The Once and Future Regulation of Biotechnology

By Seán Finan

whitehouse_slideOn 16th September, 2016, the White House released two documents jointly authored by the FDA, the EPA and the USDA. Together, the “Update to the Coordinated Framework for the Regulation of Biotechnology” (the “Update”) and the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” (the “Strategy”) will form the basis for the federal government’s regulatory policy for biotech for the foreseeable future. So, where did these documents come from? What do they contain?

Background

Last year, the federal government asked the FDA, the EPA and the USDA to

  1. Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
  2. Develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
  3. Commission an expert analysis of the future landscape of biotechnology products

(Source)

14 months, three public meetings and 900 responses to a Request for Information later, the two documents were released. The Update sets out to respond to the first of the above prompts and the Strategy aims to respond to the second. An answer to the third is still in the pipeline.

Aims

The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):

The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers

Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim

  • to help the public understand how the safety of biotechnology products is evaluated and
  • to help businesses navigate the current regulatory structure.

Continue reading

Initial Quick Thoughts on the Announcement of the Birth Through Mitochondrial Replacement in Mexico

The science media is abuzz about the birth of a child using mitochondrial replacement techniques in Mexico to Jordanian parents at the hands of NY Doctors. A few quick reactions (I am heading to this unrelated NAS/IOM Committee meeting tomorrow evening so may have some more thoughts when that settles down).

  • This is the first time this particular technique has been used to produce a live, but I am not sure from an ethical standpoint the arguments are all that different. That said, for those deeply interested in the more philosophical question of harm to children and the propriety of best interests argument in light of Parfit’s Non-Identity Problem (my take here and here) it may matter whether mitochondrial replacement is done through Pronuclear Transfer or Maternal Spindle Transfer as argued quite well here.
  • The fact that the doctors are from New York, the Patients are from Jordan, and the procedure took place in Mexico is not insignificant. This is a form of medical tourism, a topic I wrote a book on, most similar to cases of fertility and stem cell therapy tourism I cover in the latter half of the book. Absent making domestic prohibitions extraterritorial, something that I argue is permitted by international law and justified in some instances, there is very little that a home country can do about this. The going abroad is likely in part at least a function of some U.S. laws on the subject Eli Adashi and I wrote about for JAMA prohibiting FDA from considering approval of the technology.
  • As I wrote on this blog in February in relation to the IOM report “whatever the US policy in a world where medical tourism is possible and other countries adopt their own systems, so long as not everyone adopts the approach of the US some of these problems will manifest no matter what. So this is about harm reduction not harm avoidance.” This was a bit quicker than even I thought, but is not surprising. More generally if your concern about MRT is harm to offspring and transmission to future generations, people born elsewhere through the technology will inevitably enter the United States and/or marry, and procreate with U.S. citizens who themselves become U.S. citizens. To sound a bit X-Files about it “THEY WILL BE AMONG US!” This is a great example of the limits of unilateral regulation in a world of globalized health care.
  • Interesting that it was a male birth. This may be coincidence or in keeping with the IOM recommendation that only male embryos be transferred (to get rid of germ line transmission). Eli Adashi and I raised some ethical questions in Nature about whether that was an ethically problematic form of sex selection or not but in the reporting I have seen so far it has not been clear that they used only male embryos on purpose.
  • I wish we could stop calling it in the media “Three Parent IVF” or “Three Parent Reproduction.” That assumes the answer to what I think of as a subtle and interesting set of questions — is the mitochondrial donor a “parent” and what sense of the word do we mean.

More soon, I hope!

Bioethicist Art Caplan: Right-To-Try Laws For The Terminally Ill Are Bad Policy

A new piece by Bill of Health contributor Art Caplan in Forbes:

Nathan Nascimento thinks that right-to-try laws aimed at the terminally ill are sound public policy. He is wrong.

Mr. Nascimento’s commentary misrepresents the complexities of the drug development process and the issues surrounding granting access to experimental medicines before they have been fully tested.

