Merck’s woes with Vioxx never seem to end


Multiple strategies adopted by pharmaceutical companies to suppress and manipulate can always surprise and shock a layperson.

In April 2008, the Journal of American Medical Association (JAMA) published a paper (you can read only the abstract.  You need a subscription to read the full paper) on how the company withheld safety data to make the drug appear as safe.  The paper talks about how the company did not even inform the Institutional Review Board, the first point of check, of the deaths.

And now comes the news about how the company went about conducting “seeding trials” to promote Vioxx.  It got 600 primary care physicians to prescribe the drug to more than 5,500 patients.

Seeding trials are done primarily to market the drugs and not to collect scientific data. That being the objective, it should not surprise us that it was the marketing division and not the research division that designed and conducted the “trial.”

The FDA did not know it, nor did the doctors or the poor patients.  Well, even the journal Annals of Internal Medicine that published the “trial” data did not know the real objective of the study.

That tells us how good drug companies are in making a study with fabricated/manipulated data appear good and real.

But the ghost of Vioxx keeps haunting the company even months after it withdrew the drug from the market. The latest is the paper  (again you can only read the abstract and need a subscription to read the full paper) published in the Annals of Internal Medicine .  The journal also published an Editorial in the same issue of the journal (sorry, even an abstract is not available for free reading).

One can one wonder how those who reviewed the paper failed to find out the real objective of the study.  The Annals of Internal Medicine is a reputed journal.  And if reputed journals can miss it, I think we need to take every paper that deals with results of clinical trials with a pinch of salt.

This may be the fist instance where the company’s documents prove that it was involved in a seeding trial.  But that companies engage in such unethical practices is a common knowledge.

Now compare this with what companies that manufacture and sell GM seeds.  While the drug companies have to submit the data to FDA prior to a drug’s approval, there is no such compulsion for companies like Monsanto.  All they have to do is to provide the “summary” of the results to the FDA.

Summary ensures that there is no scope for verifying the claims made by Monsanto or Syngenta.

I think the drug companies should be feeling down and frustrated that they could not get the Congress and the FDA to adopt a similar policy for them.