Over at our sister blog for the Safra Center’s Institutional Corruption Lab, Paul Thacker has a great post about how the Physician’s Payments Sunshine Act came to exist. The new database created by the Act is just now going live, and its a good time to reflect on how we got here. Thacker was a staffer for Senator Chuck Grassley, and from that vantage, has rare insight into how the bill was conceived and how initial objections of Big Pharma were overcome. Thacker also outlines several complementary efforts, including pressure to reform NIH policies around conflicts of interest. That proposal went all the way to the White House, where it was gutted. Worth reading.
By Christine Baugh
A recent British Medical Journal blog post by Dr. Michael Stone sheds insight into the professional trials and tribulations of physicians working with professional soccer teams in England. As described, it is not uncommon that the team physician is recommended by a team manager and hired by the team’s executive board without thorough review. This hiring process, in turn, leads to the implicit expectation that the physician answers to the manager rather than the entire team, making the physician’s employment with the team insecure and the need for him to appease the manager a required condition of his employment. Beyond leading to an uncomfortable and potentially ineffective working environment, it is possible that this type of relationship could compromise care. These types of conflicts of interest within the sports medicine environment have been documented elsewhere.
A 2013 article in the Chronicle of Higher Education written by Brad Wolverton detailed a similar phenomenon in American collegiate sports. According to their survey of collegiate sports medicine clinicians, approximately one-third of clinicians indicated that members of the football coaching staff had influence over their employment and about half of clinicians reported having felt pressure from coaches to prematurely return athletes to play. Wolverton was able to provide striking examples of professional relationships between coaches and clinicians that led to compromised care. He also indicated that the topic was so sensitive that very few of the athletic trainers contacted were willing to talk about the issue for fear of losing their jobs.
Both the Stone and Wolverton articles highlight the complexity of sports medicine as a field and the specific conflicts that can arise when competing interests from multiple stakeholders are in play. However, critical to both authors’ conclusions, is that seemingly simple structural changes could play a major role in positively affecting health outcomes. Namely, to ensure quality of care, it is critical that the clinician’s employment is based upon the care he gives to his patients, not the team manager or team coach’s opinions of him. This is not a novel assertion. For example, the National Athletic Trainers’ Association, the National Collegiate Athletic Association (page 65), and others have put forth guidelines and recommendations indicating that having the coach serve as a primary supervisor for a clinician is inappropriate. However, it is not clear that these best practices are being implemented uniformly across sports, leagues, and teams. Given the health risks faced by athletes, and the role that sports medicine clinicians can play in mediating those risks, taking steps such as implementing an appropriate supervisory structure for sports medicine clinicians is imperative.
[This post reflects my own views only. It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]
I have a long article in Slate (with Chris Chabris) on the importance of replicating science. We use a recent (and especially bitter) dispute over the failure to replicate a social psychology experiment as an occasion for discussing several things of much broader import, including:
- The facts that replication, despite being a cornerstone of the scientific method, is rarely practiced (and even less frequently published) not only in psychology but across science, and that when such studies are conducted, they frequently fail to replicate the original findings (let this be a warning to those of you who, like me, cite empirical literature in your scholarship);
- Why replications are so rarely conducted and published, relative to their importance (tl;dr: it’s the incentives, stupid);
- Why it’s critical that this aspect of the academic research culture change (because academic science doesn’t only affect academic scientists; the rest of us have a stake in science, too, including those who fund it, those who help researchers produce it (i.e., human subjects), those who consume and build on it (other scholars and policy-makers), and all of us who are subject to myriad laws and policies informed by it); and
- Some better and worse ways of facilitating that cultural change (among other things, we disagree with Daniel Kahneman’s most recent proposal for conducting replications).
by Donald W. Light
Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.
Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.
Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?
However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.
In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.
By Timo Minssen
In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees of transparency. But also medical authorities have been very active in developing their transparency policies.
In the US, the FDA proposed new rules which would require disclosure of masked and de-identified patient-level data. In the EU, the EMA organized during 2013 a series of meetings with its five advisory committees to devise a draft policy for proactive publication of and access to clinical-trial data. In June 2013 this process resulted in the publication, of a draft policy document titled “Publication and access to clinical-trial data” (EMA/240810/2013).
In a letter to the EMA’s executive director Dr. Guido Rasi, dated 13 May 2014, the European Ombudsman, Emily O’Reilly, has now expressed concern about what seems to be a substantial shift of policy regarding clinical trial data transparency. Continue reading
Nadia N. Sawicki
Oklahoma’s botched execution of Clayton Lockett has brought increased attention to an issue that I have been concerned with for years – the increased “medicalization” of legally sanctioned executions, and, in particular, the role that medical professionals and the scientific community play in this process.
