Science, politics, ethics, and emergency contraception

Last December 7th, Health and Human Services Secretary Kathleen Sebelius instructed the FDA not to give over-the-counter (OTC) status to the emergency contraceptive drug Plan B One-Step for girls under age 17 (It is currently OTC for all women 17 years of age and older). Sebelius gave as her reason her “conclusion that the data … are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional.”

Commentators immediately went ballistic, bemoaning the “fact” that the science shows that this product should be approved OTC for all ages, but that politics overruled the science. Last week a Perspective piece in the New England Journal of Medicine (NEJM) made the same assertion, as did an earlier Viewpoint in JAMA.

However, there is more to these claims of scientific-objectivity-being-overruled-by-politics than meets the eye. Science can only tell us what is or what can be, never what should be. You cannot from the premise, “We can do such-and-such,” derive the conclusion, “Therefore, we should do such-and-such,” without the intervening value statement that “Such-and-such is good, or desirable, or right.”

In his inaugural address, President Obama promised to “restore science to its rightful place” in government, to “base our public policies on the soundest science.” But public policy decisions are inevitably decisions about what should be done; every regulation in the law is an acknowledgement that those governing believe that one particular way of doing or taxing or regulating something is better than the alternatives. In other words, every policy decision is based in some part on ethics and morals — things which objective science cannot reveal to us. To “restore science to its rightful place” means “let’s get our facts straight.” This is important: good ethics (and good policy) must start with good facts. But science’s rightful place is not, and cannot be, to make the ethical decision for us.

Science can tell us the chances of Plan B One-Step preventing pregnancy after unprotected intercourse. It can give us statistics about how women use it and what the potential side effects are. It can not tell us whether or not it is a good thing that a 12-year-old who just had unprotected intercourse should be able to get the medicine without talking to an adult such as a medical provider.

Sebelius appealed to a lack of scientific data in making her decision; I do not know if she also had an unspoken political agenda. It seems at least mildly improbable that someone so staunchly pro-choice, who is part of the administration of a President and a political party that do not oppose Plan B on political or ideological grounds, would herself do so to gain political points or power. But I do know that, contrary to all the pundits, this decision, like all policy decisions, cannot be made by empirical science alone. The accusation of “Politics trumps science” is just a front for those whose own politics, morals, and ethics lead them to a different conclusion.

Inappropriate clinicians

An article in the December 28th 2011 JAMA reports a study of doctors and nurses in 82 ICUs across Europe and Israel. These clinicians were asked whether they had provided inappropriate care, defined as “care that clashes with your personal beliefs and/or professional knowledge,” on a particular day. More than one-fourth believed the care they provided on that day was inappropriate.

An accompanying editorial asks the million-dollar question, “If so many clinicians are providing care that is not motivated by its appropriateness, what then are they trying to accomplish?”

What, indeed? Isn’t providing care that contradicts one’s beliefs and knowledge tantamount to providing unethical care?

From my own experience, I will hazard a guess that if the clinicians had been questioned about a longer time period than just one day, way more than one-fourth of them would have reported providing inappropriate care; and that the problem of providing inappropriate care extends well beyond the ICU to clinicians everywhere. I will also hazard a few guesses at just some of the motivations behind providing inappropriate care:

-The clinicians want to please patients or families, and/or are experiencing pressure from the families to provide inappropriate care;

-The clinicians are required to follow guidelines that are based on the statistical analysis of large populations, but happen not to apply to the individual patient being treated;

-The clinicians are attempting to prevent a malpractice lawsuit by doing more tests and procedures than are appropriate;

-The clinicians are following inappropriate laws, such as the one  drafted by the NRA and the Florida legislature restricting physicians’ ability to properly counsel patients.

Most reasons underlying inappropriate care stem not from the deliberately unethical practice of the clinician (although I do not deny that such things occur), but from characteristics of the system which induce them to act in ways that they feel are inappropriate.

The idealist in me believes that most people who go into medicine and nursing do so because they want to help people. Virtually all of the nurses and physicians I know (and I know quite a few) want to do the best thing for their patients. But all of these idealistic people are taken and thrown into a system that influences them to act in ways that they believe are inappropriate. The clinicians find themselves, for reasons beyond their control, giving inappropriate care.

Is inappropriate care always unethical care? How can one be an ethical clinician in a system that prevents one from acting appropriately?

A Lament For the Loss of Community

This guest post is authored by LL French, a current student at TIU.

