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The American Medical Student Association: On “integrating” quackery with science-based medicine

There’s a saying in medicine that we frequently hear when a newer, more effective therapy supplants an older therapy or an existing therapy is shown not to be as efficacious as was once thought, and it has to do about how long it takes for the use of that therapy to decline. The saying basically says that the therapy won’t die out until the current generation of established physicians retire and are replaced by the new generation coming up through medical schools. From my perspective, it’s a bit of an exaggeration, because in the mere 13 years that I’ve been a real doctor (i.e., an attending physician) our practices in breast cancer surgery has changed markedly. Although certain core principles of breast cancer care remain the same, there have been major changes in terms of how we deal with the axillary lymph nodes, our use of hormone therapy and chemotherapy, and our very understanding of the different subtypes of breast cancer. Of course, I have spent my entire career as faculty at two different NCI-designated comprehensive cancer centers; so my experience is not representative of that of most physicians, particularly given that I’m super subspecialized. It’s generally expected that if you’re faculty in an academic medical center you will be at the very least up to date, if not beyond at the cutting edge.

Even so, there is some truth to the observation that it takes the rise of a new generation of physicians to force out certain old ideas, which means that how we train our medical students is of utmost importance. Unfortunately, these days, it is medical students who have become a major force for promoting the “integration” of quackery into medicine (which these days is known as, appropriately enough in a way unintended by its proponents, “integrative medicine”). No, I’m not saying that all or even most medical students are prone to the blandishments of quackademic medicine, but rather that there is a large enough contingent of medical students who have gone beyond being shruggies to become activists for unscientific medicine. There are CAM clubs, CAM interest groups, and student-driven CAM electives.

And then there’s the American Medical Students Association (AMSA), specifically its various initiatives in “integrative medicine.” I fear that each successive generation of medical students is more prone to embracing unscientific medicine than the last.

AMSA and CAM: A long history together

On its website, AMSA describes itself as the oldest and largest independent association of physicians-in-training in the United States. Founded in 1950, it currently boasts a membership of approximately 68,000 medical students, premedical students, interns, and residents. The goals of the organization, as described on its website, are as follows:

It’s hard to argue with any of these aims as goals, but, of course, as always the devil is in the details. For instance, AMSA has managed to cause some controversy with its PharmFree initiative, which is fine on the surface, but, as some argue, might have unintended consequences. Another problem is that AMSA declares itself to be all about the evidence and evidence-based medicine, as well as ethics. This would be great if it were true, but there’s one big hole in the claim. It’s a hole big enough to pilot an aircraft carrier through, and that hole is, to put it briefly, “complementary and alternative medicine” (CAM). To boil it down, AMSA promotes integrating quackery into medicine, and it does it in a big way. Let’s see how.

I first became aware of how AMSA promotes “integrative medicine” several years ago, when Dr. R. W. Donnell pointed it out to me. This led me to a document, still available on the AMSA website on a page called the ICAM Resource Center (Integrative, Complementary and Alternative Medicine), Complementary Therapies Primer (formerly “The Quick and Dirty Guide to Complementary Therapies”) and the 2006 UCSF Guide to Integrative Medicine. I’ll get to the primer in a minute. First, let’s look at AMSA’s position on CAM laid out on its ICAM webpage:

AMSA believes that students and physicians can best serve their patients by recognizing and acknowledging the availability of integrative medicine in their communities. By pursuing education in complementary and alternative medical (CAM) treatments, medical students and physicians can better facilitate the appropriate education, treatment and counseling of patients and consumers.

  • AMSA believes that an empowered patient can serve as a powerful and central actor in their own healing.
  • Appropriate education in CAM treatments uses scientific and ethnographic methods, including quantitative and qualitative outcomes research of efficacy and effectiveness. Although it is informed by evidence, it considers explanatory models and cultural.
  • AMSA supports students who wish to work within the healthcare system to create an environment which is supportive of the whole patient.
  • AMSA believes that medical students and other health care professionals need to be restored and whole in order to be empowering and healing for their patients.

Let’s look at numbers one, three, and four first. These are nothing more than CAM-speak blather worthy of one of Kimball Atwood’s installment of Weekly Waluation of the Weasel Words of Woo. For instance, there is nothing in SBM that says an “empowered patient” is a bad thing or that he can’t serve as a “powerful and central actor” in his own healing. Indeed, as I’ve pointed out before many times, paternalism is steadily going away within EBM/SBM, and most physicians of my generation and younger agree that’s a good thing for the most part. We want our patients to be engaged and provide input into their care and what’s important to them. Most of us don’t feel comfortable anymore taking a “doctor knows best” attitude in which we simply give orders and prescriptions and expect to be obeyed. This brings us to number three, which is what I like to call the “holistic” trope, in which CAM practitioners claim to be so much better than conventional medicine at caring for the “whole patient.” It’s utter bunkum, nonsense, a fetid pair of dingo’s kidneys. A good science-based primary care doctor is a holistic doctor! A good science-based primary care doctor does take care of the “whole patient.” A good science-based primary care doctor also “empowers” the patient. None of these things are inherent in or exclusive to CAM, nor are they unachievable in SBM. It’s a false dichotomy that AMSA fully buys into, lumping its CAM promotion initiatives under “humanistic medicine.” Again, I resent that — I don’t need CAM to practice “humanistic medicine.”

More importantly, let’s look at number two, how AMSA supports using both “scientific and ethnographic methods” and claims that appropriate education in CAM uses explanatory models and culture. While this is not completely unreasonable on the surface (certainly to understand how traditional Chinese medicine came about one has to understand a bit about the Chinese culture out of which TCM sprang), but notice the not-so-subtle denigration of science. Notice how AMSA considers qualitative and quantitative outcomes research and doesn’t even mention proper randomized clinical trials (RCTs), unless one assumes it to be subsumed under “scientific” methods. Odd that it’s not mentioned, though, isn’t it? Well, no, it’s not so odd. As we’ve discussed many times, CAM proponents are very much enamored of “pragmatic” research, of the sort that seeks to see how various modalities perform in “real world” settings. The problem with this emphasis is that pragmatic studies and outcomes research are not appropriate for modalities that have not yet been shown to be efficacious and safe in proper clinical trials. The reason for “pragmatic” research is to test whether treatments shown to work in RCTs do as well once they are let “out in the wild,” so to speak, where they will be used to treat patients who might not have fit the inclusion criteria of the RCTs used to test the treatment or in hospitals and settings where the capabilities for monitoring the therapy might not be as good as they were for the RCTs. Doing outcome studies on therapies that haven’t been validated in RCTs is putting the proverbial cart before the horse.

Informational resources that AMSA recommends: Quackery

Now, let’s go back and look first at the UCSF guide. It begins with a disclaimer:

Inclusion of a therapy, resource, or practitioner in this guide does not imply endorsement by UCSF, the Integrative Medicine Network, or the Osher Center for Integrative Medicine.

Too bad this disclaimer and the frequent mention that many of these modalities are pure pseudoscience and that there are no good randomized clinical trial data demonstrating the efficacy of most of these treatments is belied by the utterly credulous description of various alt-med modalities found in many of the chapters. For example, check out this description of acupuncture:

Acupuncture relies on the idea of Qi, the energy force that run in regular patterns called meridians through the body. A person’s health is influenced by the flow of Qi in the body, in combination with the universal forces of Yin and Yang. If the flow of Qi is insufficient, unbalanced or interrupted, Yin and Yang become unbalanced, and illness may occur. By inserting fine needles on the body’s surfaces at specific points to connect the meridians, acupuncture is used to regulate or correct the flow of Qi to restore health.

At the initial visit, the practitioner evaluates the patient’s current problems, medical history, available laboratory values and radiological tests, as well as a traditional physical exam of the tongue, reflex points, radial pulse, and external ear. The goal of the evaluation is to link the patient’s problems to a specific imbalance or block of Qi

Note how the description of qi is described as fact, not as an explanation that has no scientific basis for whatever effects (if any) acupuncture has on pain or disease in humans. Even in the section on scientific studies, there is no mention that qi has never been measured or detected, despite many attempts. But the description of acupuncture isn’t that bad compared to some others. At least acupuncture has a potential physiologic mechanism for doing something, as misrepresented and exaggerated as it is. OK, over time I’ve become less and less convinced of this; certainly claimed mechanisms do not persuade me. However, acupuncture does involve sticking needles in the skin. Not knowing anything else about it, one might think that something could be going on. In contrast, most homeopathic remedies are nothing more than water, pure placebo, but that doesn’t stop the fine folks at UCSF from serving up another heaping helping of credulity:

Dr. Hahnemann first formulated his principle of the Law of Similars after testing quinine, a cure for malaria. He found that it produced the symptoms of malaria in a healthy individual. However, when he discontinued the quinine, the symptoms disappeared. After several similar studies, Hahnemann found that very small doses of the substance are nontoxic and yet still work to produce the desired symptoms of the illness in healthy individuals. Homeopathic remedies are therefore diluted to different degrees so that only traces of the original substance are present. Often chemical testing will show no presence of the active ingredient. This, however, is completely consistent with homeopathic philosophy as they believe that the ingredient leaves an imprint on the remedy and it is this ghost print which then acts within the body.

There are also several testimonials, just as good as that of any seen on Mercola.com or NaturalNews.com (or any alternative medicine website selling products). For example, here’s one from a Reiki practitioner:

“I am a Second Degree Reiki Practitioner of the Mikao Usui Tradition. In the 10 years of my Reiki practice I have seen healing transformations in all my clients, on all levels (mental, emotional, spiritual, and physical). One patient that stands out most is a nurse for the U.S. Embassy that had been suffering from Shingles for nearly three years. After several hospitalizations and medical evacuations for treatment, she called me for an appointment. She was on daily doses of morphine painkillers, was exhausted and in pain all the time and had gained a lot of weight. We began weekly Reiki treatments that lasted for about six months. During the six months, she first began sleeping well, feeling more energetic, reducing her morphine and ultimately eliminating all pain medicine, and arriving at full energy balance and recovery.” — Lauretta Agolli, Reiki Practitioner

This, of course, follows a credulous description of what Reiki is, although at least the manual does mention that “Reiki is not recommended as the sole treatment for potentially serious medical conditions, and its use should not delay the time it takes to consult with a health care provider or receive established therapies.” Imagine my relief, after that lovely testimonial and the glowing description of Reiki that preceded this disclaimer.

I could go on, but what’s the point. The UCSF manual has credulous and, in some cases, promotional treatments of a wide variety of woo, including reflexology, Reiki, naturopathy, fasting, spiritual healing, and others, mixed in with the occasional less woo-filled modality, like biofeedback. But what disturbed me even more was some of the descriptions of treatments for specific diseases, for example cancer (of course). Take a look at this schizophrenic passage:

Alternative therapies may be dangerous because they are often unproven and administered in lieu of traditional treatment such as chemotherapy or radiation. Using alternative therapies instead of conventional treatment for highly curable, early-stage cancers is not recommended.

CAM therapies are also considered useful approaches to recurrence, metastatic cancers, and secondary cancers.

In actuality, as far as the cancer goes, alternative therapies are no more useful for curing recurrent or metastatic cancers than for curing early stage curable cancers. The only reason they sometimes appear useful for early stage cancers is because most such cancers are cured by the surgery, with adjuvant chemotherapy and radiation therapy serving mainly to reduce the risk of recurrence. If you undergo surgery for an early stage tumor and use an “alternative” medical therapy on top of that, you’ve almost certainly added exactly nothing to the surgery, whereas chemotherapy and radiation produce measurable decreases in the risk of cancer recurrence. Basically, you got lucky.

Worse, there are yet more credulous descriptions of all manner of cancer quackery, including megavitamins, “colon detoxification” with coffee enemas (as in the Gerson/Kelley/Gonzalez protocol), antineoplastons, the same is found for all the other diseases discussed individually, all with liberal comparisons between the woo and the dreaded “allopathic” medicine. Indeed, the only quackery I can think of that the UCSF manual does not mention, to its credit, is chelation therapy.

That’s where AMSA’s very own manual comes in. While the UCSF manual is a bit—shall we say?—reticent about promoting the quackier therapies, the AMSA manual has no such compunction. For instance, on p.20, this is what AMSA says about chelation therapy:

Chelation is used to reverse the process of atherosclerosis by removing calcium from plaques. It is used to prevent myocardial infarction and stroke, and as an alternative to bypass surgery and angioplasty. Since it improves blood flow, it is also helpful in gangrene, intermittent claudication caused by peripheral vascular disease, and poor memory due in part to insufficient cerebral blood flow. Reduction in metal ions reduces inflammation caused by free radicals, and makes chelation therapy helpful in arthritis, scleroderma, and lupus. Chelation therapy has also been used to normalize cardiac arrhythmias, improve vasculogenic vision loss, reduce cancer mortality, protect against iron poisoning and detoxification of snake and spider bites.

Chelation therapy involves between twenty and thirty treatments given at intervals of two to seven days. Each treatment takes approximately three and a half hours, and involves the intravenous infusion of EDTA, vitamins and minerals. Oral chelation is also effective for patients with mild disease, or as a preventive measure. EDTA and penicillamine (another chelating agent used in heavy metal poisoning, Wilson’s disease and rheumatoid arthritis) can be used orally, leading to reduced serum cholesterol.

