There is a storm brewing around Zetia, Merck and Schering Plough’s blockbuster cholesterol-lowering drug. However, let me preface this post by reminding everyone that all drugs have side effects and if a drug’s benefits outweigh its risks then it will likely be prescribed to patients. That said, new evidence has been uncovered which shows that Merck, and Schering Plough, conducted at least 8 clinical trials from 2000 to 2003– to evaluate Zetia’s risk to the liver when taken with other cholesterol-lowering drugs (statins) – but chose to not publish the results of those studies. This is what we know about Zetia:
- Zetia has annual sales of over $ 5 billion
- Despite no evidence that Zetia’s cholesterol-lowering ability actually reduces the incidence of heart attack or stroke in patients who take the medication, it was approved by the US FDA in 2002. A 10,000 patient Zetia clinical study called ENHANCE is currently underway to determine whether the drug’s ability to lower cholesterol really translates into a reduction in heart attacks and strokes
- Millions of people who take Zetia also take statins such as Zocor, Lipitor, Pavachol, Crestor and Mevacor to lower cholesterol (Vytorin, Merck’ new cholesterol-lowering drug contains Zetia and Zocor in a single pill)
- From 2000 to 2003 Merck and Schering Plough conducted 8 long-term safety studies of Zetia in combination with a variety of statins but only published the results from 3 of the 8 studies. Also, the unpublished studies were not listed on industry websites where companies are supposed to register by law the results of all ongoing clinical trials after 2002 (because some of these trials were initiated before 2002 the law does not apply to them)
- FDA supposedly reviewed the results of the unpublished studies and approved Zetia use with statins anyway
- Prior to its approval in 2002, at least one internal FDA reviewer recommended that Zetia not be approved for use with statins because the combination caused liver disease in animals. Also, since 2006 a number of case reports have been published in medical journals that suggest the combination of Zetia and statins has caused severe liver damage in some patients
- In the US, Zetia’s product label only contains mild warnings about the drug’s potential to cause liver damage. However, since 2005, product labels in Canada and Australia have carried strong warnings about Zetia’s potential to cause hepatitis, pancreatitis and depression—warnings that have seemingly been ignored in the US
So what do Merck and Schering Plough have to say about the results of the unpublished safety trials?
According to the New York Times, Dr. Robert J. Spiegel, Schering Plough’s Chief Medical Officer said “The companies had not considered the studies scientifically significant enough to publish their findings. Some may eventually be published.” Similar statements were made by Merck executives about Vioxx’s safety after they pulled it from the market! Not surprisingly, most of the safety studies that were published by Merck and Schering Plough generally played down the liver problems associated with Zetia and statin combination therapy.
Although many physicians still think that Zetia is safe, I believe that the failure of Merck and Schering Plough to promptly and openly disclose all research about the drug may be leaving the American public with a misleadingly favorable view of Zetia’s safety and efficacy (sort of like Vioxx). For the past 8 years or so, FDA has been slow in issuing safety warnings and demanding label changes for many widely used drugs like Merck’s pain killer Vioxx, GSK’s diabetes medication Avandia and Lilly’s anti psychotic drug Zyprexa that have turned out to carry serious safety risks. I think that it is time for FDA to “step up to the plate” and do its job—provide Americans with SAFE and efficacious medicines. Also, I hope that pharmaceutical companies are beginning to realize that they must be more forthcoming about the safety of their products if they want Americans to use them. Finally, and perhaps most importantly, drug company profits should never come at the expense of patient safety—NEVER!
Until next time….
Good Luck and Good Job Hunting!!!!!!!!!!!
that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain. 
