Mighty nervous: GE Healthcare (West Chester, Ohio) and comparative effectiveness research

It is interesting to view the worries and troubles at GE Healthcare, with all its tentacles, including West Chester, Ohio, as it watches the government healthcare takeover. The HR 3200 takeover will likely enable the Immelt/GE juggernaut to earn a ton of money in the administration of health care rationing-that-is-not-rationing under the guise of "comparative effectiveness" viz.

GE is a global leader in healthcare. We are deeply engaged in medical diagnostics and information technology…

GE expects to grow its revenues by 2-3 times the U.S. gross domestic product and increase earnings…

Comprehensive reform must include properly structured Comparative Effectiveness analysis including the value of healthcare choices – for example, physician and hospital quality and efficiency, health plan options and treatment and pharmaceutical options.
GE Viewpoint: Enabling Better Health and Healthcare Reform

Good. Very nice. But…. effectiveness compared to what?

Critics, like Betsy McCaughey, point out that comparative effectiveness means seasoned citizens and Mike Sola’s son would get rationing, or as the president famously suggested, a painkiller instead of a pacemaker.

The stimulus bill, American Recovery and Reinvestment Act, has plenty of money for comparative effectiveness research (CER). Dr. Eugene C. Rich, in Journal of General Internal Medicine, states that there has not been enough high quality research on the matter.

Perhaps no issue in the CER debate is more controversial than the role of assessment of the comparative “value” or cost of clinical services. This subject was explored in depth in a recent series of Annals articles, and anxieties of manufacturers and some patient advocacy groups have been highlighted in the recent editorializing over the comparative effectiveness research provisions in the American Recovery and Reinvestment Act of 2009. In brief, opponents of CER view the inclusion of cost or value within the context of comparative effectiveness research as equivalent to payer-oriented cost-effectiveness analysis (CEA). Such CEA is assumed a precursor to nationwide coverage determinations and rationing of access to expensive but effective therapies. Advocates for patients with rare conditions, and for disease groups with particularly expensive treatments, are of course particularly alert to these concerns, as are the developers of expensive innovations.

I conjecture that the government still has a sense of shame and will not justify rationing decisions without the fig leaf of CER.

But is CER really pernicious or is it a gray area — maybe pernicious, maybe not, depending on the how-what-when-where-why of the research. Here are a few grant categories underwritten by the porkulus act:

05-AG-101* Data Infrastructure for Post-Marketing Comparative Effectiveness Studies. (p. 12)
The challenge is to create the data infrastructure that will enable comparisons of particular therapies, prescribing patterns, and benefit designs on health outcomes. Problems with currently available studies include omission of key patient groups (such as the elderly in nursing homes)
05-AG-103* Imaging and Fluid Biomarkers for Early Diagnosis and Progression of Aging-related Diseases and Conditions including Neurodegenerative Diseases. (p. 13)
Diseases and conditions of aging have a huge public health burden… most studies have not compared multiple imaging and/or fluid biomarkers in the same study with the same study participants to evaluate their comparative effectiveness at being able to provide for the early diagnosis or for following the progression of disease.

Maybe a professor of bioinformatics could explain that this research is hard to come by because of the nightmarish Tuskegee Syphilis Study. Please post a comment if you are a bioinformatics professor. Comparative effectiveness research will probably be worthless unless somebody allows a LOT of seniors go for a few years without expensive treatment for Alzheimer’s disease or some other disease.

Ordinary rules of scientific research would preclude such studies today, but the American Recovery Reinvestment Act and its CER funding might reverse that protection. Dr. H. K. Beecher expressed this very worry back in the 1960s: big research money as a factor in unethical medical research in the United States.

A similar worry exists regarding the health care takeover legislation HR 3200. Lots of money at stake, lots of pressure for unethical methods.

The government is asking for all of us to trust them with ALL life and death medical decisions: pre-birth, newborn, grade schoolers and teens, adults, seasoned citizens. That would make any normal person mighty nervous.

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