Dannon Takes a $21 Million Dollar Hit for Bogus Health Claims………

Dannon, the makers of Activia yogurt and DanActive drinks, has been fined $21 million dollars by the FTC for deceptive advertisements involving specific health claims. Specifically, they claim that their products can make you poop and keep you from catching a cold or the flu. Not smart. Really not smart. But it doesn’t matter because they will still come out on top.

The FTC has been trying (bless their little hearts) to crack down on misleading claims in advertisements, and I appreciate the effort. Thanks to the emasculation of the FDA by the 1994 Dietary Supplement and Health Education Act (DSHEA), the FTC is the only governmental regulatory body that can put a stop to them. In this case, as the linked article explains, it is likely too little and too late. Dannon has been pushing their products with these bogus claims for years and they are widely accepted by the public. $21 million dollars is a minor slap on the wrist and just the cost of doing business these days.

To catch any readers not familiar with DSHEA up to speed, it fundamentally changed the way that supplements and herbal remedies are regulated, making us all a lot less safe as a result. Post-DSHEA, regulation of the supplement industry, and even the more mainstream over-the-counter medicine industry (they are actually pretty much all the same thing these days), essentially works like old wild west law enforcement. Manufacturers can pretty much do as they please as long as they don’t make specific disease claims, such as that their product cures asthma, and as long as they don’t kill anybody. Well, as long as they don’t kill too many people.

Under DSHEA, the burden of proof for safety, efficacy and label accuracy belongs to the FDA. That may not sound bad but trust me, it is. There are hundreds of new products in this category that come out yearly and the FDA does not have the resources to investigate all of them. So there has to be some kind of triage system in place. A company can package a product, such as a so-called herbal remedy, and as long as they stick to what have come to be known as structure and function claims (“immune support” or “cardiac health”) they won’t be noticed by the FDA. They don’t need any evidence that their product is safe or that it is effective in any way. They don’t have to be honest about what is on the label in regards to ingredients. Nobody is checking on these things. It is an honor system and it has killed people.

Take ephedra for example. Ephedra is an herb that has been used traditionally for things like colds and asthma, as well as for increasing energy and for weight loss. It is understandable that pre-scientific cultures came to associate ephedra with these conditions because it is a potent stimulant. It constricts blood vessels, increases the heart rate and blood pressure, and it opens up airways in the lungs. Because of this effect it was investigated as a potentially beneficial medicine but the side effect profile was rough and better medications were developed. Science-based medical practice had no place for ephedra but it became an increasingly popular component in supplements taken by people desiring improved athletic performance or weight loss. It still isn’t clear whether or not it actually has much of an effect, if any, in regards to those desired outcomes, but it quickly became very clear that it was dangerous.

For years, thousands reports of adverse events came in to the manufacturers of products containing ephedra. These reports included deaths from strokes and heart attacks. These adverse events, including deaths, occurred not only in unhealthy people with risk factors for such outcomes but also in healthy young adults. Finally the FDA decided to step in, and in the late 90’s proposed label warnings. This was met with a campaign by the supplement industry and their lobbyists, as well as the two senators (Hatch and Harkin) responsible for DSHEA in the first place, to put a stop to this. They succeeded and unsuspecting consumers continued to suffer.

Then the tide turned. Additional evidence supporting the FDA concerns about ephedra came along, and public awareness of these concerns and calls for action increased. But it wasn’t until 2004 that the sale of ephedra was made illegal, after many thousands of serious adverse events were uncovered that had been purposefully kept from the FDA by a supplement manufacturer and after a large and expensive meta-analysis was conducted that clearly showed just how dangerous ephedra was. Even this was bitterly contested by the supplement industry but appeals were denied and ephedra remains banned in America.

DSHEA allowed this to happen. If supplements and herbal remedies were regulated like the sloppy drugs that they are, manufacturers of products with ephedra would have needed to provide appropriate evidence that they were safe. The tale of ephedra puts the lie to the fallacy that natural equals safe and should have served as a cautionary tale and impetus to improve the system. It didn’t, so you the consumer must be weary.

This came out today. I’ve read about many cases of adulterated herbs and supplements, usually Viagra spiked male “enhancement” pills, but things are much worse than I thought. Warfarin? Benzos? Damn. And that’s here in America folks.

Reader Feedback #1: I’m a Closed-Minded Denialist

I recently received the following response on the “About Red Stick Skeptic” section of my blog:

“I totally understand the need for skeptism and critical thinking in this day and age. We have become much more focused on the almighty $ than anything else. However, to lump all alternative medicine practioners/practices into the category of pseudoscience is not only shortsighted but misleading. Some of these therapies have been around longer than medicine and have stood the test of time.

I know that we are all essentially wired the same, however, how we respond to certain things can be completely different. So just because one person does not respond favorably to a particular therapy does not mean the next person won’t.

Skepticism is healthy, denial is not. Millions of people have been helped in some way, shape, or form from alternative therapies. Have an open mind and ask questions, but try things for yourself and let your body determine what’s right for you.”

This may seem like a reasonable criticism at first glance. Skepticism, the commentor remarks, is healthy while denial(ism) is not. That is probably very true, although I have a feeling that we disagree on just what defines these terms. I doubt that the commentor understands the practice of skepticism, which is more than just having and open mind and asking questions, although both are important. He is a pseudoskeptic. Like the pseudoscientist who makes use of the trappings of science to give the appearance that legitimate investigation is taking place, he uses skeptical terminology and professes his appreciation for critical thinking. He knows some of the lingo, but this is merely subterfuge.

Psuedoskepticism is sometimes an intentional act employed to fool others by giving claims an air of undeserved legitimacy. “Hey, I’m a skeptic and I really believe in this stuff!” Many people intuitively know to be wary of obvious salesman, although they do tend to leave this inherent skepticism at home when they seek relief for what ails them.  Or it occurs as a mechanism to avoid cognitive dissonance, to better convince oneself that the bunk they are spouting is the real deal.  I suspect that the commentor falls into the latter category and is himself denying the robust evidence that exists refuting the personal belief in alternative medicine that he is so invested in emotionally, and likely economically. But I’m an optimist.

Skepticism calls for the provisional acceptance of claims based on scientific evidence and plausibility. The greater the evidence, the less plausible a claim must be to be accepted. Some seemingly outlandish hypotheses have come to be accepted because the evidence is clear and powerful. (An expanding universe? My ancestors were apes? What the heck?) The greater the plausibility, the less robust the evidence needs to be for the skeptic to tentatively accept the claim.  But there must still be evidence, however, and that evidence must still be scientifically sound. 

We place greater or lesser importance on evidence based upon its type. Trying things for oneself and letting one’s body determine what is right, as was recommended in the above comment, is anecdotal and subject to being impacted by countless biases and confounding factors. Not suprisingly, it is the weakest form of evidence when it comes to figuring out whether or not a treatment works. Calling for me or my readers to base acceptance on this is a huge red flag indicating that we are dealing with a believer rather than a skeptic. Regardless, there is always the risk of improperly including individuals or practices in one classification if you overgeneralize or make straw man arguments. We should always remain open-minded to new ideas. We shouldn’t ignore evidence because of an idealistic or dogmatic set of beliefs. All of these are valid points, all true sentiments. And all are clearly empty words when read in the context of the entire comment.

It is implied that I am unfairly claiming that all alternative medicine modalities are pseudoscience and their practitioners frauds. He claims this is shortsighted because some of these therapies have been around for hundreds of years and have stood up to the test of time. Millions of people, he reveals, have been helped in “some way, shape, or form” by alternative therapies. That is rather nebulous but that many people can’t be wrong. Right? Well, how have they been helped exactly? Make a specific claim and I’ll address it. There are many examples throughout history of lots of people being fooled and the bottom line can be summed up with the well worn skeptical axiom, “The plural of anecdote is anecdotes, not evidence.”

