Saturday, July 6, 2013
Glen Weyl and Eric Posner have proposed an agency to license financial Innovation, to be modeled on the Food & Drug Administration:
We propose that when firms invent new financial products, they be forbidden to sell them until they receive approval from a government agency designed along the lines of the FDA, which screens pharmaceutical innovations. The agency would approve financial products if they satisfy a test for social utility that focuses on whether the product will likely be used more often for insurance than for gambling. Other factors may be addressed if the answer is ambiguous.
In health care regulation, the government's goals are relatively clear: raise quality, cut costs, and increase access. These goals are often in tension, but they provide guidance for policymakers. Weyl and Posner note three similarities between finance and drug regulation:
1) Expertise is key to good decisionmaking.
2) There is delayed and uncertain feedback on the wisdom of decisionmaking.
3) Decisions have high stakes.
This is a very interesting paper overall. However, I'd say the fundamental discontinuity is that while finance orders capital allocation for an entire society, health is merely one of many sectors ordered by finance. That means ethical and social considerations should be far greater in the finance sector than in health. Presently, nothing seems to be further from the case.
Wednesday, July 3, 2013
The Affordable Care Act has largely weathered its challenges in court, but its political vulnerability continues to result in erosion of the Act's provisions.
The provisions for long-term care were abandoned two years ago, many state legislatures and governors are balking at the Medicaid expansion, and now the Obama administration has delayed implementation of the employer mandate to offer health care coverage.
To be sure, glitches are to be expected with major legislation such as the Affordable Care Act. Many states were slow to adopt the original Medicaid program, and it took a decade to take food stamps nationwide. In the end, we may see an Affordable Care Act whose key provisions remain intact.
Still, the history of health care reform efforts give reason for concern. Health care rights have been unstable in the United States to the extent that they adopt different approaches for rich and poor. Thus, while Medicare has provided a reliable guarantee of coverage because it covers all seniors, Medicaid has not provided adequate access to health care because it relies on the willingness of wealthier Americans to fund a program that does not benefit them.
The Affordable Care Act looks much more like Medicaid than Medicare. Prosperous Americans will continue to receive private health care coverage from their employers, while low-income Americans will have to rely on Medicaid or on federal subsidies to purchase private coverage. Over time, it is not clear how willing wealthier people will be to maintain funding at adequate levels for Medicaid or the subsidies.
Tuesday, July 2, 2013
Teaching the regulation of human subject research gives me the ability to demonstrate, just about every class period, how blurry the line can be between what is legal and what is ethical. What individuals must do as a matter of law and what they cannot do as a matter of law are very different from what they should do. I tell my students that outside the assessment of legal risk, "should" is a business decision, a science decision, an ethics decision, a public relations decision or some combination of all four--and it's one other people (clients) are going to make for themselves.
A tip of the hat Fran Miller who clued me in to some very recent events that provide a perfect example of the relationship between law, ethics and science in human subject research. Many will have read the New York Times article about a letter sent by the Office of Research Protection (OHRP) to the lead researcher University of Alabama at Birmingham (UAB) criticizing a study they had run in 23 major medical centers involving infants requiring oxygen support in the neonatal intensive care unit (NICU). Called the SUPPORT Study (and please follow the links--the complexities here are beyond a blog post), it was intended to find out the safe, but effective, limits for providing a premature infant supplemental oxygen. Too little oxygen, of course, affects breathing but too much oxygen, we have known for a long time, causes blindness. The babies were randomized to receive different levels of oxygen and the results measured.
Whether or not the study should have ever been approved is a matter of debate-the fact that many of the babies involved had worse results than they would have under standard of care and even the fact that one of the babies involved does not, in and of itself, mean that the study was illegal or unethical. Here's the explanation by the researchers themselves. This is the Government version.
The issue under dispute is not the study itself--it's the consent process. Soon after the letter became public and OHRP began the process of assessing wehther there should be sanctions, what in theory is OHRP's sister institution, the NIH which provided funding for the study, criticized the warning and supported the SUPPORT study (these puns are invevitable). And soon afterwards OHRP backed down--agreeing to hold a public hearing.
