The Stanford Center for Law and Biosciences has decided to leave the WordPress servers for greener pastures: namely, the Stanford Law School blog aggregator.
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The Stanford Center for Law and Biosciences has decided to leave the WordPress servers for greener pastures: namely, the Stanford Law School blog aggregator.
This address will no longer be updated. All posts from this address have been migrated to the new address:
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The Stanford Center for Law and Biosciences has decided to leave the WordPress servers for greener pastures: namely, the Stanford Law School blog aggregator.
This address will no longer be updated. All posts from this address have been migrated to the new address:
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The Stanford Center for Law and Biosciences has decided to leave the WordPress servers for greener pastures: namely, the Stanford Law School blog aggregator.
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present…
Panel on H1N1 Influenza: Legal issues in responding to a pandemic
Thursday, Nov. 12th
12:45-2:00 p.m.
Room 280B
Featured Panelists:
Cornelia L. Dekker, M.D.
Hank Greely, J.D.
Martin Fenstersheib, M.D., M.P.H.
ALL ARE WELCOME TO ATTEND AND LUNCH WILL BE SERVED!
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On October 22, the mandate that all health care workers with direct patient contact be vaccinated against the H1N1 flu and seasonal flu was suspended. State Health Commissioner Richard Daines suspended the mandate, not because of the lawsuits described elsewhere on this blog, but rather because New York has only a limited supply of flu vaccine.
New York has received less vaccine than expected. Governor David Paterson explains, “Over the last week, the Centers for Disease Control and Prevention (CDC) acknowledged that New York would only receive approximately 23 percent of its anticipated vaccine supply by the end of the month. As a result, we need to be as resourceful as we can with the limited supplies of vaccine currently coming into the State and make sure that those who are at the highest risk for complications from the H1N1 flu receive the first vaccine being distributed right now in New York State.” A mandate, in combination with the vaccine shortage, “set[s] up a dynamic where health care personnel covered under the regulation might compete for vaccine with persons with underlying risk factors for adverse outcome of influenza infection.” By suspending the mandate, the Department of Health allows the available vaccines to be used for populations at the greatest risk (especially pregnant woment and children).
Under Secion 66-3.2 of the emergency regulation that created the mandate, Commissioner Daines has the authority to suspend the vaccination requirement if he “determines the vaccine supplies are not adequate given the numbers of personnel to be vaccinated or vaccine(s) are not reasonably available, the commissioner may suspend the requirements(s) to vaccinate and/or change the annual deadline for such vaccinations(s).” Commissioner Daines exercised that authority and determined (given the low supply, slow delivery of more vaccine, and need elsewhere) there is not enough vaccine available to vaccinate all health care workers before the November 30 deadline.
Although there is an insufficient supply of vaccine to enforce the current mandate, Commissioner Daines believes that, when feasible, requiring health care workers to get flu shots is important for patient safety. “Patients in hospitals and other health care settings have the right to expect that they will not be infected by their health care worker with a preventable disease which could be fatal. [He] believes that New York’s experience with mandatory influenza vaccination for health care personnel in 2009 will have a positive impact on the health of New Yorkers this year. The current emergency regulation mandating influenza vaccinations for health care workers will expire on November 11, 2009, and a second emergency regulation would not have the desired effect during the current H1N1 influenza season or the expected seasonal outbreaks expected later this year and in early 2010. Therefore, no new emergency regulations will be promulgated.”
The lack of new emergency regulations, however, does not mean the conflict over mandatory flu vaccinations is over; it may just be delayed. Commissioner Daines writes that “the [Department of Health] is advancing a permanent regulation requiring health care personnel in these settings to be vaccinated. Draft regulations will be published soon for a period of public comment.”
– Kelly Lowenberg
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The Stanford Center for Law and Biosciences has decided to leave the WordPress servers for greener pastures: namely, the Stanford Law School blog aggregator.
