That the drug produced by Merck posed cardiovascular risks could have been established much before the drug was removed from the market in September 2004, had the complete data been made available to physicians and consumers, says a study into the matter.
The company withdrew its drug from the market in September 2004. However, lack of data available to both consumers and physicians deferred the detection of Vioxx’s side-effects.
Dr. Joseph S. Ross, lead author of the study conducted into risks involved in consumption of Vioxx and an assistant professor of geriatrics and palliative medicine at New York's Mount Sinai School of Medicine, said, "We need comprehensive, transparent, independent access to clinical-trial data in order to do a much better job of making this information available to the public."
Researching risks
Research carried out by Ross and his colleagues, published in the Archives of Internal Medicine, analyzed 30 studies to assess the cardiovascular risks posed by Vioxx.
Twelve of these 30 studies were made available to the public only after consumers filed suits claiming the drug had harmed them. These studies, conducted on over 20,000 people, indicate that those consuming Vioxx were increasingly on the risk of hypertension, heart attacks and strokes.
Dr. Harlan Krumholz, from Yale University School of Medicine and member of the research team for the study, said, "You could have known there were marked safety problems with Vioxx as early as 2000 and the signal only grew stronger."
On Monday, U.S. researchers said that the analysis calls for a public disclosure of the drug safety data, at the earliest.
Withdrawing Vioxx
In September 2004, Merck deliberately pulled out Vioxx from the market when a clinical trial established that the drug enhanced the risk of heart attacks and strokes in those who consumed it regularly for longer periods of time. However, Food and Drug Administration had expressed its apprehensions about side-effect of Vioxx as early as 1999, even before it received a sanction.
In June 2001, many studies indicated a 35 percent rise in cardiovascular hazards and deaths. Authors of the study claim that many a warning about the risks posed by the medicine was lost in Merck’s snowstorm marketing of its drug.
In November 2007, Merck also signed a $4.85 billion deal in order to resolve claims of strokes, heart attacks, and deaths said to have been caused by Vioxx.
Dr Lisa M Schwartz from the Veterans Affairs Outcomes Group said, “The Vioxx story really highlights the difference between marketing and informing. If physicians and patients had had the facts, it would have taken an alchemist, not a marketing department, to turn this lemon into gold."
Merck defends
Meanwhile, officials from Merck have rubbished the conclusions, claiming that erratic methods were used to assess the data for the purpose of this study.
A statement released by the company on Monday said, "The first time Merck observed a difference in a placebo-controlled study was when it learned the results of the APPROVe study in September 2004."
It added that Merck’s own examination of Vioxx did not point towards any cardiovascular risks.
Ron Rogers, an official spokesperson of Merck, said, "There is nothing new here. We studied Vioxx before and after it was on the market. We studied it extensively using more rigorous methods than these authors used and we didn't see any cardiovascular risk."
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