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Natural Health Products: Loosely regulated, little evidence of benefit, and an industry intent on preserving the status quo

Shouldn't you know that the pills you are paying for are safe, and actually do something?

Shouldn’t you know that the pills you are paying for are safe, and actually do something?

This week’s post will revisit a topic I recently covered, but it’s time-sensitive and needs your input. Health Canada, the Canadian equivalent to the US Food and Drugs Administration, is considering revisions to the way in which it regulates dietary supplements, which are called “natural health products” in Canada. It is rare that a regulator acknowledges that a regulatory system isn’t working, and publicly expresses a commitment to being more science-based. There is a time-limited opportunity for the public (including all of you non-Canadians!) to provide comment on how supplement regulation could be more closely aligned around scientific principles, rather than the supplement industry’s priorities. Whether you take dietary supplements or not, we can probably all agree that consumers should have access to safe products as well as credible, relevant information about these products, in order to make informed health decisions. It will likely not surprise you that these ideas are seen as threats to supplement manufacturers, who benefit from little regulatory oversight and few restrictions on what can currently be claimed about any product’s effectiveness. Since my last post, there have been some new reactions to the consultation that are worth discussing. (more…)

Posted in: Herbs & Supplements, Legal, Politics and Regulation

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Another way ibuprofen can kill us?

Does ibuprofen really raise your risk of heart failure by 83%? No.

Does ibuprofen really raise your risk of heart failure by 83%? No.

Do you ever take ibuprofen? Naproxen? Cold medication with an anti-inflammatory ingredient? The non-steroidal anti-inflammatory drugs (NSAIDs) are among our most well-loved medications. We start giving them in infancy, for fever, and continue use through to adulthood for everyday aches and pains. But it’s our later stages of life when we really ramp up the use, and daily consumption becomes common for conditions like arthritis. While they may be easily accessible and included as ingredients in thousands of consumer products, NSAIDs have a long list of potentially serious side effects. Not only can they cause stomach ulcers and bleeding by damaging the lining of the gastrointestinal tract, they can also increase the risk of fatal cardiovascular disease. Now there’s new research that looks at the relationship between NSAIDs and heart failure, a condition where the heart cannot pump adequately and appropriately. The study, “Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study” resulted in some fairly dramatic, alarming headlines:
daily mirror headline NSAIDS ibuprofen heart failure

Headlines like this suggest that NSAIDs are killing us indiscriminately, which may make you wonder how so many of us manage to have lived this long. And while The Daily Mirror got the facts wrong, they quoted from a well-conducted study. There is a real risk of heart failure from NSAIDs. But context is everything. (more…)

Posted in: Science and Medicine

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Fixing the supplement market for consumers

vitamins and supplements

Unsubstantiated claims could be on their way out in Canada

When it comes to regulating and selling dietary supplements, should consumer interests be higher priority than those of manufacturers? While regulations are seemingly created to protect consumers, governments around the world have consistently given manufacturers the upper hand, prioritizing a company’s desire to sell a product over a consumer’s right to a marketplace with safe, effective products. Nowhere is this more the case than in Canada and the United States, where similar regulatory approaches have led to an industry boom and massive sales, but also a confusing marketplace for consumers and no persuasive evidence that all those supplements have any meaningful effects on our health. Drug store shelves in 2016 are packed with hundreds of products with unsubstantiated claims and untested products, and little credible information to guide selection. Since its beginnings, the contributors to this blog has been consistent in calling for more appropriate regulation: one that puts consumers first, not manufacturers, and evaluates all products (drugs, supplements or otherwise) with a consistent standard of science and evidence. Today, it looks like one regulator is preparing to move in that direction. Health Canada, Canada’s equivalent to the FDA, has proposed a new regulatory approach that is expected to block manufacturers from selling products with unsubstantiated and often misleading health claims. And they are asking for your input. Carly Weeks in The Globe and Mail writes: (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Oxygen water? You can’t breathe through your stomach

Unless you have gills, this won't make you a strong, faster athlete.

Unless you have gills, this won’t make you a stronger, faster athlete.

My exercise of choice is running. Despite the heat I’ve been having a great summer, training for the Chicago marathon. I’ve followed the training schedule fanatically since June. But it all came crashing down in one run last week when I moved from the ranks of “marathoner in training” to “injured runner”.

