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.

Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls

By Michael Young

In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”  This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.

In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.

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New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

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Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading

Dov Fox quoted on pre-natal DNA testing

Dov Fox is quoted in a story in this morning’s Boston Globe on a new study recommending pre-natal DNA testing as a superior method for detecting chromosomal abnormalities in a fetus. 

“This technology is certainly only in its infancy as the range of testable conditions expands, physical conditions, cognitive conditions, even behavioral ones,” said Dov Fox, an assistant professor of law at the University of San Diego School of Law. “That will only further complicate how parents decide what counts as healthy or acceptable in the children that they have.”

Read the full article.

 

Disclosing Genetic Risks: Lessons from the Philosophy of Language

By Michael J. Young

Earlier this month, landmark findings were published in the American Journal of Psychiatry illuminating the effect of disclosing genetic risk for Alzheimer’s disease on older adults’ cognition and memory.  In a case-control study, researchers administered memory function tests to a group of known carriers of the apolipoprotein E4 allele (one of the best studied genetic risk factors for developing Alzheimer’s disease), half of whom were informed of their carrier status, and half of whom were not informed of their carrier status.  They reported “[s]ignificant genotype-by-disclosure interaction effects were observed on several memory rating scales and tests of immediate and delayed verbal recall. Older adults who knew their ε4+ genotype judged their memory more harshly and performed worse on an objective verbal memory test than did ε4+ adults who did not know. In contrast, older adults who knew their ε4− genotype judged their memory more positively than did ε4− adults who did not know…informing older adults that they have an APOE genotype associated with an increased risk of Alzheimer’s disease can have adverse consequences on their perception of their memory abilities and on their performance on objective memory tests. Similar consequences might be expected if other indices of an increased risk of Alzheimer’s disease are disclosed (e.g., neuroimaging or CSF biomarkers of preclinical Alzheimer’s disease.)”

These findings raise profound questions for practitioners who must make regular decisions concerning how to communicate health risk information to patients, and more fundamentally, about what principles and policies ought to govern which findings should be disclosed or disguised.

The study and its implications bear striking correlates to a set of key issues in philosophy of language relating to the meta-descriptive aspects of speech and discourse.  In a series of lectures later published as How We Do Things with Words, philosopher J.L. Austin persuasively argued against a longstanding philosophical tradition that had conceptualized language as a construct that exists solely to describe reality as it is or is imagined to be; Austin reasoned that language can serve not only to describe facts but can also serve to establish new facts by representing them as such.

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Book Review published on SSRN

Three weeks ago I blogged about my recent review of  ”Pharmaceutical Innovation, Competition and Patent Law – a Trilateral Perspective” (Edward Elgar 2013). The full review, which is forthcoming in a spring issue of European Competition Law Review (Sweet Maxwell), is now available at SSRN: http://ssrn.com/abstract=2396804.

DC Circuit Upholds FDA Authority Over Stem Cells

Earlier this week, the D.C. Circuit upheld the FDA’s authority to regulate stem cells (for a good news report see here). The company in question, Regenerative Sciences, had received a warning letter from FDA, which the company challenged claiming that its use of stem cells as therapy was not prohibited by existing federal law and that the FDA lacked authority to regulate it. They lost before the district court and appealed to the D.C. Circuit.

In a unanimous decision (by judge Griffith for himself, Judge Srinivasan and Edwards) the D.C. Circuit affirmed this decision. Here are some key passages: Continue reading

Capturing Value in Advanced Medical Imaging

On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients.  Structured around appropriate use criteria  developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.

Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria.  The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria.  In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”

Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.

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Sleep versus Training: The NY Times on Surgical Work Hours

Pauline Chen at the NY Times Blog has an article on cut backs on the number of hours of training for young surgeons.

