Tag: Homeopathy

  • There is no scientific evidence that the product works

    Have a press release from the Federal Trade Commission:

    The Federal Trade Commission today announced a new “Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs.” The policy statement was informed by an FTC workshop held last year to examine how such drugs are marketed to consumers. The FTC also released its staff report on the workshop, which summarizes the panel presentations and related public comments in addition to describing consumer research commissioned by the FTC.

    The policy statement explains that the FTC will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. That is, companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions. The statement describes the type of scientific evidence that the Commission requires of companies making such claims for their products.

    Homeopathy, which dates back to the 1700s, is based on the theory that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people. Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance. According to the policy statement, homeopathic theories are not accepted by most modern medical experts.

    For the vast majority of OTC homeopathic drugs, the policy statement notes, “the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.” As such, the marketing claims for these products are likely misleading, in violation of the FTC Act.

    However, the policy statement also notes that “the FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. Accordingly, it recognizes that an OTC homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

    The policy statement notes that any such disclosures should stand out and be in close proximity to the product’s efficacy message and might need to be incorporated into that message. It also warns marketers not to undercut a disclosure with additional positive statements or consumer endorsements reinforcing a product’s efficacy. The statement warns that the FTC will carefully scrutinize the net impression of OTC homeopathic marketing claims and that if an ad conveys more substantiation than a marketer has, it will violate the FTC Act.

    The Commission vote approving the enforcement policy statement and issuance of the staff report on the Homeopathic Medicine & Advertising Workshop was 3-0.

    I would rather see them say just “The label must say in enormous letters THIS STUFF IS USELESS” but this is still a big improvement.

  • An extended discussion with their homeopath

    But we mustn’t say that anti-vaxxers are wrong or that homeopathy is bullshit, because that would be Elitist and Wrong.

    One of the attractions of homeopathy is the inclusiveness it offers patients, in contrast to the perceived exclusivity and elitism of medicine and science. Participants are welcomed and can engage in an extended discussion with their homeopath. They are able to develop a longstanding relationship with an individual who gets to know them personally and offers supportive guidance. Consider this in contrast to the doctor’s surgery, often over-subscribed, where patients may be required to wait up to two weeks for an appointment.

    I think it would be great if people could get to see doctors more promptly, and if doctors could spend a lot more time talking to patients – but that’s not a reason to embrace homeopathy. Of course “participants” (aren’t they supposed to be patients? seeking treatment?) are welcomed and can engage in an extended discussion with their homeopath. Guess why that is! It’s because the homeopath has nothing else to do. It’s all just magical handwaving, so there’s no need for an examination or a look at the patient’s history, so there’s all the time in the world for a nice long chat. Nobody really needs a homeopath, either, so they can schedule an hour or two for each patient participant.

    We don’t really want or need “inclusiveness” from our doctors, apart from the obvious basic inclusiveness of accepting us as patients. We want competence and a working knowledge of medicine.

    Corbyn’s critics’ attempt to reinforce the perception that believers in homeopathy are ignorant is divisive political rhetoric and an attempt to discredit a progressive political figure.

    It also helps to reinforce the perception that science and the methods that it applies are elitist and exclusionary.

    They are “elitist and exclusionary” in the sense that we can’t just pick them up by reading the odd magazine. There is an accumulated body of knowledge behind medical science, and it takes time and effort to learn it. The result is that doctors can quite often fix what’s wrong with you, and that’s a good thing. It’s an improvement on the days when the remedy for most things was bleeding, which tended to kill people. Amateurism isn’t useful in medicine. Sorry to be so elitist not really sorry.

  • The fox would be delighted to guard the hen house

    John Tozzi at Bloomberg is also on the homeopathy story.

    On a recent afternoon in midtown Manhattan, I popped into a chain drug store and picked up some $12 sleep tablets whose label promises both “courage and peace of mind” and “focus when ungrounded.” I also got a $17 tube of cream offering “rapid, soothing relief of pain” from conditions as varied as arthritis, carpal tunnel syndrome, and bug bites. Both products sat on shelves alongside familiar drugs such as Tylenol and Claritin, which regulators have carefully scrutinized for safety and effectiveness. The half- dozen products I bought—labelled as “homeopathic”—aren’t vetted for either.

