Saturday, December 30, 2006

State official was paid consultant for drug company

http://www.statesman.com/news/content/news/stories/local/12/19/19mhmrdrugs.html

State official was paid consultant for drug company

Doctor forced to leave state employ says arrangement was approved by the state.


AMERICAN-STATESMAN STAFF
Tuesday, December 19, 2006

A high-ranking state health official who was ordered to leave his job in October was a paid consultant for a drug company whose product became part of a standard treatment plan in state mental health programs.

Dr. Steven Shon, former medical director of behavioral health at the Department of State Health Services, was forced to leave after Attorney General Greg Abbott investigated whether drug companies improperly influenced Shon to promote one of their medicines in a state treatment plan, according to state documents and officials.

On Friday, Abbott joined a lawsuit against Johnson & Johnson and several subsidiaries saying they misrepre- sented the safety and effectiveness of a schizophrenia drug and unduly influenced Shon.

Shon is not named in the lawsuit, but Stephanie Goodman, a spokeswoman for the Texas Health and Human Services Commission, confirmed Monday that it refers to him. Shon denies the allegations in the lawsuit.

But he acknowledged that he was a paid consultant for Janssen, a subsidiary of Johnson & Johnson. He said a health department attorney approved the consulting, which he did on vacation time.

"I was not told it was any kind of problem," he said.

He said he earned $1,000 to $1,500 on three occasions for advising Janssen on topics such as side effects his patients had experienced.

Goodman, whose agency oversees the health department, said the commission was not aware of the consulting.

"We would not have approved that arrangement," she said.

The lawsuit, filed in state district court in Travis County by a former Pennsylvania state investigator, focuses on a Janssen drug called Risperdal that became part of a standard treatment plan developed in 1997 for Texas' mental health programs. Sixteen other states use the plan, which for the first time set a drug protocol in Texas for people in state mental health programs.

The protocol requires doctors to prescribe Risperdal and other anti-psychotic drugs before trying older, less expensive medications to treat schizophrenia, major depression and bipolar disorder. If doctors decide not to follow the plan, they must document why. Shon led development of the protocol.

Despite the allegations against Shon, commission officials said Monday that they stand by the treatment plan, Goodman said.

"Because those guidelines required broad consensus, it would have been very difficult to sway them just by trying to influence the opinion of one person or a narrow group of people," she said.

Shon traveled across the country promoting the drug, the lawsuit says. Allen Jones, the former Pennsylvania official who filed the lawsuit, said some of the drug companies' representatives told him that they paid Shon.

The lawsuit says the drug companies promoted Risperdal outside Texas by influencing policymakers with trips, perks, travel expenses, speaking fees and other payments.

But Shon said that the allegations are "absolutely untrue" and that he traveled from about 1998 through this year at the request of states that wanted to learn about the Texas program.

"The project was held up as a model by the President's New Freedom Commission on Mental Health for 'better consumer outcomes, including reduced symptoms, fewer and less severe side effects, and improved functioning,' " a Health and Human Services Commission document says.

Shon said that he directed money he received for speeches to the state and that he did not keep any. He acknowledged that drug companies were sometimes the source of the money because they fund research.

Health department officials Monday were unable to immediately provide information on whether Shon had given all of his honorariums to the state.

"Our project was not done for any of us to make personal gain," Shon said. "It was made to improve the quality of care in the area of prescription medications for psychiatric illness."

The Texas protocol was developed to address concerns that "mental health patients in the public health system did not have the same access to newer, more expensive medications that had fewer side effects than older drugs," Goodman said.

The lawsuit alleges that Johnson & Johnson and some subsidiaries misrepresented side effects and long-term health risks of Risperdal to qualify for reimbursement under Medicaid, the state-federal health insurance program for low-income people. The lawsuit seeks to recover money paid under the state's Medicaid program.

Shon, however, said his recommendations were "not focused on a particular drug or medication."

An Oct. 9 letter to Shon from Dr. Charles Bell, acting commissioner of the Department of State Health Services, shows that the department intended to fire Shon.

"It is my determination that your services are no longer required by the Department," Bell wrote in the letter, which was obtained by the Austin American-Statesman under the Texas Public Information Act. "I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately."

Goodman said that she does not comment on personnel matters but that "the attorney general's office briefed Bell and other key health and human services leadership on some of what they were finding." The briefing was in mid- or late September, she said.

Shon said he was forced to retire after superiors threatened to fire him. He said he was told only that he and the department were headed in different directions.

Johnson & Johnson and Abbott's office declined to comment on the lawsuit.

cmaclaggan  (at) statesman.com, 445-3548

jembry (at) statesman.com, 445-3654

Additional material from staff writers Andrea Ball and W. Gardner Selby.

 
 

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