Weighty Thoughts

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

I’ve been thinking a lot about Paula Deen, but not for the reason that you might suspect. I’m not all that interested in the way she allegedly treats her employees, her casual use of ethnic slurs, or her half hearted apologies for the way she has behaved. All of that just confirms what I already know: that despite what five US Supreme Court justices seem to think, there is still a strong undercurrent of racism in American society.

I’m more interested in Paula because of her weight, because of her type II diabetes, and because of the culinary lifestyle that she publicly promotes. But I’m not just interested in her. I’m also interested in James Gandolfini, the rotund actor best known for his portrayal of mobster Tony Soprano, who died last week of an apparent heart attack. And I’m interested in New Jersey Governor Chris Christie, a man whose physical size is exceeded only by his personality, but who recently admitted undergoing gastric bypass surgery.

Put simply, I’m fascinated by fat and by America’s obesity epidemic. The problem has grown so large (pun intended) that, at its annual meeting last week, the American Medical Association adopted a policy that defines obesity as a disease that requires medical intervention. Given that 35% of all US adults are considered obese — defined has having a body mass index, or BMI, of 30 or higher — this means that over a third of Americans are now “sick”.

Is being excessively overweight a sickness? Sure, obesity has been linked to as many as 60 illnesses, including heart disease, high blood pressure, stroke, cancer, and diabetes. Moreover, according to the US Centers for Disease Control and Prevention, obesity-related health care expenses cost Americans over $200 billion annually. But obesity is only a risk factor for these diseases, not a disease itself, and there are plenty of overweight individuals who are actually quite healthy.

But is there any harm in labeling obesity a disease? Supporters see the AMA’s decision as an important step in combating the obesity epidemic. It could, for example, increase access to obesity-related treatments like nutritional counseling or personal training not currently covered by most insurance plans.  In the long run, this could actually lead to significant cost savings should the frequency of obesity-related ailments decrease as Americans eat better and exercise more.

Despite this, there are a number reasons to be concerned with the pathologization of obesity. First and foremost, obesity is rarely the result of actual physiological and metabolic problems. The vast majority of cases are the result of a sedentary lifestyle and poor nutritional habits. The obesity epidemic isn’t a medical problem. Rather, it is a social problem with medical consequences. Social problems require social solutions: educating people from an early age about the lifelong benefits of eating right, creating physical environments that encourage activity, and engaging with the food and restaurant industry so that they provide healthier meals and smaller portions.

Unfortunately, Americans tend to look for the easy answer or the quick fix. For many of us, it may be more tempting to pop a pill rather than make the difficult lifestyle changes necessary to lose weight. Our doctors are also more likely to reach for their prescription pad rather than discuss other approaches like exercise or diet. But these pills can come with substantial physical risks or financial costs. For example, almost all FDA-approved weight loss drugs have been taken off the market because of unexpected side effects.

Finally, there is the problem of stigma. As a society, we are already obsessed with media-constructed but often unattainable notions of beauty and health. Pathologizing obesity compounds this problem. Not only are fat people unattractive, at least according to our deeply entrenched cultural standards, they are now diseased. This gives people a ready excuse to provide unsolicited advice, to make snide comments, or to make snap judgments about fat people: they are just worried about their health. Hating the overweight among us will remain an acceptable form of bigotry. Should Paula Deen’s media empire ever recover from her ill-timed and racially insensitive comments, she would be wise to stick with telling ‘fat jokes’.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on June 27, 2013. 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.]

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Autism Anger

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

This week I read an article on Bloomberg.com about a possible link between air pollution and autism.  The article itself didn’t peak my interest as much as the comments.  There were over 200 comments and almost all of them were emotionally charged.  This didn’t surprise me exactly, but made me realize again how passionate people are about finding the cause of autism.

Over the years the rise in autism cases has been blamed on vaccinations, fluoride, GMOs in food, and now pollution.  Vaccination is probably the best known theory of autism cause and has been given a lot of press by Jenny McCarthy.  Ms. McCarthy is the mother of an autistic child; she is joined in her fight by many parents of autistic children.  Their passion is understandable; they love their children and want to know what caused the disease, how to prevent it, and how to treat it.