Community is dead. Cause of death: uncertain. But definitely dead, gone, passed, slipped on a banana peel, deceased, dead!

For Millennials like me, we’ve never lived in a world where neighbors help each other. After all, isn’t that the job of the government? Welfare? Food stamps? Medicaid? (Please note the heavy tone of sarcasm in my voice right now.)

Let me explain the reason behind my cynical rant on community. Today my little bioethics-obsessed mind ran across a CNN news article. In the story, Baby Pierce, a four-month-old with rare Heterotaxy Syndrome, needed heart surgery. Demanding the best care for her infant son, Pierce’s mother insisted on sending her baby to a top Boston hospital for his care.

Problem: Medicaid wouldn’t pay to send him to Boston when another “capable” hospital existed in Indiana.

Solution: fundraising on Facebook and donations from mothers of children with heart problems!

Now for the quote that convinced me that community was dead – in the words of Pierce’s mother: “I think it is sad that a bunch of moms and strangers who don’t even know me or my child have stepped up to the plate more than… the government, and insurance, and Medicaid.” This statement troubles me. She thinks “it is sad” for strangers to help? Isn’t that the very essence of community? Isn’t community, by definition, any group of people that come together to encourage, support, and protect you?

Should Medicaid have helped the young mother? I’ll leave that question to more capable minds. What I am shocked by is the assumption that strangers shouldn’t help! I fear we now live in a world where we rely on the government too much. We rely on the government to be the Good Samaritan that we once were. I mourn the loss of a traditional community where generosity to those in need was normative. Indeed, I fear bioethics and health care in general has much to lose if community dies.

Yes, I exaggerate. There is hope. Community is not dead, but perhaps transformed? Yes, we don’t live in a world where neighbors help each other. Instead, we live in a world where random people on Facebook can form a community to save a baby! Our traditional sense of community has been replaced by Facebook, Twitter, and texting, etc. As a natural cynic, I doubt Facebook’s power to bring people together in community, but Baby Pierce gives me hope that people can come together to form a new kind of community – but only if we are intentional in our pursuit of community and we lose this silly notion that strangers shouldn’t help each other.

See more on Baby Pierce

Of IOM, IT, EMRs, patient safety, and quality

 

If your doctor’s not looking you in the eye quite as much as he or she used to, it may be partially the fault of the Institute of Medicine (IOM).

In 1999, the IOM published a report entitled “To Err is Human: Building a Safer Health System,” which famously concluded that preventable medical errors cause up to 98,000 patient deaths annually. This was followed by the 2001 report, “Crossing the Quality Chasm: A New Health System for the 21st Century.” These reports touted, among other things, the power of health information technology (IT), including Electronic Medical Records (EMRs), to reduce medical errors, increase patient safety, and increase the quality of medical care. Subsequently, the federal government has stepped in, providing financial incentives for physicians who can demonstrate “meaningful use” of an EMR, and will soon be imposing financial penalties on those physicians who don’t climb onto the EMR bandwagon. Thus, the IOM is directly or indirectly responsible if your doctor isn’t looking you in the eye because she’s gazing into a computer screen instead.

Upon what evidence did the IOM base its assertion that EMR’s would improve safety and quality? Well … you know … it’s just kinda obvious, isn’t it? I mean, after all, it’s technology, and it’s gotta be better than paper, and it just makes sense that using more technology is better, right?

In fact, there was no data to suggest that health IT would improve either the quality or the safety of medical care. In the intervening years, as health IT implementation has exploded, there continues to be a paucity of data to suggest that health IT improves either the quality or the safety of medical care. There is good data that it introduces new errors and quality problems into health care.

Last month the IOM released a new report, calling for the formation of an independent federal body to investigate patient deaths and other adverse events caused by … drumroll, please … health information technology.

Dr. Richard I. Cook, an associate professor of anesthesia and critical care at the University of Chicago, said, “It’s not surprising that such adverse events are being found related to health IT, and it’s not surprising that those promoting these systems have neither looked for them nor anticipated them. To make large-scale investments in these systems and only now be looking at the impact on patient safety borders on recklessness.” Dr. Scot M. Silverstein, a consultant in medical informatics at the Drexel University College of Information Science and Technology in Pennsylvania, said that it is “unethical” to expand health IT so dramatically without understanding the precise nature of the risks it poses to patients.

