Death Panels are Back, and They Want to Pay Grandma to Die

by Patricia Mayer, MD, Bioethics Program Alumna (2009)

Run for the hills: federally-funded Death Panels are back!

Ok, that was a bit of a cheap shot.  But many of us in medicine – especially those in hospice and palliative care – are still incensed by the “Death Panel” scandal.

As many know, the myth of the “Death Panels” almost derailed health care reform in the Summer of 2009.  Sarah Palin, one-time candidate for Vice President, posted a scathing critique of health care reform on Facebook. In that critique, she decried the inclusion of federal “Death Panels” as part of the Affordable Care Act. In a follow-up post, Ms. Palin specifically mentioned Section 1233 of the bill, implying that this section sanctioned the creation of these panels, whose purpose would be to decide who was “worthy of health care”.  The claim went viral. Within a couple of weeks, 86% of Americans had heard of the phrase “Death Panels.” Half of those actually believed that they existed.

In fact, no section of the Affordable Care Act (then or as passed into law) included any determination of which patients were or were not worthy of health care. As proposed, the oft-cited (and maligned) Section 1233 simply provided coverage under Medicare for advance care planning consultations.  Every five years, a physician would be able to bill Medicare for a visit whose purpose was to discuss advance care planning with a patient.  As this Section specified, doctors could bill for discussions of “the level of treatment indicated [which] may range from an indication for full treatment to an indication to limit some … specified interventions”.  So the charge that these visits were to tell the elderly “ how to end their life sooner” was clearly untrue.  There was no language at all that sanctioned limiting the care provided to patients. Rather, these voluntary visits were simply designed to help patients complete advance directives (ADs), should they wish to do so. Patients were free to specify in their advance directives that they wanted no limitations on treatment, or they could specify when they wanted to forgo particularly invasive treatments. It was their choice, not their physician’s.

Advanced directives are considered vital in providing proper care and treatment, particularly the types of care people want and the types of treatments that they do not want.  The Joint Commission – which accredits more than 20,000 health care organizations and programs in the United States – actually requires hospitals to inquire about ADs at every admission, to honor these directives when patients have them, and to offer educational materials and assistance in drafting these documents for patients who do not already have them.

Despite claims to the contrary, Section 1233 of the Affordable Care Act simply attempted to make the existing advance planning process simpler by encouraging patients to have these conversations with their primary care physicians.  Having such a conversation is often easier as a healthy or healthier outpatient than as a sick or dying inpatient. However, public outcry about mythical death panels was so great that the provisions of Section 1233 were left out of the Affordable Care Act when it was signed into law in 2010.

So, why were we who work in hospice so upset about the death panel myth? Quite simply, the notion of federal death panels fed into misconceptions about hospice that we’ve tried for years to erase.  Many people already think that hospice provides (and even encourages) euthanasia, a claim that is simply not true. In addition to fighting the “hospice kills people” myth for years, suddenly we also had to confront the “death panels” myth.

Thankfully, the Obama Administration has been determined to encourage and support advance care planning. It has managed to do so with little fanfare or notice. In January 2011, for example, Medicare began paying doctors for advance care planning discussions (just as Section 1233 had intended) in the context of the newly covered annual wellness visit.

But now we have a new twist on this old story.  Conservative Senator Tom Coburn (R – OK), a physician himself, has introduced legislation that would actually pay eligible Medicare beneficiaries $50 if they complete an advance directive. Patients get $75 if they do so online.  This legislation would also establish a process for accrediting advance directive vendors, and it would create a registry of advanced directives accessible by clinicians, institutions, and health care proxies.

Had this legislation had been introduced by a Democrat in early 2009, Ms. Palin would likely have complaining that the federal government is bribing patients to forgo treatment. The cacophony would have been deafening: We are paying Grandma to die!

If we are serious about wanting people to have ADs, however, we must consider this idea carefully.  As angry as those of us who work in hospice are about the “death panel” claim, we need to get over our bitterness. This idea deserves fair consideration, even if it originates from the “death panel” party.

Senator Coburn’s proposal is a good one. It would increase the number of patients with advance directives, empower both them and their health care providers.  Patients are more likely to get the types of care they want. Health care providers will also have guidance on the types and limits of care desired by patients.  Too often patients admitted to the hospital lack decision-making capacity. Without well-informed surrogates or advance directives, the clinical team has no guidance about an individual’s treatment preferences. So they tend to err on the side of caution, doing everything and anything they can to prolong a patient’s life. This scenario often leads to patients receiving a great deal of invasive, hi-tech, and sometimes inappropriate treatments that they may (or may not) have wanted.

We know we need to increase the number of patients with advance directives, so why not try Coburn’s idea?

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

Income Inequality and Health: Can the Poor Have Longer and Better Lives?

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership

The issue of income inequality has been in the news a lot lately. The gap between rich Americans and poor Americans has grown considerably since the 1970s. The United States now ranks first among the developed nations of the world in terms income inequality as measured by the Gini coefficient, a way of describing the distribution of wealth in a society. Globally, we’re fourth overall, surpassed only by Lebanon, Russia and the Ukraine.

Income inequality is a serious problem, so much so that Nobel Prize-winning economist Robert Shiller called it, “the most important problem that we are facing today.” Income inequality negatively affects economic growth, social mobility, political stability and democratic participation. It also affects the public health.

Quite simply, wealthier Americans tend to live healthier and longer lives. As the income gap has grown, so has the longevity gap. For example, consider the report recently released by the Brookings Institute that looked at income and differential mortality.

