Dec 8-10: Seminar Series on Social Medicine in South Africa

By Kelsey Berry

The Harvard School of Public Health Department of Global Health and Population (GHP) is hosting what promises to be a fascinating 2-seminar series on Monday Dec 8 and Wednesday Dec 10 entitled: “A Practice of Social Medicine: South Africa and Beyond.” This event should be of interest to those thinking about models for Universal Health Coverage, community-based approaches to health, history and sociology of medicine and health care delivery, and population-level ethics.

The series will feature Professor Shula Marks, Emeritus Professor, University of London, and Fellow of the British Academy.

A word from the organizers: For just over a decade in the mid-twentieth century, perhaps somewhat surprisingly, South Africa was widely acknowledged as being in the forefront of progressive thought in health care delivery, its distinctive social conditions and developed medical practice making possible an experiment in social medicine with far-reaching implications.  These two lectures trace the story to its South African roots in the 1930s and 1940s, its propagation via the subsequent diaspora of progressive physicians, and its links to kindred developments throughout the world.  Its vision of a community-based, equitable, effective, inclusive, low cost approach to health emphasizing prevention and education may offer a distinctive model for Universal Health Coverage.

*The first lecture South Africa’s Experiment in Social Medicine, 1940-1960: A Model to the World? will be held on Monday December 8th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208.

*The second lecture Social Medicine in South Africa, 1960s to the Present will be held on Wednesday December 10th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208

For non-Harvard affiliated attendants, please email mclark@hsph.harvard.edu to arrange for access to the buildings in advance.

The Civil Rights Movement and the Blood Supply

By Emily Largent

This year marks the 50th anniversary of the Civil Rights Act of 1964, and this semester, I have been fortunate enough to take a class on the Civil Rights Movement with Professor Randall Kennedy.  This has prompted me to examine the influence of race on healthcare delivery in the 1940s, ’50s, and ’60s.  Racism infected all aspects of the healthcare system, including medical schools and schools of nursing, residencies and post-graduate training, professional societies for doctors and nurses, ambulance services, outpatient clinics, staff privileges at hospitals, hospital admissions, and medical research.  Doubtlessly, the color line in medicine compounded physical ills with emotional and dignitary harms.

I find the stories related to the segregation of the American blood supply during World War II to be particularly interesting because they show that discrimination was a national (i.e., not just a Southern) problem, and there is a small connection to Harvard Law School.  Speak Now Against the Day: The Generation Before the Civil Rights Movement in the South by John Egerton has proven to be an excellent source of information on this topic.

Blacks made contributions to the war effort in many capacities.  William H. Hastie, a graduate of Harvard Law School, took leave from his position as Dean at Howard University School of Law (HUSL) to accept an appointment as civilian aide to Secretary of War Stimson.  Charles R. Drew, a physician who had conducted pioneering research on typing, preserving, and storing blood for later transfusion, helped both Britain and the United States establish blood programs to support military operations. In February 1941, Drew was made medical director of the American Red Cross blood bank program.

Late in 1941, the surgeons general of the United States Army and Navy informed the Red Cross that only blood from white donors would be accepted for military use.  Although it had been conclusively proven that there were no racial differences in blood, the military yielded to prevailing social bias and heavy political pressure.  In January 1942, the War Department revised its position, agreeing to accept blood from black donors, though also insisting on rigid adherence to segregation of the blood supply.  The Red Cross not only accepted that decision but declared that it had no interest in trying to settle racial-social controversies.  Later, Red Cross officials “suggested that those who persisted in criticizing the policy were unpatriotically attempting to cripple the blood donor service and thus harm the war effort itself.”  Continue reading

Call for Proposals: The 2016 Brocher Foundation Residencies

By Timo Minssen

I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.

A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.