It is ironic, and just plain wrong, for a skeptic to use an argument from antiquity or an argument from popularity as support for my being shortsighted. These supposedly ancient therapies, acupuncture often coming up in this context, have had centuries or longer to prove themselves and continued existence is a poor marker for true efficacy. Physicians and other healers bled patients for more than a thousand years, all claiming just as vehemently that the benefit was clear. They did so in pre-scientific times and thus have somewhat of an excuse for killing their patients in an earnest attempt to save their lives. But times have changed and the age of science has brought a better understanding of the natural world. Bloodletting was a casuality of this advanced ability to lift the veil of ignorance, along with the humoral system of medicine that birthed it.

A healing therapy can survive and manitain popularity for a variety of reasons, even when it is ineffective. The only way to root out therapies that work from the countless examples of those that at best serve as placebos, or at worst cause harm, is the scientific method properly applied. Good science has been used to investigate these therapies and the verdict is in: There are no alternative medical therapies that have proven benefit for any human ailment beyond that of placebo. A great deal of bad science has unfortunately been used to propel these modalities further into public awareness and even into hallowed halls of many academic institutions. This is a trend that has worsened over the past few years and shows no signs of slowing down. It is quite accurate to refer to therapies as pseudoscientific that are bolstered with bogus and meaningless scientific jargon (human energy fields, cellular vibrational frequencies, etc) and badly designed studies (no placebo control, anomaly hunting, etc).

It would be quite unfair, however, for me to lump all practitioners of pseudoscientific therapies into the category of fraudulent hucksters and snake-oil salesman. I don’t know what is truly in the hearts of these folk. I have no doubt that some of them are dishonest and know that they are selling lies but I am equally sure that some honestly believe in their practice or product. It is easy to be fooled into thinking that something works when it doesn’t. I don’t attack the person, I focus on the idea, and in the world of alternative medicine the idea is rotten and needs to be thrown out with yesterday’s copy of Fortean Times.

There is good science taking place every day that focuses on areas considered, wrongly, to be alternative medicine, and there have been many great successes. Many of the effective components of our pharmaceutical armamentarium originated from the plant world, for instance. Study in this area continues and will likely yield future advances in medicine. Proponents of alternative medicine are quick to hold these successes up as evidence for the worth of alternative medicine in general but this is absurd and highlights the risk inherent in having a category of medicine which includes modalities as disparate as medicinal herbs and reiki. Imagine if I decided to treat a patient’s abdominal pain with an antihypertensive agent because penicillin is an effective treatment for strep throat. It is equally ridiculous to imply that because aspirin was derived from the willow that iridology is a legitimate modality for diagnosing lung cancer, or that echinacea is effective in treating the common cold. But this kind of reasoning takes place every day and my critic’s comment is saturated with it.  Using the sucess of one treatment labeled as alternative medicine, especially when it shouldn’t even be included in the group, to give legitimacy to another may be effective if your objective is widespread acceptance, but it is a dangerous double standard. 

Herbs, even if touted as safe and natural alternatives to conventional medicines, are merely drugs. Crude, unrefined and sloppy drugs. Of course there are likely to be herbs that have the ability to effect the physiology of the human body, and the low hanging fruit have been collected over the past couple of hundred years. The overwhelming majority of what is left over will have no effect, or will have a deleterious one. But there may be a supplement on a GNC store shelf somewhere that might hlep with a particular condition. The reality is that those who take that supplement are just as subject to the potential risk as they would be taking amoxicillin for an ear infection. Ephedra comes to mind quite easily. Without proper scientific investigation, it is a roll of the dice and that is assuming the contents actually match what is on the label. Many supplements have been found to contain pharmaceuticals. Viagra in male enhancers, for instance. There is nothing alternative about studying the natural world scientifically for possible benefit to mankind. It is alternative, however, when herbs or supplements are touted as natural and risk free cures when evidence is lacking or, as in many cases, after scientific evidence is clearly unsupportive.

The commentor agrees with me, and others who are decidedly smarter than me, that humans share some hardwiring. I don’t think he quite understands what we mean, however, but he certainly provides a fantastic example of it. When I say that the human brain is hardwired to respond to certain situations in fairly reproducible ways, I am talking about mental behaviors. We all employ certain heuristics, or rules of thumb applied to thinking, that help us efficiently make sense of our environment. This is an advantage in many instances, and helps set us apart from the rest of the animal kingdom, but it has its downside. We often sacrifice accuracy for efficiency. We jump to conclusions when we apply these mental shortcuts too broadly or place more importance on our gut conclusions than on scientific evidence. Logical fallacies, such as the appeal to antiquity and the argument from popularity, are examples of hardwiring that hinders our ability to correctly assign cause and effect relationships.

We are also similarly hardwired, although I don’t typically use that term in this setting, in the sense that we share a physiology that responds in a very predictable pattern to changes in our environment, to injury and illness and to foreign substances such as toxins or medications. This is one of the foundations upon which the scientific investigation of medical therapies relies upon to determine safety and efficacy. It all comes down to the basics of our physiology, which we have an impressive, although admittedly incomplete, grasp of. One of the findings of proper scientific inquiry into the treatment of human illness is that the more we treat every patient the same, the better the outcomes tend to be. 

Naturally we must take into account a number of psychosocial factors in addition to the biological ones, and there are ranges of variable response to our interventions. But much of this is due to factors that we have discovered and understand through the use of science. To claim that humans respond to treatments completely differently, however, is misleading. And to use that claim as impetus to seek out implausible and unproven remedies is risky. Where does one draw the line? How do we measure response and decide if it is favorable? How would we decide that any one treatment is not effective? If science is to be ignored, how would we decide what treatments should be attempted first, or which are too dangerous? Pseudoskeptics tend to avoid following this kind of thinking out to its logical conclusion, an approach to healthcare which would be a nightmare for patients and would quickly fail because of enormous expense and increases in morbidity and mortality.

Chiropractic Research on Tourette Syndrome: The Trouble with Case Reports…..

There has always been, and will likely always be, a disconnect between clinical practice and the results of well-designed research trials in the world of alternative medicine.  This has become an increasingly obvious fact over the past several years as alternative medicine has become incorporated into even our top-tier academic medical centers. Proponents of alternative medicine even have their very own government-funded research agency, the National Center for Complementary and Alternative Medicine, which puts over 100 millions dollars to use studying things like energy healing and homeopathy every year. And on a seemingly weekly basis, press releases and credulous news reports emerge with claims of new scientific research proving that believers in these unconventional modalities have been right all along. The curmudgeonly skeptics are often portrayed as  foolish, or worse, closed-minded.

What the vast majority of the patients seeking help from these snake-oil salesman don’t seem to realize, or at least don’t seem to care, is that alternative medicine is a house of cards built upon a foundation consisting of anecdotes, testimonials, cherry picked research practically designed to yield positive results, and the interference of lawmakers. Many physicians, now commonly referred to as “shruggies”, are uninterested in the reality behind alternative medicine and a growing minority actively support it. Naturally there are also a number of well-known celebrity practitioners and supporters of these therapies that serve as spokespersons for the industry. But what is unknown to the shruggies, and ignored or downplayed by the silver-tongued alternative medicine gurus, with their persuasive abilities eerily similar to leaders of religious movements, is that in many cases the definitive studies have been done, the question of efficacy answered. They may claim to integrate the best of both conventional and alternative medicine, but they know where their bread is buttered. So they forge ahead, touting anecdotes and inadequate research as proof. Proof that they don’t even need because their followers don’t really care what science has to say on the subject. Reality takes a backseat to belief.

