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 Pharmacists are not meant to provide misleading impartial or out-of-date information.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 First off, it is worth noting that the book was published in 2007, so is now 9 years out of date.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.

Why Wakefield’s autism-MMR association claim was wrong

The number of cases of measles continue to rise in Wales, a man has died with measles, and private clinics continue to profiteer from the fears of an association between MMR vaccine and autism. I’ve decided to put up a post-print of a paper I wrote with a real life “rocket scientist”, from NASA’s Jet Propulsion Labs, about a graph Wakefield was allowed to have published at The Lancet. This is the paper as accepted for publication by Drug Safety. The final published version can be viewed hereCox AR, Kirkham H. A Case Study of a Graphical Misrepresentation: Drawing the Wrong Conclusions about the Measles, Mumps and Rubella Virus Vaccine. Drug Safety 2007; 30(10): 831-836

A case study of a graphical misrepresentation: Drawing the wrong conclusions about MMR vaccine

Anthony R Cox, Harold Kirkham

Abstract
Graphs have been used in attempts to show a relationship between the MMR vaccine and autism. We examine the topic of graphical representation of data in general, and one of these graphs in particular, the one in a 1999 letter to The Lancet. That graph combined data from England and from California. The author alleged that this graph illustrated a rise in autism rates linked to the use of MMR vaccine. By examining the presentation closely, we are able to show how this graph misrepresented the data used. We give advice for both authors and publishers in the use of such graphical treatments of data.

Introduction

Graphs are often used in scientific and technical papers. They can make things easier to understand. They can clarify relationships. They can allow straightforward extrapolation. They can present a lot of data concisely. However, they can also confuse and deceive, so they should always be constructed carefully by the author and viewed carefully by the reader. The controversy over a link between MMR vaccine and autism provides an example of why.

The 1999 Lancet graph

The publication in 1998 of a paper by Andrew Wakefield and co-authors [1], and a subsequent controversial press conference at which Wakefield called for suspension of the triple MMR vaccine [2], led to a crisis in confidence about MMR vaccine which has had a detrimental effect on vaccination rates. [3] However, in 2004, the 1998 paper was retracted by ten of the authors [4], and the editor of the Lancet stated the publication of the paper would have been handled differently if the full context in which the research had been done had been known [5]. Public confidence in MMR vaccine has subsequently risen, with increased uptake of MMR vaccine in 2005-2006 [6].

The 1998 paper was not the only contribution to the MMR vaccine debate to appear in The Lancet. In September 1999, one of the original 1998 paper authors published a letter in The Lancet [7], containing a graph combining data from the Department of Development Services in California, with data from England obtained from a paper by Taylor et al [8]. (Figure 1) The graph was used to allege that both sets of data illustrated a rise in autism rates coinciding with the introduction of MMR vaccine in each country.

 

 

 

 

 

 

 

Figure 1: The original graph published by The Lancet

The original caption accompanying the graph was

Temporal trends for autism in the USA (California*) and the UK (north-west London) In 1998 the expected numbers of newly diagnosed autistic children in California should have been 105–263 cases, according to DSM-IV; the actual figure was 1685 new cases. The temporal trend in north-west London is almost identical, although the rise is delayed by about 10 years. The two countries use the same diagnostic criteria. The sequential trends are consistent with the timing of introduction of MMR to both regions.
*Data from Department of Developmental Services, Sacramento,1987-98 (www.dds.ca.gov)

It is not uncommon to use a time-series graph such as this to show correlation between two variables. Probably the example that springs most readily to mind is the similarity between planetary temperature variations and carbon dioxide levels shown by studies of ancient ice. But it is often not good practice to use a time-series. Sometimes, the supposed association can be demonstrated only weakly. In any case correlation does not imply causation.

In the case of the autism data of Figure 1, the two data sets do not have a cause-and-effect relationship. They are presented by Wakefield as if both curves represent an effect (autism) with a common cause (MMR vaccine). Were that truly the case, the graphical approach would be both valid and useful. However, as we shall see, it is misleading to show the two curves in this way.

