misleading consumers
Regular readers of this blog will be aware of the many bogus claims made by chiropractors. One claim, however, namely the one postulating chiropractors can effectively treat low back pain with spinal manipulation, is rarely viewed as being bogus. Chiropractors are usually able to produce evidence that does suggest the claim to be true, and therefore even most critics of chiropractic back off on this particular issue.
But is the claim really true?
A recent trial might provide the answer.
The purpose of this study was to compare the effectiveness of chiropractic spinal manipulative therapy (cSMT) to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.
Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 who suffered from chronic low back pain (LBP) were included in the study – with 69 being randomly assigned to cSMT and 67 to the sham intervention. Patients were treated twice per week for 4 weeks. The outcomes were assessed at baseline, 5, and 12 weeks post baseline.
Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the cSMT group when compared to the control group. There were no significant differences in adverse events between the groups.
The authors concluded that cSMT did not result in greater improvement in pain when compared to our sham intervention; however, cSMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.
Hold on, I hear you say, this does not mean that cSMT is a placebo in the treatment of LBP! There are other studies that yield positive results. Let’s not cherry-pick our evidence!
Absolutely correct! To avoid cherry-picking, lets see what the current Cochrane review tells us about cSMT and chronic LBP. Here is the conclusion of this review based on 26 RCTs: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain.
Convinced?
I just came across an announcement which could be important. Here are what I consider the important passages:
The Federal Trade Commission will host a public workshop on Monday, September 21, 2015 in Washington, DC, to examine advertising for over-the-counter (OTC) homeopathic products…
Because of rapid growth in the marketing and consumer use of homeopathic products, the FTC is hosting a workshop to evaluate the advertising for such products. The workshop will bring together a variety of stakeholders, including medical professionals, industry representatives, consumer advocates, and government regulators.
The FTC invites the public to submit research, recommendations for topics of discussion, and requests to participate as panelists. The workshop will cover topics including:
- A look at changes in the homeopathic market, its advertising, and what consumers know;
- The science behind homeopathy and its effectiveness;
- The effects of recent class actions against homeopathic product companies;
- The application of Section 5 of the FTC Act to advertising claims for homeopathic products; and
- Public policy concerns about the current regulation of homeopathic products.
Public comments can be submitted electronically. Paper submissions should be sent to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex B), Washington, DC 20580, or delivered to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024. Paper submissions should reference the Homeopathic Medicine & Advertising Workshop both in the text and on the envelope. The deadline for submitting public comments is Friday, November 20, 2015.
The FTC also has set up an email box for anyone interested in being a panelist at the event or suggesting additional topics for discussion. It is [email protected] (link sends e-mail), and will be open until August 1, 2015.
The workshop is free and open to the public. It will be held at the Constitution Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date…
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad…
In my view, this is a long overdue initiative. Consumers are constantly and outrageously misled by the advertising of homeopathic products. This has the potential to impact negatively on public health.
It would not surprise me, if homeopathy advocates were to try to swamp this event with their promotion of homeopathy. Therefore, I thought it was important to post the announcement on my blog, in the hope that as many scientifically minded people as possible might file their evidence and objections.
Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:
- Respect for autonomy – patients must have the right to refuse or choose their treatments.
- Beneficence – researchers and clinicians must act in the best interest of the patient.
- Non-maleficence – the expected benefits of interventions must outweigh their risks.
- Justice – the distribution of health resources must be fair.
- Respect for persons – patients must be treated with dignity.
- Truthfulness and honesty – informed consent is an essential element in research and clinical practice.
While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?
After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.
- Nonsensical research projects
- Lack of informed consent
NONSENSICAL RESEARCH PROJECTS
At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.
But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.
I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.
INFORMED CONSENT
Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.
In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.
But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:
- you will receive either a homeopathic remedy or a placebo,
- the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
- this means that you will receive either a homeopathic or a conventional placebo,
- neither of these can possibly help your condition,
- the study can therefore not advance our knowledge in any way,
- during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.
If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.
I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.
CONCLUSION
There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.
Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Conclusions
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.
While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.
This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.
In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.
Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.
The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.
This sounds like good news for naturopathy! However, there are several important caveats:
- the authors seem to have only looked at US studies (naturopathy is a European tradition!),
- the searches were done three years ago, and more recent data were thus omitted,
- the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
- rigorous trials were very scarce; and for each condition, they were even more so,
- the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.
My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.
Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.
I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.
The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.
Proponents of alternative medicine regularly stress the notion that their treatments are either risk-free or much safer than conventional medicine. This assumption may be excellent for marketing bogus treatments, however, it neglects that even a relatively harmless therapy can become dangerous, if it is ineffective. Here is yet again a tragic reminder of this undeniable fact.
