“Most people probably believe when they get a medical device implanted–be it a pacemaker or a joint–that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that is not the case.”
As the Director of Public Citizen’s Health Research Group, Michael Carome works to improve public health by calling for corporate accountability and helping people make informed medical decisions. After working for decades as a medical doctor and a senior leader with the U.S. Public Health Service, he moved into the nonprofit world to fight for patient safety.
Carome is especially determined to hold corporations accountable for putting dangerous drugs and devices on the market, and challenging the U.S. Food and Drug Administration’s approval process for these medical products. With his leadership, Public Citizen has been instrumental in pressuring the FDA and other government agencies to uphold patient safety over corporate profits.
“Companies can develop new products that may not be safer and more effective than other products already on the market, but they will certainly heavily promote them to doctors, to hospitals, to drive up their profits,” he said in “The Bleeding Edge”.
Carome has made it his mission to expose the risks carried by these new products, and particularly by products marketed to women such as Essure and transvaginal mesh. “The FDA clearly has been reckless in failing to remove [transvaginal mesh] from the market,” he told Drugwatch.
“The Bleeding Edge” filmmakers celebrate Michael Carome for championing the rights of all people to make safe, informed decisions about their health.
Watch Michael Carome in the Netflix Original documentary, “The Bleeding Edge”.