For years, Merck & Co. had a good scientific reputation. But, all of that has changed and unfortunately not for the better. Before the giant drug company was taken over by the marketing group that put the Merck doctors and scientists on the shelf, it had a very good record. Up to that point in time, science and medicine had been the top priority for the company. That has really changed. The marketing of Vioxx is a prime example of what happens when drug safety is placed far behind a company’s profits. As a result of its change in philosophy, now the maker of Vioxx will suffer long-term consequences for a case of scientific misconduct that occurred five years ago. Last month editors at The New England Journal of Medicine published online an “Expression of Concern,” which says that important heart attack data were deleted from the manuscript of the VIGOR study, the biggest study of Vioxx, before it reached the Journal.
Dr. Gregory Curfman, an executive editor at the Journal, says that a computer disk had shown that the data, including three heart attacks suffered by patients taking Vioxx, had been intentionally deleted by Merck. Two Merck scientists were co-authors of the paper, including Dr. Alise Reicin, an executive who helped manage Vioxx’s development and who has been called “the tenacious defender of Vioxx.” Dr. Reicin has been a key witness in court for Merck in the three Vioxx cases that have been tried. Her value to Merck as an expert has been severely damaged. Who could believe anything she says – even under oath?
Dr. Garret FitzGerald, a pharmacologist at the University of Pennsylvania, says that if the accusations by the NEJM are true, deliberately omitting data from the manuscript would be “extraordinarily serious.” What Merck did is clear evidence of how the company has lied to the FDA, the medical community, and the public. It now appears they lied to the one medical journal that all doctors rely on. In fact, the NEJM is generally referred to as the doctors’ “bible.” Merck’s conduct can’t be tolerated and they should be held accountable. Medical doctors should be able to rely on articles in medical journals, and especially the NEJM, as being completely accurate. It is obvious that Merck used the VIGOR study as a marketing tool.
Dr. FitzGerald notes that with or without the heart attacks in question, patients taking Vioxx were far more likely to have heart attacks than those who were taking naproxen, a painkiller sold over-the-counter by Bayer as Aleve. The additional three heart attacks up the total in the Vioxx group from 17 to 20, meaning that patients were five times more likely to have heart attacks when on the drug, instead of four times more likely. A number of leading authorities have pointed out that, on the face of it, Merck’s decision flouted standard scientific practice. Dr. Alastair Wood, associate dean of the Vanderbilt University School of Medicine, stated in an interview with the New York Times:
The way the process is supposed to work is that people submit an article with the full facts in it, so that the rest of the world can look at the facts and draw a conclusion. If The New England Journal had that information at the time, prior to publication, they would have highlighted the risk much more prominently than they did.
We intend to dig deeply into what Merck did relating the NEJM article, as well as with other articles where Merck employees or persons being paid by the powerful drug companies were involved. To put it mildly, all of this “stinks to high heaven!” When you consider that VIGOR was the big clinical study on Vioxx, it is quite apparent that the medical community would believe an article on the study in the NEJM to be totally accurate. Obviously, it wasn’t. I have had a number of doctors tell me recently that they were shocked to learn that Merck would lie to the NEJM. These doctors depend on the Journal in their clinical practice. They say that if Merck would intentionally misled the journal, which they rely on much like the Bible, what can you believe that comes from their company?
We were able to expose two big lies by Merck during our Vioxx trial in Texas. Merck had been telling the medical community and the medical journals for years that Naproxen was cardio-protective. Another lie told – involved short term use of Vioxx. Over the past year, Merck has been saying to anybody who would listen – and especially the news media – that Vioxx only causes heart attacks after 18 months of use. Neither of those statements is true. I suppose if a company will lie to the NEJM, it will lie to the public. We now know that Naproxen is not cardio-protective and we also know that short term use of Vioxx causes heart attack. We intend to continue with our efforts to expose Merck’s false statements to the public.
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