“Reckless” … “unethical” …

Meanwhile, my doctor’s still not looking me in the eye because he’s trying to find something in the computer. Sheesh! This is quality improvement?? Have we simply created a new “Quality chasm”?

 

(The quotes above are from this story which was published in the AMA news.)

Infinite demand and the drawing of lines

 

Many of the problems with health-care financing in our country come about as a result of difficulty with line-drawing. I’m not talking about geometry, but about making hard decisions.

This difficulty with line-drawing is not new. In 1971, while Congress was debating national health insurance (!), a man named Shep Glazer testified in dramatic fashion before the House Ways and Means Committee about funding for renal dialysis — while hooked up to a dialysis machine. “Gentlemen,” he said, “what should I do? End it all and die? . . . If your kidneys failed tomorrow, wouldn’t you want the opportunity to live? Wouldn’t you want to see your children grow up?” After thirty minutes of debate in the Senate and ten minutes in a House-Senate conference committee, Congress voted to extend Medicare coverage to any and all who need dialysis. The uncharacteristically short amount of time spent considering this action, one that should have raised some very hard questions about things like the just distribution of limited resources, suggests that the hard questions were ignored in favor of doing something that feels on the surface very good — paying for everybody’s dialysis — but that has far-reaching, unexamined consequences.

An excellent article in the Chicago Tribune last week described a recent iteration of the old problem. Through medical advances, increasing numbers of our oldest citizens are being made healthier by procedures that were once reserved only for younger people: it is not unusual for people in their 90s to have hip replacements or a 102-year-old to have a heart valve replacement. Now, these are good things! These people are living more fruitful lives through medical procedures. But they are living under a system, Medicare, that does not consider price, but only benefit to the patient, in making decisions about what medical procedures it will cover. And as the proportion of the population receiving Medicare expands, and as expensive medical techniques proliferate, the demand for such procedures will be virtually infinite. Unfortunately ,the resources to pay for them will be all-too finite.

At some point we have to go beyond emotional appeals, beyond doing the thing that feels the best but which bankrupts the country (covering everything for everybody at any cost). At some point we have to draw lines, to make hard decisions about who will get what — and who won’t.

What is the most ethical, most just way to make this decision? The Tribune article mentions one solution put forth by Daniel Callahan and Sherwin Nuland: set a cutoff age (they suggest 80) beyond which people will not be covered for anything beyond “good basic health care.”

Callahan said, “If you want to save all lives, you’re in trouble. And if you want to save all lives at any cost, you’re really in trouble. . . We need to stop thinking of medicine as an all-out war against death, because death always wins.”

Callahan’s perspective in that last statement is a good corrective to distorted expectations of medicine. I don’t agree with how and where he draws the line on providing medical care; but if it gets the discussion going, it’s at least a place from which to start.

Musings from a nursing home

 

It has been five months today since my sister had the first of many brain surgeries for a burst aneurysm. I was visiting her yesterday, and the visit prompted the following random bioethical thoughts.

Health-care payment reform – My sister is in a nursing home, and until recently had been receiving various therapies. Earlier this month her insurance ran out, and suddenly — without notice — now she receives none.

This situation is not surprising, given the claptrap patchwork of healthcare payment that passes for a system in our country. The health-care payment reform debate has been so politicized — that is, it has become a tool of political power that each party wields as a weapon against its opponent — that rational, ethical discourse on the subject seems to have been left in the dust. There is a more ethical way to deliver health care; however, as long as we leave it up to lobbyists, interest groups, and two political parties that seem more intent on power than government, we will see increasing numbers of people left in the medical and political dust.

Human dignity – By some standards, my sister might be thought of as having lost her human dignity. Before June 11th she was an energetic, triathlon-running, blog-posting woman; now we are excited if she can manage a hand-squeeze or a groan. By some estimations, she might be said to have a “life not worth living.” According to some bioethicists, she doesn’t have what it takes to be treated with the respect due to human persons. I’m sure glad they haven’t been taking care of her these last five months.

The search for a cure – Putting aside for the purpose of argument all of the insurmountable hurdles that have to be overcome, imagine for a moment that the fondest dreams of certain researchers reach fruition, and that embryonic stem-cell therapy for brain trauma becomes a reality. Imagine (you have to imagine, because it is all imaginary at this time, never mind the rhetoric to the contrary): What if my sister could walk and talk and laugh again, if only we were willing to sacrifice an embryo, “a glob of cells smaller than the period at the end of a sentence,” maybe an embryo leftover from IVF in fertility-clinic-freezer limbo somewhere?

