Doctors, Lethal Injection, and Firing Squads

Yesterday JAMA published a new perspective I co-wrote with Bob Truog and Mark Rockoff  “Physicians, Medical Ethics, and Execution by Lethal Injection“. In that article we make the case that the recommendations coming out of the Oklahoma botched lethal injection executions to require physician involvement would force physicians into an untenable medical ethical position. We also argue that it supports a kind of kabuki theater of medicalization, where execution becomes normalized.

Now comes a news report of a Utah lawmaker pushing to give those set to be executed the option of firing squad which he views as more humane than lethal injection. Many people will no doubt recoil at this notion. But here is my intentionally provocative question (and this is on my behalf not my co-authors): If you are in favor of capital punishment, wouldn’t a single close range shot to the head as a form of execution be, in some ways, more defensible than lethal injection? If you recoil at the notion of this being a way of doing execution, have you perhaps fallen for the kabuki theater of medicalization? Why not choose a method of execution that is more honest about the gravity (and perhaps the horror) of what we are doing rather than present something as somewhere on a continuum with sedation?

Summer Course for Professionals in “Pharma Law & Policy” at the University of Copenhagen

Stay abreast with recent developments and trends determining the legal and regulatory framework of the European pharmaceutical industry.

What are the most significant current issues shaking and shaping the pharmaceutical industry today? The business environment and legal framework relevant to the pharmaceutical industry continues to change rapidly in the face of constant challenges posed by competition, politics and technological innovation. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments.

This course provides a broad and practical understanding of the ‘hot topics’ and will present and analyse these topics from scientific, legal and policy perspectives.

Further information about the course is available here.

Course content

The course begins with a general overview of the current scientific and legal trends in pharmaceutical R&D, organisation and policy. This is followed by a review of the hot topics through a combination of lectures, discussions, group work and case studies. The course is designed to allow room for the issues and challenges crucial to the participants’ daily work and practice.

Participants

The course is designed for professionals working with legal issues and/or regulatory aspects of drug development, decision-makers, administrators and health care practitioners within both the public and private sectors, e.g.:

  • Legal departments in the pharmaceutical industry.
  • Law firms dealing with patent and competition law in the pharmaceutical industry.
  • Branch organizations in the pharmaceutical sector.
  • Health care professionals and decision makers.
  • Bank and finance consultants working with risk and investment in the pharmaceutical industry.

Credit – especially for lawyers and trainee solicitors

This course meets the Danish requirements for compulsory supplementary training for lawyers and trainee solicitors.

Course dates

5 days, 18 – 22 August 2014, 9:00 – 17:00 at the University of Copenhagen, Frederiksberg Campus.

Course director

Timo Minssen, Associate Professor, Dr., LL.M., M.I.C.L., Centre for Information and Innovation Law, Faculty of Law, University of Copenhagen

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A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

By Timo Minssen

Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law:

“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”

Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.

These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).

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How should we label these “cognitive errors” that are particularly common among MDs?

Behavioral economists are really into giving the cognitive errors they study, and the corrective policy interventions they favor, labels. “Status quo bias,” “availability bias,” “recall bias,” etc., can all be fixed through “nudges” that involve “asymmetric paternalism” and the like.

Here’s an interesting “cognitive error” that I’m trying to crowd-source a label for: When America’s joint surgeons were challenged to come up with a list of unnecessary procedures in their field, their selections shared one thing: none significantly impacted their incomes.

And here’s another odd cognitive anomaly that seems to be especially limited to ophthalmologists: forgetting there’s a $50 dollar alternative that works just as well as the $2,000 injection they get 6% commission on. 

I’ve thought of my own labels (or rather, euphemisms) for the policy interventions I would suggest in response: “continuing medical education”  for the first of these neat little errors, and “resocialization” for the second.

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

By Jonathan J. Darrow

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

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

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

Professional Licensing Boards and Antitrust Liability

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone, in which she discusses North Carolina Board of Dental Examiners v. FTC, drawing on both her scholarly work on the intersection of health care and antitrust law and on her deep experience prosecuting medical licensing actions for the state of New Jersey.]

By Tara Adams Ragone

Cross-Posted at Health Reform Watch

Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct?  The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.

Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case.  He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here.  Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.

While we wait to learn if the Supreme Court will review this case, Professors Aaron Edlin and Rebecca Haw tackle the question of whether the actions of state professional licensing boards should be subject to antitrust scrutiny in their article, “Cartels by Another Name: Should Licensed Occupations Face Antitrust Scrutiny?” (available on SSRN and forthcoming in the University of Pennsylvania Law Review).  Although they use a question mark in their title, their characterization of licensing boards as cartels is a powerful tipoff to their ultimate conclusion – that licensing boards composed primarily of competitors regulating their own profession should not escape antitrust review: Read More

International Aid, Public Health, and Corruption

My wonderful HLS colleague Matthew Stephenson has just launched the Global Anticorruption Blog (GAB). As it happens, his first two posts may be of interest to BOH readers, especially those  may be of interest to readers interested in international aid for public health projects, of the sort supported by the Gates Foundation.  The first post argues that the extent of corruption in these projects is much larger than the Gates Foundation and others acknowledge.  The second post contends that one reason for lowballing of corruption estimates is political: these projects depend substantially on public funding, and political support for health aid may be undercut by candid assessments of the extent of the corruption and fraud problems. Both the posts and the blog are well worth a read.

DC Circuit Upholds FDA Authority Over Stem Cells

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

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

Encouraging Innovation in Chronic Care Management

By Michael Young

The growing burden of managing chronic illness has long been a critical issue for policy makers and clinicians seeking to improve the quality, cost and efficiency of healthcare systems in the United States. According to the Institute of Medicine, the costs of treating and managing the segment of the population living with chronic illnesses currently represents nearly $1.5 trillion of the over $2 trillion in annual healthcare spending in the U.S.  Over 90% of Medicare costs are allocated to beneficiaries living with two or more chronic conditions, with close to 50% of spending on individuals living with 6 or more chronic conditions (approximately 14% of beneficiaries).  The immense share of healthcare spending attributable to chronic illness is expected to climb as the population ages. 

Earlier this month, a bipartisan bill entitled the Better Care, Lower Cost Act was introduced in Congress which aims to address the complex issues involved in chronic care management.  The legislation outlines three key innovations toward this end.

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Capturing Value in Advanced Medical Imaging

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

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

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

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