FDA Warns Homeopathy Manufacturer Hyland to Stop Mislabeling its Products

I’ve written previously about the official regulation of homeopathy by the Food and Drug Administration (FDA). The bottom line is that homeopathy was exempted from the standards of proof for safety and efficacy required of all other medications regulated by the FDA due to the efforts of the senator who first introduced the Food, Drug & Cosmetics Act (FD&C), who happened to have practiced homeopathy. It is legal to sell homeopathic remedies without a prescription for conditions people can reasonably be expected to diagnose and treat themselves. And it is legal to claim safety and efficacy and sell such remedies with a prescription for more serious illnesses. Fortunately, few doctors authorized to write such prescriptions are foolish enough to believe homeopathy is appropriate as treatment for such illnesses.

Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with Section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.

Despite this historical accident, the reality is that the FDA does not endorse the safety and efficacy of homeopathy as homeopaths often claim. Unlike all other drugs and medical devices, FDA approval of homeopathy does not imply any real evidence or scientific testing of safety or efficacy. The FDA says as much on its web site, ““FDA is not aware of scientific evidence to support homeopathy as effective.” With regard to veterinary use of homeopathy, it is technically against the law, but the FDA has bowed to political reality and decided not to enforce this rule.

A recent warning letter issued to one of the largest homeopathy manufacturers in the U.S. emphasizes the fact that the FDA does not consider homeopathy as a valid form of therapy for serious disease despite its formal status as legal under the Food and Drug Act. It reminds the company that marketing homeopathic remedies without prescription for serious health problems is illegal.

Your firm markets numerous drugs that are misbranded in violation of sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act…The products [mentioned in the letter] are prescription drugs within the meaning of section 503(b)(1) of the FD&C Act because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Because they may be dispensed only by prescription of a licensed practitioner, these products are misbranded… If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication. 

Furthermore, your products listed above are misbranded within the meaning of section 502(a) of the FD&C Act [21 U.S.C. 352 (a)] in that their labeling is false or misleading because the labeling represents the products as suitable for use by consumers to treat conditions which the Agency has found not appropriate for OTC drug treatment.

In this letter, the FDA also addresses the issue of testimonials, that meaningless yet ubiquitous and persuasive form of marketing preferred by purveyors of unproven or bogus alternative therapies. The agency recognizes that such testimonials are presented with the intention of suggesting that the products are safe, effective, and appropriate for the conditions customers claim to use them for, and that this creates a false, and in this case illegal, impression even if the words used are not those of the company itself.

We also note that you include customer reviews of products on your websites. These customer reviews are evidence of the intended uses of your products; your firm is responsible for ensuring that statements made by customers and included on your websites do not cause your product to be misbranded…

So the next time you hear a homeopathy advertise their magic water as “FDA Approved,” remember this does not in any way suggest that homeopathy has been scientifically proven to work or that the FDA believes it to be an effective therapy for any condition.

Posted in Homeopathy | 29 Comments

Toxicologists Recommend “Say ‘No!’ to Unregulated Herbs and Homeopathy”

The Choosing Wisely project is an effort by the American Board of Internal Medicine Foundation to encourage physicians and patients to choose diagnostic and therapeutic interventions in a rational, evidence-based way. Specialists make recommendations about tests and treatments in their area of expertise. The most recent recommendation list comes from the American College of Medical Toxicology and the American Academy of Clinical Toxicology. It contains a number of recommendations relevant to potential toxins, and the first highlists the dangers of unregulated herbal remedies and homeopathy.

Toxicologists Recommend Against Herbs and Homeopathy

 

Posted in Herbs and Supplements, Homeopathy | 27 Comments

Evidence Update-Safety of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Dogs

One of the most common and effective classes of drugs for the treatment of pain are the non-steroidal anti-inflammatory drugs (NSAIDs). Like all medicines that have any benefits, they do have potential risks as well. Unfortunately, an unrealistic assessment of these risks is just as harmful as an unrealistic assessment of benefits. While many pets take these medications safely, and find relief from their pain, dramatic stories of animals who have been harmed are widely circulated, and these can generate an excessive fear in pet owners, which can lead to their denying their pets the pain relief these drugs can provide. Proponents of alternative therapies often exaggerate the risks of NSAIDs in order to frighten people into using their remedies instead, despite the fact that these are often untested and their risks and benefits not truly known.

