Posts Tagged Medicine

New Zealand Pharmacy Ethics in Relation to Homeopathy in the Wake of Homeopathy Report Darcy Cowan Feb 24

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Earlier this year I wrote a post (along with fellow Sciblogger Grant) concerning the sale of homeopathic remedies in pharmacies. Monday night saw the release of England’s Science and Technology Committee’s “Evidence Check 2″ report on Homeopathy (also ably covered by Grant). One of the issues covered by the report is that of pharmacy responsibilities regarding sale of these remedies. Essentially the report recommended that sales continue but with adequate disclaimers stating that there is no scientific evidence that homeopathic products work beyond the placebo effect.

I see this as a compromise between commercial freedom to sell safe, though not necessarily effective, products and patient informed consent. It’s reasonable even if I disagree that it is ideal. Regardless, I thought it was a good excuse to look once again at our own pharmacies and see how the selling of scientifically unsupported remedies aligns with their professional responsibilities.

Enquiring into this area I was directed to the Pharmacy Council Code of Ethics for pharmacists. The Pharmacy Council seems to fill the function of professional association and regulatory body for pharmacists their functions including:

prescribe the qualifications required for scopes of practice within the profession, and, for that purpose, to accredit and monitor educational institutions and degrees, courses of studies, or programmes

and

consider the cases of health practitioners who may be unable to perform the functions required for the practice of the profession

Perusing the Code of Ethics (which may be found Here) I found a number of sections that I feel should preclude pharmacists from selling homeopathic remedies in good conscience. In order to try and represent the spirit of the code as accurately as possible I have included here both the relevant over-arching Principles that pharmacists should strive for as well as the Specific Obligations that I feel make my point (any emphases are mine).

The first principle is one of patient autonomy:

Principle 1: Autonomy
The pharmacist shall promote patient
self-determination, respecting the
patient’s right to understandable
information, privacy, and confidentiality

1.4 Professional services
Where the patient is seeking or receiving, from the
pharmacist or from other personnel for whom he or
she has responsibility, any professional service or
intervention, the pharmacist must ensure that the
patient is provided with credible, understandable
information about reasonably expected results,
outcomes or effects of the service or intervention, any
risks of receiving the service or intervention, and any
insufficiency of evidence about the efficacy of the
service or intervention, to allow the patient to make
an informed choice.

This to my reading implies that should pharmacists sell homeopathic remedies they are obligated to inform the patient of the lack of scientific underpinnings for the use of the remedy. One of the objections I have run into regarding the sale of these remedies in pharmacies is that they are commercial enterprises and are within their rights to sell products regardless of their medicinal value. This is partially true but these remedies are specifically sold to treat symptoms, not as entertainment, confection or cosmetic. The Code has several entries covering this aspect the first of which is:

1.5 Independent information
The pharmacist must ensure that their advice is
independent of personal commercial considerations.

Does this not imply that the sale of unscientific medicines should not be undertaken simply because it make financial sense? We will return to this point later.

The next Principle covers patient needs:

Principle 2: Beneficence
The pharmacist shall optimise medicines
related health outcomes for the patient
according to their concerns, needs,
cultural values and beliefs

2.2 Quality use of medicines
The pharmacist must provide scientifically-based,
unbiased medicines information to healthcare
providers, patients and the community in order to
optimise medicines related health outcomes.

My reading of this point leads me to understand that any information provided regarding pharmacy products must have scientific backing and moreover must not be biased by the pharmacist’s own views. Any such information regarding homeopathy must therefore be negative.

But, what if the pharmacist is not asked for this information? After all, I do not usually go in asking for a lecture if I already think I know what I need. I think the next obligation covers this instance:

2.8 Involvement in sale of medicines and other
therapies
The pharmacist must be involved and intervene in the
sale of any medicine, complementary therapy, herbal
remedy or other healthcare product whenever this is
necessary to ensure a reasonable standard of
pharmaceutical care.

Scientifically speaking homeopathy should not be considered to encompass a “reasonable standard of pharmaceutical care”.

The next Principle of relevance concerns fairness:

Principle 4: Justice
The pharmacist shall practise fairly and
justly and promote family, whanau and
community health

4.4 Commercial interests not to override good
practice
The pharmacist must ensure that commercial interests
are not permitted either to override the independent
exercise of their own professional judgement on
behalf of a patient or to compromise the standard of
care provided by them or to affect their cooperation
with other healthcare providers.

