FDA Raises Serious Concerns About UK’s Nelsons Homeopathics

Nelsons, UK manufacturers of such products as Bach Rescue Remedies,  and a range of Homeopathic sugar pills, such as Teetha, have been inspected by the US authority the FDA as their products are exported to the US.

The FDA reports many concerns about their manufacturing processes in London and have ordered them to report how they are going to remediate their concerns.

It all makes rather odd reading, as I am sure you are aware, homeopathy contains no active ingredients – they are just sugar pills, granuals and vials of water and alcohol. One would have thought that manufacturing such products would have been as simple as owning a large tub of sugar pills, a scoop and a printer to put the right name on the bottle.

But Nelsons appear to go through the magic rituals of homeopathic preparation, including the impossible dilutions and magic shaking. Therein lies their problem.

There are genuine concerns in the letter, such as the failure to keep manufacturing production free of broken glass,

During the inspection, the investigator observed glass fragments present during the manufacture of Kali Phos 30 c Clikpak, Batch #36659. Specifically, glass fragments were observed in the Clikpak Assembly (b)(4) enclosed area where open glass vials are inserted into the outer plastic Clikpak sheaths and move uncovered on the conveyance mechanism. Your firm failed to implement adequate measures to prevent glass contamination and had no documentation to demonstrate that appropriate line clearance and cleaning is conducted following occurrences of glass breakage, which has been a recurring problem.

Sorting that ought ought to be a matter of implementing good manufacturing process. Other concerns raise more bizarre issues,

Your firm does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.

As homeopathic products are inert and identical to each other,  (all ‘ingredients’ are diluted out in the magic rituals), being able to demonstrate that their products have the right identity and strength is impossible. Homeopaths measure the ‘strength’ in terms of dilution. A 30C dilution has no physical difference from a 200C dilution and a Belladonna 30C will be identical to a Sulphur 30C. Quite how they could comply with this requirement is beyond me. Indeed, homeopathy cannot have post-manufacturing quality control as no test has ever been demonstrated that could show one remedy was different from another. They are just sugar pills.

And as such, one concern raised by the FDA need not be a concern at all,

The investigator also observed for Batch #36659 that one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly during filling of the active ingredient. The active ingredient was instead seen dripping down the outside of the vial assembly. Your firm lacked controls to ensure that the active ingredient is delivered to every bottle.

Given that they are dripping pure water/ethanol onto sugar pills, which quickly evaporates, the fact that some pills were not getting their magic mixture is immaterial. Of course, no homeopaths have complained that the pills they received were duds as all pills are duds. Homeopathy does not work. Its a placebo treatment.

Such are the absurdities of regulating magic.

Some questions arise though.

Why has our own medicines regulator, the MHRA, failed to spot such lax manufacturing processes on its own turf?

Will Boots the Chemist and Holland & Barrett remove these products from its shelves until such time as Nelsons can demonstrate that their magic rituals are being applied appropriately? I have written to them both to find out.

There are precedents to do this. In France, five years ago, Boiron mixed up its tinctures and had to recall its products, even though, the end products were just inert pillules.

Of course, if this was a genuine pharmaceutical company, we would be seeing a scandal of the highest order, with coverage in national newspapers. It is almost as if we all know these products are nonsense, but we have to go through with the pantomime of pretending to regulate this industry.

But there are people that really buy these products believing they can treat their baby’s teething pain or their own hayfever. Its indistinguishable from a giant scam. And I am still astonished that we all go along with it.

 Update 15th October 2012

Eventually, I received a response from NBYT (parent company of Holland and Barrett). It speaks for itself,

Assigned Case Ref: CA196487

Dear Andy Lewis,

Thank you for your patience whilst we were looking into this query.

On behalf of our Regulatory Department I can advise that this document is in relation to Nelson’s selling their products in the USA.

This document would have been passed to the MHRA (equivalent Regulatory Authority) and if they feel these non- compliances mentioned are significant for the UK market then they would take appropriate action and would advise us accordingly. So at the moment this document only related to Nelson’s products being sold in the USA.

Please be assured that your comments have been passed onto the relevant department and to the MHRA for their information. I would like to further assure you that if any action was deemed appropriate by the MHRA when investigating this matter, then this action would have been taken and implemented.

Assuring you of our best attention at all times.

Yours sincerely

Wayne Young
Customer Service Team.
NBTY Europe.
The home of Holland & Barrett, GNC, Nature’s Way and De Tuinen.

 

 

On this theme…

144 Comments on FDA Raises Serious Concerns About UK’s Nelsons Homeopathics

  1. “As homeopathic products are inert and identical to each other, (all ‘ingredients’ are diluted out in the magic rituals), being able to demonstrate that their products have the right identity and strength is impossible. Homeopaths measure the ‘strength’ in terms of dilution” In theory, a less diluted remedy is more likely to contain a molecule of the substance than a more diluted one, isn’t it? After all, they don’t actually split molecules. So, the strength has a chance in theory of varying according to the amount of dilution- more chance of a speck of remedy being in a less diluted then a more diluted one. I assume what the FDA mean is the remedies aren’t actually succussed/shook a particular amount of times for the purported different strengths, but just jushed up for a while. Or perhaps they aren’t actually diluted again, but only once and then labelled 30CC, 60CC or whatever at random, which would be quite shocking to believers.

    • Yes, lower dilutions will have a statistically higher chance of containing a molecule of the original substance. However, once you get past ~17 dilution cycles the chances drop below one, so a 30C dilution will have a 1 in 10,000,000,000,000 chance of containing a molecule and a 40C dilution will have a 1 in 100,000,000,000,000,000,000,000 chance. To determine the difference between them you’d have to check a hundred thousand million, million, million bottles, and do so using equipment sensitive to a single molecule. All that to certify a single batch of the product.

