Search all of the Society for Participatory Medicine website:Search


Keywords: Side effects, health information, online communities, patient engagement, participatory medicine.
Citation: Graedon J, Graedon, T. Harnessing the power of patient experience for understanding side effects. J Participat Med. 2013 Jan 24; 5:e3.
Published: January 24, 2013.
Competing Interests: The authors are the founders and owners of

A long time ago, but not so very far away, right here in this same galaxy, patients were almost totally isolated and on their own if they experienced problems with their medicine. Back before internet access became routine, they had no way to connect to others who might be having the same kind of trouble. They felt alone, and what’s worse, they had no access to the wisdom of the crowd. In case of a peculiar symptom, they mostly had to accept their doctors’ judgment as to whether or not it could be related to their drug. Often, this meant the doctor or pharmacist would look up the medication to see if the symptom was listed as a side effect. If it was not, it was not unusual for the patient to be told that it was unrelated to the medicine.

This explains why the PDR (Physicians’ Desk Reference — the doctor’s “drug bible”) was an underground legend in the 1960s and 70s, and why it then became one of the most popular reference books in public libraries. When it became available for consumers to purchase (instead of hoping that a doctor would give them a hand-me-down), it sold surprisingly well for such an expensive tome.

After a while, however, consumers began to realize that the PDR is far from perfect. The trouble is that the official prescribing information found in the PDR is often incomplete and sometimes inaccurate. The data are based on drug company studies that were designed to determine the efficacy of new agents and get them approved. Such studies are not well designed to discover side effects and usually don’t do a very good job of it. It frequently takes many years (or decades) for complications to surface so that the Food and Drug Administration can have the drug company add them in the official prescribing information.

One way the FDA learns about adverse reactions is through MedWatch. This program for reporting serious problems with medications has been running for 20 years, but at first only health care professionals were encouraged to submit reports. In the early 1990s, such reports were usually made on paper, and mailed or faxed to the agency. At that time, the FDA did not solicit patient reports for MedWatch, as these were considered unreliable anecdotes. This meant that the agency was overlooking an important source of information about drug side effects; but even today, submitting a report to MedWatch is a one-way communication. Patients or even physicians who notice untoward reactions to drugs cannot see what reports others may have submitted.

Once patients were able to connect with each other online, however, they realized that certain problems were more common than they had imagined. Now the FDA has also come to the realization that the patient experience matters.

Not long after the FDA approved the first generic formulation for the popular antidepressant Wellbutrin XL 300, people started writing to us about problems with a branded generic called Budeprion XL 300. Their complaints were surprisingly consistent: after years of success on the brand-name formulation, they began to experience a constellation of side effects: tremor, nausea, headache, insomnia, irritability, crying spells and anxiety. These were sometimes accompanied by a loss of antidepressant effectiveness. Some people even became suicidal.

After seeing the reports from patients, we began writing about the problem of generic Budeprion not behaving like brand-name Wellbutrin. We started receiving a flood of comments. When the experts at tested the dissolution rates of the two pills, they discovered a significant discrepancy in dissolution rate between the two. Eventually, because of the mounting concerns, FDA took the unusual step of releasing the bioequivalence data that had been submitted for approval. Here again, we noticed a significant discrepancy. We were also surprised to see that the product that was approved (Budeprion XL 300) had never actually been tested for bioequivalence. (Instead, the firm had submitted data for Budeprion 150 XL.) FDA broke with its precedent and asked the generic maker to conduct an additional bioequivalence study with particular attention to patients who had reported problems, but the company was unsuccessful in completing its planned research.

All this time, patients continued to report their difficulties and exchange information online. We were fascinated to see them using comments on our website,, almost as a bulletin board or forum for mutual support. We continued to pass those reports, informal as they were, along to the FDA. This helped galvanize the agency to investigate the bioequivalence of this formulation more closely. It commissioned its own study of Budeprion XL 300 in comparison to Wellbutrin XL 300 and found that the generic product did not meet its bioequivalence standards. On Oct 3, 2012, FDA withdrew approval for Budeprion XL 300 and the drug was taken off the market.

We count this a great success for patient power and believe it is a demonstration of how the internet and its crowdsourcing capabilities can begin to make medications safer for everyone.

This dynamic community is highlighting other possible drug complications, including the intense itching that often accompanies cetirizine withdrawal; a potential connection between statins and the development or acceleration of ALS (Lou Gehrig’s disease); and the devastating consequences of C. diff infections triggered by the antibiotic clindamycin.

Not all the reports are negative. On the plus side, people have shared their success with improbable home remedies such as turmeric for psoriasis or arthritis; dried coconut for diarrhea; or soy sauce for kitchen burns. Online communities are becoming a powerful way for people to share and compare information about their experiences. Patient power and participatory medicine go together like hand and glove.

Copyright: © 2013 Joe and Terry Graedon. Published here under license by The Journal of Participatory Medicine. Copyright for this article is retained by the author, with first publication rights granted to the Journal of Participatory Medicine. All journal content, except where otherwise noted, is licensed under a Creative Commons Attribution 3.0 License. By virtue of their appearance in this open-access journal, articles are free to use, with proper attribution, in educational and other non-commercial settings.