The California data were obtained from a 1999 graph produced by the Department of Developmental Services [8]. The authors of this diagram were at pains to point out in their report that their graph did not show how many people entered their system in a given year, but instead the number in the system born in any given year. The graph was a distribution of birth dates. They argued that the quality and type of information examined in their report were not suitable for measuring incidence in the population of persons with autism. (Incidence in this context is a term of art meaning the number of people per unit of population diagnosed with a condition in a specified time such as a month or a year.) Nor does the California report present prevalence data. (Prevalence is the number of people diagnosed with the condition per unit of population regardless of the date of diagnosis.) That is why the vertical axis of the original California graph was labelled “Number of Enrolled Persons with Autism” as shown in Figure 2. The authors of the California report were making the case to the legislature for increased departmental funding- theirs was not an academic study.

 

 

 

 

 

 

Figure 2: The Californian chart

Root cause

Instead of using a time-series graph, the authors of the California report should have used a bar chart. In fact, they should have used a specific kind of bar chart: a histogram. The use of a histogram, instead of a line graph, is required by the interaction between the bin width and the count. Were the bins to be made narrower (less than one year), the count in each bin would decrease. This is a characteristic of the histogram. The distribution of birth dates of people enrolled in a growing programme is not a time-series trend. Indeed, the data are neither continuous nor differentiable: the data do not represent a function of time. Given that the data show the count by years, the usual presentation is the population pyramid, a histogram with the bars horizontal.

Re-drawing as a population pyramid the data from the original Department of Developmental Services graphic presents the Californian data in a different light. It is shown in Figure 3 along with the English data, treated similarly. We discuss the English data later.

figure3

 

 

 

 

 

 

 

 

 

 

Figure 3: The combined data presented as a population pyramid

In this figure, the meaning of the bars is unambiguous. The first horizontal bar for California can only be interpreted as the number of people “in the system” who were 38 years old when the data were taken, and so on. The caption for the pyramid could have indicated that the data were analyzed in 1998 for patient records up to 1992. (It should also be pointed out that, in the period shown, the population of California grew by nearly a factor of 2. This fact alone must lead, ceteris paribus, to there being a higher number of young patients.)

This population pyramid presentation is valid, and a line graph is not. However, this was not the graph published in California. Nor was it used by Taylor et al. [9] In both cases, a line graph was used instead.

Examination of the 1999 Lancet graph

Taking the California graph (Figure 2) as the starting point, we can see that when the English data were added to create the 1999 Lancet graph (Figure 1), a number of changes were introduced,

  1. A new scale was added on the right, to be used with the added English data, labelled “number of new cases per year”
  2. The word “œenrolled” was deleted from the label on the left, so it reads “Number of persons with autism”
  3. The old figure caption, with its words about “Distribution of Birth Dates” is gone.
  4. New words appear at the top of the graph, explaining that the arrows added to each curve indicate the “First birth cohorts [that were] eligible for MMR . . .”

The data in each graph are a snapshot of the birth years of people in the system. We have no information about when they were diagnosed.

The California report included all diagnosed cases of autism, without exclusion criteria. In contrast, Taylor et al. obtained their data by selection from medical records. They selected patients who were in the records of eight North Thames health districts who were born since 1979 and before 1992, and who were aged 5 or less at the time of diagnosis. The use of these criteria makes the data not directly comparable with the California data.

We may note some problems with the changes made to the graphs in order to merge the data sets:

