PatientsLikeMe

Sally Okun explains the new research collaboration with the FDA

Yesterday, we announced a new research collaboration with the U.S. Food and Drug Administration (FDA) that will explore how patient-reported data can lead to new insights about drug safety. It’s the first time the FDA will analyze patient-generated data for pharmacovigilence (aka drug safety).

But we’re no strangers to drug safety. Check out some of the previous work the community has helped to drive:

To learn more about this new (and unprecedented) collaboration, we talked to our very own Sally Okun, Vice President of Advocacy, Policy and Patient Safety.

What will this collaboration do?
Patients’ lives and well-being often depend upon medical products approved and regulated by the FDA. But most of the information we see on safety labels comes from clinical trials, which aren’t typically representative of the actual populations of patients who will take the medication. Working with us, the FDA will be able to see the real-world impact of taking medications over time, which can help identify benefits and risks earlier. The FDA isn’t just talking about patient-centricity; they are partnering with us to work directly with patients, and give them a collective voice as part of the FDA’s surveillance system.

How does the FDA normally hear about side effects?
Right now the FDA uses a voluntary reporting system consisting of individual case safety reports, the majority of which are submitted by healthcare professionals and patients to drug product manufacturers, who then are required to report them to the FDA. Our data are different in that the information is generated by patients themselves, and provide real-time insights about what its like to use medical products over time, like tolerability of the drug and factors that may influence taking the drug as prescribed.

When did PatientsLikeMe’s start gathering information about side effects and adverse events?
We’ve actually been collecting information about patients’ experiences with treatments, including patient-attributed side effects, since we launched the website in 2006. In 2008 we took steps to formalize adverse event reporting by developing a customized version of the FDA’s MedWatch tool for use in a pilot project with our MS community. The pilot set us on a path to develop our future drug safety functionality. By 2009 we had created a fully integrated, standards-based drug safety platform, the first on social media. It enabled industry partners to meet their regulatory obligations.

What’s the future?
It’s pretty exciting! The patient experience can more deeply inform the way medications are regulated. And patient-reported data can ultimately have a greater impact on the way that drugs are developed. This collaboration can lead to all of that.

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1 comment

  • Exciting work! Is Patients Like Me interested in getting into the other side of the medical equation, medical devices? Unfortunately, some inflammatory autoimmune and neurological diseases are caused by immune responses to medical and dental devices in people with common genetic variations in methylation, who do not methylate or clear toxins well, with systemic inflammation as the result. I am working to spread science, patient experience, and clinical experience in this area. While drugs are highly regulated and go through extensive premarket testing, there are devices that were grandfathered that have been approved and given acceptable risk classifications over the objectives of the Scientific Expert Advisory Panels reviewing those devices, which is troubling, and quite damaging to many PLM members. I would love to explore PLM becoming proactive on the prevention and remediation side, as you are active in the testing, efficacy and management of Rx. Remediation may ultimately be more effective than Rx for many of these diseases when there is an inflammatory agent involved that can be removed.