Boots Unconcerned About Nelsons Production Problems.

So, to recap: Nelsons, manufacturers of Bach Flower Remedies and various homeopathic products, had their London factory inspected by the the American regulators as they export to the US. The report was damning. They found no control over broken glass entering their medical products, poor production processes resulting in 1 in 6 products failing to receive the homeopathic ingredient, poor labelling and lack of quality control on the products.

The US authorities have placed Nelsons products on their ‘red list’which means they will be seized if imported.

The major outlets for their products in the UK are Boots and Holland and Barrett. Boots sells their homeopathic baby teething product and other sugar pills. I wrote to them alerting them about the FDA concerns.

A week later, I get a response from Boots:

Thank you for your recent email regarding Nelsons.

I can confirm that the audit undertaken was on a targeted area of their business.  I can assure you that this does not affect any of their products supplied to the UK market.

Nelsons are currently engaged in addressing the concerns raised by and are providing all the information the FDA have requested in respect of their products sold in the US.

Pam Summers
Senior Customer Manager
Boots Customer Care.

That is quite a stunning statement. How could Boots know that the lax production standards applied only to shipments to the US? The products are made in Wimbledon. Do Nelsons have ‘lax Fridays’ where they all bunk off to the pub while the US export runs are made?

This response lacks any credibility.

I wrote to Boots when I received this to ask how they can be confident that these problems do not affect the UK. I have received no response.

Of course, we know Boots have a rather cynical attitude to the homeopathic products they sell. When giving evidence to parliament, Paul Bennett, professional standards director and superintendent pharmacist at Boots, admitted they have no evidence these products work, but sold them because they could.

One then might understand they were unconcerned about the homeopathic pills not being manufactured correctly – it does not matter one jot if the sugar pill receives a drop of magic ju-ju juice – it’s just water. But why would Boots be unconcerned that their products lack the quality control procedures to prevent glass entering products? To remind you, Boots sell homeopathic babies teething powders – a completely useless product, but may make the baby forget its teething pain if it crunches down on shards of glass.

So, to be fair to Boots. At least they saw fit to dream up this response. Holland and Barrett, owned by giant US vitamin pharma company, NYBT, have not thought it important to reply at all. Whereas Boots do have their uses, toothpaste and tampons, Holland and Barrett have built a business of the wishful thinking of vitamin pills and food supplements. They do recall products, but in the case of this recall, only when the MHRA have told them to.

Which leaves us with the obvious question in all of this? Just where is the MHRA? Asleep?

UPDATE 29th August

Boots have now responded to me again,

Thank you for your further email.

I’d like to reassure you that we take your comments very seriously and had already started discussions on this issue. It’s important that we investigate this thoroughly with Nelsons, and are in the process of doing so.  Rest assured, we’ll take any action necessary regarding this, and customer safety remains our upmost priority.

So, previously, these problems did not affect the UK. Now, Boots say they are investigating this with Nelsons.

I suspect we will hear no more, unless, that is, the MHRA do indeed decide they need to intervene.

 

40 comments for “Boots Unconcerned About Nelsons Production Problems.

  1. Mark
    August 17, 2012 at 12:25 am

    Have you contacted Superdrug? they sell Nelsons teething granules and Bach Rescue products in all their stores too.

  2. August 17, 2012 at 2:22 am

    Re: “poor production processes resulting in 1 in 6 products failing to receive the homeopathic ingredient”

    aka: our magic beans and unicorn tears meter did not sense your woo.

    -r.c.

  3. Slipp_Digby
    August 17, 2012 at 8:13 am

    Lets remember the reason for the July letter from the FDA was because after the initial letter in Dec 11, Nelsons had still failed to provide the FDA a risk assessment with regards to the risk of glass fragments in products already exported and distributed.

    It seems surprising that Boots can make such a categoric assurance their propduct was not effected when it seems Nelsons have not yet responded to the FDA with the required information.

  4. August 17, 2012 at 8:31 am

    Kiss me, Hardy! Nelson’s is going down with the ship!

