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August 14, 2019

‘Scientific Implausibility’ – Is the Monarchy Meddling in Manufacturing?

Homeopathic Medicine

United Kingdom flag waving in the blue sky

Students of British history will no doubt recall the highs and lows of the Royal Family, that patrilineal dynasty that has ruled the island and the later ‘Empire’ seemingly forever. The institution of the Monarchy has long been the subject of debate and discussion with royalists clashing…well, royally…with abolitionists, who increasingly view the House of Windsor as an outdated fiscal burden within a 21st century egalitarian society. Although the fresh world view of the new generation of young royals is arguably raising public esteem, individuals within the family have often found themselves the source of concern if not, at times, outright ridicule. Take, for instance, King George III…

Not only is this unfortunate monarch remembered as the sovereign who lost ‘the Colonies’ but also as the one who, as rumor has it, was observed shaking hands with a tree which he believed to be the King of Prussia. George was long believed to have suffered from porphyria, a hereditary blood disorder that manifests with symptoms of confusion, red/purple urine, and seeming insanity, and his reign was eventually cut short by the passing of the Regency Act of 1811, establishing his son, George IV Prince of Wales, as Prince Regent. ‘Prinnie,’ as he was known to his close friends, became somewhat infamous as ‘both ‘The First Gentleman of Europe’ and an object of contempt and ridicule […] known for his drunkenness, spendthrift ways and scandalous love life.’(1)

Fast forward almost 200 years and once again the Prince of Wales and heir to the throne is in the news.

In an article published in The Guardian, staff writer Haroon Siddique chronicles the controversy around Prince Charles espousing an anti-science and ‘scientifically implausible’ position when it comes to medicine.(2) Recently becoming a patron of the Faculty of Homeopathy, an organization that promotes the use of what some see as a complementary therapy and others as ‘quackery,’ Prince Charles has incurred the wrath of the British government’s chief medical officer, Dame Sally Davis, who described the treatment as ‘rubbish.’(3)

But given the modern approach to manufacturing these ‘remedies,’ could this characterization be unjustified? After all, the days of grinding a plant root in a mortar and pestle, mixing with water and calling it a cure are long gone, with contemporary homeopathic manufacturers employing the latest in technology – purpose-built facilities incorporating cleanrooms with laminar airflow hoods, HEPA filtration, and positive pressure – to create products that are both high quality and contamination-free. So why the derision and outcry over this latest royal ‘peculiarity’? Let’s take a closer look at the Prince’s passion…

Homeopathy is an alternative practice founded on the concept that ‘like cures like.’ In other words, a substance that can cause an illness can also, in small doses, trigger the body’s own defenses to cure it. But it’s all in the ratios. Contrary to the conventional pharmacological paradigm, central to homeopathic remedies is the use of small doses in which the potency is diluted in a ‘series of successive deconcentrations of a mother tincture [which…] is called dynamization or potentiation.’(4)

A ‘mother’ what? Think of it like bread-making: in sourdough loaves, instead of using active commercial yeast, a portion of a starter – known as a ‘mother’ – is added. This concentrated mix of flour, water, and wild (environmental) yeasts is the basis for the finished bread. And so it is with preparing homeopathic tinctures: a concentrated base tincture (a ‘mother’) is created by dissolving soluble essences of plants, animals, or minerals in alcohol, purified water, and/or glycerine at the ratio of 1 part tincture to 99 parts carrier. The ‘attenuation’ (potency) of the ‘succussed’ (shaken) mix is described as 1C, with each successive dilution yielding a more dilute, but therefore more potent, solution. The tincture diluent is readily absorbed when applied to an inert substance such as a sugar pill and left to evaporate. According to guidelines by the Homeopathic Pharmacopoeia of the United States (HPUS), carriers must meet purity standards as specified in the United States Pharmacopoeia (USP), as should the finished product. Such testing includes analysis of potential spoilage through improper storage, stability of the product, and the antimicrobial effectiveness of preservatives added for shelf stabilization.

And for commercial preparations, all of the production processes and quality assurance testing should be performed in a cleanroom with HEPA filtration.

So what does this look like? An example is Hahnemann Laboratories, a producer of homeopathic remedies based in San Rafael, CA. Producing more than 52,000 remedies, Hahnemann is an FDA-licensed laboratory with custom-built facilities constructed to minimize or eliminate particulate matter and gas residues. All steps in the manufacturing and packaging processes are isolated from each other to prevent cross-contamination and the air quality of working areas is controlled by HEPA filtration which vents to the exterior of the building rather than recirculating the air. In creating the finished product, the application of the attenuated liquid to the sugar pellets is conducted in a sterile environment, with the individual pills placed on specialized filters in a drying chamber. Using a laminar airflow hood, air moves unidirectionally across the drying pellets before also being exhausted externally. And, of course, within the packaging area, the potential for airborne contaminants is minimized by the application of increased air pressure.

To all intents and purposes, this kind of facility is the standard we would hope to see for all manufacturers of medicinal products, whether pharmacological or ‘alternative.’ But, for Hahnemann Laboratories, it doesn’t end there. All employees must commit to maintaining an odor-free environment, meaning no scented deodorant or perfumes, and the potential impact of electromagnetic fields is kept at a minimum via a ban on cellphones (https://cleanroom-news.com/2016/12/should-cellphones-be-allowed-in-cleanrooms/) in the cleanroom environment. The finished product offers a patient an incredibly dilute amount of a substance, which is considered to be the most potent. In homeopathy, this correlation of dilution and potency is termed the ‘Law of Infinitesimals’ and governs which concentration of a product should be prescribed for any given severity of a condition. For home use, common potencies are expressed in three strengths – 6c, 12c, and 30c – with the latter being the strongest concentration and therefore the weakest remedy. Counterintuitive? Yes, and this, in part, is what has medical professionals outside of the field skeptical as to the efficacy of the remedy.

