FDA Alert...on Homeopathy
The FDA released an alert in September of this year. Homeopathic "Teething tablets and gels" are to be avoided by consumers and unused portions discarded because of reports of weakness, flushing, difficulty breathing, and seizures, in a few children who have received the problem-specific, combination remedy from Hyland's. The company has voluntarily recalled the product.
The online news source, Vox.com, reports that "The US government is finally telling people that homeopathy is a sham". Golly, I hate online news. Simmer down.
No. The FDA reported on exactly what one would expect to see when millions of people use a medicine unsupervised, a medicine that comes from a system, a philosophy that is completely different from the thing we all use a reference point for understanding medicine, health, and healing: "Western technological biomedicine" --WTB.
In homeopathic circles there has been an argument among many different philosophical perspectives. I practice "classical" homeopathy, the origin-story of homeopathic medicine. Therapeutic homeopathy, is a more European practice, and one frequently used by naturopaths and chiropractors (however this is by no means the case among all NDs and DCs). It's fairly straightforward and easier to prescribe, and certainly enables the practitioner to see more patients in less time. There are other variations, but I needn't digress. It's enough to add that one related homeopathic prescribing philosophy is that if you throw a bunch of remedies together in a mixture, only the "right" one will act: "combination remedies".
Many remedies are made from toxins, poisonous plants, and venoms. If "like cures like", and if the proving* data of Hahnemann are to be believed, then it follows that the wrong remedy could, in susceptible individuals, be enough to trigger a bad outcome.
I tell my students, if it's strong enough to cure you, it's strong enough to kill you. That may be a bit of an overstatement for some therapies (e.g., Reiki), but the harm will be proportional in any case. Nature doesn't give any free lunches.
I've also shared that things like Zicam Intranasal Spray should be avoided because it can cause the loss of sense of smell. It's "homeopathic"--that is the company legally uses a loophole in the FDA regulations concerning homeopathic remedies. The law provides that all the remedies in the Homeopathic Pharmacopea of the United States automatically can be marketed. By potentizing even a small part of a product it can be labeled "homeopathic" and marketed for specific indications (colds, teething, etc.).
Both the homeopathic pharmaceutical industry and the allopathic industry are each using homeopathy in a way in which it was not conceived and cannot be.
The whole premise of the art is that each person is, at some moment, in some state of imbalance. Think of it as an imbalanced manifestation of some unifying field. The practitioner must understand the field in that moment and prescribe (or not) on that basis alone. When used as a "specific" agent to treat a communal diagnosis (the "name" of the "disease" in WTB) it ought to fail much of the time. In fact studies of the remedy Arnica montana for bruises and sprains--its homeopathic indication--fails about have the time and performs no better than placebo.
For my part, I'm surprised that it has taken so long for this phenomenon to emerge. How could it not? If we develop the picture of symptoms statistically associated with a verum (real) remedy in a homeopathic proving trial (see again note * below), then it follows that if people randomly take remedies on a regular basis using an allopathic model (or at best a weak homeopathic model) some are going to start to show symptoms of some remedies.
Ok, ok. I'm getting into the weeds here. Let me just say that WTB is a great thing. It does some things that only it can do, and it does a lot of things fairly well. I mean, if I (or one of my patients) has pneumonia, I might take a remedy, but I'll certainly have some antibiotics on stand by! The antibiotics will not be without harm, but it beats dying, and medicine--of any sort--is never perfect.
But the pursuit of perfection, practice, doesn't come without an ethics. In the case of homeopathic medicine, sound judgement prevents poor outcomes, and when done well, at least the homeopath listens, even cares. In the opposite case I would argue that allopathic practitioners also care, but their care is constrained by the necessarily industrial, high throughput model I detailed in the previous entry.
I would argue that WTB is also more motivated for profit than anything homeopathy can muster. Homeopathic medicine is a "weak force" medicine. Before interpreting that as self-deprecation, recall that the "weak nuclear force" is one of the building blocks of the Standard Model of physics. It's necessary, critical, but only to a point. Thus, don't ever expect homeopaths to rake it in using classical methodology.
Although it will hurt the industry's revenue, I can't argue against the FDA. Homeopaths will have to come to terms with their "weak" science--that is, a weak-force medical technique that nevertheless can have profound effects on the organism. The "science" of that: you have to thoroughly understand the possibilities and constraints imposed by an alternative medical system. Allopaths will have to accept hypothetical models other than what they are used to in order to properly judge whether or not homeopathy is "a sham", as Vox.com put it.
Other have tried to put homeopathy in the grave. Even I have my doubts. However there are enough studies that leave tantalizing loose ends--genuine effects--that it remains unburied. However homeopaths will have to revisit their philosophical origins in order to determine not only if the basic system is really effective, but how these other, admittedly more efficient, systems have a place, and if so how the whole thing should be regulated. Right now, every homeopath is his own captain.
I have advised families who have members not under my treatment** that they can try things like Hyland's Teething Remedy. On balance many fewer are harmed in this way than by regular medicine. In recent years, since the Zicam incident, I am a bit less free with this, and half the time warn people away from these combination remedies and faux-homeopathics. I don't know the details of these incidents reported by the FDA. It isn't many I'm sure, but it urges caution in the use of these combinations.
I am certain that in low potencies I've never seen a reaction that was truly grave, and I am also certain that in high remedy potencies there lies hazard in careless prescribing--how could it not? This is consistent with homeopathic--and natural--theory: there's no free lunch. I have the clinical experience to confirm this. But larger systematic studies of this effect in the community are lacking. I would like to come up with a way to evaluate this system on the system's terms (there are a few clinical trials but results and quality vary).
I am certain that I have seen clinical improvements that are not satisfactorily explained away by "placebo effects" or the "clinical encounter" and similar psychosomatic phenomena. Not that I haven't seen those too--every doctor has! However, homeopaths are humble in the face of placebo effects; allopaths (physicians and pundits) aren't, viewing them as a confounder in most cases and a "miracle" in others. Yes, people do get better just because they would anyway. We recognize that. The best of us recognizes all of these phenomena. Hahnemann did! Surely allopaths have the right set of intellectual tools to do consider homeopathy on its own terms: rigorous scientific philosophy accepts the twin pillars of hypothesis and falsifiability. Sometimes opponents seem weak on the first part and too-quickly convinced on the latter part.
