NCHR Testimony to the FDA Patient Engagement Advisory Committee on Medical Devices

National Center for Health Research: November 15, 2018.

Good morning.  I’m Jack Mitchell, and while I’m with the National Center for Health Research, today I’m speaking on behalf of members of the Patient, Consumer and Public Health Coalition, an informal consortium of about two dozen public health and non-profit organizations which work together on policy and legislative issues.  I have no financial conflicts of interest.

We thank FDA for holding this meeting and for exploring these important patient-centric issues.  We appreciate Dr. Shuren and senior CDRH officials giving presentations on their latest efforts to enhance patient engagement and post-market surveillance and safety, which are primary areas of concern for our non-profit organizations.

As we’ve heard, social media, when utilized properly, can be a highly useful source of shared information for patients.  The independent USA Patient Network has reported to us that their members regularly use social media to communicate about drug and medical device safety and treatment issues; and to report device-related adverse events to FDA

However, concerns remain, especially when social media are used to collect data.  Patients have reported to us that industry-sponsored social media patient platforms can influence discussions in ways that are not always in patients’ interest.  For example, a recent news story in Stat News of the Boston Globe revealed how patients and non-patients alike can earn money as so-called “influencers”, to provide opinions or promotions on the Internet about medical devices and drugs.  In fact, there are a few companies which act as talent recruiters for such influencers, and facilitate their communications with device and drug companies.

These influencers can be paid for posting about a device or drug, or for bringing opinions of people like them to the companies which are developing these medical products.  Industry companies have paid fees and travel expenses for some of these influencers to sit in on sponsored patient engagement meetings. The companies also gain insights into the patients from these interactions.

Some regard this activity as a form of relatively inexpensive advertising for industry, and often there is not much, if any, transparency concerning exactly who the influencer might be representing or being paid by.  The Federal Trade Commission has cited influencers who fail to reveal that they are being paid for an endorsement of a device or drug. There are a lot of confusing ethical thickets to wade through with these kinds of social media influencing.

There’s certainly nothing wrong with the industry trying to gain insights into its potential patients and customers.  But members of our Coalition, and the USA Patient Network, represent independent, non-sponsored patient voices who wish to gain helpful information on their conditions from FDA and other legitimate medical sources, and that is why we are concerned about hidden commercial influences on social media.  The patient groups which we work with also would prefer a balanced approach to reporting: adverse events should be clearly reported in social media, not just positive experiences.

Along those lines, USA Patient Network members have told us that the very helpful MedWatcher app has recently not been functioning properly, a complaint you have also heard from another speaker today.  When the MedWatcher app was functioning properly, patients were able to report and edit their adverse events to FDA.

These same patients have used Facebook, Twitter, Instagram, and other social media to report problems with the birth control device Essure, vaginal mesh, hip implants, breast implants, and other medical device issues.  That type of interactive communication, which was not technologically possible a decade or so ago, is a critically important tool for patients who sometimes mistakenly feel they are the only person with their particular type of medical condition.  On social media they learn that there is a community of patients just like them who can share information, do research, and suggest qualified medical professionals to consult.

Social media can serve as an invaluable, interactive forum both for patients and the FDA, provided that some of the financial and ethical conflicts that can arise from their use does not interfere with patients’ ability to access accurate and unbiased medical information.

Thanks to the Committee for the opportunity to speak today.