Patients and Profits

One of the things I found difficult about being in full time private practice was the pressure to make money. Without getting too deep in the weeds, I'll say that the mechanics of paying the bills and funding a reasonable livelihood in medical practice isn't as obvious as many people think. Physicians mostly do ok, even if they practice at the fringes, and if they practice anything like mainstream medicine, and keep overhead manageable, they'll make a tidy living.

The rest of us? Well, making a good living is harder to do than it would seem. Chiropractors do ok, as do physical therapists. Nurse practitioners can do pretty well outside of being in a physician-led practice, but mostly they struggle. It's still very much a physician-centric economic model out there.

One thing I've observed is that there are very few "sweet spots" in which someone can practice without leaning toward going broke on the one hand, and having to push their practice hard toward opportunities for revenue generation on the other. In the latter case I've seen this emerge as everything from taking on questionable drug studies (for which practices get paid, usually per enrolled research subject), to pushing retail herbs and food supplements sold by the practice, to developing complicated treatment plans that require more patient office visits than are really necessary.

I found myself in that position many years ago. I didn't like it, and ended up allowing the practice to close in near-bankruptcy rather than come up with novel ways to milk patients for more money. Today, I practice part-time, and I have a full time university job, and those two engagements complement each other nicely. I make enough money to pay the bills, make improvements, and put a few bucks into my own pocket, but I don't have to constantly try to keep up: stuffing more patients into a tighter schedule, getting them to buy stuff through the practice, and all that other stuff that I'm sure many practitioners hate.

Corporate practice--and that's most health care these days--allows practitioners of all sorts a similar refuge from worry about the bottom line...but somebody is worrying about it, usually an executive physician, or businessperson, or administrator. Everything costs so much, and it needn't.

Recently, Mylan Pharmaceuticals has taken a PR hit associated with its price increase on epinephrine injectors, the EpiPen. Epinephrine, or adrenaline, is a natural substance that can be used in large doses to stop an allergic reaction in its tracks--and I mean fatal allergic reactions, like some people get from bee stings. Mylan says it needs to do this, but in fact there is no effective competition for this product, and for many people, it is absolutely necessary. Epinephrine is cheap, but the injector, which is automatic, has apparently become quite dear!

I saw an article in the Harrisburg Patriot-News by David Wenner last Sunday. In a sidebar he details some of the more rapacious price increases: Novocort up 3,000%, tetracycline and amitriptyline both up almost 1,000%, and Zestril up 800%, all over the last 5 years. Daraprim was a famous case, up 5,500%. An old drug for malaria (and sometimes AIDS), the license was bought by Turing Pharmaceuticals under CEO Martin Shkreli, who viewed it as an "investment." In fact every single one of the drugs in this paragraph is old, and was cheap, an example of how the free market should work, as better or newer drugs come along (and they aren't always the same thing!)

The companies say it's to pay for "research and development," but having been in this industry (I was involved in a large number of trials for AIDS drugs in the late 1990s and early 2000s) I can tell you it is not the case. This is an area well-researched, and in fact most of the excess profit goes to shareholders, where there's a lot of pressure to turn high short-term profits, and to marketing newer drugs to doctors. There is some research, but essentially, drug companies are turning people's dependence on these drugs into cash cows. And it is not for your benefit. (Although your 401k may see a few pennies of it.)

Some industry analysts have reported that this is really about trying to get more money out of insurance companies, as though it somehow doesn't touch the average consumer. That's a false comfort. Insurance money comes from somewhere--you.

We want medical miracles. I get that. But the fact is, most of this should cost us less than it does. In 2009 National Public Radio reported that in Japan, an MRI costs about $160 US. There are reasons for this, not just that the Japanese are somehow less greedy. Nevertheless, that's a difference of something like 1000% more expensive. Americans pay more for prescription drugs (even generics) than anyone else in the world (Wall Street Journal, 2015). Of course, they argue that the US effectively subsidizes research and development in other parts of the world. We simply spend more because there is money, and the opportunity for profit...and perhaps innovation.

Although as I tell my students, most "new" drugs are really what we call "me too" drugs: essentially drugs that do the same thing as many other drugs (Forbes, 2015).

It is more profitable to effectively market a new-but-only-slightly-new drug than it is to develop a truly remarkable breakthrough drug. A drug rep costs less than research, that's just a fact. In fact many drugs are completely interchangeable.

This just isn't right. I learned that making a killing on the backs of your patients is a hard, soulless road. I didn't go far down it. I could see what lay ahead. Earlier I discussed vaccination as a conflict between different American values, there, individualism versus communitarianism. A similar conflict poses itself to us with our health care, in that case, perhaps profit versus justice. Or, maybe innovation versus stagnation, although I doubt research would completely stop. I'd hope it would become more parsimonious, less a dog-eat-dog, sweaty race for the next grant, license, or patent.

I get it. Money's great. But it doesn't seem quite right, the way things are rigged now.

The Vaccine Debate

Ok, so now everyone's gathered together for the 2016 Summer Olympics in "Zika Central"--Brazil--where it's reported that some some 9000 people have been infected and about 900 of those have been pregnant women, according to the World Health Organization. Public health authorities report that the epidemic may have peaked, and researchers continue to look for a vaccine, even while municipal authorities apply their efforts at improved mosquito control, contraception use, and standing water mitigation.

So even though it's been a bit of a lazy summer while I've been on vacation, let's return to this matter of "The Vaccine Debate".

I'll summarize the debate as I see it. Public health experts, doctors, and nurses say that the full, recommended vaccination schedule is a must for both children and adults. They say that this or that disease was a "scourge" that "killed thousands" (or millions), and that anything other than full compliance is tantamount to child neglect, and also puts millions in our society at risk for the disease. People with concerns about vaccines aren't taken at all seriously: they are "anti-scientific", worry-worts, or just daft. Those who want to pick and choose vaccinations based on their risk estimates are dismissed, and usually coerced into compliance. The educational approach to patients, or parents with children, is to deliver the scientifically-blessed, officially-approved statistics on known side effects. These days, I've had some parents being asked to take their kids to another pediatrician if they aren't going to comply with full vaccination.