Homeopaths aren't anti- or psuedoscientific (ok, some are), rather we just choose to offer people something we have a method for evaluating the effectiveness of, and take on some faith that the effects are real, even if we don't understand the mechanism. When the method is properly applied, I've seen some pretty amazing things happen. And it's all happened safely.
And safety is why I am glad that the FDA is forcing homeopathic medicine to come to terms with its own philosophy.
------------------------------------------------- * -------------------------------------------------
Notes:
* Hahnemann's original drug testing in which subjects received the real remedy or a placebo, and after several homeopathic-strength doses, would report on symptoms (or lack of) which would be recorded. These are considered the first systematic drug tests.
** Under my treatment, patients are not to use any other remedies under any circumstances unless I direct. The reason is beyond the scope here; maybe I'll write about that later. But it makes sense: why interfere with such a subtle and poorly-understood process? If they need some support, there's drugs, herbs, nutritionals and so on.
A public diary of 30 years in the medical arts with Dr. Eric Doerfler, nurse practitioner and researcher. Observations, philosophy, and advice.
Sunday, November 27, 2016
Sunday, November 20, 2016
Tales of the Profession, part 2
The good news is, I didn't get hit by a truck! Life goes on.
It's been a while since my last entry--the semester seems to overbear everything else. In the fall I and another instructor are responsible for supervising the graduating seniors in their final clinical rotations. Unlike their earlier education (a mere two weeks before they begin again in late August) these experiences are not directly supervised by faculty.
Students are assigned to RN mentors, we call them "preceptors", who work in the various agencies to which they are assigned. Each student has two sites, a "regular" hospital site, and a specialty site. The regular site is what we call medical/surgical or "med-surg", and it's the typical thing you'd see on TV, or have experienced if you've been in a hospital for a routine surgery, or some illness. The specialty site can be pretty varied and includes intensive care, emergency, labor and delivery, inpatient rehabilitation, school nursing, community nursing, and so on.
At 360 hours total, it is the most extensive clinical rotation of any nursing school in the state.
There's a lot I can write about this clinical course and what I observe, but today I'll just begin with how students transform from the idealized world in which we train them up, to the real world in which they will practice.
In the first group of students we ever enrolled in the accelerated second degree program, now some five years past, we all got together at University Park, at the nursing college, and held a day-long orientation. I helped to lead an exercise intended to tease out their preconceptions of nursing and health care, and they were to draw something on the whiteboard that they thought about the profession, health care, or something related to the journey they were soon to undertake.
So this one guy draws a factory on the board, with little stick figure patients going in one side and coming out the other. Although I have thought for many years now that the wonder of the modern hospital isn't its technical wizardry, but its amazing throughput, I was surprised that he saw it the same way--rather cynical, for a young guy. But I thought he was dead-on.
American health care is very expensive, and this is for a variety of reasons. Being able to move a lot of people through quickly saves a bit of money. There are lots of moving parts. Nurses and doctors to be sure, but also respiratory, speech, and physical therapists, nurse aides, maintenance workers, food service, pastoral care (of several faiths), pharmacists, security personnel, tech specialists, bioengineers, lab workers, and even sub-specialists in all these specialties, such as IV nurses, and pharmacists that design certain drug protocols for cancer and heart disease. There are supply chains for drugs, food, medical supplies, and technology. There are layers of administrators, MBAs, lawyers, risk managers, and community advisers.
It probably does feel like one is a chassis on a factory assembly line, when you're going through it.
Throughout the fall semester, my colleague and I visit as many of our students' sites as we can fit in, and we do so while the students are on duty with their assigned nurse-mentors. It's a great experience for the students because they begin to transition into the real world with the help of an assigned person who sticks with them throughout their time on a given unit. It's great for the agencies because they get an "extended interview" experience with a potential hire.
I see a strong difference between the early visits and those scheduled later, near the time we are at now at Thanksgiving. In the beginning, the students are anxious, excited, intimidated, and keen to best the challenge of operating with less faculty supervision. They quickly become attuned to the culture of a unit or community agency; they learn the language and expectations of anyone who would enter the fold as it were.
Later, they begin to assess the discrepancies between the ideals they have been taught in their regular schooling, and the real-world pressures faced by their preceptors as working nurses. My colleague and I read the structured journals they are to submit for review each week. We witness the disturbing events the students have experienced, sometimes it's prejudice, sometimes it's inappropriate care, sometimes it's the futile efforts to save someone that should be allowed to pass unmolested from this life.
But I can see them also becoming a part of the thing that they hope to join--including some of the less than ideal attitudes and behaviors. The stress of clinical work among the very ill, injured, and hopeless often brings out the best in them, but it can also reinforce the negatives. We, the faculty, continually try to reinforce the best in them, to get them to see things in more subtle and complex ways. It is one thing to "put on a smile" when faced with an angry, difficult patient who just seems mean! It is another, higher-level thing to get beyond that and determine what is beneath that anger. Is it a growing neurological reaction to a new medication? Is it despondency? Is it a youth trying to control just one thing in his world? And then what? How do you break through and build a therapeutic moment from that?
It's pretty high level thinking, that. And it's very easy to let that be the unachieved thing during a day of call bells and tests and medication passes and anxious family with questions and doctors' orders (which are sometimes in conflict with each other!) and on and on...
And then the RN clocks out. Tomorrow it will happen again. And so it goes every day until the nurse changes positions or finds a comfortable way to retire early (and these are both quite common in nursing). Maintaining a high level of enthusiasm in The Factory is difficult. One recent study found that nursing's high turnover is often directly related to declining levels of intellectual challenge and sense of control over one's practice, two features of the profession that are being systematically eliminated in favor of throughput and productivity, uniformity of experience (from the patient's perspective), and "quality control."
