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. Martin 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 ?
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Drug companies enrich Brown professor
Dr. Martin 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 Laura 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 Georgetown, 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. James Thompson, 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,'' Thompson 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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Last updated October 5, 1999 by NARPA