MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

big pharma

1 2 3 5

Boiron is the world’s largest manufacturer of homeopathic products. The 2016 sales figures of the company amounted to 614 489 000 Euro. Boiron has recently been very active promoting its products, not least on Twitter where I note about 10 of their promotional tweets every day. I saw the following tweet yesterday:

Acidil temporarily relieves occasional heartburn, acid indigestion, bloating or upset stomach. (link: http://bit.ly/2gCARdu)

This prompted me to look up what this product contains. The ingredients (potencies) are as follows:

  • Abies nigra (4C)
  • Carbo vegetablilis (4C)
  • Nux vomica (4C)
  • Robinia pseudoacacia (4C)

Just to remind you, 4C means the substance is diluted at a rate of 1: 100 000 000. Even the most deadly poison would be ineffective at such a dilution.

So, how can they claim that it is effective?

To find the answer, I did a Medline search and found the only listed trial of Acidil (if anyone knows of further studies, please let me know). Here is its abstract:

BACKGROUND:

It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.

METHODS:

24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.

RESULTS:

There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.

CONCLUSION:

An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.

The question I have is simple: why are they allowed to make false medical claims?

Is there anyone out there who can answer it?

Samuel Hahnemann invented homeopathy about 200 years ago. His placebos were better than (or not as bad as) the ‘heroic’ medicine of his time which frequently was more dangerous than the disease it aimed to cure. Thus, homeopathy took Germany by storm. When, about 100 years ago, medicine finally became scientific and was able to offer more and more effective treatments, the popularity of homeopathy began to wane. Yet, before its natural demise, during the Third Reich, it received a significant boost from Nazi-greats such as Hess and Himmler. After this nightmare was over, German homeopathy went into another slow decline. But when the New Age movement and the current boom in alternative medicine reached Germany, homeopathy seemed to thrive once again.

In the 1990s evidence-based medicine (EBM) grew into one of the central concepts of medicine. In Germany, however, EBM had a relatively hard time to get established. This might be one of the reasons why homeopathy continued to prosper, despite the arrival of ever clearer evidence that highly diluted homeopathic remedies are pure placebos. While, in the UK, we had an increasingly lively debate about the uselessness of homeopathy, Germany remained the promised land of homeopathy. Sales figures of homeopathics continued to increase steadily and reached a level of about half a billion Euros per annum.

The golden age of German homeopathy had dawned:

  • The media, often sponsored by homeopathic interest groups, kept on promoting homeopathy largely unopposed.
  • The mighty Carstens Stiftung worked tirelessly to promote it.
  • Homeopathy became established in many medical schools.
  • Homeopathy was available and often advertised in almost all pharmacies.
  • The public was convinced that homeopathy worked.
  • The Heilpraktiker adopted homeopathy fully.
  • The medical and other conventional healthcare professions embraced it to a large degree.
  • The adult education institutes (Volkshochschulen) offered courses.
  • Politicians were squarely on the side of homeopathy,
  • Health insurances, paid for it.

Of course, there were also some (and always had been) opposing voiced and organisations, such as the GWUP (the German sceptic organisation), for example. But somehow, they remained relatively low-key. When, every now and then, courageous journalists dared to think of a critical take on homeopathy, they had to search far and wide to find a German-speaking expert who was willing or able to tell them the truth: that homeopathy is neither biologically plausible nor evidence-based and therefore an expensive, potentially harmful waste of money that makes a mockery of EBM. During this period, journalists (far too) often asked me for some critical comments. I hardly ever published my research in German, but they nevertheless would find me via my Medline-listed papers. I often felt like a very lone voice in a German desert.

For the German homeopathic industry, I evidently was more than just a lone voice. Unbeknown to me, they clubbed together and financed a PR-man/journalist (at the tune of Euro 30 000/year) to write as many defamatory articles about me as he could muster. First, I was bewildered by his activity, then I tried to communicate with him (only to get mis-quoted), and eventually I ignored his writings. Yet, a German investigative journalist found Fritzsche’s one-sided activities offensive and started investigating. His research and subsequent article disclosed the fact that he was being paid by the homeopathic industry. Once I learn about this scandal, I wrote to some of the financiers directly and asked for an explanation. As a result, they discontinued their sponsorship. Shortly afterwards, Fritzsche committed suicide.

At heart, I have always been an optimist and strongly believe that in medicine the truth, in this case the evidence, will always prevail, no matter what obstacles others might put in its way. Recent developments seem to suggest that I might be right.

