big pharma
The global market for dietary supplements has grown continuously during the past years. In 2019, it amounted to around US$ 353 billion. The pandemic led to a further significant boost in sales. Evidently, many consumers listened to the sly promotion by the supplement industry. Thus they began to be convinced that supplements might stimulate their immune system and thus protect them against COVID-19 infections.
During the pre-pandemic years, the US sales figures had typically increased by about 5% year on year. In 2020, the increase amounted to a staggering 44 % (US$435 million) during the six weeks preceding April 5th, 2020 relative to the same period in 2019. The demand for multivitamins in the US reached a peak in March 2020 when sales figures had risen by 51.2 %. Total sales of vitamins and other supplements amounted to almost 120 million units for that period alone. In the UK, vitamin sales increased by 63 % and, in France, sales grew by around 40–60 % in March 2020 compared to the same period of the previous year.
Vis a vis such impressive sales figures, one should ask whether dietary supplements really do produce the benefit that consumers hope for. More precisely, is there any sound evidence that these supplements protect us from getting infected by COVID-19? In an attempt to answer this question, I conducted several Medline searches. Here are the conclusions of the relevant clinical trials and systematic reviews that I thus found:
- KSK (a polyherbal formulation from India’s Siddha system of medicine) significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings.
- There is currently insufficient evidence to determine the benefits and harms of vitamin D supplementation as a treatment of COVID-19.
- Herbal supplements may help patients with COVID-19, zinc sulfate is likely to shorten the duration of olfactory dysfunction. DS therapy and herbal medicine appear to be safe and effective adjuvant therapies for patients with COVID-19. These results must be interpreted with caution due to the overall low quality of the included trials. More well-designed RCTs are needed in the future.
- No significant difference with vitamin-D supplementation on major health related outcomes in COVID-19.
- there is not enough evidence on the association between individual zinc status and COVID-19 infections and mortality.
- Omega-3 supplementation improved the levels of several parameters of respiratory and renal function in critically ill patients with COVID-19.
- A 5000 IU daily oral vitamin D3 supplementation for 2 weeks reduces the time to recovery for cough and gustatory sensory loss among patients with sub-optimal vitamin D status and mild to moderate COVID-19 symptoms. The use of 5000 IU vitamin D3 as an adjuvant therapy for COVID-19 patients with suboptimal vitamin D status, even for a short duration, is recommended.
- In this 2-sample MR study, we did not observe evidence to support an association between 25OHD levels and COVID-19 susceptibility, severity, or hospitalization. Hence, vitamin D supplementation as a means of protecting against worsened COVID-19 outcomes is not supported by genetic evidence.
- These antiviral and immune-modulating activities and their ability to stimulate interferon production recommend the use of probiotics as an adjunctive therapy to prevent COVID-19. Based on this extensive review of RCTs we suggest that probiotics are a rational complementary treatment for RTI diseases and a viable option to support faster recovery.
- In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care.
- These findings neither support nor refute the claim that 3M3F alters the severity of COVID-19 or alleviates symptoms. More rigorous studies are required to properly ascertain the potential role of Chinese Herbal Medicine in COVID-19.
- NSO (Nigella sativa oil) supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies.
- The clinical application of LQ (Lianhua Qingwen Granules or Capsules ) on the treatment of COVID-19 has significant efficacy in improving clinical symptoms and reducing the rate of clinical change to severe or critical condition. Nevertheless, due to the limited quantity and quality of the included studies, more and higher quality trials with more observational indicators are expected to be published.
- The study identified some important potential traditional Indian medicinal herbs such as Ocimum tenuiflorum, Tinospora cordifolia, Achyranthes bidentata, Cinnamomum cassia, Cydonia oblonga, Embelin ribes, Justicia adhatoda, Momordica charantia, Withania somnifera, Zingiber officinale, Camphor, and Kabusura kudineer, which could be used in therapeutic strategies against SARS-CoV-2 infection.
- Shenhuang Granule is a promising integrative therapy for severe and critical COVID-19.
- Low-certainty or very low-certainty evidence demonstrated that oral CPM (Chinese patent medicine) may have add-on potential therapeutic effects for patients with non-serious COVID-19. These findings need to be further confirmed by well-designed clinical trials with adequate sample sizes.
- XYP (Xiyanping) injection is safe and effective in improving the recovery of patients with mild to moderate COVID-19. However, further studies are warranted to evaluate the efficacy of XYP in an expanded cohort comprising COVID-19 patients at different disease stages.
- Our meta-analysis of RCTs indicated that LH (Lianhuaqingwen) in combination with usual treatment may improve the clinical efficacy in patients with mild or moderate COVID-19 without increasing adverse events. However, given the limitations and poor quality of included trials in this study, further large-sample RCTs or high-quality real-world studies are needed to confirm our conclusions.
- Reduning injection might be effective and safe in patients with symptomatic COVID-19.
- In light of the safety and effectiveness profiles, LH (Lianhuaqingwen) capsules could be considered to ameliorate clinical symptoms of Covid-19.
