Congress today sent letters requesting that Food and Drug Administration commissioner Andrew von Eschenbach and executives of the drug companies Merck and Schering-Plough hand over documents detailing the marketing campaign for the cholesterol drug Vytorin.
The results of a clinical trial released Monday found that Vytorin did not reduce the buildup of harmful plaque in arteries any better than a much cheaper generic drug.
But the study was completed in April 2006. Typically, results are released in three to six months. Merck and Schering-Plough, the two companies that developed and marketed the drug, withheld test results for 19 months.
Additional clinical trials are often started after a drug is on the market so companies can make bigger claims and gain more market share. In Vytorin's case, it didn't work out that way.
"The company's goal in doing this kind of study is to show their drug was better than the alternative drug. And they failed to do that," said Dr. Brian Strom of the University of Pennsylvania.
Companies are required to release test results to the FDA. But the FDA is not allowed to tell anyone else. So "disappointing" results have often been hidden, even from the doctors who prescribe the medications.
"The FDA considers the results from a clinical trial to belong to the company, that it's a 'trade secret' even if it's about a drug not working," said Dr. Jerry Avorn of Brigham & Women's Hospital.
Dr. Sydney Wolfe of Public Citizen said, "Good news gets out quickly. Bad news gets out much more slowly."
Merck, one of the sponsors of the clinical trial, blamed the delayed release of the results on "variability in the data in some of the images."
Strom said he wasn't convinced by Merck's response.
"That explanation doesn't make any sense to me. If there was a problem early on, it should have been caught early on," he said.
So, how did Vytorin results finally become public?
After the trial ended, Merck and Schering-Plough announced they wanted to change the way results were analyzed. In short, the companies wanted to redefine "success" and "failure." That drew a wave of questions and criticism from cardiologists, as well as Congress.
"So an investigation about this was begun, and as a result, the company was really forced to reveal the results of the study." Dr. Wolfe said.
Legislation signed into law just a few months ago will now force companies to release all study results, both positive and negative. Under the new law, companies can take up to two years from the end of a clinical trial to report the findings. So it's unlikely even this new law would have done nothing to speed up the release of Vytorin results or help millions of Americans learn any sooner the truth about a vital medication they're taking.
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