Peter Thiel sponsors offshore testing of herpes vaccine, sidestepping U.S. safety rules

Marisa Taylor
Kaiser News
Originally posted August 28, 2017

Here is an excerpt:

“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”

The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact, but also can be released through skin.

The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

The article is here.

Study questions why thousands with developmental disabilities are prescribed antipsychotics

Peter Goffin
The Toronto Star
Originally published August 23, 2017

Researchers with the Centre for Addiction and Mental Health and the Institute for Clinical Evaluative Sciences have called for “guidelines and training around antipsychotic prescribing and monitoring” for doctors, pharmacists and care home staff after finding that nearly 40 per cent of people with developmental disabilities were prescribed antipsychotic drugs at some point over a six-year period.

One-third of the patients prescribed antipsychotics had no documented diagnosis of mental illness, according to the study, which tracked more than 51,000 people with developmental disabilities who are eligible for provincial drug benefits.

“We don’t know, with the data, why this one person was prescribed or this (other) person was prescribed so we’re trying to almost guess at why,” said psychologist Yona Lunsky, lead author of the study.

“It could be behaviour, aggression, self-injury, agitation.”

For people with developmental disabilities who live in group homes, the rate of antipsychotic prescriptions was even higher.

About 56 percent of developmentally disabled group home residents were prescribed antipsychotics. Of those, around 43 percent had no documented mental health issues.

The article is here.

CIA Psychologists Settle Torture Case Acknowledging Abuses

Peter Blumberg and Pamela Maclean
Bloomberg News
Originally published August 17, 2017

Two U.S. psychologists who helped design an overseas CIA interrogation program agreed to settle claims they were responsible for the torture of terrorism suspects, according to the American Civil Liberties Union, which brought the case.

The ACLU called the accord “historic” because it’s the first CIA-linked torture case of its kind that wasn’t dismissed, but said in a statement the terms of the settlement are confidential.

The case, which was set for a U.S. trial starting Sept. 5, focused on alleged abuses in the aftermath of the Sept. 11, 2001, attacks at secret “black-site” facilities that operated under President George W. Bush. The lawsuit followed the 2014 release of a congressional report on Central Intelligence Agency interrogation techniques.

The claims against the psychologists, who worked as government contractors, were filed on behalf of two suspected enemy combatants who were later released and a third who died in custody as a result of hypothermia during his captivity. All three men were interrogated at a site in Afghanistan, according to the ACLU.

ACLU lawyer Dror Ladin has said the case was a novel attempt to use the 1789 Alien Tort Claims Act to fix blame on U.S. citizens for human-rights violations committed abroad, unlike previous cases brought against foreigners.

The article is here.

Psychologists Open a Window on Brutal C.I.A. Interrogations A Lawsuit Filed on Behalf of Former Prisoners Reveals New Details

Sheri Fink & James Risen
The New York Times
Originally posted June 21, 2017

Fifteen years after he helped devise the brutal interrogation techniques used on terrorism suspects in secret C.I.A. prisons, John Bruce Jessen, a former military psychologist, expressed ambivalence about the program.

He described himself and a fellow military psychologist, James Mitchell, as reluctant participants in using the techniques, some of which are widely viewed as torture, but also justified the practices as effective in getting resistant detainees to cooperate.

“I think any normal, conscionable man would have to consider carefully doing something like this,” Dr. Jessen said in a newly disclosed deposition. “I deliberated with great, soulful torment about this, and obviously I concluded that it could be done safely or I wouldn’t have done it.”

The two psychologists — whom C.I.A. officials have called architects of the interrogation program, a designation they dispute — are defendants in the only lawsuit that may hold participants accountable for causing harm.

The program has been well documented, but under deposition, with a camera focused on their faces, Drs. Jessen and Mitchell provided new details about the interrogation effort, their roles in it and their rationales. Their accounts were sometimes at odds with their own correspondence at the time, as well as previous portrayals of them by officials and other interrogators as eager participants in the program.

