The company's 1993 Product Market Plan called for penetration of three customer segments: providers (prescribing physicians), KOLs who could "influence the politicians," and payors (government agencies). But first, the company had to, through the use of a comprehensive marketing campaign, "create a need and demand for new first-line antipsychotics" and then persuade everyone that Risperdal was the one drug to meet that need. (Risperdal's patent didn't expire until 2007.)
According to an expert witness report filed in the Texas AG's lawsuit, the push kicked off in earnest in 1995 with the establishment of what would come to be known as the Tri-University Guidelines. Janssen funded the research of three friendly physicians at Duke, Cornell and Columbia, with the understanding that they'd all agree that Risperdal was better than first-wave antipsychotics, according to an expert witness report commissioned by David Rothman, a Columbia University professor and psychologist. [See "Down the Hatch: The Rothman Report."]
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To better proselytize their Risperdal-friendly findings — and to better line their pockets from the sale of publications and speaking engagements — the three professors incorporated Expert Knowledge Systems. The J&J-funded entity acted as a "strategic partnership with Janssen," according to a filing in the AG's lawsuit, whose mission was to build brand loyalty. Between grants, educational conferences and dissemination of publications, ESK accepted $942,000 from J&J.
Enter the Texas Medication Algorithm Project, or TMAP.
With the Tri-University Guidelines in place, Janssen now had to find key opinion leaders in order to move Risperdal to the top of the state's preferred-drug list. The idea was to claim Texas, and then export TMAP to as many other states as possible; ultimately, at least 16 states incorporated the project.
According to the Rothman report, some KOLs recruited for the job included Dr. Steven Shon, then the director of the Texas Department of Mental Health and Mental Retardation; Dr. Lynn Crismon of the University of Texas's College of Pharmacy; Drs. Alexander Miller and John Chiles of UT Health Science Center in San Antonio; and Joe Lovelace, then the head of the Texas chapter of the National Alliance on Mental Illness.
Janssen, of course, denies the Texas AG's claims. A company spokeswoman said she could not discuss details while the case was pending, but did state in an e-mail that "Janssen is prepared to vigorously defend itself against these claims. We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication. If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action."
Prior to TMAP, Medicaid guidelines called for doctors to prescribe generic, conventional antipsychotics; they couldn't touch the much more expensive second-generation drugs, called "atypicals," until two or three conventionals had failed.
The drug companies' hurdles, then, were to come up with solid arguments to move their atypicals to the front of the line, despite their cost and the lack of data showing they were any better than conventionals. They had to persuade KOLs that the exorbitant upfront cost would actually save money in the long run because of the atypicals' relative lack of side effects as compared to conventionals. Of course, there wasn't much unbiased data supporting that.
As Rothman — the Texas AG's expert witness — wrote, "From the very beginning of TMAP, its leaders gave only lip service to conflict of interest considerations, ignoring principles in their search for industry funds...J&J fingerprints were all over the TMAP algorithms."
In one example, Rothman pointed out how in 1996, TMAP positioned both atypicals like Risperdal and the generic conventionals at Stage One, meaning physicians would be able to pick either one as a first choice for patients. But after Dr. Steven Shon and his fellow KOLs accepted $300,000 from J&J and other companies in 1997, conventionals dropped to Stage Four in 1998.
By the time of Janssen's 1999 Tactical Plan, Risperdal was the most prescribed atypical antipsychotic, more than doubling projected sales for each year. (While it was the second-most prescribed atypical, Eli Lilly's Zyprexa actually generated a higher dollar amount because it was more expensive.)
Janssen also desperately wanted to corner the pediatric market. Although Risperdal was already being used off-label to treat children, the company didn't have enough data on pediatric safety and efficacy for FDA approval. When the company sought the pediatric nod in 1996, the FDA responded somewhat incredulously: "You never state for what child or adolescent psychiatric disorders Risperdal would be intended. Indeed, you acknowledge that you have not provided substantial evidence from adequate and well-controlled trials to support any pediatric indications nor developed a rationale to extend the results of studies conducted in adults to children. Your rationale...appears to be simply that, since Risperdal is being used in pediatric patients, this use should be acknowledged some way in labeling."
This was hardly a stumbling block; all Janssen had to do was not tell anyone about this denial and just buy favorable pediatric research and ghostwrite glowing articles.
The go-to man for psychiatric disorders in children was Harvard's Joseph Biederman, a man who would one day explain in a deposition that the only entity with a higher professional ranking than him at Harvard was God. (In 2010, Harvard disciplined Biederman and two other researchers for not disclosing $4.2 million they accepted from pharmaceutical companies between 2000 and 2007. The doctors wrote a letter of apology, explaining that they had "learned a great deal from this painful experience.")
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