This letter could serve as a model template for all regulators. It is as timely as it is informative. I am sure that the writer is not personally responsible but perhaps she needs to consider the part she plays in the farce. The letter no doubt reflects with some honesty the spirit of the actual procedures used to deal with a serious complaint. Below the letter are details of the complaint (of 2005) that precipitated the response received last week. It is truly amazing how hilarious these "regulatory" bodies are - and how little they care that actual human beings die as a result of their actions.
This letter was the sole response to a formal complaint made by four Canadian health policy researchers about illegal and misleading direct to consumer advertising of the drug Diane-35 (cyproterone and estradiol) during 2005. The complaint mentioned that the advertisements were in contravention of the Food & Drugs Act. Diane-35 increases the risk of venous thromboembolism compared to other similar hormone combinations, and there were at that stage at least six reported deaths in Canada. Diane-35 was the subject of two safety advisories in Canada which warned doctors not to use Diane-35 for two unapproved (off-label) uses: for birth control or mild acne. Diane-35 was only approved for a restricted indication in Canada: treatment of a subgroup of patients with endocrine disorders and very severe acne who have failed to respond to all treatments. Nevertheless the DTC advertisements promoted Diane-35 for unapproved uses, and targeted a vulnerable population: adolescent girls. The ads conveyed scientifically false information. Risks were also not mentioned.
Mild acne was promoted as an indication through the use of images of young girls with flawless skin preening in the mirror and the message to 'Ask your doctor or your dermatologist' at the end of the ad. The addition of dermatologist was a clear hint of the indication. Anyone who had severe acne that had failed to respond to previous treatment would not have the flawless skin of these models, either before or following treatment. There is also no indication for the use of Diane as a contraceptive. Three to 10 extra cases of venous thromboembolism occur per 10,000 women taking Diane-35 per year, as compared to the rate of venous thromboembolism in users of other oral contraceptives. Several other illegal aspects of the advertisements were noted.
Of course it is possible that the "satisfactory" actions taken by Health Canada might have included prison sentences for those implicated (the usual sanction in a sane society when individuals recklessly break laws and endanger real people). Readers might wish to contact Saveen Kamarn at (604)666-8516 or Saveen_Kamarn@hc-sc.gc.ca to find out what happened. As usual my profession remains silent.
Onwards and upwards for honest science.
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