As the government looks at how it regulates medical devices, a steady stream of critical studies emerge.
At least 10 studies have been released in medical technology circles in the past two years, almost all of them sounding an alarm about the way medical devices are regulated in the United States.
The research-driven criticism comes as the Food and Drug Administration (FDA) considers changing how medical devices are cleared by the agency, a move that could result in more regulation of the industry.
But most of these analyses have been funded by med-tech lobbyists and interests, and critics say the conclusions can be more spin than science. Academic researchers, including those funded by the industry, insist that their data are unfettered by corporate influence.
The research purports to shed light on the FDA’s 510k regulatory process, the most common way new devices get to market. It usually doesn’t require companies to conduct clinical studies to prove a product is safe and effective before using it in patients.
Several studies comb through the same data, but reach wildly different conclusions. The Institute of Medicine, an independent group that advises government, will release recommendations on the process this summer.
Questions over various studies are “a surrogate for the philosophical debate about the balance FDA must strike,” said Ralph Hall, a University of Minnesota law professor, med-tech executive and lawyer, who conducted his own study of FDA device recalls. “The FDA has to balance safety versus access to new products and innovation. That’s a philosophical, not a scientific or legal, question. It’s also a policy question.”
Hall and others say the 510k process works pretty well without the requirement for additional, expensive clinical studies.
But Dr. Diana Zuckerman, president of the National Research Center for Women & Families, concluded in her study that most medical devices recalled for life-threatening hazards were originally cleared by the FDA through the 510k pathway, or were exempt from regulatory scrutiny altogether.
“Our conclusion was, ‘Why are so many devices that are supposed to be low- and moderate-risk devices killing people when they fail?'” she said, noting the study was funded by donations to her research center — and not medical device companies.
Zuckerman’s study, the only one of the 10 published in a peer-reviewed medical journal, was attacked by AdvaMed, the med-tech lobbying group in Washington, D.C. The organization issued a six-page rebuttal claiming her methodology was “seriously flawed.”
Allegations of ‘spin’
A similar statistical tête-à-tête occurred earlier this year when the Boston Consulting Group released a study indicating there is no discernible difference in the safety records of devices approved in Europe than those in the United States, where it takes a lot longer to gain approval.
That evoked a vociferous response from Dr. Sidney Wolfe, of the consumer group Public Citizen. The study was “spin” promulgated by AdvaMed. “The individuals who conducted the study and authored the report are highly biased,” he wrote in an online blog. “The report should be viewed with extreme skepticism.”
One of the study’s authors, Simon Goodall, admitted it was difficult to compare both regulatory systems, but stood by his methodology, nonetheless. “Our data sources and underlying methodology is transparent and available,” he said. “It’s not based on a survey of members or opinions. It is based on facts reported by regulatory bodies in Europe. We call the data as it is, and we put it out there in the public for debate.”
Several studies critical of the FDA have been released by organizations whose names don’t suggest they have industry connections. A group called InHealth (or the Institute for Health Technology Studies) released a survey last month suggesting the most-innovative devices are being launched in Europe first, leaving U.S. patients in a medical lurch.
While the research was conducted at Northwestern University, the organization’s board consists of industry heavy hitters such as the chairman emeritus of orthopedic device maker Stryker Corp. Another is Stephen Ubl, the Mounds View native who heads AdvaMed.
James Linehan, a biomedical engineering professor who conducted the InHealth study, said he was under no pressure to reach a particular conclusion. “Absolutely not,” he said. “I am not taking sides in any of this.”
Not all of the studies reach a conclusion. A 2010 study on FDA device recalls by the research firm Battelle Memorial Institute offers no opinion on the data its researchers gathered. That was left to the lobbying group AdvaMed, which funded the study. The group said in a press release that the Battelle data confirmed the “extraordinary safety record” of the 510k process.
Battelle spokeswoman Katy Delaney says the institute often gathers objective information for a client, but has no say in how it may be subsequently interpreted.
“Members of Congress like having a study so that they can quote it,” says Zuckerman. “The study doesn’t need to persuade them one way or another on an issue, it can just be useful to back up something they would have said anyway.”
Meanwhile, the FDA often finds itself on the defensive whenever a new study is released, even though the agency announced changes in the past year that will allay some of industry’s concerns about the 510k process.
Dr. Jeffrey Shuren, chief of the FDA’s device division, says it’s more important to look beyond who funded the study to the data itself. “If they’re not good studies, then they lead you down the rosy garden path, and you don’t end up in the right place,” he said. “That’s not good for patients.”
Overall, he added, the barrage of studies has had “minimal impact” on agency decisions.