The Dietary Supplement Health and Education Act of 1994 (DSHEA) has been aptly described here at SBM as a travesty of a mockery of a sham. The supplement industry’s slick marketing, herb adulteration due to lack of pre-market controls, Quack Miranda Warning, and the many supplements for which claims of effectiveness failed to hold up under scientific scrutiny (e.g., antioxidants, collagen, glucosamine and hoodia) have been impaled on the sharp pens of SBM posters as well.
And we’re not the only ones. Investigations of the supplement industry (or, Big Supp) by reputable institutions such as the U.S. Government Accountability Office and the Institute of Medicine have resulted in numerous recommendations to improve dietary supplement safety by, in part, strengthening the FDA’s ability to effectively regulate the industry. Many of these have gone unheeded.
A recent federal law tried to ameliorate this situation by directing the FDA to take specific steps designed to increase supplement safety. Yet the ink of President’s Obama’s signature was barely dry when a bill was proposed in Congress to gut its provisions. In fact, there are now several bills pending in Congress which would actually weaken the government’s already puny regulatory authority over supplements. Yes, things could get even worse.
As I write this, the American news cycle is firmly focused on the issue of drug harms. It’s in the headlines not because of the thousands of cases of drug toxicity, hospitalizations, and even deaths that are documented each year, but because of the untimely death of singer Whitney Houston. While the cause of Houston’s death has not yet been identified,prescription drugs and alcohol are suspected to have played a role. If that’s the case, she’ll join a long list of celebrities whose deaths have been attributed to the abuse of prescription drugs. Over at Natural News, Mike Adams has already added her name to the list of “celebrities killed by Big Pharma“. He elaborated on drug-related deaths back in 2009 when actor Brittany Murphy died, deeming her death to be due to “Acute Pharmaceutical Toxicity“: (more…)
I spend a lot of time as a pharmacist discussing side effects and allergies to drugs. For your own safety, I won’t recommend or dispense a drug until I know your allergy status. I don’t limit the history to drugs—I want to know anything you’re allergic to, be it environmental, food, insects, or anything else. Allergies can create true therapeutic challenges: We can’t dismiss any allergy claim, but as I’ve blogged before, there’s a big gap between what many perceive as an allergy and what is clinically considered a true allergy. My concern is not only avoiding the harm of an allergic reaction, but also avoiding the potential consequences from selecting a suboptimal therapy that may in fact be appropriate. You may need a specific drug someday, so I encourage patients to discuss vague drug allergies with their physician, and request allergist testing as required.
Food allergies can be as real as drug allergies, and are arguably much harder to prevent. We can usually control when we get penicillin. But what about peanuts, eggs, or milk, all of which can also cause life-threatening anaphylaxis? Food allergies seems to be growing: not only anaphylaxis, but more people believe they have some sort of allergy to food. Allergy is sometimes confused with the term “intolerance”, which seems more common, possibly as the availability of “food intolerance testing” grows. Food intolerance testing and screening is particularly popular among alternative practitioners. Testing can take different forms, but generally the consumer is screened against hundreds of food products and food additives. They are then provided with a list of foods they are “intolerant” to. I’ve spoken with consumers who are struggling to overhaul their diet, having been advised that they are actually intolerant to many of their favourite foods. These reports are taken seriously by patients who believe that they’ll feel better if they eliminate these products. In the pharmacy, I’ve been asked to verify the absence of trace amounts of different fillers in medications because of a perceived intolerance. Children may be tested, too, and parents may be given a long list of foods they are told their child is intolerant of. I’ve seen the effects in the community, too. Think going “peanut free” is tough? A public school in my area sent home a list of forbidden food products: dairy, eggs, bananas, tree nuts, peanuts, soy, sesame, flax seed, kiwi, chicken, and bacon. Were these all true allergies? It’s not disclosed. Anaphylactic or not, the parents had informed the school, and the school had banned the food product.
But can a simple blood test actually identify and eliminate food intolerance? That’s the question I wanted to answer.
I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:
Here’s the front cover:
It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:
A point I make over and over again when talking about new or alternative therapies that are not supported by good clinical trial evidence is that lower-level evidence, such as theoretical justifications, anecdotes, and pre-clinical research like in vitro studies and animal model testing, can only be suggestive, never reliable proof of safety or efficacy. It is necessary to begin evaluating a new therapy that does not yet have clinical evidence to support it by showing a plausible theory for why it might work and then moving on to demonstrate that it actually could work through pre-clinical research, which includes biochemistry, cell culture, and animal models. These sorts of supporting preclinical evidence are what we refer to when we refer to the “prior plausibility” of a clinical study. But this kind of evidence alone is not sufficient to support using the therapy in real patients except under experimental conditions, or when the urgency to intervene is great enough to balance the significant uncertainty about the effects of the intervention.
In support of this conclusion, we can consider the inherent unreliability of individual human judgments and all the many ways in which inadequately controlled research can mislead us. And we can reflect on how promising results in early trials often melt away when better, larger, more rigorous studies are done that better control for bias (the so-called Decline Effect). And it is not at all difficult to compile a large list of examples of the harm inadequately studied medical interventions can cause.
But what I’d like to do here is focus on a particularly good specific example of why thorough clinical trial evaluation of promising ideas is not just a nice extra to confirm what we already believe is true, it is the only way to genuinely know whether our treatments to more good than harm.
