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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5 comments:
Most public servants are very aware of the requirements of their job. Go through the motions, never push anything controversial and end up with a pension. The Australian version of the FDA is very good at imposing silly requirements like different formats for drug listing applications than the FDA, even though they have so little expertise that they rely on the FDA and European reviews.
Aubrey, I had pretty much the same response off the Therapeutics Goods Administration (TGA) - Australia's medicine regulator when I pointed out to them that the Delphi Centre in Melbourne were blatantly advertising one of their sponsors antidepressants on their webpage.
After emailing them to and fro the TGA asked/told the Delphi Centre to remove the advertisement. However, when I asked if any action would be taken I recieved pretty much the same letter as Barbara Mintzes did.
See: http://fiddaman.blogspot.com/2007/09/tga-delphi-centre-commercial-in.html
Fid
Senior Compliance Officer? How bloody dare she? Compliance is a profession, not a sodding office. I hope she's qualified, although, judging by her response, that seems unlikely.
Anyway, why didn't she just write "the shutters are down: we've applied the only fix we're going to, so kindly go away"? And why do people think that just because they use a more socially "acceptable" form of language, the message isn't extremely unpalatable, when translated into plain english?
Matt
If it was not so serious it would be funny.
DTC in the U.S. and New Zealand
Often, usually on television, one viewing will often at times see an advertisement for some type of medication- usually one involved in a large market disease state and the commercial is sponsored usually by a big pharmaceutical company for a particular network.
This is called direct to consumer advertising, and doctors would prefer they did not exist.
Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry spends around 5 billion annually on this media source now. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns. And involves money spent that could be applied to greater uses, according t many, but we are dealing with a corporation here.
The purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective, which is to increase sales and grow their market and, in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition.
DTC advertising is also a catalyst for and similar to disease mongering.
Disease mongering is the creation of what some believe to be medical flaws, and illustrated by the creators through exaggeration and embellishments through media sources as an avenue for suc propaganda, as is often seen with DTC advertising. Yet the flaws may not be medical, but corporate creations of these questionable human ailments that do not require treatment, possibly, and may be an attempt to develop a particular medical condition to acquire profit. One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.
Also, DTC ads discuss only one treatment option normally, so it seems, when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the doctor, as they assess your health, not your television or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of our country and New Zealand.
Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome for the doctor chosen for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription.
Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some over-prescribing, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which is far from financial prosperity.
“Men of ill judgment oft ignore the good that lies within their hands till they have lost it”---
Sophocles
Dan Abshear
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