The following information has been extracted from the webpage of the Brocher Foundation:  Continue reading

The Constitutional Implications of Ebola: Civil Liberties and Civil Rights In Times of Health Crises

Join us for an important public forum:

Constitutional Implications of Ebola:
Civil Liberties & Civil Rights In Times of Health Crises

This public forum addresses the constitutional and public health implications of Ebola response in the United States.  According to state and federal laws, patient information is deemed private and is to be held in strict confidentiality.  However, in the wake of Ebola, well-established protocols to guard patient privacy have been neglected or suspended without public debate.  At this forum, a panel of experts raise questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy, civil liberties, and civil rights.  To what extent are Americans’ Ebola fears influenced by the origins of the disease?  What liberties are Americans willing to sacrifice to calm their fears?  How to balance the concern for public welfare with legal and ethical privacy principles?

Speakers: Reverend Jesse L. Jackson, Sr.;  Michele Goodwin, Chancellor’s Chair, UC Irvine School of Law;  Professor Andrew Noymer, UC Irvine School of Public Health; and Dr. George Woods, American Psychiatric Association.

This Forum intervenes in the current national and international discourse on Ebola by probing law’s role in addressing public health crises.  This forum is free and open to the public.

WHEN: Wednesday, November 19, 2014, 3.30pm-5.30pm

WHERE: University of California Irvine, School of Law; ROOM EDU 1111, 401 E Peltason Dr, Irvine, CA 92612

FOR HARVARD STUDENTS: TOMORROW: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

FOR HARVARD STUDENTS: 4/16: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

Snotty Hand-Washing

Hand-washing is one of the mainstays of public health and of good clinical practice. Images of surgeons with their hands raised in the air, as they enter the OR to have a nurse help them don sterile latex gloves after having meticulously washing their hands, have been immortalized by pop-culture representations of medicine. Indeed, learning the “surgical hand-wash” is one of the glorified coming-of-age rituals for med students. It quite literally initiates aspiring physicians into being legally and morally allowed to cut people open for their own benefit.

Proper hand-washing is crucial for non-surgical clinical practice as well. At my hospital, clinicians are supposed to wash or sanitize their hands as soon as they enter a patient’s room, and after they have made any contact with a patient. And although the procedure for “clinical hand-washing” is much less thorough than its surgical counterpart, there’s still an evidence-based, 11 step process that WHO officially recommends in its annual “SAVE LIVES: Clean Your Hands Campaign.

The rationale for all this rigor in medical practice is pretty obvious, and any hospital-based physician who doesn’t have overly dry skin without moisturizing is probably shirking an important responsibility. However, the clinical obsession over asepticism has spilled over to mainstream culture, but not without some controversy.

Relax: I’m not going to get into the debate over the hygiene hypothesis. I’m also not even going get back on the bacterial-resistance soapbox (except for one quick point–although asepticism in clinical settings certainly does help prevent resistance, it might be counterproductive beyond the clinical setting as wiping out benign bacteria might simply open more ecological space for nastier bugs).

I just want to point out that simple repugnance is probably a better explanation  for the hygiene-neurosis of current times than any legitimate public health concern. Normal people today would probably have seemed like obsessed germophobes fifty years ago. What’s interesting is there’s lots of neat evidence that even the most visceral types of disgust are socially constructed. For example, Norbert Elias’ treatise on snot in “The History of Manners” (1982) describes dinner-table behavior that was deemed perfectly polite by in the most sophisticated European social circles of previous centuries, but which would probably make even the coarsest sailor of today vomit in disgust. I’ll leave you with some highlights, taken from pages 143-148 of this wonderful (yet long, two volume) work by Elias.

Continue reading

FSMA Conference Part 3: Regulating Farm Production: From Zero to Sixty

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond."  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jason St. John, JD candidate, Harvard Law School

The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety and Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.

Continue reading

Art Caplan on “Accepting Brain Death”

Art Caplan has a new piece, co-authored with David C. Magnus, Ph.D. and Benjamin S. Wilfond, M.D., in the NEJM, addressing the legal and medical reasons for accepting brain death as death. From the article:

Over the past several decades, brain death has become well entrenched as a legal and medical definition of death. It is clearly defined by the neurologic community [...], standards for diagnosis are in place, and it is established in law. It has become the primary basis of organ-procurement policy for transplantation. Ironically, the other standard for defining death, irreversible cessation of circulation, lacks consensus about diagnosis.

