Conflict of Interest

[Guest guest]

Friends,

This is an older article submitted by one of our members, but still

relevant:

http://www.narpa.org/drug_companies_enrich_researcher.htm

On Jan 12, 1999, The Boston Globe reported that after a three-year criminal

investigation by the Attorney General's Office, Brown University " agreed to

return $300,170 " of taxpayer money to the state of Mass for psychiatric

research Brown's psychiatry department never performed.

In a follow up report, Oct 4, 1999 (below), Alison Bass of the Globe reports

about the on-going cozy financial relationship of Brown's Chief of

Psychiatry, Dr. Keller, who got over $500,000 annually from

pharmaceutical companies that manufacture the antidepressant drugs that he

" lauded in a series of medical research reports. " Brown University

officials toldd the Globe that " the School of Medicine has no problem with

Keller's consulting arrangements. "

The erosion of ethical standards at prestigious medical research

institutions is the result of just such collaborative partnerships between

the pharmaceutical industry, medical researchers and academic institutions.

Could the fact that Dr. Keller brings in tens of millions of dollars in

research grants annually to Brown University--about $14.4 million in

pharmaceutical funding, $8.4 million in Federal grants from NIMH--influence

the university's inability to recognize a conflict of interests?

What about the integrity of articles published in professional medical

journals whose authors fail to disclose financial ties with the manufacturer

of the drugs being evaluated? Dr. Keller's articles were published in major

medical journals: Biolgoical Psychiatry, the American Journal of Psychiatry,

Journal of Clinical Psychiatry and JAMA. Physicians reading such

endorsements have, no doubt, been influenced by them -- they may have been

led to prescribe these " effective " drugs to patients who may have been

better served by psychotherapy. Does it matter if thousands, perhaps

millions of patients are poorly served ?

CITIZENS FOR RESPONSIBLE CARE & RESEARCH

142 West End Ave, Suite 28P

New York, NY 10023

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Drug companies enrich Brown professor

By Alison Bass, Globe Staff, 10/04/99

Brown University professor who was forced last year to forfeit hundreds of

thousands of dollars in state grant money was paid more than $500,000 in

consulting fees in 1998, most of it from pharmaceutical companies whose

drugs he touted in medical journals and at conferences.

Dr. Keller of Newton earned more than $842,000 last year while

serving as chief of the psychiatry department at Brown, according to

financial records. More than half of his compensation came from the

pharmaceutical industry, including companies such as Pfizer Inc.,

Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly, all of which market

antidepressants that Keller lauded in a series of medical research reports.

In addition, Keller did not disclose the extent of his financial ties with

the companies to the medical journals that published his research in 1998,

or to the American Psychiatric Association, which sponsored the meetings at

which Keller presented his findings.

While cozy financial relationships between drug companies and medical

researchers have long been a source of concern for universities and medical

institutions, consumer advocates worry that the problem is growing as

universities tighten their budgets and researchers are pressed to bring in

more outside funding.

Several ethicists contacted by the Globe say Keller's unusually large

consulting fees - he pulled in a total of $556,000 in 1998 and $444,000 in

1997 - constitute the most serious potential conflict they've heard of yet.

''Such financial ties can't help but influence a researcher's objectivity

and can lead to the inappropriate prescribing of drugs that are less safe

and effective and more expensive than older drugs,'' said Larry Sasich, a

health-research analyst for Public Citizen, a watchdog group in Washington.

''The victim in all of this is the patient.''

Brown University officials said its School of Medicine has no problem with

Keller's consulting arrangements. However, they declined to comment on what

the university knew about his financial ties. Brown does not require its

researchers to disclose the specific amounts they receive in consulting

arrangements, only whether they are earning more than $10,000, as required

by federal law.

''We're very concerned about potential financial conflicts,'' said

Freid, executive vice president for public affairs and university relations.

''You're making the assumption that someone who earns more than $10,000 has

an immediate conflict, and I don't think you can do that.''

Keller did not return repeated phone calls to his office.

Several prominent medical schools, including those at Harvard and

town, prohibit or strongly discourage faculty members from performing

research if they are receiving more than $10,000 from a company that stands

to benefit from it.

''The public relies on academics to find out the truth and advise public

agencies about what is safe and what isn't, what is true and what is

false,'' said Dr. Arnold Relman, editor emeritus of the New England Journal

of Medicine and professor emeritus of medicine at Harvard Medical School.

