CCHR International » TMAP

J&J Paid Texas Official to Speak Around the U.S., Jury Told

cchrint — Wed, 11 Jan 2012 22:55:41 +0000

Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said.

Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin. Texas is suing J&J, saying the company fraudulently promoted Risperdal and overbilled Medicaid by at least $579 million.

State lawyers say Janssen’s payments to Shon were part of a scheme to influence development of the guidelines, known as the Texas Medication Algorithm Project, or TMAP, and tout them as a model for other states trying to advise doctors on prescribing drugs. Shon was asked how often he went around the U.S. to talk to other states about the TMAP.

“I would say once or twice a month for a period of several years,” Shon said in a video deposition shown to jurors on the trial’s second day of testimony. “I knew that Janssen paid for a substantial number of those trips.”

Texas also claims that New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, defrauded the state Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders. The state joined a lawsuit filed by a whistle-blower, Allen Jones, a former investigator for the Pennsylvania Office of Inspector General.

Medical Director

Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006.

Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called “Mental Health Issues Today” and was a continuing medical education speaker in programs sponsored by the company.

Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said.

In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years.

Jones’s attorney Thomas Melsheimer asked Shon about Texas regulations that bar a public official from “soliciting, accepting or agreeing to accept any honorarium for doing services” that he wouldn’t be asked to provide “but for that person’s official position or duties.”

Outside of Texas

Shon said his TMAP talks outside of Texas didn’t conflict with his official duties, and he gave them during compensatory time. When asked about a 2000 trip to Scottsdale, Arizona, when his timesheet showed he was at work, he said: “It appears that things were not recorded correctly.”

On cross-examination, Shon said Janssen had no influence over the development of the TMAP guidelines.

He said a state attorney, Cathy Campbell, told him that his appearances in other states were proper. He said he usually gave his honorariums to the state, based on Campbell’s advice.

In those cases when he kept the payments, Shon said, the lawyer advised him that his actions were proper.

‘Something Wrong’

“Did anybody ever tell you that you were doing something wrong in conjunction with your work with TMAP?” a J&J attorney asked Shon.

“No,” he answered.

Shon said he left his state job when he was told “it was time to move on,” he testified.

“Did anybody ever tell you that you had done something wrong, and that’s why it was time to move on?” he was asked.

“No,” he said.

In his opening statement yesterday, Melsheimer said J&J made $34 billion in Risperdal sales after its launch in 1994.

J&J denies wrongdoing and never acted illegally, attorney Stephen McConnico told jurors yesterday in his opening statement.

The case is State of Texas ex rel. Jones v. Janssen LP, D- 1GV-04-001288, District Court, Travis County, Texas (Austin).

Read article here: http://www.bloomberg.com/news/2012-01-11/johnson-johnson-paid-texas-official-to-speak-around-the-u-s-jury-told.html

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Texas AG suit over the drug Risperdal goes to trial Monday

cchrint — Mon, 09 Jan 2012 17:40:30 +0000

The Dallas Morning News
By Janet Elliott and Mark Curriden
January 8, 2012

AUSTIN — A routine inquiry a decade ago by an investigator for the Pennsylvania inspector general exposed a pattern in which pharmaceutical companies showered trips, meals and other perks on state officials in positions to influence which drugs would be used to treat patients under Medicaid.

The efforts appeared to have been particularly successful in Texas, which has one of the largest Medicaid populations.

In 2004, Allen Jones, a whistle-blower who worked with the Pennsylvania inspector general, filed suit alleging that pharmaceutical giant Johnson & Johnson improperly marketed its antipsychotic drug Risperdal for unapproved uses while funneling money to members of a state panel charged with recommending drug treatments for those in state health programs.

Two years later, Texas Attorney General Greg Abbott joined the lawsuit, seeking hundreds of millions of dollars in damages.

The case has been described by lawyers as the biggest lawsuit in Texas since the tobacco litigation in the 1990s. It goes to trial Monday in state court in Austin.

The high-stakes lawsuit alleging Medicaid fraud seeks $579 million in damages from Janssen, a division of New Jersey-based Johnson & Johnson, and penalties that could exceed an additional $500 million. The federal government will get half of any money recovered in the case, and Jones could receive between 10 and 25 percent.

The Texas case is separate from a reported $1 billion settlement reached just last week between Johnson & Johnson and others states over the marketing of Risperdal.

