Bei Bei Shuai First Degree Murder Charges Dropped

By Michele Goodwin

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.

The Tylenol Debate: Can Hospitals be Sued for Excessive Markups on Medications and Devices?

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.

Financial Conflicts of Interest

By Joanna Sax

A recent article in the Journal of Law, Medicine & Ethics (Vol. 41:1, pp. 315-22) nicely describes the contours of Physician Payment Sunshine Act (PPSA) on pharmaceutical marketing.  Similar to other policies addressing financial conflicts of interest, the lion’s share of the PPSA focuses on disclosure.  That is, pharmaceutical companies will be required to disclose how much money they are “giving” to physicians.  A financial conflict of interest can arise when the gifts of money unduly influence a physician’s prescribing habits.

I’ve previously argued here, here and here that the system of disclosure is inadequate to properly address financial conflicts of interest.  Disclosure does only that; it discloses.  So now people know about it – that’s it.  Instead of a system that increases disclosure, I’ve proposed changes to the underlying environment to decrease or eliminate the possibility of a conflict of interest arising.

My research on financial conflicts of interest focuses on scientists at academic medical centers.  I’ve suggested that if academic scientists are in stressful situations, such as worrying about funding, they might be more likely to enter into a situation in which a conflict of interest might arise.  For this reason, if we change the underlying environment of our academic scientists such they are not living in a state of chronic stress, then they might make different decisions, which in turn should lead to fewer situations in which a conflict of interest might arise.

Private physicians operate in a different world than scientists at academic medical centers.  I’m curious if readers have suggestions to change the environment of private physicians such that they will be less likely to enter into situations in which a conflict of interest might arise.

Live Blogging from FDA in the 21st Century Conference, Panel 2: Preserving Public Trust and Demanding Accountability

By Michelle Meyer

[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

First up is Mark Lange from Eli Lilly (who notes that he is here in his personal capacity only!), speaking about “Data Transparency and the Role of the FDA.”

He prefaces his talk by noting that when he refers to “data,” he means raw, patient-level data from clinical trials. Most calls for the transparency of such data, he says, reflect a common theme about lack of trust in the pharmaceutical industry. So we might wonder: why doesn’t the pharmaceutical industry simply accede to that request and make their data available?

Mark notes that industry has several concerns. One important one pertains to data exclusivity. In several (if not all) markets, data exclusivity rights are premised on keeping the relevant data confidential, and posting it publicly would be deemed a waiver of those rights. In addition, data exclusivity prevents generic competitors from free riding, and publishing data could allow them to circumvent the very point of data exclusivity.

Moving to privacy concerns, Mark notes that research subjects’ understanding is that their data will be used for particular purposes and shared with regulators, but not be publicly posted on the Internet for anyone to do with whatever they want. Relatedly, there is the potential for interpretation of public data to be biased; research results may be over-interpreted and analyses may be flawed or even erroneous. Competitors might look for fairly trivial flaws the the data and try to use them to their advantage rather than sincerely trying to advance scientific progress and transparency.

Mark suggests, however, the choice between privacy and transparency is a false one. A better alternative is available — namely, for objective, expert regulators such as the FDA to receive and vet data in ways that address both audiences and both sets of concerns. The FDA is in fact already experienced in doing this. For example, it determines whether research demonstrates that a drug is safe and effective for a particular use through its marketing application approval mechanism, and it determines the accuracy and adequacy of the portrayal of research results in product labeling and product advertisements. And late last year, it was given responsibility for overseeing clinicaltrials.gov, which includes results from all pre-specified primary and secondary outcomes measures from nearly all clinical trials either conducted in the U.S. or intended to be used in support of an application for marketing approval in the U.S. This new responsibility, Mark suggests, could be a powerful tool, depending on how the FDA uses it. For instance, the FDA could exercise authority to monitor and enforce the absence of required results and the inclusion of false or misleading results data.

In concluding, Mark stresses that, when faced with requests for public access to patient-level trial data, we should consider the important role of regulators as trusted intermediaries who can balance competing concerns. Read More

When Ethics Collide

[Posted on behalf of Nancy Dubler and Art Caplan]

Surprising that for a week there was constant news from Boston.  Minute by minute we heard details of carnage, searching, killing, lock down and capture.  Now, pretty much, silence.

The suspect, captured in a boat in a backyard in Watertown, is now both a prisoner and a patient.  That has proved, historically and most recently, to be a difficult dual status for physicians to address.  It is hard for those who want to interrogate him.  And hard for those who wish to initiate his arraignment and prosecution.  But they along with the rest of us must wait.

Prison and jail health care present an anomaly for medical caregivers.  The goals of medicine are to diagnose, cure and comfort.  The goals of the justice and correctional systems are to confine, try, sentence and punish.  These are not only mutually exclusive goals but, they make strange and strained bedfellows when the two must work together.