The other side? They argue that vaccines aren't "natural" (whatever that means), that immunization is a scheme developed by pharmaceutical companies to make money, and that vaccines cause a host of ills from autism to allergies--even though research tends to argue against that relationship. They magnify the risks of catastrophic-but-rare side effects in the published literature (including drug manufacturers' own package inserts), and ascribe time associations between a vaccination event and the subsequent diagnosis of things like autistic spectrum disorder, night terrors, and meningitis that may be mere coincidence. They also say that vaccines don't work, that the diseases vaccines protect against don't exist anymore or were never serious problems. The opinions of  celebrity "experts" hold more water than the facts of scientists for many of these folks.

Ok, stark enough difference?

If anyone reads this blog, it may be someone who isn't in either of those categories, and who wants to come back at me with how they are different, and how their opinion is more complicated than what I have presented.

I'd have to agree. After all, I talk to these folks in my practice, and have talked to people about this for 30 years, in the emergency room, in the hospital, in nursing homes, in general medical practice, and in my own holistic practice. Individuals aren't the issue. The general public discourse is. The "debate" that the media cover is between Vaccination Is A Universal Good and Vaccination Is A Universal Evil.

What rubbish. No discussion of an issue this complex is ever described by such a false choice.

I can kind of understand it from the perspective of the laypeople, celebrities, and holistic spokespeople who argue that it's a Universal Evil. After all, they're laypeople. They aren't trained scientists and clinicians. Although some are better-trained, and ought to know better.

But from the pro-vaccines folks? They should know better. They should have the sense to understand the complexities of this issue enough that their impulse to magnify risk, to frighten, and coerce should be resisted. 

As I noted previously, immunization works...mostly, and it works better to prevent some diseases than others, and there are biological reasons for that as well. Sometimes the results of a vaccination event are catastrophic, and parents will worry about that. What doesn't get said is that many of these diseases we immunize against aren't themselves that catastrophic. Examples include measles, mumps, and chicken pox. Moreover, some of these diseases may be mitigated by alternative efforts. For example, HPV (human papilloma virus) vaccine really does significantly reduce the likelihood of a woman developing cervical cancer later in life, but so does regular gynecological examination with a Pap smear.

In one lecture I give my students, I provide a detailed analysis of measles deaths that occurred prior to the development of measles vaccine in the early 1960s. The death rate was quite low, about 2 children in 500,000. Moreover, such deaths tended to be clustered among the very poor. This makes sense in light of Thomas McKeown's research in 1976 that most of the epidemics that were such "scourges" prior to modern immunization were actually on the decline because of improved nutrition and a rising standard of living. Although the British physician and medical historian tended to dismiss sanitation as another cause, other research strongly suggests that public infrastructure improvement to water distribution and sewage treatment also contributed to that decline.

By magnifying the real hazard, I tell my students, any parent with an internet connection can disprove that hazard, place it into a real context, and end up deciding that the doctor or nurse is a liar. That is a recipe for bad rapport and distrust, and when you have a bad rapport, and your patient thinks you're overstating the hazard, good luck with winning that parent or patient over with your otherwise scientifically-sound argument!

My concern is not with patients and parents who understandably hold onto worries about immunization, although many of their arguments are fraught with half-truths, myths, and urban legends. Indeed, it's hard to dismiss personal experience:

    "My friend took her child to get the MMR, and two months later he was diagnosed with autism!"

It's easy to see how this tale, retold a thousand times (among 100s of millions of vaccination events) can gain traction among ordinary folks with limited understanding of science. (It's a little less tolerable when told by people with such training who should know better.)

My concern is with health professionals who seem to evince some social authority from the seemingly hermetic "facts" presented by public health experts.

   "You must listen to me...for I am the authority, and you are a layperson (and an idiot)."

You health care workers out there who think you aren't represented by the above caption? Think again. I've seen it hundreds of times. It's a guaranteed rapport-killer.

So then why is this polarity in public discussion of the issue still the case? I think it has several causes. First, the constantly-evolving nature of biology and biological science unnerves us. Especially among clinicians, having something--anything--certain to bank on is a working day comfort. I've been doing this a long time: there's tons of uncertainty, tons of weird stuff with no easy answer. It's nice to be able to say "About this we are certain!"

Second, both corporatized and socialized health systems depend on thruput, that is, high production numbers. This means two things: 1) You can mitigate the potential disease risk of lots of people with a one-size-fits-all management plan. Mass immunization is such a plan. 2) Even if some people are greatly harmed, it will be few, and many more will be saved (so the argument goes). Individualized risk analysis and planning is time consuming and perhaps costly. It risks the loss of "herd" immunity if many people opt out. It is an essentially utilitarian analysis. In the words of Mr. Spock, "The needs of the many outweigh the needs of the few."

Third, there really is a corporate-capitalist motivation for mass immunization. It is true that some of the diseases we immunize against are really bad things. Rabies and tetanus and polio are good examples. Other diseases such as mumps, measles, and whooping cough can be deadly but usually aren't, and there's ample evidence that these are things that will pass. However, I can certainly understand the impulse to try to prevent them in our lovely children; who wants to see a child suffer? Nevertheless, there's a lot of financial gain to be had in finding less threatening diseases, like chicken pox, to immunize against. If we spent as much money making sure that all young children have enough healthy food to eat, rather than developing vaccines that may not really change the real health of our population (rotovirus vaccines are one example of this), evidence suggests the health gain overall would be immense.

But then there's no corporate profit in making sure poor kids eat well.

Families: Immunization does work, mostly, and most people don't have catastrophic outcomes. But don't depend on it alone, because many times it doesn't work (the flu). On the other hand, in some cases it can actually be life-saving (tetanus, rabies). Find yourself a clinician who can have a measured conversation about this choice. I have observed immunization to sometimes cause interference against an acting homeopathic remedy, but most of the time this can be repaired. Timing can matter. Immunizations can often be delayed or rescheduled without real harm. If you're looking for a list of recommended versus not-recommended vaccines, you won't find it here. Risk analysis is personal and individual.