Risperdal was among antipsychotic drugs introduced in the 1990s. Initially approved for adults with schizophrenia, it soon became widely used in Texas mental hospitals and prisons for “off-label” uses, including for youths in the state’s foster care system.

“Not only was Risperdal not more effective, its risks were worse than its competitors and it was 45 times more expensive,” said Tom Melsheimer, a partner at Fish & Richardson in Dallas who represents the whistle-blower. “The company’s claim that its product was superior and its off-label promotional efforts were not supported by science.”

What did support Janssen’s promotional efforts were influential decision makers — including state employees, University of Texas faculty and mental health advocates — who received consulting fees, extravagant meals and travel accommodations, research funding and honoraria, according to the lawsuit.

Janssen denies that it misrepresented Risperdal and rejects allegations that its marketing efforts inflated the state’s spending on the drug. In court filings, the drug company points to the state’s continued use of Risperdal since joining the whistle-blower’s case in 2006.

Follow the money

In the 2010 fiscal year, Texas spent $15.016 million on Risperdal and $13.275 million on its generic equivalent for patients enrolled in Medicaid and the Children’s Health Insurance Program. The drugs cost an average of $229 per prescription, a 2006 Texas comptroller’s report said.

The program known as the Texas Medication Algorithm Project, or TMAP, started in the mid-1990s when state mental health officials contracted with the University of Texas and some of its professors to evaluate medications for treating mental illnesses and disorders.

Jones and the state allege that a process designed to be based on independent experts was co-opted by Janssen using false and misleading information, including ghostwritten articles and industry-funded studies, while playing down side effects, including weight gain and diabetes.

“Defendants thus ‘seeded the literature’ and increased the ‘noise level’ in the Texas health care community, including the Texas Medicaid community, with their false and misleading tale of Risperdal’s superiority to other antipsychotics and suitability for off-label use on vulnerable populations,” the state says in its most recent filing in the case.

Janssen is prepared to vigorously defend itself against these claims, spokeswoman Teresa Mueller said in emailed statement.

“We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication,” Mueller said. “If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action.”

Before the marketing blitz, the market was limited for Risperdal, Melsheimer said.

“Janssen determined in 1993 that the market for this drug was the 1 percent of adults with diagnosed schizophrenia, which was a $1 billion market,” he said. “So, the company created a new market for the drug. They created the perception that the drug was a breakthrough for expanded off-label treatments. As a result, the revenue generated by the sale of Risperdal jumped to $34 billion between 1997 and 2010.”

Fees, meals and trips

The most sensational allegations involve Janssen’s use of inducements, including consulting fees, meals, travel accommodations, research funding and honorariums. A key target was Dr. Steven Shon, medical director of the Texas Department of Mental Health and Mental Retardation. Records filed in the case show that Shon received $30,000 in fees and honoraria as a frequent speaker at Johnson & Johnson-sponsored events around the U.S.

David Rothman, a Columbia University professor who studies relations between medicine and the pharmaceutical industry, said in a report that Shon’s conduct was an “acute conflict of interest.” Shon, who resigned in October 2006, said in a deposition that he did not believe he influenced the placement of drugs on TMAP because he was an administrator and not a decision maker in the TMAP process.

Another potential witness in the case is M. Lynn Crismon, dean of the University of Texas College of Pharmacy. Crismon was a professor and member of the TMAP advisory panel in the mid-1990s when he “cultivated a financial relationship with J&J, accepting substantial fees and honoraria and soliciting research grants from the company,” according to Rothman’s report. “As a result, Dr. Crismon subverted the scientific integrity of his research and educational presentations, and biased his decision-making capacity as a member of TMAP.”

Crismon did not respond to a request for comment.

Jury selection is expected to take one day, with opening statements starting Tuesday. The trial could last four weeks.

Read article here: http://www.dallasnews.com/business/health-care/20120108-texas-ag-suit-over-the-drug-risperdal-goes-to-trial-monday.ece

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Drug firms paid ‘independent’ experts

cchrint — Thu, 28 Jul 2011 17:09:34 +0000

Practice led to AG-whistleblower lawsuit

KXAN.com
By Nanci Wilson
July 27, 2011

Watch video: Allen Jones, former investigator, Office of the Inspector General, Pennsylvania

AUSTIN (KXAN) – When Cliff Gay was told to switch medications to treat his bipolar disorder, he never dreamed a significant gain in weight and then to twice-daily injections of insulin would follow.