The article is here.

Nuremberg Betrayed: Human Experimentation and the CIA Torture Program

Sarah Dougherty and Scott A. Allen
Physicians for Human Rights
June 2017

Based on an analysis of thousands of pages of documents and years of research, Physicians for Human Rights shows that the CIA’s post-9/11 torture program constituted an illegal, unethical regime of experimental research on unwilling human subjects, testing the flawed hypothesis that torture could aid interrogators in breaking the resistance of detainees. In “Nuremberg Betrayed: Human Experimentation and the CIA Torture Program,” PHR researchers show that CIA contract psychologists James Mitchell and Bruce Jessen created a research program in which health professionals designed and applied torture techniques and collected data on torture’s effects. This constitutes one of the gravest breaches of medical ethics by U.S. health personnel since the Nuremberg Code was developed in the wake of Nazi medical atrocities committed during World War Two.

Delving into the role health professionals played in designing and implementing torture, the report uses newly released documents to show how the results of untested, brutal torture techniques were used to calibrate the machinery of the torture program. The large-scale experiment’s flawed findings were also used by Bush administration lawyers to create spurious legal cover for the entire program.

PHR calls on all medical and scientific communities to convene a commission to lay out what is known about the torture program, including the participation of health professionals, and urges the Trump administration to launch a criminal investigation to get a full accounting of the crimes committed by the CIA and other government agencies.

The report is here.

Psychiatry’s “Goldwater Rule” has never met a test like Donald Trump

Brian Resnick
Vox.com
Originally published May 25, 2017

Here is an excerpt:

Some psychiatrists are saying it’s time to rethink this core ethical guideline. The rule, they say, is acting like a gag order, preventing qualified psychiatrists from giving the public important perspective on the mental health of a president whose behavior is out of step with any other president in history.

“The public has a right to medical and psychiatric knowledge about its leaders — at least in a democracy,” Nassir Ghaemi, a Tufts University psychiatrist, recently argued at an APA conference. “Why can’t we have a reasoned scientific discussion on this matter? Why do we just have complete censorship?”

The controversy is sure to rage on, as many psychiatrists stand by the professional precedent. The rule itself has even been expanded recently. But just the existence of the debate is an incredible moment not only in the field of psychiatry but in American politics. It’s not just armchair psychiatrists who are concerned about Trump’s mental health — some of the real ones are even willing to rethink their professional ethics because of it.

The article is here.

Association Between Physician Burnout and Identification With Medicine as a Calling

Andrew J. Jager, MA, Michael A. Tutty, PhD, Audiey C. Kao, PhD Audiey C. Kao
Mayo Clinic Proceedings
DOI: http://dx.doi.org/10.1016/j.mayocp.2016.11.012

Objective

To evaluate the association between degree of professional burnout and physicians' sense of calling.

Participants and Methods

US physicians across all specialties were surveyed between October 24, 2014, and May 29, 2015. Professional burnout was assessed using a validated single-item measure. Sense of calling, defined as committing one's life to personally meaningful work that serves a prosocial purpose, was assessed using 6 validated true-false items. Associations between burnout and identification with calling items were assessed using multivariable logistic regressions.

Results

A total of 2263 physicians completed surveys (63.1% response rate). Among respondents, 28.5% (n=639) reported experiencing some degree of burnout. Compared with physicians who reported no burnout symptoms, those who were completely burned out had lower odds of finding their work rewarding (odds ratio [OR], 0.05; 95% CI, 0.02-0.10; P<.001), seeing their work as one of the most important things in their lives (OR, 0.38; 95% CI, 0.21-0.69; P<.001), or thinking their work makes the world a better place (OR, 0.38; 95% CI, 0.17-0.85; P=.02). Burnout was also associated with lower odds of enjoying talking about their work to others (OR, 0.23; 95% CI, 0.13-0.41; P<.001), choosing their work life again (OR, 0.11; 95% CI, 0.06-0.20; P<.001), or continuing with their current work even if they were no longer paid if they were financially stable (OR, 0.30; 95% CI, 0.15-0.59; P<.001).

