Less Médecins Sans Frontières and more Médecins Sans Medicine

Via CBC News:

Chagas disease (American trypanosomiasis) is an insidious tropical infection that begins with flu-like symptoms and can end with heart failure.

The only proven treatments are a pair of costly pharmaceutical drugs.

But a group of Canadian homeopaths say they can detect, prevent and treat the disease, and the federal government is paying to take their remedies to sick Hondurans.

Quebec-based Terre Sans Frontières (TSF) is spending $350,000 in aid money from Global Affairs Canada to dispatch more than a dozen volunteer homeopaths to Honduras over five years.

More on the ridiculousness of homeopathy here, here, and here.  Not only is this a waste of money, it’s going to harm Hondurans.

This is excellent – Britt Hermes, of Naturopathic Diaries fame, has been awarded the John Maddox Prize.

Hermes said her own professional journey had come at a personal cost and she was being sued for defamation by an American naturopath in a case due to be heard in a German court.

“I was a naturopath, until I looked at the evidence and decided to speak up about the dangerous therapies used in naturopathy, especially those to treat cancer,” she said. “Walking away cost me my friends. I am harassed and being sued for defamation. I am honoured to be recognised by the scientific community for changing my mind.”

Hermes deserves all the accolades she’s getting. As a former naturopath, she’s effectively pointed out that naturopathy is a pseuoscientific practice that is based on vitalistic thinking – and has no place in a modern, science-based health system.

Congratulations, Britt!

See the full story at The Guardian.

More here.

Britt is being sued by a naturopath who believes you can treat cancer with vitamins and baking soda. From Britt’s post:

Colleen Huber is a naturopathic cancer crusader and owner of Nature Works Best (NWB) naturopathic cancer clinic in Tempe, Arizona. She is not a medical doctor and, to the best of my knowledge, has no formal training in cancer research. Yet, Huber promotes herself as a cancer expert (here, here, and here) and is an outspoken critic of standard-of-care treatments for cancer. She wrote that “conventional treatments (chemo, radiation, etc.) sicken and weaken you and ultimately strengthen the disease.”

Huber treats cancer using alternative therapies, including intravenous injections of vitamins and baking soda. She staunchly advocates that her cancer patients should follow a strict sugar-free diet. She advertises that a sugar-free diet increases a cancer patient’s overall survival, regardless of cancer stage or type.

Naturopathy is based on the idea of vitalism, a pre-scientific belief that some type of magical “energy” is a part of all living things. The idea of vitalism was disproved by Wöhler in 1828, yet the idea remains central to naturopathic ideas about medicine. Naturopaths believe their treatments restore this “vital force”. The practice of naturopathy has evolved over time into a mix of disproven or unproven health practices that includes homeopathy, acupuncture, “detoxification” and herbalism, along with the occasional science-based belief repackaged as “alternative”. (For more information, see my series of naturopathy vs. science posts at Science-Based Medicine.)

If you support science-based medicine you’ll recognize the importance of helping Britt defend herself. See her post here. If you can’t donate, please amplify her post by sharing it widely on social media.

This year will bring a Canada Day for the history books. Only July 1, 2018, recreational marijuana (also called cannabis) will be legalized and regulated in Canada. The federal Cannabis Act creates a legal framework for producing, possessing and selling marijuana across Canada, meaning that each Canadian province will set its own rules to oversee its distribution, subject to federal government conditions. Provincial and federal governments will share in the responsibility for the oversight of this new system, and will also share in the tax revenue. Different provinces are taking different approaches, similar to how alcohol purchases vary between jurisdictions. This trend follows what we’re seeing at the state level in the United States, with different states moving to decriminalize recreational use.

Marijuana has been legal to some extent in Canada (and in many US states) for some time, in the form of “medical” marijuana. The Canadian government authorized the sale of marijuana for that purpose, while it simultaneously emphasizes that cannabis is not an approved therapeutic product. The medical market, for many, appears to simply be a means to access products for recreational, or non-medical use, and has generated wildly unsubstantiated claims about the medical merits of marijuana for conditions like autism and the treatment of cancer. Dispensaries have appeared across Canada and the US, usually with very easy referrals for prescriptions. Some dispensaries ignore any prescription requirement entirely and will sell marijuana directly to the public without any medical assessment or advice. With the introduction of government-overseen (and in some Canadian provinces, government-delivered) retail sales in Canada later this year, it’s reasonable to assume that unregulated dispensaries will eventually disappear.

With recreational sales imminent in Canada (and already here, in states like California), there are questions about the future market for “medical” marijuana. Should use for medical purposes be treated like recreational use, where consumers make their own selections, and purchases are taxed like other consumer products? Or should some forms or uses of marijuana be treated like prescription drugs, where a health professional remains involved, and products may be even be covered by insurance plans? Given the major changes we are seeing in how we can access marijuana, it’s worth summarizing the current state of evidence for marijuana when used for specific medical purposes. With marijuana becoming much more accessible, physicians, other health professionals, and their patients need high-quality information about its value for different medical conditions. David Gorski reviewed much of the evidence in a series of posts over the past three years. Now, three new documents prepared for Canadian physicians and health professionals concisely summarize the current evidence base for medical marijuana.

The pharmacy profession seemingly sees a bright future in medical marijuana, with big chains striking deals with producers and even hiring “brand managers” in anticipation of the shuttering of unregulated dispensaries and a continued demand for “medical” uses. The argument being made by the pharmacy profession seems to be that (1) marijuana is a legitimate drug for medical purposes, and should be treated as such, which includes (2) a pharmacy and pharmacist being involved in the provision. The latter we can set aside for now, and focus first on whether or not marijuana is indeed a drug that should be treated like other prescription drugs.

Before I continue, I should state my personal position on marijuana. I am fully supportive of the legalization of marijuana for recreational use and support regulation and taxation, treating it along the lines of alcohol or tobacco. I should also state that I have no “skin in the game” when it comes to marijuana in pharmacies, or medical marijuana more generally – I don’t work in retail pharmacy, and while pharmacy professional associations seem enamored with the idea of medical marijuana in pharmacies, I have no personal opinion on it, other that wanting pharmacies to be places that offer and promote science-based and medically useful products, not pseudoscience or harmful/ineffective products (see my post on the commercial and professional ethical obligations of pharmacists for more).

It’s worth mentioning as an aside that there’s a somewhat similar set of circumstances in US history, when alcohol was available only by prescription during Prohibition. This prescription (via the Smithsonian Institute) could be used by physicians to prescribe alcohol for an array of ailments:

Naturally, the prescription market for alcohol disappeared once Prohibition ended. But marijuana is not alcohol. It contains an array of potentially medically useful chemical substances, several of which have been clinically investigated for the treatment of different medical conditions.

The pharmacology of marijuana

As David Gorski has pointed out in previous posts, there are a number of biologically active chemicals in marijuana. The main psychoactive ingredients are called cannabinoids, and the primary cannabinoid produced is delta-9-tetrahydrocannabinol (Δ⁹-THC, or simply THC.). Cannabinoids are produced in the stalk, leaves, flowers, seeds and resin of marijuana plants. Marijuana can be smoked, vaporized, or eaten, among other forms of ingestion. THC is rapidly absorbed, and when inhaled, reaches the brain within minutes. (Oral absorption is lower owing to a significant reduction in available drug after passing though the liver.) These chemicals bond to cannabinoid receptors on cells throughout the body, triggering or modulating different effects. Marijuana immediately affects and impairs attention, concentration, memory, learning and motor coordination, proportional to the dose. You might wonder why our cells have receptors for THC and other cannabinoids. That’s because we (and other mammals) have an endocannabinoid system, and we naturally produce endocannabinoids. It is absolutely plausible that drugs that target endocannbinoid receptors, like THC (or derivatives), have the potential to produce beneficial medicinal effects, given the presence of receptors on nearly every organ system. With the growing understanding of the endocannabinoid system, and the identification of different types of receptors, there’s the potential for targeting specific effects on specific organs. That could mean products that produce beneficial effects and minimize any adverse effects (e.g., fewer psychoactive effects).