My RNs tell me that hospital practice is highly regulated, and to my view it seems more highly regulated than when I started out in the hospital. Arguably care is safer and more efficient, although the evidence is conflicting. "Evidence-based practice" is the catchphrase everyone uses now, so much that it starts to sound like Dilbert-esque corporate gobbledygook, it starts to sound like a joke. Nurses still solve problems, and practice still poses intellectual puzzles to challenge the practitioner. But my survey of the field convinces me that a lot of my newly minted colleagues might not stay in the profession very long if they continue to be treated like factory workers.
Evidence-based practice may be a means to reducing unnecessary health care costs, but it won't be the only way, since some of the cost drivers are unregulated drug costs, unnecessary equipment, redundant testing, defensive medical practice, and an emphasis on "customer satisfaction" in a setting in which it's kind of normal to be unsatisfied. I see EBP as having another side: a way to convince practitioners and patients alike that one size of health care fits all. Hardly the art of Medicine or Nursing.
The good news is, I didn't get hit by a truck! Life goes on.
It's been a while since my last entry--the semester seems to overbear everything else. In the fall I and another instructor are responsible for supervising the graduating seniors in their final clinical rotations. Unlike their earlier education (a mere two weeks before they begin again in late August) these experiences are not directly supervised by faculty.
Students are assigned to RN mentors, we call them "preceptors", who work in the various agencies to which they are assigned. Each student has two sites, a "regular" hospital site, and a specialty site. The regular site is what we call medical/surgical or "med-surg", and it's the typical thing you'd see on TV, or have experienced if you've been in a hospital for a routine surgery, or some illness. The specialty site can be pretty varied and includes intensive care, emergency, labor and delivery, inpatient rehabilitation, school nursing, community nursing, and so on.
At 360 hours total, it is the most extensive clinical rotation of any nursing school in the state.
There's a lot I can write about this clinical course and what I observe, but today I'll just begin with how students transform from the idealized world in which we train them up, to the real world in which they will practice.
In the first group of students we ever enrolled in the accelerated second degree program, now some five years past, we all got together at University Park, at the nursing college, and held a day-long orientation. I helped to lead an exercise intended to tease out their preconceptions of nursing and health care, and they were to draw something on the whiteboard that they thought about the profession, health care, or something related to the journey they were soon to undertake.
So this one guy draws a factory on the board, with little stick figure patients going in one side and coming out the other. Although I have thought for many years now that the wonder of the modern hospital isn't its technical wizardry, but its amazing throughput, I was surprised that he saw it the same way--rather cynical, for a young guy. But I thought he was dead-on.
American health care is very expensive, and this is for a variety of reasons. Being able to move a lot of people through quickly saves a bit of money. There are lots of moving parts. Nurses and doctors to be sure, but also respiratory, speech, and physical therapists, nurse aides, maintenance workers, food service, pastoral care (of several faiths), pharmacists, security personnel, tech specialists, bioengineers, lab workers, and even sub-specialists in all these specialties, such as IV nurses, and pharmacists that design certain drug protocols for cancer and heart disease. There are supply chains for drugs, food, medical supplies, and technology. There are layers of administrators, MBAs, lawyers, risk managers, and community advisers.
It probably does feel like one is a chassis on a factory assembly line, when you're going through it.
Throughout the fall semester, my colleague and I visit as many of our students' sites as we can fit in, and we do so while the students are on duty with their assigned nurse-mentors. It's a great experience for the students because they begin to transition into the real world with the help of an assigned person who sticks with them throughout their time on a given unit. It's great for the agencies because they get an "extended interview" experience with a potential hire.
I see a strong difference between the early visits and those scheduled later, near the time we are at now at Thanksgiving. In the beginning, the students are anxious, excited, intimidated, and keen to best the challenge of operating with less faculty supervision. They quickly become attuned to the culture of a unit or community agency; they learn the language and expectations of anyone who would enter the fold as it were.
Later, they begin to assess the discrepancies between the ideals they have been taught in their regular schooling, and the real-world pressures faced by their preceptors as working nurses. My colleague and I read the structured journals they are to submit for review each week. We witness the disturbing events the students have experienced, sometimes it's prejudice, sometimes it's inappropriate care, sometimes it's the futile efforts to save someone that should be allowed to pass unmolested from this life.
But I can see them also becoming a part of the thing that they hope to join--including some of the less than ideal attitudes and behaviors. The stress of clinical work among the very ill, injured, and hopeless often brings out the best in them, but it can also reinforce the negatives. We, the faculty, continually try to reinforce the best in them, to get them to see things in more subtle and complex ways. It is one thing to "put on a smile" when faced with an angry, difficult patient who just seems mean! It is another, higher-level thing to get beyond that and determine what is beneath that anger. Is it a growing neurological reaction to a new medication? Is it despondency? Is it a youth trying to control just one thing in his world? And then what? How do you break through and build a therapeutic moment from that?
It's pretty high level thinking, that. And it's very easy to let that be the unachieved thing during a day of call bells and tests and medication passes and anxious family with questions and doctors' orders (which are sometimes in conflict with each other!) and on and on...
And then the RN clocks out. Tomorrow it will happen again. And so it goes every day until the nurse changes positions or finds a comfortable way to retire early (and these are both quite common in nursing). Maintaining a high level of enthusiasm in The Factory is difficult. One recent study found that nursing's high turnover is often directly related to declining levels of intellectual challenge and sense of control over one's practice, two features of the profession that are being systematically eliminated in favor of throughput and productivity, uniformity of experience (from the patient's perspective), and "quality control."
My RNs tell me that hospital practice is highly regulated, and to my view it seems more highly regulated than when I started out in the hospital. Arguably care is safer and more efficient, although the evidence is conflicting. "Evidence-based practice" is the catchphrase everyone uses now, so much that it starts to sound like Dilbert-esque corporate gobbledygook, it starts to sound like a joke. Nurses still solve problems, and practice still poses intellectual puzzles to challenge the practitioner. But my survey of the field convinces me that a lot of my newly minted colleagues might not stay in the profession very long if they continue to be treated like factory workers.