Until the 20th century, most executions were conducted publicly – execution was a communal ritual that served as a means of catharsis. But the American execution process has, over time, become less visible, and, as a consequence, subject to less public oversight. I believe that the movement of the capital punishment process “behind the curtain,” both literally and figuratively, should trouble death penalty opponents and supporters alike.
The standard lethal injection protocol used throughout the United States was developed in 1976 by Dr. Jay Chapman, Oklahoma’s state medical examiner, and Dr. Stanley Deutsch, chair of the Oklahoma Medical School anesthesiology department. Without testing or research, they settled on a three-drug protocol for executing prisoners – sodium thiopental, a short-acting barbiturate; pancuronium bromide, a paralytic; and potassium chloride, which stops the heart. Until recently, this was the combination used in every state.
Things began to change when Hospira, the U.S. pharmaceutical company that manufactured sodium thiopental, stopped making the drug in 2011. Since then, European manufacturers of sodium thiopental and pentobarbital have limited the production of these drugs, and the European Commission has restricted their export to the U.S. for execution purposes. And just last year, the U.S. Court of Appeals for the District of Columbia ruled in Cook v. FDA that the FDA lacks authority to permit importation of these drugs, which, when used for lethal injection, are considered “misbranded” under the FDCA. As a result, many states, including Oklahoma, have had to resort to other alternatives.
Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard. The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.
I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.
Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.
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
My wonderful HLS colleague Matthew Stephenson has just launched the Global Anticorruption Blog (GAB). As it happens, his first two posts may be of interest to BOH readers, especially those may be of interest to readers interested in international aid for public health projects, of the sort supported by the Gates Foundation. The first post argues that the extent of corruption in these projects is much larger than the Gates Foundation and others acknowledge. The second post contends that one reason for lowballing of corruption estimates is political: these projects depend substantially on public funding, and political support for health aid may be undercut by candid assessments of the extent of the corruption and fraud problems. Both the posts and the blog are well worth a read.
Today, there are two big stories that relate to the “institutional corruption” of medicine (aka conflicts of interests). For those who have been working long and hard on these issues, they are cause for hope. The needle does move.
First, one of the biggest pharmaceutical companies, GlaxoSmithKline, has decided that it will stop paying doctors to promote their drugs. My prior work has shown that such payments are quite common (e.g., 61% of urologists and 57% of gastroenterologists taking money), and that they likely influence the prescribing decisions of the doctors who take such money. In recent months, Glaxo has made several such moves towards greater transparency and integrity, often as a result of threatened or actual criminal prosecutions. (See their newfound commitment to opening up their clinical trial data too.)
The NYT story quotes an industry consultant suggesting that the move to stop paying physicians is a result of the Affordable Care Act’s “sunshine” requirement that such payments will be disclosed, and that several other drugmakers are considering similar moves. I am a bit skeptical that the disclosure mandate had such an effect, since the disclosures were already required by Massachusetts and other states, and as part of the “corporate integrity agreements” that came of several federal prosecutions. My sense is that such disclosures are not likely to reach patients in a useable way, so its hard to understand how the transparency could really impose much of a disincentive on the companies. Yet, something has caused Glaxo to change course.
Second, the National Football League has decided to give the National Institute of Health $30 million to study brain injuries. The counterfactual is that the NFL could have kept the money, of course. But the more interesting alternative is that the NFL could have just spent the money itself, hand-picking the researchers and carefully specifying how the research should be performed, in order to buy the scientific conclusions that it preferred. This has been the classic strategy of industries facing litigation risk, from tobacco, to asbestos, and now the paper industry, whose law firm actually commissions scientific studies on its behalf. The NFL’s move instead proves that it is possible for a self-interested party to nonetheless fund independent, credible, gold-standard research, by using an intermediary, such as the NIH.
This is exactly the sort of reform that I have called for, as an alternative to the false dichotomy between public funding and private interest. For companies that have a bona fide interest in discovering and publicizing the scientific truth, a credible intermediary like the NIH can reassure consumers of scientific information that it is valid. Now, if only we can get big pharmaceutical companies to make the same move for their clinical trials and other scientific research studies. Perhaps the first-movers will be the most innovative companies who have bona fide products and are tired of them being lost in the cheap talk? If physicians making prescribing decisions continue to give greater credence towards NIH-funded research, such integrity could be rewarded.