The only warning given about chelation therapy provided is to point out that chelation therapy is “contraindicated in pregnancy, renal failure (the drug is cleared by the kidneys), and hypoparathyroidism (due to its calcium-binding properties).” There’s no mention that it doesn’t work, that it doesn’t clear plaques from coronary arteries, or that it doesn’t do anything for autism.

Then there’s this description of homeopathy:

The Law of the Infinitesimal Dose was formulated by Dr. Hahnemann when he experimented with dilute solutions, seeking to avoid toxicities, and found them to be more effective than full strength preparations. Homeopathic remedies are repeatedly mixed with water or alcohol and shaken (succussion), often diluting the substances to such a degree that no amount of the original medication can be found in the remedy. Some believe that the remedies retain their effect because of electromagnetic frequency imprinting, changing the structure of the diluent subtly.

Initially, as a patient is treated by a homeopathic physician, he or she may actually worsen. This is know as a “healing crisis.” As the presenting, most recent, symptoms are treated, older, underlying disorders come to the surface. Dr. Constantine Hering, the father of American homeopathy, believed that healing progresses from recent diseases to chronic maladies, from emotional imbalances to physical disorders, from superior to inferior, and from the deep structures to the superficial. This is known as Hering’s Laws of Cure. By following Hering’s Laws when treating a patient, a practitioner can successively unravel many layers of pathology, eventually recreating internal order and achieving a more permanent cure.

The skeptical take included in this guide? It’s mentioned that homeopathy has “lost favor with the medical establishment in the US” (gee, that couldn’t possibly be because homeopathy is a load of pseudoscientific rubbish with a mystical vitalistic overlay, could it?), after which a 1991 BMJ study finding that most controlled clinical trials suggested a beneficial effect of homeopathic remedies is cited. Unfortunately, there are also similarly credulous takes on a wide variety of dubious, non-science-based therapies, including aromatherapy, acupuncture, chiropractic, naturopathy, and others. I can see AMSA apologists retorting that this particular guide was written in 1995, making it 17 years old and potentially out of date. If that were the case, however, why would AMSA not remove it from its website as one of its suggested resources? Ditto the UCSF guide. Alternatively, AMSA could add a note to its 1995 guide pointing out that chelation therapy is dangerous and doesn’t work or remove that section altogether. It hasn’t. At worst, this failure implies endorsement of this particular form of quackery; at best, it implies indifference to whether chelation therapy is science- and evidence-based or not. The same could be said for all the other quackery credulously discussed in these two tomes of pseudoscience.

If the above doesn’t convince you, just peruse AMSA’s webpage for its Naturopathic Medicine Interest Group, which not only represents naturopathy as scientific but actively encourages interactions and “cross pollination” between medical students and naturopathy students, complete with a link to a list of alternative medicine conferences.

Promotion of CAM and a bootcamp for quackery

Unfortunately, AMSA goes far beyond simply providing unscientific and pseudoscientific information on its website and falling for typical distortions of language used by CAM apologists. In other words, it goes beyond words into deeds. For instance, if you peruse AMSA’s website, it won’t take you long to find several initiatives related to CAM. One example is AMSA’s Educational Development for Complementary & Alternative Medicine (EDCAM), whose goals are described as:

  1. Improve medical student proficiency in CAM theory, methods, and practice;
  2. Enhance medical student education of preventive health, holistic care, and self-care through clinical examples using integrative medicine; and
  3. Improve cultural competence and comfort of future physicians increasingly exposed to a diversity of world populations and healing methods.

To manage that, EDCAM has created modules whose use it encourages medical schools to use in their curriculum that it refers to as Core Curriculum CAM Integration in 10 categories. These include:

  1. Nutrition and Lifestyle: Diet, Exercise, Sleep and Stress Management
  2. Mind-Body Medicines 
  3. Alternative Systems of Medical Thought: Traditional Chinese Medicine, Kampo, Tibetan Medicine and Acupuncture 
  4. Alternative Systems of Medical Thought: Yoga, Ayurveda, Native American and Yoruba Based Medicines 
  5. Alternative Systems of Medical Thought: Homeopathy and Flower Essences (updated 5/03)
  6. Bioenergetic Medicines 
  7. Pharmacologic/Biologically Based: Herbal Medicines 
  8. Pharmacologic/Biologically Based: Nutrition, Dietary Supplements and Vitamins 
  9. Manipulative Therapies: Chiropractic and Osteopathy 
  10. Manipulative Therapies: Therapeutic Massage

Let’s take a look at one of these, the section on bioenergetic medicines. This is a subcategory of CAM commonly referred to as “energy healing” and includes therapeutic touch, reiki, and several others. The objectives described include being able to:

  • understand the concept of subtle energy, the vital force, qi, and prana and their roles in medicine, now and historically.
  • define the terms bioelectromagnetic medicine, biofield therapies, biofield, frequency, electromagnetic field, magnet therapy, medical qigong, Reiki, therapeutic touch, and external qi.
  • explain how energy medicine works according to our present scientific understanding and discuss what scientific questions and controversies still remain, discussing the scientific loopholes in studying bioenergetic fields.
  • understand what skeptics say about energy medicine, and what scientific arguments are used to refute those claims.
  • explain the present and most promising future applications of bioelectromagnetic therapies, citing some key studies showing effectiveness of bioelectromagnetic therapies.
  • list the main types of biofield therapies used in the U.S. and know what they are clinically used for.
  • discuss several key studies examining effectiveness of biofield therapies.
  • experience some form of biofield or bioelectromagnetic energy practice.

AMSA states that “bioenergetic medicine” (BEM) can be used to treat bone fractures, soft tissue injuries, chronic venous insufficiency, osteoporosis, Alzheimer’s disease, and others. Interestingly, the most recent references cited to support these claims date back to the 1990s. Instead of stating that there is no evidence that the “life energy,” “vital force,” or qi exists, this is what the BEM section states:

The biofield refers to the complex, dynamic, extremely weak EM field within and around the human body that has been proposed as a super-regulator of health and healing (Rubik, 2002). Besides the EM components of the biofield emitted by the brain (EEG) and heart (ECG) that are well known in conventional medicine, the human biofield may also consist of more subtle energy fields as elaborated in Oriental Medicine, Ayurvedic Medicine, and other indigenous systems of medicine.

This subtle energy, vital force, or cosmic life energy is a key concept in many CAM modalities, and it is referred to by the many terms listed above from various medical systems (Rubik et al., 1994a). Such vitalistic principles underlie many CAM modalities besides energy medicine, but have been banished from conventional medicine. This fundamental philosophical difference is at the root of medicine’s divided legacy (Coulter, 1994).

Amusingly, the BEM module does cite Emily Rosa’s famous study of therapeutic touch that demonstrates that it doesn’t work and tries to refute it:

Several methodology issues were questioned in this study: 1) consistency of the distance between the experimenter’s and subjects’ hands, 2) lack of reference or use of methodology used by TT experts in 28 prior quantitative studies, 3) lack of accounting for conditions during which HEF cannot be detected by those denying desire for interaction with proper intention. Researchers have concluded in other studies that college students can sense another’s intention to interact with them (Schwartz 1995, 1998).

One notes that the two studies cited that claim that college students can detect another’s intention to interact with them appeared in a journals called Subtle Energies and the Journal of Scientific Exploration. Interestingly enough the Subtle Energies website triggered a malware warning on Safari when I tried to access it; so I didn’t. Maybe its energies are more powerful than expected! Be that as it may, neither journal is what I would describe as reputable, and neither study is a good study. (Maybe I could go into detail on another occasion.) None of the other modules are any better, either. If you don’t believe me, take a look at the homeopathy module, where one of the objectives is to “discuss the scientific controversies and questions that remain for homeopathy and explain basic evidence for and against its clinical application.” There are no “scientific controversies” about homeopathy. It is water; it is a placebo. How many times does this need to be pointed out?

Unfortunately, this is the sort of stuff that AMSA wants to place in medical school curricula, and, to a large extent, it’s succeeding.

In case that isn’t enough, though, AMSA goes far beyond informational resources, helpfully providing its AMSA Medical School CAM Directory, which allows a fast and easy search of CAM programs at various medical schools for medical students looking for CAM electives and sponsors an International Integrative Medicine Day. If that’s still not enough, AMSA offers what is in essence a boot camp for students who want to become leaders in integrative medicine, which it calls Leadership and Education Program for Students in Integrative Medicine (LEAPS into IM). LEAPS into IM is designed to groom future thought leaders in CAM and integrative medicine by choosing 30 students to take part in a week long retreat at the Kripalu Center for Yoga & Health in Berkshire Mountains of Massachusetts. If that’s not enough, there’s also a month long retreat offered known as the Humanistic Elective in Alternative Medicine, Activism and Reflective Transformation (HEART):

Specific sessions will be focused on intentional community building, complementary and alternative/holistic and integrative medicine, social justice and activism, reflective transformation including meditative practices, and personal growth skills such as communication and intention. Any clinical site visits will demonstrate ways to incorporate social justice and patient advocacy into clinical care.

There’s nothing like tying the idealistic impulses of young people to indoctrination in pseudoscience and quackery, is there?

Finally, for students who can’t travel to Massachusetts next June or give up a month of their lives for HEART, there is an online CAM course AMSA calls the Integrative Medicine Scholars Program that allows students interested in integrative medicine to learn and interact online.

Conclusion

As admirable as many of AMSA’s initiatives might be, it is very clear that, when it comes to the promotion of nonscientific medicine, AMSA is far more part of the problem than the solution. I wish it were otherwise, but it is not. That being said, I realize that the “humed” (humanistic medicine) contingent of AMSA is the minority, and my conversations with numerous medical students leads me to believe that many of them quite correctly take a dim view of AMSA’s promotion of woo in the medical school curriculum. Unfortunately, the majority of them are also shruggies, much like most of physicians they will “grow up” to join and ultimately replace, which probably explains why they don’t band together to do something about AMSA’s blatant promotion of pure quackery. How to get medical students more interested in science-based medicine and willing to confront the infiltration of pseudoscience into their main professional organization is the most pressing issue supporters of SBM have in medical education. One wonders what would happen if an SBM-minded group of students tried to form an SBM interest group within AMSA. We can only encourage, offer help to interested students, and hope.

Posted in: Medical Academia

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92 thoughts on “The American Medical Student Association: On “integrating” quackery with science-based medicine

  1. RenegadeSynapse says:

    I joined AMSA when I was a MS1 for the free Netter’s atlas. The membership was 4 years, and over that time I loosely kept up with what AMSA was all about, and while I agree with many of their political stances re: health care, what’s outlined above is one of the primary reasons why I didn’t keep my membership. I’m glad to have this excellent analysis to point any of my interested colleagues to. As usual, thank you for the great, in-depth post David.

  2. Janet says:

    This left me wringing my hands in despair until I read RenegadeSynapse’s comment–which gives me some hope.

  3. cervantes says:

    What if there were a movement among students of physics to promote “integrative” physics? You know, young earth creationism, geocentric universe, there is no gravity the earth sucks, whatever. This is unimaginable in biology as well. Alternative and complementary mathematics, anyone? What is it about medicine?

  4. evilrobotxoxo says:

    @cervantes: it’s because doctors are not scientists. As a group, they are not scientifically trained. They learn and use a lot of stuff that science figured out, but they are not trained in the process itself. In my med school class, 1/3 of them were non-science majors, and I think that’s probably pretty close to the national average. Even the ones that were science majors mostly just learned science from books at the undergrad level and never really developed the critical thinking skills that come with being a practicing scientist.

  5. The Dave says:

    The pharmacy school I go to has 2 campuses and a Facebook page for the students of each. A few weeks back I posted the following article: http://www.homeowatch.org/policy/pharm.html about why pharmacists should not sell homeopathic products

    While the response was neutral-to-positive on my campus, I actually had a few students from the other campus start to argue with me about how we need to give our patients options and let them choose and to be open-minded, etc. etc. etc.

    It made me rally glad I’m not going to that campus, otherwise I would be bashing my head against a wall.

    (I should clarify that it was 1st year pharmacy students, within the first couple weeks of the school year, so hopefully they change over these next 3 years)

  6. nybgrus says:

    Evilroboto is exactly right. Most of the students in my cohort can barely explain the difference between an RCT, case-control, cohort, or pragmatic study, let alone why that actually matters.

    I also agree that in my experience there are typically a preponderance of students who are skeptical of sCAMs but are shruggies, some who are very much like myself, a decent number of “what’s the harm” and “leave your mind open” types, and then a minority of loud and vocal CAM proponents.

    I myself was just recently elected the president of my med school cohort (of all 4 years) and have a cabinet of very non-shruggie students. One of my goals will be to establish our group and cohort at large as academically rigorous and science based. Wish me luck! Lol

  7. Bogeymama says:

    @ The Dave – Thanks for your efforts at your school! As I was reading this, it occurred to me that the same thing is happening in pharmacy schools. When I was in pharmacy school (really, not THAT long ago..) homeopathy was actually briefly taught to us in a course titled “History of Pharmacy”. There was virtually no mention or inclusion of CAM remedies throughout my pharmacy education, and it remained on the fringe for the first decade of my career. The internet has changed all that, and it’s shocking to me how many of our pharmacy colleagues have embraced the woo. We are not helped by our corporate overlords, who – seeing the dollar signs – impose planograms onto us that give homeopathy prominent shelf space alongside the regular products in the therapeutic category. We are also expected to hand out the free health magazines that are full of ads for wellness prodcuts and herbs. Sadly, in the retail pharmacy profession, much of what is included on our shelves is decided by marketers and not health care professionals.