Between 1977 and 2007, Brookings economists Barry Bosworth and Kathleen Burke found that life expectancy increased an average of five years for men and one year for women.  But the gains in life expectancy accrued primarily to the rich. The richest 10% of Americans gained 5.9 and 3.1 years of life for men and women, respectively.  For men in the poorest 10%, the increase in life expectancy was less than two years.  The poorest women actually lost two years of life.

To really get a sense of how stark this divide is, however, consider the recent article by New York Times Reporter Annie Lowrey. She compared average life expectancy in Fairfax County, Virginia with that of McDowell County, West Virginia. A suburb of Washington, DC, Fairfax has one of the highest median incomes in the country:  $107,000. Men in Fairfax also have a mean life expectancy of 82 years. By contrast, the coal mining communities in McDowell have one of the lowest median incomes: $23,000. Men in that county only live to 64 on average.

There are a myriad of reasons why this longevity gap exists. The most obvious is access to health care. Wealthier individuals are more likely to have health insurance, a fact that the Obama Administration is trying to change through the Affordable Care Act.

But even if the Affordable Care Act succeeds in reducing the number of under- or uninsured Americans — which now seems likely, given that 8 million people signed up for one of the new health insurance exchanges — inequities in access will still exist.

For example, wealthier Americans will have far more choice in the types and numbers of doctors they can see.  Many clinicians are now refusing to accept any insurance plan, particularly publicly funded plans like Medicaid. Others are setting up concierge practices that guarantee same day appointments to those willing to pay. By contrast, poorer patients will have to wait for treatment, assuming they can find a doctor willing to see them.

The quality of care that the poor receive is also lower. Numerous studies have shown that lower-income patients are more likely to be misdiagnosed, prescribed the wrong medication, or suffer from complications of treatment. This is not because their doctors are incompetent or don’t care about their poorer patients. Rather, doctors that serve lower-income communities often do not have the time to adequately examine patients, take a full medical history, properly explain treatment options, or prescribe the newest drugs; they simply have too many patients to see and insurance reimbursement rates are too low to provide a full range of services.

Finally, wealthier individuals tend to live healthier lives overall. They are less likely to smoke, to drink to excess, and to be overweight. Part of this is due to differences in education, but part of it is due to time and resources. The investment banker who works in Manhattan can afford to buy fresh produce and other healthy meals at the local Whole Foods. He can also afford a gym membership, and he likely lives in a neighborhood that offer safe opportunities for exercising out-of-doors. By contrast, the single mother of four who lives in the Bronx must feed her family on a limited income, buying pre-packaged food at the corner market. She also probably lacks the time to exercise, assuming that the local playground isn’t overrun with drug dealers and gang members.

As we struggle with the issue of health care in America — expanding access to treatment while controlling costs — it is important to remember that the current health care crisis is not just about medical insurance. There are other problems in our society that will affect the outcome of the current debate. The Affordable Care Act will help address some of the current inequities in our health care system. Until we attack the fundamental issue of poverty and the income gap, however, we are probably just putting a small bandage on a large and gaping wound.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on April 24, 2014. It is also available on the WAMC website. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Being Wrong is Unacceptable: The Continued Saga of Justina Pelletier

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

Alright, as many of you certainly know I have developed an addiction to the Justina Pelletier case.  I promise someday I will write on another topic, but today is not that day.  If you haven’t been privy to my latest obsession please see: When Doctor’s Disagree.

An opinion I hear for too often is that this is a “conservative” story, driven by “conservative” groups and media.  I don’t understand this claim, how is a story about parental rights only a conservative issue?  What if Boston Children’s Hospital (BCH) did overreach on this family, the Massachusetts Department of Children and Families (MA DCF) rubber stamped this case, and the court showed bias toward MA DCF in their decision, wouldn’t that be important to parents of all political beliefs?

As I have said in every article about Justina, we need to remember that we are only seeing half of the story.  Because of this we do need to be a bit skeptical and cautious in forming an opinion.  Though, it seems that there is enough of a question to keep watching this story.  The best thing to do is investigate with an open mind and a calm nature.

There are two main opinions on DCF swirling around this case.  The first comes from those who side with BCH and believe that the hospital and MA DCF are justified and must certainly have evidence against the family that they are unable to share due to privacy laws.  This opinion is represented well here.  The article reminds us to not lose all faith in the medical community because of this story and that the vast majority of providers are appropriate at BCH, even if this story is true.   Pediatric providers have a deep love for their profession and a passion to help the children in their care.  Cases like Justina’s can make us lose sight of this and develop an irrational fear of pediatric medical professionals.   We must not allow our concern in this case to shape our judgment of all pediatric clinicians.

The second opinion is one that is very critical of child protection departments throughout the country.  An article explaining this case and the inadequacies of child protection services in general can be found here.  The author explains how child protective services employees often develop the idea that most parents will abuse their children and even a whisper of possible abuse should be acted on with the removal of the child.

At this point I want to clarify a part of my opinion that I realize may not yet be clear.  Though I feel that there may have been overreach by the state of Massachusetts in Justina’s case, I do not believe the goal of MA DCF, BCH, or their employees has been to harm this girl.  I believe every person in this case is working for what he/she feels is in Justina Pelletier’s best interest.

