- brief discussion of epigenetics

- brief discussion of newborn blood screening

In my first post, I'd like to introduce a point that I've discovered during my internship experience, something that I've learned from my supervisor there. As I am still in the process of earning my Masters degree, there is much left for me to learn about health care. I have no conclusive opinion yet to offer on this topic, so that's why I say I am only bringing this to your attention. Actually, some students who already went through an internship praticum might agree with me already.

With that said...

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The practice of public health often does not mirror the public health theory we are exposed to in academic settings.

Especially at well-endowed universities, we the students are trained in our courses to strive for optimal care for our patients. We aren't aware of it when we are being schooled, but we are shielded from the real world by the luxuries in our home institutions. It is my opinion that the rift between academic health research and health delivered in practice is here, in the discrepancy between the "Ideal" and the "Next Best Option."

Studies must always be planned out thoroughly. Before we even propose the study, we must read all of the literature already present on the topic and make sure, through and through, that this will be a promising study. We must get a massive sample, and leave little room for error. A difficult situation, an unexpected problem that is out of your area of expertise--no problem, contact a specialist, hire a biostatician, call your lifeline.

It's a common exercise in my public health classes to create hypothetical research studies or intervention programs. Although we are presented with challenges, many times we brush them off by using the excuse "this is just a hypothetical study." In this hypothetical setting, we have lots of money and time and all the resources we need, so why should we bother thinking further?

Now, graduate and you've got the degree. Come the real world, and this is what you might really see....

Shortages in supplies (such as ink for the fax machine) that seem most trivial at first, but end up halting the entire process. Workers retiring/getting laid off, nurses taking week-long vacations at all the wrong timings. Deadlines for grant applications that leave no time for you to consult the previous literature. Software that won't stop crashing on you. And will you ever, ever have enough money?

When I worked at my summer internship at a correctional facility, I realized that we were constrained like this (I won't go into excruciating detail). Jail inmates are a unique population in every sense. The most important limitation on our screening and treatment programs was that many inmates didn't stay in our facility long enough for us to give them treatment. Infected patients were released back into society, free to spread whatever they might have been carrying. All it took was maybe a little delay in getting laboratory test results back because of lazy workers forgetting to fax us the paperwork. Just like that, we'd lose the opportunity to treat several sick patients. Not to mention, if we conducted research evaluations, the sample size was never ideal, there were human mistakes and data were often incomplete (we lost entire sets of answers to certain questions because someone copied the survey questionnaires and didn't notice the bottom was cut off!).

Ideally, we'd screen everyone for every reportable disease and treat all the positives properly. But taxpayers' money just didn't give us enough resource to do so. And that is only one of a million other limits we faced. I imagine this tight situation does not apply only to the place I worked in. The economy, the special population, the political situation...whatever the reason, health care workers everywhere on the planet must be facing such difficult decisions as to "What is the Next Best Option available to us for our patients and the public?"

We need to learn to be opportunistic, flexible, and resourceful. The main point of my account here is that we must be ready. Not only for crises, but for little holes in our planning that can cause the whole boat to sink.

And so, from this point forward, I intend to learn how to really think when I practice public health.

This summer, I worked for the company everyone hates. Doctors, nurses, patients, pharmacists- everyone hates dealing with us and with the paperwork we create. I worked for a pharmacy benefits management company.

Those of you not in the pharmacy world might ask: What is a pharmacy benefits management company? The standard answer, which I always found extremely circular and frustrating, is that we manage pharmacy benefits for various insurance companies. In practice, it means that we are contracted by an insurance company to handle the everyday affairs of prescription claims. The patient takes a prescription to the pharmacy, they electronically bill the insurance company, and the insurance company's computer software automatically (according to a standard protocol) accepts or rejects the claim. When the pharmacy gets a rejection, either they or the doctor's office can call us, the PBM, to fight it. When the doctor's office sends in a prior authorization, we get it and we either make the decision, call the doctor's office for more information, or call and tell them it's been rejected.

We didn't have the final say in most cases, but we knew the general rules. No Nexium unless you've tried (and failed) Prilosec OTC. No Allegra unless you've failed Claritin. The list goes on. And so the doctors hated us because we were denying their patients meds that they felt were superior, and because we made them go search the patient's chart to find out whether they'd ever been on Claritin. And the pharmacies hated us because they had to tell the patients that their drug wasn't covered.

But with healthcare costs (especially prescription drug costs) spiralling higher and higher, insurance premiums rising, and the possibility of universal healthcare that would cost taxpayers however-many trillion dollars, there is clearly a role in healthcare for cost containment.