- QPT (Qingfei Paidu Tang) was associated with a substantially lower risk of in-hospital mortality, without extra risk of acute liver injury or acute kidney injury among patients hospitalized with COVID-19.
- This community-based RCT found that the use of a herbal medicine therapy (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) could significantly reduce the risks of the common cold among community-dwelling residents, suggesting that herbal medicine may be a useful approach for public health intervention to minimize preventable morbidity during COVID-19 outbreak.
- Based on unresolved controversies and inconclusive findings, it could be said that generally, a single and specific therapeutics to COVID-19 is still a mirage.
- Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients.
Confused?
Me too!
Does the evidence justify the boom in sales of dietary supplements?
More specifically, is there good evidence that the products the US supplement industry is selling protect us against COVID-19 infections?
No, I don’t think so.
So, what precisely is behind the recent sales boom?
It surely is the claim that supplements protect us from Covid-19 which is being promoted in many different ways by the industry. In other words, we are being taken for a (very expensive) ride.
Weleda, the firm founded by Rudolf Steiner and Ita Wegman originally for producing and selling their anthroposophic remedies, celebrates its 100th anniversary. It is a truly auspicious occasion for which I feel compelled to offer a birthday present.
I hope they like it!
On the Weleda UK website, we find an article entitled ‘ An introduction to Homeopathy‘ which contains the following statements:
- Homeopathy works by stimulating the body’s own natural healing capacity. The remedy triggers the body’s own healing forces and so a remedy is prescribed on a very individual basis.
- If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who specialises in homeopathy.
- Today there are four homeopathic hospitals offering treatment under the National Health Service – in London, Glasgow, Liverpool and Bristol.
- It’s still the only alternative medicine incorporated into the NHS.
- 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.
- Over-the-counter homeopathic medicines are made using natural plant, mineral and, occasionally, animal substances
- … active elements are in infinitesimally small quantities.
As I understand a bit about the subject – not as much as my friend Dana Ullman, of course, but evidently more than the Weleda team – I thought I might offer them, as a birthday present, a free correction of these 7 passages. Here we go:
- Homeopathy is claimed to work by stimulating the body’s own natural healing capacity. In fact, it does not work. Yet, believers argue that the remedy triggers the body’s own healing forces and so a remedy is prescribed on a very individual basis.
- If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who specializes in something other than homeopathy.
- Today there are no homeopathic hospitals offering treatment under the National Health Service – the ones in London, Glasgow, Liverpool, and Bristol all closed or changed their names.
- It’s no longer incorporated into the NHS.
- Homeopathy cannot be used to treat the same wide range of illnesses as conventional medicine and is not successful when all other forms of treatment have failed.
- Over-the-counter homeopathic medicines are made using any imaginable substance and even non-material stuff like vacuum or X-rays.
- … active elements are absent.
HAPPY BIRTHDAY, WELEDA!
So-called alternative medicine (SCAM) for cancer is the title of my new book. I was informed that it has been published but, in reality, the hard copy might still take a few days until it is available (there were major problems at the proof-reading stage which caused a considerable delay). To give you a flavor of the book, allow me to show you my introduction; here it is:
In February 2013, my wife and I were in good spirits. I had recently retired from my post at Exeter University, and we were heading off to celebrate Danielle’s round birthday with her family in Brittany. There was just one thing that bothered us: Danielle had recurring abdominal pains. She had seen our GP in England several times about it. The last time, she had received a prescription for some antibiotics. I knew they would not help; her symptoms were not due to an infection.
After our arrival in France, things got worse, and Danielle consulted a gynaecologist at the out-patient clinic of the local hospital. More tests were ordered; an ultrasound showed an abnormality; a subsequent MRI revealed a tumour of the uterus. The gynaecologist advised to operate as soon as possible, and Danielle agreed.
The operation went well, but the gynaecologist, Dr Matthieu Jacquot, was concerned and said he had to be more radical than he had anticipated. The diagnosis was still uncertain until the results from the histology lab were in. A few days later, when we saw Dr Jacquot again, our hopes that all was fine were thoroughly dashed. He explained that Danielle had cancer of the endometrium and laid out the treatment plan which an entire team of oncologists had designed after an in-depth review of her case: a second, much more extensive operation, followed by six sessions of chemotherapy, followed by months of daily radiotherapy, followed by two sessions of brachytherapy.
Dr Jacquot could not have been more empathetic. He explained in detail what consequences all this would have. Danielle’s life would be dominated for the next year by a long series of treatments that were unpleasant to say the least. We were both shocked and close to tears.
Before arriving at a decision, we talked to friends and experts in this area. Opinions differed marginally. Two days later, we had made up her mind: we would stay in Brittany for the entire year and get Danielle treated exactly as Dr Jacquot suggested.
