Zetia: Just the Latest Chapter in Hiding Data

There have been many interesting posts written about how data regarding Zetia were buried for quite some time. One of the main storylines in this saga is that it took about two years after the study was completed to analyze and release the data. The most disappointing aspect of this story is that few if any outlets are noting that this is not a fluke event.

Clinical trials are a huge part of how drugs are marketed. After examining clinical trial data, physicians who prescribe their drug believe they are engaging in evidence-based medicine. Granted, most physicians have little training in actually understanding statistics or research design, which are key in understanding clinical trial evidence. But that's not the point of this post...

The point is that Zetia is just the latest chapter in a lengthy volume of hidden clinical trial data. Here's one study in which it appears that data were reported on 1 of 15 participants. There was also a study examining Zoloft for PTSD in which data were reported about 10 years after the end of the study. How about suicide attempts apparently vanishing from a study report on Prozac? And a 5-6 year delay in reporting results on Effexor for depression in youth?

The above reports on hiding data were all based on studies I encountered randomly. I did not go fishing to find studies which published their data many years after it was collected or only reported a partial picture of their results. I was just looking through journals and happened to run across the studies mentioned above. Publication bias does not just occur when negative results are simply not published (which seems a fairly common practice), but it also occurs when negative results are published after a long delay. Delaying negative data means raking in more cash before the negative data reduces prescriptions for a product.

So you can be outraged by the Zetia story if you'd like, but please don't act surprised. Similar events will happen again and again and again.

Update: Welcome to those of you who have clicked the link from the Wall Street Journal. Please take a look around to find a series of documented incidents where science has been overrun by marketing. Add comments as you deem appropriate.

Zetia: But Why Would We Show You the Scary Data?

Alex Berenson has potentially unearthed another December Surprise for a major drug company. You may recall that last December, Berenson started writing on the Zyprexa mess (1, 2), which everyone can now read about through accessing the now-infamous Zyprexa documents over at Furious Seasons.

It now appears that there have been at least three unpublished studies regarding the health effects of Merck/Schering Plough's anticholesterol drug Zetia that point to the drug causing liver problems. Read the full article at the New York Times. Only time and a little sunshine on these studies will reveal whether this is a big story, but it is important to note that this is not particularly surprising -- on this modest blog, I have documented several incidents of data pointing to poor efficacy and/or drug risks being buried (1, 2, 3, 4, 5, 6 are just a few examples). Many other blogs, newspapers, and other sources have also documented such problems. Hiding data is an everyday occurrence. For whatever new medication is approved, the public dissemination of risks and benefits are managed by the sponsoring company and what would be the company's motivation to provide data that paint a scary picture of their new drug?