Wednesday, December 24, 2008
In a recent blog post on Psychology Today, Nassir Ghaemi MD of Tufts University frankly discusses the "steroid problem of academia."
This concerns ghost authorship. What happens is common practice in journal publishing, especially in psychiatry. A drug company will design and write its own study, complete with its own spin favoring the drug in the study. Then the company invites respected academic researchers to front the study as authors. The study then appears in a medical or psychiatric journal. (For more detail how this works, check out my website article.)
What's in it for the "authors" is fame and academic distinction. In a university publish or perish environment, there is intense pressure on academics to rack up credits any way they can. The problem, says Dr Ghaemi, is that "some of our experts get their fame artificially, their achievements appearing greater than they really are."
In his blog, Dr Ghaemi reports how a department head actually encouraged him to engage in this type of fraud (he refused). Dr Ghaemi also reports how, fairly recently, a past president of the American Psychiatric Association and another luminary expressed complete surprise to him that this type of thing was going on. (This ignorance is astounding in light of the fact that eight or nine years ago, about a dozen journals worldwide ran simultaneous editorials highlighting the situation and promising corrective action in their own publications.)
Dr Ghaemi has devoted much of his professional life to researching the use of antidepressants in treating bipolar depression. His research has been influential in convincing psychiatrists to think twice before prescribing. His data shows that not only is the benefit problematic in a bipolar population, but there is risk of switching patients into mania and rapid cycling.
Not surprisingly, you will not find drug companies stampeding to fund studies to prove Dr Ghaemi right.
How serious is the problem? Early in 2008, in preparing for a grand rounds lecture I was to deliver to a psychiatric hospital in Princeton, I came across a 2006 study published in the American Journal of Psychiatry, which is put out by the American Psychiatric Association. The study concerned bipolar patients on Zyprexa, and was designed and written by Eli Lilly, which manufactures the drug.
The article listed Mauricio Tohen MD, DrPH as the lead author of the study. In all likelihood, Dr Tohen most likely did have a major hand designing and writing the study. A PubMed search of "Tohen M, olanzapine" reveals 92 published articles he authored between 1998 and 2008.
Dr Tohen is virtually unique in psychiatry in that he is affiliated with Harvard and Mass General Hospital AND is employed by Eli Lilly. In addition to Dr Tohen, the article listed eight other authors. Three of the names were instantly recognizable as prominent academic thought leaders.
According to the abstract of the study:
"Compared to placebo, olanzapine delays relapse into subsequent mood episodes in bipolar I disorder patients who responded to open-label acute treatment with olanzapine for a manic or mixed episode."
But the study data, not mentioned in the abstract, told a far different story. In fact, eighty percent of the patients in the study stopped taking their Zyprexa.
When I raised this to my audience of clinicians in my talk, I asked if anyone thought this was deceitful. All hands went up. I would go further, I said. I would say it's immoral.
Zyprexa is an antipsychotic with a high side effects profile, and it's not surprising that four in five bipolar patients choose not to take it, even if they are otherwise doing well on it. As Holly Swartz MD of the University of Pittsburgh told a symposium at the 2006 APA annual meeting: "If a patient doesn’t stay on it, it doesn’t do any good, even if it works.”
No doubt, I ranted and raved far too much in my talk, but as a patient I represent the greatest stakeholders in this debate. Am I going to end up in crisis - or worse - as a result of a well-meaning doctor sending me out the door with the wrong prescription based on deliberate misinformation?
Does anyone see a blatant violation of the "do no harm" principle at work?
I have no objection to productive partnerships between industry and academia. Indeed, drug companies would be incredibility stupid not to tap into this invaluable brain trust. Likewise, academics deserve to profit handsomely from any research that improves our chances of leading productive and rewarding lives.
What I object to is drug companies debasing psychiatry by employing its best and brightest as errand boys. Meanwhile, far too many highly-dedicated researchers are forced to leave the field due to lack of funding. We are left struggling in the dark. Our doctors get treated to infomercials.