In the last few years, several individuals in Germany have, from entirely different angles, taken a fresh look at the evidence on homeopathy and found it to be desperately wanting. Independent of each other, they published articles and books about their research and insights. Here are 5 examples:

Die Homöopathie-Lüge: So gefährlich ist die Lehre von den weißen KügelchenChristian Weymayr, Nicole Heißmann, 2012

In Sachen Homöopathie: Eine Beweisaufnahme, Norbert Aust, 2013

Homöopathie neu gedacht: Was Patienten wirklich hilft, Natalie Grams, 2015

Der Glaube an die Globuli: Die Verheißungen der HomöopathieNorbert Schmacke, Bernd Hontschik, 2015

Der wahrscheinlich teuerste Zucker der Welt: Was Sie über Homöopathie und Alternativmedizin wissen sollten, Oliver Grunau, 2017

Inevitably, these individuals came into contact with each other and subsequently founded several working-groups to discuss their concerns and coordinate their activities. Thus the INH and the Muensteraner Kreis were born. So, now we have at least three overlapping groups of enthusiastic, multidisciplinary experts who voluntarily work towards informing the German public that paying for homeopathy out of public funds is unethical, nonsensical and not in the interest of progress:

  • the GWUP,
  • the INH
  • and the Muensteraner Kreis.

No wonder then, that the German homeopathic industry and other interested parties got worried. When they realised that (presumably due to the work of these altruistic enthusiasts) the sales figures of homeopathics in Germany had, for the first time since many years, started declining, they panicked.

Their reaction was, as far as I can see, similar to their previous response to criticism: they started a media campaign in an attempt to sway public opinion. And just like before, they have taken to employing PR-people who currently spend their time defaming all individuals voicing criticism of homeopathy in Germany. Their prime targets are those experts who are most exposed to activities of responsibly informing the public about homeopathy via lectures, publications social media, etc. All of us currently receive floods of attack, insults and libellous defamations. As before (innovation does not seem to be a hallmark of homeopathy), these attacks relate to claims that:

  • we are incompetent,
  • we do not care about the welfare of patients,
  • we are habitual liars,
  • we are on the payroll of the pharmaceutical industry,
  • we aim at limiting patient choice,
  • we do what we do because we crave the limelight.

So, what is going to happen?

I cannot read tea leaves but am nevertheless sure of a few things:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

If you thought that Chinese herbal medicine is just for oral use, you were wrong. This article explains it all in some detail: Injections of traditional Chinese herbal medicines are also referred to as TCM injections. This approach has evolved during the last 70 years as a treatment modality that, according to the authors, parallels injections of pharmaceutical products.

The researchers from China try to provide a descriptive analysis of various aspects of TCM injections. They used the the following data sources: (1) information retrieved from website of drug registration system of China, and (2) regulatory documents, annual reports and ADR Information Bulletins issued by drug regulatory authority.

As of December 31, 2017, 134 generic names for TCM injections from 224 manufacturers were approved for sale. Only 5 of the 134 TCM injections are documented in the present version of Ch.P (2015). Most TCM injections are documented in drug standards other than Ch.P. The formulation, ingredients and routes of administration of TCM injections are more complex than conventional chemical injections. Ten TCM injections are covered by national lists of essential medicine and 58 are covered by China’s basic insurance program of 2017. Adverse drug reactions (ADR) reports related to TCM injections account for  over 50% of all ADR reports related to TCMs, and the percentages have been rising annually.

The authors concluded that making traditional medicine injectable might be a promising way to develop traditional medicines. However, many practical challenges need to be overcome by further development before a brighter future for injectable traditional medicines can reasonably be expected.

I have to admit that TCM injections frighten the hell out of me. I feel that before we inject any type of substance into patients, we ought to know as a bare minimum:

  • for what conditions, if any, they have been proven to be efficacious,
  • what adverse effects each active ingredient can cause,
  • with what other drugs they might interact,
  • how reliable the quality control for these injections is.

I somehow doubt that these issues have been fully addressed in China. Therefore, I can only hope the Chinese manufacturers are not planning to export their dubious TCM injections.

“Homeopathic remedies are inherently harmless” this is what many seem to think – homeopathy friends and foes alike. After all, they contain nothing – so, how can it cause harm?

The notion is, of course, not entirely true. Homeopathic remedies can be directly harmful, if:

  • they are not highly dilute (low potency) – imagine Arsenic C1;
  • they are contaminated with harmful substances – this might happen with poor quality control during the manufacturing process;
  • they might not be as dilute as advertised – this too might happen with poor quality control during the manufacturing process.

