The Shifting Politics of Health Care

The landscape of medicine is shifting rapidly as efforts to reform the health care system gather steam. Long-time political alliance and positions are in flux as major players prepare for a change in administrations.

Two straws in today's wind. First, the president's veto yesterday of the State Children's Health Insurance Program expansion drew strong condemnation from the American Hospital Association (hospitals) and the American Medical Association (doctors), but not America's Health Insurance Plans (insurance companies) or the Pharmaceutical Research and Manufacturers Association (drug companies), which did not issue press releases. In AHIP's case, it had praised the Senate bill when it passed last August, but it was noticeably quiet yesterday.

Why? No doubt the insurance and drug companies are bracing for more Democratic legislative assaults on the health care front in the waning days of the Bush administration, and they are banking on the veto pen to bail them out of any incremental changes that would jeopardize their short-term bottom lines. Better to fight for their corporate needs in the context of a major health insurance overhaul, where they can quietly craft provisions with friendly legislators that protect their long-term interests.

But wiser heads in those sectors know change is coming. I was intrigued this morning by comments made by Eli Lilly CEO Sidney Taurel at the Cleveland Clinic earlier this week (reported by FDA Webview, subscription required). He called on government and industry to collaborate on a health information technology system "to provide more rapid and useful insights on drug effectiveness and improve drug safety."

A well-functioning health IT system could not only frame hypotheses for post-marketing Phase 4 research studies but also be the practical equivalent of massive real-world trials. Such a system, he said, would collect detailed data from day-to-day medical practices and feed insights quickly, seamlessly, and at a lower cost to doctors, regulators, and drug manufacturers. . . “Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly,” he said.

But, as can be seen from the Medicare registry of implantable cardioverter-defibrillators (see yesterday's GoozNews post), such data will also give patients and their insurers a tool for studying how well those drugs and devices are performing in the real world. One of the great promises of universal electronic recordkeeping is that it will enable researchers to study how much benefit new technologies actually provide the general population that visits physician offices, clinics and hospitals, where economic incentives often trump medical science.

As we've seen time and time again, real world prescribers do not behave like the prescribers who participated in the limited clinical trials that led to a drug or device's approval. Their patients are usually younger or older, sicker or healthier, or women and minorities who are underrepresented in clinical trials. The efficacy seen in a clinical trial often disappears in the world of actual medical practice. Those interventions all too often are, in short, waste.

Universal registries enabled by a comprehensive health information technology system could become a powerful tool for rolling back the hundreds of billions of dollars of waste that is dragging down our health care system and making health insurance -- whether provided by the government or private companies -- unafffordable.

Posted by gooznews at October 4, 2007 08:52 AM