Once again the issue of financial gain over patient care is addressed with commercial interests coming off second best when the standard of care is concerned.

The next Principle is one I feel is of especial importance when the reputation of pharmacists in the wider community is considered and their self representation in the media is a factor (remember, they’re the health professional you see most often). This is trustworthiness, pharmacists are seen as, and promote themselves as, first and foremost medical professionals not business interests. The sale of homeopathic medicines is antithetical to this position and undermines their credibility in this regard, in direct contraction to the Code of Ethics as follows:

Principle 7: Trustworthiness
The pharmacist shall act in a manner
that promotes public trust in the
knowledge and ability of pharmacists
and enhances the reputation of the
profession

7.7 Non-medical goods and services
The pharmacist must not purchase or sell from a
pharmacy any product or service which may be
detrimental to the good standing of the profession or bring the profession into disrepute.

If the sale of scientifically worthless remedies such as homeopthy does not do this I don’t know what would, perhaps offering Therapeutic Touch?

Finally the Principle of dignity undermines the pharmacist’s sale of unsupported medicines:

Principle 8: Dignity
The pharmacist shall provide
information about professional services,
medicines and healthcare products in a
dignified manner without making
exaggerated or unsubstantiated claims

8.4 Medicines not ordinary articles of
commerce
A pharmacist must only participate in promotional
methods that do not encourage the public to equate
medicines with ordinary articles of commerce.

If the previous examples of why remedies should not be sold with the sole purpose of earning money for the pharmacist this should put that argument to rest. The sale of medicines (which many people consider homeopathy to be) should not be equated with ordinary articles of commerce. This puts the lie to arguing that these remedies are simply another commodity to be bought and sold like chewing gum regardless of therapeutic value.

8.8 Evidence of efficacy
The pharmacist must only promote to a potential
purchaser that any medicine, complementary therapy,
herbal remedy or other healthcare product associated
with the maintenance of health is efficacious when
there is credible evidence of efficacy.

This last obligation explicitly refers to promotion of a therapy to a patient by the pharmacist which I don’t think any reputable pharmacist would do for homeopathy but arguably the presence of the product in the store constitutes an implicit promotion of it to potential customers. This point goes back to the principle of trustworthiness, the public trusts the pharmacist to stock efficacious products. To include unscientific therapies among their wares undermines and betrays this trust. Perhaps I am naive to think so but I think the Pharmacy Council’s own Code of Ethics backs me up when I say that we should hold pharmacists to a higher standard than your average shop owner.

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Filed under: Alternative medicine, Medicine, Sciblogs, Science, skepticism Tagged: health, Health and Medicine, Health care, Herbalism, Homeopathy, homoeopathy, Medicine, Pharmaceutical drug, Pharmacy, Placebo, Science and Society

What is the Harm of Alternative Medicine? Darcy Cowan Jan 26

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Yesterday fellow Sciblogger Grant posted about homeopathic medications in pharmacies and questioned the legitimacy of reputable organisations selling such patent snake oil. The comments to this entry reveal one of the most frustrating aspects of speaking out against unscientific medicine and can be summarised thusly: “I’m far too sophisticated to be taken in by this stuff myself but other people seem to like it and if it doesn’t work then what’s the harm?”.

This attitude is ever present and comes from a reasonable starting point i.e. everyone is entitled to their own opinion and it’s not my job to save them from themselves. I can totally get behind that, usually. When it comes to ineffective medications of the alternative variety however this impulse though understandable is misguided and I’d like to put down a few reasons why I think so, some are speculative but I think the possibility of harm is great enough that they deserve to be considered.

For a start there may well be direct harm caused by using alternative remedies. As there is little to no regulation of these medications then no proof of safety or efficacy is required for sale. Witness the Zicam debacle last year regarding a “homeopathic” cold medication.

Further more the possibility for indirect harm (as multiply alluded to by Grant) may be significant. In case your imagination is not up to the task I will outline a few ways this may be the case. For instance the underlying principles of something like homeopathy are no only unscientific they are in direct contradiction of the last 200 years of scientific understanding. If they are used as the basis of reasoning about health then the results can be more dire than someone getting a bad nights sleep (in the case of the homeopathic sleep aid Grant used as an example).