      • Correction – it’s 1/100 dilutions, not 1/10, so please double the number of zeroes above. Whether there are enough water molecules in the observable universe to do the test is doubtful.

  2. Rich!

    I like the recent suggestion that the UK homeopathy makers relabel themselves into confectioneries.

    Is is possible that food standards are tougher than homeopathy’s current ‘magic beans and unicorn tears’ manufacturing standards?

    -r.c.

    • naturocrit said:

      Is is possible that food standards are tougher than homeopathy’s current ‘magic beans and unicorn tears’ manufacturing standards?

      It will not be easy for them to not present them in such a way as not to fall foul of the second limb of the definition of a medicinal product. And just being homeopathic is fraught with difficulties in itself. But I think you’re right about the food regs: I don’t think it’s allowed to label a food with an ingredient that isn’t actually in the product!

    • Given that it is not permissible to sell confectionary in a form that resembles tobacco products how likely is it going to be that they are allowed to package confectionary such that it resembles medicine?

  3. I see Nelsons’ products were also the subject of an Import Alert on 26 June 2012:

    Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs

    Charge:
    “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control of pharmaceutical products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).”

  4. Considering the near zero cost of the materials, the low cost of any quality control and the high profit margin it is scandalous that they don’t carry out good manufacturing process.

    It’s almost as if they knew it is all quite ineffective and therefore shouldn’t matter.

  5. We all know that Nelsons are fraudulent. The truly amazing part of this is that the FDA fuss about the exact dilution as though they were talking about real medicine.

    It’s a bit like the MHRA making mandatory misleading labels on homeopathic products, complete with instructions about what to do if you take an overdose.

    That shows the consequences of trying to regulate magic medicine as though it were real.

    Why can’t the FDA and the MHRA insist on honest labels, like “these pills contain no active ingredient”? The dishonesty of the regulators upsets me even more than the dishonesty of Nelsons.

    • The FDA is legally constrained by an idiotic law, unfortunately (and not surprisingly.) One of the major laws establishing federal control over drug manufacturing specifically exempted homeopathy from having to demonstrate that it was safe and effective. However, homeopathic ‘drugs’ do have to demonstrate that they were manufactured correctly, according to the rules established at that time (in the 1930’s?)

      This action by the FDA is an attempt to regulate Nelsons as best they can within their legal power. They realize that homeopathic drugs are garbage, but they don’t have the power to stop Nelson’s from selling them as real medicine. Instead they are forced to resort to hand waving and forcing them to improve manufacturing processes. It’s essentially a fine on Nelsons, since everyone involved realizes that it doesn’t matter whether a drop lands on pill or not, and it ought to remove a real danger in the form of broken glass.

      I wonder whether some pills accidentally get multiple drops instead of single drops. Wouldn’t that drastically reduce their efficacy?

      Why do nations with the ability to launch rockets into space, crack open the innards of atoms, and see into the farthest depths of space have to deal with such a ridiculous industry?

      • It was the Federal Food, Drug, and Cosmetic Act of 1938, if anyone cares. The primary author was Senator Royal S. Copeland, who was a homeopath before he was a politician.

      • You know nothing about homeopathy. It saved my life and potency and material used is noticed with minutes of taking a remedy if your ill. Wrong remedy you get worse right remedy you feel better.

        I was like you, I thought no way will this work, but after my medical doctors gave up on me I figured a it’s just a sugar pill it can’t hurt me. If does help it will save my life and if it doesn’t help it isn’t going to kill me and it won’t make me any worse.

        But the homeopath gave me the wrong remedy and I did get sicker immediately. He told me it was probably just worsing of the symptoms and it was the right remedy. So I waited and I didn’t get better eventually I the effects wore off and I started feeling like I did before I took it. So he suggested I try it again. I did and I got worse. I switched homeopaths. At that point I knew the little white pellet was doing something, but it wasn’t good. But it did something. I then went and bought a bunch of books and started reading and went to another homeopath. The next homeopath gave me a different remedy and it didn’t work either and made me feel worse but with a different set of symptoms. Not like the first remedy. So when the symptoms calmed down I tried it again. Same thing within and hour I was worse. After the third time I tried the remedy I was convinced it was the wrong remedy. He then perscibed a different remedy. It didn’t do anything one way or the other. Then another remedy and it made be feel a little better but nothing to call home about. Then a friend suggested that I see a homepath that had written six books or more and I thought why not.

        After taking the first persciption from this homeopath I felt better immediately. It was like I was well for the first time in ten years. It was like a miracle. The effects lasted for about four weeks then the old symptoms started coming back and I took the remedy again. Once again I felt better. I felt like I was well. But it didn’t hold. Eventually he would have to change the remedy for me to get the same effect but I never really felt one hundred percent again. But another interesting thing happened the tumor I had, had gotten smaller. It gave me a little hope. Then he suggest I take what homeopathes call a nosode. It didn’t cure or make me feel well like the first remedy he gave me but over time I started slowly improving. Ocassonally I would have to take a different remedy has the symptoms changed. Then take the nosode again. After being sick for ten years I actually started getting well. The tumor I had disappeared. It was gone. I still wasn’t a hundred percent. But I was getting better.

        Let me digress here.

        For ten years before I started homeopathy I kept getting worse and worse. I was weak, tired all the time and then after ten years of medical treatment I had developed a tumor in the cardio junction of the esphogus. They wanted to operate but still couldn’t tell me what was causing the problem.