Autism affects about 1% of children in the United States, or about 1 in 88 births.  It is a spectrum disorder, meaning that not all cases are of the same severity.  The number of autism cases has risen over the last several years and continues to rise.  The facts listed here were obtained from The Autism Society.

An interesting chart on the increase of Autism cases over time can be found on the Autism Speaks Official Blog.  The chart begins tracking autism cases in 1975 at 1 in 5,000 children and ends in 2009 at 1 in 110 children.  This rise has been at least partially attributed to better techniques for diagnosing cases of autism, meaning we are catching more cases than ever before.  Also, because of earlier and earlier diagnosis there is the possibility of over-diagnosing, meaning children who do not truly suffer from the disorder would be categorized as autistic.  The increase could also, of course, be caused by a true rise in the number of autism cases over the years.

I understand that parents of autistic children are passionate about finding the true cause and a cure for the disorder.  What I have difficulty understanding is the anger expressed in the Bloomberg article comments, some of them are obnoxious and downright cruel.

The possible connection to pollution is a correlative relationship and therefore more research needs to be done to confirm a connection.  The suggestion of pollution as a cause of autism is substantiated by the same type of evidence as vaccinations or fluoride: correlative evidence.  In other words, we need to do more research to know the truth in any of these areas.

So, why isn’t correlative evidence good enough?  A correlation takes two independent events and finds a potential relationship in real world scenarios.  This cannot be considered true scientific proof because the events have not been isolated in the study.  Does this mean that a correlative study is useless?  Certainly not!  Events that seem to correlate in the real world should point us toward future research.  Potential correlations should cause researchers to design studies to prove or disprove the correlation scientifically.

In my opinion, we should be actively designing scientific trials to answer the questions of autism relationship to vaccinations, pollution, fluoride, and any other potential cause supported by a real world correlation.

I think that much of the anger coming from the public stems from the idea that vaccinations are to blame for the increase in autism cases.  Remember, that studies supporting this idea are merely correlative at this point and more extensive research would need to be done to prove this hypothesis.

The anger is deepened for some because it is felt that the research funded by the government on vaccination safety has not been enough.  To this I say, “Do it yourself if you think you can do better.”  I don’t say this at all flippantly or sarcastically, I believe very strongly in privately funded research projects and encourage doctors to design trials and concerned citizens to fundraise and pay for these trials.  If you could present me with a solid study to prove whether or not vaccinations play a role in autism cases I would lighten my wallet for you and I am sure you would find parents willing to allow their children to be in the trial as well.  It’s a common theme I see lately in this country of too much complaining and not enough creativity.  Stop crying that “it isn’t fair” and put your energy into positive discovery.

When speaking of vaccinations however, one must also remember how vital they are to our society.  Childhood vaccinations have decreased child deaths by an incredible amount and we have all but eliminated some terrible diseases like Polio.  The good they have done cannot be thrown away because of correlative evidence possibly linking them to autism.

Anger in this issue is not one sided however, some strong advocates for vaccination are downright unwilling to admit that those vaccinations could have side effects.  It is suspected that vaccination side effects are under reported and under studied because of this bias and the idea that the benefit vaccination has brought to our society outweighs any and all potential risks..  This mindset only proves to increase the conspiracy theories about autism and vaccination however.  It’s a vicious circle.  In my opinion, strong supporters on both sides need to take a breath, step back, and be rational.

We spend too much time arguing with emotion instead of fact.  We need to start putting our money and energy into finding information rather than shooting down ideas.  We are in an age of INCREDIBLE technology and ability; there is almost no question we cannot answer.  Let’s stop name calling and tap into some of that potential.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on June 22, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

On Being Amish

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

Being Amish is a red herring.

I have an interesting history with the Amish community. You see, while living in SE Iowa I was homeschooled for three years of grade school. My mother, in addition to her primary profession, was also a midwife, and for reasons I am not entirely certain she worked a fair amount with the Amish community near us. I had the opportunity to travel with her on her prenatal visits with them, and would often help the men with chores. Granted, I was under ten years old during this time, so perhaps “help” is bit … ineffectual. I know this: I look back on that time fondly, and I feel a particular connection to Amish communities whenever I encounter them, whether in Iowa, Missouri, or Vermont. But this post isn’t really about me, or even about the Amish.

