Check out the October 17th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
This November citizens of Colorado will have an opportunity to vote on a proposed amendment (Amendment 67) to their state constitution that would define the words “person” and “child” in the Colorado Criminal Code and Colorado Wrongful Death Act to include “unborn human beings.” Similar personhood measures were rejected by a margin of 3-to-1 by Colorado citizens in 2008 and 2010, and a proposal in 2012 failed to receive the requisite signatures to get on the ballot. Is this version 4.0 all that different?
A New Strategy
In short, the language is different, but not in ways that ought to matter for those concerned about the implications for reproductive rights. I was initially surprised that a fourth personhood proposal was able to secure enough signatures to get on the ballot when the third measure was not. After speaking with a reporter from Colorado, it became clear that the strategy this time around was very different.
This most recent personhood effort rode the wave of momentum generated by the 2012 story of a Colorado woman, hit by a drunk driver, who lost her pregnancy in the eighth month of gestation (a boy she had named Brady). At that time, Colorado did not have a law on the books that permitted the drunk driver to be prosecuted for the death of the fetus. Amendment 67, advertised as “The Brady Amendment” was offered as a solution, and there was no trouble generating over 100,000 signatures. Even without Amendment 67, Colorado has since passed a Crimes Against Pregnant Women Act, which criminalizes (with varying degrees of punishment) the termination of a woman’s pregnancy without her consent. This new law does not define the fetus as a person, expressly permits women to choose to have abortions, and certainly is not considered to go far enough for those in favor of sweeping personhood measures. Amendment 67 was thus still viewed to be necessary by some. Continue reading
The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory to predict risks in early-phase HIV cure studies, assess how much likely candidates for participation understand those risks, and make ethical recommendations on the conduct of HIV cure studies.
The research assistant will help prepare, conduct and analyze a pilot survey expected to take place in a US site of the AIDS Clinical Trials Group (ACTG). The survey will assess perceptions of HIV cure and of cure study risks. The research assistant will also promote other research and grant-related activities, through literature reviews and assistance in the preparation of abstract, poster, and manuscripts for publication, grant applications, a simple project website (using Harvard’s user-friendly OpenScholar platform), and slides for lectures and seminars. The research assistant will be in touch with top researchers in HIV cure, medical decision making, and ethics from around the country, to facilitate our meetings, a workshop, and regular conversations to plan the research and debate ethical issues around early-phase HIV cure studies.
In “Ethical considerations of experimental interventions in the Ebola outbreak“, published yesterday by The Lancet, Zeke Emanuel and I discuss what we take to be the key ethical questions about the use of Zmapp and other investigational agents in the current Ebola epidemic. In essence, we argue that the national and international response to the epidemic should focus on containment and strengthening health systems, rather than experimental treatments and vaccines; that experimental interventions, if they are used, should be distributed fairly and only in the context of clinical trials; and that advance planning is needed for research in future Ebola and other epidemics, as well as for making any proven interventions against Ebola accessible in affected regions.
The full article is available open access. Be sure to check out the Lancet’s new Ebola Resource Centre as well, which includes many other interesting pieces and a podcast (access here podcast) covering—among other things—our paper.
[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy." This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]
In this next installment of today’s live-blogging of the conference (and with all of the caveats of live-blogging mentioned by my colleagues and my apologies for any errors or misrepresentations) we have Professors David Hyman (DH), Mark White (MW) and Andrea Freeman (AF) in a panel moderated by Glenn Cohen (GC) on the “Potential Problems and Limits of Nudges in Health Care”.
The panel began with DH, H. Ross & Helen Workman Chair in Law and Director of the Epstein Program in Health Law and Policy, University of Illinois College of Law, and a talk entitled, “what can PPACA teach us about behavioral law and economics” (Patient Protection and Affordable Care Act). DH began with the observation that nudges often work quite well… “unless they don’t”. While many nudges are “sticky”, i.e. they influence behavior in the way they were intended, others are “slippery”, i.e. they fail to influence behavior in the way they were intended. His talk set out to illustrate the phenomenon, and to pose two questions. The first was an empirical question: what makes a nudge sticky vs slippery? The second was philosophical: is it meaningful to talk about a “failed nudge” or when we do, do we really just mean failed marketing? He focused on an analysis of PPACA as a case study.
