Merck & Schering-Plough Battle Skepticism
7 CommentsBy Ed Silverman // November 19th, 2007 // 10:31 pm
The drugmakers are facing a growing chorus of doubters that a study of Vytorin, which is a combo of Merck’s Zocor and Schering-Plough’s Zetia, is going well. The study began in 2002 and the results have been delayed two years. So tonight, a statement was issued saying an independent panel of clinical and biostatistical experts was created to help analyze the data. But they insist data will be shown at the American College of Cardiology meeting in March.
The study, called Enhance, was designed to explore whether Zetia increases the effectiveness of Zocor at preventing heart attack by keeping plaque from building up in the arteries. It’s an important question for Merck and Schering-Plough because there’s never been a study showing their combo prevents heart attacks, strokes or deaths any better than Pfizer’s Lipitor or generic Zocor.
If the news were good, the companies would rush it out, but delay doesn’t bode well, Forbes points out this week. “It starts to raise suspicion,” Allen Taylor, head of cardiology at Walter Reed Army Medical Center, tells the mag. “The more time it takes, the more you start to naturally wonder what is wrong.”
Reasons to be suspicious: The trial wasn’t listed clinicaltrials.gov until asked by Forbes about its absence. The drugmakers say that it was an oversight because the study began before the industry listed every study online. Also, clinical trial experts often recommend that outside researchers conducting a study, not a company, control the computerized database created to analyze study results. In this case, that database is held by Schering-Plough.
In explaining the delays, the drugmakers point to difficulties reading some 30,000 artery pictures of 1,000 patients, who received Zocor or Vytorin. Ultrasound pictures were taken of arteries in their thighs and necks. If adding Zetia, the key ingredient in both drugs, was good for arteries, Vytorin patients would have less plaque than those who just got Zocor, Forbes notes. The patients have a genetic disorder that causes high cholesterol.
“This has been time consuming and taken longer than originally anticipated because during the analysis, observations of variability in some of the data were detected as part of the validation/data review procedures” the statement reads. “Such potentially confounding observations are not unusual in studies of this kind.”
“It is critically important for researchers to take the appropriate time and rigor to conduct clinical trials, analyze data and report study results. The Enhance trial is complex and is being conducted with great care,” says John Kastelein, a professor of medicine and chairman, Department of Vascular Medicine, Academic Medical Center, Amsterdam, Netherlands, in the statement. And as he tells Forbes, “I certainly want it finished. There are all sorts of conspiracy theories that are not good for my reputation.”
Dusgusted
Dear Ed,
Forbes and the WSJ are right on target! Fifteen months after the clinical portion of the study is finished, they’re going to change the primary endpoint? They haven’t looked at the data? An Advisory Board that includes the lead investigator has advised to change the endpoint? No conflict of interest there! The integrity of the study has been destroyed and the regulatory authorities should render it worthless!
Just ask Steven Nissen or the FDA for their opinion. 10 to 1 they would agree. Merck and Schering-plough are just trying to protect their $4+ billion flagship products (Zetia and Vytorin). It’s very bad for them if they don’t do the same thing as Lipitor and Crestor have been shown to do. The FDA needs to audit them!
Disgusted
Concerned CV MD
Who is going to believe any of this? Merck and Schering-Plough are trying to protect their $4 billion franchise of Zetia and Vytorin. This smacks of a failed trial. Whoever heard of changing the primary endpoint 15 months after the clinical trial is done? They haven’t peeked at the data? ENHANCE is now worthless for anything.
MDMD
I hope they get audited by the FDA! They’ll get to the bottom of this fiasco!
CV MD
Hey Merck Schering-Plough,
I’ve got some oceanfront land in Arizona. Are you interested? Why not? You expect people to buy your latest “spinning of the truth.”
CV MD
FDAAA - Results Database
Under the Title VIII of the FDA Amendments Act of 2007 (Public Law 110-85, Sec. 801(a)), the ENHANCE trial (http://clinicaltrials.gov/ct2/show/NCT00552097) summary data of the results would be posted on the “results database” at ClinicalTrials.gov, to be operational by Sept 2008. The required basic results data — including demographic and baseline characteristics; primary and secondary outcome; and serious and frequency adverse events — are required to be submitted within 1 year of study completion for approved drugs, with a delay up to 2 years for trials for “new uses.”
Regarding trial registration, PL 110-85 Sec. 801 also expands the ClinicalTrials.gov registry to require registration of trials for all diseases and conditions, not just those that are “serious or life-threatening” under the previous law, no later than 21 days after enrolling the first patient (http://prsinfo.clinicaltrials.gov/fdaaa.html).
The result should be increased transparency in clinical research, including timely disclosure about ongoing trials and their results.
Lilli
Zocor and all the other Statin medications have toxic ingredients that doctors are not watching or reporting the serious harmful side effects that leads to premature death. Hospitals, medical industries, ddoctors and Congress and the the courts to be influenced by the power of the Pharmceutical Companies.
My husband died because doctors would not admit his problem was from Zocor. Pharamceuticals are causing death from medications. Labels on medications mean nothing if doctors do not monitor or report the problems with the medications.
If Americans want honest medical healcare they must contact Congress. Instead of saying, “We Can Not fight City Hall,Keep calling .” Over the counter prescription for cholesterol must be stopped and Congress must pass a honest truthful medication reporting system.
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