I work in pediatrics currently and frequently disagree with choices parents make for their children, but my respect for the institution of parenthood reminds me that people are entitled to make choices for their children that I consider wrong.  It is only in the direst of circumstances that anyone is entitled to intervene.  It is not always easy, but I remember that my view is merely a snapshot and that parents have the right to raise their children as they see fit.  Even if their home isn’t perfect (keep in mind that no home is), we must consider the harm done by removal versus the harm (or potential harm) done in the home.

Unfortunately, it doesn’t appear that this evaluation is always done appropriately.  The reality is that there is always harm done to a child when removed from their parent’s custody.  Sometimes, it is warranted, but should be a last resort because of the psychological turmoil removal has on the child.  When removing parental custody, it is absolutely and ALWAYS unacceptable for DCF to be wrong!

Anyone who works for child protective services should work under a constant fear of being wrong, as deeply as or even more deeply than the medical community fears mistakes.  The responsibility given to those who work for DCF is intense and workers should feel the weight of that responsibility.  It is unacceptable for these agencies to become reactionary, ie remove a child too quickly and find proof for the removal later.  I am not saying that this happened here, though we must admit it as a possibility.  I am trying to make the broader point that DCF should be under the strictest regulation, and that the burden of proof should be on their side for removal of a child.  The bar should be set high, weighted always on leaving the child with their natural family unless serious and imminent harm is certain.

Since we have said that a harm comparison should be done, let’s use the information we have in the Justina Pelletier case to compare her life with Mom and Dad vs. her life in DCF care:

Life with Mom and Dad

–        Participated in social activities (figure skating)

–        Attended and enjoyed school

–        Frequent medical appointments (possibly unnecessary)

–        Frequent medical procedures (possibly unnecessary)

–        Many medications (possibly unnecessary)

–        Family structure intact

Life in MA DCF Care

–        Over a year in institutions

–        No schooling (alleged by the family)

–        Deterioration of overall health and physical appearance (assessed by pictures and family report)

–        Less medical procedures (that were possibly unnecessary)

–        Fewer medications (that were possibly unnecessary)

–        Family unit and child’s normal support system fractured

It has also been alleged that Justina has not been allowed to participate in elements of her faith that are important to her.  If the parents are medically abusing their daughter this certainly needs to be dealt with, but to add intellectual, emotional, physical, and psychological harm to this child under DCF care is not the way to handle it.

Remember that there are respected physicians who have cared for this child for years and feel she has Mitochondrial Disease and that the family has appropriately dealt with this diagnosis.  This case is not cut and dry, one respected physician’s opinion is in direct opposition to another and a child’s care and wellbeing hangs in the balance.

I have said it before and will say it again: It is unacceptable to be wrong.  In any DCF case there should be a harm analysis and abuse, willingly or unwillingly inflicted by the government agency on the child needs to be addressed and appropriately handled.  It does no good to move a child from a potentially harmful environment into a definitely harmful one.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on April 20, 2014. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

 

Pint-Sized Pot and Hospice Hallucinations: The Role of Illicit Drugs in Medicine

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

Consider a paradox of sorts: there is a variety of illicit drugs that are used legally for the treatment of medical conditions, and there is a variety of legal drugs that are abused illegally to sustain drug addiction. Does anyone else see a problem with this?

Opiate addiction and abuse has had its share of news cycles lately, and for good reason. Access to prescription opiates continues, and addiction has reopened the door for heroin to make a resurgence in a big way. Vermont has recently taken efforts to address this epidemic head on, and other states are working on responses to their own respective crises.  This is a real problem that destroys lives and communities and I applaud the efforts to find solutions.

Alternatively, marijuana has taken a different path into America’s collective consciousness. Marijuana’s contemporary legal status (it was federally legal in the U.S. until 1937) was first introduced in 1996 when California legalized marijuana for medicinal use. Medical marijuana is now legal in 21 states (and Washington, D.C.), and marijuana’s most notable recent headline was when the states of Colorado and Washington legalized marijuana for recreational use in 2013.

Medical marijuana, with it being a federally illegal, Schedule 1 drug, has had a relatively limited amount of research devoted to it, although its claims for relief remain popular and broad. Most studies have revolved around treatment of symptoms associated with cancer and cancer therapies, although preclinical trials (in animals) have indicated the possibility of actual tumor inhibition. This push has been increasing, with stories about children finding relief bolstering pro-pot advocates.

Another illegal drug that has piqued the interest of researchers is LSD. A recent study indicated promising results in reducing anxiety among patients with life-threatening diseases.  Additionally, ecstasy has been studied – again, with promising results – in treating post-traumatic stress.

So we return to our paradox. We have illegal drugs that show promise in the medical field, and we have legal drugs that are being massively abused illegally and causing them to be restricted in significant ways. How ought one reconcile this? Are the researchers acting unethically by studying an illegal drug? Are they acting ethically by studying the most promising drug for their respective conditions or patients, legality be damned?

The line between legality and ethicality can often be a fine one. They are separate entities that do often overlap, but this is one area in which they diverge. From an ethical perspective, it can certainly be beneficial to study a drug with promise. Beneficence dictates that we are to promote actions that can provide a maximum of benefits with minimal harms. By encouraging of these otherwise illegal compounds within the context of a controlled research environment, the otherwise significant harms and risks of harm are minimized, for the patients and researchers.

Our paradox requires a final consideration, that we reconsider how we interact with drugs in America. Illegal ones, legal ones. Prescribed ones, recreational ones. Popular ones like alcohol and tobacco, and taboo ones like LSD or marijuana. They are all in need of social reclassification and put into a single category: drugs. From there, we as a society, as a medical profession and as individuals, can rebuild how we interact with them. Sometimes, as it turns out, the most ethical choice could also the most illegal.

