Ezetimibe, a cholesterol-lowering agent that is a key ingredient of Zetia and Vytorin—both marketed by Merck—has been a subject of controversy since 2007, when it became known that Merck and its partner with ezetimibe at the time, Schering-Plough (with which Merck later merged), had been avoiding the analysis of study data that suggested the drug might have no actual benefit (Results of a large study intended to measure Vytorin’s heart-attack-preventing-potency are expected late this year).
The controversial nature of ezetimibe and the questioning of its efficacy got a renewed boost recently when the Italian branch of MSD (as Merck is known outside the United States and Canada) used legal threats to try to silence criticism of Zetia and Vytorin.
Specifically, MSD Italy sent two “cease and desist” letters—one in February and the other in May—to stop a leading public health doctor and administrator, Alberto Donzelli, from circulating texts to physicians advising them to curtail the use of ezetimibe. This affair was reported by the British Medical Journal on July 4.
The BMJ, which called Donzelli “the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare),” noted that 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.
Although Donzelli had analyzed published evidence on ezetimibe as part of his public discouragement of its prescription in addition to statins, he then took down his cautionary notes online—as he put it, “until the issue is further clarified within the scientific community”—in response to the second letter from MSD Italy and the threat of legal action. According to BMJ, MSD Italy accused Donzelli of serious misconduct and a breach of medical ethics and threatened to sue him and Milan Healthcare for as much as €1.3 million.
The cease and desist letter came from MSD Italy’s medical director, Patrizia Nardini (cosigned by a director of legal affairs), and she defended her company’s actions by saying, as BMJ reported, “We are in favor 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.” Once Donzelli removed the material, Nardini apparently indicated no legal action would be forthcoming in light of that removal.
However, things quickly took a turn after BMJ’s coverage and further coverage by Forbes on July 6 just a couple days later, when MSD Italy’s parent company entered the picture publicly.
According to updated Forbes reporting on July 7, Merck expressed regret over the use of legal threats by MSD Italy and the magazine quoted Merck spokesperson Steve Cragle as writing: “Merck is committed to the open and transparent exchange of scientific information. We believe this exchange should take place in medical meetings and peer-reviewed scientific publications. We believe this to be an isolated incident in Italy and regret how it was handled by our company. Merck has not taken any legal action in connection with this situation.”
Forbes noted that in a phone conversation with Cragle, the spokesperson said Donzelli could once again post his arguments regarding ezetimibe on his website without fear of legal retaliation by Merck. As far as taking actions within the company to perhaps prevent such legal threats in the future (and, as the BMJ reported, MSD Italy has reportedly used such tactics even before the Donzelli incident), Cragle told Forbes that Merck was reviewing the situation.