A reminder that these are not merely theoretical considerations was just published in the shape of a press-release by the US Food and Drug Administration:

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

Administration or use of drug  products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness.

The Aquaflora HP9 product is used as a Candida control product. The Lymph Detox product is used for symptoms associated with lymphatic toxicity. The Baby Teething product is used for symptoms of teething pain, irritated gums, delayed teething, etc.

Product UPC Lot Numbers Expiration Date Distribution
Aquaflora
Candida HP9 8
oz. liquid in a
carton
3-57955-80018-7 120217R
102017C
101017G
111417C
12/02/19
10/20/19
10/10/19
11/14/19
8,000 bottles
nationwide to
retail stores and
websites
King Bio
Lymph Detox
2 oz. liquid in a
carton
3-57955-50632-4 010118BE 01/01/20 276 bottles
nationwide to
retail stores and
websites
King Bio Baby
Teething 2 oz
liquid in a
carton
020118F 13 bottles
marked NOT
FOR RESALE

King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement. of all recalled products.  Consumers/distributors/retailers that have product which is being recalled should stop using/and contact King Bio prior to returning the product.

Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail custcare1@kingbio.com, Monday – Friday 830am – 430pm, EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

END OF QUOTE

KingBio have a website where they disclose their mission statement:

  • To provide safe, all-natural medicines without harmful side effects.
  • To offer affordable natural medicines that help people overcome common health challenges.
  • To achieve the trust and respect of our customers and uphold the best product quality.
  • To empower people with the most effective ways to achieve abundant health.

… The FDA classifies homeopathic medicines as pharmaceutical drug products. King Bio is an FDA-registered pharmaceutical manufacturer and is strictly compliant with FDA guidelines and current good manufacturing practices (cGMP). Unlike most pharmaceutical drug products, homeopathic medicine offers gentle symptomatic relief, without recorded harmful side effects. 

SAY NO MORE!

On this blog, we have seen more than enough evidence of how some proponents of alternative medicine can react when they feel cornered by critics. They often direct vitriol in their direction. Ad hominem attacks are far from being rarities. A more forceful option is to sue them for libel. In my own case, Prince Charles went one decisive step further and made sure that my entire department was closed down. In China, they have recently and dramatically gone even further.

This article in Nature tells the full story:

A Chinese doctor who was arrested after he criticized a best-selling traditional Chinese remedy has been released, after more than three months in detention. Tan Qindong had been held at the Liangcheng county detention centre since January, when police said a post Tan had made on social media damaged the reputation of the traditional medicine and the company that makes it.

On 17 April, a provincial court found the police evidence for the case insufficient. Tan, a former anaesthesiologist who has founded several biomedical companies, was released on bail on that day. Tan, who lives in Guangzhou in southern China, is now awaiting trial. Lawyers familiar with Chinese criminal law told Nature that police have a year to collect more evidence or the case will be dismissed. They say the trial is unlikely to go ahead…

The episode highlights the sensitivities over traditional Chinese medicines (TCMs) in China. Although most of these therapies have not been tested for efficacy in randomized clinical trials — and serious side effects have been reported in some1TCM has support from the highest levels of government. Criticism of remedies is often blocked on the Internet in China. Some lawyers and physicians worry that Tan’s arrest will make people even more hesitant to criticize traditional therapies…

Tan’s post about a medicine called Hongmao liquor was published on the Chinese social-media app Meipian on 19 December…Three days later, the liquor’s maker, Hongmao Pharmaceuticals in Liangcheng county of Inner Mongolia autonomous region, told local police that Tan had defamed the company. Liangcheng police hired an accountant who estimated that the damage to the company’s reputation was 1.4 million Chinese yuan (US$220,000), according to official state media, the Beijing Youth Daily. In January, Liangcheng police travelled to Guangzhou to arrest Tan and escort him back to Liangcheng, according to a police statement.