[This blog entry was originally posted in a slightly different form on Mr. Dahlke’s blog on April 19, 2014. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Sorry Kid, But Your Mom’s in Jail for Having You

by Patricia Mayer, MD, Bioethics Program Alumna (2009)

Last week the Tennessee legislature voted to approve a bill that criminalizes drug use in pregnancy. Mothers can now be charged with criminal assault if a child is born addicted, harmed or dies as a result of pre-natal use of narcotics. The bill, amended to preclude charges for women who voluntarily enter treatment, now goes to Governor Bill Haslam for signature or veto.

Tennessee eliminated these same criminal penalties just two years ago, deciding treatment made more sense than jail time. The state is now planning to reinstate these sanctions. This would make Tennessee the only state that allows criminal charges against drug-using pregnant women. Seventeen other states consider drug use during pregnancy to be child abuse subject to civil penalties.

Resurrecting criminal penalties for drug-using mothers is a response to pressure to halt the “epidemic of drug dependent newborns” reported by the Tennessee Department of Health. Interestingly, that same Department of Health report reports that the largest percentage of narcotic-addicted newborns was born to mothers taking “substances prescribed to them for legitimate treatment”. That, of course, is another conversation.

While no one is arguing that drug-addicted babies are a good thing, this approach is wrong in every way. First, it creates a new status of criminal. It is not illegal to be a drug addict according to the US Supreme Court (Robinson v. California). It is not illegal to be pregnant. But a person who is drug addicted and pregnant at the same time can be charged with a crime.

Second, this law flies in the face of all medical recommendations, including those by the American Medical Association, the American Pediatrics Association, and the American College of Obstetricians and Gynecologists (ACOG). The latter group issued a formal opinion in November 2005 that specifically condemned “punitive and coercive” approaches to addicted pregnant women. That opinion summarizes legal cases up to that point, reviews pertinent ethical principles, and reports six main objections to the punitive approach Tennessee is considering. In particular, medical societies, professional organizations and substance-abuse experts are convinced this law will discourage pre-natal care. What woman will admit to use of narcotics (legal or otherwise) if she thinks she might go to jail or have her baby taken away? Pro-choice advocates also oppose the bill, fearing that it will cause more women to get abortions in order to avoid criminal sanctions.

Third, the law makes no medical sense as written. The law refers to children addicted, harmed or who die as a result of a mother’s narcotic use. But far too many pregnancies have poor outcomes. Often, the exact causes of a poor outcome are unclear. The ACOG report particularly highlights the limitations of medical knowledge and predictions of birth outcomes. Will prosecutors now investigate every woman who has the misfortune of delivering a child with birth defects? Are we then going to prosecute women for stillbirths? In 1999, South Carolina did this with a cocaine-addicted mother whose child was stillborn. In that case, the grieving mother was convicted of homicide by child abuse, and sentenced to 12 years in jail. That case, upheld by the South Carolina Supreme Court, was refused a hearing by the US Supreme Court.

Fourth, these types of prosecutions disproportionally are directed at women of color. Despite similar rates of addiction in Caucasian and non-Caucasian women, multiple studies have found that women of color are uncommonly subject to criminalization of pregnancy related behaviors.

Finally, it is unclear who will benefit under this scheme. It certainly won’t benefit the addicted mothers, who will be in jail instead of in treatment. It won’t benefit the affected babies, who will have no chance to be with their families; mom will likely be in jail and unavailable to her baby. This is despite the fact that there is no proof drug addicted mothers do not care about their children. In fact, the opposite is true, and there is compelling evidence that women who have custody are more likely to complete treatment for addiction. Society is also unlikely to benefit. Taxpayers in Tennessee will end up paying for more inmates in prison and more children in foster care. Abortion rates and infant mortality rates could rise, as drug-using mothers selectively terminate their pregnancy or avoid pre-natal care out of fear that they will be arrested. None of these outcomes benefits society.

There are fatal flaws in this bill, and the Governor should not sign it. Tennessee (and all states) can do better than this.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

What Price Immortality? Privately Funded Projects and the Prolongation of Life

By Richard Koo, Bioethics Program Alum (MS Bioethics 2011) and Adjunct Faculty

Seemingly ripped from the covers of comic books, no less than three privately funded projects seeking the prolongation of human life have been publicized in the past year.

The 2045 Initiative, dubbed “the Avatar Project”, is arguably the most futuristic and non-traditional of the three projects.  Founded by Russian media entrepreneur, Dmitry Itskov, and featured at a conference in New York last summer, the Avatar Project seeks to create technologies that enable the transfer of human “personalities” to a non-biological avatar, thereby extending life to the point of immortality.

Plans are for the project to be divided into four stages with corresponding developmental time-frames.  Stage 1 (2015-2025) contemplates the improvement of technologies that will allow for the control of prosthetics and robotic components through a brain-computer interface.  Stage 2 (2025-2035) calls for the creation of a full-functioning robot, an avatar, with which the human brain can be linked.  Stage 3 (2030-2035) envisions the achievement of technological capabilities that allow for the transfer or uploading of human consciousness into the avatar.  Stage 4 (2045 and beyond) involves endowing the “humanized avatars” with capabilities that exceed what humans are now capable of doing.

