How private enhancement decisions led to a public health crisis

 

The proponents of using medical techniques not just for treating disease and dysfunction, but also for enhancing normal form or function, often appeal to privacy. Since most public and private insurance schemes do not pay for enhancement technologies, people who desire such “treatments” pay out of their own pockets; so, the argument goes, if they’re not hurting anybody, and they’re paying for it themselves, what’s the problem?

One of the more popular enhancement technologies worldwide is the cosmetic surgical procedure of breast augmentation. In the last few weeks a crisis of sorts has erupted around a particular brand of silicone breast implant, manufactured by the now-defunct French company Poly Implant Prothese (PIP) and exported all over Europe and South America. It turns out that the silicone used in PIP’s implants was not medical-grade, but industrial-grade, made to be used in mattresses; this may make the implants more prone to rupture. Rupture can lead to increases in inflammation and scar tissue formation.

About 300,000 of PIP breast implants are thought to have been used worldwide. This week, France and Venezuela took the step of offering to pay for the removal (but not the replacement) of all PIP implants. “We have to remove all these implants,” said Dr Laurent Lantieri, a French plastic surgeon “We’re facing a health crisis …” France will pay for ultrasounds every six months for those women who opt not to have the surgery.

Two things to note: first, removal of an implant is not like taking out a splinter. It is a major surgery, under general anesthesia, with all of the attendant risks — and expenses — of surgery. Second, other than those women who had implants inserted after breast cancer surgery, all of the women involved paid for their augmentation themselves. But now the state — that is, the citizens of France and Venezuela — will be paying for the corrective surgeries.

All techniques and technologies carry unintended and unforeseeable consequences. Even with the best planning and forecasting, all techniques will surprise us in some way. Medical techniques, because they work directly on the human body, have the potential and power to do very great unintended harm. The silicone breast implant crisis is an example of how choices made in private can have significant unforeseen consequences and costs for the public. The argument that using medicine for enhancement is merely an individual and private decision is simply not valid. How many more individuals will be hurt, and how much more will society pay, as enhancement techniques — and their unforeseen consequences — proliferate?

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

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.)

Reflections from the Front: For Whose Good?

Reflections From the Front: For Whose Good?

On October 26, the New York Times published a news story, http://www.nytimes.com/2011/10/26/health/policy/26vaccine.html?scp=2&sq=hpv%20vaccine&st=cseabout a recent recommendation from the Centers for Disease Control and Prevention that boys and young men should be vaccinated against human papillomavirus, HPV, to protect them from anal and throat cancers resulting from sexual activity. It is much less expensive to vaccinate only the boys who will engage in homosexual sex, but since this is hard to predict, the argument goes, we need to vaccinate them all.

Interestingly, the CDC came out with a similar recommendation for girls in  2006, but fewer than half of the girls between 13 to 17 have received even one dose, and less than a third have received all three required for efficacy.

The cost of administering the vaccine per year would be around $140 million, but the initial costs of catching up on the unvaccinated boys might approach $1 billion. The vaccine would combat several but not all strains of HPV; to provide greatest protection, it would ideally be given prior to any sexual activity. Since by age 15 one of five teens are no longer virgins, the aim would be to vaccinate prior to any sexual activity.

An October 29th editorial, http://www.nytimes.com/2011/10/29/opinion/the-hpv-vaccine-is-for-their-own-good.html?scp=1&sq=hpv%20vaccine&st=cse, tells us that it is “For Their Own Good”, and strongly encourages that all 11 to 12 year-olds receive the vaccine.

The editorialist cannot help himself. He takes a gratuitous swipe at conservative politicians (identified as Republicans in the first article), and conservatives in general for their reluctance to endorse the vaccine recommendations wholeheartedly. It is always easier to employ ad hominem arguments than it is to seriously address counterarguments to one’s own position. He fails to address:

1)       If this is such a great idea, why is the vaccination rate so low among girls, 5 years after the CDC’s endorsement? Are two-thirds of all Americans conservative, religious Luddites?

2)       Are there alternative ways to decrease the spread of HPV? What are their risks and benefits?

3)       There is no mention of abstention education, which has been proven to reduce sexual activity prior to marriage. http://www.cmda.org/wcm/CMDA/PublicPolicy2/Press_Room1/NewsReleases/2010_News_Releases/Landmark_abstinence_study_.aspx

4)       Contrary to the types of statistics generated by Alfred Kinsey, thoroughly debunked but still occasionally quoted as an authority, a true estimate of homosexual behavior in American males is probably between 1-5%. Is it really reasonable to vaccinate 95-99% of American boys for a disease that is very rare in their population?