A 43-year-old pregnant woman (Mrs. M) is admitted to a rural hospital, with increased blood pressure and heart rate. She was found to have severe preeclampsia and prolonged preterm premature rupture of her membranes (PPROM), likely more than eighteen hours. These two conditions combined can be quite dangerous for both the mother and fetus. Mrs. M’s pregnancy was determined at the time to be 24 6/7 weeks – extremely premature. This pregnancy was complicated by four months of bleeding and swelling in the last two weeks. Mrs. M’s past medical history is significant for multiple miscarriages and stillbirths. (This was her 17th pregnancy, with seven surviving children.) She has no known primary care physician, and had not sought any prenatal care prior to this admission. Upon admission to the local hospital, Mrs. M and husband indicated that they did not want resuscitative measures for the baby upon delivery, which were consistent with their religious and cultural (Amish) beliefs. How ought the medical team respond?

Autonomy is a well-established principle in both law and medical ethics.  Patients with decision-making capacity (DMC) have the right to either accept or decline medical intervention in the context of their goals and values. Within the context of pregnancy, the mother’s autonomous wishes are sufficient to make decisions surrounding the pregnancy, which include the decision to continue or to terminate the pregnancy. Of particular note is that this is not any ‘regular’ pregnancy or potential delivery, due to the early stage of pregnancy. Many practice guidelines agree that any fetus less than 23 weeks has such low probability of survival that resuscitation ought not be attempted. Fetuses at 26 weeks are generally thought to have at least a 50% chance of survival (the basic definition of viability) and resuscitation is the default treatment. So there is this grey zone, between 23 and 26 weeks, which presents interesting and difficult challenges regarding decision-making. It not a period that is marked by singular events, as it is often recorded, as in ’23 1/7 weeks, 24 3/7 weeks’, etc. There is nothing definitive on any particular date, but it is instead more of a continuum of time, with medical confidence or certainty being at either far end of the spectrum.

Beneficence (to do good) and non-maleficence (to avoid harm) are also core principles, and they exist in dynamic balance with the principle of autonomy. Physicians are obligated to offer their best to patients, facilitating the two goals of medicine – the maximization of health and wellness and the alleviation of pain and suffering. At the same time, physicians are also obligated to avoid interventions that may represent an unreasonable or disproportionate burden (harm), unfavorable risk-to-benefit ratio, or those that are medically inappropriate. Patients may request things from us as they seek to further their autonomous goals, but it is the clinician’s domain to assess for the reasonableness of achievability in light of their professional duties and obligations.

In this case, Mrs. M is known to have a complicated past pregnancy history, with the present one similarly complicated. The deliberations and decisions on the part of the parents are likely based – at least in part – on their familiarity with having to make such decisions in the past. Mrs. M’s decisional capacity to make this request to limit treatment upon delivery was never questioned, and it is a decision backed up both by past decisions and by her religious and cultural perspectives.

Regarding the reasonableness of the request from the physician’s perspective, there is nothing in this case to automatically preclude the honoring of the request. However, in order to avoid harm in this case, it may also be prudent to continue to gather as much information as possible to ensure an adequately informed decision on the part of the mother. Some factors that may prove relevant (unknown at the time of this consult) may include a more accurate determination of the fetus’ gestational age, due to the approximated age being so near the edge of the acceptable age range for limiting resuscitation for premature infants. Additionally, state law may provide further clarification regarding the request or its subsequent response. Finally, further discussion with the parents (which was scheduled to happen after this consult) could further illuminate their goals and values, as well as a better understanding of this particular medical situation and its likely outcomes.

Easy enough, right? Well, no. Here is how the scenario played out. The medical team chose to resuscitate the baby upon delivery (via C-section), regardless of the parents’ request to allow for a “natural” course of actions. Additionally, the hospital filed a report with Child Protective Services in order to facilitate the transfer of the baby to a bigger hospital that could manage such a uniquely critical infant. The parents decided to accept the medical interventions and transfer, and the CPS report was dropped as quickly as it was filed. (I have no evidence that the two may have been related, but I suspect they were.)

