diet
I had come across them so often that I had almost stopped noticing them: the ‘little extras‘ that make ineffective so-called alternative medicines (SCAMs) seem effective. Then, recently, during an interview about detox diets, the interviewer responded to my explanation of the ineffectiveness of these treatments by saying: “but these diets include stopping the consumption of alcohol, cigarettes, and other harmful stuff; therefore they must be good.” This seemingly convincing argument reminded me of a phenomenon – I call it here the ‘little extra‘ – that applies to so many (if not most) SCAMs.
Let me schematically summarise it as follows:
- A practitioner applies an ineffective SCAM to a patient.
- Because it is ineffective, it has little effect other than a small placebo response.
- The ineffective SCAM comes with a ‘little extra‘ which is unrelated to the SCAM.
- The ‘little extra‘ is effective.
- The end result is that the ineffective SCAM appears to be effective.
The above example makes it quite clear: the detox diet is utter nonsense but, as it goes hand in hand with effective lifestyle changes, it appears to be effective. A classic case. But SCAM offers no end of similar examples:
- Acupuncture is useless but it involves touch, time, attention, and empathy all of which are effective in making a patient feel better.
- Chiropractic is useless but it involves touch, time, attention, and empathy all of which are effective in making a patient feel better.
- Homeopathy is useless but it involves a long, empathic consultation and attention which are effective in making a patient feel better.
- Osteopathy is useless but it involves touch, time, attention, and empathy all of which are effective in making a patient feel better.
- Reflexology is useless but it involves touch, time, attention, and empathy all of which are effective in making a patient feel better.
Do I need to continue?
Probably not!
The ‘little extras‘ are often forgotten or subsumed under the heading ‘placebo’. Yet, they are not part of the placebo effect. Strictly speaking, they are concomitant treatments comparable to a pain patient using SCAM and also taking a few paracetamols. In the end, she forgets about the painkillers and thinks that her SCAM worked wonders.
Even ardent SCAM proponents have long realized this phenomenon. Here, for example, is a paper entitled ‘Acupuncture as a complex intervention: a holistic model’ by ex-colleagues of mine at Exeter looking at it but coming up with a very different perspective:
Objectives: Our understanding of acupuncture and Chinese medicine is limited by a lack of inquiry into the dynamics of the process. We used a longitudinal research design to investigate how the experience, and the effects, of a course of acupuncture evolved over time.
Design and outcome measures: This was a longitudinal qualitative study, using a constant comparative method, informed by grounded theory. Each person was interviewed three times over 6 months. Semistructured interviews explored people’s experiences of illness and treatment. Across-case and within-case analysis resulted in themes and individual vignettes.
Subjects and settings: Eight (8) professional acupuncturists in seven different settings informed their patients about the study. We interviewed a consecutive sample of 23 people with chronic illness, who were having acupuncture for the first time.
Results: People described their experience of acupuncture in terms of the acupuncturist’s diagnostic and needling skills; the therapeutic relationship; and a new understanding of the body and self as a whole being. All three of these components were imbued with holistic ideology. Treatment effects were perceived as changes in symptoms, changes in energy, and changes in personal and social identity. The vignettes showed the complexity and the individuality of the experience of acupuncture treatment. The process and outcome components were distinct but not divisible, because they were linked by complex connections. The paper depicts these results as a diagrammatic model that illustrates the components and their interconnections and the cyclical reinforcement, both positive and negative, that can occur over time.
Conclusions: The holistic model of acupuncture treatment, in which “the whole being greater than the sum of the parts,” has implications for service provision and for research trial design. Research trials that evaluate the needling technique, isolated from other aspects of process, will interfere with treatment outcomes. The model requires testing in different service and research settings.
I think the perspective of viewing SCAMs as complex interventions is needlessly confusing and deeply unhelpful. The truth is that there is no treatment that is not complex. Take a surgical treatment, for instance, it involves dozens of ‘little extras‘ that are known to be effective. Should we, therefore, try to use this fact for justifying useless surgical interventions? Or take a simple prescription of medication from a doctor. It involves time, empathy, attention, explanations, etc. all of which will affect the patient’s symptoms. Should we thus use this to justify a useless drug? Certainly not!
And for the same reason, it is nonsense to use the ‘little extras‘ that come with all the numerous ineffective SCAMs as a smokescreen that makes them look effective.
