A Faustian Bargain?

From the FDA’s Psychopharmacologic Drugs Advisory Committee meeting, Silver Spring, MD

To strike a Faustian bargain is to trade your soul to the devil in exchange for limitless knowledge or power.  Some might say the FDA skirts the edges of such a trade-off with many of the decisions it makes on whether to approve a drug or device. No approval means no knowledge, while putting a product on the market can vastly expand what is known about what it can and cannot do, but perhaps at the expense of many people’s health or lives.

Photo by Flickr user rahego

Photo by Flickr user rahego

That certainly was in evidence at today’s panel meeting on whether the agency should OK Seroquel XR as a first-line treatment for the millions of Americans who have major depressive disorder or generalized anxiety disorder.

Seroquel XR was judged effective by the agency and its panelists.  But the drug, an atypical antipsychotic approved for schizophrenia and bipolar depression and mania, presents a dastardly range of side effects, including tardive dyskinesia.  All antipsychotics increase the risk of sudden cardiac death — at least that’s what many studies have indicated.

There’s so much that’s not known about these medications and the people they’re meant to help:  Do the drugs lead to more diabetes, movement disorders, and cholesterol problems, or are the mentally ill predisposed to all of these illnesses? 

That question couldn’t be answered in just 8 hours. 

In the end, the committee judged the safety dilemma presented by Seroquel XR to be too much of a trade-off for the relatively small benefits seen in major depression and generalized anxiety.

To some of those who already had experience with the drug, there was no question that they had met the devil.  More than a handful of people who testified at the open public hearing said their relatives had become zombies, suicidal, or both on Seroquel XR, or had died suddenly while taking it, while in their 20s or 30s. 

Sadly, it seems to remain the case that, when it comes to mental illness, those who suffer are damned if they do take the medications and damned if they don’t.

— Alicia Ault (on Twitter @aliciaault)

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