Sales of Hongmao liquor reached 1.63 billion yuan in 2016, making it the second best-selling TCM in China that year. It was approved to be sold by licensed TCM shops and physicians in 1992 and approved for sale over the counter in 2003. Hongmao Pharmaceuticals says that the liquor can treat dozens of different disorders, including problems with the spleen, stomach and kidney, as well as backaches…

Hongmao Pharmaceuticals did not respond to Nature’s request for an interview. However, Wang Shengwang, general manager of the production center of Hongmao Liquor, and Han Jun, assistant to the general manager, gave an interview to The Paper on 16 April. The pair said the company did not need not publicize clinical trial data because Hongmao liquor is a “protected TCM composition”. Wang denied allegations in Chinese media that the company pressured the police to pursue Tan or that it dispatched staff to accompany the police…

Xia is worried that the case could further silence public criticism of TCMs, environmental degredation, and other fields where comment from experts is crucial. The Tan arrest “could cause fear among scientists” and dissuade them from posting scientific comments, he says.

END OF QUOTE

On this blog, we have repeatedly discussed concerns over the validity of TCM data/material that comes out of China (see for instance here, here and here). This chilling case, I am afraid, is not prone to increase our confidence.

The ‘European Scientific Cooperative on Anthroposophic Medicinal Products‘ claim that there is a need for a regulatory framework for anthroposophic medicinal products (AMPs) in Europe. The existing regulatory requirements for conventional medicinal products are not appropriate for AMPs. Special registration procedures exist in some countries for homeopathic products and in the European Union for herbal products. However, these procedures only apply to a proportion of AMPs and the particular properties of AMPs are only in part accounted for. Suitable registration procedures especially for AMPs exist only in Germany and Switzerland.

The European Commission has acknowledged the existence of therapy systems, whose products have no adequate regulation, and it has proposed that the suitability of a separate legal framework for products of certain traditions such as Anthroposophic Medicine should be assessed. This statement should be seen in the context of developments in international trade, whereby representatives of therapy systems such as Traditional Chinese Medicine and Ayurveda wish to market their products in Europe.

It seems obvious that the safety of AMPs must be demonstrated, if regulators are to comply with the wishes of the AMP-industry. In other words, they require evidence. As luck has it, a recent paper provides just what they need.

The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.

The researchers conducted a prospective pharmacovigilance study with the patients of physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. A total of 38 German physicians trained in AM were asked to link all AMP prescriptions to the respective indications (diagnoses), and to document all serious ADRs as well as all ADRs of intensity III–IV. In addition, a subgroup of 7 ‘prescriber physicians’ agreed to also document all non-serious ADRs of any intensity. The study was conducted under routine care conditions with ADRs identified at ordinary follow-up consultations, without any additional scheduled follow-up visits. Physicians were remunerated with 15 Euro for each ADR report but not for their regular participation; patients received no remuneration. Patients were eligible for this analysis, if they had one or more AMP prescription in the years 2001–2010, followed by one or more physician visit.

A total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. The highest ADR frequency was 0.290% of prescriptions for one specific AMP. Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.

The authors concluded that in this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.

Most AMPs are highly diluted, and therefore, one would not expect frequent or serious ADRs. Yet, I still find these incidence figures mysterious. The reason is simple: even the ARDs of pure placebos (such as most AMPs) are known to be much more frequent. In other words, the nocebo-effects of drugs are much more common than these results seem to reflect.

This, I think, leads to one of two possible conclusions:

  1. AMPs are somehow miraculously exempt from the known facts of ADRs.
  2. There is something fundamentally wrong with this study.

I let you decide which is the case.

Oh, I almost forgot. At the end of this paper there is a not unimportant note:

The EvaMed study was funded by the Software AG-Stiftung. This analysis and publication was commissioned by the European Scientific Cooperative on Anthroposophic Medicinal Products (http://www.escamp.org) with financial support from foundations (Christophorus-Stiftung, Damus-Donata-Stiftung, Ekhagastiftelsen, Mahle-Stiftung, Software AG-Stiftung) and manufacturers (Wala, Weleda). The sponsors had no influence on the planning or conduct of the EvaMed study; the collection, preparation, analysis or interpretation of data for this paper; nor on the preparation, review or approval of the manuscript.

