Raise your hand if you�ve breathed a sigh of relief seeing
your doctor had a CME certificate next to the medical school diploma on the
Did your doctor pass, Bipolar
Disorder: Individualizing Treatment to Improve Patient Outcomes, Part 2 �taught� by Trisha Suppes, MD, PhD and offered
by CME Outfitters?
Suppes is a professor
in Stanford�s Department of Psychiatry and Behavioral Science and funded by
Abbott, AstraZeneca; GlaxoSmithKline, Janssen, Novartis, Pfizer, Wyeth,
Bristol-Myers Squibb, Eli Lilly, Shire and four more pharma companies.
Maybe your doctor
passed Quadrivalent HPV Vaccine May Be Effective in Women 24 to 45 Years Old -- which sounds like a sales pitch for
Gardasil because it is -- which �studies� a Lancet article written by Nubia
Munoz, MD, two Merck employees and other authors.
Sample question: �What was the main conclusion of the current
study by Munoz and colleagues of HPV vaccine among women between the ages of 24
and 45 years?� (Italics CME�s) Hint: the answer is in the title.
Upon �completion on this activity� offered by CME giant Medscape -- still
available for credit if you hurry -- participants will be able to: �Specify the
currently recommended age range for the administration of the quadrivalent
human papillomavirus vaccine� and �Describe the effects of the quadrivalent
human papillomavirus vaccine among women between the ages of 24 and 45 years.�
Maybe your doctor passed Medscape�s Innovative
Approaches to Vaccination Challenges: Overcoming Barriers for Adult Patients
sponsored by vaccine makers Novartis, GSK and Merck and referring to sales
CMEs, continuing medical education courses, are sponsored by pharma, �taught�
by pharma funded specialists and bracketed by pop-up drug ads which sometimes
occlude the text you�re reading. (�Which of the following manic symptoms are
most seriously impacting your bipolar patients� lives?� asked a disease-baiting
ad for Geodon, direct-to-consumer style, when we looked at a CME.) Yet doctors
are required to sit through the
canned message like a time-share presentation and answer a quiz just to keep their state licenses and sometimes insurance policies.
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 due to 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.�
Similar methodology questions are raised about the �science� behind
Medscape�s Quadrivalent HPV Vaccine May
Be Effective in Women 24 to 45 Years Old CME in the October 10 Lancet.
Why did Munoz et al exclude women �with pre-existing infections and women
who do not complete the full course of the vaccine,� ask six researchers with
US National Cancer Institute. Is this also a sample of convenience? And why was
�infection of 6-month duration or longer� used as an endpoint for showing a public health cancer benefit asks a different set of researchers, Stefanie Schenk
and Jutta Halbekath from Berlin, when no �differentiation� between infection
and cancer is given?
Clearly the letter writers need to do their CMEs.
Martha Rosenberg is a Chicago
columnist/cartoonist who writes about public health. She may be reached at firstname.lastname@example.org.