“I used to think that if studies were subject to rigorous peer review it would then be enough to simply disclose authors’ commercial ties,” she said. “But I no longer believe that’s enough. It’s too hard for anyone — editors, peer reviewers, readers — to tell whether that bias has affected the work.”
The review process
Caught in the middle of this vast shift are the editors of the New England Journal of Medicine, which is owned by the nonprofit Massachusetts Medical Society and runs on advertising, subscriptions and other revenue.
More than 600,000 people in 177 countries read it each week, according to the journal’s Web site, and it influences the practice of medicine around the world.
“Overall, we’re in the business of trying to make people better,” said Editor in Chief Jeffrey M. Drazen, who is also a Harvard Medical School professor.
The journal receives about 5,000 submissions a year. Those are reviewed by a staff of 10 editors — nine physicians and a geneticist — in addition to another 10 editors on contract.
Once an article makes the first cut, the article is sent to “peer reviewers” — the journal has an index of more than 10,000 such people — to scrutinize the reports. The reviewers typically assess the paper based on what is presented — they do not see all the data — but they often can tell when researchers are overstating their drug discoveries.
“We spend a lot of our time reworking language indicating that a drug is a blockbuster, when in fact the data show it’s just so-so,” Drazen said.
As the industry’s influence has grown, the journal and Drazen, who arrived at NEJM in 2000, have repeatedly taken steps to root out commercial bias.
In 1984, the editors laid out a policy calling for authors to disclose their funding and financial associations. In 2001, they asked for more details about the company’s role in the research. Then, last year, Drazen and his team required that the lengthy “protocols” of studies also be published, so anyone can see the exact steps that were taken.
Medical journals have also acted in concert. In 2004, Drazen and editors at other journals made it much harder for companies to hide unflattering experiments, requiring drugmakers to register a summary description of their trials in a public database.
“The drug companies went nuts about requiring registration,” Drazen said. “They said, ‘That’s secret information.’ We said, ‘That’s bull----.’
“As a group, we stood them down,” Drazen said.
Despite such measures, medical science appears to have reached a crisis: Doctors have grown deeply skeptical of research funded by drug companies — which, as it happens, is most of the research regarding new drugs being published in NEJM.