Drugmakers delayed release of damaging data on Vytorin for months

According to emails released yesterday by the Senate Finance Committee, Merck & Co. and Schering-Plough Corp. delayed publication of negative results from a study involving their cholesterol drug, Vytorin. They withheld the data for months, despite concerns expressed by the lead researcher about the delay. Millions, or possibly even billions, of dollars in sales were generated as a result of the drugmakers’ decision to place their interests over the best interests of the public.

>>PRIOR POST (1/15/2008): Concerns about Zetia and Vytorin Side Effects
following data which suggests drugs have limited benefits

Vytoring is a cholestoral drug which combines Merck’s Zocor with Schering-Plough’s Zetia. The controversy surrounds a long term study which followed about 720 individuals with very high cholesterol. The study, known as ENHANCE, found that the expensive combo drug worked no better than inexpensive, generic statins, such as Zocor, taken alone.

Although the study ended nearly two years ago, Schering-Plough and Merck delayed the publication of the results, and only released preliminary findings in January after intense pressure from the media and medical community. The full study was released Sunday, at the annual meeting for the American College of Cardiology. However, internal emails indicate that the data should have been released as early as November 2007, at the meeting of the American Heart Association.

In a disturbing internal email from John Kastelein, the lead researcher on the study, he wrote to an executive from Schering that, “you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!”

Vytorin and Zetia generated annual sales of about $5 billion in 2007. While the data was available and being withheld, the companies continued to run their heavy marketing campaign with direct to consumer television ads indicating that individuals concerned about their cholesterol should talk to their doctor about getting a prescription for Vytorin.

The findings that Vytorin is no more effective than cheaper, generic drugs has resulted in substantial lost sales for Merck and Schering-Plough. Given the number of prescriptions written each day for the medication, the delay in releasing this damaging data raises serious concerns about fraud. The Senate Finance Committee is requesting additional documents from the drug makers, as government funded Medicare and Medicaid insurance programs pay for many of the prescriptions.

The drug makers could face severe consequences from their decision to delay the data, including legislative scrutiny, fines and Vytorin class action suits. However, with the huge financial stakes involved with prescription medications, many are concerned about whether anything will convince pharmaceutical companies that they can not place their desire for profits about the health and good of the public.