Japanese doctors reported the case of 2-year-old girl who died of precursor B-cell acute lymphoblastic leukaemia (ALL), the most common cancer in children.
She had no remarkable medical history. She was transferred to a hospital because of respiratory distress and died 4 hours after arrival. Two weeks before her death, she had developed a fever of 39 degrees C, which subsided after the administration of a naturopathic herbal remedy. One week before death, she developed jaundice, and her condition worsened on the day of death.
Laboratory test results on admission to hospital showed a markedly elevated white blood cell count. Accordingly, the cause of death was suspected to be acute leukaemia. Forensic autopsy revealed the cause of death to be precursor B-cell ALL.
With the current advancements in medical technology, the 5-year survival rate of children with ALL is nearly 90%. However, in this case, the child’s parents had opted for naturopathy instead of evidence-based medicine. They had not taken her to a hospital for a medical check-up or immunisation since she was an infant. If the child had received routine medical care, she would have a more than 60% chance of being alive 5 years after diagnosis of ALL.
The authors of this case-report concluded that the parents should be accused of medical neglect regardless of their motives.
Such cases are tragic and infuriating in equal measure. There is no way of knowing how often this sort of thing happens; we rely entirely on anecdotes because systematic research is hardly feasible.
While anecdotes of this nature have their obvious limitations, they are nevertheless important. They can serve as poignant reminders that alternative remedies might be relatively harmless, but this does not necessarily apply to all alternative practitioners. Moreover, they should make us redouble our efforts to inform the public responsibly about the all too often trivialized risks of alternative medicine.
When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.
A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.
The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.
At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.
This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.
This is not disappointing; in my view, this is scientific misconduct by
- the authors,
- the institutions employing the authors,
- the ethics committee that has passed the ‘research’,
- the sponsors of the ‘research’,
- the peer-reviewers of the paper,
- the journal and its editors responsible for publishing this paper.
The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.
This article is hilarious, I think. It was written by Heike Bishop, a homeopath who works in Australia. Here she tries to advise colleagues how best to defend homeopathy and how to deal effectively with the increasingly outspoken criticism of homeopathy. Below is the decisive passage from her article; I have not changed or omitted a word, not even her grammatical or other mistakes [only the numbers in brackets were inserted by me; they refer to my comments added below]:
Getting up in the morning and hearing that all the television and radio station report that it is dangerous for people to see their homoeopath, is utterly heart breaking. Even more so because I grew up in East Germany where the government suppressed free speech and anything that was off the beaten path [1]. So what can we do in times like these?
First of all, watch out for Government inquiries. History has shown that they are usually not favourable towards homoeopathy [2] unless you live in Switzerland [3]. It is vitally important in times like these to put differences aside amongst our professional peers. Every association should be mobilised to take an active and ONGOING role to educate and advertise the benefits of homoeopathy [4]. If things have gone too far already, talk about freedom of choice [5]. Write articles and join blogs talking about what you can do specifically for certain conditions [6]. Encourage your patients to tell their success stories in blogs and other social media forums [7]. It is in most cases utterly useless to engage in any conversation [8] online with trolls [9].
Try to develop a calloused skin when it comes to criticism. Your patients don’t want to hear how difficult it is to be a homeopath [10], they want you to be in control and to be reassured that their treatment continues [11]. When someone asks you to comment on an attack on homoeopathy, put your best smile on and state how threatened the pharmaceutical industry must be to resort to such tactics [12].
Staphysagria is indeed a good remedy. Hahnemann also knew its benefits and even alternated it with Arsenicum the day his first wife died and he got a letter that the hospital built in his name allowed patients to choose their treatment between allopathy and homoeopathy [13]. That was the only time he took two remedies on the same day! [14]
Find out what you can about your country’s own internet trolls [15]. However, don’t underestimate their effectiveness in swaying popular opinion [16]. There is no denying that their methods are very effective [17]. It doesn’t matter how ludicrous their comments are, don’t go into direct explanation [18]. Learn from the enemy [19] and repeat a positive message over and over again so it can’t be contorted [20].
Our colleges should support post-graduate studies featuring marketing and media courses [21]. I once met a Homoeopath from the UK and she pointed out that part of the training in the UK is for students to hold homoeopathic first aid courses to promote homoeopathy [22]. Everyone is different – some of us are happy to stand in front of an audience others choose the pen as their sword [23]. The main thing is to do something to save the image of our healing art [24].
- Is she implying that facing criticism of homeopathy is akin to living in a totalitarian state? Or that criticism is a violation of free speech?
- I wonder why this is so – nothing to do with the evidence, I presume?
