by John M. Curtis
(310) 204-8700

Copyright June 11, 2008
ll Rights Reserved.

xposing the dark side of medical research, a world renowned Harvard psychiatrist Dr. Joseph Biederman, conducting pioneering studies in the use of antipsychotic medication with children, failed to report $1.6 million from Ely Lilly, Inc., and other drug makers from 2000-2007. While there's nothing new about scientists getting paid hefty consulting fees from drug or device makers, the lack of disclosure indicates concealment. Most research institutions have strict rules about scientists taking two salaries, euphemistically called double-dipping. Sen. Charles E. Grassley (R-Iowa), ranking member on the Finance and Judiciary Committees, expressed grave concerns June 8 about egregious conflicts-of-interest. Grassley questioned scientists' objectivity when failing to disclose lucrative ties with drug and device companies trying to get new products on the market.

      Showing that Biederman's actions were no fluke, his Harvard colleague, Dr. Timothy E. Wilens, also may have violated federal laws and university policy, earning himself $1.6 million during the same period. When pressed by Grassley's senate investigators, another Harvard researcher, Dr. Thomas Spencer, admitted earning at least $1 million in consulting fees. “My interests are solely in the advancement of medical treatments through rigorous and objective study,” Biederman wrote in an e-mail, insisting he took conflict-of-interest policies “very seriously.” Before admitting getting $1.6 million, Biederman told instigators he received no payments in 2001. When drug maker Johnson & Johnson checked their records, they found $58,169 in payments. Extravagant consulting fees paid by drug companies to university and government researchers are ubiquitous.

      When Biederman said he took conflict-of-interest policies “very seriously,” he's not kidding. Biederman and others see no conflict-of-interest in taking cash from drug companies, believing they're entitled to such rewards. Whatever the outcome of the research, scientists like Biederman believe that cash payments don't influence the outcome of their research. They complain about not earning enough and need to supplement incomes with consulting fees. “If there have been any violations of N.I.H. policy—and if research integrity has been compromised—we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and the N.I.H. will not tolerate it,” said National Institutes of Health spokesman Josh Burklow. Burklow knows it's next to impossible to prove tainted research integrity.

      Numerous reports in the nation's leading newspapers, including the New York and Los Angeles Times, have shown egregious violations of ethics and conflicts-of-interest at the N.I.H. N.I.H. director Dr. Elias Zerhouni has publicly excused and justified N.I.H. scientists for taking money from drug and device makers. He expressed the view that various “consulting” arrangements save the N.I.H. money by allowing scientists to work for smaller salaries. Zerhouni was warned by Grassley to stop instructing his scientists to resist congressional inquiries into blatant conflicts-of-interest with the nation's biggest drug companies. When Burklow talks about punishing uncooperative researchers, he's ignoring the N.I.H.'s role under Zerhouni in giving scientists a green light to collect lucrative consulting fees. Under Zerhouni, the N.I.H. is the guilty party.

      New N.I.H. guidelines require researchers to report to universities earnings of more than $10,000. N.I.H. awarded over $23 billion to over 325,000 scientists at more than 3,000 institutions. Under current policies, the N.I.H. doesn't audit researchers or institutions with respect to outside consulting relationships with drug and device makers. Most scientists don't see a conflict-of-interest in accepting cash, perks, stock, stock options or any other compensation from outside companies. “It's really been an honor system,” said Dr. Robert Alpern, dean of Yale School of Medicine. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don't even know how to check that. Alpern's confession suggests that drug and device makers' payola in the research community is so ubiquitous that the N.I.H. and other institutions chose to turn a blind eye.

      Researchers like Biederman don't like to disclose outside consulting relationships because it impeaches their credibility. It's doubtful that the N.I.H., universities or other research institutions have policing power to stop scientists from double-dipping, getting a paycheck and simultaneously taking money or other compensation from drug or device makers. When Dr. Christy Ludlow, a leading N.I.H. researcher in neurologic disorders, an expert in Botox for treating spasmodic dysphonia or “the strangled voce,” was asked whether she received any payment or compensation from the drug maker Alleran, Inc. [the maker of Botox] over the last 10 years, she answered, “I can't answer that question.” When the N.I.H. was asked the same question, they said to file under “The Freedom of Information Act.” With answers like that, it's no wonder people question today's scientific research.

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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