The consequences of legitimizing nonsense
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:
The Harms of Nonsense
From Bradford, England:
A Respect party campaigner who died on the Bradford West by-election trail when his heart suddenly stopped had given up doctors’ orders of beta-blockers and turned to homeopathy instead, an inquest heard. Father-of-one Abu-Bakr Rauf collapsed on March 20 in the Mumtaz restaurant car park after a heated discussion with another party member. Bradford coroner Peter Straker yesterday recorded a narrative verdict that the 28-year-old died at Bradford Royal Infirmary despite every effort to save him.
Why would a man with arrhythmia, diagnosed at age 9, willingly discontinue his medications?
“He was told he should stay on them and many a time this was reinforced, but he and his family decided they did not want to do that. He was told about the risks, but they decided to rely on homeopathic medicine,” said Dr Khan in her statement that was read out.
Only in a culture where homeopathy is given medical legitimacy would anyone ever rely on homeopathic products. And that’s just the case in the United Kingdom, where the largest pharmacy chains carry homeopathy. The Boots chain has gone so far to admit that they have no evidence homeopathy works – they offer it because people want it.
Regrettably, this isn’t the only case of homeopathy leading to bad medical decisions. What’s the Harm? catalogs over 400 cases. One of the most horrific was that of infant Gloria Thomas in Australia who died of eczema (eczema!), simply because her parents refused to use medication, and relied on homeopathy. Watch the video for the horrific details. Her father, a homeopath, and her mother, were eventually convicted of manslaughter.
One of the most frightening and dangerous aspects of homeopathy are “homopathic nosodes” which are sugar pills based on dilutions of infectious pus, saliva, and diseased tissue. They are marketed as alternatives to vaccines. Sadly, Health Canada is complicit in this charade and actually registers these products as “remedies”, contradicting its own public health objectives. It’s nice to see Bad Science Watch, a new Canadian science advocacy organization, has publicly called on Health Canada to deregister these products. Regrettably, Health Canada has of yet taken no action, and seems content granting unique registration numbers to indistinguishable sugar pills. On a positive note, Health Canada seems to be an outlier among regulators, judging by recent American and British regulatory action.
Recent developments in the United Kingdom are important to science advocates worldwide, as they give some insight into the interactions between regulators and homeopathy manufacturers. The Medicines and Healthcare products Regulatory Agency (MHRA), the UK equivalent of the FDA or Health Canada, has declared that all homeopathic products must be registered to be sold. This is occurring in part because of a European-wide agreement to implement a regulatory system for homeopathic products. Consequently, products are being prohibited from sale until they are registered. Manufacturers are not pleased, and amazingly, have offered the MHRA a possible approach that would allow continued sale. Here is the suggestion to the MHRA from manufacturer Helios, as reported by Martin Robbins in The Guardian:
If necessary we could revise the manufacturing method, the labelling of the bottles and kit box to present them as non-medicines and non-homeopathic and market them as ‘confectionery’. Customers who have an interest in homeopathy would still know how to use them and would continue to purchase them despite limited labelling. (emphasis added)
Let consider the implications here. Helios is willing to relabel their homeopathic products as candy. Which in a way is appropriate. Strip off the non-existent ingredient name from the label, and all you’re left with is indistinguishable pellets of sugar.
Yet even allowing these products to be sold as candy is unacceptable, if there’s no assurance these products are in fact safe. The FDA is required to inspect foreign manufacturers of products that are sold in the United States – and this includes manufacturers of homeopathic products. And the FDA posts warning letters to manufacturers publicly, giving the public insight into manufacturing practices. The FDA’s recent inspection of the homeopathic manufacturer Nelsons should concern critics and advocates of homeopathy alike:
“During the inspection, the investigator observed glass fragments present during the manufacture of Kali Phos 30 c Clikpak, Batch #36659. Specifically, glass fragments were observed in the Clikpak Assembly (b)(4) enclosed area where open glass vials are inserted into the outer plastic Clikpak sheaths and move uncovered on the conveyance mechanism. Your firm failed to implement adequate measures to prevent glass contamination and had no documentation to demonstrate that appropriate line clearance and cleaning is conducted following occurrences of glass breakage, which has been a recurring problem.”