Cannabinoids are highly fat soluble and so are difficult for the body to eliminate – the complete elimination of a single dose may take up to one month. With repeated doses, levels can rapidly accumulate. While the liver eliminated cannabinoids, even the metabolites of THC can persist in the body, and there is little relationship between the levels of THC found in the blood and the degree of THC-induced effects. Owing to metabolism in the liver, THC has the potential to interact with other drugs. The overall impact has not been well studied. As a drug, there is lot we do not know about marijuana. However, we can be confident in observing that there is little acute toxicity of marijuana, unlike many other drugs and substances. While not addictive, there are also cases of cannabis use disorder, which while infrequent, can occur. It should be acknowledged that cannabis use disorder is a minor public health issue compared to the widespread harms and mortality caused by substances like alcohol and opioids.

The evidence check

Let’s now look at a trio of documents prepared by the Alberta College of Family Physicians. They routinely produce “Tools for Practice” which are concise, actionable answers to clinical questions. All the documents are available online, and are fully referenced, but I will summarize each document here:

Are medical cannabinoids (MC) effective for the treatment of pain?

Bottom Line: Evidence for inhaled marijuana for pain is too sparse and poor to provide good evidence-based guidance. Synthetic MC-derived products may modestly improve neuropathic pain for one in 11-14 users but perhaps not for other pain types. Additionally, longer and larger studies (better evidence) show no effect. Adverse events are plentiful.

The full document is available here.

• Chronic pain: 39% experience pain reduction of >30% versus 30% with placebo, resulting in a number needed to treat (NNT)=11. Larger and longer RCT show no effects. The mean pain improvement is 0.5 on a 0-10 scale, which isn’t clinically meaningful.
• Neuropathic pain: With inhaled MC, the NNT=6. With any MC, the NNT=14.
• Cancer pain: In six randomized controlled trials, the pain reduction was not statistically significant.
• HIV neuropathy: with smoked MC: NNT=4.
• Pain from multiple sclerosis: Mean pain improvement over placebo was 0.8 on a 1-10 scale which was borderline insignificant.
• Acute pain: One positive trial, one negative trial, and five trials showing MC is equivalent to placebo.
• When compared to medication, MC was no better than amitriptyline (with more adverse events), or worse than dihydrocodeine with similar adverse events.
• No overall differences shown in quality of life.
• Little evidence for back pain, fibromyalgia, or osteoarthritis.

What are the harms associated with medical cannabinoid therapy?

Bottom Line: Compared to placebo, medical cannabinoids cause multiple different adverse events in patients, from visual disturbance or hypotension (1 in 3-10) to hallucination or paranoia (1 in 20). Stopping due to adverse effects occurs in 1 in every 8-20 patients. Regardless of the type of medical cannabinoid used, adverse events are common and likely underestimated. Given the extensive harms, potential benefits must be impressive to warrant a trial of therapy.

The full document is available here.

• Eleven systematic review with meta-analyses of harm were identified.
• 79-92% of patients using MC experienced any adverse event versus 56-78% with placebo, giving a number needed to harm (NNH)=5-8.
• Serious adverse events measured in 3 meta-analyses, with two studies reporting no significant differences versus placebo. The third reported an odds ratio of 1.41.
• Seven meta-analyses reporting stopping MC due to adverse events, with a range of 7-14% for MC versus 1-5% for placebo, giving an estimated NNH of 8-22. One of the seven analyses showed no significant difference versus placebo.
• Side effects, overall, are very frequent: Sedation (NNH=5), feeling high (NNH=2-4) and euphoria (NNH=9). Other adverse events include visual blurring/hallucinations (NNH=3), dizziness (NNH=5), speech disorders (NNH=5), ataxia/muscle twitching (NNH=6), disconnected thought (NNH=7), dysphoria (NNH=8), hypotension (NNH=8), impaired memory (NNH=12), and disorientation (NNH=15).
• MC increased adverse effects compared to drugs like prochlorperazine, causing more sedation and dizziness.
• Adverse event rates varied little between different MC products, including synthetic cannabinoids and inhaled marijuana (NNH=4-7).

Besides pain, are medical cannabinoids effective for other conditions?

Bottom Line: For most conditions (example anxiety), cannabinoid evidence is sparse (at best), low quality and non-convincing. Dronabinol/nabilone improve control of nausea/vomiting post chemotherapy for 1 in 3 users over placebo. Nabiximols likely improve multiple sclerosis spasticity ≥30% for ~1 in 10 users over placebo. Patients’ preference for cannabinoids exceeds cannabinoids effectiveness.

The full document is available here.

• Two comprehensive systematic review suggest reasonable evidence for nausea and vomiting due to chemotherapy (NNT=3) and for spasticity (NNT=7).
• Evidence is sparse but suggestive for potential for children with Dravet epilepsy.
• Evaluations show that patient preference exceeds effectiveness measures.
• In other conditions, high level evidence is sparse, low quality, or negative, for conditions such as glaucoma, anxiety, or other causes of nausea and vomiting.
• Blinding in trials was noted to be difficult, with 85-95% of patients and clinicians identifying who receiving MC.

Developing an evidence base for marijuana

Studying marijuana under rigorous circumstances has been difficult until fairly recently. The plant itself isn’t patented, so even ignoring the legal access issues, there may be a lack of industry enthusiasm in conducting clinical trials. The other issue is the challenge of a proper placebo control, particularly for non-oral forms of use. Given the psychoactive effects and the widely heralded effects on conditions that can only be assessed subjectively, like nausea, fatigue or appetite, a proper placebo is essential to separate out actual from placebo effects. While some commercial products have been developed and marketed with standardized ingredients and quality control (e.g., nabilone), these products are exceptions. However, these purified and standardized products have allowed for proper placebo controls and more rigorous assessments of effectiveness. Regrettably, these products haven’t been shown to be that effective which may suggest that the perceived beneficial effects may be largely placebo effects. Hopefully, clinical trials will become more common and more marijuana-based drugs can be more rigorously evaluated.

Evidence is lacking

The use of psychoactive drugs like marijuana is a health issue, particularly when used for medical purposes. Regrettably, there is a lack of high-quality data that shows marijuana for most medical purposes is both safe and effective. What little evidence exists is of poor quality and may not even be representative of the purposes for which medical marijuana is sought. There are significant gaps in information necessary to treat marijuana like other forms of medicine: Dosage standardization and overall quality control may not be in place. Overall effectiveness, contraindications, drug interactions, adverse events and long-terms risks when marijuana is used as medicine are not well understood. The best evidence suggests that marijuana may be a reasonable treatment option only when safer, more effective, and better tolerated treatment options have been tried first. If marijuana is to be treated as medicine, then it needs to meet the same standards of quality, effectiveness, and safety we would expect of any other prescription drug. That standard has not yet been met.

Images from flickr users Chuck Coker used under a CC licence.

From The Guardian:

Nearly one third of pharmacists are recommending complementary and alternative medicines with little-to-no evidence for their efficacy, including useless homeopathic products and potentially harmful herbal products.