With the sudden onset of very sharp, radiating back pain, I was struggling to walk. My marathon plans seemed to evaporate. And in that moment of weakness, I became prey. Prey to pseudoscience, and prey to anyone offering a quick fix. (more…)

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

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Do pill organizers help or hurt?

"Blister packs" help people take their medication on the correct schedule.

“Blister packs” help people take their medication on the correct schedule.

In order for medication to work, getting a prescription filled isn’t enough. You have to actually take the medication. And that’s where you (the patient) come in. Estimates vary based on the population and the medication, but a reasonable assumption is that 50% of people given a prescription don’t take their medication as prescribed. In pharmacy terminology we usually call this medication compliance, but because that sounds a bit paternalistic, the term medication adherence is also used. People forget doses, deliberately skip doses, and sometimes even take more than directed. Often, the prescription isn’t finished completely. Perhaps not surprisingly, people are less likely to adhere to their prescribed medication schedule when the condition they are treating has no symptoms. All things being equal, you’re more likely to take your pain control medicine than your hypertensive medications: Pain medications have side effects, but should help you feel better right now. Hypertension medications can only make you feel worse. Statins (as a group of medications) are another good example. We treat high cholesterol to lower the risk of heart disease: heart attacks, strokes, and death. It has no obvious benefit now, nor will we ever be able to point to the benefit we received. We’re taking the medication to reduce the risk of something happening in the future. If the drug isn’t taken regularly (or at all) then you’re not going to get the expected benefits of statin therapy. The “value” that treatment delivers is reduced (or eliminated). And if you stop a medication periodically, then restart it, you might get more side effects than you would have if you just took it regularly. (more…)

Posted in: Medical devices, Pharmaceuticals, Quality Improvement, Science and Medicine

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Does acetaminophen during pregnancy raise the risk of behaviour problems?


In my career as a pharmacist I’ve answered a lot of questions about medication use in pregnancy. Pharmacists are among the most accessible health professionals, and we’re usually found near a wall of medicines and supplements.  Many don’t trust Dr. Google, and for good reason: There are conflicting answers online. When it comes to medication use in pregnancy and effects on the fetus, we have no perfect data. Since no-one is randomizing women to drug treatment or placebo, we must rely  on weaker, less definitive evidence. An appropriate response from a health professional will describe known risks and expected benefit, summarizing what we know, and how confident we are in that answer. One of the most popular drugs used in pregnancy is acetaminophen (sometimes called paracetamol or APAP), and commonly known by the brand name Tylenol. An emerging concern with acetaminophen is whether use during pregnancy raises the risk of attention deficit hyperactivity disorder (ADHD) and related behavioural problems. While I covered this question once, back in 2014, there’s a new paper that’s putting this issue back in the news. From Evie Stergiakouli and colleagues is the paper, “Association of Acetaminophen Use During Pregnancy With Behavioral Problems in Childhood: Evidence Against Confounding“, published this week in JAMA Pediatrics. (more…)

Posted in: Epidemiology, Obstetrics & gynecology, Science and Medicine

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Pharmacy and homeopathy: Will the profession change, or will change be forced upon it?

comforting lies unpleasant truths

Retail pharmacy is giving itself a credibility problem. While pharmacists are highly trusted health professionals, there are increasing questions about the products sold in pharmacies. Many of the non-prescription products that you can find aren’t backed by good evidence. And the number of dubious products seems to be growing. Homeopathy is an extreme example. Homeopathic “remedies” look like conventional medicine, but unlike actual medicine, homeopathic products don’t contain any active ingredients. They are effectively and sometimes literally sugar pills: placebos that are marketed to treat health concerns. Not surprisingly, there is zero convincing evidence to show that homeopathy has any value in medicine. Homeopathy is fundamentally incompatible with the current scientific understanding of the medicine, biochemistry, and even the basic physics that form the foundation of a pharmacist’s knowledge base about medicines. There is no medicinal benefit to homeopathy. Yet despite the obvious ethical issues of selling sugar pills to patients who may be led to believe these products may be beneficial, the profession of pharmacy hasn’t acted, or even seriously asked itself if selling these products is appropriate. And homeopathy has moved quickly from a fringe product to one that you can find in most retail pharmacies. Here’s a picture from a local pharmacy near me. Imagine you’re in a rush, searching for a cough and cold product. How easily can you identify the homeopathy? (more…)

Posted in: Ethics, Homeopathy

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Should you try a “natural alternative” before medication?

