Clamors born of jealousy and rage have periodically plagued the patrician New England Journal of Medicine. Over 176 years, the Boston-based weekly compendium of medical research has, because of its accuracy and thoroughness, come to be regarded as the world`s preeminent medical publication. Dr. Arnold Relman, a kidney specialist who assumed the helm 11 years ago, is the latest in the Journal`s line of controversial hard-line editors. Relman`s
outspokenness has brought him his share of headaches.
Now aspirin has given him a doozy.
”Over nearly two centuries, we have become the voice of American academic medicine and the medical research establishment,” Relman declares.
”The notion that we are fiddling around and withholding information while people are dying is irresponsible and totally unjustified.”
On Jan. 28 the Journal broke a sensational story about the preliminary results of a major nationwide 5-year-study involving 22,000 doctors, showing that an aspirin tablet taken every other day can significantly lower the risk of heart attacks.
That same day, Lawrence Altman, a physician and senior medical writer for the New York Times, wrote in a front-page story that the results of the study had been known for weeks ”by many scientists, government officials, business leaders and journalists.” Yet public knowledge of the results ”deemed urgent by the National Institutes of Health” had to wait for publication in the Journal.
The study did not address the potential benefits of taking aspirin for only a few weeks; nor did it suggest any beneficial effects for women. Relman says researchers simply don`t know if publication of the article earlier could have affected lives.
Altman wrote that the growth into a national institution by this private profitmaking magazine, owned and published by the Massachusetts Medical Society, has paralleled the growing importance of medical news. Yet, wrote Altman, many experts say the Journal exercises ”undue power over the flow of information on medical research. It is information that influences government policy, promotions, careers, financial markets, science policy, grants and, not least, the treatment of patients.” Indeed, publication in the journal for a young researcher may be a critical factor in future jobs and funding.
It long has been charged that the Journal`s power, particularly to enhance careers, can have a chilling effect on the flow of information. Why should this magazine have a virtual monopoly on the manner in which hot and often commercial medical news is conveyed to the public?
In the Altman article, Princeton University health economist Uwe Reinhardt was quoted as saying that the Journal ”has honed the manipulation of data and information to a fine art, and it is all in the name of peer review. But it really is in the name of profit.”
Not surprisingly, Relman is upset. From his office atop the Harvard Medical School Library, Relman labors to glide his famous journal over the perilous shoals of puffery, quackery and self-delusion that he perceives threaten to swamp real medical science. Relman says he seeks nothing but the truth about discoveries that can save and prolong life. In turn, Relman demands the right to rigorously check out all claims and tell the truth to the world-first.
Such has been the goal of this venerable institution since January of 1812, when two Boston physicians, John C. Warren and James Jackson, founded The New England Journal of Medicine and Surgery, and the Collateral Branches of Science. The first issue carried articles about angina pectoris, the treatment of burns, and gastrointestinal disorders of children.
Later, in 1846, the Journal was the first to describe the use of ether for anesthesia during surgery. It scooped the world on historic operations, including the procedure (in 1934) to remove a herniated spinal disc. Today 250,000 subscribers, most of them doctors, teachers and medical personnel, turn to the Journal to learn about the latest advances in all of medicine. Of the estimated 4,000 papers submitted each year, only 10 to 15 percent are deemed fit for survival in its pages.
Scarcely a week goes by without the Journal making news, and Relman and his policies have been criticized before. Eight years ago, in fact, Time magazine wrote: ”. . . the Journal itself has become news, a target for reporters who charge that its editorial policies delay the revelation of medical developments to the public.”
At issue then and now was the journal`s controversial ”Ingelfinger Rule,” named for former editor Franz Joseph Engelfinger, under whose tenure the Journal began refusing to publish studies that had received publicity elsewhere. Relman supports the policy. ”Information without peer review is half-baked,” he says.
The rules of the game are known throughout medical research. Any scientist who wants to write for Relman`s magazine-and everybody does-must play along. Breathe a word about your work, if you must, to your wife and a colleague or two. But leak a single page of data to a reporter and you`ve had it.
Relman has given the green light to the quick release of AIDS research and other emergencies that directly affect public health. ”Any other position would be irresponsible and foolish,” he says.
As for everything else, only work that has been checked out and approved by the Journal`s platoon of volunteer experts reaches print in the Journal. Other information is presumed to be untrustworthy.