The finding comes from a Choice survey of 240 pharmacies including Priceline, Chemist Warehouse and Terry White. Mystery shoppers were sent in to speak to a pharmacist at the prescription dispensing counter and ask for advice about feeling stressed.

Three per cent of the pharmacists recommended homeopathic products, despite a comprehensive review of all existing studies on homeopathy finding that there is no evidence they work in treating any condition.

Twenty-six percent recommended Bach flower remedies to shoppers, homeopathic solutions of alcohol and water containing diluted flower essences. The solution was invened by a British homeopath, Edward Bach, who claimed to have a psychic connection to plants. A comprehensive review of all existing studies on Bach flower solutions found no difference between the remedies and placebos.

The Choice survey also found products containing a B group vitamin complex were recommended by pharmacists for stress in 46% of cases. Other frequently recommended products were St John’s wort and valerian. There is no good evidence that these products reduce stress.

A more detailed summary, from CHOICE, is here.

Unsubstantiated claims for natural health products could be a thing of the past in Canada.

I suppose I owe Health Canada some thanks. It was Health Canada’s lackadaisical  regulation of dietary supplements and natural health products that turned me from a “shruggie” pharmacist into one that started advocating, publicly, for putting consumers’ interests ahead of those of supplement manufacturers. While health regulations are seemingly created to protect consumers, Health Canada has  consistently given manufacturers the upper hand, prioritizing a company’s desire to sell a product over a consumer’s right to a properly regulated marketplace with safe, effective products. It’s now very clear that the Natural Health Products Regulations 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. Canadian drug store shelves in 2016 are packed with hundreds of products with unsubstantiated claims and untested products, and little credible information to guide selection.  Yet all of these products have been reviewed and deemed to be “safe and effective” by Health Canada.

I’ve been criticized numerous times for my position on dietary supplements and natural health products, but many critics misunderstand my perspective. Since my earliest post, my position has been the same: Canada needs more appropriate regulations: ones that put consumers first, not manufacturers, and evaluates all products (drugs, supplements or otherwise) to a consistent standard of science and evidence. I’m very pleased to report that Health Canada is proposing a move in that direction. They have 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,

Currently, natural health products are regulated in a manner similar to drugs – manufacturers must apply to Health Canada for a licence to sell and products are assigned a unique number that must appear on product labels to signal the department’s approval. But unlike drugs makers, natural health product manufacturers are not required to provide robust evidence that a product works before it’s allowed on the market.

Under the proposed new system Health Canada would bring natural health products, over-the-counter drugs and cosmetics under one set of rules and regulate them based on the potential health risks they pose.

The new regime would classify many vitamin, mineral and homeopathic products and cosmetics as “low risk,” meaning they would not be licensed by Health Canada. Manufacturers would still have to meet Health Canada’s quality standards, but they would be prohibited from making disease treatment or prevention claims on product labels. Any other claims on product labels would have to be accompanied by a disclaimer stating the information has not been verified by Health Canada.

Products deemed “moderate” or “higher” risk – such as over-the-counter painkillers, allergy medications and products that contain new medicinal ingredients – would be reviewed by Health Canada and could only make health claims if enough scientific evidence is presented to prove the statements.

Treating products according to their risk, rather than their source, has the potential to be far more sensible from a scientific perspective than the status quo we see in Canada and around the world.

Why Canada Lowered the Evidence Bar

Not too long ago, there was no such thing as a “natural health product” in Canada. Products were either drugs, and were registered as such, or they were food products, and drug regulatory requirements did not apply. A grey area existed and and all kinds of supplements appeared – with no specific regulatory oversight, no defined quality or content standards, and no objective evaluation of the efficacy claims. In 2004, the Natural Health Product Regulations (NHPR) became a reality. They grouped together a disparate group of products: nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy. Rather than fully regulating these products as drugs, or leaving them unregulated, the NHPR were a regulatory compromise. They introduced manufacturing quality, safety, labelling, importation, and distribution standards, while dramatically relaxing the standards for product efficacy claims. For example Health Canada’s Evidence for Homeopathic Medicines: Guidance Document (yes, it’s an actual document) states that applications for licenses for homeopathic products must include “evidence” to support the “safety, efficacy, and quality” of a homeopathic medication. Health Canada realized that given there’s no credible evidence to support homeopathy, it had to lower the evidence bar. So to Health Canada, anecdotes became evidence. Homeopathic manufacturers can use materia medica, which are essentially compilations of anecdotal information, to satisfy this requirement. Health Canada offers a list of 59 references it will accept, including texts that date back to 1834, which was three decades before germ theory was proposed. This is acceptable “evidence” today to earn Health Canada’s seal of approval.

Is there anything Health Canada won’t approve?

Health Canada’s absurdly low evidence standard was elegantly demonstrated by the television show CBC Marketplace in 2015. Having having previously described how homeopathic remedies lack any medicine at all, they went one further, and decided to test Health Canada’s own licensing process. They applied for approval to market a homeopathic remedy they named “Nighton” (an anagram of “nothing”) to be used to treat fever and pain in infants and children. For evidence, they submitted a few pages photocopied from an old homeopathy textbook. No trials were conducted and no safety data was provided. Just some forms, a few photocopies and a fee. Without any questions, their product was approved and licensed as a “natural health product”, and for a time, was listed in the national database of health products Health Canada declared were “safe, effective, and of high quality.”

Industry wins, and consumers lose

After being embarrassed by the CBC, Health Canada finally acted. It announced new rules for homeopathic remedies marketed as cough, cold and influenza remedies (but ignoring the thousands of other homeopathic products had approved.) It prohibited any products for children 12 and under, unless those claims are supported by scientific evidence. That’s a significant change, and essentially created an impossible bar for homeopathy manufacturers.

Health Canada took action again when it was demonstrated (again by CBC Marketplace) that Canadian homeopaths were selling homeopathic “nosodes” as vaccine substitutes. A “nosode” is a remedy that starts with infectious material, like polio, measles or smallpox, and then it’s diluted sequentially until mathematically, there’s nothing left but water. Health Canada had approved 82 of these “nosodes” for sale over the years, and naturopaths and homeopaths were selling them as vaccine substitutes that were claimed to be “Health Canada approved”, which was technically true – but approval as a “natural health product” means completely different standards than actual medicine. It should be self-evident that fake vaccines are a public health problem. Canadian advocacy group Bad Science Watch launched a public campaign against nosodes, and succeeded in getting Health Canada’s agreement to force commercial manufacturers to place a label on their products stating “This product is not intended to be an alternative to vaccination.”

Putting warning labels on approved products to tell consumers that they really don’t actually work is a clumsy and possibly dangerous approach to regulation, and sidesteps the real issue: shaping a marketplace where consumers have good information to make their own self-care decisions. The picture below is from a retail pharmacy near me, where you can see homeopathic remedies shelved alongside real drug products for treating colds. All are approved for sale, but they are held to widely different regulatory standards – something that few consumers (and possibly even health professionals) understand:

Can you tell which products are sugar pills without any evidence of effectiveness?

Why the change?

In the explanatory document about the consultation, Health Canada explains the current problem frankly and accurately:

When shopping for a self-care product, you will often see various options grouped together on store shelves based on the condition for which they are intended to be used. For example, a wide variety of products for skin care may be grouped together or a number of different products for headache relief may sit next to each other on the shelf. Many of the products you see might make the same or similar claims about what they do and they may have packaging that all looks alike. These similarities may lead a consumer to believe that these products are equally effective and have had to follow the same rules and oversight to be allowed to be sold, but this may not be the case.

