What sort of anti-vaccine books do homeopathic pharmacies sell?

Vaccination is a key component of the strategic to deal with anti-microbial resistance, as the recent Review on Antimicrobial resistance set out.(1) The GPhC, the UK regulator of Pharmacies, are concerned enough about the professional role pharmacists have in tackling anti-microbial resistance to carry an interview about this important subject with the Chief Pharmacist Keith Ridge in their house journal.(2) Yet, registered UK pharmacies are able to continue selling anti-vaccine books, as the GPhC, has decided not to take forward complaints about these sales to their investigating committee.

As previously noted on this blog, pharmacists and pharmacies have professional standards (currently out for review) which the GPhC enforce, to ensure that pharmacists are safe and protect the public from harm. This does not just mean individuals, but the broader public health. Pharmacists are not meant to provide misleading impartial or out-of-date information.

The invention of written communication was the most important steps forward in human development. Regardless of whether it is a Mesopotamian clay tablet, a book, or an ebook, the ability to provide written information has changed and continues to change the world. Books have been one of the main forms of information exchanges for centuries.

The selling of a book is therefore the provision of information.

This is a simple, irrefutable, yet important point.

So what sorts of book do these UK registered pharmacies sell? Here’s one.

sussman

This is described as a “Measured contribution to the vaccine debate; weighs up pro’s & con’s of each individual vaccine; the evidence re autism, & the likely impact of the combined MMR. jab.”

Note that the website contains a link to NHS Choices online Is Vaccination Safe? This is a reputable website for vaccine information, and presumably provided as some protection against the accusation that the pharmacy is providing poor information.

Sumerian_account_of_silver_for_the_govenor_(background_removed)

An early form of information.

So what is in Sussman’s Understanding MMR? First off, it is worth noting that the book was published in 2007, so is now 9 years out of date. At the time of publication it was 9 years after the initial concerns about MMR safety raised by Andrew Wakefield in The Lancet and at the infamous press conference at the Royal Free. By 2007, GMC hearings were looming for Wakefield, there was a large amount of data showing no link between MMR vaccine and autism, and the legal aid paid to Wakefield had become public knowledge.

Understanding MMR is written by a homeopath. It is a slim 32 page book, with pretensions to credibility (such as Vancover referencing). After the introduction, it runs through measles, mumps and rubella infections, then in a series of brief assessments, the immunisation options. These are set out as:

  • OPTION 1: The triple vaccine MMR jab
  • OPTION 2: The single vaccines
  • OPTION 3: Giving the MMR jab when older
  • OPTION 4: No vaccinations
Underplaying the benefits of vaccines is a common anti-vaccine trope
Underplaying the benefits of vaccines is a common anti-vaccine trope (figure from Sussman’s Understanding MMR)

As well as downplaying the risk of childhood diseases, the book gives a number of “tips” on improving the immune system to deal with such infections, including sleep, exercise, and happiness. It also says that “homeopathy is a safe and effective way to increase your child’s immunity and ability to fight disease” and that it can “offer constitutional treatment to boost a child’s immunity so that if they get the disease, then they are better able to fight it.” There is no scientific basis for this effect, nor evidence that such an effect has been demonstrated.

In a personal note about vaccination, citing her experience of her child crying after a DTP vaccine, and her work with vaccine damaged children, she finishes by noting that “homeopaths believe that vaccinations lower a child’s immunity. Furthermore, without vaccinations, your child may get a childhood disease such as measles. Thereafter, she would not only have immunity from measles for life, but she would pass this immunity on to her children for the first few months of their lives, when they are at their most vulnerable.”

The conclusion states that “If your child is healthy, eats well, and has plenty of fresh air, then you might not worry about him getting measles, as long as you take care to avoid passing it on to vulnerable people”

An excellent paper by Anna Kata gave an overview of the tactics and tropes used by the online anti-vaccination movement.(3) This book does rely on one of the major tactics used by the anti-vaccination movement: skewing the science. In the two page commentary on autism and MMR vaccine, it provides a highly pro-Wakefield view of the link between inflammatory bowel disease, autism and the MMR vaccine. It also gives a very partial view of the epidemiological data showing no link, and counters this with anecdotal experiences and claims of a link.

Sadly, I appear to have reached the end of the road in trying to get the GPhC to take this seriously. After my initial complaint I responded to the GPhC. The results of that are here. Having looked into potential ways forward, there appear to be no mechanisms of complaint/review available that do not end up back in the GPhC’s court. Further correspondence appears to be pointless.

Pharmacies can continue to sell anti-vaccination books.

