- Amy Fairchild et al, The Renormalization of Smoking? E-Cigarettes and the Tobacco “Endgame,” N Engl J Med
- Evelyn Tenenbaum, The Union of Contraceptive Services and the Affordable Care Act Gives Birth to First Amendment Concerns, Albany LJ Sci & Tech
- Sharon Long et al, The Health Reform Monitoring Survey: Addressing Data Gaps To Provide Timely Insights Into The Affordable Care Act, Health Affairs
- Kevin Outterson,The Drug Quality and Security Act — Mind the Gaps, N Engl J Med
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.
This is worth a read, and, in my opinion, absolutely right. The discussion is relevant to broader questions of identified v. statistical lives, as well as “choice architecture” questions about how charities ought to seek out donations. Take a look:
Full disclosure: Several years ago my family took advantage of a Make-A-Wish trip resulting from my younger brother’s leukemia. He is now a thriving adult and doing great, and the experience was incredible, especially for those families with children facing terminal diagnoses. But the fact remains that this really has to be seen as a “luxury” charity – and when faced with a stark side-by-side choice of where the dollars could be spent, Peter’s analysis nails it.
Yesterday the CMS issued a document, Options Available for Consumers with Cancelled Policies, that describes four options available to people who received notice that their healthcare plans were cancelled. (I blogged about the cancellations here.)
The first three options aren’t newsworthy: you can buy a new plan from your insurer, buy a plan through the marketplace, or shop outside the marketplace. The fourth option is newsworthy, because the CMS has for the first time announced that people whose plans were cancelled may qualify for a hardship exemption allowing them to enroll in (cheaper) catastrophic coverage.
Not surprisingly the announcement is receiving lots of attention. Seth Chandler has a roundup of some of the early news coverage. Since he posted, Nicholas Bagley blogged here and Jonathan Adler noted the change here.
I am still digesting this interesting news, but have one contribution to the discussion so far. Many people are saying that those in cancelled plans are now “exempt” from the individual mandate, that having a plan cancelled is now itself a “hardship.” That is not quite right in a way that obscures an important aspect of this announcement. The CMS has not exempted anyone with a cancelled plan yet. Read More
Art Caplan has weighed in, with a piece for NBC News online, on the debate over the case of a thirteen-year-old California girl whose parents are suing to keep her on life support despite the fact that doctors have pronounced her brain dead. From the piece:
This case is so sad it is almost beyond description. But that fact should not be a reason to take the view that we don’t know what to do when someone is pronounced brain dead.
Brain dead is dead. It is as reliable a way to determine death as declaring that a person’s heart has forever stopped beating. In fact, due to the strict tests and procedures that have to be followed to determine brain death, it is probably even more error-free than pronouncing someone dead due to cardiac failure.
Brain death is not a coma. People wake up from comas—they still have brain activity. Brain death is not a vegetative state. People in a vegetative state still have some, minimal brain activity. Those who are brain dead have lost all brain activity except the random firing of a few cells. They will not come back.
For more, read the full piece.
There’s an interesting post up on the New York Times’ Well Blog about children with three biological parents—in this case, three genetic parents. Here, a mother and a father provided chromosomal DNA (i.e., the standard 23 chromosomes from each leading to the diploid 46 chromosomes), and another woman provided the egg, which included DNA found in the mitochondria (the “powerhouses of the cell” which are found in the cytoplasm of the egg). The idea behind this practice is that women with problems in their mitochondria can still have healthy children with their own genetic material. While it’s not that unusual to talk about children with three biological parents (two genetic and one gestational, as happens frequently with a surrogate mother or egg donor), we don’t often think on examples with three genetic parents (and the potential for a fourth biological (gestational)).
In connection with our work on the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Center, the Petrie-Flom Center seeks to hire a Senior Law and Ethics Associate immediately. This is a full-time position for a doctoral-level hire (J.D., M.D., Ph.D., etc. in law, ethics, public health, social science, or other relevant discipline) with extensive knowledge and understanding of clinical research and its regulation. The Senior Law and Ethics Associate will support a new program aimed at developing creative, practical solutions to reduce seemingly intractable legal and ethical barriers to clinical and translational research.
View the full job description and apply HERE.
Contact Executive Director Holly Fernandez Lynch with questions.
Last week, the Food and Drug Administration finalized a long-awaited guidance document that aims to reduce non-therapeutic uses of antibiotics in livestock production and thereby limit the evolution of drug-resistant bacteria.
