Author: Elsa Abruzzo
Drs. Greene and Kesselheim outline three key issues covering the intersection of social media, medicine and industry in a “Perspective” article “Pharmaceutical Marketing and the New Social Media” in the New England Journal of Medicine (NEJM). While they direct their comments to drugs, this is equally applicable to devices and biologics:
- “First, there is a dearth of research on the clinical and public health impact of communication about drugs. Such work should NOT be led solely by entities with financial interests in its outcome.”
To give you an example, I have recently been researching Lasik surgery—yes, my eyes are old and withered from all the small screen computer use over the years. Most of the searches of course landed me on physician or treatment center sites, or nebulous third party sites. It was hard to tell, aside from the FDA webpage on Lasik:
- Were all the risks being clearly presented to me?
- How much of the webpage was in any way financed or sponsored by an interested industry entity?
- What would these parties gain by my procedure?
As with clinical data to support submissions, physician presentations, conferences, and peer review journal articles; it is equally important to disclose financial interests in social media promotions. Greene and Kesselheim go on to say:
- “Although most Internet users can often (but not always) find data on drugs’ risks and benefits within a few keystrokes, it is hard to determine whether the source is credible and disinterested. It is now recognized that the ghostwriting of medical research articles can have important public health implications; financial disclosures should be just as explicit for leading providers of social media content as for authors of articles in .”
As for my Lasik search, there certainly was a “dearth” (or how about “paucity”, I like that word too) of disclosure information — well as far as I could see (all puns intended). For my presbyopia, I’ve decided that for now I will stick with my readers (I have one stashed in every room of my home). However, I can foresee countless others being lured by some of the great promises of improved vision without fully appreciating the risks.
The third point made by Green and Kesselheim is:
- “…physicians and consumers should hold the FDA and pharmaceutical manufacturers responsible for maintaining credible information in social media regarding the benefits and risks of therapeutic products.”
One on hand, they suggest that, based on comments made at an FDA hearing, FDA could provide a “digital ‘seal of approval’ that would identify FDA-reviewed content in posts and discussion threads and provide a hyperlink to pages with FDA-approved content.” Then, they retract this idea because,/ “…this approach would address only a fraction of potential therapy-related claims, and the FDA lacks the resources to police all health-related marketing in social media. Manufacturers are in a better position to monitor online discussions about their products: most U.S. companies that depend on copyright and trademark recognition currently engage in brand-protection activities through aggressive surveillance and litigation.”
Although I make my living from regulatory consulting and sincerely appreciate FDA’s role (shameless plug), I also believe in smaller government and having more liberties to do the right thing. Before we are castigated with overly stringent regulations which we may not be able to live with, I strongly believe that we should start doing the right thing and self-policing ourselves as individual companies and as industry. As always, I am interested in your thoughts.