The Canadian law firm Roy Elliott O'Connor LLP has filed a class action lawsuit against Shoppers Drug Mart and Boiron Canada charging that Oscillococcinum, which is a homeopathic medication sold to combat "flu-like symptoms," does not actually have the active ingredient in it its manufacturer advertises it to contain. More here from the Committee for the Advancement of Scientific Skepticism, here from the blog Skeptic North, here from Skeptic Magazine.
Homeopathic medicines are said to have no side-effects; this is considered a major selling point. It is less often noticed that this is because they have no effects at all. This is why you can't overdose on homeopathic remedies. (I wouldn't try this myself, but see here.)
Homeopathic remedies are sold as just that, remedies. Homeopathic doctors prescribe their solutions to help patients suffering specific maladies; the medicines cost real money; they come in impressive looking bottles with precise dosage and usage instructions. In many countries, insurance companies pay for such treatments. Friends of homeopathy think of their medicines as intervening effectively in the causal nexus. But the simple fact is, they do not. Or rather, evidence that they do remains inconclusive. And we know exactly why this should be. The solutions are too dilute for the "active ingredients" to be active at all.
And yet — and it is crucial that there is an "and yet" — homeopathic treatments do have effects. I have very close friends who swear by these treatments; the comfort they take, not only from the drops and tablets, but also from the guidance and counsel of homeopathic "doctors," is undeniable.
Is this just ignorance? Or self-deception? Have my friends been swindled? Or is this an example of the well-documented, but poorly understood placebo effect? Or are things more complicated even than that? In the coming weeks I will return to this topic.
I don't quite understand the point of this post. Is the writer suggesting that homeopathic treatments ought to be regulated more closely because they may have economic and psychological effects, even if their medical effects are unproven? BTW: the link in the post is to James Randi's TED talk about psychics, which includes a bit in which he takes an awful lot of Calms Forte.
The UK's Advertising Standards Authority (ASA) has upheld complaints concerning the Reflex Clinic online portal. The website's text stated
“As well as being used to assist in a wide variety of conditions, Reflexology techniques may be used in cases where there are fertility issues (Fertility Reflexology) ... Whilst reflexology does not claim to diagnose, treat or cure a disorder, it is thought that some disorders, detailed below, may respond well to reflexology. This is based mainly on anecdotal evidence and some limited scientific research: - Nervous system - Headaches, Migraines, Insomnia, Stress, Emotional Stress, ADHD, Anxiety, Panic Attacks and Depression; Glandular System - Reproductive - Hormone Imbalances, Menstrual Problems, Menopausal Concerns, PMT, Perimenopause, Fertility Issues, Pregnancy Issues, Prostate Problems; Glandular System - Metabolic - Hormone Imbalances, Thyroid Imbalance, and Adrenal Stress; Circulatory System - Hypertension, Stress, Poor Circulation and Oedema; Respiratory System - Asthma, Hay Fever and Sinusitis; Immune System - Viruses (M.E., glandular fever, Epstein Barr), Cancer, Fatigue, Stress and Auto-immune Disorders such as Rheumatoid Arthritis and Lupus; Urinary System - Hypertension, Water Retention and Backpain; Structural System - Sciatica, Stiff Neck, Muscle Cramps, Tennis Elbow, Toothache and Frozen Shoulder; Digestive System - Indigestion, Heartburn and Stomach Cramps; Intestinal System - Constipation, Poor Appetite and Irritable Bowel Syndrome (IBS); Post operative recovery; Palliative Care and more ...”.
We have done everything possible to make this website compliant with the ASA. We have however, for the purposes of your convenience, left in some medical terms where appropriate as these are the terms that you the user would be searching on and we are therefore unable to remove them because you would no longer be able to find the website using those terms in your google or yahoo search criteria. (We have no control of terminology used by searches). All material on this website is subject to this disclaimer. See the footer link on each page. Reflexology is not intended to replace the relationship with your primary health care providers and the consultation is not intended as medical advice. The consultation is intended as a sharing of knowledge and information from education, research and experience. The information and service provided is not used to prescribe, recommend, diagnose or treat a health problem or a disease. It is not a substitute for medical care. If you have or suspect you have a health problem, you should consult your GP ...”.
The complainant challenged the efficacy claims, which it alleged were misleading; the disclaimer, which it said contradicted the text on the website; and the website itself, which the complainant alleged discouraged visitors from visiting mainstream medical practitioners in cases in which mainstream medical treatment was a preferable alternative. The ASA challenged the claims made for efficacy with regard to the testimonials.
