Press Council Complaint: Homeopathy in the Wairarapa Times-Age

In February this year, an article was published in the Wairarapa Times-Age (both in print and online) headlined Use of natural remedies is on the rise. The article discussed some specific cases of so-called “natural remedies” being used to treat serious diseases, such as intravenous vitamin C for leukaemia and homeopathy to treat various forms of cancer.

Except for a brief mention at the bottom of the article encouraging people with cancer to talk to their doctor before using any “alternative therapies”, there was no mention of the fact that none of the treatments discussed are supported by any reliable evidence. Instead, the article uncritically included various quotes such as this, from homeopath Claire Bleakley:

Featherston-based homeopath Claire Bleakley said she has treated cancer patients using similar natural remedies [to intravenous vitamin C] – significantly extending life expectancy.

She mentioned two of her patients in particular: A man with tumours who lived for seven years after being given two to live, and a woman with ovarian cancer who lived 15 years past her initial prognosis.

“There have been some exceptional results,” Mrs Bleakley said.

“We are indoctrinated to think chemotherapy is the only cure for cancer, but alternative [remedies] have been proven to be more life giving.”

Medical anecdotes such as these unfortunately tend to be very convincing despite the fact that they can also be completely misleading. The reasons why people might get better are varied and complex. Without running a controlled test, there’s no way to know whether or not a particular treatment contributed to an improvement in health. That’s exactly why we need to undertake rigorous clinical trials before we can say with confidence what the effects of any particular treatment are. It’s also why the Medicines Act prohibits the use of health testimonials like this in advertisements, although that restriction of course doesn’t extend to news articles in publications like the Times-Age.

I thought, and still do think, that the lack of balance in this article has the capacity to do serious harm. I wrote to the editor of the Wairarapa Times-Age to make my case, and to give some suggestions for how they might attempt to mitigate the damage this article could do, in a formal complaint:

To whom it may concern,

I am writing to you to make a formal complaint regarding the article “Use of natural remedies is on the rise” published in the Wairarapa Times-Age this morning:
http://www.nzherald.co.nz/wairarapa-times-age/news/article.cfm?c_id=1503414&objectid=11399310

This article uncritically promotes the use of so-called “natural remedies” such as vitamin C or homeopathy for the treatment of cancer. They are promoted by the inclusion of quotes such as “There have been some exceptional results”, regarding the treatment of cancer with homeopathic products.

None of the relevant controversy regarding these treatments is discussed in the article. Although there is a brief note at the end that “those living with cancer [are encouraged] to consult their doctor or specialist before embarking on any alternative therapies”, this does not sufficiently address the important and relevant fact that these treatments are entirely unsupported by scientific evidence, as well as the utter implausibility of treatments like homeopathy.

The failure to discuss the lack of scientific evidence supporting these treatments, as well as the complete lack of plausibility underlying homeopathy, violates the Press Council’s principle of “Fairness, Accuracy and Balance”. The description of this principle on the Press Council’s website states that:

“Publications should be bound at all times by accuracy, fairness and balance, and should not deliberately mislead or misinform readers by commission or omission. In articles of controversy or disagreement, a fair voice must be given to the opposition view.

Exceptions may apply for long-running issues where every side of an issue or argument cannot reasonably be repeated on every occasion and in reportage of proceedings where balance is to be judged on a number of stories, rather than a single report.”

This is not a long-running issue in which readers can readily be expected to be familiar with the lack of evidence supporting the treatments discussed in the article, so the exception should not apply. There is significant controversy surrounding the issues discussed in this article, but a fair voice has not been given to the opposition view.

Particularly as this article could lead to people living with serious diseases such as cancer to rely on ineffective treatments such as homeopathy, its lack of balance has the potential to cause real and serious harm. Therefore it is important that the Wairarapa Times-Age take appropriate action to prevent this harm by amending the article, publishing a prominent correction, or publishing a followup article linked to from today’s article, that discusses the lack of evidence and plausibility underlying the treatments discussed in today’s article.

If the Wairarapa Times-Age has trouble finding any experts to talk to about this topic, either the Society for Science Based Healthcare (http://sbh.org.nz/contact) or the Science Media Centre (http://www.sciencemediacentre.co.nz/contact-us/) will be able to help.

Sincerely,

Mark Hanna
Society for Science Based Healthcare

Despite sending a follow-up email a few days later, I still hadn’t heard back from the editor over the next 10 working days, which is the deadline set in the Press Council’s complaints process as the time to wait before escalating a complaint to them if you don’t hear back from the editor. After I forwarded my complaint to the Press Council, the editor contacted me to apologise that he’d overlooked my complaint messages, which was apparently due to his having to deal with another complaint about the same article from Peter Griffin, manager of the Science Media Centre (Peter is also the editor and manager of Sciblogs, where my blog is syndicated, and we’d discussed our complaints via email prior to submitting them).

