Patients Informing Practice: Post-Marketing Drug Data in PatientsLikeMe, an Patient-Centered Online Community (closing keynote - winner of the JMIR Medicine 2.0 Award 2009)

Jeana H Frost*, PatientsLikeMe, Cambridge, United States
Sally Okun, PatientsLikeMe, Cambridge, United States
Paul Wicks, PatientsLikeMe, Cambridge, United States
James Heywood, PatientsLikeMe, Cambridge, United States

Track: Research
Presentation Topic: Web 2.0 approaches for behaviour change, public health and biosurveillance
Presentation Type: Oral presentation
Submission Type: Single Presentation

Building: MaRS Centre, 101 College Street, Toronto, Canada
Room: Auditorium
Date: 2009-09-18 03:00 PM – 03:30 PM
Last modified: 2009-08-25

If you are the presenter of this abstract (or if you cite this abstract in a talk or on a poster), please show the QR code in your slide or poster (QR code contains this URL).


Background: Typically, evaluating a new use of an existing drug is either expensive and time consuming or anecdotal and unstructured. In some cases, researchers conduct clinical trials to test off-label uses. Yet in many situations where drugs are off-patent, or are only used by a small population, providers and patients must rely upon their own individual-level experience to inform clinical practice. In this work, we explore how a patient-centered online platform could supplement trials to create a richer understanding of medical products by efficiently aggregating structured post-marketing data.
PatientsLikeMe is a tool for patients, researchers, and caregivers (currently 40,000 members) across 9 condition-based communities to help members make treatment decisions, manage symptoms, and reason about outcomes. Members enter demographic information, longitudinal treatment, symptom, and outcome data, and drug evaluations. These are reflected back as longitudinal health profiles and aggregated reports. Over the last three years, patients have entered treatment histories and drug evaluations on thousands of medical products. These data may suggest the efficacy and safety of some drugs more efficiently and for longer duration than is feasible through formal clinical trials.
Objective: We present the illustrative case of Amitriptyline - a drug with a single FDA approved purpose (depression) which is commonly used to manage other symptoms. There are currently 14 Amitriptyline clinical trials recruiting subjects ( reflecting an ongoing interest in its use.
Method: We conducted an analysis of treatment histories and drug evaluations across usage scenarios for Amitriptyline, examining prevalence, treatment purpose, and evaluations of efficacy, side-effects, and burden.
Results: There are 602 treatment histories and 220 evaluations of Amitriptyline across 5 PatientsLikeMe communities (In MS, Parkinson’s, Mood Conditions, Fibromyalgia, and ALS). Depression is the fourth most commonly reported purpose after pain, insomnia, and excess saliva. In Mood Conditions, the top purposes reported were headaches, pain, insomnia and then depression. Prevalence is highest in the ALS community, where 166 people (8%) report taking the drug with the most common purpose being to control excess saliva (39%). In the treatment evaluations, reported efficacy varies across purposes. More people reported a moderate or major effect of the treatment who were taking it for insomnia (67%, N=42), general pain (63%, N=51), or neuropathic pain (78%, N=18) versus those taking it as an anti-depressant (36%, N=25) or to control excessive saliva (37.5%). The burden and side-effects reported also differ by purpose. The small sample of patients taking Amitriptyline for excess saliva who evaluated the drug report nothing beyond mild side-effects (N=10) and no burden (N=10). Some patients taking Amitriptyline for the other common purposes (Insomnia, Depression, Pain and, Neuropathic Pain) do report moderate and severe side-effects (28%, N=136) as well as burden (23%, N=136). Dry mouth and daytime sleepiness are the most commonly cited side-effects.
Conclusions: PatientsLikeMe offers a unique real-time approach to understand both utilization and performance of drugs across different populations. This patient-supplied data can provide evidence about secondary uses such as control of excess saliva, or about drugs that are off-patent and therefore unlikely to be studied systematically.

Medicine 2.0® is happy to support and promote other conferences and workshops in this area. Contact us to produce, disseminate and promote your conference or workshop under this label and in this event series. In addition, we are always looking for hosts of future World Congresses. Medicine 2.0® is a registered trademark of JMIR Publications Inc., the leading academic ehealth publisher.
Creative Commons License
This work is licensed under a Creative Commons Attribution 3.0 License.