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Statins for everyone? Not so fast.

In rosuvastatin we trust?

In rosuvastatin should we trust?

People love the idea of preventive medicine. Preventing a disease, before it occurs, seems intuitively obvious. But when it comes to taking medicine to prevent a disease before it occurs, people tend to be much less comfortable. Not only are there the concerns about the “medicalization” of healthy people, there are good questions about benefits, risks, and costs. Cardiovascular disease will kill many of us, so there’s been decades of research studying how to prevent that first heart attack or stroke. But even if you’re born with good genes and do everything possible to prevent heart disease (e.g., don’t smoke, exercise regularly, eat a healthy diet, moderate your alcohol, and keep your weight down) you’re still at risk of heart disease. And if you have one or more risk factors for disease, your lifetime risk goes up dramatically. Once you’ve had your first heart attack or stroke, the effectiveness of medical therapy is clear. Drug therapy with medication like the “statins” class of cholesterol-lowering drugs reduces deaths from cardiovascular disease. Given their unambiguous effectiveness, and the high likelihood that many of us will eventually have cardiovascular disease of some sort, the idea of “pre-treating” otherwise-healthy people with drug therapy to possibly prevent that first event has been held out as a potential public health strategy. There’s new evidence that tests this hypothesis, and the results are surprising. (more…)

Posted in: Clinical Trials, Public Health

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More drugs, more supplements, and potentially more problems

drugs and supplements

Early in my career I was fortunate to be offered a role as a hospital pharmacist, working on an inpatient ward along with physicians, nurses, and a number of other health professionals. My responsibilities included conducting a detailed medication review with each newly admitted patient. We would sit together, often with family members, going through what was sometimes a literal garbage bag full of medications, and documenting the drug, the dose, and the reason for use. I can’t remember the most medications I ever counted, but a dozen or more was normal. Some were taking medications four or five times per day, every day. Were all these drugs necessary? In many cases, no. They’d been started at different times, often by different physicians. Some drugs treated the side effects of other medications. Few had ever had a health professional document them all in a single list. There had rarely been an overall review for safety and appropriateness. Few patients knew the treatment goals of their medications. Often, they’d never been asked about their treatment preferences.

In addition to auditing every prescribed medication, I asked about vitamins, supplements and over-the-counter drugs. I usually encountered the same scenario – multiple products, often without any clear medical need. There were vitamins for “eyes”, tonics for “the blood”, and supplements believed to treat or prevent illness. There was regular (and sometimes dangerous) over-the-counter painkiller consumption. Sometimes all of these combinations were clearly antagonistic: concurrent laxatives and treatments for diarrhea, or sleeping pills taken along with stimulants. Worryingly, few had disclosed the use of many of these products to their physician beforehand.

Medication reviews were a tremendous amount of work – but enormously rewarding. It was not difficult to find one or more cases of drugs potentially causing harm, or situations with clear drug-drug or drug-supplement interaction. In some cases, it was the medications that had put them in the hospital in the first place. Working with the residents and medical staff we could usually find ways to simplify their regimen, often discontinuing one or more drugs, reducing the doses of others, and suggesting ways to cut their supplement and over-the-counter drug use – or at a minimum, reduce the risk that these products could cause problems. Not only did patients end up with simpler medication schedules, we were helping them feel better, too. Before every patient was discharged, they’d get a follow-up visit from me. I’d provide a detailed list of current medications with a simplified schedule designed to make medication use easier. We’d provide copies for them to take to the pharmacy and to any specialist. In many cases, patients were still on a long list of drugs. But we’d cleaved away the most harmful and unnecessary, trying to leave only the medications that were appropriate. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals, Science and Medicine

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Not natural, not safe: Grapefruit Seed Extract

The image is "natural", but is grapefruit seed extract a case of misleading advertising?

The image is “natural”, but is grapefruit seed extract a case of misleading advertising?

