Bill of Health Contributor Dov Fox was interviewed today on NPR’s “Marketplace” about the FDA’s decision to ban all sales of direct-to-consumer genetic testing by 23andMe.
23andMe provides information about genetic health risks to people who buy at-home “DNA spit kits.” The company seeks to inform consumers about their susceptibility to more than 250 diseases. But the FDA now says the company hasn’t proved the tests are accurate enough, and the agency is worried Americans are relying on the results instead of visiting their doctor. The FDA exercised its jurisdiction under the Food Drug & Cosmetic Act to regulate the DNA spit kits as a genetic device used in the diagnosis or treatment of disease.
“This field of personalized medicine is really in its infancy,” said Fox, “and its terrifically exciting what we might learn one day, but its just not there yet. 23andMe hasn’t shown that their reports about your health from your genes alone are all that useful. They’re just not accurate at this time in the way that the FDA requires.”
Critics say regulators are standing in the way of consumers having the convenience of obtaining information about their own health at a reasonable price point without an expensive trip to the doctor. According to Fox, it’s a powerful argument that is often made by genetic testing companies such as 23andMe. The problem is the public’s understanding of genetics is very low. “These tests,” he argued, “come not only with limited accuracy, but also without the benefit of genetic counseling.”
It is estimated that 500,000 patients are discharged from U.S. hospitals against the recommendations of medical staff each year. This category of discharges, dubbed discharges against medical advice (DAMA), encompasses cases in which patients request to be discharged in spite of countervailing medical counsel to remain hospitalized. Despite safeguards that exist to ensure that patients are adequately informed and competent to make such decisions, these cases can be ethically challenging for practitioners who may struggle to balance their commitments to patient-centered care with their impulse to accomplish what is in their view best for a patient’s health.
Writing in the most recent issue of JAMA, Alfandre et al. contend that “the term ['discharge against medical advice'] is an anachronism that has outlived its usefulness in an era of patient-centered care.” They argue that the concept and category of DAMA “sends the undesirable message that physicians discount patients’ values in clinical decision making. Accepting an informed patient’s values and preferences, even when they do not appear to coincide with commonly accepted notions of good decisions about health, is always part of patient-centered care.” The driving assumption here seems to be that if physicians genuinely include patients’ interests and values in their assessments, then the possibility of “discharge against medical advice” is ruled out ab initio, since any medical advice issued would necessarily encapsulate and reflect patients’ preferences. They therefore propose that ”[f]or a profession accountable to the public and committed to patient-centered care, continued use of the discharged against medical advice designation is clinically and ethically problematic.”
While abandoning DAMA procedures may well augment patients’ sense of acceptance among medical providers and reduce deleterious effects on therapeutic relationships that may stem from having to sign DAMA forms, it leaves relatively unaddressed the broader question of how to mitigate health risks patients may experience following medically premature or unplanned discharge. Alfandre and Schumann’s robust interpretation of patient-centeredness also raises the question of how to handle situations in which patients refuse medically appropriate discharge. On this interpretation, can the ideal of patient-centered care be squared with concerns for optimizing the equity and efficiency of resource allocations more broadly?
These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.
In July, the Lancet covered Turkey’s development and implementation of universal health coverage extensively in an article and in supplementarycomments. The main article, written by those who are directly involved in the development of the health systems reform (including the former Health Minister), presents a success story. Within Turkey, however, the success of the reform hasbeendisputed. Two points in particular are being repeated by the Turkish Medical Association (TTB), doctors, and journalists: the negative effects of the reform on (1) the quality of health care personnel and (2) privacy.
