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
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?
Harvard High Impact Philanthropy presents:
Evaluating Effective Charities with Elie Hassenfeld of GiveWell
How can you maximize the impact of your charitable giving? What distinguishes the most effective causes and organizations? Elie Hassenfeld, co-founder and co-Executive Director of GiveWell, will describe how his organization is revolutionizing charity evaluation with completely transparent, rigorous analysis. Q&A to follow.
8 pm, Tuesday, Nov. 12; Sever 102
Elie Hassenfeld graduated from Columbia in 2004 and co-founded GiveWell in mid-2007 where he currently serves as co-Executive Director. GiveWell finds outstanding charity and publishes the full details of its analysis to help donors decide where to give. The Boston Globe has called GiveWell “The gold standard for giving” and its research has attracted attention from Peter Singer and other media. GiveWell has tracked over $10 million in donations to its recommendations as a direct result of its research.
According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:
On Monday, October 22, at the urging of Governor Kasich, the Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5 billion in federal funding to expand Medicaid in the State of Ohio. Under the laws of Ohio this action was valid.
The Controlling Board is a state agency created by statute. The agency has two principal powers: it can transfer funds and authorize purchases by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code states: “Controlling board authorization for a state agency to make an expenditure of federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”
Two advocacy organizations (the Buckeye Institute and the 1851 Center for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the Controlling Board. They contend that the action of the Board violates Section 127.17 of the Ohio Revised Code, which provides that the Board is bound by the intent of the Ohio General Assembly. The challengers quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich vetoed this bill, but the challengers argue that despite the Governor’s veto it’s clear that the General Assembly did not want the Controlling Board to accept federal funding to expand Medicaid.
Harvard High-Impact Philanthropy presents
Effective Altruism or Mobilization for Institutional Reform?
a lecture by Thomas Pogge
Director of the Global Justice Program and Leitner Professor of Philosophy and International Affairs, Yale University
Wednesday, October 9, 8 PM Sever 214
Professor Pogge will discuss whether some institutional reform efforts may be as effective or more effective than “effective altruism” and also whether effectiveness is the only standard by which such alternative ways of protecting people are to be compared.
Thomas Pogge is the Director of the Global Justice Program and Leitner Professor of Philosophy and International Affairs at Yale University. Additionally, he is the Research Director of the Centre for the Study of the Mind in Nature at the University of Oslo; a Professorial Research Fellow at the Centre for Applied Philosophy and Public Ethics at Charles Sturt University; and Professor of Political Philosophy at the University of Central Lancashire’s Centre for Professional Ethics. He is also an editor for social and political philosophy for the Stanford Encyclopedia of Philosophy and a member of the Norwegian Academy of Science and Letters.
Planning on coming? RSVP here.
On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died and 741 more became ill after contracting fungal meningitis from contaminated steroid injections made by the New England Compounding Center (NECC). Committee member Sen. Pat Roberts (R-KS) stated that given prior reports of problems with NECC, this tragedy could have been averted but for a “shocking failure to act” by NECC, state and federal regulators, and Congress.
As NECC’s role in the meningitis outbreak came to light,gaps in regulatory oversight did, too. The federal Food Drug and Cosmetic Act (FDCA) currently recognizes only two categories of pharmaceutical manufacturers: commercial pharmaceutical companies and compounding pharmacies. To qualify as the latter under federal law, the entity must make individual or small batch, patient-specific drugs and do so only with a physician’s prescription for that patient. Compounded drugs must be either be unavailable in the commercial market or needed in commercially unavailable doses or combinations. The FDCA exempts such compounders from its pre-marketing requirements applicable to commercially manufactured drugs. Thus, federal law clearly covers commercial pharmaceutical manufacturers, state law just as clearly oversees and licenses pharmacies but as the NECC case demonstrates, there is nothing clear about the responsibility for inspecting, licensing or otherwise overseeing compounders that do not fill prescriptions on a per patient basis.
Instead of compounding in response to an individual prescription, the New England Compounding Center made large batches of drugs for institutional buyers such as hospitals. Many of its drugs were commercially unavailable but some were knock-offs of marketed FDA-approved drugs – a practice which is clearly unauthorized. NECC’s business model was certainly not unique; neither was the limited and erratic response of state and federal regulators to complaints about the facility’s unsafe manufacturing practices. Congress knew that large-scale compounders existed along with concerns about their safety. Several members of the Senate HELP Committee had worked on curative legislation for over ten years, but made few inroads until the NECC crisis prompted the HELP Committee to shift from park into drive.
According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.
States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.
In the wake of an election season peppered with references to rape by legislators vying for reelection or elevation to more prominent political positions: Representative Todd Akin’s woefully unscientific claim that “legitimate” rapes rarely result in pregnancy because women can “shut that whole thing down” or Richard Mourdock, Indiana state treasurer, reminding voters that when pregnancies result from rape “that it is something God intended to happen,” the deeply political intersections of criminal and health law became more visible. Representative Joe Walsh (Ill), for example, claimed that “with modern technology and science, you can’t find one instance” where a woman’s life can be saved with an abortion. Problematically, such comments to unwitting constituents parade as fact and stand contrary to vetted medical studies. For example, a recent study found that “women were about 14 times more likely to die during or after giving birth to a live baby than to die from complications of an abortion.” An abstract of the study can be found here.