According to her story:

“For the past decade, in response to increasing pressure from politicians, unions and sleep experts, the Accreditation Council for Graduate Medical Education, the organization responsible for accrediting American medical and surgical training programs, has been working to cap the hours that residents work. In 2011 the council passed the strictest limits yet. To maintain their accreditation, residency training programs had to abide by a 22-page set of scheduling rules that limited all in-hospital work including any elective “moonlighting” jobs to 80 hours per week, mandated the number of hours “free of duty” after different “duty periods” (eight hours off after 16-hour duty periods and 14 hours off after 24-hour duty periods) and even specified the timing of “strategic napping” in no uncertain terms (after 16 hours of continuous duty and between the hours of 10 p.m. and 8 a.m.).

While most residency programs chafed under the exhaustively detailed regulations, surgical training programs had particular difficulty adopting the new mandates. For nearly a century, surgical residency had been a period of both intensive experience and increasing responsibility under the guidance of more experienced surgeons. More recent research has affirmed that approach, demonstrating the strong link between a surgeon’s operative skill, the number of operations performed and patient outcomes. With limits set on their time at the hospital, young surgeons-in-training had fewer opportunities to care for patients or scrub in on operations. While previous generations of trainees had the luxury of participating in at least one operation a day, new trainees had only enough time to be involved in two or maybe three operations each week.

Calculating the number of hours “lost” by cutting back on in-hospital time, surgical leaders estimated that young surgeons-to-be were now missing out on as much as a year’s worth of experience”

She relies heavily on an new Annals of Surgery Article, wherein, as Chen reports,

“Researchers sent questionnaires to the directors of subspecialty fellowship training programs and asked them to comment on the bedside and operating skills of the young surgeons enrolling in their programs. These fellowships are a kind of high-level and often prestigious surgical “gap year” where young surgeons who have completed the basic five-year surgery residency can delay independent practice to pursue an additional year or two of training.

The results were abysmal. Fewer than half of the young surgeons could operate or make clinical decisions on their own. Nearly a third of them were incapable of performing even the most basic operations like a gallbladder removal on their own. And a quarter were unable to recognize the early signs of complications.

Even in areas of surgery where the young surgeons had had supplementary online learning modules during their residency, they performed poorly, with more than half unable to perform basic maneuvers.”

While acknowledging that “some observers have criticized the study for being self-serving – most respondents also noted that the young surgeons’ deficiencies resolved after additional training under their auspices —” Chen’s article reads largely as an attack on these new residency work hour rules.

Since I have written on the subject of these residency work hour rules with sleep specialists earlier this year in the Journal of Law, Medicine, and Ethics, it may be unsurprising that I take a somewhat different view.

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The FDA Strikes Again: Its ban on home testing kits is, as usual, likely to do more harm than good

Cross-post from PointOfLaw.

Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard University Press.

On November 22, 2013, the Food and Drug Administration flexed its regulatory muscle by sending a warning letter to a genetic-testing company that goes under the stylish name of 23andme. The object of FDA scorn was a diagnostic kit that the tech company, backed by among others Google and Johnson & Johnson, sold to customers for $99. The kit contained an all-purpose saliva-based test that could give customers information about some 240 genetic traits, which relate to a wide range of genetic traits and disease conditions. The FDA warning letter chastised 23andme in no uncertain terms for being noncooperative and nonresponsive over a five-year period in supplying information that the FDA wanted to evaluate its product as a Type III device under the Medical Devices Act.

Legal Regulation of 23andme

There is no doubt that the FDA is on solid legal ground. This case is not like the processes involved in Regenerative Sciences, LLC v. United States, where the FDA asserted that physicians’ use of certain stem-cell procedures for joint disease involved the use of a drug that required FDA approval before it could be approved for use. In an earlier essay for the Manhattan Institute, I argued that this classification was in fact both legally incorrect and socially mischievous. In this case, the legal arguments are not available to 23andme because the current definition of “medical devices” covers not only those devices intended for use on the human body, but also those used for the diagnosis of disease. The Type III classification means that this device has to receive premarket approval from the FDA, which in turn requires that it be shown to be safe and effective for its intended use. Getting approval under this standard is arduous business, because any such approval must be for each of the tests separately. 240 tests thus require that number of approvals. The costs are prohibitive, and the delay enormous.

