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Anti-Vaccine Charity, No More

Last year I wrote a series of posts[1] around the Charitable organisation Immunisation Awareness Society and a complaint I had made to the Charities Commission. The Thrust of these posts and the complaint was that the Society does not fulfill the requirements of a charity and should be removed from the register. The effect of this is that they would also be stripped of their tax exempt status.

This indeed was my main goal. There are innumerable groups out there that I don’t agree with but you get that in a wide and varied world. In the case of the IAS though the speech they engage is is effectively publicly subsidised via the tax exemption, this should mean that they are constrained in what they can say. At the very least it should mean that they must present the facts undistorted by ideology.

Yesterday I found out that the Charities Commission agrees with me. In a decision handed down late last month they determined that the IAS does not qualify for charitable status and removed them from the charities register.

So, I guess you could say – I won.

It the words of one of my colleagues it also shows that one person can make a difference. Clichéd but true.

Reading through the Charities Commission decision it seems they focused on two things:

1. The biased nature of the information provided by the IAS and;

2. The political nature of their campaigning for a change in public policy.

This makes sense given the requirements that the Commission need to fulfil to determine whether an organisation meets the requirements to be a charity. Even so I’m a bit disappointed that there was no focus on the factual inaccuracy of and misrepresentation in the materials published by the IAS.

The decision does seem to skirt this line though when stating that “Overwhelmingly, the information on the website argues that vaccination is ineffective and dangerous” the inference being that is view is incorrect as well as being biased. Even so, none of the language of the report actually states this outright (that I can see).

There was also an additional point touched on that merely providing information does not in and of itself “advance education”. In other words to be an educational charity you actually have to actively educate people, not simply act as a repository of information – otherwise every private citizen with a decent library or informational website could become a charity.

Finally, in my personal 15 minutes of fame, the Commissions decision has been reported in the Dominion Post – complete with a quote from me. Not my most eloquent moment but it’s close enough to the point I wanted to make that I’m fairly happy.

[Edit: Thanks goes to commenter Hemlock for sharing the IAS response to this news]

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1. And here they are in all their tedious glory:
http://scepticon.wordpress.com/2011/10/11/anti-vaccine-charities-is-there-any-quality-control-on-charities/

http://scepticon.wordpress.com/2011/10/11/ias-complaint-part-1-thimerosal-in-your-vaccine-no/

http://scepticon.wordpress.com/2011/10/12/ias-complaint-part-2-gardasil-horrors-horrific-reasoning/

http://scepticon.wordpress.com/2011/10/13/ias-complaint-part-3-vaccine-ingredients-not-so-bad-really/

http://scepticon.wordpress.com/2011/10/14/ias-complaint-part-4-anti-vaccine-impact-in-new-zealand/

http://scepticon.wordpress.com/2011/10/17/defending-the-term-anti-vaccine/

http://scepticon.wordpress.com/2011/10/18/the-legitimate-risks-of-vaccines/

2012: 11/07
CATEGORY: Medicine
Sciblogs
Science
skepticism
5 comments

TCM and You: Cupping

I have noticed that Chinese massage seems to be becoming popular, and seemingly with it Traditional Chinese Medicine (TCM¹). At least browsing through two of the larger shopping centres in Hamilton (bring on the hick jokes) I saw massage centres offering these services. In particular cupping was advertised. But what exactly is cupping²?

As with many modalities in TCM Cupping appears to be based on pre-scientific notions of blood stagnation and energy blockages³. Applying cups with a slight vacuum to the skin is meant to draw out the “toxins” which then results in improved health, somehow.

The active part of cupping essentially boils down to a pressure difference. The pressure is lower on the inside of the cup and greater on the outside, this difference causes the skin to be forced up into the cup⁴. This process in turn causes blood to gather in the region and may cause minor damage to the area resulting in bruising.

Presumably the fact that the skin appears to be drawn up into the cup gives the impression that there is a general pulling action at work here and that toxins and other “bad stuff” are pulled out of the body in this fashion.

The trouble with this is that pressure difference is a fairly crude physical process and with regard to this biological system lacks what we in the science biz call “Specificity”⁵. What this means is that there is no way for the cup to restrict the “pulling action” to only harmful chemicals (the “toxins”, say) and allow everything else to be unaffected, i.e. it is not “specific” to toxins. Everything will be drawn up in the same way.

In which case you get a lovely bruise and feel like you’ve done something but that’s about it.

Ok, that’s fine for just thinking about it. What about evidence, we’re always going on about evidence here.

I attempted to find a Cochrane review on cupping but while one was listed for pain relief there did not seem to be a completed review for perusal. I did come across this review that found equivocal results for the effectiveness of cupping for pain.

The review comments on the putative mechanism of cupping:

“Assuming that cupping was beneficial for the management of pain conditions, its mechanisms of action may be of interest. The postulated modes of actions include the interruption of blood circulation and congestion as well as stopping the inflammatory extravasations (escaping of bodily fluids such as blood) from the tissues. Others have postulated that cupping could affect the autonomic nervous system and help to reduce pain . None of these theories are, however, currently established in a scientific sense.” [Emphasis added, citations removed]

The discussion of the reviews limitations is especially worth noting:

“Our review has a number of important limitations. Although strong efforts were made to retrieve all RCTs on the subject, we cannot be absolutely certain that we succeeded. Moreover, selective publishing and reporting are other major causes for bias, which have to be considered. It is conceivable that several negative RCTs remained unpublished and thus distorted the overall picture. Most of the included RCTs that reported positive results come from China, a country which has been shown to produce no negative results. Further limitations include the paucity and the often suboptimal methodological quality of the primary data. One should note, however, that design features such as placebo or blinding are difficult to incorporate in studies of cupping and that research funds are scarce. These are factors that influence both the quality and the quantity of research. In total, these factors limit the conclusiveness of this systematic review.

In conclusion, the results of our systematic review provide some suggestive evidence for the effectiveness of cupping in the management of pain conditions. However, the total number of RCTs included in the analysis and the methodological quality were too low to draw firm conclusions. Future RCTs seem warranted but must overcome the methodological shortcomings of the existing evidence.”

In conclusion then, you may see a placebo effect from this treatment – though I suspect this is over rated as a therapeutic outcome⁶. You may also find yourself covered in bruises (though I hear they are painless – think of them as CAM hickies). So… Dubious premise with dubious benefit, same thing – different day.

Here are a couple of images for you to keep in mind…

Mmmmm, cupping goodness.

[UPDATE 30/5/12: Islam appears to support cupping, check out this completely unbiased arabic wikipedia article]

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Footnotes:

1. Can’t get away from TLAs

2. So many jokes spring to mind, I mean come on – “cupping”?

3. See this link for some scary science illiteracy around cupping. And here’s good old Wikipedia. And “blood stagnation” really? isn’t that gangrene or septicaemia or something?

4. Keeping in mind that a vacuum does not suck, high pressure pushes. If I may geek out a bit here; hence one of my favourite exchanges from ST:TNG:

“You were right. Somebody blew out the hatch. They were all sucked out into space.“
“Correction, sir, that’s blown out.“
“Thank you, Data.“
“A common mistake, sir.“

- Riker and Data get precise about the physics of rapid decompression into the vacuum of space

5. Yeah, I know, it sounds made up.

6. See here, here and here.

Vaccines and Autism – Media Report Card (sciblogs.co.nz)
What’s The Harm of Alternative Medicine? (scepticon.wordpress.com)
Yoga Thai Massage: Herald, Wherefore Art Thou Sense? (scepticon.wordpress.com)
Why Do People Use Alternative Medicine? (scepticon.wordpress.com)
The Freedom of Ignorance: Health Freedom, What is it and Do We Want it? (scepticon.wordpress.com)

2012: 04/04
CATEGORY: Alternative medicine
Medicine
Questionable Techniques
Sciblogs
skepticism
4 comments

Amber Teething Beads: A Follow-Up

Over the week or so I expect the page views for my amber teething necklace post to top 20,000 over the two blogs. Interest in the article has just kept increasing over the last year or so of it being up, as opposed to the majority of my posts which slip into internet obscurity within days. In anticipation of the occasion I thought I’d cover some of the comments that this post has gathered over the last few months.

Many of the comments are along the lines of “It worked for me” and “Try it yourself”.

To the first, I don’t really have much to say. I can’t peer inside the inner workings of your child and determine what is going on. But at the same time a bunch of individuals making claims of efficacy without adequate control for bias, natural history and various other contingencies is not a compelling argument to me. Plenty of others swear by practices that have no hope of working*, why should this one get more credibility based on personal experience?

As to the second, three words for you: Anecdote and Confirmation bias. I know enough to realise that I am not immune to the wiles of confirmation bias, which would make my trial just another anecdote – something I don’t accept from others so what would make my own experience any more valid? I also realise that for most people this sort of reasoning is at best foreign and at worst incomprehensible. The general thinking appears to go something like “If I try something and it seems to work, then it works – QED”.

No.

Related to this point are appeals to the “Placebo Effect”, the idea being that simply trying something helps, somehow. This may be true. But I’ll expand on the faulty reasoning behind this assertion.

The placebo effect as this seems now to be the “go-to” explanation for all things unexplained so it might be a good idea to dwell on this concept on it’s own for a bit. First off with regard to talking about the placebo effect, it depends on what you mean. The placebo effect started off being simply the improvement seen in the control group for clinical studies. It was the group that was given everything except the active treatment. Therefore by definition the placebo response is what happens when people aren’t treated. It was the catch all for everything that could affect the outcome that wasn’t due to the treatment itself: poor method design, confirmation bias, reporting bias, observer effect on the patients, regression to the mean, natural history of the disease, etc, etc.

Recently there has been some work done to see if there is a real change in people that is due to thinking they are getting an active treatment, the so called “Placebo response/effect”, this has been mixed. It is true that people will report less pain and their brain will show less activation in pain related areas. But people are susceptible to what they are told, it turns out if you tell people a cheap wine is expensive they will enjoy it more. Is there a placebo wine effect? possibly, but the wine didn’t change and neither did any underlying physiology in relation to placebo medical treatments.

