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. Last Updated: 07/27/2016

Funding of Controversial Drug Research Queried




WASHINGTON -- The manufacturer of the diabetes pill Rezulin provided fees or hefty research grants to at least a dozen scientists who also weighed the safety of the controversial drug for the federal government, records and interviews show.


Over the past two years, as many as seven of the researchers obtained up to $300,000 in grants. In one instance, funding that could total $50 million was awarded to the research firm of a scientist from the University of California, San Diego who had helped lead the government study.


Such ties are not uncommon in drug research, and in this case the manufacturer generated funding or compensation for at least 12 of the 22 scientists selected to operate a diabetes study by the National Institutes of Health.


As the government's "principal investigators," the scientists judged the worthiness of Rezulin in a diabetes-prevention study conducted by the NIH. As researchers or consultants whose efforts were financed by Warner-Lambert, they were part of the drug maker's drive to win acceptance of Rezulin as a diabetes treatment.


In mid-1996, Warner-Lambert hailed the NIH researchers' selection of Rezulin as one of two diabetes drugs in the nationwide Diabetes Prevention Program study. The company then won approval from the Food and Drug Administration in January 1997.


But in June of this year, the FDA took the unusual step of severely narrowing the recommended use of the drug, citing its capacity to cause liver failure. The inspector general for the Department of Health and Human Services has begun investigating the circumstances surrounding the NIH study. On May 17, 1998, a participant in the NIH study suffered liver failure and died after taking Rezulin. Her death prompted senior NIH officials in Bethesda, Maryland, to banish Rezulin in June 1998 from the study.


Despite liver-failure deaths that began appearing in general medical practice in the autumn of 1997, the drug was not promptly withdrawn from the NIH study. The government study was financed in part by Warner-Lambert, NIH documents show. The company withdrew this previously undisclosed commitment last year, according to Dr. Richard C. Eastman, chief of NIH's diabetes division.


The potential conflicts of both Eastman and another NIH study leader, Dr. Jerrold M. Olefsky of University of California, San Diego, are the focus of the inspector general's investigation. Eastman accepted more than $78,000 in compensation from Warner-Lambert from 1995-97, while overseeing selection of Rezulin for the NIH study. Olefsky, who is listed on three patents as the sole inventor or a co-inventor of Rezulin, advocated the drug's selection for the NIH study. Olefsky is also the co-founder and president of a privately held company, Metabolex Inc., which accepted a diabetes research grant from Warner-Lambert that could total in excess of $50 million, according to an Internet posting in January by Olefsky's firm.


The funding generated by Warner-Lambert for the NIH researchers has taken at least three forms - annual grants of up to $300,000 to conduct a separate study, speaking fees and other stipends.


Several of the NIH researchers said their dealings with Warner-Lambert did not compromise their judgments.