FDA Investigates Vytorin Link To Cancer
4 CommentsBy Ed Silverman // August 21st, 2008 // 4:32 pm
One month after the curious finding that a few dozen cancer and cancer-related deaths were found in a Vytorin trial called SEAS, the agency has decided the results warrant its own investigation.
Earlier today, the House Energy & Commerce Committee stepped up its own probe of the controversial cholesterol pill by demanding Merck and Schering-Plough, which jointly market Vytorin, turn over documents relating to the trial and its analysis. The FDA expects to receive a “final” report from the drugmakers in three months.
In announcing its investigation, the FDA notes that “interim data from two large ongoing cardiovascular trials of Vytorin – the Study of Heart and Renal Protection (SHARP) and the Improved Reduction in High-Risk Subjects Presenting with Acute Coronary Syndrome (IMPROVE-IT) – show no increased risk of cancer with the combination of simvastatin plus ezetimibe. The SHARP trial is expected to be completed in 2010. The IMPROVE-IT trial is scheduled for completion around 2012.”
The “FDA is aware of previous reports suggesting a link between low on-treatment cholesterol levels and an increased risk of cancer. A 2007 pooled analysis of 16 studies with 23 statin drug arms, published in the Journal of the American College of Cardiology, reported an association between the level of LDL-cholesterol achieved and incident cancer in patients receiving a statin. However, most large prospective studies of statin drugs have reported no difference in cancer incidence between the active and placebo arms.”
One theory being kicked around - Vytorin inhibits cholesterol absorption (as opposed to removing cholesterol from the blood like statins). But Vytorin also inhibits absorption of dietary plant sterols, and so maybe the reduction in sterol absorption in the patients in the SEAS trial may have increased their risk of contracting cancer. A tentative hypothesis: by inhibiting absorption of dietary plant sterols in the Vytorin group in the SEAS trial, the drug could have promoted the development and/or progression of cancer. PM at GoozNews first floated this notion recently. “There’s a body medical literature that says those very plant sterols can inhibit the growth of cancer,” says Steve Nissen of the Cleveland Clinic Foundation.
pharma PR hack
I don’t think this really captures the essense of where the debates should be. Here is my problem with cholesterol lowering drugs– cholesterol is just a risk factor– and lowering cholesterol only reduces risk. It doesn’t prevent disease in the sense that you are for sure going to get it and you are for sure going to prevent it. But side effects or consequences of any drug are a certainty.
This is from the FDA’s release:
An elevated LDL-cholesterol level is an established risk factor for heart disease and lowering cholesterol reduces the risk of death from heart disease and stroke. Patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have questions about whether to continue to take the medication. Until further information is available, healthcare professionals and caregivers should continue to monitor patients taking Vytorin as outlined in the prescribing information.
BP Watch
Somebody has to! Can’t leave it up to MSP and Sir Richard! Too much at stake for both of them. Sounds like a whitewashing!
CV MD
Duh! Nobody should be thinking it’s the statins! It’s potentially the ezetimibe!
Lipid Doc
If I remember correctly, the results for cancer incidence were clearly significant (p<0.02), while the results for cancer death were at p<o.o5. This doesn’t seem to be an “anomaly.”