TMAP - Texas Medication Algorithm Project (algorithm - guideline) was
created by various pharmaceutical companies working in concert. These
companies recommended and helped implement a scam where Texas was to pay
for the most expensive new antipsychotics, Abilify, Geodon, Risperdal,
Seroqul and Zyprexa over the older cheaper antipsychotics. The TMAP
scam was exported to many other states.
A 2005 study by the federal government's National Institute of Mental
Health showed that these new antipsychotic drugs, which cost roughly 10
times more than the older drugs, performed no better and had just as
many side effects.
The below Texas article describes how CMAP - The Child version of TMAP
has been suspended over fears that government Medicaid programs have
been influenced by pharmaceutical companies.
Letters to the editor here:
<http://www.dallasnews.com/cgi-bin/lettertoed.cgi>
http://www.dallasnews.com/cgi-bin/lettertoed.cgiThe Dallas Morning News
MEDICATION PROTOCOL
August 18, 2008
By EMILY RAMSHAW
AUSTIN - A state mental health plan naming the preferred psychiatric
drugs for children has been quietly put on hold over fears drug
companies may have given researchers consulting contracts, speakers fees
or other perks to help get their products on the list.
The Children's Medication Algorithm Project, or CMAP, was supposed to
determine which psychiatric drugs were most effective for children and
in what order they should be tried at state-funded mental health
centers. In April, high-ranking state health officials gave researchers
the go-ahead to roll out the guidelines.
A month later, the officials delayed the protocol, after Texas Attorney
General Greg Abbott's office objected to it.
At most, the suspension indicates that state investigators fear fraud
has occurred. At the least, it reflects nationwide unease with potential
conflicts of interest between leading medical researchers and the
pharmaceutical firms that fund much of their work.
Publicly, officials say it's because the state is suing a pharmaceutical
company alleged to have used false advertising and improper influence to
get its drugs on Texas' now-mandatory adult protocol, the Texas
Medication Algorithm Project.
Privately, individuals with knowledge of the case - who spoke only on
condition of anonymity because of the pending litigation - say the
attorney general's investigation of possible fraud in the adult protocol
has spread to the children's version.
There's no way to know exactly what authorities are investigating. But
their probe into the adult protocol turned up allegations of drug
companies paying researchers who worked on the adult protocol speaking
fees, and footing the bill for trips to market the Texas program.
The researchers who designed the children's protocol, who are not
parties to the lawsuit over the adult drug program, insist they are
motivated only by children's health. No evidence has emerged to disprove
that; many have dedicated their careers to advancing child psychiatry.
And grants and consulting fees from drug companies are legal and
increasingly common, despite fears that they may influence doctors'
prescription habits. In the last quarter-century, drug makers have
replaced the federal government as the nation's main source of research
funding, even though some studies suggest this money affects the outcome
of clinical trials.
At least four of CMAP's key developers - all affiliated with the
University of Texas system, and all of them published child psychiatry
experts - have received research funding from drug companies, or have
been consultants and speakers for several different pharmaceutical
firms, according to their own published papers and financial disclosure
forms filed with the university. Drugs made by some of these
manufacturers appear in the children's drug protocol.
The doctors say there's no room for improper influence when their
reputations are at stake. If the drugs weren't effective, they wouldn't
endorse them - and the research they conducted to craft CMAP wouldn't
have been published in prestigious medical journals.
"When you really look at the investigators involved and the procedures
they followed, they were all within what has been defined as appropriate
in every medical field," said Dr. Steven Shon, who led the effort to
create the adult drug list, and was forced to resign in 2006 over
allegations he was improperly influenced by a drug company, according to
previously published reports. "To block access to this protocol is
really hurting the people who need it most."
Dr. Graham Emslie, a UT-Southwestern psychiatry expert, said he never
once witnessed improper influence from drug companies while he helped
conduct CMAP research. "There's much more influence relative to
day-to-day prescribing" of drugs than there is doing university research
or designing a protocol, he said.
At stake is the psychiatric care of tens of thousands of children
treated at state and community mental health centers across Texas - many
of whom are covered by Medicaid and don't have access to private health
care. Without the protocol, experts say, these children will continue to
be treated by individual doctors who have their own personal influences.
