How weak regulation leads to fake and contaminated herbal supplements

Herbal Supplements
If there is one aspect of “alternative” medicine that both critics and fans should agree on, it’s that products should be manufactured to high standards. What’s on the label should accurately describe what’s in the bottle. Product quality standards are essential, whether you’re using herbs or drugs. And when it comes to ensuring the products we buy are of high quality, we’re all effectively reliant on regulation to protect us. As a pharmacist, I can’t personally verify that each tablet in your prescription contains the active ingredient on the label. I am dependent on a supply chain that may stretch around the world. While the product manufacturer may be reputable, it’s only a regulator that can realistically verify and enforce production to strict quality standards. The same cannot be said for products like supplements and herbs which are regulated differently than drugs, and held to different, and in some cases, weaker standards. A weak regulatory framework, which doesn’t hold manufacturers to account, would be expected to result in a product of lower quality. And that’s exactly what you see when you look at supplements on the market today.

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Mozi-Q – “Insect repellent you eat”. But does it work?


Today’s post is a guest contribution from a Canadian pharmacist who is writing under the pseudonym Sara Russell:

Every morning I open up Facebook and expect to see the usual sharing of my friends’ latest adventures in pseudoscience, but it wasn’t until this morning that I felt compelled to write about something.  A friend had posted this video asking for feedback. Continue reading

Weekend Reading

Keep the heat on Health Canada:

Keep the heat on Health Canada:

Here’s what’s keeping this pharmacist engaged and sometimes outraged:

Health Canada explicitly puts the financial interests of homeopathy manufacturers above broader public health goals. From the BC Medical Journal, Health Canada licenses homeopathic vaccines:

Remarkably, at the same time as Health Canada focuses on influenza education, flu shots, and other proven prevention measures, that same body has licensed 10 products with a homeopathic preparation called “influenzinum.”[8] According to providers, in­fluenzinum is for “preventing the flu and its related symptoms.”[9] Homeopathic vaccines are available for other infectious diseases as well. Health Canada licenses homeopathic preparations purported to prevent polio,[10] measles,[11] and pertussis.[12] Health Canada continues to assure Canadians that it tests products for safety and efficacy before allowing them to enter the market. All approved homeopathic products are given a DIN-HM number. The website states, “A NPN or DIN-HM means that the product has been authorized for sale in Canada and is safe and effective when used according the instructions on the label.”[13]

Pharmacist John Greiss compares Health Canada and the FDA and their action on opiates. The results are striking and reiterate the question above: Is Health Canada putting public health objectives above manufacturers? Continue reading

Thermography: Worse than useless

Earlier this spring, I described the Choosing Wisely campaign in the United States, an initiative designed to redirect resources away from medical treatments that are useless or harmful. In the spirit of the campaign, I suggested Five Things Pharmacists and Patients Should Question. My list included unvalidated IgG food intolerance blood tests like Hemocode, dubious “Body Chemistry Balancing”, inaccurate heel ultrasound bone density testing, and saliva hormone testing. I also singled out breast thermography as a particularly questionable test that pharmacies offer. Cancer tumours need a rich blood flow to grow, so cancer cells secrete chemicals to stimulate the development of new blood vessels. More blood flow means warmer tissue. Thermography, sometimes called digital infrared thermal imaging (DITI) uses infrared measurement to detect skin temperature differences. Thermography has emerged as an alternative therapy offered by naturopaths, homeopaths, and some health professionals, like pharmacists. Note the claims made: Continue reading

It’s time for transparency in Canadian clinical trial data

Science-based health professionals hold the scientific method is pretty high regard. We advocate for evaluations of treatments, and treatment decisions, based on the best research. We compile evidence based on fair tests that minimize the risks of bias. And we consider this evidence in the context of the plausibility of the treatment. The fact is, it’s actually not that hard to get a positive result in a trial, especially when it’s sloppily done or biased. And even when a trial is well done, there remains the risk of error simply due to chance alone. So to sort out true treatment effects, from fake effects, two key steps are helpful in reviewing the evidence.

1. Take prior probability into account when assessing data. While a detailed explanation of Bayes Theorem could take several posts, consider prior probability this way: Any test has flaws and limitations. Tests give probabilities based on the test method itself, not on what is being tested. Consequently, in order to evaluate the probability of “x” given a test result, we must incorporate the pre-test probability of “x”. Bayesian analysis uses any existing data, plus the data collected in the test, to give a prediction that factors in prior probabilities. It’s part of the reason why most published research findings are false.

2. Use systematic reviews to evaluate all the evidence. The best way to answer a specific clinical question is to collect all the potentially relevant information in a structured way, consider its quality, analyze it according to predetermined criteria, and then draw conclusions. A systematic review reduces the risk of cherry picking and author bias, compared to non-systematic data-collection or general literature reviews of evidence. A well-conducted systematic review will give us an answer based on the totality of evidence available, and is the best possible answer for a given question.

In order for our evaluation to factor in prior probability, and to be systematic, we need all the evidence. Unfortunately, that’s not always possible if evidence remains unpublished or is otherwise inaccessible. There is good evidence to show that negative studies are less likely to be published than positive studies. Sometimes called the “file drawer” effect, it’s not solely the fault of investigators, as journals seeking positive results may decline to publish negative studies. But unless these studies are found, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention. How bad is the problem? We really have no complete way to know, for any particular clinical question, just how much is missing or buried. This is a problem that has confounded researchers and authors of systematic reviews for decades. Continue reading

The consequences of legitimizing nonsense

Smarties: As effective as homeopathy

For a blog established to examine the role of science in pharmacy practice, I’ve given a disproportionate amount of attention to homeopathy. Which is frustrating, because homeopathy is not something that pharmacists, or the pharmacy profession, should even need to discuss. Unlike herbal remedies, and some supplements, there isn’t even any science to discuss. As pseudoscience goes, homeopathy is the worst of the worst – it is a belief system, nothing more. If homeopathy actually worked as claimed, it would mean that all we know about biology, biochemistry, pharmacology, and toxicology was wrong. Not a little wrong, but completely wrong. Which would then mean that all we know about science-based medicine is wrong.