Where do you draw the line between “supplement” and “drug”? And how much processing of a “natural” substance can occur before it’s no longer “natural”? These seemingly-philosophical questions are very real when it comes to the supplement industry. In many countries, regulators have implemented weaker safety, effectiveness and quality standards for anything branded a supplement or natural health product. The result has been a boon and boom for manufacturers, with thousands of products flooding the market. This same boom has challenged consumers and health professionals who are seeking products that are safe, effective, and manufactured to high quality standards (and in the bottle you are buying). Nowhere is this challenge better illustrated than a supplement that I’ve seen for sale for some time. Grapefruit seed extract (GSE), according to promoters, is a panacea that destroy bacteria, viruses and fungi anywhere in the body, without any risk of harm. But the actual science is quite telling. Grapefruit seed is a supplement that’s of such poor quality that even herbal medicine boosters recommend against its use. (more…)

Posted in: Herbs & Supplements

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Genomic testing at your pharmacy: Ready for prime time?

Is genomic testing as useful as pharmacies claim it can be?

Is genomic testing as useful as pharmacies claim it can be?

Despite science’s ability to develop sophisticated and targeted new drugs, predicting the effect of a drug in an individual is still maddeningly difficult. Not every drug works for everyone that takes it. Similarly, the very same drug can be well tolerated in some, but can cause intolerable side effects in others. So-called “targeted therapies” were supposed to improve our accuracy, by focusing on specific targets on cells. That’s been good – but not sufficient to make drug treatments more consistently effective. Pharmacogenomics is the relationship between your DNA and how your body responds to drugs: how they’re absorbed, how they work, and how they’re eliminated from the body. It has been heralded for some time as the white knight of drug therapy. The genome revolution was supposed to remove (or dramatically reduce) the uncertainty in medicine, telling us which drugs will work more effectively, and which we might want to avoid. And to some extent, the genome-based treatment era is already here. There are over 100 drugs approved by the Food and Drug Administration (FDA) now that include genomic information in their prescribing information. For a small number of drugs, genomic testing is warranted. Increasingly, genomic testing is more accessible, moving from the research bench directly into retail pharmacies for sale when you pick up your prescription. Given pharmacies have a less-than-stellar record of selling laboratory testing that isn’t validated or even useful, I was immediately skeptical when I saw a new story on pharmacy-based genomic testing. Titled “Your pharmacist’s secret weapon: How your DNA can help perfect your medication,” it appeared in last week’s Globe and Mail: (more…)

Posted in: Science and Medicine

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Is it ethical to sell complementary and alternative medicine?

Legal to sell, yes. But ethical to sell?

Legal to sell, yes. But ethical to sell?

Complementary and alternative medicine (CAM) is no longer fringe, and anything but the mom-and-pop image that manufacturers carefully craft. CAM is big business, and most Americans today take some sort of supplement. The impetus for my blogging (and tilting at CAM windmills) emerged from years spent working in a pharmacy with a heavy reliance on CAM sales. If it was unorthodox, this store probably sold it. Conventional drug products (the ones I was familiar with) were hidden off in a corner, and the store was otherwise crowded with herbal remedies, homeopathy, and different forms of detox kits and candida cleanses. All of this was unlike anything I’d ever seen or heard about in pharmacy school – so I started researching.

I looked at CAM from a scientific evidence perspective, the one I was taught in pharmacy school, using the same approach I’d take when assessing a new drug. Did the evidence support the claims made about these products, or not? The answers, as you might expect, were often the same. There was little or no credible evidence to demonstrate CAM had any meaningful benefits. I started blogging my own reviews as a way of documenting my own research, while offering some information to anyone on the Interwebs who might be searching for evidence.

Over time my blogging focus expanded, as I asked myself the inevitable questions: How could implausible products with no scientific backing even be approved for sale at all? I discovered the regulatory double-standard allowed for anything considered a dietary supplement (or in Canada, a “natural health product“) and the history and politics that have made CAM the “Wild West” of health care, with a marketplace that prioritizes a manufacturer’s right to sell over a consumer’s right to purchase a product that is safe and effective. Given the retail marketplace that’s been established by regulators like the FDA and Health Canada, I’ve turned my focus on to health professionals, who have an ethical responsibility to put patient interests above that of commercial interests. From a professional practice and medical ethics perspective, I have argued that health professionals that sell or promote CAM are on ethically shaky ground, and compromise the credibility of the profession.

