Physician Disclosure – Device CEO’s Should Take Action

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In case you missed it, on Monday 13 September 2010, the Archives of Internal Medicine reported that highly-paid physician-consultants to medical device companies did not disclose device company relationships in peer-reviewed journal articles.  In New York Times coverage,”Representatives from Stryker, Zimmer and DePuy had no immediate comment on Monday.”

That’s the wrong answer.  Here’s what medical device companies should do instead.

First, a little background.  Undisclosed consulting relationships between physicians and the pharmaceutical industry have been in the news for a while, leading to the passage of the “Physician Payment Sunshine Act” in March of 2010.  This Act requires every pharmaceutical and medical device company to publish lists of physicians who receive compensation from the company.  While the Act does not become legally effective until 2013, many companies have voluntarily begun to publish these lists, and a web-based start-up (PharmaShine) has emerged to collect all the data in one place.

Device company publication of physician payments is a step in the right direction towards re-establishing trust with the health care consumer.  But it is not enough.

Public trust has been shaken recently by the Boston Scientific / Guidant  recalls, the Medtronic ICD lead failures, Allergan‘s Botox off-label promotion and J&J’s poor handling of its Motrin recalls.  The public sees medical device makers and pharmaceutical companies as members of a single, greedy, health products industry that aims to profit from ill health.

Like most people in the industry, I have spent my career in medical devices with the aim of helping people live healthier, higher quality and happier lives.  The public erosion of trust is both personally distressing and bad for business.  We can hardly expect distrustful consumers to rapidly adopt new medical device innovations.

So, how should device companies respond to the Archives article?  Despite the fact that disclosure is made by the physician directly to the publishing journal, medical device companies should take responsibility for fixing the disclosure gap.

  1. If they don’t have them already, medical device companies should create corporate policies requiring education of physician-consultants regarding disclosure responsibilities.  This education should occur at the beginning of any relationship and should be refreshed at least annually.
  2. Every consulting contract should require appropriate physician compliance to disclosure rules.  Failure to appropriately disclose could be grounds for termination.
  3. All device company employees should be trained in the consultant disclosure policies.  Those employees in marketing or clinical affairs should be given special training, as they are often involved with (or aware of) pending publications.
  4. Medical device companies should make a public statement describing their actions to improve disclosure compliance.  The statement should be personally delivered by the CEO.  It’s that important.

It’s time for medical device companies to step up and proactively address behaviors that the public rightly sees as just plain wrong.  If we don’t do this ourselves, it will be no surprise to see continued public distrust, and a government that is obligated to fix our problems via new regulations.

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