Clinicians: Immunization isn't the panacea you've been taught. It kinda, mostly works, sort of. Scoring a win during a patient visit may feel good, but it's a small part of patient care. I know you get incentivized by the various insurers for vaccinating. But do know that you are settling for an aggregated health measure, rather than the health of the individuals in your practice. Be kind. People want answers and can live with uncertainty if it's discussed in context. Be happier than you have been with a negotiated settlement, like an alternative vaccination schedule. Be honest about social benefits (herd immunity) versus individual benefits (disease risk). You might be surprised by how many people share your view about the values of social good that may arise from individual choices. And if it's financial harm to the practice that frames your decision-making, consider the implications of that honestly.

And all you people on news programs, and blogs, and internet boards, and on TV? Go ahead an argue just as one-sidedly and vociferously as you have been--it's good for business! But know that you are just going around in circles with your opponents, locked in a pointless struggle that will yield no victor and just keep alienating the "other side." Don't imagine you are making the world a better place. You are just making the world a louder place, and mostly, you're missing the real opportunities to create change that would matter far more than whether or not some infant gets vaccinated against a sexually-transmitted disease like hepatatis B in the delivery room.

After all, it didn't work for me.

Reference
McKeown, T. (1976). The Role of Modern Medicine: Dream, Mirage or Nemesis? London: Nuffield Provincial Hospital Trust. ISBN 0-900574-24-0.

A Vaccine Side Note This Week: Intranasal Flu Vaccine ("FluMist") Ineffective

One of the concerns I've had about vaccines is that we humans have evolved to mount an immune response to bacterial and viral invaders as they come to us. For example, tetanus is "injected" by deep injuries into soft tissue. Polio is ingested in the mouth and invades via the gastrointestinal tract. The flu is either inhaled into the nose, or gets sort of rubbed in there when our hands touch a contaminated person or surface, then we touch our own faces. (This is why hand-washing is such a big preventive of infections!)

So, I've always thought that it would make the most sense to deliver vaccines to people the way the germs are "delivered" to us in nature. Thus, FluMist, sprayed into the nose should be safer and more effective than injecting it into the arm with a needle; and polio vaccine dropped onto a sugar cube and eaten (anyone remember that? I do.) should be safer and more effective than another shot. Right?

However, in both instances this hasn't been the case.

Oral polio vaccine is no longer used in the country because it led to a detectable increase in cases of "post-polio syndrome": a condition in which polio-like paralysis occurs late in life. This has been seen in both types of polio vaccination, but the oral form seemed actually worse and more frequent. Now this week we find that the effectiveness of intranasal flu vaccine is only 3% in children aged 2-17. (Adults were not discussed in this article.)

Then there's the case of hepatitis B vaccine. The manufacturer states that it must be injected into the arm muscle (the deltoid) in young people and adults, rather than one of the other common sites (the rear end, the thigh, etc.) we could use. This is because immunity doesn't "take" as well when injected into these other sites.

So now what?

Well, it's likely that multiple factors affect this equation: composition of the vaccine (protein "parts" vs. killed virus, for example), how much blood circulation a vaccine site gets, and perhaps some special aspects of the genetic coding of our immune cells and how that plays out in the overall system.

For a long time, I felt that we should try to give vaccines to people just like Nature gives people the germ in a natural setting. I felt that made intuitive sense. These days, I no longer believe the analysis is that simple. Not everything we intuit about medicine and biology works out the way we believe it ought to--and this, of course, is the purpose of science! For the reader contemplating a flu shot next season, the less painful path may not turn out to be very effective, which is too bad, especially for the kids who don't like shots (and that's all of them, right?)

Reference

1. ACIP votes down use of LAIV for 2016-2017 flu season [news release]. Atlanta, GA: Centers for Disease Control and Prevention. Published June 22, 2016. Accessed June 30, 2016. (Image from Clinical Advisor online.)

The History & Science of Vaccination

Previously, I talked about the vaccination debate in the context of two opposite views: the good of the public and the good for individuals. Immunization advocates typically argue that the science supports the safety and effectiveness of immunization as an absolute good. Immunization opponents argue that the science is incomplete, and that this incompleteness is actually a deliberate act; they argue that drug companies and doctors actually overlook science that doesn't support their view that immunization should be universal and complete.

Vaccination is actually a very old practice. There's evidence that in the 1100s, the Chinese, Turks, and Africans used materials contaminated with smallpox to immunize against that disease. We often think of smallpox as being very lethal. It's true that one series found a case-fatality rate of 62%. On the other hand, smallpox epidemics existed during times that were less technologically advanced. Moreover, some subtypes of smallpox are more lethal than others, so overall the fatality rate is about 30%--still pretty scary! Mild cases exhibit a fatality rate of less than 1% (CDC, 2007), and inducing "mild" cases was the basis of the crude immunization techniques in the ancient world.

The story we are most familiar with is the work of Edward Jenner, who in 1796 used material from the lesions of cowpox, found on the hands of milk maids, to immunize against the similar virus, smallpox. Later, Louis Pasteur and Emile Roux used the blood of a rabies-infected mouse to immunize a boy who had been bitten by a rabid dog. Allowing the blood to dry out for nearly 2 weeks "devitalized" the virus, which must live in blood. This process preserved the viral proteins, however, and the boy's immune system could recognize these proteins, and act on them, reprogramming itself to fight the virus.

Rabies has a case-fatality rate of about 99%. Most victims die because their immune systems can't act fast enough to fight the virus before it kills them. The cause of death is general neural failure. Basically, nerve functions, including the drive to breathe, fail. Introducing a germ--or parts (proteins) of a germ--allows the body to see and begin to recognize it. There are two main branches of immunity, innate and acquired. Innate immunity is prompt and readily attacks germs, but it does a sloppy job and often misses a lot of them. Those germs that get past the innate immune cells go on to cause disease.

