The U.S. Food and Drug Administration is turning to patients to enhance the processes of monitoring the side effects, risks and adverse effects of drugs. The agency announced on June 15 it will collaborate with a social media website to determine drug safety data from patients themselves.
PatientsLikeMe, which is a networking forum that enables patients to find fellow disease sufferers and share experiences with them, is the social media company that FDA is partnering with. The website has more than 350,000 members and approximately 2,500 medical conditions being discussed in their threads.
The data being exchanged in the forums is quite extensive and could be sold to drug companies, health care agencies and medicine regulators. Instead, the company plans to partner with the FDA to revolutionize the methods of detecting and monitoring adverse effects of drugs.
"There's no one perfect bullet for surveillance," said Ben Heywood, co-founder and president of PatientsLikeMe. "We know it's just another way for patients to have a voice in the market."
Although the project has just started, it shows promising influence on the way drugs are labelled and the speed at which the FDA can take action on drug safety issues. The company has collaborated with the FDA in the past as well, helping patients with multiple sclerosis report adverse events directly to the FDA, then launching the first drug safety platform on social media and working with industry partners so they could use the information to meet their regulatory obligations.
The FDA aims to find out about the side effects of drugs in the eyes of actual patients, because what might seem noninjurious to drug reviewers may pose an utmost discomfort to patients.
"We're hoping we can find information on the impact of adverse events on patients' day-to-day lives," said Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA. "We don't know if it will give us the kind of information that will be sufficient to make label changes. That's what we're trying to find out."
Pharmaceutical companies report adverse effects of their drugs to the FDA only when a bad reaction was reported to them. Doctors and patients may also submit reports pertaining to unusual effects and bad reactions. The FDA is said to have received about 1 million adverse effects reports in 2013. With the agency's partnership with PatientsLikeMe, it is hoping to use the information contained in the website as an additional monitoring tool after the drug has been approved and dispensed in the market, and a way to get real-time information. This is also a way for them to ensure that the drug manufacturers carry on their quality control measures for optimal patient safety.
Photo: Taki Steeve | Flickr
