Thursday, 25 October 2018

US Regulation of Homeopathy #4 - "Outliers" etc

It was clear from a previous post that there are homeopathic drugs that are considered of concern or are a source of content. Some individual products have been mentioned in discussion of FDA/FTC enforcement and class actions but it is worth having a slightly different discussion, partly because of the unethical practices of some businesses.

The issue of homeopathic hCG products was discussed in post on Manufacturing. But these products are not isolated. There are also other products based on homeopathic Human Growth Hormone, Insulin-like Growth Factor and even Testosterone which make extraordinary claims. Homeopathic drugs that purport to contain hormones or synthetic versions thereof. Testosterone may appear appear in the Homeopathic Pharmacopeia of the United States, but the others do not and thus can not be marketed as an OTC homeopathic drug. The FDA would treat such products as a "new drug". 

Something that seems to have appeared in the past few months is a product- a gel - that purports to contain Human Growth Hormone (HGH) that is using a Multi-Level Marketing model. Affiliates are turning up on social media selling the product and some are very aggressive in their marketing.

The American Association of Homeopathic Pharmacists (AAHP) issued a position statement back in 2014 which clearly spells out the illegality of these products. It is a felony under Sections 303 and 505 of the Food, Drug and Cosmetics Act to manufacture, distribute or sell these products. It is also a felony under the Controlled Substances Act which is the remit of the Drug Enforcement Agency.  In addition, the FDA have made rules that require topically products containing hormones to go through the New Drug Application process.

The FDA have acted against similar products in the past as this FDA warning letter to Libido Edge Labs shows (FDA don't always archive warning letters). Worse was yet to come as the products were subject to a recall by the manufacturer Apotheca Inc in 2011 due to bacterial contamination. Yes, Libido Edge Labs are still going but none of their products contain HGH or any other hormone now.

This product represents a triple deception. Firstly, the claims made for HGH itself in terms of rejuvenation are simply not backed up by evidence. Secondly - the principle of "like cures like" suggests that homeopathic HGH would be used to treat symptoms similar to those caused by an excess of HGH - very different from the claims made for Somaderm. Thirdly, that homeopathy has any effect that is not consistent with placebo, regression to the mean, etc.

This product does not represent the same risks of medical harm that homeopathic hCG does (no dangerous diet associated with it) but the MLM model poses a great risk of financial loss to consumers. This article on the scam is highly recommended. The numerous comments make for interesting reading. It is sad to read affiliates who persist in their belief in the product even when it is pointed out selling it is a felony (and once this is pointed out, ignorance of the law is no longer considered a mitigating factor in a court of law). The MLM aspect falls under FTC jurisdiction.

The product and the MLM scam have been reported to both the FDA and the FTC multiple times. Neither of them is known to have acted yet but it is likely they will. 

Products containing actual and "Inactive" ingredients. There are also products like Zicam (again discussed in the post on Manufacturing) that actually do contain active products and are "homeopathic" by virtue of a 1 in 10 dilution.The reasons for doing so are unclear. Possibly the manufacturers believe they can evade certain aspects of regulation. It's worth pointing out that even a 1 in 10 dilution of a herbal extract can result in far higher concentrations of active ingredients than, say, a capsule of dried herbs.

Valerin is good examples. It contain valerian root (1X), passiflora (1X) and magnesium carbonate (1X) - which are often ingredients in dietary supplements. 1X is a 1 in 10 dilution of an extract. Because of the way that the product is labelled, it is difficult to determine how much of each is in each tablet. The label says that it has a distinctive smell - which would be consistent with high concentrations of herbal extracts. But magnesium carbonate is insoluble and will react with acids. These may actually be made of dried herbs and the magnesium carbonate is used as a binder. It's not really homeopathic in the generally accepted sense of the word.

In the EU, the product would be permitted Traditional Herbal Registration. It would be allowed indications of a limited kind. But US regulation doesn't have such category. Products are either homeopathic drugs, drugs (medicines) or dietary supplements and the latter are only permitted very limited indications (although this widely ignored). This probably explains why Valerin is labelled as homeopathic when it very likely isn't.