Said the ASA:
The ASA noted that four of the six studies submitted (both of the stress reduction studies and two of the pain management studies) were pilot studies, designed as preliminary studies to test methodologies before larger quantitative studies took place. A number of the studies acknowledged the limitations of their findings for that reason, such as a pain reduction study that concluded “Reflexology appears to offer promise as a treatment in the management of LBP (lower back pain); however, an adequately powered trial is required before any more definitive pronouncements are possible”. We therefore considered that we would need to see the results of the larger quantitative studies, and not just the results of the pilot studies, before we could conclude that reflexology was able to assist with stress, anxiety and pain management.
We noted the third pain management study provided was not a pilot study, but also noted it stated that reflexology had no statistically significant effect after three or 24 hours. We therefore considered the study did not provide evidence that reflexology could assist with pain management.
We noted the PMT study was small, with 18 women undergoing reflexology treatment and 17 women undergoing a placebo reflexology treatment as a comparison. We noted the study found a positive link between reflexology and PMT, stating that it found a “significantly greater decrease in premenstrual symptoms for the women given true reflexology treatment than for the women in the placebo group” and “The primary benefit reported by the women receiving true reflexology was the experience of profound relaxation”. We also noted the study stated that it looked at 38 symptoms of PMT and stated that reflexology could benefit both somatic and psychological symptoms, but that it did not specify which of those symptoms reflexology was able to benefit.
We noted that the ASA and CAP had accepted previously that reflexology might help with relaxation, mood improvement, tension reduction and an improved sense of well-being. Those benefits were relevant to PMT symptoms such as poor mood and tension, and we therefore considered that claims that reflexology could have those benefits were acceptable. However, because the study was very small, involved self-reporting by subjects rather than objective measures, and did not specify whether reflexology could benefit symptoms beyond the general benefits we found acceptable, we considered we were unable to accept the study as sufficient substantiation that PMT responded well to reflexology. We considered that stating reflexology could benefit PMT implied it could benefit the more specific or serious symptoms of PMT that women might experience such as depression, anxiety, breast tenderness or cramps, when we had not seen evidence for that.
Because we had not seen evidence that reflexology could provide benefits beyond relaxation, mood improvement, tension reduction and an improved sense of well-being, we considered the efficacy claims for reflexology listed had not been substantiated and were misleading.
The claims breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicines, medical devices, health-related products and beauty products).
While we noted the disclaimers clearly stated that the site was not intended to prescribe, recommend, diagnose or treat a health problem or disease, we considered they directly contrasted with the claims in the main text of the site, which outlined a large number of serious medical conditions that the site stated reflexology might be able to assist with. We therefore concluded the disclaimers contradicted rather than clarified the main text of the website.
The claims breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), and 3.7 (Substantiation).
We noted The Reflex Clinic had ensured the site contained a number of disclaimers and replaced “can” with “may”. We considered that the term “may” still implied reflexology could have some benefit on the conditions listed, when we had not seen evidence that that was the case. We noted a number of the conditions listed in the ad were serious conditions that medical supervision should be sought for such as cancer, depression and auto-immune disorders. We were concerned that by stating reflexology could assist with those conditions, the site might discourage some individuals from seeking medical advice when it was required. As noted in (2) above, we considered the disclaimers on the site contradicted rather than clarified the text, and therefore did not consider the disclaimers were sufficient to ensure individuals were not discouraged from seeking medical advice.
The claims breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicines, medical devices, health-related products and beauty products).
While we noted the testimonials may have been genuine opinions from clients, we noted we had not seen objective evidence that reflexology was able to have the benefits those clients claimed it could, such as treating depression or anxiety. We therefore concluded that the efficacy claims in the testimonials had not been substantiated.
The claims breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.47 (Testimonials), 12.1, 12.2 and 12.6 (Medicines, medical devices, health-related products and beauty products).
The ASA ruled that the Reflex Clinic could not publish the claims again "in their current form" and told the Clinic not to repeat the claims that had not been "substantiated."
From the August 27, 2011 New York Times, an article that discusses those unregulated drugs, marketed as supplements, that can cause serious health problems for the unwary user. These drugs seem to be available in many places that customers shop for magical cures for everyday ailments and problems: overweight, fatigue, and that bugaboo: impotency. U.S. Customs agents and the F.D.A. try to stay on the alert for products that shouldn't be coming into the country and shouldn't be sold, but some wares sneak in, and manufacturers of legal products say their wares and problem products look almost the same to the consumer. Meanwhile, some consumers risk their health by taking dangerous pills and potions, often without telling their physicians. What to do?