Use of these therapies for minor ailments by the “worried and wonky well” may increase the possibility they they will be used for more serious health issues where the results could be deadly.

Look no further than the position statement of the WHO regarding the use of homeopathy in the treatment of Malaria and AIDs (among other things). The consequences of such thinking could be incalculable in terms of human suffering and spread of disease. But what’s the harm, right?

Additionally it is one thing for adults to make an informed choice for themselves based on available evidence filter through their particular world view but what about when this choice id forced on their children? The recent case of parents being found guilty of manslaughter over giving homeopathic remedies to their sick daughter is a terrible reminder that sometimes it is innocent children that pay the price for people’s gullibility. But, you know, what’s the harm?

When ostensibly professional medical providers such as pharmacists sell demonstrably irrational treatments they lend credibility to them that the average person uses to base decisions on. I mean the wouldn’t sell it if it didn’t work, right?

So while I understand the commitment to individual autonomy and freedom of choice that leads to the “What’s the Harm?” question, I fail to see how this means that fraudulent therapies must be let off the hook simply because there is a demand for them.

This has been a more vitriolic post than I normally write but what’s the point of a blog if you can’t vent once in a while?

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Posted in Alternative medicine, Medicine, Questionable Techniques, Sciblogs, Science, skepticism Tagged: alternative, health, Health and Medicine, Homeopathy, Medicine, Practitioners and Clinics, Science and Society, Scientific method

Smoking Bans and the Effect of Health Warnings Darcy Cowan Jan 21

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In the world today there is an increasing focus on the negative aspects of smoking and a concerted attempt to reduce the presence of smoking in society. Given the harmful effects of this addiction on not only the active smoker but those around them this seems like a prudent move. Two of the approaches with the goal of minimising public exposure to cigarette smoke are the banning of smoking in businesses and public places and the addition of more strenuous warning labels on the cigarettes themselves.

Both of these tactics have been used in New Zealand with varying levels of acceptance (and success). Smoking bans draw the criticism that individual freedoms are being curtailed. This may be a legitimate point but conceptually it is no different than government enforcement of wearing seatbelts while driving on public roads. The aim is to reduce the risk of harm to the public. The real question in each case is whether the intervention is effective in it’s goals.

Addressing this question two studies last year looked at each of these methods, the first I will look at is a meta-analysis (with the concomitant problems those have, that’s another story) of the effect of smoking bans on the hospital admissions of acute myocardial infarction (that’s a heart attack to you and me). The analysis found that smoking bans were associated with an average reduction of heart attacks by 17%.

For each year a ban was in place it was accompanied by a reduction of the incidence rate ratio (the number of new cases per unit of population eg 10 cases per 100,000 people) of 26%. This indicates that the longer a ban is in force the fewer people who will be affected by heart attacks. Looks like an effective strategy to me, 17% is nothing to be sneezed at when it is individual lives you are considering. Depending on individual risk factors the chance of death in the 30 days after a heart attack can be up to 16%.

An editorial discussing these findings in more depth (in the Journal of the American College of Cardiology, the journal this study was published in) can be found Here and is a good read.

The second study focused on the how well explicit (i.e. emphasising death) cigarette pack warnings encouraged smokers to quit. Specifically it looked at smokers for whom the act of smoking formed part of the basis for their self-esteem. Subjects undertook a questionnaire that evaluated whether smoking was tied to their self esteem using statements like ‘‘Smoking allows me to feel valued by others,” and ‘‘Smoking allows me to feel worthy.” (as well as negative versions). The subjects rated how much they agreed with the statements and this was used to determine the smoking-based self esteem for each subject.

Participants were then shown pictures of cigarette packs that either had mortality related warnings (e.g. ‘‘Smoking leads to deadly lung cancer.”) or more moral or self esteem related warnings (e.g. ‘‘Smoking brings you and the people around you severe damage” and ‘‘Smoking makes you unattractive”). After a delay to allow the warnings to be filtered out of conscious awareness the subjects were asked a further series of questions to assess the effect of the warnings (e.g. ‘‘Do you intend to smoke more or less in the future?” ‘‘Do you intend to quit smoking in the future?”).

