My stimulant of choice is coffee. I started drinking it in first-year university, and never looked back. A tiny four-cup coffee maker became my reliable companion right through graduate school. But since I stopped needing to drink a pot at a time, an entirely new category of products has appeared — the energy drink. Targeting students, athletes, and others seeking a mental or physical boost, energy drinks are now an enormous industry: from the first U.S. product sale in 1997, the market size was $4.8 billion by 2008, and continues to grow. (1)
My precious coffee effectively has a single therapeutic ingredient, caffeine. Its pharmacology is well documented, and the physiologic effects are understood. The safety data isn’t too shabby either: it’s probably not harmful and possibly is even beneficial. (I’m talking about oral consumption — no coffee enemas. Please.) In comparison, energy drinks are a bewildering category of products with an array of ingredients including caffeine, amino acids, vitamins, and other “natural” substances and assorted “nutraceuticals,” usually in a sugar-laden vehicle (though sugar-free versions exist). Given many products contain chemicals with pharmacologic effects, understanding the risks, signs of adverse events, and potential implications on drug therapy, are important.
So are energy drinks just candied caffeine delivery systems? Or are these syrupy supplements skirting drug regulations?
As much as I support vaccines, I see the short term consequences. Vaccines can be painful. Kids don’t like them, and parents don’t like seeing their children suffer. That this transient pain is the most common consequence of gaining protection from fatal illnesses seems like a fair trade-off to me. But that’s not the case for every parent.
Today’s post isn’t going to focus on the extremes of the anti-vaccination movement. Rather, it’s going to look at ways to make vaccines less painful and more acceptable to children. The pain of vaccines can lead to anxiety, fear, and even nonadherence with vaccination schedules. Fear of needles and injections is not uncommon, it’s estimated that 10% of the population avoids vaccinations for this reason.
The vaccine schedules are intense. Where I live, the public vaccination schedule specifies seventeen injections of six different products over six visits in the first 18 months of life, plus influenza vaccinations and one-offs like H1N1. That’s a lot of visits, and a lot of tears if a child doesn’t handle them well.
In light of what’s known about the prevalence of needle fears, their potential effect on vaccination adherence (that could persist through adult life), and the possible impact on public health because of unvaccinated individuals, it makes sense to do whatever we can to minimize the pain and discomfort of vaccines, increasing their acceptance to children and their parents. But what works? I’ve personally found Smarties (the real ones) and Dora the Explorer stickers are effective distractions and bribes. But I’m not about to call my n=2 trial good science. Nicely, there’s much more evidence to guide our recommendations.
We spend a lot time at SBM discussing different elements of the art and science of medicine, and how we believe that practice can be improve. Yet our science-based intentions can be thwarted at the last possible moment – in the form of dosing errors. The workup may have been comprehensive, the diagnosis could be correct, the most clinically and cost-effective intervention chosen, and whammo. An overdose or underdose, possible toxicity, and a failure to achieve the desired outcome. It’s a completely avoidable, but often overlooked aspect of the practice of medicine.
In my last post, I noted how cough and cold products for children have largely been withdrawn from the market due to their lack of efficacy, and the risks related to toxicity. Today’s post is going to dive a little more deeply into factors that can contribute to toxicity in the pediatric population. Let’s start with a vignette that may be familiar to parents:
The new father is wakened from a blissful, deep sleep by a crying child. Once Dad realizes when and where he is, and the source of the crying, he silently curses the short duration of action of the acetaminophen liquid he gave his child at bedtime. It has probably worn off already, and the fever is back. Stumbling into his child’s room in the dark, he can feel the heat radiating off his body. He fumbles around for the Tylenol, and something to measure it with. He can’t find the dropper bottle, but finds a bottle of syrup. It’s hard to measure the dose in the dark, and the medicine cup he finds is hard to read. “I think the dose is a teaspoon..that’s 5mL”. He pours the medicine into his child’s throat, tucks him back into bed, and both are back asleep within minutes.
One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:
- Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
- Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
- Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
- Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
- Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
- Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.
In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.
As Vaccine Awareness Week draws to a close, I thought it might be instructive to step back and look at the tactics, impact, and successes of the anti-vaccine movement. Yesterday, Orac questioned the best approach to counter the anti-vaccine movement. With today’s post, I’ll summarize two pertinent papers on the effectiveness of their tactics, and suggest some possible approaches.
There’s overwhelming evidence that vaccines have provided us with tremendous health benefits. Smallpox has been eliminated (except, apparently, for homeopathic nosodes), polio is almost gone, and occurrences of diseases like measles or rubella are now rare. In use for over a century, they are a public health triumph: diseases that terrified us a generation ago are now never seen. Epidemiologic evidence demonstrates that vaccines have a remarkable safety record, and are exceptionally cost-effective interventions. Yet in spite of this, concerns about vaccine safety seemingly continue to mount. And as we see time and time again, when vaccination levels drop, diseases reappear. So what’s driving anti-vaccine sentiment, and why is it successful?
The H1N1 pandemic of 2009/10 is now about a year past its peak, and is instructive as a case study on communication on vaccine safety and efficacy. Remember the H1N1 vaccine? Judging by the anti-vaccine rhetoric of just last year, by now we should all have been rounded up by the army, given forced injections, and if the vaccine didn’t kill us right away, or make us walk backwards, we’d be immunosupressed (from the aluminum adjuvant), or have Gulf War Syndrome (from the squalene). And not only did it not work, it doubled our odds of getting H1N1. All we needed was vitamin D and a proprietary supplement formula to avoid the flu, they said.