Evidence-based practice may be a means to reducing unnecessary health care costs, but it won't be the only way, since some of the cost drivers are unregulated drug costs, unnecessary equipment, redundant testing, defensive medical practice, and an emphasis on "customer satisfaction" in a setting in which it's kind of normal to be unsatisfied. I see EBP as having another side: a way to convince practitioners and patients alike that one size of health care fits all. Hardly the art of Medicine or Nursing.
Sunday, October 23, 2016
On Why We Do What We Do
I read this morning that Junko Tabei died in Japan. Tabei was the first woman to conquer the "Seven Summits", the tallest peaks on each of the seven continents around the world. Her long career in mountain climbing occurred over the last 40+ years. She died, at 77, of cancer. She kept up some mountaineering while undergoing treatment.
After I read that, I lingered in bed awhile, thinking about a life worth remembering. I started thinking about my own lifespan, and my parents'. I thought that if I die at 77, then I have about 22 years left. I thought about what happened in my life, what I did and didn't do, over the last 22 years. My mom is 78, and she's still alive. Ok, maybe I get 23. My dad's 81, so maybe I could last 26 more years. My wife has survived cancer and she's 59; her father died of cancer at 68, but her mother--living with multiple sclerosis for over 50 years--didn't die until she was 91...
Or maybe I get hit by a truck tomorrow! You never know.
Don't imagine that I was looking back (or forward) with regret for what I've done and haven't done. Granted, we all have things we regret, but for the most part, I let go of that some time ago. I feel like I'm doing what I want to do and what I should do. I goof off, too, but that's part of life's fun, isn't it?
No, this isn't a retrospective on my life or anyone's, and it's not a wet-eyed missive on the importance of "living life to the fullest." Rather, it made me think about why we--in this business of healing and health care--do what we do.
People get into this business for a variety of reasons: a stable job, intellectual challenge, a love of others, and a wish to relieve suffering. The highest aim, though, is sung by The Fray's Isaac Slade: "to save a life." This is what I was thinking about, "saving" life. From this spun a web of other things.
I'm a homeopath. I'm also a scientist. As a scientist I know that science may one day decidedly judge that homeopathic medicine isn't a thing. The remedies are sugar pills. The improvements are illusions, accidents, and placebo effects. And my career of treating patients with this method was a waste of effort. The materialist model of treatment was correct all along.
Or, I could be right. Science may show that everything we have observed and theorized about homeopathy since Hahnemann coined the term is pretty close to the truth, and we, the crackpots, were on the leading edge.
If I'm wrong, was my life wasted? If I'm right, was it justified?
Hahnemann left the "regular" medicine of his time because he felt it caused more suffering than good. In Aphorism 1 of the Organon he states that the physician's highest calling is to make the sick healthy. His conception of this strange new medicine, this "homeopathic" medicine, was that it should make healing genuine, that it should extend, or save, a life. He differed with his "regular" colleagues in what saving a life looks like, but the result is the same: more time.
More time to do what?
That's when it occurred to me that more life and better life are not especially relevant to framing these questions of duration and value. I've seen cases in which a baby dying in childbirth caused a tectonic change for good in the life of a family. A very short life that changed the lives of others.
Nothing we do will last. No life we save will be saved forever. Lives we save may not change. In the end, there is only The End. Then why do we do it?
It was then I thought of what I have observed in my practice. I am not always successful, and sometimes when I am successful, I later learn that the person died anyway, of that problem or of something else, either spectacular or mundane. I connect this to others--doctors, nurses, therapists--and it is the same. No matter what we do, the victory will be fleeting.
So we all say, it's not how long you lived, it's what you did with your life. But how do I, or any of us, contextualize this then?
It was then I thought that Hahnemann was right for his time, but not right for all time. The highest calling for any of us is to relieve the suffering of others. And that's a calling that demands more than any medicine we can deliver with all our technologies, homeopathic, allopathic, or otherwise.
When I began this journey, I hoped that I had found a way of cheating Death. As a child I feared disease. Hospitals scared me. My precocious head was filled with fears of brain tumors and leukemia, and more exotic fears like scleroderma and myasthenia gravis. In nursing school--a school I entered because I sought a portable, well-paying job while on my way to earning a living in the arts--I learned about so many more diseases, injuries, catastrophes that beset us at every turn.
After I graduated I began to explore alternative medicine because I found it interesting. I was attracted to the rococo beauty of things like traditional Chinese medicine. Homeopathy, however, seemed above the other things I was learning about, so tiny, so subtle, and most of all it appeared to me to be a link to some medical magic that could forestall the seeming random assault of these many diseases.
In homeopathic medical school, I met a former student, a young physician, who was said by our teacher to be something of a genius at the art. He was what the rest of us aspired to be. He also had colon cancer, and in his 30s, he died of this disease, despite homeopathy and everything else. I've seen similar things among those who diet and exercise and eat only organic foods and practice yoga and don't smoke and don't drink alcohol and pray every day--and those who climb mountains.
So it seems the only "magic" is in us, not the wands we wave or the potions we carry. And that magic is limited to relief, to kindness, to creating a space for hope. That's it. That's all we get. So I guess I'm making the best of that, whether I have a few more days or 30 more years.
I read this morning that Junko Tabei died in Japan. Tabei was the first woman to conquer the "Seven Summits", the tallest peaks on each of the seven continents around the world. Her long career in mountain climbing occurred over the last 40+ years. She died, at 77, of cancer. She kept up some mountaineering while undergoing treatment.
After I read that, I lingered in bed awhile, thinking about a life worth remembering. I started thinking about my own lifespan, and my parents'. I thought that if I die at 77, then I have about 22 years left. I thought about what happened in my life, what I did and didn't do, over the last 22 years. My mom is 78, and she's still alive. Ok, maybe I get 23. My dad's 81, so maybe I could last 26 more years. My wife has survived cancer and she's 59; her father died of cancer at 68, but her mother--living with multiple sclerosis for over 50 years--didn't die until she was 91...