Based on definitions in legislation and regulations, Health Canada considers self-care products to be made up of three different product types:

• Cosmetics, which are used for cleaning, improving or altering the complexion, skin, hair or teeth, such as moisturizing creams, deodorants, and shampoos;
• Natural health products, which include vitamin and mineral supplements, probiotics, herbal preparations, homeopathic remedies, and traditional medicines (such as traditional Chinese medicines); and
• Non-prescription drugs, also commonly referred to as “over-the-counter drugs” which include products for pain relief, cold and flu symptoms, and allergy relief.

Health Canada has different ways of overseeing the safety, efficacy, and quality of cosmetics, natural health products, and non-prescription drugs. By safety, we mean that the product will not be harmful or toxic when you use it according to the directions and warnings on the label. Efficacy refers to what the product is meant to do and is usually represented by a claim, e.g., “relieves headache”. A health claim is a description on the product about what it does in relation to someone’s health. Finally, quality means that the product is manufactured under controlled conditions and will be made properly.

And in this section, Health Canada finally acknowledges that homeopathy is magical thinking:

The level of evidence required for similar claims varies. Generally speaking, non-prescription drug claims require supporting scientific evidence. For natural health products, however, a wider range of supporting information is accepted for claims, ranging from scientific evidence to encyclopedias of health and wellness philosophies based on premises other than science. Health Canada’s practice of accepting other non-scientific information to support claims for natural health products is based on an attempt to recognize that these products are not the same as conventional drugs, and often have a basis in philosophies that support the general health benefits of some ingredients through means other than scientific standards. Some products, like traditional Chinese medicines, are based on thousands of years of use. Homeopathic products (also a type of natural health product) are grounded in homeopathy, a system that is not supported by science.

What this means for consumers is that a non-prescription drug and a homeopathic product could be making a similar claim (such as “relieves cough”) but only the claim on the non-prescription drug would be supported by scientific evidence. In our current system, this difference may not be clear to the consumer because there is no signal on the product label, so these products could appear to consumers as if they are equally effective.

This is exactly the situation we are in today. Products need proper labelling to ensure that consumers have the information they need to make evidence-informed health decisions. When consumers buy homeopathy thinking that they’re buying medicine, they’re wasting time and money, and may be putting their own health at risk.

What Health Canada wants to hear

There are three main proposals in this consultation:

Products of similar risk profiles would be treated in a similar manner: This ensure rules for bringing products to market are more consistent and easier to understand

The Department would review health claims based on a new definition. Companies would require scientific proof to support these health claims.

A risk-based approach to compliance and safety monitoring will continue. This allows Health Canada to take quick action to protect consumers

I really like the wording in this section of the consultation summary, and I wonder if someone’s been reading this blog in Ottawa:

Health Canada, as a science-based regulator, wants to make sure that Canadians can trust that a standard has been met when we authorize a claim. We want to support consumers in making informed choices in selecting and using self-care products by providing them with the necessary information to do so. This means a proposal that redefines what is currently considered a health claim and requiring scientific evidence to support these health claims. Under this proposal, only those claims that pertain to diagnosis, treatment, prevention, cure, or mitigation of a disease or serious health condition will be reviewed by Health Canada.

What this means is that non-medicine, like homeopathy, would no longer be reviewed and approved by Health Canada. And the manufacturer wouldn’t be permitted to make efficacy or treatment claims, as a result. Any claims would have to be supported by evidence, and held to the same standards as drug products. What Health Canada seems to prefer are more similar to the structure/function claims that you see in the United States. Examples of wording they would find acceptable would include:

• Improves the look of acne scars
• Moisturizes and nourishes the skin
• Cleans teeth
• Product A is 50% more effective than Product B
• “Number one choice of dentists”
• Source of omega-3
• Generally supports health maintenance
• Helps metabolize fat
• Maintains healthy bones
• Source of vitamin C

It’s this particular part of the proposal that I have the most problem with. Many of these statements are meaningless to consumers and health professionals alike. “Source of vitamin C” or “moisturizes the skin” is fair, but what does it mean that a product supports “health maintenance”? And how could a regulator approve a relative effectiveness claim, unless there’s actual evidence of efficacy to begin with? These types of claims need strict limits, otherwise Canada risks creating an American-style supplement market, where anything still goes.

The supplement industry hates the proposal: A good sign?

The supplement industry in Canada, represented by the Canadian Health Food Association, has launched a “NHPs are not drugs!” campaign. They’re ignoring the fact that this move is about labelling and information, not access, and they’re fighting to keep the lowered bar for efficacy claims. They’re intent on keeping the marketplace healthy – for manufacturers:

Our current pre-market approval system respects traditional values from many different cultures and allows Canadians freedom of choice and access to these important products. Changing the current NHP Regulations is trying to fix a system that is not broken. Natural health products shouldn’t be regulated like drugs. Natural health products are different in nature from drugs and must be treated differently.

They’re asking supporters to send the following letter to their Member of Parliament. Fill out your address and this letter will be auto-generated:

Dear XXXX:

As a constituent in your riding I was shocked to learn of a proposal from bureaucrats at Health Canada to take away consumer choice in natural health products. Our natural health products are just that – natural! They are not drugs and shouldn’t be regulated the same way as drugs.

Natural health products are safe and effective, and the current regulatory framework protects consumers and consumer choice. The proposal by bureaucrats throws out a world-class Canadian system brought in by Liberal Health Minister Allan Rock with all party support and a full year of parliamentary committee study.

As someone from your community, I am asking that you oppose this proposal and make my views known to the Minister of Health.

Add your own perspective to the consultation

Health Canada is accepting comments until October 24, 2016. You can complete a short survey here, and you don’t have to be Canadian. The supplement industry can be expected to lobby hard to keep the status quo. I’m encouraged by the direction Health Canada is signalling here. The proposed approach isn’t perfect, but will go a long way to clearing the confusion the current regulations have created for consumers. If you care about science-based medicine, and pharmacy, take a few minutes and complete the survey today.

Comments are open here.

Natural remedies are popular. But are they an appropriate substitute for medication?

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.

Given I want to ensure patients are making informed health decisions based on good scientific evidence, I was eager to read a post that naturopath Reuben Dinsmore recently posted on the website of the British Columbia Naturopaths Association (BCNA). Entitled “The Top Five Medications You Shouldn’t Take Without Trying a Natural Alternative First,” Dinsmore states that supplements can offer all the benefits yet none of the side effects of prescription drugs:

Natural supplements, or nutraceuticals, have been given a bad rap lately—which, in some cases, has been absolutely warranted. But natural formulas that actually contain what they claim on the label, and that are formulated to have maximal efficacy, can be equal to their pharmaceutical counterparts. Better yet, they can be just as effective without the laundry list of side effects.

I approached the article with curiosity. Are supplements an appropriate therapy before medication? I have no bias against supplements, but I do have a bias against unsubstantiated claims. I want to know what works, supplement, drug or otherwise. I looked at each recommendation as if it was given to me by a patient in the pharmacy, and evaluate it against the scientific evidence.

Understanding the naturopathic approach

I’ve written multiple posts in the past about treatment claims by naturopaths, and how they stack up against the scientific evidence. Naturopaths offer an array of unconventional health practices like homeopathy, acupuncture and herbalism that are linked philosophically by a belief in vitalism – the prescientific idea we have a “life force”. From this philosophy can sometimes emerge sensible health advice, but it can also be illogical and even potentially harmful. In past posts I’ve looked at the naturopathic perspectives on fake diseases, infertility, autism, prenatal vitamins, vaccinations, allergies, and even scientific facts themselves. As long as a treatment is viewed as being congruent with the naturopathic belief system, it’s acceptably “naturopathic” – no matter what the scientific evidence says. Despite this obvious disconnect from science-based medicine, naturopaths present themselves as primary care providers, just like medical doctors. The BCNA’s own marketing campaign describes naturopaths as “medically trained”:

Britt Hermes is a former naturopath and has written extensively about naturopathy, and her perspective is clear: There are no naturopathic standards of care and naturopathic training is very different than what naturopaths claim. She argues is that naturopathy has too much quackery and that what actually makes naturopathy unique is its embrace of pseudoscience.