In short, homeopathy is an elaborate placebo system, based on the idea that “like cures like” (which is simply a form of magical thinking) involving successive dilutions of products in water, like Berlin Wall, “Mobile Phone (900mHz)“, and even the light reflecting off Saturn. These substances are believed to have medicinal effects, and the dilutions are believed to increase, not decrease, the potency of the final product. But the dilutions in homeopathy are so great you’re not even getting any Berlin Wall. Think of putting one drop of a substance into a container of water. Only that container is 131 light-years in diameter. That’s the “30C” dilution. Homeopaths believe that the water molecules retains a “memory” of the original substance (while conveniently forgetting all the other products it has come in contact with.) The final remedy is diluted so so completely that most products on store shelves don’t contain a single molecule of the ingredient listed on the label. After all that dilution, the water is dripped on tablets of sucrose and lactose: They are, as a final product, sugar pills. Chemically indistinguishable, and as medicinal as a box of Smarties.

Not surprisingly, a review of clinical trials, when you control for biases, confirms what grade-school numeracy and scientific literacy would suggest – homeopathic products are no more effective than a comparable placebo. Yet frustratingly, regulators in Canada and in other countries have given legitimacy to homeopathy by registering both the medication and their purveyors – risking the perception that homeopathy may in fact offer medicinal value. And whether it’s due to ignorance of homeopathy, or indifference to the unfounded ideas of “alternative” health, legitimate health professionals continue to give a pass to homeopathy, taking a “What’s the harm” attitude. Yet harms can result: Continue reading

When homeopathy is approved as an insect repellent, there’s a serious regulatory problem

Mozi-Q won't protect against mosquito bites

Given their visibility in the pharmacy, a recurring topic of this blog are the category of products deemed “natural health products”. My philosophy towards their uses has changed over the years, and what was an “evidence-based” approach is now firmly a “science-based” approach. A central principle to science-based medicine or pharmacy is that all health interventions and treatments should be evaluated based on a single, scientific standard. One of the biggest successes of the alternative medicine industry, worldwide, has been the embedding of different regulatory standards for the evaluation and approval of so-called “non-drug” products such as supplements, herbal products, and non-scientific treatment systems like homeopathy or traditional Chinese medicine (TCM). The implications cannot be overstated: this different and lower standard is now so firmly entrenched in most health systems that few seem to question its rationale, or consider the consequences. As a practicing pharmacist I spent the first decade of my career working within this regulatory framework without ever stepping back to question why we regulate some products differently.  Comparing two countries illustrates my point: Continue reading

Should you take expiry dates seriously?

Is is safe to take expired drugs? Are they still effective? Consider this scenario:

You’re in good health and take no prescription drugs. You use the following remedies occasionally:

  • Excedrin for the rare migraine
  • Arnica 30CH for bumps and bruises
  • Echinacea capsules, when you feel a cold coming on

Today you look in your cupboard, and notice all three products expired last year. Would you still consider taking any of them? Why or why not?

Your answer is probably influenced by a number of factors, including perceptions of risk and benefit. I’ve encountered patients who believe that drugs are less active as they near the expiration date, and others who see expiry dates solely as marketing ploy from Big Pharma. Few understand  how they’re calculated.

Over the past few months I’ve written several posts on different aspects of drug development and testing, including drug interactions, fillers and excipients in drug products, the equivalence testing of generic drugs, and the management of drug allergies. I’ve done this for two reasons. The first is to develop a resource for common questions and misconceptions about the mechanics of modern medicines. The second, less obvious reason for these posts has been to illustrate the serious credibility gaps with CAM (so-called “complementary” and “alternative”) therapies. Largely because of lax regulatory frameworks in the USA and Canada, the CAM industry has ballooned into a multi-billion dollar market without answering basic questions that should be asked of any supplement or drug, “alternative” or otherwise. What’s not well known to consumers, but is glaringly obvious to science-based health practitioners, is that CAM largely ignores issues of pharmacology: understanding how a chemical substance, once consumed, behaves in the body. It’s critical to scientific medicine, but an unnecessary step for CAM, where there’s no need to determine if a product has a beneficial biological effect before selling it. Fundamental tests in medicine, like the identification and isolation of an active ingredient, or understanding dose-effect relationships, are simply ignored. Science-advocates are regularly accused of being biased, to which I plead guilty. I have a reality bias, and don’t believe that magical thinking and pseudoscience form the basis of credible medicine, or pharmacy practice. And this bias is equally jarring when it comes to considering expiry dates for products: real drugs, and also CAM.

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Who’s to Blame for Drug Shortages?

Are more empty vials something to expect?
All the best effort to practice science-based medicine are for naught when the optimal treatment is unavailable. And that’s increasingly the case – even for life-threatening illnesses. Shortages of prescription drugs, including cancer drugs, seem more frequent and more significant than at any time in the past. Just recently manufacturing deficiencies at a large U.S.-based contract drug manufacturer meant that over a dozen drugs stopped being produced. This lead to extensive media coverage, speculating on the causes and implications of what seems like a growing problem. So who’s to blame? Continue reading