Tag: Miers Laboratories
Ethical Pharmacy Practice 3: Running Out of Excuses
Ethical pharmacy practice is something I have written about before. If you've read those posts, please bear with me as I cover some familiar background.
In New Zealand, we are lucky enough to have an industry code of ethics for pharmacists, published by the Pharmacy Council of New Zealand, which holds pharmacists to high ethical standards. This code of ethics is the Safe Effective Pharmacy Practice Code of Ethics. One of the most important parts of this code of ethics is section 6.9, which states:
[PHARMACISTS] MUST:… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
Pharmacy Council's Safe Effective Pharmacy Practice Code of Ethics Section 6.9
The Pharmacy Council of New Zealand isn't a voluntary member organisation like the Pharmacy Guild or the Pharmaceutical Society. Instead the council is established as part of the Health Practitioners Competence Assurance Act 2003. Their roles are set out in this act and include:
Registering pharmacists
Reviewing and maintaining the competence of pharmacists
Setting standards of clinical competence, cultural competence, and ethical conduct for pharmacists
Which means that the Safe Effective Pharmacy Practice Code of Ethics is not a voluntary code of ethics. It is published by the body whose legal duty it is to set the standards of ethical conduct for pharmacists. Yet all over New Zealand, many pharmacists ignore it.
Walk into any New Zealand pharmacy. Chances are that you will find a section where they advertise and sell a range of homeopathic products. To anyone familiar with the evidence for homeopathy, it will come as no surprise when I tell you that there is no credible evidence of efficacy for any homeopathic product. Therefore, it seems to me, New Zealand pharmacists have an ethical obligation not to promote or sell them.
Yesterday, the Australian National Health and Medical Research Council (NHMRC) issued their final statement on homeopathy, following an incredibly extensive and rigorous review of the literature. They looked at over 1,800 scientific papers, and found that 225 met their criteria for methodological rigour, sample size, and placebo control. Their main finding was:
there are no health conditions for which there is reliable evidence that homeopathy is effective.
NHMRC Statement: Statement on Homeopathy
As I said, this conclusion does not come as a surprise. This research is the latest in a long line of reviews of the evidence for homeopathy that drew essentially the same finding:
A 2002 systematic review of systematic reviews of homeopathy published in the British Journal of Clinical Pharmacology concluded that:
the hypothesis that any given homeopathic remedy leads to clinical effects that are relevantly different from placebo or superior to other control interventions for any medical condition, is not supported by evidence from systematic reviews. Until more compelling results are available, homeopathy cannot be viewed as an evidence-based form of therapy.
A systematic review of systematic reviews of homeopathy
A 2010 systematic review of systematic reviews of homeopathy published in the Medical Journal of Australia concluded:
The findings of currently available Cochrane reviews of studies of homeopathy do not show that homeopathic medicines have effects beyond placebo.
Homeopathy: what does the "best" evidence tell us?
A 2010 report from the UK House of Commons concluded:
homeopathy is a placebo treatment.
Evidence Check 2: Homeopathy
In 2013, the NHMRC published a report based on their research that found:
There is a paucity of good-quality studies of sufficient size that examine the effectiveness of homeopathy as a treatment for any clinical condition in humans. The available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans.
Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence
I could go on, but I hope by now you get the idea.
New Zealand pharmacists need to respond to the NHMRC's research. And if they mean to practice responsibly and ethically, that response should be to immediately stop all promotion and sale of homeopathic products. The ethical standard to which they should be held is clear, and it is not consistent with promoting or supplying homeopathic products.
Last year, I complained to the Advertising Standards Authority under the auspices of the Society for Science Based Healthcare about a homeopathic product for preventing jet lag (No-Jet-Lag) that was advertised in Parnell Pharmacy. The pharmacy responded by removing the advertisement, and agreeing to stop selling the product if it was found that the claims were not supported by credible evidence, and my complaint was upheld. Unsurprisingly, my complaint was upheld when the ASA decided claims such as "it really works" were not supported by credible evidence. However, despite Parnell Pharmacy's example, many New Zealand pharmacies still sell this exact product.
The NHMRC's report represents the same finding, but on a larger scale. New Zealand pharmacists who promote and sell homeopathic products should follow the responsible example of Parnell Pharmacy, and remove homeopathic products from their shelves.
