FEBRUARY 13, 2017
Russia Declares Homeopathy ‘Junk Science,’ Urges Ban on Public Use R
February 12, 2017
Russia’s Commission against Pseudoscience has called for the Health Ministry to ban homeopathy; however, the psychological effect of the medicine will continue to ensure its popularity, expert in pharmaceutical economics Roland Cash told Sputnik.
A recent memorandum on homeopathy (http://klnran.ru/2017/02/memorandum02-homeopathy/
in Russian) by the Russian Academy of Sciences (RAN) Commission against Pseudoscience and Falsification of Research (see page 2 for English translation) has put the practice in the spotlight in Russia.
Last week, the Commission called homeopathy a “pseudoscience” whose effectiveness hasn’t been proven, which is harmful to patients because they spend money and time on ineffective treatments.
Since 1995, qualified doctors who are also trained in homeopathy have been licensed to practice homeopathic medicine in Russian hospitals and clinics, and their practice regulated.
However, the Commission has now recommended that Russia’s Ministry of Health forbid doctors from prescribing homeopathic medicine, and ban the medicines themselves from state medical institutions.
“Homeopathy is not harmless: patients spend a lot of money on drugs that don’t work and neglect means of treatment with proven effectiveness. This can lead to adverse outcomes, including death of the patient,” the Commission wrote.
In response to the recommendation, the health ministry announced the formation of a working group of medical experts to come up with proposals for further regulation of homeopathy. A spokesman told Vesti.ru that medicines whose efficiency is not clinically proven should not be procured using public funds, nor prescribed to treat the sick.
Russia has proved a profitable market for foreign suppliers of homeopathic medicine such as French company Boiron, which opened its Russian subsidiary in 2005.
“Today, the Russian market is our company’s fourth largest in terms of turnover, after France, the US and Italy,” general director of Boiron in Russia Irina Nikulina told the Russian news channel RBK.
“Russia has always been interesting for Boiron because of the large population, and a relatively high incidence of illness and lower level of medicine consumption in comparison with Europe,” Nikulina said.
According to figures from Russian pharmaceutical market analysts DSM Group, Boiron sold 35 percent of all the homeopathic medicine sold in Russia last year, or 2.88 billion rubles ($49.5 million) worth of medicine.
Boiron produces Russia’s most popular homeopathic medicine, called Oscillococcinum, which is marketed to relieve flu symptoms and accounted for 18.98 percent of all homeopathic medicines sold in 2016.
The recommendations from Russia’s Commission against Pseudoscience and Falsification of Research follow similar advice from healthcare officials in other countries. A 2015 review by the Australian National Health and Medical Research Council found that there are no health conditions for which there is reliable evidence that homeopathy is effective.
In France, homeopathy has been regulated since 1965, and 30 percent of the cost of the medicine is reimbursed by the country’s social security system. According to the French Pharmaceutical Companies Association (LEEM), in 2013 the French market for homeopathic medicine was worth 100 million euros ($106 million).
French doctor Roland Cash, a specialist in the economics of the pharmaceutical industry and author of a book called, “Storm in Homeopathy,” told Sputnik Francais that effective marketing has enabled the business to thrive in France.
“(Ordinary) people don’t have a scientific background, so they can’t understand that after many successive dilutions with water, all active substances have been removed. They are used to buying these remedies, some doctors prescribe them, pharmacies put them on display, there are good adverts – it’s all just marketing. It’s not lobbying, this is about marketing by laboratories and homeopathic doctors who have filled a niche and differentiated themselves from ordinary doctors, but there is no effect,” Cash said.
“Homeopathy isn’t dangerous. The Agency for the Safety of Medicine and Health Products (Agence nationale de securité des medicaments et des produits de santé), allows the sale of these remedies because they are not dangerous. In addition, there is a legislative procedure which approves homeopathic medicine for use if it has been produced according to historical rules about the proportions and so on,” Cash explained.
Homeopathic medicines are considered harmless because they contain very small amounts of substances. As such, they have to pass a less stringent procedure than ordinary medicine in order to reach the pharmacy shelves. In addition, their composition remains the same from year to year, which also saves Boiron and other companies considerable expense.
