1 Boring Old Man

Medicine as we know it emerged from the array of "healing arts" in antiquity based not on the promise of cure, but on the promise of doing no harm [primum non nocere] – an antidote to false claims or misplaced therapeutic zeal. And the traditional relationship between doctor and patient was called Aesculapian Authority. Roughly put, it means, "I make look in places where people don’t usually look, and suggest treatments that are unpleasant, but it’s only in the service of seeing if I can help you out with the problem you’ve brought to me." Throw in truthfulness, and that pretty much covers the field of medical ethics.

Scientific Fraud: Eric Poehlman / Richard Borison
Alliance for Human Research Protection
29 October 2006

^{Psychiatrist Richard Borison, a far more influential disgraced researcher whose corrupt practices landed him 15 years in prison to be followed by another 15 year probation, and his partner in crime, pharmacologist Bruce Diamond, who received a 5 year prison term, have the odious ‘distinction’ of worst academic research offenders. Both were tenured professors at the University of Georgia – Borison was chairman of the department of psychiatry. Psychiatric Times reported [In 1997, before their trial] "the 3-inch thick indictment chronicles a history of alleged misconduct dating back to 1988. The grand jurors charged that Borison and Diamond "developed and executed a scheme through which they systematically stole in excess of $10 million from the Medical College of Georgia," and that they "routinely lied to conceal their crimes and endangered the safety of the patients and study participants they were employed to serve, protect and heal."}

^{In 1997, the Wall Street Journal reported "Between 1988 and 1996, companies including Abbott Laboratories Inc., Hoechst AG, Warner-Lambert Co., Pfizer Inc. and Sandoz showered [Borison] and Dr. Diamond with contracts for more than 160 studies." In at least 44 trials, the WSJ reported,  Borison and Diamond contracted commercial ethics committees "including  one in Olympia, Washington" .  The two researchers "had been active in the development of many successful drugs, and they were good recruiters," says William Kennedy, vice president of Zeneca Inc., of Wilmington, Delaware, which hired them in 1990 to test Seroquel, a schizophrenia drug.}

^{"Among other companies, Johnson & Johnson hired the men to test Risperdal, its new schizophrenia medicine, and SmithKline Beecham PLC had them evaluate Paxil, a now-popular antidepressant. Their dozens of other clients also included Bristol-Myers Squibb Co., Eli Lilly Co. and Glaxo Wellcome PLC…}

^{Furthermore, the FDA failed to question the integrity of Borison’s data from antipsychotic, antidepressant, and Alzheimer’s drug trials – even after the agency had itself uncovered that he had made fraudulent claims in 1984. …the FDA had rebuked Borison after ascertaining that he lied in a paper delivered in May 1985 before the American Psychiatric Association. "He reported that the generic version of Thorazine, a SmithKline schizophrenia drug, wasn’t as effective as the brand-name medicine. Patients on Thorazine at the VA hospital in May 1984 became agitated and hostile, he said, when they were switched to generics the following month.  But when the U.S. Food and Drug Administration examined Dr. Borison’s claims, it found that the VA hospital hadn’t stocked Thorazine in May 1984 and had been using a generic equivalent exclusively for months. In addition, three of the 11 patients supposedly taking Thorazine that month weren’t in the hospital then, the FDA said. In response, Dr. Borison said he had altered the time periods to protect patient confidentiality. But the FDA said a review of all possible time periods also failed to corroborate his data. It publicly rebuked him."}

^{The fraud committed by Borison and Diamond has had enduring influence – their 50 odd articles continue to corrupt the scientific literature and their fraudulent data which the companies submitted to the FDA helped bring to market highly toxic drugs whose severe adverse effects are shortening the life-span of those for whom they are prescribed. The drugs are even being widely and irresponsibly prescribed for young children. Strangely, the case of Borison-Diamond has remained in the shadows, known only to a few specialists in the annals of psychiatry…}

I’ve never seen another case remotely like that one since [reference]. But the topic of Pharmaceutical companies influencing medical practice secretively via academic physicians has stayed on the front burner for the last twenty years, particularly in my specialty – psychiatry. And charges of academics cooperating and profiting from ties to drug manufacturers fill this and any number of other blogs.

That’s a long lead-in to something that happened recently. I wrote the organizer of a particular Continuing Medical Education Course inquiring into why he had included several speakers who have been recurrently implicated as having inappropriate ties to the pharmaceutical industry. He responded with a thoughtful email, letting me know that he was aware of the problem and detailing his plans to insure that there was no sponsorship of particular drugs. I believed what he said, but he made a particular comment that has stayed with me – "It is not my role, or the place of this educational activity to question their ethics or influences."

My internal response was immediate, "Why not?" As I thought further about it, I began to wonder who really should monitor the ethics and influences of the top dogs in medicine. I thought back to Dr. Borison’s talk, a Grand Rounds presentation in 1987. I heard that talk and I knew he was working for Sandoz, the company that made Mellaril – the drug he kept talking about. There was no question in my mind. I expect Sandoz actually paid for his trek from UGa [Medical College of Georgia in Athens] to Emory where he spoke [in Atlanta]. Back then, such things just weren’t declared. But I didn’t do anything. I just blew it off as a wasted hour and went on with my life. Dr. Borison continued on for another decade, actually becoming the Chairman of the Department of Psychiatry at MCG, and he did a lot of damage in that 10 years. When I think back on it, I wonder why I didn’t do something when it happened. I certainly hope I would act differently if it happened today.