I have previously discussed a paper reviewing the safety of NSAIDs, which concluded that while the evidence was often weak, it suggests that the risk of serious adverse effects from NSAID use is very low. This is essentially the same conclusion reached by the authors of a new, more rigorous systematic review of the literature concerning NSAIDs side effects in dogs.

Monteiro-Steagall BP, Steagall PVM, Lacelles BDX. Systematic review of nonsteroidal anti-inflammatory drug-induced adverse effects in dogs. J Vet Int Med 2013;27:1011-19.

This paper identified and critically appraised 64 studies concerning 14 different NSAIDs. The quality and quantity of the evidence was high for 3 of the drugs (carprofen, firocoxib, and meloxicam), moderate for 3 (deracoxib, robenocoxib, and ketoprofen), and low for the others drugs evaluated.

Adverse effects were reported in about ½ the studies, however aspects of the design and reporting of the studies made it impossible to determine a reliable rate of such events or the severity of them. Overall, adverse effects were reported at rates from 0% to as high as 37.5% of dogs. However, the drugs, study characteristics, and patient populations different widely, so it was not possible to directly compare particular drugs or studies.

Interestingly, when the highest quality studies were considered (randomized, placebo-controlled clinical trials), no difference in adverse effects was detected between dogs receiving NSAIDs and those on placebo. Though it is clear that such side effects do, of course, occur in some dogs on NSAIDs, and while real clinical patients are likely to respond differently than research subjects, this at least suggests that worries about common and severe harm from these medications are not justified.

A couple of interesting observations were made from these data. Adverse effects were more common in clinical trials than in research studies. This is likely associated with the fact that research subjects are usually healthy young dogs, whereas clinical trial subjects represent a variety of ages, medical conditions, and use of medications and other therapies. It is a reminder of why we cannot entirely trust research studies to predict the effects of medical treatments used in actual patients.

Gastrointestinal side effects, such as vomiting and diarrhea, were the most common in all studies, but the evidence did not allow calculation of specific rates if these symptoms.  More serious side effects, involving liver and kidney problems, were only detected very rarely, and liver problems seemed only to occur in dogs with pre-existing liver abnormalities.

Overall, this study adds to the existing evidence base to suggest that NSAID side effects are uncommon, apart from gastrointestinal symptoms, and that serious injury is rare. There is unquestionably some risk associated with these medications, and the patients they are used in have to be selected and monitored carefully and appropriately. However, they are very effective pain control drugs, and denying their benefits to our pets without a realistic assessment of the risks is a disservice to our animals.

Posted in Science-Based Veterinary Medicine | 22 Comments

Vaccines

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Turmeric for Pets

One of the more popular herbal products in the last few years has been turmeric. Used as a spice in cooking, this herb has also been used for the usual wide range of unrelated conditions in traditional folk medicine, particularly in Ayurvedic and Chinese medicine. Turmeric is sometimes suggested for use in the treatment of cancers and inflammatory conditions, such as arthritis, in veterinary patients. A recent question from a reader prompted me to have a look at the evidence concerning the use of this herb.

What Is It?
Turmeric is a root cultivated as a spice and herbal medicine throughout Asia and parts of Africa. It contains a plethora of compounds, however the most studied in terms of medical applications are the curcuminoids.

What’s the Evidence?
There are abundant in vitro studies examining the chemical and biological properties of compounds found in turmeric. These studies suggest antioxidant, anti-inflammatory, and anti-cancer activity for curcumin and other constituents of turmeric. Such in vitro studies can never, of course, prove a clinical benefit for patients. Bleach kills cancer cells in a petri dish, but it is hardly a cure for cancer. However, these studies are important for identifying possible uses to be investigated and for building a plausible foundation for conducting clinical studies. The in vitro research certainly does suggest a number of potential medical uses for turmeric.

The actual clinical research, however, is sparse. As the National Center for Complementary an Alternative Medicine (NCCAM) puts it, “There is little reliable evidence to support the use of turmeric for any health condition because few clinical trials have been conducted.” Many of the studies that have been done in humans have focused on curcumin and have found that it is poorly absorbed when taken orally. Large quantities must be taken to achieve detectable levels of curcumin in the blood.

There has been one systematic review of the research concerning the use of turmeric for a wide range of conditions:

Ulbricht C, Basch E, Barrette EP, et al. Turmeric (Curcuma longa): An Evidence-Based Systematic Review by the Natural Standard Research Collaboration. Alternative and Complementary Therapies. August 2011, 17(4): 225-236.

