TMAP and today’s transparency and conduct rules
In the controversial case of the Texas Medication Algorithm Project, or TMAP, recently unsealed expert testimony in an upcoming trial in Texas reveals details of the pharma tail wagging the dog, and the need for more rigorous transparency and conflict guidelines in academia and statute.
Remember, TMAP is a decision-making algorithm that was incorporated into guidelines for medication management of mental disorders that were adopted as policy in public programs.
Ethics expert David Rothman of Columbia University details the way that Johnson & Johnson funded the Texas treatment guidelines as a marketing tactic for its antipsychotic Risperdal, and worked closely with three academic physicians to try to persuade other states to adopt the guidelines. The clinicians then created a spin-off company that used the J&J money to promote the guidelines and host “educational conferences.” You can read more at Pharmalot and Boring Old Man blog, where there’s a link to the first 20 pages of Rothman’s testimony.
These activities occurred in the late 1990s and early 2000s, overlapping with another huge illegal marketing scheme, Neurontin. Since then, awareness of the industry’s aggressive and often covert attempts to influence prescribing via academic medicine has grown, and conflict-of-interest guidelines have grown stronger to counteract them. But it’s worth looking at whether today’s transparency and conflict rules would have caught the J&J TMAP infiltration any earlier.
If the same activities happened two years from now, it seems Johnson & Johnson would have had to disclose the unrestricted grant paid to the three psychiatrists’ teaching hospitals under the Sunshine provisions of health care reform, which require pharmaceutical and medical device companies to report payments to physicians and teaching hospitals annually into a public database beginning in 2013.
If the J&J grant in question was made to the university-at-large, though, the Sunshine provisions would not have captured it. Lawmakers should take another look at unrestricted grant payments data to make sure that there’s a way to capture such expenditures that have so clearly been used to strong-arm medical science and policy to fit marketing plans.
Recently, authors of a JAMA paper suggested that the law ought to seek to capture researchers who may not have clinical credentials but still influence pharmaceutical policies. A recent story in the Milwaukee Journal-Sentinel showed the power that University of Wisconsin Pain and Policy Studies Group wielded in the suppression of regulations and increased prescribing of addictive opioids. The group received $2.5 million from makers of such drugs over several years, but the researchers weren’t physicians – and therefore would not have been subject to Sunshine disclosures.
Such examples make strong case studies for updating disclosure and conduct rules. As pharmaceutical companies find new channels by which to peddle influence, medical centers and lawmakers should make sure rules like Sunshine–designed to keep those payments transparent–capture the widening array of actors pharma works through – including nurses, non-profits, and consumer groups.
But transparency alone isn’t sufficient to keep medicine and marketing separate. Just because the money trail is out there doesn’t mean that anyone necessarily follows it. It’s an open question whether today’s transparency measures would have caught the TMAP payments Rothman discusses. Academic medical centers need to have strong guidelines in place that prohibit physicians from profiting by using their professional positions to pass off pharmaceutical marketing activities as evidence-based medicine.
(Risperdal, as you may have heard, has much more recent troubles. Johnson & Johnson’s marketing flubs converged with its safety flubs at the end of last week when it recalled about 16,000 bottles of the schizophrenia drug and 24,000 of its generic equivalent after reports of bad odors, most likely caused by a chemical used to treat wood shipping pallets that has been responsible for a swath of the company’s recalls in the last two years. )
–Kate Petersen, PostScript blogger