In fact recent studies in asthma showed that while people reported feeling better while taking placebo their ability to perform on objective measures remained the same, while those on active medications improved. If you feel better while still having a life threatening condition are you better? I don’t think so.

So in appealing to the placebo effect you have to concede that 1. the beads don’t have any active ingredient, and 2. don’t make any difference to the underlying condition.
i.e. They do nothing.
Now notice in my original piece this is not what I say, I merely point out there is no good reason to think they are doing anything, not that they definitely aren’t. A subtle distinction I admit.

In essence the argument becomes: “If you think it works then it does”, well I would counter with why don’t you use something that we know does work and then you can capitalise on both effects: You will think it works and it will actually work too. Double goodness.

One poster asserted that amber necklaces were registered with the Therapeutic Goods Administration in Australia as a Medical Device. Arguing that this must mean they have therapeutic properties.

This one was my favourite as it was almost laughably easy to dismantle. After only a few minutes I found that this was completely untrue (you can search the TGA resister here). Not only that but there were suppliers admitting** that they couldn’t claim therapeutic benefits because they were not on the register:

“Amber Teething Necklace Information – TGA Australia

Due to regulations of the Therapeutic Goods ACT, policed by the Therapeutic Goods Administration (TGA), whose register does not recognise the claimed healing and theraputic[sic] properties of Amber we are unable to offer any detailed information on Amber Teething necklaces or Amber in general in a theraputic[sic] advisory capacity.

Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with influencing, inhibiting, or modifying a physiological process in persons.

In all amber related cases that we have seen, the TGA Panel note “that the advertisement appeared likely to breach section 42DL(1)(g) of the Act, which prohibits the publication of advertisements for therapeutic goods that are not included in the Register“” [Emphasis added]

A complaint was made against a supplier for making claims for the product and this was upheld in part because the necklaces are not on the register.

“The Panel noted, without making any formal finding, that the advertisement appeared likely to breach section 42DL(1)(g) of the Act, which prohibits the publication of advertisements for therapeutic goods that are not included in the Register.“

The website involved changed their wording to get around the regulations, spot the difference:

OLD: “natural pain relief provided by Amber works by placing the necklace on your body, this allows your skin to warm the amber beads, releasing healing oils which are then absorbed into the blood stream.“

NEW: “Amber is believed to soothe naturally, when Amber is worn next to the skin it is warm and it is reputed to release natural oils that can care for the skin.”

What a difference a few words make.

At the time the comment was made alleging the necklaces were on the register I suspected that intended therapeutic benefits would be enough to fulfil the therapeutic benefits category.

This is supported both in the declaration of the supplier above and from the wording from the complaint, just prior to the excerpt above it states:

“Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with influencing, inhibiting, or modifying a physiological process in persons.

In representing the advertised products to have an “active ingredient”, to release “healing oils which are then absorbed into the blood stream”, and to relieve teething in infants, the advertisement clearly constituted an advertisement for therapeutic goods.” [Emphasis added]

Lets say though that the product had been registered with the TGA or will sometime in the near future, I would note that unless the administration was in possession of studies that are not published elsewhere there is no way that they could be sure that an actual benefit is occurring. Bringing us right back where we are now.

As an extra note on the activities of the Australian government on this topic I found it amusing to see that the Australian Competition and Consumer Commission issued a safety warning about Amber teething beads end of September last year (see here and here and here).

I say amusing because, while it’s not impossible, I do find it unlikely that one branch of the government is condoning their use while another warns against them. Luckily this is not actually the case.

Finally, this post is not intended to address every conceivable objection to my arguments, merely a survey of what has been proffered so far. I am not really convinced by anything I have yet seen but I remain open to changing my mind so long as the evidence is of good quality. It doesn’t have to be much, a good start would be something that suggests succinic acid has the analgesic properties attributed to it. Then we could address whether succinic acid is released from the beads at ambient/skin temperature. Finally we would need to tackle whether the succinic acid is absorbed topically in any significant dose (decent dose response curves could be obtained at stage one of this theoretical research programme).

All three of these items would need to be looked at in order to state that amber beads have good plausibility for what they are marketed for.

[Update 29/4/13: Apparently there is a chain email circulating blaming amber beads for a case of SIDS. This seemed implausible to me and a very brief check seems to back up my gut feeling. There is no reason to think that amber beads contribute to SIDS at all. For a more thorough break-down go here: http://www.hoax-slayer.com/amber-teething-necklace-sids.shtml . I am not one who feels we need to latch onto any reason to vilify our intellectual opponents and spreading misinformation (especially easily debunked misinformation) is a big no-no in my book.]

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*Not that I think this product has “no hope” of working, it could as far as I know. We just can’t make that determination on the basis of anecdote and there are no trials that I’m aware of.

** Argh, this site seems to have removed any trace of of this page. Should have archived it. It has essentially been replaced with this (archive):

In keeping with Australian Fair Trading guidelines no therapeutic claims are made and no medical advice is offered. The material provided on allaboutamber.com.au is for information and educational purposes only and is not a substitute for medical treatment or diagnosis. We assume no responsibility for treatment or cure of any illness or disease. If you have a health problem we recommend seeking medical advice from your qualified natural/health professional. This information is strictly a source of general information and is not intended for use as a tool for self-diagnosis. All About Amber provides this information for you to make your own decisions, if you want to use them on your own family, we believe they work for us and please read the reviews to gather many other peoples opinions.

Which seems to me to be saying “We can’t claim the beads have any healing powers directly, but they really do.”

They haven’t yet learned this lesson for Hazelwood jewellery (archive)though:

How does hazelwood jewellery work?

Hazelwood products are believed to help to create an alkaline environment in your body, which may help, precent[sic] and appease many of the symptoms caused by being to acidic. Hazelwood, being an alkaline wood, has the natural property of absorbing and neutralizing the body’s acidity through contact with the skin. By doing so, the necklaces can also help with digestion, constipation, eczema, migraines, acid reflux, heart burn, nausea, arthritis, skin problems, etc. If you suffer from one of these issues, it is highly probable that you are suffering from an acidity imbalance, and hazelwood may be able to help you alleviate these symptoms in a natural way. Most people who suffer from an unbalanced pH are unbalanced towards the acidic. This condition forces the body to borrow minerals—including calcium, sodium, potassium and magnesium—from vital organs and bones to buffer (neutralize) the acid and safely remove it from the body.

Hhhhm, perhaps another post is in order. And a complaint.

As a brief aside, as it seems there are quite a few parents out there hungry for this information if you know of a good parenting or early childhood publication that would be willing to print the original article (probably in an altered form) then let me know.

And I’ll stop there before the footnotes become longer than the post.

Placebo Again. (sciencebasedmedicine.org)
Amber Teething Beads: A Few Points to Consider (scepticon.wordpress.com)
“I Was A Skeptic, but…” (scepticon.wordpress.com)
Why Do People Use Alternative Medicine? (scepticon.wordpress.com)

2012: 04/02
CATEGORY: Alternative medicine
Medicine
Questionable Techniques
Sciblogs
Science
skepticism
46 comments

Why Do People Use Alternative Medicine?

I often read that the reason people are turning to complementary/alternative/integrative(take your pick) medicine is because they are dissatisfied with the care received from mainstream/conventional/”western”* medicine. This may be true for a small segment of the population, those with a chronic illness or with terminal cancer spring to mind. But is this generally true of altmed users? Those who pick up a bottle of homeopathic remedy from the pharmacy or occasionally visit a naturopath?

I don’t think it’s quite as simple as that. A study “Why Patients Use Alternative Medicine” published in 1998 in the JAMA looked at this question using a survey sent to randomly selected participants. 1500 participants were sent the survey and 1035 completed it. Not too bad for a survey response rate.

The survey was geared to look at the use of altmed based on three paradigms:

“1. Dissatisfaction: Patients are dissatisfied with conventional treatment because it has been ineffective,5-6 has produced adverse effects, or is seen as impersonal, too technologically oriented, and/or too costly.

2. Need for personal control: Patients seek alternative therapies because they see them as less authoritarian16 and more empowering and as offering them more personal autonomy and control over their health care decisions.

3. Philosophical congruence: Alternative therapies are attractive because they are seen as more compatible with patients’ values, worldview, spiritual/religious philosophy, or beliefs regarding the nature and meaning of health and illness.”

According to the survey results satisfaction, or lack thereof, with conventional medicine did not correlate well with altmed use. 54% of respondents reported being “highly satisfied” with conventional medicine providers, of these 39% use alternative therapies. Of those who were highly dissatisfied (40%) only 9% were users of altmed.

It seemed as if those who were fans of medicine overall were more likely to participate in both camps. A sort of “the more the merrier” approach to health care.

What was predictive of alternative medicine use was personal philosophy. Those who considered there to be a strong mind/body/spirit connection as well as those who had had a “transformational experience” were more likely to use alt med than those who did not.

Education and health status also correlated with altmed use. Those with higher educations were more likely to use it, as were those who described themselves as having a lower health status.

The situation was slightly different for those who shunned conventional medicine altogether in order to embrace altmed. These folks tended to be distrustful of and dissatisfied with conventional practitioners, as well they desired a high degree of control over their health and believed in the importance and value of “inner experiences”.

This proportion of the population was quite small however – only 4.4% of the survey respondents fell into this group. Even so somehow the reasons for this group’s embrace of altmed has been generalised to the wider population.

The observation that users of altmed tend to be greater consumers of health services overall is also supported by the paper “Association Between Use of Unconventional Therapies and Conventional Medical Services“. This survey had a base of 16,068 individuals from which to pull data representing a 77% response rate from the 24,676 pool that was originally sampled.

According to this survey only 6.5% of the population use both altmed and conventional medicine** (and 1.8% using only altmed), with this group making more visits to their physician than those who used conventional medicine only. One possible reason for this is the so-called “worried well”, a portion of the population that focuses on their health to a degree higher than would be expected given their health status. Support for this is given within the paper:

“Compared with those with only conventional visits, those who used both types of care had significantly more outpatient physician visits (7.9 vs 5.4; P<.001), and used more of all types of preventive services except mammography. These groups did not differ significantly in inpatient care, prescription drug use, or number of emergency department visits.”