In 1999, Gay’s doctor recommended he begin taking Zyprexa, which then was a new antipsychotic medication. At the time, Gay says it seemed like a good idea.

“The side effects were going to be less,” he said.

Gay says he immediately noticed a profound change — not so much in his symptoms, but in his appetite. Within a few months, he put on about 60 pounds, and that was followed by diabetes.

Records maintained by the U.S. Food and Drug Administration show that such stories are not uncommon among patients across Texas who, who beginning in the middle to late 1990s, were switched to medications called “atypical antipsychotics.”

Many who have been put on the new class of drug reported similar gains in weight over time.

Doctors working in state hospitals and community mental health centers began switching patients to the atypical antipsychotics because they were deemed the best treatment by an expert panel convened by the Texas Department of Mental Health and Mental Retardation.

But a detailed examination of public records documents on file in a whistleblower lawsuit that has been joined by the Texas Attorney General’s Office allege that the experts hired to evaluate the drugs and make recommendations for their usage were also accepting hundreds of thousands of dollars in payments from the companies developing and marketing the medications.

It started in the middle 1990s when MHMR contracted with University of Texas and some of its professors to evaluate the medications and develop a set of treatment guidelines.

The program was named the Texas Medication Algorithm Project, or TMAP. The result was step-by-step guidelines for treating major depression, bipolar disorder, schizophrenia, attention-deficit hyperactivity disorder.

TMAP was supposed to be based on the latest science, evaluated by an independent group of experts in the field.

But a 2004 lawsuit filed by whistleblower Allen Jones and the Texas Attorney General’s Medicaid Fraud Division against Janssen Pharmaceuticals, a division of Johnson & Johnson, suggests that the project was actually a vehicle for boosting sales of expensive new drugs that government funded studies found were not more effective, but cost far more than conventional medications.

According to records compiled from company documents, Janssen was making substantial payments over several years to the decision makers, many of whom were University of Texas professors.

While the professors were under contract with the state of Texas to provide their expert opinions on medications, records show many were also being paid by the companies whose drugs were being evaluated.

The suit alleges that Janssen improperly influenced the development of TMAP and compromised the objectivity of the decision makers by paying consulting fees, funding research and providing extravagant meals and lavish travel.

Such relationships were not always disclosed in TMAP manuals distributed to state hospitals and community mental health centers.

The depth of the financial relationship between the drug companies and the Texas Department of Mental Health weren’t always disclosed, either.

Extent of funding not fully disclosed

Steven Shon, who then was medical director for Texas MHMR, publicly reported in media interviews pharmaceutical company funding for TMAP was only $285,000.

However, documents obtained through the Texas Public Information Act show far more funding from the companies whose drugs were recommended as a first-line treatment in the TMAP guidelines.

Donations to the Texas Department of Mental Health/Mental Retardation from pharmaceutical giants Eli Lilly, Pfizer, GlaxoSmithKline, Abbott, Bristol-Myers Squibb, Forest, AstraZeneca, Novartis, Janssen and Forest and Wyeth-Ayerst totaled more than $1.2 million.

An additional $2.8 million was donated by the Robert Woods Johnson Foundation, which stock portfolio benefits from sales of Janssen’s medication.

Shon claimed he never personally received any money from the drug companies. A claim that was disputed in financial records turned to the court over by Janssen.

According to court records, Janssen paid Shon nearly $30,600 in honoraria and travel expenses. An additional $17,000 was directed to Association of Korean Americans at Shon’s direction.

In June, 2002, Janssen hosted a meeting and paid the travel expenses for seven TMAP decision makers. The meeting was held at the lavish Mansion on Turtle Creek Resort in Dallas with the purpose of advising Janssen on its newest antipsychotic.

Attendees included Steve Shon MD, Madhukar Trivedi MD, Tricia Suppes MD, John Rush MD, Larry Ereshefsky MD, Lynn Crismon, John Chiles MD and Alexander Miller MD.

Trivedi, Suppes, Rush and Ereshefsky were employees of University of Texas Southwestern Medical Center in Dallas.

Crismon was a professor

at the University of Texas School of Pharmacy in Austin.

Chiles and Miller were professors at University of Texas Health Science Center in San Antonio.

