Drug Companies Ignore or Distort Side Effects
December 7, 2009
The Epoch Times
By Dr. John Briffa
Some of you may remember that in 2004 the drug company Merck pulled its painkiller Vioxx (rofecoxib) from the market after research revealed it more than doubled risk of heart attack.
Subsequently, there were accusations that Merck knew about the problems way before it pulled its money-spinner. This story has resurfaced now, on the publication of a study in the Nov. 23, 2009, edition of Archives of Internal Medicine titled “Pooled analysis of rofecoxib placebo-controlled clinical trial data.”
In this study, research (some published, some not) was analyzed, to see at what point there was a clear indication that Vioxx was increasing the risk of “cardiovascular thrombotic (CVT) events” such as heart attack and stroke, as well as death. It turns out that by 2001, there was clear evidence of harm.
This was more than three years before Merck “voluntarily withdrew” Vioxx from the market. In the intervening time, literally thousands of people died and had heart attacks as a result of this drug.
I saw a report of this study on Reuters Health in which one of the study authors, Dr. Harlan Krumholz, makes the point that “most of the information we are using in this study was never published, or if it was published, they never included the key safety data.” This sounds like information on critically important adverse effects might have been “neglected, restricted, distorted, and silenced” to me.
Of course Merck denies any wrongdoing and is sticking with its story that the first time it was aware of any problems was in 2004. I suppose we need to take this stance in context. It has emerged in a review published in the April 16, 2008, Journal of the American Medical Association titled “Guest Authorship and Ghostwriting in Publications Related to Rofecoxib” that some studies and review articles supportive of Vioxx were ghostwritten by employees of Merck.
In addition, an article in the British Medical Journal, April 2009, titled “Moynihan R. Court hears how drug giant Merck tried to ‘neutralize’ and ‘discredit’ doctors critical of Vioxx” reveals that doctors who were not “on side” regarding Vioxx were targeted by Merck for softening-up, and if that didn’t work, an attempt was made to discredit them.
Merck happens to manufacture ezetimibe, the cholesterol-reducing drug. Ezetimibe doesn’t appear to do anyone much good and has also been linked with a statistically significant increased risk of death due to cancer.
Never mind, though, because it appears Merck has managed to find some scientists who claim that this association is likely to be due to chance, even though the stats show it’s very unlikely to be due to chance. This analysis was published in the New England Journal of Medicine on Sept. 2, 2008, titled “Analyses of cancer data from three ezetimibe trials.”
Let’s hope history isn’t repeating itself.
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