MEDICINE Doctors’ ties to drug companies questioned In letter to UT, senator says psychiatrists haven’t reported all income
September 24, 2008
Between 2000 and 2007, Dr. Rush failed to report another $12,000 from various drug companies, the records show.
Dr. Rush – who is now working at Duke University’s medical school in Singapore – and Dr. Wagner were both contributors to the Texas Medication Algorithm Project , a controversial state drug protocol that has been trailed by allegations that drug companies improperly influenced its designers. It is currently the subject of a state lawsuit.

September 19, 2008
ANTI-PSYCHOTICS Study backs generics Drugs funded by state found to have bad side effects, no added benefit
Meanwhile, the state lawsuit accuses Janssen of using false advertising and trips and other perks to get Risperdal listed on the Texas Medication Algorithm Project, which mandates the use of certain drugs for adults whose medications the state pays for. Individuals with knowledge of the case say it has spread to the children’s drug protocol.

August 18, 2008
MEDICATION PROTOCOL Mental health project on hold State delays kids’ plan over concerns of drug com-pany influence
AUSTIN – A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list.
Publicly, officials say it’s because the state is suing a pharmaceutical company alleged to have used false advertising and improper influence to get its drugs on Texas’ now-mandatory adult protocol, the Texas Medication Algorithm Project.
Privately, individuals with knowledge of the case – who spoke only on condition of anonymity because of the pending litigation – say the attorney general’s investigation of possible fraud in the adult protocol has spread to the children’s version.

St. Petersburg Times
April 13, 2008
The idea of establishing state guidelines for prescription practices origi-nated in Texas in 1996, under an ungainly name:
The Texas Medications Algorithm Project. TMAP for short.
The goal was to bring together some of the best minds in the field to reach consensus on how best to treat schizophrenia and bipolar disorder. TMAP would tell Texas doctors: Start with this drug, and if it doesn’t work, try this one. If a drug made the top of the list, the manufacturer stood to make millions.
The atypical drug companies stacked the deck: TMAP was seeded with a $1.6-million grant from the charitable arm of the company that owns Jannsen, which makes Risperdal. The panel was packed with doctors and academics who were paid on the side from the companies that make atypicals.
Proponents of guideline committees say they discourage unproven practices, such as prescribing combinations of several antipsychotics.
Spearheading TMAP was Steven Shon, the Texas Health Department’s medical di-rector for behavioral health. A state employee, he was not allowed to accept money from the pharmaceutical companies.
He resigned amid an investigation that revealed he was taking money from Janssen. By then, with Shon’s help, the Texas guidelines model had been exported to more than a dozen states, including Florida.
The Florida Behavioral Health Collaborative was the brainchild of Eli Lilly and Co., which proposed it in 2004 and, with other drug companies, gave the state $10-million to create it…
The Florida collaborative convened an expert panel to recommend state stan-dards for treating mental illness. National scholars were invited – all with fi-nancial ties to drug companies.
To treat schizophrenia, the panel decided, doctors should try an atypical first. If that didn’t work, they should try a different atypical. If that still didn’t work, they should try a third atypical or, if they would rather, one of the older generation drugs.

The Philadelphia Inquirer
December 29, 2006
Suit: Janssen Pharmaceutica misled Texas officials on drug
By Rob Waters
Jones’ complaint alleges that the Texas health department received as much as $6 million in contributions from Janssen and other parties to implement the treatment guidelines under the Texas Medication Algorithm Project, known as TMAP.
The largest contributors, according to the lawsuit, were Janssen and the Robert Wood Johnson Foundation, the Princeton-based charity endowed by J&J’s cofounder that operates independently of the company.
The foundation provided three grants totaling $2.8 million to evaluate TMAP as part of an effort “to improve treatment of chronic disease,” foundation spokesman David Morse said.
After the guidelines were adopted, Janssen “experienced a significant increase in sales of Risperdal” in Texas and worked to bring the program to other states, the suit alleges. State officials “traveled extensively, at the expense of defendants, to tout the wonders of the new drugs,” the complaint says.
Janssen “improperly influenced state decision-makers with trips, perks, travel expenses, honoraria,” and paid state officials “to speak in their official capacities” to promote the drugs, the complaint says.
In Pennsylvania, allegations about drug-company influence over Medicaid policy resulted in ethics charges against Steven J. Fiorello, of Palmyra, former chief pharmacist for the Public Welfare Department.
Fiorello was fined more than $27,000 last year and fired for using his position to earn extra income from two drug manufacturers, including Janssen. Fiorello also faces criminal charges.

Austin American-Statesman
December 23, 2006
Texas suit takes lead in debate on drugs
By: Jason Embry and Corrie MacLaggan
The advent of new mental health drugs spurred the state’s $5.6 million project to develop the treatment plan, known as the Texas Medication Algorithm Project, or TMAP. The Robert Wood Johnson Foundation, founded by a former executive at Johnson & Johnson Inc., gave $1.8 million to the project. Janssen is a subsidiary of Johnson & Johnson, and both companies are defendants in the lawsuit.
But Jones’ lawsuit claims that Risperdal became part of the treatment plan because of drug companies’ “improper influence” over Dr. Steven Shon, the former medical director for behavioral health at the Department of State Health Services. The lawsuit says the companies pushed Risperdal by giving state officials around the country trips, perks and speaking fees.
Shon, who lost his state job after Abbott’s investigation of Jones’ claims, has served as a paid Janssen consultant and traveled the country promoting the Texas plan. He denies the allegations in the lawsuit, however.
Doctors treating patients in state-run mental health programs are required to follow the protocol, which is still in use, unless they document why they should not. Risperdal is one of five drug options in the initial treatment options for schizophrenia.

Fort Worth Star-Telegram
December 20, 2006
Lawsuit says drug companies conned state
Drug-company donations
A major portion of the lawsuit focuses on the Texas Medication Algorithm Project, which Shon coordinated. That program offers a series of treatment plans, or algorithms, for various mental illnesses, including which drugs to use. In many cases, the plans recommend the newest drugs, which are the most expensive and are not available in generic form. The plan allows doctors to deviate from the recommendations if they have sound reasons to do so, state officials say.
Supporters of the algorithms say that in many cases, the newer drugs are more effective than their older counterparts and can have fewer debilitating side effects. But many of the newer drugs have come under increasing scrutiny from federal regulators, including warnings that they can increase the risk of suicidal behavior or can lead to illnesses such as diabetes.
Such drugs generate much income for pharmaceutical companies. In a recent three-year period, more than $190 million was paid in Texas for outpatient Medicaid claims for Risperdal alone, according to the state Health and Human Services Commission. During those same years — 2002 to 2005 — almost $700 million was spent on all antipsychotic medications combined. That does not include care for those who are in state institutions.
Drug companies, including Janssen, gave the state more than $1 million to help promote the plan. And the Robert Wood Johnson Foundation, established by the founder of Janssen parent company Johnson & Johnson, gave $2 million. A company spokesman previously said the foundation is independent of the company.
The exact amount donated by the companies remains unclear. Shon has acknowledged that his agency did not always seek required approval from the department’s governing board before accepting donations.


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