When I forwarded my complaint to the Press Council, I fleshed it out a bit more. I won’t quote the whole thing here as a lot of it would just be repeating myself, although I’d be happy to share my full complaint if anyone would like to see it, but here is one part I added that I think is important and worth sharing:

As far as I’ve been able to tell, the Wairarapa Times-Age has not published a large number of articles regarding this, so it cannot be argued that the counterpoints have already been published in earlier articles.

When it comes to whether or not readers can be expected to be familiar with the important facts not mentioned in this article, I would like to bring the Press Council’s attention to a 2009 study (I am not aware of any more recent data collected on this) published in the New Zealand Medical Journal entitled “Beliefs about homeopathy among patients presenting at GP surgeries”. This study can be accessed for free on Page 94 of this PDF:
http://www.nzma.org.nz/__data/assets/pdf_file/0010/17794/Vol-122-No-1295-22-May-2009.pdf

This study found that only 8 out of 124 respondents disagreed to some extent that “There is good scientific evidence that homeopathy works”, and only 24 respondents reported that they believed homeopathic products were either “very dilute” or that there was “nothing there”. In contrast, 82 respondents agreed to some extent that “There is good scientific evidence that homeopathy works”, and 80 believed that homeopathic products are either “Very concentrated”, “Moderately concentrated”, or “Moderately dilute”.

Contrary to these common beliefs, most homeopathic products are diluted to the point that it is astronomically unlikely that there is even a single molecule of the original ingredient present in the product, and there effectiveness is thoroughly unsupported by scientific evidence. For example, a rigorous review undertaken by the Australian Government’s National Health and Medical Research Council (NHMRC) in 2013 investigated the evidence regarding homeopathy for 68 clinical conditions and concluded that “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”
(https://www.nhmrc.gov.au/_files_nhmrc/file/your_health/complementary_medicines/nhmrc_homeopathy_overview_report_october_2013_140407.pdf)

For this reason, and especially because the article discussed the use of ineffective therapies in the treatment of terminal illness, it is very important that stories such as this be balanced. As I stated in my original complaint to the editor, I believe the article in its current form has the capacity to do serious harm and that the Wairarapa Times-Age has a responsibility to mitigate this harm. An appropriate response would be amending the article, publishing a prominent correction, or publishing a followup article linked to from the article from the 10th of February that discusses the lack of evidence and plausibility underlying the treatments discussed in today’s article.

(The NHMRC link I provide there is from their 2013 conclusion. Within 2 weeks of submitting this complaint, however, they released their final statement on homeopathy, which states “there are no health conditions for which there is reliable evidence that homeopathy is effective”. This statement was not reported in the Wairarapa Times-Age)

Once the complaint was escalated to the Press Council, the editor of the Times-Age was given an opportunity to respond, then I had a final opportunity to write a short response to that. His primary argument was that the topic of “alternative medicine” was a long-running issue in a wider context, and that the exemption to the principle of balance should apply because other media have reported on the opposing side of the issue.

I strongly disagree with this argument. Although it’s true that media like the Wairarapa Times-Age do not exist in a vacuum, I don’t think this should mean that they don’t have a responsibility to provide balanced articles for their readers. The way I interpret the Press Council code, the exception can be useful when an article is part of a series of articles on the same issue, and when taken in the context of other articles in the series the overall view still maintains an appropriate balance. In the interest of balanced reporting, I believe exceptions to the principle of balance should be applied very sparingly.

Unfortunately, the Press Council disagreed with me. They have ruled not to uphold the complaint, and you can view their entire decision on their website here:
Case Number: 2426 MARK HANNA AGAINST WAIRARAPA TIMES-AGE

Here’s a link to their similar ruling regarding the complaint from the Science Media Centre:
Case Number: 2425 SCIENCE MEDIA CENTRE AGAINST WAIRARAPA TIMES-AGE

Here is a summary of their decision:

The Press Council agrees with the editor that the debate over alternative remedies is sufficiently well known not to require balancing comment in every story about them. The subject falls within the exception to the principle of balance for issues of enduring public discussion.