Or maybe I get hit by a truck tomorrow! You never know.
Don't imagine that I was looking back (or forward) with regret for what I've done and haven't done. Granted, we all have things we regret, but for the most part, I let go of that some time ago. I feel like I'm doing what I want to do and what I should do. I goof off, too, but that's part of life's fun, isn't it?
No, this isn't a retrospective on my life or anyone's, and it's not a wet-eyed missive on the importance of "living life to the fullest." Rather, it made me think about why we--in this business of healing and health care--do what we do.
People get into this business for a variety of reasons: a stable job, intellectual challenge, a love of others, and a wish to relieve suffering. The highest aim, though, is sung by The Fray's Isaac Slade: "to save a life." This is what I was thinking about, "saving" life. From this spun a web of other things.
I'm a homeopath. I'm also a scientist. As a scientist I know that science may one day decidedly judge that homeopathic medicine isn't a thing. The remedies are sugar pills. The improvements are illusions, accidents, and placebo effects. And my career of treating patients with this method was a waste of effort. The materialist model of treatment was correct all along.
Or, I could be right. Science may show that everything we have observed and theorized about homeopathy since Hahnemann coined the term is pretty close to the truth, and we, the crackpots, were on the leading edge.
If I'm wrong, was my life wasted? If I'm right, was it justified?
Hahnemann left the "regular" medicine of his time because he felt it caused more suffering than good. In Aphorism 1 of the Organon he states that the physician's highest calling is to make the sick healthy. His conception of this strange new medicine, this "homeopathic" medicine, was that it should make healing genuine, that it should extend, or save, a life. He differed with his "regular" colleagues in what saving a life looks like, but the result is the same: more time.
More time to do what?
That's when it occurred to me that more life and better life are not especially relevant to framing these questions of duration and value. I've seen cases in which a baby dying in childbirth caused a tectonic change for good in the life of a family. A very short life that changed the lives of others.
Nothing we do will last. No life we save will be saved forever. Lives we save may not change. In the end, there is only The End. Then why do we do it?
It was then I thought of what I have observed in my practice. I am not always successful, and sometimes when I am successful, I later learn that the person died anyway, of that problem or of something else, either spectacular or mundane. I connect this to others--doctors, nurses, therapists--and it is the same. No matter what we do, the victory will be fleeting.
So we all say, it's not how long you lived, it's what you did with your life. But how do I, or any of us, contextualize this then?
It was then I thought that Hahnemann was right for his time, but not right for all time. The highest calling for any of us is to relieve the suffering of others. And that's a calling that demands more than any medicine we can deliver with all our technologies, homeopathic, allopathic, or otherwise.
When I began this journey, I hoped that I had found a way of cheating Death. As a child I feared disease. Hospitals scared me. My precocious head was filled with fears of brain tumors and leukemia, and more exotic fears like scleroderma and myasthenia gravis. In nursing school--a school I entered because I sought a portable, well-paying job while on my way to earning a living in the arts--I learned about so many more diseases, injuries, catastrophes that beset us at every turn.
After I graduated I began to explore alternative medicine because I found it interesting. I was attracted to the rococo beauty of things like traditional Chinese medicine. Homeopathy, however, seemed above the other things I was learning about, so tiny, so subtle, and most of all it appeared to me to be a link to some medical magic that could forestall the seeming random assault of these many diseases.
In homeopathic medical school, I met a former student, a young physician, who was said by our teacher to be something of a genius at the art. He was what the rest of us aspired to be. He also had colon cancer, and in his 30s, he died of this disease, despite homeopathy and everything else. I've seen similar things among those who diet and exercise and eat only organic foods and practice yoga and don't smoke and don't drink alcohol and pray every day--and those who climb mountains.
So it seems the only "magic" is in us, not the wands we wave or the potions we carry. And that magic is limited to relief, to kindness, to creating a space for hope. That's it. That's all we get. So I guess I'm making the best of that, whether I have a few more days or 30 more years.
Sunday, October 9, 2016
Private Health: American Individualism and the Tyranny of Evidence
I've criticized the two main sides in the vaccine "debate" previously. One of the things I made clear concerned the personal nature of health care decisions in American culture. Not that other cultures don't share some similar values, such as avoiding harm, doing good, and confidentiality. They do. But many state-run or "single payer" systems are operated on the premises that health care is a right of the citizenry and that therefore all citizens must contribute to the general welfare.
This basically means that the people as a society make sure that everyone has health care. In the US, this has often been interpreted as everyone has terrible health care, which is rationed and miserable. However, most Britons and Canadians like their systems. You get sick. You go to the doctor. You get treated, and you leave better. Simple.
There are problems, but they aren't as bad as they're made out to be. Yes, sometimes people wait for elective procedures. The systems can be overburdened. Like any public enterprise, these things go through good times and bad. Political neglect can lead to actual neglect and poor service or shortages or mismanagement. These systems may be closed (Canada) or open (Britain), meaning there may or may not be a legal cash system outside of the national health service. I'm really simplifying this a bit, so bear with me. But this does describe the essentials, and many countries operate this way.
We here in America have criticized ourselves soundly for our failure to pick up these habits of advanced societies. Of course, by a lot of metrics we do have some pretty bad stats--higher infant mortality, lower life expectancy, much higher costs, and so on. But still, are we that bad?
America is "the land of opportunity." We value the frontier. Although that frontier has become less physical and more metaphorical: we pursue the edge of things, space, medicine, technology. It makes sense that ours is a "free market medicine" opening the doors to creativity and innovation.
These other societies that have centralized their health care delivery and payment streams have managed to achieve remarkable gains in health and longevity. That is true. But perhaps ours is a different metric. Perhaps we measure health as much by our perceptions as we do by our statistics.
I hear a lot of complaints about doctors, medicine, hospitals--but that happens everywhere. Sick people aren't at their best, and to the sick the world can seem a sour place. And mistakes and misadventures happen in all systems of health care delivery, regardless of who's paying the bills. So it also makes sense that our system, despite its obvious faults, "works" in that it imbues us with a sense that the impossible is possible.
