At 200 years, fortress of medical research confronts the Information Age
At 200 years, fortress of medical research confronts the Information Age
Tuesday, April 17, 2012
In 1812 a group of doctors and researchers in the Boston area founded the New England Journal of Medicine to exchange scientific and medical information more freely.
For most of its 200-year history, the NEJM has been a bastion of the medical establishment, a prestigious outlet for the publication of research and clinical findings.
But in recent years, in large part because of the Internet and the national debate over health care reform, cries for transparency in medicine and health care have been getting louder -- and the New England Journal has found itself increasingly on the defensive.
Medical journals have been upbraided for what some say is a failure to be open about the increasingly close financial ties between medicine and industry. In addition, some researchers argue that medical journals have too much control over scientific information.
And, people are demanding more access to research as they take more control over their own health and medical care.
On all of these fronts, the New England Journal will face major challenges as it charts its course for the next generation.
The medical-industrial complex
Dr. Arnold Relman, a professor emeritus at Harvard Medical School, was one of the first to write about the potential danger of mixing commercialism with research and medicine. He coined the term "medical-industrial complex" in the 1960s.
After becoming editor of the New England Journal in 1977, he led the charge for greater transparency in the NEJM's operations and pioneered the first financial disclosure rules for a medical journal.
The rules require all authors to report all potential conflicts of interest in their research, including company money that paid for research or money they received to attend conferences or do consulting work. Other major medical journals followed suit. (Connecticut tried for years, unsuccessfully, to pass a "sunshine" law requiring drug and medical device companies to report payments they made to doctors; now, a similar provision in the federal health care reform law will mandate such disclosures beginning in 2013.)
Today Relman doubts that the rules he imposed on the New England Journal have made much of a difference.
"Despite all attempts to prevent it, the conflicts of interest are more pervasive than ever. And I think that the medical literature is not as rigorously policed, not as rigorously regulated as it used to be," Relman said in a recent interview.
After the pharmaceutical giant Merck & Co. came under fire for failing to disclose certain side-effects associated with its blockbuster drug, Vioxx, the editors of the journal published a scathing editorial in 2005. They accused Merck of misrepresenting data that had appeared in a New England Journal article touting Vioxx's benefits in 2000. Dr. Jeffrey Drazen, editor-in-chief, later told the media he'd been "hoodwinked" by Merck.
Dr. Marcia Angell, who was one of the top editors of the NEJM for more than 20 years before stepping down in 2000, said it will be more and more difficult to guard against such episodes.
"I think the public is in a difficult situation," said Angell, who has written extensively about companies who publish studies that cherry-pick the positive information about a product. "It's hard to know what to believe. And you can hardly be too skeptical."
But calls for more financial disclosure fall flat for Dr. Thomas Stossel, a doctor who teaches at Harvard Medical School. He calls naysayers such as Relman and Angell "pharma-scolds" -- old-fashioned doctors who don't realize how much industry contributes to medical advances.
Pharma-scolds rail against the medical-industrial complex not because they're worried about biased research, Stossel said, but because they're worried that their establishment publications could lose control over scientific and medical information. After all, he said, the research that drug companies submit to the Food and Drug Administration is subject to very strict federal regulations -- far stricter than those required by academic journals.
"When a new product comes out ... industry knows best how to use it, and that's how doctors in practice get that information. That's valuable information," said Stossel. "The journals, and all the editors, including Drazen, demonize industry marketing ... because they want to control the flow of information."
Some researchers argue that the journal won't disclose its own conflicts of interest -- such as the amount of money it takes from industry in advertising.
A subsidiary of the nonprofit Massachusetts Medical Society, NEJM doesn't disclose its own profits. According to its 990 tax form, in 2009, it made $70 million in publishing revenue and $20 million in advertising revenue. That includes revenue from other publications, although the NEJM is the largest.
But the journal won't say how much it makes selling reprinted articles, which drug companies buy and distribute to doctors.
The fact that Merck spent nearly $1 million on reprints of the 2000 flawed Vioxx study is only known because of the deposition of Dr. Gregory Curfman, deputy editor of the NEJM, during a lawsuit against the company.
Even the journal's editor from 1991-1999 didn't know how much his publication made. All Dr. Jerome Kassirer knew, he said, is, "It was a lot of money ... I remember so clearly my very first budget meeting.
"I was given a sheet with the expenses of the journal. And I asked naively, 'Where is the income?' And they said, 'You don't get that.' And I shrugged my shoulders, and began to understand."
The journal is a major money-maker for the Massachusetts Medical Society, which reported a 2009 profit of $11.7 million on its tax form. The American Medical Association -- with more than 10 times the membership -- reported a profit of $15 million in 2010, according to its 990 form.
Researchers and others have tried, unsuccessfully, to get more specific financial information from the New England Journal and similar publications.
The authors of a 2005 study in PLOS Medicine asked six major medical journals how much of their income came from reprints. Only the British Medical Journal and the Lancet responded, with 3 percent and 41 percent, respectively. In the discussion section of the study, the authors wrote that they were puzzled at journals like the NEJM -- which claim to take conflict-of-interest rules very seriously, but don't disclose their own possible conflicts.
"We suggest that journals abide by the same standards related to conflicts of interest, which they rightly require from their authors, and that the sources and the amount of income are disclosed to improve transparency," they wrote.
But the Massachusetts Medical Society remains tight-lipped.
"Our policy is that we release aggregated financial information in the 990 form, but that we don't talk about the specific numbers for revenues or break it out by individual publication, because the journal is one of the publications that we publish," said Tom Easley, the NEJM's publisher and managing director. "I'm supportive of that policy."
Asked about an estimate of $88 million that appeared in Boston Magazine in 2005, Easley would say only, "It's not off by a factor of 10."
That kind of profit margin is one reason a new generation of researchers and publishers say the journal is resisting calls to be more transparent -- not only about its finances, but also about how it gets medical research to the public.
Wednesday: More and more researchers are rejecting traditional journals like the NEJM by posting their work online for free. Part II is available here.