EDIT: Corrected link to NFL story on NYT, and corrected amount from $100M to $30M. Also, disclaimer: I am not involved in this Petrie Flom Center collaboration with the NFL, and the views expressed here are entirely my own.
There are many ways to drive medicine forward. One is to work to remove economic, political, or geographic barriers to accessing care, and thus aid those whose suffering can be assuaged but is not being so. Another is to work to develop treatments for types of suffering poorly eased (or addressed) by current care. Both are important. Serious pursuit of the second strategy, however, requires the participation of industry; to translate bench science into benefits for real people will usually require manufacture of new medicines or devices, a function that universities and public institutions do not do but industry does well.
But for those students, like myself, currently training in MD-PhD programs in hopes of pursuing this goal of translational medicine, it is not at all clear what attitude we should take towards industry. On the one hand, the vision to move science from bench to bedside would seem best served by those clinician-scientists who do not see publication as the end result but are devoted to responsibly guiding their discoveries into the industrial setting and propelling them to patients. On the other hand, connections between industry and academia are often described categorically as “conflicts of interest” that must be disclosed and ideally divested. I will not attempt to comment here on the events that have led to a prima facie (pharma facie?) negative valence of academic-industrial connections; I was struck to hear, however, one of the panelists (an academic) on a recent panel discussion on translational medicine open with a slow and measured statement affirming her belief that collaborations between academics and industry can be a “good thing.” She then paused, as if to let the shock of the statement permeate the audience.
The new American Heart Association and American College of Cardiology guidelines on how patients should manage their cholesterol are likely to dramatically increase the sales of statins. (E.g., check out the bump to Pfizer’s stock price.) Yet, the new guidelines have become instantly controversial, with prominent cardiologists calling them into doubt. In addition to the substantive scientific dispute, there are also questions about whether the guidelines panel may have suffered from biases, due to conflicting interests. As PharmaLot reports:
Of the 15 panelists that authored these new guidelines, six reported having recent or current ties to drugmakers that already sell or are developing cholesterol medications. And among the half dozen who disclosed these relationships was one of the two panel co-chairs, which contradicts an Institute of Medicine suggestion about managing conflicts on such panels. Each of the six panelists disclosed they worked as a consultant and received funding for personal research. And among the 10 expert reviewers, half listed consulting relationships.
I, of course, do not know the right answer about statins on the merits. As a layperson, I must use proxies and heuristics to decide, and to some extent busy non-specialist physicians must do the same. That is the whole point of the guidelines — so that each individual physician does not have to review the science himself or herself. They are supposed to be able to simply rely on the guidelines, as the state of the art. Yet, the conflicts of interests undermine our confidence in the AHA/ACC guidelines, making them less impactful on our prior beliefs. (My own research has documented this sort of discounting, among both physicians and laypersons). That sort of discounting is perfectly rational.
Some have argued that it is unrealistic to find experts who do not suffer from such conflicting interests. But what if the AHA/ACC had just proceeded with the nine unconflicted panelists, and the five unconflicted reviewers? Regardless of whether the panel reached the same outcome, it might have then better served the bona fide interests of the AHA and ACC, as well as the interests of public health. If that panel did reach the same pro-statin outcome, which boosted Pfizer’s stock price, all the better.
The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008. The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.
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.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Edmond J. Safra Center for Ethics at Harvard University co-sponsored a conference exploring the issue of financial conflicts of interest at research universities in November 2012. The conference resulted in a final report, which is now available for download on the Petrie-Flom Center’s website. From the report:
In the latter 1990s, the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG) and the now-named Government Accountability Office (GAO) sharply questioned the trustworthiness of research universities as stewards of federal research funds and overseers of the research, especially research that involved human subjects, when the institutions themselves increasingly had financial interests in research conducted by their faculty scientists. This was the first time the federal government had expressed concerns about institutional fCOIs in research universities and academic medical centers.
These concerns have only intensified in the ensuing years as research universities have been exhorted with increasing urgency to become ever more deeply engaged with industry in accelerating the translation of their faculties’ inventive research into tangible public benefits. Defining, let alone mitigating, institutional fCOIs in research universities becomes especially challenging as the institutions, in response to expanding and intensifying public expectations, progressively accrete missions that may themselves not be concordant.
This Symposium, organized by Professor David Korn and co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Edmond J. Safra Center for Ethics at Harvard University, was intended to examine, clarify, and deepen our understanding of institutional fCOIs in the contemporary research university, and thereby help to identify effective measures that will ensure the continuing trustworthiness of these vital institutions.