We know one can coopt the other.  American doctors who agreed that torture could continue, without killing the prisoner, during recent years when water-boarding was a clear part of the anti-terror arsenal, violated their oaths as physicians to attend only to the medical, physical and emotional needs of the patient…to do no harm.

In the same vein, on July 17, 2008, the AMA articulated its policy about executions clearly and unambiguously — “requiring physicians to participate in executions violates their oath to protect lives and erodes public confidence in the medical profession. A physician is a member of a profession dedicated to preserving life when there is hope of doing so. The use of a physician’s clinical skill and judgment for purposes other than promoting an individual’s health and welfare undermines a basic ethical foundation of medicine — first, do no harm”.  Yet physicians do participate in executions often using their respect for the criminal justice system as their rationale.

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Industry-Provided Meals, Gifts — Still Happening?

One of my primary areas of research is in conflicts of interest (COI). I generally focus on the financial relationships between physicians/researchers and the pharmaceutical industry. See Here Here and Here.

However, COI researchers and policy makers need to expand our scope to include other health care professionals who have relationships with other key health care industries, other than pharma and device companies. In this blog, I focus upon the relationships between discharge planners and long-term care providers (including home care, skilled nursing facilities and others). Long-term care is a growing part of health care expenditures, and represents an area where patients’ preferences and best-interests should be the primary obligations of discharge planning professionals — who are not biased due to industry marketing.

As I reflect back upon my almost two decades in health care, as a clinician, researcher and bioethicist, I am amazed at how pervasive marketing activities are in hospitals… other than seeing drug reps visiting doctors (in fact, this was banned in the hospital I worked). For example, during my first clinical internship, at a rural hospital near Atlanta, home care agency marketing reps were often bringing food and providing educational/marketing materials to the Case Management/Social Work office. We all hung out together. Same thing happened in NYC; although I was not directly involved in discharge planning, home care and post-acute care providers bestowed small gifts, food and other marketing materials – obviously, with the hope of building goodwill, and hoping that as a clinical social worker, I would indirectly influence referrals to their businesses. In addition to gifts and marketing, representatives from these health care companies were often ever-present in the inpatient units to help the Case Managers and other clinicians with the necessary paperwork, insurance reviews, and overall referral facilitation. From what I understand, this type of post-acute care industry “detailing” still occurs in American Hospitals with frequency.

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Family, Privacy, Secrets & The Law

Join us for an important meeting:

Roundtable: Family, Privacy, Secrets & the Law  March 7-8, 2013

March 7-8, 2013
University of Maryland
Francis King Carey School of Law
500 West Baltimore Street
Baltimore, MD 21201

March 7, 5 p.m. – Book Reading and signing by Jonathan Odell, author of The Healing

March 8, 9 a.m. – 4 p.m. – Roundtable discussions

Eventbrite - Family, Privacy, Secrets & The Law Roundtable

Family, Privacy, Secrets & the Law roundtable engages the intersections of medicine, criminal law, family law, and constitutional law. The conference faculty will chart contemporary issues that span genetic privacy, disclosure of parental identity in assisted reproduction cases and DNA conscription to domestic violence and child sexual abuse.

There are times in which the law protects secrets, such as between a lawyer and client, doctor and patient, or clergy and congregant.  Yet, there are times when the law demands that secret-keepers reveal their confidences such as the increasing demand on doctors to disclose confidential medical information on pregnant women to law enforcement. How should we understand the contours and boundaries of these dynamics within the law?  On one hand, law tends to address secrets through the lens of legal duties to protect the vulnerable via its regulations governing abuse and neglect. On the other hand, this set of laws captures only a small percentage of secrets held by family members and other trusted “secret keepers” (doctors, clergy, extended family, neighbors) who, for a variety of reasons elect not to inform the state.

This roundtable interrogates states’ obligations to protect the vulnerable and at what cost. It considers the ways in which the law promises/owes protection and the success, failure or harms it brings about when endeavoring to intervene and offer protection. Against that backdrop, the law also has the obligation to honor individual and family autonomy and privacy.

Schedule

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Twitter Round-Up (2/16-2/23)

By Casey Thomson

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)

Professional Athletes and Personal Responsibility for Health

[Disclaimer: I am not involved in this, and the views expressed here are entirely my own.]

