If Nelsons goods are banned from being imported into the US…

August 10, 2012

…guess which US homeopathy advocate is still flogging one of their products on his website?


UK based manufacturer of homeopathic remedies Nelsons have been severely reprimanded by the US FDA for a slew of manufacturing cock-ups. [ Quackometer | FDA letter to Nelsons]

Cock-ups include:

  • “glass fragments present during the manufacture” and ” in the Clikpak Assembly”
  • “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.”
  • “The dosing process has not been validated appropriately. Specifically, your surrogate validation study, “Medication of un-medicated pillules with (b)(4),” visually demonstrates the variability of the amount of (b)(4) for the pillules in one vial. Your firm lacks control of the variation for the amount of the active ingredient in the pillules.”
  • “Your firm does not have an established written program to calibrate/qualify the Perkin Elmer Clarus gas chromatograph (GC) at suitable intervals.”
  • ” Your firm did not calibrate and qualify the Jasco high performance liquid chromatography (HPLC) instrumentation adequately, in that there is no periodic qualification or evaluation of the pump, oven, injector, or detector. The “Use and Calibration of HPLC” procedure does not include criteria to define adequate calibration of the instrument.”

Basically – they don’t manufacture their remedies in a controlled and consistent manner, and they cannot monitor this because it’s homeopathy, there’s nothing to monitor they don’t maintain the equipment for doing so in the correct and proper fashion.

If this was a real drug company, the implications could be disastrous. If one in six packs of antibiotics was duff, you can bet that we’d hear about that and there would be huge fines levied all round.

One wonders if users of the duff batches of remedies noticed the lack of “powerful gentle natural effective” homeopathic active ingredient, and promptly complained to Nelsons about this?

This failure to adhere to best practice has landed Nelsons on the FDA red list [Link – scroll down to United Kingdom] – “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs” – it seems (from my reading of this notice) that Nelsons cannot export their goods to the US, and if US customers officials discover people bringing Nelsons products into the US they are to confiscate the goods. This will clearly have a negative impact on their US exports, and Nelsons are clearly rather proud of their export success [Link].

NB. Nelsons also make the Prince Charles’ Duchy Orignal line of herbal remedies [Link – Warning – Daily Mail].

So, can Nelsons products be sold in the US?

I don’t know about the legal ramification about being on the red list, but I cannot find mention of a US based manufacturing facility. Indeed, the Nelsons website states that

Our range of products meet the appropriate UK and global regulatory and licensing requirements, and are made in our Wimbledon manufacturing facility which operates to Good Manufacturing Practice (GMP) and rigorous procedures. [Link]

Clearly the FDA might have something to say about the “Good Manufacturing Practice (GMP) and rigorous procedures”.

However, as Nelsons homeopathic products are manufactured in Wimbledon, UK, it follows that any Nelsons products sold in the US must have been imported. I don’t imagine that the FDA red notice acts retrospectively, but obviously, as we are repeatedly told that “homeopathy is exceedingly popular and therefore it must work” 🙂 – one imagines that US stocks of Nelsons goods will soon run dry. I invite you to keep your eye on this page [link – warning – may cause nausea and temporary blindness ;)] to see when then this occurs.

Obviously, such a high profile and conscientious homeopath will ensure that the information on his website will remain up-to-date and entirely responsible. Moreover, given the concerns about the quality of Nelsons goods, one wonders if said homeopath will stop supplying them, to avoid the stigma of being tainted by Nelsons new-earned reputation for poor quality goods.

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Slurps.

August 5, 2012

An unusual and relevant protein structure.


A recent paper [BBC coverage] regarding work conducted at the MRC centre for human reproductive health in Edinburgh has revealed a role suggested a role for the proteoglycan Decorin in prostate cancer. The paper describes observational work looking at the presence and production of 5 proteins (including Decorin), and their distribution within different cell layers in the developing rat prostate. Looking at differential expression of Decorin during prostate development is an entirely reasonable thing to, given Decorin’s previously hypothesised role in organogenesis (development of organs) and tissue differentiation [REF].

In the recent paper, Henke et al also show that levels of Decorin are often significantly reduced in prostate cancer, and this is suggestive that Decorin might be a tumour suppressor gene – i.e. remove Decorin, and you may remove a barrier that prevents normal cells from becoming cancerous. Potential mechanisms are discussed in the paper, and it seems entirely plausible that decorin might function in this way – its role in organogenesis requires that it regulate cell division in some way – failure of this regulation of this might result in unchecked cell division – i.e. cancer.

Anyway, this all served to remind me of the small leucine rich repeat proteoglycans, or SLRPs – pronounced, ‘slurps’.

Decorin was the first SLRP (of the 17 known in the human genome) to have its structure determined [ PDBe | Pubmed ], by Jordi Bella and Paul Bishop, working at the University of Manchester (disclosure: I work there now).

SLRPs are pretty unusual looking structures – officially their fold is called a “beta-alpha-right-handed-superhelix”, and it looks a little something like this:

Each leucine rich repeat forms a single helical turn of the “beta-alpha-right handed superhelix” – the hydrophobic (water-hating) leucine residues form a continuous beta sheet (the rainbow coloured arrows in the figure below) which makes up the concave face of the protein. The convex face of the protein is made up of hydrophilic (water loving) loops.

The fact that this large concave hydrophobic face exists and is exposed to solvent is energetically unfavourable – however, in both the crystal structure, and in solution, Decorin exists as a dimer (2 Decorin molecules non-covalently bound to each other), and formation of this dimer hides this hydrophobic concave face from the solvent, making it thermodynamically more favourable.

Hopefully it is clear in the above figure that the concave faces of the protein are packed against each other, preventing them from having to interact with solvent.

It’s a neat example of how the primary (amino acid sequence – in this case rich in hydrophobic leucine residues), secondary (beta-strands) and tertiary (beta-sheet) structure of a protein influences its quaternary structure – in this case its oligomeric state.