Valerin makes various claims to be a pain reliever, to treat muscle spasms, relieve stress etc. Most worryingly -

An All-Natural Homeopathic Alternative to NSAIDs and Opioid Pain Relief Prescriptions
Valerian and passiflora may have mild sedative effects. They are not an alternative to prescription only analgesics - if Valerin works for you, you'd never have needed a prescription analgesic.

A further variation on this products that contain highly diluted homeopathic ingredients but also "inactive" ingredients which may have an actual effect. Curoxen is an example and one with very strange marketing claims. Here is the back of the packaging

It lists Olive Extract 2X and Calendula 3X as "Active Homeopathic Ingredients". It listed "oxgenated olive oil" and lavender oil as inactive ingredients yet the marketing focuses on the supposed antibacterial properties -
95% of CUROXEN’s formula is comprised of ultra-pure, certified organic olive oil. The olive oil undergoes an oxygenation process (yep, it’s infused with good old O2, necessary for cell repair) that creates a highly antimicrobial substrate that heals quickly and effectively.
Oxygenated olive oil is rancid olive oil. Probably not harmful. It's a permitted inactive ingredient - a "carrier" for active compounds but no claims can be made for it. No OTC monograph exists of olive oil based antiseptics. If the manufacturers wish to make such the kind of claims they do, they should really submit a New Drug Application. It is likely that the labelling of the product is merely an attempt to avoid this.

Combination Products
Many of the OTC homeopathic drugs available contain multiple ingredients. This may seem strange to anyone familiar with the tenets of homeopathy, especially classical homeopathy. They would appear to violate the Law of Simplex. However, combination remedies are not unusual in other variants of homeopathy such as homotoxicology - although it is questionable whether it is strictly speaking homeopathy but it would seem that the products do meet the legal definition of a homeopathic drug.

It is not clear whether homotoxicology has had a direct influence on US manufacturers. Certainly Dr Reckeweg has a North American importer but the products don't seem to carry indications and seem to be aimed at practitioners rather than the OTC market. It seems unlikely.

The initial complaint in Forcellati v.Hyland's does provide some useful information.
C. Background Of Hyland’s  
42. In 1903, Hyland’s was founded as a Los Angeles pharmacy when homeopathy was a standard medical practice in the United States. Countless conventional medicines, both prescription and OTC, were developed and began to dominate the pharmaceutical market in the middle of the 20th Century. In response, Hyland’s pharmacists began to develop “combination” homeopathic medicines, which they formulated by combining several single homeopathic remedies believed to be effective for a particular ailment into one tablet. 
43. In the 1970s, Hyland’s began marketing these combination homeopathic remedies in health food stores. By the late 1980s, Hyland’s used Hyland’s Teething Tablets to break into the chain drugstore market. Since 2000, the company has annually enjoyed double-digit growth, introduced many financially successful new products, put its medicines on the shelves of every major drug retailer and has engaged in aggressive marketing to take advantage of the increasing demand for medicines that are perceived as effective without carrying negative side effects.
Whether Hyland's were the first to do this is unknown. It is not known what proportion of the market combination products make up but likely to be considerable if Amazon is anything to go by. Single ingredient homeopathic drugs appear less common than in EU markets.

Some practitioners of classical homeopathy are dismissive of these products. In general, these practitioners select single remedies by comparing patient symptoms (which can be incredibly bizarre and specific) to a list of remedies and the symptoms they are purported to treat. They select the remedy that is the best match to those symptoms. What these combination remedies contain are remedies that have been selected on the basis notional, pretty non-specific symptoms. Some practitioners would say they are unlikely to work.

Another objection is that combination remedies, in theory, could regarded as a new remedy rather than a collection of remedies in one pill. They may behave very differently. It is also the case that homeopaths believe some remedies "antidote" others. But that assumes that homeopathic remedies have any efficacy.

A tangled web

Previous blogposts here and here dealt with the dubious activities of Indian homeopaths et al in the UK. Whilst their activities are relatively small scale, they are monitored. Something has come to light that raises real questions about certain persons' willingness to collaborate with unsavoury characters.

Unified Brainz Virtuoso Limited
Harjit Singh Sidhu was mentioned in a previous post. He is the director of this and various other companies - most associated with homeopathy some of which have clearly failed (possibly because they attempted to engage in illegal activities). But it is the other directors who are of more interest as is the company name...