Acquired immunity engages a series of very specialized cells that go through a complex dance which results in the generation of very specific, highly targeted antibodies and cells that are highly lethal to those germs. Let's say you get a cut on your finger. Immediately, special cells in the skin and blood go after whatever germs got into that cut. But at the same time, a few cells "read" the proteins on those germs and send signals to other cells that start to rearrange their own DNA in order to develop a profile of those germs. They then grow and divide, these new-reprogrammed cells, to create highly specific cells ("killer cells") and chemicals ("antibodies") to eliminate those germs.

If there are any immunologists out there reading this, I know I'm simplifying this quite a bit. The thing is this is a well-understood mechanism for how we fight off disease, which we are exposed to every day.

It's possible to take advantage of this feature of our biology to prevent disease. Exposing people to germs or parts of germs, whether viruses or bacteria, can engage this system of acquired immunity. Once the acquired system has been activated, a lineage of these specialized cells will persist in the body, one line for each unique germ. These are called memory cells. Because of these memory cells, whenever the body is re-exposed to a given germ, instead of it taking 7-14 days to develop a targeted response, it takes only hours to days.

One of the important features that we have to know about is the stability of whatever germs we're trying to protect ourselves against. Smallpox is very genetically stable. Cowpox is also very stable, and presents a very similar protein "picture" to smallpox. Again, I'm simplifying here to make a point, and that is that genetically unstable germs are more difficult to vaccinate against. For example, the common cold still defies attempts to develop a vaccine. That's because the viruses that cause the common cold (mainly rhinoviruses or "nose viruses" literally! There are few less common viruses that cause colds) are prone to mutate. 

This is also why we get multiple colds. Cold viruses mutate.

But if the infecting agent is genetically stable in the wild, and you either had the infection before, or you got a vaccine against it, your memory cells ramp right up to fight the infection if you run into it again. 

This is also the case with HIV, for example. HIV mutates a lot! Those mutations often cause viruses to become inactive, but it also often gives them a "stealth" characteristic that makes it hard to the acquired immune lineage to recognize that this was seen before, say in a vaccine shot. It's also why some people can have multiple strains of HIV at one time.

Unfortunately, this system isn't perfect, and we don't fully know why. Hepatitis B vaccine typically provides protection to 96% of healthy adults (Merck & Co., 2014). Looked at another way, about 1 in 24 vaccinated adults will not develop immunity to hepatitis B when vaccinated properly. I am one of those people. I was vaccinated four times when I was ER nurse, and I never developed antibodies to give me immunity to an infection that at the time had an incidence rate among ER personnel of 35%!

Infanrix, a product that immunizes against diphtheria, tetanus provides, and whooping cough reportedly provides 100% immunity for the first two conditions, and 84% of children achieve immunity for whooping cough (GlaxoSmithKline, 2016). 

Last year, the flu vaccine--which mutates a lot--had a protection rate of 47% (CDC, 2016). Not all that great.

One study that looked at duration of immunity over time found that this was disease-dependent, and that actually having the disease tended to confer more durable immunity than having been vaccinated for it (Amanna, Carlson, & Slifka, 2007).

In short, vaccination works most of the time for its stated purpose. In cases like the flu, most years you could flip a coin to predict who it will work in (until we figure out why, at least). And while a lot of people get protected, that protection can wane over time, necessitating booster shots.

The U.S. now immunizes for 18 diseases in 35 doses plus approximately another 15 doses if one includes annual flu vaccines. Many of these are given in combinations (e.g., measles, mumps, rubella), or several in one child health visit, and on several occasions, since in many cases a single shot isn't enough. 

References

Amanna, I.J. Carlson, E. & Slifka, M.K. (2007). Duration of humoral immunity to common viral and vaccine antigens. New England Journal of Medicine, 357: 1903-1915.

CDC, 2007. Smallpox Disease and Its Clinical Management.

CDC, 2016. Seasonal influenza vaccine effectiveness 2005-2016.

GlaxoSmithKline, 2016. Infanrix Package Insert.

Merck & Co. 2014. Recombivax HB Package Insert. 

Public vs. Private Health

As we close in on the Summer Olympics in Rio de Jeneiro, the persistence of the Zika virus problem has led to various recommendations, not all of them official. Some say attendance poses a hazard to certain people, like pregnant women, so those people should not attend. Others worry about the possibility of male to female sexual transmission (which is a thing) and so, what? Maybe no one should attend? All of this angst overlays concerns about the displacement of native Brazilians from their homes during the construction of Olympic venues, the shifting of public money into that construction, money that many Brazilians have said could have been used for education, health care, and improving the lives of the poor--all things that would materially improve the public health. Meanwhile, pharmaceutical companies, funded in part by public dollars, are trying to develop a vaccine. More public money is going toward mosquito abatement, although there are those who warn that some approaches (like genetically engineered mosquitoes, GEM) could have untoward environmental consequences, themselves a threat to public health.

I once asked my teacher at homeopathic medical school if he could discuss the "health issues of vaccines." He responded with, "Vaccines aren't a health issue, they're a public health issue." He went on to say that we are taught to view vaccination as an individual medical intervention. But the "benefits" of immunization programs are not necessarily individually oriented; they are oriented toward a manipulation of the environment in which germs must live, to make that environment inhospitable for those germs. They're an environmental intervention.

Take smallpox for example. It has only one possible host: man. If all humans are successfully immunized, the environment for smallpox disappears. It has no place to reside. This is exactly what has occurred with smallpox, and now the only known examples of this virus exist in laboratories in Russia and the U.S. The disease is gone.

Smallpox did kill a lot of people (ask the Indians of North America), so this killing off of wild smallpox seems like a real win. It's possible that the existence of smallpox had some sort of environmental upside, but to date I haven't seen anything like that reported. This shouldn't be dismissed casually. In working toward management of the Zika problem, some proposals have us killing most mosquitoes using either poisonous sprays or genetically engineered mosquito-attacking germs or even GEMs themselves, which would reduce or eliminate the bug's ability to breed.

Terrific! No mosquitoes!--except that mosquitoes are food for many birds and beneficial insects. We've seen successful mosquito-borne disease reductions in many parts of the world. Yellow fever, malaria, and other diseases have been reduced, mostly at this moment by using poisons. But then those poisons have ended up in the food chain and come with their own public health risks.

