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).
Tag: Bioethics
Petrie-Flom Intern’s Weekly Round-Up, 2/28-3/7
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.
Harvard Effective Altruism: Josh Greene this Tuesday
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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
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Petrie-Flom Interns’ Weekly Round-Up, 2/14-2/21
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.
Check out the latest news from the Petrie-Flom Center!
Check out the February 7 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.
Petrie-Flom Interns’ Weekly Round-Up, 1/31-2/7
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.
Technological Solutions to Moral Problems
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.
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