Mr. and Mrs. M were preparing to cope with something they were all too familiar with: mourning the loss of an infant child. And now they are not. For as good of a thing as it sounds, it may not have been. And as much of a help as the medical community was trying to be, it may have a bit too … ineffectual.

[This blog entry was originally posted in slightly edited form on Mr. Dahlke’s blog on June 21, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Look Before You Leap

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

Last week a US Food and Drug Administration (FDA) Advisory Committee recommended that restrictions on the diabetes drug, Avandia, be lessened.  The restrictions were originally placed in 2010 because of concerns that the drug caused an increased risk of heart failure.  The increased risk of heart failure was originally suggested by a researcher at the University of Cincinnati, he performed a study compiling data from several old Avandia trials.  His work suggested a 43% increased risk of heart attack in diabetic patients taking Avandia.  GlaxoSmithKline, the developer of Avandia, insisted that they had a study being performed that showed no increased risk of heart failure and had a superior design to the data analysis study.

At the time of the 2010 decision, Avandia was the most popular diabetes drug on the market, its popularity instantly dropped and the pharmaceutical company was accosted with lawsuits.  Settling these lawsuits and dealing with other issues from the FDA’s decision cost the company a small fortune.

The re-review we saw at the FDA last week is extremely rare.  The committee was called because of an analysis performed by Duke University.  Duke re-analyzed the data from the original study by GlaxoSmithKline.  This is a study that was specifically designed to show cardiac risk and that the company had stated showed no increased risk of cardiac event in patient’s taking the medication.

Duke’s analysis matched that of GlaxoSmithKline and because of this the board reversed their initial decision and recommended that restrictions be lessened. They have also asked that additional studies be performed to confirm this result.  It is important to note that the advisory board decision is only a recommendation to the FDA, so no formal lessening of restrictions has been made at this point.

If this reversal is formally made by the FDA it won’t erase the damage done.  Millions of Americans were using Avandia and were forced to change drugs because of these restrictions; they were told that the drug was dangerous to their health, which may not have been true.  Avandia’s stock plummeted, the company lost millions on penalties and legal cases, and the drug’s reputation is forever tarnished.

GlaxoSmithKline is certainly not a hapless victim. They had a history of data integrity issues with other drugs that led to a mistrust of the Avandia data.  However, when making decisions like this it’s a fine line between being cautious for reasons of patient safety and jumping to unfair conclusions about the risks of an experimental drug or treatment.

Pharmaceutical companies are often placed in a bad light by our society.  We view them as power hungry, money grabbing machines that have little or no regard for the people they claim to help.  This is a gross misinterpretation.  Certainly, they are companies and therefore concerned with profit margins, but our American market system is based on a big risk/big reward theory.

These companies risk billions of dollars on drugs that have a limited chance of ever getting to market. Clinical trials are hugely expensive and placed under heavy scrutiny along the way.  This is not to say that data cannot be manipulated.  However, even the most cynical among us should admit that a pharmaceutical company would be concerned about the safety of their drug, if for no other reason than that being repeatedly sued is an expensive endeavor.

It is important in a situation like this, with so much at stake, to have all of the facts before making a decision.  It’s nice that the advisory committee has corrected their mistake, but it would have been nicer to have avoided the error in the first place.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on June 14, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

 

Of DNA and Databases

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

You have the right to remain silent, but your DNA can and will be used against you…

On Monday. The United States Supreme Court decided to allow DNA to be taken at the time of arrest from those accused of “serious” crimes. The DNA sample is taken by a cheek swab and the information is then held in a database. The sample is run against others in the database, some of which are unknown samples that were collected at crime scenes. Occasionally, there is a match and the new DNA sample can help the police to solve one of their cold cases.

The case that went to the Supreme Court is that of Alonzo King. Mr. King was arrested on an assault charge and his DNA swabbed at the time of arrest. The DNA matched that of an unsolved rape case and King was charged with this rape. The problem arose when King pled guilty to a lesser crime than the assault. Under current Maryland law, the police would not have been allowed to take his DNA for the crime for which he pled guilty. King’s attorneys argued that because he was convicted of a lesser crime the DNA evidence should not be permissible in the rape case.