Conclusion

Physicians who experience more burnout are less likely to identify with medicine as a calling. Erosion of the sense that medicine is a calling may have adverse consequences for physicians as well as those for whom they care.

Lawsuit Aims to Hold 2 Contractors Accountable for C.I.A. Torture

By Sheri Fink and James Risen
The New York Times
Originally posted on November 27, 2016

Here is an excerpt:

Dr. Mitchell was first publicly identified as one of the architects of the C.I.A.’s “enhanced interrogation” program nearly a decade ago, and has given some news media interviews, but is now providing a more detailed account of his involvement. His book, “Enhanced Interrogation: Inside the Minds and Motives of the Islamic Terrorists Trying to Destroy America” (Crown Forum), was written with Bill Harlow, a former C.I.A. spokesman. It was reviewed by the agency before release. (The New York Times obtained a copy of the book before its publication date.)

In the book, Dr. Mitchell alleges that harsh interrogation techniques he devised and carried out, based on those he used as an Air Force trainer in survival schools to prepare airmen if they became prisoners of war, protected the detainees from even worse abuse by the C.I.A.

Dr. Mitchell wrote that he and Dr. Jessen sequestered prisoners in closed boxes, forced them to hold painful positions for hours and prevented them from sleeping for days. He also takes credit for suggesting and implementing waterboarding — covering a detainee’s face with a cloth and pouring water over it to simulate the sensation of drowning — among other now-banned techniques. “Although they were unpleasant, their use protected detainees from being subjected to unproven and perhaps harsher techniques made up on the fly that could have been much worse,” he wrote. C.I.A. officers, he added, “had already decided to get rough.”

The article is here.

Editor's note: If you think torture works, please read: Why Torture Doesn’t Work: The Neuroscience of Interrogation, by Shane O'Mara.

Cryonics: hype, hope or hell?

Neera Bhatia & Julian Savulescu
The Conversation
Originally posted November 22, 2016

Here is an excerpt:

Is cryonics ethical?

There are some arguments in favour of cryonics, the simplest of which is one of free will and choice. As long as people are informed of the very small chance of success of future re-animation, and they are not being coerced, then their choice is an expression of their autonomy about how they wish to direct the disposal of their bodies and resources after death.

In this light, choosing cryonics can be seen as no different to choosing cremation or burial, albeit a much more expensive option.

However, this case raises several other ethical and problematic concerns. There is the issue of potentially exploiting vulnerable people. Some might argue vulnerable people are trading hype for hope.

But if we were to replace the science of cryonics with the promises of religious or spiritual healers made at the bedside of the dying – of earlier access to “eternal life” in return for large payments known as indulgences – would this be so different?

Serious regulatory problems ahead

Legal and ethical issues aside, there are other serious issues to consider.

How can dying people have confidence in the ability of a company to keep their remains intact? If the cryonic company were to cease operating because of financial difficulties, what would happen to the frozen body?

The article is here.

Crossing the Line: Daubert, Dual Roles, and the Admissibility of Forensic Mental Health Testimony

Sara Gordon
Cardozo Law Review, Vol. 37, No. 4, 2016

Abstract:    

Psychiatrists and other mental health professionals often testify as forensic experts in civil commitment and criminal competency proceedings. When an individual clinician assumes both a treatment and a forensic role in the context of a single case, however, that clinician forms a dual relationship with the patient — a practice that creates a conflict of interest and violates professional ethical guidelines. The court, the parties, and the patient are all affected by this conflict and the biased testimony that may result from dual relationships. When providing forensic testimony, the mental health professional’s primary duty is to the court, not to the patient, and she has an obligation to give objective and truthful testimony. But this testimony can result in the patient’s detention or punishment, a legal outcome that implicates the mental health professional’s corresponding obligation to “do no harm” to the patient. Moreover, the conflict of interest created by a dual relationship can affect the objectivity and reliability of forensic testimony.