  5. NoaNoaNoa
    August 17, 2012 at 10:32 am

    Hardly a surprise – 2 years ago I wrote to them asking why is it that they sell Homoeopathic Arnica, when there’s no evidence of it’s efficacy … they replied :

    Thank you for taking the time to contact us about the sale of Homeopathic products in our stores.

    At Boots we take our responsibilities as the leading Pharmacy-led Health & Beauty retailer in the UK very seriously and as part of this we pride ourselves on being able to offer all of our customers a choice of products that support them in their day-to-day lives. We know that many people believe in the benefits of complementary medicines and we aim to offer the products we know our customers want.

    We can confirm that Boots Arnica is a licensed homeopathic product without approved therapeutic indications. The pack is labelled in accordance with the requirements placed upon the marketing authorisation holder, Nelsons, by the Medicines and Healthcare Products Regulatory Agency. If you would like to contact the marketing authorisation holder to discuss the formulation of this product and the manufacturing process in more detail they are contactable at enquiries@nelsons.net

    Our Pharmacists are trained healthcare professionals and are on hand to offer advice on the safe use of complementary medicines. The Royal Pharmaceutical Society of Great Britain issues guidance to pharmacists on the correct selling of homoeopathy, which our pharmacists adhere to.

    I would like to conclude by confirming that Boots support the call for scientific research and evidence gathering on the efficacy of homoeopathic medicines as this would help our patients and customers make better informed choices about using homoeopathic medicines.

    Pam Summers
    Senior Customer Manager
    Boots Customer Care

    • August 17, 2012 at 1:15 pm

      From the Boots reply sent to NoaNoaNoa:

      Quote
      “Our Pharmacists are trained healthcare professionals and are on hand to offer advice on the safe use of complementary medicines. The Royal Pharmaceutical Society of Great Britain issues guidance to pharmacists on the correct selling of homoeopathy, which our pharmacists adhere to.”

      Let’s hope that’s true nowadays in view of Prof. David Colquhoun’s investigations back in 2006:

      Quote
      “I have been into several Boots stores, sought out the most senior pharmacist that I can find, and asked them the following question. “I have a 5 year old son who has had diarrhoea for three days now. Please can you recommend a natural remedy”. The response was interesting. In every case but one, the pharmacist reached for a copy of the Boots pamphlet on homeopathy, and thumbed through it, while desperately, but unsuccessfuly, trying to retain an air of professional authority. Then one or another homeopathic treatment from the booklet was recommended. In only one case out of six did the pharmacist even mention the right answer (GP and rehydration). One pharmacist, who turned out to have qualified in Germany, was very insistent that homeopathic treatment was inappropriate and that I should should start rehydration and take the child to the GP. The other five, including one who had an impressive-looking badge saying “consultant pharmacist”, did not even mention rehydration.

      Conclusion: The education of the pharmacists was clearly insufficient for them to give reliable advice. On the contrary, their advice was downright dangerous.”

      More…
      http://www.dcscience.net/?p=191

  6. h-jo
    August 17, 2012 at 2:28 pm

    As a pharmacist myself, I can honestly say we get very little training on homeopathy. And why on earth would we, considering it is entirely inactive and, lets be honest, NOT A MEDICINE.

    Our training does include a lot about Evidence Based Medicine and critical appraisal though. Hence, I am excruciatingly embarrassed that pharmacists are willing to sell such hokum unquestioningly.

    • Grumpycat
      August 17, 2012 at 3:02 pm

      I think that lots of people would like to see these homeopathic products catergorised as a special non medicine though for various reasons. That would maybe? keep Mr Duck and Co happy. It would also stop some of the testing, validation and label requirements whereby homeopathic manufacturers are playing a pretend game as though they are manufacturing a cytotoxic drug. Manufacturers would still have to be inspected and prove to a regulatory body that they run a rigorous manufacturing process. However people on here can shout as much as they like. The simplified scheme and National Rules scheme are law and I cant unfortunately see anything being changed unless the UK leaves the EU. Meanwhile I suggest a punchbag for all as therapy.

      • h-jo
        August 17, 2012 at 5:25 pm

        What I would like to see is some logic. And some evidence. If neither of those materialise, I would like homeopathy to go away and stop taking advantage of vulnerable people.