    Tablets that give you courage and peace of mind – that’s funny. I suppose it wouldn’t have sounded spiritual enough to say “calms you the fuck down” – not that it does that either.

    About 3.3 million Americans spent $2.9 billion on homeopathic treatments in 2007, according to the latest estimates from the Centers for Disease Control (CDC), though private industry research suggests a smaller market. The industry has “mushroomed” since the early 1980s, when homeopathic sales were just $1.5 million a year, says Bill Nychis, who worked at the FDA for 39 years in compliance and enforcement. At the time, the agency was midway through a decades-long process reviewing older over-the-counter drugs for safety and efficacy. The FDA had the authority to regulate homeopathic remedies, but because sales were so small, the agency opted to outsource much of that job to the industry itself. “Risk is always depending upon the number of products on the market and the sales volume of the products,” says Nychis, who now advises importers at FDAImports.com.

    In 1988, the FDA issued a policy guide “where we basically allow these drugs to come to the market without premarket approval,” says Cynthia Schnedar, director of compliance for the agency’s Center for Drug Evaluation and Research. Federal regulators allow the sale of any substance listed in the Homeopathic Pharmacopeia, a document published since the 1800s and maintained by a nonprofit industry association. The remedies need to meet certain FDA manufacturing guidelines and can be marketed over the counter only for “self-limiting” conditions, meaning illnesses like colds that go away on their own.

    Oh? Is that right? Then why are homeopathic asthma “treatments” sitting on the shelf at the chain drugstore less than a mile from where I am at this moment? Sitting on the shelf with the real asthma medications?

    Critics of homeopathy say FDA action is overdue. Stephen Barrett, a retired North Carolina psychiatrist who operates the fraud-busting site Quackwatch, petitioned the agency in 1994 to require that homeopathic remedies meet the same standards for safety and effectiveness as other drugs. The agency has cracked down on claims that homeopathic products can treat cancer or substitute for flu vaccines, but Barrett says it hasn’t done enough to warn consumers about common over-the-counter remedies. “You can’t separate safety from effectiveness,” he says. “If it’s not effective, it’s not safe.”

    And there are homeopathic asthma “treatments” out there. I can’t emphasize this enough. It’s not just for headaches and other things that can be hard to treat and aren’t fatal. Asthma.

    Manufacturers of homeopathic products argue that the consumer should be the judge. “Millions of Americans use homeopathic medicines and want access to them,” says John P. Borneman, chief executive of Hyland’s Homeopathic and president of the industry association that publishes the Homeopathic Pharmacopeia. “These medicines are very effective, people like using them, [and] it’s part of consumer choice in the United States.”

    No. Medicine is a technical subject. People can’t evaluate medicines on their own, and manufacturers can’t (and shouldn’t and mustn’t) be trusted to give all the necessary information on the package. Manufacturers of homeopathic products are doing it to make money, and they’re not going to say on the label “THIS IS FAKE MEDICINE.” It has to be an outside body that does that, one with no financial stake in the outcome – a disinterested party.

    In the U.S., homeopathic remedies have become more common at national pharmacy chains, says Yale historian Naomi Rogers, who has studied the history of medicine and homeopathy. “Homeopathic drugs didn’t disappear, but they moved from prescription drugs to all over-the-counter drugs,” she says. “They start to be seen as—or even packaged as—the equivalent of special vitamins, special kinds of extra things you can take to stay healthy, or to get healthy, or to treat something that you have that you don’t want to go to a doctor for.”

    Or just as one of the several asthma treatments on the shelf, and one that is cheaper than the others.

    At this week’s hearing, the FDA will consider whether its current approach is “appropriate to protect and promote public health in light of the tremendous growth of the homeopathic market.” Barrett says the answer is no, and he suggested a way 20 years ago to deal with it: “Hold homeopathic drugs to the same standards as other drugs.” Which would probably make them harder to find at your local pharmacy.

    I sure as hell hope so. It horrified me to find homeopathic asthma “treatments” right there on the shelf.

