E-DRUG: Conflicts of interest management in French HTA
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Dear E-druggers,
Thank you for welcome me on this forum.
I¹m a French GP, working in Burgundy. I¹m president and founder of Formindep
(Formation Independante).
Formindep is a French non-profit group of health professionnels and citizens
acting since 2004 for independant education and information in healthcare.
See on : http:/www.formindep.org
Reading some of your posts, I note you¹re of interest to the matter of
conflicts of interests.
Formindep recently wins two-year battle against French Health Authority
(HAS) over conflicts of interests. HAS was 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.
A meaningful initiative from Formindep for the implementation of a proper
management of conflicts of interests in the French healthcare system.
Please read the press release below.
Best regards.
--
Philippe FOUCRAS, president of Formindep
Philippe Foucras <p.foucras@formindep.org>
Press Release - June 20. 2011
Independent Doctors¹ group Formindep wins two-year battle against French
Health Authority (HAS) over conflicts of interests
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.
The French State Council, the country¹s 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 physicians¹ organization, Formindep
<http://www.formindep.org> (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
Alzheimer¹s disease. Formindep charged that the guidelines development
process contravened national law on conflicts of interests and the Agency¹s
own internal rules.
Formindep reviewed these guidelines in March 2009
<http://www.formindep.org/Des-recommandations.html> 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 major¹ 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 HAS¹ refusal, Formindep appealed before the State Council in December
2009 <http://www.formindep.org/le-Formindep-saisit-le-Conseil-d.html> .
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
<http://www.formindep.org/Le-Conseil-d-Etat-abroge-la.html> 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
<http://www.formindep.org/Communique-La-HAS-retire-egalement.html> its
decision to withdraw the Alzheimer¹s Disease guideline as well. In a move to
contain turmoil, with many other guidelines likely to be challenged on the
same grounds, HAS¹ 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 HAS¹
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
<http://www.formindep.org/-RECOURS-CONTRE-LES-RECOMMANDATIONS-.html>