These days, we’re so inured to stories of payments to ‘KOLs’ and ghostwritten articles in psychiatry that new instances have become almost routine. There were, however, some variations on the theme in that Report in my last post that I found jarring.
Dr. Allen Frances was Chairman of Psychiatry at Duke [1992-1998] and lead the DSM-IV task force [1994]. The Duke
web-site says he was "…perhaps best known for his work in constructing the DSM-IV and a number of
groundbreaking practice guidelines in psychiatry."
Dr. John Docherty was Vice-Chairman at Cornell at the time. His
bio:
Trained as a clinical research fellow in neuropsychopharmacology at NIMH, he later returned as Chief of the Psychosocial Treatments Research Branch, responsible for all federally supported psychosocial treatment research in mental health nationwide. He oversaw the landmark National Collaborative Study in the Treatment of Depression and served as a member and Chairman for over 10 years on the NIMH and then NIDA Treatment Research IRGs. Dr. Docherty has wide experience in successfully implementing innovation in both clinical and managed health care. He founded Northeast Psychiatric Associates in 1985. As National Medical Director for National Medical Enterprises, he oversaw medical control and quality improvement in 74 hospitals in 34 states. He was the Executive Vice-President and Chief Medical Officer for Merit Behavioral Care, which then covered 30 million people. In 1998, he founded Comprehensive NeuroScience (CNS). Its Care Management Technologies are currently implemented in 17 state Medicaid plans. Dr Docherty has received numerous honors and awards and has authored over 100 scientific publications.
After his research fellowship, Dr. Kahn pursued a clinical administrative career, initiating a number of core programs including two new inpatient units and new outpatient psychopharmacology and psychotherapy teaching clinics. He currently oversees faculty practice outpatient programs including the Columbia Day Program at East 60th Street, the inpatient teaching service at New York Presbyterian Hospital/Columbia, and the inpatient and outpatient research and clinical programs at the Psychiatric Institute. He has served on numerous advisory committees related to mental health services and quality management. He has published over 40 articles and book chapters related to psychopharmacology focusing on bipolar disorder, issues in combining medication with psychotherapy, and the quantification of expert consensus in the development of practice guidelines.
Notice that all three list their guideline work as accomplishments. And the Report lists some other big names. Dr. A.J. Rush was in charge of TMAP and went on to be the Principle Investigator on the largest Clinical Trial in depression every done [STAR*D]. The Report was particularly critical of Dr. Joseph Biederman at Harvard who essentially created a J&J funded research center to include children in the Risperdal target population. But equally jarring were the reports of the Texas psychiatrists Dr. Lynn Crismon, Dr. Alexander Miller, Dr. John Chiles, and particularly Dr. Steven Shon who essentially functioned like they were Johnson & Johnson employees selling Risperdal, even though they held jobs working for the Texas State Mental Health system.
On my first time through the Rothman Report, I couldn’t stay with the ghostwriting examples. I kept getting sidetracked – googling Excerpta Medica, anything to divert my attention from what I was reading. Usually, when we’re talking about ghost-writing, we define it by who wrote the first draft. With J&J, the early drafts [or whole articles] were often written before the author was picked:
Rothman included these two reports to show how many articles were written prior to the authors even being chosen [TBD], but there’s something else. "Of the 80 articles listed in the July 2003 schedule …" "Of the 65 articles that EM was developing in December 2003 …" The number of articles being written [ghost-written] is in itself staggering. When we say the literature was being flooded, we aren’t kidding. So it looks like
Janssen and
Excerptia Medica have a
close working relationship:
That whole decade [1995-2005] must have been the apogee of some kind of curve – the flagrant disregard for even the appearance of scientific integrity [not that the curve has fallen even yet].
The EKS Guideline company [archives] founded by Frances, Docherty, and Kahn is still in existence [hat tip to EP & jamzo]. Excerptia Medica is still just down the road from Janssen in New Jersey. The Risperdal profits are banked and/or spent. And the TMAP suit still awaits trial. Looking back over that Report, I have a difficult time reading it without taking a break, even after multiple readings. I think it’s still hard for me to imagine the climate of those few years ago when the events in that Report were taking place. The Doctors involved in writing the Guidelines and proselytizing TMAP must’ve thought at some level that what they were doing was okay. The people at EM must’ve felt like ghost-writing those articles was also okay. The Drug Company executives who masterminded this whole story must’ve seen this as good business – making profits for their shareholders. That’s what psychiatrists call denial. I doubt that any of them visited a Texas mental health center where the schizophrenic patients whose lives they were playing with congregate, or went to a nursing home where the elderly were being dosed per their instructions.
There’s a
blurb on the Excerptia Medica web-site about GPP [Good Publication Practice] that I also had some trouble reading without wincing. It sure wasn’t in place in their "Risperdal Years"…
Flying the Industry Standard, which is available both online and in a special publication planning edition of Pharmaceutical Marketing Europe, brings Excerpta Medica’s wealth of knowledge in this field to a wider audience.
Program Director and author of Flying the Industry Standard Hester van Lier believes that “The publication of GPP standards reinforces the industry-wide commitment to ethical and transparent practices. Now is the time to take the next step and demonstrate actual adherence to these standards. This will benefit the medical communications agency, authors, publishers, and industry alike. By operating together with transparency towards high-quality and accurate reporting of medical research, we can have a positive impact on the evidence base that healthcare providers use to make decisions and, ultimately, on patient care.”
The publication offers a six-step guide to assist agencies partnering with pharma and biotech, authors, and publishers, in creating robust processes from staff education to innovation and documentation, to ensure that all steps in publication development are in line with GPP.
Unbelievable! I’m wondering whether anybody but me has found this news most unsettling, in large part, because of the way Allen Frances has been using his blogging privileges on popular websites, for a year now, to deflect the blame for the origin of the epidemic in atypical antipsychotic prescribing onto everybody else instead of where it apparently belonged. I have to wonder if he wrote all those blogs not knowing he would be outed by this report, or as a preemptive defense because he knew what was coming.
The article, “Bipolar kids: Victims of the ‘madness industry’? @ http://www.newscientist.com/article/mg21028151.900-bipolar-kids-victims-of-the-madness-industry.html?full=true has this quote from Allen Frances, “It’s very easy to set off a false epidemic in psychiatry. The drug companies have tremendous influence.”
Frances clearly knows from whence he speaks.
When reading that article Ed posted it almost sounds like Frances has a guilty conscience. Really it does come across that way to me. Maybe he has seen the error of his ways but then he should come right out and say it, like Mickey says in his post today.