  1. Review on Antimicrobial Resistance. Vaccines and Alternative approaches: Reducing Our Dependence on Antimicrobials. February 2016. [PDF)]
  2. General Pharmaceutical Council. Tackling Antimicrobial resistance. Regulate. 2013; 12:7 [PDF]
  3. Kata A. Anti-vaccine activists, Web 2.0, and the postmodern paradigm–an overview of tactics and tropes used online by the anti-vaccination movement.Vaccine. 2012 May 28;30(25):3778-89. doi: 10.1016/j.vaccine.2011.11.112.A presentation given by Anna Kata on her findings is here [PDF], which includes the tactics and tropes.

Previous posts about this matter:

Registered Homeopathic Pharmacies Can Sell Anti-vaccine Books (initial concerns)

Pharmacies can sell anti-vaccine books (initial GPhC response).

 

Pharmacies can sell anti-vaccine books.

Goya, "Los Caprichos": The sleep of reason produces monsters, 1799.

Last August I submitted a complaint to the GPhC (the pharmacy professional regulator) about two homeopathic pharmacies. Both pharmacies were selling anti-vaccination books. The GPhC’s tagline on their website is “Upholding standards and public trust in pharmacy”, so I felt given the misleading nature of such information I ought to send in a complaint.

They have now made a decision not to refer the complaint to the investigating committee. They have instead issued advice to the two companies reminding them to adhere to the Professionals Standards set by the GPhC (bold emphasis my own):

4.3 Explain the options available to patients and the public, including the risks and benefits, to help them make informed decisions. Make sure the information you give is impartial, relevant and up to date

6.2 Not abuse your professional position or exploit the vulnerability or lack of knowledge of others

6.4 Be accurate and impartial when you teach and when you provide or publish information. Do not mislead or make claims that you have no evidence for or cannot justify

It has been interesting being a complainant to the GPhC, and I have had no complaints with the staff I have dealt with, who were professional in their approach to me.

My original complaint was that anti-vaccination books were being sold from registered pharmacies and that this was incompatible with being a member of the pharmacy profession (by breeching the Professional Standards 2012 – see above). I also argued that this put patients at risk by promoting anti-vaccination books.

This was the GPhC’s series of points that address my complaint.

GPhC Ruling Homeopathy

The following are some brief partially formed thoughts.

The first argument that the books are “hidden” seems irrelevant. Virtually all websites require members of the public to navigate around the site to find items for sale. The argument that the books are therefore some form of hidden item, and that clicking through to them is some sort of explicit consent to be misinformed is an assumption.  In any case, the professional standard that “Make sure the information you give is impartial, relevant and up to date doesn’t have a qualifier “except where you have hidden it behind the counter or off the front page of your website”. It also isn’t clear that the professional standards related to misleading or providing out of date information only applies to patients/customers. The same surely applies to the supply of information to other practitioners, and that should include even homeopathic practitioners.

That point also applies to the second bullet point. The fact that the customer profile of the books was homeopaths or customers with a clear interest in homeopathy does not absolve the pharmacies of their professional responsibility. If a patient decides to buy a drug that interacts with other medication which would cause harm, the pharmacist has the right and responsibility not to supply. The same applies here. There is a professional responsibility not to sell information to either homeopaths or customers that may cause harm to children (either through a parent’s decision not to vaccinate, or a homeopathic practitioners decision to advise patients on the basis of the information in these books). The buck stops (or rather doesn’t) in the pharmacy (see professional standards 4.3, 6.2, 6.4 for clear statements to that point).

The third bullet point, seems to be suggesting that the pharmacists’ professional responsibilities can be diluted by telling customers to seek independent medical advice. Really? Comment is made about training of staff members. One hopes they don’t use the books they sell as training material…

The fourth point, about not receiving a complaint. I am a member of the public. I have complained. Homeopaths aren’t going to complain. Do we have to demonstrate harm before drawing attention to poor practice? I have no doubt that dangerous professional practice found on a registered pharmacy related to the supply of prescribed medicine when a GPhC inspector visits would be dealt with on the basis of future risk to patients. Why is this any different?

Is the sale of misleading anti-scientific material about vaccination from a registered pharmacy “Upholding standards and public trust in pharmacy”?  Put that starkly I suspect most would say no. Breaking this case down into constituent “trees”, the “wood” starts to dissolve. This needs to change.

The professional standards are clear: “Make sure the information you give is impartial, relevant and up to date.” There is no possible way that the sale of anti-vaccine books is compatible with this statement. If anyone can explain how it is in the comments, I would be most grateful.

When it comes to the professional responsibilities of pharmacies supplying anti-vaccination books, the buck should stop here. Sadly, in this case, the books are staying there instead.

