Sanofi at Center of Controversy Over "Best Practice" for Heparin Use in VTE Cases

Sanofi-Aventis sponsored a set of “best-practice” guidelines for dealing with venous thromboembolism in Australia that has become controversial because of their recommendation of prophylactic use of heparin (a Sanofi drug), and because the guidelines were not properly peer-reviewed even though doctors widely took them as gospel. Patients who are given heparin run a risk of bleeding.

The guidelines were, at one point, only available in a booklet distributed by Sanofi, and were published by a company that had no address, no phone number, no web site and no email address of its own.

In the Medical Journal of Australia, the guidelines are criticized for:

… failure to divulge the precise writing process and the details of the relationships between the publisher, the Working Party [of authors] in general, and individual Working Party members and the sponsoring pharmaceutical company; and

… publication as a booklet that was initially distributed only by the sponsor [Sanofi], and thus not easily or independently accessible.

The guidelines were titled “Prevention of venous thromboembolism: best practice guidelines for Australia and New Zealand.” The author of the MJA article, J Alasdair Millar, criticizes the guildelines for their murky origins, and possible conflicts of interest:

… neither the Guidelines nor the Working Party have a specific website. Unlike similar overseas guidelines on the prevention of venous thromboembolism (VTE) which have been published in peer-reviewed journals, these Guidelines have only been published in independent booklet form …

… The current (fourth) edition of the Guidelines acknowledges commercial sponsorship by a “non directed” grant from Sanofi-Aventis, the manufacturer of the LMWH enoxaparin. This implies that the Working Party receives funds from the sponsor but retains editorial discretion, although the precise funding mechanism is uncertain. Some of the Working Party members have disclosed additional financial associations with Sanofi-Aventis in an editorial previously published in this Journal. No acknowledgement of sponsorship was present in the third edition of the Guidelines, so the sponsorship is either new or previously unannounced. The provisions for medical prophylaxis are the same in both editions.

The Guidelines are published by Health Education and Management Innovations (HEMI) Australia Pty Ltd, which is incorporated in New South Wales. In a shared website, HEMI describes itself as providing “a ‘broker’ service between clinicians and the healthcare industry”. At the time of writing, the company had no telephone number listed in the White Pages, no easily accessible public address, no dedicated website detected by Google, and used a generic email address (hemiaustralia@aol.com).

A plain-English report on the controversy can be found in The Age.