And the use of these approaches assumes that the majority of people in affected areas support the benefits of these programs and accept the risks.

What I have observed in practice is that the selection of acceptable risks by individuals is a lot more complex. The individual calculus of risk acceptance isn't the same as the calculus used by public agents (citizens, policy-makers, doctors and nurses) to decide what measures should be imposed on everyone in a jurisdiction or an environment.

In upcoming posts I'll tackle the vaccine issue with this in mind. To get us started, I circle back to my teacher's comment about the real issues in immunization: public versus private health. The former is a collective decision that makes a choice about what is valuable for all and what the acceptable risks are for society as a whole. The latter is an individual decision undertaken in private with one's clinician. Such benefits and risks are based on particular features of the person. Here's an example: A person accepts his nurse practitioner's offer of a tetanus booster shot because she knows the man has a high risk of suffering dirty wounds in the course of his work as farmer. Opposite this would be the person who declines the offer, because she has a history of tetanus allergy, even though she has suffered a dirty wound.

If that sounds far-fetched, it's not. I had a patient once who nearly died because the doctor insisted she try a tetanus shot for an injury she suffered from an electric fan blade. We resuscitated her, but it was a close call!

One might ask, What's the risk of getting tetanus from such a wound? In about a half hour of searching the scientific literature on this Sunday morning, I have been unable to find an "attack rate" for tetanus. That is, I couldn't find information that would predict the number of people who get the disease tetanus ("lock jaw") from any wound, or from specific types of wounds ("clean", "dirty", etc.). This makes some sense, because conventional wisdom says that the risk of a known adverse reaction from the tetanus vaccine is fairly low, and the risk of dying from tetanus is about 13%. Furthermore, almost all cases of tetanus occur in unvaccinated people, or in people who'd been vaccinated but then didn't get boosters for long periods. Their protection had waned.

The numbers are small enough that attack rates for certain kinds of wounds haven't been calculated. Tetanus itself is a disease that is caused by a specific event: a wound, usually dirty and deep (hence the rusty-nail-in-the-foot as a common cause, in the popular mind). Tetanus from other types of wounds (paper cuts, shallow wounds, scrapes, blunt trauma, cuts from kitchen knives, etc.) is rare.

But tetanus isn't a disease that spreads from person to person, like measles, whooping cough, or diptheria, among others. When that's the case, how does it reframe our discussion? The vaccine "debate" has two poles: those who believe it to be necessary and those who believe it is not. Each side demonizes the other. Advocates argue that immunization is a medical marvel that saves lives with little adverse consequence. Opponents argue that it's unecological, harmful, and even a plot by Big Pharma to make money.

In upcoming posts, I'll deconstruct this argument in a different way.

Medical Drugs as Lifestyle Choice

Omeprazole was invented in 1979 and marketed in the U.S. by 1989, under the name Losec, which was changed in 1990 to the name Prilosec that we know today. It's the first of a class of drugs called proton pump inhibitors (PPIs). Basically these drugs reduce the production stomach acid (hydrochloric acid) from the cells of that organ which produce it. A lot of people think stomach acid helps digest food. That's only sort of true. Really all it does is break down some of the bonds in protein-based foods, but it doesn't digest food per se. The acid does signal the intestine to get ready to do the actual work of digestion. And it helps reduce the number of germs we ingest when we eat.

In people with heartburn and "reflux"--a condition in which the stomach acid splashes up into the base of the esophagus and causes pain, cough, etc.--and in people with ulcers, these "PPIs" help to reduce the acid enough that the stomach can heal a bit.

When these drugs first came out, they were prescription-only, and they were said to be limited to 8 weeks' use. There was a concern that they could cause stomach cancer if used too long. Over the decades, evidence for this didn't emerge, and in June 2003, the U.S. FDA approved omeprazole for over-the-counter use.

Now, it's hard to turn on the TV without running into Larry the Cable Guy (comedian Daniel Lawrence Whitney) selling Prilosec OTC. He's also usually seen enjoying foods traditionally thought to cause heartburn: fried chicken, barbeque, and so forth. The idea you're supposed to get is that if you want to eat that junk on a regular basis, just take some Prilosec OTC and you can go nuts on potato salad, hot dogs, and beer. Here's a typical commercial:

(By the way, food is only a small part of heartburn, reflux, and ulcer disease.)

Sometimes it takes quite a while--and a bit of careful observation--to sort out the real hazards of a drug or class of drugs. With PPIs we've been learning some interesting things.

One is this little tidbit from the Journal of the American Medical Association: Neurology (JAMA Neurology), from February, and follows up on and confirms the findings of a previous and smaller study. Turns out that the risk for dementia increases with the use of PPIs.

Now don't freak out if you have taken Nexium or Prevacid or something like that for a short period, say, to treat an active stomach ulcer or esophagitis, because it's likely the benefits far-exceeded the risks. And if you have used one of these a few times for bad heartburn, don't fret. This study looked at duration of use of these drugs. Basically, the more the subjects had used these drugs, the more likely they were to be diagnosed with dementia. Duration of use had to be over 18 months to be really significant. More intermittent "regular" use was associated with lower risk. Occasional use didn't display any significant risk. The study controlled for many of the other possible causes of dementia.

Research shows that up to 70% of the use of these drugs does not fall into the recommended guidelines for their use. In other words, some comedian on a TV commercial says "Hey take this for heartburn..." and that's what people do. If you clicked on the video link, you'd see the safety caption warning against use for longer than 2 weeks. But I ask: do you think people really follow that?

In my experience, people often self-treat until they can't anymore. And doctors often have people on these drugs for years.

My aim here is not to criticize what may be some medically appropriate drug use (Rx or OTC), but to illustrate how unintended consequences may stem from the casual application of therapeutics we don't fully understand, especially when that application rests on a relatively shallow "suppress the symptom" approach to health and healing.

And fried chicken? Heck, that's ok now and again, but should we really be encouraging people to use OTC drugs to promote eating badly? What about the basic causes of such digestive complaints? Shouldn't we, at some point, ask ourselves if there's a more fundamental treatment to get at the cause or imbalance that led to the complaint? This is why I do what I do. Homeopathy, Chinese medicine, and other medical approaches that try to get at the root imbalance often reverse the problem, and hence reverse the symptoms, as opposed to merely suppressing them, the duration of which may be indefinite!