A prospective cohort study recently published in the New England Journal of Medicine adds to a growing body of research illuminating the neurocognitive sequelae of critical illness requiring intensive care. Researchers reported that “one out of four patients [treated in the ICU] had cognitive impairment 12 months after critical illness that was similar in severity to that of patients with mild Alzheimer’s disease, and one out of three had impairment typically associated with moderate traumatic brain injury.” They underscore the possible role of delirium – a syndrome of disturbed consciousness commonly seen in critically ill patients treated in the ICU – in contributing to downstream cognitive impairments. More broadly, these findings prompt intensivists to rethink the relative priority assigned to the mental health needs of patients during ICU stays.
For those of you who haven’t seen it yet, there’s a great ongoing online forum over at the joint Harvard Business Review and New England Journal of Medicine Insight Center on Leading Health Care Innovation. It’s online at HBR here, and will feature an ongoing series of posts about innovation in high-value health care through November 15. Short articles from scholars in various fields will focus on three main areas: Big Ideas (foundational principles of high-value health care); Managing Innovations (organization and delivery); and From the Front Lines (stories of specific case solutions from practitioners).
They’re looking to host a lively forum, so comments seem both quite welcome and unusually thoughtful so far.
As healthcare institutions work to meet the triple aim of reducing healthcare costs while improving quality of care and population-wide health, efforts to expand the role of patient involvement in clinical decision making have gained appreciable momentum. Interest in increasing patient participation in clinical decision making and goal setting is premised in large part on the notion that greater patient involvement can improve health outcomes by ensuring that treatment plans align with patients’ interests, abilities and sociocultural contexts. A recent study published in the Journal of Personality and Social Psychology adds to the growing body of empirical research supporting these efforts, suggesting that the very act of allowing patients to choose between treatment alternatives can augment the efficacy of treatment by enhancing patients’ sense of personal control. By giving patients more opportunities to exercise autonomy at times when many are inclined to perceive their circumstances as well beyond their influence, healthcare providers can help to restore patients’ sense of self-governance and optimize patients’ perceptions of their situations and the medical care they receive.
The idea that empowering patients to choose between treatment options might itself contribute to better health outcomes invites clinicians to rethink how to approach formulating and conveying treatment plans to patients. Whereas traditionally some clinicians might have conceptualized their roles as experts whose responsibility is to design therapeutic plans on behalf of their patients, the principle of patient-centered care encourages providers to regard patients as associates in developing shared plans to advance and sustain health. This paradigm of care and the distinctive stance that it demands of clinicians is poetically captured by a letter penned by novelist John Steinbeck to his personal physician, in which he incisively relates “What do I want in a doctor? Perhaps more than anything else—a friend with special knowledge.”
Effectively transitioning to this horizontal model of therapeutic relationships will require careful planning and implementation. Indeed, boosting patient involvement in clinical decision making may prove increasingly elusive as medical knowledge continues to grow exponentially complex in substance and scope. As such, to realize the promises of patient-centered care, clinicians should work to develop concrete plans and quantifiable measures to operationalize the ideal of patient engagement within the context of day-to-day practice. As a first step in this direction, healthcare providers might consider ways to deliver complex biomedical knowledge to patients and surrogates in ways that are more accessible, timely and actionable. By coupling enhancements in patient education with efforts to promote patient involvement in clinical decision making, clinicians can play a pivotal role in maximizing the efficacy of healthcare innovations and delivery systems of the future.
The WHO Surgical Safety Checklist is unusual as a patient-safety intervention in that it has been widely promoted as universally effective, i.e. effective both in high-income and resource-limited settings; checklists are now used in approximately 1800 hospitals worldwide. In a paper recently published in the journal, BMJ Open, Aveling and colleagues report the results of a qualitative study on the implementation of the WHO checklist in two UK hospitals and two hospitals in resource-constrained settings in Africa. Their results suggest that the checklist is “no magic bullet” – that if adopted without proper investment and adaptation to the context of the target hospital, the checklist not only may fail to replicate benefits, but can actually levy its own unintended costs – especially in resource-limited settings. Though the study raises a number of interesting questions, given the nature of this blog, I am hoping that we might start a discussion about those in the domain of ethics and law.