Let's take proton pump inhibitors (PPIs). We got a lot of prior authorizations for PPIs. Most of the insurance companies we worked for would approve Prilosec (omeprazole) with no problems. If you wanted to use a different PPI, you would have to show that the patient had used Prilosec and still had symptoms. To me, this was a reasonable rule. The efficacy rate of omeprazole is very similar to that of the other PPIs (such as rabeprazole, lansoprazole, pantoprazole, or esomeprazole). In fact, esomeprazole is just an isomer of omeprazole. They are essentially the same drug, except that esomeprazole is brand-name only (Nexium) and costs probably ten times as much. Doctors know this, or they should if they routinely prescribe PPIs. Yet we still got tons of requests for Nexium, or Protonix, or Aciphex for brand-new patients. Maybe a drug rep had given some samples to a doctor. Maybe the patient wasn't satisfied with something that was "just" an OTC drug and wanted something "better." There could be any number of reasons. I would call the doctor's office and ask if the patient had ever tried Prilosec. The nurse would say no, and I would say okay, they have to try Prilosec before we'll pay for anything else. And they would say okay, and a few hours later I would be able to check and see that the patient had filled a prescription for Prilosec.

So in that case, it makes sense to have someone regulating the transaction whose primary interest is economic. The insurance company saves money (sometimes over $100/month), the patient pays a lower copay, and insurance premiums nationwide go down (or at least don't go up).

Another benefit to PBMs is in catching medication errors (which, again, saves money). The best example of this is in Advair inhalers. There are two types of Advair inhalers- a traditional aerosol inhaler and a diskus. Unfortunately, the directions are different. The inhaler is taken as two puffs twice daily, and the diskus is taken as one inhalation twice daily. So when we saw a prescription for Advair diskus, two puffs twice daily, we knew that some doctor had confused the directions. We would call to get it fixed because the insurance company wouldn't want to pay for two inhalers in one month- but in the process, we saved a patient from overdosing on salmeterol and getting tachycardia or even a heart attack.

Of course, this isn't all-inclusive and won't catch everything, but it's always good for the system to have more checks.

The major problem with an insurance company or a PBM is the inherent conflict of interest. It was in our best interests to choose the lower-priced Prilosec over the equally-effective and higher-priced Protonix...but it was also in our best interests to choose a less effective but lower-priced drug over one that was more effective but higher-priced. And if there was ever a judgement call on a case, it almost always resulted in us rejecting the claim. Transdermal patches, for example, are really expensive in general, and we were very reluctant to cover them if there was an oral version available. A request for transdermal patches might be rejected solely because the patient had other oral meds in their profile and clearly was physically able to take drugs orally. Even a liquid version of a drug for a child might be questionable if the child was older than 6 or 7. There were times when I dreaded calling the doctor's office back, because I disagreed with the judgment that had been made and I knew that the doctor's office would too.

How can we get rid of this conflict of interest while still being cost-conscious? There is, obviously, no easy answer. Perhaps one of the best systems is what's used in hospitals, where a P&T committee, made up of the doctors who will be prescribing these drugs to their patients, is able to create the formulary for the entire hospital. This isn't very practical in the real world, unless we want to create groups of doctors who would also have a financial interest in an insurance company. (Which, of course, would create other conflicts of interest.) So I really don't know what the answer is. Educating patients and doctors helps, of course, and so does choosing conscientious pharmacists to work at PBMs. But that won't solve the problem entirely.

It's just one of the problems that will hopefully be addressed when our country's healthcare system is overhauled, over the next few years.

So I'm going to initiate this by writing the first post. A couple months ago I came across an intriguing article* that discusses the intersection between pediatrics, public health, and human rights. It mentions some great and valid points, but I'm not too sure I agree with them on every point.

The article essentially asks what are the criteria to allow prophylactic interventions to be done on children, "in their best interest" and/or for public health reasons. Children can be considered a "special population" in that they have little/no voice for themselves and are thus very vulnerable. Parents provide proxy consent until they reach the age of majority (teen years) but does that mean parents and health care workers should have near-complete power over their health decisions until then? Four cases are examined and they can be broken down broadly into routine immunization and prophylactic and/or cosmetic surgery. I will not discuss the criteria but I would like to point out the essential difference between routine immunization and prophylactic/cosmetic surgery in infants and young children.

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Routine immunization protects individuals from contracting highly communicable diseases. In addition, routine immunization helps to protect the public from these highly communicable diseases by limiting their spread through "herd immunity." In ideal cases the pathogen may be eradicated through routine immunization, as in the example of smallpox.

Broadly speaking, routine immunization is most often done in infants and young children, as they are most at risk for these communicable diseases and they are also most likely to suffer severe complications from these diseases. Routine immunization is minimally invasive and the key point is: the child is given something - immunity - and nothing is taken away. Overall there is a net gain with routine immunization in general. However, the rare but serious side effects that can occur as a result of immunization cannot be discounted. The more complex question is, what about immunizations for diseases that either have a low morbidity/mortality or are not so highly communicable? Examples such as chickenpox, Hepatitis B, and HPV vaccinations come to mind.

