The FDA once again demonstrates how closely it works with corporate clients, and how ineffective it is in actually protecting consumers. Maybe the FDA boards should be appointed differently, from a different pool of employers. Perhaps FDA employees should be restricted from ever working with pharmaceutical companies, in any capacity.
TribuneMore than two years before Merck & Co. pulled the popular painkiller Vioxx from the market over safety concerns, federal regulators knew studies had indicated older people taking the drug were more likely to die than those in a placebo group.
Despite receiving this information from two studies involving Alzheimer's patients, the Food and Drug Administration did not require the company to warn physicians of the spike in deaths in older Vioxx users.
Nor did the drug company publicize the results of the studies it conducted, which were preliminary but raised a red flag about Vioxx's safety.
The Vioxx studies surfaced among documents posted on an FDA Web site last weekend in advance of a major meeting in Washington on Vioxx and similar painkillers. Beginning Wednesday, the FDA-sponsored forum will address the safety of these drugs and if the agency should restrict their use.
In this context, the Alzheimer's studies raise important new questions about what Merck and the FDA knew about Vioxx's risks and when they knew it, and whether both organizations acted responsibly to protect public safety.
Doctors who raised red flags were shut out:
Dr. Gurkirpal Singh, director of the post-marketing drug surveillance program at Stanford University, said he was astonished when he found the information about higher mortality rates for Vioxx patients on the Web site--information he said has not been previously disclosed.“You would think physicians would want to know Merck had evidence indicating that patients on Vioxx in two clinical studies were twice as likely to die as those on placebo,” Singh said. “It's a very important finding. I only discovered it when I looked at the site. And I'm one of the foremost experts in the world on this subject.”
Singh had previously reported that Merck executives threatened him when he raised questions about whether the company was disclosing all relevant data about Vioxx. He also has said Merck's chief executive put an end to the harassment after it came to his attention.
Late last year, [Dr. Curt Furberg, a professor at Wake Forest University] said an FDA official asked him not to participate in the committee's meetings on painkillers after expressing concerns about a medication similar to Vioxx--Bextra, made by Pfizer Inc. A high-level official recently apologized and asked Furberg to continue to serve on the committee, Furberg said Wednesday.
And Merck tried to continue selling the drug, even though there were all sorts of red flags....
Company officials have maintained for months that Vioxx was withdrawn from the market as soon as Merck had reliable data from clinical studies documenting the drug's adverse effect on people's hearts. But critics have questioned those claims, and controversy has engulfed the company and the FDA.In testimony, Gilmartin did not mention the increased rate of deaths found in the Alzheimer's studies. Nor did Merck note the FDA's suggestion in the March 2002 report that “fluid retention, edema and hypertension may play a role in the different cardiovascular safety profile” of Vioxx.
