It’s the time of year where if you’re not sick, someone you know probably is. The influenza season in the Northern hemisphere started out slowly, but seems to be accelerating and hasn’t peaked yet. Add that to cold viruses circulating, and you get the peak purchasing period for cough and cold remedies. John Snyder gave a nice summary of the evidence base for the common treatments a few weeks ago. In short, despite all the advertising, there is little evidence to suggest that most of the “tried and true” products we’ve used for decades have any effect on our symptoms. One of the most sensible developments that’s occurred over the past few years has been the discontinuation or relabeling (depending on your country) of cough and cold products for children. The rationale to pull these products is compelling: Cough and cold remedies have a long history of use, and were sold without prescriptions before current regulatory standards were in place. They were effectively grandfathered onto the marketplace. When it comes to their use in children, the data are even more limited. There are few published trials and the results are complicated by different age groups, irregular dosing, lack of placebo control, and very small patient numbers. What’s even harder to believe was that doses were based mainly on expert opinion, not data, and generally didn’t consider that children don’t handle drugs the way adults do. So why withdraw them from pediatric use, but not adult use? Like most regulation, it comes down to risk and benefit. Both are troubling for pediatric use. (more…)
Note to SBM’s regular readers: Today’s post revisits some older material you may have seen before. Happy New Year!
New Year, New You, right? 2014 is the year you’re finally going to get serious about your health. You’re winding down from a week (or more) of celebrations and parties. You’re pretty much recovered from New Year’s Eve by now. It’s time to make some resolutions. Conveniently, there is no shortage of solutions being advertised to absolve you of your sins while overhauling your body and soul for 2014: What you need to do is “detox”. You’ll see the detox kits at your local Whole Foods (or even your local pharmacy). Books, boxes or bottles, with some combination of “detox”, “cleanse” or “flush” in the product name. Supplements, tea, homeopathy, coffee enemas, ear candles, and footbaths all promise detoxification. The advertising suggests you’ll gain a renewed body and better health – it’s only seven days and $49.95 away. Or try to cleanse yourself with food alone: Dr. Oz is hyping his Holiday Detox plan. Bon Appetit is featuring their 2014 Food Lover’s Cleanse. Or what about that old standby, the “Master Cleanse”? It’s the New Year – wouldn’t a purification from your sins of 2013 be a good idea to start the year? After all, the local naturopath offers complete detoxification protocols, including vitamin drips and chelation. There must be something to it, right? (more…)
If scientific evidence guides our health decisions, we will look back at the vitamin craze of the last few decades with disbelief. Indiscriminate use is, in most cases, probably useless and potentially harmful. We are collectively throwing away billions of dollars into supplements, chasing the idea of benefits that have never materialized. Multivitamins are marketed with a veneer of science but that image is a mirage – rigorous testing doesn’t support the health claims. But I don’t think the routine use of vitamins will disappear anytime soon. It’s a skillfully-marketed panacea that about half of us buy into.
Not all vitamin and mineral supplementation is useless. They can be used appropriately, when our decisions are informed by scientific evidence: Folic acid prevents neural tube defects in the developing fetus. Vitamin B12 can reverse anemia. Vitamin D is recommended for breastfeeding babies to prevent deficiency. Vitamin K injections in newborns prevent potentially catastrophic bleeding events. But the most common reason for taking vitamins isn’t a clear need, but rather our desire to “improve overall health”. It’s deemed “primary prevention” – the belief that we’re just filling in the gaps in our diet. Others may believe that if vitamins are good, then more vitamins must be better. And there is no debate that we need dietary vitamins to live. The case for indiscriminate supplementation, however, has never been established. We’ve been led to believe, through very effective marketing, that taking vitamins is beneficial to our overall health – even if our health status is reasonably good. So if supplements truly provide real benefits, then we should be able to verify this claim by studying health effects in populations of people that consume vitamins for years at a time. Those studies have been done. Different endpoints, different study populations, and different combinations of vitamins. The evidence is clear. Routine multivitamin supplementation doesn’t offer any meaningful health benefits. The parrot is dead. (more…)
Once again, it’s influenza season. The vaccine clinics are open, and the hysterical posts about the vaccine’s danger are appearing in social media. There’s familiarity to all of this, but also a big new change – at least in Canada, where I am. Pharmacists can now administer the vaccine. And it’s completely free to anyone in Ontario (where I am), so the barriers to obtaining the vaccine are pretty much eliminated. There’s no longer a need to drag your kids to their family doctor or line up at a public health clinic. Anyone can walk into a pharmacy, show their health card, and walk out minutes later, vaccinated. It’s another enabling change that may help improve immunization rates, as uptake rates in the population remain modest.
