by John M. Curtis
(310) 204-8700

Copyright December 22, 2004
All Rights Reserved.

ew revelations at the National Institutes of Health help answer the question of how drugs approved by the Food and Drug Administration harm consumers. Recent concerns about Merck's Vioxx and Pfizer's Celebrex—powerful FDA-approved arthritic pain medications called Cox-2 inhibiters—causing heart attacks and strokes raise red flags about the drug approval process. In the past, independent medical research determined, with scientific objectivity, which drugs were deemed safe and effective. Today's approval process involves a complex maze in which NIH researchers hold dual employment with both the government and drug companies. It's difficult maintaining objectivity when scientists take consulting fees from drug makers seeking FDA approval. Consulting fees or a combination of stock or stock options compromise scientific research and drug approval process.

      NIH Director Elias A. Zerhouni takes a permissive stance, allowing NIH scientists to take lucrative consulting fees while simultaneously receiving government salaries. Zerhouni argues that consulting fees save the government money by providing, in effect, retention bonuses to NIH researchers. Without private consulting, Zerhouni sees a brain drain of top NIH scientists. There's nothing wrong if “the scientist is giving advice in an area . . . that is not part of his official duties,” Zerhouni told Congress, ignoring the current approval process that places greed over ethics and scientific objectivity. Zerhouni can't have it both ways: Maintain the integrity and credibility of the NIH and, at the same time, allow scientists keep outside consulting jobs. Chartered with mission of reducing “the burdens of illness and disability,” current conflicts-of-interest at the NIH contribute to both.

      When paid consultants or grant recipients skew research to favor drug companies, the FDA can't make accurate assessments of drugs' safety and effectiveness. Without disclosures about consulting relationships, it's difficult for journals and industry newsletters to qualify scientific research. It's different saying, for instance, Merck found Vioxx effective for treating arthritic pain, than an independent NIH study. Under the aegis of the NIH comes instant credibility. “If you work for the NIH, you're not working for a drug company, you're working for the public . .” said Dr. Philip R. Lee, assistant secretary of Health under presidents Johnson and Clinton. With a $28 billion budget, Zerhouni knows the extent to which his scientists moonlight with outside companies. Sponsoring research and paying scientists consulting fees helps assure eventual FDA approval.

      Failing to disclose financial arrangements leaves FDA officials in the dark trying to weigh the validity of scientific research leading to eventual drug or product approval. Drug companies frequently cite the credibility of the NIH to bolster product claims without disclosing the extent to which NIH scientists were on the drug makers' payroll. “The [company] reps tell the doctors. ‘You should follow these guidelines,' implying that your not a good doctor if you don't follow these guidelines,” said Dr. Curt D. Furberg, former head of clinical trials for the National Heart, Lung and Blood Institute, explaining how clinical recommendations reach physicians. Dr. H. Bryan Brewer Jr., an NIH employee, failed to mention his paid relationship to several drug companies when he urged in July 2003 lowering current guidelines for prescribing cholesterol-reducing drugs.

      Brewer's case, while by no means unique, reveals how scientists conceal relationships to drug companies standing to reap big profits by promoting more prescription drug use. Brewer's direct involvement with the National Cholesterol Education Program shows how NIH scientists directly influence non-profit organizations giving advice to physicians. Brewer never explained how his ties to drug companies affected his vote to lower guidelines and promote the ubiquitous use of cholesterol drugs. While there's nothing wrong with lowering cholesterol, there's something wrong with paid consultants failing to disclose financial arrangements to drug makers. It's one thing to publish drug maker-sponsored research in scientific journals. It's still another to fund and control non-profit organizations or educational institutions for the unexpressed purpose of marketing drugs.

      Current conflicts-of-interest at the NIH make it difficult to trust the credibility of its scientific research. Too many undisclosed consulting relationships with drug companies directly affect the outcome of research. “When they have financial ties to companies that they're supposed to be impartial about it, we can't assume that,” said Dr. Marcia Angell, former editor of the New England Journal of Medicine, explaining how dangerous drugs like Vioxx get approved. Published scientific research directly influences the FDA's willingness to grant drug approval. With so much research at the NIH sponsored by drug makers and conducted by paid consultants, it's difficult for the FDA to protect public safety. Without getting NIH scientists off the drug industry payroll, it's impossible to trust the results. Zerhouni must get the message, do something about it or get out.

About the Author

John M. Curtis writes politically neutral commentary analyzing spin in national and global news. He's editor of OnlineColumnist.com and author of Dodging The Bullet and Operation Charisma.

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