The concept of brain death has periodically come under criticism.4  Continue reading

Ethics and Oversight in Recombinant Genetic Research

By Michael Young

In 1972, biochemist Paul Berg and his student Janet Mertz published groundbreaking details of their first successful attempt at devising a procedure to cleave separate pieces of DNA and recombine them into a single novel molecule.  These innovations, dubbed recombinant DNA (rDNA) technology, spurred a flurry of concerns from members of the scientific community who worried about the safety, risks and potential drawbacks of creating recombinant DNA molecules.  Motivated by these concerns, the NIH established the Recombinant DNA Molecule Program Advisory Committee (RAC) in 1974.  The RAC was charged with the mission of overseeing research and implementation of rDNA technologies, with a particular focus on proposals involving the transfer of recombinant or synthetic DNA into humans (i.e., human gene transfer).

Last week, after nearly 40 years of providing an additional layer of oversight to this class of research, the RAC received recommendations from an independent Institute of Medicine (IOM) committee that was convened to assess “whether the current oversight of individual gene transfer protocols by the Recombinant DNA Advisory Committee (RAC) continues to be necessary.”

The committee’s report calls for significant changes to the prevailing structures of rDNA research regulation and oversight, and represents a victory for many gene transfer researchers who have challenged RAC regulations. Continue reading

A disenfranchising effect of the right to health?

By Julian Urrutia

Human rights embody the humanist egalitarian principle that all human beings are morally important, and that they are morally important simply because of their humanity. Princes and paupers, bankers and bums, women and men . . . we’re all subjects of human rights that are not contingent on anything other than our humanity.

There is widespread agreement that the rise of humanism is one of the most important milestones in the history of moral progress. However, it also clear that the rise of humanism did not, by itself, bring us all the way down the path of progress to where we are today: throughout colonial history, for example, humanism failed to deliver us from outrageous discrimination when the boundaries of humanity were delineated too narrowly.

Humanists are just as prone to inhumane conduct when they fail to recognize other’s humanity. When we determine what is human (and must therefore be treated with respect), we tacitly also determine what is un-human (and can therefore be exploited). As Carl Schmitt put it “Given the coherence of this two-sided aspect of humanity, it should be remembered that Bacon opposed the axiom homo homini deus to that of homo homini lupus.” (The nomos of the earth, 1950)

That’s why contemporary, liberal constitutions that recognize human rights are so great. All people are recognized as being equally human, and therefore equally subjects of human rights. This is certainly a form of moral progress. However, narrow human rights-based approaches to politics, legislation and policy-making can have similarly perverse consequences as narrow forms of humanism. Instead of delivering us from outrageous discrimination, marginalization and exploitation, a narrow focus on rights might confine us to them. For example, there is growing evidence that human-rights-based legislation and litigation often fails to achieve an effective enjoyment of the right to health to among those who need it most. Even more troubling is the possibility that, sometimes, rights-based approaches not only have little positive effects, but might in fact lead to further marginalization and disenfranchising of the poor.

Continue reading

Racism in Transplant Denial? Or Too Few Hearts To Go Around?

Anthony Stokes, a fifteen year old kid from Decatur County, Georgia, is expected to die in a matter of months, according to his doctors at the Children’s Healthcare of Atlanta.  Maybe, they say, he will live for six months.  Who knows?  Anthony suffers from an enlarged, increasingly less functional heart.  His condition is not unusual, and a reasonably effective cure is at hand: a heart transplant. (Learn more about Anthony’s story here.)

However, Anthony has become the latest victim of a dysfunctional U.S. transplantation system, which tempts Americans with a transplant waiting list, but kicks them off if they become too sick or too old.  The problem is that there are too few organs to meet demand, and this perennial problem receives far too little attention from Congress.  Indeed, the U.S. transplantation list, coordinated by the United Network for Organ Sharing, UNOS, (a private organization that coordinates significant aspects of the U.S. transplant system) is so overcrowded that patients increasingly turn to black markets in India, China, Pakistan, South Africa, and other countries if they hope to survive.  (Learn more about that here.) Congressional hearings document Chinese prisoners dying and shortly thereafter Americans receiving organs.