One of the realities of being a pharmacist is that we’re easily accessible. There’s no appointment necessary for consultation and advice at the pharmacy counter. Questions range from “Does this look infected?” (Yes) to “What should I do about this chest pain?” to more routine questions about conditions that can easily be self-treated. Part of the pharmacist’s role is triage — advising on conditions that can be self-managed, and making medical referrals when warranted. Among the most common questions I receive are related to stress and fatigue. Energy levels are are down, and patients want advice, and solutions. Some want a “quick fix,” believing that the right combination of B-vitamins are all that stand between them and unlimited energy. Others may ask if prescription drugs or caffeine tablets could help. Evaluating vague symptoms is a challenge. Many of us have busy lifestyles, and don’t get the sleep and exercise we need. We may compromise our diets in the interest of time and convenience. With some simple questions I might make a few basic lifestyle recommendations, talk about the evidence supporting supplements, and suggest physician follow-up if symptoms persist. Fatigue and stress may be part of life, but they’re also symptoms of serious medical conditions. But they can be hard to treat because they’re non-specific and may not be easily distinguishable from the fatigue of, well, life.
This same vague collection of symptoms is called something entirely different in the alternative health world. It’s branded “adrenal fatigue,” an invented condition that’s widely embraced as real among alternative health providers. There’s no evidence that adrenal fatigue actually exists. The public education arm of the Endocrine Society, representing 14,000 endocrinologists, recently issued the following advisory:
“Adrenal fatigue” is not a real medical condition. There are no scientific facts to support the theory that long-term mental, emotional, or physical stress drains the adrenal glands and causes many common symptoms.
Unequivocal words. But facts about adrenal fatigue neatly illustrate why a science-based approach is a consumer’s best protection against being diagnosed with a fake disease. (more…)
Are you frustrated by the prevalence of pseudoscience in medicine? Are you interested in critical thinking and science? Is SBM your rational refuge? Want to meet like-minded science advocates? On October 23, 2010 four Skepticamps will take place across Canada. If you enjoy reading this blog, you’ll probably enjoy Skepticamp.
Happily, Skepticamp involves no actual camping. It’s a flexibly organized, collaborative conference on science and critical thinking. Skepticamp is not your typical medical conference with high fees, bad PowerPoint, long talks and little interaction with speakers. Skepticamps are open, collaborative, interactive, and FREE.
Here are the four events, and a few of the SBM-related highlights.
- Vancouver: ear candling; dopamine as an explanatory model for superstition; and SBM copy editor Paul Ingraham speaking about his first year as an alternative medicine apostate.
- Winnipeg: fad diets and detoxes; homeopathy; and the continued relevance of vaccinations
- Ottawa: self-help cults; genes and inherited diseases; science denial; and forensic science
- Toronto: I’ll be speaking about natural health product regulation. Other talks include a guide to the medical literature; the cognitive underpinnings of sympathetic magic; and naturopathy.
If there’s one near you, consider attending Skepticamp on October 23. Given it’s free, Skepticamp offers tremendous value-for-money. We invite our American colleagues to grab their passports, make a break for the border, and keep driving until there are Tim Hortons everywhere. And if you’re attending the Toronto Skepticamp, be sure to say hello.
Chelation is the provision of a substance to increase the body’s excretion of heavy metals. In poisoning situations (lead, aluminum, iron, etc.), chelation is medically necessary, objectively effective, and approved for use. But the same term has a completely different meaning in the alternative medicine universe, where proponents often believe heavy metal toxicity is the “one true cause” of disease, and chelation can undo microvascular inflammation, atherosclerosis, and even aging itself. From early days as an unproven treatment of coronary artery disease, its use has expanded to include autism, Alzheimer’s disease, cancer, and dozens of other diseases. Today, chelation is widely available. Regrettably, my own profession, pharmacy, facilitates this pseudoscience by manufacturing and selling chelation products.
Provoked urine tests are a common entry point to chelation therapy. Patients are given a product to provoke heavy metal excretion. The urine is tested and the patient is informed that they’re “toxic” and require chelation. Unfortunately, these results are meaningless and provide no evidence that chelation is medically necessary. But that’s the justification used for advocating a treatment regimen that will be useless at best and fatal at worst. A recent Medical Letter review concluded:
Medical Letter consultants believe that the use of chelation therapy in non-standard protocols for unsubstantiated indications should be discouraged. The results of provoked urine testing are not an acceptable basis for such treatment.
Providing chelation to patients isn’t a straightforward matter. It’s typically an intravenous infusion (though there are some oral products). Unless you’re part of the dubious TACT trial, which has administration centres across the United States and Canada, there are few products commercially available. For example, edetate calcium disodium (EDTA) is approved for sale in the United States but not Canada. Edetate disodium (also called EDTA) is not approved for sale in either country. But these products are widely available: they’re manufactured by pharmacists in pharmacies.
A topic of growing interest (and concern) at SBM is laboratory and diagnostic test pseudoscience. Bogus tests are everywhere, and Kimball Atwood recently discussed several of them. But over the past several years, diagnostic tests have emerged that appear to be science-based and offer gene-level insights into your health. And these tests don’t even require a physician’s visit – just a swab of saliva and a credit card get you reams of information on your genetics, traits, and risks of dozens of diseases. It looks like the ultimate in consumer health information, with the potential to offer truly personalized treatment strategies. Companies like 23andme, deCODEme, and Navigenics all promise “genetic insights” to improve your health. How could this information be anything but helpful?
Personalized medicine describes medical practices that use information about a person’s genes, proteins, and environment to prevent, diagnose and treat disease. Science-based practice has routinely incorporated environmental advice (e.g., diet and exercise) into medical management. And there are a number of genetic tests in routine use that are well established, clinical validated, and are highly predictive of future outcomes, such as tests for Huntington’s disease and hereditary breast cancer.
A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.
Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:
Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.