So let’s examine the five categories of drugs that Dinsmore says have equally effective natural remedies. He lists statins, antacids, SSRIs (selective serotonin reuptake inhibitors), antihypertensives, and benzodiazepines.

Statins for high cholesterol

Why do we treat it?

High cholesterol has no symptoms. We treat high cholesterol to lower the risk of heart disease: heart attacks, strokes, and death. One’s risk of heart disease goes up with the LDL cholesterol level, along with the total number of heart disease risk factors.

When is drug treatment appropriate?

High cholesterol doesn’t mean that drug treatment is mandatory. An assessment will include age, family history, and other health conditions such as diabetes, heart disease, or a prior heart attack or stroke. Lifestyle changes are important: A healthy diet, an appropriate weight, regular physical exercise, and quitting smoking can also reduce your risk of heart disease. In those at low risk, drug therapy many not be necessary. “Statins” are a class of drugs that reduce LDL cholesterol. In those with a prior heart attack or stroke, the benefits of treatment with drugs like statins are well documented.

What benefits have drugs been shown to offer?

There’s two general uses for statin therapy: primary prevention (avoiding a first heart attack or stroke), and secondary prevention (using a statin in someone that has already had a heart attack or stroke) to reduce the risk of another cardiovascular event. There is good evidence that statins reduce the risk of heart attacks and strokes, when used for both primary and secondary prevention. Much of the debate on the usefulness of statins has focused on the net benefit when used in lower-risk groups. This is a fair question, and one that I’ve discussed at length previously. But what is not in question is that statins have been proven to reduce the risk of heart attacks, stroke, and death.

What does naturopathy suggest?

As per Dinsmore:

High cholesterol is blamed for heart attacks and strokes via formation of arterial plaques. But the real culprit is inflammation, without which the plaques wouldn’t form in the first place. Bottom line: You can lower cholesterol all you want, but as long as there is inflammation present, plaques can still form.

Some common side effects of statins include muscle pain, cognitive impairment, sexual dysfunction, and increased risk of cancer and diabetes.

Nutraceuticals are an alternative to statins. These include: Omega-3 fatty acids (best sourced from wild-caught fish oils) and curcumin (the active component in turmeric). Both are excellent supplements to lower inflammation. Garlic extracts have been proven to improve cholesterol levels as well. Another option I discuss with patients is red rice yeast extract, which is the natural compound statins were derived from in the first place, and works in a similar manner. This product may have side effects; I find that it can be beneficial for some patients, but not all, something I deal with on a patient by patient basis.

What evidence supports the use of naturopathic treatments?

The reason we use drug therapy to treat high cholesterol is to lower the risk of heart attacks, stroke, and death. Consequently, that’s the benefit we want to see when we consider taking any treatment – naturopathic or drug. Statins are proven effective, so that’s the effectiveness we should be looking for if we’re going to use supplements as an alternative. There is no published evidence to demonstrate that garlic extracts or curcurmin supplements can prevent heart attacks and stroke, or reduce the risk of death. The data are a bit more encouraging with omega-3 fatty acids (which, incidentally, exist as both a drug and a supplement with different regulatory standards for each), but whether or not these products actually produce a real survival advantage is not clear. There is a Cochrane review on dietary modifications for the treatment of high cholesterol, in which the authors conclude:

No conclusions can be made about the effectiveness of a cholesterol-lowering diet, or any of the other dietary interventions suggested for familial hypercholesterolaemia, for the primary outcomes: evidence and incidence of ischaemic heart disease, number of deaths and age at death, due to the lack of data on these. Large, parallel, randomised controlled trials are needed to investigate the effectiveness of a cholesterol-lowering diet and the addition of omega-3 fatty acids, plant sterols or stanols, soya protein, dietary fibers to a cholesterol-lowering diet.

Red rice yeast extract is effectively a natural but crude source of the statin drug lovastatin (the active molecules are identical). There are questions about its safety that are exclusive to red yeast rice, but not present with prescription drugs. Why red rice yeast extract would be preferred over a drug product is unclear, unless one puts a priority on something “natural” over something that’s standardized, predictable, and demonstrated to be effective.

What approach has the best evidence?

Statins provide proven benefits, reducing heart attacks, strokes, and the risk of death. Even if a supplement reduces cholesterol levels, real benefits haven’t been established. There’s no obvious reason to use supplements for high cholesterol.

“Antacids” (anti-ulcer medications for gastro-esophageal reflux)

Why do we treat it?

The reflux of stomach contents, often called “heartburn” requires medical attention when there is damage to the esophagus, or there are unpleasant symptoms. The objective of treatment is to repair any tissue damage and/or to reduce the symptoms of heartburn.

When is drug treatment appropriate?

So called “lifestyle” modifications are usually recommended first, and they aren’t always effective. Weight loss (if appropriate) can provide relief, as can elevating the head of the bed for those with heartburn at night. Minimizing specific foods or “triggers” is usually not necessary, but some find this approach helpful. Drug treatment with medications like proton pump inhibitors (PPIs), which suppress stomach acid production, are usually appropriate when symptoms are severe, or where there’s esophageal damage.

What benefits have drugs been shown to offer?

PPIs are among the most effective drugs to treat heartburn and heal esophagitis. PPIs are well tolerated over the short term. When acid production is suppressed for long-term periods (months to years), there are concerns this may predispose people to infections and malabsorption conditions. Whether or not PPIs raise the risk of osteoporosis or hip fractures isn’t clear. Many people find these medications highly effective, but some stay on therapy far longer than necessary. Current guidance suggests the lowest dose should be used for the shortest duration possible to minimize these risks.

What does naturopathy suggest?

As per Dinsmore:

It’s said that five million Canadians suffer from heartburn symptoms weekly. Prescriptions for the acid-blocking drugs PPIs (proton pump inhibitors) accounted for $24 million in BC alone in 2013. Risks of taking these mostly involve nutrient deficiencies from poor absorption DUE TO LOW STOMACH ACID (see the problem here?). Examples include bone fractures from poor calcium absorption or anemia from decreased levels of vitamin B12 or iron. B12 deficiency can also cause dementia and neurological damage. There has also been a correlation shown between PPI use and C. difficile infection, which causes life-threatening diarrhea.

Nutraceuticals: Long story short, most people don’t have too much stomach acid. The problem is the acid they have is getting into the wrong place (the lower esophagus) where it burns. This can be from the muscle between the esophagus and the stomach not closing properly, either from poor tone or insufficient stomach acid, which is the signal for the sphincter to close. Limonene (an extract from citrus peel) helps strengthen this muscle and promotes movement of food downward to the stomach. DGL (an extract from licorice root) stimulates mucus production in the stomach, which acts to coat and protect the sensitive lining of the esophagus.

What evidence supports the use of naturopathic treatments?

Limonene is an ingredient in citrus oils, and is considered “possibly safe” as a supplement by the Natural Medicines database. I could locate no published evidence in PubMed it has been studied for heartburn or GERD. I did find a reference to clinical trials in Alternative Medicine Review, but there’s not a lot of information to review: one trial had 19 adults and had no control group. The other had just 13 participants but was randomized and blinded, noting improvements in heartburn symptoms with limonene. There’s not much safety information on limonene, and it appears to have multiple interactions with drugs. How limonene might work isn’t clear. Long-term effects haven’t been reported.