According to an expert report filed in the Janssen lawsuit, the meeting cost the company $114,000. The report says that the investment paid off. Shortly after, emails between some of the TMAP decision makers and Janssen discuss where the company wanted to place its newest antipsychotic on the guidelines.

The expert report, notes that other similar meetings were held at resorts in Scottsdale, Ariz., and the Ritz Carlton in Amelia Island, Fla. In most cases, participants were paid an honorarium.

Court records show Janssen paid Crismon, now the dean of the UT College of Pharmacy, more than $61,200 for various consulting fees and speaking engagements, including some that took place in state hospitals and community MHMR clinics.

Janssen reported paying Alexander Miller, professor at UT Health Science Center in San Antonio, $82,485.42. John Chiles, a UT professor at the time, was paid $151,254.73. Crismon, Miller and Chiles served on the TMAP panel at the time they received the payments.

Huge boosts in sales

The pharmaceutical companies funded trips for certain members of the TMAP team for travel to other states to expand TMAP to other states. More than a dozen states adopted the guidelines.

It meant huge sales for the drug companies because TMAP not only recommended their drugs for disorders in which the FDA had granted approval.

But for some illnesses that were not approved. Doctors are allowed to prescribe a drug with FDA approval for any reason, but manufacturers are only allowed to promote drugs for disorders that have been approved by the FDA.

While TMAP was touted as evidence-based or based on science and actual experience, the medications chosen to be included in the guidelines raised questions to exactly what evidence was considered by decision makers.

For example, several of the participants were involved in one of the largest independently funded studies to determine which medications provide the best treatment for schizophrenia.

The Clinical Antipsychotic Trials of Intervention Effectiveness Study, known as CATIE compared several of the new antipsychotics, risperidone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel) and ziprasidone (Geodon) with an older, cheaper drug, perphenaxine (Trilafon).

The results, announced in 2005, found the new drugs, which cost roughly 10 times as much, had no substantial advantage over the older medication.

Despite the scientific findings, the TMAP team continued to recommend the more expensive drugs as a first-line treatment.

In 2008, the TMAP guideline for major depression was revised. The first non-medication treatment was added. The Vagal Nerve Stimulator, or VNS, manufactured by Cyberonics, is a medical device that is surgically implanted and sends electrical impulses to the brain.

The studies provided to the FDA during the approval process were conducted by several of the members of the TMAP team, including John Rush of the University of Texas Southwestern Medical Center in Dallas.

Reviewers with the FDA found the evidence submitted to the FDA to be lacking.

They recommended against approval. However, their decision was overruled and the device was approved.

Alarm bells sounded

The reviewers sounded an alarm, and the U.S. Senate Finance Committee launched an investigation into the approval process. Its findings raised questions about how the device could be approved by the FDA absent the scientific data showing the product was safe and effective.

In a speech on the floor of the Senate about the investigative report, U.S. Senator Charles Grassley said the conclusions of the person overruling the decision raise serious questions.

He read from the override memo, “I think it needs to be stated clearly and unambiguously that [certain VNS data]failed to reach, or even come close to reaching, statistical significance with respect from its primary endpoint. I think that one has to conclude that, based on [that] data, either the device has no effect, or, if it does have an effect, that in order to measure that effect a longer period of follow-up is required.”

The FDA approved the VNS with the condition that the company would conduct further studies and report the results to the FDA.

The Centers for Medicare/Medicaid refused to pay the estimated $25,000 bill for VNS treatment for depression. Most insurance companies wouldn’t pay, either.

But that didn’t deter the TMAP team from including the VNS on the revised guideline for treating depression. Such decisions were made behind closed doors and records revealing which members approved the inclusion are not available.

Rush’s relationship with Cyberonics was not fully disclosed to the University of Texas in his annual Statement of Financial Interest filing. His filing dated Aug. 7, 2006, lists his role as a member Cyberonics Speakers Bureau with an annual income equal or

less than $10,000.

But in records submitted to the office of U.S. Sen. Charles Grassley, R-Iowa, by Cyberonics, Rush was paid $100,000 in 2006 by the maker of the VNS. Cyberonics also reported paying Rush more than $75,000 in 2003 and 2004, and $62,000 in 2005.

Of the 10 decision makers who worked on the revision to the TMAP guideline for depression, six reported they owned stock or had a financial relationship with Cyberonics, including the project director, Crismon. Such disclosures were made to their employers or though industry publications.