Registered Homeopathic Pharmacies Can Sell Anti-Vaccine Books

[There is an update at the bottom of this webpage, which I will keep updated as further information arrives]

Last week, I discovered that two UK homeopathic pharmacies (Helios and Ainsworths) were selling anti-vaccination books. This is no surprise, since homeopaths have a track record of engaging with anti-vaccine views as found by Schmidt & Ernst in 2002 (as one example), and on occasion have been found to be providing ineffective homeopathic alternatives to vaccines in the UK. Concern has been expressed that regulators are not taking this issue seriously enough.

This is the sort of book they were selling (several were for sale).

Anti-vaccine book sold at Helios
Anti-vaccine book sold at Helios

Pharmacies in the UK are regulated by the General Pharmaceutical Council (GPhC), they exist to ‘protect, promote and maintain the health, safety and wellbeing of members of the public by upholding standards and public trust in pharmacy.’ The GPhC has stated in 2011 that they would continue to monitor the situation in one pharmacy after the selling of homeopathic malaria prevention treatments‘the information gathered as part of the (recent Newsnight) investigation including the original complaint may be taken into account if we receive any further complaints about the pharmacy professional in the future.’

I was therefore hopeful that action, or at the very least an investigation, might happen when I complained to the GPhC about the two registered pharmacy premises who were selling the books, and additionally I noted that a homeopathic preparation (pertussin homeopathic remedy) that could be used as a homeopathic vaccine was being sold by one.

Despite being pretty much an absolutist on free speech, I feel this is appropriate. That is, I do not have a problem with the publication or selling of anti-vaccine literature from bookshops, my only concern is that registered healthcare professionals are supplying this material from registered premises.

In my opinion, the selling of anti-vaccine books by a registered pharmacist/pharmacy is incompatible with the Code of Conduct for Pharmacists.

I have received a prompt response from the GPhC this morning to my complaint. They have not investigated my complaint, but have looked at whether it sits in their area of jurisdiction.

GPhChomeopathyresponse-1

 

The response raises a number of issues for me since it dropped through the postbox this morning:

1. How can someone be fit to practice as a pharmacist (which includes knowledge) and knowingly sell an anti-vaccination book?

2. Is selling an anti-vaccine book from a pharmacy purely a commercial matter? I might agree if I had complained about hair dryers or cameras. Does the pharmacy regulator not have a role in public health? Remember they exist to ‘protect, promote and maintain the health, safety and wellbeing of members of the public’. Does this mean anything if pharmacists can sell anti-vaccine books? Can they sell cigarettes on this basis too?

3. There is a hole in regulation. Selling anti-vaccine books, and selling homeopathic remedies that are suggested in those books is tantamount to putting an indication on the remedy.

4. There is no evidence that a registrant is acting outside of their competency. Isn’t a pharmacist in control of a registered premises? If so, isn’t the fact the book is on sale evidence they are dangerously ill-informed, and a threat to public health?

5. There is no evidence they holding themselves to be anti-vaccine specialists.  I am not sure that is important. I was not making the accusation they are anti-vaccine specialists in my complaint, but implying their are vaccine ignorant. Selling anti-vaccine books shows a startling lack of knowledge of immunity, the science of vaccination and public health. How is that compatible with professional registration as a pharmacist?

I’m not a fundamentalist on homeopathy, I can see how differing health beliefs of patients might lead them to use such products, despite the lack of plausible mechanisms, and evidence for their effectiveness. I also have some issues on how pharmacists are targeted as suppliers of homeopathy by skeptics, when they may well be employees with little to no control over stock in their store (unlike their superintendent pharmacists). However, in this case it seems clear-cut to me that products dangerous to public health are on sale from a registered pharmacy, which is under the control of a pharmacist.

And there is apparently nothing to be done about it.

NOTE: A big thanks to eagle-eyed Rob who spotted this material in the first place

UPDATE 11th September 2015

The GPhC have noticed this post and treated it as a complaint, and combined it with a review of my initial complaint. A Fitness to Practise investigation into these concerns has been initiated, an apology was issued about the initial letter’s inaccuracies, and the GPhC are identifying improvements that can be made to the initial assessment of concerns. They have promised to keep me updated about progress on the investigation. This is reassuring news.

 

 

Let’s have some over-the-counter evidence

I have an editorial in The Pharmaceutical Journal on over the counter medicines and pharmacists relationship with them. Here’s part of it:

While the secret shopper work carried out by the consumer watchdog Which? in 2013 investigated[1] the quality of advice on OTC medicines given in pharmacies at the point of sale, an earlier report[2] in Which? published in 2012 focused on OTC products themselves. Among the products that were judged to be below par were sub-therapeutic doses of drugs, dubious herbal slimming tablets, oils that allegedly reduce scarring and some highly implausible alternative remedies. A pharmacist drawing up a local formulary of prescription drugs for a GP would take into account evidence of effectiveness, advice from evidence-based guidelines and a positive risk-benefit ratio. How many OTC products would reach the required standard?

