Testimony of M Dolan MD at Psychopharmacologic Drugs Advisory Committee Meeting 12-13-06

My name is Dr. Moira Dolan, Executive Director of Medical Accountability Network.
We are non-profit, accepting donations from individuals only, and have no support from commercial interests or from other groups. Our purpose is to make medicine accountable, based on full informed consent.

Here are some of our grave concerns with the adult suicidality studies: Inexplicably, the drug makers only had to report ONE event per subject. Incredibly, events occurring within the tapering period were NOT included. Events more than one day after the last double-blind treatment period were NOT included.  This is in spite of drug half lives of from 5 hours to over a week. And the attempted compensation for informative censoring was wholly inadequate. Again, inexplicably, the FDA made no attempt to adjudicate the drug-makers’ reports of what consisted of “suicidality.”

Even with these handicaps, however, the data did show an increased incidence of suicidality in 18-24 year olds. Remarkable increased suicidality was found in the evidence supplied by the makers of  Celexa, Cymbalta,  Wellbutrin and to a lesser extent, Luvox.

There is no biological explanation for such a drug effect on adolescents and young adults  and yet not on people over 25.  In fact, there is no precedent for any adverse drug event warning to be given for children but  not for adults when it does not relate to growth or maturation. Obviously more studies need to be done, this time with data collection that is designed to give some answers.

However, to have this data in hand, and yet to continue to REFRAIN FROM undertaking an urgent, broadly disseminated information campaign with immediate and plainly worded warnings, warnings against the POSSIBILITY of tragic unnecessary deaths by drug induced suicide, well this is nothing less than a gross abdication of the patient protection responsibilities of the FDA.

The concerns of the Medical Accountability Network are that physicians and pharmacists have legal and ethical obligations - we have to provide patients with adequate information so that they can give informed consent for any particular treatment.

When you settle for “more study” in the absence of urgent consumer protective action,
frankly physicians and pharmacists  are forced to ignore the FDA. Unlike the FDA, those of us on the front lines cannot ignore the fact that we are faced with peoples lives –

Look at your ethics codes, ladies and gentlemen of the committee, and recall that we're talking life and death here. Then take a  look in the mirror. Let this bear on your actions as advisory committee members.

Thank you.

www.medicalaccountability.net


*Correction: Buspirone (Buspar®) was inadvertently incorrectly identified in recent FDA testimony as one of the agents with a risk of increased suicidality in the FDA review of antidepressant drugs. The unrelated drug with a similar name bupropion (Wellbutrin®) was found to be associated with increased suicidality in some age groups. The error was inadvertent and we apologize for any misunderstanding this may have caused.