The complainant in this case raised the important question of whether the exception can be invoked for an article in a newspaper that may not itself have covered both sides of the debate. The Council considered this point closely and came to the view that the exception has not been applied as narowly as the complainant contends and should not be. A newspaper, even if it is the sole newspaper of its locality, does not exist in a vacuum. Its readers, meeting an uncritical story on the supposed popularity of homeopathy and natural remedies, are likely to be aware the efficacy of these treatments is strongly contested by medical science.

I think this is a very worrying precedent to set. Newspapers such as the Wairarapa Times-Age can now feel justified in publishing unbalanced articles on topics such as homeopathy without feeling bound to uphold the Press Council’s principle of balance. The public have a reasonable expectation, given that the Press Council exists to uphold standards in reporting and its first principle is that articles should be accurate, fair, and balanced. While it’s a good idea to take everything you read with a grain of salt, you should be able to feel justified in expecting media reports on controversial topics to provide a balanced view. I worry that people might read articles such as this with that assumption in mind, and falsely conclude that the views omitted from the article are not merited.

I’m also rather frustrated that the Press Council concluded that anyone reading articles such as this is “likely to be aware the efficacy of these treatments is strongly contested by medical science” even though I provided data from a survey that found only 6% of respondents disagreed that “there is good scientific evidence that homeopathy works”. I understand that the survey I cited was conducted 6 years ago, but as I said in my complaint I’m unaware of anything more recent.

Although I don’t think it is, I really hope that the Press Council’s conclusion that most people are aware that homeopathy is not supported by evidence is correct. Following last year’s story about Green MP Steffan Browning backing homeopathy for ebola and March’s story about the Australian National Health and Medical Research Council concluding that homeopathy does not improve people’s health, I think there is some basis to believe that more people are familiar with the lack of evidence surrounding homeopathy than 6 years ago, but I don’t expect there would be that large a difference.

One positive thing to take away from this, at least, is that the journalist who wrote the article said in a Facebook comment that she understood the article was unbalanced and that she should have done better. I hope she’ll take this as a learning experience and, when she or other Wairarapa Times-Age reporters write on matters of “natural health” in the future, that they get in touch with the Science Media Centre to provide that much-needed balance. If we can’t rely on the Press Council to hold journalists to a high standard of balanced reporting, then we’ll have to rely on journalists’ and editors’ own standards.

EDIT 2015/04/14 10:05 am: Peter Griffin, who also complained to the Press Council about this article, has published his thoughts on the ruling as well: When balance goes out the window

EDIT 2015/04/04 1:13 pm: The Wairarapa Times-Age has published a short article on this ruling: Times-Age supported by Press Council

EDIT 2015/04/14 2:21 pm: Grant Jacobs has also published a post with his thoughts on this ruling: Press Council rules on knowing readers minds?

EDIT 2015/04/15 2:51 pm: Andrew Bonallack, the editor of the Wairarapa Times-Age, has published his thoughts on the Press Council decision in an opinion piece for the Times-Age: Your right to choose sacrosanct

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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.

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:

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.

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:

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:

  1. Make the health and well-being of the patient your first priority.
  2. Promote patient self-determination, respect patients’ rights, autonomy and freedom of choice.
  3. Use your professional judgment in the interests of the patients and the public and promote family, whānau and community health.
  4. Show respect for others and exercise your duties with professionalism.
  5. Actively seek and apply contemporary pharmacy knowledge and skills to ensure a high standard of professional competence.
  6. Act in a manner that promotes public trust and confidence in pharmacists and enhances the reputation of the profession.
  7. 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:

NO-JET-LAG

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

Effective

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):

TRY NO-JET-LAG
It Really Works

NO-JET-LAG
Homeopathic Jet Lag Prevention
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:

The Perfect Travel Companion

NO-JET-LAG
Long Haul, for flights longer than 7 hours
Homeopathic Jet Lag Prevention

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:

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.

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.

Homeopathy and Anecdotes

In the Herald today, a letter to the editor from a Mr Barry Davis was published regarding an article about a recent scientific report on the evidence regarding homeopathy published by the Australian National Health and Medical Research Council: Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence

The report evaluated the evidence regarding homeopathic treatment of several conditions, and drew the following conclusion:

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.

This letter to the editor, given the title “Homeopathic treatment”, mostly took the form of an anecdote. As far as I am aware letters to the editor are not published online, so here it is in its entirety:

I strongly disagree with your Saturday article on homeopathy. After having open-heart surgery for a faulty valve, I had a series of transient ischaemic attacks (mini strokes).

This resulted in seven visits to hospitals, totalling 42 days, numerous tests and scans, and two outpatient visits. The doctors told me they had no idea what was causing the strokes.