  • It’s a tough question

    NPR covers the homeopathy issue in its usual insouciant way. It starts with a human interest story about a practitioner named Anthony Aurigemma in Bethesda (handy for NPR).

    Aurigemma went to medical school and practiced as a regular doctor before switching to homeopathy more than 30 years ago. He says he got disillusioned by mainstream medicine because of the side effects caused by many drugs. “I don’t reject conventional medicine. I use it when I have to,” Aurigemma says.

    Throughout his career, homeopathy has been regulated differently from mainstream medicine.

    In 1988, the Food and Drug Administration decided not to require homeopathic remedies to go through the same drug-approval process as standard medical treatments. Now the FDA isrevisiting that decision. It will hold two days of hearings this week to decide whether homeopathic remedies should have to be proven safe and effective.

    Wait.

    What?

    It will hold two days of hearings this week to decide whether homeopathic remedies should have to be proven safe and effective.

    It will hold two days of hearings this week to decide whether homeopathic remedies should have to be proven safe and effective.

    Let’s see…should they?

    Naaaaaaaaaaaah. So they’re dangerous and useless – so what?! What’s the harm?

    Remember that time I read something about homeopathic asthma “medication” and went ballistic? Remember I went to the local chain drugstore to see if they carried it and sure enough they did, with the actual asthma medication? That’s the harm. It’s cheaper than the real stuff. A naïve shopper could buy the homeopathic stuff not realizing it’s not real medication. Asthma can kill you, quickly.

    That’s what’s the harm.

    So yes, FDA, since homeopathic remedies claim to be medically effective, yes of course they should have to be proven safe and effective.

    Homeopathic medicine has long been controversial. It’s based on an idea known as “like cures like,” which means if you give somebody a dose of a substance — such as a plant or a mineral — that can cause the symptoms of their illness, it can, in theory, cure that illness if the substance has been diluted so much that it’s essentially no longer in the dose.

    “We believe that there is a memory left in the solution. You might call it a memory. You might call it energy,” Aurigemma says. “Each substance in nature has a certain set of characteristics. And when a patient comes who matches the physical, mental and emotional symptoms that a remedy produces — that medicine may heal the person’s problem.”

    And then he spun around three times and disappeared, leaving behind only a frog in a football jersey.

    “Homeopathy is an excellent example of the purest form of pseudoscience,” saysSteven Novella, a neurologist at Yale and executive editor of the website Science-Based Medicine. “These are principles that are not based upon science.”

    Novella thinks consumers are wasting their money on homeopathic remedies. The cost of such treatments vary, with some over-the-counter products costing less than $10.

    Some of the costs, such as visits to doctors and the therapies they prescribe, may be covered by insurance. But Novella says with so many people using homeopathic remedies, the costs add up.

    Plus, it’s money for nothing. $9 for a pretend pizza may be not much money, but on the other hand a pretend pizza is worth zero.

    Plus there’s the whole killing you thing.

    There’s also some concern that homeopathic remedies could be dangerous if they’re contaminated or not completely diluted, or even if they simply don’t work.

    I don’t know what that “even” is doing there. Yes of course medicine that doesn’t work could be dangerous!

    Somebody who’s having an acute asthma attack, for example, who takes a homeopathic asthma remedy, “may very well die of their acute asthma attack because they were relying on a completely inert and ineffective treatment,” Novella says.

    Precisely. Yet there it is sitting on the shelf at the big chain drugstore, mixed in with the real medicine! Not marked “DOES NOT WORK”.

    For years, critics like Novella have been asking the FDA to regulate homeopathy more aggressively. The FDA’s decision to revisit the issue now was motivated by several factors, including the growing popularity of homeopathic remedies and the length of time that has passed since the agency last considered the issue.

    What’s the thinking here? That it’s part of our sacred freedom to let people sell water labeled medicine?

    The FDA’s decision to examine the issue is making homeopathic practitioners like Aurigemma and their patients nervous. “It would be a terrible loss to this country if they were to do something drastic,” he says.

    Yeah, quack medicine is what makes this world a better place.