        • allan K
          August 18, 2012 at 2:50 pm

          people who choose homeopathy aren ot vulnerable, they make a choice that you disagree with, but it is their choice.

          • Grumpycat
            August 18, 2012 at 3:04 pm

            All people who buy homeopathic products are not vunerable. Call them what you like but if these people dont want to listen to ‘logic’and science then start your own blog, chill out or buy a punchbag. Those who think that people buying homeopathic products are all vunerable need to look at themselves as to why they should be so concerned with the free choice of others.
            Boots should not nanny their customers when a powerful and transparent organisation like the MHRA is their to monitor things.

          • Matt
            August 19, 2012 at 10:54 pm

            Grumpycat

            Free choice is important, but ensuring access to free choice is complicated.

            Most people proceed, quite reasonably, on the assumption that regulators ensure products and services can’t be sold unless they live up to the claims they make. This is not actually true of CAM. So people who trust CAM on this basis are proceeding on a false premise. Their choice isn’t really free, it is manipulated.

          • h-jo
            August 20, 2012 at 11:16 am

            Not ALL people who choose homeopathy are vulnerable, no. If you would like to point out where in this comment the word “ALL” appears that would be great.

            However, would you be suggesting that malnourished Indian children are not vulnerable? What about patients with incurable cancers, desperate for any sort of “miracle”?

            and frankly, most people who do buy homeopathy do so with little knowledge of the principles or evidence base. Is this actually, truly an informed choice?

            I appreciate that the holistic approach of a homeopathic specialist may be comforting to some. However, picking up something from the shelves in Boots, with no knowledge of what homeopathy is about doesn’t seem to be a particularly convincing “choice”.

      • Grumpycat
        August 20, 2012 at 2:28 pm

        h-jo- I would like to challenge your statement that ‘most people who do buy homeopathy do so with little knowledge of the principles or evidence base’. I think the media in recent years have made the dilutions very clear for most people. In case anyone doesnt read papers or watch TV or tweet then these people would get friends/family/work collegues enquiring/challenging them about the dilutions from time to time about homeopathy. There can be very few people who dont know about the dilutions of homeopathy. Yet despite this 1.7-10% in the UK(depending whether you believe malleus or Kent Woods) carry on using it.You may just have to accept that there are a lot of people out there who just dont agree with you. Some may wonder why you care so much about their choices. Why not write to the Indian embassy and advise them about the use of homeopathy in India for dehydration- see what letter you get back? In the UK the MHRA are bound by EU treaty and they have no choice but to treat homeopathic remedies as medicines. Boots as a commercial company go with the flow just like their competitors do. If Boots stop homeopathy then their compeitors will benefit. If all pharmacies stop then health shops will benefit greatly. Is that what you want?

        • h-jo (@sparklewildfire)
          August 20, 2012 at 4:36 pm

          I want Evidence Based Medicine, thank you very much.

          I want no misleading claims about efficacy which cannot be backed uo by evidence.

          I would particularly love no harm to be done by peddlars of woo.

          It would be an interesting study to do, to assess the levels of knowledge of those purchasing homeopathic products, along with those selling it, and in particluar whether that changes based on where you get it from.

          So far, I have only my anecdotal knowledge garnered through 6 years of working as a pharmacist about people’s level of knowledge. Obviously, this would need to be backed up by evidence, but i would say the majority of my customers considered homeopathy as a herbal medicine, and the obligatory “safe ergo natural” attitude.

          As a pharmacist, I felt obliged to advise them on the evidence base of the products they were buying (I would also do this for conventional products with a shaky evidence base- cough remedies for example). Many were horrified, many looked blank, and yes, some did go ahead and buy it. The pharmacy I worked in sold one homeopathic remedy for hayfever. I would often see them again in a week or so for antihistamines.

          Obviously, all anecdotal, and merely an observation.

          • Grumpcat
            August 20, 2012 at 9:09 pm

            I gotta laugh at your observation about people coming in for antihistamines after trying the homeopathic hayfever remedy. I have seen this also so of course I believe you. Any homeopath though will tell you that they also have observations that lots of people go to homeopathy because the antihistamines dont work for them and the homeopathy does! It seems that observations may = anecdotes.

