The newly appointed editor of the New England Journal of Medicine has been criticised by the US Food and Drug Administration (FDA) for overpraising a new asthma drug made by a company that he had advised as a paid consultant.
Dr Jeffrey Drazen said his error had been an honest one and vowed he has learnt from it. “We were probably a little overzealous,” said Drazen, a prominent asthma researcher and chief of the pulmonary division at Brigham and Women's Hospital in Boston, who is scheduled to take the helm of the medical journal in July. “In the future, we'll be more careful,” he said.
Drazen's statement comes after news reports that the FDA had last year issued a “notice of violation” against Sepracor, the maker of the pulmonary drug levalbuterol. The FDA had found that Drazen was guilty of making “false or misleading” statements about the value of the drug, according to the original letter. Having been paid by the firm to evaluate studies on its drug, Drazen concluded that the product was “the first real advance in rescue asthma therapy in over 20 years,” the FDA letter said. But the FDA found the statement overstated both the safety and the efficacy of the drug. It said the studies evaluated by Drazen found the drug to be about the same as albuterol in terms of efficacy and only slightly better in terms of side effects. Sepracor used Drazen's ambitious statements to aggressively promote the drug.
In an interview with the Boston Globe on 30 May, Drazen said he found the data “very interesting … highly significant” from a scientific viewpoint. But he conceded that the clinical findings were insignificant. The statement about the drug being the first real advance in 20 years “wasn't quite right,” he said. “But I was interested in the science,” he said. “I thought it was an advance. But from a purist's point of view, it was not.” Drazen said the statement was fine for a scientific meeting but not for marketing. “I'm a scientist first, not a drug marketer,” he said. “But I'm wiser for it, and I think I'll be a better editor for it.”
“I think the disconnect between money and individual should extend also to researchers,” said Dr Timothy Johnson, a physician and chief medical correspondent for ABC News. “I personally believe there must be a strong firewall between any money from industry and the research being supported by such money,” Johnson said.
When he took the job of editor of the New England Journal of Medicine last month, Drazen was immediately criticised for his close ties with several pharmaceutical companies that have funded his pulmonary research and hired him as a consultant. Under the journal's rules on conflict of interest, he is barred from writing editorials or review articles relating to his research or related work within two years of accepting commercial funding. Outgoing interim editor Dr Marcia Angell lashed out at doctors who place profits first in a journal editorial on 18 May entitled “Is academic medicine for sale?”
Drazen has had financial ties with at least 21 drug firms since 1994, according to several reports. After the most recent disclosure, he said he realises that the issue of conflict of interest is an important one but that academic researchers must continue to work closely with drug companies if they want to see new drugs come to market. “There's no way around it,” he said.
Figure.
AP PHOTO/JULIA MALAKIE
Dr Jeffrey Drazen: criticised by FDA for overpraising asthma drug