French guidelines are withdrawn after court finds potential bias among authors
BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d4007 (Published 24 June 2011) Cite this as: BMJ 2011;342:d4007
All rapid responses
Dear Editor,
A few inaccuracies appeared in the June 24 news (BMJ 2011;342:d4007 doi:
10.1136/bmj.d4007) on the withdrawal of guidelines by the French Health
Authority. The court ruled out that the Authority did not follow its own
rules on conflict of interest disclosure regarding experts that serve on
guidelines panels. Jeanne Lenzer had information from one source that only
represents few doctors (less than 0.5% of French doctors).
1. the retracted guidelines were removed from the French Health Authority
website: it's a mistake; there are no French ethical guidelines suggesting
a policy for retracted guidelines; we are convinced that they must remain
on the website, as the BMJ does with retracted papers;
2. the retracted guidelines are now accessible on other websites, such as
Formindep, with the proper mention of the retraction; one was published in
a Journal (Diabetes & Metabolism) that did not inform its readership;
3. there are no French guidelines such as the COPE (Committee On
Publication Ethics, http://www.publicationethics.org/) ones: "Retracted
articles should not be removed from printed copies of the journal (e.g. in
libraries) nor from electronic archives but their retracted status should
be indicated as clearly as possible". The Health On the Net foundation
(Geneva, http://www.hon.ch/) has accredited the French Health Authority
website and does not have a policy;
4. the court did not discuss the substance of the guidelines; the decision
was based on the absence of disclosure of 4 panel members; many people
incorrectly believe that the court rules that the recommendations were
flawed and do not constitute good advice; you should interview the opinion
leaders, and some experts on the panel;
5. France has no border with Holland, and Roubaix is close to Belgium!
We recommend the development of French ethical guidelines using the COPE
experience; the retracted guidelines must be posted back on the websites
with a clear mention that they were retracted.
Competing interests: Deputy editor at La Presse Medicale; member of a working group on the quality of journals at the French Health Authority
Dear Sir
Maintaining the quality of care certainly requires establishing guidelines
and strict adherence. Even though literature has documented evidence of
bias in adherence to guidelines to an extent of 27% of self reports, no data exist for suspected bias in establishing guidelines(1).
This news establishes a literature landmark. Though suspected by many
but refuted by all, guideline establishment bias should be condemned. This
order is a welcome move by a French court.
reference:
(1) Alyce. A et al: Evidence of self report bias assessing adherence to
guidelines. International Journal of Quality in Health care 1999: 187-192
Competing interests: No competing interests
Author responds
Dr Herve Maisonneuve introduces his letter by saying that a "few
inaccuracies" appeared in my article, and he enumerates 5 points, as if to
suggest there were quite a few errors. Of the five points, I agree with Dr
Maisonneuve on one: the location of Roubaix was incorrectly described, an
error introduced during edits.
As for his first point that removal of the retracted guidelines was a
"mistake" because, he states, there is no policy demanding removal of
retracted guidelines, I would like to point out that nowhere did I suggest
that removal of the guidelines from the French Health Authority's website
was a matter of policy. Whether retracted guidelines should or should not
be removed from websites is, quite reasonably, a point for others to
discuss. What I reported - accurately - was that "The highest
administrative court in France has ruled that guidelines issued by the
French Health Authority must be withdrawn immediately because of potential
bias and undeclared conflicts of interest among the authors."
Dr Maisonneuve, in points numbers 2 and 3, simply expands on the same
issue of access to a retracted guideline, which I did not address and
which was outside of the scope of the article.
As for his final point, Dr Maisonneuve states that the retraction was
based only on undeclared conflicts of interest and not on the scientific
merits of the guidelines, and he goes on to assert that "many people
incorrectly believe that the court rules that the recommendations were
flawed," I can only say that precisely that point was addressed in the
article - but with one caveat - whether people believe the court's ruling
was based on scientific merit may have something to do with another point
raised in the article: another organization, Prescrire, had recently
evaluated the two guidelines in question and found them lacking in
scientific merit.
Finally, I would like to ask Dr Maisonneuve why he chose to identify
himself as "Deputy editor at La Presse Medicale; member of a working group
on the quality of journals at the French Health Authority," and not as a
consultant and education director for the various drug companies:
http://www.yatedo.fr/p/Herve+Maisonneuve/normal/581cbc05838e28cad86252c8...
?
Perhaps he forgot to read the BMJ requirement that authors state their
competing interests?
Jeanne Lenzer
Competing interests: author of article