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Research Should Be Released More Quickly

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Scott Gottlieb, a physician, is a medical writer for the British Medical Journal

Years ago, the professional societies that govern medicine were dedicated to the rapid release of important medical news. Today they work hard to keep it from the public.

Take last month’s annual meeting of the American Society of Clinical Oncologists (ASCO), a high-profile medical organization for cancer specialists. Medical journalists from around the country camped out at the 4-day meeting to report findings from important research presented publicly for the first time. Most of the results, however, were already old news to insiders.

Each year, a thick book summarizing the studies to be presented at ASCO is sent to the organization’s members more than a month before the meeting, with the understanding that none of the information can be publicly divulged. This common practice of selectively prereleasing--yet tightly controlling--important medical research is troubling. In an attempt to make meetings more splashy, more worthy of headlines, ordinary people, including patients who might benefit from a timely release of research findings, don’t have access to them.

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Medical societies are bent on protecting their franchise, and these days that means protecting the revenues they generate from their meetings and medical journals. Of course they don’t always say that’s what they’re doing. The societies hide behind academic integrity, claiming it is important not to release information that hasn’t been properly refereed. They also cite a need to release information that could affect stock prices in an orderly fashion. So they have embargoes.

Currently, securities laws require that publicly traded drug companies release market-moving information in a timely manner, but this usually involves only broadbrush conclusions from the biggest studies. Tradition dictates that complete disclosure is revealed only at presentations at major medical conferences or in articles published in journals. Scientists often participate in clinical trials of new drugs in exchange for the opportunity to present their findings in these career-making venues.

Meetings like ASCO wouldn’t be so important if doctors and scientists were able to discuss their ongoing research and get important information out to the public in a timely fashion. But the medical societies use their position as a blunt instrument to punish researchers or enterprising reporters who leak study results ahead of what the doctors had in mind.

This stems, in part, from the widely recognized Ingelfinger rule, named for Franz Ingelfinger, who created it in 1969 while he was editor of the New England Journal of Medicine. Ingelfinger’s rule was that his journal would not publish a study if it had been previously offered to another publication or if the authors publicly discussed their research prior to publication. The spirit of this rule has infused the entire system by which medical researchers announce their findings.

As with any such rule, certain people find ways around it. Institutional investors heavily positioned in biotechnology pay hefty sums to hire doctors as “consultants” to selectively leak the information. In the case of ASCO, the day the organization prereleases its research abstracts to members has become a sort of holiday among Wall Street’s biotechnology insiders. Last year, a Wall Street analyst quantified the rise of cancer-related stocks in advance of positive news at ASCO meetings, something he termed the “ASCO effect.” He found that stock prices begin rising more than two weeks prior to the meeting--before research findings are released to the public, but after the information has been disseminated to ASCO members. Meanwhile, media organizations, which could disseminate the same information to the public, are barred from reporting on it by ASCO’s strict embargoes and gag clauses that silence researchers and journalists.

The medical societies which publish the journals and run the meetings say that all of this is part of the “peer-review process,” a system in which important findings are carefully picked apart by panels of experts before they’re made public. The process is meant to protect against the dissemination of poor research or improperly drawn conclusions. But by the time the conference books are issued, peer review is usually already complete.

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In an age when the flow of information is becoming instantaneous and egalitarian, medical groups should expect important findings to be divulged as they are developed, not amalgamated over months into thick books and then selectively released to hype a conference. In the current environment, medical societies have created a multitiered system where a handful of doctors and investors are getting a glimpse at important medical findings, while everyone else has to wait much longer.

Medical societies could clean all this up by releasing important studies as soon as they come off copy machines. Some leading journals are already using the Internet to facilitate the early release of important research. Medical groups should also free scientists and doctors to communicate with the public and the press about ongoing studies, instead of just talking to each other. Of course, this will require educating journalists and the public about the importance of peer review and the shaky nature of preliminary findings.

Doctors could still have some quiet time to reflect on medical studies in advance of their meetings, while patients and small investors wouldn’t be denied the same disclosures some enterprising hands on Wall Street now enjoy.

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