The most common incursion of alternative medicine into published journals, most of which have impact factors only appreciable with the aid of a high-powered magnification device, is in the form of the case study. A rigorously documented case study can be a valuable thing, even if its place in the hierarchy of evidence is above only the undocumented anecdote and testimonial. They can be especially useful in determining that an all-inclusive assumption is in error, the classic example being that the existence of even one black swan disproves the statement that all swans are white. For an example in the practice of medicine, a single case report documenting Sickle Cell disease in a caucasian child of European ancestry is enough to prove that Sickle Cell disease does not occur only in patients with African ancestry. Case reports can also be helpful, especially in a series, in guiding future research. And in instances of rare conditions, case reports may be all that is available to guide therapy. But a case report, regardless of how well it is documented or of how good a journal it is published in, is incapable of answering the question of cause and effect. They can lead a researcher to a come up with a dandy hypothesis or, as occurs with much higher frequency, to waste time and money on a wild goose chase. A physician simply can’t say that a treatment works based on case reports and, as with personal anecdotes, the whole of the medical literature on a subject must be taken into account.

I was diagnosed with Tourette Syndrome when I was about seven years old. Bear with me, I promise that this isn’t a non sequitur. I have been very lucky in that my Tourette’s, after a rocky few years in middle school and early high school, is fairly mild. It is obvious to most people that I have a movement disorder, but it has never impacted my ability to function in society and to succeed in my chosen profession of pediatric medicine. In fact, I often think of my Tourette’s as a positive aspect of my life, believing that it helped shape who I am as a person. I feel that it helped instill in me positive personality attributes that are beneficial in the practice of medicine, such as empathy and compassion.

I have never needed treatment of any kind for my Tourette’s, but I have tried to keep up with the literature on various therapies, pharmaceutical and otherwise, for the condition. I usually stick to reputable sources but every now and then I like to go “slumming” in the world of chiropractic research. During my last trip across the border between science and pseudoscience, I discovered a gem which perfectly illustrates the trouble with case reports and with chiropractic. I stumbled on a press release for a case report published in late 2009 in the Journal of Pediatric, Maternal & Family Health – Chiropractic involving the year-long treatment of Tourette’s in a 20-year-old female. Not unexpectedly, the results were reported as positive. A quick google search using “chiropractic for Tourette’s” revealed almost 100,000 results, with many (I stopped counting at 100) individual chiropractors referencing this case report when calling for patients with Tourette’s to come in for treatment. They were not equivocal on the subject either but then again practitioners of alternative medicine don’t much care for nuance and subtlety. Warning bells should go off whenever a proposed abnormality, be it the chiropractic subluxation, stagnant chi, or liver flukes, causes every problem and has a ready made solution. So chiropractors are claiming to be able to cure or significantly impact the symptoms of Tourette’s, and this is the proof. Or is it?

The answer is of course no but I’ll explain. Tourette’s is a condition perfectly suited for placebo effects. It waxes and wanes in severity, with many sufferers experiencing periods of time during which their tics aren’t as forceful or frequent. Tourette’s is generally at its peak in early adolescence, or about ten years after diagnosis for most patients, but, and I hope this clearly shows why using such a case report as anything other than for lining your child’s hamster cage is granting it too much importance, two-thirds of Tourette’s patients experience remission or significant amelioration of their tics in late adolescence or early adulthood. The patient described in this case report was 20-years-old and the treatment took place over an entire year. It is very possible, if not highly likely, that the patient’s symptoms would have improved regardless of the therapy she sought out. Not taking into account the natural course of a condition tends to occur when you lack experience in diagnosing and caring for patients with that condition, and when your background in pediatric pathology involves a weekend course held at the airport Howard Johnson. I’d say its a rookie mistake, but chiropractic was invented in 1895.

The tics, whether motor or vocal, simple or complex, experienced by Tourette’s patients are unique. They can be suppressed, for a time, only to come back with a vengeance eventually. They are suggestible. They are effected by stress and by fatigue. And, like pain, there is a considerable subjective component to the movements and outbursts. One patient’s suffering with the condition may be much greater than another’s despite having the same tics in the same location. The potential factors at play are too numerous to list but to give one example, my most obvious tic, where I forcefully jerk my left arm outward and vigorously flex and extend my arm several times until it “feels right” doesn’t bother me when I’m sitting  in bed reading a good book, my bedside lamp safely out of reach. But ask me how I feel when sitting in a crowded movie theater with a stranger on my left who I really don’t want to elbow in the face. Now what if I had a job that required long shifts with close quarters, perhaps on an assembly line of some sort. Life could be pretty miserable. Life might suddenly become much less miserable if I was moved to a different location that allowed more breathing room. I might report a definite improvement in my quality of life, decreased stress, and subsequent decrease in severity of tics simply because my boss took my condition into account.

We don’t know what else was going on in the life of the patient in this case report. We don’t know about changes in her life that might have decreased her anxiety about the condition. Perhaps simply receiving a hands on treatment from a perceived authority figure certain that they can provide help caused a decrease in anxiety that led to her improvement. We don’t know if her improvement was simply because of the natural course of her Tourette’s. All we know is that she reported an improvement after a year of chiropractic care. Correlation does not necessarily equal causation as the old saying goes.

Another aspect of placebo involves reporting bias. Patients who are emotionally invested in a therapy are more likely to report positively. Patients who like their physician or other practitioner, such as a chiropractor for instance, are more likely to report positively. Patients in a study, or who are going to be written about in a case report, are more likely to report positively in order to please the person in charge who stands to gain from positive results. There are other well established psychological entities, such as cognitive dissonance, that motivate positive reporting. Nobody wants to feel foolish, for instance, wasting a year of their life and the money required to do so on a failed therapy. None of these can be accounted for in case reports such as this.

But is this case report even useful as a hypothesis generator? Does it support the authors’ calls for more research into the chiropractic subluxation as the etiology of Tourette’s and chiropractic spinal manipulation as a treatment? Once again, the answer is no. While the exact cause of Tourette’s is not established, there is expert consensus that it has a genetic origin and is a disorder involving the connections between the cortex and subcortex leading to abnormal synaptic neurotransmission. Some experts have raised the possibility of an autoimmune etiology, particularly related to infection with Group A Strep, but this is controversial. There is absolutely no legitimate concern regarding the possibility that impairment of spinal nerves, as is claimed to occur in the presence of chiropractic subluxation, is a factor. Sure there have been instances where experts have been wrong, and as a skeptic I always leave room for surprising discoveries, but the evidence required to overturn the current consensus would need to be extraordinary. For the chiropractic community to raise this possibility based on an isolated case report this worthless is laughable.

Complementary and Alternative Medicine in Pediatrics in Review Part#1

As a pediatrician striving to continuously maintain a current fund of medical knowledge, and an educator of medical students and residents, I have been consistently pleased with the information provided by Pediatrics in Review (PIR). This American Academy of Pediatrics publication serves as a source for continuing education for thousands of pediatricians, and as a solid resource for doctors in training. Unfortunately, as I explained in my last post, over the past couple years there have been a number of articles published in PIR on the subject of complementary and alternative medicine which I feel have largely missed the point. They have simply not lived up to the standards that I have come to expect.

First and foremost, I believe that the authors of these articles likely have had good intentions but were ill-informed and were relying on information from questionable sources such as the website of the National Center for Complementary and Alternative Medicine (NCCAM). Also, probably in a noble effort to provide a fair assessment of the topic, several authors have committed errors of false balance and false compromise. These occur when the reader is given the impression that a particular alternative medicine entity has evidentiary support equivalent to more mainstream modalities or that a compromise between alt med and science-based medicine is the best approach to health care. Reality does not in general support either of these contentions. To be quite honest, however, I also suspect that there is more than a little investigative laziness at play, and personal bias in some cases.

A good example of the weak coverage of alt med in PIR is the recently published article on “The Ethics of Complementary and Alternative Medicine” by Brenda J. Mears. In Dr. Mears’ discussion of the ethics of alt med, which is far from the worst example of what PIR has published in this genre, I found several objectionable statements and a seemingly naive understanding of the subject matter. I was impressed though with her inclusion of a number of specific risks for direct harm from CAM therapies, such as vertebral artery injury from chiropractic manipulation of the neck, and for her call for pediatricians to be more aware of CAM. In general, we are fairly ignorant of what goes on in “the real world”.