”There would be chaos without peer review,” Relman says. ”There would be endless claims and counterclaims-total confusion.”
Critics charge that the game has changed since the 19th Century, when such journals were the only sources of new medical information. Too much data is being presented at too many meetings attended by thousands of scientists for the Journal to cling to its demands for exclusives, critics say.
Yet the Journal strictly enforces the Ingelfinger Rule. In 1977, for example, Relman yanked a paper scheduled for publication suggesting that vigorous exercise reduced the risk of heart attacks. The paper had been presented at an open meeting of the American Heart Association and reported on by the press.
The Journal and the Times have clashed before. In 1976 Ingelfinger rejected a report by Allen Steere, a Yale University internist, giving the first details of Lyme arthritis, a newly discovered tick-borne disease. Steere had presented his findings at a meeting. The Times covered the story and fleshed it out with an interview.
The current Relman-Altman flap continued on Feb. 10, when the Times printed letters to the editor that further expanded the controversy. Princeton`s Reinhardt, who frequently debates Relman on the lecture circuit, criticized Altman`s story, saying that he (Reinhardt) in no way was
”impugning the integrity of Arnold Relman.”
But Reinhardt stuck to his guns about the Ingelfinger Rule, claiming that it ”exists as much to enhance the economic position of the Journal as to protect the public from the premature release of information.”
Relman denies this. And in the same edition of the Times, he challenged Altman`s assertion that ”many” unidentified ”medical leaders” decry his policy. He wrote that the Journal had received the aspirin manuscript on Dec. 21 and published it five weeks later, which is relatively quickly, Relman said. Two weeks were devoted to peer review by editors and outside experts. Revision, production, printing and mailing filled the remaining three weeks.
”We then were prepared to shorten this period by a week, but the authors of the study did not want their report to appear before they had notified the 22,000 participants,” Relman wrote.
He insisted that physicians needed to study the data in a scientific article before their patients started asking them about the benefits and risks of taking aspirin to prevent heart disease.
However, in another letter, Dr. I. Herbert Scheinberg, of the Albert Einstein College of Medicine, claimed that ”thousands of the heart attacks that occurred in American men between Dec. 18 and Dec. 28 could have been prevented” if the Journal had released the news immediately.
Here was an ugly charge.
”It`s very hard to answer it,” Relman says. ”We simply don`t know. As yet, we don`t understand if the beneficial effect of aspirin is immediate or total. No one can say whether you gain maximum protection from the first day, or whether it takes weeks or months to build up. Until we do know, there`s no justification to draw conclusions.
”Furthermore, even if we did know that aspirin protects you immediately, we still must consider all the problems that result from the immediate public dissemination of claims before the doctors are fully informed. We could do great mischief and damage to those people who rush out to take aspirin and shouldn`t. These people may get bleeding ulcers, stroke, kidney and liver damage.
”What would be the box score in a case like this? Would people have been helped or hurt by the news getting out immediately? I don`t know, and I don`t think anybody can say.
”But I do know how medical research is handled. Evidence is being developed, the work is progressing, and judgments constantly must be made as it is analyzed and criticized. At some point, the study gets published.
”Along the way, though, a discovery may turn out to be invalid and the whole thing abandoned. Premature disclosure would have fooled the public.”
By ironic coincidence, the nation`s second-leading medical journal, the Chicago-based Journal of the American Medical Association (JAMA), also is under fire, but for publishing a story that many people doubt ever happened.
The magazine said it wanted to stir up controversy and public debate by publishing ”It`s Over, Debbie,” a Jan. 8 essay in which an anonymous writer, supposedly a young doctor, told of injecting a fatal dose of morphine to end the agony of a young cancer victim whom he had never seen before.
Many journalists are skeptical of the story, but JAMA says it believes it to be true. The editors, however, spent last week fending off subpoenas from local prosecutors seeking to investigate the alleged mercy killing.
Meanwhile, Relman`s problems were compounded by an internecine struggle that could prove particularly damaging to the New England Journal and that even may change the way medical advances are reported to the public.
Relman`s difficulties actually began last November as he was preparing to publish the results of the Helsinki Heart Study, in which 4,081 middle-aged Finnish men were put on the cholesterol-lowering drug Lopid (gemfibrozil) for five years to see if it prevented heart attacks. The results showed that the drug had beneficial effects, which meant Relman had another big story on his hands. He scheduled it for the Journal of Nov. 12.