Much of the Church has taken a stand against embryonic stem-cell research, as is right. But it’s easy to oppose something that has no forseeable hope of becoming reality. What would happen if the unthinkable became possible? Would the Church still stand against it? If cures for your daughter’s diabetes, your son’s leukemia, your wife’s brain tumor, your mother’s Alzheimer’s, were an embryo away? Would we be like the liberal bioethicists and find justifications for what we now rightly oppose? Or would we continue to respect all humans, no matter what size or developmental stage, even to our own hurt?

The procurement of organs for transplantation: China vs. the WMA

Can a convict sentenced to death give truly free and informed consent to the harvesting of his or her organs after execution?

There is great difficulty obtaining organs for transplant in China. Much of this is blamed on cultural factors, although suspicion of corruption in the medical profession is also a significant reason. Whatever the reasons, between 2003 and 2009 there were only 130 voluntary organ donations in all of China. Yet in 2006, there were 11,000 organ transplants performed.

So where are all of these organs that are not voluntary donations coming from? Answer: executed prisoners. To its credit, China does try to make sure that prisoners give informed consent. According to Bing-Yo Shi MD and Li-Ping Chen PhD, writing in Wednesday’s JAMA, “If a sentenced convict [in China] would like to donate his organs, the convict and his family must submit an official application and sign an informed consent statement with a lawyer present. Before execution, the convict is asked to confirm his organ donation again, and if consent is reneged, organ procurement is explicitly prohibited.”

However, the World Medical Association (WMA) in its Statement on Human Organ Donation and Transplantation explicitly states that “Because prisoners and other individuals in custody are not in a position to give consent freely and can be subject to coercion, their organs must not be used for transplantation except for members of their immediate family.” (Section F par. 4) In a 2005 resolution the WMA addressed China specifically, stating unequivocally that “The WMA demands that China immediately cease the practice of using prisoners as organ donors.”

In a society such as China’s with such strong biases against organ donation, what are we to make of this large number of sentenced convicts apparently consenting to donation? Are they simply the most altruistic segment of the Chinese population? In the absence of another explanation, one must wonder whether the fact of imminent execution itself is somehow a form of coercion, an external constraint on behavior. In the absence of another explanation, one must wonder whether China or the WMA is right:

Can a convict sentenced to death give truly free and informed consent to the harvesting of his or her organs after execution?

 

(Information for this post came from the letters, “Organ Transplantation and Regulation in China,” and its reply, published on pages 1863-4 of the November 2nd issue of JAMA: The Journal of the American Medical Association, which were in response to the article “Regulation of Organ Transplantation in China: Difficult Exploration and Slow Advance,” by Shi and Chen, published on pages 434-5 of the July 27th issue.)

The ethics of PSA testing

 

The humble little PSA test has become a hot-button ethical issue.

The PSA (prostate-specific antigen) test is a blood test that can detect prostate cancer at an earlier stage than can physical exam. It is not a perfect test; it misses about 25% of cancers. But it is the best thing we have for detecting prostate cancer early.

The United States Preventive Services Task Force (USPSTF) reviews all of the available evidence regarding screening tests for various conditions, and makes recommendations based on the scientific evidence. Earlier this month, the USPSTF posted a draft of its update to its 2008 prostate cancer screening guidelines. The earlier guidelines had recommended that men over 75 not be screened with a PSA test, and said that there wasn’t enough evidence to make a recommendation one way or the other for younger men. The proposed new guidelines, based on more recent studies, go further, giving screening a “D” recommendation, which means that there is moderate or high certainty that the service has no net benefit, or that the harms outweigh the benefits, and the task force discourages use of the service.

But how can a PSA cause harm? It’s just a poke in the arm, right?

It is not the test itself that causes harm, but what we do with it. 90% of men with PSA-detected prostate cancer undergo radiation and/or surgical treatments that have considerable risks and side effects. The chair of the USPSTF said that for every 1,000 men treated for prostate cancer, five die of perioperative complications; 10-70 suffer significant complications but survive; and 200-300 suffer long-term problems, including urinary incontinence, impotence or both.

These numbers might be acceptable if there were evidence that treating early prostate cancer did some good. But, counterintuitive as it may seem, studies have shown little if any positive benefit from treating prostate cancer early. When men diagnosed and treated by PSA screening are compared with those who are not treated, there is virtually no reduction in prostate cancer mortality at 10 years.

