In November, a trial is scheduled to take place that pits the state of Texas against Johnson & Johnson over a controversial program that was allegedly designed to boost the use of the Risperdal antipsychotic in the public sector. A whistleblower lawsuit filed in 2004 described how J&J surreptitiously designed and helped fund what became known as TMAP, or Texas Medication Algorithm Project, which relied on various state officials and academics to develop and sell the program as a policy tool.
The lawsuit, which was joined in 2006 by the state attorney general, was filed by a former Pennsylvania state investigator, Allen Jones, who uncovered the program after the health care giant began peddling TMAP to other states. He was subsequently fired and the vast majority of the documents have remained under seal, although a few have recently become available. Among them is a report filed last October by David Rothman, who heads the Center for the Study of Society and Medicine at Columbia University, who has studied conficts between physicians and drugmakers (see this).
In his report as a witness for the plaintiffs, Rothman takes note of what were called Tri-University Guidelines, which were published in supplements in the Journal of Clinical Psychiatry in 1996 and 1999, and were used to create TMAP. Although not publicly connected to the program, the guidelines were funded by a J&J grant. As noted by The Boring Old Man, who first disclosed this report, the guidlines were "one step in the process." And this is what Rothman wrote:
"As one of its first activities, and in disregard of professional medical ethics of principles of conflict of interest, in 1995, J&J funded a project led by three psychiatrists at three medical centers [Duke, Cornell, and Columbia] to formulate Schizophrenia Practice Guidlines. From the start, the project subverted scientific integrity, appearing to be a purely scientific venture when it was at its core, a marketing venture for Risperdal. In fact, the guidelines produced by this project would become the basis for the TMAP algorithms, giving a market edge to the J&J products in Texas. "Three psychiatrists, Dr. Allen Frances, Chairman of the Department of Psychiatry, Duke University, Dr. John P. Docherty, Professor and Vice Chairman of Psychiatry, Cornell University and David A Kahn, Associate Clinical Professor of Psychiatry, Columbia University, took the lead in designing and developing the Tri-University Guidelines. The project would employ three questionnaires to establish the guidelines: one went to academic experts, one to clinicians and one to policy experts. Including the third group was in all likelihood J&J’s idea as witness to the fact that Frances wrote J&J: 'This is new to us and requires additional discussion. The panel members would include mental health commissioners, community mental health directors, NAMI representatives (a non-profit partly funded by industry), experts in pharmacoeconomics, and so forth.'
"These were precisely the constituencies that J&J was eager to influence. J&J was the exclusive supporter of the project, dividing an 'unrestricted' grant of $450,000 among the three schools. It further agreed to a $65,000 bonus incentive payment if the team was timely with its product. The team met the requirement, requested the additional payment, and received it.
"The guideline team promised wide distribution of its product, including publication in a journal supplement. The team was prepared to have J&J participate in its work, not keeping the company even at arms length. With a disregard for conflict of interest and scientific integrity, the group shared its drafts with J&J. On June 21, 1996, Frances wrote (John) Lloyd (a J&J employee): 'We are moving into the back stretch and thought you would be interested in seeing the latest draft of the guideline project… Please make comments and suggestions.'
"So too, the group was eager to cooperate with J&J in marketing activities. Frances wrote without embarrassment or equivocation: 'We also need to get more specific on the size and composition of the target audience and how to integrate the publication and conferences with other marketing efforts.' Indeed from the start J&J had made it apparent to the team that this was a marketing venture. In a letter to Frances, Lloyd set forth what he called an 'aggressive time line' for the project, and added: 'There are a number of other Treatment and Practice Guidelines for schizophrenia being developed or published during this same period that may well serve our marketing and implementation needs at a substantial lesser cost.'
"Not only were Frances, Docherty, and Kahn ready to violate standards of conflicts of interest in mixing guideline preparation with marketing for J&J, but also in publicizing the guidelines in coordination with J&J. The three men established Expert Knowledge Systems (EKS). The purpose of this organization was to use J&J money to market the guidelines and bring financial benefits to Frances, Docherty, and Kahn.
"EKS wrote to Janssen on July 3, 1996 that it was pleased to respond to its request to 'develop an information solution that will facilitate implementation of expert guidelines.' It assured the company: 'We are also committed to helping Janssen succeed in its effort to increase its market share and visibility in the payor, provider, and consumer communities.' Now that the 'first phase' was completed, with guidelines created, 'EKS is now ready to move forward in a strategic partnership with Janssen.' The strategy will allow Janssen to influence state governments and providers… Build brand loyalty and commitment with large groups of key providers around the country.'
"EKS also promised 'rapid implementation,' with particular attention to having an impact on Texas decision making. 'It is our intent to work with the State of Texas immediately in implementing this product in a select number of CMHC’s with the assistance of A. John Rush, MD,' (who headed TMAP). Again, EKS emphasized: 'It is essential for Janssen to distinguish Risperidone from other competitors in a timely and creditable way.' In its summary of the document, EKS wrote: 'Your investment in the development of state of the art practice guidelines for schizophrenia is already beginning to pay off in terms of positive exposure in the Texas implementation project.'
"The costs for these various activities included: $250,000 for 'educational conferences;' and dissemination of publication at $177,659. J&J agreed to them. So all told, J&J paid at least $942,659 on the production and marketing of the Tri-University guidelines" (here are the first 20 pages of the Rothman report).
In other words, the various efforts in Texas were the early stages of what was envisioned as a national effort - albeit a stealth campaign - to greatly widen the reach of the Risperdal antipsychotic and establish market dominance. This sort of approach, however, was not confined to interactions with state officials and academics. J&J was recently penalized $327 million by a judge in South Carolina for 'detestable' behavior in choosing to illegally market Risperdal (read this).
The trial in Texas is likely to yield still more revelations, unless J&J reaches a settlement and succeeds in keeping most documents out of reach. The health care giant recently set aside reserves to settle litigation and sources suggest a $1 billion-plus payout has been discussed (look here). You may recall has been probed by the Office of the Inspector General of the United States Office of Personnel Management, the US Department of Justice, the US Attorney in Philadelphia and Attorneys General of multiple states over off-label Risperdal marketing for years. And other whistleblower lawsuits have also been filed.
Hat tip to the Boring Old Man