By Chloe Reichel
This Thursday the Food and Drug Administration (FDA) proposed new regulations for the sale of e-cigarettes. These regulations would prohibit sales to minors and make health warnings on packages mandatory.
This Wednesday a law was passed in Vermont that requires the labeling of genetically modified foods. Vermont is the first state to pass such a regulation.
Estimations for state spending on Medicaid have been reduced by the Congressional Budget Office. The office is now predicting that the cost of Medicaid expansion will be $46 billion, compared with their previous estimate of $70 billion.
Researchers at King’s College London have grown human skin in the lab from stem cells. Animal rights proponents herald these developments as a potential end to testing on animals.
Sovaldi, a medication for hepatitis C that costs $1,000 for one day’s dosage, has had the most successful drug launch ever. From its FDA approval in December to March 31, its manufacturer sold $2.27 billion worth of the drug, though the drug has faced criticism for its high price.
The FDA is considering banning electrical stimulation devices, used to discourage aggressive behavior in people with disabilities. Students from the Judge Rotenberg Educational Center testified against the use of these devices, though some parents of children at the Center and administrators there defend the use of these devices.
Following an audit of Illinois Medicaid expenditures, it was found that the program paid $12 million for medical services for dead people. These findings have led some to support stricter scrutiny in determining Medicaid eligibility.
Pervasive use of pesticides and genetically modified seeds in Hawaii has led to unrest among the state’s residents. Groups have been organizing to prevent the cultivation of genetically modified crops, and in Hawaii County such a law has already been adopted.
At least since the publication of the President’s Commission on Bioethics’ report in 2003, “Beyond Therapy: Biotechnology and the Pursuit of Happiness”, there has been an ongoing debate about the ethics of using drugs to modify emotional memories. Rather than focus on the Hollywood-type total memory erasure featured in the Eternal Sunshine of the Spotless Mind, many ground the debate in the molecular neuroscience of memory reconsolidation (for an excellent overview, see here). In the process of memory reconsolidation, a newly reactivated memory triggers certain molecular events that are necessary for it to return to long-term storage; during these events, the memory is temporarily susceptible to disruption by certain drugs like the beta-blocker, propranolol. Further work with people with Post-Traumatic Stress Disorder (PTSD) suggests that using propranolol in this way doesn’t erase a memory, but may blunt the reconsolidation of the memory’s negative emotional content. In the ethical discussion, most agree that 1) it should usually be acceptable to use drugs to modify memories in cases of PTSD where the emotional content of memories becomes debilitating, but 2) the use of memory modifying drugs is usually morally problematic when the target is everyday unpleasant memories, disappointments, and rejections.
Existing debate has focused on intentional memory modification. But what about those who modify memories in these problematic ways unintentionally? Conspicuously under-discussed is the ethics of continuing to use drugs with potential memory-modifying properties for the treatment of other medical conditions. Propranolol, for example, is on the Department of Veterans Affairs (VA) National Formulary for treatment of patients with severe liver disease (liver cirrhosis). This (not-small) population of people, in theory, risks unintentionally (and pre-emptively) modifying memories every day!
By Chloe Reichel
Following the release of information on Medicare billing practices, it was revealed that approximately 4,000 physicians each billed over $1 million in 2012. This data may shed light on medical billing procedures.
Despite a proposed 1.9 percent cut to the Medicare Advantage program, these cuts will not be implemented. On Monday the Centers for Medicare and Medicaid Services announced that funding to Medicare Advantage will increase by an average of .4 percent in 2015.
Though genetic testing is becoming cheaper and more accessible, many Americans refrain from getting tested. This is because the Genetic Information Nondiscrimination Act does not protect consumers from discrimination for life, disability, and long-term care insurance plans.
