Category: Health Law

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Bones and Genes: Fortune’s Bones Redux

As a follow up to my post last week asking about human dignity, unburied bones and ownership of human cells, here are two related issues that appeared in the Sunday news.

The first item from Sunday’s Baltimore Sun is the belated report of a Reuters story about the controversy over disposition of King Richard III’s newly discovered remains uncovered in a municipal parking lot by the University of Leicester.  The long-lost remains of the King, who died in 1485, were exhumed, and the University was given permission to re-inter the remains in Leicester. But the King’s descendants objected claiming that they were not “consulted … over the exhumation and the license allowing the university to re-bury the King, and [that] this failure breached the European Convention on Human Rights.” They want the body buried in York.

The second item is an op-ed by two medical school academics, Jeffrey Rosenfeld and Christopher E. Mason, that appeared in Sunday’s Washington Post about Association for Molecular Pathology et al v. Myriad Genetics, et al, a case that will be argued in the Supreme Court on April 15th. This is important case that has been mentioned on this blog as recently as last February.  SCOTUS even featured a symposium spurred by the controversy. At issue is whether, on some level, human genes are patentable. Rosenfeld and Mason oppose patenting DNA.  On the other hand, much like the researchers discussing the HeLa cell, the respondents, Myriad Genetics, et al, argue that the issue is much narrower, namely whether the “human” aspect of the specific sequence of isolated human DNA is the result of the efforts of the respondent, and thus patentable. Read More

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Fortune’s Bones: Is There Dignity after Death?

In 1995 Gunther von Hagens presented his Body Worlds exhibit, described as a collection of real human bodies that have been “plastinated” to prevent their decay and make them more malleable. Some of these plastinated bodies were cut open to reveal their inner organs and then positioned in lifelike poses. The exhibit toured the world and was wildly popular.

Body Worlds also generated some criticism. Canadian social scientist, Lawrence Burns, argued that “some aspects of the exhibit violated human dignity.” (7(4): 12-23 Amer. J. Bioethics 2007)  Although touted as an educational experience Burns and others worried that the bodies were being used as “resources to make money from the voyeurism of the general public.” A key concern was that the bodies were denied burial and that this was a dignitary affront. Burns conceded, however, that the concept of human dignity as applied to deceased individuals is unclear.

I started to think about whether there is dignity after death and, if so, what are its parameters, when I read a news article from the New Haven Register, about the skeleton of an enslaved man that was being studied by the anthropology faculty and students at Quinnipiac University prior to burial.

The enslaved man who died in the 1798 (slavery was not abolished in Connecticut until 1848), was named Fortune. At the time of his death Fortune was the human chattel of a Waterbury Connecticut physician who upon Fortune’s death boiled his body to remove the flesh keeping his skeleton to study human anatomy. Fortune’s body remained unburied and was on display as late as 1970 at the Mattatuck Museum where until recently it was still housed. Read More

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Volume 60, Issue 3 (February 2013)

Volume 60, Issue 3 (February 2013)


Articles

Urban Bias, Rural Sexual Minorities, and the Courts Luke A. Boso 562
Private Equity and Executive Compensation Robert J. Jackson, Jr. 638
The New Investor Tom C.W. Lin 678


Comments

The Fate of the Collateral Source Rule After Healthcare Reform Ann S. Levin 736
A New Strategy for Neutralizing the Gay Panic Defense at Trial: Lessons From the Lawrence King Case David Alan Perkiss 778

Comparing Aetna and Medicare: $30 vs. $4 a claim

Steven Brill has a remarkable article in Time on health care. Perhaps the paragraph that stood out the most to me was this one:

[T]he only players in the private sector who seem to operate efficiently are the private contractors working — dare I say it? — under the government’s supervision. They’re the Medicare claims processors . . . . Medicare’s total management, administrative and processing expenses are about $3.8 billion for processing more than a billion claims a year worth $550 billion. That’s an overall administrative and management cost of about two-thirds of 1% of the amount of the claims, or less than $3.80 per claim.

According to its latest SEC filing, Aetna spent $6.9 billion on operating expenses (including claims processing, accounting, sales and executive management) in 2012. That’s about $30 for each of the 229 million claims Aetna processed, and it amounts to about 29% of the $23.7 billion Aetna pays out in claims.

I’ll soon be publishing an article looking at public-private partnerships in Medicare and Medicaid. I, too, was impressed by many contractors, however much remains to be done to optimize their performance. The other lesson: the harder one looks at the supposedly “public” or “private” parts of our health care system, the more one realizes how imbricated they are. The categories simply cease to be meaningful in the context of US health care (and increasingly outdated in our finance, telecom, and other industries, as well).