This on it’s own does not show a “worried well” connection but in the comments section of the paper it was noted:

“…there was no difference in any of the 4 self-reported health measures between respondents who had physician visits only, and those who had those visits in conjunction with unconventional therapy. Poor health status appeared to drive use of health services in general, that is, those using no services reported better health than those using either conventional medical services or unconventional therapies. However, poor health was not associated with increased use of unconventional therapies over and above conventional medical care.” [emphasis added]

So it would seem, at least in this sample, that dissatisfaction with conventional care cannot be the driving force for the majority of altmed users. More plausible is that altmed users seek to make the most of every perceived avenue for health.

Another survey published in 2001 also supported the general conclusion that dissatisfaction with conventional medicine does not lead to altmed use for most consumers. “Perceptions about Complementary Therapies Relative to Conventional Therapies among Adults Who Use Both: Results from a National Survey” surveyed 831 respondents who used both regular and alternative medicine.

Of these 70% would visit a conventional medicine practitioner as their first port of call. Only 15% went to a altmed provider first. There was also no significant difference in the level of confidence in altmed providers and regular medical professionals.

To quote the conclusion:

“National survey data do not support the view that use of CAM therapy in the United States primarily reflects dissatisfaction with conventional care.”

From a paper presented at the Proceedings of the 1997 Conference of
the Australian Association for Social Research and published in the Journal of Sociology; “Postmodern values, dissatisfaction with conventional medicine and popularity of alternative therapies“[PDF File download]:

“Those individuals who value natural remedies, are against chemical drugs, do not favour technological progress, and welcome variety in choice of therapy are more likely to have a positive attitude towards alternative medicine.”

These attitudes were enveloped under the “postmodern” rubric and were found to be a better predictor of altmed use than satisfaction levels with regard the conventional medicine.

To elaborate on that point, a further finding was that dissatisfaction with interactions with physicians rather than health outcomes was associated altmed use. This is a subtle point and worth dwelling on as it seems to be a valid criticism of the way in which conventional medicine is practised. It was not that altmed users were unhappy with the actual results of the care received via conventional medicines but the way in which they feel they are treated by doctors.

It seems that those turning to altmed may feel that conventional doctors do not give enough respect, time, don’t listen and are too authoritative. I don’t want to put too much emphasis on this perspective as it isn’t entirely consistent with the picture built up so far and the sample size of this survey was relatively small compared with the ones above (only 209 respondents), but it is worth considering.

In conclusion, while it might be true that some dissatisfaction does lead to an increase in the use of alternative medicine it seems unlikely to me that this is the main reason. I’m not sure why it has become the go-to reason trotted out by participants on both sides of the debate, ease I suppose. I could of course be wrong, perhaps there is a mountain of research out there that I’ve missed pointing in the complete opposite direction. I’m willing to grant that possibility, in the absence of such though I’ll have to go with personal philosophy being the largest contributing reason people use altmed.

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*I hate with a passion the label “Western Medicine”, what? – people from other cultures can’t use science? Nonsense.

** I suspect that the wildly differing definitions of what constitutes “Alternative” medicine are to be blamed for the fluctuating figures around the proportion of users.
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Astin, J. (1998). Why Patients Use Alternative Medicine: Results of a National Study JAMA: The Journal of the American Medical Association, 279 (19), 1548-1553 DOI: 10.1001/jama.279.19.1548

Eisenberg DM, Kessler RC, Van Rompay MI, Kaptchuk TJ, Wilkey SA, Appel S, & Davis RB (2001). Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey. Annals of internal medicine, 135 (5), 344-51 PMID: 11529698

Druss, B. (1999). Association Between Use of Unconventional Therapies and Conventional Medical Services JAMA: The Journal of the American Medical Association, 282 (7), 651-656 DOI: 10.1001/jama.282.7.651

Siahpush, M. (1998). Postmodern values, dissatisfaction with conventional medicine and popularity of alternative therapies Journal of Sociology, 34 (1), 58-70 DOI: 10.1177/144078339803400106

Aditional reading:

Joy, J.M. (2004). Complementary and Alternative Medicine (CAM): Do Barriers to and Dissatisfaction with Traditional Care Affect CAM Utilization Patterns, Masters Thesis, Texas Tech University Health Sciences Center

Chiropractic for the 21st Century (scepticon.wordpress.com)
First, Do No Harm (scepticon.wordpress.com)
The Freedom of Ignorance: Health Freedom, What is it and Do We Want it? (scepticon.wordpress.com)
Thai Yoga Massage: Herald, Wherefore Art Thou Sense? (scepticon.wordpress.com)
Breaking News!: Have Constipation? Moxibustion Won’t Help! (scepticon.wordpress.com)

2012: 03/26
CATEGORY: Alternative medicine
Medicine
Psychological
Sciblogs
Science
4 comments

First, Do No Harm

Primum non nocere

A while ago I was accused of advocating that doctors should break the Hippocratic oath. That the cardinal rule of “First, do no harm” should be ignored. Setting aside that this phrase does not appear in the Hippocratic oath, what do we mean by harm in the context of medicine?

I was reminded of this by a post on Science Based Medicine by David Gorski in which he muses over the measure of patient satisfaction as a proxy for how well hospitals meet their obligations with regard to patient care. To kick it off the good doctor notes that many interventions used by modern medicine cause harm, often direct harm.

Does this mean that doctors are throwing out their obligation not to harm patients? No, because we recognise that the concept of harm in this case includes those harms that would occur were we to withhold treatment as well as recognising that the total harm is reliant on the amount of benefit obtained by the patient.

The accusation against me was in the context of my arguing against the claims of anti-vaccinationists that vaccines do more harm than good. I don’t want to rehash that argument here but I do want to dwell a bit on our concept of harm and how it applies in the medical arena.

One of the themes that return to over and over again on this blog is that of risk vs benefit. The amount of harm or risk can only be appropriately assessed in light of the benefit accrued. As pointed out by doctor Gorski there are many procedures that hurt, they hurt a lot. Should a doctor refuse to perform them then? Even if they could save a patient’s life?

Of course not.

It is plainly ridiculous to assert that short term harm out weighs long term benefit, it might but that calculation has to be made in each case. In many cases the benefit will be clear, in others less so. If a patient undergoes a painful procedure that is relatively short lived and then makes a full recovery then the choice is fairly simple. If the recovery is likely to be only partial and the patient’s quality of life is ever after severely reduced then we may weigh up the benefits of that treatment differently.

What then of treatments that are good for most but may harm a few? These are the tricky cases and it depends on a few variables. One is can we identify the persons that will be harmed, second, how much harm are they likely to suffer and what percentage of the treatment population do they make up? Finally what total benefit will accrue to the population if treatment is green lit?

I listed these variables in the order of importance I estimate they have. If we can identify prospectively harmed persons then they may be removed from the treatment group, harm avoided. If this information is unavailable then we may move to the next criterion: how much harm will they suffer? If this is likely to be relatively mild then all to the good. If the harm is considerably more serious then we may stop the treatment altogether in order to avoid these instances. The last two variables may switch in order depending on the situation or individual values.

Should a vital treatment be withheld from the general population if a very small percentage with be greatly harmed by it? Frankly I don’t know. Help – is there a Medical Ethicist in the house?

Often I’ll find that the people who oppose modern medicine will emphasise the risks of medicine while over-hyping the benefits of alternative medicine. The claims that iatrogenic (caused by medical treatment) harms are enormous abound. This point of view seems completely ignore the benefits received by individuals and society by medicine in it’s current form*.

This seems perverse to me, the idea appears to be that any risk is unacceptable – a completely untenable position to my mind – every action carries risk. I take my life in my hands every time I drive to work, but the risks a relatively low and the benefits are more important to me – and the majority of other drivers I suspect. To argue that we should abstain from automotive transport until it is completely safe misses the point entirely. As does decrying the risks of the majority of medical science in the face of the undoubted benefit received.

To conclude this ramble, harm or risk is part of the human condition. Arguably the complete removal of risk is not only impossible but not even desirable**. We have to live with risk and harm, the key is to ensure we balance these against the good that comes from acting in the world to oppose even greater harms.

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*This is quite an extreme view and I would hasten to add that I don’t think the majority of alternative medicine users (however you may break that group down) would subscribe to it, but it exists.

** Depending on how this might be achieved. Possibly we could make ourselves impervious to harm rather than removing everything that might harm us.

Keeping the customer satisfied (sciencebasedmedicine.org)
What’s The Harm (scepticon.wordpress.com)
The Freedom of Ignorance: Health Freedom, What is it and Do We Want It? (scepticon.wordpress.com)
The Legitimate Risks of Vaccines (scepticon.wordpress.com)
Anti Vaccination in NZ (scepticon.wordpress.com)
Defending the Term “Anti-Vaccine” (scepticon.wordpress.com)

2012: 03/21
CATEGORY: Alternative medicine
Medicine
Psychological
Sciblogs
skepticism
1 comment

The Freedom of Ignorance: Health Freedom, What is it and Do We Want it?

When policy around how herbal remedies, alternative medicines, supplements and all sorts of other practices outside the mainstream of medical practice is discussed the concept of “Health Freedom” inevitably comes up. It’s not always couched in that term but the idea is that people should be free to choose whatever method of healthcare that they wish.

Sounds good right? Who wants to impinge in someone’s freedom to make their own decisions? Isn’t that what living in a free country is all about? Personal autonomy, the right to take action unfettered by how someone else thinks I should run my life. That’s how I want to live, why should I want to take that away from others?

Well, I don’t. But the notion of freedom has always come with a caveat (several actually), that is – it is inherently restricted by ignorance. Is someone who is uninformed about the actual state of affairs truly free?

That’s what those who speak out about alternative medicine are actually trying to achieve. We aren’t attempting to “defend our turf” or “squelch the competition” we are attempting to inform the public about the true underpinnings of these therapies and point out they they are either unsupported by science or have in fact been disproved.

As has been noted before, a majority of New Zealanders are unaware that Homeopathic medicines do not contain any active ingredient and yet many people think they are scientifically proven.