        I had went to UCLA, Cedars, and some of the best doctors in the country and none of them had been able to help me at all. Before I got sick I was running ten miles a couple times a week. Running in marathons and fighting in martial art tournaments, competing it gymnastics, then I got sick and I lost fourty pounds I couldn’t get out of bed and I only weighed a hundred and eighteen pounds when I started homeopathy. Something I refused to even look at for ten years I rarely was able to go out or even go to a movie show with out ending up in the emergency room. Now I’m back to working making money and feel at least eighy five percent better. But I’m still seeing homeopath. So it’s not like an instant cure at least not in my case but has a helped a great deal. But I’m pretty much like a normal person now.

        I tried acupuncture, diet, Aurvedic medicine you name it. And nothing really helped but homeopathy. So say what you will. I’m just glad this is American and it’s available to me. However they have stopped a lot of the rememdies including one I take from being sold in this country. I have to have friends bring it in from England. Interestingly the Queen of Englands doctor is a homeopath. I can see from the comment on here that this will attract a lot of strange and even nasty comments. But I’m still feeling better. Are YOU?

      • You are mistaken. That is all.

        You are making the very obvious mistake of supplying a narrative to your fluctuating health. If you get better, the remedy was ‘the correct one’. If you get worse, it was obviously not.

  6. “Your firm does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.”

    I wonder if the FDA inspector is silently laughing as he holds the mfr. to the purity levels required in homeopathy. One mustn’t misuse a 6C when 30C is called for. If you want magic, you should follow the laws of magic.

    What piffle!!!

  7. The FDA is utterly corrupt and a perfect example of the quackery and bad science you object to.

    The FDA has zero credibility, having dreamed up the absurd concept of ‘substantial equivalence’ in the 1990s in order to approve genetically modified (GE) organisms without adequate (or indeed any) safety testing.

    If the FDA didn’t have their heads up death merchant Monsanto’s arse then they might be worth listening to, but unfortunately that is not the case.

    • Can you say how that affects the glass particles they found on Nelsons production line? Or did the FDA plant that evidence?

    • If you had taken the time to get any kind of education you might “be worth listening to” as well.

      By the way, I have some educatrix pills for sale that will boost your IQ 1000×0 times. Good deal, yes? Call me at 1-800-NOTSCAMMING

  8. The FDA letter makes great reading. It shows up some of the true absurdities in homeopathy, particularly the lack of any active ingredient. But these companies insist that their products are medicine and so they must be held to the same standards as the huge drug companies. If anything will shut these companies down it will be exactly that, as the problem of the unregistered products previously highlighted shows. Big drug companies spend millions, or even billions, on proving their products are safe (as far as is known at the time) and ensuring quality. I doubt most homepathic suppliers can afford that, even with Prince Charles ordering in bulk.
    Also, surely if you are sold a bottle of 30C Berlin Wall, or whatever, but it hasn’t been diluted the requisite 30 times, or banged on a bible the incorrect number of times, then that is fraud. A lot of people who use homeopathy genuinly believe ( or at least seem to) that it works. They are buying these sweeties based on them being prepared in a certain way. If they are not then to me that appears to be straight forward fraud by misrepresentation of the goods offered.

  9. Glass fragments in homoeopathic remedies? Have you never heard of the “silica hypothesis“?

    For instance, the “silica hypothesis” is particularly intriguing, especially in light of the fact that approximately 6 parts per million of “silica fragments” or “chips” are known to fall off the walls of glass vial during the shaking process.

    Or see here:

    …and that you knew about the “silica hypothesis” that suggests that the silicate fragments that fall off the walls of the glass (6ppm) in the making of a homeopathic medicine. How can you say with a straight face that this would not or could not influence water structure? Is it just a coincidence that silica has a tendency to store and to broadcast information?

  10. The reaction of homeopaths on this one will be interesting. Will they:
    a) attack the FDA (see above) thus indicating that they don’t actually really care what is in the pills or what customers are paying for, or
    b) attack Nelsons and demand improvements, which would at least be consistent with the laws of their fantasy world

    I note Mr. Sutherland has volunteered for group (a) already.

    • I expect total silence from homeopaths. It is far more important that Nelsons survive to them than there is any sort of external monitoring of what they do.

      Nelsons have also been working with homeopaths to try to change the law regarding distribution and supply of their pills. The relationship between homeopaths and these pill manufacturers would make any real doctor blush.

      Any noise is going to threaten the existence of Nelsons – hence, total silence is best.

      • The presence of glass and the medicating method would probably be described as a critical observation by the MHRA. You have a point in highlighting this. However you should also kick up a fuss though about the 26 critical observations reported by the MHRA out of 303 GMP inspections in year 11/12.
        All or most of these critical observations would involve licensed drugs manufactured by what you would call ‘proper’ pharmaceutical manufacturers. You might want to ask why Drs and pharmacists are not up in arms about this number of critical deficiencies.
        They wont be and it is interesting that you think that homeopaths should be up in arms.
        I think you will find that very few homeopaths use Nelsons or in fact any other companies OTC licensed products.

      • Thanks, Grumpycat, I’ll add those to the list. But just a thought – I don’t want to step on your toes if you’ve already complained to the MHRA about these serious issues. No point in burdening the MHRA with duplicate paperwork, is there? You have complained to the MHRA, haven’t you?

      • For various reasons I dont respect the MHRA for very much at all but I assure you that I can trust the MHRA to sort out the critical deficiencies that they have found during GMP inspections. Critical deficiencies faciliate an exaustive process and my opinion is that there is no need for me or anyone else to chase these up. My point is why are critical deficiencies for homeopathic manufacturers more of a concern? What about all the recalls for none homeopathic manufacturers?

