxx several years ago would have behaved any differently had the journal article showed that the risk of heart problems was very slightly higher. Scientific judgments about the risks and advantages of drugs are not black and white -- which is why they are best made by scientists and by the regulatory agency that employs them, not by jurors through the lens of hindsight.

Regulation through litigation makes Americans less safe, as companies have little incentive to be proactive in the search for new risks associated with marketed products. No matter when Merck discovered the risks associated with Vioxx, it would have faced a torrent of litigation. Creating a safe harbor for responsible companies who comply with FDA regulations would improve both American law and American medicine.

Source: http://www.washingtonpost.com/wp-dyn/content/article/2006/01/02/AR2006010200416.html


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In this week's issue:

spotlight

Ariel Sharon and Stroke Treatment

news

AARP edges away from drug imports
US Pharmaceutical industry limbers up for Medicare’s brave new world: Overhaul of healthcare systems will put drug manufacturers on a collision course with government
Reaction to new Medicare drug plan mixed
Action sought on drug imports: The governor asks Congress to allow purchases from foreign suppliers
Senate passes pandemic bill to help developing countries
Cholesterol Drugs Have No Effect in Fighting Cancer, It Now Seems

commentary

A healthy strategy
Ominous Prospects for an Aging Population
Vexing Vioxx

research

The Promise of New Rotavirus Vaccines
Center for Medical Progress 
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