Education And Debate

The making of a disease: female sexual dysfunction

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7379.45 (Published 04 January 2003) Cite this as: BMJ 2003;326:45

Investing in spin doctors

As a convincing example of “disease mongering” by the pharmaceutical
industry (1), Moynihan (4 Jan 2003, 45-47) has analysed the way female
sexual dysfunction has been made into a “new” disease. In the same issue
(p. 9), news item detailed how Viagra could become a providential
preventive treatment for one of the main concerns of half of humanity (at
the very least) – male impotence. One might wonder, however, whether
Viagra itself is not a perfect example of the increasing tendency of
larger companies to make blockbusters from trite chemical entities.

Twenty years ago, I participated in the development of an alpha-blocker,
actually a simple me-too: as we were very impressed by the sexual
reactions of the young male volunteers included in the phase I studies, it
was a joke for us to predict that the registration of a product like this
one to treat impotence would certainly lead to an impressive commercial
success. The obstacle, of course, was that of potential toxicity… Then, as
it was pharmacologically banal that a number of drugs had genuine effects
on the male erectile function, any rigorous analysis of sildenafil should
have focussed on two crucial questions: 1) is there any evidence that this
drug is more efficient than any other product known to have similar
effects? 2) is there any evidence that the potential safety problems have
been reasonably controlled?

Pfizer provided no answer to the first question, since evidence of
efficacy for Viagra was given by placebo-controlled studies: this was
correct from a regulatory point of view (since, for the above mentioned
reasons, there was no “reference” drug), but ignored the fact that everybody knew that a
number of drugs had similar pharmacological properties.

Concerning safety and having regard to the number of severe hazards
reported after Viagra was marketed, it may be interesting to recall that
when this compound was developed, Pfizer was making an enormous fuss about
tenidap, an anti-arthritic compound, which, quite early in its
development, was massively presented as a fantastic potential blockbuster.

Yet, once reaching the registration phase, tenidap was rejected by most
regulatory bodies with unusual promptness, precisely because of unresolved
safety questions (SCRIP 10-14 May 1996: 22). At the same time, Pfizer
received a severe warning letter from the FDA because of repeated failures
in reporting serious hazards of its drugs (SCRIP 21 May 1996: 11). These
two convergent precedents patently do nothing to reassure us about the
reliability of Viagra’s manufacturer regarding the process of safety
assessment. Recent information about the fallacies of the benefit/risk
assessment of doxazosin (18 Jan 2003, p. 170), another drug marketed by
Pfizer, is consistent with these remarks.

Lack of new drugs is reaching crisis point (18 Jan 2003: 119), and this is
explained by analysts as the tendency of giant companies resulting from
mergers to concentrate on blockbusters. As is well-known, merging does not
stimulate creativity, but gives an unprecedented financial power for
commercial promotion. Viagra could be the typical example of the way
intensive marketing allows big companies to make people believe that the
moon is made of green cheese and to give substance to the idea that new
chemical entities of problematic benefit/risk ratio represent far-reaching
achievements in therapeutics. This policy of mystification is an
alternative to the recent recommendation of The Lancet that given the
current crisis in drug discovery, pharmaceutical companies should “invest
preferentially in the creative minds in their laboratories” (instead of
investing in their legal staff) (2): investing in the creative minds in
the reps might not be such a bad idea either – as exemplified by Pfizer’s
impressive success story…

(1) Moynihan R, Heath I, Henry D. Selling sickness: the pharmaceutical
industry and disease mongering. BMJ 2002; 321: 886-91

(2) Anon. An innovative challenge to the drug industry. Lancet 2002; 360:
1341

Competing interests:  
None declared

Competing interests: No competing interests

21 February 2003
Girard Marc
Consultant
Versailles, France (78000)
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