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 →
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.
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.
5) Following the implementation of the Affordable Care Act, between 1 to 2 million Americans have enrolled in Medicaid. A study from Avalere Health states that this number increased only partially because of the ACA.
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?
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.
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.
In general, the panel rightly pointed out practical limitations of these technologies. Panelist Nancy Kanwisher highlighted, for example, that research on lie-detection is done in a controlled, non-threatening environment from which we may be unable to generalize to criminal courts where the stakes are high.
While I was sympathetic to most of this discussion, I was puzzled by one point that the panel raised several times: the problematic nature of applying data based on a group of people to say something about an individual (e.g., this particular defendant). To present a simplified example: even if we could rigorously show a measurable difference in brain activity between a group of people who told a lie in the imager and a group of people who told the truth, we cannot conclude that an individual is lying if he shows an activity pattern similar to the liars. Since the justice system makes decisions on individuals, therefore, use of group data is problematic.
To me, this categorical objection to group data seems a bit odd, and this is why: I can’t see how group data is conceptually different from ordinary circumstantial evidence. Continue reading →
It astonishes me how many people do not realize the controversial nature of “brain death” and the fact that it is not the same as death. There is a substantial body of literature showing that brain death is not the equivalent of death. The President’s Council on Bioethics issued a white paper in 2008 acknowledging the deficiencies with our current approaches to determining death. The literature on the topic is fascinating—some brain dead individuals have gestated babies successfully to viability and gone through puberty. Many brain dead individuals can heal wounds, regulate their body temperatures, and persist on ventilators for many years. (If you are unfamiliar with this literature and want to read further, see the citations provided below.)
Frank Miller and I have argued that best the way to think about the status quo is that brain death is a status legal fiction, much like the legal construct that a corporation is a person. A corporation is similar enough to a person that it is convenient to treat corporations as persons under the law, rather than writing an entirely new body of law meant to apply to corporations alone. We have argued that brain death is similar to death—Frank Miller and Bob Truog express this by saying that a person who is brain dead is “as good as dead.” For this reason, we can ethically and legally treat the two states in the same way for the purposes of determining death and allowing vital organ transplantation.
There are many open and interesting questions about brain death that I will be exploring on this blog for the next few weeks. Michael Nair-Collins has a recent article in the Kennedy Institute of Ethics Journal that argues that the current approach to determining death in the U.S. is paternalistic and, presumably, unjustified. He cites as evidence the kinds of information that are shared with people deciding whether to become organ donors. But is this true, or is there evidence that the public is able to distinguish between brain death and death? Kenneth Kasper, Frank Miller, and I are investigating this at the moment, and we are finding some surprising answers in the literature. Continue reading →
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell  came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.
Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells. ASCs are found throughout the body. Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells. It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.
A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices. Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells? In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.
Are you interested in foreign aid, global development, medicine? Want to know how philanthropy and charitable giving can do the most good?
Aid Works(On Average) - By Toby Ord
Tuesday, March 26th; Emerson Hall 108; 8 PM
There is considerable controversy about whether foreign aid helps poor countries, with several prominent critics arguing that it doesn’t. Dr. Ord shows that these critics have only reached this conclusion because they have failed to count the biggest successes of aid, such as the eradication of smallpox, which have been in the sphere of global health rather than economic growth. These health successes have often been neglected in analysis of aid because they have only made up a small proportion of aid spending. When we look at the impact of this spending, though, we see that it the big wins have been so utterly vast that they more than justify all aid spending to date.
The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects. Equitable in this context means that the risks and benefits of the study are distributed fairly. Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and 2) avoiding the unjustified exclusion of any population ( whether out of bigotry, laziness or convenience).
Recruitment strategies invariably shape the selection of research subjects and the extent to which a pool of participants really represents a cross-section of society. Institutional Review Boards (IRBs) are charged with evaluating whether study recruitment plans and materials used to obtain informed consent are easily understood and free of misleading information. This is relatively straightforward when researchers, IRB members, and study subjects all speak the same language. But when studies are done in geographical areas that include numerous cultural and language communities, it can be quite tricky.
One of the barriers that prevents people from enrolling in (or even knowing about) studies is a lack of awareness and planning by researchers to address language differences. The human research protection regulations at 45 CFR Part 46.116 require that informed consent information must be provided to research participants (or their representatives) in language understandable to them. IRBs are supposed to be vigilant about this and require investigators to obtain translated Informed Consent Documents (ICDs) for use with non-English speaking research subjects. But researchers commonly balk at this expectation, saying it’s unreasonable. (A disproportionate number of objections have been raised to me thusly, “And what am I supposed to do if someone shows up speaking only Swahili?!”) Continue reading →
The George W. Gay Lecture is the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. The lectureship was established in 1917 by a $1,000 gift from Dr. George Washington Gay, an 1868 graduate of HMS. Since its inception, many of the nation’s most influential physicians, scientists, researchers and social observers, including Erich Fromm, Felix Frankfurter, Margaret Mead, Elizabeth Kübler Ross, E.O. Wilson, and Joshua Lederberg have given the Gay Lecture. Elie Wiesel, Marian Wright Edelman, Paul Krugman, Nicholas Kristof and Donald Berwick have given recent Gay Lectures.
