Whytorin? HHS Spends Millions On The Drug

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money-23Given the controversy over the Arbiter trial, which found Abbott Labs’ Niaspan appeared safer and more effective than Merck’s Zetia as a secondary cholesterol treatment, the Senate Finance Committee’s Chuck Grassley wants to know what the Department of Health and Human Services will do about spending on Vytorin (which is a combination of Zetia and simvastatin).

In a letter to HHS Secretary Kathleen Sebelius, he notes that Merck and Schering-Plough (which jointly sold Vytorin before Merck acquired its marketing partner this year) made more than $300 million in 2006 and 2007 through Medicare Part D sales of Vytorin. His point - why is HHS spending all that money now that a second clinical trial has raised questions about Vytorin’s effectiveness.

Meanwhile, Forbes notes that the only trial underway to provide a definitive answer about Vytorin’s effectiveness is an 18,000-patient study Merck began in 2005, comparing Zetia with a placebo. But this won’t be complete until June 2012, and so far, 15,000 patients have enrolled. One problem, Elliott Antman, a cardiologist at Brigham and Woman’s Hospital in Boston, tells Forbes is that the bad press may cause patients to withdraw from the study or become skittish about enrolling.

And Cleveland Clinic cardiologist Steven Nissen tells Forbes the FDA should have demanded Merck begin a big study comparing Zetia with a placebo upon approval. If regulators had done this, the big Merck trial might have been finishing up by now. Instead, the trial didn’t begin until Zetia had been available for three years. He also points out that patients in the study are sicker than the average heart patient and that the results may not translate to most patients who take Zetia or Vytorin.

Money thx to Flickr Creative Commons AMagill

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  1. In truth, it is only a matter of time — time for the gears of the machinery of the governmental reimbursement bureaucracy to fully-engage — before Vytorin/Zetia is a Tier III drug, or dropped to the lowest tier of reimbursement, and thus assigned the highest level of out-of-pocket co-pay — often over 70 percent for Tier III drugs. Inother words, the consumer will pay over 70% of the cost for a drug that costs ten times what a generic statin, plus niacin, does. . . .

    I hat-tiiped your PDF of letter — thanks, Ed!

    Namaste

  2. To my friends and defenders of Niaspan vs. zetia.
    “Niacin not beneficial in patients at goal with statins: NIA Plaque”

    This is exactly the same conclusion, expressed differently. Niacin does not help outcomes in patients already treated for LDL.

    And Niaspan is very expensive niacin.

  3. Why would anyone pay for a drug with no proven benefits? Just saying

  4. Exactly…and niacin has been shown to have no benefits on patients who are at goal with statins.

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