Sometimes we need drugs. Sometimes we need to suppress a symptom to relive short-term suffering, to get a handle on things and buy some time. But do we need to promote this approach as a lifestyle?

End-of-Life Concerns

The second thing of interest to these seasoned (and a few not so seasoned) RNs was end of life issues. This is also a concern of mine. I gained an interest in it over the last several years, while teaching a professional development course to RNs. It's a survey course: we cover a number of topics, and I really try to elicit their concerns and then incorporate their concerns into the material.

One thing that emerged was the distress they feel during resuscitation efforts in the hospital. People outside of the business mostly get their experience with resuscitation--essentially CPR--from TV. They call a "code blue" or simply a "code", and a few super-efficient doctors and nurses rush in, pushing gingerly on the chest. That's not real CPR. If they were doing real CPR the actors would be compressing the chest about 2 inches--and you'd likely hear some ribs cracking. CPR is rough stuff!

Survival isn't great, either. Various studies have found that survival with out-of-hospital CPR is less than 20% or less than 1 in 5, and often less than 1 in 10 cases. Even when cardiac arrest occurs in the hospital, survival isn't much better, although it may rise to about 40% under the best circumstances. This would maybe be a patient who arrests on the operating table and perhaps because of the anesthesia. Those cases are pretty easy to save, comparatively speaking. They're also ideal. I mean, you're right there with all the drugs and the defibrillator and the best people to revive you!

That's not most cases.

Survival with full mental function to leave the hospital, that's even less common. People are often led to believe that when grandma wakes up after CPR she'll be ok. But odds are she'll never wake up, and if she does, she'll be in considerable pain and perhaps have suffered some loss of mental function from the lack of oxygen to the brain, depending on how long it took for CPR to start, how long it took to get a heartbeat back, and grandma's other health issues at the time.

As an ER nurse and an EMT, I worked a lot of "codes". Hardly anyone ever lived. That's partly because a lot of them were performed on the very elderly, many of whom already had significant disease. The few who did survive? They were mostly younger, and the cardiac arrest was witnessed by us. Arrests in "the field"--outside the hospital at accident scenes or in homes--things weren't so good. We would bring those folks sometimes, but then they'd go to intensive care and die again there.

Pretty grim stuff.

What a lot of the nurses and doctors suffer from is just a sense of fruitlessness and sadness over this. Yes, it's hard to lose a patient, but it's often even harder to participate in these efforts when you feel like you're just abusing a corpse. Since a lot of folks getting coded are older and sicker and frail, it is appropriate to just let go. Why doesn't that happen more often?

Mainly, it's a lack of communication between health care workers and patients and families. Now it is true that a lot of times, there is good communication, and many times we allow natural death to occur. That can be a good, well-planned death when the diagnosis is fatal and hospice services are at work. (I do some hospice work, so I've seen this a lot.) But a lot of families aren't fully appraised of just how fatal a family member's condition is, and there's been no discussion of the circumstances in which the hospital staff can allow death to occur.

I've been to codes--and so have my students--where families are in conflict about this decision, even when the patient himself made his wishes clear. There's also a lot of misunderstanding about what a "living will" and similar documents mean. For example, it is typical that a living will or other health care power of attorney doesn't go into effect unless the doctor has declared that a person is terminal, or if in a persistent vegetative state, that is, brain dead. Or it might be in effect if the person simply won't wake up and have any life quality.

So a living will isn't a will to forestall CPR. It's just a statement of assent to the withholding of lifesaving measures in the event that the person is in one of the specific states I described above.

A "DNR"--"do not resuscitate"--is an order written by a physician, and in some hospitals, it can be written by a nurse practitioner or physician assistant, who is working on a team with a physician. Some hospitals call them levels, and so a level 1 is "do everything". Level 2 is don't do CPR but you can use drugs like adrenaline to try to bring someone back, and so on. They usually go to something like a "level 5" or comfort-care only.

Most people don't realize that such orders are routinely suspended if someone goes to the operating room, even for a "comfort" procedure. This is partly because sometimes the anesthesia itself caused the cardiac arrest--so why not just reverse a doctor-caused problem anyway? But it is also because surgeons are graded, in part, on their intraoperative death rate, so they don't want anyone dying on the table.

What bugs me about this is that nurses and doctors often don't tell patients or their families that this will be the case. They just don't like having the conversation. For my students, I try to teach them how to advocate for their patients' wishes, how to negotiate with often-reluctant doctors and families, to have more productive conversations. Sometimes it can be enough that a patient simply says "if my heart stops, don't bring me back." The nurse or doctor can then chart that information as a legitimate expression of a person's last wishes, and write the DNR order.

I said in another post that I'd discuss how what I teach my students says about health care in America. Recently, Atul Gawande, himself a doctor, wrote Being Mortal, on how we do death in this culture. We don't do it very well. We're often convinced that medicine and surgery will cure everything. We often allow popular culture to convince us that technology can do more than it does. We don't stop to think what it might be like for our loved ones, having their chests broken, having tubes shoved into lungs and veins and bellies. You might think that "unconscious" persons don't hear or feel. They often do. How miserable it must be to suffer those physical insults when all you wish to do is die peacefully.

So if I could give one piece of advice to everyone, it would be the advice I teach my students: make the conversation happen before it's too late.

Pain

Narcotic pain medication is big news these days. Thousands of people are reportedly addicted to opioid pain medication, like Percocet or Vicodin. Many more are using heroin--these days it's a lot cheaper than a $40 Norco pill bought on the street, and less fuss than trying to get legitimate oral medication from a doctor's office. Some doctors have managed to turn their offices into "pill mills", complete with an armed guard at the door. Overdose deaths have risen. Musician Prince, we learned this week, seems to have died of an overdose of the prescription drug fentanyl, a drug roughly 200 times more potent than heroin. 