      • Grumpycat – you might find it useful to read the MHRA information on GMP and their reports on the reasons for non-compliance. The numbers you give don’t really tell the whole of the story. http://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con028433.pdf is a good place to start.

        Of course manufacturer non-compliance with GMP is a source of concern to doctors, pharmacists and the general public. But it’s the spectacular failures that result in recalls that attract media attention.

        The question is now: what will Nelsons do? Obviously, they will need to make changes to their processes and systems to ensure that this does not happen again. But do they know which batches are contaminated? Do they have adequate systems in place to recall affected products?

        Certainly, the MHRA will step up the frequency of GMP inspections of Nelsons.

  11. When Prince Charles visited Nelson’s manufactory, he was not shown any pieces of glass.

    He has given his Royal Warrant to Ainsworth’s who sell Nelson’s products. And Royal Warrants are only given to companies who can show they maintain the standards required of them. I do not know what standards HRH requires. His Private Secretary should be asked to enlighten us. I will do so shortly.

    Nelson’s were the major sponsor of the first Annual Conference of the College of Medicine. It is hard to imagine its President, Sir Graeme Catto, formerly Chairman of the GMC, offering vicarious endorsement of Nelson’s products by accepting their underwriting of his “College” if all was not well. But a man has to be judged by the company he keeps.

    Incidentally, I have asked the “College” for a copy of its constitutuion so that I can understand how its President and Council were appointed. No reply. How do we know they are not all sponsored by Nelsons?

    And now for The Big Mystery – as identified by Andy Lewis:

    WHY IS THE MEDIA IN GENERAL NOT REPORTING THIS?

    I hope to see you all at Dartington Hall Round House (up the River Dart from where I am now writing) on 27th August when Andy will be speaking to Skeptics in the Pub at 7 p.m. On Homeopathy no less!

  12. I don’t know whats more depressing the misguided nature of the FDAs questions (who are I guess just doing their job), or the feeble nature of the responses from Nelsons. I’m trying to imagine how they would word the recall notice for this if they chose to do one. I’m thinking along these lines:-

    Product Recall Kali Phos 30 c Clikpak, Batch #36659

    If you have bought this product please discontinue use immediately and return it to the point of purchase for a refund.

    Due to a manufacturing problem it has come to our attention that nothing was put in these bottles by accident. We have rigourous manufacturing processes and quality controls to ensure that under normal circumstances nothing is put in the bottle in a stricly controlled manner and accordance with FDA requirments.

    We apologise for any inconvenience and for any healing crisis wrongly attributed to the use of these inert placebos pills instead of the properly manufactured homeopathic pills. However, we trust that any alternative homeopathic remedy which you used was equally effective.

    Contrary to rumours from Big Pharma we take pride in the quality of our pills and we definately do not just drop it willy nilly onto the top few pills using a machine which is running too quickly near some broken glass.

    Cheers ears
    Nelsons

  13. So let me get this right. In a homeopathy factory the magic water isn’t dotted onto individual pills. It’s squirted into a bottle already filled with sweetner tablets. If so how does anyone EVER know that each tablet has received an equal dosing (or any dosing) of diluted/bashed magic water any way?

    What strange people!

    Jonathan

    • The request by the FDA for them to prove that each pill acquires the same dose is interesting. I’m rather hoping that Nelson’s refers the FDA to the reply given to the select committee which was basically:
      ‘because it says so on the label’

    • In a homeopathy factory the magic water isn’t dotted onto individual pills. It’s squirted into a bottle already filled with sweetner tablets. If so how does anyone EVER know that each tablet has received an equal dosing (or any dosing) of diluted/bashed magic water any way?

      As long as at least one pill in each bottle is dosed, it can tranfer the magic to the rest by “grafting”. Look it up if you don’t believe me.

  14. Does anyone know if these same faulty production lines are used to produce remedies for Dutchy Originals? Now that would be a major story for MSM wouldn’t it?

    • There is no action in vitro. There are some careless experiments and some fraudulent ones and some which through the workings of chance produce an irreproducible positive result.

      The simple truth is, if it were as you say then there would be no debate. The debate only exists because homeopaths persist in denying the obvious, and engage in various types of sophistry in order to protect their source of income.

    • How do you explain that, after more than 200 years, there isn’t a single properly documented case study showing homeopathy incontrovertibly curing anything at all.
      If homeopathy were as successful as homeopaths claim, after 200 years there should be millions upon millions of documented cases showing incontrovertible cures.

      And why has a Nobel Prize for Science or Medicine ever been awarded to a homeopath or a homeopathic “researcher”.

  15. I must say I’m tempted to start a homeopathy business. Seems like a good way to make money without having to do much, plus a customer base that I allready have no respect for.

    You think I’m joking? You’d be so very wrong.

    If you at some point in the future should stumble upon a ‘neopathy’ remedy containg torus-energy stored in water, be shure to buy a bottle 😉

    • Fact is Chrisbee your homeopathic business would go bust very quickly as you are not a believer.
      Homeopathic pharmacies are all run by believers who sell to customers who are believers.
      Glass in the bottles and a malfunctioning assembly line wont help the company concerned but will not put people who believe off homeopathy.

      • @ Slipp Digby

        Homeopathic pharmacies charge a fortune for a consultation (or a series of consultations) and then prescribe sugar pills.

        Selling homeoquack remedies off the shelf doesn’t make Boots a homeopathic pharmacy.

