Last April, journalist Ray Moynihan wrote this Crikey article revealing that public hospital “guidelines”, recommending widespread use of a group of drugs to stop serious blood clots, had been funded by Sanofi-Aventis, the company that makes one of these drugs.
Moynihan subsequently also reported that an international PR firm Fleishman-Hillard, was involved in a high-profile campaign, involving Sanofi-Aventis, to raise public awareness about blood clots in Australia.
The campaign generated headlines claiming blood clots are more deadly than AIDS, and articles suggesting drug injections for at-risk patients in hospitals could become mandatory, quoting a doctor saying “all patients should be given the prophylaxis.”
Moynihan’s article quoted a specialist, Professor Alasdair Millar, saying that suggestions like these were extreme and could “cause more harm than good.”
Those who followed this story are likely to be interested in a series of articles just published in the Medical Journal of Australia.
In an article that would do an investigative journalist proud, Millar details the ties between Sanofi-Aventis and the expert panel that developed the guidelines, “Prevention of venous thromboembolism: best practice guidelines for Australia and New Zealand, fourth edition”.
He says the guiderlines “have achieved widespread dissemination and acceptance in Australia despite being produced by an autonomous group and not having been peer-reviewed.
“Two major factors appear likely here — first, the Guidelines are sponsored by a global pharmaceutical company and are professionally marketed; second, clinical quality and safety bodies appear to have adopted them “on trust”, without further independent assessment.
“I believe there needs to be greater transparency of all aspects of guideline production, and that current standards need to be more closely adhered to.”
The MJA’s editor, Dr Martin Van Der Weyden, has also commented on the “disquiet” surrounding the guidelines.
He says: “The Guidelines were published in booklet form by a company part-owned by a member of the Working Party, and were supported by a grant from a pharmaceutical company that manufactures enoxaparin, a low molecular weight heparin recommended in the Guidelines for prophylaxis and treatment of venous thromboembolism.”
Van Der Weyden says that in light of the NHMRC criteria for guideline development, these ones can be criticised for:
- the apparent lack of independent peer review
- the lack of comprehensive declarations of conflicts of interests in a setting where at least a perception of pecuniary interest is possible
- failure to provide levels of evidence or costing for the recommendations
- a failure to include a full and readily available list of the references on which the evidence for the recommendations are based
- a failure to divulge the precise writing process and the details of the relationships between the publisher, the Working Party in general, and individual Working Party members and the sponsoring pharmaceutical company
- publication as a booklet that was initially distributed only by the sponsor, and thus not easily or independently accessible.
Van Der Weyden has also argued that it is the medical profession’s responsibility to put patient care ahead of industry marketing, and suggests a national policy covering medical-pharma interactions may be needed.
He says: “The profession’s individual members are obliged to maintain a respectful distance from the pharmaceutical industry and show some disdain for the apparent benefits of pharmaceutical sponsorship — to avoid being stabbed, one should not waltz too closely with the porcupines!”
The journal also publishes a response from Professor John Fletcher, who chaired the working party that produced the guidelines.
All of this raises some interesting and important questions including: should health departments, hospitals, safety and quality groups be reviewing their support for these particular guidelines as well as their approach to endorsing and disseminating guidelines generally?