The overarching issue, despite his rhetoric to the contrary, is that the safety and efficacy profile of a new medicine is not sufficiently understood until after the drug has completed at least a pivotal Phase 3 clinical trial.

The underlying principle of every clinical development program is to understand, via testing first for safety usually in a small number of patients afflicted with the target condition, and, subsequently, in increasing numbers of patients, the benefits as well as the risks of new medicines. Like it or not, this is a time-consuming, expensive, but appropriate and necessary process. []

Read the full post here.

Melinda Buntin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5This week we welcome Melinda J. Beeuwkes Buntin, Chair of the Department of Health Policy at Vanderbilt University’s School of Medicine. She previously served as Deputy Assistant Director for Health at the Congressional Budget Office (CBO), and worked at the Office of the National Coordinator for Health IT. At RAND, Melinda served as deputy director of RAND Health’s Economics, Financing, and Organization Program and co-director of the Bing Center for Health Economics. Her research at RAND focused on insurance benefit design, provider payment, and the care use and needs of the elderly. For the lightning round, Nic discussed technological improvement of decisionmaking, both for consumers and doctors. Nic also covered CMS’s rejection of Ohio’s request for a new section 1115 demonstration (which would have charged “premiums, regardless of income, to the 600,000 individuals in Ohio’s new adult group, as well as hundreds of thousands of low income parents, foster care youth, and beneficiaries with breast and cervical cancer”). Frank offered a counterintuitive look at the EpiPen and the present technocrat rage to privatize the VA. During the conversation, we covered some topics in CBO modeling, including Melinda’s recent paper on changes in spending by age of beneficiary. Frank mentioned some general concerns about CBO’s modeling raised by Federal Reserve economists, the GAO, Tim Westmoreland (in 2008 and 2007), Maggie Mahar, Timothy Jost, and Bruce Vladeck. We look forward to more conversations on the nature of health cost projections!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Subscribe to TWIHL here!

Petrie-Flom seeks Harvard student RA for project on human subjects research

The PFC Logo-New-Horizontal_slidePetrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science Center) on challenges and innovation in human subjects research, addressing such issues as the regulatory and ethical aspects of research using electronic and online mediums, payment of research participants, models of community engagement and patient-centered research, and participant comprehension in informed consent. The work will initially involve 6-8 hours per week for 3 months. Applicants who have completed at least one year of a graduate program in law, health policy, or a related field are particularly encouraged to apply. Please contact Luke Gelinas, PhD, lgelinas@law.harvard.edu.

Social Media Use in Research Recruitment: A New Guidance Document from Petrie-Flom and Harvard Catalyst

stethoscope_computerImagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for!

But what are your obligations in approaching members of this group for recruitment? Would such recruitment be ethically advisable? Under what conditions? And what ethical norms apply when approaching sick and potentially vulnerable people for recruitment over social media? How should you (and the IRB) evaluate this type of activity from an ethical perspective?

Continue reading

Confidentiality or Public Disclosure: Trump’s Gastroenterologist and an Ethical Dilemma

By Brad Segal

“If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency,” proclaimed Dr. Harold Bornstein. The gastroenterologist’s letter, released on the candidate’s website nine months ago, stumbles from the outset with a typo (“To Whom My Concern,”), then steamrolls over the most basic descriptions of health (medical school teaches us that vital signs are, well, vital), omits information pertinent to the public discourse (why does it fail to mention the medical reason exempting Trump from the Vietnam draft?), and strangely emphases non-medicalized traits (“His physical strength and stamina are extraordinary”). Most experts agree that this medical record, if we can even call it that, is at best hyperbole. It draws grandiose conclusions without medical justification. Even Dr. Bornstein conceded, “In the rush, I think some of those words didn’t come out exactly the way they were meant.”