  1. The new title for the graph, in boldface, is “Temporal trends for autism in the USA (California) and the UK (north-west London).” However, this is in defiance of the injunction given by authors of the original California graph not to use the information in this way.
  2. The new scale on the right starts at zero, while the suppressed zero of the original left scale has been retained. It is not valid in terms of the graphics to present one curve with a zero and the other with a zero suppressed. When the two things graphed are the same, there is at least an expectation by the reader that the offset is zero and the scale factor (at least when the data are normalized) is the same. It is not appropriate to increase the scale factor and change the offset of one of the graphs. In fact, the California numbers have a smaller dynamic range than the English results.
  3. The deletion of the word “enrolled” in the ordinate label is significant: it considerably broadens the meaning from the scope of the original, giving the impression that it was fair to compare the California data of enrolled children with the data from England, with its stricter inclusion criteria, supposedly representing “Number of new cases per year.”
  4. The 1977 arrow purporting to show the start of the MMR program in California is misleading in its precision. Combined MMR vaccine was licensed for use in the United States in 1971 [10], therefore the first eligible birth cohorts would have been those born a year or two before that. Throughout the 1970s, MMR vaccine replaced use of the individual measles, mumps, and rubella vaccines.
  5. Locating the appropriate age for the arrows in the population pyramid makes a very different case. For several years after the introduction of the MMR vaccine in California, the number of people who (at some time) entered the DDS system remained more or less constant. This contrasts with the English data, where the numbers appear to be increasing even before MMR was introduced.

The number of changes associated with adding the English data is unusually large, and many of them are important in creating an impression in the mind of the reader. Of course, unless the reader has taken the trouble to examine the original graphs, none of the differences listed above will be obvious. As readers, we take it for granted that a citation is valid, that the author of the citation actually said what he is alleged to have said. It is a matter of trust between reader and author.

It is worth noting that a later publication by the California Department of Health Services correlation shows no correlation between early childhood MMR immunization rates in California and the numbers of children with autism enrolled in California’s regional service center system [10].

Discussion

We believe there are lessons to be learned by both authors and editorial staff from this case study.

There are some general points for those wishing to use graphics:

  1. Choose carefully the kind of graph you use to show your data. Even if you select an apparently conventional kind of graph, be sure your selection is appropriate. Had the California DDS authors and Taylor et al. selected the histogram or the population pyramid, it would have been much harder to misinterpret their birth year distribution as a time series. Wakefield’s choice of graph is understandable in view of the graphical choices made by the authors of the California report and by Taylor et al.
  2. Quote sources accurately. That applies both to verbal and graphical statements. In quoting verbal material, it is customary to show words left out (ellipsis) by printing dots or a long dash, and to show additions in square brackets. Changes to graphical material are not exempt from having such changes indicated.
  3. When referring to a graph, authors are under an ethical obligation to have read and understood the paper it was extracted from, and any surrounding explanatory text. In this case, the authors of the original California report clearly and repeatedly stated that the graph they had created did not show the incidence of autism in a given year or indicate any temporal trend. This word incidence is chosen correctly: to show incidence, the numbers would have to show how many new cases occurred in a given time per unit of population. The authors of the California report were not concerned with incidence, they were concerned with total numbers: theirs was a report to the legislature (for funding), not a science paper. (One might note in passing that Taylor’s study does not show incidence, either.)

There is also a lesson for medical journals. The alleged link between MMR vaccine has been refuted by both epidemiological studies [11, 12] and virological studies [13, 14]. In addition, the World Health Organisation’s Global Advisory Committee on Vaccines has also dismissed any link between autism and MMR vaccine [15].

However, the debate about MMR vaccine continues outside of the scientific community – particularly in tabloid newspapers in the United Kingdom. Although a lack of trust in the scientific consensus runs through these concerns, paradoxically the high reputation of journals is invoked in”appeals to authority” by anti-vaccination campaigners. So, the respectability of The Lancet is invoked as a defence of the initial 1998 paper, and the 1999 graph can be invoked as further published evidence, in a peer-reviewed journal, for a link between MMR and autism. It is therefore important that the publication of such figures, even if they are correspondence items, perhaps not normally subject to formal peer review, should be done with great care, especially in crucial areas of public health.

Statistical review policies of biomedical journals are not consistent, and it has been argued that improvements could be made in biomedical publishing [16]; we would add the recommendation that specific review of visual presentations of data should be also be made. Although it would have necessitated some investigation of the original sources, a review of the 1999 graph may well have influenced the decision about the graphic’s suitability for publication, and prevented propagation of its erroneous message. Whether such specialist review is easily available is open to discussion, but given the controversial situation that existed when the Lancet letter was published, further scrutiny would have been justified.