By Mark Hannain Alternative Medicine, Australia, Ethical Pharmacy Practice, Health and Medicine, Homeopathy, Medicine, New Zealand, Regulation, Scepticism, Science, Society for Science Based Healthcare 2015/03/12 2015/10/15 833 WordsLeave a comment
Ethical Pharmacy Practice 2: Time for a Spring Clean
In July, I wrote an article on Ethical Pharmacy Practice and Homeopathic No-Jet-Lag. In it, I described the importance of the role pharmacies play in the healthcare system, and their ethical obligation not to mislead consumers or promote ineffective healthcare products. In particular, I described an advertisement I saw in an Auckland pharmacy for a homeopathic product called "No-Jet-Lag", and the complaint I submitted to the Advertising Standards Authority about it via the Society for Science Based Healthcare. There's also a write up of this decision and the 2 others released at the same time on the Society's website: Pharmacy to Remove Homeopathic Product Following Complaint
On the 9th of October, the ASA released their decision to the public. They ruled to uphold my complaint, which means the advertisement has to be removed. More importantly, in response to my complaint the pharmacy made a promise to remove the product from sale if the complaint was upheld. Here's what they said:
We believe that the manufacturer, Miers Laboratories ought to respond to the substantive complaint that it's [sic] representations fail to comply with the Therapeutic Products Advertsing [sic] Code.
We believe that the product is sold in many pharmacies in New Zealand and it is somewhat arbitrary that our pharmacy is the subject of the complaint.
We are interested in the outcome of the complaint and can indicate that if the Authority upholds the complaint we will remove the product from sale. In the meantime, the product has been removed from the counter and placed on a less prominent position.
I agree with their first two points. While I think pharmacies shouldn't promote or sell healthcare products without a sound understanding of the evidence behind them and the claims made about them, I also think it's reasonable to expect the manufacturer (who also produced the advertising in this case) to substantiate the claims. Moving the display to a less prominent position in the meantime seems like a reasonable compromise as well, although of course I'd prefer it if the product were never stocked in the first place.
I also agree with them that their inclusion in this complaint is somewhat arbitrary. For that reason I am not going to specify in this article which pharmacy it was. If you really must know then you can read the full decision on the ASA's website. As they said, many New Zealand pharmacies sell this product and I think this complaint applies to all of them.
I also think this pharmacy's promise to remove the product from sale in the event that this complaint is upheld, as it now has been, is the appropriate response. I think that every single New Zealand pharmacy that stocks No-Jet-Lag should follow suit. There are a lot of them. The website for this product even claims on its New Zealand Retail Outlets page that "Most chemists nationwide" stock it.
As I mentioned in my original post on this topic, and in my complaint, New Zealand pharmacists are bound by the Pharmacy Council's Safe Effective Pharmacy Practice Code of Ethics 2011. Perhaps the most important part of this industry code of ethics, at least in my mind, is section 6.9:
Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
This is a very fine standard to adhere to, and I would hope that all businesses to which it could possibly apply would adhere to it as well, although realistically I know that's not the case.
In response to the complaint, Miers Laboratories submitted a few studies to the ASA. They were pretty laughable though when you look at the sample size:
In all our research we base our work on previous studies, the first study for jet lag used 5 people, then it was 10 and at the time the accepted worldwide minimum was 12 for clinical trialOur [sic] bigger study used 19 people.
So basically "most of our studies didn't even meet the very low minimum accepted size, and even the largest one was tiny". Very impressive, Miers Laboratories.
The 19 person study they mention is also promoted on their website, and I pre-emptively discussed it in my complaint. It seems the Advertising Standards Complaints Board essentially agreed with my criticisms:
The majority of the Complaints Board said the statement "It really works" was an absolute therapeutic claim and, as such, required a high level of support. However, it noted the trial population in the pilot study was small, the methodology was not robust and the results had not been published or peer reviewed. The Complaints Board also noted the study was an in-house trial conducted by the Advertiser rather than independent research.
Given the weaknesses in the study, the majority of the Complaints Board said the Advertiser had not satisfactorily substantiated the claim the product "really works" and, as such, the Complaints Board said the advertisement had the potential to mislead consumers. Consequently, the Complaints Board said the advertisement did not observe a high standard of social responsibility required of advertisements of this type. Therefore, the majority of the Complaints Board ruled the advertisement was in breach of Principles 2 and 3 of the Therapeutic Products Advertising Code.
For context, Principle 2 of the Therapeutic Products Advertising Code states that:
Advertisements must be truthful, balanced and not misleading. Claims must be valid and have been substantiated.
And Principle 3 states that:
Advertisements must observe a high standard of social responsibility.