Just this morning the Trump campaign released a second letter from Dr. Bornstein. But this time the doctor rather humbly concludes, “In summary, Mr. Trump is in excellent physical health.”  These letters from Dr. Bornstein’s letter demonstrate a modern-day moral dilemma in providing care for a party nominee. At conflict is the physician’s professional duty to respect patient confidentiality, and his or her obligations to care for society more broadly.

First, patient-doctor confidentiality is not merely a byproduct of the law—it is a moral obligation grounded in the core tenants of the medical profession. To put it simply, if a patient comes to expect that his doctor will tell the entire community about the patient’s most embarrassing bodily defects, the patient may understandably deny his worsening symptoms of poor health at the next office visit. In the long run, erosion of trust in the medical system could endanger the public’s health–everyone is thus better off when doctors uniformly respect patient privacy. It is important to point out, however, that an informed and competent person can voluntarily waive one’s right to patient-doctor confidentiality, such as when a patient gives a physician the permission to provide updates to family members. Or when then-candidate John McCain instructed his physicians all 1,100 pages in his medical records.

Continue reading

Mental Health First Aid Training in Prisons, Police Departments, and the Presidential Election

By Wendy S. Salkin

It has been widely reported and acknowledged that many incarcerated Americans live with mental illness. In 2014, the Treatment Advocacy Center and the National Sheriffs’ Association published The Treatment of Persons with Mental Illness in Prisons and Jails: A State Survey, a joint report that included the following findings:

  • In 2012, there were estimated to be 356,268 inmates with severe mental illness in prisons and jails. There were also approximately 35,000 patients with severe mental illness in state psychiatric hospitals. Thus, the number of mentally ill persons in prisons and jails was 10 times the number remaining in state hospitals.
  • In 44 of the 50 states and the District of Columbia, a prison or jail in that state holds more individuals with serious mental illness than the largest remaining state psychiatric hospital. For example, in Ohio, 10 state prisons and two county jails each hold more mentally ill inmates than does the largest remaining state hospital.

Similarly widely reported and acknowledged is that prisons often either cannot or simply do not serve the mental health treatment needs of those housed within their walls. As Ana Swanson of The Washington Post observed:

Unsurprisingly, many prisons are poorly equipped to properly deal with mental illness. Inmates with mental illnesses are more likely than other to be held in solitary confinement, and many are raped, commit suicide, or hurt themselves.

Solitary confinement is often used as a means of separating inmates living with mental illness from the rest of a prison population. As Jeffrey L. Metzner and Jamie Fellner reported in their March 2010 article, “Solitary Confinement and Mental Illness in U.S. Prisons: A Challenge for Medical Ethics”: Continue reading

Kidneys and Livers, Made to Order?

By Seán Finan

Last week, Organovo might just have revolutionised the pharmaceutical industry. The San Diego-based company specialises in producing structures that mimic the behaviours and functions of human tissue, using 3D bioprinting. They announced last week that they were beginning the commercial manufacture and sale of their ExVive Kidney. The product models the proximal tubule of the human kidney and holds significant promise for clinical trials of new drugs. The commercialization of the ExVive Kidney follows the release of ExVive Human Liver Tissue in 2014.

In essence, Organovo is using 3D printing technology to produce samples of “human” tissue that can be used to test the toxicity of new drugs. The printing process, known as 3D bioprinting, involves extracting human cells, culturing them and suspending them in a solution. The resulting “bioink” is fed through a modified 3D printer. Layer by layer, the printer deposits cells, producing a mass with a similar structure and density to a sample of, for example, human liver. Just like “organ on a chip” technology, these synthetic liver and kidney samples present significant advantages over traditional clinical testing.