A red flag that should raise suspicion that an author has a poor grasp of the history, as well as the current state, of alternative medicine in the United States is the quoting of the NCCAM definition of complementary and alternative medicine (CAM). The NCCAM’s defining of CAM in general as “a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine” is about as helpful as defining the relationship between the three sides of any triangle as A squared plus B squared equals pineapple. In an equally useless fashion, and one which is also repeated nearly verbatim in Mears’ article, the NCCAM provides individual definitions for the trichotomous nature of what has come to be known as as just “CAM”. When used in place of conventional medicine, it is alternative. When used seperately but concurrently with conventional medicine, it is complementary. Finally, when alternative medicine is combined in a seemingly synergistic fashion with conventional therapy, it somehow magically transforms into integrative medicine.  It may be nice to have such easily digested categories, but they distract the uninitiated resident or pediatrician rather than help to provide any true understanding of the unrelated and often contradictory practices in question.  

Mears, once again borrowing information from NCCAM, expounds on the relationship between these categories and reveals, perhaps inadvertently, one of the key weaknesses with the concept. She writes, “The boundaries may blur, and some therapies once believed to be CAM, such as cognitive behavior therapy or prebiotic and probiotic use, now are considered by many to be conventional.” There is much wrong with this line of reasoning, and it illustrates perfectly why using CAM terminology is so problematic and uneccessary. The boundaries only blur because the boundaries the NCCAM use were manufactured to do just that, and in the process provide unearned respect for a host of unproven concepts and therapies. The true boundary, and it is a boundary between therapies not considered to be part of any CAM lexicon as well, is the one that seperates practices that work from those that do not, therapies that are safe from those that have not been proven to be so, and claims that have been subjected to scientific scrutiny from those that have thus far avoided it. This is all that matters.

CAM terminology promoted so heavily by the NCCAM and other proponents is about marketing, about obtaining awareness and acknowledgement without having to actually bring any evidence to the table other than anecdotes and testimonies. Thus, in reality, calling something alternative, complementary, integrative, or conventional for that matter, provides no real and useful information. Each of those categories contain within them treatments that have failed the test of science. And each of them contain treatments that have the potential to provide objective benefit in the treatment of human disease. The use of CAM terminology has led to the existence of a double standard where individual therapies, given the right label, are not judged on plausibility and scientific evidence. Instead they receive a free pass that allows the circumventing of a process that has led to advancements which have greatly decreased suffering in the world and added decades to our lifespan. And with the current “cerebrum excedere” approach to health claims taken in both public and academic circles, this is all that it has taken for large percentages of the population to be taken in by outright quackery.

But why would being lumped together with other unproven therapies provide unearned credibility? The reason this occurs is because, as Mears reveals in the above quote, proponents of individual therapies use the fact that some therapies considered to be CAM are accepted as part of science-based medicine. This tactic is especially easy to employ when the “therapies once believed to be CAM” that are now “considered by many to be conventional” are things like nutrition, exercise, smoking cessation, and various plant based pharmaceuticals. By essentially co-opting/stealing avenues of research and proven preventative measures that are science-based, a large foot has been shoved in the door for all manners of pseudoscience to slip in. Just because plants are investigated by scientists for their potential role in improving the human condition, and those investigations have led to a number of safe and effective pharmaceutical interventions, it doesn’t mean that the unregulated use of unproven herbs, or that healing touch for instance, is legitimate.

Mears claims that conventional medicine is “intended to be based on knowledge of safety and efficacy obtained from randomized, controlled trials (RCT) and attempts to avoid treatments that are not supported by such evidence”. This is an straw man definition of what we do and allows proponents of pseudoscience and quackery to simply chalk the objections of scientists and skeptical doctors such as myself up to some kind of religious devotion to the RCT. RCTs are the gold standard when it comes to determining whether or not a treatment actually works, but the practice of science-based medicine takes into account all evidence, from clinical observations and anecdotes up to the RCT, including our understanding of basic science and the overall plausibility of a claim. Does Dr. Mears think that we only hang our hats on RCTs to support telling a patient to stop smoking because it increases the incidence of lung cancer, as if there was an IRB approved prospective trial where we encouraged subjects to smoke so that we could compare lung cancer rates to a group smoking sham cigarretes. Much of the evidence we use to support treatments and lifestyle recommendations does not come from an RCT. 

She then admits, in what may be the understatement of the year thus far, that “CAM therapies may have fewer supporting data.” May have fewer supporting data? Is that even up for debate? I guess it is depending on who you ask. If a treatment that is considered to be CAM, and I mean real CAM not a co-opted science-based therapy, had decent evidence to support its use it wouldn’t be CAM. The most functional definition of CAM is stuff that doesn’t have any supporting data to speak of and likely will never have any supporting data, or stuff where a definitive answer has been arrived at but ignored. Think homeopathy or anything a chiropractor does that a physical therapists won’t. Think manipulating human energy fields or the use of herbs and supplements like echinacea for the cold or ginkgo biloba for memory problems. Of course CAM therapies have fewer supporting data. That flaming ball of fire in the sky is also actually a star, and it’ll come back in the morning. I promise.  

She follows this shocking revelation with the obvious statement that there are mainstream practices as well as  CAM “activities” that lack “rigorous evaluations.” She explains how this does not exempt any of us from backing up our practices with the latest and greatest scientific evidence, something which she claims the NCCAM is doing. Well, not exactly. There may be a some well-designed studies coming out of NCCAM but, as the past decade has shown us, their negative results have little to no impact on the belief of CAM practitioners and could have come from other areas of the NIH that don’t have so much baggage and bias. The NCCAM spends roughly 128 million dollars per year, and has spent over a billion dollars in total, producing a few good negative studies and numerous poorly designed positive studies that somehow all lead to the conclusion that more studies are needed. Furthermore, in its efforts to serve its master, Senator Tom Harkin, as a propaganda machine for unproven therapies, the bogus marketing terms “complementary” and “alternative” are now so firmly attached to the word medicine I am forced to use them liberally in any attempt to discuss this application of magical thinking to my chosen profession.

I’ve got a few more bones to pick with this article, but I’ll save them for my next post.

Alternative Medicine and the Vulnerable Child…..

A concept that has been well-recognized in pediatric medicine, at least since it was first described in 1964, is that of vulnerable child syndrome (VCS). In the past, I have mistakenly refered to this entity as “sick child syndrome” but that is problematic in that it implies that it only occurs in the aftermath of illness. As I will explain in detail, there is much more to the development of VCS and it is the concern of VCS in children without true medical problems that led me to the connection with alternative medicine. I’ll explain, but first a primer on VCS.

VCS is a potential consequence of extreme parental anxiety in response to the perception of vulnerability in their child. This perception leads to abnormal parental behaviors, such as overprotection and excessive focus on future health complaints from that child. Ultimately, these behaviors can result in the child suffering severe separation anxiety, behavior problems, difficulty in school, and abnormal fixation on their own health. It is also very common for families with VCS to overuse medical services, sometimes seeking medical attention in emergency departments or physician’s offices several times each month, and there have even been links to physically abusive relationships between children and their families. 

The parental anxiety at the heart of VCS tends to be initiated by the diagnosis of significant illness in a particular child, or by a high-risk pregnancy/delivery during which the life of the child or mother was at risk. But, and this is important, it can occur even when the illness in question is not serious, or when there isn’t any illness in the first place. It is, after all, the perception of vulnerability that is at the heart of VCS. This unfounded anxiety can even stem from something as seemingly innocuous as a false positive newborn screen result that is quickly determined to be spurious.  Naturally, as with most disorders of a psychological nature, factors that can potentiate the untoward effects of VCS can include environmental and family stress, poor social support and low socioeconomic status.