Deglycyrrhizinated licorice (DGL) is licorice processed to remove the glycyrrhizic acid, which can cause steroid-like side effects when consumed in excess. Short term use of licorice as a supplement is considered “possibly safe” and long-term use is considered “possibly unsafe”. Some branded supplements combining licorice with other herbal ingredients have been studied for the treatment of acid reflux, stomach pain and cramping. How DGL might work isn’t clear. There’s a lack of evidence to suggest DGL is effective.

What approach has the best evidence?

There’s good evidence to show PPIs work, and they work quickly. There are some concerns when used for long-term purposes. The effectiveness of the remedies suggested by Dinsmore is unclear, as is their long-term safety. Given the lack of good evidence showing they work, I wouldn’t recommend the products, but if someone wanted to try them for mild heartburn, they appear to be low risk when used for short-term use.

SSRIs (selective serotonin reuptake inhibitors) for depression

Why do we treat it?

Depression is the most common psychiatric disorder and a major public health issue. It is associated with functional disability and greater risk of death. It frequently recurs.

When is drug treatment appropriate?

We treat depression to put symptoms into remission and to restore baseline (pre-depression) levels of function. The usual initial treatment of depression can include drug therapy or psychotherapy. Psychotherapy alone appears to be just as effective as drug therapy alone. There’s some evidence the combination may be more effective than either approach alone.

What benefits have drugs been shown to offer?

Antidepressants can help with depression, but the magnitude of that benefit has been questioned. The overall advantage of antidepressants over placebo can be modest for mild-to-moderate depression. Selective publication of trials may have led to an overestimate of the efficacy of antidepressants. SSRI’s or selective serotonin reuptake inhibitors are a popular class of antidepressant medications. No particular SSRI is dramatically and consistently superior to any other antidepressant drug in terms of effectiveness, but the side effects can vary. In severe cases of depression, drug therapy is combined with psychotherapy.

What does naturopathy suggest?

As per Dinsmore:

SSRIs (selective serotonin reuptake inhibitors) are the most common class of anti-depressant drugs. One in twelve Canadians will experience major depression in their lifetime, but it’s still one of the most misunderstood conditions. Standard treatment protocols typically target neurotransmitter activity (most commonly serotonin). However, new research indicates the underlying cause may actually be inflammation. Either way, natural medicine has you covered.

Some nutraceuticals to consider are 5-HTP, which is used to make serotonin, with the help of vitamin B6. The herb St. John’s Wort has been studied extensively and appears to work in the same way as SSRIs. Both 5-HTP and St. John’s wort have shown similar efficacy to SSRIs when given for mild to moderate depression. And as I mentioned earlier, omega-3 fatty acids and curcumin decrease inflammation throughout the body, including the brain.

Side effects of SSRIs include sexual dysfunction, weight gain, and worsened/chronic depression. St. John’s wort also has a side effect which should be considered if taking other medications—it impacts liver function, which can result in either higher or lower blood medication levels.

What evidence supports the use of naturopathic treatments?

5-HTP is considered “possibly effective” for the treatment of depression by the Natural Medicines database. It notes:

Overall, despite the preliminary beneficial effects shown in clinical research, the trials to date are generally small and have methodological problems or a lack of generalizability to mixed populations of depressed people. More higher-quality studies in larger patient populations are needed to confirm these result.

St. John’s Wort is considered to be “likely effective” for the treatment of depression by the Natural Medicines database. It’s an interesting natural product that is used widely for antidepressant effects. Trials have many limitations, but the data suggest that SJW may be as effective as SSRIs, but the evidence is less consistent. However, it’s not recommended in most treatment guidelines for many of the reasons discussed before at this blog: preparations of the product are often not standardized, supplement manufacturing quality is not clear, and the dosing may consequently not be predictable. Moreover, St. John’s Wort causes a wide array of drug interactions with other medications, making it difficult to use safely.

What approach has the best evidence?

Overall, there’s better evidence with the SSRIs compared to 5-HTP and St. John’s Wort. However, a decision to use St. John’s Wort is effectively a decision to use medicine, so unsupervised, unmonitored use, when treating depression, should be avoided.

Anti-hypertensives for the treatment of high blood pressure

Why do we treat it?

Untreated high blood pressure, or hypertension, can increase your risk of heart attack, stroke, heart failure, and kidney disease. We treat hypertension to reduce these risks.

When is drug treatment appropriate?

Non-drug treatments are usually considered before drug therapy, and can reduce the need for medication. Weight reduction (when necessary), quitting smoking, avoiding excessive alcohol, a healthy, reduced-salt diet, and regular exercise are all low-risk strategies that can be beneficial. Drug therapy can have side effects. People are usually unwilling to tolerate side effects for a symptomless condition, unless there is a good reason to take medication. There is good evidence that drug therapy provides real benefits to those with hypertension that can’t be controlled by lifestyle changes.

What benefits have drugs been shown to offer?

When drug treatment is considered appropriate (usually when blood pressure exceeds 140/90), there are multiple treatment options that may be appropriate. From Up-to-Date:

In large-scale randomized trials, antihypertensive therapy produces a nearly 50 percent relative risk reduction in the incidence of heart failure, a 30 to 40 percent relative risk reduction in stroke, and a 20 to 25 percent relative risk reduction in myocardial infarction.

The absolute benefit is less impressive, but still real: There’s an approximate 2% reduction in heart attacks and strokes. The benefits of medical treatment are not as clear in those with mild hypertension, those with few risk factors, or the frail elderly.

What does naturopathy suggest?

As per Dinsmore:

Hypertension (i.e., high blood pressure) affects 6 million Canadians, and is responsible for approximately 13 per cent of all deaths. Various classes of anti-hypertensives include diuretics, ACE inhibitors, angiotensin II receptor blockers (ARBs). Diuretics increase urine output, which can negatively affect sodium and potassium levels, which can cause muscle cramps. ACEIs and ARBs may both cause a chronic dry cough. All anti-hypertensives can cause dizziness, headache and low blood pressure.

Again, there are many nutraceutical options for patients to consider, such as CoQ10, magnesium, garlic extracts, omega-3 fatty acids, L-arginine and vitamin C. All of these have all been shown to lower high blood pressure by various means. Dandelion leaf is an effective diuretic that doesn’t lower potassium levels.

What evidence supports the use of naturopathic treatments?

I could find no published evidence that coenzyme-q10, magnesium, garlic, omega-3 fatty acids, l-arginine, or vitamin C supplements reduce the risk of heart attacks, stroke, heart failure, or kidney disease. There is some evidence to show that eating fatty fish (a source of omega-3 fatty acids) can reduce the risk of heart disease or stroke. Omega-3 supplements (also discussed above for hypercholesterolemia) may modestly reduce blood pressure. None of the products listed are considered both safe and effective for treatment of hypertension by the Natural Medicines database. I could find no published evidence that demonstrates dandelion leaf is an effective hypertension treatment.

What approach has the best evidence?

The only reason to treat hypertension with a drug or supplement is to reduce the risk of a future catastrophic event. If medicine is necessary, there’s little reason to choose a “natural” remedy first, as the real-world benefits of supplements have not been proven.

Benzodiazepines for anxiety and insomnia

Why do we treat it?

The term “anxiety” describes worries and fears that are difficult to control and can cause debilitating effects. Insomnia describes difficulty falling asleep or staying asleep. We treat both to reduce the consequences of these conditions, and to restore normal functioning.