On Friday, Kathleen Sebelius, current Secretary of Health and Human Services, will resign from her role. Sebelius oversaw the oft-criticized implementation of the Affordable Care Act. Sylvia Mathews Burwell, director of the White House Office of Management and Budget, has been selected by President Obama to fill the role. Burwell served in the Clinton administration, and was president of the Walmart Foundation, prior to her work with the Obama administration.
This Thursday the European Parliament debated a petition that would prevent the allocation of EU funds for research, aid, and public health programs that involve the destruction of human embryos. The petition had 1.8 million signatures, and is seen as a sign of popular support for social conservatism.
Hawaii’s extensive health system has led to excellent health outcomes for the state’s residents and the state’s budget, since the state has some of the lowest healthcare costs in the nation. Hawaii has near-universal health insurance coverage, and starting forty years ago, has required employers to provide health benefits to their employees.
On Saturday, Maryland legislators voted to decriminalize possession of small amounts of marijuana. Those found in possession of less than 10 grams of marijuana will now be charged with civil fines, as opposed to criminal penalties.
By Chloe Reichel
In an attempt to increase transparency and accountability of Medicare, the Obama administration will release data about the services provided as a part of this program. The information will focus on the number and kind of services provided.
In the six months following the implementation of the Affordable Care Act, over seven million Americans signed up for insurance plans. These figures are in accordance with those estimated by congressional budget analysts.
Teva Pharmaceutical Industries has appealed a case to the Supreme Court about a generic form of its drug Copaxone. Teva is trying to keep their patent on the drug to prevent the manufacture of generics.
Judge David C. Bury, a federal judge in Tucson, will not stop the implementation of rules that restrict the usage of the abortion drug mifepristone in the state of Arizona. The legislation that restricted the usage of this drug went into effect on Tuesday.
On Monday, the last day for sign ups for health insurance plans under the Affordable Care Act, hundreds of thousands attempted to register for policies. The website HealthCare.gov had some glitches on this day, including a period of a few hours in which the site failed to accept applications.
The Affordable Care Act has allowed many Americans who were previously uninsured to sign up for health insurance, leading to increased usage of health services. This is creating new stresses for small health clinics, but also providing additional funds that allow these clinics to operate.
On Thursday the FDA approved a handheld antidote for painkiller overdoses. The naloxone device, made by kaleo Inc., is called Evzio.
An ethics report was recently released on the risks of long-term space travel. The report addresses physical and psychological risks associated with space travel.
By Chloe Reichel
The Hobby Lobby case that is currently before the Supreme Court may have effects far beyond the contraceptives mandate stemming from the Affordable Care Act. Other health care services and non-discrimination provisions may also be at stake.
Deadlines will be extended for people who need more time to complete their enrollment in insurance plans through HealthCare.gov. Those who apply will be given until mid-April to complete their applications.
Social media efforts led to the provision of an experimental drug to treat a young boy’s life-threatening infection. Bioethicists are now debating the ethics of this case and its implications for future social media interactions.
Due to stringent approval processes, researchers interested in studying marijuana face difficulty in attempting to do so. Despite growing interest in researching the substance, it can take years for researchers to begin their studies on marijuana.
Enrollment in health insurance policies through the Affordable Care Act reflect vast differences in the legislation’s implementation across the country. State-by-state enrollment data varies widely, and overall enrollment statistics neglect this important variation.
Tanning salons in New York are now forbidden from making claims about the health effects of their services. Previously, tanning salons in New York suggested that “sunlight prevents cancer,” a misleading statement considering the negative health effects of tanning.
Changes to Medicare’s policy manual have shifted the agency’s policies on paying for care used to maintain, rather than improve, patients’ health. Medicare will now pay for physical therapy, nursing care, and services for patients with chronic diseases.
Responding to a statewide public health crisis, Governor Deval Patrick has proposed a ban on the the opiate Zohydro. He has also suggested designating $20 million in funds for the purpose of bolstering treatment and recovery programs.