- Does she refer to the famous ‘Swiss Government report’ which was not by the Swiss Government at all?
- ‘Advertise and educate’ seems to be homeopathic speak for ‘MISLEAD’
- Good idea! Freedom of choice is a perfect argument (in this case, my choice would be to have a bottle of champagne at around 6 pm every day – on the NHS, of course).
- Certain conditions??? And I thought homeopaths do not treat conditions, only whole people.
- And forbid them to disclose stories where things did not work out quite so well?
- Very wise! Conversations are fraught with the danger of being found wrong.
- Critics are not critics but ‘trolls’ – makes sense.
- I would have thought that practising as a homeopath is not difficult at all – in most countries, they don’t even check whether you can spell the name correctly.
- Is it not rather the homeopath who wants the treatment to continue – after all, it is her livelihood?
- Ah yes, BIG PHARMA, the last resort of any quack!
- Did she not just praise patient choice as an important virtue?
- Hahnemann was famously cantankerous and argumentative all his life; does that mean that his remedies did not work?
- Homeopaths might need that for your ad hominem attacks.
- Never underestimate the power of truth!!!
- This might show that it is you and not the ‘trolls’ who are ludicrous.
- Particularly as there are no direct explanations for homeopathy.
- First the critics were ‘trolls’, now they have been upgraded to ‘enemy’! Is it really a war?
- You need to repeat it at least regularly so that eventually you believe it yourself.
- Are marketing and media a substitute for evidence?
- Really, first aid? Do homeopaths know what this is? Obviously not!
- But real clinicians, homeopaths call them allopaths, are quite happy simply with effective treatments that help patients to improve.
- And I thought the main thing was to treat patients with the most effective therapies available.
ENOUGH JOKING AND SARCASM!
There is, of course, a very serious message in all of this: when under pressure, homeopaths seem to think of all sorts of things in their (and homeopathy’s) defense – some more rational than others – but the ideas that criticism might be a good way to generate progress, and that a factual debate about the known facts might improve healthcare, do not seem to be amongst them.
Sanevax is a US organisation that claims to promote only Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries. Recently they seem to have become active in the UK as well; even in my rural neck of the woods, I found a poster that claimed the following:
The side effects experienced by some girls [following HPV vaccination] have been severe and long lasting and include:
- persistent headaches
- persistent sore throat
- ME
- problems with eyes and vision
- muscle aches
- muscle weaknesses/twitches
- numbness of limbs
- pins and needles/tingling
- joint pains
- chest pains
- breathing problems
- racing heart or palpitations
- sensitive to light or noise
- cold hands and feet
- abdominal pain
- skin problems and rashes
- memory impairment
- concentration problems
- difficulty multi-tasking
- difficulty taking in information
- dizziness
- fainting
- postural orthostatic tachycardia syndrome
- seizures
- persistent nausea and vomiting
- acid reflux
- new allergies
- menstrual problems/ changes to menstrual cycle
- difficulty regulating body temperature
- excessive sweating
- frequent urination
- insomnia or change of body clock
- autoimmune diseases, e. g. autoimmune encephalitis. Raynaud’s disease, rheumatoid arthritis, thyroid.
Scary? Yes, I think so – I am always afraid of people who write about health and think that THYROID is a side effect!
Elsewhere the connection to alternative medicine becomes more obvious and the mission of Sanevax gets a little clearer. However, the claims are similar:
The most common side effects of HPV vaccines are pain, swelling, itching, bruising and redness at the injection site, headache, fever, nausea, dizziness, vomiting and fainting.
The following side effects are less common, but more dangerous:
*Difficulty breathing, shortness of breath or wheezing (bronco spasm)
*Hives and/or rash
*Swollen glands (neck, armpit, or groin)
*Joint, leg, or chest pain
*Unusual tiredness, weakness, lethargy, brain fog, or confusion
*Chills
*Generally feeling unwell
*Aching muscles and/or muscle weakness
*Difficulty keeping food down, vomiting or stomach ache
*Seizures
*Shortness of breath
*Chest pain
*Bad stomach pain
*Skin infection
*Bleeding or bruising more easily than normal
This list is by no means comprehensive; it is taken directly from HPV patient Product Information inserts. Many young girls from around the world have experienced many more severe events after HPV vaccination. For the health and safety of the children in your care, please be alert to any changes in your student’s health and behavior post-vaccination.
Should a student experience any of the less common side effect symptoms even months after vaccination, please alert their parents to the possibility that the student may be exhibiting a vaccine reaction, so they can consult their physician for proper medical care.
