Today’s New York Times Editorial — on Vytorin and Zetia. . . .

I debated about holding this until the end-of-day, Friday — or, posting on it, over the weekend — inasmuch as it breaks no real “new” ground on the Vytorin/Zetia v. other therapies questions. . . . but on the chance you haven’t already seen it, do go read this editorial, in full. ‘Tis very sober, balanced and still very troubling — here’s a snippet:

. . . .The risks and benefits of a best-selling anti-cholesterol drug remain thoroughly muddled despite a new analysis that purports to exonerate it from the worst safety concerns. For now, patients and doctors are best advised to use Vytorin only as a last resort when other treatments have failed. . . .

A huge marketing effort propelled Vytorin and Zetia to blockbuster status. Then the bad news started coming in. A small clinical trial indicated that while Vytorin reduced cholesterol levels, it failed to slow the growth of fatty plaques in the arteries. A second trial showed that Vytorin did not help people with heart-valve disease avoid further heart problems. Worse yet, that trial suggested that Vytorin increased the risk of developing and dying from cancer. . . .

The F.D.A. will conduct its own analysis of the cancer risks. The agency also needs to evaluate whether it should demand larger and more definitive clinical trials before approving certain drugs. Meanwhile, millions of people are still taking Vytorin and Zetia without knowing whether they are safe and clinically effective. . . .

By the way — here’s the Timesmost-recent actual reportage on Vytorin/Zetia — from Monday, of this week — as a reference point.

Expect these sorts of articles and editorials to come into play at the Senate Health Care Reform Hearings, starting next Tuesday morning. We’ll cover ’em — wall to wall. Bank on it.

2 responses to “Today’s New York Times Editorial — on Vytorin and Zetia. . . .

  1. Schering-Plough and Merck repsond to the NYT editorial:

    September 5, 2008

    Letter to the Editor
    The New York Times
    620 Eighth Avenue
    New York, NY 10018

    To the Editor:

    Today's editorial "Many Questions About Vytorin" continues the Times' record of publishing inaccurate information regarding VYTORIN. The editorial is inappropriate because it could interfere with the doctor/patient relationship, and may cause patients who need this medicine to stop taking it. Patients should take healthcare advice from their healthcare professionals, not the editorial pages of The New York Times.

    The fact remains that VYTORIN, when used in a manner consistent with the FDA approved label, is an excellent treatment option for patients with elevated cholesterol. Both Merck & Co., Inc. and Schering-Plough stand behind the efficacy and safety profile of VYTORIN.

    Finally, the assertion that VYTORIN was approved based on only a handful of "short-term clinical trials" is wrong, as we have tried unsuccessfully to explain to your reporter in the past. The filing of VYTORIN with the FDA included data from patients who were studied in excess of one year. To date, VYTORIN has been evaluated for safety in more than 10,189 patients in clinical trials. In addition, large scale, outcomes trials involving 21,000 are ongoing. Times readers deserve to know the facts.

    Peter S. Kim
    President, Merck Research Laboratories
    One Merck Drive
    Whitehouse Station, NJ 08889-0100

    Thomas Koestler
    President, Schering-Plough Research Institute
    2015 Galloping Hill Rd.
    Kenilworth, NJ 07033-1300

  2. My reaction (to that letter)?

    “. . . .in excess of one year. . . .”

    Does not strike me as a particularly “long-term” trial — not for a medicine, once started, most patients will stay on — for the rest of their natural lives. . . .

    Nope — I’d say that the companies’ letter tells us less about Vytorin’s strengths — and more about its weaknesses.

    Your mileage may vary — in fact, I am sure it does.

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