Johnson & Johnson Sued over Texas Medication Scheme
TMAP, the Texas Medication Algorithm Project, was initiated by Johnson & Johnson, together with other pharmaceutical producers, as a way to assure prescription of certain psychiatric medicines through State medical programs. The program, which was exposed by Allen Jones, an investigator turned whistleblower, is complemented by TeenScreen, a psychiatric screening program to be run in schools all over the US. The plan was to test kids by simple questionnaire and then prescribe them psychiatric drugs in accordance with TMAP, and it is being put into effect right now.
Allen Jones had filed a lawsuit against Johnson & Johnson in 2004, but the case was sealed from public view until recently, when Texas Attorney General Greg Abbott joined the case.
A message from TeenScreenTruth calls on parents across the US to act to bring the fraudulent medication program and its sister, the screening scheme, to the attention of school boards, politicians and the media:TeenScreen's Evil Sister - TMAP, Texas Medication Algorithm (guidelines) Project is a dastardly plan concocted by drug companies to influence government officials to push the newest most expensive antipsychotic drugs. The below story is the first of surely many more to come. Both TMAP and TeenScreen were "recommended" by the President's New Freedom Commission on Mental Health.
Both are going to go down with a thud but your help is needed. To augment the national controversy, pick a school in your neck of the woods www.teenscreen-locations.com/index.htm and raise the dickens with school board members, legislators, newspapers, radio and your local TV news. Any talk radio show, for example, would be interested in what you have to say about the national controversy of TeenScreen asking kids as young as 9 years old questions about suicide and then referring them to "treatment" (drugs).
Meanwhile, the lawsuit filed by whistleblower Allen Jones looks set to bring some additional motion to the scene. With Medicaid all but bankrupt ... paying for expensive and often unnecessary medications, there might be a synergy of interests to recover some of the lost money for the State and save the children's sanity at the same time.
Here is 'the below story', an article about the lawsuit in the Austin American Statesman:
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Austin American Statesman
State's mental facilities duped into using drug, Abbott alleges
Lawsuit claims state official pushed drug, was rewarded with money.
By Jason Embry, W. Gardner Selby
December 16, 2006
A major corporation and several subsidiaries misrepresented the safety and effectiveness of an anti-psychotic drug and unduly influenced at least one state official to make it a standard treatment in public mental health programs, according to a lawsuit the state has joined.
Attorney General Greg Abbott joined a lawsuit filed in Travis County district court by Allen Jones, a former investigator for the state of Pennsylvania, against Johnson & Johnson Inc. and five related companies. Jones says in the lawsuit that he learned of payments to at least one Texas mental health official in interviews he conducted as an investigator. No official is named in the lawsuit.
The lawsuit, which came to light Friday, seeks to recover for the state untallied alleged overcharges to the state's Medicaid program, which pays for health care for low-income people.
Jones' lawsuit alleges that the companies launched a drug named Risperdal in 1994 to treat schizophrenia. About the same time, the state was developing a protocol, or treatment guidelines, for which drugs should be used in public mental health programs. The defendants "provided substantial financial contributions to and improperly influenced the development" of the protocols, the lawsuit said, and Risperdal took precedence in the protocols over cheaper, equally effective medicines.
The drug later received recommendations as the medicine of choice in the state's mental health protocol for treating children and adolescents, even though it lacked a Food and Drug Administration indication for those age groups, the lawsuit says. It says side effects and health risks include increased chance of stroke, renal failure and hyperglycemia.
The companies pushed Risperdal in other states through paid consultants on expert panels, peer-to-peer marketing strategies and "administrative decisions made by a select few public officials," the lawsuit says. The companies sent an unnamed Texas official around the country as a spokesman for the drug, and they hired third-party contractors to conceal their control and funding of medical education programs, speakers' bureaus and clinical research that promoted the benefits and safety of Risperdal, the lawsuit says.
The lawsuit says at least 17 states, including Texas, have implemented the protocol or are doing so.
"We allege it's a scheme whereby they passed off as medical science phony representations and misleading facts about the efficacy and appropriateness of these drugs," said Thomas Melsheimer, a lawyer for Jones.
Abbott's office declined to comment on the lawsuit, as did spokesmen for Johnson & Johnson and the state's Health and Human Services Commission, which oversees the Medicaid program. A commission spokesman did say Texas paid 308,000 claims totaling $73.5 million for Risperdal in 2005.
Melsheimer described Jones as a "classic whistle-blower" who filed the lawsuit in 2004 on behalf of Texas to recover the companies' overcharges. Because of his whistle-blower status, the lawsuit was sealed from public view until Abbott joined it.
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Vera Hassner Sharav of the Alliance for Human Research Protection comments on the case as follows:
The Texas whistleblower lawsuit against Johnson & Johnson promises to topple the house of cards upon which the public mental health system rests. 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 exorbitant cost paid for by taxpayers.
The Texas Statesman reports 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."
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To see how TeenScreen and TMAP relate, here are additional references:
Over 500 doctors have now signed the TeenScreen petition. Please pass the word: http://www.petitiononline.com/TScreen/petition.html
Drug Makers Accused Of Misleading Health Dept.
"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."
J&J Sued by Texas in Whistleblower Case on Marketing
The guidelines and deceptive marketing techniques boosted sales of Risperdal, raising costs for Texas and endangering patients, according to the complaint, which was secret until it was unsealed Dec. 15. The state is seeking unspecified damages. Risperdal sales were $10 billion in the U.S. from 2001 through 2005, according to IMS Health Inc.The guidelines and deceptive marketing techniques boosted sales of Risperdal, raising costs for Texas and endangering patients, according to the complaint, which was secret until it was unsealed Dec. 15. The state is seeking unspecified damages. Risperdal sales were $10 billion in the U.S. from 2001 through 2005, according to IMS Health Inc.
Drug research: To test or to tout?
Allen Jones knew the instant he was destined to be a whistle-blower. He says it was when his boss told him: "Quit being a salmon. Quit swimming against the stream with the pharmaceutical case."
"They got expert opinion to be the deciding factor," Jones said in an interview. "Essentially, the drug companies could pay people to say what the drug companies could not claim themselves," namely that they were superior to the older generation of antipsychotics.
posted by Sepp Hasslberger on Saturday December 16 2006
updated on Thursday December 9 2010
URL of this article:
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