          • h-jo (@sparklewildfire)
            August 21, 2012 at 9:34 am

            Sorry, I now genuinely have no idea what your point is. Yes, I clearly stated that this is anecdotal, and merely an observation.

    • Kate Corwyn
      October 3, 2012 at 12:36 pm

      That suggests two things to me. First, that because pharmacist’s training makes no mention of homeopathy, pharmacists may genuinely not know what it is and cannot therefore reject it as being hokum. Second, that Boots may actively push their pharmacists to recommend homeopathic preparations.

  7. August 19, 2012 at 2:27 am

    Dear Quackometer
    Your blog, and a minority of other Champions of Reason in the U.K. are flickering torches i a storm, a hurricane, a perpetual monsoon of gullibility, superstition and general stupidity, nurtured, fed and exploited by unscrupulous conmen, and their mignons, riding the bandwagon. What is more profitable on a large scale, even globally: hard work, farming, industry, education, research and science, to the benefit of the many, or scam, fraud, be it Internet fraud, robbery, or large scale selling the “real remedy for everything, without any sideeffects (who said snake oil?), whith the corny and ignorant academics and “school medics” begrudge the needing masses. And naturally, companies like Boots and others are willing to promote and sell as much rubbish, useless potions, remedies and a large amount of cosmetics, plastic rubbish and other useless things. But pardon me, dear Sir, they are mainly not to blame, there ought to be a Serious Pharmacy Regulation Act, inspected and with upheld high standards by really independent, impartial and hyper active authorities. I believe there are mostly decent pharmacies in the Nordic countries and Spain, with generally good professional standard in employees, well educated, but even there are the “diversification” of stock by commercial reasons a strong incentive. I have no idea why “western society” (US and EU) and our national governmets have generally failed, no, discarded the ideal from late 19-th and early 20-th century that the gross majority ov the people, “the working classes” should reach the educational and intellectual, economic nivels of the “commn Bourgeoisy way of life and thinking.

    In Järna Sweden; a smaller community where

    • Bad toro
      August 19, 2012 at 4:56 pm

      you will never have sex

  8. John H
    August 20, 2012 at 7:00 pm

    I think it is appalling that the gullible are fed mignons by unscrupulous comment!

  9. John H
    August 20, 2012 at 7:07 pm

    I am not sure why I am so appalled. I just filet in my bones.

    Perhaps people choose pixy dust remedies (word used loosely) because they feel the need to have a steakholding in their treatments.

  10. John H
    August 20, 2012 at 7:09 pm

    And thank you Crapple Inc for recklessly converting conmen to comment.

  11. Lancelot
    August 22, 2012 at 10:08 pm

    “There are periods of history when the visions of madmen and dope fiends are a better guide to reality than the common-sense interpretation of data available to the so-called normal mind. This is one such period, if you haven’t noticed already.”
    ― Robert Anton Wilson

    http://en.wikipedia.org/wiki/Iatrogenesis

    • Mojo
      August 22, 2012 at 10:46 pm

      20 points, I think.

      • Alan Henness
        August 23, 2012 at 12:05 am

        At least.

  12. August 23, 2012 at 3:24 pm

    One quick clarification: Although the report does mention broken glass on the production line, which is a very serious problem, it does not say that they glass has been found in actual retail products.

    This is not to condone Nelson’s in any way, but we should be careful to get our facts straight.

  13. Adzcliff
    August 25, 2012 at 10:32 pm

    Just on this comment about Holland & Barrett’s ownership:

    “Holland and Barrett, owned by giant US vitamin pharma company, NYBT…”

    According to Wikipedia “…the Carlyle Group, the US private equity group, agreed to buy NBTY in July 2010 for $55 a share, estimated to be about $3.4bn to $3.8bn. The Carlyle Group owns Alliance Boots, which includes Boots The Chemists in the UK and Alliance Pharmacies in the UK.”