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Last Friday, Justice Thomas J. McNamara, an acting justice of the State Supreme Court in Albany, issued a temporary restraining order preventing the enforcement of the New York state mandate requiring all health care workers with direct patient contact to get the H1N1 and seasonal flu vaccines. Justice McNamara scheduled a hearing for October 30 and consolidated three lawsuits challenging the mandate brought by a group of emergency room nurses, New York State Public Employees Federation, and the New York State United Teachers Union. In addition to these cases, a nurse from Poughkeepsie, N.Y., filed a lawsuit in State Supreme Court in Manhattan challenging the mandatory vaccinations.
The full requirements of the New York mandate can be read here. The New York Times blog post on the ruling cites a September 24, 2009 statement from State Health Commissioner Richard F. Daines, M.D. to explain the reasoning behind the mandate:
“Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination – not the 40-50 percent rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed.”
After the temporary restraining order was issued, the State Department of Health officials said in a statement (reported by the NYT):
“In two weeks the Department is scheduled to be in court, where we will vigorously defend this lawsuit on its merits. We are confident that the regulation will be upheld. The Commissioner of Health and the State Hospital Review and Planning Council have clear legal authority to promulgate the mandatory regulation. As one court said in a 1990 ruling rejecting a challenge to regulations requiring mandatory rubella vaccinations and annual tuberculosis testing for health care workers: ‘Hospitals . . . exist for the benefit of their patients. They exist to cure the sick. The Legislature of this State has charged the Commissioner of Health with the responsibility of making hospitals safe places to get well. These regulations are tailored to accomplish that end.'”
In addition to the lawsuits challenging the New York mandate, the New York Civil Liberties Union testified before the New York State Assembly Committees on Health, Labor, Education, Higher Education and Workplace Safety, and sent a letter to Mr. Daines explaining that the mandate “conflicts with well established legal principles and public health policy” and “violates the right of competent adults to direct the course of their medical care and treatment.” The NYCLU argues the H1N1 vaccine is distinguishable from other mandatory vaccines because the mortality rate for those who contract H1N1 is lower (compared to smallpox), and the vaccine is not 100% effective in preventing the disease, treating it, or preventing transmission (unlike the vaccines for measles, mumps, and rubella, diphtheria, polio, and tuberculosis). Furthermore, the NYCLU points out that,
“If significant numbers of health care workers refuse to be inoculated and are fired, health care facilities could be seriously understaffed at the very moment HINI is expected to cause a surge in hospital visits. And if health care workers are confused and upset about compulsory vaccinations, what are their patients to think? As reports of health care workers refusing vaccinations become public, confusion and worry will grow in the general population. And even if vaccination is the appropriate medical option for individuals, people may become increasingly reluctant to choose that option.”
Part of the reasoning behind the mandate is to keep health care workers healthy, so they can care for patients. New York already has a shortage of nurses, and maximizing the number of working nurses will be critical if H1N1 causes an influx of patients. As the NYCLU points out, however, if a significant number of nurses (and other health care workers) are fired because they refuse the vaccination, the mandate will prevent many healthy nurses from caring for patients. George Annas, professor of health law and bioethics at Boston University School of Public Health, adds that “if enough physicians and nurses refuse vaccination, the mandate will be unenforceable, since no responsible public health official would try to close a hospital for failure to comply with the mandate in the midst of a flu epidemic.” How many health care workers would choose dismissal over vaccination? Enough to close a hospital? More than how many, without the mandate, would miss work after catching the flu? How will these changes in staff size and flu exposure impact patient health? In the previous post, I cited Professor Art Caplan’s estimation that if all health care workers were vaccinated against the seasonal flu, there would be 40% fewer flu-related patient deaths. How does that number adjust for the dangers of H1N1 flu, the effectiveness of the H1N1 vaccine, and the loss of health care workers who refuse vaccination?
