Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the only manufacturers of the vaccine, GlaxoSmithKline and Pfizer. MSF claim that the only sustainable solution to a disease that claims the lives of almost a million children each year is an overall reduction in the cost of the vaccine, and not one-off donations that come with restrictions on where MSF may use the medicines, and a constant power disparity between the parties, where Pfizer may release the medication on their own timeline, and revoke access as they see fit.
By Timo Minssen
I am happy to announce the publication of our collaborative paper with Helen Yu and Jakob Wested on “Innovation and intellectual property policies in European Research Infrastructure Consortia (part I)” in the Journal of Intellectual Property Law and Practice (Oxford University Press). Taking the European Spallation Source ERIC as an example, our paper investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability in various research areas, including the health and life sciences.
The authors would like to express their special gratitude to Dr. Ohad Graber Soudry, Head of Legal, European Spallation Source ESS-ERIC in Lund, Sweden, for all his support and valuable comments. This paper is supported by the CoNeXT project (see http://conext.ku.dk/ last visited July 23, 2016) under the University of Copenhagen’s Excellence Program for Interdisciplinary Research.
Research and innovation are key pillars of the EU’s strategy to create sustainable growth and prosperity in Europe. Research infrastructures (RIs) are central instruments to implement this strategy. They bring together a wide diversity of expertise and interests to look for solutions to many of the problems society is facing today, including challenges in the health and life sciences. To facilitate the creation and operation of such RIs, the EU adopted legal frameworks for European Research Infrastructure Consortia (ERIC). On August 31, 2015, the European Spallation Source (ESS) was established as an ERIC. Under the ERIC Regulations and ESS Statutes, the European Spallation Source ERIC is required to adopt various policy documents relating to the operation and management of the facility. These cover a wide variety of issues such as user access, public procurement, intellectual property rights (IPR), data management, and dissemination. One of the main goals of the ESS policies is to ensure that the research environment at ESS is compatible with a wide variety of international users’ obligations to multiple stakeholder-interests. But how can these policies best be aligned with the EU objective to achieve economic growth and scientific excellence by encouraging international research collaborations? The complex relationship between scientific excellence, innovation, and IPRs must be carefully considered. Taking the European Spallation Source ERIC as an example, this article investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability. In Part II, we will analyze and compare the different IPR policies of the various ERICs in a subsequent article.
By Brad Segal
Manuel—not his real name—was admitted to the hospital with decompensated heart failure. As a child he had scarlet fever which, left untreated, had caused the valves of his heart to calcify and stiffen. Over time, pumping against increased resistance, his heart’s contractions began to weaken until finally, they lost all synchrony and the normal function of his heart spiraled out of control. At this stage, his fate was tied to whether or not he would receive a new heart in time.
He was in his 30’s and had no other illnesses. From a medical perspective, Manuel was the ideal candidate for a cardiac transplant. But a decade ago Manuel crossed the United States border in pursuit of a better life. As an undocumented immigrant, he was ineligible for the insurance coverage necessary to pay for a heart transplant. After being thoroughly evaluated by the hospital’s transplant center, given his modest financial resources and inability to obtain new insurance coverage, Manuel was not placed on the waiting list for a new heart.
The average heart transplant costs about a million dollars to perform. Subsequent follow-up care adds another $30,000 annually. Health insurance will usually cover most, if not all, of these costs. But uninsured patients are kept off transplant lists on the grounds that the inability to pay for care allegedly jeopardizes an organ’s long-term success. Continue reading
Picture it: Tuesday, February 14, 2017. It is four o’clock and the Tsai Auditorium of the Center for Government and International Studies is packed to the gills, abuzz with energy. Harvard faculty, students, staff, and community members fill every seat, line the steps, and stand shoulder-to-shoulder in the back. They are turning would-be attendees away at the door. The occasion for such excitement is this: The Hutchins Center for African & African American Research here at Harvard hosted the event, “Bobby Seale in Conversation with Jim Sidanius.”
Jim Sidanius is the John Lindsley Professor of Psychology in memory of William James and of African and African American Studies. His work spans broadly across both decades and areas of inquiry. He and his co-author Felicia Pratto are famously responsible for formulating social dominance theory, “a general model of the development and maintenance of group-based social hierarchy and social oppression.” He has also pioneered work in other areas of political psychology, including such research areas as “political ideology and cognitive functioning, the political psychology of gender, group conflict, institutional discrimination and the evolutionary psychology of intergroup prejudice.”