    While it may not seem that our efforts are making a dent at this point, please keep up the leadership. Our voice is getting louder …

  8. The Dave says:

    @nybgrus: Good luck! We need more med students like you.

    @Bogeymama: Thanks. impositions by corporate overlords has me worried for the profession, and will definitely be an ethical dilemma in my mind, but I’m hoping to make my career in a hospital setting, eventually specializing in psychiatric. Then, I won’t have to worry about dispensing homeopathy :)

    I’m actually still fairly new to the concept of science-based medicine. I used to be really naive and a “shruggie”. We used Hyland’s homeopathic teething tablets with our first child (and we swear it worked :) ) but gave up on them when they didn’t work on our 2nd child. Then my wife started using Bach’s Flower Remedies and they set off some red flags. (Side note: I got my bachelor’s in psychology and have always been scientifically-minded) I was curious how they figured out mustard was good for mood-elevating (or whatever it was) so started looking online. That’s when I read about succussions and morning dew (but since its impossible to harvest enough morning dew, you can shine sunlight through regular water) and the water having memories, etc. and that’s when I had my WTF?! moment.

  9. MTDoc says:

    When I entered Med School in the 1950′s, most students were selected on the basis of science backgrounds, not just a few “premed” courses. But even then there was a movement to reshape the future physician, with talk about a “better rounded” applicant from the liberal arts side. As a BS (that’s bachelor of science) candidate at Yale, I felt considerable discrimination from the “other side”, the only group considered lower on the scale of evolution being engineers. For what it’s worth, my classmates from the “other side” are the folks who have always run the country because they know best.

  10. NeuroTrumpeter says:

    Like RenegadeSynapse, I joined the AMSA as a first year student (I’m now a 4th year) for the free goodies.

    Already immersed in medical skepticism (I was reading SBM, Neurologica etc years before medical school), I was disgruntled to discover AMSA’s endorsement of CAM, but my dismay was eclipsed by the growing number of student interest groups at my institution that are dedicated to quackery.

    Fortunately, the official curriculum at my school generally champions EBM and avoids teaching alternative medicine, with the exception of raising awareness to various treatments/herbs to which patients might be subjecting themselves. I only wish there was stronger emphasis on the dangers of CAM and the implementation of exercises to strengthen critical thinking skills. It’s frightening to me that many of my fellow students, no matter how intelligent, take for granted that complementary medicine holds some legitimacy.

  11. cervantes says:

    Well folks how about this. First semester, first year of medical school should feature a course titled “Research methods and causal inference in the biomedical sciences.” And a second semester after that.

    Instead they’re cramming for the anatomy final, 90% of which they’ll forget the next week. (Which limb of the internal capsule contains cortical afferents?)

  12. moderation says:

    This would be good for a laugh, if it did not make me cry. I am embarrassed and afraid of what the future holds for medicine, if people with such malfunctioning critical thinking skills are able to get in to medical school.

  13. Newcoaster says:

    It’s very sad that the next generation of docs are being indoctrinated into the woo, at least in the USA
    Out of curiosity as to what’s going on in my own country, I went to the Canadian Medical Students Association, and was relieved to find nothing at all about CAM or woo in general. It’s full of earnest position papers on diversity, patient rights and the like.

    I take medical students occasionally as part of their “rural experience’ and always bring up the topic of CAM. I’ve been encouraged that the students I have seen do appear to have an EBM/SBM point of view. When they aren’t, I do my best to educate them, among other things pointing out this blog as a good resource.

    One student mentioned to me that a Naturopath had come in to give a talk, and he was asked a lot of hard questions, and basically laughed out of the lecture hall. I don’t recall from my med school days in the early 90′s ever learning anything about CAM at all. We were too busy with anatomy, physiology, biochemistry, pharmacology, embryology, histology….and all the other -ologies. I can only recall one classmate from residency who was into the woo. He stated he went into medicine specifically so he could do acupuncture with the aura of an MD to separate him from the TCM practitioners.

  14. aeauooo says:

    I wonder if the new generation of malpractice lawyers will have a “holistic” approach to harm caused by ineffective therapies.

    “Researchers have concluded in other studies that college students can sense another’s intention to interact with them…

    …especially after a few beers.

  15. makaira says:

    Dr. Gorski,

    At the time I began reading your work at Respectful Insolence I was working in a quantitative genetics laboratory full-time, and it was in the midst of reading one of your pieces that I decided, though I had never considered it previously, to shadow a physician and have a peak into the world of medicine. Fast forward four years and here I am, an MS2 knee-deep in the complexities of the basis of clinical practice. I have continued to read your work all along, and value your breadth of knowledge on subjects I am only now just beginning to grasp. In all these years I have never commented at RI or SBM, but I feel the need today to draw attention to the inaccurate implications of this article.

    As you mention early on, the American Medical Student Association (AMSA) is the largest independent association of medical students in the United States, which allows the organization an amazing opportunity medical students, individually, have not traditionally possessed – the ability to directly impact not only medical education, but also the practice of medicine and the way we interact with the broader public. For instance, it was medical students who fought for civil rights and Medicare when the medical establishment, then the AMA, fought both off tooth-and-nail.

    Indeed, the “old ideas” that you cite are being forced out of the practice of medicine, driving the profession in a more evidence-based direction, are primarily being forced out by to the actions of medical students in AMSA, or individuals who are now interns, residents or attendings and have come up through the ranks of AMSA.

    At the same time AMSA is also an organization of over 35,000 medical students in the United States, which is about the population of the city I grew up in. As you might imagine, such a large group of diverse individuals will result in diverse passions and interests, only some of which 100% of the membership will agree with at any given time.

    You’ve written a lengthy article criticizing AMSA as “far more part of the problem than the solution,” while simultaneously writing that your “conversations with numerous medical students [have] lead [you] to believe that many of them quite correctly take a dim view of AMSA’s promotion of woo in the medical school curriculum.” Interestingly, you’ve left out of your article any reference to the PSQLI, and completely glaze over the PharmFree initiative which, while citing a seven-year-old blog post that provides nothing of substance as criticism, is perhaps the most important evidence-based medicine initiative in the entirety of medical education today.

    I encourage the medical student element of your readership who take issue with the role CAM plays in their medical education to join AMSA and speak-up. AMSA is not an organization run by a static few for an indefinite period of time; it is an organization that renews itself each year and provides ample opportunities for every member to hold local or national positions and influence the direction of the organization.

    AMSA is far more a part of the solution to issues in the practice of medicine and the education of medical students than it is part of the problem, as you’ve purported here, Dr. Gorski.

  16. David Gorski says:

    Interestingly, you’ve left out of your article any reference to the PSQLI, and completely glaze over the PharmFree initiative which, while citing a seven-year-old blog post that provides nothing of substance as criticism, is perhaps the most important evidence-based medicine initiative in the entirety of medical education today.

    This post is not about PSQLI, nor is it about PharmFree. It is about AMSA’s promotion of quackery through its EDCAM initiative and other programs that are steeped in pseudoscience. It is also about AMSA’s efforts to “integrate” quackery into medical school curriculums. Whatever their merits, PSQLI and PharmFree are separate subjects, and I’m still not completely convinced that PharmFree isn’t driven more by the anticorporatism inherent in a lot of AMSA’s more progressive stances than it is on an actual concern for evidence. My personal misgivings about PharmFree aside (and they are also largely irrelevant to this discussion, which is why I barely mentioned PharmFree), for purposes of this post, when it comes to CAM, AMSA’s PSQLI and PharmFree initiatives do not make AMSA any less of a problem when it comes to the promotion of pseudoscientific CAM in medical academia or absolve it of the damage it is doing to medical education through EDCAM. Mentioning PSQLI and PharmFree in the context of a criticism of AMSA’s CAM promotion is, I’m afraid, a non sequitur.

  17. weing says:

    It’s curious to me. The PharmFree initiative is an attempt to remove the influence of Pharma on medicine. Why allow quackery to influence medicine instead?

  18. norrisL says:

    “Chelation therapy has also been used to normalize cardiac arrhythmias, improve vasculogenic vision loss, reduce cancer mortality, protect against iron poisoning and detoxification of snake and spider bites.”

    So maybe the AMSA should send a few of their students to Australia, get them bitten by some of our snakes (In order of toxicity…Inland Taipan most potent land snake on earth, Eastern Brown Snake 2nd, Coastal Taipan 3rd, the well named Death Adder 4th, Tiger Snake 5th, King Brown Snake 6th, Red Belly Black Snake and more, which, I am afraid leave American snakes for dead. No offence to your snakes!), then try chelation therapy and see just how well (or not) that works out for them. My suspicion would be ….not at all well with any of the above named snakes.

    I had a beautiful copper-red Border Collie in my surgery last year bitten by an Eastern Brown Snake. What happens with a brown snake bite is that you, or in this case, the dog, go downhill, then you get better, then you die. Sadly this is exactly what happened to the Border Collie he went downhill, he got better,he was sitting in his cage about 30 minutes after being bitten and looked quite alert and happy, then he fell to the floor and passed blood from nose and mouth and was dead.

  19. nybgrus says:

    @makaira:

    I myself am less than 4 week away from being an MS4. You make some very good points and definitely outline some of the strengths of AMSA.

    However, those do not negate or make up for the negatives of CAM promotion. Even though AMSA is a diverse and large group with renewing and changing leadership, it is also comprised of those who are supposed to be learning about evidence. Diversity of ideas is always an positive, as long as they are constrained within the reality of the organization and purpose they are to serve. In other words, even if AMSA only had 1% of its group interested in woo, it should not grant them an open forum to be apologists for CAM since the basis of medicine should be rooted in evidence. Furthermore, they do not just say that a small population of its members like CAM, but actually have workshops, boot camps, promotional events, and actively try and influence medical school curricula to include the credulous teaching of rank quackery and CAM. I myself would advocate classes on CAM literacy taught from the perspective of why it makes no sense and why CAM studies are always of poor quality, but that is not what AMSA is doing.

    It is for these reasons that AMSA is much more a part of the problem than the solution when it comes to CAM. Not any of its other endeavors, but CAM specifically. I believe that is the point of Dr. Gorski’s post and he is quite correct in his assertion.

    Remember that part of the purpose here (or at least mine, and I reckon the authorship as well) is not just to demonstrate why CAM is garbage and then have people do whatever they want anwyays. It is to educate and empower people to be active in pointing out why CAM is garbage and why it shouldn’t be “integrated” (cow and apple pies are coming to mind) into medical education and practice.

    As an anecdote… I was in the ICU a few weeks back with two students from a different SoM. I was swapping cool medical blogs with one of them and mentioned this and explained briefly it was about evidence in medicine and often focuses on why CAM is a useless construct. He said, “Cool” but the other student said, “Wait, you think all of CAM is useless?” I said yes. “All of it? Even acupuncture, herbs, and diet and exercise?” So I had to give the 60 second version of why CAM is a meaningless term, that yes acupuncture is placebo nonsense, and that herbs, diet, and exercise are not CAM in any way. My point is that many students are simply not educated on the topic and think there is validity to the nomenclature and constructs generated by the CAM proponents. And if (when) they hear about AMSA’s workshops, boot camps, etc that only reinforces the idea and gives it even further legitimacy. They buy into the BS false dichotomy of CAM and “mainstream” medicine, East vs West, etc. It is easier for me to demonstrate why acupuncture is garbage than it is to answer “Well, then why is AMSA and UCSF advocating for CAM in their workshops and the Osher school?” In other words, a significant part of the problem.

    [PS - I am pretty sure Respectful Insolence is written by a sentient cube shaped computer with blinking lights]

  20. David Gorski says:

    You are correct. It is. :-)

  21. The Dave says:

    Nybgrus mentioned “herbs, diet, and exercise are not CAM in any way” I have an honest question regarding herbs (remember, I’m kind of a novice). I know it might open up a much larger discussion, but how exactly do herbs fit into the SBM vs. CAM debate. I know that some herbs do have therapeutic effect (and that a lot of medicines are derived from the herbs) but at the same time a lot of herbalists sell preparations for a wide range of woo-tastic “remedies” including, but not limited to, detoxing, immune boosting, etc.

    Thank you

  22. nybgrus says:

    @thedave:

    Don’t have time for a full response but look up (here and in google) pharmacognosy. That is the science of herbs. You can object woo into anything. Yoga it’s fantastic exercise. Add in that it balances your chakras and it becomes woo.

  23. The Dave says:

    I have a minor understanding of the concept of pharmacognosy (mostly from this blog) but I always assumed it was distinct and separate from what herbalists do, perhaps not. I like your statement about injecting woo into anything. That makes a lot of sense

  24. Zetetic says:

    Herbal therapy has many issues. Yes, herbs have many and sometimes strong pharmacological effects. However, purity and strength are significant problems and synergism with other medications is not often assessed. Additionally, the application of herbs to medical conditions is rife with anecdotal evidence and even myth, not supported by thorough scientific evaluation.

  25. The Dave says:

    That’s what I had been thinking about it. I’m of the opinion (perhaps because I’m a pharmacy student) that it is far better to isolate and purify the active, therapeutic chemical, put it in a pill, and regulate it for safety and efficacy. In my opinion, there’s a double standard, with herbal preparations and herbalists getting let off easy, but I feel that it shouldn’t be like that.