Subjects for whom smoking formed part of the basis for their self esteem actually increased their likelihood of smoking in response to warnings emphasising mortality. For these people it was the self image warnings that were most effective. Unfortunately is seems that the opposite is true for individuals that do not consider smoking to be an important factor of their self esteem so a one size fits all approach would probably not be effective. The study authors suggest that specific populations could have warnings tailored to be most effective depending on the relevance smoking has to the group identity (e.g. “young smokers who want to impress their peers.”).

This result may be applicable to other areas where minimising harm is the goal, such as drink driving campaigns.

In summary, despite any reservations regarding the form that inducements to stop smoking take it seems that the benefits are indeed worth the attempt. Also, as I often point out, the real world is more nuanced and complicated than we would generally like it to be, more effort may be required to identify sub-groups that respond most to different strategies but this also looks to be worth trying.

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Posted in Medicine, Psychological, Sciblogs, Science Tagged: American College of Cardiology, Cigarette, health, Health and Medicine, Lung cancer, Myocardial infarction, New Zealand, Review, Science, Science and Society, smoking, Smoking ban, Tobacco smoking

Persistent Vegetative States and the Problem with Facilitated Communication Darcy Cowan Nov 25

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If you read the print version of the NZ Herald today you would have seen featured on the front page a miraculous case of a man [Rom Houben] recovering from a persistent vegetative state and communicating with the world through a touch screen with the help of a carer. The topic of persistent vegetative state (PVS) is an interesting one and has received increasing attention in recent years. It would seem that this man was incorrectly diagnosed after an accident as being in a PVS while at the time of the accident it is more likely that he was in a minimally conscious state (MCS). A fine distinction sometimes and an excellent summary of the differences between the two diagnoses and the difficultly of accurately deciding between them can be found at the Science Based Medicine site.

Essentially a PVS is defined as the patient exhibiting no signs of consciousness, as with everything, whether you find something is dependent on how hard you look, simply opening a couple of drawers and glancing in the cupboard may not turn it up. In determining a case of PVS a more thorough search will reveal fewer legitimate cases as you may find extremely subtle signs of intermittent consciousness that will then flip the designation to a MCS. This process is also dependent on the sensitivity of the equipment used to perform the examination, the sophisticated scanning technology we have today simply did not exist 20 years ago. This equipment is the equivalent of rummaging around in the back of the couch and looking behind the fridge.

That this man was unfortunately diagnosed incorrectly is not in dispute, we have made significant advances in brain imaging technology that allows us to determine activity quite well. The issue here is the man’s ability to communicate so coherently and poetically. After so long without mental stimulation it seems bordering on the fantastic that this could be the case. When watching the video of the touch screen being used to bring this man’s thoughts to the world it seems very close to a practice known as Facilitated Communication, (this is actually confirmed in the TimesOnline article) this consists of a facilitator supporting the arm or hand of a subject ostensibly to allow them to then choose letters and words themselves which otherwise they would not have the strength or the focus to do.

The difficulty here is that this technique is very susceptible to the unconscious influence of the facilitator. In this way it can seem as though it is the patient communicating when in reality it is the thoughts of the facilitator that we are hearing. It is difficult to say for sure in this case, the video is ambiguous as to how much control the patient has over his movements so it is possible that we are indeed being exposed the inner world of a man with a very unique perspective but from the evidence shown it is equally plausible that the facilitator is the true originator of these words.

I would be interested in if any simple tests to determine the true origin of this material have been carried out, some of the suggestions I have seen elsewhere include swapping the facilitator for someone who does not speak the patient’s language, asking the patient questions that presumably only he would know, or asking the facilitator to leave the room while the patient is shown an object or told specific information and then seeing if this can be reliably produced after the facilitator returns. Any of these would help determine whether this man is truely communicating.

The print version of the Herald is mostly credulous in it’s coverage of this story but it appears that enough scepticism has filtered through the journalistic world that the online version has incorporated some of it. Better late than never.

