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.


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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.

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.