  • But it’s social

    Andy Lewis aka le canard noir tells us the Society of Homeopaths are applying to become accredited as a voluntary professional register with the Professional Standards Authority.

    Professional how? Standards of what? Professional standards in what universe? What “professional standards” are even possible for homeopathy?

    I wonder if homeopaths ever get charged with malpractice.

    Back to our black duck friend.

    Should the PSA approve their application, it will mean that the PSA, rather than ensuring standards in health care, has become a direct threat to public health.

    The PSA are calling for feedback by the 17th of January on the Society of Homeopaths before they approve them. Perhaps you might want to let them know what you think about their fitness against the stated standards.

    That sounds like a good project to me.

    So I take a look at the professional standards [pdf] that Andy linked to. Right at the start I see a problem –

    Standards for organisations holding a voluntary register for health and social care occupations

    Uh oh…

    The Professional Standards Authority for Health and Social Care¹ oversees statutory bodies that regulate health and social care professionals in the UK. We assess their performance, conduct audits, scrutinise their decisions and report to Parliament. We also set standards for organisations holding voluntary registers for health and social care occupations and accredit those that meet them.

    ¹ The Professional Standards Authority for Health and Social Care was previously known as the Council for Healthcare Regulatory Excellence.

    Hoo-boy. I can see homeopathy making it in because of that “Social Care” addition. It could make it in as “Social Care” but then of course use the accreditation to make homeopathy seem valid as Health Care, which is to say, medical treatment. Andy gives ten compelling reasons why they shouldn’t, but concludes that they probably will anyway because

     Recently, in the House of Lords, a quesiton was asked about “whether they intend to appoint a scientist to the Professional Standards Authority”. The response from Earl Howe was frightening,

    My Lords, the Government have no plans to change the membership of the council of the Professional Standards Authority. The authority is required under the Health and Social Care Act 2012 to set standards for organisations holding voluntary registers for health and social care occupations, and accredits those which meet these standards. It is not required to make a judgment on the beliefs and practices of individuals registered with the organisations that it accredits.

    Let that sink in. The regulator has no obligation to consider the beliefs and practices of those it wishes to regulate.

    Even more shocking perhaps was the response of Baroness Pitkeathley, who just happens to be the Chair of the PSA.

    Does the Minister agree that as by next March more than 75 occupations and 100,000 practitioners will be covered by the accredited voluntary register scheme, the public are much better informed and better protected than they have ever been?

    It is not clear how Pitkeathley thinks that the public are going to be better informed and protected by her rubber stamping the most egregious form of quackery that we have to put up with.

    What a mess.

    To remind you, if you wish to make your views known about this issue, then you have until the 17th of January to send a submission to the PSA about the suitability of the Society for accreditation.

  • High-end cutting-edge research

    Gosh – a whole big sciencey conference with sciencey people in sciencey clothes and sciencey glasses, using sciencey words and sciencey concepts, to talk about…

    …homeopathy.

    What a lot of effort for such a futile activity.

    The Homeopathy Research Institute’s International Research Conference, ‘Cutting Edge Research in Homeopathy’, took place in Barcelona in May-June 2013. With a programme dedicated solely to high-end, robust scientific research, this was the first gathering of its kind in a decade. After 18 months of preparation and anticipation, it was a pleasure to witness the event being hailed as a resounding success by respected peers from around the world.

    “High end” research? Who says that? That’s a word from advertising, not science. They might as well call it prestigious, or bijou, or exclusive, or glamorous.

    Headline speaker, Dr Stephan Baumgartner (University of Bern, Switzerland), summarised the state of play and way forward for basic research (i.e. establishing fundamental principles about the properties and action of homeopathic dilutions).

    Yes…it really is more than time to establish fundamental principles about the properties and action of homeopathic dilutions, because so far nobody has the faintest idea how “homeopathic dilutions” could possibly have any curative properties.

    Discussions of new findings defined the ‘cutting edge’ theme of the conference and were typified by a plenary session looking at possible mechanisms of action of homeopathic medicines. Prof Iris Bell (University of Arizona College of Medicine) joining the conference live online from the US, shared her theory that nanoparticles play a key role in the mechanism of action – an appealing hypothesis as it potentially brings homeopathy into the realms of conventional nanomedicine.