The ‘keto diet’ is a currently popular high-fat, low-carbohydrate diet; it limits the intake of glucose which results in the production of ketones by the liver and their uptake as an alternative energy source by the brain. It is said to be an effective treatment for intractable epilepsy. In addition, it is being promoted as a so-called alternative medicine (SCAM) for a wide range of conditions, including:
- weight loss,
- cognitive and memory enhancement,
- type II diabetes,
- cancer,
- neurological and psychiatric disorders.
Now, it has been reported that the ‘keto diet’ may be linked to higher levels of cholesterol and double the risk of cardiovascular events. In the study, researchers defined a low-carb, high-fat (LCHF) diet as 45% of total daily calories coming from fat and 25% coming from carbohydrates. The study, which has so far not been peer-reviewed, was presented Sunday at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.
“Our study rationale came from the fact that we would see patients in our cardiovascular prevention clinic with severe hypercholesterolemia following this diet,” said Dr. Iulia Iatan from the Healthy Heart Program Prevention Clinic, St. Paul’s Hospital, and University of British Columbia’s Centre for Heart Lung Innovation in Vancouver, Canada, during a presentation at the session. “This led us to wonder about the relationship between these low-carb, high-fat diets, lipid levels, and cardiovascular disease. And so, despite this, there’s limited data on this relationship.”
The researchers compared the diets of 305 people eating an LCHF diet with about 1,200 people eating a standard diet, using health information from the United Kingdom database UK Biobank, which followed people for at least a decade. They found that people on the LCHF diet had higher levels of low-density lipoprotein and apolipoprotein B. Apolipoprotein B is a protein that coats LDL cholesterol proteins and can predict heart disease better than elevated levels of LDL cholesterol can. The researchers also noticed that the LCHF diet participants’ total fat intake was higher in saturated fat and had double the consumption of animal sources (33%) compared to those in the control group (16%). “After an average of 11.8 years of follow-up – and after adjustment for other risk factors for heart disease, such as diabetes, high blood pressure, obesity, and smoking – people on an LCHF diet had more than two times higher risk of having several major cardiovascular events, such as blockages in the arteries that needed to be opened with stenting procedures, heart attack, stroke, and peripheral arterial disease.” Their press release also cautioned that their study “can only show an association between the diet and an increased risk for major cardiac events, not a causal relationship,” because it was an observational study, but their findings are worth further investigation, “especially when approximately 1 in 5 Americans report being on a low-carb, keto-like or full keto diet.”
I have to say that I find these findings not in the slightest bit surprising and would fully expect the relationship to be causal. The current craze for this diet is concerning and we need to warn consumers that they might be doing themselves considerable harm.
Other authors have recently pointed out that, within the first 6-12 months of initiating the keto diet, transient decreases in blood pressure, triglycerides, and glycosylated hemoglobin, as well as increases in HDL and weight loss may be observed. However, the aforementioned effects are generally not seen after 12 months of therapy. Despite the diet’s favorable effect on HDL-C, the concomitant increases in LDL-C and very-low-density lipoproteins (VLDL) may lead to increased cardiovascular risks. And another team of researchers has warned that “given often-temporary improvements, unfavorable effects on dietary intake, and inadequate data demonstrating long-term safety, for most individuals, the risks of ketogenic diets may outweigh the benefits.”
Konjac glucomannan (KGM), also just called ‘glucomannan’, is a dietary fiber hydro colloidal polysaccharide isolated from the tubers of Amorphophallus konjac. It is used as a food, a food additive, as well as a dietary supplement in many countries. KGM is claimed to reduce the levels of glucose, cholesterol, triglycerides, and blood pressure.
The objective of this study was to evaluate the effect of the consumption of gummy candy enriched with KGM on appetite and to evaluate anthropometric data, biochemical, and oxidative stress markers in overweight individuals. Forty-two participants aged 18 to 45 years completed this randomized, double-blind, placebo-controlled clinical trial. Participants were randomly assigned to consume for 14 days, 2 candies per day, containing 250 mg of KGM or identical-looking placebo candy with 250 mg of flaxseed meal, shortly after breakfast and dinner. As a result, we observed that there was a reduction in waist circumference and in the intensity of hunger of the participants who consumed KGM. The authors believe that a longer consumption time as well as an increased dose of KGM would contribute to even more satisfactory body results.
These findings seem promising, yet somehow I am not convinced. The study was small and short-term; moreover, the authors seem uncritical and, instead of a conclusion, they offer speculations.