"This attack is causing us to go back to the system we had before, with
individual doctors who may have individual influence, instead of using a
standardized protocol," said Aaryce Hayes, a mental health policy
specialist with Advocacy, Inc.
The News' investigation into the doctors prescribing psychiatric drugs
to children in state foster care has found that many doctors received
money from pharmaceutical companies, for tasks such as running clinical
trials and consulting.
Most states don't require doctors to report such financial arrangements
with drug companies. The few that do have found some evidence their work
was affected, including doctors with drug company connections writing
more prescriptions for children.
About the protocols
Drug protocols are designed to ensure all patients with a particular
diagnosis receive the most effective, proven treatment available.
They're created by bringing together academics, researchers and public
health experts, who run trials, compare best practices and recommend a
road map, or algorithm, for which drugs should be used.
While the protocols are generally created with the best intentions, they
can be controversial, particularly when drug companies have a hand in
designing them.
Some lawmakers and activists say it's time the state took a close look
at the financial motivations of experts making drug decisions for
hundreds of thousands of Texans. The adult protocol determines treatment
decisions in state mental health facilities, despite the lawsuit and
studies that have played down the benefits of some of the drugs chosen
for it.
"In our country, there's been a switch from taking care of people to
focusing on big corporate money," said Rep. Juan Escobar, D-Kingsville,
who unsuccessfully offered legislation last year that would have banned
researchers or government employees funded by the pharmaceutical
industry from designing state psychiatric drug protocols. "There need to
be restrictions on how these things are done, because the victims are
our children."
State health officials and the attorney general's office refused to
comment on either the adult or child drug protocols or on the formal
letter the office sent ordering that CMAP not be rolled out. The News
found no evidence that any particular drug companies had been pulled
into the Medicaid fraud investigation into CMAP.
The CMAP research wasn't funded by drug companies, but most of the
country's renowned scientists have used industry money for their work.
Without the private dollars, which are more readily available than
government grants, many pharmaceutical advances would be drastically
delayed, researchers contend.
The flip side is that the scientists conducting the research become
familiar with and invested in the drugs, making them, in effect, some of
the pharmaceutical firms' best salespeople.
Some universities, like UT, require that their researchers fill out
extensive financial disclosure forms, and document every case where they
conduct research on drugs manufactured by a company they consult for.
Most of the CMAP researchers appear to have complied with these
guidelines.
But many of the nation's researchers must do little more than disclose
their relationships in fine print at the bottom of their published
papers. There's no way to verify these disclosures are accurate; in all
but a handful of states, drug companies aren't required to reveal their
payments.
Last month, Sen. Charles Grassley revealed that three Harvard psychiatry
experts whose research contributed to the explosion of antipsychotic use
in children had failed to report a combined $3.2 million in drug company
consulting fees to the university, a violation of Harvard's rules.
Mr. Grassley, R-Iowa, has proposed legislation to force drug companies
to disclose their payments to physicians. But he faces an uphill battle.
In 2007, drug companies spent an industry record - $168 million -
lobbying lawmakers on Capitol Hill, according to a Center for Public
Integrity study. That's up more than 30 percent from 2006.
Patricia Ohlendorf, UT-Austin's vice president for legal affairs, said
several university system researchers, including the head of UT's
pharmacy college, M. Lynn Crismon, have been asked to give depositions
for the lawsuit over the adult protocol. They are not named in the civil
suit.
Dr. Crismon, who led the effort to create the children's protocol and
has received research or consulting dollars from at least 10 different
drug manufacturers, according to his published papers, said he was "not
at liberty" to comment on the drug protocol or the lawsuit.
Last month, an e-mail sent to some employees at the Department of State
Health Services indicated that "all CMAP activities" were to be "removed
from the UT College of Pharmacy" - where Dr. Crismon and a key piece of
the roll-out program were centered.
An official close to CMAP said that within the last month, investigators
from the attorney general's office seized hard drives from state health
offices and questioned employees. That has not happened at UT, Ms.