References

[1] Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. The Lancet 1998;351:637-41
[2] Fitzpatrick M. MMR and Autism: What parents need to know. 1st ed. London: Routledge, 2004
[3] Asaria P, MacMahon E. Measles in the United Kingdom: can we eradicate it by 2010? BMJ 2006;333:890-895
[4] Murch SH, Anthony A, Casson DH, Malik M, Berelowitz M, Dhillon AP, et al. Retraction of an interpretation. Lancet 2004; 363: 750
[5] Horton R. The lessons of MMR. Lancet 2004; 363: 747-749
[6] The Information Centre. Immunisation Statistics England 2005-2005. Availible from http://www.ic.nhs.uk/pubs/immstats2005to2006 [accessed on 4th of April 2007]
[7] Wakefield AJ. MMR vaccination and autism. Lancet 1999;354:949-50.
[8] Department of Developmental Services. Changes in the Populations of Persons with Autism and Pervasive Developmental Disorders in California’s Developmental Services System: 1987 through 1998. Sacramento 1999. Availible from http://www.dds.ca.gov/autism/autism_main.cfm [accessed on 26th March 2007]
[9] Taylor B., Miller E., Farringdon C.P., Petropoulos, M.-C., Favot-Mayaud, I., Li, J., Waight, P.A., MMR vaccine and autism: no epidemiological evidence for a causal association. Lancet 1999; 353: 2026 – 2029
[10] Dales L, Hammer SJ, Smith NJ. Time trends in Autism and in MMR immunization coverage in Calfornia. JAMA 2001; 285: 1183-1185
[11] Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, et al. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med. 2002;347(19):1477-82
[12] Honda H, Shimizu Y, Rutter M. No effect of MMR withdrawal on the incidence of autism: a total population study. Journal of Child Psychology and Psychiatry 2005;46(6):572-9
[13] Afzal MA, Ozoemena LC, O’Hare A, Kidger KA, Bentley ML, Minor PD. Absence of detectable measles virus genome sequence in blood of autistic children who have had their MMR vaccination during the routine childhood immunization schedule of UK. Journal of Medical Virology. 2006;78(5):623-30
[14] D’Souza Y, Fombonne E, Ward BJ, No evidence of persisting Measles virus in peripheral blood mononuclear cells from children with autistic spectrum disorder. Pediatrics 2006;118(4):1164-1675
[15] Global Advisory Committee on Vaccines Safety. MMR and Autism. Availible from http://www.who.int/vaccine_safety/topics/mmr/mmr_autism/en/ [accessed on 4th April 2007]
[16] Goodman SN, Altman DG, George SL. Statistical reviewing policies of medical journals, caveat lector? J Gen Intern Med 1998;13:753-6

We would like to thank Don Eckley, a retired pharmacist, for bringing us together to write this article, and Dr Patrick Waller, Consultant in Pharmacoepidemiology, for his valuable advice relating to publication. We would also like to thank the anonymous reviewers of this article, whose thought-provoking comments improved the paper.

Contributors and sources:

The authors came together specifically to write this article. ARC is the Pharmacovigilance Pharmacist at The West Midlands Centre for Adverse Drug Reactions in Birmingham and Teaching Fellow at The School of Pharmacy, Aston University, Birmingham. HK is a principal engineer at the Jet Propulsion Laboratory, California Institute of Technology. He has an interest in the graphical treatment of data, and is in the process of writing a book on the topic.

Competing interests:
ARC is also employed on a part-time basis at the Yellow Card Centre West Midlands, a regional education centre of the Medicines and Healthcare products Regulatory Agency (MHRA). The viewpoints expressed in this commentary are those of the authors and are not necessarily endorsed by the MHRA. HK includes the 1999 Lancet graph discussed in this article as one of several case studies in the proposed book. No funding was received for the preparation of this review.