    How exciting! Someone has a theory – and that’s appealing because if it works out it could being homeopathy into the real world. It’s only a pity that it’s taken them so many centuries to get around to it.

    It’s also fun that they have no idea what the “possible mechanisms of action of homeopathic medicines” might be, and that that doesn’t stop them taking homeopathic medicines seriously and prescribing them to people as medicine.

    Dr Gustavo Bracho (Finlay Institute, Cuba), proposed a scheme to integrate homeopathy in hospitals as a first line of defense against epidemics, suggesting that homeopathy could be used prophylactically to treat infected patients as they come in to hospitals, thereby shortening their stay and the risks of further contamination.

    Why?

    I’ll assume that “integrate” means “add to existing, evidence-based treatments.” In which case: why? Why waste money and time on this footling conference and talk about adding water to genuine medical treatments? Why make a career out of this stupid bullshit?

    Homeopathy remains controversial because of debate around its mechanism of action. However, the strong scientific presentations at this event demonstrate that high caliber academics, medics and practitioners are engaged in robust research in homeopathy worldwide, pushing this field forward.

    It’s not research, it’s “research”; it’s just people wearing the costumes and talking the jargon while doing nothing real. They’re all playing dress-up and let’s pretend. It’s kind of embarrassing.

     

     

  • A homeopathic preparation called “influenzinum”

    Canada…you’re supposed to be more sensible than the US. You know this. What are you doing?

    Health Canada licenses homeopathic vaccines

    Come on. Really?

    Most Canadians were born too recently to see the night-and-day difference in public health brought about by immunizations—individuals who witnessed the horrors of the polio epidemics of the 1950s first hand are now well into old age, and many have passed away. Good health can be taken for granted when the public does not properly understand the link between that same good health and the measures that made it possible, and unfortunately, history and science cannot always conquer misinformation, mistrust, and fear.

    Enter “alternatives.”

    It is disheartening enough that mis­information about vaccines is spread by voices ranging from outspoken celebrities like Jennifer MacCarthy[5] to various alternative medicine trades,[6] but it is cause for urgent concern when public institutions entrusted with the health of Canadians enable misinformation about endemic communicable diseases to go forward with the imprimatur of science.

    Health Canada is responsible for ensuring that remedies sold to the public are both safe and effective. In recent years, however, Health Canada has allowed various natural health products to enter the market without requiring rigorous proof of effectiveness. Indeed, there are many remedies and homeopathic preparations currently licensed for sale that do not contain any of the allegedly active ingredient. A number of these are hom­eo­pathic “nosodes.” These are ultradilute (typically diluted far be­yond the point where anything is left except solvent) preparations of infectious agents or infected tissue, and are administered as an “oral vaccine.”[7]

    Although real vaccines use low doses of part of an infectious agent to prevent disease, homeopathic preparations typically are diluted beyond the point where a single molecule remains.

    I don’t know if the US allows that or not. Even if it doesn’t, we can’t brag, because it does allow “religious exemptions” in the majority of states, which basically just means it allows exemptions on request. That’s pretty much the same thing as an “oral vaccine” with nothing in it but solvent.

    Remarkably, at the same time as Health Canada focuses on influenza education, flu shots, and other proven prevention measures, that same body has licensed 10 products with a homeopathic preparation called “influenzinum.”[8] According to providers, in­fluenzinum is for “preventing the flu and its related symptoms.”[9]

    Homeopathic vaccines are available for other infectious diseases as well. Health Canada licenses homeopathic preparations purported to prevent polio,[10] measles,[11] and pertussis.[12]

    Oh dear god. Canada, shame on you.

  • Devon and homeopathy calling it quits

    There’s one bit of cheery news – an NHS “homeopathic outreach clinic” in Devon is closing because of falling demand.

    But why did such a clinic ever exist in the first place? Homeopathy isn’t a thing. The NHS doesn’t have outreach clinics that do bloodletting, does it? Or exorcisms? Or treatment for an excess of black bile?

    Patients who use the centre for treatments for conditions including rheumatism and allergies have reacted angrily to the news.

