A medical-industrial complex
President Dwight Eisenhower's 10-minute farewell address to the nation in 1961 is well remembered for its warning about the "military-industrial complex." His parting admonition has fresh meaning for today's "medical-industrial complex." Look no further than the current collision between the National Institutes of Health's National Cholesterol Education Program and a watchdog group, the Center for Science in the Public Interest.
The case in point is the NCEP call, through its new guidelines, for lowering America's cholesterol levels. The new target would only be achieved by tripling the current number of people taking the cholesterol-lowering drugs called statins--a bonanza for drug companies. Unlike earlier guidelines for people with known heart disease, the new ones focus on the healthy and their future heart risk. If followed, 36 million American adults--close to 1 in 5--will be popping statins or a similar drug for the rest of their lives.
But this debate goes way beyond cholesterol. So-called evidence-based guidelines are becoming codes of medical practice. Doctors will be using them to direct everyday care, and woe to those who dare not follow new rules that carry the imprimatur of medicine's research elite.
CSPI took on the experts and petitioned NIH to take another look at the guidelines, particularly those relating to women and those over age 70. The response was quick and negative. But the issue stays alive because eight of the nine experts on the panel had financial ties to companies that would benefit grandly from expanding the ranks of lifetime statin takers. It's been ugly. In a heartbeat, the panel members, a distinguished group called upon to do a hard job (after disclosing their financial interests to NIH), have had their motives questioned. This is neither fair to them nor good for the well-regarded NCEP. And it is awful for doctors and patients who are left wondering what to do.
If only we had remembered Eisenhower's less famous second warning: that "public policy could itself become the captive of a scientific-technological elite" in which the "power of money is ever present." He feared elites would dominate the nation's scholars by virtue of their federal employment or their control over large research grants. Eisenhower was thinking about the solitary tinkerer overrun by task forces of scientists, but his instincts were prescient.
Inspired by Ike. With Eisenhower-inspired wisdom, we could prevent messes like the cholesterol debacle. How about medical grand juries made up of public and private medical scholars to oversee, analyze, and give final approval to guidelines emerging from expert task forces? These "jurists" would be screened ahead of time, as judges are, for expertise, independence, and judicial temperament: compassion, decisiveness, open-mindedness, and the ability to see patients holistically. Their freedom from financial influence goes without saying. Disclosure of a conflict of interest is not enough: Such a conflict would designate an individual as technically nonindependent and thus ineligible to serve on the overarching panel that delivers the final verdict or reviews appeals. Those with conflicts would be eligible to be part of the groups that develop proposed options.
Some claim you can't find experts available these days who don't have industry ties. That is nonsense, based on my own experience running the NIH and elsewhere. Plenty of independent clinicians and scientists are up to this duty, highly skilled in analyzing medical data and wise in the ways of patients. There are also younger experts who have not yet attained the national reputation that would make industry seek them out, and an older group, just retired from active academic life or practice but steeped in wisdom and experience. These people are known and respected in every community and in every medical school in the country, even if they have not achieved national visibility in government or research.
NIH and the Centers for Disease Control and Prevention, whose work drives the evolution of medical practice, could together create a center to enable such a process, as long as the center itself is independent of other agency forces. Great Britain fashioned something along these lines in 1999, charmingly called NICE: the National Institute for Clinical Excellence. Wouldn't it be nice if Americans could have one, too?
This story appears in the January 24, 2005 print edition of U.S. News & World Report.