Thirty studies involving more than 20,000 people demonstrated an increased risk of heart attacks and strokes linked to the drug Vioxx, which was taken off the market in 2004 after generating billions of dollars annually in sales. However, this information was not easily accessible to the public, and the Food and Drug Administration's reservations about the drug were lost in a blizzard of direct-to-consumer marketing, according to a study and commentary published today in the Archives of Internal Medicine.
The analysis showed that safety concerns about Vioxx, a nonsteroidal anti-inflammatory manufactured by Merck & Co., arose at least four years before the drug was withdrawn. Under new FDA rules, however, manufacturers are now required to disclose the results of post-market safety studies.
"Substantial amounts of clinical trial data that have rarely been fully used to understand drug efficacy or safety will now be available and can be used by independent investigators to complement and corroborate surveillance done by the FDA and the manufacturers," the authors wrote in the paper.
The issue is crystallized further in a commentary by Dr. Lisa M. Schwartz and colleagues of the Veterans Affairs Outcomes Group. They point out that the FDA, as the repository of post-marketing surveillance studies, is a weak opponent to the media-savvy and heavily funded pharmaceutical industry.
"The Vioxx story really highlights the difference between marketing and informing," Schwartz wrote in the commentary. "If physicians and patients had had the facts, it would have taken an alchemist, not a marketing department, to turn this lemon into gold."
The new FDA rules requires public disclosure of study results on the ClinicalTrials.gov database within 12 to 24 months of completion. This should help prevent future Vioxx-type incidents, Schwartz wrote, but patients and doctors should be able to get this information, unfiltered, directly from the FDA. "For this to happen, the FDA needs to make what its reviews know more accessible. ... But it will take a lot of work to keep this information from being drowned in the sea of industry marketing. It's a pretty deep sea. Merck spent $500 million promoting Vioxx in 2003 alone."
-- Shari Roan
Photo credit: Daniel Hulshizer / Associated Press