As I discussed in a previous post, the use of antibiotics in livestock production is often not for the therapeutic purpose of curing disease, but rather for the purpose of speeding growth or increasing feed efficiency. Current estimates are that livestock production consumes 30 million pounds of antibiotics per year, representing 80 percent of the total volume of antibiotics sold in the United States for any purpose. The FDA policy that allows non-therapeutic uses of antibiotics in livestock has in recent years been subject to intense scrutiny by outside advocates, former FDA officials, government investigators, and judges.
The FDA has now taken action to address these concerns by finalizing industry guidelines that it first proposed over a year ago. Under the guidelines, animal pharmaceutical companies would change the labeling of “medically important” antibiotics in two ways. First, the labeling would no longer list production uses (i.e., growth enhancement and feed efficiency) in the approved uses for the drugs. Second, the labeling would require veterinary oversight for therapeutic uses (i.e., the prevention, control, or treatment of a disease), rather than allowing over-the-counter distribution. These changes in labeling would in turn require changes in agricultural use by virtue of other FDA regulations that prohibit off-label use for production purposes.
While the FDA’s action is a step in the right direction toward eliminating non-therapeutic uses of antibiotics in food animals, there are a few features of its strategy that are worth highlighting as they might significantly limit its impact. Read More
Today, there are two big stories that relate to the “institutional corruption” of medicine (aka conflicts of interests). For those who have been working long and hard on these issues, they are cause for hope. The needle does move.
First, one of the biggest pharmaceutical companies, GlaxoSmithKline, has decided that it will stop paying doctors to promote their drugs. My prior work has shown that such payments are quite common (e.g., 61% of urologists and 57% of gastroenterologists taking money), and that they likely influence the prescribing decisions of the doctors who take such money. In recent months, Glaxo has made several such moves towards greater transparency and integrity, often as a result of threatened or actual criminal prosecutions. (See their newfound commitment to opening up their clinical trial data too.)
The NYT story quotes an industry consultant suggesting that the move to stop paying physicians is a result of the Affordable Care Act’s “sunshine” requirement that such payments will be disclosed, and that several other drugmakers are considering similar moves. I am a bit skeptical that the disclosure mandate had such an effect, since the disclosures were already required by Massachusetts and other states, and as part of the “corporate integrity agreements” that came of several federal prosecutions. My sense is that such disclosures are not likely to reach patients in a useable way, so its hard to understand how the transparency could really impose much of a disincentive on the companies. Yet, something has caused Glaxo to change course.
Second, the National Football League has decided to give the National Institute of Health $30 million to study brain injuries. The counterfactual is that the NFL could have kept the money, of course. But the more interesting alternative is that the NFL could have just spent the money itself, hand-picking the researchers and carefully specifying how the research should be performed, in order to buy the scientific conclusions that it preferred. This has been the classic strategy of industries facing litigation risk, from tobacco, to asbestos, and now the paper industry, whose law firm actually commissions scientific studies on its behalf. The NFL’s move instead proves that it is possible for a self-interested party to nonetheless fund independent, credible, gold-standard research, by using an intermediary, such as the NIH.
This is exactly the sort of reform that I have called for, as an alternative to the false dichotomy between public funding and private interest. For companies that have a bona fide interest in discovering and publicizing the scientific truth, a credible intermediary like the NIH can reassure consumers of scientific information that it is valid. Now, if only we can get big pharmaceutical companies to make the same move for their clinical trials and other scientific research studies. Perhaps the first-movers will be the most innovative companies who have bona fide products and are tired of them being lost in the cheap talk? If physicians making prescribing decisions continue to give greater credence towards NIH-funded research, such integrity could be rewarded.
EDIT: Corrected link to NFL story on NYT, and corrected amount from $100M to $30M. Also, disclaimer: I am not involved in this Petrie Flom Center collaboration with the NFL, and the views expressed here are entirely my own.
The National Program Office (NPO) for Public Health Law Research (PHLR), a nationally recognized program sponsored by Robert Wood Johnson Foundation for the evaluation of the health impact of laws and legal practices, seeks a postdoctoral fellow who will provide quantitative analytical support to the PHLR team. The successful candidate holds a Ph.D. with significant experience in quantitative methods and law/health policy or a J.D. with strong quantitative and health policy research skills. The individual will produce empirical papers using the quantitative legal data currently on LawAltas.org and provide literature and systematic review support for journal publications, white papers, and grant submissions. This person will become a full member of the NPO for PHLR at the Temple University Beasley School of Law for a period of two years. PHLR staff and affiliated scholars will mentor this person in public health law research methods and provide networking opportunities with leaders in the field of public health law research. The postdoctoral fellow will be required to attend the PHLR Annual Meeting each year.