speaks for itself… »
« nothing is simple anymore…
at least…

Posted on Saturday 15 October 2011

My contention is that the AJP editorial mentioned in my last post [Anxiety Disorders and Antipsychotic Drugs: A Pressing Need for More Research] has an undeclared Conflict of Interest. This isn’t enough to allow the readers to know who is writing this article:
    Dr. Breier has served on advisory boards or as a consultant for Amgen, MedAvante, Takeda, and Teva, and he is a former employee of Eli Lilly. Dr. Freedman has reviewed this editorial and found no evidence of influence from these relationships.

Unless you know this story, you cannot properly evaluate his conclusions:
Alan Breier
VP Medical, Chief Medical Officer – Eli Lilly & Co.

Alan Breier, M.D., was named vice president for medical and chief medical officer for Lilly in August 2003. He is a member of the Lilly Research Laboratories policy committee and the company’s senior management council. Previously, Breier was a Lilly clinical research fellow, Zyprexa® product team leader, and vice president of pharmaceutical products for Lilly. Breier received a bachelor of arts degree, summa cum laude, from the University of Toledo (Ohio) in 1975. He received a doctor of medicine degree in 1980 from the University of Cincinnati School of Medicine. He served as a resident in psychiatry from 1980 to 1984 at Yale University School of Medicine.

Prior to joining Lilly, Breier completed a three-year research fellowship at the National Institute of Mental Health [NIMH] Intramural Research Program [IRP] and then became chief of the outpatient research program at the Maryland Psychiatric Research Center and associate professor of psychiatry at the University of Maryland School of Medicine. In 1993, he was recruited as chief of the unit of pathophysiology and treatment at the NIMH IRP, and then promoted to chief of the section of clinical studies. At the NIMH, he established a research program investigating the causes of schizophrenia and development of new treatments for this illness. Breier joined Lilly as Lilly research fellow for Lilly Research Laboratories, a division of Lilly, in March 1997, the same year he was appointed adjunct professor of psychiatry at Indiana University School of Medicine in Indianapolis. The next year he was named team leader of the Zyprexa product team at Lilly. In 2000, he became adjunct professor of psychiatry at the University of Maryland School of Medicine.

Breier is the recipient of many awards, including the A.E. Bennet Award from the Society of Biological Psychiatry; Yale’s Lustman Award, which he won three times; and the Joel Elkes International Award from the American College of Neuropsychopharmacology for outstanding contributions to psychopharmacology. He is on the editorial board of scientific journals and has an extensive publication record totaling more than 200 scientific articles. He is included in The Best Doctors in America. Breier is editor of the books: The New Pharmacotherapy of Schizophrenia, Olanzapine (Zyprexa): A Novel Antipsychotic, and Current Issues in the Psychopharmacology of Schizophrenia.
This bio [from around the time he left Lilly] shows that Dr. Breier is well credentialed. From 1998-2003, he was the chief medical scientist for the Zyprexa program at Lilly, then became the VP for all of Medical until 2008. I’ve previously cataloged the goings on behind the scenes at Lilly under Dr. Breier’s leadership – and they’re not at all pretty:
For example, one way to increase sales was to market directly to Primary Care Physicians and get psychiatrists out of the loop. This was to be accomplished by turning the psychiatric disorders into symptoms rather than diseases:
The suggested story line to accomplish this went like this:

or this:

But they also fought the obvious truth about weight gain and potential  diabetes with the same kind of Sales Training:
They filled the literature with pro-Zyprexa articles mentioned in this 2001 email from Dr. Breier to the higher-ups:
These are just a few reminders of how the Lilly team directed by Dr. Breier were handling their Zyprexa Program. The fought the fact that Olanzapine [Zyprexa] lead the pack with weight gain and diabetes until they could fight no more. Even then, when directly told to issue warnings, they phrased them as "class-wide" rather than specific to their drug.

In these examples from Dr. Breier’s tenure as team leader for Zyprexa, doctors were being encouraged to treat grave psychiatric syndromes symptomatically and avoid expert consultation; equally grave adverse effects like obesity and diabetes were being denied or minimized; and our scientific literature was being flooded with articles jury-rigged to increase Zyprexa sales. He was in that position for a decade, up until three years ago. He left six months before Lilly admitted to a crime – promoting its drug Zyprexa for uses not approved by the Food and Drug Administration – and paid the largest fine in history for the behavior of the team he directed.

He was hardly someone to choose to write that editorial, but if chosen, we should at least have been informed about his past. Conflict of Interest declarations have a specific intent – to inform the reader about any confounding circumstances that might introduce bias into the opinions expressed. In this case, the article reviewed discussed a five-fold increase in the fraction of Atypical Antipsychotic prescribing in Anxiety Disorders over the decade in spite of the fact that the FDA has turned down requests for their approval. There is little question that one can treat anxiety with Antipsychotic drugs, particularly the better tolerated Atypicals. They were not approved because of their risk-benefit ratio, not because of ineffectiveness. The obvious question raised is why are they prescribed in the face of non-approval? The obvious answer is that some force overcame that concern – and we all know what that force was, particularly Dr. Breier who was instrumental in mobilizing it in his Zyprexa campaign while at Lilly where the order of the day was hiding or minimizing the risks involved. So his suggestion that there is a pressing need for more research is suspect, and you can’t know that if you don’t know the story. As his name is hardly that widely known, the reader is being duped…
  1.  
    aek
    October 15, 2011 | 9:45 AM
     

    Thank you for providing the more accurate disclosure of COI.

    I know this following request isn’t the usual topic of the blog, but I hope that you or another psychiatrist might entertain it as a post:

    At this juncture, what is/are optimal course(s) of action for people to take when they are interacting with mental health prescribers?

    I can’t distinguish between medicine and snake oil, between therapy and quackery, and between patient advocacy and patient coercion and deceit.

    You have made it plain that everything and everyone is eminently “highly treatable”. In other words, suckers, marks, targets, and market share.

  2.  
    aek
    October 17, 2011 | 3:03 PM
     

    Today, the Dean at Harvard Medical School announced a brand spanking new effort to develop more drugs using, it appears to me, to be an all out COI model. Here’s the link: http://www.focushms.com/features/transforming-drug-development/

    Indeed, it’s transformational. /sarcasm

Sorry, the comment form is closed at this time.