Down the Hatch: The Rothman Report

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In its quest to quantify the collusion between Janssen and the proponents of the Texas Medication Algorithm Project, the Texas Attorney General commissioned David Rothman, a professor of social medicine at Columbia University's medical school, to produce an expert witness report. The resulting analysis, completed in October 2010, is an 86-page bitch-slap of doctors who Rothman says "subverted scientific integrity" in their rush to line their own pockets. Some highlights are listed below.

Dr. Steven Shon, Director, Texas Department of Mental Health and Mental Retardation

As the head of the state's mental health agency, Shon was perhaps Janssen's most crucial key opinion leader; his influence in pushing ­Risperdal was invaluable.

He accepted at least $47,000 from Janssen and its medical ghostwriter, Excerpta Medica, and signed an agreement to be a member of Johnson & Johnson's Speakers Bureau. Rothman writes, "The medical director of the state's mental health agency should not be serving as an official spokesperson for a pharmaceutical company whose product state agencies are purchasing."

The company paid for his trips across the country, and even overseas, to promote ­Risperdal as a safe and effective medication. (But the romance between Janssen and Shon was not without its bumps; Shon would get "upset" if the checks he accepted from Janssen were made out to the MHMRA instead of directly to him. Apparently, those were more difficult to funnel into his personal account.)

Shon retired in 2005, allowing him to collect his taxpayer-funded pension. He moved to Las Vegas, where he's the director of psychiatry for a mental health and substance abuse clinic called Harmony Healthcare.

Shon was so influential that Janssen grew paranoid and possessive when it learned that other companies sought his partnership as well. When J&J employee Yolanda Roman heard that Eli Lilly had flown him to their headquarters on a private jet, she wrote, "Steve I suppose is enjoying the vast attention and response he can command from Industry...Obviously, Steve has the right to be served by all Industry, let's hope he remains fair [and] balanced and remembers who PLACED HIM ON THE 'TMAP' MAP."

Meanwhile, another employee busted out the caps-lock to warn that "WE WILL NOT LET LILLY OR PFIZER PREVAIL WITH OUR MOST IMPORTANT PUBLIC SECTOR THOUGHT LEADER."

Shon also advised Janssen on how best to promote an injectable form of Risperdal called Consta. After meeting with Shon, a J&J employee wrote her colleagues that "Steve suggested that we take the TMAP algorithm, change it to how we see Consta fitting in, and then asking TMAP folks to respond" [sic]. He also suggested "we hit the state hospitals and county hospitals hard." Rothman writes: "That a medical director is dispensing this type of advice to a drug company and receiving payment for it is altogether inappropriate for a state official and a medical professional."

Apparently, Shon's frequent globetrotting on the Janssen dime was noticed by his colleagues. Per Rothman, one stated that, "I found Steve to be somewhat loose with his job as medical director...He was rarely there...I think Steve liked to travel."

Shon did not return calls from the Houston Press.

Dr. Lynn Crismon, Professor, UT College of Pharmacy

Crismon was not only integral to TMAP, but was also the director of the project's aborted pediatric arm, CMAP.

He was a member of J&J's Speakers Bureau and accepted at least $61,000 from Janssen and its third-party contractors. Per Rothman, Crismon "was so closely linked to J&J that the company tendered him a job offer. After consideration, he turned it down, on the grounds that it would require him to move from Texas to New Jersey."

He is now the dean of UT's College of Pharmacology and also worked on the Texas Department of Family and Protective Services' latest guidelines for use of atypicals in foster care. Crismon's secretary at UT told the Houston Press he was unavailable for comment due to a death in the family.

Crismon also advised J&J on "clinical and marketing-related issues" regarding Risperdal Consta. Rothman writes: "Although TMAP evaluated where to place Consta on its algorithm, Crismon, as per his contract with J&J, was prepared to help 'guide strategic decision making.'"