Interested in some glass with your sugar? The report should be read in full, which goes on to list a number of quality control issues. Here is another astonishing finding:
“The investigator also observed for Batch #36659 that one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly during filling of the active ingredient. The active ingredient was instead seen dripping down the outside of the vial assembly. Your firm lacked controls to ensure that the active ingredient is delivered to every bottle.” (emphasis added)
One out of every six bottle didn’t even receive any of the dilute homeopathic water. Can you imagine a pharmaceutical product where 1/6 of the supply is inert? The consequences could be fatal to patients. But in the homeopathic world, none of this really matters (except for the glass shards, perhaps) as the final products, with or without the “homeopathic drug solution”, are the same – they are chemically inert. Incredibly, despite this warning letter from the FDA, Boots Pharmacy continues to sell Nelsons homeopathy. In response to an email enquiry, Boots indicated the following:
I can confirm that the audit undertaken was on a targeted area of their business. I can assure you that this does not affect any of their products supplied to the UK market. Nelsons are currently engaged in addressing the concerns raised by and are providing all the information the FDA have requested in respect of their products sold in the US.
So it seems that Boots Pharmacy believes that the Nelsons plant (which is located in England) complies with good manufacturing standards when it produces English goods. It seems that it’s only when the plant produces homeopathy destined for the USA that it implements shoddy manufacturing and quality control issues. A few weeks ago, I asked if pharmacy regulators “get” homeopathy. Now I’m starting to wonder if the problem starts with pharmacist education.
Teaching the Nonsense
There is no serious scientific debate about homeopathy. Consequently you’d expect pharmacy schools, filled with PhD’s with backgrounds in pharmacology, medicinal chemistry, and therapeutics to have the requisite background and ethical principles to caution students, and the broader pharmacy profession, about the implausibility and ethical unacceptability for the pharmacy profession to offer homeopathy for sale. You’d be wrong. At the University of Toronto, the Leslie Dan Faculty of Pharmacy is sponsoring and hosting a CAM “Research Symposium” which includes a “HomeoNet” presymposium where the “program” [PDF] includes such topics as homeopathy for bipolar spectrum disorders and homeopathy for the treatment of attention deficit/hyperactivity disorder. And if you have any doubt about the Faculty of Pharmacy’s involvement in this symposium, there is its logo, right among the homeopathic manufacturers like Heel and Boiron (currently being sued in Canada and around the world for fraud and misleading advertising.)
The rest of the program is equally bad, and it has already been dissected and eviscerated by Orac over at Respectful Insolence. What an embarrassment to the University of Toronto, its pharmacy students and alumni (like me), and anyone that believes that the pharmacy profession should be grounded in science. Perhaps I can look forward to a future program at U of T in alchemy.
Lest you wonder if the U of T-sponsored pharmacy program is an exception, there’s another continuing education program on CAM for pharmacists being offered this fall, also in Toronto. Called the Natural Health Products Symposium, it includes among its speakers homeopath Bryce Wylde, on the topic, “What pharmacists should know about the homeopathic remedies commonly sold in drugstores”. I like the topic, but I don’t think a homeopath will give pharmacists the scientific facts about homeopathy. But I can do so in a single sentence: You should know that they don’t work.
The Consequences of Nonsense
Consider this scenario: How confident would you be if on your next flight, the pilot indicated that he’d replaced some of the airline’s parts with antique components that he admitted had failed testing, but he described his personal positive experiences with them. How would you feel about your upcoming flight, and in the pilot’s judgement? Or consider a scenario where you learn that Boeing’s engineers are being offered courses in “alternative” avionics, where physical laws and proper testing are being handwaved away with tales of anecdotal success and “different ways of evaluating effectiveness”? How would your opinion of Boeing change? Would you remain as confident flying in their planes? Probably not, as airline manufacturers live and die based on their safety standards. No avionics company ignores scientific evidence. Now think about pharmacists being offered courses in how to treat medical conditions by selling patients sugar pills. Does your opinion of pharmacists change?
The intent of this blog is to advocate for the highest scientific standards for pharmacy practice. Given the lack of evidence, the risks to patients, and the questionable ethics of positioning sugar pills as medicinal, I’m baffled why the pharmacy profession refuses to take a stand against homeopathy. Is it indifference, or ignorance? Regardless of the reasons (and there may be more), pharmacy risks its professional reputation with its acceptance of homeopathy. By continuing to dabble in pseudoscience, pharmacists, and the pharmacy profession, jeopardize their reputations as credible health care providers.
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Tags: health canada, homeopathy, natural health products directorate, pharmacy ethics, pharmacy practice, pharmacy regulation, university of Toronto