In a 5/4 decision that rocked party lines, King’s rape conviction was upheld. Kennedy, the notorious swing vote on the court, wrote the majority opinion. This opinion was that collecting DNA was like fingerprinting upon arrest and not a violation of the person’s rights. He was joined by Justices: Roberts, Thomas, Alito, and Breyer.

The dissenting justices were Ginsberg, Kagan, Sotomayor, and Scalia. Scalia wrote the dissent and argued that the ruling was too vague, the precedent the court was setting was dangerous, and collection of DNA has high potential for future misuse.

I agree with the dissent and believe the court made a mistake with this decision. It’s not that I would like Mr. King roaming the streets to rape again, but I think some of the justices neglected to look at the bigger picture. My main issue is with the saving of information, DNA information is not like having your fingerprints on file. Your DNA is a map of you and we have no idea how this information could be used in the future. We learn more and more about DNA and genetic makeup every day and the more we learn the more cautious I become about sharing my genetic information.

What about the DNA sample itself? Is this retained along with the database of information? It would be one thing to have a database, but another entirely to have the physical sample. Scientists can do amazing things and all indications point to more incredible discoveries in the world of genetics. This should give us pause when discussing the creation of a central database for anyone.

A further issue with this ruling is its vagueness. The court states that DNA gathering is permissible in cases of “serious” crimes. What does this mean exactly? What must someone be accused of to lose their right to control the use of their DNA? Drunk driving, shoplifting, protesting? Or is it truly for violent criminals? Murderers, rapists, etc.?

Taking the sample upon arrest however, flies in the face of our nation’s presumption of innocence. Keep in mind that not all of those arrested are criminals. Who knows, perhaps one day you will be in the “wrong place at the wrong time” and your genetic information will be on permanent file without your consent.

Making decisions based on what we know about DNA today is never a good idea, genetics and manipulation of genes is an ever changing field and we need to be making decisions into the future. I certainly want to give the police every advantage when catching dangerous criminals, but not at the risk of my or other innocent American’s personal privacy or freedom.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on June 6, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Death, Taxes and Medical Records

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

The Internal Revenue Service (IRS) is being charged with the illegal search and seizure of 60 million medical records from about 10 million Americans. It is suspected that these records contain personal medical information on people from all walks of life.

The claim charges 15 IRS officials with unlawful seizure of the medical records during an investigation at a California company. The IRS was investigating a former employee for a financial issue. The company is requesting $25,000 in damages be paid for each unauthorized record, but this case would also serve as a precedent case and provide future guidance for similar situations.

The unauthorized seizure of medical records is a major concern for several reasons:

  1. Our medical records contain confidential and sensitive information about us. The records contain psychological history, sexual history, drug and alcohol history, etc. Anything you tell your doctor ends up in your chart and I think it is safe to say that most, if not all of us, have at some point told our doctor something we would not like to end up on the network news, or in the hands of a government agent.
  2. The IRS has been given a vital role in the management of President Obama’s heath care reform. In this position they will likely be frequently placed in situations like the one mentioned above. Because of their position, we will need to trust the IRS officials to maintain the confidentiality of our health information. This means they will need to only view the records absolutely necessary, and extract only the information they directly need for their investigation. Many security measures are built into EMR (Electronic Medical Records) systems to keep your medical information safe. To access medical records at the hospital where I word, I have to enter two different password screens and every record I view is recorded. Also, my name is listed right on the screen in the patient’s electronic file. This means that I can see the names of the last several people who have viewed the chart for each patient and they will be able to see mine. This provides extra incentive to only view the records that you have a workplace need to view and allows other employees to see if you have been poking around records you have no reason to be viewing.
  3. When taken from the hospital system information in the medical record is no longer as tightly protected. When moved to another computer there is always the risk that the information will be misused and the confidentiality compromised.

So, ask yourself: Would you trust each individual employee of the IRS with every aspect of your life and the most intimate details of your personal health history? No? Then, we need to be extra vigilant as healthcare reform rolls out over the next few years. I do recognize that I have a hearty dose of skepticism of the government, but like the old adage says, “plan for the worst and hope for the best.” I think we need to do a bit more of the planning when it comes to the new IRS responsibilities under the Health Care Reform Act.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on June 2, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]