"Why Did My Doctor Ever Put Me On Yaz?"

That's a question we hear a lot. Studies have shown that Yaz may be more dangerous than other oral contraceptives, yet it is no more effective in preventing pregnancy. The FDA has even warned Bayer that its commercials were overstating the drug's benefits, while understating its risks. It seems that the drug's risks are now apparent.  "If the drug is bad, why did my doctor prescribe it? Why didn't she put me on something else instead?"

The bottom line is that,  just as the consumers are being duped by the drug companies, so are the doctors. Here's what happens:

In prescribing a drug, a doctor doesn't review all the medical literature about the drug's risks and side effects. She just doesn't have time. For the most part, she relies on the information provided to her by drug company representatives, called "detailers." The detailers visit the doctor in her office, and explain to the doctor the particular drug's risks and benefits. The detailers often leave free samples of the drug with the doctor, and suggest that she distribute them to her patients.

The detailers are obligated by law to be truthful with the doctors. Medical Ghostwriting - pubmedUnfortunately, the information that the detailers give to the doctors is not necessarily objective.

For example, the detailer may hand to the doctor a research study touting the benefits of the drug. The study will have been published by a prestigious research institution or medical center. The reputation of the institution -- or that of the listed authors -- goes far to reassure the doctor that the drug is safe. As it now turns out, however, many of these studies were actually "ghostwritten" by the drug manufacturers themselves, not by the listed authors. It's no surprise, then, that the study casts the manufacturer's drug in a favorable light. But because the study appears to the doctor to be independent, the doctor prescribes the drug to her patients. As a result, people are needlessly injured.

The questionable practice of medical ghostwriting, and its negative effect on the health of the public, was placed in the spotlight a few months ago by an article appearing in PLoS Medicine. The authors explained that medical ghostwriting is "dangerous to public health" because it results in prescribers being misinformed about risks:

academic medical centers enable the pharmaceutical industry to covertly shape the medical literature in favor of commercial interests. When a pharmaceutical salesperson hands a clinician an article reprint, the name of the institution on the front page of the reprint serves as a stamp of approval. The article is not viewed as an advertisement, but as scientific research; the reprint is an effective marketing tool because peer-reviewed journal articles generated in academia are perceived to be the result of unbiased scientific inquiry.

Consumer groups have called upon the drug industry to stop its practice of "ghostwriting" research papers about their own drugs. Unfortunately, though it may appear that the practice in unethical, there are no laws against the practice.  We don't expect the drug companies to stop.  There is too much potential profit on the line. 
 

Yasmin Label Change in the European Union (EU)

On Friday, March 26, 2010, Bayer announced that it will update the Yasmin label in the European Union (EU). The new Yasmin label will include the results of four epidemiological studies (epidemiological studies are conducted to figure out what factors affect the health and illness of a population).

Two of those studies found that oral contraceptive pills which contain the hormone drospirenone (such as Yaz, Yasmin and Ocella) are associated with a significantly increased risk of venous thromboembolism, a medical term used to describe a blood clot in a vein, which can lead to more serious injuries including pulmonary embolism or stroke. The studies, conducted in Denmark and the Netherlands, were published last year in the British Medical Journal.

After viewing these reports, the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) (a section of the European Medicines Agency) concluded that users should be informed of this new risk information and became the driving force behind the addition of these two independent studies to the new Yasmin label.

The other two studies to be included on the new label (EURAS and Ingenix studies) were sponsored by Bayer, the maker of Yasmin and Yaz. Unsurprisingly, the Bayer-sponsored studies concluded that the risk of blood clots in Yasmin users is comparable to the risk found for women who use historically safer oral contraceptives which contain the hormone levonorgestrel.

At this point, the Yasmin label change is only due to go into effect in Europe and the exact language for the new label has not yet been revealed.