Concussions and Performance Enhancing Drugs (PEDs) have been the dominant subject of concern in the sports world recently, and for good reason, but I would like to highlight an often overlooked and more general problem.  Our athletes are rewarded for pushing their bodies to the brink to accomplish majestic feats, requiring physical perfection.  We laud playing through injuries to succeed at the pinnacle of sport, or recovering from injuries at super human speeds, only to return those bodies to the brutal punishment of competition.[1]  With these pressures, Concussions and PEDs can be viewed as mere symptoms of a culture that runs from the fans to the teams to the players themselves, asking them to sacrifice their bodies, sometimes, to the detriment of their long-term health.  In this new age of awareness about player health, we should be asking: Are athletes making properly informed rational choices about their health?  Or are there situations where neither the players nor their teams are properly incentivized to protect long-term player health due to the culture described above?

Some recent stories have exemplified the culture:

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Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity

By Michelle Meyer

As most readers are probably aware, the past few years have seen considerable media and clinical interest in chronic traumatic encephalopathy (CTE), a progressive, neurodegenerative condition linked to, and thought to result from, concussions, blasts, and other forms of brain injury (including, importantly, repeated but milder sub-concussion-level injuries) that can lead to a variety of mood and cognitive disorders, including depression, suicidality, memory loss, dementia, confusion, and aggression. Once thought mostly to afflict only boxers, CTE has more recently been acknowledged to affect a potentially much larger population, including professional and amateur contact sports players and military personnel.

CTE is diagnosed by the deterioration of brain tissue and tell-tale patterns of accumulation of the protein tau inside the brain. Currently, CTE can be diagnosed only posthumously, by staining the brain tissue to reveal its concentrations and distributions of tau.[1] According to Wikipedia, as of December of 2012, some thirty-three former NFL players have been found, posthumously, to have suffered from CTE. Non-professional football players are also at risk; in 2010, 17-year-old high school football player Nathan Styles became the youngest person to be posthumously diagnosed with CTE, followed closely by 21-year-old University of Pennsylvania junior lineman Owen Thomas. Hundreds of active and retired professional athletes have directed that their brains be donated to CTE research upon their deaths. More than one of these players died by their own hands, including Thomas, Atlanta Falcons safety Ray Easterling, Chicago Bears defensive back Dave Duerson, and, most recently, retired NFL linebacker Junior Seau. In February 2011, Duerson shot himself in the chest, shortly after he texted loved ones that he wanted his brain donated to CTE research. In May 2012, Seau, too, shot himself in the chest, but left no note. His family decided to donate his brain to CTE research in order “to help other individuals down the road.” Earlier this month, the pathology report revealed that Seau had indeed suffered from CTE. Many other athletes, both retired and active, have prospectively directed that their brains be donated to CTE research upon their death.[2] Some 4,000 former NFL players have reportedly joined numerous lawsuits against the NFL for failure to protect players from concussions. Seau’s family, following similar action by Duerson’s estate, recently filed a wrongful death suit against both the NFL and the maker of Seau’s helmet.

The fact that CTE cannot currently be diagnosed until after death makes predicting and managing symptoms and, hence, studying treatments for and preventions of CTE, extremely difficult. Earlier this month, retired NFL quarterback Bernie Kosar, who sustained numerous concussions during his twelve-year professional career — and was friends with both Duerson and Seau — revealed both that he, too, has suffered from various debilitating symptoms consistent with CTE (but also, importantly, with any number of other conditions) and also that he believes that many of these symptoms have been alleviated by experimental (and proprietary) treatment provided by a Florida physician involving IV therapies and supplements designed to improve blood flow to the brain. If we could diagnose CTE in living individuals, then they could use that information to make decisions about how to live their lives going forward (e.g., early retirement from contact sports to prevent further damage), and researchers could learn more about who is most at risk for CTE and whether there are treatments, such as the one Kosar attests to, that might (or might not) prevent or ameliorate it.

Last week, UCLA researchers reported that they may have discovered just such a method of in vivo diagnosis of CTE. In their very small study, five research participants — all retired NFL players — were recruited “through organizational contacts” “because of a history of cognitive or mood symptoms” consistent with mild cognitive impairment (MCI).[3] Participants were injected with a novel positron emission tomography (PET) imaging agent that, the investigators believe, uniquely binds to tau. All five participants revealed “significantly higher” concentrations of the agent compared to controls in several brain regions. If the agent really does bind to tau, and if the distributions of tau observed in these participants’ PET scans really are consistent with the distributions of tau seen in the brains of those who have been posthumously-diagnosed CTE, then these participants may also have CTE.[4]

That is, of course, a lot of “ifs.” The well-known pseudomymous neuroscience blogger Neurocritic[5] recently asked me about the ethics of this study. He then followed up with his own posts laying out his concerns about both the ethics and the science of the study. Neurocritic has two primary concerns about the ethics. First, what are the ethics of telling a research participant that they may be showing signs of CTE based on preliminary findings that have not been replicated by other researchers, much less endorsed by any regulatory or professional bodies? Second, what are the ethics of publishing research results that very likely make participants identifiable? I’ll take these questions in order. Read More