And Bobby Seale, as you may know, co-founded the Black Panther Party for Self Defense (BPP). I had never before seen Bobby Seale speak and did not know what to expect. And, ultimately, I am pleased not to have watched any of his interviews in advance, as I was able to have the experience with fresh eyes. (It’s worth noting that many of his interviews and speeches are easily accessible on YouTube. It’s worth watching them, including his 2015 New York Times interview with R&B artist D’Angelo.) His energy and enthusiasm captivates his audience, as when, during his talk last week, he recited from the Declaration of Independence, and while so doing impersonated both John Wayne and Rev. Dr. Martin Luther King, Jr. He recited this passage:
“[W]hen a long train of abuses and usurpations, pursu[ed] invariably…evinces a design to reduce [a people] under absolute Despotism, [then it is the] right [of the people]…to [alter and change that] Government, and  provide new Guards for their future security.”
By Brad Segal
In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.
The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:
“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”
I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Continue reading
Health Law Year in P/Review
Featured Panel: The End of ObamaCare? Health Care Reform Under A New Administration
January 23, 2017
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event
The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.
This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.
Agenda Continue reading
By Brad Segal
In my last post I characterized how overdoses from the surging opioid epidemic have become the fastest-growing cause of mortality among organ donors. In this update, I raise one potential consequence with ethical and policy implications: so-called donor-derived infections. To be clear, I focus primarily on organ recipients as deaths from drug overdose, and drug addiction more broadly, should be prevented regardless of any implications for transplantation. With this in mind, consider how the population of injection drug users shoulders a heavy burden of HIV, hepatitis B (HBV) and hepatitis C (HCV) (Table 1). First I will focus on screening guidelines, and then will move on to transplantation of organs known to carry an infection.
Screening guidelines can help reduce the incidence of donor-derived infections, but the lab tests recommended in any policy must balance two potential concerns. First, lab tests have a rate of false negative results. Transplants of these organs will accidentally increase donor-derived infections. The policy question, then, is whether or not transplanting organs donated by individuals with higher risk of recent disease exposure will expose an unacceptable proportion of recipients to infection. This unintentional harm could undermine a duty of non-maleficence to organ recipients. Further complicating a potential screening policy is that the basic lab tests for HIV, HBV, and HCV detect the presence of human antibodies, which work well among a low-risk population, but antibodies might not appear in the blood until weeks after infection (Table 2).Recent infections are better detected by nucleic acid amplification (NAT) testing.To mitigate risk of infection,then, transplant screening policies should require a heightened level of surveillance among donors with a history of illicit drug use. Continue reading
What will happen to the current medical malpractice system under a single-payer system?
To answer this question, I started by looking at the information provided by Physicians for a National Health Program, whose mission is to replace the ACA (Affordable Care Act) with single-payer. On their website under Single-Payer FAQs, it says:
What will happen to malpractice costs under national health insurance?
They will fall dramatically, for several reasons. First, about one-fourth of all malpractice awards go to pay present and future medical costs (e.g. for infants born with serious disabilities). Single payer national health insurance will eliminate the need for these awards. Second, many claims arise from a lack of communication between doctor and patient (e.g. in the Emergency Department). Miscommunication/mistakes are heightened under the present system because physicians don’t have continuity with their patients (to know their prior medical history, establish therapeutic trust, etc) and patients aren’t allowed to choose and keep the doctors and other caregivers they know and trust (due to insurance arrangements). Single payer improves quality in many ways, but in particular by facilitating long-term, continuous relationships with caregivers. For details on how single payer can improve the quality of health care, see “A Better Quality Alternative: Single Payer National Health Insurance.” For these and other reasons, malpractice costs in three nations with single payer are much lower than in the United States, and we would expect them to fall dramatically here. For details, see “Medical Liability in Three Single-Payer Countries” paper by Clara Felice and Litsa Lambkros.
Let me address the most salient part of the above argument, which states that the significant burden of malpractice recoveries composed of future medical costs will be alleviated because all individuals will be insured. Continue reading
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
Recently, the American Medical Association (“AMA”) passed an emergency resolution at its annual conference declaring gun violence a public health crisis and calling for both restrictions on access to firearms and increased research into gun-related violence. In its announcement, the AMA noted that it plans to “actively lobby Congress to overturn legislation that for 20 years has prohibited the Centers for Disease Control and Prevention (CDC) from researching gun violence.”