Get Well Soon–or Else

There is a good debate in the WSJ on the wellness programs recently promoted by PPACA. Market-oriented thinkers have long promoted the “nanny corporation” to exert influence over workers’ lives. But as Lydia Mitts notes, this may be disadvantaging certain people:

A workplace wellness program in Wisconsin increased overweight employees’ premiums by more than $100 a month if they didn’t meet goals such as losing weight, which evidence shows can be very challenging. That kind of increase creates a real cost barrier for many families. The last thing a wellness program should do is make health coverage less affordable for those with greater health risk factors and whose health could most benefit from certain health services. Studies have found that being uninsured or underinsured leads people to delay or forgo needed care, making them sicker—and their health care costs higher—down the line.

On the other hand, it could be quite rational for an individual corporation to alienate and browbeat the people whom it sees as most likely to drive up its health care costs, as long as it can avoid running afoul of disability laws. The higher health care costs “down the line” may then rest on the balance sheet of the next employer—or the government.

Shoves, Nudges, and Freedom

Cass Sunstein reviews a book by Sarah Conly on coercive paternalism in the NYRB this month:

A natural objection [to paternalism] is that autonomy is an end in itself and not merely a means. On this view, people should be entitled to choose as they like, even if they end up choosing poorly. . . . Conly responds that when government makes (some) decisions for us, we gain not only in personal welfare but also in autonomy, if only because our time is freed up to deal with what most concerns us. . . .

Conly’s most controversial claim is that because the health risks of smoking are so serious, the government should ban it. She is aware that many people like to smoke, that a ban could create black markets, and that both of these points count against a ban. But she concludes that education, warnings, and other nudges are insufficiently effective, and that a flat prohibition is likely to be justified by careful consideration of both benefits and costs, including the costs to the public of treating lung cancer and other consequences of smoking.

As Big Beverage’s tactics come closer and closer to those of big tobacco, might it be the next target?

For those who’d like government to influence decisions in subtler ways, check out Kate Greenwood’s review of recent health care proposals from Richard Frank and Christopher Robertson. Very interesting ideas there.

RUC-rolled

A few years ago, I noted that the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) has a dominant role in suggesting payment levels to CMS.  It raises hard questions about price-setting in the health care sector, many of which cannot be answered because its processes are opaque.  Now we know that judicial relief will not improve things any time soon.  As Brian Klepper reports, “On January 7, a federal appeals court rejected six Georgia primary care physicians’ (PCPs) challenge to the Centers for Medicare and Medicaid Services’ (CMS) 20-year, sole-source relationship with the secretive, specialist-dominated federal advisory committee that determines the relative value of medical services.”  What was the complaint?

The core of the … physicians’ legal challenge was that the RUC is a “de facto Federal Advisory Committee,” and therefore subject to the stringent accountability requirements of the Federal Advisory Committee Act (FACA). This law ensures that federal bodies have panel compositions that are numerically representative of their constituencies, that their proceedings are open, and that methodologies are scientifically credible. In other words, FACA ensures that advisory practices are aligned with the public interest.

Read More

Weighty Matters

Here is an interesting article on BMI from the UK:

The body mass index has been around since Belgian scientist Adolphe Quetelet invented it in the 1830s and was designed to approximate whether people have a healthy weight.  Nick Trefethen of Oxford University’s Mathematical Institute has identified a flaw in the basic formula for BMI, and has created a new calculation which he says better accounts for the relationship between height and weight.

According to Mr Trefethen, the current formula to calculate the score (weight/height2) is incorrect because “it divides the weight by too large a number for short people, and too small a number for tall people. So short people are misled into thinking they are thinner than they are, and tall people are misled into thinking they are fatter than they are.”

Of course, even the new BMI isn’t that great an indicator.  Dr. Robert Lustig argues for a more granular approach, focused on visceral fat. Expect more controversy over biomarkers and wellness programs, as well as the inevitable privacy concerns about close monitoring of weight, waistlines, and more.

Goldacre on Pharma Research Credibility

Ben Goldacre is once again arguing that pharmaceutical “industry-funded trials are too common, can’t be trusted — and bring pills to market that likely don’t work.” The NY Times features his argument today. He has exhaustively compiled problematic practices that add up to a shocking claim: “the entire evidence base for medicine has been undermined by a casual lack of transparency.” For example, here’s one vignette from his most recent book:

In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation — searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators — they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.

When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.

I have not come across a convincing industry, FDA, or Richard Epstein response to Goldacre’s work. (I don’t find this brief letter particularly compelling.). He offers several case studies like the reboxetine one. Isn’t it time to fund systematic reviews of the evidence of effectiveness on all drugs?

A recent lawsuit against the FDA will test its usual trade secret rationale for failing to require drug companies to release all data from trials. If it succeeds, systematic reviews may be easier to complete, and will help save patients from the scourge of unnecessary or ineffective drugs. In the current information environment, perhaps the best hope we have is big data leading to more personalized comparisons of treatment effectiveness.