This sounds like the stuff of science fiction, movies (think, “Avatar”, “Surrogates”, “Transcendence”) and wishful thinking. But Itskov’s commitment to financially support  the underlying research is very real (he has a net worth of over a billion dollars). He also has the public support of the Russian government as well as several notable visionaries, including roboticist Hiroshi Ishiguro, futurists Raymond Kurzweil and Peter Diamandis, founders of Singularity University (an unaccredited educational institution whose stated purpose is to “utilize accelerating technologies to address humanity’s hardest problems”), and the Dalai Lama (whose support for this project begs to be the subject of another blog!).

Last month, J. Craig Venter announced the formation of a new company, Human Longevity, Inc. (HLI), whose purpose is to develop technologies to allow people to live longer and healthier lives.  Venter is perhaps best known as the head of the private industry effort to be the first to sequence the human genome.  Scientists have speculated that the longevity of centenarians is driven in large part by their having genetic variations that protect them from the effects of aging. Venter plans to have HLI acquire the capability of processing 40,000 human genomes or more a year in a quest to identify the human genetic variations that promote longevity.  Along the way, HLI will collect genetic data on the human microbiome (microbes that inhabit the human body) to develop advanced probiotics, and on the human metabolome (various metabolites, biochemical and fats), with a view to improving human health.  In that connection, HLI will initially target treatment of age-related diseases such as cancer, diabetes, heart and liver diseases and dementia.  HLI’s business plan sounds awfully ambitious, but then again Venter has an established track record in the field of genomics of making things happen, as well as $70 million of privately funded capital for HLI starting out of the gate.  There is apparently more than one billionaire (apart from Itskov) who is interested in living a longer life.  HLI’s co-founders include Robert Hariri, a stem cell pioneer affiliated with Celgene, and Peter Diamandis, who also supports the Avatar Project.

Last fall, Google, Inc., which needs no introduction, announced that it had made a major investment in California Life Co. (or Calico for short), a biotech start-up whose focus will be on combating aging and age-related diseases.  Thus far, Google has declined to provide details on how Calico would operate or what it would do, but it did publicize the recruitment of several biomed rockstars on Calico’s team in addition to Ray Kurzweil, who also supports the Avatar Project.  It’s worth noting that Google’s two founders, Larry Page and Sergey Brin, both attended Singularity University.

Here’s what comes to my mind:

• Should we humans being going down this road at all to seek immortality or longer life?

Some folks would even argue that it’s just plain wrong to play God or to mess with what it means to be human.  Philosophy and religion aside, on the one hand, it’s hard to argue that finding a cure to disease and suffering and helping people overcome disabilities (e.g., with the use of prosthetics) are not worthwhile goals.  On the other hand, the potential for abuse and unexpected developments along the way are frightening.

• Do these three projects, announced within the span of a year, portend the privatization of the quest for immortality or longer life?

It sure seems like it.  Governments don’t have the motivation to make a long-term investment in prolongevity R&D and wait for the return on investment to the extent that wealthy individuals do.  We can expect announcements of new private prolongevity projects or the additional funding of the ones presently off the ground in the near future.

• Can privatizing the quest for immortality and long life become problematic?

When we speak of private parties cutting the keys to open the door to changing the course of human evolution, I think the answer is yes.  For one thing, private parties do not have to act for the greater good, each project presumably having to be held accountable to obtain a return on investment for the investors first.  Furthermore, depending on the structure of the organization and how it is capitalized, a project does not even have to share any details of what it is doing (see Calico).  There also exists the concern that in the hands of private parties, benefits to be gained from the technological advances from the project will be reserved for the wealthy few.  Finally but not exhaustively, undertaking to address the socio-economic fall-out that comes with longer human life on average…e.g., how to provide for the social security, feeding, housing, health care and employment in societies where people live significantly longer on average…is undoubtedly not within the scope of any such project.

• How about regulating it?

Right now, the path between getting these prolongevity projects off the ground and the realization of their goals seems far too remote for there to be any political will to try to regulate their activity.  In fact, governments are probably glad to see private money fund these projects that might spin-off health dividends because those funds need not come out of the public coffers.  At some point if and when any of these projects get closer to realizing their stated goals, the pressure to impose regulation will rise so that we can better understand and prepare for the ramifications of such success.

What do you think?

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

New Tools for HIV Prevention: Why I am a Truvada Whore

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership

Although the epidemic likely started a decade or two earlier, AIDS wasn’t identified as a new disease until 1981. It took a few more years to isolate HIV, the virus that causes AIDS, and to develop reliable tests for diagnosing infection.

In the thirty years since, nearly 30 million people have died and another 35 million are currently infected with HIV worldwide. In the US, over a million people are living with HIV/AIDS. Although the disease still primarily affects gay men in the US, heterosexual men and women — particularly men and women of color — are also at risk. Globally, heterosexual men and women of color bear the largest burden of the disease.

Transmission of HIV is actually very easy to prevent. The virus is spread through bodily fluids, usually through sex but also through the sharing of needles, the use of improperly sterilized medical equipment, or via exposure to contaminated blood products. For most us, practicing safer sex – such as abstinence, monogamy or the use of latex or polyurethane condoms – makes the risk of acquiring HIV very small. Despite this, rates of HIV infection are still too high. Last year, 2.3 million people were newly infected with HIV. 50,000 of these new infections occurred in the US.

One problem is that those most at risk tend to be socially or economically marginalized. Such marginalization can make current HIV prevention messages and tools – abstinence, condoms, and mutual monogamy – inaccessible to many. Thus, there is an urgent need to develop new user-controlled HIV prevention tools, such as vaccines and pre-exposure prophylaxis, that will enable these individuals to protect themselves.