Simplistic prescriptions for complex ailments are seldom satisfactory.

TIUBlogNumber4Vaccines.doc

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

Black Americans and Healthcare

The USA Today recently reported on the difficulties faced by African-Americans seeking healthcare in Alabama.  Death rates are higher for most categories of illness in black communities.  Oftentimes, physicians are unfamiliar with the obstacles encountered by residents in a particular neighborhood, such as the lack of fresh, healthy food in the grocery stores.  USA Today touts a new federal Health and Human Services program as a first step in identifying health disparities.  Churches provide support groups that assist in educating people about their health.  However, there is little time or money being spent by the Christian community to build clinics in communities such as this one in Alabama.  An overall infrastructure for providing charitable ministries is missing.

In Texas, it is common for people to say that if a person wants to have good healthcare they need to pull themselves up by their bootstraps.  An African-American friend of mine at Trinity once told me in response, “The problem is, some people don’t have any straps.”

Is a CT Scan an Ethical Issue?

All third-year students at Texas A&M are required to attend Saturday-morning radiology lectures, and I was surprised to hear my professor speak for the final 30 minutes yesterday on when not to order imaging.   Radiology is his life’s calling, but he recognizes that imaging studies like the CT scan can be harmful.  Of the $2.3 trillion spent on healthcare in the U.S., the largest share is spent on imaging, totaling $800 million.  CT scans have become a part of the American vernacular, but it is estimated that 1/3 of them are unnecessary.  What ethical issues concern the use of imaging in healthcare?

  • Patient Safety: Concerning chest scans, an X-Ray exposes the patient to 0.1-0.2 mSv of radiation, but the CT dose is 8.0 mSv.  At 50 mSv a person is at increased risk of cancer, so minimizing the number of exposures to a CT scan should be an important goal in healthcare.
  • Cost: Some of the ballooning in healthcare costs over the last decade is due to tests ordered by physicians.  Many doctors order tests not because they are indicated by the patient’s symptoms but because they serve as an extra layer of protection in the case of a lawsuit.  The irony of such defensive medicine is that one day a doctor may find himself in court for exposing the patient to too much radiation.  Patients never see the thousands of dollars of imaging charges, so they often authorize such studies and let the insurance companies handle the rest.
  • Physicians Lining Their Pockets: Research has shown that physicians increase the number of scans ordered when they are able to bill for the use of their own equipment.  One gastroenterologist related to me how his clinic moves a number of unnecessary endoscopies through his office for various reasons.  An endoscopy does entail some risk and is certainly not comfortable, but every CT scan is sure to expose the patient to radiation.  Physicians should refrain from allowing revenue strategies to trump good medical practice.

For more information on radiology, visit www.radiologyinfo.org.

Cancer, Hold the Chemo

Admittedly there are some things that I would never conceive could possibly “run out” or “dry up,” even in the worst economic times. As a non-doctor, drugs are one of those things.

But imagine, if you will for a moment, having to call your friends to see if they could get you the much needed drug that your hospital could not supply. If you do not get the drug, you will not be able to keep your disease under control…

This is exactly what happened to Thomas Kornberg, a professor with Hodgkin’s Lymphoma who was forced to contact doctor-friends to supply his need.

The American Hospital Association just issued a press release showing the results of their recent survey that exposed this apparent drug shortage:

  • Hospitals report that they have delayed treatment (82%) and more than half were not always able to provide the patient with the recommended treatment
  • Patients got a less effective drug (69%)
  • Hospitals experienced drug shortages across all treatment categories
  • Most hospitals rarely or never receive advance notification of drug shortages (77%) or are informed about the cause of the shortage (67%)
  • The vast majority of all hospitals reported increased drug costs as a result of drug shortages
    • Most hospitals are purchasing more expensive alternative drugs from other sources

The AHA has proposed some solutions: They want to establish early warning systems of shortages, remove regulatory obstacles, improve communication among stakeholders, and explore incentives to encourage drug manufacturers to stay in, re-enter or initially enter the market.

Clearly Kornberg is not the only case,

So what happened to the other people who don’t have the connections/resources that he does?

How are hospitals to deliberate on the dispersion of scarce resources?

Even more concerning, if this becomes a trend, will there be an even larger motive for inconspicuous sales?