The summary conclusions of the review have been posted here. All potential uses were given the evidence grade of C, meaning the evidence is unclear, conflicting, or insufficient to draw any conclusions. Overall, there is no compelling clinical evidence in humans supporting any use of curcumin or other turmeric compounds.

As usual, there is less evidence in companion animals. One study comparing a turmeric compound to placebo in dogs with arthritis found not significant effects in an objective measure of weight bearing or in subjective owner assessment, though there was a small difference according to the subjective assessment of investigators. There are no other controlled clinical trials. A few experimental studies have been done on potential topical applications for ringworm and bacterial infections, and one research group in Brazil has published several papers looking at specific physiologic effects of turmeric compounds in dogs intentionally injected with snake venom. These studies have little relevance to the clinical use of turmeric for treatment of arthritis, cancer, and other clinical problems.

Is It Safe?
As I emphasize frequently, any therapy that has meaningful benefits will also have potential side effects. The body is simply too complex to expect to tinker with one element and not have wide-ranging effects on other elements. Therefore, it is actually a bad sign when a treatment is promoted as having no side effects since it likely suggests that treatment doesn’t actually do anything.

Potential adverse effects have been reported for turemric, including gastrointestinal upset, possible effects on blood clotting, possible increase in the risk for some kinds of bladder and kidney stones, and interactions with other herbs and pharmaceuticals. The limited clinical research so far suggests these risks are small. However, there is far less research available than is typical for a new drug before it is put on the market, and it is not unusual for unanticipated side effects to show up after a medicine is used and studied in a much larger and more diverse population. Therefore, the best we can say about the safety of turmeric for medical use (which, of course, means doses dramatically greater than its use as a spice in cooking) is that there is no obvious evidence of great risk but that the safety profile is no more clearly established than the efficacy profile.

Bottom Line
Turmeric contains a number of potentially useful chemical compounds, of which the most studied is curcumin. There is sufficient in vitro research to establish biological effects which might have clinical benefits, so the concept that these compounds could have therapeutic value is plausible. There is very little clinical research in humans, and there is not yet any convincing evidence to support the use of turmeric for any condition. There is virtually no clinical research in companion animals, and what there is does not support claims of benefit from turmeric compounds. Finally, the limited research to date suggests a few potential risks but the significance of these is unclear.

Posted in Herbs and Supplements | 90 Comments

Resources for Evidence-Based Veterinary Medicine

I write extensively about the ways in which alternative therapies are justified, and the problems with much of the evidence used to promote them. I talk less here about the way all veterinary therapies should be evaluated and appraised, through the processes of evidence-based veterinary medicine (EBVM). This is a subject I write and speak about often elsewhere, but which hasn’t been a major focus of this blog, though it is the EBVM approach which I use to evaluate all the therapies I do write about.

Since I suspect many readers will be interested in how the veterinary profession can do the best possible job determining the risks and benefits of the therapies we offer, I thought I would highlight a few resources that illustrate the EBVM approach. Even though these do not directly address the issues of alternative medicine, they demonstrate the kind of critical, science-based evaluation that should be applied to all veterinary treatment. It is this kind of appraisal which often reveals how little substance there actually is behind the claims made for many CAM practices.

The Evidence-Based Veterinary Medicine Assocation (EBVMA) is the main organization promoting EBVM here in the U.S., and it is a great resource for learning more about EBVM and for veterinarians seeking to support an evidence-based approach.

The Centre for Evidence-Based Veterinary Medicine (CEVM) at the University of Nottingham is a robust and vibrant center of research and teaching in EBVM. They have recently launched a couple of tools for veterinarians that illustrate the possiblities for the future of our profession.

The first is their new critically appraised topic database BestBETs for Vets  “BET” stands for Best Evidence Topic. The BestBETs concept was first developed for doctors working in emergency medicine (http://www.bestbets.org/). In collaboration with our medical colleagues, the folks at CEVM have developed a freely accessible database of BestBETs for veterinarians. Though the number of topics is currently small, this is a dynamic project which will eventually be an important resource for veterinarians interested in making the best, most evidence-based decisions.