The second operation was much tougher than the first, but Danielle recovered well. Ten days later, she was back in our home and looked after by a nurse who came daily to change the bandages and give injections. On her third visit, the nurse broached the subject of chemotherapy which was scheduled to start soon. She explained how unpleasant it would be and what horrendous side effects Danielle was facing. Then she said: ‘You know, you don’t need to go through all this. They only pump you full with poison. There is a much better approach. Just follow the anti-cancer diet of Dr Schwartz.[1] It is natural and has no side effects. It would surely cure your cancer.’ When Danielle told me about this conversation, I informed the nurse that from now on I would myself take charge of the post-operative care of my wife and that her services were no longer required.
Today, Danielle is cancer-free. Had she listened to the nurse, she would almost certainly no longer be with us. But the lure of a ‘natural’ cancer cure with no side effects is almost irresistible. Faced with a serious diagnosis like cancer, most patients would consider any therapy that promises help without harm. Inevitably, they encounter a myriad of so-called alternative medicines (SCAMs), and many patients give SCAM a try.
In addition to Dr Schwartz’s cancer diet, there are hundreds of SCAMs that specifically target vulnerable cancer patients like Danielle. How can patients not be confused, and who might give them responsible advice? Conventional doctors rarely do. A recent summary of 29 relevant papers concluded that physicians will discuss complementary therapies only when a patient him/herself raises this issue within a consultation.[2] But cancer patients are often too embarrassed to ask about SCAM. Those who are courageous enough usually get short shrift. Many conventional doctors are not just critical about SCAM, but also know very little about the subject.[3]
Patients deserve evidence-based information, instead they often get unhelpful blanket statements from their GPs such as:
- ‘there is no evidence’;
- ‘that’s all rubbish, best to stay well clear of it’;
- ‘if you want to try it, go ahead, it cannot do much harm’.
All of these are untrue. Frustrated by such erroneous platitudes, patients might go on the Internet for help where they are bombarded with uncritical promotion. We investigated the information on SCAM for cancer provided by popular websites and found that they offer information of extremely variable quality. Many endorse unproven therapies and some are outright dangerous.[4] Sadly, the advice patients might glean from newspapers[5] or health-food stores[6] tends to be equally misleading and potentially harmful.
Subsequently, some patients might visit a library and read one of the many books on the subject. If anything, they are even worse. We have repeatedly analysed the contents of consumer guides on SCAM and always concluded that following their recommendations would shorten the life of the reader.[7] To give you a flavour, here are a few titles currently on sale:
- Cancer Medicine from Nature
- Outsmart Your Cancer: Alternative Non-Toxic Treatments That Work
- Cancer Medicine from Nature
- Perfect Guide on How to Cure Breast Cancer Through Curative Approved Alkaline Diets & Herbs
- How to Starve Cancer
- Healing the Prostate: The Best Holistic Methods to Treat the Prostate and Other Common Male-Related Conditions
- Outsmart Cancer: Defeat Cancer With Vitamin B17, Healthy Nutrition and Alternative Medicine
Cancer patients would, of course, all like to ‘outsmart cancer’; they are desperate and vulnerable. In this state of mind, they easily fall victim to anyone who sells false hope at inflated prices. The consequences can be tragic.
In 2016, the actress English Leah Bracknell, for example, raised ~£50 000 to treat her lung cancer in the German ‘Hallwang Private Oncology Clinic’. The SCAMs used there included homeopathy, micronutrients, natural supplements, whole-body hyperthermia, and ozone therapy, none of which cures cancer. If cancer patients fall for bogus treatments, they not just lose their money but also their lives. Leah Bracknell died of her cancer in 2019.[8]
Three basic facts are indisputably clear:
- a high percentage of cancer patients use SCAM,
- misinformation about SCAM is rife,
- misinformation endangers the lives of cancer patients.
It follows that there is an obvious and urgent need for an evidence-based text naming the SCAMs that are potentially harmful and discussing those that might be helpful.
My book is aimed at doing just that.
[1] Dr Laurent Schwartz cancérologue iconoclaste — Guérir du Cancer (guerir-du-cancer.fr)
[2] Stub T, Quandt SA, Arcury TA, et al. Perception of risk and communication among conventional and complementary health care providers involving cancer patients’ use of complementary therapies: a literature review. BMC Complement Altern Med. 2016;16(1):353. Published 2016 Sep 8. doi:10.1186/s12906-016-1326-3
[3] Ziodeen KA, Misra SM. Complementary and integrative medicine attitudes and perceived knowledge in a large pediatric residency program. Complement Ther Med. 2018;37:133-135. doi:10.1016/j.ctim.2018.02.004
[4] Schmidt K, Ernst E. Assessing websites on complementary and alternative medicine for cancer. Ann Oncol. 2004;15(5):733-742. doi:10.1093/annonc/mdh174
[5] Milazzo S, Ernst E. Newspaper coverage of complementary and alternative therapies for cancer–UK 2002-2004. Support Care Cancer. 2006;14(9):885-889. doi:10.1007/s00520-006-0068-z
[6] Mills E, Ernst E, Singh R, Ross C, Wilson K. Health food store recommendations: implications for breast cancer patients. Breast Cancer Res. 2003;5(6):R170-R174. doi:10.1186/bcr636
[7] https://edzardernst.com/2013/09/drowning-in-a-sea-of-misinformation-part-8-books-on-alternative-medicine/
[8] https://edzardernst.com/2019/10/leah-blacknell-1964-2019-another-victim-of-cancer-quackery/
____________________________________________
The publication of this book is perhaps the right occasion to publicly thank two regular and one occasional contributor to this blog. I am grateful to
- Prof. Michael Baum, emeritus professor, for writing the foreword,
- Dr. Julian Money-Kyrle, retired consultant oncologist, for his constructive comments on chapter 1.4,
- Richard Rasker for his corrections and advice on the entire text.
