Medical Research and Media Circuses

By Flamm, Anne Lederman | The Hastings Center Report, January-February 2004 | Go to article overview

Medical Research and Media Circuses


Flamm, Anne Lederman, The Hastings Center Report


In this issue of the Hastings Center Report, E. Haavi Morreim analyzes the appropriateness of a restrictive information dissemination policy that was implemented during the clinical trial of the AbioCor artificial heart by AbioMed, the device's manufacturer and trial sponsor. During the trial, some prominent critics compared it to a "gag order restricting public debate about a device that had been financed with millions of public dollars" and alleged that the company's predominant motive was to protect its business interests.

Morreim urges consideration of the controversial events as a case study to illuminate the larger issues surrounding the relationship between scientific research and the media. She maintains that disclosure of moment-by-moment, patient-centered details should be discouraged because patient privacy cannot adequately be protected. Moreover, because the information is anecdotal and often competitively distorted, it does not support valid judgments about the interventions value, and its release risks the integrity of the research trial. Morreim identifies a complicated web of stakeholders in addition to "the public," and she recommends that sponsoring corporations and their collaborators formulate a disclosure policy at the outset of a trial that includes, at a minimum, periodic reports of material, cumulative data. Sharing the plan encourages collegiality among collaborators, manages the expectations of the press and the public, and enables patients and their families to be counseled about what information will be released (with and without their consent) and what factors patients and families themselves should consider before releasing information independently.

Morreim cautions against drawing universal conclusions from the "intensely human-interest" AbioCor case study because it is not typical of "mainstream clinical research." Her warning inspires the question, why not? Does the sensational nature of a high-profile trial justify special disclosure rules?

Certainly the heightened level of human interest calls for a media policy, some plan for handling inquiries about patients. None is needed in the typical, "non-intensely human-interest" research setting, in which no one asks for information. But imagine if someone did. What should be the response of an investigator of, say, a Phase 3 chemotherapeutic agent, to a reporter who asserts, "Tell me how your patients are doing today ... Of course I won't run their names, but I'd like to know their creatinine and albumin levels. I'll be checking in daily. …

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