Shortly before Christmas Inside Health Policy, a trade pub that covers the drug industry and related topics, revealed the real power behind the rapid journey of the 21st Century Cures Act through the House of Representatives last year. It wasn’t the two dozen or so public forums held by the House Energy & Commerce Committee, the Act’s cheerleader-in-chief, or the drumbeat of messages to the media, or the shameless use of kids with rare diseases like Max and twins Brooke and Brielle to tug on Congressional heart strings. It was the medical device industry working hand-in-glove with the Food and Drug Administration, a supposedly neutral regulator looking out for the public’s health and safety.
Documents and emails obtained by Inside Health Policy through a Freedom of Information request show that “CDRH [the FDA’s Center for Devices and Radiological Health] and AdvaMed [the device industry trade group] worked together on proposed language for most of the device provisions in 21st Century Cures.” Another document reveals that in preparation for the Senate’s own version of the Cures Act, AdvaMed and the FDA collaborated “to refine their regulatory strategy in a way that is agreeable to both parties.” Still another document that was prepared for a meeting with industry on August 7 noted that the trade association “thanked” Center director Dr. Jeffrey Shuren, “for meeting with AdvaMed regularly during the legislative process for getting the 21st Century Cures Act passed” and that the regulator and the lobbyists had “jointly written legislative text.” Besides AdvaMed, attendees at that meeting included the worldwide chairman of Johnson & Johnson’s medical device group and representatives from CVRx Inc., which makes implantable devices for high blood pressure and heart failure, and St. Jude Medical, a Minneapolis-based firm that bills itself as an inventor of breakthrough medical technologies.
It’s common, of course, for the regulator and the regulated to meet and discuss rules and even proposed legislation. That back and forth is as old as the FDA itself. But the communications unearthed by Inside Health Policy and then passed on in a piece by John Tozzi of Bloomberg News ten days later add up to an uncommonly cozy relationship with much of the public being none the wiser. They should be. The Cures Act, as I’ve pointed out, has profound consequences for millions of patients and would-be patients who have stents, uterine devices, pacemakers, wire mesh, and other medical equipment planted in their bodies to cure or diagnose illness.
The Act would allow the FDA to approve such devices not based on randomized controlled trials, the gold standard for determining safety and efficacy, but on less scientific, anecdotal evidence such as case histories. Scientific studies could take place after a device goes on the market, but many researchers have found problems with that approach. The Act would require the FDA to use third parties to review the safety and efficacy of devices when manufacturers make small changes as they often do. Currently the FDA does the review. The proposed changes weaken already weak rules for device approval that have led to thousands of complaints. Prominent among them are those from women who’ve taken to Facebook to discuss their injuries with the pelvic mesh.
Where were consumer advocates in this bill drafting process? Apparently not where it counted. Susan Wood, a former FDA assistant commissioner for women’s health, told Bloomberg News, “FDA’s drafting legislation in consultation with outside entities, whoever they are, strikes me as unusual. It gives a great deal more weight to the industry representatives on very specific legislation that affects both FDA and the industry, and others were not at the table.” That seems to be the point given the FDA’s bend-over-backward posture toward industry these days. A look at approvals of new drugs—those that are new molecular entities—illustrates the agency’s tilt. In 2015 the agency approved 45 new drugs — more than twice the number approved in 2005. A year ago a Forbes columnist proclaimed 2014 was “a good year for pharmaceutical innovation—the best, in fact, since the industry’s all time record of 1996.” The drive to get new drugs to market seems to be working, and the goal of the Cures Act is to do the same for devices.
Once again consumer advocates and others are asking, Whose interests does FDA represent anyway? I posed that question to Dr. Hooman Noorchashm, a cardiothoracic surgeon who has been waging a grassroots campaign to get a device called the Power Morcellator off the market. The FDA-approved device is thought to have spread a hidden cancer when his wife underwent a procedure for fibroid tumors. This fall Noorchashm and his wife, also a physician, met with top FDA officials, including Shuren. Noorchashm told me he left the meeting with the sense that Shuren and his colleagues believe that “getting life-saving devices into the marketplace efficiently by streamlining with industry is the goal of their agency. It is not public health and patient safety.”
If the FDA favors fox-in-the-hen house regulation and isn’t interested in policing the safety of medical devices, where does that leave the public? As the agency moves ever closer to the side of those it regulates, stories like those that Chad Tehune wrote for the Los Angeles Times in late December show how relevant that question is. The Times as well as other news outlets have investigated deaths at U.S. hospitals caused by transmission of antibiotic-resistant bacteria that remain in endoscopes even after the devices are cleaned according to manufacturers’ directions. Over a three-year period, 21 people died and more than two dozen became ill from infections related to dirty scopes in Pittsburgh, Seattle, and Los Angeles. The FDA identified 10 outbreaks; seven involved a device made by Olympus, but the paper reported: “Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections.”
Although Olympus did not tell hospitals about the dangers of their device, it did have to tell the FDA, but according to the paper those reports “suggested culprits other than its scope. The FDA issued no warnings based on those reports. Following federal regulations, it didn’t publicly identify the hospitals.” Maybe warning the public doesn’t matter much in today’s Washington. As the Cures Act collaboration illustrates, maybe advancing the interests of industry now takes priority over ensuring patient safety at the FDA.
Trudy Lieberman is a veteran health care journalist and regular blogger for HealthNewsReview.org. She often writes about consumer cost and safety issues. She tweets as @Trudy_Lieberman.