In the past few years, other members of the Church have been convicted of negligent homicide and manslaughter for failing to obtain treatment for their children. Some Oregon lawmakers seem to favor the removal of a ministerial exception to homicide charges, and have introduced House Bill 2721 to respond to criticism of those believers who turn to spiritual healing rather than traditional medicine to take care of medical problems. More coverage from the Oregonian of Followers of Christ Church trials here.
We are deeply concerned about Wal-Mart Stores, Inc.‘s (“Wal-Mart’s”) irresponsible marketing and promotion of Boiron Oscillococcinum, an ineffective homeopathic “flu medicine,” through its website, www.walmart.com . Wal-Mart’s website states that the product, manufactured by Boiron, is to be used “for flu-like symptoms.” The website further states that the product’s alleged active ingredient, Anas Barbariae Hepatis Et Cordis Extractum 200CK Hpus, is used “to Reduce The Duration and Severity of Flu Symptoms.” The website also features an image of the product’s package, which indicates that the product “Reduces [the] Duration and Severity of Flu Symptoms,” including “Fever, Chills, Body Aches and Pains.”
Wal-Mart’s misleading promotion of this “homeopathic medicine” as a treatment for flu is not limited to the webpage on which the product is displayed. Consumers will reach this page only after visiting Wal-Mart’s “Medicine Cabinet” page, which assures customers that the products Wal-Mart carries will “fight colds and the flu.” From there, website visitors will navigate to the “Cough, Colds & Flu Wellness Shop” page, which promises to help the customer “Stay on top of cold and flu season by learning about products that can help you and your family stay well, relieve symptoms and recover fast.” In its “Cough, Cold, and Flu Buying Guide,” Wal-Mart asserts that its products will provide the customer “with everything you and your family need for battling a cold or the flu.”
In short, Wal-Mart’s entire website is replete with assurances that the products Wal-Mart offers as flu remedies are, in fact, effective for preventing and treating the flu. People are buying Boiron Oscillococcinum based on these assurances.
Wal-Mart’s assurances regarding Boiron Oscillococcinum, however, are false and irresponsible. Boiron Oscillococcinum is ineffective against the flu and flu symptoms. Homeopathic oscillococcinum solutions were first produced in the early 20th century on the mistaken assumption that they contained “oscillococci,” microscopic bacteria that proved to be imaginary. The allegedly active ingredient of Boiron’s Oscillococcinum consists of mere liquefied duck liver and duck heart, substances that were thought to contain the nonexistent bacteria. Moreover, manufacturing a “200 CK” homeopathic preparation requires repeatedly diluting the “active ingredient” in water until the odds that the solution contains even a single molecule of it are effectively zero.
There is no credible scientific evidence to support the effectiveness of Boiron Oscillococcinum’s “200CK” homeopathic preparation beyond what is expected from the placebo effect. The premise upon which the effectiveness of this “homeopathic medicine” is founded—that highly diluted preparations of substances that cause symptoms in healthy individuals will reduce similar symptoms in patients—has no basis in reality and has been disproved repeatedly.
This statement should not be interpreted as offering a legal opinion. By marketing Boiron Oscillococcinum through its website, however, Wal-Mart may be in violation of the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and the regulations it implemented. The Food and Drug Administration and the Federal Trade Commission have issued warning letters to other marketers of Boiron Oscillococcinum stating that online marketing of the product for the treatment of flu symptoms violates the FFDCA.
Regardless of whether Wal-Mart is violating the law, its marketing of this product is a profound disservice to the public. Influenza is a serious illness. It can lead to complications resulting in hospitalization or even death, especially among the elderly, the very young, and individuals with certain health conditions. It is imperative that consumers not be led to believe that effective preventive and therapeutic measures can be ignored in favor of something that amounts to “snake oil.” A product that is useless is a product that is harmful.
The Committee for Skeptical Inquiry and the Center for Inquiry wrote to Wal-Mart in November 2010 regarding its inaccurate and misleading marketing of Boiron Oscillococcinum. To date Wal-Mart has neither issued a response to nor acknowledged receipt of CSI and CFI’s letter. Because Wal-Mart has misled consumers about the product’s effectiveness and ignored private pleadings to correct the situation, we are compelled to speak out publicly against Wal-Mart’s irresponsibility.
