Saturday, November 21, 2009

The Scylla and Charybdis of Obamacare

****First we have the fallacious and repeated reliance on "preventive care" to save all kinds of money, showing the greater wisdom of the Obamacare approach to health.
The fact is that not all screening is cost-effective since it depends on the ratio of false positives to false negatives and to the efficiency with which later-to-be expensive procedures are preempted.
This has been recognized by
"The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, and since 1998 sponsored by the Agency for Healthcare Research and Quality (AHRQ), is the leading independent panel of private-sector experts in prevention and primary care. The USPSTF conducts rigorous, impartial assessments of the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive medications. Its recommendations are considered the "gold standard" for clinical preventive services.
The mission of the USPSTF is to evaluate the benefits of individual services based on age, gender, and risk factors for disease; make recommendations about which preventive services should be incorporated routinely into primary medical care and for which populations; and identify a research agenda for clinical preventive care.
... The Task Force makes its recommendations on the basis of explicit criteria. Recommendations issued by the USPSTF are intended for use in the primary care setting. The USPSTF recommendation statements present health care providers with information about the evidence behind each recommendation, allowing clinicians to make informed decisions about implementation.*
The USPSTF is supported by an Evidence-based Practice Center (EPC). Under contract to AHRQ, the EPC conducts systematic reviews of the evidence on specific topics in clinical prevention that serve as the scientific basis for USPSTF recommendations."
****Second is the failure of similar agencies, such as NICE in the U.K., to note the injunction that these recommendations are intended for the PRIMARY CARE setting since they represent averages, not necessarily applicable to individual patients.NICE has simplistically elevated cost-effectiveness standards to absolute bans on expensive drugs and procedures.
The recent recommendation of the USPSTF to cut back on routine mammograms for women under 40 AND OVER 75 caused violent reaction from women, the women's lobby being overridingly strong on such issues. Likewise, the AIDS constituency elevated treatment of this disease far beyond cost-effectiveness criteria compared with, say, various cancers of the prostate, liver and pancreas. Allocation of health resources by lobby groups is not an effective way to run the ship.
The whole philosophy of agents such as USPSTF and NICE should not be applied universally but only in the primary care situation. A wiser and more nuanced approach is epitomized by Gilbert S. Omenn in "From Human Genome Research to Personalized Health Care":
"The vision of personalized health care is understandably very popular. It reflects the admirablegoal of tailoring the treatment to the patient and the fact that different people with the same diangose may have multiple underlying mechanisms of disease and may require quitre different therapies. For many widely-used drugs, fewer than 30% of patients treated actually experience a benefit, and some of these may be getting better on their own or through placebo effects. The path to the ideal of predictive, preventive, personalized, and participatory health care must proceed through several complex steps Ther must be sufficient evidence at molecular, physiological, and clinical levels to sub-type patient groups and stratify them for targeted therapy or prevention. There is a big leap from carefully selected patients in a randomized clinical trial of efficacy to evidence of effectiveness in patients with many co-existing diseases being cared for in the community."
The FDA might well heed this advice and revise its most recent use of "comparable efficacy" in the approval of drugs. Their evidence must, perforce, use averages and they might not approve drugs that benefit patients in the 70% referred to above who do not benefit from the existing drugs in the marketplace. Perhaps even the FDA should be more generous in its approvals and let the marketplace of doctors' judgments decide.

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