Cholesterol Combo Con Job

“Millions of patients may be taking a drug that has no benefits for them, raising their risk of heart attacks and exposing them to potential side effects. Physicians should now stop using Zetia or Vytorin as a primary therapy for patients with high cholesterol.” – Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.

Yesterday Merck (MRK) and Schering-Plough (SGP) announced that their jointly marketed drug, Vytorin, a one pill statin combining SGP’s Zetia with MRK’s Zocor (now available as a generic), failed to show any medical benefits. In fact, plaque actually grew faster in Vytorin patients than those taking Zocor alone! These are the findings from the Enhance study trial that MRK and SGP completed in April 2006, but withheld despite numerous requests from the House Committee of Energy & Commerce.

When Dr. Nissen talks, the Street better pay attention. Despite Dr. Nissen being the big kahuna of all things cardiovascular, Wall Street is standing by their statin. Yesterday analysts at Bank of America (BAC) and Morgan Stanley (MS) reaffirmed their ratings on Schering Plough (SGP). Goldman’s James Kelly reaffirmed his Buy rating, calling the Enhance study results a “nonevent”.

One wonders how much analysis is actually behind the ratings. A consumer would have to be living in a cave not to have heard the news. Even with enticements from MRK and SGP, will doctors still prescribe Zetia and Vytorin? Will patients still be willing to pay up to swallow a pill they know will harm them, AND pay more for the “privilege”? At this point, why would insurance companies keep Zetia and Vytorin on their formularies? The drugs will probably be dropped from the British government’s formulary since their policy is to only pay for performance.

The biggest factor against Vytorin and Zetia’s $5 billion a year (and comprising about 70% of SGP earnings) gravy train is the FDA. Wall Street knows the FDA tends to favor big pharma; otherwise it would have forced MRK and SGP to immediately withdraw the drugs from the market. Congress is continuing to investigate, raising the possibility that Dr. Nissen might be called to testify. At that point, Wall Street may need to readjust their ratings.

RELATED POST: “Lipitor’s Limits”

New York Times: “Study Reveals Doubt on Drug for Cholesterol”

Yahoo! Finance: “Schering Shares Fall on Vytorin Study”

Wall Street Journal: “Study Deals Setback to Cholesterol Drug”

USA Today: “Cholesterol-lowering drug Vytorin comes up short vs. statin in study”

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