Healthy Skepticism Library item: 14150

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Publication type: news

Ramshaw E.
Conflict of interest fears halt children's mental health project
The Dallas Morning News 2008 Aug 18
http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/081808dnme

Full text:

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.”

KEY PLAYERS: CMAP RESEARCHERS
Several of the researchers who developed the Children’s Medication Algorithm
Project have received income or grants from drug companies, according to
their published papers and university financial disclosure forms:

DR. M. LYNN CRISMON: The CMAP project director who heads UT-Austin’s College
of Pharmacy has received research funding or consulting dollars from at
least 10 different drug companies, according to his published studies,
including Eli Lilly, Janssen, and Pfizer. He said he could not comment on
CMAP or the lawsuit.

DR. GRAHAM EMSLIE: The UT-Southwestern Department of Psychiatry researcher
has consulted for several different drug companies, including
GlaxoSmithKline and Pfizer. He has received research grants from at least
three drug companies, including Eli Lilly and Forest Laboratories.
University financial disclosure forms, where these drug companies are
listed, report income in broad ranges. They indicate he may have made up to
$125,000 from drug companies since 2004. He said the CMAP protocol was about
evidence-based medicine, “not the [drug] the most recent representative told
me about.”

DR. STEVEN PLISZKA: The UT Health Science Center in San Antonio scientist
has received research funding from Cephalon and AstraZeneca and has served
as a consultant and speaker for McNeil and Shire. University financial
disclosure forms, where these drug companies are listed, indicate he has
made at least $130,000 in drug company speakers fees and consulting
contracts since 2002. Dr. Pliszka said he didn’t know CMAP had been delayed
until a reporter asked about it. “For any physician, the bottom line is,
does their patient get better,” he said.

DR. CARROLL HUGHES: The UT-Southwestern’s Department of Psychiatry doctor
has received research funding from GlaxoSmithKline. University financial
disclosure forms also indicate he was once an ad-hoc consultant for
BioBehavioral Diagnostics, which designs equipment to test for behavioral
disorders, and was awarded shares of company stock. He declined to comment.