Thursday, 21 January 2016

NewsSpeak: FDA responds to homeopathy

Is there a place for homeopathy in the management of MS? #MSBlog #NewsSpeak

"Most chronic disease areas have attracted various alternative or complementary medicine practices, MS is no exception. Our survey on this blog done more than 2 years ago demonstrated that over 80% of pwMS use some form of complementary medicine. I must admit that I was slightly surprised by the survey. You may therefore be interested in reading the latest history of medicine perspective in this week's New England Journal of Medicine. It makes for an interesting read. My personal view relating to homeopathy as a treatment to MS is negative. I am not aware of any class 1 evidence showing that homeopathy is effective in the management of MS or in the management of any of the symptomatic problems that pwMS have." 



Podolsky & Kesselheim. Regulating Homeopathic Products — A Century of Dilute Interest. N Engl J Med 2016; 374:201-203.

Excerpts:

..... in March, the Food and Drug Administration (FDA) filed a request for public comments to learn what the public and physicians think about homeopathic drugs and whether its limited regulatory oversight of these products was “appropriate to protect and promote public health.”....

..... The agency then held a 2-day public hearing featuring homeopathic care providers and representatives of the homeopathic drug industry, as well as drug-safety experts....

..... in September, the Federal Trade Commission (FTC) held its own public workshop on the advertising of homeopathic products and whether it might violate section 5 of the FTC Act, which prohibits deceptive acts or practices affecting commerce.....

..... Oliver Wendell Holmes, who declared homeopathy a “mingled mass of perverse ingenuity, of tinsel erudition, or imbecile credulity, and of artful misrepresentation,” while noting the potential therapeutic effect on patients of “the strong impression made upon their minds by this novel and marvelous method of treatment.”...... 

....  In 1988, recognizing the increasing size of the homeopathic-drug market, the FDA issued a Compliance Policy Guide mandating conformity with good manufacturing practices and appropriate labeling regarding ingredients and directions for use. Homeopathic drugs used for “serious” conditions were to be prescribed by clinicians, whereas those offered for self-limited conditions could be sold over the counter. Thus, the FDA not only recused itself from evaluating the efficacy of remedies prescribed by homeopathic clinicians but also allowed over-the-counter homeopathic drugs to be marketed as therapeutic......

...... Unlike dietary supplements, which were explicitly excluded from rigorous FDA regulation in 1994, homeopathic products can actually be substantially regulated by the FDA, since the Food, Drug, and Cosmetic Act allows them to be sold as “therapeutic.” .....

...... We believe that, at minimum, regulators should reconsider the way homeopathic drugs are marketed, so that consumers who are seeking conventional medicines at pharmacies don’t become confused...... 

...... In August, the FTC submitted comments to the FDA recommending that the agencies better harmonize their approaches to regulating homeopathic products and their advertising.....

..... Reconsidering the over-the-counter sale of homeopathic remedies entirely would be an even more drastic step and would require the FDA to take on the entire industry for propagating remedies that don’t meet the same standards of scientific proof applied to conventional medicines.....

...... The recent actions by the FDA and FTC may finally signal the end of homeopathic drugs’ century-long evasion of regulatory scrutiny......

24 comments:

  1. Good on you Prof G for taking a stand on this issue. Can I suggest you use the term quackery when you discuss homeopathy. I like Quackwatch's take on it; they refer to homeopathy as "The Ultimate Fake".

    http://www.quackwatch.com/

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  2. Why would someone take pills with the memory of e.g. shit and mercury if they have MS?

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  3. Complementary and alternative (CAM) techniques and treatments is a broad term.
    I think if the survey was more specific and broken down into different complementary practices it may show different results.

    I'm not sure I would use homeopathy but I do use acupuncture now and then, meditation twice a day.

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    1. I've remove "this works for me" that "works for me" we are not a soapbox.
      Sorry I haven't time to redact

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    2. If you are relating to my comment above at 9.50am I don't mean it in a "this works for me" way.

      Taking vitamin tablets can be classed as complementary medicine and I know many of Team G take vit D!

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    3. The focus of this post is homeopathy. Supplements are not homeopathy. Similarly, the off-label use of drugs, for example LDN is not homeopathy. It is debatable if off-label drug use is a 'complementary medicine' as they are prescription-only meds and need to be prescribed by a registered medical practitioner. The latter usually defines what is a medicine and not a complementary medicine.

