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?

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?

Is there any supplement in your supplement?

Is what’s on the label actually in the capsule?

Most of us are fortunate to live in countries where we don’t have to worry about counterfeit drugs. We can be confident that the prescriptions we receive, or the drugs we purchase from the pharmacy, are of high quality and contain exactly what’s on the label. But in these same countries, there’s another group of products where the risks of counterfeits are very real – it’s among the dietary supplements that are often found on the same shelves. Dietary supplements are not regulated in the same way as drug products. The American supplement industry is a multi-billion dollar free-for-all with little meaningful safety or quality regulation. Supplement quality and safety issues are in the media regularly as a result. The most recent example comes from the New York State attorney general’s (AG) office. It has accused four large retailers of selling supplements that failed to contain labelled ingredients. Testing the products with a technology called “DNA barcoding”, the AG’s office concluded that most of the products contained little to none of the labelled ingredient. And they also found ingredients that were not disclosed on the label. The AG’s office has demanded these products be removed from store shelves, and the stores stand accused of fraud.

Naturopathy, Paternalism and Infertility Treatments

This is another post in the naturopathy versus science series, where a naturopath’s advice is assessed against the scientific literature.

It’s Naturopathic Medicine Week in the United States, so it’s time for another look at the alternative medicine practice that blogger Orac likes to call the One Quackery to Rule them All. Naturopathy is an oddity among alternative medicine, because it’s a hodgepodge of other practices linked by an underlying belief in vitalism: the pre-scientific notion that living things have a “life force”. Vitalism disappeared from medicine when Wöhler synthesized urea in 1828, yet the belief in vitalism is a central tenet of naturopathic philosophy. Naturopaths liken themselves to be primary care providers akin to family physicians (general practitioners) but their practices are quite different: rather than make decisions based on scientific evidence, naturopaths pick and choose based on what they feel is congruent with their vitalistic philosophy, sometimes despite good scientific evidence that shows they are wrong. For example, homeopathy is an alternative medicine practice that is very popular with naturopaths. It is an elaborate placebo system where “remedies” contain no medicinal ingredients: they are literally sugar pills. There is no demonstrable medical effect from homeopathy, and so it isn’t part of science-based medicine. Yet homeopathy is a “core clinical science” for naturopaths, and the practice of homeopathy is part of their licensing exam.

There’s no reason to exempt Natural Health Products from Bill C-17

From Consumer Health Products Canada:

So, when is a therapeutic product not a therapeutic product? It’s a head-scratcher. Under Vanessa’s Law, disinfectant toilet bowl cleaners and hand sanitizers will be “therapeutic products,” while some cold medicines and, potentially, even low-dose statin cholesterol-reducing drugs, will not. (Health Canada has just proposed switching red yeast rice containing up to 1mg lovastatin from prescription to NHP status.) Consumer Health Products Canada believes that arming Canadians with the tools they need to take more control over their own health is vitally important to public health and to the sustainability of our health care system. Our member companies produce and sell the vast majority of the OTCs and NHPs that Canadians use in their own self-care. We embrace the provisions of Vanessa’s Law because they are entirely consistent with the law-abiding, safety-first way our members conduct business. But, if passed with the currently proposed, lop-sided definition of “therapeutic products,” we fear that Vanessa’s Law will distort the marketplace for consumer health products and could undermine consumer confidence in the roughly 50% of our member’s products that fall under the Natural Health Products Regulations.

More here.

Take action before June 10.

Natural Does Not Equal Safe: A Call to Action

One of the most pervasive yet appealing health myths is the idea that natural equals safe. It’s a statement that’s repeated constantly by manufacturers of supplements and “natural” health products. It’s been the primary argument used, with considerable success, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. It’s effectively a buyer-beware marketplace in most parts of the world, with little accurate information available to consumers. But supplement manufacturers aren’t content with the minimal regulation that’s currently in place – they want health “freedom”. In this case, “freedom” means the right to sell any product, while being exempted from safety and regulatory requirements. New Canadian legislation is poised to raise safety standards for drugs and enhance the ability of regulators to recall dangerous products, yet consumers of natural health products are left behind. The legislation proposes to exempt anything considered a “natural health product”. This is not only bad public policy, but it has the potential to cause avoidable harm. After all, shouldn’t users of supplements and natural health products be entitled to the same safety and quality standards as those that use prescription drugs? If the supplement industry gets its way, the answer will be “no”. (There is an opportunity until June 10 for you to provide feedback on this legislation – see below.)

We’re a drug-taking, supplement-taking nation. Can we do so safely?