The team at CEVM has also launched VetSRev. VetSRev is a freely-accessible online database of citations for systematic reviews of relevance to veterinary medicine and science.  As regular readers know, a systematic review is the most comprehensive and unbiased assessment of the total body of clinical research on any given subject. The number of systematic reviews in veterinary medicine has exploded in recent years, which makes it much easier for veterinarians to quickly and reliably find the “bottom line” for many diagnostic tests and treatments.

Posted in Science-Based Veterinary Medicine | 11 Comments

Animal Naturopathy

Naturopathy is a pleasant-sounding term for an approach to health and disease that is quite different from that of science-based medicine. It is an example of an alternative philosophy that has great appeal for from a certain perspective but which, when examined closely, has little real substance.

What Is It?
According to the American Council of Animal Naturopathy (ACAN), naturopathy is an ancient practice, “naturopathy has been around since the fall of Adam and Eve.” According to more neutral and skeptical sources, it took shape in Europe in the late 19th century. ACAN defines naturopathy as:

a philosophy and system of prevention of disease first and then treatment of disease that avoids drugs and surgery and emphasizes the use of nature or natural agents such as exercise, water, herbs, etc. to assist the body in bringing its self back into balance and health.

As is often the case with alternative therapies, this is contrasted with a rather caricatured description of conventional veterinary medicine:

Today’s veterinarians are in the business of disease care, they hold doctorate titles from colleges that teach them anatomy, biology, chemistry and surgery. They are taught how to use modern, high tech equipment to diagnose while the pharmaceutical companies teach them which drug to prescribe or use to treat or suppress the symptoms of the dis-ease or illness the animal is presenting with.

The Six Principles of Naturopathy, identical to those espoused by human naturopathic organizations such as the American Association of Naturopathic Physicians (AANP),  describe the philosophy in more detail. Some key points are:

The body has the inherent ability to heal itself. This healing process is intelligent and ordered.

Every illness has a cause. Causes may occur on the physical, mental or emotional level. Symptoms are expressions of the body’s attempt to heal, but are not the cause of illness.

Animal Naturopaths use nature’s methods that minimize the risk of harmful side effects. Methods designed to suppress symptoms but not remove the underlying cause are usually harmful, their use is always avoided. [by which they mean most scientific medical therapies]

All aspects of that animal (physical, mental and emotional) are taken into account.

Illness is due to improper diet, habits, exposure to toxins and general lifestyle. 

Does It Make Sense?
The assumptions upon which naturopathy is based are questionable. The distinction between “natural” and “unnatural,” and the suggestion that the former is equivalent to “healthy” and the latter to “unhealthy,” is an appealing but ultimately vacuous idea. There is no clear line dividing natural from unnatural. Are cooking, farming, tool-making, wearing clothes, or other human behaviors that alter the world we live in inherently unnatural and unhealthy? Is it a matter of degree? Is it ok to cook plants as part of preventative or therapeutic medicine, but not ok to extract medicinal compounds from plants? It quickly becomes clear that the distinction between natural and unnatural is capricious and arbitrary, and it is not a sound basis for deciding what is healthy and what is unhealthy for us or our pets.

The idea that natural things, even if we could agree on what these are, must be healthier than unnatural things is pretty obviously false. Uranium, arsenic, botulism, rattlesnake venom, and many other “natural” things are harmful or even deadly. And clearly artificial things, like the growing of food crops, sanitation and water treatment, and medical interventions such as vaccines and antibiotics have improved the length and quality of human life far more dramatically in the last few centuries than all the efforts of the tens of thousands of years before we developed a scientific approach to understanding and manipulating our world. The fact that some of the things we create are harmful doesn’t validate the belief that anything human made is unhealthy and anything unchanged from its natural state must be healthy.

Naturopathy is, itself, a complex and purely artificial set of beliefs and practices that no other animal employs and that humans invented along with all of our other unique beliefs and behaviors. Calling it natural, and labeling scientific medicine unnatural is simply s statement of belief, not a factual or verifiable claim.

Because the philosophical basis for naturopathy is so vague and ill-defined, the actual practice of naturopaths encompasses almost any form of alternative therapy. Among the practitioners listed on the ACAN website as Certified Animal Naturopaths, you find practitioners of homeopathy, Traditional Chinese Medicine, iridology, and other therapies that are questionable or completely lacking in any validity. Whatever a particular practitioner chooses to define as “natural” is apparently acceptable within a naturopathic approach apart from vaccines, pharmaceutical medicine, and many other conventional therapies.