– Kelly Lowenberg
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Psychopathy is a categorical psychological term describing chronic disregard for ethical principles and antisocial behavior. It is not a part of the DSM-IV and accordingly is not, strictly speaking, a mental disorder for the purposes of North American medical insurance or practice.
Although its medical status is somewhat muddled, psychopathy is of particular legal relevance because studies estimate that while only 1% of the general population could be described as psychopathic, up to 20% of the prison population may fall under this descriptor. It is popularly speculated that individuals who prove themselves capable of committing violent or horrendous crimes are in fact psychopathic. Categorization as a psychopath usually occurs through the use of a forensic assessment instrument such as Hare’s Psychopathy Checklist-Revised (Hare’s PCL-R).
New research by Joseph P. Newman at the University of Wisconsin suggests that an attention deficit, rather than an inability to feel emotion, may be what makes people psychopaths. Newman measured fear-potentiated startle (FPS) in a group of 125 prisoners, who were also assessed for psychopathy using the PCL-R. Each prisoner was hooked up to a device that measures how strongly they blink – in other words, FPS – and placed a screen in front of them. The subjects were warned that during tasks in which letters flashed on the screen, an electric shock would sometimes follow a red letter, but never a green one. Psychopathic subjects displayed normal FPS under these threat-focused conditions relative to the control. However, when they were told to indicate whether letters were capitals or lower-case, the psychopathic prisoners displayed significant deficits in FPS – they barely blinked upon seeing red letters, while the others continued to anticipate the mild shock.
Newman’s team hypothesizes that this might be because psychopathy, contrary to traditional belief, actually involves an “attention-related deficit that undermines the processing of peripheral information, including fear stimuli.”
Of course, as Newman notes in a New Scientist news piece, one of the hallmark problems surrounding psychopathy, aside from clinical definition, is that it is ostensibly untreatable. The implication here appears to be that if the Newman hypothesis proved correct, psychopathy would be treatable in a manner similar to a “learning disability”. Given the use of language such as “distraction” and “attention-related deficit” throughout the news piece, it would appear these researchers are suggesting that some ADHD-like symptoms are present in psychopaths with respect to moral feelings. This definitional move would then presumably make the condition treatable by stimulants such as Adderal and Ritalin. It will be interesting to see whether this implied turn into the pharmaceutical magisterium will be continued by further studies, and whether these taken collectively will result in psychopathy’s inclusion as a psychiatrically legitimated, treatable mental disorder in the upcoming DSM-V.
The proposed shift from the archetype of cold-blooded, calculating criminals to that of disabled, distracted moral learners is a remarkable one. As the researchers state, “The innate fearlessness of psychopathic individuals is arguably the most sacrosanct assumption in the field of psychopathy.” But do the results of Newman’s study provide grounds for this strong hypothetical shift?
First of all, even if we perceive a compelling link between higher cognitive processes such as attention and moral perception, whether persuaded by this study or not, should we move wholesale to a paradigm of psychopathy based on attention deficit, or simply qualify present theories accordingly? Secondly, more abstractly, should we accept the hypothesis that moral sentiments are grounded in fear? While it is surely true that fear compels some social conformity, are moral feelings such as guilt or moral apprehension necessarily connected with fear, and is the lack of this fear the hallmark of the psychopath, as is popularly supposed by current psychological theorists? Thirdly, is FPS in any way a good measure of the complex emotional state of fear? Is it possible that the behavior it measures carries many possible valences of purpose and habit in different individuals, and accordingly the correlation with fear is underdetermined on the basis of the available data?
Finally, a more speculative thought: the “fear” discussed in this context is presumably culturally bound to the social mores and punishments associated with them. Is attention not bound in such a way? If we suppose that it is, and the results of this study can be replicated and built upon, is it possible to imagine a world in which all undesirable beliefs are explained on the basis of attention and treated with stimulants? This disease market would presumably be much larger than that for categorical psychopaths. In what ways would this practice be different from the present use of atypical antipsychotics in the face of undesirable beliefs espoused by those diagnosed with schizophrenia?