Education was also the intent of the co-ordinated Sciblogs rebuttal to the poorly conceived and executed series on alternative therapies printed by the Herald earlier this year. (see here, here, here and here)

Policies that are aimed at restricting access to herbal or alternative medicine usually are doing so from the aspect of quality control. Does the remedy or practice have good evidence of efficacy, is it safe? These are the questions that we should be asking about every medical practice, not just those in the “alternative” (or complementary, or integrative, pick your marketing phrase of choice) camp.

Unfortunately is is not in the interests of those pushing alternative modalities to undergo strict evidence based testing so the issue is re-packaged from a quality control issue to a “freedom” issue.

Similar tactics are seen in arenas outside the medical realm. In biology the evolution vs creationism/intelligent design “debate” is framed as “Academic Freedom” as is the debate around climate change. This is not a coincidence. Whether or not these decisions are made consciously or not there has been convergence on the “Freedom” aspect of these cases for a reason, people respond to it. We are jealous of our freedom, and rightly so, freedom forms the basis of our society.

But as I alluded above, freedom is not an absolute and unalloyed good under all circumstances. It comes up against restrictions in all sorts of ways, some epistemological (as in the case of whether a choice is really free if the person is not aware of all the factors affecting that choice) and some are practical (as in should we allow freedom to include the freedom to sell harmful products?).

Conclusion

The natural/alternative remedies debate is not, at it’s heart, about freedom at all. Rather it is about education and quality control. We should subject all medical practices to the same rigorous examination regarding safety and efficacy. Long term “after market” monitoring should also factor into this equation to catch those practices that looked good in the necessarily limited testing that they are subjected to prior to being rolled out to the general public but may still have safety problems.

In this way we should be able to serve the public’s health interests and avoid false choices about freedom.

2012: 02/16
CATEGORY: Alternative medicine
Medicine
Sciblogs
Science
skepticism
7 comments

Chiropractic for the 21st Century

Every week I get a number of email alerts about various online medical journals. Each email represents the opportunity for blogging material though many are deathly dull.

Several of the journals I receive alerts from are in the AltMed domain and I sometimes wonder why I bother looking through them at all. The mix is usually some proportion of “Survey of x population using y alternative modality” often merely chronicling the depressing rise of AltMed/CAM in general use (either actual or claimed depending on your definition of CAM).

The rest are often boringly conventional in their attempt to be scientific having titles like “Effects of vitamin E suplementation on renal non-enzymatic antioxidants in young rats submitted to exhaustive exercise stress“. These I don’t bother with. I just don’t have the expertise to parse them with any reliability.

Then there are the odd gems, either for comedic value or because they offer an alternative perspective on alternative medicine.

Recently one of the later came down the intertubes and into my in-box. Published in BioMed Central’s journal “Chiropractic & Manual Therapies”, the article is entitled “The Five Eras of Chiropractic & the future of chiropractic as seen through the eyes of a participant observer”.

The paper starts with a potted history of Chiropractic and the environment that it was founded and grew up in to the present. The early days could be seen as Chiropractic’s first opportunity to start down the science based path. In 1910 the “Flexner Report” on medical education was published and with it’s acceptance by the medical educational community came legitimation to those who abided by it’s recommendations. As well as:

“…generous funding via the Rockefeller Foundation while schools that did not assent, simply ceased operation due to lack of funding. The result was that, by 1930, only 76 of the 168 medical schools remained.“

The impact on Chiropractic is characterised thusly:

“In part because of the rejection of science by a significant element within the chiropractic profession, and in part because the Flexner Report dismissed the chiropractors as “unconscionable quacks who should be dealt with by the public prosecutor and the grand jury”, the chiropractic profession bypassed the era of educational reform.“

The early twentieth century therefore saw a great deal of animosity towards the nascent Chiropractic practice and the emerging scientific medicine of the time. Indeed the author argues that this conflict essentially shaped Chiropractic as we know it today. In order to defend Chiropractic from the legal attacks being made on it it was necessary to develop a definition of Chiropractic that would insulate it from charges of practising medicine without a licence, charges that were common against Chiropractors of the time.

This is related as involving four simple concepts:

“1. Chiropractic is not medicine; chiropractic has a “separate and distinct philosophy and practice”.
2. Chiropractors do not diagnose, but analyze the spine for the cause of dis-ease.
3. Chiropractors do not “treat,” but adjust the spine for the cause of dis-ease.
4. The Chiropractic profession has been built upon success in cases where medical doctors failed.“

Putting aside the obvious sophistry in these concepts (how might we define the difference between diagnosis and “analyz[ing] … for the cause of dis-ease” or between treatment and “adjust[ing] the spine for the cause of dis-ease“?) it is argued then that the very fact of opposition by the medical establishment helped to solidify the tenets and practice of Chiropractic:

“During this journey, the chiropractic community developed and embraced a distinct lexicon and rationale toward health and its maintenance in order to emphasise the difference between medicine and chiropractic. Thus the “philosophy of chiropractic” became “an unyielding dogma”.“

With this legal history at it’s back Chiropractic moved into the next period of it’s history where it was the focus of a co-ordinated and sustained attack by the medical establishment in the form of the AMA.

Carrying out the opposition to Chiropractic was the “Committee on Quackery”:

“The Committee on Quackery was well funded, and operated a highly successful campaign that was centred on three main strategies:
1. An ethics based boycott, which deemed it unethical for AMA members to have professional dealings with chiropractors;
2. Convincing other organizations to adopt or adapt the AMA’s anti-chiropractic policy; and
3. Instituting a comprehensive political campaign to thwart chiropractic progress on several fronts, including but not limited to education, research and insurance funding.“

This campaign was put to an end in 1987 thanks to a permanent injunction ordered against the AMA, after a lawsuit was levelled against it by a number of Chiropractors. At this point it’s difficult not to see the Chiropractic as a beleaguered philosophy deserving of empathy on behalf of it’s persecuted adherents.

Emerging from this legal victory Chiropractic has been slowly edging it’s way into mainstream acceptance with the development of Chiropractic based courses in universities and a surge in chiropractic research. Unfortunately the steadfast refusal of many Chiropractors to relinquish the unscientific concepts of old has meant that as a profession they are still looked upon with disdain:

“Chiropractic’s problem is that subluxation based chiropractors are not only deluding themselves, they are indoctrinating patients into believing in a purportedly dangerous mythical entity, and that without regular adjustments, patients will not only fail to reach their full potential, they will likely suffer serious health problems.

Some authors have suggested that this may be a threat to public health . And this, at a time when the profession has just entered The Era of Chiropractic Opportunity.”

The opportunity discussed is that of the ever growing need for specialists in musculoskeletal care. As the worlds population ages the demand for providers who are proficient in the treatment of pack pain/musculoskeletal disorders will only increase.

It is into this world that the Chiropractic profession must be re-born as the evidence based providers of musculoskeletal care that are needed. The problem is that if Chiropractic insists on holding onto the non-scientific notions of DD Palmer then it voluntarily relegates itself to the back waters of medical practice.

This then is the proper focus of the article: where Chiropractic will go from here.

Least attractive to the author is the prospect that the practice will stay on it’s current trajectory, keeping the outdated concepts that it was founded upon and denying the very science that would confer upon them the legitimacy they crave.

Two options are given as alternatives to this “Status Quo” approach: one is to definitively split the profession into those that follow the traditional method of chiropractic practice, so-called “Straight Chiropractic”, and those who are willing to discard tradition and step into the light of science and evidence based practice.

The second and preferred option is to move forward with a united front, ditching along the way those parts of Chiropractic that are unsound and unproven. This is also recognised as the most difficult route for the profession, requiring near superhuman commitment from the individuals and organisations that make up the world’s Chiropractic profession:

“Escaping from the dogma house will require extraordinary cooperation amongst all aspects of the profession. Organizations such as the World Federation of Chiropractic and all major chiropractic associations will need to agree upon and adopt a position statement identifying the chiropractic subluxation as an historical construct that remains a hypothesis, which cannot form the basis for patient care until and unless there is a body of scientific evidence to support it.“

“If the profession is to gain the trust of the consuming public it must, of necessity, become truly self-policing.

Only in this way will chiropractic generate the cultural authority required for recognition as a group worthy of the title “Profession”.

No longer can we cast a blind eye. By our silence we are giving consent.“

Should Chiropractic refuse to move properly into the 21st Century then the consequences for it as a whole may be dire, leaving it’s future as a force in medical practice in doubt.

“The chiropractic profession can choose to be illiterate, but it will do so at its peril. It is realized that thinking is hard and that those who are unaccustomed to thinking may even find it unpleasant. On the other hand, thinkers have always found it rather fun and there are no confirmed reports of anyone dying or being seriously injured by thinking. Thinking may necessitate changing our minds – which may not be a bad thing. At the very least the profession owes it to its patients.“

Subluxation Theory: A Belief System That Continues to Define the Practice of Chiropractic (sciencebasedmedicine.org)

2012: 01/24
CATEGORY: Alternative medicine
Medicine
Sciblogs
Science
skepticism
3 comments

Thai Yoga Massage: Herald, Wherefore Art Thou Sense?

So here I am, again latching onto the brilliance of others and writing my own counterpoint to the nonsense that is currently being run in the NZ Herald under the “Alternative Therapies” summer fluff.

Previously Alison kicked us off by looking at the use of medicinal leeches, as did Siouxsie, and Michael took on Ayurvedic Medicine.

The latest round concerns something called Thai Yoga Massage or Nuad (Nuat) Boran. Essentially the practice consists of the massaged party adopting a series of yoga positions while the massager applies pressure to the body’s “Sen” lines. Those familiar with acupuncture’s “Meridians” can replace Miridian with Sen and get the general idea.

From an article describing the practice:

“The theoretical basis for traditional Thai healing is rooted in the belief that all forms of life are sustained by a vital force (lom) that is carried along invisible energy pathways (sen) running through our bodies. This energy force is extracted from air, water, and food, and it is believed that disease and dysfunction come about when energy becomes blocked along these pathways. Accordingly, Thai massage’s intent is to free this trapped energy, stimulate the natural flow of life force, and maintain a general balance of wellness.”