It is important to point out that this “board certification” in naturopathy is not recognized by the American Board of Veterinary Specialties which regulates veterinary medical specialties. It is equivalent to similar certifications for homeopaths, psychics, and astrologers in that it is invented by naturopaths to legitimize themselves and is not recognized by mainstream veterinary medicine. In fact, there is no requirement that those who take the various certification courses the ACAN offers be veterinarians or trained healthcare professionals. The ACAN web site states,

as long as you are 18 years of age or older, these courses are designed to educate no matter what level of current knowledge you may have. They prepare you to be certified in animal health coaching, nutrition consulting or animal naturopathy consulting or to inform and educate you just for your own knowledge to help your own pets if that is what you are looking for.

It seems implausible that a powerful approach to healthcare superior to modern medicine is also so simple that it can be learned and practiced by anyone without any scientific or medical knowledge. Surely such a method would have replaced all other medical practices before now?

Historically, naturopathy has been a vitalist philosophy, identifying disease as a state of imbalance in not only the physical body but the mind, spirit, or vital essence of a creature. This philosophy rejects predominantly physical causes of illness and instead considers the root of disease to be in non-physical, spiritual factors. As one proponent has put it, “vitalists analyze bodily illness mainly in terms of the spiritual factors that might be contributing to it…Disease, according to vitalists, is simply a more advanced stage of the stress that we exhibit when we persistently fail in the pursuit of physical and spiritual goals.”

Because this essentially dismisses all the progress made by science in understanding the causes and treatment of disease, and because it identifies naturopath as a purely faith-based practice, naturopaths often de-emphasize this element of their philosophy and talk more vaguely about the “inherent healing power” of the body rather than the “vital force” or spirit. It is true that the body has a remarkable capacity to heal itself and many ailments resolve without treatment, or in spite of treatment, which is one of the reasons ineffective therapies can appear to work even when they do nothing. However, naturopaths claim this inherent healing power is “intelligent and ordered,” which is a faith-based claim that cannot be examined or tested in any objective way. They also claim that this healing power can be supported by their recommendations and impeded by scientific medical therapies, which is contrary to a great deal of actual evidence.

One major problem with vitalism as a foundation for medical therapies is that its principles have to be accepted or rejected entirely on faith, which makes any claim one chooses to make immune from any objective evaluation. Given the unprecedented success of science-based medicine compared to all the methods that went before it, it seems unwise to go backwards away from the practice of objectively and critically evaluate medical claims by established scientific means.

Does It Work?
Of course the first step in answering this question is to define what “it” is, which as we’ve seen is difficult because there is no consistency to the specific interventions naturopaths employ. I have written before about homeopathy, TCM, herbal medicine, and many of the specific treatments naturopaths recommend. Many of these are unproven or clearly ineffective. Others, like herbal remedies, probiotics, and some dietary supplements may have some benefit. Categorizing them all as “natural” tells us nothing about which are helpful and which aren’t.

However, many of the recommendations naturopaths give, especially for humans, are identical to those given by conventional doctors. No one disagrees with the idea that clean, healthy food is essential for life, though what exactly this means may not be open to dispute. Similarly, clean fresh air and water, appropriate exercise, and a positive attitude are undoubtedly good for everyone, though they may not be the key to perfect health or immortality. The fact is that much of what naturopaths recommend may be perfectly reasonable, or even supported by good scientific evidence despite the fact that they are recommending it regardless of the evidence and based on a philosophy incompatible with science.

Like many alternative medicine proponents, naturopaths are happy to cite scientific research when it supports their beliefs and claims, but they are likely to dismiss any which does not. Because naturopathy is a vague philosophy encompassing many different practices, it is difficult to study in a controlled manner, and there is relatively little research on the general approach. A recent attempt at a systematic review of naturopathy found 12 studies that met the inclusion criteria, and while they appeared to show some benefits, they all had significant weaknesses and limitations that made it impossible to draw and reliable conclusions. The National Center for Complementary and Alternative Medicine (NCCAM), the American Cancer Society, and other government and private organizations have stated that there is currently no real evidence to support the claims of naturopaths. There also appears to be absolutely no controlled clinical research on naturopathy in veterinary species.