– CJ Murdoch
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The Stanford Center for Law and Biosciences has decided to leave the WordPress servers for greener pastures: namely, the Stanford Law School blog aggregator.
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The H1N1 flu vaccine became available earlier this month, and for many health care workers getting the vaccine is mandated. New York has created a state-wide mandate that all health care workers who have direct patient contact get seasonal and H1N1 flu shots or face the possibility of losing their jobs. Many hospitals have also created mandates, including the Hospital Corporation of America, Emory hospital, the University of Pennsylvania hospital, the University of Maryland hospital, the Loyola University health system, and the Good Samaritan Hospital in San Jose.
Many health care workers are opposed to these mandates, as was demonstrated by health care workers protesting the New York mandate outside of the state capitol (video). The California Nurses Association and the National Nurses Organizing Committee have recommended that the vaccine be encouraged but “nurses should maintain their right to decline for personal reasons.” Some reasons the protesters give for objecting to the mandate (here, here, and video here) include: the vaccine is not as effective as other mandated vaccines; there are equally effective alternatives, for example, wearing face masks and washing their hands; the vaccine was not sufficiently tested and may be unsafe; and H1N1 flu is not sufficiently dangerous to warrant a mandate. A common thread throughout the protest coverage is that health care workers do not want to be told what they must put in their bodies. This morning a group of New York emergency room nurses announced that they would be filing a lawsuit to block the mandate later this week.
Art Caplan, professor of bioethics and the director of the Center for Bioethics at the University of Pennsylvania argues that these mandates are appropriate because they will save lives and getting vaccinated is part of the health care workers’ responsibility to patients and to each other. Professor Caplan writes that if health care workers are vaccinated, patient mortality would decrease and nurses and doctors would remain healthy and able to care for sick patients. He estimates that in the case of the annual flu vaccination, if 100% of health care workers were vaccinated, patient deaths from the flu would drop 40%. Since April, 76 children have died from H1N1. [Note: As of October 23, 2009, that number rose to 86.]
In many states, hospital workers are already required to be vaccinated against measles, mumps, and rubella as a condition of their employment, but flu shots are voluntary. In this case, however, Professor Caplan argues that mandating the H1N1 vaccine may be the only way to obtain the individual medical and public health benefits. He reports that neither voluntary vaccinations (only 50% of health care workers elect to receive the annual flu shot) nor alternative protections like face masks (20% of health care workers who wear face masks still catch the flu) are likely to achieve the same benefits as a mandatory vaccination.
Some who object to the mandate have voiced concerns about the vaccine’s safety and efficacy because they claim it was rushed through development. But the Center for Disease Control and Prevention director, Dr. Thomas R. Frieden, assures, “We have cut no corners. This flu vaccine is made as flu vaccine is made each year, by the same companies, in the same production facilities with the same procedures, with the same safety safeguards.” The vaccine is not safe for some individuals who have egg allergies or risk factors for a rare complication known as Guilliame-Barre syndrome, and they are exempt from the mandate. Some of the mandates, although not New York’s, also exempt people with religious objections to vaccination.
If a mandate requiring health care workers to receive the H1N1 vaccination is necessary, then the penalty for opting out should be both fair and effective. Currently, health care workers in New York who refuse the vaccine risk losing their jobs. Could New York still reach its pubic health goals and increase vaccination rates among health care workers with a less severe penalty? For example, could the same purpose be served by notifying patients and other doctors that an individual has refused the vaccine, which would allow patients to choose to receive care from practitioners who are vaccinated?
Some health care workers and their advocates would prefer a program whereby adults did not have to choose between their job and taking a vaccine they have concerns about. Individuals’ choices about their own health care should be respected, and health care professionals are likely to make informed choices. On the other hand, health care professionals’ vaccination decisions will also affect the patients they see who are especially vulnerable to the H1N1 complications. And requiring vaccinations might be necessary to protect those patients.