Thank you all.
Ever wondered what homeopathy truly is?
Who better to ask than Boiron?
On their website, Boiron (the largest manufacturer of homeopthics) explains:
Homeopathy is a therapeutic method that uses natural substances to relieve symptoms. It derives from the Greek words homeo, meaning “similar,” and pathos, meaning “suffering” (such as the pathology of a disease). Homeopathy operates on a “like cures like” principle that has been used empirically for more than 200 years and continues to be confirmed in pharmacological research and clinical studies.
What this means is a person suffering from symptoms can be treated by microdoses of a substance capable of producing similar symptoms in a healthy person. It is said that homeopathic medicines stimulate the body’s physiological reactions that restore health. This is accomplished with a very low risk of side effects due to the use of microdoses.
Homeopathy in Action
An example of how homeopathic medicines work is the similarity of symptoms between allergies and chopping onions. When you cut into an onion, your eyes will water and your nose runs. If similar symptoms appear after contact with pollen or a pet, the homeopathic medicine most appropriate to treat these symptoms is made from a tiny amount of onion. Instead of masking symptoms, the medicine sends the body a signal to help it rebalance and heal.
The Benefits of Homeopathy and You
A natural choice. The active ingredients in homeopathic medicines are made from diluted extracts of plants, animals, minerals, or other raw substances found in nature.
For everyday use. Similar to other over-the-counter (OTC) medicines, homeopathic medicines can be used to relieve symptoms of a wide range of common health conditions such as allergies, coughs, colds, flu, stress, arthritis pain, muscle pain, and teething.
Safe and reliable. Homeopathy has been used for more than 200 years, building a remarkable safety record and generating a great body of knowledge. Homeopathic medicines do not mask symptoms, are not contraindicated with pre-existing conditions, and are not known to interact with other medications or supplements, making them one of the safest choices for self-treatment.
Rigorous standards. Homeopathic medicines are manufactured according to the highest standards, complying with U.S. Food and Drug Administration regulations and the Homeopathic Pharmacopoeia of the United States (HPUS).
More choices and preferences. Homeopathic medicines are available in a variety of dosage forms such as gels, ointments, creams, syrups, eye drops, tablets, and suppositories.
_________________________
Are you pleased with this explanation?
No?
One must not be too harsh with Boiron and forgive them their errors; a powerful conflict of interest might have clouded their views. Therefore, I shall now take the liberty to edit and update their text ever so slightly.
Homeopathy is an obsolete method that used all sorts of substances in the misguided hope to relieve symptoms. The word derives from the Greek words homeo, meaning “similar,” and pathos, meaning “suffering” (such as the pathology of a disease). Homeopathy was alleged to operate on a “like cures like” principle that had been used empirically for more than 200 years but was refuted by pharmacological research, clinical studies and more.
What it suggested was that a person suffering from symptoms might be treated by the absence of a substance capable of producing similar symptoms in a healthy person. It was said that homeopathic medicines stimulate the body’s physiological reactions that restore health. These assumptions proved to be erroneous.
Homeopathy in Action
An example of how homeopathic medicines were supposed to work is the similarity of symptoms between allergies and chopping onions. When you cut into an onion, your eyes will water and your nose runs. If similar symptoms appear after contact with pollen or a pet, the homeopathic medicine most appropriate to treat these symptoms was assumed to be made with the memory of an onion. These ideas were never proven and had no basis in science.
The Alleged Benefits of Homeopathy
A natural choice. The active ingredients in homeopathic medicines were often made from diluted extracts of plants, animals, minerals, or other raw substances found in nature. The appeal to nature is, however, misleading: firstly the typical remedy did not contain anything; secondly, some remedies were made from synthetic substances (e. g. Berlin wall) or no substances (e. g. X-ray).
For everyday use. Similar to other over-the-counter (OTC) medicines, homeopathic medicines were promoted to relieve symptoms of a wide range of common health conditions such as allergies, coughs, colds, flu, stress, arthritis pain, muscle pain, and teething. These claims could never be verified and are therefore bogus.
Safe and reliable. Homeopathy had been used for more than 200 years. During all these years, no reliable safety record or body of knowledge had been forthcoming. Homeopathic medicines do not mask symptoms, are not contraindicated with pre-existing conditions, and are not known to interact with other medications or supplements. In fact, they have no effects whatsoever beyond placebo.