  26. The difference I see is, herbs in their whole state are safer , atleast the majority are, and chemicals in pills are not. And, the people should have the freedom to choose what kind of remedies they prefer anyway, not left to what conventional meds decide is or isn’t ‘recommended’.

  27. Robb says:

    The Dave – could you explain what you mean by the “double standard” and herbal preparations and herbalists “getting let off easy”? It sounds like you are talking about regulations or the lack of – do you mean
    in the US specifically under DSHEA or just generally?

    Other countries have different regulations but generally herbalists are not regulated or licensed to practice medicine at all and herbal preparations are sold as dietary supplements that cannot make disease claims like pharmaceuticals can – they are also not covered or reimbursed under any health insurance programs as far as I know (it may be different in Europe).

    In Canada, herbal preparations are licensed based on scientific evidence (they can make some condition/disease claims if supported by evidence but not for “Schedule A” diseases (generally more serious ones like cancer, AIDS, etc.)) and also on “traditional use” if there is no scientific evidence done to date. Traditional use doesn’t guarantee efficacy – it simply says that there is proof it was traditionally used for a specific purpose (and there is safety evidence submitted for them to be licensed this way as well) and then people can make up their own mind if they want to try it.

    I’m not entirely clear on what evidence needs to be submitted to make “structure/function” (non-disease claims) claims in the US under DSHEA – I know it is not zero evidence but I don’t think it is as rigorous as the Canadian system – is this where your double standard perception comes from? Or is it more above and beyond the regulations and in the way they are marketed?

  28. The Dave says:

    Robb:

    “Other countries have different regulations but generally herbalists are not regulated or licensed to practice medicine at all and herbal preparations are sold as dietary supplements that cannot make disease claims like pharmaceuticals can – they are also not covered or reimbursed under any health insurance programs as far as I know (it may be different in Europe).”

    As far as I understand it, its basically like that here in the States, as well, but that doesn’t stop other people making claims about this herb doing this and that herb doing that. I do know for a fact that some herbal companies sell preparations with names like “Anti-plague”, “immune boost”, “Colon Cleanse” “Colon Detox”, “Attention Calm Formula”, and the list goes on. (My wife has bought all those listed, and more, from one company) (P.S. the “Knowledge Base” section of this particular company’s website has links titled: Article Blog, Community Answers, Ailments, Free Health Analysis, and Ways to Save. Nothing concerning scientific evidence to support their claims)

    “In Canada, herbal preparations are licensed based on scientific evidence (they can make some condition/disease claims if supported by evidence but not for “Schedule A” diseases ”

    I wish that was the case here, but as far as I understand, its not.

    I hope that clarified it a bit (maybe?)

  29. Robb says:

    The Dave,
    Yes, that clarifies – but that’s not a double standard – that’s describing a combination of companies breaking the law and people not being concerned with the science behind a product. I don’t see it as an herbs vs. pharmaceuticals double standard – I see it as an illegal business practice vs. legal practice issue. There are also issues with pharmaceuticals being marketed illegally, prescribed for off-label uses, or of sub-standard drugs entering the supply chain. This in no way excuses sub-standard or illegal practices in the supplement/herb industry, but my point is that pretty much all business sectors have issues like this that need looking at. It is a bit surprising that the FDA only just recently began enforcing supplement manufacturers to adhere to GMP but I guess better late than never.

  30. The Dave says:

    Robb,

    Yeah, I guess you’re right about that. But it still bugs me. :)

  31. Scott says:

    In practice there is a double standard. Pharmaceuticals aren’t allowed to slip through the cracks be on the market without the required safety and efficacy testing. Herbs and supplements ARE allowed to slip through the cracks to make specific disease claims. The double standard is in the enforcement, if you will.

    There’s also a fundamental contradiction in the concept of “we’ll exempt you from most safety/efficacy testing so long as you don’t make any concrete claims.” If there truly were no concrete claims, then the herb/supplement industry would be in much the same realm as if I were to run ads proclaiming “Buy my wonderful new widget! I won’t tell you what it does or why you’d want to buy it, but send me money anyway!” The ludicrousness of that as a business strategy doesn’t really need expanding upon (but here I am doing it anyway).

    This contradiction is resolved, as I see it, in two ways (above and beyond the lack of enforcement). First, structure/function claims can get pretty darn concrete. “Boosts the immune system” will be widely understood to mean “makes you less likely to catch the flu.” Second, people can be getting the message of “cures X” from other communications – e.g. an Internet community touting dandelion extract as a sure cure for psoriasis (completely made-up example).

    In either case, the consumer is buying the herb/supplement in the specific expectation of a particular disease benefit. So the entire rationale for treating them differently breaks down, since they are in practice being viewed as drugs.

    Whether you call it a double standard or not, it’s quite nonsensical.

  32. nybgrus says:

    I almost fully agree with you Scott. I see it as a double standard both in practice and in theory.

    Why is it that a pharmaceutical company can’t just develop a drug and market it in the exact same way as a supplement? Why can’t Gears (the synthetic chemist commenter here) just synthesize a chemical and make a structure function claim and then market it for “helping to reduce blood pressure” with a small bench science in vitro study of the chemical on a cell culture demonstrating changing in cAMP levels?* Because of the naturalistic fallacy. It really makes no sense to assume that a “natural” herb or whole herb would be better than a purified and well studied product.

    The double standard is that merely because of these “structure function” and bench science claims, a product can completely skip Phase I, II, III, and even IV trials and go straight to the shelf with slick advertising to make you believe it is as efficacious as an actual pharmaceutical but at the same time “better” because it is natural.

    Some may say that this is similar to other industries where they stretch truth claims and market garbage for people to buy on QVC late night TV shopping. That has no bearing on the validity of it or the fact that it is a double standard. That just means those other industries should also be more tightly regulated. But we here are not working for Consumer Reports – we are medical scientists, so obviously our focus would be here. Saying other realms of industry do the same thing does not make it right or more evidence based here.

    So yes, it is a huge double standard and all so-called supplements** should be regulated to the same degree. Especially in medicine, in many cases less is more.

    *As I wrote that, I wondered – would it be possible for that to happen? I’d be willing to bet with an elaborate enough story and the lax enforcement it would fly, at least for a while.

    ** So-called because it makes no sense what becomes labeled a “supplement” and what doesn’t. Melatonin is a “supplement” because our body makes it naturally and thus can be “supplemented” to help with sleep/wake cycles. Yet growth hormone and testosterone are also made in the body but that needs a prescription and is generally illegal to abuse. And I have no idea how echinacea or red yeast rice can be considered a “supplement” since those have nothing to do with compounds in our body to supplement and if they are just “food” then they should be marketed for adding to my pot roast for flavor, not in concentrated pills for cough and cold and hypertension.

  33. Robb says:

    Scott,
    Most of your examples of how you perceive things to work in practice that don’t relate to existing enforceable regulations fall under the realm of “consumer perception” and “implied marketing”. This is, again, nothing special to herbs and supplements – it is common marketing practice and common public misunderstanding or lack of insight or awareness. Yes, marketing often works by exploiting these things.

    When I watch a Viagra ad, I am led to believe that my life will suddenly become suffused with golden sunshine and joy and I will skip to work ecstatically while singing. When I watch a car ad, I am led to believe that my life will suddenly become a grand adventure and that my family and social life will dramatically improve just through driving a brand of car. I can read online on Coca-Cola’s Facebook page about people’s experiences with drinking Coke throughout the years and how it has helped them remember the good times in so much better detail, always with a Coke in hand. These are all implied benefits that are exaggerations or lies. In practice though, people fall for it on an emotional level.

    People need to be more skeptical of marketing and advertising in general. Claims should be specific and science based for health products. More and more companies are actually being cited for crossing the line.

  34. Robb says:

    nybgrus,
    The problem with your double standard comparison is that you are confusing disease claims with structure function claims. Your hypertension example is a disease claim, not a structure function claim. Obviously it can get into a grey area in some cases but the guidelines can be found here:
    http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm103340.htm

  35. Robb says:

    @nybgrus,
    Really wish there was an edit function to add to a post rather than make a new one….but wanted to add that as far as the definition of a supplement, you basically answered your own question. Some are things in the body naturally and some based on things from the diet (vitamins, minerals, essential fatty acids, probiotics, etc.) but various substances the body produces are very different administered exogenously compared to the small internal amounts (your testosterone example, interferon, dimethyltryptamine, etc.) and these are prescription (or illegal). Sometimes it is a bit arbitrary or of differing opinion (melatonin is prescription in EU and supplement in the US and Canada; marijuana is deemed an illegal substance while alcohol and tobacco are not).

    Really, these concerns and arguments revolve around herbs and supplements being equated with or used in place of drugs. Disease claims vs. structure function claims are supposed to mediate this. When they don’t, in practice, regulatory enforcement actions are already available. Healthwise, herbs and supplements are really part of diet, exercise, and lifestyle choices to maintain and support health, with preventative aspects in some select cases. They are not meant to replace drugs if maintenance and support, whether through poor choices, genetics, accident, or simple aging, fails and a full blown pathology develops (except for a few well researched ones like St. John’s wort and Hawthorn).

  36. The Dave says:

    @nybgrus

    That’s basically how I have felt about it (just unable to explain it so eloquently). But I got confused when, in your earlier statement, you grouped herbs with diet and exercise and removed that whole group from the designation of CAM.

  37. nybgrus says:

    When you watch a Viagra ad it leads you to believe your life will be suffused with happines because you can now get an erection and enjoy the things one can do with regaining that ability.

    When you watch an ad for ExtenZe you are lead to believe something very similar (that your erection will be longer, larger, and of more duration).

    The difference is that Viagra actually has evidence of its efficacy and nobody can call that into question. Whether you are truly happier with the effects of Viagra is a different story and that is indeed marketing. However ExtenZe is an herbal “supplement” which does…. nothing. Yet we are lead to believe essentially the same thing without any evidence that it actually does this. And it can be marketed as a pill that “naturally” promotes sexual health and improves your erection, because of the double standard of the DSHEA.

    People do need to be skeptical. But there is also an onus for those who have more means and knowledge to protect those who simply cannot reasonably be expected to thoroughly understand the difference between Viagra and ExtenZe. The marketing of supplements under the DSHEA is a deliberate tightrope walk which would reasonably be construed as fraud if it were not for the protection of the DSHEA.

    There is also no problem with my comparison at all. If you actually read the FDA regulations, I can easily market my synthetic chemical as “promoting cardiovascular health and possibly reducing high blood pressure” based on exactly what I had said above. But if something is synthesized de novo one must demonstrate efficacy and safety. If someone picks a random ass herb from their garden they can call it whatever they want and market it using slick language.

    You have also not succeeded in answering the question of what is a supplement and in fact only furthered my point – there is no uniform standard by which it can be determined. Probiotics cannot be “supplements” since they are bacteria that are not uniformly present in all gut flora nor are any known levels known to be “good” or “bad” or “low” or “high.” What are your “supplementing” when we have no evidence that it actually meets a nutritional deficiency? DMT is a great example. It is naturally occurring in our bodies and in the roots of certain eucalyptus trees. Yet somehow that becomes illegal whilst St. John’s Wort is not. Besides the fact that, as I have demonstrated before, SJW has been shown to have essentially no efficacy both are at least claimed to be mind altering substances. The only difference I can see is that one actually has demonstrated effect and the other does not (in other words, SJW gets a by because it doesn’t really do anything so “what’s the harm.”) So yes, it is quite arbitrary and indeed I am all for the legalization of recreational drugs. But not if they are marketed with health claims. Selling marijuana because it fun to smoke a doob becomes a personal choice. Selling it with the claim that it will “help promote healthy….” is entirely different.

    Disease vs structure function claims are supposed to mitigate this… but it doesn’t. And that is multifactorial but the two prime reasons being the limited resources of the FDA and the wording of the laws allows for slick advertising and marketing.

    Healthwise, herbs and supplements are really part of diet, exercise, and lifestyle choices to maintain and support health, with preventative aspects in some select cases.

    No, they aren’t. There is not only zero evidence to support the need for herbs and supplements are part of a healthy diet and some to demonstrate that supplementation is detrimental to health. The only times supplements are part of a healthy diet is in the (exceedingly rare in developed nations) context of a pathologic deficiency of a particular vitamin or mineral. No herbs have known deficiencies and supplementation beyond physiologic levels of vitamins and minerals has no positive and possibly negative effects (in addition to making your urine very expensive).

    Also there is no such thing as “full blown pathology” in medicine. You either have pathology or you don’t. It can be more severe or not, but nobody thinks of “full blown pathology” vs “occult pathology.” The implication of your statement is that until you develop overt symptoms, you don’t have pathology, and “herbs and supplements” can ensure you don’t develop the overt symptoms of “full blown pathology.” That is full blown BS. Even if there are no overt symptoms we can detect and treat pathology. If there is nothing to detect, then there is nothing to treat – supplements or otherwise.

    Once again you are left holding the bag full of claims with no evidence or rationale to support them.

  38. nybgrus says:

    @TheDave:

    I was in between patients in clinic writing, hence my brevity. However, to ensure clarity:

    the point I was trying to make in grouping diet, exercise, and herbs as being science based and not CAM was not to say that diet, herbs, and exercise are all part of a healthful lifestyle. It was to say that the application of each is science based and when utilized correctly can be part of a healthful lifestyle.

    In other words there is piles of science to demonstrate the utility of diet and exercise. And there is an entire field of science called pharmacognosy that deals with herbs in a scientific manner to produce purified and efficacious drugs.