      • I appreciate that Scepticat – i was trying to make the point to grumpycat that belief is not a prerequisite to making money from homeopathy and in fact many put aside questions about efficacy simply to make money.

        I suspect chrisbee would be quite successful, the difference between contemptuous parody and a true believer would be hard to detect.

      • Believers? Unfortunately belief doesn’t trump regulation or professional standards. Nor can it make up for poor business skills.

        Some of the products that Helios sell go well beyond a belief in homeopathy. Peter Chappell AIDS remedies? Magic homeopathic slimming drops?

      • Is it correctskepticat that homeopathic pharmacies charge a fortune for consultations? I thought people just rang up, ordered and just paid for the homeopathic pills that they required?
        Malleus-products that are not marketed and industrially made are not subjected to the EU laws if ordered to the specifications of a member of the public. These unsolicited orders are sold under section 10 as pharmacy nostrums.
        I assume you know this but my reading of your posts/blog is that all supply of homeopathic unlicensed medicines will discontinue. I dont get this.

      • I think that’s because you don’t grasp the meaning of the phrase to “place on the market”. Section 10 relates purely to what happens in a registered pharmacy premise. The specification has to be given in the pharmacy itself. Not over the internet, not over the telephone.

  16. Andy Lewis

    If the chemical medicines are evidence based and the only way forward, why such large population world wide, and also in developing countries using alternative medicine?

    • Schemeit

      If the gravity and evidence based astronomy are the only way forward, why such large population world wide, and also in developing countries believed human sacrifice was necessary to keep the Sun rising?

      The fact that you think your question was reasonable to ask rather suggests you will not newest and or will refuse to accept the rather straightforward answer.

      So, answer my question first.

      • Where can I find the write up on-human sacrifice was necessary to keep the Sun rising?-can you suggest a link.

        The reason behind Gravity is not yet understood. It is observed.

        What do you mean by evidence based astronomy?

        And your comment on my message.

      • Indeed, as Mojo said, if my reply was not self-evident, we have insufficient basis for further discussion.

        You are welcome, however, to look at my answer and think about it and, if you have something sensible to contribute, then I will happily explore the topic with you.

        TTFN

      • We should keep things simple.

        You ask a question in reply to a question posed to Andy Lewis. The points mentioned are invalid.
        Now a new Mojo is to reply on your part.
        There is no straight answer to my question?

      • Schemeit

        I’m sorry, but you are just wittering nonsense.

        The only “invalid” thing in our exchange has been your use of fallacious argumentum ad populum. I have offered you the opportunity to recognise this and explore its implications. You have decided not to. It’s your loss

      • I am ready to understand your arguments. You have not provided link to ” human sacrifice was necessary to keep the Sun rising”.

        You stated “evidence based astronomy”. What is this supposed to mean?

        How do these aspects link to the use of chemical based medicines?

      • How do these aspects link to the use of chemical based medicines?

        These ‘aspects’ relate to your fallacious comment about the supposed popularity of alternative medicine. That’s why I made them in specific response to you asking;

        why such large population world wide, and also in developing countries using alternative medicine?

        I answered your question with a question of my own to cause you to think. That has failed and you still wish to be spoon-fed information without showing any willingness or ability to understand the argument. I am very bored of exchanges with homeopaths who refuse to do any thinking whatsoever and simply repeat a set of trite homilies based on a collection of familiar fallacies.

        Do your thinking, Schemeit and show us you can do it.

  17. Malleus says “I think that’s because you don’t grasp the meaning of the phrase to “place on the market”.
    I disagree with you Malleus.
    The specification does not have to be given in the pharmacy.
    You will be in for a surprise then when some of the complaints relating to this ‘ presence in the pharmacy’ issue dont go very far.

      • We are about to find out from the people that count what placing on the market means in this context.
        Same goes for section 10.
        Might not be quite what we expect eh? Hint, hint.

    • To a degree you are right. The wording of Section 10.3 is ambiguous in terms of what “furnish with specification” actually means and what restrictions apply to that. However, it is very clear that the dispensing must occur in a registered pharmacy to be exempt. So, a client makes one trip to the pharmacy instead of possibly two. The overall effect is the same. The client must visit the pharmacy.

      But this is moot. Lists of unlicensed medicines shown to the general public with click-able purchase-ability, shopping baskets et al do constitute placing on the market.

  18. Are homeopathic remedies produced under sterile conditions? If so, why? Surely disease isn’t caused by microbes and viruses and those other things that Big Pharma cons the world into believing? Isn’t homeopathy clear on the fact that disease is caused by psora and fluxions and palpitations and ill-balanced humours?

    Deeply puzzled….

  19. What is special about error in manufacturing process found during audit?

    The reason behind FDA audits is to locate errors and for food and drug manufacturing companies to take corrective action and improve processes.

    This information is available on FDA site.

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

    Nelson figures in the list for 2012 and so do many others. The audit information is available from 1996. The issue should be to check if Nelson has been found to regularly make such errors and take no corrective action.

    Many good companies make mistakes and have to take responsibility. Toyota Motors makes automobiles known for their quality and had to recall 681,500 vehicles in US on safety concerns.

    • Schemeit

      Your analogy is a false one.

      Its clear from the FDA letter that the FDA have yet to receive a risk assessment from Nelsons on just how many bottles were likely to have been produced badly and how many carried the possibility of having glass in them.

      To use your car analogy, its like Toyota being told the brakes dont work on their cars built between 2010 and 2012 and their response being that they have ensured that all new cars have working brakes.

      You have failed to grasp the issue about how many other pills may have been effected and already exported.