A dual clinical and forensic relationship with a single patient is contrary to quality patient care, and existing clinical and forensic ethical guidelines strongly discourage the practice. Notwithstanding the mental health community’s general consensus about the impropriety of the practice, many courts do not question the mental health professional’s ability to provide forensic testimony for a patient with whom she has a simultaneous clinical relationship. Moreover, some state statutes require or encourage clinicians at state-run facilities to engage in these multiple roles. This Article argues that the inherent conflict created by these dual roles does not provide a reliable basis for forensic mental health testimony under Federal Rule of Evidence 702 and should not be admitted as reliable expert testimony by courts. Because dual relationships are often initiated due to provider shortages and the unavailability of neutral forensic examiners, this Article will also discuss the use of telemedicine as a way to provide forensic evaluations in under served areas, especially those where provider shortages have prompted mental health professionals to engage in dual clinical and forensic roles. Finally, this Article argues that courts should exercise their powers more broadly under Federal Rule of Evidence 706 to appoint neutral and independent mental health experts to conduct forensic evaluations in civil commitment and criminal competency proceedings.

The article is here.

Direct to consumer genetic testing and the libertarian right to test

Michele Loi
J Med Ethics 2016;42:574-577

Abstract

I sketch a libertarian argument for the right to test in the context of ‘direct to consumer’ (DTC) genetic testing. A libertarian right to genetic tests, as defined here, relies on the idea of a moral right to self-ownership. I show how a libertarian right to test can be inferred from this general libertarian premise, at least as a prima facie right, shifting the burden of justification on regulators. I distinguish this distinctively libertarian position from some arguments based on considerations of utility or autonomy, which are sometimes labelled ‘libertarian’ because they oppose a tight regulation of the direct to consumer genetic testing sector. If one takes the libertarian right to test as a starting point, the whole discussion concerning autonomy and personal utility may be sidestepped. Finally, I briefly consider some considerations that justify the regulation of the DTC genetic testing market, compatible with the recognition of a prima facie right to test.

The article is here.

New York State Bans Use of Unclaimed Dead as Cadavers Without Consent

By Nina Bernstein
The New York Times
Originally posted August 19, 2016

A bill that Gov. Andrew M. Cuomo of New York signed into law this week concerns the dead as much as the living and signals a big change in public attitudes about what one owes the other.

The law bans the use of unclaimed bodies as cadavers without written consent by a spouse or next of kin, or unless the deceased had registered as a body donor. It ends a 162-year-old system that has required city officials to appropriate unclaimed bodies on behalf of medical schools that teach anatomical dissection and mortuary schools that train embalmers.

The state’s medical schools recently announced that they were withdrawing their opposition to the measure, saying they would meet any shortfall in cadavers by expanding their programs for private body donations.

The article is here.

Do No Harm: The American Psychological Association wavers on its detainee policy

Susan Greene
The Colorado Independent
Originally published August 04, 2016

The American Psychological Association is wavering on a year-old policy designed to prevent psychologists from working with military or national security detainees.

Meeting in Denver for its annual convention, the nation’s largest professional association of psychologists this week considered and then postponed a decision on whether to allow members of the profession back to work at Guantanamo Bay, other military detention centers and CIA sites.
After a vote planned for Wednesday and then today, the group’s 173-member governing council tabled the discussion until February.

The debate stems from psychologists’ controversial role assisting the U.S. military and intelligence agencies in so-called “enhanced interrogation” efforts during George W. Bush’s administration. The post-9/11 program tried to squeeze information out of terror suspects detained at Abu Ghraib prison in Iraq, Guantánamo in Cuba and other sites by waterboarding, isolation and sleep deprivation – methods that international law deems to be torture. Bush’s justice officials were able to legally justify the interrogations on grounds that doctors’ mere presence assured that the tactics were safe.

The updated article is here.

Medical involvement in torture today?

