The Trouble with Vioxx
The New England Journal of Medicine can make or break a new drug. That is, an article published in the Journal which describes favorable results of tests of a drug in humans can dramatically increase sales of the drug. And having the article retracted (withdrawn) by the Journal can cause a company's stock to plummet.
Take Merck's Vioxx, for example. The results of a clinical trial involving approximately 2000 participants were submitted to the NEJM for publication. The article was read and commented upon by reviewers for the Journal -- physicians and scientists -- and, following any necessary revisions, was published in 2000. Because the article not only described how Vioxx was effective in treating arthritis pain but also appeared to cause less stomach problems than existing medications, physicians began prescribing Vioxx for their patients. Stories in the popular medical news cited the article and, of course, people suffering from arthritis asked their doctors about Vioxx. Things looked good. For awhile.
After enough prescriptions had been filled and patients had taken Vioxx for a long enough period of time, it became apparent that one of the side effects of the drug was cardiovascular problems - specifically, heart attacks. As a result, the Food and Drug Administration advised Merck to pull the plug on its very popular drug. Merck did so in September of 2004.
It was bad enough for Merck to lose revenue from its U.S. sales of Vioxx. But then, late last year, the NEJM retracted the original 2000 article. A retraction means that the publisher does not stand by the validity of the results reported. In this particular case, the Journal editors felt the entire article should be withdrawn because there was evidence that the authors of the article failed to accurately report their findings. Specifically, it appears there were at least two problems with the publication.
First, the study which was reported may have been designed so that the negative cardiac effects, which were suspected by Merck, were minimized. Second, the authors failed to mention heart problems which arose in clinical trial participants after the study period was over. It may be argued that those heart problems should not have been counted in the data because they fell outside of the official window of the study, but it has also been suggested that the authors should at least have mentioned them, either in the article or to the editors when the article was submitted for publication.
The scientific record may have been corrected (after 4-5 years) but, in the meantime, people and their doctors made medical decisions based on the results presented in that 2000 article. And they thought the decisions they were making were backed up by sound scientific evidence. Wrong.
Next time: How this experience may change the way in which articles describing the clinical trial findings are presented and interpreted.
-Joe
Related Topics: Ibuprofen, Naproxen: No Heart Risk, Painkiller Update: What You Need To Know
Take Merck's Vioxx, for example. The results of a clinical trial involving approximately 2000 participants were submitted to the NEJM for publication. The article was read and commented upon by reviewers for the Journal -- physicians and scientists -- and, following any necessary revisions, was published in 2000. Because the article not only described how Vioxx was effective in treating arthritis pain but also appeared to cause less stomach problems than existing medications, physicians began prescribing Vioxx for their patients. Stories in the popular medical news cited the article and, of course, people suffering from arthritis asked their doctors about Vioxx. Things looked good. For awhile.
After enough prescriptions had been filled and patients had taken Vioxx for a long enough period of time, it became apparent that one of the side effects of the drug was cardiovascular problems - specifically, heart attacks. As a result, the Food and Drug Administration advised Merck to pull the plug on its very popular drug. Merck did so in September of 2004.
It was bad enough for Merck to lose revenue from its U.S. sales of Vioxx. But then, late last year, the NEJM retracted the original 2000 article. A retraction means that the publisher does not stand by the validity of the results reported. In this particular case, the Journal editors felt the entire article should be withdrawn because there was evidence that the authors of the article failed to accurately report their findings. Specifically, it appears there were at least two problems with the publication.
First, the study which was reported may have been designed so that the negative cardiac effects, which were suspected by Merck, were minimized. Second, the authors failed to mention heart problems which arose in clinical trial participants after the study period was over. It may be argued that those heart problems should not have been counted in the data because they fell outside of the official window of the study, but it has also been suggested that the authors should at least have mentioned them, either in the article or to the editors when the article was submitted for publication.
The scientific record may have been corrected (after 4-5 years) but, in the meantime, people and their doctors made medical decisions based on the results presented in that 2000 article. And they thought the decisions they were making were backed up by sound scientific evidence. Wrong.
Next time: How this experience may change the way in which articles describing the clinical trial findings are presented and interpreted.
-Joe
Related Topics: Ibuprofen, Naproxen: No Heart Risk, Painkiller Update: What You Need To Know
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