    But, as I pointed out earlier, you can suffuse anything with woo. Make the herbs “all natural” and therefore better for you and you have woo. Make the diet “raw and vegan” to capture the vital essence of the foods and you have woo. Make the exercise Buteyko breathing and you have woo (or yoga to realign chakras as I had said earlier).

    And so it is with supplements. Limit them to things actually known to affect physiology, market them appropriately and within the evidence base, and I have no issue with that (like having aspirin, ibuprofen, and Tums OTC people can choose and help themselves… and misuse, overuse, or abuse as well of course). The problem is that the supplement shelves would be nearly bare if they actually did that. And all the “Big Suppla” companies out there would be out of business (BTW that is the other double standard at play here – Big Pharma is evil for selling teh toxic chemicalz but nobody cares to think about Big Suppla making billions with vague claims).

  39. The Dave says:

    Thank you for the clarification. In my mind the confusion came with the different methods used with pharmacognosy and Big Herba. I think pharmacognosy would be a fascinating field to study (delusions of being a real-life Sean Connery from Medicine Man go wafting through my head :) ) but I’ll leave that to other experts and just focus on dispensing their results in the form of pills, solutions, etc…

  40. Chris says:

    nybgrus:

    When you watch a Viagra ad it leads you to believe your life will be suffused with happines because you can now get an erection and enjoy the things one can do with regaining that ability.

    Though the data show that men who exercise their erections with a mistress or prostitute tend to have more heart attacks. Just saying.

    Oh, and there is something worse than ExtenZe. It is the “rub your member with a cream that contains capsaicin. Ouch. Funny, I can’t find the news article about this miracle cure for erectile dysfunction because of all of the websites that sell it! Though I remember when I heard about in a radio news program I winced a bit. I just remember the hurt after not wearing gloves when I cut up hot peppers and touch sensitive areas (like my eye).

  41. Chris says:

    Erg… my eyes! I do still have two eyes. Must quit while I am ahead.

  42. nybgrus says:

    lol. While working in the ER I had a patient come in because his AICD kicked in during an escapade with a young lady. Turns out the lady felt the shock as well and also checked in as a patient. Also turns out that the lady was the man’s mistress and things got interesting when the wife got worried at the late hour and started calling ER’s to see if her husband was there (knowing he had an AICD). We cannot give out any information beyond whether a person with such and such name is there or not. He was, so we said so. At some point I walked over and told him his wife (I had assumed ex) was on her way. He quickly left AMA.

    And yes, rubbing hot peppers on said areas must undoubtedly be a bad idea. Even if you manage to not take issue, I can’t imagine your partner wouldn’t!

  43. Robb says:

    nybgrus,
    SJW has been shown to be effective – you just may not be up on most of the literature on it. Even Edzard Ernst admits SJW is effective for major depression with fewer side effects than prescription medication.
    http://ebmh.bmj.com/content/12/3/78.full
    You should be happy to have something effective and less likely to induce side effects in your armamentarium.
    Anyway, the topic was double standards. If the FDA does not have enough manpower or funds to properly enforce its own regulations, that doesn’t mean the problem lies with the regulations. I would disagree with the premise anyway – they have recently been cracking down and enforcing illegal claims A LOT. Which is good – I don’t want people to be misled or ill informed. The strange thing with the US regulations is that basically companies make structure function claims and are “supposed” to have research to support them but they don’t have to submit them to the FDA unless asked. With the FDAs recent upregulation of enforcement, more and more companies are being asked but it still seems a bit of a haphazard approach open to abuse by some. In Canada it is completely different as all herbs and supplements must get pre-market license approval and submit supporting evidence.

  44. The Dave says:

    That’s great that the FDA is cracking down. However, that doesn’t change the fact that there is a double standard, manifested by the affectionately-named “Quack Miranda Warning”

  45. Robb says:

    I’m not saying I don’t see problems with the regulations or with the market place – I do. But I don’t think the regulations enshrine any double standard – a double standard means you are treating two equal things differently. Drugs and herbs/supplements are not equal. One can make disease claims, is covered by insurance and is easier to patent. The other makes lesser “structure function” claims, is not covered by insurance and is a generic ingredient, for the most part. The FDA is perfectly capable of removing supplements making disease claims. As an outside observer though, I do see how in practice things don’t always work out this way. I would even go so far as to say that most industries in the entire US economy play a bit more “fast and loose” than elsewhere in the world.

  46. nybgrus says:

    @Robb:

    That is the same study you have bandied about before. It still has big problems with heterogeneity and the significant German bias. So much so, that even the NCCAM doesn’t give it a particularly glowing endorsement:

    St. John’s wort may help some types of depression, similar to treatment with standard prescription antidepressants, but the evidence is not definitive.

    Combining St. John’s wort with certain antidepressants can lead to a potentially life-threatening increase of serotonin, a brain chemical targeted by antidepressants. St. John’s wort can also limit the effectiveness of many prescription medicines.

    Psychosis is a rare but possible side effect of taking St. John’s wort.

    St. John’s wort is not a proven therapy for depression. Do not use St. John’s wort to replace conventional care or to postpone seeing your health care provider. If depression is not adequately treated, it can become severe and, in some cases, may be associated with suicide. Consult a health care provider if you or someone you know may be depressed.

    [emphasis mine]

    The NCCAM site even discusses how the German results skew the safety data as well, since the metric is dropout rates.

    Don’t forget about GIGO. A meta analsysis is only as good as the studies it uses, and data with high heterogeneity, effect sizes that are highly influenced by country of origin and baseline values, and on a disease process that is highly amenable to placebo intervention makes me highly skeptical of the results.

    My point about SJW stands. That said, this is one exception I could see myself making in an otherwise completely healthy person with no comorbities and no other medications who is not very young or very old. Though I would have to try and vet a source, since there is always extreme heterogeneity in composition by brand. All in all, I’d likely stick with actual pharmaceuticals for the vast majority of cases.

  47. Robb says:

    nybgrus,
    Why would you defer to NCCAM’s assessment here when it is convenient to try and make your point but lambast them generally elsewhere? Do you consider the studies for conventional anti-depressants to be of better quality? Have you not noticed any issues crop up with them as well? Have you read what NCCAM’s “rare but possible” psychosis caution is actually based on? They don’t reference it to anything on their website but it comes from a few case studies. If you’re interested, you can read them here and see why I don’t think saying psychosis is a possible side effect caused by SJW is an accurate statement at all.
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2993537/
    You start off saying SJW “does not do anything”, then say it’s one exception you could make, but prefer NCCAM’s assessment over Cochrane and Dr. Ernst…I sense you are more guided by extreme reluctance to admit that this may be one case where an herb is safer and at least as effective as its conventional counterparts.

  48. nybgrus says:

    I lambaste them as being overly generous and kind to CAM and espousing poor research methodology which gives undue creedence and positive results to so-called CAM. The fact that even they have little positive to say and hedge their recommendations so heavily is telling. That is why I referenced them here.

    I have addressed the exact same article (without Ernst’s commentary at the bottom) before and my critique stands. Cochrane’s assessment is the exact same article. Ernst’s commentary is a bit too optimistic for me. I cite NCCAM because of the above mentioned fact that their bias should be towards SJW but even they are reticent and point out the many flaws I have.

    And yes, if you noticed I said I would consider using it in a very contrived case and even then would be hesitant because of the lack of homogeneity in formulations and lack of complete understanding of the side effects and interaction profile of SJW. I will agree that a few case reports does not make for a big deal. The rest of my critique still stands.

    As for the other anti depressants… that matters not to this discussion. Whether or not studies on them are done well or not has no bearing on the studies for SJW or its efficacy.

  49. The Dave says:

    My issue with herbs, and SJW as a good example, is the lack of standardization between products. Even with higher regulations and following GMP, there’s no guarantee you will get a certain concentration of active compound. SJW may have actual therapeutic effect (we even discussed it in my undergrad classes for a degree in psychology), but I would much rather refer that the therapeutic compound be extracted, purified, standardized, and regulated to ensure the patient is getting how much it says they are getting. Especially since some therapeutic agents have a small therapeutic window (the difference between the effective dose and the toxic dose)

  50. Regarding SJW: ppl hve been enthusiastic abt SJW for over a coupe decades, yet it has taken a long time fo rthere to be any studies that have stumbled across any modest degree of false-positive effect.

    True.

    At the same time, Turner, and others, have pretty much reduced the efficacy of the FDA-approved SSRIs/SNRIs to just a bit above the SJW efficacy level – if you factor in the rigged studies and unpublished studies.

    One conclusion: SJW is nearly as good as SSRI. Another: SJW is even less effective than SSRI, but only modestly less effective.

    The herbs provide fiber in the diet. Enjoy.

    Be careful with the red yeast, though. It will drop you.

    For the MDs encountering other MDs who are shruggies – it may be worth noting how EACH SCAM intervention is supposedly effective for EVERYTHING. At th esame time, allopathic medicine can only find cures that hit maybe three conditions at best? How lame. Get out the ear candles.

  51. Scott says:

    @ Robb:

    Most of your examples of how you perceive things to work in practice that don’t relate to existing enforceable regulations fall under the realm of “consumer perception” and “implied marketing”. This is, again, nothing special to herbs and supplements – it is common marketing practice and common public misunderstanding or lack of insight or awareness. Yes, marketing often works by exploiting these things.

    Actually, it is quite special in the context of herbs and supplements. The reason is that “don’t make disease claims” is the primary limitation placed on them in order to justify their freedom from regulation. In fact that limitation, even if enforced, would have little true impact. So the entire rationale for treating them any differently then pharmaceuticals disappears.

  52. Robb says:

    @nybgrus,
    “As for the other anti depressants… that matters not to this discussion. Whether or not studies on them are done well or not has no bearing on the studies for SJW or its efficacy.”

    It matters very much if you accept one but reject the other – otherwise we have a….double standard.

    @Scott,
    “In fact that limitation, even if enforced, would have little true impact. So the entire rationale for treating them any differently then pharmaceuticals disappears.”

    Why little true impact? The only way I can understand this statement is if you mean very little true impact because consumers ignore the distinction between structure-function and disease claims, which means you are advocating for supplements to be treated as drugs based on consumer misunderstanding? Or do I have it wrong? I can also see problems arising through grey areas in the distinction between structure-function and disease claims that are then further muddied in the marketing – or in a connect the dots approach to marketing that implies disease claims. But this leads back to better enforcement or more precise regulations. I’m not against some form of pre-market approval – I think it is strange that the claims are basically left up to the manufacturer to decide based on their attempts to interpret regulations – but I don’t think they should be equated with pharmaceuticals in terms of pre-market approval.

  53. gears says:

    @Robb

    I’m not saying I don’t see problems with the regulations or with the market place – I do. But I don’t think the regulations enshrine any double standard – a double standard means you are treating two equal things differently. Drugs and herbs/supplements are not equal. One can make disease claims, is covered by insurance and is easier to patent. The other makes lesser “structure function” claims, is not covered by insurance and is a generic ingredient, for the most part. The FDA is perfectly capable of removing supplements making disease claims.

    I think this is a weirdly semantic argument. The only reason drugs and supplements “are not equal” is because of the regulations. So the double standard is that drugs and supplements are regulated differently for, as far I can see, no particularly compelling reason. Why shouldn’t supplements have the same rigorous manufacturing and efficacy standards as drugs? I cannot comprehend why we trust supplement companies to make sure that their supplements are safe and pure with little oversight. If supplements can have real effects on a person, which you argue, then I think those effects should be characterized and demonstrated to be safe. Or, on the other hand, found to be ineffective and then barred from being sold.

    When people buy a supplement based on structure-function claims, I feel like there is some expectation that the supplement is supposed to do something. I guess I just think it is irresponsible to say, “Well, they are only structure-function claims, so lax regulation is acceptable” when it is obvious that the public so frequently totally misunderstands what that means.

    To my mind, herbs/supplements are simply drugs that have not been demonstrated to be safe or effective, but for some reason can be sold anyway, and therein lies the double standard (with the exception of vitamins and minerals used to treat a real deficiency, all other indications being unclear at this point).

  54. Scott says:

    Why little true impact? The only way I can understand this statement is if you mean very little true impact because consumers ignore the distinction between structure-function and disease claims, which means you are advocating for supplements to be treated as drugs based on consumer misunderstanding? Or do I have it wrong?

    Because of the very same marketing effects discussed upthread, even if the advertising only technically makes a structure-function claim, they implicitly end up making disease claims.

    I don’t think they should be equated with pharmaceuticals in terms of pre-market approval.

    I see no reason they should not. Indeed, a reasonable case can be made that they should be subject to MORE stringent testing, since herbs/supplements effectively fall into two classes:
    – Highly impure drugs of often variable concentration
    – Salad
    and they’re obviously not being sold as the latter. The impurity and variability inherent in an herbal preparation make them more dangerous.

    I’ve never seen any genuinely credible counterargument – appeals to antiquity and the naturalistic fallacy are the normal attempts at a response. Sometimes the argument is made that the profit margins in the supplement market are not sufficient to bear the burden of such testing. To which I respond that if it’s not profitable enough to be able to demonstrate that it’s safe and effective, it’s apparently not useful enough to be worth the bother.

    I’ll also note that what I’m talking about does NOT include essential nutrients which cannot, for whatever reason, be obtained in sufficient quantity (i.e. RDA) from diet. Iron supplements taken for anemia, for example. The current regulatory regime is reasonable for those. Megadoses of vitamin C taken to prevent the flu, not so much.

