And a decade after Union... and 12 years after... hello.
Can you say... anything at 8:24 am? Smile....
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 Times' most-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.
3 comments:
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
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.
Hey again -- here now 16 years to the day after I wrote this...
And a decade after Union... and 12 years after... hello.
Can you say... anything at 8:24 am? Smile.
Post a Comment