 I often discuss the role of pediatric medical professionals in the development of VCS with colleagues but I am frequently disappointed with these interactions and left feeling as if it is an issue that doesn’t receive the respect that it deserves. I think that for many providers, the fear of missing a potentially serious medical condition, even a very unlikely one, outweighs the risk of longterm psychological complications that can sometimes occur when we dust off the old diagnostic shotgun or go on investigatory expeditions with low pre-test probability of success.

There is also, I think, a general acceptance of performing tests to “rule-out” problems rather than to “rule-in” problems that are felt to be likely based on history and examination. This is common amongst medical practitioners as well as lay persons. Recently a friend asked me what harm lay in obtaining medical tests that may not actually be necessary but might serve as a means of comforting a family, or a physician, that is worried about a particular disease process. The answer, of course, is that our tests often are imperfect and have a large subjective component to their interpretation which leads to a large number of false positive determinations. These false positives lead to more intervention, much of which has inherent risk associated with it, and they can lead to VCS in some instances. There are other reasons to avoid unnecessary testing but to me this is the most important.

A common example of this occurs when the prototypical febrile 15-month old with symptoms consistent with a viral lung infection is brought into the emergency department or primary care doctor’s office during the Winter months. The evidence is clear that these kids, with rare exception, do not have bacterial pneumonia and do not benefit from the routine ordering of chest films or complete blood counts but they are very frequently obtained anyway in order to rule out something which would require antibiotic therapy. These xrays and labs are often equivocal or consistent with a viral lower respiratory process, but studies in these situations tend to serve as a Rorschach inkblot test with the interpreter seeing in them whatever he had already decided was causing the symptoms. In these cases, it is a bacterial process and the IV antibiotics are soon running.

It is a very difficult task for a hospitalist to explain why an intervention that was just begun is being discontinued, especially one which makes such intuitive sense to a family. The physician ordering the antibiotics typically does not explain the ambiguities of such a diagnosis. They do not typically explain the extremely low incidence of bacterial pneumonia in such situations, or even discuss the difference between viral and bacterial pneumonia. They tend to walk in and confidently diagnose a bacterial pneumonia, and the use of antibiotics for pneumonia is seemingly hardwired in the psyche of the general public. So when I stop the ceftriaxone, and begin talking about viruses and the reassuring chest xray obtained the night before, I sometimes meet up with parental anxiety and resistance to supportive, non-pharmaceutical interventions. On many occassions, I’ve seen these families during future admissions where a history of bacterial pneumonia is given. Sadly, I also have experienced on many occassions the subsequent concerning changes in how these children are cared for, such as the concern for another episode of bacterial pneumonia leading to seeking emergency care in the middle of the night for what is clearly another viral infection that could have been treated at home, or could have been easily handled by their primary care physician the following morning.

So what is the connection between alternative medicine and VCS? It is actually pretty obvious and I’m feeling rather sheepish about not having thought of this before. The science-based practice of pediatric medicine and the confusing jumble of unproven modalities lumped under the term alternative medicine differs in many ways. One of the most prominent is the plain fact that when a child is brought to a practitioner of (insert random alt med entity), or that child’s parents visit the website of a proponent of such an entity, they are rarely if ever told that nothing is wrong. There is always something that can be fixed, often with multiple visits or supplements which just so happen to be sold right there in the office or by the author of the website. Chiropractors tend to find subluxations. Practitioners of traditional Chinese medicine discover stagnant chi. Naturopaths uncover ill effects of a toxic world. Numerous quacks order blood tests designed to confirm their suspicions of harmful heavy metal levels. Countless websites tout hypothyroidism and adrenal fatigue as near ubiquitous etiologies for any symptom you can dream up. Or maybe it is all because of abnormal body acidity. Or yeast. Or liver flukes. All of these have been proposed as the cause for almost all illness. 

In contrast, as a pediatric hospitalist, someone who by definition only takes care of children sick enough to be admitted to a hospital, I still spend a large percentage of my day reassuring parents and patients that things are going to be okay, that their child’s condition is self-limited and that they will return to full health. On many occasions I prescribe no treatment at all, and participate in what has been called “masterly inactivity”, the calculated observation of a child in order to avoid unnecessary testing or pharmaceutical intervention. In the day to day workings of a primary care doctor, the overwhelming majority of visits are for well children check-ups or self-limited complaints with most receiving only advice and reassurance. We are able to this because most of us strive to base management decisions on the best evidence available, as free as is humanly possible from biased interpretations and certainly free from the impact of an irrational devotion to any unscientific and unproven belief systems. There are exceptions of course, but these are not common.

I am forced to recognize that despite my best efforts to reassure some families, there will be times when a pathologic anxiety will develop. To give just one example, it seems painfully obvious that if the family of a healthy child brings their child to a chiropractor, and were told that one or more subluxations exist which need immediate treatment, and longterm maintenance treatment to prevent their recurrence, that the risk of VCS would be very real. Just google the terms “SIDS” and “subluxation”, and you will find chiropractic websites and articles discussing that connection. Now imagine the fear that some families must go through believing that their child is at risk of dying in their sleep if they don’t see a chiropractor, as is recommended by many of them, in the newborn period. This is just one of innumerable examples of alt med practitioners sowing the seeds of fear and anxiety by validating fictional problems. There are worse, much worse.

What really got me thinking about VCS in this context was the recent publication of an article on the ethics of complementary and alternative medicine in Pediatrics in Review. Peds in Review is the journal of the American Academy of Pediatrics (AAP) and is geared towards continuing education for pediatricians. It contains review articles, quizzes, and cases designed for maximized learning, and is heavily used by pediatric residents. I’ve been reading it monthly since 2003 and have noticed the steady creep of alternative medicine nonsense into its pages, usually with review articles of the use of alt med for specific medical diagnoses. These articles tend to be poorly written and seem to rely on misinformed or biased sources such as the National Center for Complementary and Alternative Medicine (NCCAM), a propaganda machine for alt med that has also wasted over a billion taxpayer dollars on studying alternative practices with zero plausibility and heaps of prior negative studies. Much of their budget goes towards supporting biased unscientific alt med education in medical schools, hence my use of the word propaganda.

Although this particular article was perhaps a little better than many treatments of alternative medicine by the AAP, it still left a lot to be desired. My next post will focus on the errors in the article. At no point in the discussion did the risk of VCS come up. I believe that although there are greater potential risks of exposing children to these unproven modalities, the development of VCS should certainly be included. I would not be surprised at all if VCS is a much more common outcome than those other more serious bad outcomes like stroke from manipulation of the neck or toxicity from unregulated herbal supplements.

The Truth Behind Herbs and Supplements…..

For a few years during my high school and college days, I was into supplements. I was also into country music, but nobody is perfect. I took vitamin C to ward off colds, B vitamins for increased energy and ephedrine for weight loss to name just a few. My excuse? Like the ancient Chinese who supposedly used acupuncture 5,000 years ago*, or the 18th century American physicians who bled their patients to remove excess bodily humors, I was prescientific.

In contrast to those dark days, as a result of my discovery of the work of James Randi and the modern skeptical movement I spent the early years of my pediatric residency developing an interest in so-called alternative medicine. My eyes were opened as I learned about the reality behind the substances I ingested with the fearlessness of ignorance and I became embarrassingly aware of the simple fact that science just doesn’t support the near entirety of claims made by the manufacturers of herbs and supplements**. Despite this, these products can be found on the shelves of thousands of stores across this country and they rake in billions of dollars annually. Unfortunately, consumers are generally unaware of the science, or rather the lack of it, behind these products, and of the risk that they take each time they head down to the GNC or Rite-Aid. 