Crismon's "same disregard of standards is found in [his] grant request to J&J to study clinical and economic effects of antipsychotics in prison populations...He told J&J that he had been persuaded that 'atypicals may have even more potential benefiting this population than they do in schizophrenia'...To promote a grant application by suggesting to the company that its product's use would be enhanced goes against the core principles of research integrity...Not surprisingly, Crismon received the grant from J&J for $20,000."

In a December 2010 UT press release on how the College of Pharmacy "helps ensure proper use of psychotropic medications" for foster children, Crismon is quoted as saying "the goal of the parameters is not to encourage physicians to prescribe psychotropic medications for foster children, but to encourage appropriate care of the child when they are used."

Dr. Alexander Miller, Professor of Psychiatry, UT Health Science Center-San Antonio

A member of J&J's Speakers Bureau, Miller collected at least $82,000 from Janssen and its contractors. He declined to comment for this story, saying he may be called as a witness in the lawsuit.

Miller was a "guest author" for one of Janssen's ghostwritten articles. Upon receiving the manuscript, Miller wrote, "Yes, I am happy to be included as a co-author. I made a few minor edits and comments in the manuscript."

Rothman writes: "That he was willing to serve as a co-author after making admittedly only minor edits and comments demonstrates Miller's readiness to serve J&J's interests rather than uphold professional standards. His claims that none of his activities with J&J biased him cannot substitute for active management or elimination of conflict of interest and commitments to professional integrity."

Upon attending a J&J advisory board meeting at Dallas's posh Rosewood Mansion at Turtle Creek, Miller asked J&J employees "where in the algorithm we [J&J] thought that Consta be positioned," Rothman writes. "The record is filled with evidence demonstrating how often Miller discussed the placement of Consta in the TMAP algorithm."

Dr. John Chiles, former Professor of Psychiatry, University of Texas Health Science Center-San Antonio/Chief of Psychiatry Services for the University Health System; former Professor of Psychiatry at University of Washington School of Medicine

For his work in helping pushing Risperdal through TMAP, Chiles accepted at least $151,254 over seven years from Janssen and its contractors. The Rothman report cites an internal J&J e-mail stating, "My goal with Dr. Chiles is to keep him informed of advances with Risperdal research data and neutralize the influence of our competitors...As we get new data and slides into his hands, I believe he will use them...I will also include him in all advisory functions that we hold in the southwest part of the country."

Chiles told the Press that no one from Janssen ever told him what to write or say, and that industry-funded research was part of the "climate" in the '90s. He also said that Janssen "actually came out not looking very good when we analyzed the data."

Joe Lovelace, former President, Texas Chapter of National Alliance on Mental Illness; current Associate Director of Behavioral Health at Texas Council of Community MHMR Centers

"In light of their special standing, J&J should have placed a firewall between their marketing departments and advocacy organizations," Rothman wrote. But there was a lack of transparency regarding J&J's contributions to NAMI. Johnson & Johnson worked closely with NAMI and other advocacy groups in order to integrate pro-atypical information into their literature and speaking engagements.

But the Rothman report notes that Lovelace profited personally from his relationship with J&J. Citing Lovelace's deposition, Rothman states that Lovelace deposited some of J&J's funding into the account of his wife's law firm, because "she needed the money...there was a loss there." He admitted accepting "honoraria" and travel payments for functions in Hawaii and Europe. Other documentation showed that Lovelace wanted to "partner with Janssen as a consultant."

Rothman also wrote, "Many of the activities that Lovelace carried out in conjunction with J&J violated principles of transparency. When asked if he let state officials know that he was copying the e-mails with them to J&J, he replied no."

Lovelace originally told the Press he would answer questions about how he felt about the continued use of ghostwritten articles and other conflicts of interest in the state's latest atypicals guidelines for foster children, but after he was sent the portion of the Rothman report detailing his participation with J&J, he replied via e-mail that, "I may be subpoenaed as a witness and would rather not comment for the article."

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