What's so interesting about this dispute for lawyers is cogently explained by Lois Shepherd, the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics, Professor of Public Health Sciences, and Professor of Law at the University of Virginia in her analysis posted at the Hasting's Center Bioethics Forum Blog. She points out that the ethicists and scientists supporting UAB don't necessarily disgree that the parents lacked complete information about the risks. That the law, in other words, wasn't complied with. But, they argue, the importance of the study outweighed a flawed consent process--and moreover, in a letter published by the New England Journal of Medicine they challenge OHRP's ability to, in essence, substitue it's judgment of whether disclosure was sufficient for that of the IRB giving initial approval.
That's a big deal. 45 CFR 46.116 specifies that consent for human subject research funded by the federal government must include (among other things--read the whole thing yourself) that "a description of any reasonably foreseeable risks or discomforts to the subject”; and “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.” According to OHRP and those who support it, UAB's experiment did not meet that standard because, among other things, it did not disclose to the parents that there was a risk of death.
But who decides whether or not the information was sufficient?
As a lawyer, I would say that the fact that Congress, in its infinite wisdom, set up a system in which OHRP has the power to review the decisions of individual IRB's answers this question immediately. Of course OHRP can substitute its judgment for that of the individual IRBS approving this study-that's what it's there for.
But in the real world, things are not so clear and it's always possible for Congress to change the balance of power. In my view that would be a huge mistake--it's hard to imagine what else has to happen in order to prove the point that when it comes to protecting human research subjects science cannot reglate itself. There must be outside oversight that reflects the view of the electorate at large--the general population of human subjects--rather that of those whose primary goal is to advance science.
Is it possible to have a system where the needs of the many outweigh those of the few? Where in the face of great benefit to all future premature infants it is acceptable to give some premature infants less than the standard of care? Sure--it's possible. But it's not how, so far, the United States has chosen to regulate human subject research.
The traditional rule in wrongful death cases is that a plaintiff cannot recover unless survival was more likely than not. This means that a healthcare practitioner who causes the death of a patient through a negligent act escapes liability when the patient had a less than 51% chance of survival before the negligent act. On the other hand, a patient who proves that he or she had a greater than 51% chance of survival will recover for the negligent act that causes death.
In May of 2013, the Supreme Court of Minnesota, in Dickhoff v. Green, followed a short line of cases recognizing as actionable a patients increased risk of dying resulting from her doctor’s negligent failure to secure timely diagnosis and treatment of cancer. In Dickoff, a physician failed to diagnose a lump on a baby as cancer for over a year. The baby was then diagnosed by another physician as having a rare and aggressive cancer. The baby subsequently underwent a tumor-removal surgery, chemotherapy and radiotherapy, but remained dangerously ill. A timely referral would have given the baby, at a minimum, a 60% chance of survival. The delay in diagnosis decreased this chance 40%. Thus, the plaintiff made out a prima facie case for a 20% reduction in her chances to stay alive.
Following other state courts, the Minnesota Supreme Court ruled that this reduction constitutes actionable damage in and of itself holding that a resident can successfully sue her doctor for an increased risk of the underlying illness’s recurrence and a decreased life expectancy as stand-alone damage. The only limitation that the Court placed on this cause of action is that the plaintiff's increased risk and decreased life expectancy must be substantial.
 Dickhoff v. Green, — N.W.2d —, 2013 WL 2363550 (Minn. 2013).
 See e.g., Hesrkovitz v. Group Health Cooperative of Puget Sound, 99 Wash. 2d 609, 664 P. 2d 474 (1983); DeBurkarte v. Louvare, 393 N.W.2d 131(Iowa 1986); Roberts v. Ohio Permanente Medical Group, Inc., 76 Ohio St. 3d 483, 668 N.E2d 480 (1996); Jorgenson v. Vener, 616 N.W.2d 366 (S.D. 2000).