Directors "Dr" Nitu Singh Marwah and "Professor" Gobind Daya Singh Marwaha both have an address of Ub House, G-26 Chandroday Society, Nr. Mb House, Navrangpura, Ahmedabad, Gujarat, India, 380014. And there is an Indian company of the same name which they are also directors of. And then things get very strange...

Unified Brainz Virtuoso at first sight seems like a legitimate company but the Indian company would appear basically to offer a "who's who" service - these are scams and research suggests that Indian homeopaths do fall for them. It appears to offer some award - Award dè Excelencia and that brochure rings alarm bells. The chief guest is one "Professor Sir Dr" Lakshman Madurasinghe - President of Medicina Alternativa which is a notorious diploma mill selling all sorts of bogus qualifications in alternative medicine. Quite a few "holders" turn up during research for this blog. This is worthy of a separate blog. 

Photos from some of these events show participants dressed in very cheap fancy dress outfits being presented with unimpressive certificates and very cheap looking gold coloured awards. Likely they have had to pay for the privilege too.

Professor Sir Doctor Gobind Daya Singh Marwaha AKA GD Singh
It is a most peculiar styling - in theory, it is perfectly legitimate - you can have a Professorship, Doctorate and Knighthood but generally the three are never used together - clumsy for one thing. It is fair to say they are most commonly seen together in conjunction with Medicina Alternativa persons.

GD Singh's biography turns up on a number of different websites but this archived version from his (malfunctioning) website makes for interesting reading.

GD Singh says he is -

  • Founder and Managing Director of Unified Brainz Virtuoso
  • Founder and President of Indian Management Academy (more on which below)
  • Actively involved with the Confederation of Indian Healthcare Foundation (CIHF) - it is difficult to determine what is as the website malfunctions.
  • Doctor of Philosophy from NWMD International University, South Africa - a theological diploma mill.
  • Recipient of Distinguished Award by the IIU, European Union - a diploma mill known under various names such as "Irish International University", "Isles International University" which operates out of either India or Sri Lanka
  • Board Advisory Member of IFMS –Institute of Financial & Management Studies (IFMS, USA) - which is not the reputable school in Switzerland, it is part of the notorious Pebble Hills University which again turns up a lot in research
  • Chief Advisor - International Journals of Multidisciplinary Research Academy (IJMRA) - a predatory journal
  • Reviewer for International Journal of Business and Management (IJBM) - Canadian Center of Science and Education - a predatory journal
  • Member Editorial Board - IJSTR, International Journal of Scientific & Technology Research (IJSTR) - Paris, France - a predatory journal
  • Certified Manager - Cambridge Association of Managers, England - a diploma mill mainly aimed at Kenyans.
  • Certified Doctor of Business Administration - The Oxford Association of Management, Oxford, England - a diploma mill mainly aimed at Kenyans.
  • Honorary fellow Member - Institute of Company & Commercial Accounts, Nigeria (ICCA) - which doesn't seem to exist.
GD Singh also has a biography here where he styles himself as HE HRH Prof. Dr. Sir GD Singh. His Excellency? His Royal Highness? Doesn't explicitly say so but. It doesn't really add much to the above except -
Dr. GD Singh is actively handling Confederation of International Accreditation Commission (CIAC, Global) as its founder & president since 2009. CIAC is an International, non-Governmental, private, self-financed educational quality assurance & accrediting body.
Lakshman Madurasinghe turns up again.

It is clear that GD Singh is trying to associate his (notional) NGOs with the UN. This is likely something the UN would be particularly happy about but it is likely his operations are too small to have attracted notice.

