“This conjunction of an immense [medical] establishment and a large [drug and medical device] industry is new in the American experience. The total influence -- economic, political, even spiritual -- is felt in every city, every State house, every office of the Federal government. We recognize the imperative need for this development. Yet we must not fail to comprehend its grave implications. . .
"In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the [medical] industrial complex. The potential for the disastrous rise of misplaced power exists and will persist . .
". . . in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientifictechnological elite.
"It is the task of statesmanship to mold, to balance, and to integrate these and other forces, new and old, within the principles of our democratic system -- ever aiming toward the supreme goals of our free society.”
The above quote is my adaption of President Dwight Eisenhower’s famous farewell address to the country, warning about the influence of a military-industrial complex. I took the liberty of replacing the word “military” with “medical”—to raise the question of whether close ties between the medical profession and the manufacturers of drugs and medical devices have also resulted in “unwarranted influence” over public policy.
Eisenhower was concerned about the implications of military spending on the economy; today, rising costs of health care pose the gravest threat to the economic health of the country. We know that without changes, Medicare and Medicaid spending will consume so much of national resources there will be little left for other needs. It will be impossible to reduce the deficit and debt without getting health care spending under control.
We can’t get health care spending under control without getting control of medical technology costs. A 2009 ACP position paper, Controlling Health Care Costs While Promoting The Best Possible Health Outcomes, observed that “Technological progress has been seen as accounting for as much as 75% of the increase in U.S. health care expenditures over time.” To address the costs of health care technology, ACP proposed that:
“A coordinated, independent, and evidence-based assessment process should be created to analyze the costs and clinical benefits of new medical technology before it enters the market, including comparisons with existing technologies. Such information should be incorporated into approval, coverage, payment, and plan benefit decisions. The assessment process should balance the need to inform decisions on coverage and resource planning and allocation with the need to ensure that such research does not limit the development and diffusion of new technology of value to patients and clinicians or stifle innovation by making it too difficult for new technologies to gain approval.”
But the flap over a new IOM report on regulation of implantable medical devices shows that even a modest effort to assess the benefits of technology before and after it gets to market will run right into intense opposition by manufacturers and some physicians. The IOM recommended that the FDA no longer automatically grant approval to implantable medical devices, in the absence of clinical trials, based only on a showing that they have “substantial equivalence” to an existing device.
According to a supportive editorial by Drs. Gregory Curfman and Rita Redberg in the NEJM, the IOM found that it is “impossible for such clearance to assure safety and effectiveness, because it assesses neither, instead establishing only ‘substantial equivalence’ to an existing device. The report therefore recommended that [such] clearance be eliminated. In addition, it recommended monitoring medical devices throughout their life cycle, especially during the postmarketing period.”
Yet what Drs. Curfman and Redberg call an “insightful, judicious, sensible, and long overdue” report was subject to a “highly unusual . . . preemptive strike” by industry opponents, reports the New York Times. “That attack began even before the study panel finished its review, and has intensified in recent weeks.” According to the Times, a preemptive legal challenge to the IOM report was filed in court by a pro-industry legal foundation, with the implied support of at least some orthopedic surgeons. An orthopedics trade publication, Orthopedics This Week, labeled the IOM report as a “stink bomb,” citing a statement by AdvaMed, the medical device trade association, that it was undeserving of “serious consideration.
The IOM’s report was focused on harm to patients of the current approval process, not the cost of medical technology You can imagine then the even greater furor that would result if it called for assessing “the the costs and clinical benefits of new medical technology before it enters the market, including comparisons with existing technologies” (as proposed by ACP)!
I am sure that there are two sides to this story, and I encourage critics of the IOM report, and particularly orthopedic surgeons, to post comments to this blog. And by no means do I want to suggest the concern about physician-industry influence over public policy is limited to one specialty or one trade group. I plan to examine the issue of drug industry sponsorship of clinical trials in the same light in a future post.
The larger question is whether the close ties between drug and device manufacturers, and physicians who benefit from the products made by them, have created a medical-industrial complex with “unwarranted influence” over “every city, every State house, every office of the Federal government.”—today’s health care version of Eisenhower’s prescient warning about the military-industrial complex.
Today’s questions: Do you think there is a medical-industrial complex that has unwarranted influence over public policy? And what is your take on the specific controversy over the IOM report on medical device regulation?