    The trust said patients would be offered continued care in Bristol.

    Greta Rankin, from Willand, is one of the patients against the closure.

    She said: “They will lose all that personalised expertise. The approach of the homeopathic doctors is completely different. If I want to continue I will have to go all the way to Bristol.”

    Expertise in what? How can you have expertise in homeopathy? You can’t overdose on homeopathic remedies (unless you take so much that the water kills you). That’s because there’s nothing in them to overdose on, so how can there be expertise? There can’t.

    It makes no sense for the NHS to pay for homeopathy.

    Detractors such as Keir Liddle of Edinburgh Skeptics say homeopathy is “against all the laws of physics and chemistry” because the initial ingredients are so diluted that all that is left is a “memory” in the water.

    The British Medical Association, which represents doctors, believes there should be no further NHS funding for homeopathy, saying it is concerned that scarce resources are being spent on a treatment with “no scientific evidence base to support its use”.

    I think the BBC’s Steven Brocklehurst must have misunderstood Keir Liddle. It’s homeopaths who claim there’s a “memory” left in the water; “detractors” think that claim is risible.

    He gives Keir the last word though, and that’s clearer.

    However, Mr Liddle, chair of the Edinburgh Skeptics, a society which promotes “science, reason and independent thinking”, says homeopathy is “not effective and not efficient, which is at odds with the NHS health care strategy”.

    He says: “A substance with nothing in it cannot possibly meet those demands.

    “Apart from that, it is unethical for a health care service to prescribe something they know is nothing better than a placebo because that means GPs are put in a position where they end up lying to patients, which is a position which is untenable ethically and morally, in our opinion.

    “Where applicable the treatments offered to patients in the health service should be evidence-based. They should be proved to be safe and effective in order that we are not wasting money treating people with things that don’t work.”

    We’re talking about “a substance with nothing in it.” Not even a memory.

     

  • The magic vibrations of the original substance

    Corporate behemoth tries to put the frighteners on one powerless blogger because he said things about one of its risible products. (Yes risible. Go ahead, sue me.)

    …the international homeopathy producer, Boiron, is threatening a lone Italian blogger because he dared to criticize their product, Oscillococcinum. The blogger, Samuele Riva, wrote two articles on his blog, blogzero.it, criticizing what our own Mark Crislip has called “oh-so-silly-coccinum.”

    …

    Boiron is the largest manufacturer of homeopathic products in the world and the second largest manufacturer of over-the-counter products in France.What they are doing to this small blogger, in my opinion, is nothing less than corporate thuggery. They are using their resources and their corporate lawyers to try to silence completely legitimate criticism of their pseudoscientific products. Of course, they will only succeed in magnifying that criticism.

    Steven Novella goes on to say what there was to criticise.

    Riva suggested that Boiron’s oscillococcinum has no active ingredient. Well, let’s see- the company lists the active ingredient in this product as “Anas barbariae hepatis et cordis extractum 200CK HPUS.” The “200C” means that the listed ingredient was diluted with a 1:100 dilution 200 times. Serial dilution is a funny thing – a 200c dilution is the equivalent of diluting 1ml of original ingredient into a volume of water that is the size of the known universe. This is far far beyond the point where there is any reasonable chance of there being even a single molecule of original ingredient left.

    And then, even if it’s not diluted…

    That’s right, oscillococcinum does not even exist – essentially Boiron takes fairy dust and then dilutes it out of (non)existence. The “anas barbariea hepatis” is basically duck liver, which is supposed to contain the most concentrated nonexistent oscillococcinum. It’s a pseudoscience trifecta.

    …

    I hope Boiron does draw a line in the sand over their oscillococcinum product, and that it becomes the center piece of a broader public discussion about homeopathy. Most of the public does not understand what homeopathy actually is. They think it means “natural” or “herbal” medicine. They have no idea that homeopathy is about taking fanciful ingredients with a dubious connection to the symptoms in the first place, and then diluting them into oblivion, then placing a drop of the pure water that remains and placing it on a sugar pill. The resultant pill is then supposed to contain the magic vibrations of the original substance.

    “Supposed to”?? Sue that man!