Originally published January 15 2010
Merck Sat on Data Showing Vioxx Risks for Years Before Pulling Drug
by E. Huff, staff writer
(NaturalNews) A recent study published in the Archives of Internal Medicine has revealed that information about heart risks from pharmaceutical giant Merck's Vioxx drug was available in 2000, four years before the Merck pulled the drug from the market. Because the information was not published and made public, Merck sat on it until a later clinical trial openly revealed that the drug was causing strokes and heart attacks.
Dr. Harlan Krumholz, study author from the Yale University School of Medicine, noted that he obtained pertinent safety data about Vioxx only after a lawsuit was filed against Merck by those who had been injured by the drug. It was discovered that out of the 30 studies conducted by Merck prior to when Vioxx was withdrawn, only 18 of them had been published. Six were published after the drug was withdrawn and six were never published at all.
After mulling through the study data, one trial at a time, Krumholz and his team clearly identified a link between Vioxx usage and increased heart attacks and strokes in patients. Based on when the studies were conducted, the connection was visible as early as December of 2000.
Ron Rogers, a Merck spokesman, denied the claims that any link could be observed and decried the methods used by researchers to come to this conclusion, despite acceptance of the findings following a rigorous peer review process. Rogers stated that the company's own extensive analysis showed no connection between Vioxx usage and increased cases of heart attack and stroke prior to the time when it was removed from the market, emphasized that the company had no prior knowledge of Vioxx's dangers.
However in 2004, the Wall Street Journal (WSJ) reported that it had seen internal Merck emails exchanged between company executives that expressed concern over Vioxx's tendency to increase the risk of heart attack. The entire series of emails clearly indicated that Merck knew about the dangers of Vioxx and was doing its best to conceal the information.
Dating back to the late 1990s, early emails contained dialogues about how to craft a study that would minimize the truth about Vioxx. An email from March of 2000 sent by Merck's research chief, Edward Scolnick, expressed clear affirmation that heart problems associated with Vioxx were "clearly there" and that it was a "shame."
When questioned about the emails, Merck once again denied the allegations, claiming that the emails were taken out of context. Merck never provided an explanation as to what the emails were referring to in their supposed proper context.
Thousands of injured patients and company shareholders filed a class action lawsuit against Merck following its removal of Vioxx from the market. Merck appealed the lawsuit on the grounds that "sufficient" information about the drug's risks were available when the drug hit the market. Merck succeeded in convincing a U.S. district judge to dismiss the lawsuit because it was filed after the two-year statute of limitations ended.
However an appeals court in Philadelphia reversed the decision on behalf of the many shareholders who lost a great deal when Vioxx was suddenly removed from the market, which caused Merck's stock values to plummet. Since it was determined that shareholders could not have known what was coming based on the information that was made publicly available, the Supreme Court is going to evaluate the case and make a decision on it next year.
Merck also agreed to a $4.85 billion settlement, one of the largest in history, on behalf of the thousands who filed personal injury lawsuits against the company due to serious injuries caused by Vioxx. (These cases were different from the ones included in the initial class action suit). The drug giant said it agreed to the settlement because the litigation process would have taken countless years to resolve, most likely hurting the company's reputation even further.
At the very least, drug safety tracking once receiving approval from the FDA to go to market needs a major overhaul. Dr. Krumholz and his colleagues stressed this point following their Vioxx discoveries. When fraud and criminal behavior are involved, as has shown to be the case with Merck, justice must be served.
The Vioxx scandal illustrates an important fact about the drug industry in general. Big Pharma continually gets away with massive impropriety. Its business practices, from research and development to marketing, are wrought with dishonesty, manipulation and downright fraud. There is arguably no other industry that gets away with its crimes as much as the pharmaceutical industry does. The consequences are also the most severe, costing millions of people their health and oftentimes their lives.
Bringing the issue to light as often and loudly as possible will only go so far. Massive reform, in some way, shape, or form, must be implemented if there is ever going to be an end to the madness.
Sources for this story include: http://www.reuters.com/article/idUSTRE5AM4MV... http://money.cnn.com/2004/11/01/news/fortune...
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