Anthony’s family and some local organizations claim that racism is behind doctors refusing to place the boy on the transplant list.  Anthony is African American.  They ask, what is the harm in letting him on the list?

Continue reading

Art Caplan on the NIH’s Agreement Regarding Control of Henrietta Lacks’ Cells

Art Caplan has a new opinion piece up at nbcnews.com on the longstanding controversy over the use of the cells of Henrietta Lacks, a poor African American woman who died of cervical cancer in 1951, for research that has generated billions of dollars through scientific research over more than six decades. This research was conducted without Lacks’ or her family’s consent. According to a new NIH agreement with the Lacks family:

Lack’s genome data will be accessible only to those who apply for and are granted permission. And two representatives of the Lacks family will serve on the NIH group responsible for reviewing biomedical researchers’ applications for controlled access to HeLa cells. Additionally, any researcher who uses that data will be asked to include an acknowledgement to the Lacks family in their publications.

The new understanding between the NIH and the Lacks family does not include any financial compensation for the family. The Lacks family hasn’t, and won’t, see a dime of the profits that came from the findings generated by HeLa cells. But this is a moral and ethical victory for a family long excluded from any acknowledgment and involvement in genetic research their matriarch made possible.

Read the full article here.

Too Young For Sex, But Old Enough For The Sex Offender Registry, Part III

I conclude Part III in this series from Uganda—a nation recovering from what one doctor describes as a “genocide” from HIV and AIDS. Parts I and II can be found here and here.

As a society, do we really care that teens and preteens have sex? On the one hand we care too much—so much so that the criminal law is the central form of regulating teen sex. This form of regulation is derived from statutes that treat all sexual behavior alike, even though consent and context may drastically vary.  In Law’s Limits: Regulating Statutory Rape Law, found here, I articulate why the criminal law approach, filtered through the judiciary, leads to absurd results. These absurd results include the extralegal punishments inflicted on youth who are punished for participating in consensual sexual activity, such as lifelong registration as a sex offender. These types of consequences and outcomes are problematic because they are morally wrong and foster significant harms across a series of areas, including creating social status harms, by reifying racial and homosexual stereotypes. The criminal law approach also leads to cruel and unusual punishments in an era where sex offender registries are increasingly the norm and a condition of release from prison.  On inspection, such punishments are disproportionate and unjustified.

On the other hand, maybe we care too little about teen sexuality. The notorious Steubenville, Ohio rape case bears this out (where the rape victim suffered backlash and threats), as do the high rates of HIV, sexually transmitted diseases, and syphilis infections among teens, and teens’ relatively high use of alcohol and drugs prior to sex. Parents fail to talk to their children about sexuality when children most need to understand it: prior to commencing sexual experimentation. Empirical data shows that fathers barely speak to their daughters about sex and these omissions may impact their daughters’ sexual attitudes and behaviors. Governors and prosecutors sometimes demonstrate selective interest in teen sexuality—when it involves specific ethnic populations or the poor. This failure to care enough is manifested in the criminal law approach to shaping teen sex norms, rather than the public health where it is most justified.

So, how might we move forward? Continue reading

Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

Continue reading

Twitter Round-Up (3/31-4/6)

By Casey Thomson

This week’s slightly belated round-up concerns palliative care across cultures, the threat and problems of over-prescribing, and Big Pharma’s failure to create prices with the patient in mind. Read on for more from this week’s round-up.

