Did your doctor pass “Bipolar Disorder: Individualizing Treatment to Improve Patient Outcomes, Part 2” “taught” by Trisha Suppes, M.D., Ph.D., and offered by CME Outfitters?
Suppes is a professor in Stanford’s Department of Psychiatry and Behavioral Science and is 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—that “studies” a Lancet article written by Nubia Munoz, M.D., 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 of 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,” which refers to sales barriers and is sponsored by vaccine makers Novartis, GSK, and Merck.
CMEs, continuing medical education courses, are sponsored by pharma, “taught” by pharma-funded specialists, and are bracketed by pop-up drugs 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 their malpractice 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—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, M.D., 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 funded,” by Seroquel maker AstraZeneca and taught by disgraced Emory University psychiatrist Charles Nemeroff, M.D., 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. A JAMA article red flags Seroquel’s metabolic proclivities—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, M.D., and Kaustav Chakraborty, M.D., 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, M.D., D.P.M., Ashok Kumar Jainer, M.D., MRCP, and Wajid Shafi, M.D., from Coventry, U.K. “In this regard, Healy [David Healy, M.D., 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,” they write.
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 Oct. 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 U.S. National Cancer Institute. Is this also a sample of convenience?
And why was “infection of six-month duration or longer” used as an endpoint for showing a public health cancer benefit when no differentiation between infection and cancer is given, asks a different set of researchers, Stefanie Schenk and Jutta Halbekath from Berlin.
Clearly the letter writers need to do their CMEs.
Martha Rosenberg is a freelance writer living in Chicago.
