Sunday, July 6, 2014

MSD Italy Using Legal Process -- To Stifle Scientific Dissent? Does The Case Of Zetia® Echo. . . That MSD Vioxx®-Era?

A very dear friend of the blog, online -- and in life, since the 1990s -- has pointed me to this. If she'll consent, I'll give her public credit -- via a link to her fine evidence based life sciences blog, right here. [Hint Hint.] Now, on with. . . the show!

It seems that (in an eerie echo of the 2002 to 2004 Vioxx® era spats) a local Italian MSD affiliate has threatened a recalcitrant academic with a lawsuit, to end his advocacy about the clinical outcomes benefit (or lack thereof) of Zetia® (ezetimibe). Of course, the global scientific debate about that has been raging since 2006 at least. So this seems just a little bit over the top. Doubly so, if one believes that some time in December of this year, we may finally learn whether Zetia with a statin, called Vytorin® (in IMPROVE-IT) is showing any real clinical outcomes benefit -- for some 32,000 cholesterol management patients, worldwide. [That is to say, the proverbial fat lady is clearing her throat now, at least. And, as in Vioxx, Merck may end up eating quite a bit of crow, if as many now suspect -- IMPROVE-IT actually generates a null-result. See count-down clock, at left.]

Here (do go read it all!) is The British Medical Journal, on it -- just published July 4, 2014:

. . . .The Italian branch of the drug company Merck Sharp and Dohme (MSD) has stopped a leading public health doctor and administrator from circulating texts to GPs advising them about the use of one of the company’s drugs.

In the texts, Alberto Donzelli—the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare)—had analysed the published evidence on the cholesterol lowering drug ezetimibe and discouraged its prescription in addition to statins.

A letter telling Donzelli to “cease and desist” was sent in February by MSD’s medical director, Patrizia Nardini, and was cosigned by the company’s director of legal affairs. They accused Donzelli of serious misconduct and a breach of medical ethics and threatened to sue him and Milan Healthcare for as much as €1.3m (£1m; $1.78m). The letter was addressed to Donzelli, with a copy sent to Milan Healthcare’s director general and to the president of the Order of Physicians of Milan (the doctors’ regulatory body), Roberto Carlo Rossi. . . .

Enjoy those last few beach-side open fired S'Mores. . . I know I will. And thanks, Marilyn!

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