The FDA Warning Letter is significant both for what it says and for what it does not say. Continue reading

Video Now Available: Responsibility and Integrity in the Pharmaceutical Industry

On November 21, the Petrie-Flom Center hosted a lecture by Neil Flanzraich on responsible pricing strategy, access to care, clinical trial design, outsourcing, and other topics that raise thorny but crucial issues for pharmaceutical and biotechnology companies.  (You can read a summary of the lecture here.) You can now view the lecture online.

Mr. Flanzraich graduated from HLS in 1968, and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012. He is the Executive Chairman of Kirax Corporation and the Executive Chairman of ParinGenix, Inc., both of which are privately owned biotech companies. He previously served as the Vice Chairman and President of Ivax Corporation, an international pharmaceutical company, which was sold to Teva in 2006 for an enterprise value of $10 billion.

Art Caplan on emergency meningitis vaccines at Princeton

Art Caplan has a new piece at bioethics.net on Princeton’s plan to import and administer a meningitis vaccine not approved for use in the US in an effort to curb an outbreak of meningitis B that has already sickened several students.

Government health officials said Friday they have agreed to import Bexsero, a vaccine licensed only in Europe and Australia that does protect against meningitis B.  And that decision seems entirely reasonable given the threat that this nasty strain of meningitis poses.

That said, the question arises — what should those getting the vaccine be told?  Are they being offered a proven vaccine, an experimental vaccine, a vaccine believed to be the best choice given the threat of an epidemic or something else?  Can a student, campus worker or faculty member refuse the vaccination and stay in school or in a dorm?  Should those who have visited the campus recently be tracked down and offered the vaccine?  If people do refuse should they identify themselves in anyway as unvaccinated and to whom?

Read the full article here.

Going On Now: IOM Stem Cell Therapies Workshop

The IOM is hosting a workshop *right now* on Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings.  You can sign up via a quick online form, and they’ll immediately send you a link to the live webcast (agenda here), which will hopefully be archived.  Our own Glenn Cohen is slated to discuss stem cell medical tourism at 1:15 this afternoon.

Here’s the description from the IOM site:

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently, however, the evidence base to support the medical use of stem cells is still limited, with few clinical applications shown to be safe and effective. Despite the preliminary nature of clinical evidence, consumer demand for treatments using stem cells has risen, fueled by direct-to-consumer advertising of stem cell-based treatments. Clinics have been established throughout the world, both in newly industrialized nations such as China, India, and Mexico, as well as developed countries such as the United States and within Europe, that offer “stem cell therapies” for a wide range of diseases and conditions. Often provided at great expense and often promoted as established and effective, these treatments have generally not received stringent regulatory oversight, have not been tested through rigorous trials to determine safety and likely benefit, and the claims remain largely unsubstantiated by medical science. Complications from treatments have ranged from tumor formation to the death of patients. Some feel that the false claims and potential for harm to patients could significantly damage the real potential of research to produce valid stem cell therapies.

The Institute of Medicine and the National Academy of Sciences will co-host a workshop with the International Society for Stem Cell Research that will take a critical look at the practice of unproven stem cell treatments. Speakers will examine the evidence base of unsubstantiated treatment offerings and the associated research and clinical risks and concerns. Discussions will delve into legal hurdles for establishing standards and criteria to govern stem cell trials and treatments and explore a range of potential solutions for assuring the quality of unregulated therapies.

FDA Suspension of Ponatinib: Serious Problem, Wrong Solution

By Richard Epstein

Bad News On December 14, 2012, the US Food and Drug Administration granted an accelerated approval to the drug Ponatinib, which is used to treat patients with serious and life threatening forms of leukemia.  Unfortunately, the risks associated with the use of the drug have proved to be far greater than anticipated.  Thus on October 31, 2013, the FDA switched course and asked the manufacturer of ponatinib, Ariad Pharmaceuticals of Cambridge Massachusetts, to suspend marketing and sales of the drug pending the FDA’s further evaluation of the potential costs and benefits of ponatinib’s use.  The FDA wants to conduct that study so that it can better determine which patients are the ideal targets for the drug, and which patients are most likely to succumb to its grave negative side effects, “the risk of life-threatening blood clots and severe narrowing of blood vessels.”