Pre-exposure prophylaxis (PrEP) involves the use of current drugs to prevent rather than treat HIV. Recently, several large-scale clinical trials found that daily use of the antiretroviral drug Truvada® – popping this pill every morning like you would a multivitamin – reduced the risk of acquiring HIV by nearly two-thirds. The US Food and Drug Administration (FDA) has since approved the marketing ofdaily Truvada for HIV prevention, and Medicaid and other health insurance plans now cover the cost of PrEP for patients at high risk for HIV.

Despite clear evidence that this approach works, however, the use of antiretroviral drugs for HIV prevention has sharply divided the AIDS community. Many activists and advocates have voiced concerns that the use of Truvada for PrEP will lead many people to abandon other methods of protecting themselves, particularly the use of condoms.

Michael Weinstein, president of the AIDS Healthcare Foundation, the largest provider of HIV care and treatment in the US, has described Truvada as “a party drug”. Widespread use of PrEP, Mr. Weinstein believes, will cause the gay community to return to the hedonistic days of the sexual revolution, when promiscuity was rampant and condom-use non-existent. This, he fears, will actually lead to an increase in HIV and other sexually transmitted infections in the homosexual community, not a decrease.

The public relations attack by Mr. Weinstein and his allies has been so viscous that proponents or users of PrEP have been labeled “Truvada whores.” While some of these so-called ‘whores’ view this epithet as a badge of honor, others now hide their support or use of Truvada for HIV prevention out of fear or shame.

But what opponents of PrEP fail to consider is the very point I’ve already made: not everyone at risk for HIV can use condoms or insist on monogamy. For many people, daily use of Truvada may be the only HIV prevention tool that is available to them. Others may make a conscious decision not to use condoms or be sexually abstinent. That is their choice, as unwise as some might consider it to be, but that doesn’t mean that they shouldn’t have access to other prevention tools.

By publicly disparaging the use of PrEP, Mr. Weinstein and others are discouraging those individuals from seeking out and using this effective HIV prevention tool. They are also preventing them from seeking all of the other prevention-related services that accompany it, including routine HIV testing and STI screening and treatment. That is unfortunate, and likely hurts efforts to prevent the spread of HIV/AIDS.

Advocates and activists like Mr. Weinstein are right to voice a concern that use of Truvada alone is not as effective as consistent use of condoms, but they also need to recognize that PrEP is it better than nothing at all when it comes to HIV prevention. This is true not just for the gay community, currently being torn asunder by the acrimonious PrEP debate, but also for injection drug users, women of color, and other high risk groups. More importantly, these adovcates need to acknowledge that use of PrEP with condoms is even more effective at preventing the spread of the virus.

Truvada is a lifesaver, both in terms of preventing the spread of HIV and in prolonging the lives of those living with HIV/AIDS. We should be encouraging its use, not disparaging it. So I’ll say it loud and say it proud: “I’m a Truvada whore!”

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on April 10, 2014. It is also available on the WAMC website. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Health Disparities: They’re Not Just for Patients Anymore

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

Much is written – and justifiably so – about the disparities that exist in our healthcare system in the U.S. The CDC, for example, reports a few: non-Hispanic blacks die more frequently from stroke and coronary heart disease than whites; homicide deaths are 2.5 times higher for men than women, and over 6.5 times higher for non-Hispanic blacks than whites; non-Hispanic whites and American Indian/Alaska Natives than other ethnic groups. Health disparity can be viewed as a sort of volatility risk of the healthcare system: as the difference in health among various groups of patients increases, so does the possibility (or likelihood) than people within the system will be treated more unjustly or unfairly. This leads to likely further social disparities, increasing the likelihood that these groups will not be able to manage their health effectively. A vicious cycle, indeed.

A primary stakeholder in the health disparity discussion in the U.S. is the Centers for Medicare and Medicaid Services (CMS). This government agency manages the healthcare for nearly a third of the entire U.S. population – about 100 million people. They even covered me and my family for about four years. They play a deep role in American healthcare, and so it is usually when a group like that provides data in the name of transparency. This is just what they did, releasing Medicare payment records for physicians for 2012. It was a controversial move, opposed primarily by the American Medical Association (AMA). The AMA’s position was based on a concern that the data’s release would “mislead the public into making inappropriate and potentially harmful treatment decisions and will result in unwarranted bias against physicians that can destroy careers”. While I understand that view from the perspective of protecting the interests of it constituents – physicians – I think this view in particular comes off as condescending and paternalistic. Perhaps that can be discussed another time…

The data release shows some dramatic differences that is not unlike American society at large. The data includes payment information for 880,000 physicians who received Medicare payments from CMS in 2012, totaling $77 billion. To make simple comparisons about the disparity within this particular system, consider a ‘flat’ disparity, where every one of those physicians received an equal amount of payments. Payments would be $87,500 to each physician. To contrast, then: the top recipient of Medicare payments in 2012 earned $20.8 million. This comparison is far too simplistic, of course: it presumes that all physicians saw an equal number of patients with the same health conditions, and charged the same price for those services. None of these hold for every physician in the U.S. (I am waiting for Nate Silver to run some numbers on this- it could be another bestseller for him.) 