This is basically exactly the result I was hoping for, which is great. However, I was a little concerned by one part of the decision:
A minority of the Complaints Board disagreed [that the advertisement was in breach of Principles 2 and 3 of the Therapeutic Products Advertising Code]. It acknowledged the study sent by the Advertiser to support its claims. While it noted the issues with the study, the minority of the Complaints Board was of the view the product was not harmful and said the consequences of the product not working were not significant or serious for the consumer.
I'd expect anyone who has ever paid money for a pill to prevent jet lag would disagree with this, although it is obviously a lot more serious than something like a cancer treatment that doesn't work. More importantly, although I do agree that it's important to consider the severity of what happens if the product doesn't work, I hope that the ASA will not give a free pass to misleading therapeutic advertising simply because it's for a condition that they deem insignificant.
Now that this complaint has been upheld, the pharmacy in question has promised to remove No-Jet-Lag from sale. I hope this is the start of a spring clean for all New Zealand pharmacies that stock this product. They should follow this responsible example and take the opportunity to examine other products they have for sale – especially homeopathic products – to ensure that they are abiding by their ethical duty not to promote or supply healthcare products for which there is no credible evidence of efficacy.
You can help. Next time you see a homeopathic product in a pharmacy, ask them what the evidence for it is. If you see this particular product, ask them if they're aware that the Advertising Standards Authority upheld a complaint against it on the basis that the evidence for it just isn't good enough.
EDIT 2014/10/12
It's great to see that several media outlets have picked up this story:
2014/10/10 Complaint about No-Jet-Lag upheld(Consumer NZ)
2014/10/11 'No Jet Lag' product pinged over false advertising(Newstalk ZB)
2014/10/12 The Advertising Standards Authority has upheld a complaint about a display box advertisement of 'No Jet Lag' (03:10)(Radio NZ News)
By Mark Hannain Alternative Medicine, ASA, Complaints, Ethical Pharmacy Practice, Homeopathy, Medicine, New Zealand, Regulation, Scepticism, Society for Science Based Healthcare 2014/10/11 2015/08/09 1,289 Words2 Comments
Ethical Pharmacy Practice and Homeopathic NO-JET-LAG
Pharmacies are an integral part of the healthcare industry. They provide a valuable decoupling between the doctor you see for an examination and potentially a prescription, and the institution that stands to profit from the medicine you pay for. Without this separation, there's the potential for a conflict of interest where the physician examining you would profit more from giving you a prescription than they would from telling you that you're fine and sending you on your way.
I'm not trying to imply that bias has been entirely removed from the healthcare industry, but having independent pharmacies fill prescriptions from doctors does help. You unfortunately don't generally see this sort of separation of interests in the alternative healthcare industry, where practitioners who claim to know the secret true cause of your "dis-ease" or "lack of wellness" (blocked chi, misaligned chakras, vertebral subluxation complexes etc.) also just so happen to also offer the solution; for a price, of course.
This association between pharmacies and doctors leads pharmacies to be respected and trusted institutions. After all, we expect the person behind the counter – the pharmacist – to not only be able to dispense the correct amount of the correct drug we've been prescribed, but also to have a sufficient understanding of how it works so they can advise us on such things as precautions we should take. "Do I need to take this with food?", "Will this make me drowsy?", and so on. However, pharmacies also need to be profitable to work as a business, which is why you'll also be able to find all sorts of non-prescription products for sale such as cosmetics and non-prescription medication. Because of their involvement with the healthcare industry and respected status, it's important that these other products sold in pharmacies also be reliable, and they should not be stocked without good reason. Essentially, pharmacies should be held to a relatively high ethical standard.
In New Zealand, there is a crown entity known as the Pharmacy Council that is established by the Health Practitioners Competence Assurance Act 2003. The Pharmacy Council is responsible for duties such as registering pharmacists and setting standards of conduct, although in cases where pharmacists require disciplining that is carried out by another crown entity also established by the Health Practitioners Competence Assurance Act: the Health Practitioners Disciplinary Tribunal. In order to ensure that pharmacists are held to an appropriate ethical standard, the Pharmacy Council has developed a Safe Effective Pharmacy Code of Ethics, published in 2011, which is publicly available on their website.
In my opinion, this Code of Ethics is an admirable document, and I'm encouraged by the idea that New Zealand pharmacists might be held to such an appropriate ethical standard. For example, it defines its principles to be the following:
AS A PHARMACIST YOU MUST:
Make the health and well-being of the patient your first priority.