This is the title of an editorial by Alan Schmukler. You probably remember him; I have featured him before, for instance here, here, and here. This is what was recently on Schmukler’s mind (I have added a few references referring to comments of mine added below):

England’s National Health Service (NHS) is proposing that NHS doctors no longer be permitted to prescribe homeopathic remedies [1]… They claim lack of evidence for effectiveness. Anyone who’s been remotely conscious the last 10 years will see this as a pretext. Homeopathy is practiced by board certified physicians in clinics and hospitals around the world [2]. The massive Swiss review of homeopathy, found it effective, safe and economical, and the Swiss incorporated homeopathy into their national health care system [3]…

The reason given for banning homeopathy and these nutrients is a lie. Why would the NHS ban safe, effective and affordable healing methods? [4] Without these methods, all that is left are prescription drugs. Apparently, someone at the  NHS has an interest in pushing expensive prescription drugs [5], rather than safer and cheaper alternatives. That someone, also wishes to deny people freedom of choice in medicine [6]. I say “someone”, because organizations don’t make decisions, people do. Who is that someone?  In looking for a suspect, we might ask, who is the chief executive of the organization? Who introduced this plan and is promoting it? Who at the NHS has the political clout?  Who was it that recently declared: “Homeopathy is a placebo and a misuse of scarce NHS funds which could better be devoted to treatments that work”.

The quote is from Simon Stevens, NHS England’s chief executive. He got the job in 2014, after ten years as a top executive at UnitedHealth, the largest health insurance company in America. His past work experiences and current activities show that he favors privatization [7]. That would make him an odd choice to run a healthcare system based on socialized medicine. In fact, he has been moving the NHS towards privatization and the corporate, profit based American model. [8] The last thing a privatizer in healthcare would want, are non-proprietary medicines, for which you can’t charge exorbitant fees [9]. Banning homeopathy on the NHS is just one small part of a larger plan to maximize corporate profits by letting corporations own and control the health care system [10].  Before they can do this, they have to eliminate alternative methods of treatment.

Personally, I think Schmukler is wrong – here is why:

1 The current argument is not about what doctors are permitted to do, but about what the NHS should do with our tax money.

2 Argumentum ad populum

3 Oh dear! Anyone who uses this report as evidence must be desperate – see for instance here.

4 Why indeed? Except highly dilute homeopathic remedies are pure placebos.

5 Maybe ‘someone’ merely wants to use effective medications rather than placebos.

6 Freedom of choice is a nonsense, if it is not guided by sound evidence – see here.

7 No, that’s Jeremy Hunt! But in any case privatisation might be more profitable with homeopathy – much higher profit margins without any investment into R&D.

8 No, this is Hunt again!

9 Homeopathic remedies are ideal for making vast profits: no research, no development, no cost for raw material, etc., etc.

10 I am sure Boiron et al would not mind stepping into the gap.

I very much look forward to the next outburst of Alan Schmukler and hope he will manage to think a bit clearer by then.

The title of this post is a statement recently made in an article by Mike Adams in ‘Alternative Medicine News’:

The cancer industry goes to great lengths to deny patients access to any information that they might use to prevent, treat or cure cancer without requiring expensive (and highly toxic) medical interventions. That’s what makes the BMJ documentation of this curcumin cancer cure so astonishing: In years past, the BMJ never would have even tolerated the publishing of such a scientific assessment. So what changed? In truth, the evidence of natural cures for cancer is now so overwhelming that even the BMJ cannot remain in a state of denial without appearing to be hopelessly out of touch with scientific reality.

The story is based on one single patient who apparently was cured of cancer using curcumin (turmeric). The case was also recently (3/1/18) featured on BBC’s ‘YOU AND YOURS’ (http://www.bbc.co.uk/programmes/b09k0ng7) in a similarly uncritical way: no expert was asked to provide an evidence-based assessment and bring some reason into the discussion. Even the DAILY FAIL reported about the story, and predictably, critical assessment had to make way for sensationalism.

So what?

We hear about such nonsense almost every day!

True, but this case is different; it is based on a publication in the highly-respected BMJ (well, actually, it was the ‘BMJ CASE REPORTS’ and not the BMJ, as reported). Here is the article:

START OF QUOTE

A woman aged 57 years was initially diagnosed with monoclonal gammopathy of undetermined significance (MGUS) in 2007 following an incidental finding of M-protein (18 g/L) during investigation for hypertension.

Within 15 months, the patient had rapidly progressed to ISS stage 3 myeloma with M-protein 49 g/L, urinary protein 1.3 g/24-hour, Bence-Jones protein 1.0 g/24-hour, Hb 9.7 g/dL and increasing back pain. She initially declined antimyeloma treatment but 6 months later, following vertebral collapse at T5 and T12, started cyclophosphamide, thalidomide and dexamethasone (CTD) treatment. However, after a week, the patient was admitted with idiosyncratic syndrome including hyponatraemia, a fall in albumin and worsening of blood counts. She received red cell transfusion and her electrolyte abnormalities were carefully corrected.