The result: laws passed giving police and EMS personnel the authority to carry and administer the drug naloxone, which blocks opioid receptors in the nervous system, and can reverse an overdose before death occurs; increases in training for physicians and nurses on how to prescribe and use narcotic pain medication; and new guidelines from national organizations on when to use--and when not to use--such medicines.

Last time, I said I'd share some bits about what today's nurse wants to know more about and what it says about health care in America. Today we'll start with the "Opioid Crisis". 

RNs fulfill a variety of roles here. Yes, they administer pain meds in the hospital, but they also manage panels of outpatients in clinics that need to treat pain, like orthopedics or pain management. They survey what patients are using during medication reviews and help fill pillboxes in those who have difficulty managing their meds, like some elders or folks with mental health problems. They teach patients how to use their meds safely, and because of their more regular, closer contact with patients are often the first to see that a person is showing signs of a drug problem. They advocate for patients, too, and are often the ones requesting that pain meds be increased, decreased, or adjusted based on changes in a patient's condition.

So when today's news describes growing numbers of overdoses, patients causally prescribed opioids for all sorts of ills, and the emergence of cheaper heroin, nurses want to know how to deal with all that. In the mini-mester course I just taught, the syllabus is broadly written enough to allow us to be topical with our lessons, so I polled the incoming class, 14 nurses from local hospitals and agencies, working on their bachelor's degrees, and asked what they wanted to learn about. Several of them said they wanted to learn more about these changes in how we prescribe and monitor opioids.

They know the history: that in the mid-20th century it was hard to get doctors to take pain seriously and prescribe adequately. They know that in the late 1960s nurse Margo McCaffrey was advocating for more humane pain treatment, having written that pain is, “whatever the experiencing person says it is, existing whenever the experiencing person says it does” (McCaffrey, 1968, p. 5).

She wasn't trying to create an epidemic of overdoses. She just wanted people to suffer less.

If I ask the question, "what is pain?" to these seasoned nurses, they all reply with essentially this quote from McCaffrey. Mission accomplished. 

There's also a lot of suspicion. Nurses and doctors routinely suspect patients of "drug seeking", and sometimes they are right. Sometimes they aren't seeing the bigger picture. As the largest consumers of prescription and non-prescription drugs in the world, Americans seem more prone to medicate than other societies. We often think of drug use as something people do to "party", but as Hanson, Venturelli, and Fleckenstein (2014) note, a lot of drug use and abuse is for "illegal instrumental" purposes. That is, people are self-medicating, not just getting high for fun.

In short, understanding why a society uses drugs the way we do, understanding how medical professionals see their role in managing problems humanely, and building a coherent educational program around those issues is a real challenge. For the course I just taught, I included the Centers for Disease Control's new Guideline for Controlling Chronic Pain.

Bear in mind, this is a reaction to the sudden wave of overdose deaths and the growing problem of people addicted to prescribed pain meds. One thing that struck me was the following passage, "Benefits and Harms of Opioid Therapy":

This screenshot is just a bit of the section, but I read it and not a single "benefit" was stated. The entire section is about "harms". Why is this a concern to me? Because too often our health care system is less about science and more about culture. I know what will happen: doctors will go from generously (and carelessly) prescribing opioids to refusing to use them at all.

My working nurses, these students I taught in May, reported routine prescriptions for post-surgical patients for 30, 60, even 90 tablets of opioids. If the prescription is for "1 to 2 tablets every 4 hours as needed"--which by the way is a perfectly correct prescribing of, say, Vicodin--that means a few patients could end up using as many as 12 tabs per day, or upwards of 36 in 3 days. If one doesn't want calls in the middle of the night for more meds, then you write for 30-60 tabs. That'll cover the worst case scenario.

And what happens in most cases? People take a few, maybe one or even none. What happens to the unused meds? They end up in the toilet...or in some enterprising person's hands, to be distributed, sometimes for money, for other people's pain--or fun. By the way, the ones we flush? They end up in your water supply because treatment systems aren't equipped to remove drugs from the wastewater stream.

In our class discussions we concluded that we need a more complex, nuanced national discussion that encompasses more realistic goals for the use of these drugs. Health care workers often operate with fear running in the background: fear of being sued, fear of delicensure, fear of criticism from colleagues, fear of hospital administrators. When leading organizations like the CDC assemble unbalanced, sloppy "guidelines" like the one depicted above, it contributes to this culture of fear that drives health care workers to the lowest common form of practice. Hysteria, driven by salacious news (overdoses, "pill mills") ends up creating a new culture to displace the old one.

I expect that new culture will bring some genuine innovations--and I did highlight several of these in the class, like the use of regional pain blocks for certain routine surgeries. But I expect the new culture will bring on more suspicion, and the undertreatment of pain, too. 

References

Hanson, G.R., Venturelli, P.J., & Fleceknstein, A.E. (2104). Drugs and Society (12th Ed.). Burlington MA: Jones & Bartlett.

McCaffery, M. (1968). Nursing practice theories related to cognition, bodily pain, and man-environment interactions. Los Angeles: University of California at Los Angeles Students’ Store.

A Lengthy Absence

Well, I'm back after a few very busy weeks. Soon after my last post it was time for final exams, and then afterward I taught a "May-mester" course--25 hours of class time in 2 weeks. Now it's time to catch my breath as I look forward to a summer of writing.

The mini-mester course was composed of RNs who are returning for their bachelor's degrees. This may seem odd to some, but the fact is, nursing has had 3 levels of educational entry for decades. Originally nurses were trained in hospital-based schools of nursing. This provided a labor supply, and guaranteed that student nurses would have practical, clinical training sites, as well as training that would teach them a specific hospital's procedures and inculcate them into that specific hospital's culture.

This passed out of fashion in most parts of the country, in part because nursing students were being treated as a source of labor more than they were being treated to an education that would have applications outside of this or that specific hospital. Also, as health care has matured, many smaller hospitals have closed specialty units such a pediatrics and obstetrics, that form key parts of a nurse's education. Interestingly, Pennsylvania has more remaining hospital-based diploma programs than any other state, although many, like a program in Lancaster PA, have converted into chartered degree granting institutions, providing a more rounded experience that includes things typical in a college education (like history, philosophy, writing, and so on).

