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How the FDA forgot the evidence: the case of donepezil 23 mg

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e1086 (Published 22 March 2012) Cite this as: BMJ 2012;344:e1086

Rapid Response:

Re: How the FDA forgot the evidence: the case of donepezil 23 mg

Pill them, bill them. Whose interests are served by regulatory agencies?

Schwartz and Woloshin wisely pointed out that the FDA, despite lack of evidence, granted a new marketing authorization for the 23 mg dose of donepezil (pricept) in Alzheimer’s disease.(1) This allows Pfizer to avoid generic competitors as the patent for donepezil, first approved in 1996, expired in November 2010.

In 2007, the Transparency (sic) Committee of the French High Authority for Health (Haute Autorité de Santé), which is in charge of drugs assessment for reimbursement and pricing, rated donepezil as an “important” (the highest) medical utility and stressed the “structuring role of the drug in the global care of the patients with Alzheimer’s disease”.(2) Again, this challenged clinical evidence.(3) This also contrasted with NICE’s evaluation restricting the donepezil use to clinical trials.(4) However this looks quite similar to a claim made in 2004 by the Pharmaceutical Industries’ Union about “the structuring role of drugs on hospital practices”.(5)

In 2011 the French highest administrative court (Conseil d’Etat) has ruled that guidelines issued by the Haute Autorité de Santé must be withdrawn because it allowed conflicts of interest among its experts.(6) Accordingly, several guidelines including the one concerning Alzheimer’s disease were withdrawn.

1 Schwartz LM, Woloshin S. How the FDA forgot the evidence: the case of donepezil 23 mg. BMJ 2012;344:e108
BMJ 2012; 344 doi: 10.1136/bmj.e1086 (Published 22 March 2012)
Cite this as:
2 Haute Autorité de Santé. Avis de la Commission de la transparence ARICEPT. 20 June 2007. Available at www.has-sante.fr/portail/display.jsp?id=c_594386
3 Courtney C, Farrell D, Gray R, et al. Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial. Lancet 2004;363:2105-15
4 National Institute for Health and Clinical Excellence. Technology appraisals, TA111: Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine (TA111) September 2007 Available at http://www.nice.org.uk/TA111
5 Les entreprise du médicament. Chiffres clé. 2004.
6 Lenzer J. French guidelines are withdrawn after court finds potential bias among authors. BMJ 2011;342:d4007

Competing interests: the Haute Autorité de Santé did not renew Dr Braillon as a locum tenens advisor in 2007 because he was “uncontrollable”. This was disclosed from a memo obtained after a court decision in 2011 as the Haute Autorité de Santé also breached the Freedom of Information Act.

26 March 2012
Alain Braillon
Public Health
Public Health
27 rue Voiture. 80000 Amiens. France