Healthy Skepticism Library item: 19594

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Publication type: Media Release

Independent Doctors’ group Formindep wins two-year battle against French Health Authority (HAS) over conflicts of interests
FormIndep 2011 Jun 20
www.formindep.org

Abstract:

HAS forced to withdraw treatment guidelines on Alzheimer’s disease and type 2 diabetes, announces review of all guidelines for proper management of conflicts of interests.

Full text:

The French State Council, the country’s highest administrative court has ruled that the Haute Autorité de Santé (HAS), the national technology assessment body, has contravened its own rules on management of conflicts of interests. The charges were filed by a physicians’ organization, Formindep (Formation Indépendante), a non-profit group based in Roubaix, France, that promotes independent medical education and information. Formindep appealed before the French State Council after HAS refused to withdraw two professional guidelines on type 2 diabetes and Alzheimer’s disease. Formindep charged that the guidelines development process contravened national law on conflicts of interests and the Agency’s own internal rules.

Formindep reviewed these guidelines in March 2009 and found evidence that experts involved in guidelines development had failed to declare conflicts of interests. Amongst those who had declared their interests, several, including Pr Florence Pasquier who chaired the AD working group and Pr Serge Halimi who chaired the type 2 diabetes group, had ‘major’ conflicts of interests according to HAS criteria, including durable links as consultants to the companies marketing medicine for these diseases. HAS internal rules prohibit participation in guideline development in these cases.
Formindep asked for both guidelines to be withdrawn, given the lack of respect for rules governing conflicts of interest and the high risk of bias. Upon HAS’ refusal, Formindep appealed before the State Council in December 2009.
Formindep had examined these two guidelines because of the large number of patients affected. However, based on their own findings, the group considers that most if not all of HAS guidelines may not stand up to legal scrutiny for similar reasons.
The State Council ruled on April 27 that HAS had indeed breached the rules in the diabetes 2 working group, with 4 experts failing to file any public declaration of interest. In its conclusions, the State Council demanded the immediate withdrawal of the type 2 diabetes guideline.
Anticipating a second adverse ruling, HAS declared on Wed May, 18 its decision to withdraw the Alzheimer’s Disease guideline as well. In a move to contain turmoil, with many other guidelines likely to be challenged on the same grounds, HAS’ freshly appointed President, Pr Jean-Luc Harousseau, announced that all professional treatment guidelines issued since 2005 would be reviewed for proper management of conflicts of interests and withdrawn if necessary.
For Philippe Foucras, founder and president of the Formindep, the outcome of this two-year legal case is ‘an important step towards a recognition and proper management of the major risk to public health from conflicts of interests. In the wake of the French Mediator scandal (an appetite suppressant marketed as an antidiabetic that is believed to have led to the deaths of 500 to 2000 people), the impact of conflicts of interests on public health in France can no longer be ignored.’
Formindep is calling for proper education of health professionals, officials, media and the general public on conflicts of interests and their impact on public health. ‘This ruling highlighted the gap between HAS’ theoretical rules and their real-life implementation’. Whereas independence is key to the mission of health technology assessment, this case demonstrates that the French Agency has still much progress to make to reach the international credibility it aims for.

Contact : p.foucras@formindep.org + 33 (0)6 25 17 23 34
More informations (in french) and all files of procedure in the special folder on Formindep website :
http://www.formindep.org/-RECOURS-CONTRE-LES-RECOMMANDATIONS-.html