Sometimes Keeping Patients in the Dark Makes Sense

Originally Published MDDI September 2001

EDITOR'S PAGE

Patients in clinical trials should always be fully informed—but the media don't need to be fully informed about the patients.

The medical device industry has bemoaned for years that it gets far too little publicity—except perhaps for the bad kind (breast implants, anyone?). Despite well-planned campaigns by organizations like Advamed and MDMA, efforts to make the general media more aware of this industry's achievements have mostly fizzled. So the positive, even thunderous, buzz generated by Abiomed's artificial heart should be played to the hilt, right?

Curiously, however, Abiomed's publicity campaign has been restrained. This phenomenon was called to the public's attention by an August 23, 2001, editorial contribution in The New York Times. The author, George Annas, a Boston University professor, in essence criticized Abiomed for going too far in resisting a media circus. While acknowledging the legitimacy of the company's concern over patient privacy, Annas suggested that Abiomed might be using this issue as a shield. The "motives for secrecy can be mixed," he argued; "researchers are also conscious, inevitably, that publicity can destroy a research project."

However well intended it may be, we believe this criticism is grossly unfair. We remember all too clearly the whirlwind of publicity in 1982 surrounding Barney Clark, the first recipient of a permanent artificial heart. Both Clark's humanity and scientific progress suffered at the hands of the publicity machine. Wisely, Abiomed has chosen to avoid this situation.

Indeed, Abiomed has recognized something that more and more device companies will be facing in coming years. As devices increasingly stretch the limits of existing medical technology, and as more desperately ill patients become candidates for clinical trials, the rights of those patients become paramount. In such extreme circumstances, it is all too easy to take advantage, even inadvertently, of these patients.

Recognizing this situation, Abiomed funded and established an Independent Patient Advocacy Council. This group, wholly independent of the company thanks to an irrevocable trust fund, provides patient advocates to help counsel and speak for potential recipients of the AbioCor heart. They help these extremely vulnerable patients make rational decisions about their medical treatment and whether or not they should participate in a trial.

It is perhaps not surprising that a company on the leading edge of medical technology should be finely attuned to patients rights. But we fear that some medical device companies are not aware of these issues as they should be. Last May, after the FDA announced the formation of the Office for Human Research Trials (OHRT), we were surprised to find that few in industry were aware of this new office or its duties. Responsible for FDA's human subject protection policies, the office also serves as the main organizing body for all agencies that regulate human subject protection. (FDA itself seems uncertain about how to publicize OHRT, and is even considering changing the name.)

This lack of awareness perhaps reflects on the general public as well. A Harris Interactive/BBK Healthcare poll announced last June found that "the public would be more apt to participate in clinical research studies if they knew about patient protection measures." According to the survey, 81% of respondents were not aware of safeguards like the Declaration of Helsinki, the Belmont report, institutional review boards, and the informed consent process. After these protections were described, nearly 40% of the respondents said they would be more likely to take part in a clinical trial.

In light of these facts, we believe that Abiomed's insistence on protecting the rights of research subjects, even at the cost of immediate publicity, is ultimately the best possible long-term PR for clinical trials and investigative medical devices. While others may criticize the company's "secrecy," we applaud their effort to put patients first.

The Editors

Copyright ©2001 Medical Device & Diagnostic Industry