FDA learns about drug side effects from patient website data

The Food and Drug Administration announced that it has signed an agreement with PatientsLikeMe for access to data generated by the sites 350,000 members in order to help the FDA in post market surveillance of drugs on the market.The FDA needs the information because companies whose drugs are approved with minimal clinical trials do not provide much information on safety and effectiveness of a drug until after the public has tried it for a while. Companies often provide information and small populations, sometimes just a few hundred patients, from which the FDA is supposed to determine a drug’s risks.

“Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world. Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time,” PatientsLikeMe Co-Founder and President Ben Heywood said in the press release. “We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.”

PatientsLikeMe allows members to interact with others with similar conditions and diseases, share experiences with drugs and volunteer medical data which can be used by industry, researchers, non-profit groups and now the FDA to get a better picture of the drug’s safety profile and provide better services. Patients can also learn what to expect or how to cope or avoid certain adverse events linked to drugs and medical procedures from other patients’ experiences.

Serious side effects of prescription drugs are often not discovered until after the medication has been approved and is  on the market. Even worse, drug companies are seriously lax in completing post-marketing studies and indicated that the FDA lacked the authority to enforce completion. Congress passed the FDA Amendments Act (FDAAA) in 2007, which required post-marketing studies as part of the drug approval process, and offered the FDA more latitude in mandating compliance with completing the studies.