State-Federal Investigations of Mental health officials financial ties to drug industry-Phila Inquirer

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State-Federal Investigations of Mental health officials financial

ties to drug industry-Phila Inquirer

 

Sen Arlen Specter; John Ashcroft

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

 

Promoting openness and full disclosure

 

http://www.ahrp.org

 

FYI

 

The Philadelphia Inquirer reports (below) that State and federal officials

are examining the connection between payments by pharmaceutical companies to

state officials and the state's treatment guidelines that give preference to

the most expensive antipsychotic drugs under state and federal programs.

" The U.S. Department of Health and Human Services referred the case to the

FBI and the Food and Drug Administration, which opened investigations. " The

state Ethics Commission is also reviewing the case.

 

These investigations were commenced when Allen J. Jones, a whistleblower who

is an investigator in the Pennsylvania Inspector General's office (OIG),

provided documented evidence showing that pharmaceutical companies had

penetrated state mental health agencies, correctional facilities, welfare

agencies that establish preferred treatment guidelines.

 

Jones found evidence of kick backs by drug companies to state mental health

officials who had set up a special bank account. The guidelines that were

adopted by Pennsylvania and many other state mental health agencies

recommend the use of the most expensive so-called atypical antipsychotic

drugs--although these drugs have not demonstrated superiority over the older

drugs at low doses. The guidelines were developed in Texas by a panel of

psychiatrists, most of whom have financial ties to the drugs' manufacturers.

This panel formulated The Texas Medication Algorithm Project (TMAP) which

established treatment guidelines for the atypical antipsychotics and SSRI

antidepressants, declaring them safe and superior to either generic drugs or

older drugs.

 

The TMAP guidelines were adopted on the basis of " consensus " by the TMAP

panel. Although the TMAP panel called their guidelines " science-based, "

there was, in fact, no scientific evidence to justify the choice of drug or

the expenditure for taxpayers.

 

The financial stakes for the drug industry are enormous. The Inquirer

reports, in Pennsylvania alone: " More than 85 percent of the state's mental

patients now take the medications, state officials say. About 4,000 inmates

in the state prison system are prescribed antipsychotics, with about 1,600

of them taking the new drugs. "

 

" The state welfare department in 2002, the last year figures were available,

paid more than $17 million to the two drugmakers and other firms, or about

$6 million more than the previous year. No prison costs were available. "

 

The TMAP case was first reported By Melody Petersen, " Making Drugs, Shaping

the Rules, " in The New York Times on the front page of the Business section,

February 1, 2004. " Since the mid-1990's, a group of drug companies, led by

Johnson & Johnson, has campaigned to convince state officials that a new

generation of drugs - with names like Risperdal, Zyprexa and Seroquel - is

superior to older and much cheaper antipsychotics like Haldol. The campaign

has led a dozen states to adopt guidelines for treating schizophrenia that

make it hard for doctors to prescribe anything but the new drugs. That, in

turn, has helped transform the new medicines into blockbusters. "

 

The state and federal investigations were prompted by Allen Jones'

report--available online at: http://psychrights.org/

 

 

 

Contact: Vera Hassner Sharav

 

Tel: 212-595-8974

 

e-mail: veracare

 

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THE PHILADELPHIA INQUIRER

 

Posted on Tue, Feb. 17, 2004

 

State account draws ethics scrutiny

 

Mental health officials used money from drugmakers for a variety of

expenses. By John Sullivan Inquirer Staff Writer

 

HARRISBURG - Two pharmaceutical companies paid nearly $14,000 into an

unauthorized state bank account that was used by state mental health

officials for travel, meals and other expenses at a time when the drugmakers

were courting state business, records show.

 

Janssen Pharmaceutica and Pfizer Inc., also paid at least $10,000 to two

state officials who helped win approval for a mental-health treatment plan

that uses drugs manufactured by the companies, according to interviews and a

review of documents from the state Office of Inspector General. Those

payments - some of which went to charity and the general state fund - were

for speaking engagements and attendance at company meetings.

 

State and federal officials are examining the connection between the

payments and the state's program.

 

The state Inspector General's Office ended its investigation in January

2003. The case is being reviewed by the state Ethics Commission, officials

of the Department of Public Welfare said.

 

The U.S. Department of Health and Human Services referred the case to the

FBI and the Food and Drug Administration, which opened investigations,

according to a Dec. 11 letter U.S. Rep. Tim Holden (D., Pa.) wrote to a

state investigator.

 

The FBI and the FDA declined to comment. A spokesman for the Health and

Human Services Office of Inspector General said the matter remained under

review.

 

There is no indication the drug companies are the subject of the

investigation.

 

Doug Arbesfeld, a Janssen spokesman, said the company received a request for

information from the state in 2002.

 

" We complied and we have not heard anything since, " he said. " We think it's

appropriate for the industry to provide support for physician education on

treatment guidelines. "

 

.. In the mid-1990s, some of the largest drugmakers began selling the state

on a new generation of drugs to treat schizophrenia and depression.

 

In 1996, public health officials in Texas, with funding from drug

manufacturers, had developed a medication program. Within a few years, the

program caught the attention of Pennsylvania officials, but the program

would require them to rewrite Pennsylvania's prescription guidelines to

encourage doctors to use the drugs.

 

The state began the program in the Department of Corrections. In August

2001, it was expanded to Allentown State Hospital.