The UT School of Pharmacy reported Cyberonics was the source of funding for a $54,938 research project in which Crismon was the principal investigator.

In a news release by Cyberonics, the company said the purpose of funding the research was to use the data to convince Medicaid and insurance companies to pay for VNS.

“By demonstrating the cost-effectiveness of VNS Therapy for treatment resistant depression (TRD) through this standardized, extensive and thorough analytical approach,” the release said, “it is our expectation that many more payers will come to recognize and understand the unique safety, effectiveness and cost effectiveness of VNS Therapy and grant psychiatrists and Americans with TRD access to VNS Therapy through national and regional coverage policies.”

Several TMAP panel members wrote letters urging the Centers for Medicaid to reconsider and pay for VNS treatment for depression.

Cyberonics cited it’s inclusion in the revised TMAP guideline for depression as reason for the government to pay.

It didn’t work.

CMS ruled the evidence did not show the treatment was effective for treating depression. A year after the ruling, the revised TMAP guideline was published recommending VNS, although many patients in the states hospitals and community centers would have had to pay out-of-pocket for the treatment.

Travel and out-of-state lobbying

Some of the TMAP team members were instrumental in expanding its usage across the nation. Largely funded by the drug companies, UT professors and state employees traveled to other states to lobby state legislatures and conduct training sessions.

But not all doctors in Texas centers and state hospitals were on board with the program. Emails between the TMAP team blamed a reluctance to change.

Texas MHMR paid two University of Texas at Dallas professors $100,000 to design a change management program.

Doctors were still reluctant, so the state made complying with the TMAP program a condition of its contract with community centers. The centers were required to show they were in compliance or would lose a percentage of their medication funding.

TMAP was at one time heralded. It was included in recommendation by the White House New Freedom Commission Report.

Psychiatrist Daniel Fisher, who was appointed to the commission said, members were encouraged to include TMAP in the recommendations, but never told of the pharmaceutical company involvement or that members of the consensus panel that developed the guidelines received money from the drug companies.

Fisher said he was stunned to learn the depth of involvement of the drug companies.

“This is the story of the century,” he said.

The pharmaceutical involvement came as a surprise to Cliff Gay. He was asked to participate in TMAP activities early on in the development. His role was as a patient and family advocate.

“I am totally blown away by the amount of money that was put into this thing,” said Gay. “I didn’t find out about the extent of the payments until I went to work for NAMI Texas.”

According to expert reports filed in the lawsuit against Janssen, NAMI, the National Alliance on Mental Illness in Texas, played a big role in helping TMAP and the pharmaceutical companies.

The expert report quotes from internal Janssen memos and depositions, efforts to utilize advocacy groups to their advantage, particularly NAMI Texas executive director Joe Lovelace.

The expert report filed in court reads “Lovelace received funding from J&J not only for the organization but personally, noting in his deposition that he deposited the monies in his wife’s law firm account because “she needed the money…there was a loss there.”

One of Janssen’s employees explained that “Lovelace desired to partner with Janssen as a consultant.”

Lovelace became a frequent speaker for J&J between 2000 and 2003. The report details the value of Lovelace when company officials asked if he would have NAMI members “come up to testify and relate their personal stories”, he responded by noting the when he had a chairman of a legislative insurance committee from Amarillo, he “made sure that a person in his church sat down in front of him.”

Lovelace no longer works for NAMI Texas. He is now the Associate Director of Behavioral Health for Texas Council of Community Centers.

TMAP’s rapid expansion began to crumble in 2004, when the first whistleblower lawsuit was filed against one of the drug companies involved. The State of Texas

Attorney General’s office joined in the lawsuit and filed suits against the other companies. Attorney Generals in other states filed suits, too.

Big-dollar settlements

To date, all but one of the suits has settled.

Bristol-Myers Squibb paid $15.7 million to Texas under a national settlement for allegations relating to its anti-depression drug, Serzone.

According to the press release issued by the Attorney General, the investigation also revealed BMS unlawfully marketing and promoting, Abilify, an atypical antipsychotic drug. It’s marketing partner, Otsuka paid $220,OOO to settle that claim.

Eli Lilly paid more than $30 million to Texas in a state and federal lawsuit over the marketing of its drug Zyprexa. In total, Eli Lilly paid $1.6 billion in criminal fines and reimbursing the government for charges to Medicaid.