  20. Just how can anyone tell a sincere homeopath from a quack?

    How do we know all homeopaths are genuine “believers”?

    Most Registered Medical Practitioners do not “believe”, but refer patients to homeopaths (or at any rate, tolerate such consultations) to take advantage of placebo effects and get the patient of their hands.Unethical IMHO, but understandable.

    • This is a true but illogically expressed statement.

      True. I have come across some patients asked by their doctors to seek homeopathic treatment as they showed no improvement in present treatment.
      Illogical, as to why would Registered Medical Practitioners refer patients for placebo effect to homeopaths only? Especially if the homeopathic medicines are water only. And by placebo effect you mean here that the patient gets well after treatment.

      • Oh, Schemeit, you find yourselfl unable to answer even the simplest questions for yourself.

        Why would doctors send patients to homeopaths even it the doctors accept that homeopathy is bollocks? The possibilities are fairly obvious: exasperation, bowing to pressure from patients, confidence that if the patient actually gets really ill then real medicine can stil step in to pick up the pieces. Those have certainly been my reasons when I have done it.

        It is unlikely that the patients get better at all by any process other than the natural history of their disease, but it they want tea and sympathy from a homeopath, which is all their placebo effect amounts to, then some doctors will send patients for that or, at least passively, support the patient’s desire to seek sugar pill therapy.

        You seem to be finding these concepts to be difficult. I hope they are now easy for you.

      • P.S. when reading the reports I have received back from homeopaths on what they have done with the patients, I am ineluctably drawn to the phrase, ‘fiddling while Rome burns.’ They fiddle about picking sugar pills from their big book of rules while we deal with the real practicalities of the problem.

        The other comedic feature of their interventions is how they pay so little regard to their essential rules of their faith: multiple remedies all at once, each prescribed as if it was a conventional drug targeting a single pathological process with not even the pretence of trying to find the proper sillymum. Mix in a few herbs as well. Have you heard of Old Thrashbarg? You should find out about him then look in the mirror.

      • P.P.S. any reply you make to my comments on the activities of homeopaths had better steer a wide course away from the No True Scotsman fallacy or I shall just point and laugh at you.

      • When reading the reports I have received back from homeopaths on what they have done with the patients, I am ineluctably drawn to the phrase, ‘fiddling while Rome burns.’

        Well, being stuck in Hahnemann’s 18th century medical paradigm, they follow Voltaire’s 18th century definition of medicine: “amusing the patient while nature cures the disease.”

      • This means they have two other career options, busker and clown.

        I think this is good news for them.

      • I am surprised to see your message. No where did I come across homeopaths writing reports for patients. Where did you see this report? Can you share one such report?

        I see the following:

        The patient at best gets a prescription stating names of medicines and number of times he has to take it. Mostly he will only get bottle of pills to take in a defined manner.

        The patient answers questions to defined work sheet that is termed as “case history”. This is not shared with the patient and remains with doctor. Mostly this sheet is linked to a software that lists out the probable medicines from which the doctor will make a final choice of medicines. No herbs.

      • Schemeit

        The homeopaths send the reports to me because they have an ethical obligation so to do.

      • You are only raising more questions than answering:

        1.exasperation: why? for what reason?
        2. bowing to pressure from patients: why? what kind of pressure does a patient exercise?
        3.confidence that if the patient actually gets really ill then real medicine can stil step in to pick up the pieces-why does it not happen with the patient in the first place? did the patient come to you for no apparent reason?

        I am in contact to some homeopath doctors as part of my biochemistry research work. No where I saw the practice of tea being offered to patients.

      • I think you are just pulling my plonker. No one can really be that dim.

        Sorry, Schemeit, it’s been amusing, but Game Over now.

      • My first message was to the blog writer Andy Lewis. You started an irrelevant discussion. If you believe it showed you as intelligent and informed, then you are mistaken. You come out as a liar, writing statements with no background, that you your self do not understand. It was a disgusting experience.

      • ‘tea and sympathy’ is a standard expression in idiomatic English to denote a ritual empty of efficacy that may yet be comforting to the receiver. Homeopaths, unlike GP doctors have more than 5-10minutes to devote to each patient and thus is able to sit and be sympathetic as the patient expounds on their history and all that ails them, unlike the overworked, harassed and time limited GP.

        This effect of much CAM therapy is well documented by people like Edzard Ernst and is behind much of the strong placebo effect thus elicited. See Ben Goldacre’s Bad Science for discussion of the power of the placebo and nocebo effects.

      • And by placebo effect you mean here that the patient gets well after treatment.

        No, that sounds more like the post hoc ergo propter hoc fallacy.

      • We ought to get together to prepare an I-Spy book of logical fallacies as deployed by SCAMsters. I think that one only gets 5 points.

      • If patient does not get well after treatment then what would be the context of using “placebo effect”.

      • I refer you yo my original post on the fallacious belief in the efficacy of human sacrifice. Unless you apply yourself to that, I am simply going to conclude you are a troll and make no further replies to you. As I said in my immediately previous post, Game Over.

        I ask merely rhetorically, are homeopaths really this thick? I suspect Poe’s Law to be operating, but I suspect deliberate trolling.

      • Homeopaths have obligation to send reports to you because you are a monkey or because you are a liar?

        Ethics?

      • Stylish accusations, Schemeit. You are a class act. Though, no different from most of the homeopaths who pop up here.

        They have an obligation because they are vets and so am I. They are under an ethical obligation to inform me of what they do with patients who are primarily mine.

        Now, perhaps you would like to show your understanding of the the nature of the fallacy of argumentum ad populum. This is the topic that you originally raised and which you have steadfastly refused to engage with having had the fallacious nature of your argument pointed out to you.