Kenneth Boyd
J Med Ethics 2016;42:411-412 doi:10.1136/medethics-2016-103737

In the ethics classroom, medical involvement in torture is often discussed in terms of what happens or has happened elsewhere, in some imagined country far away, under a military dictatorship for example, or historically in Nazi Germany or Stalin's Russia. In these contexts, at a distance in space or time, the healthcare professional's moral dilemma can be clearly demonstrated. On the one hand, any involvement whatever in the practice of torture, countenancing or condoning as well as participating, is forbidden, formally by the World Medical Association 1957 Declaration of Tokyo, but more generally by the professional duty to do no harm. On the other hand, the professional duty of care, and more generally human decency and compassion, forbids standing idly by when no other professional with comparable skills is available to relieve the suffering of victims of torture. In such circumstances, the health professional's impulse to exercise their duty of care, albeit thereby implicitly countenancing or condoning torture, may be strengthened by the knowledge that to refuse may put their own life or that of a member of their family in danger. But then again, they may also be all too aware that in exercising their duty of care they may simply be ‘patching up’ the victims in order for them to be tortured again.

The article is here.

Madness

By Eyal Press
The New Yorker
Originally posted May 2, 2016

Here are two excerpts:

By the nineties, prisons had become America’s dominant mental-health institutions. The situation is particularly extreme in Florida, which spends less money per capita on mental health than any state except Idaho. Meanwhile, between 1996 and 2014, the number of Florida prisoners with mental disabilities grew by a hundred and fifty-three per cent.

(cut)

After the Herald article appeared, Jerry Cummings, the warden, was placed on administrative leave, and many people questioned whether the Department of Corrections had tried to cover up a case of lethal abuse. Far less attention was paid to why an inmate had exposed it, rather than one of the prison’s mental-health or medical professionals. The duty to protect patients from harm is a core principle of medical ethics. According to the National Commission on Correctional Health Care, an offshoot of the American Medical Association which issues standards of care for prisons, any mental-health professional who is aware of abuse is obligated “to report this activity to the appropriate authorities.”

The article is here.

New Technologies as Social Experiments: An Ethical Framework

By John Danaher
Philosophical Disquisitions 
Posted: Mar 19, 2016

What was Apple thinking when it launched the iPhone? It was an impressive bit of technology, poised to revolutionise the smartphone industry, and set to become nearly ubiquitous within a decade. The social consequences have been dramatic. Many of those consequences have been positive: increased connectivity, increased knowledge and increased day-to-day convenience.

A considerable number have been quite negative: the assault on privacy; increased distractability, endless social noise. But were any of them weighing on the mind of Steve Jobs when he stepped onstage to deliver his keynote on January 9th 2007?

Some probably were, but more than likely they leaned toward the positive end of the spectrum. Jobs was famous for his ‘reality distortion field’; it’s unlikely he allowed the negative to hold him back for more than a few milliseconds. It was a cool product and it was bound to be a big seller. That’s all that mattered. But when you think about it this attitude is pretty odd. The success of the iPhone and subsequent smartphones has given rise to one of the biggest social experiments in human history. The consequences of near-ubiquitous smartphone use were uncertain at the time.

The article is here.

We're Already Violating Virtual Reality's First Code of Ethics

By Daniel Oberhaus
Motherboard.com
Originally published March 6, 2016

Here is an excerpt:

Indeed, it was in light of this potential for lasting psychological impact during and after a virtual reality experience that Madary and Metzinger drafted a list of six main recommendations for the ethical future of commercial and research virtual reality applications. Broadly summarized, their recommendations are:

1) In keeping with the American Psychological Association’s principle of non-maleficence, experiments using virtual reality should ensure that they do not cause lasting or serious harm to the subject.

2) Subjects participating in experiments using virtual reality should be informed about the lasting and serious behavioral effects resulting from virtual reality experiences, and that the extent of this behavioral influence might not be known.

