Devices & Diagnostics

FDA advocates find flaws in studies critical of federal agency

House Democrats are taking a new tactic in defending the FDA against criticism from the GOP and the medical device industry; attacking the source. Democratic leaders distributed a memo to members of the House Energy & Commerce Committee’s oversight subcommittee yesterday that takes aim at claims made in two well-publicized studies the medical device industry has […]

House Democrats are taking a new tactic in defending the FDA against criticism from the GOP and the medical device industry; attacking the source.

Democratic leaders distributed a memo to members of the House Energy & Commerce Committee’s oversight subcommittee yesterday that takes aim at claims made in two well-publicized studies the medical device industry has used in supporting claims that the FDA is impeding innovation from getting to the U.S. market.

The congressional delegation asked three editors of prominent medical journals to review both the “FDA Impact on U.S. Medical Technology Innovation,” a study released earlier this year by Stanford University researchers led by Dr. Josh Makower and another report by the California Healthcare Institute and the Boston Consulting Group, which takes aim at the pace of clearances and approvals at the federal watchdog agency.

Both studies are very critical of the FDA and have been used ad nauseam by critics.

House Dems asked Dr. Gregory Curfman, executive editor of New England Journal of Medicine, Dr. Rita Redberg, editor-in-chief of the Archives of Internal Medicine; and Dr. Howard Bauchner, editor-in-chief of the Journal of the American Medical Assn. to review the studies to “determine whether these studies form an appropriate basis for policymaking.”

The report was released ahead of a hearing at the House Energy & Commerce Committee’s oversight subcommittee on the FDA and medical device regulations.

Perhaps not surprisingly, all three editors of the prominent peer-reviewed journals found problems with both studies’ methodologies and conclusions.

On the Makower study, the panel said:

“After reviewing the paper, the editors of the three premier peer-reviewed medical journals concluded that the study would not be fit for publication in a peer-reviewed journal.” Dr. Curfman concluded that “it is not really a study at all.” Dr. Redberg found “several serious methodological issues with the Makower report that render its findings scientifically invalid.” Dr. Bauchner determined that “[g]iven the extent of these limitations, the inferences and conclusions that can reliably drawn from this report are limited.” Finally, all three editors identified significant conflict of interest concerns with the report.

The objections to the study were similar to reactions by Dr. Jeffrey Shuren, director of the Center for Devices & Radiological Health, who lambasted the study when it was released in December. Shuren told MassDevice that the study was “horrible.”

“That’s well below the quality level of a good study,” Shuren told us at the time. He pointed out that lower response rates would magnify the opinions of people unhappy with the process. He added that a sufficient response rate would have been 35 to 40 percent. “We want to have good data.”

Makower responded in kind, saying that his study “points out for the first time some of the most upsetting and difficult aspects of the FDA process and it’s not a good report,” he told us. “Those at the FDA have reason to feel defensive about it but we put real definitive thought into evaluating regulatory processes.”

The journal editors weren’t much kinder to the CHI study, saying that the paper “reflects little or no understanding of the complexity of medical devices and the sometimes unpredictable adverse health consequences of seemingly minor changes in design.”

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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