I support single payer health care. It's parsimonious and efficient, and it can be humane and expeditious, if supported properly. But I do begin to understand why it's so hard for many in our culture to accept that communitarian health care is to be rejected as a policy change. It robs us of our power, although arguably there's no evidence that Britons feel "robbed" of anything. It is possible here to pay for anything. It is harder in Britain--they make choices that to Americans feel like a defeat. If everything can be done it should be done, regardless of the cost, although held in check somewhat when the "everything" is painful, tortuous, and causes it's own suffering when the benefit really is small.
Recently I helped a family member navigate a new health problem that had all the earmarks of "going bad"--and by this I mean an ever-growing list of tests that obscure more than they reveal, and would expose this family member to an ever-growing list of potential side effects, medical misadventures, and puzzling-but-likely-inconsequential findings that would require "further investigation" but lead to nothing.
This, I have seen before.
The thing that brought me into the picture was the cost of a special type of MRI that the insurance wouldn't cover. This was not because the insurance company is mean, but because experts there know that risks would exceed the benefits at moment in the diagnostic process, and they would pay for a different kind of test--one I might add that is a bit painful for the patient!--but one that would yield more useful diagnostic data in the process. My relative didn't want to pay for her daughter's uncovered special MRI if there was no good reason to do so, but she was a bit peeved at the insurance company.
This is how people experience the "tyranny" of evidence: the evidence pointed to not pursuing the testing that my relative intuitively felt would be more useful to sorting out her daughter's problem. This is understandable, and in my view it's also the reason why Americans instinctively turn away from the possibility of single-payer health care.
In short, we don't want a system that uses evidence to guide health care decision-making because we fear we won't get the care we think we need. We are willing to suffer the inefficiencies and excess costs of our current system because each of us wants what we feel is the "very best."
There's a wrinkle in this argument, and it's similar to the wrinkle in my family member's health care adventure.
If the original operators who evaluated her had done a careful history and thorough physical exam perhaps they'd have found what I did, that the "problem" which seemed on its face so dire was really a less serious problem, nothing that would require extensive, expensive, and painful testing, and nothing that would require the specialists to whom she had been referred.
So, it's not the means of delivery, but the means of execution of our health care that perhaps we ought to be concerned with. I'm not proposing that every clinician needs the clinical acumen of TV's Dr. Gregory House. But heck, I'm just a nurse practitioner and I figured it out!
I propose that the problem is not how we pay for health care, nor who controls the delivery, whether it's insurance companies or a government agency. The problem is that clinicians have become mentally lazy. Listening with empathy, hearing the patient's story while mentally framing that story with basic principles from anatomy, physiology, and pathology, and doing a careful, attentive examination would save more money, deliver more effective care, and produce more healthy, satisfied patients, than anything else we could do with system organization.
I started this blog entry over a week ago. The event I described happened just a week ago--so it closes out the theme in the title in a way I didn't initially expect. It's not about who will pay for health care, nor how it will be paid for. Ultimately, we as a society have to figure out how much waste and inefficiency we will tolerate, and how much control we will cede to others (whether it's an insurance company or a government is merely a matter of aesthetics!).
If I sound a bit sour toward my colleagues in health care, it's on this deeper point concerning the actual clinical encounter. My family member's health concern was treated by decent people, I'm sure. But those same people (one, a specialist) got all tied up in fruitless speculation and punted to exotic tests without good cause. I realize the pressure to order tests that clinicians are under. But I have universally found that simply explaining one's reasoning process and the potential hazards and inconveniences of excess testing soothes people. It's not that you're being stingy, you're acting in their interest.
And by the way, my family member's doing fine. It seems all will be well at this point. It just took a bit of thought and kind, non-technical explanation.
I've criticized the two main sides in the vaccine "debate" previously. One of the things I made clear concerned the personal nature of health care decisions in American culture. Not that other cultures don't share some similar values, such as avoiding harm, doing good, and confidentiality. They do. But many state-run or "single payer" systems are operated on the premises that health care is a right of the citizenry and that therefore all citizens must contribute to the general welfare.
This basically means that the people as a society make sure that everyone has health care. In the US, this has often been interpreted as everyone has terrible health care, which is rationed and miserable. However, most Britons and Canadians like their systems. You get sick. You go to the doctor. You get treated, and you leave better. Simple.
There are problems, but they aren't as bad as they're made out to be. Yes, sometimes people wait for elective procedures. The systems can be overburdened. Like any public enterprise, these things go through good times and bad. Political neglect can lead to actual neglect and poor service or shortages or mismanagement. These systems may be closed (Canada) or open (Britain), meaning there may or may not be a legal cash system outside of the national health service. I'm really simplifying this a bit, so bear with me. But this does describe the essentials, and many countries operate this way.
We here in America have criticized ourselves soundly for our failure to pick up these habits of advanced societies. Of course, by a lot of metrics we do have some pretty bad stats--higher infant mortality, lower life expectancy, much higher costs, and so on. But still, are we that bad?
America is "the land of opportunity." We value the frontier. Although that frontier has become less physical and more metaphorical: we pursue the edge of things, space, medicine, technology. It makes sense that ours is a "free market medicine" opening the doors to creativity and innovation.
These other societies that have centralized their health care delivery and payment streams have managed to achieve remarkable gains in health and longevity. That is true. But perhaps ours is a different metric. Perhaps we measure health as much by our perceptions as we do by our statistics.
I hear a lot of complaints about doctors, medicine, hospitals--but that happens everywhere. Sick people aren't at their best, and to the sick the world can seem a sour place. And mistakes and misadventures happen in all systems of health care delivery, regardless of who's paying the bills. So it also makes sense that our system, despite its obvious faults, "works" in that it imbues us with a sense that the impossible is possible.
I support single payer health care. It's parsimonious and efficient, and it can be humane and expeditious, if supported properly. But I do begin to understand why it's so hard for many in our culture to accept that communitarian health care is to be rejected as a policy change. It robs us of our power, although arguably there's no evidence that Britons feel "robbed" of anything. It is possible here to pay for anything. It is harder in Britain--they make choices that to Americans feel like a defeat. If everything can be done it should be done, regardless of the cost, although held in check somewhat when the "everything" is painful, tortuous, and causes it's own suffering when the benefit really is small.