3) Researchers and media outlets should avoid over-hyping the benefits of virtual reality, especially when virtual reality is being discussed as a medical treatment.

4) Awareness of the problem of dual use, or using a technology for something other than its original intention, in the context of virtual reality. The author’s particularly are wary of military applications for virtual reality (which are already being put to a lot of use), whether this means its use as a novel torture device or a means of decreasing a soldier’s empathy for the enemy.

The article is here.

Advancing Medical Professionalism in US Military Detainee Treatment

Leonard S. Rubenstein, Scott A. Allen, Phyllis A. Guze
PLOS One
Published: January 5, 2016
DOI: 10.1371/journal.pmed.1001930

Summary Points

• The United States Department of Defense and Central Intelligence Agency (CIA) promulgated policies and requirements that required health professionals to participate in the mistreatment of counter-terrorism detainees through participation in such practices as abusive interrogation and force-feeding of detainees, in violation of ethical standards established by associations representing the health professions.

• A report of the Defense Health Board to the Secretary of Defense on military medical ethics released in 2015 found that the Department of Defense “does not have an enterprise-wide, formal, integrated infrastructure to systematically build, support, sustain, and promote an evolving ethical culture within the military health care environment.”

• The Board also found that ethical codes promulgated by the health professions, including the duty to avoid harm, provide a sound basis for military medical practice, even taking into account the unique challenges often faced by military health professionals in reconciling the military mission with patient needs.

• The health professional community should urge the Secretary of Defense to adopt and implement the recommendations of the Defense Health Board, rescind directives authorizing participation of health professionals in interrogation and force-feeding because they are inconsistent with professional ethics, and provide ongoing advice and support for the reform process.

The article is here.

The A.I Anxiety

by Joel Achenbach
The Washington Post
Originally published December 27, 2015

Here is an excerpt:

But the discussion reflects a broader truth: We live in an age in which machine intelligence has become a part of daily life. Computers fly planes and soon will drive cars. Computer algorithms anticipate our needs and decide which advertisements to show us. Machines create news stories without human intervention. Machines can recognize your face in a crowd.

New technologies — including genetic engineering and nanotechnology — are cascading upon one another and converging. We don’t know how this will play out. But some of the most serious thinkers on Earth worry about potential hazards — and wonder whether we remain fully in control of our inventions.

The article is here.

Editor's Note: What if a form of consciousness emerges from AI? There are many reasons, except for anthropomorphic bias, to expect a form of consciousness to surface from highly complex, synthetic, artificial intelligence.  What then?  This concern is not addressed in the article.

Your Cells. Their Research. Your Permission?

By Rebecca Skloot
The New York Times
Originally posted December 30, 2015

Here are two excerpts:

What’s riding on this? Maybe the future of human health. We’re in the era of precision medicine, which relies on genetic and other personal information to develop individualized treatments. Those advances depend on scientists working with vast amounts of human tissue and DNA. Dr. Francis S. Collins, director of the National Institutes of Health, believes involving donors in this process gives scientists more useful information, and can be life-changing for donors. In announcing plans for the $215 million Precision Medicine Initiative, which he sees as a model for other future research, Dr. Collins said, “Participants will be partners in research, not subjects.” But people can be partners only if they know they’re participating.

(cut)

People have told me by the thousands, and numerous public opinion studies find the same: They want to know if their biospecimens are used in research, and they want to be asked first. Most will probably say yes, because they understand it’s important. They just don’t want to find out later. That damages their trust in science and doctors. It makes them wonder, what else are you hiding from me?

People tell me this because I wrote a book about Henrietta Lacks, a black tobacco farmer whose cancer cells, taken without her knowledge in 1951, are still alive in laboratories worldwide. Those cells, code-named HeLa, were the first such cells grown and one of the most important advances in medicine. But they came with troubling consequences: Her children were later used in research, their medical information was published, and the HeLa genome — including personal information about Mrs. Lacks and potentially her descendants — was sequenced and posted online. All without the family’s knowledge.

The article is here.