Our own review of 2014 included 9 clinical studies. There was a variation in the reporting quality of the included RCTs. A meta-analysis (random effect model) of 8 RCTs revealed no significant difference in weight loss between glucomannan and placebo (mean difference [MD]: -0.22 kg; 95% confidence interval [CI], -0.62, 0.19; I(2) = 65%). Adverse events included abdominal discomfort, diarrhea, and constipation. We concluded that the evidence from available RCTs does not show that glucomannan intake generates statistically significant weight loss. Future trials should be more rigorous and better reported.
Rigorous trials are required to change my mind, and I am not sure that the new study falls into this category.
The concept of ultra-processed food (UPF) was initially developed and the term coined by the Brazilian nutrition researcher Carlos Monteiro, with his team at the Center for Epidemiological Research in Nutrition and Health (NUPENS) at the University of São Paulo, Brazil. They argue that “the issue is not food, nor nutrients, so much as processing,” and “from the point of view of human health, at present, the most salient division of food and drinks is in terms of their type, degree, and purpose of processing.”
Examples of UPF include:
- Carbonated soft drinks,
- Sweet, fatty or salty packaged snacks,
- Candies (confectionery),
- Mass-produced packaged breads and buns,
- Cookies (biscuits),
- Pastries,
- Cakes and cake mixes,
- Margarine and other spreads,
- Sweetened breakfast cereals,
- Sweetened fruit yoghurt and energy drinks,
- Powdered and packaged instant soups, noodles, and desserts,
- Pre-prepared meat, cheese, pasta and pizza dishes,
- Poultry and fish nuggets and sticks,
- Sausages, burgers, hot dogs, and other reconstituted meat products,
Ultra-processed food is bad for our health! This message is clear and has been voiced so many times – not least by proponents of so-called alternative medicine (SCAM) – that most people should now understand it.
But how bad?
And what diseases does UPF promote?
How strong is the evidence?
I did a quick Medline search and was overwhelmed by the amount of research on this subject. In 2022 alone, there were more than 2000 publications! Here are the conclusions from just a few recent studies on the subject:
- Higher intake of UPFs was associated with higher incidence of Crohn’s disease, but not ulcerative colitis. In individuals with a pre-existing diagnosis of inflammatory bowel disease, consumption of UPFs was significantly higher compared to controls, and was associated with an increased need for IBD-related surgery. Further studies are needed to address the impact of UPF intake on disease pathogenesis, and outcomes.
- In this prospective cohort study, higher consumption of UPF was associated with higher risk of dementia, while substituting unpr2ocessed or minimally processed foods for UPF was associated lower risk of dementia.
- In almost all countries and age groups, increases in the dietary share of ultraprocessed foods were associated with increases in energy density and free sugars and decreases in fiber, suggesting that ultraprocessed food consumption is a potential determinant of obesity in children and adolescents.
- Higher ultraprocessed foods consumption was independently associated with a higher risk of incident chronic kidney disease in a general population.
- These data suggest that a consistent intake of ultra-processed foods over time is needed to impact nutritional status and body composition of children and adolescents.
- This meta-analysis suggests that high consumption of UPF, sugar-sweetened beverages, artificially sweetened beverages, processed meat, and processed red meat might increase all-cause mortality, while breakfast cereals might decrease it.
- The consumption of ultraprocessed foods represents a significant cause of premature death in Brazil.
- Available evidence suggests that UPFs may increase cancer risk via their obesogenic properties as well as through exposure to potentially carcinogenic compounds such as certain food additives and neoformed processing contaminants.
- The high consumption of UPF, almost more than 10% of the diet proportion, could increase the risk of developing type 2 diabetes in adult individuals.
Don’t get me wrong: this is not a systematic review of the subject. I am merely trying to give a rough impression of the research that is emerging. A few thoughts seem nonetheless appropriate.
- The research on this subject is intense.
- Even though most studies disclose associations and not causal links, there is in my view no question that UPF aggravates many diseases.
- The findings of the current research are highly consistent and point to harm done to most organs.
- Even though this is a subject on which advocates of SCAM are exceedingly keen, none of the research I saw was conducted by SCAM researchers.
- The view of many SCAM proponents that conventional medicine does not care about nutrition is clearly not correct.
- Considering how unhealthy UPF is, there seems to be a lack of effective education and action aimed at preventing the harm UPF does to us.
