Battle over drugs hits crescendo
Lawsuit claims state official who pushed drug was rewarded.
Saturday, December 23, 2006
Texas Attorney General Greg Abbott's effort to recoup public money spent on prescription drugs in state mental health programs highlights the growing cost of those drugs, the emotional debate about how to treat mental illness and the pharmaceutical industry's role in creating support among experts for its products.
Abbott has joined a lawsuit alleging that the makers of a schizophrenia medicine called Risperdal misrepresented the benefits of their drug so the state would purchase it for patients in public mental health programs instead of anti-psychotic drugs that cost less and were just as effective. The drug became part of a much-celebrated treatment plan not only used in Texas facilities but also exported to 16 states.
"We believe Texas has been defrauded of some money, and we're going to be looking to get our money back," Abbott said this week.
Texas is the first state to go after drug companies accused of improperly influencing state officials who decided to adopt the treatment plan. The case is not only about the hundreds of millions of dollars Texas spent on one drug. It also raises questions about the role powerful drug companies play in crafting state decisions about how to treat mental illness.
Abbott would not say how much money Texas could gain from the lawsuit.
Thomas Melsheimer, a Dallas attorney for Pennsylvania whistle-blower Allen Jones, said Texas has paid hundreds of millions of dollars for Risperdal since 2000. Jones is teaming up with Abbott to sue six drug companies.
"We certainly believe that (the treatment plan) was essentially a marketing scheme masquerading as medical science," Melsheimer said.
The lawsuit Jones filed asks that Jones receive an unspecified percentage of what the state recovers.
State officials defended the drug plan. It is "firmly grounded in the latest research and science," said Stephanie Goodman, a spokeswoman for the Health and Human Services Commission.
Representatives for Janssen, the New Jersey company that makes Risperdal, have not responded to requests for comment, and two Texas scholars involved with the development of the treatment plan said university lawyers told them not to speak to reporters.
The plan at issue was developed in the 1990s as state officials sought a standard process for treating schizophrenia, major depression and bipolar disorder. The development of such guidelines has become common in medicine in the past 20 years, said Dr. Robert Rosenheck, director of the Northeast Program Evaluation Center in the federal Department of Veterans Affairs.
"There's been movement among academic doctors to make the information available in a simple form and to encourage people to follow the evidence," said Rosenheck, a psychiatry professor at the Yale School of Medicine. "These guidelines are there not just to tell you what's a good thing to do, but to increase the likelihood that doctors will do it."
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.
The first two phases of the project, including a four-month trial at 16 clinic sites, produced surprisingly positive results, with good patient response, according to American-Statesman accounts at the time.
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.
"I didn't personally benefit from this project," he said.
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.
In 1997, the year the protocol was developed, 7,314 people in state hospitals, state schools and mental health community centers were treated with Risperdal for at least one day, according to the health department. In the 2006 budget year, 21,537 people were treated with the drug.
One of the states that copied Texas' treatment plan was Pennsylvania. Jones says in his lawsuit that, while working for the state inspector general in Pennsylvania, he looked into allegations of impropriety in the adoption of the program there. One of the drug companies' representatives revealed payments made to Shon, the lawsuit says.
Jones says his supervisors in Pennsylvania sought to limit his investigation and told him drug companies "write checks to politicians on both sides of the aisle," and they eventually removed him as lead investigator on the case.
Jones left the inspector general's office in 2004, the same year he filed the lawsuit against Texas. In the process, he became a hero of sorts to people suspicious of the ways medicines are used to treat mental illness. Abbott could take on the same status as the case develops.
Jerry Boswell, president of the Citizens Commission on Human Rights of Texas, a mental health watchdog organization, commended the attorney general for taking on drug companies Boswell says have pushed certain drugs on a "captive audience": Medicaid and Medicare patients.
"This is going on all over the nation, and we can be proud that Texas is the first one to take the bull by the horns . . . to put a stop to this fraud," Boswell said.
Defenders of the Texas plan often grumble privately that Jones is propped up by the Church of Scientology and that Boswell's commission was co-founded by that church. Although his commission was indeed co-founded by the church, Boswell said, that's a red herring.
Jones "is not a Scientologist, and he is not doing this on behalf of Scientology or any other cause other than the truth," Melsheimer said.
A two-part study funded by the National Institute of Mental Health emboldened Risperdal's critics when the first part was published in 2005. It concluded that an older, less expensive drug called perphenazine performed as well in treating schizophrenia as Risperdal and three other newer drugs.
"There was the general belief that risperidone and the newer drugs were superior and had less side effects than the older drugs," said Yale's Rosenheck, who worked on the study. It and "several other independent government studies in the last three years have led me and some other people to question whether those conclusions are warranted."
But Goodman, with the state health commission, said the new drugs "make it possible for people with serious mental health issues to control their symptoms and avoid the side effects that kept them from having normal lives. Yes, there, are still side effects with the new drugs. There are side effects with all drugs."
Rosenheck, who is familiar with the Texas protocol but said he is not an expert in it, said its development came at a time when doctors and scholars had great hope for powerful new drugs.
"The people that did TMAP are quite highly respected," he said. "I think it was developed out of the current beliefs that were widespread in the profession. I've been surprised the way it's been linked to commercial purposes. There are lots of promotional activities that many of us are aware of and wince at, but TMAP was never one of them."
Still, the attention to the Texas system comes at a time of heightened scrutiny surrounding medicine's relationship with pharmaceutical companies.
Two former editors of the New England Journal of Medicine wrote books recently voicing concerns about the drug industry's role in determining medical treatment.
Jones' lawsuit, in fact, says the Texas program was only one piece of a Risperdal marketing effort that also spanned continuing education programs, speakers bureaus, advisory boards and trade publications.
"We don't for a minute believe that Janssen was the only company out there that was doing things this way," said Charles Siegal, one of Jones' attorneys.
Mental health drugs in Texas
1950s: First anti-psychotic drugs are introduced.
1990s: Anti-psychotic drugs considered to have fewer side effects are introduced.
1997: Texas Medication Algorithm Project, or TMAP, a drug treatment plan, is developed by a panel of health experts and state officials.
1999: Texas Legislature requires the state mental health program to follow TMAP protocol.
Late 1990s-early 2000s: Texas mental health official Dr. Steven Shon travels around the country speaking about TMAP.
Sixteen other states eventually adopt the protocol.
2003: President Bush's New Freedom Commission on Mental Health recommends TMAP.
2004: After questioning drug company payments to state officials, Allen Jones is fired from his job as an investigator at the Pennsylvania inspector general's office.
2004: Because the drug protocol used by many states originated in Texas, Jones files lawsuit in Travis County District Court against Johnson & Johnson and some subsidiaries.
The lawsuit is sealed from public view because of protections that whistle-blowers such as Jones are granted.
October 2006: Shon is forced by superiors to retire from the Texas health department after officials learn of findings of a Texas attorney general investigation into whether Shon was unduly influenced by drug companies.
December 2006: Texas joins Jones' lawsuit. The lawsuit is opened to the public.
Sources: Office of Comptroller Carole Keeton Strayhorn, Health and Human Services Commission, lawsuit