Thus Nuad Boran is a system of energy medicine based on pre-scientific notions of “Vital Force” or “Life Energy”, blockages in which are the cause of disease (though exactly what disease seems to be harder to pin down). It is also claimed to be based partly on Ayurvedic medicine.

So what exactly does this “Alternative Therapy” treat? From the same article quoted above:

“The result of a full-body Thai session is often an exciting and powerful mind/body experience, bringing both the recipient and the practitioner to greater states of physical and mental well-being.”

But that’s kind of vague, what else?

Like many alternative treatments and especially the ones covered by the Herald this week the actual claims for Thai Massage seem to centre around improved blood flow. At least that’s the impression I got from looking at the listed clinical research on this page.

But apparently in the medical literature Thai Massage is mainly focused on pain relief, though there is this one hopeful study trying to use it as a treatment for Autism (the current trendy target for alternative therapies where nothing is too insane to try including chemical castration). Though a brief look at the abstract implies to me that they took one implausible treatment added a second implausible treatment and decided that Implausible² = Success.

Pain is a good candidate for effective use of Thai Massage; the end point is subjective and massage involves close contact which humans generally find inherently soothing. Hopefully any successes in the pain arena will not be parlayed into evidence that the treatment “works” for any other condition.

The main issue I have with all the literature I’ve been able to dig up so far is that only Thai Massage was included in the studys. The specific reason for using Thai Massage (at least traditionally) is the claims regarding redirecting and unblocking life energy. Remove that unscientific aspect and why wouldn’t any massage work just as well?

I’m perfectly sanguine about the possibility that Thai Massage may be beneficial for perception of pain and reliving stress for the reasons given above. Should we be saddled with the extra hypothesis about life force, with the implication that there is something mystical and magical going on; giving the added justification that the therapy could be of use beyond pain and stress (and whatever else massage is good for)?

I don’t think so.

As Michael pointed out in his post, even the Herald reporters aren’t approaching these “therapies” as medical treatments but more as a relaxing massage/spa session (except for the leeches, but perhaps there are those out there who would consider this relaxing).

Frankly, after the above it should be “’nuff said”. But how does the Herald approach this wellspring of traditional medical wisdom?

Well, possibly this article is the most honest so far, explicitly calling the technique a “relaxation therapy”. The life force concept is only briefly and obliquely referenced and the main emphasis is that this is simply a massage.

Even so, there are vague hints that the procedure is beneficial to your health is way that go beyond simple massage.

Passages like:

“…the yoga-like stretches help to stimulate and move air through the body.

“Every vital part of the human body, from the heart to the lungs, needs good air flow to function well, and Thai massage is aimed at stimulating these air vessels in the body,” said Nucharee Weerawan”

Do subtly imply that the massage will not only relax you but will help your body to “function well” whatever that might mean in this context. Which in turn may lead people to be more open to the idea that the massage could be used to treat more serious ailments. Or maybe the population will actually think things through for themselves and see through more extravagant claims.

I’m hoping for the later.

Though reading further into the description of the massage given, it doesn’t sound especially pleasant. Despite the attempt at a positive spin in the last line.

2012: 01/13
CATEGORY: Alternative medicine
Medicine
Questionable Techniques
Sciblogs
skepticism
5 comments

The Webwhisperer: A Medical Resource

I generally look with interest to see how people are getting to my blog. Often the referrer is Mr Google, the next culprit is usually Facebook, then there are pages where someone has posted a link to an article I written for others to check out. These are the most satisfying.

Sometimes it’s someone pointing out how stupid I am, many times I’m being used as a resource on some forum discussing AltMed. Today I found I was being linked to by a site called the Webwhisperer.

The Webwhisperer is a blog run by a UK doctor who is attempting to create a resource of reliable medical information, mainly for the doctor’s own family to access it seems but I think it has wider appeal and application.

Since the beginning of the year the Webwhisperer has been running a series on infant teething, the fifth and latest post is a link to my own article on Amber Teething Beads with a favourable intro. Ok, so I’m referred to as a mother but I’ll let that go (mainly because comments are disallowed and I can’t see any other way to contact the author. But also because I’m secure in my masculinity. Mostly).

Teething is something that can be quite distressing for new parents and is a topic that that every family member has an opinion on the best way to handle. A medical resource that gives factual information can be invaluable. So check it out.

There are many, many other topics covered on the site from allergies and alopecia to breast implants and pregnancy. I plan to browse it regularly. You should too.

2012: 01/12
CATEGORY: Medicine
Sciblogs
Science
Leave a comment

Breaking News!: Have Constipation? Moxibustion Won’t Help!

What’s Moxibustion, And why would you want to use it for constipation? The first I can answer, the second…not so much.

Moxibustion is the practice of burning ground up mugwort and applying the smouldering plant indirectly or directly to the skin to alleviate illness. In the indirect method acupuncture needles are inserted and the burning mugwort is used to heat either the skin or the needle. Direct methods are exactly what it sounds like, the mugwort is burned while sitting on the skin and your skin burns too. The amount of skin burning can vary – from minor to burns that will leave scars. On purpose.

Why would you want to subject yourself to this? Beats me.

But people do, and others study what it might be good for and publish papers about it. One of these turned up in my in-box this morning courtesy of BioMed Central Complementary and Alternative Medicine. With a title like “The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial” how could I ignore it?

Reading the study I was transported to a place where the underlying physical process of disease matters not a whit and where the sweat, facial features, , body energy, duration of disease, and pulse type are methods of determining treatment. To be fair other measures were also used, including stomach pain, stuffiness and duration of disease.

No indication was given of how “body energy” was measured. Stuffiness was not defined – I’m sure these are standard things that every doctor knows about.

Frankly, if you are using a magical treatment to unblock your magical life energy then this is the type of thing you should expect to be important.

The study itself was quite small, as the title suggests, only 25 participants. 12 in the treatment arm and 13 in the sham moxibustion arm. Now, how do you do sham moxibustion? Apparently, as it is the heat from burning the mugwart that is important, you just introduce an insulator to stop that heat reaching the patient.

Luckily the procedure used was the indirect acupuncture type, so those in the sham group didn’t wonder why no third degree burns where in evidence.

This approach leaves all the burny, smokey goodness of the mugwort though. Given the negative outcome of the study I suspected this would come up in the discussion. I was not disappointed.

We’ll get to that in a bit. First I want to cover how the patients were divided into “deficiency syndromes” and “excess syndromes”. Constipation in traditional Chinese and Korean medicine is apparently due to either a deficiency or excess of qi (chi), you know, the life energy. This is where checking out people’s faces and sweating etc comes in.

I’ll quote directly from the paper at this point:

“A patient with a deficiency syndrome has sunken, weak pulse, whereas a patient with an excess syndrome has superficial and broad pulse. The patients having symptoms such as a pale face, heavy sweat, and depression were considered to have a deficiency syndrome; the patients having symptoms such as a swollen face, little sweat, and chest pressure were considered to have an excess syndrome. Syndrome pattern differentiation was conducted by an OMD before randomization.”

Further on:

“Five participants were diagnosed with an excess syndrome, and twenty-one participants were diagnosed with a deficiency syndrome. In this study, the most prevalent symptoms for an excess syndrome were a strong body energy and superficial pulse; for a deficiency syndrome the symptoms were a long duration of disease and weak body energy.”

Given that “body energy” plays such a part in dividing the patients I was hoping at this point it would be defined and a method to assess it given. Alas, I was out of luck. Obviously it’s too basic to explain here.

To the results!

I already gave the game away: moxibustion was no different than sham moxibustion when it comes to improving symptoms of constipation. To their credit the authors admitted this could be because moxibustion is, in fact, ineffective. But then, maybe they chose the wrong acupuncture points (never mind that large well designed studies show that where you stick the needles has no effect on outcomes). Or perhaps the sample size was too small – I’ll give them this one, though if there was a significant effect then even a small sample should have shown it.

Then the inevitable, perhaps the sham moxibustion was effective after all. Because, you know, the smoke and stuff. And, oh yeah, the patients actually had “excess-cold” syndromes when normally you’d expect excesses to be warm – so maybe that has something to do with it…

Can you say “rationalising”?

The authors also note that while a number of adverse events have been reported for moxibustion, the patients in this group only experienced redness. Another quote:

“Previously reported adverse events related to moxibustion treatment include burns [no kidding, I thought that was a feature - not a bug], an itching sensation, infection, allergy and xerophthalmia [dry eyeballs]“

Dry eyeballs…. hmmm, better than a punctured lung.

The paper concludes with the obligatory call for larger more rigorous studies, despite the fact that this is an implausible treatment based on magical thinking. Oh well, such is the way of things nowadays.
———————————————-
Park JE, Sul JU, Kang K, Shin BC, Hong KE, & Choi SM (2011). The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial. BMC complementary and alternative medicine, 11 (1) PMID: 22132755

2011: 12/06
CATEGORY: Alternative medicine
Medicine
Sciblogs
Science
skepticism
2 comments

Get Your Up-To-Date Vaccine News

Thanks to my recent single-minded posting I’ve stumbled across this resource that pulls together news and blog posts on vaccines and anti-vaccine topics.

It uses a cool functionality of Scoop.it to collect posts which are then “curated” by a real person (hate those obviously fully automated ones that often ping my posts).

Vaxfax monitor is a Scoop.it site, which means the curator specifies keywords and the software trawls Twitter, Google, Digg and Youtube to generate content that matches the keywords. Once this is done the output is offered to the curator to vet. The posts that are retained through this process are published to the main site while those that don’t make the cut are discarded.

The curator of this feed is a poster who goes by the handle anarchic_teapot. Regarding anarchic’s chosen Nym I took this from the about page:

“My handle was chosen entirely at random, so don’t read anything political, social or ironic into it. I have no connection with the Anarchist Teapot Collective, or the coder using the handle anarchic.teapot (with a period, not a hyphen). I’m pretty certain I used the name first, though.”

I contacted anarchic_teapot to get a bit more information about the process involved in putting this feed together and to get a feel about the person behind the page and for why this resource is important.

[Scepticon] Where abouts in the world are you based?

[anarchic_teapot] I live in France, surrounded by sunshine, wine and cheese. And lots of other stuff that’s bad for my diet.