Ohlendorf said.
The adult protocol
Texas' adult-drug protocol, spearheaded in the mid-1990s, aimed to
provide better and more consistent treatment to adult patients in state
mental health facilities. The plan was designed and tested by a team of
university researchers, state government experts and mental health
advocates, and a presidential mental health commission lauded it in 2004
as a model for the nation.
But there were criticisms from the start by clinicians who feared the
protocol would override their judgment and Scientologists opposed to all
use of drugs for psychiatric care. And its research funding from 11
pharmaceutical companies prompted allegations of improper influence
after several cutting-edge, high-dollar drugs were chosen over
traditional generics.
Most researchers involved in the protocol, many of whom also conducted
research for the children's version, declined to comment for this
report. But privately, they say their financial relationships with drug
companies didn't cloud their judgment. While the newer drugs were
costly, the researchers believe they are better and that they should be
available for people in state care, not just for those with private
insurance.
State lawmakers moved forward with the adult protocol, using it in state
psychiatric hospitals and community mental health facilities. Texas
researchers were shuttled across the nation to give drug company-hosted
lectures about the protocol's merits, according to previous newspaper
reports and allegations in the state lawsuit. Within years, 16 other
states were using similar protocols, and Texas was designing its own for
children.
But as new research about the drugs chosen for the protocol emerged,
questions resurfaced. A 2005 study by the federal government's National
Institute of Mental Health showed the new antipsychotic drugs, which
cost roughly 10 times more than the traditional drugs, performed no
better and had nearly as many side effects.
"Taken as a whole," the report notes, "the newer medications have no
substantial advantage over the older medication."
A year later, a British national study mirrored those findings.
Meanwhile, a Pennsylvania official became an unlikely whistle-blower
when he discovered the state's chief pharmacist - who was designing a
drug plan based on Texas' protocol - was reportedly on the payroll for a
drug company, according to previously published news reports.
Allen Jones' bosses in the Pennsylvania inspector general's office told
him to lay off, Mr. Jones alleges, and when he didn't, he was fired. Mr.
Jones traced the pharmaceutical influence all the way back to the TMAP
protocol, filing a whistle-blower lawsuit in Texas that quickly caught
the eye of state authorities.
Mr. Jones could not be reached for comment. His Dallas-based attorney
did not return phone calls.
Not long after, Dr. Shon, then the medical director for the Department
of State Health Services, was ousted over allegations the pharmaceutical
company Janssen improperly influenced him to include its schizophrenia
drug in the protocol, according to previous news reports and the TMAP
lawsuit.
Dr. Shon was accused of accepting consulting money from the company -
income he says was unrelated to his work for the state - and of taking
dozens of trips underwritten by drug companies to promote the protocol.
In 2006, the Texas attorney general's office joined Mr. Jones' lawsuit,
accusing Janssen of concealing the risks and exaggerating the benefits
of the drug, Risperdal, and of trying to persuade researchers with
"trips, perks, travel expenses, honoraria and other payments." As a
result, the state says, the protocol includes high-priced drugs instead
of cheaper generics, which costs Texas' Medicaid program more money.
Executives with Janssen did not return repeated phone calls. In court
papers filed in Travis County, the drug company denied any wrongdoing,
calling Mr. Jones an "opportunistic 'late-comer' " who had "at best,
only secondhand knowledge of the alleged fraud."
Dr. Shon, who retired to Las Vegas, says for every speaking engagement
where he represented the state of Texas, he gave the payment he received
to the state. Over the course of 15 years, he said, he probably earned
less than $15,000 from private consulting gigs with drug companies -
jobs that weren't related to his state position.
"They were done on my own time, and they followed all the guidelines,"
he said. "In terms of what I've been involved with, I haven't seen
anybody paid by the industry to promote a product."
Link here:
<http://www.dallasnews.com/sharedcontent/dws/news/texassouthwest/stories
/DN-cmap_18tex.ART.State.Edition2.4d6163c.html>
http://www.dallasnews.com/sharedcontent ... t/stories/DN-cmap_18tex.ART.State.Edition2.4d6163c.html
