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February 21, 2014

Medications: Never any good side effects

by: Kimberly Barone Baden

Co-authored by: Ann E. Rice Ervin

Synchronized women swimmers … friends catching up at a girls’ night in … a family sailing and snorkeling on vacation in Hawaii: a painted picture of happiness and better life, juxtaposed by vague on-screen or voice-over disclaimers, including serious risks of blood clots, heart attack, and stroke hidden amongst a litany of side effects we have all experienced at one time or another such as diarrhea, nausea, headaches, dry mouth and insomnia. These are all aspects of many national pharmaceutical ad campaigns targeting women. These ads may be appealing to you and lead you to try one of these drugs without fully being aware of the real dangers the products could present.

So, it was interesting to read recently that the FDA is considering changing its regulations for television and radio ads for pharmaceutical products. In its announcement last Friday, the FDA stated it believes that “consumers in some cases become inured to real dangers because there are so many disclaimers.” Obviously, pharmaceutical companies must be required to inform the public, especially through direct-to-consumer marketing such as commercials, about serious risks associated with their products. However, these serious risks should not be cataloged between a list of 30 general side effects that most consumers would shrug off as being trivial.

For example, there are studies reflecting an increased risk between antidepressants and birth defects. That type of information is much more important to know about rather than diarrhea or vomiting, and exactly the type of warning that needs to be front and center and available for the consumer in promotional spots and not sugar coated or omitted in its entirety. Or take Fosamax®, for example. While promotional spots warn of diarrhea, nausea and vomiting, it would be nice for women to know that Fosamax can cause a femur to snap in mid stride. The last example that comes to mind recently is Lipitor®. While Lipitor is a cholesterol lowering drug, it can hand you a lifelong diagnosis of type 2 diabetes. These are the important risks that the public needs to be warned about up front.

It will be interesting to see the outcome of the FDA’s study that will quiz participants on different versions of the same commercial to gain insight into their perceptions of risk, product quality and manufacturer trustworthiness. We believe the public wants to know more about the serious risks of pharmaceutical drugs and less about the more common side effects. However, it would certainly be a shame if pharmaceutical companies see this as an opportunity to create yet another argument for immunity from lawsuits by a distortion of preemption rather than seeking to better inform the public of serious risks.

You might also be interested reading in Big Pharma takes a big hit in Pennsylvania.