 

More than 85 percent of the state's mental patients now take the

medications, state officials say. About 4,000 inmates in the state prison

system are prescribed antipsychotics, with about 1,600 of them taking the

new drugs.

 

The state welfare department in 2002, the last year figures were available,

paid more than $17 million to the two drugmakers and other firms, or about

$6 million more than the previous year. No prison costs were available.

 

Joan Erney, deputy secretary for Mental Health and Substance Abuse Services,

said the program has been a great success and will save money down the road.

" The small amount of data we have suggests our clients are feeling and

functioning better " than they were with earlier drugs, she said.

 

The program had the support of the state's top medication experts: Steven J.

Fiorello, a pharmacist who oversees drug policies at state hospitals; Steven

J. Karp, the medical director for the state's mental health office; Robert

Davis, the state's psychiatric physician manager; and Frederick R. Maue, who

directs clinical services for the state Department of Corrections. Fiorello,

Karp and Davis are also members of a 21-member committee that decides what

types of drugs patients receive at the state's hospitals.

 

Department of Public Welfare officials, who discovered the unauthorized

account, said they asked the state inspector general to investigate in

January 2002, a month after the payments and the unauthorized account raised

questions at the department.

 

Welfare department officials " were concerned about the relationship between

the drug companies and some department officials, " Erney said.

 

Since April 2003, the welfare department has not taken money from drug

companies, Erney said. " We do not want to do anything that would be

perceived as making any decision based on anything other than the well-being

of our clients, " she said.

 

Corrections Department officials investigated the $6,000 in honoraria that

drug companies paid to Maue, but found no evidence the funds swayed his

decision to use the drugs in the state's prisons. Maue says he gave the

money to the state's general fund.

 

State ethics officials say state law prohibits public employees from taking

honoraria, even if the money goes to charity or the state. It is a

misdemeanor, punishable by a $1,000 fine and not more than one year in jail.

 

All four men remain in their state jobs. They did not return phone calls for

this article.

 

.. Allen L. Jones was the lead investigator for the state Inspector General's

Office. He began his inquiry in July 2003 and was removed from the case in

mid-September. He alleged political interference from his supervisors. He

has since filed a federal whistleblower suit and made his files available to

The Inquirer. The case was first reported by the New York Times.

 

His investigation focused on use of the unauthorized account, which was

opened in November 1999 under the name of Harrisburg State Hospital until

officials in the Department of Public Welfare froze the account in December

2001, Erney said.

 

The state has strict guidelines governing the opening of accounts, including

notification of the Comptrollers' Office and the Bureau of Financial

Operations.

 

Karp opened the account and told state investigators he followed the rules

in creating it.

 

" It was an unauthorized account because it was done without the knowledge of

then-Deputy Secretary Charles Currie, and it is currently being

investigated, " Erney said, referring to the ethics review.

 

The account was officially closed in October 2003 and officials used the

balance for indigent care at the hospital.

 

Over two years, the account took in $13,765.75, much of it from Pfizer and

Janssen. Investigators do not know who made two deposits totaling $3,500.

 

For example, Janssen paid $4,000 into the account in May 2001. Fiorello and

Davis used the money to attend a conference in New Orleans, where they

delivered presentations and met with Texas officials over dinner to discuss

adopting the drug program.

 

Overall, Fiorello and possibly others spent $5,493.39 from the account,

according to records.

 

Fiorello endorsed checks for a $249.99 Palm Pilot, $240 for box lunches, and

$40.50 for picture frames, among other items, investigator Jones said.

 

On at least one occasion, Fiorello requested a $3,000 educational grant from

Pfizer, according to an Oct. 2, 2001, letter from the company to Fiorello.

Those funds were deposited into the account on Oct. 16, 2001, according to

records.

 

Fiorello also told Jones that he acted as a paid consultant for Pfizer and

Janseen. Pfizer paid him to travel with a salesman to meet with Maryland

officials about the Pennsylvania program. And Pfizer paid for two trips he

took to the company's headquarters in New York. He did not recall the

amount, but it was less than $1,300 per visit, he told Jones.

 

In December 2000, Karp joined an advisory board of a Janssen-funded

newsletter, Mental Health Issues Today, and he flew to Seattle; Tampa Bay,

Fla.; and Washington, D.C., for board meetings. He resigned in 2002 after he

became uncomfortable with a Janssen executive attending the meetings, he

told a state investigator.

 

.. The issues raised by payments to public officials is so thorny that the

U.S. Department of Health and Human Services issued guidelines last year to

help public officials steer clear of violations. The agency warns that money

given to officials to generate business could violate the federal

antikickback statute.

 

" Any remuneration from a manufacturer or its agents directly or indirectly

to a person in a position to influence formulary decisions related to the

manufacturers' products are suspect and should be carefully scrutinized, "

the guidelines say.

 

Advocates understand the concern. " The hands of pharmaceutical companies are

everywhere, " said Mary Hurtig, the policy director for the Mental Health

Association of Southeastern Pennsylvania.

 

But, she said, " none of these programs could exist without drug company

money.

 

" What the state is doing is done with the best possible motive, " she said.

" I'm sorry there are no other ways to pay for these programs, but there just

aren't. "

 

 

 

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Contact staff writer John Sullivan at 717-787-5934 or

johnsullivan.

 

 

 

© 2004 Philadelphia Inquirer and wire service sources. .

http://www.philly.com

 

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