Now I am not just scared, I am positively alarmed. This makes the HPV vaccine look like something to be avoided at all cost. In this state of alarm, I do a quick search for published evidence. My findings make me concerned again – this time not about the vaccination but about Sanevax. The Sanevax text is in stark contradiction to the published information on this issue. The most recent article I could find stated that serious adverse events such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism, and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates.
This makes me wonder, who is trying to mislead us here? Are we duped into ignorance by scientists bought by BIG PHARMA, or should we perhaps re-name ‘Sanevax’ into INSANE ANTI-VAX?
I think I know the answer, but I would like to hear your views.
The notion that the use homeopathy instead of real medicine might save money (heavily promoted by homeopaths and their followers, often to influence health politics) has always struck me as being utterly bizarre: without effectiveness, it is hard to imagine cost-effectiveness. Yet the Smallwood report (in)famously claimed that the NHS would save lots of money, if GPs were to use more homeopathy. At the time, I thought this was such a serious and dangerous error that I decided to do something about it. My objection to the flawed report might have prevented it being taken seriously by anyone with half a brain, but sadly it also cost me my job (the full story can be read here).
Later publications perpetuated the erroneous idea of homeopathy’s cost-effectiveness. For instance, an Italian analysis (published in the journal ‘Homeopathy’) concluded that homeopathic treatment for respiratory diseases (asthma, allergic complaints, Acute Recurrent Respiratory Infections) was associated with a significant reduction in the use and costs of conventional drugs. Costs for homeopathic therapy are significantly lower than those for conventional pharmacological therapy. Again, this paper was so badly flawed that, other than some homeopaths, nobody seemed to have taken the slightest notice of it.
Now a new article has been published on this very subject. The aim of this study was to compare the health care costs for patients using additional homeopathic treatment (homeopathy group) with the costs for those receiving usual care (control group).
Cost data provided by a large German statutory health insurance company were retrospectively analysed from the societal perspective (primary outcome) and from the statutory health insurance perspective. Patients in both groups were matched using a propensity score matching procedure based on socio-demographic variables as well as costs, number of hospital stays and sick leave days in the previous 12 months. Total cumulative costs over 18 months were compared between the groups with an analysis of covariance (adjusted for baseline costs) across diagnoses and for six specific diagnoses (depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache).
Data from 44,550 patients (67.3% females) were available for analysis. From the societal perspective, total costs after 18 months were higher in the homeopathy group (adj. mean: EUR 7,207.72 [95% CI 7,001.14-7,414.29]) than in the control group (EUR 5,857.56 [5,650.98-6,064.13]; p<0.0001) with the largest differences between groups for productivity loss (homeopathy EUR 3,698.00 [3,586.48-3,809.53] vs. control EUR 3,092.84 [2,981.31-3,204.37]) and outpatient care costs (homeopathy EUR 1,088.25 [1,073.90-1,102.59] vs. control EUR 867.87 [853.52-882.21]). Group differences decreased over time. For all diagnoses, costs were higher in the homeopathy group than in the control group, although this difference was not always statistically significant.
The authors of this paper (who have a long track record of being pro-homeopathy) concluded that, compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system.
The next time someone does a (no doubt costly) cost-effectiveness analysis of an ineffective treatment, it would be good (and cost-effective) to remember: WITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS.
“So what? We all know that homeopathy is nonsense,” I hear some people argue, “at the same time, it is surely trivial. Let those nutters do what they want; at least it is not harmful!”
If you are amongst the many consumers who think so, please read this announcement that arrived in my inbox today:
The first International Conference:
Homeoprophylaxis:
A Worldwide Choice HP
The NON-TOXIC form of disease prevention
Are you questioning the pressure to vaccinate?
Is there another way to protect your children?
Do you have another choice?
YES YOU DO!
Homeoprophylaxis or Homeopathic Immunization
Healthcare Professionals!!
Learn how to incorporate homeoprophylaxis into your existing practise
Parents!!
Learn how you can get a homeoprophylactic program going for your family
Everyone!!
Learn how homeoprophylaxis is a gentle, nontoxic alternative for you to choose
Where: Dallas, Texas, USA
When: October 2-4, 2015
Reserve your place TODAY to hear speakers from around the world.
- Dr Isaac Golden (Australia) – 20 years of HP research
- Neil Miller (USA) – vaccines and infant mortality rates
- Dr Harry van der Zee (the Netherlands) – HP for epidemics
- Dr Tetyana Obukhanuch – how the healthy immune system works
- Ravi Roy& Carola Lage Roy (Germany) – HP in Europe
- Alan Phillips, JD (USA) – legalities of vaccine exemptions
- Ananda More (Canada) – “In Search of Evidence” movie
- And special guest, Dr Andrew Wakefield
I THINK I CAN REST MY CASE.