This past Sunday, a group of researchers reported in the journal, Nature Medicine, a preliminary technique that uses variation in blood levels of 10 fats to predict the likelihood that elderly individuals would develop mild cognitive impairment (MCI) or Alzheimer’s Disease in the following 2-3 years. The sample size was small and the results may not generalize beyond the narrow age-range and demographics of the study group (i.e. the assay is far from ready for “prime time”), but the study is an important first step towards a lower cost (vs PET imaging) and less invasive (vs spinal tap) predictive biomarker of cognitive decline*. Its publication has also triggered a flurry of discussion on possible ethical ramifications of this sort of blood biomarker. I will not attempt to address these ethical issues specifically here. Rather, I seek to highlight that how ethically troubling one views the technology to be may depend partly on the sort of knowledge one thinks these biomarkers reveal (applied epistemology at its best).
By Chloe Reichel
The majority of people in La Crosse, Wisconsin have advance directives. The initiative to increase the utilization of advance care planning began as a way of helping patients, but resulted in large decreases in health care expenditures.
Due to Texas’ recently passed regulations on abortion clinics, two clinics closed this week. Abortion clinics in Texas are required to have a physician with admitting privileges at a hospital within 30 miles of the clinic under the new regulations.
A new law passed recently in Arizona would limit access to medication used for medical abortions. Planned Parenthood of Arizona filed a lawsuit this Wednesday to contest the law.
An HIV-positive baby treated with aggressive drugs immediately after birth was reportedly cured of the disease. This is the second such case of this treatment working, and is a promising development for the future of HIV treatment.
On Wednesday it was announced that Americans will be allowed to keep insurance plans that are not compliant with the Affordable Care Act. These plans will continue to be offered for the next two years.
Two surveys have found that uninsured Americans largely have not signed up for insurance following the implementation of the Affordable Care Act. Some suggest that the changes to the new healthcare law that have occurred since its adoption may be responsible for these low rates of enrollment.
In Washington state, people who operate medical marijuana dispensaries are worried about the effects of the state’s recent legalization of recreational marijuana. They worry that the increased demand for marijuana will put smaller dispensaries out of business.
Twenty-six states have introduced mandatory programs that emphasize private long-term care over nursing homes. Many states have modeled their plans after Tennessee, but long-term care in this state is suboptimal for many residents.
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.” Continue reading
By Chloe Reichel
1) Belgium’s recent vote to legalize euthanasia for children has drawn international debate and criticism. The law would allow terminally ill children to end their lives, provided that they have parental consent.
2) Lawmakers in California have proposed adding a warning label on soda and juice that has sugar added and over 75 calories per 12 ounces. The labels would warn against the health risks associated with consuming sugary beverages.
3) The Food and Drug Administration announced today that it will hold a meeting on the topic of changing the over-the-counter monograph system. Currently, the processes of publishing and changing a monograph are very time consuming.
4) Monsanto is producing new strains of vegetables without using GMOs. Instead, they are selectively crossbreeding different varieties of plants.
5) A recent study conducted by a group at Stanford University released findings that seriously injured patients with insurance are less likely to be transferred to trauma centers than uninsured patients. The group hypothesized that this difference in trauma care can be explained by the fact that non-trauma center hospitals have a financial incentive to keep insured patients under their care.
6) The sale and use of electronic cigarettes will be regulated in Beverly Hills, as decided by the Beverly Hills City Council earlier this week. Los Angeles passed similar legislation this December.
7) Enrollment in health insurance plans for one fifth of people who have registered under the Affordable Care Act was not completed, due to their failure to pay the first premium. Some insurers have granted more time for subscribers to pay their premiums.
8) Wendy Davis recently said that she would support restricting abortion access to the first twenty weeks of pregnancy, but filibustered last year against a bill containing that provision because of the wording of the bill and the other restrictions included within it.
By Chloe Reichel
1) On February 11, the FDA will launch its “Real Cost,” anti-smoking campaign. The $115-million campaign is geared toward discouraging teenagers from smoking by emphasizing the “personally relevant” effects of smoking.
2) Lawsuits against the manufacturer of Pradaxa, Boehringer Ingelheim, have revealed internal documents about the dangers of the drug. The drug, a blood thinner, has been associated with over 1,000 deaths.
3) By October 2014, CVS will no longer sell tobacco products. CVS has decided to implement this ban because, increasingly they see their role as providing health care, and tobacco products cause negative health effects.
