Patients and Advocates Get Involved

According to Duane Roth, author of “A Third Seat at the Table: An Insider’s Perspective on Patient Representatives”, our nation is taking a fresh look at “medical care, advances in the health sciences—from genetic sequencing to stem cell technology—“ and taking new opportunities “to make health care better, faster, and more cost-effective.” However before this can occur, we must reconsider our current strategies on health care innovation; specifically the area of regulating new products. At this point federal agencies, like the Food and Drug Administration, together with product development companies discuss and negotiate the regulatory approval process of new products.

Patients, as well as their families, are immensely affected by these approval processes. Roth states that “their [patients] lives and their quality of life hang in the balance.” Thus patients stand in a unique position because they are able to evaluate both the risks and benefits of existing and upcoming medical products. And so, Roth believes that the time has come to involve patients in the regulatory approval processes. Patients will serve as “mediators” and assist regulators and companies discover new ways for “fostering innovation, building public trust, cutting costs, and addressing quality-of-life issues.”

Patient representatives became prominent in the late 90’s as the AIDS epidemic surfaced. In the 1990’s the FDA summoned patient representatives to serve on advisory committees that assessed products made for life-threatening illnesses. Although patient representatives were consulted to partake in committees, Roth writes that they made up less than 10 percent of the committee. Even today they face struggles as they attempt to influence “product decisions.”

Roth predicts that if patient representatives actively participate in the discussions and negotiations for the regulatory approval processes as mediators, they will serve as catalysts “for making real progress on urgently needed products.” This is the right time to include patient representatives/mediators into the approval processes. This is the right time to improve “costs, payoffs in the therapeutic efficacy, procedural efficiency, and public confidence.” This is the right time to add a third seat to the table.