Accordingly, the ever-prudent FDA immediately recommends the adoption of a three part program.  First, no new patients should begin treatment with the drug. Second, those who are using the drug who are not responding to it should immediately cease use. And third, those patients who are responding favorably to the drug should be allowed to continue its use if their health care professionals believe that the potential benefits from the drug use justifies their filing for a “a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues.”  Not surprisingly a recent New York Times Editorial takes the view that the FDA has set up the right process for dealing with this problem by allowing physicians and other health care professionals to go through a “streamlined” process to continue drug use where they think that the anticipated benefits exceed the anticipated costs.

Whose Cost Benefit Analysis?  Both the FDA and the Times have done the wrong cost benefit analysis.  For starters, all the information about the adverse effects of ponatinib are in the public domain, available to all professionals who prescribe the drug.  If the FDA had done nothing other than republish the conclusion of the recent studies, we can be confident that the serious risks associated with its use would quickly work themselves through the system.  The amount of the drug prescribed for established and new patients would drop, given the increased revelation of the risk.  Higher cost means lower use.

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Skype co-founder Jaan Tallinn highlights X-risk

Young people often assume that their life expectancies will remain what life expectancy is today—although life expectancy will grow by the time they are old. When all of us imagine our futures, we often neglect to take account of radical technologies which were not foreseeable prior to their invention, just as the internet wasn’t, and instead imagine something closer to present realities. We do not appreciate how different the future could be.

Among other things, the future might be dangerous to humankind in ways that we fail currently to appreciate. We got lucky, and nuclear energy seems hard for individuals to develop at home, but will that last, and will new WMDs be impossible to replicate with 3D printers or other future technologies? Can anyone guarantee that viruses manufactured for scientific research will not be spread by error or terror? Can we guarantee that robots designed for contained military purposes would not go out of control? Or that once artificial intelligence is advanced enough to design other artificial intelligence, humans will remain safe for long? Some of the greatest dangers to our species are unknown, simply because the technologies that create them have not been invented yet—just as many technologies that exist and threaten us today were not invented 100 years ago.

In a multimedia presentation that drew a prolonged applause from a crowd of Harvard undergraduates, Estonian programmer Jaan Tallin wove together three stories: the story of Kazaa and Skype, which he helped start; his personal journey into studying and promoting the study of existential risk; and a “sermon” (as he put it, tongue in cheek) on the ethical responsibilities of technology developers.

Tallin proposed taking active steps in anticipation of our future errors, both to make businesses robust and to keep our species safe in an opaque future: incorporating safety margins, and continually questioning one’s assumptions. He concluded by arguing, provocatively, that indispensable to both goals is having fun.

The talk was organized by the student organization Harvard High Impact Philanthropy (HHIP).

HHS Proposes Rule to Amend NOTA, Nullify Flynn v. Holder

On October 2, in the midst of the government shutdown—either HHS somehow managed to convince itself that the rule was “necessary for the protection of life” or, more likely, it had already been scheduled for printing—HHS quietly published a Notice of Proposed Rulemaking. The proposed rule would effectively moot the recent Ninth Circuit case of Flynn v. Holder by criminalizing the compensation of bone marrow donors, even when the life-saving stem cells are extracted through a newer, minimal risk procedure. In this post, I’ll explain the medicine, the Ninth Circuit’s decision, and what HHS proposes to do in response. In my next post, I’ll have some reaction to HHS’s policy arguments, about which I’m skeptical, and perhaps a few thoughts about where plaintiffs might go from here.

Section 301 of the National Organ Transplant Act (NOTA) of 1984 criminalizes the transfer of “human organs” for “valuable consideration.” Reimbursement of reasonable out-of-pocket expenses associated with travel and lost wages are okay—as are, since the 2008 amendment of NOTA, paired living donor chains—but any other “valuable consideration” that might incentivize sources of organs is not. Under NOTA, as amended,

‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation

(emphases added). HHS has since added to this list “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.”