Promote patient self-determination, respect patients' rights, autonomy and freedom of choice.
Use your professional judgment in the interests of the patients and the public and promote family, whānau and community health.
Show respect for others and exercise your duties with professionalism.
Actively seek and apply contemporary pharmacy knowledge and skills to ensure a high standard of professional competence.
Act in a manner that promotes public trust and confidence in pharmacists and enhances the reputation of the profession.
Practise in a manner that does not compromise your professional independence, judgement or integrity, or that of other pharmacists.
The Code of Ethics goes on to expand on each of its principles in seven sections. I encourage you to read through the document, as it's interesting to come to a better understanding of the ethical standards to which New Zealand pharmacists should be held. For example, part 2.4 regards the patient's right to informed consent:
YOU MUST… Explain the options available to patients and the public, to help them make informed decisions. Make sure the information you give them is impartial, relevant, up-to-date and independent of personal commercial considerations.
The section of this Code of Ethics which I found most interesting, as well as most encouraging, is section 6.9 (emphasis mine):
YOU MUST… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
Although it is written here in this code, most people who use a pharmacy in their day to day lives aren't aware of it. Instead, it is more like an unspoken assumption: if it's sold in a pharmacy, then surely it's legitimate, reliable, and effective. And of course, this should be the case – if there is no credible evidence of efficacy then an ethical institution should neither promote nor supply it. The Pharmacy Council has also published Advertising Guidelines, and its General Principle 7 reiterates this point (emphasis mine):
Any medicine, complementary therapy, herbal remedy or other healthcare product associated with the maintenance of health must have credible evidence of efficacy and safety (Code of Ethics 2011: 6.9). Health claims for complementary therapies or herbal remedies must be able to be substantiated and must not breach the Medicines Act with regard to therapeutic purpose.
Unfortunately, it appears many New Zealand pharmacists do not abide by these rules. I was unfortunate enough recently to discover an instore display in an Auckland pharmacy for a product called "NO-JET-LAG". While I was in the pharmacy, I took a photograph of this display with my phone:
As you can see, this display makes some strong and explicit claims regarding the effect of the product:
TRY NO-JET-LAG
It Really Works
Homeopathic Jet Lag Prevention
Hang on a minute… "Homeopathic"… That sounds familiar. I wonder what exactly is in these pills? Luckily, there's a website listing their ingredients:
The five homeopathic remedies listed below are the active ingredients in No-Jet-Lag.
Arnica Montana 30C (Leopard's Bane), Bellis Perennis 30C (Daisy), Chamomilla 30C (Wild Chamomile), Ipecacuanha 30C (Ipecac), Lycopodium 30C (Clubmoss)
If you've read my post on homeopathic dilutions, you may recall that "30C" means the ingredient has been diluted by 1/100 30 times. That is a mind bogglingly large dilution. If you were to end up with just one single molecule of the original ingredient at the end of that, you'd have to start with 1060 molecules of it.
That's a hard number to visualise though, and it's hard to think of things in numbers of molecules, so let's compare it to something more familiar. The Earth is made up of roughly 1050 atoms, so the amount of ingredient we'd have to start with would be roughly 10,000,000,000 (yes, that's ten billion) times bigger than the planet. Even the Sun only has around 1057 atoms in it: still 1,000 times fewer than the number we'd need. Needless to say, after the dilution is done there is absolutely no amount of any of these ingredients remaining in any "NO-JET-LAG" pills.
Knowing this, it seems rather implausible that they'd be effective for anything at all, let alone specifically preventing jet lag, but all the same it's best to look at the evidence. The manufacturer's website has a Scientific Test page. Now, given that I have spent some time writing up a complaint to the Advertising Standards Authority because I don't think this evidence even comes close to being enough to substantiate the claims made about these products, I don't particularly want to write out the same arguments all over again. So I am going to make this complaint public. While the first section specifically regards the instore display I saw in Parnell Pharmacy on the 2nd of July, the other sections are about the evidence regarding "NO-JET-LAG" and the ethical implications of my complaint, and these sections apply to all of the many New Zealand pharmacies that promote and supply this product.
This complaint should be read with the following in mind: Assuming I am correct regarding the evidence for this product, I think the appropriate response of pharmacies stocking it would be to immediately remove it from their stock, and to apologise to the customers they have failed to protect. The Code of Ethics for an industry is the absolute minimum acceptable level of ethical behaviour, and it appears for all the world that many New Zealand pharmacies haven't even been doing that.