[EDIT: The incomparable Dr Novella of the SGU and SBM has posted his take on this news item, as I hoped he would. Get the thoughts of a neurologist. Also had to add a link to this video from Dr.N's site that shows the patient typing with his eyes closed, simply not possible. Added Patient's name]

Posted in Psychological, Sciblogs, Science, skepticism Tagged: consciousness, Facilitated communication, Health and Medicine, MCS, Medicine, minimally conscious state, persistent vegetative state, PVS, Rom Houben, Science and Society

Simon Singh Granted Permission to Appeal, Darcy Cowan Oct 15

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This just in (sort of), for those following the unfortunate case of the British Chiropractic Association suing columnist and author Simon Singh for libel, Singh has just been granted the right to appeal original ruling on the meaning of his article. For those not aware of all of this see here for a rough run down of the back story.

See Jack of Kent’s blog for the legalese, thanks to The Lay Scientist for the breaking news.

Posted in Medicine, Sciblogs, skepticism Tagged: Health and Medicine, libel law, Science and Society, simon singh

Natural Health Expo(sed)? Darcy Cowan Oct 15

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Driving around Hamilton the past few weeks I couldn’t help but notice the signs sprinkled around the city for the “Natural Health Expo” which is to take place here this week end. As I perused the website for this event yesterday I was disturbed by the large number of anti-scientific “treatments” that will be showcased. Like my co-blogger Grant who has already posted on this, I was troubled by the amount of misinformation that will be leveled directly at consumers.

As I was pondering how to answer the bewildering array of AltMed that will be promoted I checked my email and found a great little article just published in Chiropractic & Osteopathy (made available through the open access publisher BioMed Central).

The paper, “Why do ineffective treatments seem helpful? A brief review” written by Steve E Hartman, looks at how practitioners and patients can fool themselves into thinking that ineffective medical interventions actually work. An excellent example of Evidence Based Medicine 101, Steve covers the cognitive biases that hinder our ability to draw logical conclusions in the medical sphere such as the Post Hoc, Ergo Propter Hoc logical fallacy, confirmation bias and cognitive dissonance. Also covered are explanations of how it can seem that a treatment has been directly responsible for improvement in a patient’s condition when it may not  have been.

The paper touches on disease natural history, which simply refers to how a particular malady might be expected to progress without treatment. Self limiting diseases such as colds, headaches and fatigue can be expected to get better on their own . If a patient is taking a treatment at the time, the treatment (rather than their own immune system) might erroneously be given the credit.

This combined with the overlapping arenas of the placebo effect and regression to the mean can be a powerful confounding factor when treatments are not being considered in light of scientifically controlled settings. The placebo effect is referred to frequently in common culture but regression to the mean is a less well known entity for the layman. Steven does a good job of explaining the concept, essentially people experience a variety of different intensities in their symptoms. Also they will tend to seek medical help when the symptoms become severe, knowing that the severity of the symptoms will tend to cluster about a mean value it is likely that whether treatment is sought or not the patient’s condition will tend to get better.

Thus the patient will feel relief and attribute that relief to what ever modality they are using at the time. Practitioners are not immune to these effects either and will in their practice see time and again that patients are getting better after their pet therapy is applied. In which case they will feel justified in proclaiming it works in the absence of confirming studies (or even in the face of disconfirming evidence).

The one aspect that I felt was missing from the paper, although it may have been obliquely implied, is the role of prior plausibility in evaluating treatments. Many modalities that will be on offer at the Natural Health expo are not only unusual they fly in the face of currently understood science. Scientific plausibility is our compass, without it we can become lost in the wilderness of fanciful ideas without any method of discerning the way forward. This concept is what separates Science Based Medicine from simply Evidence Based Medicine. The former takes the plausibility of a treatment into account when deciding the threshold of evidence needed before it can be considered effective. The later only measures outcomes and so is less able to distinguish true effects from chance outcomes.

Consider the following scenario: I claim to be able to influence the outcomes of coin tosses by virtue of what I had for breakfast on a particular day. If I have eggs then tails with predominate, lettuce produces more heads. Now without considering the plausibility of the setup we could run a trial, perform statistical analysis and find that my predictions are correct. But given that there is no good reason to suspect that my diet can influence a coin toss the positive is more likely to be because of chance than because of a real effect. In this case then a higher standard of evidence would need to be achieved than if I had said I could alter the probabilities be sticking a piece of gum to one side.

All-in-all though this a very nice paper and my complaint is a small one, given the probable readership of the journal the inclusion of plausibility may even have alienated those that might otherwise have been receptive to the other points presented. I recommend reading it for yourself, it is a very easy and informative read.

