2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC17
Submitter : Dr. John Ryan Date & Time: 11/18/2005 02:11:20
Organization : Dr. John Ryan
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
November 17, 2005
Food & Drug Administration

Subject: "Consumer Directed Promotion of Regulated Medical Products; Public Hearing."

Ideally, I would love to see direct-to-consumer ads for prescription drugs prohibited in the United States.

One that particularly galls me is the Pfizer ad for Zoloft. I would like to see Pfizer told to cease and desist that fraudulent claim that Zoloft corrects a "chemical imbalance" of serotonin in the brain, and other drug companies enjoined from making such a claim for their SSRI drug, or any other type of drug.

It is asserted that chemical imbalances of the brain, of unknown, random origin are the causes of depression, "schizophrenia," anxiety, obsessive- compulsive disorders, and maladaptive behaviors such as violence, alcoholism, drug addiction, excessive gambling, compulsive shopping, kleptomania, mathematics disorder, written expression disorder, etc. These (and many more) are all listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). These "chemical imbalance" hypotheses are just that, unproven hypotheses. The scientific evidence in support of them is weak. Maybe at some future date we will discover that a chemical imbalance (chemical change or neurological aberration of some sort) is the cause of some or all mental illnesses. It may turn out to be at the molecular level. Maybe these illnesses are metaphysical, not somatic - in the mind as opposed to the brain. We don't know.

We have no way of quantitatively measuring (directly or indirectly) the amount of serotonin (or any other of the approximately 60 neurotransmitting chemicals) that are present in the brain or in any part of the brain at any given time. Therefore we have no way of ascertaining what the correct "balance" of any neurotransmitting chemical is.

Researchers claim that they can indirectly estimate the amount of a neurotransmitter in the brain by measuring metabolites of the chemical that are excreted in the urine and cerebro-spinal fluid. There are a lot of problems with this claim. They make assumptions that are not scientifically proven to be valid. For example most of the neurotransmitting chemicals are also synthesized in other parts of the body. More than half of the body's serotonin is synthesized in the stomach and in the gastrointestinal tract. This serotonin cannot get into the brain because of the blood-brain barrier.

Spinal taps are going to obtain very small samples. Who wants to agree to have spinal taps performed on them very often?