(Note that the original complaint was in plain text but I've edited it to add appropriate formatting here)
An instore advertisement for "NO-JET-LAG" in Parnell Pharmacy contains misleading therapeutic claims, in violation of the Therapeutic Products Advertising Code Principle 2. Because these claims are misleading, the advertisement also fails to observe the high standard of social responsibility required of it by the Therapeutic Products Advertising Code Principle 3.
The advertisement contained the following text (also see image attached):
NO-JET-LAG
Natural | Effective | No Side Effects or Drug Interactions
The Perfect Travel Companion
The product packaging, also visible from the front in the attached image, displayed this text:
Long Haul, for flights longer than 7 hours
The strong and absolute therapeutic claims "Homeopathic Jet Lag Prevention", "Effective", and "It Really Works" require robust substantiation. Although it may not fall within the ASA's jurisdiction, it is important to consider the advertisement within therapeutic context implied by its placement on the front desk of a pharmacy and by the prominently displayed name of the product "NO-JET-LAG".
As far as I can tell, the only substantiation offered by the manufacturer is a small (n=19) pilot study that does not appear to have been published in a peer-reviewed scientific journal. This pilot study can be found on the manufacturer's website: http://www.jetlag.co.nz/jet-lag6.html
Although it is not stated in the study, the POMS scale on which subjects rated their level of "fatigue-inertia" (the only measured end point reported to have statistically significant differences between control and experimental groups) is measured on a scale from 0-28. In this context, the mean difference between control and experimental groups of 3.84 is less impressive than in the context of a smaller scale that seems a sensible conclusion from reading the study, given that the y-axis of the bar chart only goes from 0-12. The non-significant measure of "vigor-activity" is similarly displayed on a chart with a y-axis from 0-22, whereas the actual scale is from 0-32.
Also, the POMS scale includes 6 measurements, yet there is no mention in the study of having corrected their statistical analysis for multiple measurements. Assuming that no adjustment for this was made, as none is mentioned in the study, this means that although one of the 6 measurements purportedly reached statistical significance it is fairly likely to have been a false positive. From random chance alone, the chance that 1 out of 6 measurements would reach this level of statistical significance is approximately 1/4 (26.5%). A relatively conservative method of correction, the Šidák correction, would alter the required p-value for statistical significance in this case to 0.0085. However, the measurement's p-value of 0.026 doesn't even come close to crossing below this threshold and would therefore not normally be considered statistically significant.
The study also brings the effectiveness of its participant blinding measures into question with the following statements:
When asked if they knew whether they had taken the remedy or the placebo, they said that at the time of arrival in Germany the whole party all felt very tired but most were already fairly sure which treatment they had taken.
On the outward journey, of the 19 taking part 13 (68%) correctly guessed whether they had taken the placebo or No-Jet-Lag. Of the others, three did not know and three incorrectly assigned themselves to the wrong group.
On the return journey, two were incorrect, three did not know and 14 (74%) correctly guessed.
Also, one of the study's authors was the Director of Research at Miers Laboratories, the manufacturer of this product. It is not clear how much influence the manufacturer had over the study design or operation, or to what extent it may have been funded by them.
So, as far as I've been able to find, the only evidence that could be used to support the very strong claims made on this advertisement is a small unpublished non-independent pilot study with questionable blinding that does not appear to have reached the threshold for statistical significance. In short, the claims do not appear to have been adequately substantiated, and should therefore be considered to violate the Therapeutic Products Advertising Code Principle 2.
Although it falls outside of the ASA's jurisdiction, I feel it would be appropriate to briefly discuss the Pharmacy Council's Safe Effective Pharmacy Practice Code of Ethics 2011. Section 6.9 of this industry code of ethics states that:
I sincerely hope that the manufacturer of this product has high quality rigorous scientific evidence that substantiates the claims made about this product hidden away somewhere and that, despite the fact that the only evidence they publicise on their website is the tiny low quality pilot study I discussed above, they have shared this evidence with every single one of the many New Zealand pharmacies who stock their product. If not, and things really are as they seem, then this would be an appallingly widespread violation of perhaps the most important part of the Pharmacy Council's Code of Ethics.
By Mark Hannain Alternative Medicine, ASA, Complaints, Ethical Pharmacy Practice, Health and Medicine, Homeopathy, New Zealand, Scepticism, Society for Science Based Healthcare 2014/07/03 2015/10/15 2,245 WordsLeave a comment