Increasingly, the FDA seeks out corporate partners to provide data for use in its evaluations.
“A traditional case report is a snapshot in time of when an adverse event happens,” the president of PatientsLikeMe.com said recently in an interview with the Washington Post. The online forum details patients’ symptoms and medications before and after the event, he said, so that “the FDA could see additional signals or earlier detection of an event.” “There’s a lot of interesting app development for reporting adverse events,” added the FDA’s Gerald Dal Pan. “I think we’re going to have to explore the value of social media.”
Wonderful! Sounds like a happy partnership. However, health professionals and patients alike ought not to ignore the great difference in value between data analytics and unsponsored, randomized, controlled placebo trials. Interested parties are already attempting to blur the lines. “A study is a study,” they’d like you to think.
“With more patients using online forums to seek out fellow sufferers for support or discuss their medications, drug makers and even hedge funds are listening in, trying to tease out a signal among the reams of data,” the Post reported. Though the article did not specify the degree to which pharmaceutical companies and PatientsLikeMe.com are collaborating, it’s safe to say that no rules have been put in place to prevent Pharma from attempting to influence data. The report did mention that the social media company is already collaborating with private firms on research, “including a Biogen Inc. study that used Fitbit wristband health trackers on multiple sclerosis patients.”
A June 2015 article on AlJazeeraAmerica.com states “the drug flibanserin, billed as a pill to boost the female libido and amp up sexual satisfaction in women, has come to the forefront. After more than a decade of development, clinical trials and two previous attempts at FDA approval, the drug is on the cusp of hitting the market. Last week, an FDA advisory panel approved the pill, and the agency has until Aug. 18 to make its final decision. Many say the drug is long overdue and will address an enormous unmet need.” Often, studies indicating little efficacy and great risks such as breast cancer are pushed aside by the FDA, in favor of recommendations of “advisory panels” who are the targets of intense and disingenuous lobbying by pharmaceutical companies and “patient advocacy groups” created and managed by those companies (the “many” referred to by Al Jazeera America).
“The little pink pill has been mired in controversy,” according to their report. “Even the sexual disorder it’s designed to treat has been the subject of intense debate.”
It is well to remember that the FDA already partners with drug companies who sponsor trials and then provide their “findings” to the agency for approval. The public and the medical community must be more vigilant than ever due to the FDA’s reliance on conflict-of-interest partnerships and untested data-mining strategies.
PatientsLikeMe.com, a privately held company backed by investors including EBay founder Pierre Omidyar, currently sells anonymous data to drug makers. The partnership with the FDA will last three years, according to the Post.
UPDATE: On August 18, 2015, the FDA approved flibanserin, now marketed as “Addyi.”