4) Naxolone, a drug that is used to reverse the effects of opiate overdoses, is now available to patients in California through their doctors. Prior to the creation of this law, the drug was much less widely available–primarily it was administered in emergency rooms.
6) This Thursday, the Food and Drug Administration released regulations to guarantee that infant formula is safe for consumption. The regulations stipulate that certain nutrients are included in the product, and require tests for pathogens.
When we consider our society’s tough moral questions, like whether it is acceptable to use embryonic stem cells for research and medicine, we often look towards governmental leaders, policy makers, lawyers, and ethicists to find solutions. But should we look more often towards engineers?
This week in Nature, a research group from the RIKEN institute in Kobe, Japan described a new and simpler way to induce cells from differentiated tissues to return to a pluripotent-stem-cell-like state. The method is not only scientifically interesting, but also a member of a class of what I have come to think of as Morally Modifying Technologies.
Morally Modifying Technologies represent an under-incentivized means through which scientists and engineers could help us disentangle our society’s most controversial moral issues and have three key components. The first is that they neither resolve a moral debate (in this case, the acceptability of embryonic stem cells for research and medicine) nor do they comment on the validity of the reasons on each side of an issue; the moral questions raised are equally problematic before and after the invention of the technology. The second is that, even though the issue itself is unaffected, the importance of our resolving it seems to matter less. That is, morally modifying technologies make a moral dilemma less practically problematic. The third is that the new technology often does not perform the desired function empirically better than existing technology (it might even be worse), but does so in a morally less problematic way – that is, if it were not for the moral advantage, the technology might be thought of as redundant.
I recently saw someone walk into a signpost (amazingly, one that signalled ‘caution pedestrians’); by the angle and magnitude that his body rebounded, I estimated that this probably really hurt. What I had witnessed was a danger of walking under the influence of a smart phone. Because this man lacked the ability to tweet and simultaneously attend to and process the peripheral visual information that would enable him to avoid posts, the sidewalk was a dangerous place. If only there existed some way to enhance this cognitive ability, the sidewalks would be safer for multi-taskers (though less entertaining for bystanders).
In a public event on neurogaming held last Friday as part of the annual meeting of the International Society for Neuroethics, Adam Gazzaley from UCSF described a method that may lead to just the type of cognitive enhancement this man needed. In a recent paper published in nature, his team showed that sustained training at a game called NeuroRacer can effectively enhance the ability of elderly individuals to attend to and process peripheral visual information. While this game has a way to go before it can improve pedestrian safety, it does raise interesting questions about the future of our regulations surrounding distracted driving, e.g., driving while texting. In many jurisdictions, we prohibit texting while driving, and a California court recently ruled to extend these regulations to prohibit certain instances of driving under the influence of smart phones (i.e. smart driving).
But if individuals were to train on a descendant of NeuroRacer and improve their ability to visually multitask, should we give them a permit to text while driving?
“Examining the intersection of law and health care, biotech & bioethics”
- the subtitle of the Bill of Health blog.
I approach this intersection like many of my fellow students: outfitted with the tools and spectacles of a specific discipline. Whether that is health law, policy, medicine, engineering, philosophy, genetics, or cognitive science, none of us have had the ideal education that would enable not only an approach, but an inhabitation of this intersection.
What would that ideal education be? To consider the ideal education for a citizen, Rousseau conducts an elaborate thought experiment giving that education to a fictional young boy named Emile (hence the title of the work: Emile, or On Education). Let us begin a similar experiment to consider the ideal education for someone to inhabit the intersection of law and health care, biotech & bioethics.
Let’s call our fictional young person, ELSI.
The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation. And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human research studies. Under its list of Frequently Asked Questions (FAQ) related to informed consent, there is a question (7) which reads, “When does compensating subjects undermine informed consent or parental permission?” (http://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).
Aside from the fact that it’s still a very leading question (asking “when does it?” implies that, in fact, it does…), the new answer provided by OHRP clarifies that compensation in and of itself is not necessarily coercive or a source of undue influence. It says that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research.
That is a real paradigm shift. Continue reading