[Scepticon] The agregator uses keywords to collect content, is there any way to get random stuff you’ve noticed into it?

[anarchic_teapot] It’s also possible to scoop stories directly off the Internet, using a browser widget. In fact, the 3 main aggregators I use: paper.li, scoop.it and newsvine now all offer this service.

[Scepticon] What’s the difference between those services?

[anarchic_teapot] Scoop.it will publish each article immediately it’s validated. You choose any tags and which sites you’re going to publish to. It’s useful for getting breaking news out the door, but does require a lot of time curating. Another drawback is that it can mean a lot of tweets going out, and I don’t like flooding the intertubes, out of respect for my long-suffering readers. I want to keep them!

Paper.li does quite a good job of finding keywords, and you can pick the regularity at which it’s updated. At most, you’ll have two tweets a day.
The (big) disadvantage is that you can’t remove unwanted content until after an update.

Newsvine doesn’t send out tweets, although I suppose it would be easy to send your personal RSS feed through a service like Twitterfeed for that. On the other hand, it does allow comments, so you can get a discussion going. You can also write quite a lengthy post about the article you’ve seeded, as they call it. However, you have to go find your content for yourself; it won’t go looking for you. Although you *will* be warned if Newsvine thinks someone has already seeded the same story.

[Scepticon] Once the stories are gathered what happens?

[anarchic_teapot] Every time I check the feed, I have up to 100 stories that I can either discard, block the source (porn sites, bots, or other minor noise) or decide to publish. I try to keep Scoops recent (past 2-3 days) and from reliable sources. I also try to keep repetition down.

[Scepticon] Why did you feel the need to create such a resource, what do you see as the goal of aggregating all this stuff in one place?

[anarchic_teapot] I suppose the need comes from not having enough time to check major news sources regularly, and nobody to do it for me. I’ve always been one to let the computers do the spadework. Putting it all in one place gives me the chance to spend more time sifting through the dross. There is a lot of dross. I have some absolute doozies lined up for future blogging.

At the same time, to see so much quackery being sold so hard scares me.
It keeps me motivated, and I understand why others are so implicated in the struggle for science too.

[Scepticon] What is the criteria for inclusion, do you simply include those things you already agree with?

[anarchic_teapot] Well, it’s all a bit subjective, as things have to be when you’re playing editor (I hate the word curator, that’s for museums) to any sort of publication. As a rule of thumb, I try to keep to stuff that’s informative, not too technical – I’m not the health professional in the family – and of immediate use. I had to think about announcements of potential breakthroughs (HIV and malaria are currently doing the rounds) but decided it would be quite enough to deal with currently available vaccines.

[Scepticon] What is the main focus, news stories that demonstrate harm of anti-vaccine views or information about vaccines themselves?

[anarchic_teapot] Both, really. For reasons of space, I try to avoid localised reports, unless the story is of wider relevance (e.g. a clinic offering free shots probably won’t make it, but an outbreak of mumps may). I occasionally throw in some of the nastier antivax stuff, well flagged as such, in the hope that someone better qualified than me will pick it up and pillory them.

The teapot also admitted to using the generated content prior to publishing as a means of keeping an eye on the shall-we-say “less reasoned” content out there. I believe the term used was “Stupidity detector”, turning these gems into the bases of blog posts.

One of the things that I am grateful the anarchic for is the attempt to keep the feed from turning into an agglomeration of random crap.As noted earlier, I often get pingbacks from sites that have linked to my posts (and sometimes published portions of them) that when I check are simply grabbing everything with a keyword with in filtering, even to the point that the main purpose of a page is 180^o opposed to what I’ve written but presents my content as if it’s in line with the site’s philosophies.

According to the teapot:

“The nice thing about Scoop.it is that you don’t *have* to publish anything.”

Ah, how refreshing.

Vaccines and Autism – Media Report Card Expanded (sciblogs.co.nz)
Anti-Vaccine Charities – Is there any Quality control on Charities? (sciblogs.co.nz)
IAS Complaint Part 1: Thimerosal in Your Vaccine? No. (sciblogs.co.nz)
IAS Complaint Part 2: Gardasil Horrors – Horrific Reasoning (sciblogs.co.nz)
IAS Complaint Part 3: Vaccine Ingredients: Not So Bad Really (sciblogs.co.nz)
IAS Complaint Part 4: Anti-Vaccine Impact in New zealand (sciblogs.co.nz)
Defending The Term “Anti-Vaccine” (sciblogs.co.nz)
The Legitimate Risks of Vaccines (sciblogs.co.nz)

2011: 10/19
CATEGORY: Interviews
Medicine
Sciblogs
Science
skepticism
1 comment

Defending The Term “Anti-Vaccine”

I have spent some time recently labelling the IAS as anti-vaccine. They themselves categorically state that they are not anti-vaccine. Who am I to say that I’m right and they are wrong?

Well, nobody really. I can’t read their minds, although if I could would that change anything? All anyone can do is examine their output, and that of others, and try to make a determination as to whether it is more consistent with an impartial, or simply safety concious, approach to vaccines and vaccination or an anti-vaccine stance.

I hope that my previous posts have demonstrated that the IAS in particular produces anti-vaccine rather than balanced vaccine safety material. The mission of the IAS is to cast doubt on the safety and efficacy of vaccines not to educate responsibly about the real concerns and limitations of vaccine use. If this was their aim they could do a much better job. Look at the articles produced on their website and you will see many that promote the “dangers” of vaccinations, try to discredit health campaigns and generally aim to undermine public confidence in vaccines.

An organisation concerned about vaccine safety and promoting responsible use of vaccines might write about reducing wide-scale vaccination in favour of targeted vaccination of at risk populations. Perhaps They would also try to work with health authorities to examine ways in which vaccine production can be improved (better production techniques might avoid allergy issues mentioned below), or ways in which the distribution of vaccines can be made more effective and thereby reducing the need to preservatives that are thought by them to be harmful.

It is important to note that someone can be concerned about the safety of vaccines while not being anti-vaccine at the same time. I alluded to this above, but there are legitimate safety issues surrounding vaccine use and vaccines should indeed be closely scrutinised prior to mass roll-out via safety and efficacy trials and post roll-out via surveillance systems and doctors reports. It is a valid complaint that procedures are not always carried out effectively.

Sometimes though they are carried out quite effectively and in a follow-up post I will look at a couple of examples of this. The trouble is that often when a “danger” of vaccines is reported more coverage is given to the sensationalistic claims than the eventual explanation. Also (perhaps because of this) these claims have a tendency to hang around and affect public sentiment long after the coast is clear from a safety standpoint.

As I mentioned there are real risks associated with vaccine use, there are known side effects that can have implications for the health of a small number of vaccine recipients. One of the more obvious being allergic reactions to the vaccine ingredients. Those with egg allergies are urged to use vaccines cultured via chicken embryos with caution and may be unable to receive the vaccine at all. There can be other serious and not so serious or transitory side effects for specific vaccines and effects that are general to vaccines (such as redness, soreness, syncope etc).

As such there are a variety of non-histrionic ways that vaccine safety can be discussed, without impugning the general safety of vaccines. Likewise reasonable conversations may be had regarding relative efficacy of vaccine preparations against the myriad of infectious agents that we are exposed to as well as discussions about cost effectiveness of mass vaccination for low incidence infections.

Serotype replacement (or replacement disease) is another issue that can be raised. As infectious strains are targeted by vaccines there is the possibility that other strains that were less important in the pathology of disease become more prominent once the “Top Dog” has been removed.

Encouraging the production and research into more effective vaccines that give better or more long lasting protection could also be a fruitful line of approach. Perhaps we could focus on immunogenicity, better adjuvants would give a vaccine the ability to provoke a stronger immune response, possibly with fewer antigens – as has already been achieved with modern vaccines. If vaccines are improved in this way then there will likely be more local reactions with the inclusion better adjuvants. This again is a reasonable discussion to have.

The lack of large RCTs on all vaccines and the challenges of working around this (for example ethics prohibit withdrawing a measles vaccines then trying a new one against a placebo). The types of studies required or currently used to give us the appropriate information to act upon is something that we can all try to resolve together.

All these things are such that reasonable people may disagree and we should be able to marshal evidence based (rather than emotive) arguments to discover the optimal us of vaccines in society. To my reading of the IAS, their output appears limited to vitriolic and divisive attacks on health authorities and other informational agencies, vilification of pharmaceutical companies, fearmongering over the alleged dangers of vaccination and downplaying the risks of infectious diseases.

Where we start treading into anti-vaccination territory is when we start to become entrenched in a view that sees vaccination as an evil unto itself, perpetrated in the name of profits by immoral pharmaceutical companies and carried out by unethical doctors who are either ignorant dups or willing accomplices. Those who take this stance may make all of the reasonable arguments that I outline above but also be resistant to evidence that contradicts their views and committed to a general non-vaccine outlook.

In discussing this it is very difficult to convey the range of views that may be represented. Obviously we all exist on a spectrum – from fully pro-vaccine to recalcitrant anti-vaccine. It can also be very difficult to determine the views of people in conversation. I prefer to err on the side of caution and assume people are generally well intentioned and open to evidence until proven otherwise.

One of the defining characteristics of the anti-vaccination crowd, it seems to me, is the hyping of dangers far beyond what the evidence supports. As can be seen in some of the attacks on vaccine ingredients, lists of ingredients are given and scary information accompanies them with the toxicological effects of these compounds on living organisms. In these cases though the dose is often ignored. Dose response is one of the corner stones of medicine and the dose makes the poison. Drink large quantities of formaldehyde and you’re in trouble, but in the tiny doses found in vaccines your body can easily handle it. as noted in a previous post our bodies actually make formaldehyde as part of normal metabolism and the amount found in vaccines is far smaller than that made by the normal process of living.

When it comes down to the bottom line – Vaccines work, and they actually perform that holy grail of CAM, “boosting” the immune system and allowing the body to heal itself. Not in some vague, feel good alternative medicine way but in real objectively measurable and observable ways. Your immune system is primed to react to infectious agents in such a way as to reduce the amount of time that it takes for an effective immune response to be mounted against the pathogen.