This report – over 10 million lines of text – highlights a massive disparity in payments. $1.5 billion of the (almost 2% of the total payouts) was distributed to only 344 physicians (0.038% of the total number of physicians). About 1 out 4 of the physicians practice in the state of Florida. Over half of these top physicians (193 of the 344) practice in just five states – FL, CA, TX, NJ, and NY – whose populations account for only a third of the total US population. (Those states account for less than 16% of the total U.S. Medicare population.)

Whether all of this is a fair characterization remains to be seen. It is obvious that a physician that simply sees more payments ought to be compensated more than a physician who doesn’t.  But the numbers appear so skewed – at this point, at least – that further scrutiny is surely warranted. If we as a nation are truly interested in maintaining or improving our social systems – and most of us are – then this improvement on transparency at CMS can lead to better things, and I hope that it continues.

As an alternative, though, we could just follow Vermont’s lead.

[This blog entry was originally posted in a slightly different form on Mr. Dahlke’s blog on April 9, 2014. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

If Hobby Lobby Wins, We All Lose

by Dr. Patricia Mayer, Bioethics Program Alumna (2009)

Late last month, the US Supreme Court heard oral arguments in the case of Sebelius v. Hobby Lobby Stores, Inc. The Supreme Court is currently considering whether Hobby Lobby, a privately owned chain of 640 arts and crafts stores, may deny its employees insurance coverage for things like birth control pills, emergency contraceptives and IUDs. Under the Affordable Care Act (ACA), employers are required to provide health care that covers all forms of contraception at no cost. However, the evangelical owners of Hobby Lobby argue that the company should not be required to provide contraceptive choices that violate the owner’s religious beliefs, particularly birth control methods that they believe “induce abortions”, such as the morning-after pill or the IUD.

Hobby Lobby’s owners are appealing to the Supreme Court for an exemption to the ACA contraceptive requirements on the basis of the Religious Freedom Restoration Act of 1993. That act stipulates the government “shall not substantially burden a person’s exercise of religion even if the burden results from a rule of general applicability”.

Now Hobby Lobby’s owners are not asking for exemption from the obligation to provide insurance. In fact, they believe that providing heath insurance to their 14,000+ employees a moral obligation, but they do not want to pay for an insurance plan that covers certain types of contraceptives. They’ve even stated publicly that this obligation to provide their employees with health insurance is so strong it precludes them from discontinuing insurance coverage (instead of paying a new tax under the employer obligations of the ACA) even though this would then allow their employees to obtain insurance through the new health exchanges. Insurance plans available through the exchanges all provide complete contraceptive coverage in accordance with the ACA.

But should for-profit businesses be exempt from the Affordable Care Act’s contraception mandate? Do these companies have the same rights of religious freedom as individuals under the Religious Freedom Restoration Act?

I believe it would be wrong for the Supreme Court to grant Hobby Lobby’s request for an exemption. A private for-profit company, even one with religiously devout owners, should not dictate which legal, available, medical treatments an employee may receive by contradicting a federal law that represents a national decision – though not a consensus. While the Supreme Court has allowed exemptions to the contraceptive mandate of the ACA, they are few and highly specific, such as church employers. Even religiously-owned health care institutions (such as Catholic hospitals) have not been granted this exemption.

To grant such an exemption would represent unjust discrimination against a group of employees based on morally irrelevant factors such as youth, gender, and reproductive capability. The ACA clearly stipulates particular health care services must be provided. So it is not for a group of individuals (such as the family that owns Hobby Lobby), by way of a for-profit nationwide corporate employer, to deny its employees those services.

It is also not for the Supreme Court to damage the integrity of the ACA by granting such exemptions.

The owners of Hobby Lobby are free to make business decisions in accordance with their faith (such as closing on Sundays). But they are not free to impose their beliefs on their employees by seeking to control their personal health care choices.

Hobby Lobby has a viable option for avoiding involvement with contraceptive choices: by getting out of the health insurance business. Hobby Lobby could drop its employee insurance coverage altogether and pay the modest $2,000 per person yearly tax incurred by doing so. Employees could then obtain their own insurance through the exchanges. Hobby Lobby’s attorney points out this would cost the corporation the current tax breaks it receives from providing insurance and might also force the company to pay higher wages to attract employees willing to buy their own insurance. These statements may be true, but they are also irrelevant.

In a pluralistic society, we tolerate a variety of beliefs without allowing persons to impose those beliefs on others. If the Supreme Court agrees with Hobby Lobby, why would other for-profit corporations not follow suit with other objections? What would prevent corporations from declining coverage for other services based on “religious objections”? What if corporations want exemptions from covering HIV treatment based on religious objections to homosexuality or exemptions from treating Trichinosis on the basis that it is immoral to eat pork?

No corporation should make health care decisions for its employees. Hobby Lobby should abide by the provisions of the ACA, or get out of the way of its employees by paying the “penalty” tax, increasing wages if it must, and allowing employees to select their own plans from the insurance exchanges.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

Whose Business Is It If You Want a Bee To Sting Your Penis? Should IRBs Be Policing Self-Experimentation?

by Michelle Meyer, Bioethics Program Faculty.

You might think that the answer to the titular question is pretty obvious. Obviously, it’s your business, and yours alone if you want to induce a bee to sting your penis? Right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

Well, it turns out that, depending on who you are and why you want to induce a bee sting to your penis, the answer may be: a committee of your peers. As academics whose research involves other human beings know, what others can do freely, they often require permission to do. When you study humans and your research is funded by the federal government, before you can conduct your study — in fact, before you can even recruit a single subject for it — you must submit all of your research plans to your institution’s Institutional Review Board (IRB) for ethics review. Indeed, you must do this even if your research is not federally funded but you work at a college or university that receives federal research grants and is among the 75-90% of such institutions that has promised the federal government that it will require IRB review of all the human subjects research that its students and faculty conduct.