Despite regulation by the European Pharmacopoeia and specific national Pharmacopoeias such as the Pharmacopee Francaise (Ph. Fr.) in France and the German Homeopathic Pharmacopoeia (HAB) which give relevant authorities ‘a legal instrument by which too review the quality [of products]’, some doctors and food/drug safety officials are also concerned at the potential for contamination by undeclared allergens in some remedies.(5) Several years ago, for instance, the US Food and Drug Administration (FDA) issued a recall of Pleo Homeopathic drug products distributed by Sanum USA Corp. Affected items had the ‘potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.’(6) For those with an allergy to beta-lactam antibiotics, exposure to penicillin can result in anaphylaxis and death.

Equally, the FDA has had cause to question the rigor in manufacturing oversight when it examined some teething products for infants. When both Hyland’s Inc and CVS marketed products were found to contain differing levels of belladonna alkaloids a nationwide recall of the products was initiated. Baby Teething Tablets and Baby Nighttime Teething Tablets, produced by the Los Angeles based manufacturer Standard Homeopathic Company, were found to contain non-uniform amounts of atropine, scopolamine, and also caffeine. Moreover ‘FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s tablets far exceeded the amount stated on the products’ labels.’(7) For the FDA, the bottom line was that ‘homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children’ and strongly suggested that parents not use them.(8)

Most recently, the FDA issued a news release in which it lambasted a handful of homeopathic drug companies for violations of current Good Manufacturing Practices (cGMPs) which potentially placed consumers at risk.

In a letter to King Bio Inc, a homeopathic remedy producer based in North Carolina, the FDA highlighted ‘a number of ongoing, serious violations with [the] manufacturing operations that must be corrected.’(9) The letter was issued following an inspection of the King Bio facilities in which the agency collected samples of finished products, which were found to contain ‘inordinately high’ levels of microbial contamination, probably originating in the plant’s water system. Furthermore, lapses in the quality assurance systems used by King Bio meant that more than 900 potentially contaminated products had to be recalled – products intended to treat infants, pregnant women, children, and patients with compromised immune systems, in addition to pets.

Microbial contamination, however, may pale in comparison with violations observed by the FDA  upon an inspection of B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, India. In a warning letter to the company the agency outlined a litany of violations, including observations of flying insects in the raw materials storage rooms, a live moth floating in some raw materials (which went on to become part of the batch), mold covered packaging, and unidentified particulates in and around air filtration vents. In addition, the structure of the facilities was called into question when FDA observers noted an exposed holding tank on the roof and pipework that had clearly been temporarily patched to repair leaks.

And perhaps equally important was the company’s misbranding of its products. As we are already aware from previous articles, not all products intended for the healthcare market are necessarily overseen by the FDA. Vitamins, supplements, and functional foods, for instance, are not currently regulated in the same way as pharmacological products but, under section 201(g)(1) of the Food, Drug & Cosmetics Act (FD&C Act), 21 U.S.C. 321(g)(1), some homeopathic preparations are subject to this regulation because they are ‘intended to diagnose, cure, mitigate, treat, or prevent disease and/or intended to affect the structure or any function of the body.’ (10) In the case of B. Jain Pharmaceuticals Pvt. Ltd, the products listed in the warning letter – The Relief Products Ring Relief (Ear Drops and Fast Dissolving Tablets) – were classed as drugs ‘in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use’ and as such were ‘not safe for use except under the supervision of a practitioner licensed by law to administer.’(11) Therefore, where a medical professional is required to supervise their administration, they are also required to prescribe the drug. And this is another area in which B. Jain Pharmaceuticals was out of compliance: failing to incorporate the ‘Rx’ symbol, the products were misbranded and violated section 301(a) of the FD&C Act, 21 U.S.C. § 331(a) in being made available for interstate commerce within the US.

B. Jain Pharmaceuticals was given 15 working days to rectify the problems and to report back to the FDA with details of the remedial actions taken or risk its products being refused admission to the US market. We shall follow this story to find out further developments. But in the meantime, it is clear that even when a product is marketed as health-promoting and closely allied with natural processes, the potential for contamination and the concomitant threat to public health exists. As with so many other products of mass production – from pharmaceuticals to foods – a corporate focus on cost-cutting, fast turnaround, off-shoring, and maximal profit can lead to an inferior product which might place patients in jeopardy. And, as the most time-honored rule of medicine is ‘First do no harm’ this would seem to be incompatible with the values of the medical profession – whether traditional or complementary.

Have you ever turned to homeopathy as a remedy for a malaise? Are you a devotee of alternative medicine or an adherent to the traditional paradigm? We’d love to know your thoughts.

References:

  1. https://www.historic-uk.com/HistoryUK/HistoryofBritain/George-IV/
  2. https://www.theguardian.com/uk-news/2019/jun/25/prince-charles-criticised-continuing-promote-homeopathy
  3. ibid
  4. https://www.boiron.ca/education/manufacturing-process/
  5. https://www.echamp.eu/our-sector/manufacturing/quality/pharmacopoeia
  6. https://wayback.archive-it.org/7993/20170406123829/https:/www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm390002.htm
  7. https://www.fda.gov/drugs/information-drug-class/fda-warns-consumers-about-homeopathic-teething-products
  8. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-standard-homeopathic-companys-nationwide-voluntary-recall-hylands-teething-tablets
  9. https://www.fda.gov/news-events/press-announcements/fda-warns-homeopathic-firms-putting-patients-risk-significant-violations-manufacturing-quality
  10. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/b-jain-pharmaceuticals-private-limited-567957-03212019
  11. ibid

 

 

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