Herbal remedies are often promoted as a substitute for drug therapies.

Natural and herbal remedies are often promoted as a substitute for drug therapies. But do they actually work?

The idea of taking medication can be frightening. And as consumers and patients that want to make our own informed health decisions, it’s understandable and even appropriate to question our physicians when they recommend drug treatments. We need to understand the rationale for any medication that’s recommended or prescribed, the benefits of therapy, the side effects, and if there are any other approaches that might be more appropriate. Dietary supplements and natural health products are widely marketed as being safe and effective, and are occupying more and more shelf space in pharmacies, usually right beside the pharmacy counter. Many of my patient encounters in the pharmacy have included a discussion on the merits of drug therapy, versus the supplements that may have flashy packaging and impressive claims of effectiveness.

One encounter from my time working at a local pharmacy still sticks with me. I met a new patient who was anxious and eager to get my advice. He’d been cautioned by his family doctor that he was on the borderline of being diagnosed with diabetes. He had come to the pharmacy seeking a supplement that could help him avoid diabetes and medication. Rather than recommend any supplement, I suggested that the best approach he could probably take would be to lose some weight and get some exercise – it could be more effective than any supplement or drug, and would definitely help his health. He agreed, and then asked me what supplement he could take that could help him with some weight loss.

This type of discussion occurs all the time, and seems more common when there’s a lack of trust in the physician, or when the goals of treatment aren’t understood. The patient, reluctant to accept the physician’s recommendation, heads to the pharmacy for what they believe is a second opinion. In some cases, the patient may question the physician’s advice: “All my physician wants to do is prescribe drugs,” is a statement I’ve heard more than once. In those that are reluctant to accept medical treatment, there’s often a willingness to consider anything that’s available without a prescription – particularly if it’s perceived as “natural.” Natural products and dietary supplements are thought to be gentle, safe, and effective, while medicine may be felt to be unnatural, harsh, and potentially dangerous. Yet when I explain to patients that there’s actually little evidence to suggest most supplements offer any meaningful health benefits, I am sometimes met with puzzled or dismissive looks. The supplement industry’s marketing has been remarkably effective, glossing over the fact that the research done on dietary supplements is overall unconvincing and largely negative when it comes to having anything useful to offer for health. (more…)

Posted in: Naturopathy

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A systematic review about nothing

There is dubious content in PubMed that you won’t find unless you look for it, or stumble across it inadvertently. It’s the entire field of alternative medicine which is abstracted and complied along with the actual medical literature. In this world, the impossible is accepted as fact, and journal articles focus on the medical equivalent of counting angels on pinheads. I’ve been trying to avoid blogging about alternative medicine practices like homeopathy lately because the practice itself is a scientific dead end. There is no emerging evidence or interesting research to describe, because there is no science to build on. But research on homeopathy is interesting if one wants to understand how placebo effects can appear to be real. Importantly, research and clinical trials of homeopathy allow us to see the underlying (baseline) challenges, flaws, and biases in evaluating real medicine more clearly. Today I want to review a newly-published systematic review of, adverse effects attributed to homeopathy. The casual reader might not see the multiple problems with this type of research. But once you understand the basis of homeopathy, the conclusion that one can draw is quite different from that of the author’s. And if inert sugar pills can appear to have medicinal effects, and even adverse effects, then we can better adjust for these biases when we’re studying actual medicine. (more…)

Posted in: Clinical Trials, Homeopathy

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The rise and inevitable fall of Vitamin D

Is Vitamin D a panacea? The evidence says otherwise.

Is vitamin D a panacea? The evidence says otherwise.

It’s been difficult to avoid the buzz about vitamin D over the past few years. While it has a  long history of use in the medical treatment of osteoporosis, a large number of observational studies have linked low vitamin D levels to a range of illnesses. The hypothesis that there is widespread deficiency in the population has led to interest in measuring vitamin D blood levels. Demand for testing has jumped as many physicians have incorporated testing into routine care. This is not just due to alternative medicine purveyors that promote vitamin D as a panacea. Much of this demand and interest has been driven by health professionals like physicians and pharmacists who have looked at what is often weak, preliminary and sometimes inconclusive data, and concluded that the benefits of vitamin D outweigh the risks. After all, it’s a vitamin, right? How much harm can vitamin D cause? (more…)

Posted in: Herbs & Supplements, Nutrition

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