    All one big happy family it seems…

    • Alan Henness
      August 26, 2012 at 12:14 am

      Now that is interesting…

      • Adzcliff
        August 26, 2012 at 12:04 pm

        A handy fact, I find, when CAM apologists see Big Pharma’s hand in anything critical of their preferred therapies. Not of course that the Carlyle Group in necessarily synonymous with ‘Big Pharma’, but it’s quite an inconvenient truth when CAM retail giant Holland & Barret have the same owners as pharmaceutical retail giants Boots the Chemists and Alliance Pharmacies, and sort of removes any anti-capitalist argument…

  14. John H
    August 26, 2012 at 12:00 pm

    Andy

    Have you moderated some of the comments in this thread? I assume they got somewhat fractious.

    My comments above seem to have become orphaned. They were replies to various postings and appear to have been cast adrift in terms of their meaning. I went away for a few days and lost the thread.

    The reference to steak was a response to someone confusing minions with mignons and the Joda/Gollum comment was in response to a posting with remarkably fractured English and a proliferation of superfluousssss S’s.

    I now seem to have become a new form of Internet pest – the Random Stream Of Consciousness Troll. Such is fame in the modern world.

  15. John H
    August 21, 2012 at 8:10 pm

    Are you the offspring of Joda and Gollum?

  16. Erwin Alber
    August 27, 2012 at 7:34 am

    Unfortunately vaccine production is far more vile than this could ever be, and vaccines have a world-wide detrimental effect which leaves this homeopathic storm in a tea cup for dead.

  17. Badly Shaved Monkey
    August 27, 2012 at 8:31 am

    [citation needed]

  18. Alan K
    August 27, 2012 at 9:27 pm

    A positive association found between autism prevalence and childhood vaccination uptake across the U.S. population.
    Delong G.
    Source

    Department of Economics and Finance, Baruch College/City University of New York, New York, New York, USA. gayle.delong@baruch.cuny.edu
    Abstract

    The reason for the rapid rise of autism in the United States that began in the 1990s is a mystery. Although individuals probably have a genetic predisposition to develop autism, researchers suspect that one or more environmental triggers are also needed. One of those triggers might be the battery of vaccinations that young children receive. Using regression analysis and controlling for family income and ethnicity, the relationship between the proportion of children who received the recommended vaccines by age 2 years and the prevalence of autism (AUT) or speech or language impairment (SLI) in each U.S. state from 2001 and 2007 was determined. A positive and statistically significant relationship was found: The higher the proportion of children receiving recommended vaccinations, the higher was the prevalence of AUT or SLI. A 1% increase in vaccination was associated with an additional 680 children having AUT or SLI. Neither parental behavior nor access to care affected the results, since vaccination proportions were not significantly related (statistically) to any other disability or to the number of pediatricians in a U.S. state. The results suggest that although mercury has been removed from many vaccines, other culprits may link vaccines to autism. Further study into the relationship between vaccines and autism is warranted.

  19. Badly Shaved Monkey
    August 27, 2012 at 10:11 pm

    Alan K

    I’m sorry to say but you may look a bit of an idiot for posting that abstract in the wrong thread.

    But, I’m also sorry to say you look a bit of an idiot for posting it anywhere.

    Read Orac’s analysis of it here;

    http://scienceblogs.com/insolence/2011/06/08/more-bad-science-in-the-service-of-the-discredited-idea/

    and ask yourself why you found it necessary to waste a litte part of your life pimping that piece of faecal nonsense.

  20. Muscleguy
    August 28, 2012 at 6:54 pm

    Alan K

    “Department of Economics and Finance”

    Does that not raise a red flag with you? It does with me and it probably did with Orac. Not that this fact alone takes apart the paper, but indications like that should ring alarm bells and cause you to examine the methods and conclusions of the paper extra carefully.

    These things are all part of learning to read the literature critically and the credibility and track record of the authors is one of those things. Again it doesn’t stop the research being good, but it drops the probability down around 30C (in homeopathy terms).

  21. h-jo (@sparklewildfire)
    August 30, 2012 at 12:41 pm

    I wish there was a like button on these posts.

    In absence of one: @muscleguy LIKE!

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