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General News    H3'ed 11/1/09

Aren't You Glad Your Doctor Completed Pharma's CMEs?

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Martha Rosenberg
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In fact the only good thing doctors have to say about CMEs is they are hard to fail--"second chance" questions pop up if you miss the first ones; whew!--and they are often free. Why?

CMEs are supposed to be monitored by the Accreditation Council for Continuing Medical Education (ACCME) but like Standard and Poor's and Moody's stock ratings funding comes from the client side so buyer beware.

Last year Bernard Carroll, MD a former chairman of psychiatry at Duke, challenged the objectivity of a CME Outfitters course called Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough (what are they trying to say?) funded by Seroquel maker AstraZeneca and taught by disgraced Emory University psychiatrist Charles Nemeroff, MD who lost his department chairmanship from unreported pharma income.

Two doses of Seroquel were tested but only the results of one were "statistically significant," writes Carroll on a blog called Health Care Renewal. "One of the junior presenters stated very clearly that there was 'significant improvement in both response and remission with both doses' of Seroquel. That is a falsification of the scientific record."

In October AstraZeneca agreed to pay $520 million to settle Seroquel suits and investigations of "physicians who participated in clinical trials involving Seroquel," presumably on which safety was established, and a JAMA article red flags Seroquel's metabolic proclivities in which studied children gained a pound a week and more. Yet AstraZeneca still seeks FDA approval to market Seroquel to kids.

Nor did the April 2009 article about Seroquel, Maintenance Treatment For Patients With Bipolar I Disorder: Results From A North American Study Of Quetiapine In Combination With Lithium Or Divalproex in the American Journal of Psychiatry (AJP) by CME presenter Trisha Suppes fare well.

Why were two-thirds of pre-randomization patients discontinued because of "lack of therapeutic response, developing an adverse event" and being lost to follow-up ask Debasish Basu, MD, and Kaustav Chakraborty, MD from Chandigarh, India in the October AJP? "Could it be possible that the remaining patients, who did eventually proceed to the randomization phase, represented a group favorably predisposed to the quetiapine combination?"

A second letter in the same AJP echoes the methodology questions. "Only one-third of the patients were selected for maintenance therapy, which raises the possibility of selection bias," write Bettahalasoor S. Somashekar, MD, DPM, Ashok Kumar Jainer, MD, MRCP and Wajid Shafi, MD from Coventry, UK. "In this regard, Healy [David Healy, MD, Cardiff University professor] stated that company sponsored clinical trials invariably recruit samples of convenience, which by definition do not actually sustain extrapolation to normal clinical practice."

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Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by (more...)
 

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