Although there was evidence of a response to CTD (M-protein 34 g/L), bortezomib and dexamethasone treatment was initiated as an alternative, but this was discontinued after three cycles due to progressive disease (M-protein 49 g/L). The patient was then treated with lenalidomide and dexamethasone with the aim of reducing disease burden prior to high-dose therapy and autologous stem cell transplantation. Treatment was frequently interrupted and dose adjusted to account for neutropenia and despite a minor response after six cycles (starting M-protein 47 g/L, finishing M-protein 34 g/L), in October 2009, she proceeded with stem cell mobilisation. However, neither cyclophosphamide nor plerixafor/GCSF priming were successful. A bone marrow biopsy revealed 50% myeloma cells and a course of CTD was restarted with cautious titration of thalidomide.

The patient achieved a partial response with CTD retreatment over the course of 17 cycles (M-protein 13 g/L) with no further episodes of idiosyncratic syndrome. However, attempts to harvest stem cells in February 2011 and again there months later, both failed. By then, her M-protein had risen to 24 g/L and the patient was too neutropenic to be considered for a clinical trial.

At this point, the patient began a daily regime of oral curcumin complexed with bioperine (to aid absorption), as a single dose of 8 g each evening on an empty stomach. A few months later, she also embarked on a once-weekly course of hyperbaric oxygen therapy (90 min at 2 ATA) which she has maintained ever since. Her paraprotein levels gradually declined to a nadir of 13 g/L, her blood counts steadily improved and there was no evidence of further progressive lytic bone disease.

Outcome and follow-up

The patient continues to take oral curcumin 8 g daily without further antimyeloma treatment. Over the last 60 months, her myeloma has remained stable with minimal fluctuation in paraprotein level, her blood counts lie within the normal range and she has maintained good quality of life throughout this period. Repeat bone imaging in 2014 identified multiple lucencies <1 cm in the right hip and degenerative changes in both hips, but these were attributed to osteoarthritis rather than the myeloma. Recent cytogenetic analysis revealed she had no abnormal cytogenetics by fluorescent in situ hybridisation.

Discussion

A small but significant number of myeloma patients consume dietary supplements in conjunction with conventional treatment primarily to help cope with the side effects of treatment, manage symptoms and enhance general well-being. Few, if any, use dietary supplementation as an alternative to standard antimyeloma therapy. Here, we describe a case in which curcumin has maintained long-term disease control in a multiply-relapsed myeloma patient. To the best of our knowledge, this is the first report in which curcumin has demonstrated an objective response in progressive disease in the absence of conventional treatment.

Curcumin is a polyphenol derived from the perennial herb Curcuma longa (turmeric) and has, for centuries, been used as a traditional Indian medicine. Several reports published over the two decades have claimed various health benefits of curcumin and this has led to its increasing popularity as a dietary supplement to prevent or treat a number of different diseases.

The biological activity of curcumin is indeed remarkable. It is a highly pleiotropic molecule which possesses natural antioxidant, anti-inflammatory, antiseptic and analgesic properties. More recently, it has demonstrated antiproliferative effects in a wide variety of tumour cells including myeloma cells and exerts its antiproliferative effects through multiple cellular targets that regulate cell growth and survival.

In vitro, curcumin prevents myeloma cell proliferation through inhibition of IL-6-induced STAT-3 phosphorylation and through modulation of the expression of NF-kB-associated proteins such as IkB〈,Bcl-2, Bcl-xL, cyclin D1 and IL-6 and apoptosis-related molecules including p53 and Bax. In other studies, curcumin was shown to circumvent resistance to dexamethasone, doxorubicin and melphalan as well as potentiate the effects of bortezomib, thalidomide and lenalidomide. Furthermore, curcumin-induced cell death was not influenced by myeloma molecular heterogeneity.

The antimyeloma effects of curcumin in the clinical setting however are less clear. Only one phase I/II study has evaluated curcumin treatment in myeloma patients. These patients were either asymptomatic, relapsed or had plateau phase disease. Treatment with curcumin downregulated the expression of NFkB, COX-2 and STAT3 in peripheral blood mononuclear cells, but no objective responses were observed in any subgroup of patients. This may be as a result of small sample size in this study, follow-up was limited to 3 months and clinical responses may have been observed with longer follow-up. However, downregulation of NFkB, COX-2 and STAT3 expression may not correlate with the clinical activity of curcumin and there may be further mechanisms of action that remain unclear, possibly through the modulation of another target. We would not be able to identify any patient-specific mechanisms of activity in this case study, as the patient has been taking curcumin for some time now and baseline bone marrow or peripheral blood samples are not available. However, in the setting of a clinical trial, it may be possible to use next-generation sequencing to help identify a mutation that may be a potential target for curcumin.