Months ago, I wrote that it would be a mistake to isolate these politically-charged comments to republicans or even male legislators; on inspection, recent personhood amendments and the passage of fetal protection laws expose bipartisan collaboration on laws that may be unconstitutional, undermine women’s reproductive health, and prioritize criminal law interventions over healthcare and rehabilitation. More of that work can be found here, here, and here.
Most recently, Representative Cathrynn Brown of New Mexico stepped into the political fray on rape, exposing once more the ways in which women’s reproduction can become hostage to political pandering. Last week, Brown proposed House Bill 206, a law that would criminally punish rape victims who seek abortions. According to Brown, obtaining an abortion after sexual victimization amounts to “tampering with evidence.” Rape victims could face felony charges and up to three years in prison for violating the law.
Likely, Brown’s rape bill will not gain sufficient political support for passage. Nevertheless, recent political efforts to redefine rape, blame victims, and use the criminal law as a sword to regulate victims’ responses to rape deserve serious scrutiny and sustained critical engagement.
Next Wednesday, Professor Sean Cash of the Friedman School of Nutrition Science and Policy at Tufts will deliver a seminar presentation titled, “Fat Taxes and Thin Subsidies: Can food price interventions improve health?” Professor Cash will discuss the efficacy and health impacts of food price interventions that increase the cost of undesirable foods and/or decrease the cost of desirable ones. (For a little advance reading, take a look at his 2005 article by a similar title, which argues that estimates of the cost per statistical life saved through such subsidies compare favorably with existing U.S. government programs). Here’s a brief description of the lecture:
Activists often argue that food prices drive the obesity epidemic, and call for a change in taxes to raise the cost of undesirable foods and subsidies to lower prices of more desirable ones. Do these fat taxes and subsidies actually work? This seminar will review the evidence on efficacy, producer and consumer responses, distribution of health impacts and financial gains or losses, as well as the role of non-price interventions in relation to price changes.
As an added bonus, the seminar will be broadcast via live stream here—so no need to brave the icy cold!
Sheerr Room, Fay House
10 Garden Street, Cambridge, MA
Joan Ruderman will be giving a talk titled, “Hormonally Active Pollutants: What Are They, What Can They Do, and How Do We Know They’re Out There?” Here is a summary of her talk:
Over the past few decades, an increasing number of chemicals that were designed for one purpose have now been found to have the surprising, additional ability to mimic hormones like estrogen. Examples of such chemicals, often called environmental estrogens, include certain pesticides, plasticizers, detergents, and compounds added to personal care products. There is growing concern that everyday exposures to these chemicals, and to others yet to be discovered, are contributing to increases in reproductive abnormalities, infertility, and estrogen-dependent cancers in both males and females. Previously identified environmental estrogens show little structural similarity to estrogen, making it impossible to predict simply on the basis of structure alone which other chemicals may also be estrogenic. Transgenic zebrafish embryos can play a unique role in screening chemicals that mimic estrogen.
The website for this lecture series can be found here. Hope to see you there! ~YK
We Who Follow ACA Litigation will continue to be in business. [On September 19], Oklahoma’s Attorney General sought leave to amend the state’s original complaint regarding the individual mandate. Now the state claims that the tax subsidies offered to those qualifying for financial assistance to obtain insurance through the exchanges are impermissible. This amended complaint builds on an existing thread of new challenges that was promoted before NFIB was decided. (The amended complaint also asks the court to consider the state’s nullification law, which should be struck down based on the Supremacy Clause.) The ACA challengers that never advanced beyond district court have been seeking leave to amend their complaints with regularity. Last week I posted about the Pacific Legal Foundation’s new strategy, which is rooted in the Orgination Clause. (The case was also noted over at Balkinization.)
Oklahoma’s amended complaint is grounded in theories advanced by Jonathan Adler and the Cato Institute. The argument is that tax credits to support the purchase of health insurance through qualified health plans in the exchanges are only available when the exchanges are created by the states, not the federal government. They claim that section 1311 of the ACA only contemplated providing tax subsidies in state-run exchanges to incentivize states to create the exchanges and that the federally-established exchanges cannot offer the same tax benefit. In testimony to Congress, they argued the problem is that the proposed IRS regulation implementing the subsidies for people from 100-400% of the FPL in the exchanges applies to both state and federally-run exchanges, not just state exchanges. Thus, they claim that the IRS has exceeded its statutory authority. As Tim Jost noted here, the ACA did intend to permit tax credits in federal exchanges. I agree with Tim’s analysis and would add that the Anti-Injunction Act probably would apply to this provision; unlike the “penalty” of the individual mandate, this is actually described as a “tax.” Also, the states are not the appropriate parties to raise this issue; individuals benefit from tax credits, individuals would need to pursue the alleged problem.