Despite the lack of evidence that CAM (in general) offers any health benefits at all, it’s been remarkable to watch its popularity grow, to the point where even large pharmacy chains now sell aisles of products that are implausible and often highly questionable. Generally meeting these changes with a collective shrug, the pharmacy profession has even tried to lower its own ethical standards. While I do get the occasional encouragement from some of my peers, most just say “it’s business” or “the customer wants it, and these are legal products.” My argument today is CAM fails even this lower ethical bar. (more…)

Posted in: Ethics, Herbs & Supplements, Homeopathy, Medical Ethics, Politics and Regulation

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The consumer lab rat: More questions about supplement safety

Laboratory Rats
Do you take a vitamin or dietary supplement? Over half of all American adults do, making this a $30 billion dollar business. Many of us even take supplements in the absence of any clear medical or health need. I’m often told it’s a form of nutritional “insurance” or it’s being taken for some presumed beneficial effect – like Steven Novella outlined in yesterday’s post on antioxidants. We love the idea of a risk-free magic bullet that improves our health and wellness. Especially one that avoids what are presumed to be toxic, unnatural drugs. Supplements are marketed as safe, natural and effective, and there is no question that messaging has been effective.

I used to take supplements. For me it was multivitamins. But as I’ve taken a closer look at the evidence for supplementation, my personal behaviors changed. The primary reason is a lack of evidence. There is no evidence to suggest that vitamins offer any health benefits in the absence of deficiency. The balance of evidence suggests that routine multivitamins are unnecessary for most people. Vitamins should come from your food, not from supplements. More generally, looking at the broader category of supplements that range from probiotics to herbal remedies, there is little evidence to support most of them. With a few exceptions, the research done on dietary supplements is unconvincing and largely negative. If you don’t supplement, you don’t seem to be missing out on any tremendous health benefits.

Going beyond the lack of evidence, there’s an even more compelling need for consumers to be wary of them. The safety of supplements is increasingly being called into question. Evidence has emerged demonstrating that quality standards for supplements sold in many countries are erratic and unpredictable. The root cause seems to be regulatory systems that prioritize manufacturer interests ahead of consumer protection. With supplements, products are effectively being tested for safety after they are marketed, and the consumer is the unwitting research subject. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Don’t drink hair bleach

H2O2-hydrogen-peroxide-meme-small-480x636

One of the most satisfying parts of being a health professional is the opportunity to help people make better health decisions. In between the emails suggesting I’m a paid lackey of the Pharmaceutical-Industrial Complex™ for not endorsing coffee enemas, vitamin C, or homeopathy, I do receive the occasional note thanking me for my advocacy, or for writing about a subject in a way they found helpful. I’m also sent questions – too many to answer, but occasionally opening my eyes to new “concepts” in alternative medicine. And while I spent years working in a pharmacy with a huge “holistic” health section, containing products that, if they worked, would have defied one or more laws of physics or chemistry, I can still be surprised at novel alternative-to-medicine approaches to health care. Last week I was sent a questions about hydrogen peroxide – not for first aid use (where it may not be as useful as thought), but for oral consumption, as some sort of health “cure-all”. I was baffled, but the concept does exist – and the Big Pharma Overlords apparently don’t want you to know about it. There must be a rule 34 of alternative medicine – if it exists, there is an (inappropriate) alternative medicine use for it. The active ingredient in hair bleach and teeth whitening strips is no exception. (more…)

Posted in: Science and Medicine

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The one thing you need to know before you detox

detox will to live small

New Year, New You, right? Here’s a perennially popular post, revised for 2016.

