Speaking of ethics

Image via The Guardian.

The New York Times medical correspondent Gina Kolata is terribly concerned about ethics, in this case the ethics of a woman carrying

the gene for Gerstmann-Straussler-Scheinker disease, or GSS, which would inevitably lead to her slow and terrible death.

Should she marry and undergo IVF treatments with her husband, test the embryos for the gene, and throw away those that have it? Or should she—what, exactly?

the procedure... raises unsettling ethical questions that trouble advocates for the disabled and have left some doctors struggling with what they should tell their patients. When are prospective parents justified in discarding embryos? Is it acceptable, for example, for diseases like GSS, that develop in adulthood? What if a gene only increases the risk of a disease? And should people be able to use it to pick whether they have a boy or girl?

This isn't infanticide, you know, or even abortion. This is selecting which to lose of a bunch of blastocysts that will mostly be thrown out no matter what, and not on grounds of sex (which is a real problem for millions of Chinese men who will never marry because of the Chinese parents of the previous generation who refused to shoot their wad on daughters) but of life itself. How is this an ethical issue, unless the Catholic bishops have taken over the editor's job?

Funny, Kolata isn't able to mention ethics once in regard to a case where it isn't a spurious issue at all, that of government-funded health care research by randomized controlled clinical trials. She's too busy concern-trolling the Affordable Care Act:

The idea seemed transformative. The Affordable Care Act would fund a new research outfit evocatively named the Innovation Center to discover how to most effectively deliver health care, with $10 billion to spend over a decade.

Actually, that would be the Centers for Medicare and Medicaid Services (CMS) Innovation Center,

established by section 1115A of the Social Security Act (as added by section 3021 of the Affordable Care Act). Congress created the Innovation Center for the purpose of testing “innovative payment and service delivery models to reduce program expenditures …while preserving or enhancing the quality of care” for those individuals who receive Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) benefits.

 But, Kolata continues,

now that the center has gotten started, many researchers and economists are disturbed that it is not using randomized clinical trials, the rigorous method that is widely considered the gold standard in medical and social science research.

Not only that, but they've totally failed to work on verifying the authorship of Shakespeare's plays, establishing whether or not there is an afterlife, and giving me a pony.

Such trials have long been required to prove the efficacy of medicines, and similarly designed studies have guided efforts to reform welfare-to-work, education and criminal justice programs.

No, they have never been "required to prove" the efficacy of medications, they have been extremely useful in providing evidence for efficacy. But the technique is ethically limited, when human lives are at stake. In particular, you don't want to be in the position of witholding effective treatment from the members of a control group because giving it to them would fuck up your experiment. The ethical issues are extremely well known, as are the additional expenses, time issues, and questions of external validity. We should be moving away from the traditional model, as far as possible, in favor of the new style of big data projects.

As for the projects within the Innovation Center's terms of reference as defined by the act of Congress that created them of studying payment and service delivery models, it is not very easy to see how you'd go about subjecting such models to randomized clinical test, or why you would want to. For example:

The Indiana Health Information Exchange (IHIE) provides the Quality Health First (QHF) Program to individual practitioners. QHF obtains claims information from commercial carriers, Medicare, and Medicaid and uses the information with clinical information from physician offices, labs, and clinics to produce quality reports, alerts and reminders.... The demonstration was designed to determine if the QHF program reduces Medicare expenditures and improves quality of care for beneficiaries.  The design consists of a comparison group trended baseline intended to determine if the QHF intervention affects Medicare expenditures.

In a "gold standard" clinical trial, the subjects must be kept unaware whether they belong to the experimental group or the control group; for example, if you're testing a medication, members of the control group are given a placebo so that nobody—including the experimenter—knows who is getting it and who isn't (the experimenter works only with the METADATA for any individual subject). Are we going to provide members of the control group with fake quality reports, alerts, and reminders so they won't know whether they're getting the real thing or not? I think the first time you get a reminder of your imaginary appointment with Chuckles the Counselor you will suspect something's up.

Randomized clinical trials as needed can be funded by institutions that are designed for the purpose such as the National Institutes for Health, and if Kolata cares about that she should be worrying about that funding, catastrophically affected by Republican thuggery over recent years, not about a new institution that was designed for something altogether different. Maybe journalistic ethics would suggest focusing on a problem where it actually exists instead of where it's in some TV sense "controversial", i.e., frameable as Republican vs. Democrat.