– Kelly Lowenberg
Update: https://lawandbiosciences.wordpress.com/2009/10/22/update-on-new-york-mandatory-h1n1-vaccinations/
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Applications are now being accepted for Penn’s Neuroscience Boot Camp, a 9-day academic program on neuroscience for professionals and graduate students in law, ethics, and other fields. Excerpts from the website:
“The Penn Neuroscience Boot Camp is designed to give participants a basic foundation in cognitive and affective neuroscience and to equip them to be informed consumers of neuroscience research. Penn’s Neuroscience Boot Camp has been endorsed by the Neuroethics Society as a way for non-neuroscientists to gain a better understanding of the science behind the proliferation of new “neurofields” including neuroethics…
“Through a combination of lectures, break-out groups, panel discussions and laboratory visits, participants will gain an understanding of the methods of neuroscience and key findings on the cognitive and social-emotional functions of the brain, lifespan development and disorders of brain function. Each lecture will be followed by extensive Q&A. Break-out groups will allow participants to delve more deeply into topics of relevance to their fields. Laboratory visits will include trip to an MRI scanner, an EEG/ERP lab, an animal neurophysiology lab, and a transcranial magnetic stimulation lab. Participants will also have access to an extensive online library of copyrighted materials selected for relevance to the Boot Camp, including classic and review articles and textbook chapters in cognitive and affective neuroscience and the applications of neuroscience to diverse fields…
“The academic program spans nine days, Monday-Wednesday, with half of Saturday and all of Sunday off. We begin with a welcome reception on Sunday evening, August 1st and end with a gala dinner party on the evening of August 11th. Complete applications are due by midnight on February 1st.”
– Kelly Lowenberg (Hat tip to Professor Adam Kolber via Neuroethics and Law Blog)
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A new study in Psychiatric Services is the first systematic analysis of comorbidity in general with schizophrenia in the U.S. hospitalized population. A series of recent studies have examined single comorbidities with schizophrenia, but these studies were generally conducted with small or unrepresentative sample sizes and tested hypotheses rather than taking a broader approach. By contrast, this study looked at nearly 6 million hospital discharge records to calculate proportional morbidity ratios.
Somewhat predictably, psychiatric and behavior related diagnoses accounted for 45% of comorbidity. Anyone who has been diagnosed with schizophrenia, or has a diagnosis in their family knows that other diagnoses frequently precede or follow suit.
However, the study showed more than just that. Among non-psychiatric diagnoses, many patients with a primary diagnosis of schizophrenia were also diagnosed with acquired hypothyroidism, obesity and other hyperalimentation disorders, asthma, chronic airway obstruction not elsewhere classified, essential hypertension, and type 2 diabetes.
Head author Weber notes in a Psychiatric News article that the researchers expected cardiovascular and metabolic conditions to occur at a rate even greater than they found. Author Newcomer explained that this likely represented endemic underdiagnosis. “The very nature of the problem with this diagnosis [of schizophrenia] is that the patients tend to receive a lower standard of medical care, so there is going to be massive underestimation”.
Interestingly, the news article does not mention one likely cause of increased metabolic dysfunction among schizophrenics: weight gain, often leading to diabetes is a well-known side-effect of atypical antipsychotic use. Taking statistical comorbidity without this contextualization can be misleading, and so followup research is required. The study authors seem well aware of this, as Weber notes: “”Our study is hypothesis-generating rather than hypothesis-testing.”
Is it intuitive that psychiatric conditions would be co-morbid with non-psychiatric medical conditions? Why or why not? Do lifestyle and behavioral factors associated with mental illness increase risk? Is there is a biological connection? Finally, how much of this comorbidity is due to iatrogenic harm? If psychiatric conditions show significant non-iatrogenically induced comorbidity, what are the public health policy ramifications for the treatment of mental health?
– CJ Murdoch
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Stanford Center for Law & the Biosciences Blog 