Continue reading

REGISTER NOW (11/7): The Ethics of Early Embryo Research & the Future of the 14-Day Rule

egg cells flowing in a blue background

The Ethics of Early Embryo Research & the Future of the 14-Day Rule
November 7, 2016 3:00 – 6:00 PM
Austin Hall, North Classroom (100)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA
 

Description

For over 35 years, the “14-Day Rule,” prohibiting in vitro experimentation on embryos beyond 14 days, has stood as an ethical line in the sand for embryo research around the world. Throughout the arc of the rule’s existence it has not been questioned, as scientists have been unable to grow embryos in vitro either up to, or beyond, 14 days; a practical limitation that served as a backstop to the ethical rule. However, in May of this year, labs in the U.S. and the U.K. were the first to report being able to sustain human embryos in vitro for up to 13 days. This development and other advances in in vitro research involving organized, embryo-like cellular structures have raised a number of questions about the rule, its genesis, application, and future scope. This conference will convene experts in bioethics, stem cell research, embryology, and law to discuss the ethical underpinnings and future scope of the rule. Questions to be discussed include:

  • What are the historical, ethical and scientific rationales for establishing the 14-Day Rule?
  • Should the 14-Day Rule be revisited in light of recent advances?
  • Should the 14-Day Rule even apply to research involving the in vitro culture of embryo-like cellular structures?

Tentative Agenda Continue reading

Corralling the Herd: California Medical Board Acts Against Anti-Vax Doc

This summer, California’s strict new childhood immunization law, barring all exemptions except those needed for medical purposes, went into effect for public and private schools, preschools, and day cares. This law was passed as a response to the highly-publicized 2014-2015 multi-state measles outbreak that originated at Disneyland, and also in response to the growing number of California communities with large clusters of families exempting their children from vaccine requirements, putting at risk community protection from vaccine-preventable illnesses.

As I’ve written about before, both here and in articles with Tony Yang, there are many different ways to structure childhood vaccination laws. While much of the attention goes to whether or not states offer parents the right to exempt their children based on religious and/or philosophical grounds — see, for example, the recent American Academy of Pediatrics report supporting mandated vaccination for school and daycare attendance —  there are many other implementation-related details in the laws that can increase or decrease the law’s efficacy at maintaining high vaccination coverage rates. For example, some states may require that exemption requests be filed annually (increases efficacy), some states require only that a form be correctly completed (decreases efficacy), some states allow for historically anti-vax practitioners, such as naturopaths, to complete medical exemption forms (decreases efficacy, and creates a new, permanent loophole for gaining exemptions), some states require that medical exemptions be reviewed and approved by a state public health officer (increases efficacy). Continue reading

DUE TOMORROW, 9/9! Call for Harvard Submissions to Journal of Law & the Biosciences

image001The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of Law and the Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a Notes & Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie-­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students and postdoctoral fellows from any school to contribute papers to be published in JLB’s Notes & Developments section in early 2017. We will consider student papers that will be generated specifically for JLB, as well as papers that have been (or will be) initially written as student notes or course papers and edited for this particular purpose. JLB Notes & Developments are limited to 5000 words, including footnotes and references, and should be on a topic of relevance to law and the biosciences, in particular a topic of relatively recent concern, controversy, or change. They should focus on describing the issue at hand, explaining why it is relevant to scholars, and providing analysis and questions for further consideration. For recent examples of submissions by Harvard students, check out the April 2016 issue of the JLB. Continue reading

Introducing the 2016-2017 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2016-2017 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.

Sean Finan PhotoSeán Finan is an LLM candidate from Ireland at the Harvard Law School. He recently graduated from the LLB programme at Trinity College, Dublin, where he served as a Senior Editor of the Trinity College Law Review. His research interests include the ethical implications of emerging biotechnologies. For his Fellowship project, he intends to investigate the use of morality tests on patent applications as a means of indirect regulation of research.

Wendy Salkin Square HeadshotWendy Salkin is a Ph.D. candidate in the Department of Philosophy at Harvard University. Her primary research is in political philosophy, moral philosophy, social philosophy, and philosophy of law. She also works on questions in feminist philosophy and bioethics. She is writing a dissertation on informal political representation under the supervision of Tommie Shelby, T.M. Scanlon, Richard Moran, and Eric Beerbohm. She holds a J.D. from Stanford Law School and a B.A. in Philosophy and Africana Studies from New York University. For her Fellowship project, she will examine new directions in the debate over lifespan extension.

