The making of a disease: female sexual dysfunctionBMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7390.658 (Published 22 March 2003) Cite this as: BMJ 2003;326:658
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Cripps (22 March 2003, letter: Company defends "campaign to 'counter'
BMJ claims") states that "Maintaining confidentiality of both the
potential new drug under investigation and the sponsor company is
paramount in preserving the integrity of the clinical research" to allow
for "unbiased" patient recruitment and study results. To the contrary,
such confidentiality would render a research proposal completely unethical
by most Research Ethics Boards.
To be able to make an informed choice about taking part in a clinical
trial, participants must know the name of the sponsoring organization,
private as well as public, governmental or commercial. Similarly,
informed choice requires knowing about the intervention: its general
effects as well as the potential side effects. Having this knowledge
does not "bias" recruiting or data analysis so long as all those
participating (patients, researchers, data analysts, etc.) are fully
blinded as to the assignment of any participant.
True, this knowledge might limit the numbers willing to take part in
a trial, thereby affecting how generalizable the findings are. But this
problem of external validity is one that ALL trials face, no matter how
rigorously they are done to ensure internal validity.
The company Cripps directs contacted several women's health
organizations in Canada, (Moynihan, Author's Reply, 22 March 2003, page
660), asking for "help" to "counter" parts of Moynihan's article on female
sexual dysfunction. This is quite an unacceptable -- and heavy-handed --
lobbying effort. The misreading of ethical standards for clinical trials
Cripps expresses in his BMJ letter only reinforces the importance of
independence from commercial support for women's health groups and further
underscores our ongoing concerns about the contracting out of research.
Competing interests: No competing interests