The suit by Allen Jones, formerly assistant Inspector General in Pennsylvania, and the Texas Attorney General charges Johnson & Johnson with concocting TMAP (Texas Medication Algorithm Project) a marketing scheme to increase sales of its antipsychotic drug, Risperdal.
The suit will unravel the fraudulent TMAP prescribing guidelines that were promulgated by a consensus panel of psychiatrists from the University of Texas, and promoted with the help of public officials–all of who were paid by J & J (and other Big Pharma companies). TMAP is a prescription drug scheme ensuring that the most expensive psychotropic drugs would be used, the exorbidant cost paid for by taxpayers.
The Texas Statesman reports (below) that the AG suit which is primed to retrieve taxpayer money that was misspent on Risperdal could result in penalties of more than a billion dollars.
Though not charged in the suit, "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."
Dr. Shon, it was discovered, was a paid consultant to Janssen (subsidiary of Johnson & Johnson) who actively lobbied other states to adopt TMAP.
Long before the Texas AG joined Allen Jones' suit, investigative reporter Nanci Wilson of KEY-TV-CBS 42 in Houston, Texas, was tracking the skyrocketing cost of psychotropic drugs paid for by the Texas Medicaid program.
Wilson discovered that Dr. Shon was a major lobbyist for TMAP who "spent a great deal of his time traveling around the country promoting the TMAP treatment guidelines." He made at least 84 trips around the country –so far 17 states have adopted TMAP.
Jones uncovered evidence of how "unrestricted educational funds" –a favorite pharmaceutical ploy for laundering money to public officials and academics– were deposited in an "off the books" account made out to Dr. Shon.
When asked in 2004 by Nancy Wilson, "So when ever you were going on trips to speak on behalf of this and the money was coming from the pharmaceutical companies were you ever aware that it might look like a conflict of interest?"
Dr. Shon responded: "I think that it possible could, but I thought that given the fact that this is how conferences and education works, I didn't think that this was really any different then what was going on anywhere else."
See Video; http://keyetv.com/investigates/local_story_352223055.html
Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org>
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http://keyetv.com/investigates/local_story_352223055.html
KEY TV-CBS
Dec 18, 2006
Drug Makers Accused Of Misleading Health Dept.
Nanci Wilson
(CBS 42) AUSTIN One of the nations largest drug makers is accused in a lawsuit of misleading the Texas Mental Health Department about the safety and effectiveness of one of its top selling drugs.
The drug in question is the anti-psychotic risperdal. The Texas attorney general joined a whistle-blower lawsuit that could cost the Johnson and Johnson companies more than a billion dollars.
If you go to any state or community mental health center in Texas and are diagnosed with major depression–bipolar disease or schizophrenia–doctors there are required to follow a step by step treatment guideline. The guideline is called TMAP, and stands for Texas Medical Algorithm Program. It lists specific drugs that doctors are to prescribe for each illness.
It caught our eye when CBS 42 noticed the drugs listed in TMAP are the most expensive on the market, with little scientific evidence the drugs work better than cheaper alternatives. Then, CBS 42 learned that the drug makers, whose drugs are specified, were giving thousands of dollars to the state of Texas Mental Health Department and paying to send the medical director to lobby other states to adopt the guidelines.
That's when CBS 42 met whistle-blower Allen Jones. He is a former assistant inspector general for the state of Pennsylvania. What he found as Pennsylvania was adopting TMAP for its mental health department, prompted a lawsuit against one of the biggest drug companies in the world.
Until a few weeks ago, Dr. Steven Shon was the medical director for the state of Texas Mental Health Department in charge of making sure the state's mentally ill get the care they so desperately need.
But CBS 42 found Shon spent a great deal of his time traveling around the country promoting the TMAP treatment guidelines. So far 17 states have adopted TMAP.
"We didn't think it was going to become anywhere near this large in the beginning," Shon told CBS 42 in 2004. "We thought we'll maybe we'll do something and maybe some people will pick up on it."
CBS 42 found Shon made at least 84 trips. Many of the trips were courtesy of the drug companies whose drugs are specified in TMAP and have a financial interest in getting other states to adopt the program.
"So when ever you were going on trips to speak on behalf of this and the money was coming from the pharmaceutical companies were you ever aware that it might look like a conflict of interest," CBS 42's Nanci Wilson asked.
"I think that it possible could, but I thought that given the fact that this is how conferences and education works, I didn't think that this was really any different then what was going on anywhere else," Shon said.
But Shon's trips to Pennsylvania weren't business as usual. "The check originated as an unrestricted educational grant from Janssen to the Harrisburg State Hospital here in Pennsylvania," Allen Jones said. "However, the check was deposited to an off the books account and a separate check written out to Shon in the exact amount of the unrestricted educational grant. And while they called it an unrestricted grant, the supporting documentation clearly, clearly established that the purpose of the monies was to bring Shon to Pennsylvania to sell the TMAP program to Pennsylvanian officials."
Over the past three years, sales of risperdal cost Texas taxpayers more than $191 million.
The suit also claims the company misled the state about the safety and effectiveness of the risperdal.
Two government funded studies–the largest of it's kind–found risperdal is not more effective in treating mental illness than cheaper alternatives.
Now, the attorney general is suing to get the money back that taxpayers spent on the drug.
The possible penalties could end up being more than a billion dollars.
(C MMVI, CBS Broadcasting Inc. All Rights Reserved.)
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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.
By Corrie MacLaggan, Jason Embry
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@statesman.com, 445-3548
jembry@statesman.com, 445-3654
Additional material from staff writers Andrea Ball and W. Gardner Selby.
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