  55. Robb says:

    gears,
    Drugs and supplements are not equal for a number of reasons that I’ve already touched on. Being regulated differently acknowledges this rather than creates the distinction in the first place. Of course supplements should have the same manufacturing standards to ensure quality and they do – you must be aware of GMP regulations?

    As far as efficacy and “doing something” along structure-function lines – of course this is also a reasonable expectation – I’ve said that it is strange that companies are not required to submit any supporting evidence beforehand in the US – this doesn’t mean the evidence doesn’t exist – it just isn’t linked to disease treatment.

    I get the feeling that the problem lies more in lack of awareness of distinction between structure-function and disease states. Herbs/supplements are generally about a) preventing deficiencies in essential nutrients, along with diet b) supporting and maintaining health – structure and function of bodily organs and systems in order to prevent, not treat existing, disease states. I’m thinking for example of lutein for eye health, milk thistle for liver health, and omega-3 supplements for cardiovascular health. They are not proven to treat diseases (well, a specific milk thistle extract from Europe has been used to effectively treat mushroom poisoning and was granted an IND by the FDA for this purpose in a few cases, but this is not the same as most milk thistle sold in the US as a dietary supplement) but there is research showing them to support structure-function and linking them to less incidence of disease. This is where the expectation to “do something” would come from. They are more like insurance that diet alone is not providing.

    The evidence of this may not exist in all supplement cases but it certainly does for some. The type of evidence/studies is obviously going to be different than for drugs treating specific existing conditions. I do not know what exact criteria or level the FDA considers adequate for structure-function claims. I suspect a lot of supplements would probably be swept from the market if evidence had to be pre-submitted. This is exactly what has happened in Canada with our pre-market approval – probably close to 40% of herb-supplement “natural health products” were denied licenses. So it separates the wheat from the chaff but clarifies and strengthens the position of what remains.

    If you are stuck in the paradigm of just drug for disease state and don’t see or acknowledge any role for anything other than diet to maintain health and prevent disease, then obviously a structure-function claim will be confusing or not make sense. This is why regulations and many people do not equate drugs with supplements though – because they are not intended for use in the same way. They are not substitutes for each other unless the herb or supplement has the evidence level of the drug.

  56. nybgrus says:

    @Robb:

    It matters very much if you accept one but reject the other – otherwise we have a….double standard.

    No, no it doesn’t. We aren’t discussing the efficacy of pharmaceutical antidepressants. I am holding all claims to the same standard. Now, if I accepted pharmaceuticals but not herbs whilst both have the same level of evidence, yes, I would be wrong in doing so. But that would still not change the fact that efficacy of herbals does not depend on efficacy of pharmaceuticals nor my interpretation of that data. So stop building a straw man when the topic of conversation is the efficacy of SJW on depression.

    Why little true impact? The only way I can understand this statement is if you mean very little true impact because consumers ignore the distinction between structure-function and disease claims, which means you are advocating for supplements to be treated as drugs based on consumer misunderstanding?

    You say this as if it were a bad thing. Yes, we have an onus to ensure that the laws and regulations governing the marketing and dispensation of any consumer goods is in line with consumer understanding and the reality of use. Using obfuscatory language and slick marketing to dupe consumers, despite the spirit of the law, means we need to make the laws better at protecting consumers – not assume that we should educate en masse so that they can eschew the products. It boggles my mind that medicine is the only field where such thinking would fly. Should we allow bridge builders and designers to use slick technical language to hoodwink and get by regulators to build inferior bridges? And then demand that drivers read up on the bridge and how it was built in order to make an “informed choice” about whether they should drive over it or not? That is just as ridiculous as expecting the general population to understand what the difference is between a “structure-function” and “disease” claim is, as well as determine the level of actual evidence past the marketing hype and sales tactics used. Freedom of choice is important, but so is consumer protection from BS claims.

    And to top it all off, we know from immeasurable scientific knowledge and experience that in vitro and structure-function most oftenly does not translate into effects in humans (or any complex biological system). That is why we don’t run a test compound (or herb!) on a cell culture, see an effect, do a Phase I trial to make sure it doesn’t kill anyone immediately, and then go straight to market and prescribe it in a hospital. Why on earth can we allow “supplements” and herbs to go straight to market with such incredibly minimal data yet nothing else can? Because of the DSHEA and that is the double standard.

    Drugs and supplements are not equal for a number of reasons that I’ve already touched on.

    You have yet to give a single convincing reason as to why drugs and supplements are fundamentally different. Both are (at least claimed) to be active compounds which will affect physiology. And very often supplements and herbs are not taken in forms or concentrations or compositions available in “nature” (which even if they were is still not a good argument).

    But that is what it boils down to. As Scott said, it is either salad (food) and can be called “part of a healthy diet” or it isn’t. None of the supplements we are talking about is akin to saying “eat more garlic because it is good for you” it is about getting a ton of garlic and concentrating it into a pill so a person can consume more garlic than would otherwise be reasonably feasible. That is not food anymore. And it is associated with claims – regardless of whether you want the pretty much useless label of structure-function or disease claim – that it will somehow change your physiology. The only argument one can make is that “supplements” are likely to have a smaller effect (ahem, usually none) and that they are likely to have fewer and less severe side effects. But that is an argument of where on the spectrum they lay – not a fundamental distinction between the two.

    Herbs/supplements are generally about a) preventing deficiencies in essential nutrients, along with diet b) supporting and maintaining health – structure and function of bodily organs and systems in order to prevent, not treat existing, disease states.

    There is no evidence to support wide spread nutritional deficiencies in developed nations. The most common in the US is calcium deficiency leading to osteoporosis.

    Furthermore there is no such thing as an “herbal deficiency.” I am all for increased awareness and intake of calcium and Vitamin D, especially in at risk populations, but the notion that we need a supplement aisle that has more than about 10 different products on it is ridiculous. Nobody has a deficiency of echinacea, SJW, Saw Palmetto, or panax ginseng.

    There is also no good evidence to demonstrate that any of these herbs or other “supplements” actually prevent any disease and plenty to think they do nothing at best and may be harmful at worst. And there is data to show us that taking vitamin supplements (actual ones – not herbal “supplements”) leads to worse health outcomes. So once again, your argument sounds good but has absolutely no evidence to back it up and no leg to stand on here (there are some exceptions here, but as I have said before – if you limited the supplement aisle to these actual exceptions, it would be about a dozen or so items to choose from and ginseng and gingko would not be there).

    The evidence of this may not exist in all the vast majority of supplement cases but it certainly does for some a very small minority of them, mostly confined to the known vitamin and mineral deficiencies

    FTFY

    If you are stuck in the paradigm of just drug for disease state and don’t see or acknowledge any role for anything other than diet to maintain health and prevent disease, then obviously a structure-function claim will be confusing or not make sense.

    Seriously? Now you are claiming a new paradigm of how to look at preventative health and claiming that structure-function is a valid and useful tool in this? I think it is you that is confused about what structure-function actually means in terms of actual outcomes and the field of translational research. Scaling up anything – go watch some engineering documentaries and learn this concept – is not as straightforward as merely multiplying all factors by the scaling vector and assuming it will work the same… or even at all. You cannot take a 1 meter long bridge, multiply everything by 2,737 and expect to have a fully functional Golden Gate Bridge. You also cannot take a structure-function claim and scale it up to a pill and expect it to work in humans.

    This is why regulations and many people do not equate drugs with supplements though – because they are not intended for use in the same way.

    As I said above, only someone not familiar with the science involved would think they would not be used in the same way. In medical science we do not make a distinction in evidence and determination of best practice by the intended use (i.e. prevention vs treatment of active disease). Evidence for intervention is evidence for intervention and is guided by individual risk and diagnostic assessment.

    The argument that supplements are different somehow just doesn’t pan out – they are fundamentally the same and can (and should) answer to the same level of evidence. If you want to tell me ginseng tastes great on my pot roast and I’ll have better memory or that salmon is tasty and has omega-3 which might also help heart disease, that is different. But getting the same ginseng or omega-3, packing it into pills to concentrate the dosages, and then selling it at a pharmacy is making it a drug and it should have the same level of evidence as any other OTC drug.

    It is not that they actually are different and the regulations reflect that. They are made different by the regulations – hence the double standard.

  57. Robb says:

    This is probably one major reason why patients do not bother reporting their supplement and herb usage to their doctors. Lol @ “herbal deficiency” – thanks for pointing out the obvious, which I wasn’t referring to. How familiar would you say you are with research on herbs and supplements nybgrus? In the quote that you “fixed” for me, which are the “small minority of supplements besides vitamin/mineral deficiencies” that you have investigated and found worthy? What percent of supplements on the market would you say you have thoroughly investigated the research on in order to “fix” that quote for me. I’m curious…

    If I were a patient interested in taking the omega-3 DHA for age related cognitive decline or had some early stage age-related maculopathy and wanted to start including a lutein supplement in my regimen, would you discourage me? Think it was useless? Feel that they play no role whatsoever in supporting structure-function as a preventative measure to more serious conditions?

  58. gears says:

    @Robb

    Of course supplements should have the same manufacturing standards to ensure quality and they do – you must be aware of GMP regulations?

    I don’t think this is true; the manufacturing standards and enforcement are not the same. For starters, analysis of supplements is entirely after the fact, in terms of purity and safety, and I think that is a double standard. Surveillance of pharmaceuticals is more stringent. From the FDA’s website:

    The [FDA] does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the “Supplement Facts” label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label.

    and here:

    FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

    Ultimately, my objection is that supplements are regulated as if they weren’t drugs, when, in fact, many of them contain compounds with physiological effects, i.e. drugs: ephedra, red yeast rice, St. John’s Wort, kava kava.

    If you are stuck in the paradigm of just drug for disease state and don’t see or acknowledge any role for anything other than diet to maintain health and prevent disease, then obviously a structure-function claim will be confusing or not make sense.

    I am stuck in this paradigm. I just don’t see any merit to colon cleansing or immune system boosting, and I think it’s a failure of the regulation that companies can sell these things to credulous people.

  59. Jeff says:

    gears,

    Supplement manufacturing standards may not be exactly the same as pharmaceuticals, but they are comprehensive:
    http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/ucm110858

    The FDA has made it clear GMP enforcement will be a priority:
    http://www.nutraingredients-usa.com/Regulation/FDA-files-injunction-against-NY-supplements-company-for-GMP-violations

  60. gears says:

    Jeff,

    I’m happy to hear that supplement manufacturers are being held to higher standards with respect to GMP. That being said, I’m still going to agitate for FDA approval to release a supplement to the market. A supplement that contains what it says on the bottle, and is not contaminated, is a good thing, but I would like to know that it is safe and effective, too. It’s backwards that the FDA has to demonstrate that a product is unsafe to have it removed from the marketplace.

    I think there is room for improvement, anyway.

  61. Robb says:

    I also wanted to respond to the comment upthread about supplement companies and research and how if they don’t have money to do it, it’s probably because there’s nothing worth investigating. Besides being a completely asinine comment, it does bring up the topic of what exactly is barring them from researching.

    The millions of dollars it takes to fund proper RCTs is a huge gatekeeper for starters, but let’s say some of the larger companies actually have this cash flow sitting around and they want to invest it in RCTs rather than something else. Why would I do that? Let’s say I have a CoQ10 product and I’ve read some preliminary studies showing CoQ10 may have a positive effect on hypertension. I spend my millions and I find that indeed a couple of good quality RCTs resulted in significant improvements. Now what? Will pharmacies begin carrying it and insurance companies reimbursing it? Maybe I can trademark some special extraction process to try and retain some control or rights over it but what’s to stop Joe Average from just reading about this and going into the local health food store and picking up some generic CoQ10 instead? Worse, what if generic CoQ10 turns out to be just as effective as mine but the research had just never been completed before?

    Most pharmaceutical companies do not touch any generic ingredient with a ten foot pole because they know there is no ROI for any research done. They instead purchase supplement companies…but that’s a different story.

  62. weing says:

    “….what’s to stop Joe Average from just reading about this and going into the local health food store and picking up some generic CoQ10 instead?”

    Nothing. How about saying that you did the studies and showed that your CoQ10 is what was studied and not the generic kind. How do we know that the generic CoQ10 even has CoQ10?

    “Worse, what if generic CoQ10 turns out to be just as effective as mine but the research had just never been completed before?”

    How will you know that without testing?

  63. BillyJoe says:

    The point is that CoQ10 should not even have gotten onto the market without evidence of effectiveness.

  64. weing says:

    “The point is that CoQ10 should not even have gotten onto the market without evidence of effectiveness.”

    Could that be the real reason they won’t do the studies?

  65. nybgrus says:

    from Robb:

    Herbs/supplements are generally about a) preventing deficiencies in essential nutrients, along with diet b) supporting and maintaining health

    So yes, I addressed both implied statements. Which is quite fair to do since things like melatonin, green coffee bean extract, and antabine are considered “supplements.”

    How familiar would you say you are with research on herbs and supplements nybgrus?

    Pretty darned familiar, considering I have been reading and writing about them for almost 3 years now.

    In the quote that you “fixed” for me, which are the “small minority of supplements besides vitamin/mineral deficiencies” that you have investigated and found worthy?