Do you take a vitamin or dietary supplement? It’s increasingly likely that you do, as over half of all American adults took some sort of supplement over the past 30 days. Now there’s evidence to suggest that about one-third of all Americans are taking supplements and prescription drug at the same time, which is renewing questions about risks and benefits. (I have not seen equivalent Canadian data, but I suspect the trends are very similar.) The same study reveals that combining supplements and prescription drugs is more common among those with certain medical conditions, compared to those without.

Many of us supplement in the absence of evidence of benefit, or even medical need. For example, there is little persuasive evidence to suggest that routine supplementation with products like multivitamins is necessary. There are exceptions of course: Those potentially becoming pregnant, those on dietary restrictions (e.g., vegans), and those with demonstrable medical need are among the cases where there is a clear benefit to vitamin supplementation, for example. The majority of us take supplements, like multivitamins, for “insurance” rather than because we have a deficiency or medical need. The evidence for non-vitamin supplements, like herbal products, is just as questionable as it is for vitamins, with few products showing meaningful health benefits. Ultimately decisions about supplements come down to evaluations of risk and benefits. Since I started working as a pharmacist, I’ve always cautioned consumers about the quality concerns and efficacy with herbal products and supplements, and the resultant risks that make me very hesitant to suggest their routine use – especially when they’re combined with prescription drugs. Yet the evidence suggests that it’s occurring – with increasing frequency.

Weekend Reading

Happy 2014 Everyone! It’s been a while since the last weekend reading update. Here’s some links and posts for your reading pleasure. The picture above is from the Toronto ice storm that we’re still recovering from.

The facts about alternative medicine

People have been living on earth for about 250,000 years. For the past 5,000 healers have been trying to heal the sick. For all but the past 200, they haven’t been very good at it.

– Dr. Paul Offit

Twenty years is a long time in medicine. I celebrated my 20th pharmacy class reunion last weekend. Of course reunions are time to reflect back to our early years as pharmacists. Lots has changed. Much of the therapeutics I was taught is now obsolete. In 1993, HIV was a death sentence and there were only three, largely ineffective drugs available. Thanks to new drugs, HIV can now be managed like a chronic disease, and some of my colleagues have HIV-focused pharmacy practices. The same dramatic changes have occurred in fields like cancer, and transplant medicine. And in some cases, the cause of disease has become more clear – my old textbooks make no mention of Helicobacter pylori as a cause of ulcers.

The practice of pharmacy has changed, too. On the positive side, pharmacists are working in new settings where they can focus on medication management, and not just dispensing prescriptions. Regulators are granting pharmacists the ability to take on new roles, and pharmacists are being compensated for more than simply “count, pour, lick and stick.” From that perspective, it’s a promising time to be a pharmacist. But there’s a much more disturbing side to the profession that’s emerging, too. Community (retail) pharmacy practice is under pricing and competitive pressure, and smaller pharmacies are being subsumed into big retailers where the pharmacy department is buried in the back – a loss leader to bring in patients, but hardly with a health-care focus. And most disturbingly, I see a move within retail pharmacy practice to leverage its professional credibility to sell all types of modern-day snake oil, ranging from detox kits and “cleanses” to dubious “food intolerance” testing. Homeopathic remedies (an elaborate placebo system of sugar pills) are increasingly found on pharmacy shelves, alongside real medicine. And don’t forget the enormous wall of vitamins that seems to get larger and larger. Yes, complementary and alternative medicine is booming, and pharmacy wants its share. Pharmacy regulators turn a blind eye. What do my pharmacy colleagues tell me? They’ll tell me it’s customer demand, and that they don’t recommend the quackery. To me, I see this trend as damaging the credibility of pharmacists in the eyes of the public and of other health professionals.

Is Coenzyme Q10 a supplement that really works?

Could a product sold as a dietary supplement really be delivering the benefits that advocates have claimed for decades? That’s what you might be wondering about coenzyme Q10, following recent stories like:

• The energy-boosting supplement that could HALVE the number of deaths from heart failure screamed The Daily Mail.
• It’s Official: Coenzyme Q10 Improves Heart Failure Survival from the “orthomolecular” advocates AOR.
• Could Antioxidant Supplement Cut Heart Failure Risk? asked eMaxHealth.
• First Drug to Significantly Improve Heart Failure Mortality in Over a Decade from Live Science.
• Could supplements be the key to boosting survival from heart failure? asked WebMD.

What’s caused all the excitement about CoQ10 is the Q-SYMBIO trial, more properly called “The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure”, presented at the European Society of Cardiology conference last month. I’d normally wait for the full article to come out, and will review it if possible at that time, but the results are too interesting to ignore so I’ll dive into the study and the reaction – which is equally as interesting as a lesson in why scientific skepticism is so important.