Tobacco and Dietary Supplements – The Role of the FDA

By Joanna Sax

Thank you for inviting me to blog.  Later this week, I’ll be attending Harvard Law School’s Petrie-Flom Annual Conference on the FDA in the 21st Century.  My paper/presentation addresses the role of the FDA in the regulation of dietary supplements.  By way of preview, my paper compares similarities between the dietary supplement industry and tobacco.  Both industries have successfully avoided heavy regulation by the FDA. 

A tension exists between the personal choice/autonomy to use a variety of dietary supplements with the actual or potential health danger.  With the current light-handed regulation, costs for dietary supplements are much lower than they would be if they had to be approved by the FDA prior to market.  Some consumers believe that if a product says it is ‘natural’ then it must be safe.  This, however, is not necessarily true.  Would you eat any wild plant or mushroom just because it is natural?  I hope not.  In recent years, a number of adverse events, including death, have been shown to be correlated or caused by use of dietary supplements. 

It seems that some of the tactics employed by the tobacco industry to avoid regulation are similar to tactics employed by the dietary supplement industry.  My paper/presentation addresses what lessons we can learn from the tobacco industry to analyze if the FDA should be granted the authority to increase the regulation of the dietary supplement industry.  I hope to see you all in Boston.

Introducing Joanna Sax

We’re excited to introduce and welcome Joanna Sax as a guest blogger for the month of May.

Joanna is an Associate Professor of Law at California Western School of Law.  She teaches Contracts, Trusts & Estates and a seminar entitled Law, Science & Medicine.  Her main area of research is biomedical policy; specifically, how to create incentives to advance scientific research and protect scientific integrity.  In this area, Joanna has recently focused on issues such as financial conflicts of interest and the relationship of politics and science.  Another area of interest is FDA regulation; Joanna will be presenting at the upcoming conference on the FDA in the 21st Century hosted by Petrie-Flom.  Prior to focusing her research interests on the intersection of law and science, she was a molecular biologist and spent years researching cancer.

Joanna attended the University of Wisconsin – Madison, where she earned a B.S.  After undergraduate school, she was a pre-doctoral fellow at the National Cancer Institute.  In 1999, following her fellowship, she began a PhD program in Cell and Molecular Biology at the University of Pennsylvania School of Medicine.  In 2003, after earning a PhD, she entered law school at the University of Pennsylvania.  After law school, she spent 2 and a half years as an attorney at Morgan, Lewis & Bockius, LLP.  In 2009, Joanna joined the faculty at California Western School of Law.

Some of Joanna’s recent publications include:

Welcome, Joanna!

Blackjack and Cognitive Enhancement

Blackjack players who “count cards” keep track of cards that have already been played and use this knowledge to turn the probability of winning in their favor. Though many casinos eject card counters or otherwise make their task more difficult, card counting is perfectly legal. So long as card counters rely on their own memory and computational skills, they have violated no laws and can make sizable profits.

By contrast, if players use a device to count cards, like a smartphone, they have committed a serious crime. For example, several iPhone apps helps players count cards and at least one has a “stealth mode” that lets users surreptitiously enter data and receive feedback. In response, the Nevada Gaming Control Board issued an open letter reminding the public that using such an app when betting at blackjack violates the state’s antidevice statute which provides for up to 6 years imprisonment for a first offense. Somehow using a device to augment our abilities to remember and to calculate turns a perfectly legal activity into an offense with a very serious penalty.

The fact that we do not criminalize natural, unassisted card counting raises interesting questions of criminal and constitutional law: Could we criminalize natural card counting without violating fundamental principles that protect thought privacy? (Email me for a manuscript on that question.) In this recently published paper, however, I focus on a puzzle about technological enhancement. Namely, can we justify criminalizing device-assisted card counting but not unassisted card counting?

The importance of the question extends beyond the world of blackjack and casino gaming because it appears, at least superficially, that antidevice statutes criminalize a kind of technological enhancement. Some ethicists distinguish therapies that seek to return us to normal, healthy functioning from enhancements that promise to give us extraordinary abilities. People are often much more comfortable with therapies (e.g., drugs or devices to treat attention deficit disorder) than with enhancements (e.g., drugs or devices to give us better-than-normal concentration).

As a historical matter, casinos lobbied for antidevices statutes in the 1980s to protect their revenue as computers were becoming more popular and accessible. I focus on a deeper question: Is there any moral justification for permitting an activity, like card counting, when it uses only our natural abilities but severely punishing the activity when it is technologically enhanced? I consider a couple of possible justifications for the differential treatment and suggest that both are lacking.

[Adapted from Criminalizing Card Counting at the Blackjack Table; Originally posted at Prawfsblawg]

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.

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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.

Replies to the Organ Conscription Trolley Problem

Yesterday, I argued for more aggressive efforts to boost the supply of cadaveric organs available for transplant: If an out-of-control trolley were heading toward a living person strapped to the tracks, we surely ought to divert it to another track, even if doing so will crush a corpse along the alternate path. If we are permitted to crush a corpse when it’s the only way to save a life, even if the family of the deceased doesn’t want us to, then we can recover organs from the deceased when the invasion is fairly minimal (it won’t interfere with burial) and the gains are not one life but several. I emphasized an important qualification, however: we are not permitted to just take organs when we can obtain consent with less invasive approaches, like offering financial or priority incentives.

Commenter SG raised questions about whether trolley problems do a good job of testing our intuitions. There is certainly a lively debate about the reliability of trolley problem intuitions and the reliability of moral intuitions more generally. Despite pitfalls, I believe trolley problems can help us abstract away  morally irrelevant considerations. A family considering donation, for example, doesn’t know whose lives are in the balance. But we know that as a matter of policy, many lives end prematurely because lifesaving organs are wasted. Therefore, the trolley problem I posed helps us removes distractions and confront the loss of life more directly.

Commenter Mitch proposed a variation: Suppose the deceased on the alternate track is your recently-deceased loved one.  I have two replies: First, we need not frame the problem that way in order to draw conclusions about organ donation policy. The destruction of the corpse will be very upsetting to the family, but when we decide public policy, we typically abstract away from who our particular loved ones are. It would bias my hypothetical to stipulate that the living person is your relative, and it would bias the opposite way to assume the deceased was.

Second, even if the trolley problem were posed in this  fashion, you should still flip the switch if it’s the only way to save a living human. (Perhaps families should be excused from blame given that they must  decide under pressure while grieving, but that’s another matter). Interestingly, medical examiners frequently conduct autopsies in which consent is irrelevant. Some of these investigations may save lives by preventing murders. But organ donation is plausibly much more lifesaving than medical investigation.

One last point: It’s easy to think that our choices are to give up our organs or have them stay intact forever. Perhaps mandatory autopsies are viewed as different than conscripted donation because autopsies do not involve a prolonged “using” of someone’s organs. But the “using” happens either way. Your organs can be taken over by bacteria and insects or they can go to save living people. If we were better able to come to terms with such unpleasant facts, we’d more effectively save and heal the living.

[Originally posted to Prawfsblawg]

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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