Bill of Health Contributor Art Caplan and ethicist Kelly McBride have launched a new twice-weekly podcast, Everyday Ethics, in which they explore the moral dimensions of our everyday lives. Recent topics have included conflicts of interest on Dr. Oz, recent “Right to Try” laws, and Jenny McCarthy’s anti-vaccination campaigns.
You can access the podcast online here, or subscribe to it on iTunes.
We’re pleased to formally introduce Dr. Greg Curfman as a contributor to Bill of Health. Dr. Curfman is already a familiar face here as a regular guest, and we’re thrilled to officially welcome him.
Dr. Curfman is currently editor in chief of Harvard Health Publications at Harvard Medical School. Previously he was executive director of the New England Journal of Medicine, a position he held for 14 years. In his tenure at NEJM, he founded and currently directed the Perspective section, which focuses on issues at the interface of medicine and society. His work at NEJM played a critical role in driving the national dialogue on health care.
A board-certified internal medicine physician and cardiologist, Dr. Curfman is also an assistant professor of medicine at Harvard Medical School. He graduated magna cum laude from Princeton University and received an M.D. cum laude from Harvard Medical School. Dr. Curfman has previously served as the director of the coronary care programs at the Brigham and Women’s Hospital and Dartmouth-Hitchcock Medical Center, and was also medical director at the Cardiovascular Health Center at Mass General.
Dr. Curfman regularly publishes on current topics in health law and the regulation of medical products. His publications include: Read More
[Ed. Note: Cross-posted from Reproductive Rights Prof Blog]
Today, U.S. District Judge Myron Thompson issued a decision – following a 10-day bench trial – declaring unconstitutional Alabama’s admitting privileges requirement for abortion providers. The decision is remarkable in at least two respects. First, Judge Thompson employs a brilliant interpretation of Planned Parenthood v. Casey that is different from any lower court opinion I have seen and yet that is well-grounded in the decision. (He had already laid out this framework in an earlier ruling on summary judgment.) It resolves a longstanding puzzle about the undue burden standard, namely whether and how a court should factor in the state’s burden of justification for an abortion restriction when it conducts an undue burden analysis. Judge Thompson focuses in on a little-noticed aspect of Casey, namely its reliance on ballot-access case law. The Casey joint opinion analogizes to the states’ “substantial flexibility in establishing the framework within which voters choose the candidates for whom they wish to vote,” in order to explain why “not every law which makes a right more difficult to exercise is, ipso facto, an infringement of that right.” Yet, in describing the state’s power to regulate elections as “similar” to its power to regulate abortion, the Court suggests that its analysis in the ballot access cases is instructive in the abortion context.
Judge Thompson takes up this suggestion. He points out that, in the specific cases that the Casey joint opinion cites, the Court looked at whether the state’s interest in the election regulation was “sufficiently weighty” to justify the restriction it imposed. In Anderson v. Celebrezze, for example, the Court explained that, when analyzing constitutional challenges to specific provisions of a state’s election laws, the Court
must first consider the character and magnitude of the asserted injury to the rights . . . that the plaintiff seeks to vindicate. It then must identify and evaluate the precise interests put forward by the State as justifications for the burden imposed by its rule. In passing judgment, the Court must not only determine the legitimacy and strength of each of those interests, it also must consider the extent to which those interests make it necessary to burden the plaintiff’s rights. Only after weighing all these factors is the reviewing court in a position to decide whether the challenged provision is unconstitutional.
Judge Thompson applies this framework, first analyzing the burden that Alabama’s admitting privileges requirement would impose on abortion access in the state. Finding that the burden would be substantial, he then closely examines the state’s purported justifications for the law and concludes that they are “exceedingly weak.”
By Rachel Sachs
On Thursday, the FDA finally began to take an action that it had been publicly contemplating for over four years: the regulation of laboratory-developed tests (LDTs). In the FDA’s words, LDTs are diagnostic tests which are “designed, manufactured and used within a single laboratory.” There are thousands of LDTs, including very high-profile ones, such as Myriad Genetics’ test for assessing breast cancer risk. Although these diagnostic tests fall under the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of “medical device,” the FDA has for decades stated it was exercising its enforcement discretion in declining to regulate LDTs. (The FDA has exercised its regulatory powers over diagnostic tests that are designed and manufactured by one laboratory and sold to another for use.) Although the official draft guidelines have not yet been released, the FDA’s report regarding their anticipated contents suggests that regulation of LDTs will follow a risk-based framework similar to the one in place now for other medical devices.
Much (though not all) of the relevant industry opposes the FDA’s actions here, and it’s easy to see why. Many of these LDTs would now be subject to premarket review, or at the very least additional reporting requirements, which make the development of these tests both riskier and more expensive. Some firms argue that the FDA lacks jurisdiction to regulate LDTs, but they also argue that their LDTs are already sufficiently regulated by the Clinical Laboratory Improvement Amendments (CLIA), under the auspices of the Centers for Medicare and Medicaid Services. But here’s the problem: CLIA and the FDCA regulate different aspects of LDTs. And it can be detrimental to patient health to leave the FDCA aspects of LDTs unregulated.
Clinical Ethicist
Boston Children’s Hospital
Boston, MA
The Office of Ethics at Boston Children’s Hospital has an immediate opening for a clinical ethicist. Applications are being accepted online, at www.childrenshospital.jobs. To locate the position on the website, enter “32902BR” in the box labeled “AutoReqID.”