Rigorous standards. Homeopathic medicines were said to be manufactured according to the highest standards, complying with U.S. Food and Drug Administration regulations and the Homeopathic Pharmacopoeia of the United States (HPUS). This guaranteed that they were devoid of any active ingredient and made them pure placebos.
More choices and preferences. Homeopathic medicines were available in a variety of dosage forms such as gels, ointments, creams, syrups, eye drops, tablets, and suppositories. This means they offered a range of placebos to chose from.
In case, Boiron feels like adopting my updated, evidence-based version of their text, I am sure we can come to an agreement based on an adequate fee.
Ever since I published a post about the irresponsible and aggressive advertising campaign of LYMA (“the world’s 1st super-supplement”), I am pursued by them with emails informing me about the wonders of this supplement. Here is one I received recently:
Here at LYMA we are firm believers that optimal productivity depends on good quality sleep and your day is only as good as the previous night.
Suffering from bad sleep is debilitating whether it’s ourselves or we’re watching someone we love suffer, the search for good rest is something we’re all united in.
Energy levels, positive mindset and strong cognitive function all come from sleep, which is why we spent so long formulating the LYMA supplement. Our patented KSM-66® Ashwagandha is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world. The hefty combination of purity and potency make it unrivalled in its ability to reduce inflammation, neutralise anxiety and promote deep, restful sleep, night after night.
Thousands of customers have told us that after years of bad sleep, they’re finally getting the rest they need and feeling transformed as a result. In fact, it’s one of the very first benefits most people notice. We’re happy to hear it.
And the knock-on effects of a good night’s sleep in how we feel, how we perform and our overall health are far reaching. Which is why we are so delighted to welcome Michael Grandner, world-renowned sleep expert and Director of the Behavioural Sleep Medicine Clinic, Arizona to the LYMA team.
Michael is one of the most cited sleep experts in the world and has himself published over 175 articles on issues relating to sleep and health. We plan on tapping into every area of his expertise to understand our own sleep habits and how we can all become the best at rest.
To introduce Michael to the LYMA community we’re hosting a seminar dedicated to understanding sleep on Tuesday 22nd June…
I was tempted to discard all this as rather pathetic advertising hype. But then I had second thoughts. This text does after all make several medical claims, and the question is: ARE THEY SUPPORTED BY EVIDENCE?
It claims that KSM-66® Ashwagandha:
- is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world.
- That the hefty combination of purity and potency makes it unrivalled in its ability to reduce inflammation.
- That the product neutralises anxiety.
- That it promotes deep, restful sleep, night after night.
I ran a few searches to find out whether there is any sound evidence for any of these claims.
- There seem to be several supplements that contain,KSM-66® Ashwagandha’. The impression that LYMA is the only one is thus wrong. Zero toxicity must also be wrong; not even water has zero toxicity. In fact, epigastric pain/discomfort and loose stools were reported as most common (>5%); and giddiness, drowsiness, hallucinogenic, vertigo, nasal congestion (rhinitis), cough, cold, decreased appetite, nausea, constipation, dry mouth, hyperactivity, nocturnal cramps, blurring of vision, hyperacidity, skin rash and weight gain have all been associated with the herbal remedy. Moreover, if it is true that Ashwagandha stimulates the immune system, it might cause problems for people with autoimmune diseases.
- I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha reduces inflammatory conditions in humans.
- I found a study concluding that Ashwagandha given as an adjunct offered some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. Yet, I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha as a single supplement reduces anxiety in otherwise healthy individuals.
- A 2021 study suggested that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Yet the authors cautioned that additional clinical trials are required to generalize the outcome.
So, what does that tell us?
It could mean that:
- My searches were not sufficiently thorough and that I have missed compelling evidence. If so, I would appreciate, if the LYMA promoters would show me their evidence so that I can assess it.
- The LYMA people are irresponsible and mislead the public with untenable claims.
I am looking forward to their response.
By guest blogger Michael Scholz
For several years, the “flower essences” invented by Dr. Edward Bach had a difficult time in the European Union and especially Germany. The manufacturers were regularly taken to court for violating the EU Health Claim Regulation. This now culminates in the fact that the manufacturer, Nelsons, who sells the “Original Bach Flowers” in Germany, was forced to rename its popular “Rescue” remedies.
What happened?
The “Rescue” remedies were promoted with statements such as “calm and strong through the day” and “recommended use in emotionally exciting situations, e.g. at work” or to “face emotional challenges”. The competitor, Annoyax Nutripharm, regarded this as a health-related statement that is prohibited according to the EU Health Claim Regulation. Since the “Bach Flower Remedies” are not considered to be medicinal products in Germany, they are treated as food supplements, according to a ruling by the Oberlandesgericht (Higher Regional Court) Hamburg in 2007.