The Texas Attorney General and 42 other states reached a $33 million agreement with Pfizer to settle claims of its marketing of Geoden to health care providers.

In a separate action, Pfizer also settled another case involving Geoden and another medication by paying $55 million to Texas as part of a $1 billion multi-state agreement.

Texas and 38 states reach a $68.5 million settlement with AstraZeneca stemming from a federal suit charging the company with unlawfully marketing Seroquel.

Texas share of the settlement was $3.8 million.

Janssen settled multiple Medicaid fraud and deceptive drug marketing cases related to its drug, Topamax, by agreeing to pay $50.7 million to several states.

Texas share is $2.86 million.

The Texas case against Janssen is pending and scheduled to go to trial in November.

Shon was fired as medical director for the state of Texas on Oct. 9, 2006. However, he was allowed to stay on the payroll in an unpaid capacity until he qualified to retire with full benefits.

He is now living in Las Vegas.

Crismon was promoted from professor to Dean of the UT School of Pharmacy. His work on TMAP was cited in the press release announcing his promotion. He continues to consult on guidelines for mental health treatment through a contract with the Reach Institute.

Rush left the University of Texas Southwestern Medical Center and is now working for Duke University in Singapore.

The other TMAP professors are still employed at various University of Texas System campuses.

Crismon declined to grant an interview for the report. KXAN’s request for an interview with Chancellor Francisco Cigarroa was denied, but UT System Vice Chancellor Barry Burgdorf said outside employment arrangements decisions are made by the individual campuses within the system.

“Supervisors are charged with evaluating requests to approve outside employment by assessing whether the potential outside employment constitutes a conflict of commitment — whether the time required to fulfill the outside employment would interfere with UT job duties — or a conflict of interest,” said Burgdorf, also the system’s general counsel.

“With regard to conflicts of interest in some cases the employee requesting approval of outside employment is required to enter into a conflict of interest management plan designed to prevent potential conflicts from maturing to an actual conflict,” he added. “Many times approved outside employment is synergistic with UT employment such as when a faculty member works for a start -up company spun out from UT using technology invented by the faculty member.”

In 2010, The Texas Department of State Health Services approved recommendations by a committee tasked to review the TMAP to stop using the guidelines.

Cliff Gay said he feels betrayed. He is among those who they were supposed to be helping.

“I don’t think any of them could look me in the eye and tell me they were doing it for me,” said Gay. “They did it for the money. It’s all about the money.”

http://www.kxan.com/dpp/news/investigations/drug-firms-paid-independent-experts

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Congressman Ron Paul’s Parental Consent Act

admin — Thu, 15 Oct 2009 00:49:31 +0000

By John Breeding
Psychologist, Author, The Wildest Colts Make the Best Horses
October 14, 2009

On April 30, 2009, Congressman Ron Paul introduced H.R. 2218, known as The Parental Consent Act of 2009.

The bill forbids federal funding for universal or mandatory mental health screening, and also forbids money for any educational or other government agency that would use a parent’s refusal to consent to their child’s screening as basis for a charge of child neglect or abuse.

Click here for video interview with Kent Snyder, Ron Paul’s Presidential Campaign Manager, speaking about why Congressman Paul introduced the Parental Consent Act.

A little recent history is relevant. On April 29, 2002, President George Bush created the New Freedom Commission on Mental Health. In 2003, this industry-studded commission presented their recommendations for the reform of the United States mental health system.

“To aid in transforming the system,” the authors of the report wanted to do many things, including:

Improve and expand school mental health programs.
Screen for co-occurring mental and substance use disorders and link with integrated treatment strategies.
Screen for mental disorders in primary health care, across the lifespan, and connect to treatment and supports.

This rhetoric serves to hide the truth that New Freedom is better called No Freedom or New Intrusion, and that mental health screening really means mass marketing and target recruitment of a captive population.

By the time of these New Freedom Commission recommendations, there already existed very large numbers of citizens around the country wising up to the extraordinary intrusion of psychiatry into our schools, as demonstrated in the first four years of this millennium by a number of resolutions, education department statements and state laws, all defending a parent’s right to make treatment decisions for a child without coercion, and a child’s right to education without psychiatric labeling and drugs.

Through 2003, there had been at least 46 state bills or resolutions supporting parental choice, in 28 states, that had either passed or were still pending action across the United States. For example, Connecticut, Minnesota and Texas had passed laws explicitly stating that a parent’s refusal to consent to the administration of a psychotropic drug to a child does not constitute neglect, therefore is not in itself grounds for Child Protective Services (CPS) investigation. Other states have passed related laws either monitoring or curbing CPS policy in this area.