This year’s flu season is (as of week 47) fairly quiet. Google Flu trends suggests a fairly typical picture, nothing like what we saw in 2009/10, the year of H1N1. My city’s influenza tracker reports only a dozen cases so far this season. Many of us will get our flu shot, continue with our lives, and not think about the flu until next season’s announcements. That’s the hope, anyway. Influenza can kill, and in its more virulent forms, is devastatingly deadly. The worst case scenario (so far) is almost unimaginable today. In 1918/19 an influenza pandemic killed 50 million people worldwide (5% of the population). So among public health professionals, that worry about the next wave is always present. Much has been written at this blog <plug>nicely compiled in the SBM ebook,</plug> on the efficacy and safety of the flu vaccine. In short, the vaccine is effective for both individual and population-level protection, but only modestly so, and its effectiveness varies based on its match with circulating strains. And despite widespread use for decades, there are frustrating limitations with the current vaccine beyond efficacy, including the need to repeat the shot annually. Someone said something about “going to battle with the army you have”. (I thought it was Crislip but he was quoting Rumsfeld.) The quote is apt. It’s not a perfect vaccine, but it does offer protection – if not directly to you, then indirectly to those at greater risk of infection. Hospitals and health facilities have been criticized for demanding health professionals either get the vaccine or wear a mask – and the arguments against vaccination are losing. But even the strongest advocates of influenza vaccine will acknowledge its limitations, which perhaps contributes to the understandable perception that there is more that could be done- beyond reasonable and effective precautions like handwashing and hygiene. (more…)
It is a triumph of marketing over evidence that millions take supplements every day. There is no question we need vitamins in our diet to live. But do we need vitamin supplements? It’s not so clear. There is evidence that our diets, even in developed countries, can be deficient in some micronutrients. But there’s also a lack of evidence to demonstrate that routine supplementation is beneficial. And there’s no convincing evidence that supplementing vitamins in the absence of deficiency is beneficial. Studies of supplements suggest that most vitamins are useless at best and harmful at worst. Yet the sales of vitamins seem completely immune to negative publicity. One negative clinical trial can kill a drug, but vitamins retain an aura of wellness, even as the evidence accumulates that they may not offer any meaningful health benefits. So why do so many buy supplements? As I’ve said before, vitamins are magic. Or more accurately, we believe this to be the case.
There can be many reasons for taking vitamins but one of the most popular I hear is “insurance” which is effectively primary prevention – taking a supplement in the absence of a confirmed deficiency or medical need with the belief we’re better off for taking it. A survey backs this up – 48% reported “to improve overall health” as the primary reason for taking vitamins. Yes, there is some vitamin and supplement use that is appropriate and science-based: Vitamin D deficiencies can occur, particularly in northern climates. Folic acid supplements during pregnancy can reduce the risk of neural tube defects. Vitamin B12 supplementation is often justified in the elderly. But what about in the absence of any clear medical need? (more…)
If there is one aspect of “alternative” medicine that both critics and fans should agree on, it’s that products should be manufactured to high standards. What’s on the label should accurately describe what’s in the bottle. Product quality standards are essential, whether you’re using herbs or drugs. And when it comes to ensuring the products we buy are of high quality, we’re all effectively reliant on regulation to protect us. As a pharmacist, I can’t personally verify that each tablet in your prescription contains the active ingredient on the label. I am dependent on a supply chain that may stretch around the world. While the product manufacturer may be reputable, it’s only a regulator that can realistically verify and enforce production to strict quality standards. The same cannot be said for products like supplements and herbs which are regulated differently than drugs, and held to different, and in some cases, weaker standards. A weak regulatory framework, which doesn’t hold manufacturers to account, would be expected to result in a product of lower quality. And that’s exactly what you see when you look at supplements on the market today.
While I’m now two full decades out of pharmacy school, I am occasionally invited to return to give a lecture or facilitate a workshop. Pharmacy education has changed a lot since the 1990’s. For me, pharmacy was a Bachelor’s degree program you started right out of high school. Today, students must have a few years of university completed before they can apply (some already have one degree), and the more common degree granted is doctorate-level, the Pharm.D. The clinical training has been bulked up and the practical training is much more rigorous. I see all this as positive change, as the practice of pharmacy has changed along with the education standard. The era of the “count, pour, lick and stick” pharmacist is disappearing as these tasks are automated or delegated to others. Today’s pharmacist has the opportunity to deliver care in different ways, including new roles like vaccine provider, and medication review/drug therapy optimizer. Many find positions that allow them to leverage their drug-related expertise to other areas of the healthcare system.
