Monday, July 07, 2014

Larry Husten writes

Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy

In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck . The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve clinical outcomes. Despite the controversy, in 2013 the drugs had combined sales of more than $2.6 billion.

MSD Italy, the Italian arm of the company, sent two “cease and desist” letters to Alberto Donzelli, who is “the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare),” according to The  BMJwhich published a news report of the affair. The letter was also sent to Milan Healthcare’s director general and to Roberto Carlo Rossi, the president of the physicians’ regulatory organization in Milan.

As reported in The BMJ, after the first letter Rossi replied that the medical commission had concluded “that there was no reason to object on ethical grounds to Donzelli’s behaviour. Donzelli also replied to each point raised in the letter. ‘I exercised my right to tell the general practitioners what emerged from our in-depth analyses of the published literature, on a peer to peer basis.’”

In a second letter MSD Italy “reaffirmed its intention to go to court unless Donzelli stopped his ‘seriously damaging activity, [that was] tarnishing the company’s and the drug’s image and reputation.’” MSD’s medical director, Patrizia Nardini, told The BMJ: “We are in favour of balanced information, and we decided to write those letters because we didn’t see a willingness to evaluate all the information in a balanced way.”

Last month Donzelli capitulated and removed the contentious material from his website “until the issue is further clarified within the scientific community,” The BMJreports.

In a published statement, quoted by The BMJ, the editors of five Italian publications expressed support for Donzelli: “In the educational and informational process, the disagreement should be expressed on the pages of scientific journals as a debate among peers, including the readers who will be able to decide freely what is the most appropriate choice for patients.”

Donzelli is hardly alone in criticizing the continued use of ezetimibe despite the absence of evidence for clinical benefit. Just recently, ACP Internist, an internal medicine blog, raised the question: “Why are we still prescribing what appears to be a useless drug?” The continued use of ezetimibe in clinical practice was also the subject of a news feature in JAMA.

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