  • Alex Smith (@AlexSmithMD) retweeted a piece on the lessons learned by Dr. Vvjeyanthi “V.J.” Periyakoil on how to approach palliative care for patients from a variety of backgrounds in ways that both extend life and fulfill the desires of the patient (in particular, reducing pain). (4/3)
  • Alex Smith (@AlexSmithMD) also retweeted an opinion piece in the NYT about the growing trend towards self- and over-medication, and the problems of overextending definitions of medical ‘conditions.’ As the piece’s author summarized: “The D.S.M. would do well to recognize that a broken heart is not a medical condition, and that medication is ill-suited to repair some tears.” (4/3)
  • Daniel Goldberg (@prof_goldberg) retweeted a link on two new wrongful death lawsuits against the NFL, which claim that the NFL withheld knowledge of the risks associated with concussions from players, that have been added to the string of other brain injury lawsuits filed against the league. (4/3)
  • Daniel Goldberg (@prof_goldberg) additionally retweeted a blog post on the striking results of a new study comparing male and female mortality amongst counties in the United States. While male mortality increased in only 34% of counties from 1992-1996 to 2002-2006, female mortality increased in 42.8%. This brings up questions concerning the cause of this demographic and largely geographic inequality, and what such a differential could mean on the health of dependents (children). (4/3)
  • Daniel Goldberg (@prof_goldberg) posted another article that put the recent New York “True Cost” campaign in historical context. The article called the campaign a “modern manifestation of…anxieties about the ‘contagion’ of working class and poor communities,” comparing it to the World War II-era venereal disease campaigns and the case of Typhoid Mary as all moralizing weapons aiming to instill shame rather than promote actual solutions to public health concerns. (4/4)
  • Arthur Caplan (@ArthurCaplan) linked to his own discussion of the problem with Novartis and India, noting that emphasis has been wrongly placed on patents when the concern should be on pharma’s hesitancy to create a pricing strategy that can provide medications for those who cannot afford huge prices. This unwillingness to do so, he claims, is violating a moral obligation. (4/4)

Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?

By Jonathan J. Darrow

Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness.  Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not applied locally but taken internally.”  The purported active ingredient? “[H]aemoglobin.”  (see Secret Remedies (1909), page 114).

While the medicinal use of a seahorse or dried blood matter may sound fanciful to modern ears, one has to wonder whether today’s public is any less credulous: Worldwide, consumers have spent over $400 million per year on a modern baldness remedy known by the trade name Propecia (finasteride).  Has science finally triumphed over a medical condition that has persisted through millennia? Today’s consumers might rationally believe that its has, given that Propecia is FDA-approved for the treatment of alopecia (baldness).  FDA-approved remedies must, according to federal law (21 U.S.C. § 355(d)), prove their efficacy in well-controlled, clinical investigations.

Yet one need only walk through a crowded street to see that, if a baldness cure has truly arrived, a surprising number of people have not availed themselves of it. Is Propecia, then, not effective? Let us take a look at the official data. Continue reading

Two Reflections on Health Law Scholarship

By Patrick O’Leary

Last spring I had the chance to work as a research assistant for Marc Rodwin, a Lab Fellow at Harvard’s Edmond J. Safra Center for Ethics, reading through hundreds (perhaps thousands) of pages of Congressional hearing transcripts from the 1960s and 1970s relating to the federal regulation of drugs. In reading the final version of the article that I helped to research, Independent Clinical Trials to Test Drugs: The Neglected Reform, forthcoming in Volume 6 of the Saint Louis University Journal of Health Law & Policy (also available online), two things occurred to me about the way academics and to some extent policymakers approach regulatory law, especially in the life sciences.

First, it struck me that in the general discourse about health policy, we are often surprisingly oblivious to history. Although the first U.S. law requiring safety or efficacy testing for new drugs was passed a mere 75 years ago, the intervening decades have been prolific when it comes to proposals and debate. What Rodwin’s article does, and I think is valuable both to support his own proposition and to advance the scholarship of others, is to frame his contemporary proposal with a close historical look at similar proposals and the debate surrounding them. What becomes clear, whether the topic is independent clinical testing, the “drug lag,” or the scope of patent protection and marketing exclusivity, is that our “new” ideas about how to improve the system are often anything but. The idea that we ought to know the history of our subject is not particularly groundbreaking, of course, but it’s plain we could be doing more. I’ve found that even the little history I’ve read–all those hearings, of course, but also wonderful books like Daniel Carpenter’s Reputation and Power and Philip J. Hilts’s Protecting America’s Health, and under-utilized resources like FDA’s Oral History Transcripts–has proved endlessly valuable even in thinking about cutting edge ideas like those I’m privileged to be exposed to as a participant in the Petrie-Flom Center’s Health Law Policy and Bioethics Workshop.