Indian Management Academy (IMA)
It has a website with address - but there are NO restriction on who can purchase these address. Like some other countries accredited educational establishments use .ac.tld rather than .edu which is for US establishments.
IMA, Since 2005 Acts as Information, Admission & Counselling Center For Various UGC Recognised Indian Universities & Partnering International Universities from across the globe.
But -
The Indian Management Academy – IMA is an academically independent and self-financed autonomous research oriented institute of higher education, offering various masters, doctoral & post-doctoral degree programs through off campus online mode. IMA is serving a global community that not only caters to the self-directed professionals who aim excellence in career but also provides a flexible, high-quality, and seamless instructional management system that gives the students better learning opportunities.
It has no campus, it has no faculty. It does not say anywhere on the website what exact courses might be available. Nor does it which University Grants Commission it acts for, if any. As for partnering International Universities? This page links a number of other websites but only a few of them call themselves universities and none are accredited institutions.

It becomes murkier. That page also links to Iberis Inc/UB Staffing (UB stands for "Unified Brainz") employment agency - the website does not function. It also mentions something called WEVERIFY -
Status: Diploma & Certification Validation PartnerThe mission of the company is to be the right partner for the customer by helping them eliminate & reduce Reputation risk, financial risk & Legal risk arising out of fraudulent employees through robust Screening and Verification process. The company is also into authentic check of Academic Certifications. Our pan India presence ensures that risk mitigation is achieved. 
WEVERIFY provides quality employment background verification services and is the core business of the company. WEVERIFY can package a solution tailored to your company's needs from the following services, designing a program to improve your hiring process and results. This will help mitigate the risk of operational losses which can occur due to bad hiring. 
The below mentioned are a few services WEVERIFY offers – Background Check, Credit rating verification, Due Diligence, Checking of daily routines of employee, Undercover agents, Debugging, Insurance claim verification, Academic / Professional verification, Previous employment verification, Criminal background verification, Banned substances check, Database checks, Litigation support, etc.
Irony rarely reaches these levels.

So what?
It would appear that attempts by Harjit Singh Sidhu et al to set up a "Bakson College of Homoeopathy UK" failed. Instead The London College of Homeopathy, United Kingdom appeared. The status of this "college" is unclear - further investigation is required.

It is unlikely that the UK Unified Brainz Virtuoso Limited will amount to anything. Those involved are obviously incompetent. It may simply exist so that the IMA can claim to have a "London office" but UK based Indian homeopaths have been involved with diploma mills and failed employment scams.

Tuesday, 16 October 2018

Lord Howe Letter

Back in 2011, a consultation was launched regarding consolidation of the Medicines Act 1968 and the plethora of other medicines legislation/regulations that can grown up around it. Medicines regulation had become fragmented, difficult to comprehend and in places even contradictory.

The intention of consolidation was not to make any substantial changes to legislation, some minor tidying up at most but it did cause some consternation amongst homeopaths, the homeopathic pharmacies and supporters of homeopaths.

This is well documented elsewhere. In essence, the concern was that the consolidation would make the supply of certain homeopathic medicines to/by lay homeopaths illegal. In reality, it was already illegal and still is.

Such was the concern amongst homeopathy supporters that they made representations to the Department of Health (as it was then called). It responded in the form of a letter.

Denial is a common mental state in homeopathy. Selective reading of clear English is a common cognitive problem. Misrepresentation of facts is deeply engrained in homeopathy.

The letter does not say what homeopaths made it out to say. Far from it.

Lord Howe Letter
Earl Howe, Frederick Curzon, was at the time the letter was written, Parliamentary Under-Secretary of State for Health. His letter (to the Society of Homeopaths) is reproduced below -

