Readers of the New York Times also know this.
Well today, lucky readers, you will get another scoop concerning Merck, Schering, and Zetia skulduggery. And you will get it a mere 4 days after the readers of The New York Times.
New evidence shows that the drug makers Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results.
The unpublished studies, conducted from 2000 to 2003 according to the F.D.A. documents, were not listed on the industry Web sites where companies are supposed to register the results of all drug trials that were ongoing after October 2002. The New York Times discovered references to the studies in briefing papers on the F.D.A. Web site.
Huh. Wonder why that is. Because you know, the studies that show Zetia lowers cholesterol don't have any trouble showing up in these databases. Or as the first thing you see when you punch up the Zetia information for health care professionals web page. Yet the studies that show Zetia may put your liver at risk seem to get lost. What are the odds really?
A Schering executive, when asked by a reporter about the unpublished studies, confirmed their existence. But the executive, Dr. Robert J. Spiegel, said the companies had not considered the studies scientifically important enough to publish their findings. Some may eventually be published, he said.
I can't believe I just fucking read that. Here's a wild, crazy idea. Publish the studies, the way you are supposed to publish every single study done since October 2002, and let scientists not on Big Pharma's payroll decide what is scientifically important. That's why the clinical trial database was set up in the first place you numbnuts.
There is at least one big-ass scientifically important study involving Zetia going on at the moment though. It's called Enhance. Big Pharma loves to give its studies cute sounding names. Enhance is the effectiveness study I mentioned at the top of this post whose data Merck and Schering are sitting on while they
Schering spokesman Lee Davies, disclosed this week that some patients in the Enhance trial had been dropped from it after tests showed that they had elevated liver enzymes — a potential sign of organ damage. But Mr. Davies said he could not disclose how many.
Why not? If the number were zero I'll bet you he'd be disclosing it. I think the story here is that Schering spokesman Lee Davies would not deny that 100% of patients in the Enhance trial had to drop out because of elevated liver enzymes. If Schering spokesman Lee Davies would like to issue a denial that 100% of patients in the Enhance trial had to drop out due to liver damage, I will happily print it here. Until he does though, all we know is that the number of people who had to drop out of the Enhance trial due to elevated liver enzymes is somewhere between one patient and all the patients. I'm sure Merck and Schering have a good reason for keeping us in the dark about this though.
There are also no studies that show Zetia actually lowers the number of heart attacks or deaths in people who take it. Unless Merck and Schering are sitting on that data as well. Don't bet on it.
4 comments:
Wow. All I can say. 'Wow'
As actions like these become more commonplace in the USA of post-Reagan deregulation and dubyaw shimmyshammy, it's difficult to think how images of FDA and American drug industry can or will ever be repaired. Still, it was 20years ago when our pharmaceutics professors who'd spent time at Bethesda, MD were telling us that we'd believe a crock.., that 'we'd still be loved in the morning', if we thought the interest of big Pharma was improvement of the nation's health.
What's really sad is that this comes as noooooo surprise to me. None at all. This summer I read "Overdosed America: The Broken Promise of American Medicine" (by some guy whose name I don't remember--Googlicize the title if you really care) and since then have regarded drug companies with even more measured distrust. Not to mention the fact that they turned my Pulmicort Turbuhaler into a Flexihaler, told me it was now less effective, and told me where I could shove it if I didn't like it. Thanks, AstraZeneca! Now, Pfizer, I really have to say I'm surprised you haven't come up with an XR sertraline product to extend your patent...it's what all the cool kids are doing. Blaargh.
I agree with your concerns about the unpublished studies. I wonder, though, if you are aware that the drug companies changed their minds about changing the primary endpoint (see below).
Drug firms' about-face brings researcher relief
By RON WINSLOW
THE WALL STREET JOURNAL EUROPE
December 18, 2007
The lead researcher of a long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly sponsored trial.
Under mounting criticism, the companies last week reversed the decision to change the primary measure to evaluate the drug. The study tested whether a combination of Schering-Plough's Zetia and Merck's now off-patent cholesterol drug Zocor works better than Zocor alone.
The results are crucial for Vytorin, a pill that combines Zetia and Zocor and is sold through a joint venture between Merck and Schering-Plough. Vytorin and Zetia's combined sales are expected to reach $5 billion this year, double their 2005 level. A positive result would strengthen the case for the $3-a-day Vytorin in high-risk heart patients over the cheaper generic form of Zocor alone.
A spokesman for Merck/Schering-Plough said the plan to change the analysis was based on the advice of an expert panel to focus on a more reliable measure of the drug's effectiveness. But after considering other views, the companies decided to go back to the original plan.
John P. Kastelein, a cardiologist at Academic Medical Center, Amsterdam, and principal investigator of the study, says he breathed a "sigh of relief" when the companies told him they were reversing course. "It's never, ever right to change the primary endpoint of a study," especially after the data are in, he says. "It is statistically not good, and it gives the wrong impression to the outside world." He says he initially went along with the plan but regrets not firmly resisting it from the outset.
The study is intended to determine if the combination treatment outperforms Zocor in slowing or reducing the accumulation of fatty deposits in the carotid arteries that carry blood to the brain. The study was initially designed to measure changes in the thickness of the carotid artery walls after two years of treatment. That measurement was taken at six points -- three locations in each artery -- and would serve as the study's primary endpoint.
The study was completed in April 2006, and results initially were expected by the end of last year. But Dr. Kastelein says new technology used to record ultrasound images of the carotid arteries, changing regulatory demands and other factors played a role in delaying reading of the tests.
When the findings weren't on the agenda for last month's American Heart Association meeting, some cardiologists expressed concern the companies were holding back on reporting negative results, according to accounts reported by Forbes.com. The companies say they don't know the study's outcome.
Meantime, Dr. Kastelein says, as data were turned over in batches, the companies noticed some images were missing; other data suggested "biologically implausible" changes in patients' carotids. The companies worried these images would undermine the results, he said.
Dr. Kastelein says such issues were anticipated in the design of the study. He says a disagreement over what to do about the problem went unresolved last summer.
The companies say that with Dr. Kastelein's agreement, they assembled a group of experts in both carotid imaging and statistics on Nov. 16 to determine what course to take. The experts' advice was to focus the primary analysis on one spot in each carotid artery, instead of three. The single measurement would yield a more valid result, the experts said.
The companies told Dr. Kastelein of the plan to make that measure the primary endpoint, and disclosed the decision in a news release Nov. 19. The new plan would "expedite" reporting, they said.
The decision drew a wave of criticism, including the launch last week of a U.S. congressional inquiry. The companies say their decision to go back to the original plan was made before they heard from Congress. They say the data will be ready to present in March. The look at the single location will also be reported.
--Sarah Rubenstein contributed to this article.
Write to Ron Winslow at ron.winslow@wsj.com
marilynmann,
No, I wasn't aware Merck & Schering had removed their heads from their asses regarding the endpoint change. I will, however, take full credit.
Thanks for the scoop. It takes a village.
DM
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