That leaves only the inevitable testimonials. For reasons I’ve discussed many times before, individual anecdotes provide no real evidence to support or reject medical therapies. At best they can suggest potential benefits or risks to be examined more closely, but despite the fact that they are highly persuasive, they are not a trustworthy source of information about naturopathy or any other medical practice.

Is It Safe?
Again, it is difficult to comment on the safety of naturopathy as a general approach because it is so ill-defined and specific therapies are not consistent between practitioners. The risks of particular practices, such as homeopathy, herbal medicine, TCM, and all the particular alternative therapies employed by naturopaths can be considered separately. The biggest risk of the philosophy itself is that it often involves counseling people against seeking and using conventional medical diagnostics and treatments. Naturopaths are frequently opposed to vaccination, for example, which is a position that clearly places people and animals at unnecessary risk of illness and death from preventable diseases. Naturopathy, like any other pre-scientific and unproven medical practice, is not a safe or reliable substitute for scientific medical care, and eschewing conventional care in favor of naturopathy risks losing the opportunity to receive effective therapy in a timely way.

Naturopaths often present themselves as appropriate substitutes for primary care doctors, for humans and animals, despite the fact that many of them lack of any real scientific or medical training. Even in those instances when the therapy they recommend is reasonable (such as diet and exercise advice) or harmless in itself (such as homeopathy), these individuals are not qualified to detect and respond to serious health problems.

Bottom Line
Naturopathy is a vague vitalist philosophy that identifies the causes of disease as imbalances in the vital life force or spirit and in supposed dietary deficiencies or undefined environmental toxins. The basic principles of the approach are unproven and, in the case of the claim that the roots of disease are spiritual, untestable.

Naturopaths use a hodgepodge of different alternative therapies according to their personal training and inclinations. Some of these are clearly ineffective nonsense (e.g. homeopathy, iridology), others are merely unproven but at least plausible (e.g. herbal remedies, dietary supplements), and some are consistent with conventional medical recommendations (e.g. exercise, some dietary advice). It is difficult to study the overall risks and benefits of naturopathy due to the varied and inconsistent treatment offered by individual practitioners. There is little research evidence in humans and none in veterinary species to support naturopathy as an effective approach.

The risks of individual therapies offered by naturopaths are also varied. Some, such as homeopathy, have no direct effect at all, for good or ill. Others, such as herbal remedies, can cause harm directly. The greatest risk, however, from naturopathic treatment is that naturopaths often recommend avoiding conventional medical care, include vaccines, surgery, and pharmaceutical medicine. Substituting unproven, untested, or ineffective therapies for scientific medicine is not an appropriate way to seek health or treat disease.

 

Posted in General | 32 Comments

An Evidence-Based Medicine Anthem?

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U.K. May Ban Unlicensed TCM Drugs

I’ve written about so-called Traditional Chinese Medicine (TCM), which is not actually traditional and which is a collection of untested folk beliefs that are inconsistent with much established scientific knowledge. The biggest problem with TCM, however, is that the remedies used are real drugs. They are combinations of plant and animal ingredients which are frequently mislabeled and sometimes completely secret, and they are often found to contain unidentified pharmaceuticals mixed in with the “natural” ingredients, or toxic heavy metals like lead and mercury. A list of reports on the dangers of these remedies can be found here.

Despite frequent acknowledgement from the government here in the U.S. that current regulations of herbal remedies generally are inadequate and not effectively enforced (1, 2), little political will exists to better protect the public from these products. However, it appears that the government of the U.K. is more willing to meet this challenge.

A recent news story indicates the U.K. equivalent of the FDA, the Medicines and Healthcare Products Regulatory Agency (MHRA) has asked vendors of unlicensed herbal products, including TCM remedies, to report their inventories in preparation for a ban on the sale of such remedies to be introduced next year. If true, this would represent a huge step towards treating such remedies as they should be treated, as drugs which need to pass the same scientific scrutiny for safety and efficacy as any conventional medication.

 

 

 

 

 

 

Posted in Herbs and Supplements | 4 Comments

2014 Roy Montgomery Research Award

The Evidence-Based Veterinary Medicine Association (EBVMA) announces the availability of an award of $3,000 to a single recipient (a person or group) designed to support research that promotes the understanding, development and application of evidence-based medicine (EBM) in veterinary medical research, practice, and education.

More information and eligibility requirements can be found at:

Roy Montgomery Research Award

The deadline for applications is Oct. 4, 2013.

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