Thank you for your letter dated 20 June 2012 concerning the Consolidation and review of the Medicines Act 1968 (Consultation MLX 375) and its impact on the continued availability of unlicensed homeopathic products. 
I understand that you have also written to the Medicines and Healthcare products Regulatory Agency (MHRA) about this issue. Please accept this as a response to both letters. 
You asked for clarification as to why Section 10 of the Medicines Act is not being consolidated. The MHRA's response to the consultation is now available on the Agency's website; the document presents a summary of responses received and a commentary on key issues raised, including those raised by homeopathic interests. In summary the response indicates that the decision not to consolidate section 10 of the Medicine Act was made following careful consideration of the potential legal consequences of doing so. Ultimately it was felt that consolidation could not safely be done without compromising the legal effect of these regulations. 
As you know the consolidation does not, and was never intended to, change either the current regulatory status of regulations governing homeopathic medicinal products or their sale and supply. It was also never the intention to change the way the MHRA approached the enforcement of these provisions. I think would be useful if I clarified the effects of Section 10 as they affect homeopathic products. Starting with Section 10(4)(a); this does not apply to the supply of homeopathic products in isolation, but relates to the supply of an extemporaneously prepared medicine in a pharmacy by a pharmacist using their professional judgement as requested so to do by a patient present in the pharmacy at the time of the request. Section 10(4)(a) broadly exempts the pharmacist from the requirements for a manufacturer's licence to be able to prepare the product, and for a product licence, to be able to supply the product to the patient. 
Section 10(3) of the Act on the other hand provides an exemption to pharmacists from the requirements for a product or manufacturer's licence, for the supply of a medicinal product prepared to the specification of the client of the pharmacist. The supply of unlicensed products under Section 10(3) does not require a face-to-face consultation and so a product may be ordered by telephone, mail order or by way of the internet, although such products can only be supplied to an individual for their own use or administration to a member of their immediate family (for example supply to the parent or guardian of a child). I understand it is under the scope of Section 10(3) that the registered homeopathic pharmacies operate their online "remedy stores". 
Changes such as those suggested by the Society and others both to me and in response to the consultation would require detailed consideration of both the policy and legal implications; not only in terms of how they would impact on homeopaths or pharmacists but also on public safety. For example exempting homeopathic medicines prepared at a dilution of one part in a million (6X) or greater, from the provisions of section 10 and regulation 195 of the Act would need detailed consideration of the safety implications. Dilution alone is not sufficient to ensure the biological safety of the first safe preparation and needs to be considered with a number of other factors. 
You are, I know, aware that I recently met with a number of representatives of the homeopathic sector to discuss these issues. At this meeting I made clear that the Government's position on patient choice and the availability of homeopathic products has not changed. It should also be remembered that any proposals for change in medicines legislation to relax regulation in respect of homeopathy would require a full public consultation and therefore would need to be considered separately from these Regulations coming into force. 
It should also be kept in mind that any changes in this area would inevitably prove controversial, and would likely lead to pressure for other changes in an adverse direction for homeopathy. While I cannot realistically see this being a priority in the immediate future I would be happy to meet with representatives of the homeopathy sector if there were any significant changes to the present situation.

What does this mean?
It means that back in 2012 the Society of Homeopaths (SoH) were aware of the legal restrictions on the supply of unlicensed medicines re lay homeopaths. It indicates that "representatives of the homeopathic sector" were also aware - this is understood to include the homeopathic pharmacies. It is believed that other trade associations such as the Alliance of Registered Homeopaths know of the legal restrictions.

Yet these restrictions are widely ignored. Enforcement of regulations pertaining to unlicensed medicines is rarely a priority for the MHRA or the General Pharmaceutical Council (GPhC) which sets standards for pharmacies and pharmacists. However, a very strong case can be made that enforcement re products used in CEASE therapy absolutely should be a priority. Dealing with these products in theory could lead to a situation where regulation was enforced across all unlicensed homeopathic medicines but historically, the MHRA have only ever dealt with individual problem products (the diet scam homeopathic hCG for example).

This is issue is a "loaded gun" for the SoH if they wish to retain Professional Standards Agency (PSA) Accredited Register status.

A next step?
Whilst it would be difficult, it would be possible to create a list of nearly every practising lay homeopath in the UK. This list would also include naturopaths (who often use homeopathy). It could be extended to include those regulated medical professions who used homeopathy but do not have (sufficient) prescribing rights to prescribe unlicensed products.

This list could be supplied to the homeopathic pharmacies, the MHRA and the GPhC and trade associations representing lay homeopaths, naturopaths etc along with text pointing out the legal restrictions on supply.

Individual practitioners could be contacted pointing out the restrictions. It may well be the case that they have no idea that they exist. If they belong to a trade association, there are some questions that need to be asked but...

These kinds of measures would not be required if the UK homeopathy community took public safety seriously, rather than paying mere lip service to them. If it dealt with things like CEASE therapy, restricted its activities to "treating" those able to consent and to minor conditions, did not dispense "advice" and spread misinformation that is injurious to individual and public health, there would be no problem.