If the cause is not found, and treated, it could lead to a full stroke.

A relative, who has a PhD in chemistry and a diploma in homeopathy, took an interest in the problem. She recommended a homeopathic treatment, and in the last year, whenever I have felt an attack coming on, I have taken two of her pills and sat down, and the attack has stopped.

The only time in the last year that I have had an attack is when I twice failed to carry the pills.

Five years ago, I had a problem with recurring sore throats and congestion – this was also cured by homeopathic treatment.

I do not criticise the doctors or the hospitals – they tried and could not find the solution – but I firmly believe the medical profession and alternative medical practitioners should work in parallel, and each recognise the other.

Citing anecdotes seems to be a common way to defend modalities such as homeopathy, which are not supported by rigorous evidence. Unfortunately, personal stories can often be much more convincing than they should be. I am sending a letter of my own to the editor of the Herald in response to this one.

As I can’t be sure if it will be published, or if sections will be removed (although I’ve tried to keep it brief), I will publish it fully here as a rebuttal to the strategy of attempting to defend homeopathy against this report by citing personal experience.


There was once a time when medicine was based on personal anecdotes such as that of your correspondent Barry Davis. This philosophy gave rise to such false ideas as the four humours and ineffective and harmful treatments like bloodletting, for which there was no shortage of anecdotes.

It is only with the advent of medical science, particularly the randomised clinical trial, that we have become able to truly test medical interventions. Isolated cases such as Mr Davis’ still have a place in medical science, but they are considered the lowest form of evidence and best used in deciding where to allocate resources for testing treatments. There is good reason why our own Medicines Act prohibits their use in medical advertisements.

In order to provide safe and effective healthcare, doctors need to be able to accurately predict the outcomes of a treatment. Relying on poor evidence, like anecdotes, is likely to lead to inaccurate predictions and lower quality healthcare.

It is only by assessing high quality evidence, like in the recent report from the Australian National Health and Medical Research Council that looked at the best evidence regarding homeopathy, that we are able to reliably provide high quality healthcare.

If you really care about the truth then evidence trumps personal experience, not the other way around. If you really care about whether or not homeopathy is effective, then you need to follow the evidence where it leads, even if it does not line up with personal experience. Currently, as the aforementioned report concludes, that means:
“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.”


Update 2014/04/24 8:38 a.m.

My letter to the editor was published in the Herald this morning. It looks like it was kept pretty much intact, the only difference I noticed is that the very end was edited to appear as though the conclusion I quoted from the report was in my own words.

The Miasm Theory of Disease

Living in Denial

In 1828, Hahnemann published his book The Chronic Diseases, in which he described his theory of miasms as the origin of disease. The three “miasms” described in this book “are held to be responsible for all disease of a chronic nature and to form the foundation or basis for all disease in general”1. Miasms are supposedly ways in which a person’s “vital force” can be tainted, and homeopaths maintain that they are heritable2.

This idea of Hahnemann’s both predates and opposes the modern established science of germ theory, stating that all contagious diseases are caused by microorganisms3, which is a fundamental part of modern medical science. Basically, Hahnemann’s opposing theory has been disproven.

However, Hahnemann’s 19th century theory of miasms as the origin of chronic disease is alive and well in the practice of homeopathy, where it is “now generally accepted by most homeopaths without question”1. While actual medical doctors recognise that infectious diseases such as influenza are caused by microorganisms and are able to effectively treat them as such, homeopaths that subscribe to Hahnemann’s outdated miasm theory of disease are still claiming that the predominant cause of all chronic disease is the miasma known as Psora, or “itch”.

Essentially, these homeopaths are living in denial – trying to practise medicine as though germ theory has never even occurred to anyone. Trying to practise medicine, essentially, as though it were still prior to the 1860s.

It is worth noting, however, that at the time of its inception homeopathy appeared to be effective. The reason for this is that contemporary medicine, consisting of practices based on the misguided idea of the four humours (such as bloodletting), tended to do more harm than good.

In contrast, homeopathy had no active effect on its patients, although it would elicit a similar placebo response (a phenomenon unheard of in those times) to the harmful treatments, without the same detrimental effects. As a result, those treated by contemporary medicine would tend to do worse than those left untreated, who would again tend to do worse than those treated with homeopathy. Even though the homeopathy itself had no effect, it seemed to be effective.

Today, however, we know better. When compared against a similarly administered placebo, the effect of homeopathy is shown again and again to be no stronger. While there may be some statistical flukes in which the result is in the favour of one or the other (if you test something enough, occasionally you’ll get a strange result simply by chance) the overall body of scientific evidence points overwhelmingly toward the conclusion that homeopathy is nothing more than a placebo.