The AMA’s decision to publicly take a strong stance on gun violence could have a substantive impact on the national conversation. The group represents one of the most powerful voices in health care policy. According to the Sunlight Foundation, the AMA is a “political powerhouse,” raising $1.3 million through its PAC during the 2014 election cycle and spending almost $22 million on lobbying in 2015 alone. To put that in perspective, the National Rifle Association — the nation’s foremost gun rights organization — spent $3.6 million on lobbying that year. Admittedly, the AMA — unlike the NRA — is a multi-issue organization, and it remains to be seen whether it will throw its financial heft behind this new position, but the fact that there is a powerful new party at the table has made some hopeful that members of Congress will start to think more seriously about finding ways to reduce gun violence. Continue reading
By Timo Minssen
New publication on the patentability of biomedical diagnostics out:
Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives. In addition to a better-funded and well-administered prize system (an interesting option for some areas of diagnostics that we did not elaborate upon), our paper highlights the need for an improved and more flexible system for regulatory exclusivities in this sector.
Citation: Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019
This new post by Nancy Beaulieu, Michael Chernew, Soren Kristensen, and Meredith Rosenthal appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.
The notion that the American health care system should transition from paying for volume to paying for value has become nearly ubiquitous. There is a broad consensus that health care providers should be paid more if they deliver higher value care (i.e. care that results in substantial health gains per dollar spent).
These beliefs have led to a proliferation of value-based payment programs in both public and private sectors. For example, at the beginning of 2015, Sylvia Burwell announced the federal government’s commitment to tie 90 percent of fee-for-service Medicare payments to quality or value measures by 2018. In January of 2015, a newly formed alliance of health care providers, insurers, and employers called the Health Care Transformation Task Force committed to shifting 75 percent of their business to contracts that provide incentives for quality and efficiency by 2020.
The details of existing value or quality-based payment programs vary enormously and without regard to any conceptual framework. For example, they vary in the size of incentives and the measures used. They also vary in whether quality payments are contingent on financial savings and whether the value-based payment model is budget neutral. Even the term value is inconsistently defined. […]
Read the full post here.
By John Tingle
One thing is clear when commentating on patient safety developments in the UK is that there is hardly ever a dull moment or a lapse of activity in patient safety policy development .Something always appears to be happening somewhere and it’s generally a very significant something. Things are happening at a pace with patient safety here.
On the 3rd March 2016 the Secretary of State for Health,The Rt Honourable Jeremy Hunt announced a major change to the patient safety infrastructure in the NHS with the setting up from the 1st April 2016 of the independent Healthcare Safety Investigation Branch. In a speech in London to the Global Patient Safety Summit on improving standards in healthcare he also reflected on current patient safety initiatives.This new organisation has been modelled on the Air Accident Investigation Branch which has operated successfully in the airline industry. It will undertake, ‘timely, no-blame investigations’.
The Aviation and Health Industries
The airline industry has provided some very useful thinking in patient safety policy development when the literature on patient safety in the UK is considered. The way the airline industry changed its culture regarding accidents is mentioned by the Secretary of State in glowing terms. Pilots attending training programmes with engineers and flight attendants discussing communications and teamwork. There was a dramatic and immediate reduction in aviation fatalities which he wants to see happening now in the NHS. Continue reading
By John Tingle
Healthcare providers and policy makers can avoid the expense of reinventing the wheel if they try and look beyond their shores for solutions to patient safety problems. In the UK the work of the patient safety unit of WHO in Geneva helps NHS healthcare providers through the development of patient safety tools and other projects. The WHO multi-professional patient safety curriculum guide is one example. The learning from error – video and booklet is another. Recently launched by WHO is the Safe Childbirth checklist and guide to implementation.
The Checklist will be a useful patient safety tool in developing, transitioning and developed countries. The scale of the problem is very disturbing. WHO calculate that in 2013, 289,000 women died during and following pregnancy and childbirth, and 2.8 million new-borns died within 28 days of birth. Most of these events could have been prevented and mostly occurred in low resource settings. Women and their babies are being very conspicuously failed by health systems which should be helping them. Continue reading
Pharmaceutical companies are making breakthrough drugs to cure diseases, but no one knows how to pay for them. In 2013 and 2014, FDA approved Solvaldi and Harmoni, which can cure hepatitis C in more than 90% of patients. Solvaldi and Harmoni cost $84,000 and $95,000, respectively, for a standard course of treatment. Government payers and health plans, without a good solution for providing Solvaldi and Harmoni to patients who need them, have restricted coverage of the drug to only those patients with advanced hepatitis C. Last year, Germany approved Glybera, a gene therapy that enables patients with lipoprotein lipase deficiency to produce the deficient enzyme. Glybera is expected to cost $1 million, and it is doubtful whether any payer could shoulder such a price.