Recently I helped a family member navigate a new health problem that had all the earmarks of "going bad"--and by this I mean an ever-growing list of tests that obscure more than they reveal, and would expose this family member to an ever-growing list of potential side effects, medical misadventures, and puzzling-but-likely-inconsequential findings that would require "further investigation" but lead to nothing.
This, I have seen before.
The thing that brought me into the picture was the cost of a special type of MRI that the insurance wouldn't cover. This was not because the insurance company is mean, but because experts there know that risks would exceed the benefits at moment in the diagnostic process, and they would pay for a different kind of test--one I might add that is a bit painful for the patient!--but one that would yield more useful diagnostic data in the process. My relative didn't want to pay for her daughter's uncovered special MRI if there was no good reason to do so, but she was a bit peeved at the insurance company.
This is how people experience the "tyranny" of evidence: the evidence pointed to not pursuing the testing that my relative intuitively felt would be more useful to sorting out her daughter's problem. This is understandable, and in my view it's also the reason why Americans instinctively turn away from the possibility of single-payer health care.
In short, we don't want a system that uses evidence to guide health care decision-making because we fear we won't get the care we think we need. We are willing to suffer the inefficiencies and excess costs of our current system because each of us wants what we feel is the "very best."
There's a wrinkle in this argument, and it's similar to the wrinkle in my family member's health care adventure.
If the original operators who evaluated her had done a careful history and thorough physical exam perhaps they'd have found what I did, that the "problem" which seemed on its face so dire was really a less serious problem, nothing that would require extensive, expensive, and painful testing, and nothing that would require the specialists to whom she had been referred.
So, it's not the means of delivery, but the means of execution of our health care that perhaps we ought to be concerned with. I'm not proposing that every clinician needs the clinical acumen of TV's Dr. Gregory House. But heck, I'm just a nurse practitioner and I figured it out!
I propose that the problem is not how we pay for health care, nor who controls the delivery, whether it's insurance companies or a government agency. The problem is that clinicians have become mentally lazy. Listening with empathy, hearing the patient's story while mentally framing that story with basic principles from anatomy, physiology, and pathology, and doing a careful, attentive examination would save more money, deliver more effective care, and produce more healthy, satisfied patients, than anything else we could do with system organization.
I started this blog entry over a week ago. The event I described happened just a week ago--so it closes out the theme in the title in a way I didn't initially expect. It's not about who will pay for health care, nor how it will be paid for. Ultimately, we as a society have to figure out how much waste and inefficiency we will tolerate, and how much control we will cede to others (whether it's an insurance company or a government is merely a matter of aesthetics!).
If I sound a bit sour toward my colleagues in health care, it's on this deeper point concerning the actual clinical encounter. My family member's health concern was treated by decent people, I'm sure. But those same people (one, a specialist) got all tied up in fruitless speculation and punted to exotic tests without good cause. I realize the pressure to order tests that clinicians are under. But I have universally found that simply explaining one's reasoning process and the potential hazards and inconveniences of excess testing soothes people. It's not that you're being stingy, you're acting in their interest.
And by the way, my family member's doing fine. It seems all will be well at this point. It just took a bit of thought and kind, non-technical explanation.
Saturday, September 10, 2016
Zika...and Dementia?
The British online Mirror reported late last month on a study that appeared in Cell: Stem Cell by Hongda Li and colleagues at the LaJolla Institute of Allergy and Infectious Diseases. We already know that Zika can affect the brain development of the fetus, leading to microcephaly (small brain) in babies. The Mirror reports that the LaJolla study's authors suggest that Zika can infect and affect the brains of adult mammals as well...and may lead to dementia.
I read the study, which is available online, and indeed the mice they studied did show evidence of damage to special parts of the little mouse brains that are responsible for growing new brain cells. For a long time we thought that nerve cells were the only cells that didn't grow more after birth. Indeed, even our skeletons are entirely replaced--cell by cell--over the course of a decade. It turns out that nerve cells can also be and are being replaced, at least in our brains, and that they grow new connections when stimulated. This is the basis of the so-called "brain games" that have become popular: challenge your brain and grow new cells and connections. Get smarter--or at least preserve what you have.
Although the authors' conclusions in the published study are justifiably cautious and include careful scientific disclaimers about the some of the dissimilarities between mouse and human brains, they acknowledge that implications include the possibility that Zika virus infection in humans may contribute to various brain-based problems like memory loss, learning problems, and other neurological issues.
Let me stress that this is very early research. No scientist has linked Zika to actual human adult brain damage!
Part of what makes this interesting to me is the fact that the article in the Mirror pushes this preliminary finding--from a mouse brain model--out to the general public. It seems a bit glib, but scaring people into believing Zika might also cause adult-onset dementia must surely get "clicks."
Another part I find interesting is because I am a homeopath.
The researchers published their findings, and it's evident that they, like most scientists, view biology as a set of intricately interacting, but ultimately understandable, connections of tiny chemical structures interacting in a completely mechanistic way. It's clear in this model that all those chemical interactions are deterministic, except to the extent that chance encounters could also influence their ultimate expression. Put another way, we are the sum of millions of tiny chemical interactions, that if known would mean we can fully predict the development and treatment of disease. The only wild card would be random environmental interactions such as trauma, toxins, and radiation. Add to that an element of really random luck in how genes express themselves (which may or may not be true), and it's thought we can someday explain the whole thing.
In some systems of medical philosophy, like homeopathy, it is believed that ways in which this mechanistic model of biology attempts to account for everything that can happen (and thus how we can fix it all) lacks a certain piece. That piece is the subject of a lot of speculation, but what is not in doubt is that weird, unexplainable things do happen. The speculation is over why.