For example, consider the following real case, which was reported in the BMJ paper:
“A patient admitted for cholecystectomy [surgical removal of the gallbladder] suffered hypoxic [oxygen depriviation-related] brain injury and died following surgery. Subsequently, two staff members (not the surgeon) were threatened with guns by the patient’s family, who said that the surgical team had killed the patient. The two staff members were later arrested and criminal charges brought against one of them. One of the questions asked during the police investigation was whether a pulse oximeter [i.e. a tool for measuring blood-oxygen levels] had been used. It had not: according to staff, no pulse oximeter was available for use, even though the checklist requiring use of this equipment was, officially, in use at the hospital.”
The staff members also did not get any legal representation for weeks because there were no clear policies established surrounding who was responsible for providing that counsel.
OHRP today announced details of the public meeting it previously said it would convene to address the SUPPORT trial and similar trials comparing two or more standard-of-care interventions in which subjects are randomized.
From an OHRP email:
On June 26, 2013, the Department of Health and Human Services (HHS) announced in the Federal Register an August 28, 2013 public meeting to seek public input and comment on how certain provisions of the Federal policy for the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context.
HHS specifically requests input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.
HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large. The meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects. HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.
The Journal of the American Medical Association (JAMA) has just posted online (ahead of print) a new article by Ben Harvey and I entitled “The Looming Threat of Liability for Accountable Care Organizations and What to Do About It.” We discuss the Accountable Care Organizations (ACOs) that that the Affordable Care Act seeks to incentivize, the malpractice and other liability claims they may, and how the lack of an Employee Retirement Income Security Act (ERISA) shield of the kind enjoyed by Managed Care Organizations will impact the liability environment ACOs will face. We also discuss self-help remedies available to ACOs as well as potential congressional intervention to deal with these issues.
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.
Given my recent piece in the New England Journal on discrimination against patients, particularly obese patients in the context of the Americans with Disabilities Act, I found this NY Times story particularly interesting: Disability and Discrimination at the Doctor’s Office. The Times story focuses on patients who are disabled in more traditional ways, but indicates that the main culprit behind the medical discrimination they may experience is not animus, but rather lack of proper equipment, which can be quite expensive. Luckily, there may be hope on the horizon, thanks to the ACA.
Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.
In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].
This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]
It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.
[Posted on behalf of Jeffrey Skopek, Academic Fellow, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration (for now – and soon headed off to Mylan), gave a keynote address exploring the ways in which the FDA’s mandate is increasingly difficult to achieve in an era of globalization.
In the first part of the talk, she provided an overview of the FDA, discussing the extent to which FDA-regulated products infuse nearly every aspect of life. For example, 20 cents of every consumer dollar spend in the US is on a good that is regulated by the FDA (for a total of over 2 trillion dollars). Further, the FDA must achieve this monumental task at very lost cost to the public – just 8 dollars per person per year.
The second part of the talk identified various ways in which modernization (e.g., the speed of technology, communications, and commerce) and globalization (e.g., the complex global regulatory landscape) is making the FDA’s mandate more difficult. Just as disease knows no borders, product safety and quality no longer know any borders. For example, FDA regulated products originate from more than 150 countries, 130,000 importers, and 300, 000 foreign facilities. And the number of FDA regulated shipments at over 300 ports has skyrocketed. For example, 10-15% of food products are imported, 50% of medical devices are imported, and 40% of drugs are imported. Further, the global supply chains are complex and hard to oversee, in part because the increased number of individuals, producers, and companies are geographically dispersed; and also because the new and hard to regulate distribution channel for products, such as the internet.
How often do you hear your students or friends or colleagues talk about operating on very little sleep for work or family reasons? In my case it is often, and depending on the setting it is sometimes stated as a complaint and sometimes as a brag (the latter especially among my friends who work for large law firms or consulting firms). To sleep 7-8 hours is becoming a “luxury” or perhaps in some eyes a waste – here I think of the adage “I will sleep when I am dead” expresses that those who need sleep are “missing out” or “wusses.” My impression, anecdotal to be sure, is that our sleep patterns are getting worse not better and that many of these bad habits (among lawyers) are learned during law school.
Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards. The IOM’s concerns with enforcement stem from well-documented non-compliance with the ACGME’s 2003 work hour rules, and the ACGME’s history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME’s 2003 standards in the year following their introduction.
Whether the ACGME’s 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. I would love reactions to our proposals in the paper, but wanted to float the more general idea in this space.
Yesterday, I wrote about Ryan Abbott‘s new article that proposes to use health information exchanges to improve the collection of data about the safety of approved drugs. Today, I want to address his recommendation that the government pay private parties to help the Food and Drug Administration conduct post-market drug surveillance.
The article argues that health information exchanges will make far more data available for observational research, but the current drug regulatory system is not structured in a way that would allow it to use the information effectively. This is because pharmaceutical companies have powerful incentives to emphasize data favorable to their products. (The FDA’s own research is dwarfed by comparison to what industry does and could do, while insurance companies and academics have weaker incentives to investigate.)
So Abbott suggests encouraging private parties to submit evidence that an approved drug is ineffective or unsafe. Under his proposal, if the FDA determines the evidence warrants a change to labeling or approval status, the submitting party would receive a financial prize. Its size would depend on how much the government saved by avoiding the costs of ineffective and unsafe medicines. Abbott suggests that the prize come from taxpayer dollars, unless it’s determined that the pharmaceutical acted negligently (or worse), in which case the company itself would be responsible for paying it.
It might make more sense to put the burden on pharmaceutical companies, even when they haven’t been negligent, given that it’s their products that are found to cause harm. Not only do they have the most opportunities to seek out problems early in testing and development; they are also the parties deriving the most financial benefit from medicine sales. Claims by pharmaceutical companies that they can’t operate with additional costs or regulation sound exaggerated, at least for many of those companies, given that the pharmaceutical industry has some of the highest profit margins of any business sector.
The bounty system nevertheless deserves serious consideration as an innovative proposal for harnessing market-based incentives to improve the regulatory surveillance of approved drugs. And it need not be restricted to health information exchanges. Abbott suggests applying this system to the way agencies deal with scientific questions generally. We might worry competitors might trump up data hostile to approved drugs. The provocative question that Abbott’s article invites us to ask is whether we are better off evaluating medicines under an inquisitorial system or an adversarial system.
This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:
Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)
Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:
Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)
Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.
Abstract: I explore the association between regional variations in physician behavior and the geographical scope of malpractice standards of care. I estimate a 30-50 percent reduction in the gap between state and national utilization rates of various treatments and diagnostic procedures following the adoption of a rule requiring physicians to follow national, as opposed to local, standards. These findings suggest that standardization in malpractice law may lead to greater standardization in practices and, more generally, that physicians may indeed adhere to specific liability standards. In connection with the estimated convergence in practices, I observe no associated changes in patient health.
Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness. Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not applied locally but taken internally.” The purported active ingredient? “[H]aemoglobin.” (see Secret Remedies (1909), page 114).
While the medicinal use of a seahorse or dried blood matter may sound fanciful to modern ears, one has to wonder whether today’s public is any less credulous: Worldwide, consumers have spent over $400 million per year on a modern baldness remedy known by the trade name Propecia (finasteride). Has science finally triumphed over a medical condition that has persisted through millennia? Today’s consumers might rationally believe that its has, given that Propecia is FDA-approved for the treatment of alopecia (baldness). FDA-approved remedies must, according to federal law (21 U.S.C. § 355(d)), prove their efficacy in well-controlled, clinical investigations.
Yet one need only walk through a crowded street to see that, if a baldness cure has truly arrived, a surprising number of people have not availed themselves of it. Is Propecia, then, not effective? Let us take a look at the official data. Continue reading →