        Your persistent efforts to engage in meta-discussion rather than deal with the substantive issues is an utterly familiar ploy. I am happy to keep reminding you of this.

      • P.S. a number of the posters here know me in the Real World and know my qualifications and credentials, so your childish namecalling has simply served to make you look rather foolish.

        I hope you see the embarrassment that you have created for yourself by refusing to deal with the actual subject matter of the discussion.

      • 7. DECLARATION OF INTEREST

        7.1 NHS West Kent operates a policy not to fund routine homeopathy treatment.
        Dr James Thallon

        Medical Director, NHS West Kent

      • @Schemeit

        They did not make the statement I quoted becase they have a policy of not fnding homoeopathy. In fact, it is precisely the other way around: the reason that the West Kent PCT decided to cease funding of routine homoepathy treatment was the results of the research and consultation exercise that produced that information – as you would have discovered if you had bothered reading the rest of the document.

        Your attempt at an ad hominem argument is a miserable failure.

  21. This is what’s been worrying me for some time. With such obviously lax standards and controls, it’s not completely beyond the realm of plausibility that one of these companies could produce a batch using totally undiluted formula. I can’t imagine a squirt of pure belladonna would be very nice on your sugar pills. Also, one of the reasons I was wary about the 1023 protests.

    • Paranoid twaddle that shows that you have no idea of manufacturing. 1023 and those who took part got it right as there never was the remotest propect of any danger of Nelsons adding mother tincture to the pills and not diluting the Belladonna. Glass appearing on the assembly shows an inadequate production process on the manufacturing line. This does not mean that the 30 steps of 1 in 100 dilutions carried out away from the manufacturing line would be a risk. Maybe 1023 wouldnt trust a 3x or 4x Belladonna but they have every right to swallow a whole bottle of 30c without fear because of the huge dilution factor means that even the most incompetent process would still ensure a safe end dilution. Anyway if the pills were medicated with beladonna tincture wouldnt the pills appear stained brown?

      • Yeah. Thats why I said 3x or 4x because that product was made to these low potencies not to 30C which is 10^60 dilution not 10^3.

      • Also, I wonder what the response would be if a similar thing happened with conventional medicine.

        “Oh, well isn’t it a shame that there’s been a 10x accidental overdose in my tablet of drug X. But hey, i’m on the higher strength tablet so you can’t really complain”

        Doesn’t compute.

      • @ h-jo

        Similar happening with conventional medicine can be little difficult.

        Check for Vioxx from Merck.

      • Schemeit, you do understand that Vioxx actually worked for its intended purpose, don’t you? What we are talking about here is homeopathy that works for nothing because it does nothing, which is why no direct harm can result from properly prepared sugar pills. Any harm caused by improperly prepared sugar pills has no benefit against which it can be balanced.

        But, well done, you’ve added the “Tu Quoque” to the list of the fallacies you have used here. You really are giving us an excellent demonstration of defective thinking. Thank you.

        I also note you have given up on the branches of this discussion where you have been given questions that you seem not to be willing to answer.

        I wonder whether you will your attention back to the Argumentum ad Populum that you used previously and show that you have understand your error.

      • Schmeit, what i meant was a physical issue going wrong with a dosage form, e.g. them forgetting to dilute the mother tincture or similar. So you wouldn’t go:
        “Whoops! I appear to have had a ten times of overdose of drug X, but its to be expected as i’m on a 40mg tablet instead of 20mg that i would be more susceptible to such terrible manufacturing problems” This clearly wouldnt happen. If it says 40mg, you expect it to have 40mg in.

        So if a product is marked 4X, it should still be trustworthy as being 4X. But those guarantees aren’t in place.

  22. Emailed Nelsons PR got the following response:

    Dear Slipp,

    In response to your enquiry, please find Nelsons’ statement on this issue below:

    Nelsons acknowledges receipt of a warning letter sent by the US FDA. We will fully review the document and address every issue detailed within the letter in due course. Nelsons expects to satisfactorily follow up with the FDA within the period stated by the FDA.

    Many thanks for your enquiry.

    Kind regards,

    Nelsons PR

    • A stonewalling response.

      What did you actually ask them? It would be interesting to see what questions they have chosen not to answer by means of that reply.

      • I gave them right of reply to my blog post and as below:

        “I note from your news feed that no public statement appears to have been made regarding this letter.

        I wonder if you could confirm if Nelsons intend to issue a recall on these products, or whether there is any response that you would wish me to publish on my blog.”

        They have played it with the straightest of bats.

      • So, your reply to them is,

        “Dear Nelsons

        Thank you for reply. I shall report that you are not recalling any products.

        Thank you for your help.

        SD. “

  23. in a sort-of similar vein, i’ve been thinking a lot about Ainsworth, and how they obtain source material for some of their more…erm…inventive remedies. Where do they get their bhrain-frontal lobe for example. So i thought i’d ask them. Am eagerly awaiting a reply.

      • i’m sure that our dear friends over at Ainsworth’s wont mind me letting you all see the reply:

        “Thank you for your enquiry and may I say I am pleased to know you have an equal interest in the protection of my staff as do I.

        Any pathogentic materials required to be used in the manufacture of our homoeopathic remedies are processed in accordance with our GMP procedures, most especially our safety protocols and are inactivated before they arrive at our facility where they are prepared in mother tincture and run to potencies of infinitesimal dose. We are therefore handling validated inert material in these cases.”

