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A Little Disclosure Might Go a Long Way

  Originally Published MDDI March 2006 From the Editors   Erik Swain  

From the Editors

Ethics issues concerning the medical device industry have made the news again. While the ethical practices of most device companies are beyond reproach and industry has established strict guidelines, the public perception may, in fact, be the opposite. Does the device industry need to do anything to change this?

On January 25, the Journal of the American Medical Association (JAMA) published an article written by a group of doctors calling for an outright ban on gifts to physicians. It argued that when device and drug companies offer gifts, and free products and classes to caregivers, patients are harmed and good medical care is undermined.

The day before, ethics accusations in a whistleblower lawsuit against Medtronic Inc. (Minneapolis) were publicized. The accuser claimed that Medtronic gave spine surgeons “excessive remuneration, unlawful perquisites, and bribes in other forms for purchasing goods and medical devices.” Among the allegations was that one surgeon received $400,000 per year in consulting fees but was only required to work eight days. Medtronic has responded that it takes the complaint seriously and does not condone illegal or unethical conduct.

All of this publicity and outcry comes despite sweeping industry reforms in recent years and the widespread adoption of AdvaMed's Code of Ethics. This code outlines appropriate consulting arrangements and puts restrictions on compensation for training and education.

Where the JAMA article errs is in its lumping together of drug- and device-industry practices. The relationship between device manufacturers and physicians is necessarily symbiotic. Physicians have to be trained on how to use a new device, but the same is not true for administering most new drugs. And many ideas for new devices or for improving on existing designs come from physicians who know from experience that there needs to be a better way.

While the JAMA article makes some good points, banning reimbursement of training expenses, especially for travel, could be extremely problematic, says Mark Brager, AdvaMed's director of communications. “The nature of the device industry is that physicians need to know how to use new technology,” he says.

“Without [reimbursement for travel], physicians might be likely to not make the effort to learn how to use something new.”

The issue doesn't necessarily add up economically, either. “The physician is in the business of making people better,” says Mark Leahey, executive director of the Medical Device Manufacturers Association. “The liability he can incur from using the wrong treatment is phenomenal. It's far greater than what he could obtain in even the most excessive agreement.”

The public perception of ethical lapses appears greater than the reality. That being said, instead of making unnecessary reforms, why not do what can be done to change the perception? Doctors already disclose any development and consulting arrangements they have when making presentations to professional societies.

Why not disclose them to patients, too? Industry is in favor of patient disclosure in other cases, such as when a reprocessed single-use device (SUD) is going to be used.

Brager argues that the two issues have nothing to do with each other, because the SUD situation is a patient-safety issue and the ethics situation isn't. And he's right, to some degree. Still, what's the harm in disclosure to patients? It could be a powerful tool to change public perception. The public reads about allegations of impropriety, such as in the Medtronic case, but never about the overwhelming majority of physicians and companies that practice the proper ethics. Regular disclosure could counteract that. And it's unlikely most patients would refuse a treatment or demand a different one because of it. In many cases, in fact, it could reassure them to know that their doctor had a hand in developing the procedure to be used on them.

It's not a good idea to adopt the ban that JAMA calls for or to make more vast reforms. But it may not be the best idea to maintain the status quo, either.

Copyright ©2006 Medical Device & Diagnostic Industry
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