Drug makers’ scientists do the Side Effects Shuffle

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The U.S. pharmaceutical industry and its federal regulator, the U.S. Food and Drug Administration, have a lot on their plates. Brand-drug makers must pump out new medications, to stay fiscally afloat, as their drug patents fall like dominoes, which the generic competitors pick up and run for their lives with.

At the same time, there is a craft in the drug makers repertoire of survival skills that is no less important than managing the books, developing the product per FDA rules, and defending themselves from pharmaceutical injury lawsuits.

This craft is the Side Effects Shuffle, the art of applied science that often does not fully vet a drug before it is marketed. The dance is about mitigating health risks in medications. The shuffle, for the most part, takes place after the damage is done and after the patients hire a personal injury attorney, at Reich and Binstock or elsewhere, to help them to recover their damages. It takes an interrelationship of pharmaceutical corporate interests to address some of these serious risks.

Here is one archetypal Skip to My Lou, which follows a summary of a particular drugs recent regulatory history.

Bayer makes the combination oral contraceptive, or COC, Yaz, which in addition to pregnancy prevention is FDA-approved also to treat premenstrual dysphoric disorder, which is not the same as premenstrual syndrome, and to combat moderate acne for patients who are at least 14 years old.

OKd by the FDA in 2001, Yazs warnings and precautions were updated in April 2012 with the following language: Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins.

Venous thromboembolism events include deep vein thrombosis, or DVT, and pulmonary embolism, appropriately abbreviated PE. As the FDA writes, A deep vein thrombosis is a rare but serious condition where a blood clot forms inside a vein. These blood clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs. If the clot travels to the lung, it is called a pulmonary embolism, a potentially fatal condition where an artery in the lung becomes blocked.

One point plaintiffs may be inclined to make in Yaz lawsuits is the unreasonableness of the risk. Patients with a PE have a 30 percent to 60 percent chance of dying from it, according to Johns Hopkins Hospital.

So suppose we have a patient with VTE associated with the use of Yaz. What can the pharmaceutical industry do?

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Drug makers’ scientists do the Side Effects Shuffle