For more, download the full report here.
Enjoying the fall foliage in Mt. Auburn Cemetery yesterday, I came across this marker for Benjamin Waterhouse. In the overwrought language that is appropriate on a grave marker: “In 1800 he introduced to the new world the blessing of vaccination. Overcame popular prejudice and distrust by testing it on his own children and thus established a title to the gratitude of future generations.”
No less today, there seems to be plenty of popular distrust of elite science. (And it doesn’t help that so much of contemporary science is infected by conflicts of interest.) Self-experimentation does have a long venerable history, which has recently become more prominent in the quantified self movement. (I’m not sure about experimenting on my kid though.)
Tomorrow, I’m heading to NYC to make a pitch to the Robert Wood Johnson Foundation’s Pioneer Fund, for major funding to launch a new project that would create a platform for robust, randomized experiments of lifestyle interventions (think: migraine management, diets, exercise regimens, nutritional supplements) for which there is virtually no FDA oversight and thus no regulatory imperative for rigorous scientific investigations. Nonetheless, these lifestyle factors are the primary drivers of health and healthcare costs. By crowdsourcing these sorts of experiments in an sound ethical framework robust against institutional corruption, I hope to develop gold-standard scientific knowledge with huge samples, but also build public engagement, public understanding, and public trust of health science.
The crowd uses Wikipedia to organize knowledge, and Indiegogo to invest in new health devices. The crowd needs a platform to create knowledge too, especially through randomized interventions, which have the potential to actually change behaviors for the better and eliminate the confounding factors that undermine observational studies.
So, wish me luck in NYC tomorrow: http://bit.ly/pioneerpitch
The Journal of Law, Medicine & Ethics plans to publish a symposium issue in Winter 2014 exploring ethical, legal, and clinical issues triggered by the increasing commercialization of health care in the United States. The symposium will address a variety of dynamics present in this quintessentially American medical marketplace, with a particular focus on how commercialism impacts practitioners, patients, and policy makers at all levels.
Papers from any perspective or disciplinary background and concerning any aspect of the “buying and selling of health care” are welcome.
Deadlines and submission instructions below the fold.
Art Caplan has a new opinion piece at MSNBC.com discussing the ethical issues raised by heiress Huguette Clark’s sometimes enormous gifts to the medical workers who cared for her while she lived in a New York hospital for over 20 years — despite being in good health.
[...] Clark’s favorite private duty nurse, Hadassah Peri, received more than $31 million in gifts during 20 years of service, including enough money to buy five homes, jewelry and other luxuries. Clark gave lavishly to Peri’s husband and children, too.
Other caregivers also got gifts, although not in those amounts. Still others got nothing. Was it ethical for those who got gifts to accept them?
Clark’s personal staff members were not the only ones with an eye on her fortune. The hospital where she lived pushed hard to get Clark to make a substantial gift, using their development staff to try to pry a promise from her, the book reports.
In 2004, Dedman and Newell write, hospital officials threatened Clark with having to move from her beloved room if she did not make a contribution of $125 million to forestall the sale of the building.
So what is the ethical deal?
Read the full article here.
Anonymity is not just an aspect of privacy and recognizing their difference reveals a powerful and poorly understood set of legal tools for facilitating and controlling the production of public goods. This is the central claim of my newest article (SSRN draft available here).
Three examples illustrate the scope of the under-explored ways in which anonymity is currently used in our law.
- The first is from June 1997, when many residents in the Boston neighborhood of Allston learned to their anger that Harvard University had spent the previous 8 years secretly acquiring over 50 acres of Allston real estate. It did so using buying agents, which can generally protect their principal’s anonymity—even by falsely stating that they are not agents.
- The second is from Election Day 2012, when many voters who had shared photos of their completed ballots on Facebook and Twitter learned, to their surprise, that they had violated their states’ elections laws in doing so. They did not know that anonymity in voting was not just a right, but also a requirement.
- The third is from a 2006 lawsuit over the control of thousands of tissue samples being used in research at Washington University. When many of the research participants sought to withdraw their tissue from future research, in response to what they saw as a breach of their consent, they were shocked to learn that the university could refuse and extinguish their rights of withdrawal by anonymizing their tissue samples.