So-called “bone marrow transplants”—in reality, infusions of hematopoietic (blood) stem cells (HSCs)—are often life-saving procedures for those with, for example, leukemia or aplastic anemia. (See these sobering statistics compiled by the Institute for Justice, which represented the plaintiffs in Flynn.) When NOTA was passed, the only way to obtain HSCs was through bone marrow aspiration using a long needle thick enough to suck liquid marrow directly from the donor’s pelvic bone. HSCs are then harvested from the marrow. The procedure is done under general anesthesia and so the donor is subject to the usual risks of anesthesia. Although the donor can return to usual activities in two to seven days, discomfort may linger for up to two weeks. Continue reading

Government Regulation of the Practice of Medicine: How the FDA overreaches the regulation of medical practice

By Richard Epstein

A sound scheme of public regulation seeks to find the best way to align the incentives of public regulators with the interests of the public at large.  That task has proven to be particularly acute with the U.S. Food and Drug Administration, which possesses vast powers to regulate the manufacture and distribution of drugs and medical devices in the United States, which it all too often overuses.

In a recent study for the Manhattan Institute entitled The FDA’s Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation, I examine the FDA’s over-regulation of new stem-cell technology in connection with the 2012 decision of Judge Rosemary Collyer (District Court of the District of Columbia) in Regenerative Sciences LLC v. United States.

That case examined the line between the regulation of pharmaceutical products on the one hand and the practice of medicine on the other. It is well established that the FDA has power over the former, but lacks power over the latter.  That distinction is of no small consequence because it allows, for example, for the rise of an extensive market in “off-label use” by physicians of drugs for purposes for which they have not received FDA approval.  This class of drug use is very large, and in cancer cases is thought to be more common than treatment using FDA-approved products.

The persistence of off-label drug use should caution people about allowing the FDA to exert extensive control over the drug licensing process.  It could be that the thousands of physicians, hospitals, and patients that use drugs off-label have, time after time, all made some major mistake.  Or it could just be possible that the accumulated level of institutional knowledge post-release demonstrates that the FDA has been too restrictive in its decisions as to whether a new drug should be allowed into the marketplace in the first instance. The FDA is heavily incentivized to be tough in its approval process lest it take heavy criticism for the all-too-visible injuries that may be caused by approved drugs. But in the social calculus, the individual losses that occur to people who are denied treatment by the heavy-handed actions of the FDA count every bit as much.  Yet these diffuse losses, often undocumented, bring much less heat to the FDA, which accordingly is prepared to shrug them off as a cost of supplying people the “protection” that is so central to the FDA mandate.

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Safe Surgery Checklists May Raise Unintended Ethical and Legal Questions, Especially in Low-Resource Settings

By Matt Baum

The WHO Surgical Safety Checklist is unusual as a patient-safety intervention in that it has been widely promoted as universally effective, i.e. effective both in high-income and resource-limited settings; checklists are now used in approximately 1800 hospitals worldwide. In a paper recently published in the journal, BMJ Open, Aveling and colleagues report the results of a qualitative study on the implementation of the WHO checklist in two UK hospitals and two hospitals in resource-constrained settings in Africa.  Their results suggest that the checklist is “no magic bullet” – that if adopted without proper investment and adaptation to the context of the target hospital, the checklist not only may fail to replicate benefits, but can actually levy its own unintended costs – especially in resource-limited settings. Though the study raises a number of interesting questions, given the nature of this blog, I am hoping that we might start a discussion about  those in the domain of ethics and law.

For example, consider the following real case, which was reported in the BMJ paper:

“A patient admitted for cholecystectomy [surgical removal of the gallbladder] suffered hypoxic [oxygen depriviation-related] brain injury and died following surgery. Subsequently, two staff members (not the surgeon) were threatened with guns by the patient’s family, who said that the surgical team had killed the patient. The two staff members were later arrested and criminal charges brought against one of them. One of the questions asked during the police investigation was whether a pulse oximeter [i.e. a tool for measuring blood-oxygen levels] had been used. It had not: according to staff, no pulse oximeter was available for use, even though the checklist requiring use of this equipment was, officially, in use at the hospital.”

The staff members also did not get any legal representation for weeks because there were no clear policies established surrounding who was responsible for providing that counsel.

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