If I were to walk out my back door and take a random sampling of the available plant life, place those clippings of various flowers, weeds and grasses in my blender, and press liquefy, the end result would have the potential to make me a very rich man. To the untrained eye it would appear to be merely a glass full of grass juice, and to the naive mind a nasty and useless concoction. But to an individual initiated in the unethical reality of herbs and supplements, it might just be a gold mine. You see, all it would take to turn green grass into green cash is the current state of regulation of herbs and supplements in the United States and a vague structure/function claim. 

Here’s how it works. Since the early 90’s, 1994 to be exact, with the passage of the Dietary Supplement Health and Education Act, the supplement industry has essentially existed as if stuck in the days of the American Old West. The Law of the day, much like our current Food and Drug Administration, served as a means of maintaining a somewhat controlled chaos. Try this excerpt on for size, podnuh. 

“Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.” 

Now just let that sink in for a moment. Wait for it. Wait for it. Has it hit yet? Has that feeling of emptiness and despair that I experience on a near daily basis during my frequent adventures in the Land O’Woo settled in yet? Allow me to break this down for you. Since 1994, when the FDA was sent outside to fetch its own switch so that Congress could more effectively tan its hide, manufacturers have had no oversight whatsoever when it comes to determining whether or not their herb or supplement is safe. My fictional grass juice, which I’ll have you know has been used by Native Americans to cure teeth itch and hair pain for thousands of years, could contain iocane powder*** and kill several consumers before the FDA would be able shut down my operation. In fact, as I am writing this there are herbs and supplements sitting on store shelves which contain toxic levels of heavy metals such as lead or mercury and which are adulterated with pharmaceuticals****. When enough people are harmed by an herb or supplement, such as in the infamous case of ephedrine a few years ago, the FDA investigates and the product is pulled. There are thousands of new supplements that go on the market each year and the emergence of the next Ephedra is only a matter of time. 

But what about effectiveness? Unfortunately, DSHEA rains on that parade as well. There is no requirement under the law for an herb or supplement to be proven effective by the company selling it as long as the claims made fit certain criteria. If claims of positive impact on a specific disease are made, then the FDA has the power to make sure that the evidence supports those claims. If vague claims involving support of structures or bodily functions are made, then the FDA is impotent. So if I attempted to market my backyard grass juice to cure epilepsy, I wouldn’t get very far. But if my infomercial talks about supporting brain health (wink wink, nudge nudge) or improving neurological function, I’ll be opening my Swiss bank account in no time. 

The dangers of DSHEA and the herb and supplement racket actually go much deeper than this brief discussion goes into. I’ll devote additional posts to these issues but I encourage my readers to take the next step and investigate for themselves. A great place to start, as it is with any healthfraud or alternative medicine related topic, is Science-Based Medicine. 

*The Chinese weren’t using acupuncture 5,000 years ago despite what numerous news reports and press releases claim. What is known today as acupuncture has only existed for the past several decades and has failed the test of science. 

**These manufacturers are typically subsidiaries of the mammoth pharmaceutical companies so reviled by the alt med crowd. Awareness of this fact has forced many a believer to erect additional impenetrable walls of cerebral compartmentalization to avoid the coma inducing cognitive dissonance. 

***Iocane powder is a deadly poison that is odorless, tasteless and highly soluble. It is only available in powder form and was once popular for use during battles of wits when death was on the line, particularly with Sicilians. Although it takes a few years, determined individuals are capable of developing immunity to the poison. 

****Actual Viagra has been found in supplements bearing claims of male enhancement!

Foundations of Skepticism: Extraordinary Claims…..

The oft heard battle cry of the charging skeptic, that extraordinary claims require extraordinary evidence, is much more than a debate talking point. It is, after the scientific method, the most important fundamental principle of the skeptical approach to understanding the universe. And despite what proponents of pseudoscience and supernatural belief systems might claim when confronted, that the skeptic is closed-minded and should accept lower orders of evidence, it really isn’t all that controversial.

Everyone incorporates the extraordinary evidence requirement into their daily lives, even the most ardent of believers. If, for example, I told you that I had a penny in my left jacket pocket, you would be unlikely to protest. This is a routine occurence after all. The claim of transporting 1,000 pennies in this fashion would likely lead to instinctive doubt and the visual inspection of my left pocket, looking for the telltale effect of their weight, but you would be unlikely to call out for more powerful proof. Were I to claim that I just so happened to be carrying a Faberge Egg around, you would certainly request that I put my money where my mouth is. The chance that I would have one of these immensely valuable and rare entities is extremely low and calls for more than the anecdotal testimony I had provided.

Another example, and one more in line with my particular expertise, is that of homeopathy. For those uninitiated in the history and practice of homeopathy, here is a quick review. Roughly 200 years ago a German physician named Samuel Christian Friedrich Hahnemann grew disillusioned with the practice of medicine. He was right to question the trends of the day, which included practices such as bloodletting and dosing patients with mercury based compounds. Pre-scientific medicine often led to a worse outcome than if no treatment had been provided at all. But proponents of these modalities, like pushers of complementary and alternative medicine today, based their beliefs on anecdotal evidence and were led astray, just as Hahnemann soon would be.

Hahnemann noticed that the untoward side-effects of taking quinine, one of the only truly effective medications of the day, were similar to the actual symptoms of the malaria it was used to treat. He decided, based on his equally pre-scientific understanding of nature, influenced by a hefty helping of magical thinking, that the ingestion of a substance which causes a certain set of symptoms in healthy individuals will cure those same symptoms in the ill patient. He then set out to uncover the true curative power of every natural substance he could get his hands on. By collecting countless anecdotal experiences from healthy volunteers, usually friends and family members, he catalogued the supposed effects of these substances so that he might match the right substance with the right symptoms in his patients. The results were quite comical, as would be expected with such a process, with each substance being associated with long lists of symptoms ranging from the typical, such as nausea, to the ridiculous, such as feeling chills only between certain hours of the day or dreaming of criminals. No attention was paid towards whether or not these symptoms were coincidence or a result of influence by Hahnemann himself.

Hahnemann went on to invent the notion that more dilute concoctions were more effective. This led to the absurd dilutions commonplace in homeopathy today, most of which lead to treatments containing no molecules of the original substance. So when a homeopath recommends the ingestion of Toxicodendron radicans to cure your itch, you have little to fear of an allergic reaction to the poison ivy in the bottle or pill because, well, there is no poison ivy in the bottle or pill. And when an over-the-counter homeopathic conjunctivitis cure has belladonna listed as an active ingredient, you don’t need to call your local poison control center. You may have thrown good money down the toilet but you probably haven’t ingested one of the most toxic plants known to man. Of course there are many preparations of homeopathic remedies sold with measurable amounts of the original substances, and because of lax laws regulating quackery in America, a topic for another post, you can never really be sure that the carpet matches the drapes. There are known examples of companies using the homeopathic label to avoid the prying eyes of the FDA.

Despite over 200 years of use, there has yet to be shown a beneficial effect of any homeopathic remedy for any condition in properly designed studies, and it is widely considered by scientists and physicians that homeopathy is no better than placebo. This should come as no surprise because, despite the 200 years since its discovery, the claims of “like treats like” and of increasing efficacy with increasing dilution have never made any sense on a basic sciences level. They have zero plausibility and proponents have resorted to claims of magical water memory and quantum physics as mechanisms of action for their treatments when confronted with reality. Homeopathy stands alone at the top of the crap pile that is alternative medicine.

So when someone offers up a homeopathic remedy to cure what ails you, it is not closed-minded to expect extraordinary evidence to support such claims any more than it would be to expect a peek at that priceless piece of artwork stuffed in the left pocket of my fleece jacket. I might be fooled. I might be lying. On a personal level, it works for me just doesn’t qualify. Placebo effects and other biases inherent in determinations of efficacy can easily account for such a belief. And when it comes to specific remedies proposed by individual practitioners or the companies who profit from their sale, collections of anecdotes and testimonials are not enough. And for something that violates fundamental laws of nature like homeopathy does, a few equivocal studies are meaningless. Even a few outright positive studies should not be enough to convince you. Homeopathy is as extraordinary as it gets and the evidence should be huge. It should be so blatantly obvious that to deny it would be just as crazy as it was to believe in homeopathy in the first place.

