Respecting privacy matters

By Kathleen Hoffman, PhD, MSPH

In May, the HealthcareNOW radio program “Harlow on Healthcare” featured Inspire’s founder and CEO, Brian Loew speaking with David Harlow, host and health care law consultant.

In the interview, Loew describes Inspire’s patient and caregiver members as a “rich and largely underutilized sources of expertise” about disease conditions and treatments, including medications. Access to this wealth of information requires profound respect for those owning it.

“The Inspire community was created to meet the need people have to find information about their conditions from other people living with the same diagnosis,” he said. He pointed out that the key component of joining patients together is respect — for the patients, their caregivers, and their privacy. Whatever medium is used to interconnect the participants must be “in a space that is safe and protected in which they are in control along with others who share the same or similar medical conditions.” Patients can only be open in an environment where the participants share similar health challenges and where they control what, how much, and with whom their stories are shared.

Having patient advocacy organizations partner with Inspire also fosters “extraordinary credibility, authority, and trust” among the participants.
The patient advocacy organizations curate the discussion forums; Inspire is the host. Inspire currently partners with 110 different patient advocacy organizations across the spectrum of diseases, from rare diseases like Wilson’s disease, to more chronic and widespread conditions, like psoriasis.

Loew said, “Many members have multiple medical issues for themselves and also, potentially, as caregivers. [The Inspire community] is a safe space to get involved in everything about health in their life.” Members always have the option to control who gets to see their posts and to change that access any time – if they choose to post at all.

One of the important discoveries from the community is the level of caregiver involvement in patient care. For example, the Inspire prostate cancer community is 50% female. “Those women are typically either spouses, or daughters, or daughters-in-law of men with prostate cancer. We see this caregiver presence across all medical conditions.”

Loew continued, “One of the things that I’ve come to realize over the life of Inspire is that there are such enormous needs that caregivers have, and oftentimes caregivers are underappreciated and under supported. We could do a lot to support caregivers more as a society.”

Inspire is more than a safe space to express health concerns, though. “Our goal ultimately is to facilitate medical progress by enabling researchers around the world. While we do some research ourselves, our real goal is to make it possible for thousands of researchers outside of Inspire to do great work more quickly.”

Loew sees the benefit of bringing patients together in a trusted environment as creating the opportunity to gather scientific information that was just not available in classically designed clinical trials. But it only works if patients own their level of participation. “The position we have now is based on lots of feedback from members over 14 years; trust is everything. “

“This is the most important ethical issue for Inspire and perhaps for health care at least in America today. What we have found is that what all of us really want is not to lock up our information forever but rather to be in control of it. You and I as patients, and as people with health information, need to be in control of who has access to our information and we need to be the one to grant that access and to decide when…it is especially important that we treat [Inspire members] with profound respect.” Loew said. Regarding any decision affecting members, “Our gut check is to ask ourselves, would I be happy if someone close to me, such as a family member, were treated in this way.”

Loew explained that patient participation and input is not a substitute for classically designed double-blind clinical studies – it’s another resource. “When we invite patients to participate [in a research study] the reaction is typically one of delight to be able to advance the research. There are not winners and losers. Everyone can benefit.”

“The key point around this privacy and control when we engage with researchers is that everything we do is permission-based,” Loew continued. “There are a number of things we never do, like sell lists of names. What we instead do is send an invitation to a member asking that member if they would like to participate in research. If the answer is no, or if the invitation is ignored, then no means no. If the member actively wants to participate in the research, we make the connection and step away.”

When asked for examples of how patient perspective is being used as a resource, Loew cited recent work Inspire has done with the NIH and FDA. “We worked to better understand the life experiences of patients with pulmonary artery hypertension. It was good for us to see that what the FDA was interested in was the lived experiences of patients and caregivers around this condition and to treat that as a source as valid as scientific, or medical, or physician information.”

In another case, by analyzing a billion and a half words across 8 million discussions in three separate forums about cancer, during a study in collaboration with Stanford Biometrics, “we found a previously unreported adverse event for one immuno-oncology drug and we also found adverse drug reactions for 2 other drugs an average of 7 months ahead of when these side effects were ultimately reported through AERS (the FDA Adverse Event Reporting System).”

“One of the conclusions that was evident was that… we should not ignore these kinds of data because they can be profoundly useful in being early warnings about things which can then be scientifically validated later on.”

“I’ve come to believe that patient perspectives, including patient-reported outcome measures, are as important as clinical data. By that I don’t mean to suggest that these patient perspectives should replace randomized clinical trials – instead that they should point us in directions for research.”

Has the research community as a whole changed in respect to its approach to patient input? Loew said, “I’m heartened a little bit by what I’ve seen as a change in attitude over the short life of our company, over the past dozen years or so, the fraction of researchers who take the attitude of ‘don’t worry your pretty little head’ attitude … seems to be decreasing. There are many more researchers and doctors now who understand that [the information] is the property of the patient and it needs to be controlled and determined by the patient. Thank goodness that’s improving.”

Having a database encompassing patients with both rare and more common conditions enables data searches that were just not possible even a few years ago. Valuable signals were found after scouring hundreds of thousands of records to find a few dozen cases meeting the criteria in the study discovering the adverse effects of the immuno-oncology study. But a study of only 70 members regarding spontaneous coronary artery dissection (SCAD) also yielded profound results. “More is always better, but sometimes you can find meaningful signals with very small numbers of people.”

Loew pointed out that the Inspire platform is allowing researchers “to focus their efforts on genomic research or other research in a way that would be impossible without the support group content and the connections among patients across geographies.”

When asked for his vision of health care research in five years, Loew said, “I would hope that all of us – as patients and caregivers – are treated with respect and our data are available to us without restriction and we are fully recognized as valuable contributors to medical progress. That is a positive vision of the future and I hope we get there sooner rather than later.” 1

(The recording of the interview is available via SoundCloud or on popular podcast apps [iTunes, Stitcher, iHeartRadio]. )

Download the case study, “What Sponsors Need to Know: Patient Insights on Protocol Design.”

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