IRBs are designed to provide a neutral, third-party review of research in large part in order to counteract the built-in conflict of interest that researchers have. The IRB system has lots of flaws, but the basic idea is sound. Researchers have lots of reasons for studying other humans, among them scientific curiosity, financial rewards, the pressures and prospects of tenure and promotion, and the desire for fame (or what passes for fame in the small pond of academe, anyway). In pursuing these benefits for society and for themselves, however, they usually impose risks and costs on their subjects (or participants, as they are now most frequently called). Investigators have lots of reasons to proceed with a study, and to characterize it as not-very-risky to people that the investigator needs to agree to participate.

But only academic researchers (and drug and device manufacturers) are subject to IRB review, and ironically, only when their motive in engaging in an activity is to learn something useful and generalizable. And so journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

So, too, it turns out, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that this was a gap in the literature. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong.

Most obviously, were Cornell to lack a specific policy about self-experimentation, that would not mean that it possesses a policy exempting self-experimentation from IRB review. As Cornell’s Office of Research Integrity and Assurance correctly notes, although

[f]ederal regulations are silent on the matter of researchers who want to participate in their own studies. . . . , the regulations do not distinguish between self-experimentation and research on people who are recruited for a specific project.

And in fact Cornell, like many other institutions (including Johns Hopkins, the University of Wisconsin-Madison, and Georgia Tech), does have a policy (last updated in October of 2013) requiring researchers to obtain IRB approval before experimenting on themselves:

As part of its commitment to the protection of the rights and welfare of individuals participating in research, Cornell’s Human Research Protection Program requires investigators who wish to act as participants in their own studies to submit for review and approval following standard procedures outline in the IRB policies.

Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

According to his paper, Smith’s research “is based on work supported by a United States National Science Foundation (NSF) Graduate Research Fellowship.” But even if it weren’t federally funded, it wouldn’t matter. Cornell filed a FederalWide Assurance (FWA) with DHHS’s Office for Human Research Protections (OHRP) promising to apply the same federal regulations to all human subjects research, regardless of funding (see #5 here).

Of course, to come within the IRB’s jurisdiction, an activity not only has to involve human subjects; it also has to constitute “research” — “a systematic investigation . . . designed to develop or contribute to generalizable knowledge.” Did Smith’s bee sting adventure fit the bill? Here’s Ed again:

Smith was methodical. He collected bees by grabbing their wings “haphazardly with forceps” and pressing them against the body part of choice. He left the stinger there for a full minute before removing it, and then rated his pain on a scale of 1 to 10. . . . He administered five stings a day, always between 9 and 10am, and always starting and ending with “test stings” on his forearm to calibrate the ratings. He kept this up for 38 days, stinging himself three times each on 25 different body parts.

Sounds systematic to me. What about “designed to contribute to generalized knowledge”? Ed again:

Now, clearly, these data are very subjective, and they all come from one person. Smith is clear that his anatomy of pain can’t be generalised to everyone else. “If someone else did this, they’d probably have different locations that they felt were worst”, he says, although from talking to his colleagues, he feels that the rough shape of the map would be similar. “I didn’t see a lot of merit in repeating this with more subjects,” he says.

But Smith’s pain map being identical to everyone else’s is hardly the only way that his experiment could lead to generalizable knowledge. And anyway, “generalizable knowledge” is a notoriously fuzzy concept in IRB review. In determining whether an activity will contribute to generalizable knowledge, Cornell’s IRB, like many, uses the proxy of asking whether it will “be used in a publication, presentation, or achievement of a degree.” Smith’s study pretty clearly passes that test.

My point in noting Smith’s error about his institution’s IRB policy is not to cause trouble for him or to impugn his character. To the contrary, I think requiring IRB review for all self-experimentation is absurd. And it’s worth highlighting absurd laws and policies.

But maybe Cornell has a point when it notes that researchers “may . . . be more willing to accept risks that are ill-advised.” In discussing the list of body parts that he tested, Smith told Ed that he “had originally had the eye on the list, but when I talked to [my advisor], he was concerned that I go blind. I wanted to keep my eyes.”

But it’s not surprising that researchers might pose undue risks to themselves or make other unwise decisions. All of us have the potential to do that. And there are a variety of mechanisms for trying to reduce the chances that people will take bad risks. A faculty advisor who pressures a graduate student to engage in risky self-experimentation might be disincentivized from doing so by faculty guidelines or disciplinary procedures, for instance.

The question isn’t whether or not to try to deter unduly risky behavior by scientists who self-experiment; it’s whether this goal requires subjecting every instance of self-experimentation, no matter how risky, to mandatory, prospective review by a committee. It’s one thing to require a neutral third party to examine a protocol when there are information asymmetries between investigator and subject, and when the protocol’s risks are externalized onto subjects who may not share much or any of the expected benefits. Mandatory review of self-experimentation takes IRB paternalism to a whole other level.

What do you think?

(Incidentally, the penis shaft turns out not to be the most painful place in which one can be stung (and as suggested above, the testicle wasn’t even close). Check out Smith’s paper or Ed’s post on it to see which two body parts won that particular contest.)

[This blog posting originally appeared in edited form on The Faculty Lounge on April 3, 2014. The contents of this blog are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]