RSS Change

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RSS Change

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:

http://blogs.law.stanford.edu/lawandbiosciences/

Please update your bookmarks and RSS feeds accordingly.

Change of URL / RSS Feed

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:

http://blogs.law.stanford.edu/lawandbiosciences/

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This Thursday – Panel on H1N1 Influenza: Legal issues in responding to a pandemic

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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joint logo

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.

  • Dr. Dekker is a professor at Stanford School of Medicine and the Medical Director of the Stanford-LPCH Vaccine Program.  She is currently a Member of the National Vaccine Advisory Committee and the NVAC H1N1 Subgroup. Dekker’s clinical focuses are Pediatric Infectious Disease, Vaccine Clinical Trials and Safety, and Infectious Diseases, Pediatric.

Hank Greely, J.D.

  • Hank Greely is a professor at Stanford Law School and a leading expert on the legal, ethical, and social issues surrounding health law and the biosciences.  He frequently serves as an advisor on California, national, and international policy issues. Active in university leadership, Professor Greely chairs the steering committee for the Stanford Center for Biomedical Ethics and directs both the law school’s Center for Law and the Biosciences and the Stanford Center for Biomedical Ethics’ Program in Neuroethics. Professor Greely serves on the Scientific Leadership Council for the university’s interdisciplinary Bio-X Program.

Martin Fenstersheib, M.D., M.P.H.

  • Dr. Martin Fenstersheib is the health officer for Santa Clara County. In this state-appointed role, Fenstersheib works closely with the Santa Clara County Public Health Department, part of the Santa Clara Valley Health & Hospital System. Fenstersheib has served as the health officer and public health medical director for Santa Clara County since 1994. He is board-certified in pediatrics, public health and preventive medicine. He is chair of the department of community health and preventive medicine at Valley Medical Center and vice president for community health at the Santa Clara County Medical Association.

ALL ARE WELCOME TO ATTEND AND LUNCH WILL BE SERVED!

New York Flu Shot Mandate Suspended

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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

Update on New York Mandatory H1N1 Vaccinations

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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

New Insights into Psychopathy

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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