Statins for everyone?

Should you take a statin to prevent heart disease?

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 (like side effects), 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 has been established. Drug therapy with medication like the “statins” class of cholesterol-lowering drugs reduces subsequent 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.

The questionable ethics of selling complementary and alternative medicine

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.

Are pharmacy-based genome tests credible and useful?

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 a recent Globe and Mail column:

Is it ethical to market complementary and alternative medicines?

Very excited to announce that a paper I collaborated on with Dr. Chris MacDonald has now been published in the peer-reviewed journal Bioethics, as part of a series on complementary and alternative medicine.  It’s also open access (for now):

Abstract:

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services – things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues – issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This article aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

The full paper is here.

Reference:

Macdonald, C. and Gavura, S. (2016), Alternative Medicine and the Ethics Of Commerce. Bioethics, 30: 77–84. doi: 10.1111/bioe.12226

 

 

What’s the best detox or cleanse?

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.

Should regulators treat the supplement industry like the tobacco industry?

The supplement industry fights any regulation that might limit sales or improve safety or quality. A new paper suggests that governments should look to tobacco control tactics to make this industry safer for consumers.

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 at health food stores and increasingly, taking space in pharmacies. 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?

Review of 17 “alternative” therapies finds no evidence of effectiveness

Reiki is as science-based as The Force

Health care systems around the world are being pressured to “do more and spend less”, to make healthcare more cost effective. Owing to aging populations and the growing cost of providing health services, there’s more scrutiny than ever on the value of different health treatments, with the goal of reducing the use of treatments that don’t help. The Choosing Wisely initiative was establishing expressly for this purpose. Regrettably, while well-intentioned, Choosing Wisely hasn’t had as much of an effect as you might expect. Medicine can be slow to change, as David Gorski discussed in a post over at Science-Based Medicine. Unless we ruthlessly scrutinize what we do for effectiveness, and are willing to act on what we learn, self-driven change is unlikely. One way that governments (and insurers) can dramatically reduce the use of a health service or treatment is to simply stop offering it, or paying for it. Yet stopping funding is something that is relatively uncommon in health care. It seems to be much more difficult to stop a practice, possibly owing to inertia, a reluctance to change, and the sometimes-vociferous protests that can emerge from patients or physicians that may feel that their preferred therapy is effective. The formidable challenge of stopping health care funding, once it has started, is one reason why this blog has been very critical of the expanding scope of practice being granted to alternative medicine purveyors – the legislative alchemy that is the first step towards insurance coverage. Because once that’s in place, it will be far more difficult to stop it. So it’s essential to understand the evidence.

A disturbing case of “naturopathic medicine” for whooping cough

Whooping cough does this to children. It can even kill them. And it’s preventable. Yet some prefer the disease over an effective vaccine.

Over at Science-Based Medicine you’ll find my recent post on Heather Dexter, who claims to be a “Board Certified Naturopathic Doctor” in Michigan,  and blogs at likemindedmamas.com. She recently used her blog to describe, in astonishing, horrific, gut-wrenching detail, how she let three of her children suffer for months with whooping cough without seeking proper medical attention. She’s pulled the post off her website now, but the internet never forgets, and you’ll find this case discussed over at Naturopathic Diaries, the Skeptical OB, and at Respectful Insolence as well.

In all my blogging about naturopathy I don’t think I’ve ever encountered a case that left me so upset – because Dexter’s belief in the “naturopathic philosophy” meant that three small children endured months of misery (apnea, vomiting, and turning blue),  useless remedies (homeopathy, herbal remedies, and even regular enemas) all because of a belief system that prioritizes a philosophy over scientific evidence.

Find the original post over a Science-Based Medicine.

Photo via OneSalientOversight via Reddit.

Are osteoporosis guidelines influenced by “Big Calcium” and “Big Vitamin D”?

Osteoporotic bone. Are the mainstay treatments for osteoporosis prevention, calcium and vitamin D, truly useless?

Do osteoporosis guidelines overstate the benefits of calcium and vitamin D supplements? And is their continued presence due to vested interests and conflicts of interest? That’s the provocative argument made by Andrew Grey and Marc Bolland, two endocrinologists who recently detailed their analysis in The BMJ, in a paper entitled “Web of industry, advocacy, and academia in the management of osteoporosis” [PDF]. They introduce their case by noting:

For many years, recommendations for prevention and treatment of osteoporosis have included increasing calcium intake (by diet or supplements) and use of vitamin D supplements. Since the average dietary calcium intake in most countries is much less than that recommended by guidelines, many older people are advised to take calcium supplements to prevent osteoporosis. The recommendations have been implemented successfully: over half of older Americans take calcium and vitamin D supplements, either prescribed or over the counter, and bone health is the most common specific motivation for use of nutritional supplements. However, this behaviour does not reflect evidence that has emerged since 2002 that such supplements do not reduce the risk of fracture and may result in harm. Guideline bodies also continue to recommend calcium and vitamin D supplements. Here, we argue that change is made difficult by a complex web of interactions between industry, advocacy organisations, and academia.

Osteoporosis is a medical condition for which supplements have been considered an accepted part of conventional medicine for some time. Are conflicts of interest trumping good science? And are calcium and vitamin D supplements truly useless? Like many clinical questions, there is evidence to support a range of opinions, and it’s very difficult to state, with certainty, that one position is the correct one. Despite this, that’s the case that Grey and Bolland make in their analysis.

Pine bark and ginkgo for tinnitus? A closer look at “Ear Tone”, a supplement marketed to treat tinnitus.

Ear Tone is a supplement claimed to help tinnitus. Does it work?

“Why do you bother blogging?” asked a colleague. “You take hours of your personal time to write, and you do it for free. You’re not even getting any citations for all that work.” I admit I found the questions a bit surprising. True, you won’t find these posts abstracted in PubMed. But I’m writing for an entirely different audience. I blog for the same reason that I became a pharmacist: to help people use medicines more effectively. Practicing as a pharmacist is one way to do that. In that setting, you’re helping one patient at a time. And seeing how your advice and support can enhance someone’s care is tremendously gratifying.

I see blogging as another form of pharmacy practice, hopefully with similar effects. Yes I do get regular hate mail, and the occasional legal threat, but there’s also gratitude for a post that resonated with someone, or helped them make better decisions about their health. When Google searches don’t give answers, I get questions — too many to answer. Today’s post is based on a request for help from someone seeking advice on natural supplements to treat ringing in their ears. They have tinnitus, and they’re frustrated at the limits of what their physician (and medicine) can do. They sent me an advertisement for a supplement called Ear Tone, a natural health product which is advertised (and approved) to provide tinnitus relief. Can natural supplements do what conventional medicine cannot?