Healthy Skepticism Library item: 7146

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Wilson N.
Drug Makers Accused Of Misleading Health Dept.
KEY TV-CBS 2006 Dec 18
http://keyetv.com/investigates/local_story_352223055.html

Abstract:

One of the nation’s 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.