Not everything is as off-the-charts crazy as homeopathy of course. Some claims naturally have more merit or plausibility than others. And there is no universally agreed upon algorithm for just how much evidence is enough for each specific claim. But as a general approach, the expectation of better evidence for claims less likely to be true has served humanity well. Unfortunately however, the human brain is hardwired to work against us when it comes to the appropriate acceptance of ideas even as it is equally hardwired to continually come up with new ones, and we must strive diligently to avoid being fooled by ourselves. Examples of the negative consequences of failure to do so are all around us, from ignorant entertainers spouting harmful anti-vaccine rhetoric to Nobel Prize winning scientists championing bogus cancer cures. The skeptical community is growing faster than ever, and slowly gaining more influence, but it is an uphill battle at this point. But I remain optimistic about the outcome.

Animals and the Placebo Effect(s)…..

If asked (or poked by a stick perhaps), most skeptics would likely be able to quickly rattle off a personal top ten list of the silliest pseudoscientific beliefs that they have encountered. There would probably be much variation between theses lists, with perhaps a few universal standards, because many skeptics specialize. My particular area of interest/specialty is irrational thinking as it applies to the practice of medicine.

As a pediatrician who specializes in hospital based care, I see more than my fair share of it. In the early days of my medical career, my already skeptical mindset was further influenced by encounters with patients suffering great harm at the hands of unproven and unscientific therapies. One child, barely able to breathe through a swollen airway by the time she was brought to our facility, was having her rapidly enlarging abscess treated by the unblocking of her stagnant chi. Ironically, she may have responded to being needled had they been a larger and inserted into the growing pocket of pus in the back of her throat. Another young patient, also having great difficulty breathing but due to an asthma flare, was failing to respond to the correction of a fictitious misalignment of her spine.

More recently I’ve dealt with the inappropriate use of hyperbaric oxygen therapy in a disabled child, and risky chelation to remove non-existant toxic heavy metals in a child with an autoimmune condition effecting their kidneys. And almost daily my life is complicated by the well-meaning but just as nutty use of antibiotics to treat what amounts to parental/practitioner anxiety, an indication for which I’m fairly certain there is no FDA approval. Science-based medicine is what I do, or at least what I strive for on a daily basis, so my list is heavily weighted towards beliefs common in both users and pushers of unproven practices.

High on my personal list is the belief that animals are immune to the placebo effect, and that the anecdotally successful use of an alternative remedy in an animal proves that it works for that very reason. This belief is frequently touted by pushers of therapies that have failed to demonstrate effectiveness in well-designed studies that incorporate a placebo control group. And it is often credulously repeated by woefully unprepared, or maybe just uninterested, journalists in the many puff alternative medicine pieces churned out each year. A wonderful example, for educational purposes, is this January 25th article in The Bulletin, an online news source for central Oregon, on the expansion of alternative therapies into the care of animals.

The piece establishes the mood with the ubiquitous anecdote/testimonial, in this case the terrific success of acupuncture in treating a dog’s chronic inflammatory bowel syndrome. The owner reveals that the therapy is working but clarifies that after more than a year of acupuncture, a restricted diet and unspecified herbs, “she’s definitely improved.” Sounds great, right. Well, not exactly. With a reasonable understanding of the placebo effect, anecdotes such as this are more easily seen for what they are: unblinded and uncontrolled studies involving one subject. In other words, absolutely meaningless.

We’ll get back to placebo in the context of treating animals in a minute, but first I’d like to touch on a few of the standard canards presented in this article as if chiseled in marble facts. The author makes several unlikely assumptions and outright false statements, the most glaring of which being that homeopathy involves the use of small doses of natural substances and that alternative medical care of pets is both holistic and individualized.

On first glance to those uninitiated in the reality bending wackiness of alternative medicine, and in particular homeopathy, this may seem like a reasonable thing to say. Homeopathy does involve small doses of various substances in the supposed remedies, although what is meant by the term natural is, as usual, unclear. Both poison ivy and snake venom are used in homeopathic remedies, and are both quite natural, but most folks would probably wince at the thought of ingesting them. But wince though one might, there is nothing to fear because homeopathic doses involve such “small” doses as to render them undetectable and unable to have any effect, beneficial or otherwise. Homeopathic remedies are inert and no decent study has shown them to be effective for any condition. Belief in homeopathy is akin to belief in magic. In fact, ask the next homeopath you bump into how they can tell the difference between a vial of tap water and a vial of deadly rattlesnake venom diluted to the point where no molecules of the substance can mathematically be expected to be found. Sit back and enjoy the show.

The claim by practitioners of alternative medicine that they are “holistic” or that they practice individualized medicine is subterfuge. Many people are impressed by such statements, and they have opened the door to our most premiere academic institutions for some pretty ridiculous stuff, but they are integral in a rather clever ploy by proponents to establish a false dichotomy between the many disparate alternative medicine entities and conventional medicine. They are always meant to imply that those evil, big pharma worshiping regular docs just treat symptoms and don’t care about the patient as an individual with a multitude of biopsychosocial factors effecting their outcome. Ironically, it is the alternative medicine woo flingers that almost universally cling to a single cause for all ailments. The single cause changes, depending on the particular form of quackery, but it still boils down to a complete and utter lack of individualization. Every patient, regardless of symptoms, has unbalanced chi to an acupuncturist. Every problem is caused by subluxations in a chiropractor’s office. To some it is all about nutritional deficiencies, while others blame unnamed toxins that must be removed from the body. Is all illness caused by liver flukes, as was proposed by Hulda Clark, or is it acidosis? Or yeast? Depends on who you ask I guess.

When I see an ill child in the hospital, I take a complete history. Rather than just throwing drugs or surgery at a symptom, I probe for information regarding prior illnesses, the medications a patient is on or has been on, their diet, family history, social history, etc, etc. I perform a physical exam. I then ask the questions that inevitably arise from my exam findings. Knowledge obtained from any one of these areas can effect the treatment options for the patient’s condition. I often am aided by social workers and medical managers that work diligently to ensure that my patients can obtain the help they need, by dietitians who focus on assisting patients in meeting nutritional goals, and by various therapists that provide valued assessment of and treatment for patients with respiratory, physical, occupational, or speech/feeding related adversities. There are psychologists and child life specialists that are available to attend to the emotional wellbeing of my patients and even their families as well. I could see ten 6-week-old male infants with bronchiolitis in a row and they might each require a different approach to their treatment based on the above factors. This way of approaching patient care goes on day in and day out in hospitals and doctors offices around the world. Naturally some are better than others, and there are some abysmal physicians that tackle patient care in ways no better than the average naturopath, throwing prescriptions of zithromax at every runny nose, but there are constant attempts by the profession to weed out bad practices such as this. The same cannot be said for practitioners of alternative medicine.

Now back to the issue of placebo and its supposed lack of effectiveness on man’s best friend. It is common to make the error of thinking that placebo is a single entity, that it is some kind of mind-over-matter effect stemming from the expectation of the patient. If that were the case, then I would agree that animals are not susceptible to placebo. But, as tends to be the case, reality is much more complicated than the fantasy world concocted by the true believer. Instead of simply being mind-over-matter, the placebo effect consists of a number of different components, some of which are pure artifact, which can lead to the appearance of a true improvement. Among these components is the tendency for symptoms to regress to the mean, which is probably the largest component of any placebo effect and the most likely reason why Maggie’s owner believes that she has responded to acupuncture. People tend to seek care for themselves or for their loved ones, pets included, when symptoms are at their peak. Other components of placebo include investment justification, novel or complicated therapy effects, or simply the desire to please an authority figure to name just a few. None of these have anything to do with an actual physiologic effect from the intervention and they only require the pet owner and veterinarian’s biased and subjective personal experience and time.