But stock market investors somehow began reacting as if they could read Relman`s mind. Nearly a week before publication, the stock of Warner-Lambert Co., parent company of Parke-Davis, the maker of Lopid, began to move.
”It dropped 5 points,” says Richard Keelty, a spokesman for Warner-Lambert. ”Rumors started. People heard we were involved with something, but they didn`t know what. There was a kind of knee-jerk reaction. The stock rose 5 points the following Wednesday, the day before publication. We were very uncomfortable.”
Not nearly so uncomfortable as Relman. The New England Journal is published each Thursday. Media subscribers, however, may receive air-mail copies a few days in advance if they sign an agreement not to release material before 6 p.m. on Wednesday, the day before publication. The embargo gives reporters time to study the Journal articles, interview experts and prepare their stories.
However, private news wires that service investment houses apparently obtained advance copies and started carrying the Helsinki study. Meanwhile, as the Warner-Lambert stock fluctuated, the nation`s medical and science reporters sat on the story, honoring the Journal`s embargo.
”I was very disturbed about the leak,” Relman says. ”Warner-Lambert had agreed to scrupulously observe the embargo, and I believe they did. They tracked down the market activity to analysts in the Midwest, and I think we figured out what happened.
”Obviously, when you get the Journal depends on where you live. The magazine is printed in a suburb of Minneapolis. We mail it out second-class a week before the publication date. If you live near Minneapolis, you`ll get your copy on Monday, not Thursday. ”We`re thinking about adjusting our mailing system so that everyone gets the second-class edition at the same time. But we don`t live in a police state. We don`t have the right to try and control every possible source of information.”
For Relman, the leaking of the Helsinki Heart study seemed to crescendo into the doctor`s aspirin report because the British news service Reuters violated the ultimate Relman taboo. The agency broke the so-called
”gentlemen`s agreement” Relman has with the media. They ignored his embargo.
The aspirin report appeared in the Journal`s issue of Jan. 28. Reuters put out a report on Jan. 26, about 24 hours before the release time. Relman always reacts to such violations sternly, but he outdid himself this time. He immediately cut off prepublication delivery to Reuters for six months. Among other things, he fears that if the embargo is broken, reporters will go with bits of a story to avoid being scooped, rather than assembling comprehensive reports.
In a Feb. 3 letter to media subscribers, Relman wrote: ”If we find that Reuters tries to obtain copies during the suspension, we`re prepared to put them on the blacklist permanently. And if we find out who was supplying them the copies, we will take similar action.”
Upon reflection, Relman admits that ”blacklist” was ”an unfortunate term. The day had been long. I felt harassed. I should have used some other word.”
Nonetheless, he was shocked by Reuters` subsequent refusal to be contrite. When he met with editors and sought to forgive them if they would agree to honor future embargoes, they politely told him, in effect, to go peddle his studies elsewhere.
”Reuters is a business-oriented news service, and they told me their first responsiblity is to investors,” Relman says. ”Their original position was that they had obtained the study independently and thus felt no compunction to honor our embargo. But they`ve backed down on that.
”Now they`re saying they won`t honor the embargo whenever it involves a story that may move the stock market. We thus have a big problem.”
Recently editors at the Wall Street Journal agreed, in principle, with Reuters, according to a story published in the Boston Globe. They will continue to honor Relman`s embargo only so long as a story is not market-sensitive. If it is, they will report the news right away.
Though beleaguered, Relman insists that he will hold fast to his scoops, his embargoes and the Journal`s traditions.
His sentiments are shared by the Journal`s counterpart in basic science:
the British weekly scientific magazine, Nature. Nature`s roots go back to Charles Darwin, who was a frequent contributor, and the magazine`s scoops have included most of this century`s great discoveries, particularly in molecular biology and its relationship to medicine. Nature demands exclusives from scientists and sets embargoes for the media.
”We absolutely agree with Dr. Relman,” says Washington editor Alun Anderson. ”We supply a lot of the world`s press with science stories. We want recognition for that. We also want readers to get it right, and there is a tremendous capability for getting it wrong if you hear about it piecemeal.
”But like the Journal, if we ever had anything that could directly affect people`s lives, we would release it immediately.”
”The Journal,” Relman concludes, ”is not seeking confrontations with the news media. We don`t want to fight.”
Still, as he nervously waits to hear the next shoe drop, he continues to take an aspirin every other day.