Boston Children’s Hospital is a 395-licensed-bed children’s hospital in the Longwood Medical and Academic Area of Boston, Massachusetts. At 300 Longwood Avenue, Children’s is adjacent to its teaching affiliate, Harvard Medical School.
Job description: Clinical Ethicist 32902BR
The Clinical Ethicist provides formal and informal ethics consultations. Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.
By Timo Minssen
Last week I blogged about recent publications concerning the global battle against anti-microbial resistance (AMR). I did not mention a recent paper published in the June 2014 issue of Nature, which describes how European and U.S. researchers and authorities are increasingly considering clinical research in unconventional areas to fight AMR. The news-report “Phage therapy gets revitalized” by Sara Reardon concentrates on the use of viruses (bacteriophages) to battle bacteria. The idea is not new, but apart from some applications in the former Soviet Union, it never was established as a major research area elsewhere. In particular the paper examines the European Phagoburn project, which is the first large, multi-centre clinical trial of phage therapy for human infections, funded by the European Commission. It involves a phase I-II trial of using viruses for the treatment of bacterial infection following burns. The European Union (EU) is contributing €3.8 million (US$5.2 million) to the Phagoburn study demonstrating that it is taking the approach seriously. Meanwhile, the US National Institute of Allergy and Infectious Diseases announced in March 2014 that it regards phage therapy as one of seven key areas in its strategy to fight antibiotic resistance.
So far Western practice has concentrated on treating complex or unidentified infections with broad-spectrum antibiotics. These antibiotics would typically eliminate multiple types of bacteria, including those who have beneficial effects to the human organism. Despite resulting in direct negative consequences for patients, e.g. gastrointestinal disorders, these “atomic bomb” approaches can result in biological niches where resistant “bad bugs” can prosper. This is the reason why scientists are turning towards more targeted approaches. This is where phage therapy comes into play. Like “guided missiles”, phage-therapy has the ability to kill just species of bacteria or strain. Quoting the US virologist Ryland Young and the head of the scientific council at the Eliava Institute in Tblisi (Georgia), Mzia Kutateladze, the Nature report explains how nature offers an almost unlimited source of different phages and that so far no identical phages have ever been found. For this reason it is fairly simple to identify a particular phage for a bacterial target. If the bacterium should become resistant against that particular phage, researchers would modify the viral cocktails that are used for treatment by adding or substituting phages. At the Eliava Institute such updates occur – according to the report – approximately every 8 months and the scientists would not be fully aware of the precise combination of phages in the cocktail.
In light of these advantages the recent interest of US and EU stakeholders in phage therapy comes as no surprise. However, the scientific and legal challenges confronting these projects are complex. After all we are talking about viruses here, which triggers alarm bells with regard to public perception, safety concerns, and the regulation of relevant research. It also appears questionable if – or under what circumstances – regulatory authorities would be willing to grant market approval for such a rapidly changing product like in the case of e.g. influenza vaccines. Another significant problem for the development of new phage therapies, also addressed in the paper, lies in the reluctance of pharmaceutical companies to invest into the field. The potential obstacles for more private involvement in phage therapy are many and range from considerable risks of failure, reputational damage, and unforeseeable side-effects to insufficient certainty with regard to intellectual property protection and guarantees of a profit.
Today the government moved for en banc rehearing in Halbig, as expected. (HT: Rachana Dixit Pradhan @ insidehealthpolicy.com.) I have not had the chance to review the petition but thought I would share it. (For those looking to brush up on some of the blog debate on the case before reading, see here and here. For more details on the en banc process see my earlier post here.)
The Government argues that rehearing en banc is warranted because the “disruption threatened” by Halbig makes the case one with exceptional importance. One interesting bit did catch my eye, in light of that assertion. It is footnote 7, which offers the Government’s view on the impact of the ruling in Halbig, and might be taken as sort of a cf.:
“The panel majority suggested that its ruling would apply nationwide, Op. 41-42, but it did not squarely hold as much or address the many reasons why relief should not extend beyond the named plaintiffs. The panel’s decision does not control in other circuits, just as the Fourth Circuit’s King decision does not control here.”
Here is the petition: Halbig En Banc Petition
I have a long article in Slate (with Chris Chabris) on the importance of replicating science. We use a recent (and especially bitter) dispute over the failure to replicate a social psychology experiment as an occasion for discussing several things of much broader import, including:
By Timo Minssen
One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.
A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.
This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.
By Deborah Cho
A recent data brief summarizing a national survey spanning from 2005-2012 on the perception of weight status in U.S. children and adolescents highlights one major finding — many children and adolescents who are overweight or obese don’t know it. Key findings were that about 81% of overweight (defined as having age- and sex-specific BMI greater than or equal to the 85th and less than the 95th percentile of the 2000 CDC growth chart) boys and 71% of overweight girls believe they are about the right weight. Additionally, nearly 48% of obese (defined as having age- and sex-specific BMI greater than or equal to the 95th percentile of the 2000 CDC growth chart) boys and 36% of obese girls consider themselves to be about the right weight.
As an article on the NPR blog noted, “Kids can be cruel, especially about weight. So you might think overweight or obese children know all too well that they’re heavy.” But it seems that this is not the case, at least according to the survey. Furthermore, not only do overweight or obese children generally seem to be unaware of their weight status, but the misperception rate appears to be higher in those children and adolescents whose families have a lower income-to-poverty ratio. Non-Hispanic black and Mexican American children and adolescents were also found to have higher rates of misperception than Non-Hispanic white children and adolescents.
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