''If I were this person's [supervisor], I would have major concerns that

such a large sum of money would bias his thinking and judgment.''

However, the journal itself was stung last week by an ethical breach when it

was disclosed that an author of an editorial praising two baldness

medications did not disclose that she was a paid consultant to the companies

that manufacture the drugs.

Keller, meanwhile, is a valuable resource for Brown University, attracting

millions in research grants and donations. According to the psychiatry

department's annual report and other documents, Keller has brought in about

$14.4 million in research funding from pharmaceutical companies and federal

agencies since 1993. Approximately $8.4 million has come from the National

Institute for Mental Health for research on mental illness.

Nine months ago, Brown was forced to return $300,170 Keller's psychiatry

department had collected from Massachusetts for research that state

officials say the department never performed. Brown returned the money

shortly after the Massachusetts attorney general's office filed a civil

lawsuit in Suffolk Superior Court, accusing Brown of breaching research

contracts with the Massachusetts Department of Mental Health.

The attorney general's investigation was prompted by a Globe series about

allegations that the Brown psychiatry department had submitted partially

fabricated invoices for research it never performed. The Globe also reported

that Keller, who has headed the psychiatry department since 1989, was

investigated by the Rhode Island attorney general's office in 1994 for

allegedly padding his travel expenses and double-billing pharmaceutical

companies and academic institutions for trips he made.

The attorney general dropped the inquiry after Brown decided to handle the

matter internally, Rhode Island police said at the time. University

officials said that Keller had repaid Brown $918 for travel expenses after

an audit of his travel billing.

A review of financial records and research Keller has published show the

extent of his financial ties to the pharmaceutical industry the past two

years:

In 1998, the same year he published three studies with colleagues in the

Journal of the American Medical Association and the Journal of Clinical

Psychiatry touting the efficacy of Zoloft, a new antidepressant manufactured

by Pfizer Inc., he received $218,000 in personal income and more than $3

million in research funding from Pfizer, a pharmaceutical giant located in

New York City.

Also in 1998, Keller authored a review article in the journal Biological

Psychiatry in which he concluded that newer antidepressants, including

Serzone, Zoloft, and Effexor, were all effective medications for depression

and that people with major depression were not receiving adequate drug

treatment. The same year, in addition to the money he received from Pfizer,

he received $77,400 in personal income and $1.2 million in research funding

from Bristol-Myers Squibb, which manufactures Serzone; and $8,785 in

personal income from Wyeth-Ayerst, which makes Effexor.

In May 1999, Keller presented findings that Serzone was an effective

treatment for chronic depression at the annual meeting of the American

Psychiatric Association, prompting glowing press reports about the

Bristol-Myers drug. In one such report, Keller is quoted as calling the

results ''truly astonishing'' and concluded: ''This study should put to rest

the widespread belief that chronic depression is resistant to drug

treatments and psychotherapy.''

In research Keller presented at the APA meeting and published in the

American Journal of Psychiatry, the Journal of the American Medical

Association, and other journals, he did not fully disclose the extent of his

financial ties to the pharmaceutical industry.

In the 1998 Zoloft study published in JAMA, for instance, Keller disclosed

that he received consulting fees or honorariums from Pfizer, Bristol-Myers

Squibb, Forest Laboratories, Wyeth-Ayerst, Organon Inc., and Eli Lilly. But

he did not disclose that he also received substantial payments from Merck &

Co. ($19,699), which manufactures another antidepressant, or a total of

$73,500 from other companies that market drugs.

Nor did he disclose those financial ties to the American Psychiatric

Association, which allowed Keller to present favorable research on various

antidepressants at its annual meeting this year and last.

Dr. , deputy medical director for the psychiatric association,

says the group requires its meeting presenters to disclose their financial

ties with all companies that provide commercial services to the

pharmaceutical industry, as well as the pharmaceutical companies themselves.

''If someone fails to disclose, that's against our rules and we'll sanction

them,'' said.

Sheldon Krimsky, a bioethicist and Tuft University professor, said: ''It is

a clear violation of ethical norms if a scientist who publishes work does

not fully disclose his financial connections with companies, whether it's a

consulting arrangement or getting funding from that company.''

This story ran on page A01 of the Boston Globe on 10/04/99.

© Copyright 1999 Globe Newspaper Company.

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