Anyway, there are still a lot of community college-based programs throughout the U.S. So there are still lots of 2-year programs out there (although they consist of so many courses, it usually takes 3 years to get through). Many colleges and universities offer so-called "RN to BSN" programs, composed of students who may have practiced little yet, or may have been practicing for many years. Part of my teaching is in such a program.

Why do they go back to school?

In the past it was mostly to secure a promotion track with their employer, or to ready themselves for graduate school to become a nurse anesthetist, nurse practitioner, or educator. By law and custom a master's degree is required for these sorts of advanced practice roles.

Today, many return because their employers require the bachelor's degree. Research that emerged in the early 2000s found some evidence of an improved safety margin when hospitals have a larger number of BSNs working in them. That's good for patients, and it makes hospitals more competitive.

Ah, but what can one teach such nurses? After all, they are already licensed. However if the research found this additional safety margin, then there must be some additional tools we can provide these students. Over the next few posts, I'll discuss what these RNs value in their extra education. Those things speak to several important and interesting features of our health care system.

The Same Old Arguments

I'm sitting here watching a recording of Frontline called "Supplements and Safety," which aired on PBS in January of this year. What strikes me early on is the editorial construction of the piece: doctors soberly reporting on their grave concerns about the cases of injury and harm, the lack of quality controls, and the mystery of what's in those dietary supplements. The manufacturers of supplements are shown to be ruthless mercenaries, and the FDA as hapless regulators who may be in the pockets of Big Business. Consumers are rubes, with selected attention paid to those grievously harmed by this relationship.

I don't object to the basis of their journalism. They accurately point out problems with the lack of quality controls in the supplement industry, the complexity and nuance of the data that are said to favor supplement use, and the risks of taking high doses of things you can't fully trust.

What they don't cover is why people do this. There's also a real effort to pump up the emotion, and you accomplish that by keeping arguments pretty simplistic.

In 1994 the Dietary Safety and Health Education Act was passed. The law emerged from the acrimony that resulted from pitting two forces against each other whose differences were irreconcilable. One force was Organized Medicine, led by Dr. David Kessler, then head of the FDA. He saw a problem with supplements--and there was a problem--and he wanted to do something about it.

Unfortunately, he fell prey to the narrow lens of empirical medicine, which tends to view things in a very reductionist manner. Also, it tends to be very chauvinistic. Since the mid-1800s, Medicine as profession has done everything in its power to make people dependent on its methodologies. Medicine condescends to people, branding their ideas, their experiences, and their genuine interests in their own health as wrongheaded and just stupid. Notwithstanding that some individual doctors who view justice and holism as worthy characteristics of medicine in society, as an industry, Medicine has consistently been as greedy and prejudicial as any industry.

On the other side was the supplement industry--not even half of what it is now--still a behemoth, and they started a campaign against the FDA's efforts to regulate supplements. They were very successful, and today the DSHEA's regulations enforce a circumstance that benefits industry at the expense of consumers.

What the Frontline broadcast doesn't get into is the culpability of Medicine and the zeal of the "lifestyle police" in the creation of this circumstance. In the early 1990s, Medicine and The Scientists could have partnered with consumers. They could have tried to think outside the box. During one sequence "Supplements and Safety" talks about Ephedra, known in Chinese medicine as ma-huang (Ephedra sinensis). The use of this herb goes back thousands of years and its use is safe and well-documented. Ephedra is an effective nasal decongestant and energy builder, when indicated.

Who decides when its indicated and how it should be used? How about specialists in Chinese medicine? That's a novel idea that didn't occur to the short-sighted zealots who were crafting a law that would make doctors and the pharmaceutical industry the arbiters of what's "good" for us. In 2004, 10 years after DSHEA, ephedra was pulled from U.S. markets after a number of deaths occurred from overdoses of weight lifting and energy supplements containing ephedra.

Thus, a perfectly useful and effective drug was removed from everyone's use because of the same old argument between the Supplement Industry and Organized Medicine. Had it even occurred to the zealots that giving licensed practitioners of other medical arts a say in the regulation of these products, would encourage partnerships with Medicine that would improve both the health and the safety of consumers?

The problems are threefold. First is money. Anyone with something to gain or lose is going to have a hard time remaining intellectually neutral in any argument when this is the case. If supplements are better regulated, to the point where some supplements are restricted to vetted practitioners of medicine or some other medical art, they lose. Doctors have something to lose when people treat themselves, and when practitioners other than physicians enter the field.

The second is chauvinism. This is a kind of intellectual classism which tends to ignore or denigrate native or folk knowledge. For example rather than viewing supplement use as the province of the ignoramus, doctors could try curiosity. Curiosity teaches us new things, and displays of genuine curiosity open rapport with patients. This is what I teach my students.

The third is rigidity. Medicine and The Scientists are fond of saying, "Where are the controlled clinical trials?"  "This hasn't been proven!" Mark Tonelli, a physician, and Timothy Callahan, a researcher, both from the University of Washington School of Medicine write in Academic Medicine (2001) that the demands that complementary and alternative medicine (CAM) fit into evidence-based practice models is a philosophical demand that doesn't cohere with the various models and understandings of "disease" and "health" in those methods.

It's not that we can't explore the value of CAM methods--or supplements themselves for that matter--using science. We can, we just have to make sure the methods we use are appropriate to the particulars of the thing were exploring! There's nothing scientific about trying to jam a square peg into a round hole. Nor must we simply ignore the square peg and allow it to remain unexplored. (This also argued by Tonelli and Callahan--they aren't giving CAM a pass! They are just suggesting that Science amp up its game, and not rely on models of study that are becoming increasingly limited in their ability to determine value.)

This is about the "same old arguments." Both sides lack verity, both are wrong, because they lack imagination, empathy, and desire to do the best for the most. What would that be? Partnerships that don't start from financial interest or intellectual chauvinism would be a start. The Frontline special shared some initiatives in the supplement industry that would improve quality and safety. These partnerships between researchers and the industry offer us hope that the same old argument is changing.