As it is strictly forbidden to advertise food supplements with health-related claims that are unproven, Annoyax Nutripharm filed a lawsuit against Nelsons that all the way to the Bundesgerichtshof (Federal High Court of Justice) in Karlsruhe. Since the case concerned European law, the judges in Karlsruhe referred it to the European Court of Justice in Luxemburg.
The judges wanted two questions clarified: 1. Are the “Rescue” remedies to be regarded simply as Brandy due to their alcohol content of 27%? (in which case, health-related claims would be strictly forbidden). 2. Does the product’s name “Rescue” itself constitute a violation of the Health Claims Regulation?
The Luxemburg judges ruled “No” and “Yes”. “No”, it is not Brandy, although the „essences“ consist of a considerable quantity of alcohol, the recommended dose is too small to be intoxicating. But “Yes”, the term “Rescue” does indeed violate the Health Claim Regulation. So the plaintiff won – and what is the result?
When the Health Claims Regulation was enacted in 2005, a transition period until 2022 was established. This applied to all products that were sold using the same brand name and composition before 2005. This now gave the defendant – Nelsons – the opportunity to use Edward Bach’s 135th anniversary for launching an advertising campaign that praises the court-ordered renaming as „modernization“ for the 21st century. And as you see, the new name is a paragon of creativity, innovation & modernism, indeed (//irony:off): “Rescue” becomes – drum roll – “Rescura”. Yes, I looked just like that too…
This pyrrhic victory for the plaintiffs shows how important it is to protect the European citizens against misleading advertising. And – far more important – it is now established through a ruling of the Federal High Court of Justice that “Bach Flowers” are an esoterical concept devoid of medical evidence.
We live in truly grim times! Let me therefore try to cheer you up a little. Here is a story that might make you smile.
In 1981, I moved back from London to Munich. While still in London, I had written an article on garlic for a German medical journal. It was published just as we arrived in our new home. Here is it’s English abstract:
Garlic has had a firm place in folk medicine since ancient times. More recent results are summarized here which show that extracts of the plant have an antimicrobial action, they are capable of lowering blood cholesterol and of reducing secondary vascular changes. They raise fibrinolytic activity and inhibit thrombocyte aggregation. Therefore the plant contains highly active therapeutic principles which appear to be particularly suitable for prophylaxis of arteriosclerosis.
Yes, you are quite right, this paper is nothing to write home about. So, why do I consider it ‘most consequential‘? Here is what happened:
My wife and I had barely arrived in our new home, when a man phoned (he had gone to a lot of trouble to find my number) and said: “I know you are the leading expert on garlic; I urgently need to talk to you”. Never correct a man’s mistake, if it’s in your favour, I thought, and we made an appointment for a meeting at the Munich train station hotel.
When I met him a few days later, he ordered me a coffee (which later I had to pay for) and explained that he had worked his whole life (he was about 50, I guessed) for the pharmaceutical industry and had now decided that this was enough. He thus planned to set up his own pharmaceutical company. He already had a photocopy machine in his basement, he proudly told me, and a wife who was willing to work as hard as he was. Specifically, his plan was to launch a garlic pill, and for that he needed my advice. I told him what he wanted to know, and we parted after about two hours promising to stay in contact.
The man’s name was Kuno Lichtwer.
During the weeks that followed, he often phoned me to pick my brain. One day, he told me that he had everything in place: he had found a supplier of the materials, a manufacturer to produce the pills and even registered a name for it:
KWAI
Then he popped the question that was foremost on his mind: ‘What do you think, Dr Ernst, should I risk it and go ahead with this or not?’. I had started to like that man; he was going to lose all his savings on a crazy idea, I felt. So, I told him: ‘If I were you, I would not do it. There are already plenty of garlic pills on the market. You are risking to lose everything.’ Then there was a long pause; eventually, he thanked me for my honest advice and hung up.
Weeks later he phoned again to tell me that he had truly appreciated my brutally direct advice, thought long and hard about it, but went ahead with his plan anyway. Would I now accept the position of ‘medical advisor’ to Lichwer Pharma? I was surprised, but accepted this new post. Thereafter, I advised him the best I could. We even conducted and published the very first clinical trial with his product. It was a rather flimsy study (we had no funds at all), but did suggest a positive result.
Each time Mr Lichtwer called me, he was elated; things were not just going well, they were booming! He was evidently hugely gifted in promoting KWAI. Then he invited me several times to come to Berlin where Lichtwer Pharma was based for business meetings. Proudly, he showed me that meanwhile his firm had moved out of his basement into a proper building. The next I knew was that he had a dozen employees. Lichtwer seemed unstoppable. This went on for 2 or 3 years, if I remember correctly.
During all this time, we had never talked about money, and my work for him had always been unpaid – that is, until one day just before Christmas he phoned and explained that he had moved his firm to yet a bigger building and hired yet more staff. He also realised that I deserved some renumeration for my advice; therefore, he had put a cheque in the post. When I told my wife about it, we both celebrated in anticipation of the substantial windfall. Two days later, his letter arrived. He very kindly thanked me for years of work and included a cheque of 500 DM (about 150 DM per year of work). A few months later, his firm had grown so big that a full time medical and research director was badly needed. He informed me that he had found a highly experienced expert and invited me to meet the new man, Prof Schulz.
