Don't Worry About Vytorin's Cancer Risk

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Investors have a lot to worry about: Is it really worse than they think? Can they make money in a bear market? What kind of spatula should they buy? But they shouldn't worry about the current rumblings in Washington regarding the safety of Merck's (NYSE: MRK  ) and Schering-Plough's (NYSE: SGP  ) Vytorin.

Two Congressmen have requested 10 years worth of information about the drug's development, after the SEAS trial suggested that Vytorin might cause elevated levels of cancer. The trial found 93 cancer cases among subjects taking Vytorin, compared with 65 taking a placebo, but researchers concluded that it was an anomaly associated with the small size of the trial. When the data was combined with data from another trial, the increase went away. The types and timing of the cancers seen in the trial also weren't consistent with the hypothesis that the drug was causing the tumors.

The FDA is also jumping on the investigation bandwagon; it plans to evaluate the data once it receives the information from the doctors who ran the SEAS trial. One has to wonder whether the agency received pressure from the aforementioned Congressmen, considering that one of them asked the agency for a preliminary copy of the SEAS report a few weeks ago. Welcome back to the wonderful world of congressional investigations, Merck and Schering.

While I don't think that the investigations are likely to turn up anything, investors should at least keep up with the amount of news surrounding the probe. If the media continues to play this up, patients might just switch to other cholesterol drugs from Pfizer (NYSE: PFE  ) , AstraZeneca (NYSE: AZN  ) , or Abbott Labs (NYSE: ABT  ) before the verdict is in.

As investors in drugmakers are all too familiar with, unknown -- and sometimes known -- side effects can cause huge drops in a company's stock. Hopefully for investors, talk of this, to me, non-existent side effect dies down as fast as it popped up.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is a pick of both the Income Investor and Inside Value newsletters. The Fool has a disclosure policy.

Read/Post Comments (3) | Recommend This Article (1)

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Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On August 22, 2008, at 4:48 PM, publichealthdoc wrote:

    I'm a physician with a Masters in Public Health. Whereas the data from the SEAS study does not prove that Vytorin causes cancer, I believe that the FDA is approprietly exercising their critical role by reviewing the clinical trial data.

    The fact of the matter is that there are several statins on the market for many years that have never been proven to cause cancer.

    Why not stay with a time tested statin therapy while the FDA is investigating the potential cancer safety signal from Vytorin?

  • Report this Comment On August 23, 2008, at 5:21 PM, publichealthdoc wrote:

    I wrote a medical thriller novel called TERMINAL NEGLECT that is is being published next month. It is a fictional account of what could happen if the drug oversight process in America is infiltrated by those with a conflict of interest or by those who do not fully support the sconcept of safety of prescription medications.

  • Report this Comment On August 30, 2008, at 1:40 AM, balcoth wrote:

    There is a possibility that zetia might inhibit the absorbtion of plant sterols and stanols. If this is the case, and these agents have some sort of anti-carcinogenic properties, that may account for the increased rate of cancer in the active agent arm of the trial. Several if's, but worth a thought.

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