Tufts doctor is chided on ethics
US senator faults federal adviser for endorsing device
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A US senator known for ferreting out conflicts of interest in medical research yesterday accused a prominent Tufts University heart specialist of crossing an ethical line by working simultaneously for the federal government, Tufts Medical Center, and a private heart-device company.
The specialist, Dr. Marvin Konstam, was hired in January as a senior adviser to the director of the National Heart, Lung, and Blood Institute, wrote Senator Charles Grassley, an Iowa Republican, in a letter sent yesterday to Dr. Elias Zerhouni, director of the National Institutes of Health.
But just last week, Grassley noted, Orqis, the private California company where Konstam is medical director, sent out a press release in which Konstam praised one of its products, a minimally invasive device for helping heart-failure patients. The press release identified Konstam as a professor of medicine at Tufts.
"Anyone would be confused about who is Dr. Konstam's employer," Grassley wrote. "Tufts? The National Heart Lung and Blood Institute? Orqis?"
Grassley, the ranking Republican on the Senate Finance Committee, and others are troubled by gaps in the oversight of federally funded researchers, arguing that their ties to companies that make drugs or medical devices could skew their tax payer-funded research.
In a statement yesterday, Zerhouni's office said, "We will work closely with Senator Grassley and his staff to address the concerns and questions" in the letter.
The statement said Konstam has been on a one-year advisory assignment while technically remaining a Tufts employee and that "he is not authorized to approve or make any grant or contract awards or conduct research" at the heart and lung institute.
Tufts Medical Center said yesterday that Konstam, formerly chief of cardiology, was traveling and unable to comment, but it confirmed that he is still affiliated with Tufts and will be returning as of Jan. 1.
"Dr. Konstam recently accepted our offer to return to Tufts Medical Center as chief physician executive of our new cardiovascular center," Tufts said.
Grassley wrote that Konstam's status as a contractor at the institute raised a concern that the NIH may be trying to avoid conflict-of-interest policies by hiring people as contractors rather than full-timers, he wrote.
In 2005, the agency adopted tough new conflict-of-interest rules for its scientists after revelations that some of them had questionable ties to drugmakers and biotech companies.
Grassley asked for a briefing by Oct. 7 on how much money the institute has paid Konstam and what outside income he might have received.
He also was critical of the fact that Konstam had submitted an article to a scientific journal in February, a month after he started at the heart institute, and that it reported on an Orqis device.
In April, an article in the Journal of the American Medical Association criticized Konstam, among other high-profile doctors, for having allowed his name to be added to research reports drafted by the drug company
Konstam defended his role in articles about the cardiovascular effects of Vioxx, telling the Globe at the time that he stood by his publications.
In June, Grassley accused three Harvard Medical School psychiatrists, including Dr. Joseph Biederman, a well-known child psychiatrist, of vastly underreporting their outside income from pharmaceutical companies. He has also advocated for tighter conflict-of-interest rules at the NIH, the huge federal complex that gives out billions of dollars in research grants each year.
Carey Goldberg can be reached at goldberg@globe.com.