No, I did not feel hard done by! On the contrary, I was happy that my prediction had been grossly wrong and that my friend Kuno was doing so well. In addition, I was also relieved, because my research at the University did not give me nearly enough time to look adequately after the now substantial firm of Lichtwer Pharma.
Thereafter, Lichtwer’s garlic pill went from strength to strength. Several larger studies confirmed our initial results that garlic positively influenced blood lipids (in 2000, our systematic review concluded: The available data suggest that garlic is superior to placebo in reducing total cholesterol levels. However, the size of the effect is modest, and the robustness of the effect is debatable. The use of garlic for hypercholesterolemia is therefore of questionable value). One day, I read somewhere that KWAI had become the most consumed pill in Germany (even beating Aspirin). Then Lichtwer Pharma went international and added several further herbal products to its portfolio. In 1991, Lichtwer Pharma was estimated to be worth 100 Million DM. Several years later, the firm had almost 400 employees and a yearly turnover of 353 Million DM.
To his credit, Kuno Lichtwer never entirely forgot me. When I had moved to the UK, he even came to Exeter, was entertained by my University, and made a donation of £100 000 towards a ‘Lichtwer Research Fellowship’ for my department. I am not sure whether Kuno Lichtwer is still alive. If he is, he would probably agree that, had I offered him 10 000 DM of my savings during our 1st meeting in 1981 (he did hint at that possibility), he would have gladly made me a partner in his enterprise.
But, as they say: money is not everything.
And a good story to tell is also not bad.
This study assessed the patterns of dietary supplement usage among cancer survivors in the United States in a population-based setting. National Health and Nutrition Examination Survey (NHANES) datasets (1999-2016) were accessed, and adult respondents (≥ 20 years old) with a known status of cancer diagnosis and a known status of dietary supplements intake were included. Multivariable logistic regression analysis was then used to assess factors associated with dietary supplements intake. Moreover, and to evaluate the impact of dietary supplements on overall survival among respondents with cancer, multivariable Cox regression analysis was conducted.
A total of 49,387 respondents were included in the current analysis, including a total of 4,575 respondents with cancer. Among respondents with cancer, 3,024 (66.1%) respondents reported the use of dietary supplements; while 1,551 (33.9%) did not report the use of dietary supplements. Using multivariable logistic regression analysis, factors associated with the use of dietary supplements included:
- older age (OR: 1.028; 95% CI: 1.027-1.030);
- white race (OR for black race vs. white race: 0.67; 95% CI: 0.63-0.72);
- female gender (OR for males vs. females: 0.56; 95% CI: 0.53-0.59),
- higher income (OR: 1.13; 95% CI: 1.11-1.14),
- higher educational level (0.59; 95% CI: 0.56-0.63),
- better self-reported health (OR: 1.36; 95% CI: 1.17-1.58),
- health insurance (OR: 1.35; 95% CI: 1.27-1.44),
- history of cancer (OR: 1.20; 95% CI: 1.10-1.31).
Using multivariable Cox regression analysis and within the subgroup of respondents with a history of cancer, the use of dietary supplements was not found to be associated with a difference in overall survival (HR: 1.13; 95% CI: 0.98-1.30).
The authors concluded that dietary supplement use has increased in the past two decades among individuals with cancer in the United States, and this increase seems to be driven mainly by an increase in the use of vitamins. The use of dietary supplements was not associated with any improvement in overall survival for respondents with cancer in the current study cohort.
Many cancer patients, when they first get diagnosed, are tested for vitamin D levels and found to be low or borderline. Consequently, they get a prescription for supplements. Other than this, there is rarely an indication to take any vitamins or other dietary supplements. Yet, cancer patients take them because they think these ‘natural’ preparations can do no harm (and because the industry can be persuasive [there is big money at stake] and the odd breed of ‘integrated’ oncologists might even recommend them). Sadly, this assumption is not correct. The biggest danger, in my view, is the possibility of supplements to interact with one of the many drugs that cancer patients need to take. So, in a way, it is reassuring that, on average, there is no detrimental effect on overall survival.
The paper will probably also reignite the perennial discussion about the effects of vitamin C on the natural history of cancer. My understanding is that there is none (and this verdict seems to be supported by the findings reported here). But I am, of course, aware that this is a ‘hot potato’ and that some readers will think differently. To them I say: please show me the evidence.
I have to thank one of our regular commentators for inspiring me to write this post. He recently contributed this insight about homeopathic provings:
If you didn’t experience anything from a proving you didn’t perform it properly.
It is an argument that, in different forms and shapes, I have heard very often. Essentially it holds that, if an investigation or a test fails to produce the desired result, the methodology must have been faulty. Donald Trump is, I fear, about to use it in the upcoming US election: if he is voted out, he will claim that there was too much fraud going on. Therefore, he cannot accept the result as valid. Thus it is his democratic duty to remain in post, he is likely to claim.
