November 10, 2005

Why Would The U. S. Food & Drug Administration Approve False Advertising?

Why would the U. S. Food and Drug Administration approve false ads for the SSRI drugs?

The human rights group MindFreedom International has been asking that question for a long time.

Millions of viewers have seen the TV ads for the anti-depressant drug Zoloft. A bouncing ball turns from a sad face to a happy face. Like many ads for similar psychiatric drugs, the voice-over claims Zoloft helps correct a "chemical imbalance."

Not true, say researchers. Not true at all.

The researchers -- Jeffrey Lacasse, a doctoral candidate at Florida State University and Dr. Jonathan Leo, a neuroanatomy professor at Lake Erie College of Osteopathic Medicine -- studied U. S. consumer advertisements for SSRIs from print, television, and the Internet. They found widespread claims that SSRIs restore the serotonin balance of the brain. "Yet there is no such thing as a scientifically established correct 'balance' of serotonin," the authors say.

According to Lacasse and Leo, in the scientific literature it is openly admitted that the serotonin hypothesis remains unconfirmed and that there is "a growing body of medical literature casting doubt on the serotonin hypothesis," which is not reflected in the consumer ads.

The widely televised animated Zoloft (setraline) commercials have dramatized a serotonin imbalance and stated, "Prescription Zoloft works to correct this imbalance." Advertisements for other SSRIs, such as Prozac (fluoxetine), Paxil (paroxetine), and Lexapro (escitalopram), have made similar claims.

According to the Public Library of Science,

The FDA is responsible for regulating consumer advertisements, and requires that they be based on scientific evidence. Yet, according to Lacasse and Leo, the mismatch between the scientific literature and the SSRI advertisements is "remarkable, and possibly unparalleled."

A news release from Mind Freedom says,

On behalf of MindFreedom, Sen. Ron Wyden (D.-OR) contacted the FDA for an explanation about why they approve such false advertising. In their response -- which took over one year -- the FDA could cite no scientific literature or studies.

It turns out there's a good reason the FDA can't find any scientific evidence for these ads.

The scientific evidence does not exist.

Read Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature by Jeffrey R. Lacasse and Jonathan Leo.

Posted on November 10, 2005