Diane-35: Reconsidering the risks

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Publication Date: 
Thu, 2013-08-01

Barbara Mintzes is intrigued by the United States’ Food and Drug Administration’s decision not to approve Diane-35. Her theory is that this seemingly unusual choice was caused by a possible connection between the Diane-35 component cyproterone acetate and liver cancer, a disease that is unlikely to be definitively linked back to the drug because it takes a long time to develop in the body and is not widely known to be a possible adverse effect.  Mintzes is critical of the lack of transparency behind Health Canada and the FDA’s approaches to drug regulatory decisions. Direct-to-consumer advertising is essentially banned in Canada, but there are few resources to deal with the pharmaceutical industry’s tenacity at getting around laws in order to reach potential customers

A US FDA appraisal in 2012 concluded with a decision to keep all drospirenone-containing pills on the market—the benefits again cited as outweighing the risks—despite accusations of conflicts of interest on the appraisal board, and a questionable process. Board members voted 15 to 11 in favour when asked, “Do you believe that, in the general population of women who desire contraception, the benefits of the (DRSP)-containing oral contraceptives for prevention of pregnancy outweigh their risks?”

Considering there are other safer options available to prevent pregnancy, this decision is questionable at the very least. 

In France, where sales of Diane-35 are still suspended, the regulatory body underwent an overhaul in response to the scandal surrounding another controversial drug: Mediator. Like Diane-35, this drug was marketed off-label with deadly results. Mediator was approved for diabetes and marketed off-label for weight loss. The head of the pharmaceutical company that produced Mediator, which caused the deaths of up to 2,000 people, is now on trial for involuntary manslaughter. In most countries, including Canada, members of medical regulatory bodies and the pharmaceutical industry are protected from such prosecution.

Acne treatments

Founder of the Edmonton-based Justisse Healthworks for Women, Geraldine Matus, argues that we must admit all hormonal contraceptives are prescribed off-label whether it is to “regulate” periods or prevent PMS. Matus does not believe, whether evidence is available or not, that Diane-35 or any hormonal birth control should be given to women suffering with acne. “I am appalled that for something like acne we give young women such a powerful endocrine disrupter. It’s like repairing a Swiss watch with a jackhammer. It is total overkill. The birth control pill in any form never cures anything. It only alters the symptoms.”

The cause of acne can be hormonal imbalance, but Diane-35, and any hormonal contraceptive, only suppresses and replaces the natural hormone cycle with a constant stream of synthetic hormones whilst suppressing the entire endocrine system. The pills do not rectify the imbalance. Metabolic issues, dietary problems, and allergies can also provoke acne. Matus believes for many women a small intervention such as restricting unhealthy foods or increasing zinc intake can make a big difference.

“The birth control pill suppresses immunological function and so can in fact aggravate acne by worsening underlying issues like poor gut health,” Matus explains. As Diane-35 is not a cure, when women come off they are likely to find their acne returns. Non-pharmaceutical treatment of acne such as lifestyle changes including diet and exercise are unlikely to be addressed in the doctor’s office when doctors, and perhaps patients themselves, almost always prefer the quick fix.

“Most acne patients are told by their dermatologist that diet has nothing to do with acne, despite research to the contrary,” explains Toronto naturopath Pamela Frank, “Every acne patient I have ever had has identified food triggers for the condition. The pill is only appropriate, I believe, if women are either unaware of the better, safer, more natural options or unwilling to make the effort to change their diet, exercise daily, and reduce their stress level. Correcting the root cause leads to greater overall health.”

Polycystic ovary syndrome

Thirty-two year old Canadian clinical social worker, Shannon Tessier, took Diane-35 for 10 years; “I was prescribed [Diane-35] at 20 years old, at my own request. I was really upset with my acne and had tried every prescription known to ‘cure’ it. After seeing several adverts in the women’s washrooms at my university, I went on the drug company website. I then made an appointment with my doctor. He asked me no questions, he just said, ‘Okay let’s give it a try.’ That was it. There was no discussion of side-effects or risks. No one ever mentioned there was a time limit to how long I could use this drug. My skin was completely clear, but I basically had no sex drive. Some 12 years later, after learning about the female hormone system, I believe Diane-35 masked what were PCOS [polycystic ovary syndrome] symptoms and worsened the underlying issue of my hormonal imbalance.”

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