In medicine, the argument has been popular since millennia. In our book TRICK OR TREATMENT?, we recount the story of blood letting. Based on the doctrine of the 4 humours, it was believed for centuries to be a panacea. If someone died after losing litres of blood to the believers in the doctrine, the assumption was not that he had been bled to death, but that he had sadly not received enough of the ‘cure all’. Eventually, some bright chap had the novel idea of running a rigorous test of blood-letting, and it turned out that the patients who had received the treatment had a worse chance of survival than those who had escaped it. Aaaahhh !!!, shouted the blood-letters, this shows that the concept of the scientific test is flawed.
Checking the methodological rigour of clinical studies (or homeopathic provings) can be a tricky and tedious business. It requires proper learning and experience – qualities that SCAM fanatics rarely possess. Amongst other things, one needs to know about:
- trial design,
- statistics,
- sources of bias,
- confounding,
- and the many tricks people use to hide flaws in published studies.
This is not easy and it takes time – lots of time – to acquire the necessary skills. Having discussed such issues with enthusiasts of so-called alternative medicine (SCAM) for decades, I realise that it would be unrealistic to expect of them to spend all this time learning all these complicated things (they have to make a living, you know!). I therefore propose an entirely new and much simpler method of differentiating between valid and invalid research of SCAM. It rests on merely 2 golden rules:
- Any research methodology is valid, if it produces the desired result.
- Any research methodology is invalid, if it fails to produce the desired result.
In analogy to these two rules, one can easily extrapolate further. For instance, one can state that:
- any person who generates or promotes the desired result is honest;
- any person who contradicts the desired result is corrupt (bought by ‘Big Pharma’).
I am sure my readers all see the beauty of this revolutionary, new system: it’s easy to learn, practical to apply, it avoids controversy and it takes full account of the previously much-neglected needs of the SCAM fraternity.
Recently, I have received this message via the comments section of my blog:
“you’re actually an evil old nut-job Ed—been following your pharma ‘science’ bullshit for years—all opinion and ignorance and anti-science”
Don’t get me wrong, such attacks do not bother me – not any more. On the contrary, they amuse me. At one stage, I even started collecting them. Nowadays, I usually ignore them.
But this one is somewhat special. Therefore, I decided to analyse it a bit. The author essentially makes 9 claims:
- I am evil.
- I am old.
- I am a nut-job.
- I am called Ed.
- I conduct pharma science.
- I publish bullshit.
- All I state is opinion.
- I am ignorant.
- I am anti-science.
Yes, that’s quite a list. Let me try to tackle it one by one.
- Am I evil? I have had many ad hominem attacks before but, as far as I remember, nobody has yet alleged that I am evil. I looked it up, evil means: wicked · bad · wrong · morally wrong · wrongful · immoral · sinful · ungodly · unholy · foul · vile · base · ignoble · dishonorable · corrupt · iniquitous · depraved · degenerate · villainous · nefarious · sinister · vicious · malicious · malevolent · demonic · devilish · diabolic · diabolical · fiendish · dark · black-hearted · monstrous · shocking · despicable · atrocious · heinous · odious · contemptible · horrible · execrable · lowdown · stinking · dirty · shady · warped · bent · crooked · dastardly · black · egregious · flagitious · peccable. I am obviously the wrong person to judge, but I do not think that these attributes describe me all that well.
- Yes, I am old, 72 to be precise.
- Am I a nut-job? I looked that one up too. It’s a mentally unbalanced person. Call me biased, but I don’t think that this applies to me at all.
- No, I am not called Ed.
- I am not quite sure what ‘pharma science’ is supposed to mean, but one thing I do know for sure: since I research so-called alternative medicine (SCAM) – and that’s about 30 years now – I have not taken research funds from the pharmaceutical industry. And before I very rarely did.
- As I have published a sizable amount of papers and blog-posts, there must have been a bit of BS in some of it. But I do not think it can be much.
- All I state is opinion? Oh really! Opinion comes into blog-posts regularly; without it my stuff would be boring like hell. But ALL of it? I don’t think so.
- Am I ignorant? Yes, certainly; there are lots of things I don’t know, even in medicine. But in SCAM I do know quite a bit – even if I say so myself.
- Anti-science? That last allegation is probably the most far-fetched of them all. No, I am not anti-science, never have been and never will be.
So, Paul – the author of the comment preferred to remain anonymous and simply calls himself Paul – I have tried to give you credit where I could but, on the whole, I fear your ad hominem attack is yet another victory of reason over unreason. I thank you Paul for two reasons:
- firstly for the just-mentioned victory; it always feels good to be on a winning side,
- secondly for the stimulus and motivation to carry on doing what I have been doing for many years; your comment has shown me how much needed my work is in disclosing quackery, correcting errors, teaching critical thinking and responsibly informing the public.
THANKS PAUL