    The onus of proof is on you Robb. You are the one asserting that herbs and supplements are good for you, have evidence for efficacy, should be sold and bought, and have better efficacy and side effect profiles than pharmaceuticals. The onus is not for me to prove the negative – that Robb is wrong – but for you to prove the positive – that you have evidence to support your claim. I have seen none yet. Nothing more than speculation based on very basic and preliminary data, usually of poor quality, to indicate that some things might have some kind of effect. Certainly nothing of the level that I could possibly recommend it to a patient.

    Off the top of my head though, red yeast rice definitely has evidence of efficacy, except when the lovastatin is removed and either way I’d rather prescribe lovastatin than a highly impure drug. Omega-3 fish oil has some pretty decent evidence and enough plausibility for a low side effect profile that I would consider it for a patient. Beyond that is castor oil, glycerin, and senna for constipation. Mentholated products also have their uses and I would have no problem recommending the naturally derived peppermint version. Ginger has some evidence for efficacy for motion sickness/nausea (though once again heterogeneous and of small effect size) and I would be comfortable saying a very low side effect profile so I could see myself recommending that for this condition. There is also some data to suggest that eating yogurt with your antibiotic may reduce the gastrointestinal side effects of the antibiotics. Since this is obviously a very low risk recommendation and overall a reasonably healthy food choice I would also have little issue recommending this to patients. All of these recommendations, of course, would be with the caveat that the data is preliminary and YMMV, and if symptoms persist or become worse to come back for actual pharmaceuticals. And that’s about as far as I could go… and even here I think I am really stretching the evidence base to its limits.

    But since you are so certain that herbs and supplements are so good for “preventing deficiencies and supporting and maintaining health” perhaps you would like to expand my knowledge and provide some examples of the latter part with actual evidence?

    And perhaps you would like to demonstrate some evidence that (at least in the US or Canada) we are concerned about and need to “prevent deficiencies in essential nutrients”?

    And lets not forget that there is always that pesky fact that herbs would be highly impure drugs with mostly unknown interaction and side effect profiles, and thus would be extremely difficult to give to a patient already on other drugs, even if there was evidence for its efficacy.

    If I were a patient interested in taking the omega-3 DHA for age related cognitive decline or had some early stage age-related maculopathy and wanted to start including a lutein supplement in my regimen, would you discourage me? Think it was useless? Feel that they play no role whatsoever in supporting structure-function as a preventative measure to more serious conditions?

    I would say that the evidence is not really there for those indications (from Cochrane: “From these studies, there doesn’t appear to be any benefit for cognitive health for older people of taking omega-3 supplements,” said Alan Dangour, a nutritionist at LSHTM and co-author of the report) but there is evidence for cardiovascular outcomes. Lutein does not have much evidence for efficacy for anything. As such I would inform my patient that I thought is was unlikely to be harmful but to make sure and pay attention for side effects and to consider the cost of the supplement in context of the paucity of evidence and the small effect sizes reported.

    (Also bear in mind that many of my patients can barely afford to put food on the table and getting the necessary antibiotics can be a significant cost burden so for them, I certainly would not recommend it as I doubt it is a cost effective solution)

    As for your other post, weing responded pretty well. The double standard should be removed, and none allowed to be sold until evidence is demonstrated. The pharmaceutical company can easily come up with a specific formulation and then sell it. If there is actually that much potential for efficacy they would do it for the profit margin. Of course, easier said than done since the cat is already out the proverbial bag, but saying we need to continue a double standard because the first time we introduced it entrenched in a bunch of poorly studied and low efficacy herbs/supplements which would never be re-studied again is a bad argument. If they aren’t re-introduced that would actually likely be a good thing. If there really is promise for efficacy someone will be motivated to find it – and right up your synergy alley they can easily pull 3 or 4 of the compounds out of the herb, demonstrate the efficacy and then patent that specific “synergistic” compound and make a killing.

  66. Scott says:

    @ Robb:

    So, your argument is that because it’s costly to perform studies to determine that something is safe and effective, we should let the manufacturers market them as safe and effective anyway? THAT is asinine, and is VERY PRECISELY the double standard!

  67. Scott says:

    And you entirely fail to refute the point that, if it’s useful enough to be worth letting onto the market without effective regulation, it’s also presumably useful enough to be profitable and fund proper research. If the profit margin is too low for that, I have no qualms whatsoever about concluding that it’s not sufficiently useful to be worth unleashing it upon an unsuspecting public.

  68. Robb says:

    Scott, I’ll try and spell it out to make it simpler: there is enough safety and efficacy evidence for structure-function uses to allow the products on the market. There is very little incentive the way the market is set up to do much further research than that. Your point that potential usefulness should = potential profit to fund research ignores all the issues I mentioned in the CoQ10 example. You are thinking in an idealistic fashion rather than considering the realities of the marketplace. Your attitude that profit margin/profitability alone should be the determining factor in what is available for people’s health is a callous one the vast majority of consumers would not agree with.

    weing and Bily Joe – don’t bother weighing in if you don’t know the topic. There is evidence of benefit for CoQ10, above and beyond it being an essential nutrient. There are also safety studies. There is just little incentive to invest in taking it further.

    nybgrus,
    Actual deficiency for most nutrients is rare in North America but there are many cases of sub-optimal intake in certain North American populations. Off the top of my head I can think of vitamin D, magnesium, B12, iron and long chain omega-3 fatty acids (US people tend to not consume much fish and overconsume competing omega-6 fatty acids). I’ll try to look up the references later if I have time. I’m curious why you would say calcium as my understanding is that it’s abundantly available and many people even overconsume it, often with supplements.
    Re: DHA and ARCD – did you miss or just dismiss the MIDAS study?
    http://www.ncbi.nlm.nih.gov/pubmed/20434961

  69. weing says:

    @Robbb,

    Rats. Show me a study that proves that supplemental CoQ10 gets into the mitochondria in humans. Now if you were talking about Skulachev’s modifications of the molecule, then I wouldn’t mind testing it.

  70. nybgrus says:

    Robb: The contention here is that there is not enough safety and efficacy evidence for the vast majority of “supplements” on the market to justify structure-function claims. It is also the contention that structure-function is a very poor proxy for actual efficacy or to guide usage. You simply saying it is otherwise is not enough – I have given heaps of example of safety concerns arising after years of use and myriad studies, and safety concerns regarding so-called traditionally used products as well. That is enough to say that you cannot use long-term term traditional use as a proxy for safety and efficacy.

    Furthermore Scott’s point – and mine as well – is not that profit margin/profitability is the sole determining factor here. The assertion was that if it were actually effective and safe, there would be profit in proving it and providing it to people. If the data is too poor to motivate trials and search for profitable avenues then your point is moot and ours is proven. If you remove CoQ10 (to use your example) from the market because of lack of evidence for efficacy and safety and there is actually a benefit to its use, don’t you think that someone would go ahead and demonstrate it in order to put it back on the market and make money??

    If there is little incentive to take it further, that means that there is little evidence to demonstrate it has utility.

    As for vitamin deficiencies:

    I agree with you about VitD. It does seem that many people have extremely low levels and supplementation to normal is a reasonable goal. I don’t think we can say much more beyond that, since other effects of VitD supplementation have been shown to be of no use. There may well be a further application, but we have no data except to say that low VitD levels leads to fatigue in some people and that supplementation is therapeutic. It has been shown that VitD has no effect on cold prevention or cancer prevention (though there is some promising preliminary data worth following up for cancer).

    Magnesium – very few people are deficient in magnesium and it has exceedingly small effects if your are, the main being decreased potassium levels.

    B12 – once again, very, very few people are deficient in B12. Most people have a 3-5 year stockpile. It is also clinically easy to detect and supplement, with absolutely no benefit in supplementation for asymptomatic and/or those with normal levels.

    Iron – is the most common deficiency world wide (primarily due to hookworm). In the United States it is also a common deficiency, particularly amongst menstruating and pregnant women. Once again, in the absence of symptoms there is no benefit to supplementation and in this case can be exceedingly toxic if supplemented without need.

    Omega-3: There is no established normal physiological range for Omega-3 and there is no evidence for benefit for administration in asymptomatic people without cardiovascular concerns.

    As for Calcium: It is one of the (if not the) most common nutritional deficiencies in the US and leading cause of osteoporosis. It is reasonable to supplement intake in middle aged and older women to ensure reserves of bone mineral density in order to head of osteoporosis.

    As for the MIDAS study: 1 study does not ever have the final say on a topic.

    The Cochrane review states clearly that there is conflicting evidence of poor quality and that good quality studies show no effect on cognitive decline and dementia.

    Even Medscape says the same thing, with some caveats that studies may just need longer durations to suss out the effects. The majority of studies show no evidence of efficacy for cognitive and mental decline and even the MIDAS study shows some mixed results and small effect sizes anyways.

    Most studies were in the 6 month range with at least one of 40 months. If even longer studies are needed to show an effect, then indeed that effect size must be extremely small. Overall, the picture is consistent with no effect or one so small nobody should care anyways.

    I’ll close by saying you should think more about your “lack of incentive to go further” arguments vis-a-vis CoQ10 and generalizable to any supplement. The supplement industry is currently measured in the 10′s of billions in the US alone – hundreds of billions worldwide. If supplements were removed from shelves and evidence on par with any other drug making any other health claim were required, don’t you think some of the big Pharma and Suppla companies would have motivation to demonstrate said evidence in order to get back at that piece of the pie? And don’t you think that motivation would be even higher since that piece would be huge after the market is bare? And even more so since doctors like myself would be much more ready to advise patients to take these supplements with rigorous evidence behind them? Yes, it would narrow the field since – as I have said repeatedly – there is little evidence for a very good reason. But those that actually passed the test of evidencial rigor would be huge money makers. Your argument is only good for allowing product that doesn’t deserve it to be sold and make money for Big Suppla.

    I also find it funny that you want to look at what you consider to be the “real world” ramifications of “denying” people their supplements to help their health but you completely gloss over the real world ramifications of having a law that allows a lower standard and massive loopholes and marketing schemes to sell people “natural” remedies and supplements that don’t do diddly squat.

  71. Robb says:

    @weing,
    Study comparing absorption of CoQ10 vs. its reduced form (ubiquinol) in humans:
    http://www.ncbi.nlm.nih.gov/pubmed

    Check the related citations at the link and you’ll see more on absorption and safety data related to both animals and humans.

  72. Scott says:

    there is enough safety and efficacy evidence for structure-function uses to allow the products on the market.

    Structure-function “uses” are meaningless. Disease claims are what they are being used for, and the only credible possible reason.

    There is very little incentive the way the market is set up to do much further research than that.

    And that is precisely the problem. The market is set up to promote selling snake oil without any kind of consumer protection. OF COURSE if you can sell whatever you jolly well please there’s no incentive to make sure you’re actually selling something that does what the people buying it expect it to do!

    Your attitude that profit margin/profitability alone should be the determining factor in what is available for people’s health is a callous one the vast majority of consumers would not agree with.

    If it ACTUALLY has any kind of REAL benefit for people’s health, there will be ample profit margin to fund proper research.

  73. Scott says:

    Apologies for the double post – as so often, I thought of something else right after hitting Submit.

    You are also completely ignoring the reality that the research we are demanding is the very research needed to demonstrate that it is beneficial. By promoting the sale of snake oil without such research, you are specifically promoting the sale of products where nobody actually knows whether the claims being made about them have any basis in reality.

  74. Robb says:

    @weing,
    Your specifying of mitochondria made me think you are questioning whether increased plasma levels would necessarily mean reaching the mitochondria. I don’t think mitochondrial testing is all that common but there is this small one in humans:
    http://www.ncbi.nlm.nih.gov/pubmed/9521279

    The fact that there are clinical improvements from ubiquinone/ubiquinol in humans should also override the need for specific mitochondrial testing no? Dietary sources obviously make it into the mitochondria as it’s essential to making ATP so why would supplemental sources not? Absorption issues are the real limiting factor as far as I know, which is why ubiquinone and other modifications are happening.

  75. Robb says:

    Scott,
    I’m not sure what you are ranting about. The market reality I’m talking about is ROI for research into generic ingredients that are already on the market and do not offer any level of confidence re: patent control. I’m sorry to hear you find structure-claim benefits meaningless. I agree they are not super-sexy sounding or treat major diseases and attract a lot of attention – but I can assure you they are still meaningful and beneficial to people’s health. I’m not promoting using anything that doesn’t have research showing it is beneficial. I have no doubt there is bunch of crap with bogus or exaggerated claims currently being sold. There’s also a lot that does have safety and efficacy behind it – with little incentive to invest in research for more than simple structure-function benefits.

  76. Scott says:

    but I can assure you they are still meaningful and beneficial to people’s health.

    Without the research you claim can’t be done, you cannot conclude that.

  77. Robb says:

    Scott – less knee-jerk and more thought will show you that I did not claim research cannot be done – obviously it is being done for all my examples – I just said that the incentives are not the same as for patentable molecules. What usually happens is you’ll have a large company that specializes in a couple ingredients and bites the bullet and funds the research with a patented extract. You’ll get safety studies and enough efficacy studies for structure-function claims. Other competitors that make or sell the same ingredient benefit as a result of this – they are cheaper as well as they are not made with the same extraction process and didn’t have to spend the money on research – they instead spend that money on marketing and infrastructure. In order to stop them from referencing your studies in their marketing material you have to take them to court.