Segal photoBrad Segal is currently a medical student at Harvard Medical School where he is enrolled in a dual MD/Master of Bioethics degree program. Brad received his BA and BS from UC San Diego where he double majored in Philosophy and Physiology/Neuroscience. In his first year at HMS Brad’s paper on the ethics of organ transplantation was awarded the Henry K. Beecher Prize in Medical Ethics. He has also studied the ethical implications of our evolving understanding of the brain, and has published on whether and when individual genetics and neurobiology should mitigate a criminal defendant’s moral culpability. During his Fellowship he will be studying what ‘harm’ means in the medical context.

Thomas Shailin PhotoShailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine. He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology behind social phenomena. His interests lie at the intersection of clinical medicine and the legal forces that shape it. Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society. He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology. A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut. For his Fellowship project, he will focus on a tort solution for faulty eyewitness testimony procedures.

Matthew Young HeadshotMatthew H. H. Young is a fourth-year MD candidate at Harvard Medical School and a second-year JD candidate at Harvard Law School. He graduated with honors from Harvard College with a major in Government and a minor in Global Health & Health Policy. He is interested in healthcare system safety, quality, and outcomes, and serves as the Director of Medical-Legal Affairs for the Institute for Patient Safety and Outcomes (IPSO). For his Fellowship project, he plans to develop a patient-centered checklist to improve perioperative safety, quality, and outcomes, and discuss the checklist’s implications.

NEXT WEEK (9/7): Battling Blood in the Streets Neuroscience Panel, followed by PFC Open House

2016.09.07_battling_blood_for_printBattling Blood in the Streets: How Can Neuroscience Promote Public Health and Support Public Policy to Prevent Community Violence?
September 7, 2016 4:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

 

 

IMMEDIATELY FOLLOWED BY:

15.09.07, 2016 Open House Visix2016 Petrie-Flom Center Annual Open House
September 7, 2016 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

 

 

Battling Blood in the Streets: How Can Neuroscience Promote Public Health and Support Public Policy to Prevent Community Violence?
Far too many people across the country are left dead, injured, or traumatized by community violence. Communities can be safer when neuroscience, public health strategies, and collective advocacy are aligned in practice and policy. What are the best next steps to fostering a broad science-informed advocacy movement to effectively address community violence? Continue reading

Considering stakeholders in policy around secondary findings in genomics

By Michael Mackley

It took nearly thirteen years and an army of scientists to generate the first sequence of the human genome. Now, patients around the world are having their genomes sequenced every day. Since the first sequence was unveiled in 2003, the cost of whole-genome sequencing (WGS) has dropped from almost $1 billion to less than $1,000—allowing WGS to enter routine clinical care, potentially transforming the way we diagnose and treat disease. Large national initiatives to read individuals’ genomes are helping to drive this transition; the UK’s NHS England is currently sequencing 100,000 genomes, and the USA has plans to sequence 1 million genomes in the near future. A 2015 study predicts that up to 2 billion people worldwide could have their genomes sequenced within the next decade—comparable to the current reach of the Internet. With so many genomes to be sequenced, it is imperative that laws and policy ensure that individuals, and society, are protected from harm. While larger pieces of legislation—such as those protecting against discrimination—are needed internationally, guidance and policies around routine management are also required.