With 2016 upon us, it’s finally time get serious about your health. You’re resolving to eat better and exercise more. But first, you need to reset your body – and purge yourself of all of your lifestyle and dietary overindulgences. But how? The options seem limitless, and everyone has advice: There’s Dr. Oz, Gwyneth, and even your favourite Kardashian has advice: They’re all telling you how it’s essential to “detox”, “cleanse” and “flush” away all of your toxins. Your local pharmacy has an ever-growing section of products promising a newer, more pure you: supplements, homeopathy, ear candles, and an entire aisle of “detox kits” all promise to suck toxins out of your body. Don’t forget your local naturopath who sells IV vitamin drips as the detoxification solution to your problems. The approaches may differ but all the advocates are completely convinced of one fact: Detoxing will deliver a renewed body and better health. Not only will you look better, you’ll feel better. It is a new year. Wouldn’t a purification from last year’s habits (dietary and otherwise) of last year be the best way to start? Well before you pull out your credit card, there is one fact that “detox” advocates are reluctant to tell you. (more…)

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Nutrition

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What’s in your Traditional Chinese Medicine?

A study found 92% of Traditional Chinese Medicine was contaminated with drugs, heavy metals, or animals including cat, dog, rat and pit viper.

An analysis of 26 Traditional Chinese Medicine products found 92% were contaminated with pharmaceuticals, heavy metals, or the DNA of animals, including traces of cat, dog, rat, or pit viper.

Two weeks ago I detailed the pervasive problem of poor quality supplements. The main reason for this seems to be weak regulatory standards that prioritize the rights of manufacturers to sell supplements over the rights of consumers to buy safe, high quality, properly-labelled products. Call it “health freedom“, where the freedom belongs to producers, who in many countries are largely freed from most of the quality and safety regulations that are in place for licensed prescription and non-prescription pharmaceuticals. The result of weak regulation is that few supplements sold on the market today have been properly tested for safety or effectiveness, and there are few quality standards for the production of these products.

Not surprisingly, there are persistent signs that consumers may face real risks to their health from using these products. Now a new study from Australia confirms what past studies have already shown: adulterated and contaminated herbal remedies are the rule, rather than the exception. They often contain undeclared ingredients ranging from potential allergens to heavy metals to endangered species. (more…)

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Politics and Regulation, Public Health, Traditional Chinese Medicine

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Holding the supplement industry to account: Can we learn from tobacco regulation?

When it comes to supplements, you can't trust what's on the label

When it comes to supplements, you can’t trust what’s on the label

The idea that “natural” products are safe and effective has been so effectively marketed to us that many don’t recognize it as a fallacy. Much of the supplement industry is built around an appeal to nature. Supplements are described as natural, gentle, and “holistic”. Medicine, especially prescription drugs, is the opposite. They’re “chemicals”. They’re risky and dangerous – just look at that list of side effects! Supplements are packaged beautifully, have impressive claims, and are for sale at Whole Foods. Drugs are hazardous: They may come in a plain vial, with warning labels, detailed information sheets, and cautious statements about their effectiveness. Is it any wonder that many consumers, when faced with health concerns or medical issues, instinctively think of supplements as a safer alternative? Purveyors of supplements and alternative medicine have leveraged this fallacy so effectively that it’s even guided the regulations that allow their sale. Regrettably, the result is a marketplace that puts consumers’ interests last. The supplement industry has completely stacked the odds against the consumer, challenging their ability to make informed decisions about their health. Most supplements on the market have never been properly tested for safety or effectiveness. And those that have been tested have largely been shown to be ineffective – or in the case of products like vitamins, often unnecessary. And while there are undoubtedly some ethical companies out there, the industry is regularly revealed to resemble a wretched hive of scum and villainy. Despite this, the industry has gone from success to success – in terms of sales, at least. In 1994 supplement sales were about $4 billion in the US. It’s now a $37 billion industry that is remains only lightly regulated – or largely unregulated. With recent action taken against fraudulent products, there are more questions than ever about how to force the supplement industry to make consumer protection a priority. A new paper in Drug Testing and Analysis makes a provocative suggestion: Local and state governments already regulate another hazardous product: tobacco. Can lessons learned from the tobacco wars improve the safety of supplements? (more…)

Posted in: Epidemiology, Health Fraud, Herbs & Supplements, Politics and Regulation, Public Health

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