… and since he’s a feisty fellow, ever ready to defend his position, UD sees a promising future for him.
He’s entirely unfazed that the editors of America’s three major medical journals found a recent study he published (it argues that the FDA’s product reviews stifle the medical device industry) scientifically shoddy and rife with conflict of interest. A congressional committee report summarizes:
“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. [Gregory] Curfman concluded that “it is not really a study at all.” Dr. [Rita] Redberg found “several serious methodological issues with the Makower report that render its findings scientifically invalid.” Dr. [Howard] 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.”
The Minnesota Star Tribune provides more conflict of interest details:
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 “do 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” [which leads] to higher health care costs that may result in economic difficulties and possible bankruptcies of small businesses.
Stanford is a hotbed of professor-entrepreneurs for whom fast approval is of course the name of the game. Note to Congress: Shut up and get out of the way. Note to Stanford: Terrific research program you’ve got going there.