Read more…

Ecigs and pharmacist autonomy

The surge in the use of ecigs has taken the health sector, including professional bodies, the pharmaceutical industry and regulators, by surprise. It’s a fascinating rise of a novel new delivery system, which has happened outside of the normal regulatory process.

This post isn’t about the evidence as to whether ecigs are harmful, whether they are a gateway to smoking, or whether they are an effective form of smoking cessation therapy (in future, they may have a role, but that should be after normal scientific evaluation and regulatory processes), but about the issues of professional autonomy they raise for pharmacists, and whether they are a good test case for exerting that autonomy.

Yesterday the Chief Pharmacists of the UK published an open letter raising concerns about ecigs. Their main points were:

  1. Health, safety and well-being of patients must be the first concern of pharmacy owners and superintendent pharmacists (as it is for pharmacy staff)
  2. Pharmacy staff should be empowered to exercise their professional judgement in the best interest of patients and public
  3. They point out ecigs are unlicensed and have limited scientific evidence
  4. They say they do not support their use as smoking cessation aids and that they should not be presented as having any therapeutic value

The response from companies who have decided to stock ecigs is interesting. Boots have agreed with concerns, suggesting that their decision to spend two years developing a ecig offering with a company is a responsible way forward. They hope to be the first to get a licensed preparation. Before that happens, Boots seem happy to sell an unlicenced product with no proven therapeutic value. Lloyds has said it is not selling ecigs as nicotine replacement therapy. Which begs the question what are they selling them for? None of this counters the concerns of chief pharmacists about the suitability for ecigs as a product pharmacy sells. At best, it is mitigation for a wrong decision to stock an unlicensed ecig in the first place.

Individual pharmacists are faced with the fact that their companies, and their superintendent pharmacists,  are happy to stock a product that is:

  • Not proven to have a therapeutic benefit
  • Is unlicensed
  • Is unsupported by the Royal Pharmaceutical Society
  • Is strongly felt should be a licensed product by the government and the MHRA
  • Is a matter of concern for all the Chief Pharmacists in the UK
  • Is also a matter of concern to the GPhC, who feel the RPS and MHRA guidance should be considered.

They should ask themselves if they are equally happy about this (and some may be).

They could of course, just ignore the ecigs and follow the advice that they tell patients they are not a smoking cessation aid. That still leaves them in the position of supplying a product they might not have personally stocked in the first place.

It is arguable that if acting as the responsible pharmacist within a pharmacy you could make a good case for removing any ecigs from display within the registered pharmacy premises on the grounds of maintaining the health, safety and well-being of patients. Certainly, you have the GPhC, the RPS, the MHRA, and all the Chief Pharmacists to support your stance. The fact that the superintendent of the company has a different opinion, does not invalidate your own professional judgement. In reality, it isn’t that simple. There may be local pressure from non-pharmacist managers who do not feel it is the place of pharmacists to make this decision – after all they have material from head office saying this is a perfectly OK product. The pharmacist may be putting themselves in a difficult position in terms of future performance reviews. It would be nice if superintendent pharmacists actually issued a statement that such action would be permissible, that the professional autonomy of individual pharmacists on stocking such products was key and that no detriment would come to pharmacists who made this professional judgment.

As for regulators, in a recent case of MUR fraud the GPhC recently said:

“What we have to ask ourselves is whether, when there are pressures [and] mistakes, as inevitably there will be, can we have confidence that the registrant might be able to stand up and not ‘buckle’?”

Should it always be down to individual pharmacists having to exert their professional independence in a battle of wills? Is that the best we can do? Hope people don’t “buckle” when they are under immense work pressures? Is it time for regulators to regulate the industry in a manner that reduces the toxicity of this commercial environment, and help create a more supportive environment for individual acts of professionalism? Of course individuals need to take responsibility, but it is naive to think that the environment they practice in has no influence. Recent NHS scandals note both the role of individuals and the culture of organisations. Could the GPhC exert more control over superintendents? Could they make it clear that employee pharmacists should have the professional autonomy as individual pharmacy owners to remove items from sale they feel are incompatible with the best interests of patients and the public? Ecigs make a great test case for what actual control pharmacists over the materials they provide to the public, just as GPs have control over what they prescribe to the public.

And from there we might make some other steps forward on OTC medicines and homeopathy….

Photograph: Creative Commons from Vap in Liberty.