This week I interviewed Ryan Armstrong of the pseudoscience watchdog group Bad Science Watch Canada.
Listen at the link below or via the iTunes and Stitcher links at the end of this post.
Read the transcript by clicking the link under the audio file.
Transcript by Julie Ann Lee: Transcript_Ryan_Armstrong_Noncompliant
Ryan Armstrong is the Executive Director of Bad Science Watch Canada, an independent non-profit consumer protection watchdog and science advocacy organization dedicated to improving the lives of Canadians by countering bad science.
Ryan has a PhD in biomedical engineering and an undergraduate degree in medical biophysics (BMSc). His research has spanned across multiple domains including bioethics, medical imaging, image processing, human-computer interaction and surgical simulation. He became interested in science-based activism after encountering false cancer treatment claims in his community. Learning that these practitioners were regulated health professionals, he found that the regulatory system was not adequately protecting the public.
Ryan and I talked about several issues around “natural health products” (such as vitamin and herbal supplements) and off-label use of prescription drugs in Canada. These issues include:
- lapses in inspection for integrity;
- misleading labeling claims;
- proxy consent for children and others who can’t give informed consent.
In the US, the Health Fraud and Consumer Outreach Branch of the Food and Drug Administration (FDA) has engaged in regulatory action on matters including products tainted with active drug ingredients such as anabolic steroids; metals like lead and mercury; and common allergens. In a recent case, the use of Hyland’s Teething Tablets was found to be associated with belladonna toxicity in infants. Between 2007 and 2016, the FDA issued warnings about unapproved pharmaceutical ingredients in 776 dietary supplements; however, one report notes that less than half of these led to voluntary recalls.
In addition to supplements, the FDA has also cracked down on off-label use of prescription drugs, such as the off-label use and sale of chelating agents to “cure” autism. Like the FDA, the National Health Services in the UK has created a list of “Do Not Do Recommendations,” including “Do not use chelation for the management of core symptoms of autism in adults”.
There is no similar Do Not Do list in Canada. Other than issuing warnings against the sale of MMS (here, at least one case has been prosecuted by the Crown), we don’t hear very much about Health Canada engaging in regulatory actions against supplement makers for integrity issues. Neither do we hear about Health Canada taking action on off-label use, a matter that is generally “handled” by self-regulating colleges.
I think Health Canada needs to take a page from US and UK regulators, for two reasons.
1. Contamination of natural health products is a serious health and safety issue.
When University of Guelph researchers tested 44 bottles of popular supplements sold by 12 companies, they found that many were mixed–or replaced entirely–by cheap fillers like soybean, wheat and rice, which were not listed on the label. Still others contained walnut, a common allergen, also not listed on the label. Bottles labeled “echinacea” were found to contain a ground up bitter weed, Parthenium hysterophorus, an invasive plant found in India and Australia that has been linked to rashes and stomach illness. Two bottles labeled as St. John’s wort were entirely comprised of fillers, with no St John’s Wort in the capsules at all. All in all, one-third showed “outright substitution, meaning there was no trace of the plant advertised on the bottle.”
As David Schardt, a senior nutritionist at the Center for Science in the Public Interest, an advocacy group. “Given these results, it’s hard to recommend any herbal supplements to consumers.” It’s not just lack of efficacy that’s the concern, but risk of illness or allergic reaction, or other reaction (as in the case of supplements tainted by steroids or Viagra). As Chris MacDonald of the Ted Rogers School of Management writes: “Unlike homeopathic remedies, which (unless adulterated) generally contain no active ingredients at all, herbal remedies can have actual biological effects.”
When products sold at GNC (US) were tested by an expert in DNA barcoding technology, just 21 percent of the test results had DNA from the plants listed on the labels. “In many cases, unlisted contaminants were the only plant material found in the product samples.” Based on DNA testing, the New York State Attorney General’s office accused four major retailers of “selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves.” Other actions have followed this one.
And last year, a report in the Journal of the American Medical Association concluded that: “Active pharmaceuticals continue to be identified in dietary supplements… even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects.”
2. Self-regulating bodies in Canada do not appear to be adequately regulating off-label use of pharmaceuticals such as chelating drugs. A Do Not Do/Use list would help provide guidance as we seek a regulatory framework that enforces the use of these products.
The system of professional self-regulation–where members of a given profession comprise the complaint body when members of the public have a grievance about a medical practitioner–is flawed. In some cases, self-regulating colleges are not taking enforcement action when legitimate complaints arise about the practices of their members. A self-regulating review board may be made up of two professionals (peers who often know the respondent professionally) and one member of the public. Rarely if ever are ethicists or other adjudicators involved. Judgements often come out in favour of the professional without due diligence or drag out for years, even decades.
As Ryan notes: “The current system has been constructed largely on the assumption that the majority of a given profession is well-meaning and ethical and that their organization into a regulatory body would help weed out the outliers and bad actors. … [W]hat has not been taken into account is the existence of cultural delusions that can possess large communities within a profession or even the entirety of a profession.
“We need an independent entity that is science-based and ideally can make judgements on diagnostic and therapeutic procedures.”
In addition to regulatory issues, Ryan and I discussed the nuances of informed consent, as well as the predatory nature of false marketing claims and the future of regulation in Canada. I learned so much from this interview about the issues in Canada, as well as major projects in the works and up ahead for Bad Science Watch, an amazing organization. Ryan, thank you for this insightful interview!!