The bad press for Merck continues. And include the FDA in the controversy, because like so many federal agencies, consumer protection takes a back seat to 'helping' the very industries supposed to be supervised. I'm too lazy to google the statistics at the moment, but a large number of employees of federal agencies, upper management mostly, are hired from the ranks of corporate america (such as EPA hiring former chemical industry executives, etc.) Pathetic, yet a long standing practice.
Further fueling the controversy surrounding drug safety in the U.S., the American journal Archives of Internal Medicine joined a growing chorus of experts calling for a major overhaul of the way the U.S. Food and Drug Administration approves and monitors new drugs.“The FDA has become a little bit too beholden to the drug companies and is either unwilling, afraid or unable to get them to do the safety studies that need to get done once there's a signal that there may be a problem,” said Dr. Jerry Avorn of Harvard, who co-authored an editorial in Tuesday's issue of Archives.
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Since the withdrawal of Vioxx, debate over the FDA's effectiveness in monitoring drug safety has continued unabated, leading many critics to call for significant reforms.“The FDA had responsibility for regulating this drug, and they didn't do what they should have,” Graham said Monday in a telephone interview. “I believe the FDA ... views industry as its client and not the public, and that what happened with Vioxx is an example of that.”
Merck & Co. forced one of its researchers to remove her name from a study linking Vioxx to heart attacks, then criticized the findings before ultimately pulling the arthritis drug from the market last fall, two of the scientist's colleagues say.“Even after funding and agreeing with the design of the study, Merck publicly discredited our findings,” Drs. Daniel Solomon and Jerry Avorn of Boston's Brigham and Women's Hospital wrote in this week's Archives of Internal Medicine.
Merck spokeswoman Anita Larsen confirmed the company's action, saying Merck believed the study's conclusions “were not supported by the data.” The name removal came about six months before another study prompted the drugmaker to withdraw Vioxx, though the company began criticizing the findings in 2003, Solomon said.
The journal contains several studies about Vioxx and Celebrex, the once popular and heavily promoted painkillers advertised as stomach-friendly alternatives to aspirin. They are under congressional and regulatory scrutiny....
Meanwhile, the British medical journal [Lancet] is releasing a study on the heart dangers of Vioxx after withholding the report because the researcher said he had been threatened by his superiors at the FDA.
The study links Vioxx to between 88,000 and 140,000 excess cases of heart disease in the United States — a conclusion that has previously been disclosed.
Dr. David Graham, who works in the FDA's office of drug safety, claimed he was threatened with dismissal and said he asked the Lancet to withdraw the paper from publication in November. Earlier this month, the FDA agreed the study could be published.