Another study examined its effects in preventing the progression of MGUS and smouldering myeloma to myeloma. The results showed that curcumin exerted a trace of biological activity with modest decreases in free light chain and paraprotein levels and a reduction in a marker of bone resorption with curcumin treatment, suggesting the therapeutic potential of curcumin in MGUS and smouldering myeloma. However, more studies are needed to address this further.

Whether such effects are observed in patients with active disease remains to be seen. The fact that our patient, who had advanced stage disease and was effectively salvaged while exclusively on curcumin, suggests a potential antimyeloma effect of curcumin. She continues to take daily curcumin and remains in a very satisfactory condition with good quality of life. This case provides further evidence of the potential benefit for curcumin in myeloma. We would recommend further evaluation of curcumin in myeloma patients in the context of a clinical trial.

END OF QUOTE

What should we make of this?

I think that much of the reporting around the story was grossly irresponsible. It is simply not possible to conclude that curcumin was the cause of the remission. It could be due to a whole host of other factors. And a case report is just an anecdote; it never can prove anything and can only be used to stimulate further research.

I fully agree with the authors of the case report: curcumin seems worthy of further investigation. But recommending it to patients for self-medication is vastly premature and quite simply dangerous, unethical and naïve bordering on stupid.

And, of course, the above-cited drivel of Mike Adams is just beyond the pale – the evidence for ‘alternative cancer cures‘ is very, very far from ‘overwhelming’; and the ‘cancer industry’ is doing what they can to determine whether turmeric or any other natural remedy can be used to treat cancer and other diseases.

If they are ever successful, the Adams of this world will shout ‘EXPLOITATION!!!’

If their endeavours are not successful, they will complain ‘CONSPIRACY!!!’

On their  website, the US Food and Drug Administration (FDA) has recently published a statement on homeopathy which, I think, is important enough to get cited extensively:

… Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…

The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients…  The FDA intends to focus its enforcement authorities on the following kinds of products:

  • products with reported safety concerns;
  • products that contain or claim to contain ingredients associated with potentially significant safety concerns;
  • products for routes of administration other than oral and topical;
  • products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
  • products for vulnerable populations; and
  • products that do not meet standards of quality, strength or purity as required under the law.

Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.

While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public…

Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.

In September 2016, the FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, after the products were associated with serious adverse events, including seizures and deaths, in infants and children. An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna. A similar issue occurred in 2010 when Hyland’s Teething Tablets were found to contain varying amounts of belladonna. An FDA inspection of that product’s manufacturing facility indicated substandard control of the product’s manufacturing.

The FDA has issued warnings related to a number of other homeopathic drug products over the past several years. These include certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and various homeopathic drug products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine (a highly toxic, well-studied poison often used to kill rodents).

“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”…

The FDA is not alone in reexamining its approach to homeopathy. In November 2016, the Federal Trade Commission (FTC) announced a new enforcement policy explaining that they will hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as other products making similar health claims. Notably, the FTC said that companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions…

END OF QUOTE

US homeopaths were quick to respond, as reported here:

The National Center for Homeopathy’s board of directors stated:

The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.

Of course, the unique aspect of homeopathic medicines undoubtedly is that they usually contain no active molecules and therefore do not work. But somehow, I doubt that the NCH was thinking of telling consumers the truth.

The NCH statement is tame in comparison with the NCH’s response to the FDA’s actions during the homeopathic teething investigation last year. Prior to the recall, the FDA issued a warning to consumers, which the NCH dubbed as “arbitrary and capricious.” The NCH went on to say that the FDA’s warning led to “exaggerated fear mongering” in the media and a “public scare” that threatened access to homeopathic products. “[G]roups interested in seeing homeopathy destroyed continue to hammer away at the system—making exaggerated claims that create misunderstandings about and limit consumer access,” the NCH wrote [emphasis theirs].

And this response is tame compared to what a prominent US homeopaths claimed at the time:

“It’s time to hold these people accountable. There are laws in every country against officials taking bribes and malfeasance in office. Write to your legislators and demand that they investigate and bring these criminals to justice. Send them the links to hundreds of homeopathy studies, including disease prevention with homeopathy, at the end of this article.   Tell them that the regulatory agencies are protecting Pharma profits, not the public.