When is drug treatment appropriate?

After a workup for underlying causes of anxiety or insomnia, drug therapy might be considered after options like lifestyle changes and cognitive behavioral therapy have been attempted. Benzodiazepines are a class of drugs that can be useful treatments for anxiety and insomnia, though they are usually not the first choice for either condition. There are justified concerns about dependence and tolerance with benzodiazepines, reinforcing the importance of using these medications cautiously and when the benefits are expected to outweigh the risks.

What benefits have drugs been shown to offer?

Benzodiazepines can work quickly and can be effective in anxiety where there’s a poor response to other medications. They are also effective insomnia treatments, with some taking effect within minutes.

What does naturopathy suggest?

As per Dinsmore:

Benzodiazepines are a class of drugs most often prescribed for anxiety disorders and insomnia. They work by binding to receptors for GABA, a neurotransmitter in the brain that calms activity of the nervous system. Interestingly, this is the same mechanism by which alcohol acts in the brain. One obvious effect of benzodiazepines is sedation—great when the treatment target is insomnia. Not so great when you just want to decrease your anxiety but still function. Other side effects include dizziness, loss of balance, and even cognitive impairment at higher doses. They also have a significant risk of developing physical or psychological dependence and rebound anxiety when discontinued.

This is an area where you should have a thorough workup with your naturopathic doctor and consider the options that are right for you. You can take GABA as an alternative (but there’s mixed evidence on whether or not it actually gets into the brain), or herbs such as passionflower (which has the same mechanism of action as benzodiazepines). Other herbs include valerian, chamomile, kava, and many others.

What evidence supports the use of naturopathic treatments?

Up-to-Date has a nice summary:

A variety of herbal products are purported to be useful for insomnia. There is little evidence from randomized controlled trials about the efficacy of many herbals, however, and for those that have been well studied (eg, valerian), there is little evidence of benefit. A meta-analysis that included 14 randomized trials in over 1600 patients found no significant difference between any herbal medicine and placebo on any of 13 clinical efficacy measures of insomnia [94]. The majority of the trials (11 out of 14) studied valerian; chamomile, kava, and wuling were studied in one trial each. Unlike the other herbals studied, valerian was associated with a greater number of adverse events per person compared with placebo. Valerian may also produce hepatotoxic effects [1]. Contamination with undesirable substances poses a problem for many such natural remedies.

And for natural treatments of anxiety, Up-to-Date notes:

None of the herbal remedies described here been shown in clinical trials to be clearly effective or ineffective for anxiety symptoms or disorders. Trials suggest that kava and chamomile may reduce anxiety in some people with generalized anxiety disorder (GAD). Findings from trials of valerian, passion flower, and St. John’s wort are either mixed or negative. Patients may wrongly equate “herbal” with terms such as “good,” “weak,” or “healthy” in evaluating these remedies. These perspectives underestimate their potential risks; some herbs can be potent, poisonous, or addictive. Potentially serious adverse effects of herbal remedies discussed here include hepatotoxicity with kava and anticoagulation with chamomile. It is not known if these remedies are safe or unsafe during pregnancy.

What approach has the best evidence?

It’s understandable to want to avoid benzodiazepines, but they can provide real and demonstrated benefit in select circumstances with close monitoring from a physician. There’s a lack of evidence to demonstrate the efficacy and safety of any of the herbal remedies recommended for the treatment of anxiety or insomnia.

Conclusion: The evidence simply doesn’t support these natural treatments

Naturopaths claim that they can effectively manage medical conditions with “natural” approaches, but the evidence supporting these recommendations has been consistently shown to be absent or weak. It may be that the treatment goals are not understood, which may explain why therapies without any demonstrated benefit are being recommended before proven therapies. In some cases, avoiding drug therapy and using natural remedies may be harmful. In light of the recommendations above, it seems prudent to discuss any naturopathic advice with a health professional like a pharmacist or physician before making any decision to delay medically-recommended drug therapy, or substitute a natural remedy or dietary supplement.

This is a cross-post from Science-Based Medicine. Comments are open there.

Photo from flickr user Ryan Somma used under a CC licence.

The tension between the “business of pharmacy” and the professional responsibilities of pharmacists, as health care professionals, has always been present in retail (“community”) pharmacy practice.  For much of the past several decades, pharmacies have generally been owned by pharmacists, elevating pharmacy ethics and professional responsibilities to the level of the owner. But the era of the independent pharmacist-owner-operated pharmacy is disappearing, and the era of the massive pharmacy chain is upon us. In the United States, CVS and Walgreens command 50% of the retail pharmacy business in major cities. In Canada, Shoppers Drug Mart has been purchased by the grocery giant Loblaw, and the Rexall chain has been purchased by American giant McKesson.  And in the United Kingdom, retail pharmacy chain Boots has about 25% of pharmacy market share.

With this retail consolidation, are we seeing a decline in the autonomy of the front-line pharmacist? A scathing series of articles in The Guardian is raising questions about whether pharmacy giant Boots is putting  a drive for profits ahead of safe and appropriate pharmacy care. And pharmacists are speaking up.The Guardian column is scathing. “How Boots went Rogue” was the headline in a long piece by Aditya Chakrabortty:

This is the tale of how one of Britain’s oldest and biggest businesses went rogue – to the point where its own pharmacists claim their working conditions threaten the safety of patients, and experts warn that the management’s pursuit of demanding financial targets poses a risk to public health. (Boots denies this, saying that “offering care for our colleagues, customers and the communities which we serve…is an integral part of our strategy.”)

At the heart of this story is one of the most urgent debates in post-crash Britain: what large companies owe the rest of us – in taxes, in wages, and in standards of behaviour.

Boots is everywhere in the United Kingdom, and plays an integral (and integrated) role in the delivery of care, just like the National Health Service (NHS) itself – yet Boots is a fully private organization, unlike the public NHS:

Britain relies on Boots – and Boots relies on Britons. It is by far the biggest pharmacy chain in the country. Healthcare professionals refer to the firm as an “essential component” of the NHS. It is to outpatient care what the high-street banks are to the UK’s money system: a massive private-sector firm delivering a vital public service.

And it takes a lot of public money to do so: around £2bn a year for prescriptions alone, according to independent financial analysis, or a third of Boots’s annual income in the UK. Then come the patient-care services paid for by the taxpayer, and the contracts Boots is now taking over from the NHS – to host GP surgeries in its stores, to run pharmacies in hospitals, to manage hearing test centres and specialist clinics monitoring drugs that prevent blood clots.

The article points to changes in the organization that it claims started in 2007, when Boots was sold for £11 billion, in a deal backed by private equity group Kohlberg Kravis Roberts (KKR). And that’s when pharmacy-level changes apparently began:

Outwardly, 2007 changed nothing. The pharmacists still wore white coats. The sign outside the shop was still the same blue and white cursive logo dating back to 1883. But behind the trusty facade was “the story of how one business model colonises another,” according to Colin Haslam, professor in accounting and finance at Queen Mary University of London. The everyday needs and ailments of communities across the UK had been reconfigured as thousands of little revenue streams for a small transnational elite of ultra-wealthy investors, whose fortunes depended on those streams getting bigger, and fast.

The column goes on at length to describe the financial consequences. But what I want to focus on (and understand) is the pharmacist and patient impact. A staff pharmacist describes a reduction of pharmacist hours (no more pharmacist checking pharmacist), and new quotas to conduct medication use reviews (MURs):

Free for the customer, a way of keeping a patient out of a GP’s waiting room, and for each one the NHS pays the company £28. To prevent the system from being abused, every pharmacy in the country is limited to 400 MURs a year. Except Tony’s managers took that number as a target for his store to hit.

