“Judges do not hear cases in which they have a financial interest. Reporters do not write stories about companies in which they have a financial interest. By the same token, doctors should not have a financial interest in treatments they are evaluating, or accept gifts from the makers of drugs they prescribe.”
That’s what Dr. Marcia Angell says, and she ought to know. She spent over 20 years as editor of the prestigious New England Journal of Medicine. She wrote these words last January in a letter to Dr. Nada Stotland, president of the American Psychiatric Association in response to Stotland’s criticisms of her essay in the New York Review of Books.
Back then, the editorial board at the New York Times had decreed:
“The medical profession needs to wean itself almost entirely from its pervasive dependence on industry money.”
Dr. Angell agreed with the Times, adding:
“Pervasive conflicts of interest corrupt the medical profession, not in a criminal sense, but in the sense of undermining the impartiality that is essential both to medical research and clinical practice.”
Dr. Angell disagreed strongly with psychiatrist Dr. Stotland’s assertion that very few drugs of any kind have been tested on children. Not so, claims Dr. Angell.
“Many have been tested and found not to warrant FDA approval; others have been tested in poorly designed trials for marketing purposes, not to gain FDA approval. Although it is illegal to promote drugs for use in children if the FDA has not approved them for that use, the law is frequently circumvented by disguising marketing as education or research.”
She slams drug giant Eli Lilly, who recently agreed to pay $1.4 billion (that’s billion with a ‘B’) to settle civil and criminal charges of marketing their anti-psychotic drug Zyprexa for uses not approved by the FDA (known as “off-label” uses). Zyprexa, which Dr. Angell reminds us has serious side effects, is one of the drugs frequently used off-label to treat small children diagnosed with bipolar disorder.
“I don’t deny the serious effects of psychiatric conditions, but it is still necessary to show in adequate clinical trials that the drugs used to treat them do more good than harm.”
Dr. Angell reserves special criticism for the psychiatric profession.
“Unlike migraines or shyness, hypertension or high cholesterol can be defined by an objective measurement—a blood pressure or cholesterol level. The measurement is easily verifiable.
“But the fact that psychiatric conditions are not objectively verifiable underscores the necessity for both diagnosis and treatment to be as impartial as possible. That is why conflicts of interest are more serious in this field than in most others, and why it is so important that the authors of the Diagnostic and Statistical Manual of Mental Disorders, which is now the standard reference for defining and diagnosing psychiatric conditions, must be free of them.
“Yet, as was the case with the authors of the current edition of the manual (DSM-IV), most members of the task force now working on DSM-V have financial ties to industry. Dr. Stotland seems to think that it is enough to disclose those ties and to limit the amount of money members may receive, but I am far less sanguine.”
Dr. Angell insists that most conflicts of interest in medicine can and should be eliminated, not just “managed”, as Dr. Stotland had allegedly suggested. But one of Dr. Stotland’s predecessors as president of the American Psychiatric Association, Dr. Steven Sharfstein, warned his colleagues in a column published in Psychiatric News on August 19, 2005:
“Drug company representatives bearing gifts are frequent visitors to psychiatrists’ offices and consulting rooms. We should have the wisdom and distance to call these gifts what they are - kickbacks and bribes.”
While industry sponsorship of research may be acceptable, it should be for work of scientific, not just commercial, importance, insists Dr. Angell.
”Academic researchers should have no other financial ties to companies whose products they are evaluating and should bear full responsibility for the way the research is conducted and reported.”
One of these doctors named by a U.S. Senate investigation last year is psychiatrist Dr. Alan F. Schatzberg of Stanford, whose $4.8 million stock holdings in a drug development company whose drug trials he is supervising raised the investigators’ concern. Dr. Schatzberg told the New York Times that he had fully complied with Stanford’s rigorous disclosure policies and federal guidelines that pertained to his research.
Schatzberg also argued that blocking or constraining researchers from trying to bring medications to market “will mean less opportunities to help patients with severe illnesses. Drugs that are helpful may not be developed by big pharmaceutical companies, for a variety of reasons, and we need some degree of communication between academia and industry to expand options for patients.”
I’d say he’s getting about $4.8 million worth of communication . . .
¤ For more background info, read this New York Times report.