Meanwhile, let us insist that pharmaceutical drugs be labeled honestly, like this:

“This drug was tested by the same company that profits from it, and which company has been fined millions of dollars in the past for lying about test results. This drug does not cure any medical condition, but only suppresses symptoms which may ultimately make the patient sicker. This drug has already  killed or injured X  number of people.”

The outrage is understandable for two reasons, I think:

  1. even homeopaths cannot deny that the days of unchecked claims are counted;
  2. against rage of this sort homeopathic remedies are obviously not working.

Weleda, a leading manufacturer of homeopathic preparations, is, according to their own judgement, a ‘unique organisation – economically thriving, kind at heart and committed to the well-being of our planet, our environment and our people. We’ve grown into that role through the adoption of seven basic principles which are unchanging, binding for everyone who works with us, and which clearly underpin the way we work.’

The first of these 7 principles is the ‘Fair treatment of customers, partners and suppliers‘. Fair treatment and being ‘kind at heart’ would include telling the truth, wouldn’t it? But reading what Weleda state about homeopathy, one might wonder!

The Weleda article entitled ‘An introduction to Homeopathy’ contains many statements worthy of some critical analysis, I think. Here is a selection of 10 just quotes:

  1. … a [homeopathic] remedy [is] made from a natural substance… in a tiny dose which has been ‘potentised’ to be effective.
  2. Many people choose this approach for every-day family ailments, with a homeopathic ‘first aid kit’…
  3. … allopathic medicine works against the disease and its symptoms using “anti” drugs…
  4. Homeopathy works by stimulating the body’s own natural healing capacity.
  5. If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who specialises in homeopathy.
  6. Today there are four homeopathic hospitals offering treatment under the National Health Service – in London, Glasgow, Liverpool and Bristol.
  7. Homeopathy can be used to treat the same wide range of illness as conventional medicine, and may even prove successful when all other forms of treatment have failed.
  8. … the fact that the remedies are widely used on animals dismisses the idea that the success of a treatment is all in the mind.
  9. Occasionally, symptoms become worse on first taking a homeopathic medicine. This is called an ‘aggravation’, and is a good sign that the remedy is working.
  10. … some homeopathic remedies will successfully treat many people with the same symptoms. For example, arnica is usually used for muscular bruising …

And here are my thoughts on these 10 statements:

  1. I had always thought that homeopathics can be made from any substance (including Berlin Wall) and not just natural ones. Moreover, the dose is often not ‘tiny’ but non-existent. Finally, the assumption that ‘potentisation’ renders remedies ‘effective’ is pure wishful thinking.
  2. A homeopathic ‘first aid kit’ is a contradiction in terms. If someone needs first aid, she surely must avoid homeopathy.
  3. The term ‘allopathy’ is a derogatory term created by Hahnemann to defame the heroic medicine of his time. The notion of ‘anti-drugs’ is popular in homeopathy, but evidently, it is pure nonsense.
  4. This notion is wishful thinking by homeopaths at its best; there is not a jot of evidence that it is true.
  5. If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who practices evidence-based medicine but NOT homeopathy.
  6. This statement is untrue; a footnote to the article states ‘Copyright 2017 Weleda UK’, it is thus odd to see that Weleda is so ill-informed.
  7. The claim that homeopathy is a panacea is dangerous nonsense.
  8. This notion is endlessly being promoted by homeopaths. Sadly the repetition of a falsehood does not create a truth (see for instance here).
  9. ‘Homeopathic aggravations’ are a myth.
  10. Yes, homeopathic arnica is used for muscular bruising – but it not effective for that or any other indication.

It is only fair, I think, that I declare my conflicts of interest in relation to Weleda.

While at Exeter, I ran during 14 years an annual conference for researchers in alternative medicine. One year, I accepted a modest sponsorship from Weleda for this meeting [I forgot how much and which year precisely this was, possibly around 1999 and probably around £ 3 000].

More importantly, Weleda was one of the companies that financed the German journalist Claus Fritzsche who then spent much time and effort to attack and defame me. This story that ended tragically with Fritzsche’s suicide.

Needless to say that I regret both events.

Arguably, I therefore have two opposing conflicts of interest, one pro and one contra Weleda. This is why I tried to focus my comments purely on demonstrable facts. They show, I think, that Weleda’s claims about homeopathy should be take with more than a little pinch of salt – or perhaps even with a dose of NaCl, C200?

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