References

  1. Morrell, Peter. Hahnemann’s Miasm Theory and Miasm Remedies. Homéopathe International [updated 24 December 2004; cited 04 April 2012]. Available from: http://homeoint.org/morrell/articles/pm_miasm.htm
  2. Modern Homoeopathy. [cited 14 April 2012]. Available from http://www.modernhomoeopathy.com/miasms.htm
  3. WordNet Search. Princeton University [cited 04 April 2012]. Available from http://wordnetweb.princeton.edu/perl/webwn?s=germ+theory

Homeopathic Dilutions

Much Ado About Nothing

After realising that giving sick people substances that caused the very symptoms he was trying to cure, Hahnemann realised that something needed to change. Instead of deciding that his principle of “like cures like” was perhaps wrong, Hahnemann decided that instead what he needed to do was dilute his remedies.

Hahnemann went further than simple dilution, however. His idea involved serial dilutions, with each step punctuated by a vigorous shaking of the dilution container. According to Hahnemann this shaking, known as “succussion”, would activate the “vital energy” of the substance1. It is here that homeopathy essentially became magic.

According to homeopathy, this process of serial dilution and succussion would prevent a substance from causing the symptoms that it could be expected to cause when given to a healthy person but still allow it to cure those symptoms via the (incorrect) principle of “like cures like”.

The claim becomes even more scandalous when you realise just how far homeopathic remedies are diluted. Each step of a serial dilution is generally a dilution of 1 in 10 or 1 in 100. The number of steps, size of each step and sometimes the method used are labelled on the remedy. The number of steps comes first, followed by the size of each step represented by a roman numeral. For example, a dilution of 30C (a common homeopathic dilution) consists of 30 steps of a 1 in 100 dilution.

Let me say that again. A common homeopathic dilution involves diluting the original substance by 1 in 100 30 times. As an example, let’s imagine a homeopathic dilution of gold (which was one of the common remedies listed on ABC Homeopathy – listed as “Aurum Metallicum”), starting with an enormous but simple amount of one mole. From Avogadro’s constant, which was unknown during homeopathy’s inception, we know the number of atoms or molecules in one mole. For gold, this amount would weigh about 200g; if it were a cube would be just over 2cm across.

After 10 dilutions of 1 in 100, we would expect to have just over 6000 atoms remaining. After 12 dilutions, we’re almost just as likely to have a single atom left as we are to have none at all. After all 30 dilutions, the probability that there is even a single atom remaining is astronomically low. So low, in fact, that for all intents and purposes it should be considered to be 0.

Now, let’s take another approach to our thought experiment. We know that the total number of atoms in the visible universe is likely to be somewhere between 1078 and 1082. Taking the liberal estimate of 1082, we can estimate the same dilution of 30 serial dilutions of 1 in 100 on the entire known universe. At the end, we would expect to have around 1022 atoms left, which is about 1/60th of 1 mol – the number of molecules in 0.3 mL of water. And that’s from the entire universe! Homeopathic dilutions that go so far as 200C are far from unheard of, either.

The idea that homeopathic remedies supposedly become stronger as they become more diluted (when dilution is accompanied by succussion) goes directly against the dose-response relationship. There has never been a plausible mechanism put forth by which shaking a solution can impart any properties of the diluted substance to the diluent. What’s more, the claim that such a phenomenon exists at all has not held up to rigorous scientific testing.

However, the fact that homeopathic remedies rarely contain any of the original active ingredient likely won’t bother many homeopaths. The reason for this is that, supposedly, the act of succussion at each dilution step “releases and concentrates the spirit-like, healing essence of the substance derived from its animal, botanical or mineral source”1. Basically, this process of “Dynamization” removes all material trace of the original medicinal substance and leaves behind only its “spirit-like, healing essence”. To quote Hahnemann himself2:

The homœopathic healing art develops for its purposes the immaterial (dynamic) virtues of medicinal substances

It isn’t usually marketed this way, but homeopathy can be placed squarely in the pseudoscientific category of so-called “energy healing”.

References

  1. Glossary of Homeopathic Terms. Omaha: Creighton University School of Medicine [updated 03 August 2009; cited 04 April 2012]. Available from: http://altmed.creighton.edu/Homeopathy/Glossary.htm
  2. Hahnemann, Samuel “§ 11”, “§ 270” Samuel Hahnemann’s Organon of Homœopathic Medicine. New York: William Radde, 1849. 99, 217. Google Books. Web. 04 April 2012.