“There is no mechanism, it is just water, as if you are drinking a glass of water with sugar. From a medical point of view the issue is the so-called placebo effect, or self-persuasion or subordination. It works well and not only with homeopathy, by the way – many conventional medicines are actually just dummies, that is, they have no proven pharmacological activity and are working solely through subordination. It works even better if the remedy is prescribed by a doctor who tells the patient that this is what they need, what precautions they need to take and so on.”
“We can’t be sure that this (the RAS memorandum) will affect Boiron, because there are a lot of irrational things with regard to health. If people really sincerely believe that something is good for them, they will continue to take it. And they will think that those who are opposed to homeopathy, are scientists who do not understand anything. This is a kind of belief, and destroying this belief with the use of rational explanation is difficult. As regards Boiron, they will not necessarily be greatly affected by this. Boiron is not the only laboratory – it is the main one in France, but there are others,” Cash said.
HOMEOPATHY AS PSEUDOSCIENCE (Abstract)
February 7, 2017
This memorandum by the Commission on Pseudoscience and Research Fraud at the Russian Academy of Sciences General Committee announces that treatment with very small amounts of different substances, used in homeopathy, has no scientific grounds. This conclusion has been made based upon detailed study of articles in scientific journals, reports on clinical trials and their systematic reviews. The facts from different scientific areas altogether – ranging from the results of clinical trials to the modern concepts on the structure of matter, from chemical principles of intermolecular interactions to the human physiology – allow the Commission to declare in this Memorandum that the theoretical principles of homeopathy have no scientific significance, and homeopathic diagnostics techniques and treatment are pseudoscientific and do not work.
Also homeopathy is not safe: patients spend significant amounts of money, buying medicines that do not work and disregard already known effective treatment. Due to aforementioned the Commission makes the number of recommendations to the Ministry of Health of the Russian Federation, the Federal Service for Surveillance in Healthcare and other organizations, and also doctors and media. The aim is to bring the regulation of homeopathy in accordance with the up-to-date scientific understanding of its inefficiency, to limit the inaccurate advertising of homeopathy, to inform patients reliably about the formula and properties of homeopathic drugs. In particular the Commission recommends the Ministry of Health of the Russian Federation to reconsider, in terms of the recent scientific data, the decision made more than 20 years ago without reasonable grounds to incorporate homeopathic drugs into the Russian Healthcare system;
to take homeopathic drugs away from state and municipal institutions; to oblige the manufacturers of homeopathic drugs to specify their actual formula (water, lactose etc.) and their quantity; to specify used substances in Russian only. Federal Antimonopoly Service is recommended to focus on inaccurate advertising of homeopathy.
This memorandum is published in collaboration with the Evolution Foundation.
More details can be found in the appendixes to the Memorandum (in Russian):
Appendix 1. Frequently asked questions and arguments for homeopathy.
Appendix 2. Placebo.
Appendix 3. The history of homeopathy in the Russian Healthcare system.
Appendix 4. Water memory.
Appendix 5. How the followers of homeopathy use sources with methodological mistakes.
Google “Russia ban on homeopathy” for more news stories.
‘An innocent deception’: placebo controls in the St Petersburg homeopathy trial, 1829-30.
By Michael Dean, Department of Health Sciences, Seebohm Rowntree Building, University of York, York YO10 5DD, UK. E-mail: firstname.lastname@example.org
Samuel Hahnemann (1755-1843), founder of the homeopathic school, began the systematic serial dilution and succussion of his medicines around 1814 (Hahnemann 1816). Since then the homeopathic materia medica has often been thought of as an elaborate collection of placebos, and it has long been known that placebo-controlled tests of homeopathy took place as early as the mid-1830s (Reubi 1986). A likely origin for this development in the history of clinical evaluation can be found in reports of two linked hospital-based trials of homeopathy that took place in Russia a few years earlier.