J. A. Muir Gray wrote, “All screening programmes do harm; some do good as well.”

For a profession that takes seriously Primum non nocere, “FIrst, do no harm,” it seems, with what we know at the present time, that this particular screening test may contravene our first ethical principle.

Managing Patients

Many people remember C.S. Lewis not only as a gifted thinker but also as someone who was very funny.  Funny in a typically British, understated, often-profound way.  When reading That Hideous Strength, the last book of his Space Trilogy, I laughed again and again at his many references to the National Institute of Co-ordinated Experiments.  Yes, you got that right: the N.I.C.E.  This vast array of committees and investigators would finally bring a “really scientific era” to managing society, and eventually all the ills of the country would be deciphered and cured.   And of course building this grand enterprise meant bulldozing a large part of a quiet university town—all for the sake of noble, or at least “nice,” goals.  True, one might have to keep the citizenry in the dark on what actually was going on inside the N.I.C.E., but of course this would be for their benefit.  (“You musn’t experiment on children; but offer the dear little kiddies free education in an experimental school attached to the N.I.C.E. and it’s all correct!”)  The book is great commentary on misguided human endeavors and is prescient on many of the bioethics matters of today.  But what is most entertaining is that the N.I.C.E. is indeed alive and well in the United Kingdom: the National Institute for Health Clinical Excellence, a.k.a. NICE.  More on this in a moment.

Christ and the Canaanite Woman by Germain-Jean Drouais (1784)

During the past five weeks of my Psychiatry Clerkship, I’ve seen that we are often in a position to simply do the best for patients with the little we have.  Many of our patients suffer from life-long substance abuse, others are being monitored because of signs they might harm someone, and others are there at the request of the courts.  It’s easy to fall into a “managing patients” mode of just keeping things from getting out of hand but never really helping the patient recover from his illness.  (Especially when the patio re-modeling keeps some patients from being able to go outside for two weeks.)

One of the populations that figure prominently into “patient management” is that group diagnosed with antisocial personality disorder.  NICE has dual concerns of managing resources as well as managing antisocial patients who may cause harm to society in the form of criminal activity, for instance.  NICE working groups have to come up with guidelines for handling these patients.  For instance:

Pharmacological interventions should not be routinely used for the treatment of antisocial personality disorder or associated behaviours of aggression, anger, and impulsivity.  Pharmacological interventions for comorbid mental disorders, in particular depression and anxiety, should be in line with recommendations in the relevant NICE clinical guideline.

Psychological interventions such as Cognitive Behavioral Therapy, on the other hand, were found to be wise uses of funds in working with these patients.

It is easy to click through a patient roster quickly in order to carry out management guidelines and lose a sense of the human being who is at dis-ease because of an illness.  This is why I think Christian hospitals and places of rest for the mentally ill offer something that our modern health care systems do not: their reason for being is first the healing ministry of Jesus, seeing that the ill become whole.

For more information

Ethical Blind Spots

Recently I have been impressed with how much there is for those of us who are involved in bioethics to learn from those who study other areas of ethics. Business ethics in particular has a lot to offer. A recent article in The Age discusses a book titled Blind Spots written by Max Bazerman, a professor of business administration at Harvard Business School, and Ann Tenbrunsel, a professor of business ethics at the University of Notre Dame, that discusses the concept of unintentional ethical misbehavior.  They talk about how we can behave unethically without being aware of it by excluding important and relevant information from our decisions.
One of the examples in the article is medical.  It involves a person with cancer who goes to a surgeon who recommends surgery and then to a radiation oncologist who recommends radiation therapy.  It could appear that each specialist is being intentionally self-serving, but they suggest that it is possible for both specialists to genuinely believe that their treatment is superior.  They can fail to realize that their opinions are biased by their training, incentives, and preferences.
It made me think about how I may do the same thing.  As a family physician I have a bias toward treating things I can diagnose as medical diseases with medicines.  I try to incorporate other things such as counseling and physical treatments such as exercises and physical therapy, but since those are not the things I was trained to do, I may not use them as much or as well as I could.  It is easier and more comfortable to prescribe a medicine.  To make ethically sound recommendations about what is in a patient’s best interest we need to be aware of our own biases and be sure to encourage input from others who can see the patient’s needs from a different point of view.