With this priming your body can fight off infections much more efficiently and this translates into keeping us healthy, or reducing the severity of diseases. While we can debate the finer points of vaccine safety and efficacy in the end we have a system that works and has saved many lives. I see that as a win.

[for more on this topic see this post from David Gorski of Science-Based Medicine published last year]

Vaccines and Autism – Media Report Card (sciblogs.co.nz/skepticon)

2011: 10/17
CATEGORY: Alternative medicine
Medicine
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IAS Complaint Part 4: Anti-Vaccine Impact in New zealand

Finally in the series of extracts from my IAS Charity complaint, I give a brief look at the impact of anti-vaccine information in New Zealand. I also bring together information from other parts of the complaint that have not been covered in the extracts so far.

Impact of Anti-Vaccinationist Misinformation in New Zealand

Maintaining a high level of vaccine coverage is important for reducing the probability of disease outbreaks and to limit the spread of disease in the community. Diseases (often) spread due to contact between infected and uninfected individuals. If the uninfected individual has partial protection from the disease due to immunisation then the disease will spread with more difficulty. This is often referred to as “Herd Immunity”.

Herd immunity does rest on several assumptions, one of which is that immunised individuals are spread evenly throughout the population. If pockets of unvaccinated individuals develop then diseases can gain a foothold in that part of the population and spread outward – even to vaccinated individuals. If parents in a community are convinced by the IAS information not to vaccinate their children then an in-road for disease is created and outbreaks can occur. As such this would constitute a detriment to both children and the wider community – in direct contradiction to the IAS stated charitable aims.

New Zealand has struggled to reach recommended vaccination levels in the past with the coverage rate in 2005 being only 77% at two years of age¹. With such low rates of vaccine uptake in the population there is a risk of vaccine preventable disease outbreaks occurring in the population and putting children’s lives at risk. In fact this is happening now with the measles outbreak in Auckland. Health officials have linked this outbreak to lowered vaccine uptake attributable to anti-vaccine misinformation².

Vaccine coverage for a disease such as measles needs to be at approximately 90% or greater in infant populations to prevent epidemics³. Despite a focus on increasing coverage since earlier this century and improving coverage since the 2005 survey New Zealand still only sees an average of 85% vaccination coverage in this age group, with some areas dropping as low as 75%⁴.

In 2004, just prior to the Vaccine Coverage survey, a study was performed to see what reasons parents gave for not vaccinating their children⁵. The results of the study found that many of the parents interviewed made a decision not to vaccinate based on perceived risk of the vaccines. The risks cited were common anti-vaccinationist misunderstandings, including linking vaccines to autism and the belief that children’s immune systems are weakened by immunisations.

While almost all of the study participants consulted their GP for vaccination information, this source was seen as biased. In fact many of the “Pro-vaccine” sources were considered biased and parents expressed interest in information provided by groups outside the “medical establishment” indicating distrust of medical advice on this topic in general. The Immunisation Awareness Society was explicitly listed as a source of information by 76% of survey respondents, along with Naturopaths and Homeopaths (43% and 48% of respondents respectively).

The Immunisation Advisory Centre is sufficiently concerned about misleading anti-vaccination claims that they have included a page dedicated to rebutting this information on their website⁶.

Conclusion

The IAS dispute that they are “anti-vaccine” both in their Charity “Rules” (3. Beliefs, subsection C⁷ and through comments on their website. This claim rings hollow though when the actual content of their writings is examined. Therefore it is important to look at the effective output of the ideologies, philosophies and stance of the charity rather than their explicit statements.

In regard to IAS staff and members, belief that they are acting in the public interest, belief that their materials constitute an educational resource and belief that they are in fact doing the right thing are not enough. I have no doubt that the founding members, the officers and members of IAS sincerely think that they are provide a public service and that their interpretation of the scientific facts is the correct one. This however only affords them the right to be respected as individuals and for their views to be given fair hearing, it does not constitute a right to charitable status and does not exempt their views from criticism.

The IAS has shown through their materials that, despite protestations to the contrary, their views are anti-vaccine. This entails that their views are factually and scientifically incorrect, that they have an agenda to reduce or stop vaccinations being performed and that through this their actions may translate into serious harm for individuals, the community and the public at large. The IAS currently enjoys charitable status, as such they are exempt from taxation on their income. This amounts to a government subsidy of anti-scientific and potentially harmful views.

————————————————————————————————-

One last point, I am pretty clear to paint the IAS as anti-vaccine. They themselves deny this label, as mentioned above. But then I have a bias don’t I? Well, heres a link to a website that has the opposite bias, they list the IAS as on of their “100+ Great Anti-Vaccination Information Links“, I’d say that;s telling.

Footnotes:
1. NZ Vaccine coverage survey 2005
http://www.moh.govt.nz/moh.nsf/pagesmh/6028/$File/national-childhood-immunisation-coverage-survey2005.pdf
found on:
http://www.moh.govt.nz/moh.nsf/indexmh/national-childhood-immunisation-survey-2005

2. Stories covering the Aucland Measles outbreak:
http://www.stuff.co.nz/marlborough-express/news/5220199/Immunisation-rate-of-refusal-growing
http://www.nzherald.co.nz/immunisations/news/article.cfm?c_id=461&objectid=10553617
http://www.stuff.co.nz/national/health/5222511/Measles-outbreak-likely-to-spread

3. Predictive model for Measles Outbreaks. Coverage at 15months should be >90%
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810912/pdf/10813154.pdf

4. Immunisation Coverage report 2010:
http://www.immune.org.nz/site_resources/Professionals/Research/2010_Immunisation_coverage_report.pdf
Found Here:
http://www.immune.org.nz/?t=603

5. Study looking at reasons NZ parents give for not vaccinating:
http://www.nzma.org.nz/journal/117-1189/768/

6. IMAC website with anti-vaccination rebuttals:
http://www.immune.org.nz/?T=938

7. Charities Register page for IAS:
http://www.register.charities.govt.nz/CharitiesRegister/CharitySummary.aspx?id=17c102eb-e79c-de11-9604-0015c5f3da29

2011: 10/14
CATEGORY: Medicine
Psychological
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2 comments

IAS Complaint Part 3: Vaccine ingredients – Not so bad really

Next up in our voyage of crank discovery, via extracts from my IAS charity complaint, is a breakdown of simplistic reasoning around vaccine ingredients. Again, I have reproduced elements of the original article here for your convenience.

The following example was posted as a look at vaccine ingredients in two parts. I will not be so lenient – Both in one for you.

Vaccine Ingredients – Part 1
posted May 6, 2011

This post contains a number of misunderstandings and falsehoods both explicitly stated and implied. The post lists the type of cell culture lines that viruses are cultivated in in order to create vaccines and then implies that the cells from these cultures are still found in the final vaccine product that is injected, including the emotive claim that we are injecting aborted foetal tissue into our children with the vaccine.

[Quote]
“I bought Sue Claridge’s fantastic book “Investigate Before You Vaccinate,” and turned to page 44 which states: “The cell cultures used to grow the viruses and bacteria include monkey kidney (vero cells), foetal calf serum, chick embryo fluid, yeast and human diploid cells (cells from aborted human foetuses). WHAT?! You mean to tell me that we are injecting aborted human fetal cells into our babies?!”

This is incorrect.

While it is true that there are some cell lines used to culture viruses used in vaccines, it is inaccurate to say that we are injecting these cells into children. Once again precision in language is important, there are currently existing cell lines that were originally cultured using aborted foetal tissue. These cell lines used originated in the 1960s¹, meaning that the cultures used now many cell replication generations removed from the original tissue and are now are simply cells grown for medical use – not foetuses.

The only vaccine in the New Zealand schedule to be developed using cell lines derived in this fashion is the MMR vaccine, due to the inability to grow Rubella virus in any other type of cell line². Vaccines must also be purified before use in order to remove these cells prior to injection^3,4. Following purification the cells of the original culture are no longer present.

The article then proceeds to give a laundry list of possible vaccine ingredients, with the implication that the levels of these compounds are harmful at the doses provided in the vaccine.

[Quote]
“…formaldehyde (an embalming fluid). SERIOUSLY?! Oh, it gets better!!! Some vaccines also contain mercury, aluminium, preservatives, stabilisers, lactose, sorbitol, sodium chloride, sucrose, sodium borate, magnesium chloride, sodium phosphate, hydrolised gelatine, neomycin, gentimicin, streptomycin and human albumin…”

This dose insensitivity of the anti-vaccine rhetoric is recurrent and important. All chemicals have a threshold above which they can have detrimental effects on human physiology, the question is whether this threshold is exceeded by vaccine ingredients. The medical community is in agreement that the answer to this question is “no”. At this point the anti-vaccine community does not need to provide proof that the levels of compounds found in vaccines are harmful, the only goal is to raise questions about safety.

The United States CDC website has a page dedicated to vaccine ingredients and countering anti-vaccine questions about them⁵. The IAS article highlights that formaldehyde is used in vaccines and points out that this is used as an embalming fluid. The CDC website answers this question and it is telling that the IAS article does not mention that formaldehyde is also made in the body during normal metabolism. In fact it is calculated that a baby (depending on size) would have more than 50 times the amount of formaldehyde in its body naturally than it would get from a vaccine dose.

Most of the rest of the ingredients listed are stabilisers and preservatives of the vaccine components. Several such as sodium chloride (table salt) and sucrose (sugar) would not be considered harmful by most reasonable people. As such I will point out a small selection that would seem to be concerning and give the actual facts behind their use.

The first that would seem worrying is amorphous aluminum hydroxyphosphate sulfate. The approximate amount of this compound used in vaccines is 225 μg. Used as an adjuvant (a vaccine additive that modifies its effects) this ingredient actually makes the vaccine more potent by enhancing the body’s immune response to the vaccine. As such it has an 80 year track record of safety in vaccines⁶. Also, dietary sources of aluminium are not insignificant, estimated at 1.6-13 mg per day⁷ or 7-60 times that in the vaccine, even though bioavailability of chemicals is affected by the method of introduction to the body (oral vs injection) it’s hard to see how this minuscule amount would make any difference.