A number of buzz-words appear repeatedly in health claims, such as natural, antioxidants, organic, and inflammation. Inflammation has been implicated in a number of chronic diseases, including diabetes, Parkinson’s, rheumatoid arthritis, allergies, atherosclerosis, and even cancer. Inflammation has been demonized, and is usually thought of as a bad thing. But it is not all bad.
In a study in Nature Medicine in September 2011, a research group led by Dr. Umut Ozcan at Children’s Hospital Boston (a teaching hospital affiliated with Harvard Medical School) reported that two proteins activated by inflammation are crucial to maintaining normal blood sugar levels in obese and diabetic mice. This could be the beginning of a new paradigm. Ozcan says:
This finding is completely contrary to the general dogma in the diabetes field that low-grade inflammation in obesity causes insulin resistance and type 2 diabetes. For 20 years, this inflammation has been seen as detrimental, whereas it is actually beneficial.
Increasing levels of these inflammatory signals might actually be therapeutic in diabetes and obesity. On the other hand, they might worsen inflammatory diseases like asthma and rheumatoid arthritis. Ozcan’s findings are intriguing and might eventually lead to new treatments, but there are no clinical applications as yet.
I’ve subscribed to Nature for many years now, even though I don’t always read it. Nature is one of the oldest and most respected scientific journals around. It’s been around since 1869 and is said to be the world’s most cited journal. What makes Nature unusual these days is that it’s one of the last of the remaining general science journals and one of the two that still publish original peer-reviewed research in a wide variety of scientific fields. Astronomy, physics, chemistry, medicine, biology, Nature publishes it all. The only other journal of its type that I can think of is Science, which also has a similar high impact factor. In any case, getting published in Nature is a big deal, one that can make a career. Believe it or not, I actually have a Nature publication. True, it’s from the 1990s, and, true, I’m only the fourth author, but it is a Nature publication. Ever since then, I keep telling myself that, one of these days, I’ll manage to find a way to be published again in Nature, although I realize that it’s looking increasingly unlikely that that will happen. Such is the power and cachet of Nature. It’s a name that has provided prestige to some of its spinoff journals, such as Nature Medicine, although of late Nature appears to have diluted the brand name beyond belief.
Nature sells out
All of the above is why I’m very, very disappointed in Nature for having dropped a huge lump of coal into the stockings of supporters of science-based medicine a mere three days before Christmas. Maybe its editors thought that it wouldn’t be noticed right before the holiday season. I don’t know. I do know that I noticed. Basically, Nature sold out to a Japanese pharmaceutical company, which, along with a research institute, bought a supplement in Nature that is in essence an advertorial for its point of view. Don’t believe me? Check out this acknowledgment of the sponsors published in the advertorial:
The demographic of SBM readers are likely to remember the early Miller Lite beer television commercials where sports personalities debated as to whether the beverage “tastes great” or was “less filling.” In one classic version, New York Mets’ Marv Throneberry breaks the shouting match to level his decision: “I feel strongly both ways.”
My colleagues at Science-Based Medicine have generally been opposed completely to the existence of the NIH’s National Center for Complementary and Alternative Medicine (NCCAM). The primary objection is that the Center awards roughly $125 million per year in taxpayer dollars to studies that are generally not based on a strong scientific foundation or, in some cases, absolutely no scientific basis. On the other hand, the best NCCAM-supported studies have provided fruitful results, if not negative with regard to clinical outcomes.
The recent series of articles by Trine Tsouderos at the Chicago Tribune (1, 2, 3, 4) has reignited a national debate as to whether NCCAM is needed at all. After all, NCCAM was not because of science but because of politics, particularly the efforts of Senator Tom Harkin and Representative Dan Burton. And other NIH institutes, such as the National Cancer Institute, seem to do a much more rigorous and science-based job of funding studies of alternative cancer therapies through their unfortunately-named Office of Cancer Complementary and Alternative Medicine, or OCCAM.
In fact, I have long argued that if alternative therapies are to be investigated rigorously, they should be done so under each of the specific NIH institutes and centers (ICs) that have been established to focus on organ systems (National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK) or a class of related disorders (National Institute on Drug Abuse; NIDA).
Having spent many hours working in close proximity to a wall of vitamins, I’ve answered a lot of vitamin questions, and given a lot of recommendations. Before I can make a recommendation, I need to ask some questions of my own. My first is almost always, “Why do you want to take a vitamin?” The most common response I’m given is “insurance” – which usually means supplementation in the absence of any symptom or medical need. Running a close second is “I need more energy.” With some digging, the situation usually boils down to a perceived lack of energy compared to some prior period: last week, last year, or a decade ago. While I may identify possible medical issues as a result of these interviews (these are referred to a physician), I’m often faced with a patient with mild and non-specific descriptions of fatigue. And more often than not, they’ve already decided that they’re going to buy a multivitamin supplement. When it comes to boosting the energy levels, they’re often interested in a specific one: Vitamin B12 (cobalamin). So why does vitamin B12, among all the vitamins, have a halo of benefit for fatigue and energy levels? The answer is part science and a whole lot of marketing. (more…)
In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)
Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.
Limit CAM? Not happening
Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products and services — the dietary supplement manufacturers, homeopaths, acupuncturists, and the like — whose actions are directly responsible for the deleterious effects on patients’ health detailed in the supplement articles and described in the earlier post.
Apparently the authors’ view is that there is no accommodation to CAM too onerous to ask the practicing physician or the patient to bear. Even though they plainly locate the problems they describe — a missed diagnosis, ineffective treatments, drug therapy interactions, poor advice — in the CAM services and products themselves, suggesting that these services and products be limited or eliminated never seems to cross their minds.