Sanofi-Aventis, Medtronic under scrutiny in press reports

May 27 2011

ProPublica details alleged activities by Sanofi-Aventis to influence regulators regarding its brand-name blood thinner, Lovenox, while other news outlets report on Medtronic's activities related to a biological agent used in back surgery.

ProPublica: E-mails Show Drug Company Used Third-Party Medical Groups To Influence Regulators, Undercut Rivals
Facing what it called "an imminent threat" to its brand-name blood thinner, Lovenox, pharmaceutical company Sanofi-Aventis launched an advocacy campaign to influence the U.S. Food and Drug Administration to delay generic competitors, according to [a new Senate Finance Committee] report. It did so by contacting medical societies and researchers, urging them to write in to the FDA — or in one case, to write an advertorial for The Wall Street Journal — to raise safety concerns about generics (Wang, 5/25).

The Milwaukee Journal Sentinel: Researchers Get Royalties, Papers Omit Sterility Link
Since 2002, Medtronic and a group of doctors with financial ties to the medical device company were aware that a new biological agent used in back surgery was linked to sterility in men. But that crucial information was not revealed in medical journal articles written by those doctors, including surgeons who would receive millions of dollars in various royalties from Medtronic. Prompted in part by Journal Sentinel stories, independent researchers at Stanford University looking at their own patients have found strong evidence connecting the lucrative product to retrograde ejaculation, a condition that causes sterility in men (Fauber, 5/25).

Minneapolis Star Tribune: Study Links Medtronic Product To Sterility Risk
A study released by a medical journal Wednesday suggests that a bone-growth product that Medtronic Inc. markets for back surgery may lead to increased risk of sterility in men. The study, published in the June issue of the Spine Journal, analyzed 243 patients who underwent some types of back surgery and found that those treated with the Medtronic product experienced higher rates of temporary and permanent sterility (Moore, 5/25).