Last month, Jim, a member of the PatientsLikeMe Team of Advisors, was invited by Sally Okun, PatientsLikeMe’s VP Advocacy, Policy & Patient Safety, to present at the Drug Information Association (DIA) Pharmacovigilance Conference. He also led a lunch roundtable for drug risk/benefit communications experts.
Sally, who also participated on the roundtable panel, says requests for patients to participate in events and meetings such as this are increasing: “There’s a lot of interest from the pharmaceutical industry and regulators to hear directly from patients about their experiences. Jim’s presentation was quite powerful and provided a perspective that most in the room had not heard before. The positive response from the audience reaffirmed the value of bringing the patient voice into the full lifecycle of drug development.”
We asked Jim to share his experience (from the patient perspective) attending and presenting at the conference. In his own words:
When it comes to treatment options, patients like us routinely face difficult treatment decisions such as: “Drug X can treat symptoms of your chronic condition and might improve your long-term prognosis. But, 5% of patients on Drug X experience serious side effects, and in rare cases, complications can be fatal. So: is this a risk you’re prepared to take?”
Question: Now, suppose you worked for a pharmaceutical company or the FDA and were assigned to inform patients like us about Drug X’s drug safety and risks/benefits: what should your primary goal be… provide clear, comprehensive and scientifically accurate advice about all of Drug X’s pros and cons?…OR… help patients review and evaluate information from any source — not just your communication, but also sources like WebMD, PatientsLikeMe, friends and family, and social media — in order to make more effective treatment decisions for themselves?
For participants attending the Drug Information Association (DIA)’s Pharmacovigilance Conference January 17‑18, 2017, this wasn’t a hypothetical question, because their job is to design and develop drug advisory communications for patients and providers.
I recently joined PatientsLikeMe’s Team of Advisors for 2017 and belong to three PatientsLikeMe patient communities (MS, chronic lymphocytic leukemia, and aortic valve insufficiency). My plenary presentation focused on how patients would answer the question above — or, more accurately, how I would answer it.
I began by asking conference participants to raise their hands if they’d ever taken a medication (100%); how many had ever read an entire drug insert from start to finish (≈ 2%); and finally, how many had read a few targeted sections of a drug insert (≈ 50%). The key points here were that (1) regardless of what information they should seek in an ideal world, practically all patients, even if it’s only for a headache or a chest infection, tend to “zero in” on just the information that seems most vital to them for making a treatment decision. And, (2) in the case of serious chronic conditions, the way newly-diagnosed patients “zero in” is dramatically reduced; so, (3) safety communicators should focus more on helping patients recognize the value of considering more useful information rather than less when reaching a genuinely effective treatment decision, and feel confident in their ability to evaluate any source of information available to them.
To illustrate, I walked conference participants through four treatment decisions I’ve personally had to make to show in each case: (a) what objective information — a tiny fraction of everything available — I actually considered, (b) how my emotions (shock, fear, anger, confusion, etc.) had influenced the way I weighed that information, and (c) the one or two factors that turned out to be key to reaching a decision that was both effective and emotionally sustainable for me.
For instance, when diagnosed with chronic leukemia, I was invited to join a clinical trial. The key objective information I considered included:
- Risks of the trial (identified and unknown)
- the +’s and –‘s of standard 1st-line treatment
- Requirements for participation
- Costs of participation.
Emotional factors which dominated my thinking at the time included:
- Desire for the longest possible remission
- Logistical complexity of participation
- Perception of this doctor’s stake in having me join the trial
- My desire to be a good citizen-hero
And, in the end, the driving factor which influenced my decision not to participate in the trial was the fact that the trial’s logistics would have been incompatible with my work life.
After reviewing three other key treatment decisions in the same manner, I summed up three key observations from the patient’s point of view that drug safety communicators should keep in mind when designing their communications:
- Personal, emotional and family factors dominate most patients’ perceptions of the objective information they look at
- Since major health care decisions are made under the press of time and powerful emotions, they generally have less to do with objective facts about a medication than the patient’s feeling about what’s best
- Objective information about a treatment’s +’s and –‘s counts, but only at certain points in the patient’s decision-making process if/when s/he feels calm and self-confident enough to do so
With these in mind, my key takeaway for conference participants was that they should design their drug safety communications first to help patients find a calm, centered place from which to consider and weigh drug information from any source, and only second to focus on the most important, scientifically accurate information about a drug’s risks-benefits. Those would be my priorities for drug communicators…. but would you agree?
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