A tale of dueling studies

Who would have thought med-tech — a business dominated by engineers and ancillary finance types — could be so feisty?

The ongoing debate in Congress and elsewhere over whether the FDA effectively regulates medical devices took a new turn this week when the editors of the nation's top medical journals weighed in. It was all prompted by a request from Democratic members on the Oversight and Investigations Subcommittee of the House Committee on Energy and Commerce (got all that?).

Drs. Gregory Curfman, editor of New England Journal of Medicine; Rita Redberg, editor of the Archives of Internal Medicine; and Howard Bauchner, editor of the Journal of the American Medical Association, each reviewed two oft-quoted industry-funded studies, including one authored by Dr. Joshua Makower, entrepreneur and Stanford Medical School professor, and a second by the California Healthcare Institute, a group of med- and bio-tech companies and enthusiasts.

It's safe to say these two studies won't be published in any of these journals — EVER.

Of the Makower study, Dr. Curfman writes that he was surprised Makower did not disclose his financial ties to the device industry since they "clearly constitute a significant conflict of interest." Further, he states, "this isn't a study as all. This is an opinion piece that is dressed up to look like a research study." The authors had a specific agenda from the outset, he continues, and "they conducted their work in a biased manner." The CHI report "advocates a potentially dangerous position — that regulation stifles innovation, he says, and "does a serious disservice to medicine and the health of the public."

Now on to Dr. Redberg, who says there are "serious methodological issues" with Makower's report, claiming a selection bias among the companies that responded to his inquiry. She goes on to claim the authors, funders and survey respondents may have a conflict of interest because their "livelihood depends on fast approval of medical devices."

She also quibbles with the report's conclusion that FDA regs are driving med-tech companies abroad. This argument is flawed, Redberg writes, because approving unsafe devices "actually hurts the economy by allowing limited health care dollars to be spent on expensive devices that do not help patients" leads to higher health care costs that may result in economic difficulties and possible bankruptcies of small businesses.

Dr. Bauchner's letter is a bit more circumspect. The Makower study has "limitations," he says, including a selected study population, a low survey participation rate, and the lack of verification of "apparently subjective data." The two studies "may be viewed, at best, as hypothesis generating, perhaps leading to a more-thorough exploration in more rigorously designed future studies."

Hmm. I hereby nominate Dr. Bauchner to moderate my next family squabble.

Of course, your humble blogger contacted Dr. Makower, who was one of the first in med-tech circles to publicly sound an alarm about the mounting challenges currently facing the industry. He responded with a rather-lengthy email. Here are the high points:

1. "We presented very clearly and openly in our report all of the study limitations, as well as the sources for potential conflicts of interest. As to the question as to whether such data would be worthy of guiding policy, if the editors have noticed, policy often gets shaped on much less data or evidence than I attempted to collect. Our work was an attempt to at least bring some more data forward which could help identify the issues and the possible impact on patients and jobs in the U.S."

2. "Anyone who has any interaction with medical innovators in this country knows the issues are real and very severe. The conclusions of the report are that the FDA process in the U.S. today suffers from a lack of transparency, predictability and reasonableness, and the impact of this is hurting companies, jobs and patient's access to new technologies in the U.S. at a critical time. As a physician innovator and inventor I have faced these issues first hand, and I am deeply concerned about the future of medical innovation in this country if we do not turn this around."

Todd Gillenwater, CHI's senior vice president of Public Policy, wrote in a response that CHI was never given the opportunity to address the "supposed major problems" that Dr. Curfman mentioned.

In a statement, Gillenwater says CHI is "very proud" of its report and stands by its content, data and findings. He notes Curfman's "review" – as he puts it – took no exceptions with the data, figures or methodology of the report.

He notes that CHI's goal involves working with Congress, the FDA and industry to assure that med-tech "can retain and create jobs, secure financing and generate revenue and [maintain] its long-term success in continuing U.S. leadership in innovation and international competitiveness while maintaining the high standards of safety and effectiveness that doctors, patients and their families" expect.

Janet Moore covers medical technology for the Star Tribune.