“Miss it and they get on your back,” said Tony. He adopted a manager’s whine: “You’ve done three MURs less than you should have done this week.”
A Boots pharmacist from another region described to me a recent staff awayday at which he and his colleagues were told: “400 MURs is an expectation now. We don’t need to tell you that.”

The focus on selecting appropriate patients waned:

So keen was Tony’s store to make that profit, he claims it did reviews on anyone, no matter how unsuitable. Tony himself was told to have one – and to give one to a patient with severe dementia. His manager came in for one – no sooner had it begun than she walked out, but it still went towards the total. All so the shop could earn that extra £11,200 from a scheme intended to help the sick. (Asked to comment, Boots said: “We make it clear to our colleagues that these services should not be undertaken inappropriately.”)

These forms of outpatient care are a good earner for Boots. Assuming each of its pharmacies churns out 400 MURs a year, that one NHS programme is worth an annual £30m to the company. Stack alongside that the new medicine service (NMS) for patients on heavy-duty drugs, worth at least £25 a time, NHS flu jabs at up to £17 a pop, stop-smoking clinics, and a lot of public money is being sent to private companies to look after our health.

Pharmacists were feeling the pressure, and The Guardian notes several spoke up about their ability to provide appropriate care:

On the one hand, you have an NHS looking to move more of its patient care into the private sector. On the other, you have giant chains such as Boots chasing lucrative new business. And in the middle, you have the humble pharmacist, responsible for diagnosing ailments and dispensing medicines – and personally liable for errors. Yet under intense managerial pressure, they are being stripped of their professional discretion – and some feel they are being turned against their own patients.

Pharmacists are being blunt – these working conditions are affecting their ability to deliver patient care. A recent survey of UK pharmacists gives some worrying signals:

Asked “how often do you believe financial cutbacks imposed by your main employer have directly impacted upon patient safety”, 56% of Boots chemists said that was true “around half” or “most” of the time. A further 20% said it was the case “all the time”. Taken together, these numbers outstrip by 10 percentage points their counterparts at other chains, and should cause particular alarm given Boots’ position as Britain’s biggest pharmacy.

Three in every four of responding Boots pharmacists believe that the cuts imposed by their employer, whether the drop in staff numbers or increased workloads, threaten patient safety at least half the time or more. In response, Boots points out that it now employs more than 6,000 pharmacists in the UK, up from about 4,500 before the buyout. However, that rise tracks the increase in its number of stores, up from 1,400 in 2005 to around 2,400 today. I asked Boots what had happened to the number of dedicated pharmacy support staff, the dispensers and assistants that Boots chemists reported they were having to do without. The company did not respond.

Following the Guardian column, Boots pharmacists responded directly about the pressure, with comments like:

“Patient safety is severely compromised as pharmacists are asked to clinically check prescriptions while ensuring people are being served at the tills, taking phone calls, giving advice to patients, handing out prescriptions, re-ordering medication for patients, texting patients, storing prescriptions, recording clinical information, etc. Self-checking, which should only be done as a ‘last resort’ is actually done on a daily basis. Having two people involved in the dispensing and checking of a prescription is a fundamental hallmark of safe dispensing, which Boots is not taking seriously. Under pressure to meet several targets … in a Boots pharmacy it is extremely difficult to counsel a patient fully on how to use their medication correctly and how to get the most out of their medication, there is simply not a time provision for this.”

and

“I am a passionate pharmacist and love doing my job so that I can help patients and provide a brilliant service to them. However with the ongoing, worsening and unrealistic budget cuts, we are working on skeleton staff every day just battling to survive. We can no longer give even a half decent service even if we wish to. What is worse is that staff are taken away and more is expected of you in terms of targets, services! How can you cope? They are setting you up for failure even before you have begun. I wake up in the morning dreading work.”

Now it looks like the UK pharmacist regulator, the General Pharmaceutical Council (GPhC) is investigating claims that Boots is pressuring staff to conduct inappropriate and unnecessary MURs to drive revenue:

The General Pharmaceutical Council (GPhC) is calling in evidence on the allegations made in the report, which revealed that managers at Britain’s biggest chain of chemists have been forcing staff to milk NHS schemes, in order to increase company profits.

The report also detailed a recent and yet to be published survey by the pharmacy trade union of its members, to which more than one in 10 of all Boots chemists responded. Asked “how often do you believe financial cutbacks imposed by your main employer have directly impacted upon patient safety?”, more than 75% of those who responded to the Pharmacists’ Defence Association (PDA) said that was the case at least half the time.

The union has been asked to show the pharmacy regulator its survey and other relevant documents, in what are understood to be the first steps towards a possible full investigation of Boots.

The GPhC, however, continues to be criticized for what is felt to be a tendency to focus on individual pharmacist behavior, rather that focusing on the broader, system-level issues that compromise the ability of all pharmacists to deliver ethical patient care. Some pharmacists feel the same way, suggesting a focus on MURs distracts away from the profession-wide issues that continue to be a part of retail pharmacy. Pharmacist Anthony Cox notes:

The real story is the poor management culture and treatment of pharmacists, which the MUR outcome is symptomatic of. No other profession would have allowed this situation to fester for years. We need only to look at the concern for junior doctors to see how other professions attempt to create a professional environment where an individual can flourish, rather than merely survive.

Staff pharmacists, please describe your own experiences in your country, and at your pharmacy. Have you experienced new pressure to deliver unnecessary pharmacy services? Are staffing cutbacks affecting your ability to deliver safe patient care? Is it different in chain (vs. independent) pharmacies? How has the environment changed over the past several years?

Please share your thoughts in the comments, or send them to sciencebasedpharmacy at gmail dot com and I’ll post your feedback. Pharmacy is a self-regulated profession. It’s our profession. Without your advocacy for your profession and for patient care, there will be no change.

A day of Science-Based Medicine, a weekend of science and skepticism

If you’re interested in science, skepticism and medicine, then NECSS, the NorthEast Conference on Science and Skepticism, is the conference for you. NECSS will be held May 12-15 in New York City at the Fashion Institute of Technology. The entire program is available schedule here.

The conference will welcome over 400 people and include panels, presentations and performances. Included in the program will be a full day of Science-Based Medicine, featuring speakers from the blog like including yours truly.

SBM day is Friday, May 13. Here’s the current schedule:

9:30-9:40 10 minutes Welcome
9:40-10:15 35 minutes Functional Medicine is Dysfunctional Harriet Hall
10:15-10:50 35 minutes Science-Based Dentistry: Where the Truth Meets the Tooth Grant Ritchey

10:50-11:00 10 minutes Break

11:00-12:10 70 minutes Natural Disaster: Dietary Supplements Scott Gavura & Jann Bellamy

12:10-1:40 90 minutes Lunch

1:40-2:15 35 minutes Kids & CAM: Playing Make-Believe with Children’s Health John Snyder
2:15-2:50 35 minutes Chronic Lyme: When Life Hands You Lemons Saul Hymes
2:50-3:25 35 minutes Your Baby’s Spine Will Be Just Fine Without Chiropractic Adjustment Clay Jones

3:25-3:40 15 minutes Break

3:40-4:45 65 minutes Debate: Should Physicians “Fire” Anti-Vaccination Patients? John Snyder, Saul Hymes, Clay Jones
4:45-5:20 35 minutes Bayesian Statistics Steve Novella
5:20-6:05 45 minutes Ask Us Anything: Audience & Twitter Q & A All Speakers
6:05-6:15 10 minutes Closing

Registration is open.

The entire conference looks amazing. I hope to see you there.