In Eastern Asian systems of medicine we talk about qi ("chi" or "chee"). In homeopathy, Hahnemann names it the "vital force" or dynamis (Aphorism 9). In other systems it goes by other names: energy field, dynamic field, organismic "vibration", and so on. This is a widespread idea, but could still be dismissed as the pervasiveness of mystical or magical thinking around the world and present in many cultures. Scientists of a materialist philosophical bent could be right. We just haven't figured out quite how all the parts work in synchrony and in disturbance.
Or, they could be wrong.
Granted, these "fields" or qi or whatever could be all wrong, but I doubt it. I think we just haven't quite gotten to a philosophy or technology that allows us to see what's really going on. That's my bias, and I'll own that. But that doesn't mean I'm wrong.
If life is governed by some sort of unifying field, it may be possible to manipulate that field, or at least understand how it becomes disturbed and causes organisms to sicken, suffer, and die. If it were so, and we already had some means of influencing that governing force, wouldn't that be worth exploring?
This week, as I do every week, I saw several people suffering from things seemingly unresponsive to regular medicine, things that seemed to "just happen". Some of them were new to me, and I'll have to wait and see if this thing called homeopathy works for them. Others were familiar, and we were following up to examine the effects of this supposedly "quack" medicine. The follow-ups were satisfying for the most part, examples of a system invented by a German crank 200 years ago because he took the time to really pay attention to what was going on with his patients. We don't fix everyone, and indeed some problems are better repaired by the materialism of regular medicine and surgery. But we fixed some people who were at their wits end.
If Zika does infect and affect human brains, is it possible that we already have at least some means to make people more resistant to it, or cure potentially disastrous effects? I haven't seen any verifiable cases of Zika yet at this latitude, but stay tuned.
The British online Mirror reported late last month on a study that appeared in Cell: Stem Cell by Hongda Li and colleagues at the LaJolla Institute of Allergy and Infectious Diseases. We already know that Zika can affect the brain development of the fetus, leading to microcephaly (small brain) in babies. The Mirror reports that the LaJolla study's authors suggest that Zika can infect and affect the brains of adult mammals as well...and may lead to dementia.
I read the study, which is available online, and indeed the mice they studied did show evidence of damage to special parts of the little mouse brains that are responsible for growing new brain cells. For a long time we thought that nerve cells were the only cells that didn't grow more after birth. Indeed, even our skeletons are entirely replaced--cell by cell--over the course of a decade. It turns out that nerve cells can also be and are being replaced, at least in our brains, and that they grow new connections when stimulated. This is the basis of the so-called "brain games" that have become popular: challenge your brain and grow new cells and connections. Get smarter--or at least preserve what you have.
Although the authors' conclusions in the published study are justifiably cautious and include careful scientific disclaimers about the some of the dissimilarities between mouse and human brains, they acknowledge that implications include the possibility that Zika virus infection in humans may contribute to various brain-based problems like memory loss, learning problems, and other neurological issues.
Let me stress that this is very early research. No scientist has linked Zika to actual human adult brain damage!
Part of what makes this interesting to me is the fact that the article in the Mirror pushes this preliminary finding--from a mouse brain model--out to the general public. It seems a bit glib, but scaring people into believing Zika might also cause adult-onset dementia must surely get "clicks."
Another part I find interesting is because I am a homeopath.
The researchers published their findings, and it's evident that they, like most scientists, view biology as a set of intricately interacting, but ultimately understandable, connections of tiny chemical structures interacting in a completely mechanistic way. It's clear in this model that all those chemical interactions are deterministic, except to the extent that chance encounters could also influence their ultimate expression. Put another way, we are the sum of millions of tiny chemical interactions, that if known would mean we can fully predict the development and treatment of disease. The only wild card would be random environmental interactions such as trauma, toxins, and radiation. Add to that an element of really random luck in how genes express themselves (which may or may not be true), and it's thought we can someday explain the whole thing.
In some systems of medical philosophy, like homeopathy, it is believed that ways in which this mechanistic model of biology attempts to account for everything that can happen (and thus how we can fix it all) lacks a certain piece. That piece is the subject of a lot of speculation, but what is not in doubt is that weird, unexplainable things do happen. The speculation is over why.
In Eastern Asian systems of medicine we talk about qi ("chi" or "chee"). In homeopathy, Hahnemann names it the "vital force" or dynamis (Aphorism 9). In other systems it goes by other names: energy field, dynamic field, organismic "vibration", and so on. This is a widespread idea, but could still be dismissed as the pervasiveness of mystical or magical thinking around the world and present in many cultures. Scientists of a materialist philosophical bent could be right. We just haven't figured out quite how all the parts work in synchrony and in disturbance.
Or, they could be wrong.
Granted, these "fields" or qi or whatever could be all wrong, but I doubt it. I think we just haven't quite gotten to a philosophy or technology that allows us to see what's really going on. That's my bias, and I'll own that. But that doesn't mean I'm wrong.
If life is governed by some sort of unifying field, it may be possible to manipulate that field, or at least understand how it becomes disturbed and causes organisms to sicken, suffer, and die. If it were so, and we already had some means of influencing that governing force, wouldn't that be worth exploring?
This week, as I do every week, I saw several people suffering from things seemingly unresponsive to regular medicine, things that seemed to "just happen". Some of them were new to me, and I'll have to wait and see if this thing called homeopathy works for them. Others were familiar, and we were following up to examine the effects of this supposedly "quack" medicine. The follow-ups were satisfying for the most part, examples of a system invented by a German crank 200 years ago because he took the time to really pay attention to what was going on with his patients. We don't fix everyone, and indeed some problems are better repaired by the materialism of regular medicine and surgery. But we fixed some people who were at their wits end.
If Zika does infect and affect human brains, is it possible that we already have at least some means to make people more resistant to it, or cure potentially disastrous effects? I haven't seen any verifiable cases of Zika yet at this latitude, but stay tuned.
Monday, August 29, 2016
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.
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.
Sunday, August 7, 2016
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.
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.
Friday, July 22, 2016
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
- 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.)
Tuesday, July 12, 2016
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.
Sunday, July 3, 2016
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.
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.
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