Nelsons manufacture and export a range of Homeopathic remedies. Amongst them is Kali Phosphoricum 30C. Kali Phosphoricum is often promoted as a remedy for anxiety and stress. Co-incidentally anxiety and stress are just what I imagine Mr. Najib Fayad (Chief Operations Officer at A. Nelson & Co Ltd) felt when this letter landed in his in tray.
As the Quackometer and Anomalous Distraction have already pointed out its a good old fashioned bollocking from the U.S Food and Drug Administration (FDA) detailing a number of significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals. The concerns relate to issues identified during an inspection in November 2011.
The first and most serious issue identifed was that:
“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”
Now I don’t claim to know about the drug industry but if this was potential contamination of food with glass, the response to prevent the risk of harm would have been immediate. Nelsons responded in December 2011 and its fair to say it wasn’t well received by the FDA:
“We are concerned that you may have released product for distribution without fully investigating the root cause of the presence of glass fragments, implementing a corrective and preventive action plan, and evaluating impact on all products manufactured using this line. Please note that the lack of current customer complaints alone is neither a verification of a robust quality system nor that you have appropriate process controls in place to conclude that glass fragments may not be present in your products.”
Nelsons response was not only shutting the stable door after the proverbial horse had bolted, but doing so after it had bolted, found a new owner and gone on to live a long, healthy and fulfilling life elsewhere. Horses like sugar lumps too, but I digress…..
Now I’m not suggesting for a minute glass actually made its way into any bottles. I don’t know that for a fact. But there is a definate risk of contamination and as the consequences of this occuring could be severe, you would expect a proactive response. To date as far as I am aware, Nelsons haven’t made any public comment [edit: they have see update 15/8/12 below] or issued a recall notice despite being made aware of these issues and responding to the FDA on the 11th December 2011. If they intend to, this is a reaction time that makes a sloth look like the homeopaths new favourite icon Usain Bolt.
The other problems the FDA found are quite incredible:
“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.”
Say whaaaaatt?! Thats right, the production line was running too fast and they weren’t even putting the
magic ‘active ingredient’ in every bottle. Every sixth bottle had literally nothing but sugar pills in it (although for entirely different reasons to the others in the batch).
“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.”
Double and then triple ouch. Their own surrogate study shows a variable amount being administered to the pills.
Now the issue of whether they put the ‘active ingredient’ actually in the bottle and whether this is delivered to each pill evenly are of course moot points because at a dilution of 30C, there are no active ingredients left to actually deliver to the sugar pills. The properly manufactured sugar pills were no more a remedy that the faulty ones. An anxious person taking a badly manufactured pill of Kali Phos 30C would have received just the same inert ritualized placebo to treat their ‘condition’ and probably found it just as useful. I don’t expect any Homeopaths to step forward criticising Nelsons for the lack of effects of batch #36659 because they are used to
making stuff up interpreting the effects of remedies in different ways.
But the problems it raises for Nelsons are extremely tricky to deal with.
Firstly they have had their claims of rigorous quality control damaged. They have also been shown to have no appetite for being proactive in tackling the extent of the problem by failing to establishing just how many badly manufactured pills are likely to have been distributed. Some may interpret this carefree attitude to production and failure to follow up the manufacturing problems as evidence that Nelsons recognise that it is in fact the ritual, and not the constituents of the pill which is important to users. They haven’t had any complaints about efficacy nor are they likely to get any. Well, not unless someone finds some glass.
Secondly it shows that if you want to treat Homeopathic remedies as if they are real drugs and distribute them as such, well….maybe the regulators will expect you to produce them like real drugs. Weird eh? The requests that the FDA make are of course misguided, but I have little sympathy for Nelsons having to show that they are in fact putting nothing in the bottles in the prescribed manner, rather than nothing due to poor manufacturing.
I’ll leave the final word to the International Academy of Classical Homeopathy who note the following symptoms associated with Kali Phosphorous:
Anxiety, nervous dread….[…]….gloomy moods, fancies, looks on the dark side of everything, dark forebodings. Great despondency about business and pecuniary affairs. Indisposition to mix with people. Disinclined to converse.”
In the case of Nelsons, for once I’m inclined to agree.
As I couldn’t see anything on the Nelsons Media Centre except the important news that Clare Nasir was revealing her beach body secret I sent their PR department an email asking if they would be recalling any products or making any public statement about the FDA letter. Here is the response:
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.
As the FDA did not demand a recall then I can only conclude that Nelsons will not be undertaking one. With regards to these issues and a number of other CGMP and Misbranding violations, the FDA state that:
“Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.”
That gives them until around the middle of next week to answer some rather tricky questions.