Another potentially scary sounding chemical in vaccines is sodium borate, the approximate dose per injection of vaccine is 35 μg. This is used to balance the pH. The LD50 (a measure of toxicity) for this compound is 2-3 g/kg in mammals⁸ and as such is actually slightly less toxic than table salt (~3 g/kg⁹), the 35 μg in the vaccine if given to a 50kg individual equals a 0.7 μg/kg dose, this isn’t even close to a dose high enough to cause even a minor problem.

The article goes on to make a specious assertion that we were “created perfect as we are” and that we shouldn’t need to inject “formaldehyde and monkey cells” into our bodies to make our immune systems work, if we did we would be “born with it”.

[Quote]
“Weren’t we created perfect as we are? Do we really need to be “fixed” or “made better” by injecting these substances into our bodies? If we were meant to have formaldehyde and monkey cells in our bodies in order for our immune systems to work, wouldn’t we have been born with it?”

Aside from the unintended irony that we actually were born with formaldehyde in our bodies this claim is poor reasoning. By this criteria some of us would have also been “born with” glasses or contact lenses or hearing aids. This article also would appear to refute the utility of acquired immunity – if we needed foreign bodies in our system to make our immune systems work then we would have been born with them.

Finally the question is asked “If we’re all suddenly going to get sick or die if we don’t get these vaccines, then how did we survive for tens of thousands of years without these ingredients inside us?” ignoring for the moment that it is not the vaccine ingredients themselves that we need but rather the antigens in the vaccine that the rest of the ingredients stabilise and preserve, the simple answer to this question is “millions of us didn’t survive”.

Vaccine Ingredients – Part 2
Posted May 9 2011

This post appears to be one long argument attempting to cast doubt on the level of knowledge we have regarding the operation of our immune system. By quoting from an anatomy and physiology text book¹⁰ and emphasising tentative sounding words such as “appears”, “may” and “apparently” the author is attempting to show that the entire field on immunology is in doubt.

[Quote]
“On page 778, after talking about T cell maturation, it mentions that “less is known about the factors that control B cell maturation in humans” i.e. they haven’t quite figured out how B cells mature in our bodies yet. Another classic is on page 792, when they try to explain why the immune cells sometimes attack foreign human cells when a patient has received a graft. Their explanation is that “apparently, [emphasis mine] the cytotoxic T cells sometimes ‘see’ the foreign class I MHC antigens as a combination of self class I MHC protein bound to foreign antigen” i.e. they don’t actually [emphasis mine] know how it works, but this is their best guess.”

The fact that the text is dealing with minutia of the immune system down to the level of cell generation and activity seems to not persuade the author that in fact there is a great deal currently known about immunity and how our immune system works. To the point that it is considered feasible (by the author) that future text books will recall the use of vaccines and their “toxic ingredients” as complete folly.

The level of argument here is such that similar reasoning could be used to show that since the fluid dynamics at the edges of aircraft wing tips is not completely worked out, in the future we may discover that airplanes cannot fly after all. The point of this parody is to show that the author is confusing knowledge of mechanism with knowledge of efficacy. We know vaccines work, study upon study of new and old vaccines verify this fact every day. The inability of science to answer every minute facet of why they work does not invalidate this data. Once again the only goal here is to plant a seed of doubt about the safety and effectiveness of vaccine in the minds of the public. As such the IAS once again demonstrates the education is not the desired outcome of their operation.

—————————————————————————————

Footnotes:
1. Cell lines

http://www.viromed.com/services/product/wi38.htmhttp://www.viromed.com/services/product/mrc5.htm

2. Vaccine Manufacture

http://www.immunizationinfo.org/issues/vaccine-components/human-fetal-links-some-vaccines

3. Vaccine Purification:

http://www.cuno.com/healthcare/pdfs/application_briefs/vaccine_production.pdf

4. Vaccine requirements(Section III, sub section B.5. paragraph 2):

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074801.htm

5. CDC Vaccine ingredients page:

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm

6. Aluminium track record:

http://www.webmd.com/parenting/news/20040129/aluminum-in-vaccines-poses-no-harm

http://www.chop.edu/service/vaccine-education-center/hot-topics/aluminum.html

7. Dietary aluminium:

http://www.efsa.europa.eu/en/efsajournal/pub/754.htm

8. Sodium Borate MSDS:

http://www.anachemia.com/msds/english/f880%28vcr%29.pdf

9. Safety sheet for NaCl

http://msds.chem.ox.ac.uk/SO/sodium_chloride.html

10. The Text book that appears to be written about:

http://www.campusbooks.ac.nz/product/21980-HumanAnatomyandPhysiology-9780321584199

2011: 10/13
CATEGORY: Medicine
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IAS Complaint Part 2: Gardasil Horrors – Horrific Reasoning

Continuing my series of extracts from the IAS charity complaint. This one focuses on the Gardasil vaccine and the paranoia that has arisen around it. I have included a link to the article but for convenience I have reproduced here the parts that I refer to in the complaint.

Gardasil Horrors
Posted April 6, 2011

First, the very title of this entry is calculated to be sensationalist and to undermine trust in a vaccine that has so far had an exemplary safety record¹.

The post is copied from the proceedings of an FDA advisory committee and is not representative of the full content of the meeting². The content is the submission of Roberta Boyce founder of the anti-Gardasil website truthaboutgardasil.org. The submission contains misleading information, misunderstandings and errors of fact as well as unsupported assertions; all aimed at undermining the vaccine.

The submission starts out by alleging that the Gardasil vaccine causes vitamin deficiencies in the girls who receive it, specifically niacin.

[Quote]
“…I presented information last September against the vaccine at a similar FDA meeting when you were considering extending the vaccine to boys and older women. At that time I told the advisory panel that many of the Gardasil girls were showing symptoms of severe vitamin deficiencies, specifically niacin.”

This appears to be based on the submitter’s personal experience as the medical literature does not seem to back-up such a claim³. A charitable interpretation might assume that the medical literature has not yet caught up with a reaction that has been observed by parents and medical professionals. To this end the VAERS database⁴ was queried by myself in an attempt to verify whether vitamin deficiency is indeed a reaction seen in “many of the Gardasil girls” as claimed in the submission. The VAERS database did not list niacin as a filtering criterion, in this case then all criteria that where related to vitamin deficiency or decreased vitamin levels were used.

The data for worldwide events was searched, a total of 44 events were found. Given that by now millions of doses of Gardasil have been administered⁵ 44 events (of which 11 were considered “non-serious”) seems minimal. Certainly far from the “many” quoted above. When it is factored in that the VAERS database does not show causal connections but is merely for reporting events that occur in close temporal proximity to the vaccine there is no reason to determine that these events are anything more than normal occurrences within a population.

Part of the submission references the May 2006 FDA VRBPAC report on the clinical results for the development of Gardasil as a prevention of HPV in women⁶.

[Quote]
“Already the May 2006 FDA VRBPAC reports that if a woman has HPV and receives Gardasil, her chances of getting cervical cancer increase by 44.6 percent after inoculation. “

The submission reference is at best a misreading of the report and at worst cherry-picks facts out of context in order to support a specific conclusion. It is alleged that women already infected with HPV strains targeted by the vaccine experience an increased risk of cancer of 44.6%. This is incorrect on two counts; first, the possible increase is in CIN 2/3. This refers to Cervical Intraepithelial Neoplasia, generally regarded as “pre-cancer”⁷. This may appear to be hair splitting but in science precise terminology is used for a reason.

Second, the data referred to is made up of small numbers and is a sub-group of the main study population. As such, further in the report it is suggested that the observed increased risk is actually due to slight imbalances between the intervention and placebo groups. This conclusion is reached after additional information about the sub-groups and data using larger sample numbers is provided by the study authors. In conclusion, it is likely that this result is simply noise and the use of it without context amounts to cherry-picking.

The submission continues with further medical misunderstandings and eventually devolves into what appear to be paranoid theories about drug companies targeting girls with a particular genetic make-up for sterilisation using the Gardasil vaccine.

[Quote]
“My daughter recently tested sterile at age 21, although she is still getting a relatively normal period. Could it be that Merck intentionally developed this vaccine thinking it would affect a small number of individuals with PK deficiencies? Is this what their intent was when they developed their recently approved fertility drug Aleva, which was just passed for European use? I wonder if Merck and other big pharmas have intentionally taken advantage of genetic deficiencies. I believe they have, and I believe this is what has happened many, many times over. In fact today’s presentation by Dr. Garner clearly stated that DNA extractions were performed in their tests.”

As corroborating evidence the submitter refers to a previous presentation during the committee that referred to DNA extractions, once again ignoring the context in which this was stated – clearly in reference to looking for evidence of HPV DNA in subjects, not screening the genetic profile of the subjects themselves.

Finally the submitter implies that the Gardasil vaccine is a self-manufactured curse from God for Christians because they have not adequately spread God’s word. Beliefs such as this may motivate some people but they do not constitute a valid argument when it comes to health and science. Evidence is required and the evidence provided, such as it is, is not adequate.

The appearance of this submission on the IAS website implies an endorsement of its views and that it is considered information worthy of inclusion about the safety and efficacy of the Gardasil vaccine. As it is based almost entirely on personal experience, assumptions and misunderstandings its inclusion on a website run by an organisation that ostensibly is concerned with providing accurate information to parents is completely inappropriate.

———————————————————————————————

Footnotes:
1. Gardasil Postlicenture safety Surveilence report:
http://jama.ama-assn.org/content/302/7/750.full.pdf+html

CDC Safety information:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm

2. Full FDA Advisory committee Meeting muinutes:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm241266.htm

3. Literature search was carried out using the PubMed database found here:
http://www.ncbi.nlm.nih.gov/pubmed

4. Vaccine Adverse Event Reporting System. Data from which may be accessed here:
http://wonder.cdc.gov/vaers.html

5. Gardasil Doses
http://www.bestshot.co.nz/Gardasil%20Q-A.pdf pg11

6. FDA VRBPAC report:
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

7. Information on Cervical intraepithelial neoplasia:
http://www.thehpvtest.com/about-hpv/cervical-dysplasia-faqs/

2011: 10/12
CATEGORY: Medicine
Questionable Techniques
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