[Disclaimer: I am not involved in this, and the views expressed here are entirely my own.]
Concussions and Performance Enhancing Drugs (PEDs) have been the dominant subject of concern in the sports world recently, and for good reason, but I would like to highlight an often overlooked and more general problem. Our athletes are rewarded for pushing their bodies to the brink to accomplish majestic feats, requiring physical perfection. We laud playing through injuries to succeed at the pinnacle of sport, or recovering from injuries at super human speeds, only to return those bodies to the brutal punishment of competition. With these pressures, Concussions and PEDs can be viewed as mere symptoms of a culture that runs from the fans to the teams to the players themselves, asking them to sacrifice their bodies, sometimes, to the detriment of their long-term health. In this new age of awareness about player health, we should be asking: Are athletes making properly informed rational choices about their health? Or are there situations where neither the players nor their teams are properly incentivized to protect long-term player health due to the culture described above?
For some time, animal rights activists in the US and abroad have been trying to pressure commercial airlines out of their long-standing practice of transporting research animals. Last week, a coalition of more than 150 leading research organizations and institutions sent a letter to the CEOs of the targeted airlines, urging them to continue transporting animals needed for research purposes. A copy of the coalition joint letter is available here.
The basic thrust of the letter can be summarized by this passage: “Your company’s commitment to transporting laboratory animals is crucial to finding treatments and cures for diseases afflicting millions of people worldwide. We ask that you continue transporting research animals, allowing lifesaving research around the world to progress.” Continue reading →
While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.” Calling upon his own work, which is focused on looking critically at published studies to examine the strength of their claims (see his heavily downloaded 2005 paper “Why Most Published Research Findings Are False”), Ioannidis raised important questions for those of us who think about research ethics, and who oversee and manage the research conducted at universities and scientific institutes across the country.
Ioannidis persuasively argued that our system for publishing only studies with statistically significant positive findings has resulted in a bizarre kind of reality where virtually no studies are ever reported that found “negative” results. Negative results are suppressed because nobody is interested in publishing them. Editors and reviewers have a major role in this problem; they choose not to publish studies that are not “sexy.” This artificially inflates the proportion of observed “positive” results and influences the likelihood a scientist will even write up a journal article because she knows what it takes to get published.
But isn’t there an ethical obligation to publish so-called negative results? In human research, people give their time and undergo risks for the conduct of a study. Their sacrifices are not meaningful if the results are never shared. Furthermore, negative results tell us something important. And if they are not published, some other research team somewhere else may unknowingly repeat a study, putting a new batch of subjects at risk, to investigate a question for which the answer is already known. Finally, to the extent a study is conducted using taxpayer dollars, the data derived should be considered community property, and there are opportunity costs associated with unnecessarily repetitive work. Continue reading →
With an approved constitution, elected officials and now, recognition from all three divisions of the American Philosophical Association (APA), a new society is finally official. The Society for Philosophy and Disability, or SPD, will hold its first two sessions at the February 2013 Central APA meeting in New Orleans.
SPD is a non-profit educational organization dedicated to furthering research and teaching on philosophical issues related to disability and to promoting inclusiveness and support for people with disabilities in philosophical education and in the profession of philosophy. SPD aims to provide a forum for philosophical discussion of disability by arranging meetings, maintaining an online presence, and organizing academic projects.
Adam Cureton, President of the Society, invites everyone to join SPD, which they can do on the Society website. You are also welcome to invite colleagues or students who are interested in philosophy and disability to join us.
A special issue published this month by the Journal of Philosophy & Technology features a collection of articles discussing evolution, genetic engineering, and human enhancement. Recent years have seen a rapidly expanding variety of approaches to exploring the normativity of human enhancement, by philosophers, bioethicists, physicians, and biologists. The articles in this special issue largely focus on the question: how can evolution and aetiological teleology inform biological ethics and theories of human enhancement?
For a separate collection of articles discussing the ethics of human enhancement from the perspective of the physician-patient relationship, see this special issue by the American Journal of Bioethics, published approximately a year ago.
How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today. Beginning at the start of the epidemic, when little was known about the HIV virus and even hospitals were refusing to treat AIDS patients out of fear of contagion, the film follows a group of leaders in the groups ACT-UP and TAG. Using existing footage interspersed with current-day interviews, it tells the story of how patients and concerned allies pushed the research community to find a way to treat what was then a lethal disease.
The film’s portrayal of the U.S. Government, specifically then-President George H. W. Bush and high ranking officials in the Food and Drug Administration, is damning. As hundreds of thousands of people became infected with HIV and the death toll rose, prejudice against marginalized groups (especially gay men, IV drug users) contributed to a lack of urgency about the need to learn how stop the spread of the virus and how to treat the opportunistic infections that killed people with full-blown AIDS. In contrast, footage of demonstrations, meetings, and conferences highlights the courage of the activists who risked and endured discrimination, beatings and arrests to bring attention to the need for more research.
But How to Survive a Plague is more than a documentary about the power people have to make change when they join together to demand action. It also is a provocative commentary about unintended consequences. I saw the film while attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R). In that context, I was especially interested in the way How to Survive a Plague highlights an interesting ethical issue in clinical research. Namely, the problem of protecting people so much from research risks that the protection itself causes harm. Continue reading →