The homeopath in both trials was a Dr. Herrmann , who received a 1-year contract in February 1829 to test homeopathy with the Russian military (Ministry of Internal Affairs 1832, Lichtenstadt 1832). The first study took place at the Military Hospital in the market town of Tulzyn, in the province of Podolya, Ukraine (Herrmann 1831). At the end of three months, 164 patients had been admitted, 123 pronounced cured, 18 were convalescing, 18 still sick, and 6 had died. The homeopathic ward received many gravely ill patients, and the small number of deaths were shown at autopsy to be due to advanced gross pathologies. The results were interesting enough for the Russian government to order Herrmann to the Regional Military Hospital at St Petersburg to take part in a larger trial, supervised by a Dr. Gigler. Patients were admitted to an experimental homeopathic ward, for treatment by Herrmann, and comparisons were made with the success rate in the allopathic wards, as happened in Tulzyn. The novelty was Gigler’s inclusion of a ‘no treatment’ ward where patients were not subject to conventional drugging and bleeding, or homeopathic dosing. The untreated patients benefited from baths, tisanes, good nutrition and rest, but also:
During this period, the patients were additionally subjects of an innocent deception. In order to deflect the suspicion that they were not being given any medicine, they were prescribed pills made of white breadcrumbs or cocoa, lactose powder or salep infusions, as happened in the homeopathic ward. (Page 56).
The ‘no treatment’ patients in fact did better than those in both the allopathic and homeopathic wards. The trial had important implications not just for homeopathy but also for the excessive allopathic drugging and bleeding that was prevalent. As a result of the report, homeopathy was banned in Russia for some years, although allopathy was not.
Within a couple of years of publication, placebo drugs became fashionable in clinical evaluation, sometimes in comparison with homeopathy, sometimes on their own, later as controls for allopathic treatments. A well-known opponent of homeopathy, Carl von Seidlitz, witnessed the St Petersburg trial and wrote a hostile report (Seidlitz 1833). He then conducted a homeopathic drug test in February 1834 at the Naval Hospital in the same city in which healthy nursing staff received homeopathically prepared vegetable charcoal or placebo in a single-blind cross-over design (Seidlitz 1834). Within a few months, Armand Trousseau and colleagues were giving placebo pills to their Parisian patients, perhaps in the belief that they were testing homeopathy, and fully aware they were testing a placebo response (Pigeaux 1834; Trousseau and Gouraud 1834). A placebo-controlled homeopathic proving took place in Nuremberg in 1835 and even included a primitive form of random assignment – identical vials of active and placebo treatment were shuffled before distribution (Löhner 1835). Around the same time in England, Sir John Forbes treated a diarrhoea outbreak after dividing his patients into two groups: half received allopathic ‘treatment as usual’ and half got bread pills. He saw no difference in outcome, and when he reported the experiment in 1846 he added that the placebos could just as easily have been homeopathic tablets (Forbes 1846). In 1861, a French doctor gave placebo pills to patients with neurotic symptoms, and his attitude is representative: he called the placebo ‘orthodox homeopathy’, because, as he said, ‘Bread pills or globules of Aconitum 30c or 40c amount to the same thing.’ (Lisle 1861).
The interest in substituting placebos for active drug treatments in clinical evaluation from the 1830s onwards is well known. However, the extract from the St Petersburg report quoted above hints at a more complex story. Apparently, ‘no treatment’ patients received placebos, ‘as happened in the homeopathic ward’. This mystifying phrase is not explained or mentioned again. Why did the homeopathic patients receive placebo, when homeopathy was being tested?
The answer can be found in Herrmann’s report of his earlier trial (Herrmann 1831). The Tulzyn patients were hard-bitten Russian soldiers, who expected ‘heroic’ drugging and bleeding. We are told they lacked confidence in the innocuous homeopathic powders and their scepticism was not reduced by the doses of unmedicated lactose Herrmann prescribed in between the single doses of active medicine. In using placebos as part of day-to-day homeopathic practice, Herrmann was following Hahnemann’s guidelines published between 1810 and 1830. Homeopaths were expected to prescribe placebo as a wash-out when discontinuing allopathic medication, and at the beginning of homeopathic treatment, to identify ‘placebo responders’. It was also frequently used in longer-term case-management, because the single rarely-repeated doses of active medicines used in homeopathy were believed to produce misleading psychosomatic responses (Peschier 1835).
