Updated: Wednesday, 27 Jul 2011, 9:15 AM CDT
Published : Monday, 25 Jul 2011, 10:46 PM CDT
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