        In other words: “We’re using inert water, then diluting it down with more inert water, then putting in onto some sugar. But at least we are doing it in a clean factory”

        Notice there is no info about the various body parts i asked them about, only the pathogens. I have emailled back requesting an answer to this part of my original question. I wish i had also asked them about how they make their dolphin sonar remedy.

      • I’m interested in what “deactivated” means. Autoclaved perhaps? From the perspective of homeopaths themselves, is that ok? Wouldn’t they think it disrupts the energy vibrations?

        I’m not sure from your post, but are you talking about human brain? They always manage to be a bit weirder than I expect. If human; the ethics would be interesting. I presume the donor consented, and you would only need one donor in the history of the universe, but I’d love to see a copy of the consent form.

      • It could have been from a homeopath, in which case it was probably a living donor and they are still carrying on in the business.

      • That’s just it, Ainsworth’s don’t make it clear. Their store lists stuff like “eye”, or “tumour”, and doesn’t clarify what they mean. That’s the answer that I really want from them. Human eye? Cow? Hamster? Snake? Fruit fly? Surely those are all different enough organs to warrant their own homeopathic preparations? Or do they all have the same fundamental essence of eye-ness?

        These are burning questions, I must know! 😉

      • Are the eyes/tumours from live animals/ humans? In which case I really dont think that would be particularly acceptable to people who want “natural” medicines. Or dead? And, as you say, what about the ethics, and where are they sourced from?

        I still haven’t gotten a reply about the body parts. Perhaps they have realised that I probably wans’t going to actually spend any money with them.

      • Of course, additional hilarity arises from claims that homeopathy is “natural”. It’s no more natural than chemical drugs. The only essential difference is that the one is bollocks and the other is not.

      • Indeed. And actually, Ainsworths sell a wide variety of products based on conventional medicines. In fact, a quick scan just at the As finds:

        Anastrazole (sic)
        Anabolic steriods (sic)
        Anthisan
        Aspirin
        Atenolol etc.

        And, weirdly: “Anaphylactic lung”

      • Ainsworth (et al) will scam their way out of any meaningful response with evasions and deceptions.

        I reported them to the Nuclear Inspectorate and the HSE with respect to their various actinoid based remedies. Presumably even the ultra-dilute pixy dust must have started out with a chunk of (say) plutonium. Most of the stuff should have been flushed down the sink – presumably resulting in giant mutant sewer rats.

        They span some cock and bull story and fobbed off our protectors (coughs politely).

        The full story and the actual letters are on DC’s Improbable Science blog.

        They probably spend a lot more on PR flunkies than they do on quality control.

        Which makes me wonder whether they have ISO9000/BS5750 or the equivalent accreditation for the production of pharmaceuticals (another polite cough).

        I feel another letter coming on.

      • So either:
        they subject their manufacturing staff to exposure to: pharmaceuticals, body parts, dinosaurs, deadly pathogens, and radiation.

        or:

        They don’t actually use any of these things, and just fraudulently sell sugar which isnt treated with any active ingredients at all, even in the mother tincture (which they’ve pretty much admitted by saying that they are handling “validated inert material”

        I’m in the process of trying to find out if they would need a home office license for handling Class A drugs also.

    • It does look like Schemeit has given up. They always do. The danger of learning by discussion does seem to be too great for them.

  24. So, you are unable to post anything and the comment to which I am replying is my own hallucination?

    I think not.

    You are able to get posts published if they at least try to stick to the topic.

    Given that you do seem to be able to get posts published, turn your attention, please, to the problem I posed you weeks ago. Show us that you understand why the popularity of homeopathy tells us nothing about the efficacy of its sugar pills. You may make reference to my comparison with the practice of human sacrifice as an attempt to influence astronomical processes or you may do it in your own way. In whatever way you choose to do it, just get it done or continue to be regarded as either a tedious troll posting nonsense deliberately just to provoke a reaction or as an idiot incapable of following a simple logical argument.

    It’s up to you.

  25. Who decides what is the correct line of reasoning?

    You have been writing a lot of nonsense. But because you toe the blog line of thought, anything written is accepted.

    Anything contrary is to be moderated. The problem is if you do not understand the contrary view, what is the reason to write a blog and expect comments? write mails to each other- a mutual admiration club.

  26. The problem is if you do not understand the contrary view,..

    Replace with: The problem is if you do not expect to receive a contrary view,..

  27. Who decides what is the correct line of reasoning?

    In a rational debate one would expect it to emerge by mutual consent. So far, you have contributed nothing but logical fallacies and complaints about the basis of discussion.

    I have repeatedly asked you to explore your own use of the logical fallacy of [i]argumentum ad populum[/i] and here you are, yet again, trollishly whingeing about the meta-discussion instead of dealing with the substantive issues.

    Schemeit, I have been playing with homeopaths for 10 years now and have seen the same tricks pulled many times. How about you make the decision to engage with the issues?

    I’m quite happy to make my next reply to you comprise a single word beginning with a T and rhyming with mole if you post yet another attempt at diversion.

  28. The problem is if you do not understand the contrary view, what is the reason to write a blog and expect comments?

    Andy will to answer for himself, but I expect it’s a mixture of public service and they enjoyment of laughing at the ridiculous.

    • Badly Shaved Monkey

      ……enjoyment of laughing at the ridiculous.

      I agree. You provide sufficient enjoyment. Starting with your name.

      • Back again, and still you can’t answer these simple questions;

        1. How many of the patients really had influenza virus?
        2. Were the puppies saved by the drug aciclovir?
        3. Why did prescientific doctors believe in leeching, purging etc?
        4. What did Linus Pauling win his first Nobel Prize for?

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