With chickenpox, the disease is rarely serious in children and mostly just an annoyance. But in adults who did not get chickenpox (or only got a very mild case of it) as children, they are at risk for developing shingles from the pathogen that causes chickenpox in children; shingles can easily be very serious and life-threatening. With chickenpox there is this gray zone. It can be argued that the chickenpox vaccine is unnecessary in children, but if a child reaches adulthood and never caught chickenpox, then he/she should be vaccinated as an adult. And by this time the person can give his/her consent.

Hepatitis B (HBV) is often transmitted via blood or sexual contact. As such most people are generally at very low risk of contacting HBV provided they practice safe sex as an adult (something everyone should do anyway) and children are at almost zero risk for contracting HBV. Certain populations - such as intravenous drug users and prostitutes - are at high risk for contracting HBV. There is also a particular risk to health care workers due to possibility of needle sticks with HBV-infected blood. The question is then, why give children routine immunization against HBV when it's possible to wait until their teen years when they can give consent themselves?

HPV, the virus that causes genital warts, cervical cancer in women, implicated in penile cancer in men (though this cancer is exceedingly rare anyhow), and implicated in anal cancer in both genders, is transmitted through sexual contact only. Currently a 3-dose vaccination is given to girls between 11- and 13-years-old, generally before (hopefully) these girls become sexually active. This vaccination is curious because it borders on the age when these girls can give their own consent independent of the parental proxy consent. This presents its own unique ethical issues.

Gray areas aside, there is general agreement that routine immunization overall is a good idea. There may be a few vaccines here and there that potentially present ethical dilemmas, but for the rest there is really not much to argue. A more critical appraisal of routine immunization may be examined in a later post.

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In contrast to routine immunization, prophylactic/cosmetic surgery in children, particularly infants, are far more controversial. The idea of prophylactic surgery is to remove tissue in the hopes of preventing or at least reducing the risk of a particular disease(s). With cosmetic surgery (separate from reconstructive surgery due to a malformation like cleft palate), it is done to help a child "fit in" or for some other reason given by the parent(s). The article presents strong arguments against any prophylactic or cosmetic surgeries in infants or young children.

An example of a highly controversial prophylactic surgery is neonatal mastectomy (removal of the breast tissue) for girls with a strong family history of breast cancer and may have tested positive for a BRCA1/2 gene mutation (though such genetic testing in children presents ethical issues of its own). Note: neonatal mastectomy is not standard or common practice, and I have no knowledge of it actually being performed anywhere in medicine. About 1 in 8 (12.6%) US women get breast cancer each year. For women who test positive for a BRCA1/2 gene mutation, their personal risk jumps to approximately between 50% and 80% chance of developing breast cancer. Prophylactic mastectomy greatly reduces the possibility of developing breast cancer (as you can't get cancer of something you no longer have). If these women were identified to carry a BRCA1/2 cancer-causing gene mutation as infants, would it be ethical to prophylactically remove their breast tissue as infants?

In general the resounding answer is: NO. Any surgery - however major or minor - has attendant risks and complications (direct or indirect). Furthermore, any surgery has the possibility of maiming or mutilating the individual. While (prophylactic) surgery may prevent or reduce one's risk of a given disease(s), there are almost always more conservative routes of prevention. If it is not immediately medically necessary, there should be no reason to remove/alter any part of the body - especially in individuals who cannot give their expressed consent. It can be argued that parental proxy consent is "not strong enough" to override the rights of the child to his/her bodily integrity, even if the parents believe the surgery to be done "in the best interest" of the child.

Cosmetic surgery is (should be) less acceptable by any medical or public health criteria. There is often (if not always) no health benefit to the individual. An example the article gives is cosmetic ear surgery to correct "bat ears" in children. One cannot say that the surgery will go well (even if it has a very high success rate and/or low complication rate), one cannot defininitively determine the future development of the child, and one cannot predict the emotional state of the child. While surgical correction of "bat ears" sounds ludicrous to many individuals, it is of genuine concern to some parents to make sure their child has "normal" ears to fit in.

In contrast to routine immunization, prophylactic/cosmetic surgery should not even be considered in infants and young children except in cases of immediate medical necessity. Unlike a vaccination, something must be removed in hopes of providing a net benefit that may never be realized - there is initially a net loss before a net gain (if any) can be attained; and unlike a vaccination, all surgeries are invasive. Furthermore, there are almost always more conservative routes of prevention until the individual reaches the age of majority and can give his/her own consent. As the US Centers for Disease Control (CDC) and the American Academy of Pediatrics (AAP) revise some of their guidelines at the end of this year, it would be wise for them to remember that prophylactic/cosmetic surgery in children is never a good idea and should not be endorsed.

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* Article:

Hodges, F.M.; Svoboda, J.S.; Van Howe, R.S. (2002) Prophylactic interventions on children: balancing human rights with public health. Journal of Medical Ethics. 28, 10-16.