Earlier this month, the Drug Enforcement Administration issued notice that it would be increasing the 2014 production quota for marijuana from 21 kilograms to 650 kilograms – an almost 3000% increase. In the words of DEA spokeswoman Barbara Carreno, “That’s a lot of marijuana.” This step, according to the National Institute on Drug Abuse (NIDA), was a necessary response to a dramatic increase in current and proposed marijuana research. Read More
Category: Scientific Evidence
Michael Jackson and Emotional Damages
By Dov Fox
You know the King of Pop died in 2009 while rehearsing for a comeback tour in London. Here’s a twist you may not have heard about: Michael Jackson fan club members sued Conrad Murray, the doctor who administered the lethal overdose of anesthesia. And the celebrity enthusiasts won. A French court recently awarded five of the grieving fans economic damages (albeit just a euro each) to compensate for their emotional suffering.
The case highlights a neglected problem in our own law, not just medical malpractice, but constitutional and common law too. It’s this: Supreme Court rules and policies about harm, compulsion, and intentionality rely on the flawed assumption that operations of the mind are meaningfully distinct from those of the body. In our new essay on Dualism and Doctrine, Alex Stein and I (1) demonstrate just how this fiction distorts the law, (2) argue that the reasons for its persistence cannot save it, and (3) identify the ways in which courts should uproot dualism’s pernicious influence on our legal system. Read More
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).
Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls
In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.
In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.
Is Medicare’s System for Challenging Coverage Determinations Unintentionally Unfair?
On March 25, Susan Jaffe published a blog post in the New York Times about Medicare’s recent change to cover skilled therapy (e.g. physical therapy, nursing care) where it is “reasonable and necessary” maintain a patient’s condition and to prevent deterioration, even when it is not likely that the patient will improve. Jaffe notes that the revisions will likely have a substantial impact on thousands of Medicare beneficiaries even though the change has been largely unnoticed.
The revision highlights a potential problem with the system in place for challenging Medicare coverage. The revision itself is unremarkable, reflecting what national Medicare policies professed, but what local contractors sometimes ignored. What is remarkable is the time it took for Medicare to make the revision, from when the controversy appeared to when Medicare posted the change in its manuals. This delay is problematic because it reflects a dichotomy in how coverage decisions are challenged and changed under Medicare – due not to medical necessity but to political and financial circumstances beyond patient control.
Constituents can change Medicare coverage policies through two processes. One is through the litigation system. Judges can overturn Medicare coverage decisions after patients have exhausted Medicare’s internal adjudication process. Yet, litigation can take years and judges usually defer to Medicare’s judgment. National Coverage Determinations (NCDs) provide an alternative under which constituents can encourage Medicare to reconsider or overturn a prior coverage decision. NCDs supersede Local Coverage Determinations (LCDs) – coverage decisions that affect a region of the United States. When Medicare determines that the LCDs for a specific technology or service are “inconsistent or conflict with each other to the detriment of Medicare beneficiaries,” Medicare can decide to issue an NCD to provide uniform coverage.
Saturday, April 5th: Aid Grade! (from Harvard Effective Altruism)
A communication from Harvard Effective Altruism:
Hi altruists,
Saturday, April 5th is a big day for EA at Harvard: we have three different awesome events for you! Our guest for the day, flying up from DC for the occasion, will be Dr. Eva Vivalt, the founder of AidGrade. AidGrade helps figure out what works in international development by doing rigorous and engaging analyses of different interventions to find out their effects. They’re also looking for interns and full-time hires for this work, so please visit if you’re interested!
We’ll be having a talk on AidGrade’s research from 1-2pm, followed by a research-a-thon from 2-6 where we help AidGrade do some meta-analysis. The day will be topped off by a Boston-area effective altruism meetup at Clover–with another special guest, Jacob Trefethen of 80,000 Hours Cambridge UK, and many awesome local effective altruists.
Evidence in Policy Innovation
In the last few decades, there has been a broad effort to strengthen the use of evidence-based law as a tool for the promotion of population health. There are two major fronts in the campaign, each essential, and both largely successful, though much work also remains. One aims to increase the quantity and quality of empirical research on the health effects of existing policy choices. The other focuses on how best to get such knowledge into action in the form of policy and practice. In a new PHLR Theory Practice and Evidence paper, Evan Anderson and I draw attention to a third front: the formulation of new legal interventions. Though policy experimentation is inevitable, it has been the subject of relatively little systematic study. For proponents of evidence-based public health law, policy experimentation presents a paradox: if a legal intervention is truly innovative, there will not yet be direct evidence of its impact. Yet direct evidence from policy evaluations is never the only source of research knowledge relevant to a policy decision, even under conditions of novelty and uncertainty. And few interventions are truly new in a broad sense; in most instances, similarly designed laws have been deployed before, just not for the same specific purpose.
We use the case of youth sports concussion and Washington’s Lystedt Law as a case study of how even new legal strategies dealing with new problems can be built on evidence. We show how evidence about the problem lawmakers are addressing, combined with widely-used analytic tools like the Haddon Matrix and an understanding of the generic mechanisms through which law influences behavior and outcomes, can bring existing research knowledge into the crafting of even very innovative legal interventions for newly perceived problems. While we don’t expect the policy sausage factory to suddenly start looking like a research lab, there’s no question that legislators typically care about getting policy right and want evidence. The point of our paper is to get the research world to think about ways we can help even when no one has yet studied the specific law at issue.
New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives
By Timo Minssen
Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard. The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.
I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.
Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.
Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON
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
New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”
By Timo Minssen
I am pleased to announce that we have today published the following paper:
Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN.
This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It is currently under review by Edward Elgar. A longer journal-version will follow.
Abstract:
An effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significance is the development of standards. Considering recent developments within the software and ICT industries, it seems fair to assume that the process of standardization may also have significant impact on the development and adoption of Synthetic Biology (SB). Within SB different standardization efforts have been made, but few have assumed dominance or authority. Standardization efforts within SB may differ within various technical areas, and also the basic processes of standard creation can be divided into various categories. The different technical areas and processes for standardization differ in their speed, handling of interests and ability to dodge possible IPR concerns.
Out of this notion arises i.a. the following questions: How comparable is engineering in SB to more traditional fields of engineering?; What type of standards have emerged and what bearing have IPRs on these?; and, How applicable are the approaches adopted by the standards-setting organizations in the information and communication technology (ICT) to biological standards? These and further legal issues related to IP, regulation, standardization, competition law & open innovation require a careful consideration of new user-generated models and solutions.
Before this background, our paper seeks to describe IP and standardization aspects of SB in order to discuss them in the context of the “open innovation” discourse. We concentrate on describing the technology and identifying areas of particular relevance. Ultimately we also sketch out open questions and potential solutions requiring further research. However, due to the limitation of this paper we do not aim to create elaborated theories or to propose solutions in more detail. Rather this paper, which will be complemented by more extensive follow-up studies, provides a first overview on the complex questions that we are currently dealing with.
To achieve this modest goal, section 1 commences with a brief introduction to the fascinating science of SB and a description of recent technological advances and applications. This will lead us to section 2, in which we will address standard setting efforts in SB, as well as the relevance and governance of various IPRs for specific SB standards. This provides the basis for section 3, in which we debate problematic issues and summarize our conclusions.