The Food and Drug Administration has announced the development of a Patient Engagement Advisory Committee.
Although the FDA still has the final say on regulation, this committee would be beneficial in these ways:
- to help identify the most important benefits and risks of a technology from a patient’s perspective;
- to assess the relative importance to patients of different attributes of benefit and risk, and clarify how patients think about the trade-offs of these benefits and risks for a given technology; and
- to help understand how patient preferences vary across a population.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The nine-member committee has not been established yet, but we thought we’d recommend our own nominees for promising contenders who have a sufficient background to represent patients.
A few of these people might be more obvious when it comes to patient input on healthcare, but that doesn’t diminish their voice on the matter of engagement. And some of the others could represent the voices that sometimes fall between the cracks.
1. Alicia Cole: As a voice for those who have suffered from hospital-acquired infections, Alicia represents patients in a very specific and important way. Dealing with a horrific ordeal herself following routine fibroid removal, which led to infections that almost led to the amputation of her leg, she vowed to speak out and has done so ever since.
2. Hugo Campos: As an “empowered patient” focused on access to data for patients, Campos worked hard to gain access to the potentially life-saving data generated from the implantable cardioverter-defibrillator in his chest. He fought to receive the XML files of reports from his defibrillator after device manufacturer Medtronic agreed to supply Campos’ doctors at Stanford Hospital & Clinics with a script to run in Medtronic’s Paceart cardiac device management software.
3. Kezia Fitzgerald: After being diagnosed with cancer herself, her young daughter was as well. During this time, Fitzgerald stood up to the daunting challenge and actually created CareAline Products, which includes a sleeve designed to prevent a young child from dislodging the central line, preventing infection. The company has been backed by Mark Cuban. She’s a prime example of how the patient experience can turn into innovation.
4. Tiffany Peterson: In 2010, Tiffany Peterson was diagnosed with SLE (systemic lupus erythematosus). Just two months later, she created Friends Against Lupus via Facebook and Twitter, which has evolved into an online support system uniting patients, caregivers, and families in the lupus community around the world. Today, there are more than 9,000 members.
5. Bruce Booth: As a venture capitalist with Atlas Ventures, Booth has been involved with many biotech companies and has a particular focus on drug research and development. His resume thus far is quite impressive, and it’s clear that his goal is to make a real difference for patients.
6. Laura Mercer: As a voice for how early-onset Alzheimer’s disease occurs and affects those around you, Mercer can speak from experience. Continuing to go through that process while still having a clear perspective could provide valuable input on what treatments or measures could be potentially effective.
7. Amy Tenderich: As a journalist, blogger and author, Tenderich has a clear voice and a big platform. She was diagnosed with type 1 diabetes in 2003, and soon after, started DiabetesMine, which has become one of the top health blogs around the world. In 2006, Tenderich won the LillyforLife Achievement Award for diabetes journalism from Eli Lilly & Co. A notable moment among her many achievements was when in 2007, she wrote a letter to Steve Jobs that went viral and developed into an international crowdsourcing competition called the DiabetesMine Design Challenge.
8. Carter Goodwin: After being challenged with the severely debilitating effects of bipolar disorder, including addiction, and later becoming sober for many years, Goodwin appears to understand his condition clearly. He can relate to those who suffer from bipolar disorder, or perhaps many psychological disorders, while still being cognizant about the fact that a disorder is not who you are. “It’s chemical,” he has said.
9. Jimmy Kimmel: Granted, his writers probably have an equal amount of input as he does for segments like this on his late-night show, perhaps it would be valuable to have someone on the committee (celebrity or not) who is willing to call it like it is, straight, fair — in this case, particularly with the issue of child vaccinations — and be willing to stand up for health concerns that some people seem to have earplugs in about.
[youtube http://www.youtube.com/watch?v=QgpfNScEd3M]
So we shall see who the FDA ends up going with for the committee, (probably won’t be Kimmel, unfortunately), but there are many patients and advocates out there who could contribute to making patient engagement a serious new consideration for regulation.
Photo: Flickr user Siebuhr
