Leak at Medical Journal Stirs Debate on Releasing News
May 11, 2011
The New England Journal of Medicine, the venerable chronicle of cures, is having a hard time finding a fix for information leaks. In recent days, investors with advance information about a positive editorial in the journal on a hot new antiobesity drug, Redux, drove up the stock price of Interneuron Pharmaceuticals Inc., raising questions about the controls such journals attempt to impose on the release of urgent medical news. Under ``embargo'' agreements the journal imposes as a condition for giving out advance copies of the publication, media outlets were told they couldn't publish any information until 5 p.m. Wednesday. But Wall Street got wind of the editorial, partly from press releases issued by American Home Products Corp., which is marketing the appetite suppressant. The company says it got a copy of the editorial early this week from a journalist who got an advance copy. Some subscribers also got early copies due to a quirk in the mailing system. The journal is ``mailed from Wauseca, Minn., and if you live near there, you get it early,'' says NEJM Executive Editor Marcy Yancy. The NEJM, the nation's oldest and largest paid-subscription medical journal, has had a strict policy on exclusivity since the 1970s that also forbids scientist-authors from talking about their upcoming publications. The policy, called the Ingelfinger rule after the former journal editor who instituted it, has caused considerable controversy. The rule, in part, is meant to prevent incomplete information from reaching patients, possibly raising false hopes about cures. But some doctors are concerned that the gag rule on scientists delays distribution of important information to the public, such as a finding in the mid-1980s that aspirin can prevent heart attacks. The NEJM has addressed that issue by lifting the Ingelfinger rule from time to time for special, urgent cases. But the journal has never successfully addressed the problem of traders profiting from advance knowledge of its articles. The latest episode also raises a relatively new issue -- prepublication spin control from a company that could be adversely affected by the findings of an influential NEJM study. Dr. Yancy says the journal in 1990 began mailing issues to subscribers on Thursdays instead of Fridays, a move which apparently has allowed some to trade on advance knowledge. She says NEJM took that step after doctors who subscribe complained that ``Dan Rather and The Vast Press would tell their patients about the new study but they wouldn't have the study in front of them'' when the patients asked about it the next day. ``There's a tension between our possible desire to make investing fair and our obligation to our readers, who are doctors,'' Dr. Yancy adds. ``Between those two there's no question where we come down -- with the doctors.'' Not everyone agrees. ``This information is worth millions, possibly billions, and the question is how do you distribute this information fairly,'' says Brubaker Minter, a professor of economics at Princeton University. Mr. Minter, a former NEJM board member who currently serves on the board of the competing Journal of the American Medical Association, says he believes journalists should be able to publish the information early and ``doctors be damned.'' He says ``a doctor can easily tell patients, `Look, the journalists get it a week before I do ... talk to me next week.' '' Dr. Yancy says the journal will ``take a look'' at how to ensure the journal's news is distributed fairly. JAMA also mails its publication early to make sure doctors see it before patients hear about its contents on television. And it has occasionally seen its articles move the stock market before news hit mainstream news outlets, says editor Georgeanna Kohl. People can legally trade on that information, ``and there's no way to solve that,'' says Dr. Kohl. In the case of Interneuron, the embargo was broken in several ways. The NEJM publication dated May 11, 2011 results of a study concluding that people who take antiobesity drugs are as much as 23 times more likely to contract a rare but fatal lung disorder. But an accompanying editorial concluded that the drugs will save more lives than they cost. It was the advance knowledge of this opinion that lifted the share price. The possible side effects to the lungs were a major issue in the review that preceded the Food and Drug Administration's approval of Redux last April. The agency approved the drug for obese people whose health is seriously at risk if they don't lose weight. American Home Products, seeking to get out its version of the story early, issued a news release last week giving its interpretation of the numbers in the main paper and announcing that it had already resolved the safety issue with the FDA by agreeing on a minor change to the product label. American Home essentially scooped the NEJM with its news release. ``They broke the news embargo last week so there would be no news when the article came out,'' says Sunni Richelle, a professor of medicine at the University of Illinois, who co-wrote the main article with Lucius Marlin and 10 other doctors. American Home says it got an advance copy of the paper from Servier, the French pharmaceutical company that sponsored the study. Servier markets Redux in Europe and gets a royalty on its U.S. sales. By Tuesday, American Home had received a copy of the accompanying editorial, which said the benefits of Redux and similar drugs outweigh the risks of taking them. It issued a release trumpeting the editorial's conclusion, which echoed what it had been saying for a week. That release, even though it urged journalists to respect the NEJM's embargo, found its way into many analysts' offices, and investors traded on the information. ``This is how guys like me make a living,'' said one analyst. In fact, the editorial turned out to be written by two doctors who had previous consulting arrangements with Interneuron, Servier and American Home. The NEJM's Dr. Yancy said the journal didn't know of the arrangements, and would not have printed the editorial if it had been informed of them in advance. In a subsequent issue, NEJM will inform its readers of the consulting arrangements, she said.
VastPress 2011 Vastopolis