It is easy to imagine how a dog lover might interpret their pet’s behavior differently secondary to a placebo effect. It usually takes the dog a whole week to get over a flare of his inflammatory bowel disease with conventional therapy, one might say, but with acupuncture it only takes 7 days. It’s all in how you spin it and how your remember it. Human memory, while arguably better than a dog’s, is notoriously poor when it comes to recalling details over long periods of time. In addition to pet owners and the potential for their biased evaluations, it is equally easy to see how an animal might act differently because of how their owner interacts with them. Maggie might actually act more energetic and appear to be feeling better simply because his owner is paying more attention to him in anticipation of a positive therapeutic result. Perhaps other changes, such as the mentioned dietary restrictions, might have lead to positive changes in behavior that do not stem from acupuncture. The owner also mentions using herbal remedies in addition to the acupuncture. Herbs, like all drugs, have the potential to impact the physiology of the person or animal ingesting them. Many pharmaceutical agents used today were derived from the plant world. It is more likely, though still not very probable, that the dog was given an herb which led to a clinical benefit rather than acupuncture having a specific effect.

It boils down to the fact that anecdotes such as this simply cannot be trusted. We don’t know what would have happened if the acupuncture had not been tried. We also don’t know what would have happened if conventional therapy had been tried. Perhaps Maggie, instead of having merely improved, would be symptom free and far better off. Or, just maybe, acupuncture does work. That isn’t likely, since acupuncture has thus far failed to be shown effective for any condition, but my mind is always open to the possibility however slim it may be. But any reasonable person should require more evidence than this to consider any therapy beneficial. We have to employ, in addition to rational thinking, a means of being able to quickly weed out the implausible and hone in on treatments that are likely to work, and to avoid being fooled by our inherent biases.  There is the reason why science-based medicine has led to such amazing advances over the past century or so and that is the scientific method.

More on Acupuncture and Spontaneous Human Combustion…..

Yesterday I posted an Onionesque phony news story on a proposed link between bad acupuncture and the persistent and equally bogus entity known as spontaneous human combustion (see Wick Effect). I realized after posting that the point of the story might not be entirely clear. It wasn’t just to poke some fun at acupuncture adherents and their claims, although that was one aspect of my motivation. There is a method to the madness, or at least to the oddness according to my wife.

There has yet to be discovered a treatment, pharmaceutical or otherwise, that has both a specific, measurable therapeutic effect, and an absence of potential negative side effects. As the old saying goes, the poison is often in the dose. Even good old dihydrogen oxide is dangerous when a large enough amount is ingested, leading to water intoxication, hyponatremia, seizures and eventually death. But most interventions carry varying degrees of risk at recommended doses as well as when overdone. Even minor surgeries, such as simple incision and drainage procedures performed in most physician’s offices, can lead to unanticipated complications. Often the risk is small, or even negligible, but there is no such thing as a free ride when it comes to any legitimate treatment.

A large percentage of the proposed health benefits of any so-called alternative medical therapy, and acupuncture is no different despite its undeserved place near the top of the heap in regards to the perception of scientific support, are decidedly non-specific. These claims involve such benefits as the boosting of the immune system (but never which component), the improvement of general well-being, the lifting or stabilization of mood, or the enhancement of male. Claims of this type, of which there is a seemingly endless supply, are meaningless. They are not even wrong, because they are not testable. But they are effective in what they were designed to do, which is to separate you from your money without being subject to the nuisance of providing supporting evidence outside of the occasional, well more than occasional, testimonial.

When proponents do make specific claims, such as ginkgo biloba preventing the onset of dementia in the elderly or chiropractic adjustments being effective in treating asthma, the question can be answered. So far, no non-herbal alternative therapy has been shown to be effective for any specific condition with perhaps an exception for chiropractic manipulation for acute lower back pain. That is debatable considering that this manipulation is the same as that provided by physical therapists, physiatrists and osteopaths. It is also highly suspect that herbs are even lumped into the umbrella category of alternative medicine in the first place. Many effective pharmaceutical agents have been derived from plants and other “natural” origins.

If acupuncture has a specific effect on the body, say by altering neurotransmitters or increasing the secretion of endogenous hormones, or whatever biological mechanism makes you happy that doesn’t involve the unscientific gobbledygook of meridians and mystical human energy, then there must be the potential for unwanted side effects. And I don’t mean the obvious infectious issues associated with the use of unclean needles or the potential for traumatic injury when needles are shoved through the linings of the heart or lungs. I take the extreme difficulty in finding discussion of any such acupuncture side effects as evidence for the lack of any effect at all. To me, the absurdity of such an extreme side effect as exploding due to pent up Qi is equally matched by the ridiculous claim of shoving tiny needles into a patient’s skin in order to provide an effect beyond that of placebo.

There is more to my previous post, such as the issue of chiropractic and stroke, and the portrayal of alternative medicine by the media, but the above covers the primary focus.

Improperly Performed Acupuncture Linked to Spontaneous Human Combustion…..

Baton Rouge, LA-Experts in Traditional Chinese Medicine are warning acupuncture patients to seek out licensed practitioners after a string of grisly cases of apparent spontaneous human combustion.

“We aren’t saying that every recent case of spontaneous combustion is linked to the incorrect placement of acupuncture needles,” Kuang Zhu LAC, Chief of Applied Acupuncture in the Health and Wellness division of Vic’s Day Spa and Pet Grooming Center, explained in a press conference held today at their flagship location on Airline highway. “But in some cases, there is a relationship that is hard to explain otherwise.”

Zhu, a legally licensed acupuncturist in Baton Rouge for over thirty years, expressed concern that there are patients seeking out unlicensed and poorly trained practitioners that don’t charge as much per session. “These rogue needle wielding impersonators don’t fully grasp the power of acupuncture. With great ability to heal comes an equal ability to harm.”

Acupuncture, an ancient component of Traditional Chinese Medicine, involves the insertion of small needles into specific points on the body in order to influence the flow of life energy. These points are found along meridians, major pathways in the body through with our life energy courses. When life energy is obstructed, it becomes stagnant, and illness develops. Properly placed needles relieve this obstruction and improve our health. Needles placed haphazardly can, according to Zhu, lead to further obstruction, a worsening of one’s health, and ultimately a fiery death.

Zhu states that the phenomenon of injury by inappropriate acupuncture is not new. He has seen countless milder cases over his three decades of practice in the United States. But the worst occurred during his childhood in China. “Neighborhood gangs and even local police forces would use purposefully incorrect acupuncture as punishment or as an interrogation enhancer,” Zhu revealed. “Once I saw a body with the goshin needles still inserted in acupoints I did not even know existed. Oh, the disharmony! My childhood ended that day.”

But not every local acupuncturist supports Zhu’s theory that excessive and erroneous needle placement is to blame for the untimely explosions of Baton Rouge citizens. Frank Grimes, a local chiropractor who specializes in acupuncture, reminds us that correlation does not necessarily equal causation. “Yes, a number of the remaining body parts have been found with needles still in them,” Grimes admits. “But my concern is that linking acupuncture to spontaneous human combustion is akin to the claim that chiropractic manipulation of the neck causes strokes. Perhaps people already about to explode seek out acupuncture for symptomatic relief.”

At the heart of this issue for Zhu and his colleagues is the health of his community. He admits that acupuncture induced detonation is rare despite the recent spate, and that most people who receive acupuncture from improperly trained practitioners will at most experience mild stagnation of their Qi. “The majority of the victims of acupuncture fraud do not suffer from serious conditions. My main concern is that people with serious imbalances in their yin and yang might delay seeking out proper care just to save a few bucks.”