Posted in Alternative medicine, Medicine, Questionable Techniques, Sciblogs, Science, skepticism Tagged: Alternative medicine, altmed, Expo, Hamilton, health, Health and Medicine, Medicine, Review, Science and Society

Legitimate Use of Magnets in Therapies Darcy Cowan Oct 09

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I have to say I cringe every time I see an advertisement for some magnet based item that promises health benefits. I’ve ragged on these Magnet Therapies before but today I’d like to cover one of the ways that magnets are legitimately being used to treat medical problems. A couple of months ago a study was published in the The Journal of the American College of Cardiology: Cardiovascular Interventions (a mouthful huh?) that detailed the use of magnetic nanoparticles and an externally applied magnet in guiding cells inside the body to a site of injury.

Specifically the study attempted to tag a particular type of stem cell, Endothelial Progenitor Cells (EPCs), with iron oxide superparamagnetic* nanoparticles. This was rather simply achieved by the addition of the particles to the growth medium of the cells. The cells then took up the particles via endocytosis. Once this was done they injected the cells into rats whose carotid artery had been damaged by angioplasty. A magnet was then applied to the outside of the rat to attract the tagged cells to the site of the damage. This technique showed a 5-fold increase in cells attaching to the damaged area compared to not using the magnet.

The difficulty of getting the cells to the right place without the magnet is due to the rapid blood flow past the injury. Imaging being swept down a fast flowing river with the goal of grabbing onto the river bank at a particular spot, not that easy, if there are thousands of you doing it some will manage but most will be carried right past. The addition of the magnet is like throwing a rope out to the hapless swimmers, once they get that helping hand they can then clamber onto the bank on their own. The EPCs will naturally attach themselves to places where damage is evident but under the high flow rates in arteries this process is inefficient.

This technique is specifically tailored to helping repair damage caused by angioplasty and it is hoped that it’s use might reduce the occurrence of Restenosis, or the re-narrowing of arteries after they have been widened by the angioplasty procedure. Even so, the guidance of the cells by magnetic field has obvious applications for other types of stem cell therapies as well as targeting drugs and gene therapies to specific organs of areas of the body.

Magnets are awesome.

*This sounds like a good name for a cheesy super hero, Superparamagnetic Powers Activate!.

Posted in Medicine, Sciblogs, Science Tagged: angioplasty, Health and Medicine, Research, stem cells, study

Tragedy in the UK Darcy Cowan Oct 06

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Last week I presented the safety study for the Gardasil qHPV vaccine, after this a reader remarked that it was a relief to see as she was concerned by a story she had read. It revolved around the unfortunate case of a UK school girl who died shortly after receiving a vaccine. As the full story does not yet seem to have been covered adequately by local news I thought I would cover the salient points here.

Firstly there are two competing HPV vaccines in the world market, Gardasil produced by Merk and Cervarix made by GalaxoSmithKline (GSK).  Here in New Zealand we have opted for the Merk version of the vaccine while the UK uses GSK’s product. Cervarix immunizes against the HPV strains 16 and 18 which are implicated in development of cervical cancer while Gardasil also covers strains 6 and 11 which cause genital warts.

Thus the first point to be made in relation to New Zealand readers is that the vaccine this young girl was exposed to is not the same one that is being given to our population.

To summarize the facts about this case, as reported by TimesOnline on the 29th of September, 14 year old Natalie Morton died in hospital on the afternoon of the 28 of September. Preceding her death by several hours was her injection of the GSK HPV vaccine Cervarix, this proximity in time is the only evidence that linked the vaccine to the girl’s death.

Late on the 29th the news that Natalie had a “serious underlying medical condition” was reported in the Guardian. At this point it was still unclear (to the public) whether the vaccine was in any way related to Natalie’s death. Health officials were however preparing to continue the vaccinations that had been put on hold following Natalie’s perceived complications.

By the 2nd of October the full story was clear, as covered in Medical News Today, Natalie’s death was revealed to have been caused by a previously undiagnosed and apparently asymptomatic malignant tumour in her chest. The tumour was described as having heavily infiltrated her heart and gone into her left lung. The HPV vaccine was officially cleared of any causitive agency in her death, in fact according to Dr Caron Grainger, Joint Director of Public Health for NHS Coventry and Coventry City Council, it could have happened at any point.