Second, it occurred to me that when we think and write about health policy, we might benefit from distinguishing–at least for ourselves–between two distinct projects: the practical endeavor of proposing “realistic” policy changes that take account of and purport to improve on our imperfect and historically contingent regulatory regime, on the one hand, and the more theoretical work of contemplating an ideal system, a “castle in the sky.” Folks who think deeply and write about these issues obviously engage in both: Rodwin’s article, for example, plainly takes the present framework as its starting point, but does so with the larger theoretical question in mind.  I just wonder if we might be more explicit in articulating how proposed incremental changes fit into a broader project of making the regulatory scheme look more like our hypothetical ideal. The history of regulatory law is so littered with incremental changes that have had unanticipated consequences elsewhere in the system that I would love to see more authors lay out explicitly what they hope the system will look like, and justify their incremental proposals as part of that broader vision.

Where Are We Now: Post 4, Looking in the Mirror, or 3 Games in Public Health

By Scott Burris

In a well-known exchange, Richard Epstein argued that modern public health had strayed far outside its traditional and proper work of preventing epidemics and injuries into a realm of social engineering in which it lacked both competence and legitimacy. William Novak, the historian, disagreed, emphasizing the continuity of our public quest for well-ordered, salubrious (and virtuous) communities. Deciding whether public health is winning or losing in the legal arena – and figuring out how we win more often — depends to some degree on what game it is we think we are playing – that is, on whether Epstein or Novak is right.

I think they both are, and it is worth considering how. I suspect that most of us think, without going too deeply, that we’re doing pretty much the same thing that Lemuel Shattuck was doing at the dawn of modern American public health: marshaling collective resources to use data to diagnose, treat and prevent harm to public health.  And if that’s what you think you’re doing, his report is still an excellent guide to making the case for legal action: evidence shows that we can prevent morbidity and mortality in a cost-effective way that does not significantly interfere with anyone’s rights and makes our society stronger and more competitive.

But law, at least, is a very good area for asking whether we are doing something quite different than our grandmother’s public health.  The use of law as a tool of intervention in public health – as a way of creating safer products and environments and incentivizing healthier behavior — has exploded since the 1960s. Yes, you can find public health law at work in the early 17th century, but when I was born in 1956, there was no OSHA, no EPA, no NHTSA. No warning labels on dangerous products. No safety belt standards or laws. Minimal limits on drinking and driving. No federal clean water or air standards. An unrecognizable FDA. And so on it goes.  In the great Novak-Epstein debate, Novak is right that we have a rich tradition of public health regulation, and plenty of paternalism and interference with individual rights based on epidemiological evidence of preventable harms. This is public health as sic utere, then and now largely a matter of showing how someone is doing something that demonstrably imposes costs on others. That’s why the debate Shattuck was waging sounds so familiar to contemporary ears. (And, by the way, that extends to the moralism implicit in our “scientific” recommendations about healthy lifestyles.)

But Epstein is right, too, I think, to observe that something is different. Public health is now a pillar of the regulatory state and the risk society, deeply enmeshed in the project of defining and minimizing risks great and, let’s face it, small.  We deploy complex regulatory systems, some of which work and some of which we continue to defend anyway, in spite of our own commitments to evidence. As matters like obesity and inequality take intervention further and further from proximate to distal links in the causal chain, our ability to back our proposals with evidence, and evidence that speaks to an everyday sense of causality, becomes severely attenuated. Much of what we propose rests on a vision of the good – salus populi – that is as much a matter of values as it is of evidence.  Failing to own that, we fool ourselves without winning over our audience.

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