This little-known aspect of homeopathic practice has been passed down in some form or other as part of formal training in the discipline until the present day. A detailed history of placebos in homeopathic clinical evaluation and practice can be found elsewhere (Dean 2000). Methodologically, Hahnemann’s guidelines seem closest to modern trials to determine optimal therapy in single patients (Cook 1996), although homeopaths gave placebos single-blind, and without randomisation of treatment periods. Whatever we may think of it now, the practice contrasts strongly with the traditional palliative use of therapeutic placebos when active treatments were unavailable or ineffective, and with the all-or-nothing placebos in parallel-group clinical trials, where patients typically receive either placebo or active treatment, but not usually both. The St Petersburg trial is probably the moment that homeopathic within-treatment placebos began to be used as external controls, as became the norm in clinical trials more than a century later.
The author has no knowledge of Russian, but worked from a contemporaneous German publication of the report. He would like to thank Ekaterina Vikhlyaeva and Tatjana A Mikhailova for their persistence in tracking down the Russian original, and checking the accuracy of the Russian-to-German-to-English translation.
Homeopathy ‘could be blacklisted’
By James Gallagher, Health editor, BBC News website, November 13, 2015
Ministers are considering whether homeopathy should be put on a blacklist of treatments GPs in England are banned from prescribing, the BBC has learned.
The controversial practice is based on the principle that “like cures like”, but has been damned as given patients useless sugar pills.
The Faculty of Homeopathy said patients supported the therapy.
A consultation is expected to take place in 2016.
The total NHS bill for homeopathy, including homeopathic hospitals and GP prescriptions, is thought to be about £4m.
But the NHS itself says: “There is no good-quality evidence that homeopathy is effective as a treatment for any health condition.”
How homeopathic pills are made
Homeopathy is based on the concept that diluting a version of a substance that causes illness has healing properties.
So pollen or grass could be used to create a homeopathic hay-fever remedy.
One part of the substance is mixed with 99 parts of water or alcohol, and this is repeated six times in a “6c” formulation or 30 times in a “30c” formulation.
A 6C formulation homeopathic remedy contains one part per trillion of the active ingredient.
The end result is combined with a lactose (sugar) tablet.
Homeopaths say the more diluted it is, the greater the effect. Scientific consensus say patients are getting nothing but sugar.
Common homeopathic treatments are for asthma, ear infections, hay-fever, depression, stress, anxiety, allergy and arthritis.
Drugs can be blacklisted if there are cheaper alternatives or if the medicine is not effective.
After the Good Thinking Society threatened to take their case to the courts, Department of Health legal advisers replied in emails, seen by the BBC, that ministers had “decided to conduct a consultation”.
Officials have now confirmed to me this will take place in 2016.
Simon Singh, the founder of the Good Thinking Society, said: “Given the finite resources of the NHS, any spending on homeopathy is utterly unjustifiable.
“The money spent on these disproven remedies can be far better spent on treatments that offer real benefits to patients.”
But Dr. Helen Beaumont, a GP and the president of the Faculty of Homeopathy, said other drugs such as SSRIs (selective serotonin reuptake inhibitors) for depression would be a better target for saving money, as homeopathic pills had a “profound effect” on patients.
She told the BBC News website: “Patient choice is important; homeopathy works, it’s widely used by doctors in Europe, and patients who are treated by homeopathy are really convinced of its benefits, as am I.”
The result of the consultation would affect GP prescribing, but not homeopathic hospitals which account for the bulk of the NHS money spent on homeopathy.
Estimates suggest GP prescriptions account for about £110,000 per year.
And any decision would not affect people buying the treatments over the counter or privately.
Minister for Life Sciences, George Freeman, told the BBC: “With rising health demands, we have a duty to make sure we spend NHS funds on the most effective treatments.
“We are currently considering whether or not homeopathic products should continue to be available through NHS prescriptions.
“We expect to consult on proposals in due course.”
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Categories: Alternative Therapy