This story, if the end had been less definitive, could have been a very powerful anecdote against the use of HPV vaccines, as comments both within and about the early news stories reveal. Some with a vested interest of discrediting vaccines will undoubtedly still try to use it as such, already there are attempts to label the cause of death as fiction.  This shows a deeply unsettling conspiracy mindset as well as disrespect to Natalie and her family in trying to use her tragic tale to further their own agenda.

Posted in Medicine, Psychological, Sciblogs, Science, skepticism Tagged: Cervarix, gardasil, health, Health and Medicine, HPV, Science and Society, Vaccines

Gardasil Post-licensure Study Darcy Cowan Sep 27

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Last month the Post-licensure safety study for Gardasil (the HPV vaccine) was released. The study focused on the reports of adverse events as reported to the VAERS database by the manufacturer, doctors and patients or caregivers. Much has been made by detractors of the vaccine about the serious alleged side effects that have struck young women given the course of injections. These allegations have been supported by referring to the VAERS database itself so if they are valid they should be upheld by this study.

Of the 12,424 reports that VAERS received in the 2.5 year period following implementation of the vaccine, 772 (6.2%) were classified as “serious”, the total number of vaccine doses distributed in this period was 23 million. The category of “serious” was defined according to the FDA regulatory definition of an adverse event that “is life threatening; results in death, permanent disability, congenital anomaly, hospitalization, or prolonged hospitalization; or necessitates medical or surgical intervention to preclude one of these outcomes”.

It must be noted at this point that the VAERS database cannot determine causality, the events reported merely have to occur after vaccination takes place. Therefore anything that happens to a patient in this time frame that someone thinks might be related to the vaccine may be entered. I point this out only to remind that while we may be looking at vaccine safety life does go on, accidents happen and co-incidences occur. The point of a study such as this is to determine if these events are occuring at a frequency higher than what we would expect in the normal population. In other words, is there really a correlation between these events and the vaccine or is is simply a statistical fluke.

The study looked into each type of adverse report in detail and attempted to answer the above question, does the rate of reporting exceed that which would be expected in the general population? In almost all cases the answer appears to be “No”, the exceptions to this were reports of syncope (fainting) and venous thromboembolic events (blood clots), this finding will certainly be followed up in future studies. Curiously one of he more prominent adverse effects that has been concerning many on both sides of the debate, Guillain-Barre´ Syndrome was not found to occur more than expected.

Guillain-Barre´ Syndrome is an auto-immune condition that can be brought on by vaccines but also by normal infections. The syndrome is caused when the immune system is stimulated by an antigen but then starts to target the body’s own nervous system, it usually exhibits as an ascending paralysis noted by weakness in the legs that spreads to the upper limbs and the face along with complete loss of deep tendon reflexes. As vaccines are made to induce an immune reaction the link between vaccines and the syndrome is biologically plausible and not controversial in the medical community.

The study concludes favourably but cautiously, as scientific studies are wont to do:

Vaccination with qHPV has the potential to decrease the global morbidity and
mortality of HPV-associated diseases, including cervical cancer. After hepatitis B vaccine, which can prevent liver cancer, qHPV is only the second vaccine licensed with an indication to prevent cancer. The postlicensure safety profile presented here is broadly consistent with safety data from prelicensure trials. Because VAERS data must be interpreted cautiously and cannot generally be used to infer causal associations between vaccines and AEFIs, postlicensure monitoring will continue, and identified signals may be
evaluated using epidemiologic observational studies.

The full study can be found here, a summary of the study here and a comprehensive discussion of the study here.

Posted in Medicine, Sciblogs, Science Tagged: gardasil, Health and Medicine, Medicine, study, Vaccination, Vaccines, VAERS

Harriet’s Toolbox Darcy Cowan Sep 26

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Harriet Hall of the Science Based Medicine Blog gave a talk at the Skeptic’s Toolbox workshop at the University of Oregon in August. The power point slides for this talk are now up on the Skeptics Toolbox website for all of us to benefit from. Head over there and check it out, the talk was titled “Tooth Fairy Science and Other Pitfalls: Applying Rigorous Science to Messy Medicine.” and is full of info and humour. Highly recommended.

Posted in Medicine, Sciblogs, Science, skepticism Tagged: Science and Society

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