Thursday, November 20, 2008

FDA's Indictment of Psychiatric CME

As covered in the business section of Tuesday’s New York Times , an FDA advisory committee has accused the agency of doing too little to warn physicians about the dangers of prescribing newer antipsychotics to children.

The committee reviewed data showing that more than 389,000 children and teenagers were treated last year with Risperdal, the majority of them 12 years old or younger. Risperdal is one of five newer atypical antipsychotics, drugs which comprise the bulk of antipsychotic prescriptions to both adults and children in the U.S.

While the atypicals have been extravagantly profitable for drug companies, a series of recent studies have shown that they are no more effective than older generic antipsychotics, and that some incur a higher risk of weight gain and blood lipid abnormalities. The most recent of these studies focused specifically on children with schizophrenia and schizoaffective disorder. In that study, the atypical drugs Risperdal and Zyprexa were no more effective than the generic molindone, and the children on the newer agents suffered significant weight gain—13 pounds on Zyprexa and 9 pounds on Risperdal over only 8 weeks of treatment. Molindone caused less than a pound of weight gain.

So who is to blame for the excessive enthusiasm for atypical antipsychotics in children? The FDA says: “Not us.” When asked why physicians were not learning enough about side effects, Thomas Laughren, the director of the agency’s division of psychiatry
products, said that the FDA has done its job by requiring appropriate warnings on the drug labeling. According to the article:

"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects."

Hmmm. Now that is going to be a tall order, considering that over half of all medical education courses in the U.S. are funded by drug companies. The medical specialty societies reap millions per year in “industry supported symposia,” which are CME courses certified by the medical societies, paid for by drug companies, and which are subtle advertisements for the sponsor’s drugs.

What is the FDA doing about this corruption of medical education? Absolutely nothing. Instead, they have given this responsibility to an agency called the ACCME. The ACCME is independent of the FDA, and is funded almost entirely by organizations that have a vested interest in continued drug company funding of CME. Because of this, it has presided over an incremental approach to regulation that has moved at glacial speed. Meanwhile, children on antipsychotics are becoming obese.

It is time for the FDA to get involved in regulating doctors’ education. I suggest that they immediately form a task force to investigate why the ACCME is moving so slowly to get industry influence out of medical education.

Let’s get real about this issue. Our health, and our children’s health, are at stake.


Bernard Carroll said...

It's not just an issue for children. For years, Pharma corporations have been eyeing adult mood disorders as a new market for atypical antipsychotic drugs. They are making steady inroads, even though the data are unimpressive, especially for nonbipolar depression. Links to some earlier commentaries are given below. Key Opinion Leaders (KOLs), operating under the hypocritical cloak of “unbiased” CME are essential in this campaign. Here is how I described the operation of this charade some months ago.

"Continuing Medical Education (CME) is a second front in the campaign to expand the AAP drug market. The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content. The KOLs are chosen for their willingness to be “on message” for the corporate sponsor. If they go “off message” they know they will not be invited back. The talk of “unrestricted grants” is window dressing. The MECC also secures the imprimatur of a nationally accredited CME sponsor, typically an academic institution. The sponsor is paid to certify that the CME program meets the standards of the Accreditation Council on Continuing Medical Education (ACCME). Everybody turns a buck: the MECC and its staff are handsomely paid (CME is now a multi-billion dollar business); the KOLs are generously rewarded with honoraria and perquisites; the academic sponsor is well paid by the MECC; the ACCME receives dues from the academic sponsor; the audience obtains free CME credits rather than having to pay for these required educational experiences; and the corporate sponsor gets what it considers value for its marketing dollar."

The pimp-in-chief is Charles Nemeroff, leader of two CME road shows this year for AAP drugs in depression, not to mention a raft of spots on supposedly unbiased education sites like CME Outfitters. Their logo is Education with Integrity. Yeah. At least Medscape had the integrity to take down Dr. Nemeroff’s Expert Interview spots.

Bernard Carroll.

Here are the links to earlier commentaries:

Supremacy Claus said...

Dr. Carroll: It feels strange correcting an eminence grise, such as you. However, the term, atypical antipsychotic, is quite misleading, given the broad range of effects.

The more accurate term, which I request, everyone start using, is, tranquilizer, a quieting drug.

So, these stop tics, vomiting, hiccups, sadness, anger, fear, voices, paranoia, and other disinhibited states.

Aspirin relieves headaches and thins the blood. Is it a headache medicine or a blood thinner? It is legitimately both in different patient groups.

I also point out that intemperate language and ad hominem epithets demean the utterer more than their target. Dr. Carroll do not start to sound as the Supremacy does.

Bernard Carroll said...

SC, the term atypical antipsychotic was the invention of the Pharma-KOL lobby. Go complain to them.

Anonymous said...

There is an organization called, The Citizen's Commission On Human Rights, that addresses this very issue, along with mental health and psychotropic drugs over-utilized. Anyone can join and volunteer.

Janelle Smith said...

As a patient who has been prescribed Antipsychotics for about seven years, I can assure you the weight gain you mention is not limited to children. I am seventy pounds over my desired weight, and this was an incremental weight gain over the past seven years, those pounds slowly but surely accumulating are no joke. What also concerns me deeply is the risk of developing diabetes, the affect on my blood sugar levels....which my psychiatrist so blithely assures me " is unlikely to occur". A previous psychiatrist attempted to mollyify me regarding weight gain using zyprexa by saying a 15 pound weight gain was typical, so, if you are changing your antipsychotic every year an half, with weight gain associated with each do the math....Present psychiatrist bluntly asked me if I'd rather be crazy or fat, and given these drugs limited efficiency ( in my case ) I had to settle for " Crazy AND fat". Not a happy choice. Your mention of the older antipsychotics interests me ( Molindome ) perhaps this drug can help me with these issues and for that I thank you.