February 17, 2012
Worth Reading This Week
Sara Rosenbaum & Tim Jost, All Heat, No Light — The States' Medicaid Claims before the Supreme Court, NEJM
Bradford DeLong & Ann Marie Marciarille, Bending the Health Cost Curve: The Promise and the Peril of the IPAB, SSRN
Mark A. Hall, Regulating Stop-Loss Coverage May Be Needed To Deter Self- Insuring Small Employers From Undermining Market Reforms, Health Affairs
February 15, 2012
O'Neil and Black on Fraud
We'll focus on the darker corners of medicine this week. First, Cathy O'Neil's post on Vioxx:
Let’s face it, nobody comes out looking good in this story. The peer review system failed, the FDA failed, Merck scientists failed, and the CEO of Merck misled Congress and the people who had lost their husbands and wives to this damaging drug. The truth is, we’ve come to expect this kind of behavior from traders and bankers, but here we’re talking about issues of death and quality of life on a massive scale, and we have people playing games with statistics, with academic journals, and with the regulators.
Just as the financial system has to be changed to serve the needs of the people before the needs of the bankers, the drug trial system has to be changed to lower the incentives for cheating (and massive death tolls) just for a quick buck. As I mentioned before, it’s still not clear that they would have made less money, even including the penalties, if they had come clean in 2000. They made a bet that the fines they’d need to eventually pay would be smaller than the profits they’d make in the meantime.
Second, William K. Black on the French entrepreneur extraordinaire behind the breast implants controversy:
Control frauds occur when the persons controlling a seemingly legitimate entity use it as a “weapon” to defraud. Such frauds occur in the private, NGO, and public sector. I write primarily about accounting control frauds because accounting is the “weapon of choice” for financial control frauds. . . .
Shareholders and creditors are the primary intended victims of accounting control fraud, which creates record, but fake profits. Other forms of control fraud create real profits. Anti-purchaser control frauds target the customer and involve deception as to the quality and/or quantity of the product. Anti-public control frauds target the public. Illegal logging, the illegal seizure and exploitation of mines, and purchasing goods one knows are likely to be stolen are examples of frauds designed to harm primarily the public. . . .
Poly Implant Prothese (PIP) was a French manufacturer of saline and silicone breast implants. The FDA found severe problems with PIP’s production of saline implants a decade ago and alerted PIP and its French regulatory counterpart to the problems in 2000. The FDA described the saline implants as “adulterated” due to eleven flaws in its manufacturing processes.. . .
PIP did not inform its poorer customers that it was illegally selling them inserts made with cheaper, unapproved industrial-grade silicon. PIP also did not inform its customers that “the casing around the filling was also faulty and prone to rupture or leakage'”
No sooner had [PIP's CEO] (for the second time) been found to have endangered his customers, than he was planning to go back into the business of producing and selling breast implants. [His business plan described the CEO] as a "creative genius". . . It takes a special kind of depravity to describe oneself as a “creative genius” after a life of defrauding one’s customers through means that put their health at undue risk.
Both are very troubling cases. [FP]
Stanford Law Review Articles Debate Virginia v. Sebelius
The Stanford Law Review has just published an interesting back-and-forth on Virginia v. Sebelius in their first print issue of the year, available at here. First, Kevin Walsh, Assistant Professor at the University of Richmond School of Law, writes about "The Ghost That Slayed the Mandate." Then, the Attorney General, Solicitor General, and Deputy Attorney General of the State of Virginia respond in "State Sovereign Standing: Often Overlooked, but Not Forgotten."
If you are interested in submitting a response for publication in SLR Online, here is the link.
O’Neill Institute Law Fellowships
The O’Neill Institute for National and Global Health Law is seeking exceptionally qualified candidates to serve as O’Neill Institute Fellows. Housed at Georgetown University Law Center in Washington, DC., the O’Neill Institute is a leading research institute for health law. For more details about the Institute and its ongoing work please visit www.oneillinstitute.org.
Fellows are based at the Law Center and report to the O’Neill Institute Director and to the Faculty Director. Law fellows work on academic legal research and scholarship projects. Duties include working closely with faculty to produce scholarly works for publication, in some cases leading to joint publication. Allocation of time is mainly determined by O’Neill Institute Faculty needs and taking into account fellow preferences; additionally, some time may be allocated to O’Neill projects. Fellowships are for one year with possible extension for two years, and will begin in July 2012. Fellows will receive an annual salary of $66,747 with great benefits.
Candidates should have a J.D. degree (or the equivalent), exceptional academic credentials, including publications, and health law-related research interests in areas like public health law, global health law, domestic health care law, empirical studies, regulatory impacts of health, health and human rights, etc. Successful candidates will have knowledge and/or experience in aspects of national and or global health law and ethics. A post-graduate degree (MPH, LL.M.), health degree, or significant work experience may be preferred.
Applications should be submitted electronically at the following website http://www.law.georgetown.edu/oneillinstitute/about/application-fellowship.html and must include: CV, cover letter, writing sample, professional references, official law school transcript, and other graduate school transcripts (if applicable).
The application deadline is Friday, February 29, 2012. Any questions about the position should be directed to email@example.com.
February 14, 2012
Physician-Assisted Suicide and the Slippery Slope
Last week's ruling by the Georgia Supreme Court provides further evidence that the slippery slope is not a real problem with a right to physician-assisted suicide. Since 1994, Georgia's assisted suicide ban prohibited the public promotion and provision of assisted suicide services, but did not reach the private decision of patient and physician to choose physician-assisted suicide. The court struck the law down on first amendment grounds--since it targeted those who publicly advertised or offered services but not others--but even while the law has been in force, there have not been any reports that physicians have misused their freedom to provide physician-assisted suicide privately.
According to a 1994 article in the Georgia State University Law Review, the legislature had rejected a broad ban, in part because it was worried about chilling palliative or other legitimate end-of-life care, but also because it did not want to interfere with private decisions of patient and physician for physician-assisted suicide.
The statute was passed at a time when Jack Kevorkian was actively assisting suicides in Michigan, and the legislature was concerned about him, or someone like him, promoting the practice in Georgia.
Georgia's experience with physician-assisted suicide adds to reassuring evidence about the slippery slope from other states and other end-of-life practices. Oregon has permitted assisted suicide by statute for nearly 15 years, and the state's annual reports tell us that patients rarely use physician-assisted suicide (about 1/5 of one percent of deaths in Oregon), and that it has not placed vulnerable patients at risk. Users of assisted suicide are just as likely to have health insurance or receive hospice care as other terminally ill patients, and they tend to be better educated. Washington and Montana have permitted assisted suicide by statute or court decision for only a few years, but in neither state is there evidence of a slippery slope.
One also can look to the experience with palliative sedation for reassurance about the slippery slope. As I have written, physicians can just as easily--and perhaps more easily--abuse their authority to palliatively sedate patients, and they have not done so. (Once called terminal sedation, palliative sedation is provided to terminally ill patients whose pain or other suffering can be addressed only by medicating the patient into an unconscious state. Once sedated, patients usually die soon, either from their illness or because artificial nutrition and hydration is withdrawn.)
It will be interesting to see if the Georgia legislature adopts a new assisted suicide ban. After the Montana Supreme Court concluded in 2009 that "a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician," the legislature did not pass a prohibition. As they consider the issue, Georgia legislators can know that failing to pass a statute will not put patients in the state at risk of abuse.
[cross posted at The Faculty Lounge]