A Consumer Representative to the FDA on Advocacy

Diane Aronson is a Special Government Employee, serving as Consumer and Patient Representatives for the Food and Drug Administration (FDA). Working through its Center for Drug Evaluation and Research (CDER), Diane has served on many of its Advisory Committees and has been a standing member of the Arthritis Advisory Committee. She is Past Executive Director of RESOLVE, the National Infertility Association, Past-President of the International Federation of Infertility Patient Associations and the Road Back Foundation, an on-line service that provides education, medical articles and peer-support about the use of antibiotics for the treatment of rheumatic diseases.  Diane has also served as a Consumer Representative for the Centers for Disease Control and Information (CDC) and the National Institutes of Health (NIH).

LG: How did you become a health consumer advocate?

DA: I noticed at a young age that I can be compelled to speak up for others when needed and that this ability can lead to making a difference.  My style is to listen carefully and provide support and information, especially where issues of safety or risk are concerned.  The path to my health consumer advocacy work started as a result of my own medical issues with arthritis, cancer, and infertility. My rheumatoid arthritis wasn’t diagnosed for years after symptoms started in my late teens.  The pain and fatigue were discounted by my physician who told me that I looked fine despite some irregular lab results and took no further action to explore what caused the symptoms.  What activated me included the consequences of this approach and a desire to help others who struggle to find successful medical treatment. This perspective encouraged me to volunteer to share my experiences and later, led to paid consumer advocacy work and to my current position with the FDA.  Despite past complex and challenging health issues, I am grateful to be healthy and very active.

LG: How did you start working at the FDA?

DA: I learned that the FDA was seeking a Consumer Representative for their Arthritis Advisory Committee and so I applied.  They are often looking for individuals who can provide a consumer perspective to their advisory deliberations as well as an interest in and ability to assess medical data. The application process is about six months long as it includes a review for any potential conflicts of interest.

LG: Tell me about what you do at the FDA.

DA: I am asked to serve on Advisory Committees to review drugs that may need an additional review of outside experts.  Committee Panels most often include physicians, researchers, statisticians, patients, consumers and non-voting industry representatives.  For each meeting, panel members are sent information from the company-sponsor as well as the FDA about the drug to be reviewed.  A list of questions is also sent to panel members who are encouraged at the meetings to ask questions and, at the end, to vote on and provide opinion about the drug under review.  For me, the position requires the combination of the advocate in me, an interest in science and biology, my past medical experiences, the desire to represent a broad constituency of health care consumers and a general interest to review details and solve problems. It is very gratifying through my research and study before meetings, and especially as a layperson, to be able to contribute a perspective that may not be considered but may be helpful to the discussion. At one panel meeting and due to my research preparation, I found myself advocating for members of the military who might be prescribed a potent drug that was being reviewed.  I found that one of the active ingredients was counter indicated with SSIs. Since many in the military are reported to be treated for depression with SSIs, I advocated for a consideration of this interaction on the label should the drug be approved by the FDA.  I am hopeful that this kind of a consumer perspective can make a contribution to the deliberations when I raise concerns such as this.

LG: Can you tell me another instance?

DA: I served on committee for a cancer drug which had a regimen of 3 years and included some serious side effects.  There was an alternative existing drug with similar side effects, effectiveness and result but with a short-term treatment.  I raised a concern that the long-term treatment would be arduous on patients with only a very slight percentage of improvement in the death rate.  Although we are asked at panel meetings to review safety and efficacy, I believe that quality of life issues are also an important perspective.

LG: What role does empathy play in your advocacy work?

DA: I leverage my own experiences and understanding of being challenged by a health concern, my broader experience in representing consumers and my desire to improve the quality of people’s lives when they are suffering physically and emotionally from health concerns. In the case of the cancer drug, it was clear to me that no one should suffer longer than necessary from side effects and with little improvement in the primary outcome of death survival.

LG: What achievements are you proudest of?

DA: I have served as a mentor for new Consumer and Patient Representatives and enjoy passing on tips to help with the initial orientation process.   I am extremely grateful to have had the past work advocacy opportunities to author countless editorials, articles, book chapters, etc. and to give many speeches nationally and internationally at consumer and medical associations, run conferences and workshops and work on legislation about consumer health care issues.

LG: What direction do you see the FDA moving in?

DA: I am truly in awe at the number of issues that the FDA considers regarding drugs that have already been approved and by ones that are in the pipeline as well as the huge number of medical devices for which they have oversight.  Since the passage of legislation (FDAAA), the FDA has been working on enhancing transparency and involving more consumers and patients in their various activities. The social media is now very important as an educational resource.  Recently, it has reported on a number of drugs that had been approved by the FDA but now have serious side effects reported which weren’t able to be considered at the time of approval.  Examples are a recent one for diabetes and drugs used for osteoporosis.  FDA leaders want consumers to more readily report side effects to them via the MedWatch area of its Web site set up for safety information and adverse event reporting.   In addition, they hold frequent meetings and Webinars on a variety of topics for patients and consumers and a number of these presentations are available through http://www.fda.gov.

LG: How do your advocacy skills work with family and friends?

DA: Most of my family and friends probably don’t realize the level of involvement I have had as a lay health consumer advocate but some do turn to me and ask for a perspective that they can add to their research and deliberations with their physician.  I might suggest resources and strategies but above all provide a listening ear to their concerns and overall experience. I speak up about health care perspectives but realize that in the end everyone has to make their own choice about their personal health care decisions.

LG: What are your recommendations to people who have health conditions?

DA: Read everything; talk to others.  Do the research.  Seek out credible internet Websites and verify information with published medical articles. Consider joining a support group.  Make informed decisions using evidence-based information not just an anecdotal experience about which you have heard.  Seek medical professionals who will work in partnership with you and respect your decisions about treatment.

LG: Should everyone who experiences health problems become “activated” and help others in some way?

DA: Advocacy is a passion.  You have to have a strong desire to take the time required to make someone’s experience easier and more hopeful.  And, you need to come from a position of knowledge so your research and perspective are critical.  In addition, you might feel activated towards advocacy at various points in your life and not at others, depending on your current experience.  The hope is that education, peer-support and advocacy on behalf of others can contribute to enhancing the health care system to benefit a broad group of individuals impacted by debilitating diseases.