One area of particular concern is that of ‘secondary’ (or ‘incidental’) findings. While WGS provides a valuable opportunity to learn about genetic contributions to disease (‘primary’ findings), it can also reveal genetic information that may not be relevant to the health condition affecting the patient or their family. This includes genetic changes associated with other health conditions—ranging from medically actionable findings, such as genetic predispositions to breast cancer where treatment is available, to non-actionable findings, such as genetic changes associated with an increased risk of Alzheimer’s. The American College of Medical Genetics and Genomics published recommendations suggesting a moral obligation to seek and return actionable secondary findings, fueling significant debate (1,2). Medical Genetics organizations from other countries (including Canada and Europe) have published more conservative guidelines restricting generation of secondary findings, at least until more evidence is available to support (or refute) clinical utility and assess wider impacts. Continue reading

Ameet Sarpatwari on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5Our guest this week is Ameet Sarpatwari, an Instructor in Medicine at Harvard Medical School and an Associate Epidemiologist at Brigham and Women’s Hospital based in the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. Ameet’s research focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes. He is currently examining the public health implications of variation in state drug product selection laws, the risk of re-identification under HIPAA pathways for data sharing for post-approval drug research, and the comparative safety and effectiveness of biosimilars.In the lightning round, Nic addressed the Notice Act and ongoing controversy over hospitals’ use of “observation status” to dodge readmissions penalties and game reimbursements. We also mentioned the strange politics of bill naming. (One also wonders what exactly vulnerable patients are supposed to do once they receive notice that they could soon be hit by huge bills.)

Nic also covered the FTC’s reversal of an ALJ’s judgment in LabMD, the case that keeps on giving. Frank riffed on an article “Medicaid Expansion’s New Cost Estimate Isn’t Alarming,” from the CBPP, and expressed some skepticism as to the degree to which episode payment models would assure better pay for hospital care.

Our conversation with Ameet focused on his many articles on counter-detailing, medical research ethics, the opioid crisis, and large firms’ misues of the FDA’s regulatory system. Links to all are available at his website.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Drug Pricing, Shame, and Shortages

By Nicholson Price

Drug prices have been making waves in the news recently.  The most recent case is the huge price hikes of the EpiPen, which provides potentially life-saving automatic epinephrine injections to those with severe allergies.  Mylan, which makes the EpiPen, has raised its price some 450% over the last several years.  The EpiPen is a particularly problematic—and media-friendly—story because the emblematic use case is the kid in school who can’t breathe because she came into contact with peanuts.  Jacking up the price on something that’s not optional—for parents and for schools—seems heartless.  Thoughtful pieces have pointed out how the EpiPen price increases demonstrate problems with our health care system and drug/device approval system in general.

Other big recent cases that have hit the news include huge increases in the price of insulin, and, of course, Turing Pharmaceuticals’/Martin Shkreli’s ~5000% price hike on the drug Daraprim.  The EpiPen and Daraprim are especially notable because patents mostly aren’t involved—the effective monopoly appears to come from the delay or challenge in getting generic products approved by FDA (although the EpiPen itself also seems tough to make).  And, of course, drug prices aren’t regulated in the US the way they are in much of the world.

These stories seem crazy, cruel, and fascinating.  And they raise (for me, anyway) the question: what’s changed?  This seems like a relatively new phenomenon.  But FDA’s had a backlog for a while, and drug prices have long been unregulated. Continue reading

Rawlsian Questions about CRISPR Gene Editing

By Kelly Dhru

We worship perfection because we can’t have it; if we had it, we would reject it. Perfection is inhuman, because humanity is imperfect. – Fernando Pessoa, The Book of Disquiet.

Pessoa may have had an “I told you so!” moment looking at the ethical debates over CRISPR-Cas9, which is the technology that has made the alteration of genomes easier. As we march towards fundamentally altering the code that governs our bodies, it is this very walk towards perfection that seems to scare us.

To start with, not enough can be said about the importance of CRISPR-Cas9, which is one of the most important scientific advances of our times. Because of this technology, we are now looking at the ability to combat some previously “incurable” genetic disorders. This technology is also opening up doors to tackle malaria, Zika and dengue fever in innovative ways and to potentially find a cure for cancer. Continue reading