Last week, MIT professor Andrew Lo proposed a new way of paying for these high-priced therapies: securitized consumer healthcare loans (HCLs). HCLs would function as mortgages for large healthcare expenses. Because the benefits of some therapies occur upfront, HCLs would allow consumers to pay for the value of their therapies over time, instead of in one upfront payment. The paper proposed two frameworks to govern HCLs. The first is a consumer-funded loan, where the patient borrows a loan to pay the upfront costs of the drug, and pays back the loan over time. The second framework operates similarly to the consumer-funded loan, except that private payers and government agencies assume the debt. Under this model, insurance companies could take the debt associated with the patient’s treatment then shift the debt onto the next payer if the patient changes insurance companies. Continue reading
Most readers of this blog will be familiar with the story of Sovaldi (sofosbuvir), a breakthrough treatment for Hepatitis C. Sovaldi is a transformative cure for a devastating disease, but priced at $84,000 per 12-week course, it has distressed insurance budgets (particularly Medicaid) and in many instances, led to rationing of access. As a result, there has been much debate about the appropriate price for such a valuable treatment.
Many have made the case that $84,000 is a pretty good value proposition compared with the ongoing expenses of living with Hepatitis C, or the cost of a liver transplant. Indeed, most of the people whose opinions I admire are willing to accept the $1,000 per-pill price tag (pills cost about $1/ea. to make) as a reward for innovation and incentive for R&D.
Even though I can accept the merits of these arguments, I find that I still cannot shake a visceral sense of injustice. I’m glad Sovaldi exists. I don’t mind that Gilead is making money. And yet, the situation feels profoundly unfair. It took me a long time to figure out why. Continue reading
By Timo Minssen
The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?
Some advice on how to address the particular challenges and opportunities in interdisciplinary research are described in our recent paper “Ten Simple Rules for a Successful Cross-Disciplinary Collaboration” published in the online open access journal PLOS Computational Biology last month. Please find below and abstract of the paper, which has inter alia been discussed and cited by Times Higher Education.
Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020” EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.
However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.
Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214
Last month, Slate columnist Reihan Salam wrote a provocative article about outrageous hospital prices that are driven, according to Salam, by greed, avarice, and market power. Salam gets a few things dead right, namely his diagnosis that we have a massive hospital pricing problem that is bleeding us dry and that the problem is largely caused by growing hospital market power. However, he misses the mark when laying out policy recommendations to curb monopoly-driven hospital prices.
Antitrust: Salam favors using antitrust enforcement to prevent health care consolidation and to reduce barriers to entry for competition. The biggest problem with antitrust enforcement is that it can do little to reverse or break up existing monopolies. Antitrust laws will be unable to help the vast majority of hospital markets that are already concentrated. Second, even with its improving success rate in court, the FTC simply cannot prevent or police the ongoing wave of hospital mergers, resulting in price increases up to 40% price increases in some areas. To be sure, increased antitrust enforcement is a necessary element of the strategy to control hospital prices to stem the tide of consolidation that is driving prices upward. But antitrust is no silver bullet, especially for hospital markets that have already become noncompetitive. Continue reading
Biogen, a Cambridge, Massachusetts biotech company, announced last week that early tests of their new drug aducanumab, a monoclonal antibody, had shown impressive results in treating those with early stage Alzheimer’s disease. The drug significantly reduced the amyloid plaque buildup in the brain that is associated with Alzheimer’s.
In a very early stage safety test aducanumab slowed the cognitive decline and dementia associated with Alzheimer’s in people. On the Mini Mental Status Exam, a widely used measure of cognitive function, people at risk of Alzheimer’s who got a placebo lost around 3 points over a year. But those who got the lowest dose of aducanumab worsened by just two points and those who got a higher dose lost less than a point.
Biogen was so excited by the early results in 166 volunteers that it is going to try to go directly to a much bigger clinical trial of the drug. Wall Street was very excited too—Biogen’s stock price shot up 10 percent. […]
See the full article here.