During a Food and Drug Administration hearing Thursday to scrutinize the safety and efficacy of the Essure female contraceptive, Essure's maker, Bayer, revealed it had received more than 17,000 adverse-event reports from women around the globe.
That's over 11,000 more than the 5,093 reports captured by June of this year on the Manufacturer and User Facility Device Experience (MAUDE) database, an FDA website for patients and clinicians to submit complaints.
The high number of events flagged on the MAUDE database may have prompted the FDA hearing, but health policy and quality and safety leaders argue the voluntary reporting system does not provide the rigorous post-market surveillance needed to capture adverse events before problems become widespread.
It takes years of evidence collection before warnings are issued about treatments that may be harming patients. That concern was voiced by Lisa McGiffert, director of the Consumers Union Safe Patient Project, in a recent Q&A with Modern Healthcare. The problem is underscored by legislation like the 21st Century Cures Act which aims to speed the development and approval of new drugs and devices.
Advocates for fast-track drug and device approval are basing their support on the theory that some kind of “magical post-market surveillance system” is going to track treatment issues, and as soon as problems are spotted, the treatment in question will be pulled from the market, McGiffert said, adding “It doesn't happen that way.”
Essure has become somewhat of the poster child for such concerns because of its delayed scrutiny.
Despite mounting criticism, Essure's manufacturer has vehemently supported the device, stating that side effects are possible with any new device or procedure, and that Essure is “supported by more than a decade of research and real-world experience.”
But a panel of independent experts Thursday told the FDA they disagreed. Not enough research was conducted by Conceptus, the original manufacturer who sold the device to Bayer, prior to approval of the permanent female sterilization device 13 years ago. The device's use should be limited, the panelists urged.
Federal officials did not provide a timeline on when action will be taken on Essure based on the suggestions offered, but said addressing its problems is a high priority, given the many complaints received.
Voluntary reporting through the MAUDE database is a passive form of tracking that often underestimates the number of adverse events that actually occur in day-to-day practice, noted the authors of an editorial posted Thursday in the New England Journal of Medicine.
With Essure, safety concerns might have been detected sooner or avoided altogether if there had been higher-quality pre- and post-marketing evaluations, and more timely and transparent dissemination of study results, wrote Yale researchers, Drs. Sanket Dhruva, Joseph Ross and Dr. Aileen Gariepy in the NEJM commentary.
The FDA should reevaluate its process for the new device rollouts, using Essure and other therapies that have proved harmful as a cautionary context, Gariepy told Modern Healthcare. “Is it sufficient? Or can we do better for our patients?” she asked. “We really need better, more transparent data.”
However, it's not just the government asking hard questions about medical evidence. Various specialty organizations and manufacturers have launched registries, big-data initiatives and other projects they hope will facilitate early detection of the problems associated with new and existing clinical therapies.
For example, in June the American Society of Clinical Oncology announced the official rollout of CancerLinQ, a health information-technology platform initiative in which participating oncology groups share data from millions of electronic health records to provide real-time feedback on cancer trends and patient outcomes.
Drug and device manufacturers have also been voluntarily participating in projects such as Yale University's Open Data Access Project and GlaxoSmithKline's Clinical Study Data Request initiative, which aim to facilitate access to clinical trial data.
In 2014, Bayer became one of 11 other drug and device manufacturers to participate in the GSK initiative, but the project's website says that Bayer data is “coming soon.”