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    4. I know the post is about homeopathy but the survey wasn't. Many MSers take vitamin D supplements, so many MSers are taking complementary medicine. That is my point.

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    5. Is vitamin d a medicine or a food stuff? Giving a meal to a starving person is not to give them medicine.

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    6. agree with this. it is a joke that the NHS funds a homeopathic hospital next to world renowned institutes such as NHNN and GOSH.

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    7. There is a scientific rationale behind taking vitamin D. Not for taking water with no trace left of a substance that has supposedly imparted some sort of molecular memory or vibes or whatever.

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    8. I've always thought, it homeopathy worked, why isn't there homeopathic beer? The brewing industry would go out of business overnight.

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    9. The comments I made relate to info I put in spam

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  4. There is even something called an aqua vortex or something, which "energises" water. The water spins around in a little spiral pipe. You can buy a gold version too. In its defence, it does come with a 30-day satisfaction guarantee.

    It's all psychological. If you believe it, it might do you some good. On the other hand, it is obfuscatory money-spinning hocus pocus, and when it begins to endanger people by causing them to turn away from scientifically proven treatment, its totally unacceptable.

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  5. I think that homeopathy is more of a placebo effect, the ability of the mind to believe that all is well ... and homeopathy is one thing, supplements, herbs are something else, are complementary treatments even ... I live in Brazil here is used very complementary treatments with herbs, plants, and I've seen people ending up in the emergency room because of side effects. Herbs, plants are definitely not homeopathy ...

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  6. I wonder how efficiency of homeopathy compares to efficiency of placebo, which has been greatly improving lately

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  7. Homeopathy does work. I grew up in India, where it is very popular and was very effective. I remember getting some strange bumps on my hands as a kid. The modern medicine doctor offered to cut them off, but a homeopathic doctor was able to get rid of them and they never came back. I wish doctors gave some credit to alternative therapies.

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    Replies
    1. Homeopathy doesn't work. There are extensive clinical trials proving this. The strange bumps on your hands went away of their own accord.

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    2. A recent large survey (n=333,104) by the Indian Government found that AYUSH (Ayurveda, Yoga & Naturoathy, Unani, Siddha, and Homeopathy) was trusted by just 6% of Indians.[1,2]

      It's not as popular as some homeopaths would have us believe.

      1 NSSO - Key Indicators of Social Consumption in India Health. The Hindu Centre for Politics and Public Policy. 2015.http://www.thehinducentre.com/resources/article7378862.ece (accessed 23 Sep 2015).

      2 90% of Indians prefer allopathy over AYUSH - Times of India. The Times of India. http://timesofindia.indiatimes.com/india/90-of-Indians-prefer-allopathy-over-AYUSH/articleshow/47981441.cms (accessed 28 Dec 2015).

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  8. What happened to the big homeopathic hospital that used to be near National Hospital in Queens Square?

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    1. It's still there. It was rebranded as the Royal London Hospital for Integrated Medicine a few years ago (with a £20 million makeover in 2005) and it no longer has a specific homeopathy service. Even then, much of the space in it is rented out to the Great Ormond Street Hospital for Children (GOSH) (costing them some £600,000 per annum), the National Hospital for Neurology and Neurosurgery (NHNN) and the Eastman Dental Hospital (EDH). See our newsletter: More needling - Nightingale Collaboration

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    2. It changed its name to The Royal London Hospital for Integrated Medicine
      homopathy- a blot on the landscape

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  9. A lot of alternative treatment providers are unfortunately quacks. But the good ones actually have a very thriving business in India. The Times of India article you have here starts off with the fact that the govt is trying to popularize alternative treatments. In fact, a lot of allopathic doctors in India suggest alternative cures along with modern drugs. Trust me, I grew up there! MS is not very prevalent in India. My parents had never even heard of it, I don't think there is even a translation for it in any Indian language. I would not pursue homeopathic treatment for it simply because there is not much knowledge about it in India and any homeopathic doctor offering a treatment for it is definitely a quack!

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  10. Last week my continence nurse suggested I try to reduce the my caffeine intake. I went straight to the supermarket and bought de-caff tea and coffee. I've only been a week in and to my suprise my spasticity has reduced significantly. This probably won't work for other people. My point is, that MS is so complex HSCT, DMTs, herbal teas can all help. So what works for you won't work for me.

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