With pharmacists’ knowledge of drug products it should not be a surprise that they are consulted widely for advice by patients as well as other health professionals. Public surveys on trust show pharmacists lead other health professionals on this measure. It should also not be a surprise that pharmacists can be quite influential in shaping drug use, particularly when it comes to advice about complementary and alternative medicine (CAM), especially when it is used with conventional, science-based drug treatments. After all, drug stores are becoming (to my professional embarrassment) purveyors of all forms of CAM, ranging from homeopathic “treatments” through aisles of herbal remedies, vitamins, and other supplements. One pharmacy I used to work at sold copper bracelets, magnets, salt lamps, ear candles, homeopathic “first aid” kits, and detox packages that were purported to “balance” your pH. If there was a plausibility limit to what this pharmacy would sell, I never saw it reached. I gave the best science-based advice I could, but eventually left due to my concerns about what was on the shelves. But my time in that setting showed me the opportunity to improve care: the pharmacist is well positioned to advise on the evidence for or against any particular treatment, as well as the describe the potential risks with combining CAM with evidence-based treatment approaches. (more…)
Recently ProPublica and This American Life (TAL) released the results of an investigation into acetaminophen, the active ingredient in Tylenol. TAL devoted an entire episode to the issue, and ProPublica has published several stories on acetaminophen’s toxicity, how it can cause harm, and how it is regulated.
The investigation summarizes the key “Takeaways” as follows:
- 150 Americans die per year from accidental acetaminophen overdoses
- The safety margin (safe dose vs. toxic dose) with acetaminophen is small
- Both the FDA and the manufacturer, McNeil, have known about the toxicity for years
- For over 30 years the FDA has failed to implement measures to reduce the risk of harms it knew existed
- The manufacturer has taken steps to protect consumers but has also opposed other safety measures
While Tylenol is a single brand out of hundreds of prescription and non-prescription products that contain acetaminophen as an active ingredient, it is the brand most closely associated with the chemical. Amazingly for a drug that has no patent and lots of competition, Tylenol products are estimated to make up half of all non-prescription acetaminophen sales in the US, a testament to the power and effectiveness of marketing. (It’s also a clear refutation to alt-med arguments that unpatented products can’t be profitable, or aren’t of interest to the pharmaceutical industry.) While much of the focus of the investigation centers on the corporate behavior of Tylenol’s manufacturer, McNeil, (a division of Johnson & Johnson), it is important to keep in mind that no single company is responsible for acetaminophen sales and marketing. (more…)
I’m sure I’m not the only health professional that bites their tongue whenever a patient starts a question with “I heard on Dr. Oz that…” More often than not, I have expectations to realign, and some assumptions to correct. I could easily devote all my posts to simply correcting information presented on the Dr. Oz show. But given I’m blogging here biweekly, and Dr. Oz has a daily television show, I’ll never be able to catch up. So while my first choice in topics isn’t to add a post to our extensive Dr. Oz archives, I often end up, like many other health professionals, needing to respond to his shows shortly after they air.
Should you happen to be someone that has never seen the Dr. Oz show, Dr. Mehmet Oz is an Oprah protégé who has gone on to build a health media empire that is possibly the biggest vehicle for health pseudoscience and medical quackery on television. Whether it’s promoting homeopathy, recommending unproven supplements, or advocating ridiculous diet plans, there seems to be no health subject too dubious to endorse. Oz has established an impressive track record of providing highly questionable health advice. A few months ago I examined his absurd endorsement of green coffee beans, followed by his dubious “clinical trial” of green coffee beans that likely didn’t meet minimal research ethics standards. Then there was the weight loss “miracle” (his words), red palm oil, which followed the same episodic formula of breathless hyperbole backed by questionable evidence. One of the meta-trends of the Dr. Oz show are weight loss secrets – typically gimmicky interventions, supplements and therapies that he promotes as panaceas for obesity. (more…)
The price of life is eternal vigilance. If you have severe food allergies, that is your reality. Every day, every meal, every bite. Eating is an intrinsic and essential part of what we do and who we are, so the idea that our bodies can rebel violently to everyday foods can be difficult to believe. But it’s real, and the numbers of the severely food allergic are growing. Frustratingly, we don’t know why. While recognized over 100 years ago, the social acknowledgment had lagged. That’s improved in the past decade. Food allergy prevention approaches are now a routine part of travel, school, sports, and the workplace. Peanuts on planes seem to have completely disappeared. The days of lunchbox peanut butter sandwiches are over, with many schools completely banning all peanut-containing products. It is the education system that seems to have become a ground zero for allergy programs and policies, where educators are challenged to ensure that schools are safe environments for all children, some of whom have long lists of food allergies. (more…)