Wednesday, December 20, 2006

Guidelines in Whose Interest? - Pharmaceutical Companies and the Texas Medication Algorithm Project (TMAP)

Out of Texas comes a story with allegations of pharmaceutical industry involvement in the crafting of state mandates for the treatment of psychiatric illness. Per the Dallas Fort Worth Star Telegram (edited, and re-ordered):

A recently unsealed lawsuit accuses Johnson & Johnson and related companies, including Janssen Pharmaceutical, of conning the state of Texas into spending millions of dollars on costly psychiatric drugs.

The suit targets a controversial state program that instructs doctors at state-funded healthcare facilities about which medicines to prescribe for a variety of mental illnesses.

The suit was filed in 2004 in Travis County by Allen Jones, a former employee of the Pennsylvania Office of Inspector General who investigated drug companies' ties to his state's officials. In the process, he learned of allegations related to Texas. The Texas attorney general's office has joined the lawsuit.

While the suit does not name a "state mental health program decision-maker" who it alleges received payments and other benefits, a spokeswoman for the Texas Health and Human Services Commission confirmed that the lawsuit refers to Dr. Steven Shon, who managed the program. Shon took more than 80 trips throughout the country and abroad to promote it, with his expenses often underwritten by drug companies.
Shon, who left the Department of State Health Services this fall while the investigation was ongoing, said he has not received money from drug companies in connection with his work for the state. Money paid for his travel expenses or to reimburse taxpayers for his time away from the office, he said.

'These assertions are really ridiculous, he said.

However, Shon said he received a few thousand dollars from Janssen several years ago for consulting work unrelated to his state job. He said he got approval from the department's legal staff, but commission spokeswoman Stephanie Goodman said the agency was unaware of payments and would not have approved them.

The lawsuit alleges that Johnson & Johnson and its subsidiaries misled state officials about the benefits of the antipsychotic drug Risperdal, including promoting it for treating children when the drug had not been federally approved for such use. The company's influence led the state to purchase the expensive brand-name drug instead of cheaper generic alternatives, according to the lawsuit. The result, it alleges, was that the state paid excessive amounts in claims for Medicaid, which covers medical costs for low-income people.

A major portion of the lawsuit focuses on the Texas Medication Algorithm Project, which Shon coordinated. That program offers a series of treatment plans, or algorithms, for various mental illnesses, including which drugs to use. In many cases, the plans recommend the newest drugs, which are the most expensive and are not available in generic form.

Such drugs generate much income for pharmaceutical companies. In a recent three-year period, more than $190 million was paid in Texas for outpatient Medicaid claims for Risperdal alone, according to the state Health and Human Services Commission. During those same years -- 2002 to 2005 -- almost $700 million was spent on all antipsychotic medications combined. That does not include care for those who are in state institutions.

Drug companies, including Janssen, gave the state more than $1 million to help promote the plan. And the Robert Wood Johnson Foundation, established by the founder of Janssen parent company Johnson & Johnson, gave $2 million. A company spokesman previously said the foundation is independent of the company.

The exact amount donated by the companies remains unclear. Shon has acknowledged that his agency did not always seek required approval from the department's governing board before accepting donations.

Shon left his job with the state in October.

Shon said he was given the option of resigning or being terminated, and he chose to leave.

In addition, per a reporter for an Austin television station,

Shon spent a great deal of his time traveling around the country promoting the TMAP treatment guidelines.

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.'

Before commenting, I need to acknowledge that the story above is based only on allegations, so far. The law-suit has not gone to trial, and there may be more than one side to this story.

Nonetheless, the allegations are striking. We have previously posted on allegations of attempts to influence guidelines by those trying to sell drugs, devices, or services that such guidelines may support. However, in the current case the allegations were of attempts to influence state mandated treatment algorithms (the Texas Implementation of Medication Algorithms, or TIMA), not mere guidelines. (As best as I can tell from the TMAP web-site, particularly its FAQ section, these algorithms are mandatory for all state mental health outpatient facilities.)

If nothing else, this reinforces the need for physicians, health care professionals, and patients to be extremely skeptical about how guidelines are written, and who has influenced their writing.

Parenthetically, note that this skepticism should extend to guidelines labelled as "evidence-based." The TMAP algorithms are described as evidence based, but I can find nothing on the TMAP web-site that explains how the process used to develop them fit this definition.

ADDENDUM (12/20/2006): See also these posts (here and here) on Clinical Psychology and Psychiatry.

1 comment:

Anonymous said...

And the news jut keeps getting better: From The Wall Street Journal

FDA Approves J&J Antipsychotic

December 20, 2006 11:05 p.m.; Page D3

WASHINGTON -- The Food and Drug Administration approved a schizophrenia drug from Johnson & Johnson that the company is counting on to shore up its franchise of medicines for mental illness.

The once-a-day pill called Invega is derived from Risperdal, another drug used to treat schizophrenia and other mental illnesses, which is Johnson & Johnson's best-selling product, with $3.55 billion in revenue in 2005. Generic Risperdal, or risperidone, could be on the market as early as 2008.

The article goes on:

"Invega was studied in 1,665 patients in three, six-week clinical trials that compared the medication to a placebo, or a fake pill. The FDA said that in the three studies, which used doses ranging from three milligrams to 15 milligrams daily, the effectiveness of Invega at relieving symptoms of schizophrenia was better than a placebo.

Without studies comparing Invega to available schizophrenia medicines, some doctors have said there is no proof Invega is superior to existing drugs."

The article notes the selling price of the drug will be $4.00 per pill with an estimated 2M potential patients. So here we have an unproven drug with an estimated cost of $8M per day being approved for use with, not being a doctor, I would consider very thin scientific proof.

We also learn from The Wall Street Journal:

Bristol-Myers Settles Probes
Into Pricing for $499 Million

December 22, 2006; Page B4

Bristol-Myers Squibb Co. said it reached a preliminary agreement with the Justice Department and the U.S. attorney for the district of Massachusetts to settle years-old investigations into its drug pricing, sales and marketing practices.The New York drug company will pay $499 million and enter a corporate-integrity agreement with the Department of Health and Human Services.

Attorneys general of several states and a number of counties in New York charged that Bristol-Myers inflated the average wholesale prices of its drugs, which are used by government programs and insurers for reimbursement purposes. All suits were consolidated under the federal district court in Massachusetts.

The article also states Schering Plough was fined $435M earlier this year for similar problems.

Given the constant barrage of corporate misdeeds and thin scientific findings one has to wonder how the medical community can look at pharma as their partners in patient care. It becomes incumbent upon doctors to view the drug industry as it is: A ruthless business willing to prey on those least able to protect themselves, the patient.

Steve Lucas