We urge Wal-Mart to cease marketing this ineffective product immediately. Although we recognize that doing so might not serve Wal-Mart’s financial interest, we hope Wal-Mart will act appropriately out of a sense of ethical obligation. The cooperation of good corporate citizens is indispensable if public consumers are to rely on the claims of health-remedy producers and the companies that market their products.
The FDA sent this warning letter last year to some manufacturers of products sold to combat symptoms or effects of the H1N1 virus. Note the mention of "Boiron Oscillococcinum." Here is a sample Wal-Mart ad. Here is a link to a manufacturer's website, with discussion of the benefits of homeopathic drugs. Note that the discussion includes FDA regulation, with a footnote suggesting a link to the relevant CFR (Code of Federal Regulations) cite, but the link takes one to more advertising, not to the CFR (Code of Federal Regulations). The website folks might want to fix the link; the cite given no longer works, but here's one to try.
The FDA regulates homeopathic drugs like OTC (over the counter drugs). Here is a link to attorney Paul J. Wisniewski's description of the homeopathic drug regulation regime.
Interesting post from an Indian judge concerning tantrik practices. Apparently tantriks are regulated under Indian law. Says Justice Kannan, in part:
The Indian Medical Council Act, 1956 establishes the Medical Council of India (MCI). The Council has notified Indian Medical Council (Professional Conduct, and Ethics) Regulations in 2002 which mandates observance of the code of conduct on the pain of suspension or removal of the licence to practice for the breach of its regulations. They include the practice against promising magic remedies and advertisements. To the extent to which the Regulations are directed against practitioners of only the allopaths, it is obvious that we have to look elsewhere for the practitioners of other systems of medicine. The Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) established by the Ministry of Health & Family Welfare in March, 1995 gives no similar guidelines.
It is not merely unethical to prescribe a magic remedy; it is illegal under the Drugs and Magic Remedies (Objectionable Advertisements) Act passed as early as in 1954. The Act proclaims its avowed object to be to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. Magic remedy includes ‘a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals’. Even machines of science or of electric treatment whose magically curative properties are advertised by a person as capable of increasing the sexual virility of a patient is prohibited under the Act. They will be treated as articles intended to influence the organic function of the human body which is prohibited under the Act.
The British Medical Journal has deemed Andrew Wakefield's 1998 Lancet paper "fraudulent" after a researcher, Brian Deer, carried out a lengthy investigation. Dr. Wakefield defended himself on CNN's Anderson Cooper show last night. The 1998 paper had asserted a link between MMR and autism, which created fear in many parents over the wisdom of child vaccinations, an increase in interest in alternative medicine, and demands for more research into the causes of autism.
Brian Deer, the journalist who carried out the detailed investigation of Dr. Wakefield's 1998 paper compares the MMR study to the Piltdown Man hoax.
Wakefield fraud had sat in plain view for six years before serious challenge. Journals, the BMJ included, had fretted over epidemiology and viral studies without giving pause to the remarkable, now fully retracted, fundamentals. Did the scientific community ever really believe that 12 families had turned up consecutively at one hospital, with no reputation for developmental disorders, and make the same highly specific allegations – with a time-link of just days – and that there was not something fishy going on?
Piltdown Man offers the salutary lesson. Polite society could not harbour such thoughts. Even as the skullcap, jaw, and tooth were first laid out for public inspection before the Great War’s outbreak, some among the audience were muttering fraud. But they were urged not to rock the establishment’s boat with the implication that a gentleman could not be trusted. “He was a delightful colleague in scientific research,” Woodward said later of the fossil-hunter Dawson.
“We all rely on trust,” Walker-Smith told the GMC panel, in words for which he will be remembered. “I trusted Dr Wakefield.”
This story has magic written all over it, from its beginning, in which Dr. Wakefield and his colleagues offered the magic answer--that MMR is linked to autism--to the ending, in which Brian Deer asks the magic question--why did they do "it," the "it" being why did they publish a study that would eventually turn out to be so flawed. Mr. Deer and the BMJ might offer one explanation if we asked them (or they might not). Dr. Wakefield might offer a different one. I can hear cell phones ringing and see fingers flying over keyboards, and I fully expect within a year to see at least one book in the bookstores about this whole affair. Maybe there'll be a movie. Will Jenny McCarthy play herself?
The Hollywood Reporter notes that India's owl population is at risk, apparently due both to the popularity of "Harry Potter" and tantric practice. Those who want to emulate J. R. Rowling's famous character want their own live pet bird, and those who want owl parts, want, well, dead ones. Animal rights groups are upset. More here from the BBC.