    You’ll find a lot of European pharma companies have nutraceutical arms to them that focus on producing high quality standardized extracts along these herb-supplement lines. They design studies just with safety and structure-function benefits in mind but go no further because they know it is just not worth the investment for something that isn’t a unique molecule to be patented. Of course there are also cases where structure-function benefits are all that can be expected. DHA has been shown to be beneficial for age related cognitive decline but not effective for treating Alzheimer’s-dementia. It’s still a meaningful, measurable, tangible benefit – it just needs to be employed earlier/with different expectations.

  78. BillyJoe says:

    Robb,

    I don’t care about structure function claims. And I don’t care about absorption studies. All I am interested in is clinical trials demonstrating benefit of CoQ10. Absent those, the product should never have been bought onto the market.

  79. Robb says:

    BillyJoe I somehow suspect you had never heard of or at least looked into CoQ10 prior to this comments section; otherwise your interest would have been satisfied long ago. CoQ10 is completely uncontroversial as far as its right to be on the market.

  80. nybgrus says:

    @robb:

    Many of these comments were probably written before mine made it through moderation. Please read my above comment.

    You demonstrated before and again that you really have only a very superficial knowledge of these topics and think a plethora of studies necessarily means something. You assert that there is data for safety and efficacy but can only toss up a few studies you have cursorily reviewed with an uncritical eye.

    For example, you ask a question that belies your inherent lack of knowledge on the topic:

    Dietary sources obviously make it into the mitochondria as it’s essential to making ATP so why would supplemental sources not?

    Because the vast majority of CoQ10 is not taken directly from dietary sources, but synthesized de novo in the cells. So your premise is incorrect and thus your framing of the results of studies is also incorrect.

    Absorption issues are the real limiting factor as far as I know, which is why ubiquinone and other modifications are happening.

    Which drives the point home even further. You’ve begged the question and doubled down on your lack of knowledge by stating that the only issue is absortion without considering the fact that it is synthesized in situ rather than absorbed (much like glucosamine/chondroitin).

    The market reality I’m talking about is ROI for research into generic ingredients that are already on the market and do not offer any level of confidence re: patent control.

    So this common statement made me wonder, since it really doesn’t make sense to me. So I did some research. Took me all of about 2 minutes to find this article the journal Biotechnology Law Report which had some interesting things to say (it is pay, but the first page you can read for free):

    Given the rise in companies producing herbal products, how does the United States Patent and Trademark Office (PTO) handle the attempts to protect inventions claiming herbal remedies as treatment for certain diseases? Will the presence of an herbal ingredient—one whose uses are well known and documented—render a patent for a product containing that ingredient invalid due to obviousness under 37 U.S.C. §103?

    Well golly gee willikers! That seems like exactly the question at hand. What, pray tell, is the answer?

    The lack of significant case law, plus the growing number of patented herbal compositions and extracts for specific disease treatment, suggests that the presence of a known and previously used herbal ingredient in a pharmaceutical drug product would not render a patent for that drug invalid because of obviousness

    [emphasis mine - and I can provide a PDF of the full article if requested]

    So there goes that idea about no ROI.

    I’m sorry to hear you find structure-claim benefits meaningless. I agree they are not super-sexy sounding or treat major diseases and attract a lot of attention – but I can assure you they are still meaningful and beneficial to people’s health.

    Thank you for your assertion Dr. Robb. But they really are pretty darned meaningless and have nothing to do with whether they “treat major diseases” or “sound super sexy” or “attract attention.” It has to do with what that means and how it applies to biological systems. Structure-function means that the molecule or compound in question has a structure which fits in some way a defined function – like saying magnesium is a co-factor in nephron tubule ATPases. Or “antioxidants help prevent cell damage.” That’s it. It just states some role of a compound in the body. But that tells us nearly nothing when it comes to what it means in the context of an entire biological system and the effects it will have on it. That is why the anti-oxidant theory of senescence is essentially dead – the structure-function of antioxidants made sense. But it does not scale up to a systems level effect!. That is why we say S/F claims are essentially meaningless. They give us just enough info to start doing research on effects – not to claim it “may” do something and then sell it!

    I’m not promoting using anything that doesn’t have research showing it is beneficial

    In a very technical sense you are right. But you are promoting using things that don’t have good research showing it is beneficial. And that is the point here.

    There’s also a lot that does have safety and efficacy behind it – with little incentive to invest in research for more than simple structure-function benefits.

    And yet… you still have to come up with that list of “a lot.” And we have now, hopefully, settled the notion of incentive to research. There is currently no incentive since they can sell whatever the hell they want with low up front costs and huge profits. If we remove the DSHEA double standard, there will be incentive.

    obviously it is being done for all my examples

    Still waiting for some good examples.

    DHA has been shown to be beneficial for age related cognitive decline but not effective for treating Alzheimer’s-dementia.

    Ahem. No, it hasn’t. And ignoring the reviews and evidence I have put forth and simply restating your claim doesn’t change reality.

    It’s still a meaningful, measurable, tangible benefit – it just needs to be employed earlier/with different expectations.

    Once again, no evidence of earlier being any more beneficial (than zero so far) and what expectations? That it won’t do anything? Or that it will make you feel like something is being done when it isn’t? Care to elaborate on what expectation would make the complete paucity of data supporting DHA for age related cognitive decline somehow look better?

    But hey! Don’t take my word for it. How about a really famous and smart medical scientist with a really strong background in statistics and many published books and articles?

    As Ben Goldacre says:

    Huge numbers of bioactive compounds extracted or derived from plants are used today in medical practice, including even common stuff like aspirin. There is little difference between herbal medicine and medicine in terms of what is used, only in how….They started with standardised preparations of the plant, but this proved dangerously inconsistent,…Now people do careful studies of large numbers of patients on digoxin to see which dose is most beneficial, to understand how it works, and careful monitoring of side effects takes place,…This process of enquiry, and standardisation, and testing, and verification, and negative findings, and dismissal of ineffective methods, and more, is one of the great developments in medical and intellectual history. Many people were disappointed along the way, as their ideas and theories were proved to be unfounded…..Until a herbal practitioner can show that giving a whole plant instead of an extract really is better, they’re making stuff up when they make those claims. Similarly, until they can show that using herbs at such low doses that they have no measurable effect is somehow beneficial, beyond the placebo (and placebo is great by the way) then they’re shooting with the stars.…It’s because of this culture, not funding, that the “research” on herbal remedies is inadequate. Huge numbers of “trials” are produced, at great expense, but the trials are inept, they are not “fair tests”, they have inadequate “blinding” and “randomisation”, positive results alone are “cherry-picked”, and worse.

    Sorry Robb, but there is still no evidence or reason to believe that whole plant extracts are better and plenty to demonstrate why purified (and often modified) extracts of the select active compounds is.

  81. Jeff says:

    Nybgrus: I think the operative phrase in your post is “patented herbal compositions and extracts for specific disease treatments”. A manufacturing process, or a particular combination of herbs can be patented.

    But no compound existing in nature, whether it be a vitamin, mineral, amino acid, single herb or herbal extract can be patented. A Google search will yield dozens of products containing St. John’s Wort extract.

    Say a company spent the $800 million or so it would cost to obtain FDA approval for a claim its St. John’s Wort extract could successfully treat depression. Said company would then have to charge an exorbitant price to recoup its investment. Nothing would prevent a consumer from buying a less expensive, unpatented brand.

  82. weing says:

    “Say a company spent the $800 million or so it would cost to obtain FDA approval for a claim its St. John’s Wort extract could successfully treat depression.”

    Say it spent the $800 million and found it couldn’t successfully treat depression? What then?

  83. BillyJoe says:

    Jeff,

    The point is that they should not have come onto the market before those efficacy and safety tests were done. Now the problem is to get them off the market. Because only then will it be profitable to do the testing. Unless, of course, they are already convinced that the stuff probably does not work and that the cost would be too high risk.

  84. BillyJoe says:

    Robb, you seem to have more knowledge than I do about CoQ10, but less understanding. (;

  85. nybgrus says:

    It is quite funny to me how incredibly narrow and non-creative the thought processes are here when discussing the patentability of herbs and herbal extracts. The party line is “it is natural, has been used before, and there it simply cannot possibly, ever, under any circumstance ever be patentable!” and whatever trite cogitations are necessary to hold this conclusion are done in order to bolster the need for a double standard law and allow whatever herbal garbage manufacturers want to sell.

    Firstly, I would have no issue with allowing for companies that actually do the research and demonstrate the efficacy and safety to hold patent rights for 10 years exactly as they would with any other pharmaceutical. There would be no generics, as Jeff claims, since the point of the move is to repeal the DSHEA and make the generics illegal to sell since they have not gone through the burden of proof. It’s as if Robb and Jeff think the only thing we could possibly do is repeal the DSHEA and still somehow allow generics to be sold thus short circuiting any profit motive. You can, of course, write legislation to mitigate this.

    Secondly, even if it were the case as Jeff and Robb like to think, there would still be incentive to patent the process and composition of the herbal compound and go through the trials as well. Think about it – you can (right this very moment) buy international knock offs of trade drugs from “internet pharmacies.” Want Viagra? Or Provigil? Just go online and buy it. Of course, the US has laws to curb this but it still happens quite regularly. But would you really trust such a purchase? I sure wouldn’t. And either way, it doesn’t seem to be killing the bottom line for the drug companies.

    So yes, if we repealed the DSHEA, gave the same trade protections to patented herbal concoctions as pharmaceuticals (i.e. that single standard I have been going on and on about), and there was actually any evidence that said herbal concoction would actually be effective and hold up to actual rigorous study… the $800m outlay would certainly be just as worth it to a drug company as any other drug they would want to develop and market.

    So please, can we put the whole “no profit motivation so please let people buy whatever they want with minimal shoddy evidence” trope to bed? There is a very straightforward way to properly incentivize actually effective treatments no matter what the source and have a single uniform standard for all compounds manufactured with the explicit intention of consumption as a health intervention while protecting consumers from the myriad of BS claims that at best will drain their wallets and at worst could have serious adverse side effects.

  86. DavidRLogan says:

    It strikes me as far too cynical to suggest, as two have, that research will only be done given a narrow financial or legal incentive. Perhaps that’s right if you’re the CEO of a pharmaceutical or supplement company (though NYB’s shot quite a few holes in that argument), but it’s almost certainly false within much of the academic community.

    The last 2 class papers I’ve reviewed, both NIH funded during 2012, were based on dietary fixes for diabetes (time restricted feeding) and using existing, patented pharmaceuticals in a novel way to treat diabetes (like TZD’s with a ppar-y inhibitor). And all of the authors will have better careers for appearing on these papers, without getting 100 billion dollar payout for it. What’s more, I know at least 3 professors (I’m such a name-dropper! I suck!) at my large state school (and there are certainly more) who’ve spent their life studying vitamins, neutraceuticals, and their associated pathways…one’s a chemistry prof. studying the much maligned TCM herbs (just doing high throughput stuff to identify molecules, ligands, gene transcripts, etc.). And none of these is a drug discovery mission: the relevance in all their research proposals is to fit these existing compounds into exactly the kind of role Robb and others thinks is important. And also they would be the first to tell you there’s not enough evidence yet.

    The perception that research only chases money and patents is sometimes accurate but usually not.

    RIP Skeptical Health.

  87. Jeff says:

    Nybgrus says, “It’s as if Robb and Jeff think the only thing we could possibly do is repeal the DSHEA and still somehow allow generics to be sold thus short circuiting any profit motive.”

    Not quite. I want to preserve DSHEA and keep natural products unpatented, affordable, and widely available. I think the law strikes a reasonable balance between regulation and consumer access. Safety is not really an issue with supplements, since they produce relatively few adverse events. If Nybgrus has data showing supplements are resulting in “serious adverse side effects”, then he should share it with us.

    Omega-3 Fish Oil is a good example of what would happen to supplement prices if they were all regulated like prescription drugs;
    http://www.lef.org/magazine/mag2006/sep2006_awsi_01.htm

    Of course more research is always welcome. There is one large ongoing trial using CoQ10:
    http://www.sciencedaily.com/releases/2009/09/090921143147.htm

  88. weing says:

    “Omega-3 Fish Oil is a good example of what would happen to supplement prices if they were all regulated like prescription drugs”

    You mean they would contain only the given amounts of the EPA and DHA and nothing else? Based on what I’ve read about the content of fish oil capsules you would need to take about 10 capsules of the OTC stuff to get the equivalent. You also get extra calories in the OTC stuff from oils that may or may not be good.

    That CoQ10 study was terminated last year.

  89. Jeff says:

    weing is right. The CoQ10 study was stopped last year – the results were negative:

    http://www.ninds.nih.gov/disorders/clinical_trials/CoQ10-Trial-Update.htm

  90. BillyJoe says:

    “The CoQ10 study was stopped last year – the results were negative:”

    Coenzyme Q10 is an example of what’s wrong with the supplement industry.
    Basic research suggests that it might be beneficial.
    However, experience has shown that the results of basic research rarely pan out in practice.
    Therefore, clinical trials are imperative before making any recommendations about supplements.
    The supplement industry, however, sells off the back of the basic research.
    And when the trials are finally done, guess what? The results are generally negative.
    But the supplement industry carries on its merry way selling the discredited supplement.

    …round and round the merry go round.

  91. Patrick says:

    Dr. Gorski: I would like to know your views on this video from the University of Miami Miller School Medicine. Warning: it may upset your stomach.

    http://www.youtube.com/watch?v=ugLyO1slu1A

  92. BillyJoe says:

    Note the slanting of exercise and nutrition as alternative.

Comments are closed.