These varied uses of anonymity in our law—as a right when purchasing land, a requirement in voting, and a trigger than extinguishes rights in biomedical research—may appear to be unrelated. But I argue that they are in fact all part of a cohesive and previously unrecognized class of rules that use anonymity not to protect privacy, but rather to incentivize or control the production and circulation of information and other socially desirable goods. Continue reading
Less than an hour ago, Indianapolis prosecutor, Mr. Terry Curry agreed to drop first degree murder charges against Bei Bei Shuai in an agreement that required her to plead to a misdemeanor. The case was a month away from trial in what would have been the first prosecution of a pregnant woman in Indiana for attempting suicide. Ms. Shaui ate several packets of rat poison in a desperate attempt to end her life after being abandoned by her boyfriend. After being saved by friends and doctors, prosecutors filed first degree murder charges against Shuai, because her baby died.
Bei Bei Shuai’s case highlights the turn to criminal prosecution in fetal protection cases as a terrible national phenomenon. Shuai was spared the horrible fate experienced by poor women, many of color, across the U.S., including Regina McKnight, Paula Hale, Melissa Rowland, and others. In a forthcoming article to be published in the California Law Review, I argue that these prosecutions represent the new constitutional battlefronts as they burden pregnant women’s due process interests while also imposing the type of cruel and unusual punishment disallowed by the Eighth Amendment. I have argued in prior works found here and here that such prosecutions often involve racial profiling and create hierarchies among women’s pregnancies. Indeed, most often the pregnant women targeted for threatening harm to their fetuses are so poor that they lack adequate legal representation, relying on overworked public defenders who make valiant efforts, but lack the economic wherewithal to properly aid in these cases. Shuai’s case was different in that she had Linda Pence, a valiant, private attorney, who spent over two years providing excellent pro-bono legal aid.
Bei Bei Shuai’s release from murder charges also represents another victory for Advocates for Pregnant Women, the leading organization advocating on behalf of indigent pregnant women.
By Alex Stein
Steven Brill’s TIME MAGAZINE blockbuster article, Bitter Pill: Why Medical Bills are Killing Us, uncovers the CHARGEMASTER: a publicly undisclosed pricelist accountable for what we see in hospital bills. What we see there doesn’t look good: it includes acetaminophen sold for $1.50 a tablet (you can buy 100 of those for the same price at Amazon); $77 for a box of sterile gauze pads (Amazon’s prices vary between $6 and $11); $18 for a single diabetes test strip (sold for 54 cents by Amazon); $108 for antibacterial Bacitracin ointment (Amazon’s prices vary between $2.50 and $6.50); and so forth. Charges for stay, scans, surgeries, canes, and wheelchairs skyrocket as well.
The American Hospitals Association (AHA) rejects Brill’s analysis. According to AHA, the chargemaster aggregates the hospital’s overall costs on delivering quality care to patients: “In order to take medications in a hospital, even over-the-counter medicines, they must be prescribed by a doctor (a little bit of cost for the doctor), that order gets transmitted to the pharmacy (a little more cost), the order gets filled by a pharmacist or pharmacy tech who retrieves just one Tylenol pill and individually packages that one pill (still more cost), the pill gets transported from the pharmacy to the nursing unit where the patient resides (a little more cost), then the pill is retrieved by a registered nurse who personally gives the pill to the patient and then must document the administration of that pill in the patient medication administration record (a little more cost). All of this process to give a patient a single dose of Tylenol in a hospital bed [must also be] in compliance with all pertaining regulations (a little more cost).”
This post will not try to resolve the Tylenol Debate. Nor will it say anything about the government as a plausible substitute for the eccentric chargemaster. Instead, I will raise a legal question: Can patients sue hospitals for excessive markups on medications and devices?
My answer to this question is a qualified YES. Entrepreneurial and business aspects of running a hospital fall under states’ consumer protection laws (Brookins v. Mote, 292 P.3d 347 (Mont. 2012)). Those aspects certainly include billing (Jaramillo v. Morris, 750 P.2d 1301, 1304 (Wash. App. 1988); Ambach v. French, 216 P.3d 405 (Wash. 2009)). The key question here is whether an excessive markup on medications and devices amounts to deceit or an unfair trade practice. If it does, the hospital would be in violation of the relevant state consumer protection law. This might happen to hospitals whose billing practices—to which patients gave no informed consent—are particularly aggressive. Those hospitals might face class action suits and the prospect of paying treble damages. They also may be stripped of the special protections given to defendants in medical malpractice suits (that include shortened limitations and repose periods for filing suits, caps on damages, and charitable immunities). For my account of the competition between medical malpractice and consumer protection rules, click here.
Brill and other participants in the Tylenol Debate call on the government to start regulating hospital prices. My short advice to hospitals: get rid of unconscionable markups forthwith.