Many states are pursuing related legislation as the wave of activity in support of parental choice continues to expand. Texas law now prohibits school personnel from suggesting a diagnosis or recommending a psychotropic drug to a parent for their child. The public will is clearly for the schools to educate, not medicate, and for the state to allow privacy and autonomy to parents and families. At a federal level the fight over the Child Medication Safety Act was eventually won so that nowhere in the country is it legal to require a psychiatric controlled substance as a condition of attending school.

Ron Paul has been a key leader in this effort for some time. On October 6, 2004, he introduced an earlier incarnation of his current Parental Consent Act. This one, aptly titled the Let Parents Raise Their Kids Act, also attempted to forbid federal funds from being used for any universal or mandatory mental-health screening of students without the express, written, voluntary, informed consent of their parents or legal guardians.

Since that time, the fight has only intensified. In 2005 in Texas, for example, we fought tooth and nail to the bitter end to defeat a bill that would have initiated mental health screening in schools throughout Texas. Since we have defeated them consistently, this session they tried to get a pilot program approved for San Antonio and we defeated that as well, but the psychiatric and pharmaceutical lobbies are relentless. PsychSearch.net provides one of the best websites on mental health screening and the ongoing resistance.

We have been aided by our awareness. Made possible largely by the work of Pennsylvania whistleblower Allen Jones, we know that many of the New Freedom commissioners are linked directly or indirectly to the Texas Medication Algorithm Project (TMAP), which provides formulas recommending specific psychotropic drugs to treat various “mental illnesses.” It has been revealed that TMAP pushed an off-label drug marketing scheme that appears to skirt federal law. We know, therefore, that this commission’s recommendations are intended to encourage an expansion of the fact that “appropriate services” in today’s psychiatric world means psychotropic drugs; there are already millions upon millions of school-age children on psychiatric drugs.

Senator Charles Grassley’s work outing the severe ethical financial conflicts of so many psychiatric industry spokespersons makes it a little easier to challenge these things. For example, it tends to impress legislators when they hear that three psychiatry department chairs—Charles Nemeroff of Emory University ($1 million from GlaxoSmithKline alone), Martin Keller of Brown University (associated with a severely compromised drug trial) and Alan Shatzberg of Stanford (who was principal investigator on a drug developed by a company in which he owned $6 million of stock) have all recently resigned their positions as a result of Grassley’s investigation.

The very high number of false positives in mental health screening is good data. In one study at Columbia University, the authors concluded that use of the Columbia Suicide Screen would result in 84 non-suicidal teens being referred for further evaluation for every 16 youths correctly identified. It also helps to know that these type programs tend not to work anyway. For example, the United States Preventive Services Task Force (USPSTF) found that screening for suicide risk does not reduce suicide attempts or mortality.

Finally, the facts about the severe dangers and lack of efficacy of the various types of psychiatric drugs gets attention once the truth is made known.

I consider this to represent a tragic situation, and a clear and present danger to our children. Here is a pledge that thousands specifically signed and that so many more are acting on in the concerted challenges around the country to this scourge:

We promise to actively resist further intrusion of psychiatry into the public schools, and will not cooperate in any way with those who act as agents of this wrong-headed government initiative. We do not now and will not later consent to the psychiatric or psychological testing of our children by those who act as agents to implement New Freedom recommendations for universal mental health screening of our children.

The Parental Consent Act of 2009 is a great idea. Passing this bill in Washington would make a significant difference in protecting children and families against further intrusion of psychiatry into the schools. I know it would also make this Texas activist’s life a little easier!

John Breeding, Ph.D. has been a counseling psychologist in Austin, Texas for 25 years. He is the director of Texans For Safe Education, a citizens group dedicated to challenging the ever-increasing role of psychiatric drugs in schools. He is the author of numerous articles and four books including: The Wildest Colts Make the Best Horses and True Nature and Great Misunderstandings: On How We Care For Our Children According To Our Understanding.

Click here to read The Parental Consent Act

Contact your member of Congress to support The Parental Consent Act. To find your Representative and get their contact information, go to http://www.congress.org/congressorg/directory/congdir.tt to look them up (you need to enter your zip code).

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