Healthy Skepticism Library item: 7147

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Publication type: news

MacLaggan C, Embry J.
State official was paid consultant for drug company: Doctor forced to leave state employ says arrangement was approved by the
The Austin American Statesman 2006 Dec 19
http://www.statesman.com/news/content/news/stories/local/12/19/19mhmrdrugs.html

Abstract:

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.