May 22 (note new date): Dan Brock delivering the Gay Lecture on “The Future of Bioethics”

Please join the Division of Medical Ethics for:

The 2013 George W. Gay Lecture in Medical Ethics

Dan W. Brock, PhD
Frances Glessner Lee Professor of Medical Ethics, Department of Global Health and Social Medicine, HMS

“The Future of Bioethics”
Wednesday, May 22, 2013 (note new date)
4:00 PM

Harvard Medical School, Tosteson Medical Education Center

Carl W. Walter Amphitheater
260 Longwood Avenue, Boston

Please pass this invitation along to other interested friends and colleagues.
RSVP to  DME@hms.harvard.edu.

The George W. Gay Lecture is the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. The lectureship was established in 1917 by a $1,000 gift from Dr. George Washington Gay, an 1868 graduate of HMS. Since its inception, many of the nation’s most influential physicians, scientists, researchers and social observers, including Erich Fromm, Felix Frankfurter, Margaret Mead, Elizabeth Kübler Ross, E.O. Wilson, and Joshua Lederberg have given the Gay Lecture. Elie Wiesel, Marian Wright Edelman, Paul Krugman, Nicholas Kristof and Donald Berwick have given recent Gay Lectures.

 

The High Price of Drugs – and Why Doctors Should Care

By Ryan Abbott

A few days ago, a group of more than 100 experts in chronic myeloid leukemia (CML) published an article in the medical journal Blood to draw attention to the prices of anti-cancer drugs and the effects of these prices on individual patients.

The authors note that three new drugs were approved by the FDA for CML in 2012, all of which were priced at “astronomical levels.” Of the 12 anti-cancer drugs approved by the FDA last year, 11 were priced above $100,000. This represents a doubling of prices from a decade ago. The authors claim that these prices “are too high, unsustainable, may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems.”

The cost of medicines is a controversial issue. Proponents of allowing the pharmaceutical industry to set its own prices argue that high prices are needed to incentivize new drug development. According to PhRMA, the cost of new drug approval is around $1.2 billion, although some independent experts put that price as low as $75 million. Yet, whatever the benefits of high prices, it is clear that high prices create a barrier to patient access to medicines.

Read More

More on NSF and NIH Funding

By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.

 

Petrie-Flom Interns’ Weekly Round-Up: 4/20-4/26

By Hyeongsu Park and Kathy Wang

  • Harvard University announced on Wednesday that it would shut down its primate research center over the next two years. The facility has been cited for animal welfare violations, but the university said that it was closing the research center due to a tough economic climate.
  • After a federal judge recently ordered the Food and Drug Administration to make the morning-after pill available to women of all ages without a prescription, a New York Times article discusses a broader issue that follows: whether birth-control pills should require a doctor’s prescription. Various groups, gynecologists, and politicians are sharply divided on this issue. The author discusses procedural hurdles and safety issues around making the morning-after pills over-the-counter drugs.
  • Utah recently became the first state to explicitly permit general prisoners (not death-row inmates) to donate their organs if they die while incarcerated. The New York Times introduces discussions among various academic and health professionals regarding the law allowing prisoners to become organ donors.
  • After Colorado voters approved a measure in November legalizing small amounts of marijuana for recreational use, Colorado legislators will discuss taxes on marijuana and the plan to use the tax revenues this week. The legislators are considering excise and sales taxes on marijuana of up to 30 percent combined. The goal is to set taxes high enough to finance the administration of new laws, but not so high that customers are driven back to the black market.
  • A group of Texas optometrists is lobbying the State Legislature for more power to negotiate contracts with health insurance companies, and the measure they support could hit consumers’ wallets.
  • British antitrust authorities accused the pharmaceutical giant GlaxoSmithKline of paying three rivals to delay the introduction of a generic version of antidepressant drug.
  • A Pennsylvania judge on Tuesday threw out three of seven murder charges against Dr. Kermit Gosnell, who was charged with killing viable fetuses while performing abortions.

A Tale of Two Polities

By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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The Organ Conscription Trolley Problem

Yesterday, Glenn discussed paying people to donate nonessential organs while they are alive. I will argue that we ought to more aggressively incentivize organ donations from the recently deceased.

Imagine that an out-of-control trolley is heading toward an innocent person who is for some reason strapped to the trolley tracks. You happen to be standing near a switch that can divert the trolley to a different track and represents the only available means of saving the person. Here’s where this trolley problem gets much easier than others you’ve seen: If you divert the trolley, it will unavoidably crush the body of an already-deceased person who is strapped for some reason to the diversion track. Are you morally permitted to flip the switch to save a life when doing so will crush a deceased person? Clearly you are. Indeed, you are morally obligated to do so.

What if the family of the deceased is standing nearby and urges you not to, pleading that if their loved one’s remains are crushed, it will interfere with his religious preferences about burial? No matter how much it upsets the family and would have upset the deceased, you are  permitted to divert. Now what if diverting  would save not one life but six or seven? And what if the trolley wouldn’t crush the deceased beyond recognition but would merely cause some internal change that would be invisible at burial? Surely the answers only become easier.

If you’ve answered as I have, we should be permitted to take the organs from the recently deceased when doing so represents the only way of saving the six or more people who need those organs to survive. Does this mean we should implement a routine salvage program where people must donate if they die with organs available for transplantation? Not necessarily. There may be financial or priority incentives that will induce sufficent donation such that we don’t have to go so far as to conscript lifesaving organs. But our current practices cause far to much unnecessary death and misery. See here and here for more. [Originally posted at Prawfs]

Impact of the “Lander Brief” in the Myriad Case – and an answer to Justice Alito’s Question

 [Cross posted at Prawfsblawg.com]

The Supreme Court heard oral arguments on April 15 in Association of Molecular Pathology et al. v Myriad, concerning whether human genes are patent-eligible subject matter. The case focused on Myriad’s patents on two genes, BRCA1 and BRCA2, involved in early-onset breast cancer.

Surprisingly, many of the Court’s questions for Myriad’s counsel focused on what Justice Breyer dubbed the “Lander Brief” – an amicus filed on behalf of neither party by one of the country’s leading scientists, Dr. Eric Lander. (Lander was one of the leaders of the Human Genome Project and co-chair’s the Presidents Council of Advisors on Science and Technology.) [Full Disclosure: I am one of the authors of this brief.] Justices Breyer, Ginsburg and Alito referred to the brief by name, and several other Justices were clearly influenced by the information in the brief.

I believe that the “Lander brief” was a hot topic of conversation because the Justices realized that it was central to applying the Court’s product-of-nature doctrine to DNA. Importantly, the brief demolished the scientific foundation of the Federal Circuit decision on appeal. The Federal Circuit panel held that human chromosomes are not patent-eligible because they are products of nature, but a majority found that “isolated DNA” fragments of human chromosomes (such as pieces of the breast cancer genes) are patent-eligible. The Federal Circuit’s distinction rested on its assumption that (unlike whole chromosomes) isolated DNA fragments do not themselves occur in nature, but instead only exist by virtue of the hand of man. Read More

Transplant Tourism: Hard Questions Posed by the International and Illicit Market for Kidneys, New Article I Wrote

[Cross-Posted at Prawfsblawg]

The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.

Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.

I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.

I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.

While We Sleep?

By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?