The UK medical doctor, Sarah Myhill, has a website where she tells us:
Everyone should follow the general approach to maintaining and restoring good health, which involves eating a paleo ketogenic diet, taking a basic package of nutritional supplements, ensuring a good night’s sleep on a regular basis and getting the right balance between work, exercise and rest. Because we live in an increasingly polluted world, we should probably all be doing some sort of detox regime.
She also happens to sell dietary supplements of all kinds which must surely be handy for all who want to follow her advice. Dr. Myhill boosted her income even further by putting false claims about Covid-19 treatments online. And that got her banned from practicing for nine months after a medical tribunal.
She posted videos and articles advocating taking vitamins and other substances in high doses, without evidence they worked. The General Medical Council (GMC) found her recommendations “undermined public health” and found some of her recommendations had the potential to cause “serious harm” and “potentially fatal toxicity”. The tribunal was told she uploaded a series of videos and articles between March and May 2020, describing substances as “safe nutritional interventions” which she said meant vaccinations were “rendered irrelevant”. But the substances she promoted were not universally safe and have potentially serious health risks associated with them, the panel was told. The tribunal found Dr. Myhill “does not practice evidence-based medicine and may encourage false reassurance in her patients who may believe that they will not catch Covid-19 or other infections if they follow her advice”.
Dr. Myhill previously had a year-long ban lifted after a General Medical Council investigation into her claims of being a “pioneer” in the treatment of chronic fatigue syndrome. In fact, the hearing was told there had been 30 previous GMC investigations into Dr. Myhill, but none had resulted in findings of misconduct.
Dr. Myhill is also a vocal critic of the PACE trial and biopsychosocial model of ME/CFS. Dr. Myhill’s GMC complaint regarding a number of PACE trial authors was first rejected without investigation by the GMC, after Dr. Myhill appealed the GMC stated they would reconsider. Dr. Myhill’s action against the GMC for failing to provide reasoning for not investigating the PACE trial authors is still continuing and began a number of months before the most recent GMC instigation of her practice started.
The recent tribunal concluded: “Given the circumstances of this case, it is necessary to protect members of the public and in the public interest to make an order suspending Dr. Myhill’s registration with immediate effect, to uphold and maintain professional standards and maintain public confidence in the profession.”
This prospective study aimed to identify an optimal lifestyle profile to protect against memory loss in older individuals from areas representative of the north, south, and west of China. Individuals aged 60 years or older who had normal cognition and underwent apolipoprotein E (APOE) genotyping at baseline in 2009 were included. Participants were followed up until death, discontinuation, or 26 December 2019.
Six lifestyle factors were assessed:
- a healthy diet (adherence to the recommended intake of at least 7 of 12 eligible food items),
- regular physical exercise (≥150 min of moderate intensity or ≥75 min of vigorous intensity, per week),
- active social contact (≥twice per week),
- active cognitive activity (≥twice per week),
- never or previously smoked,
- never drinking alcohol.
Participants were categorised into the favourable group if they had 4-6 healthy lifestyle factors, into the average group for two to three factors, and into the unfavourable group for zero to one factor.
Memory function was assessed using the World Health Organization/University of California-Los Angeles Auditory Verbal Learning Test, and global cognition was assessed via the Mini-Mental State Examination. Linear mixed models were used to explore the impact of lifestyle factors on memory in the study sample.
A total of 29 072 participants were included (mean age of 72.23 years; 48.54% (n=14 113) were women; and 20.43% (n=5939) were APOE ε4 carriers). Over the 10-year follow-up period (2009-19), participants in the favourable group had slower memory decline than those in the unfavourable group (by 0.028 points/year, 95% confidence interval 0.023 to 0.032, P<0.001). APOE ε4 carriers with favourable (0.027, 95% confidence interval 0.023 to 0.031) and average (0.014, 0.010 to 0.019) lifestyles exhibited a slower memory decline than those with unfavourable lifestyles. Among people who were not carriers of APOE ε4, similar results were observed among participants in the favourable (0.029 points/year, 95% confidence interval 0.019 to 0.039) and average (0.019, 0.011 to 0.027) groups compared with those in the unfavourable group. APOE ε4 status and lifestyle profiles did not show a significant interaction effect on memory decline (P=0.52).
The authors concluded that a healthy lifestyle is associated with slower memory decline, even in the presence of the APOE ε4 allele. This study might offer important information to protect older adults against memory decline.
This is an important and meticulously reported study. It is the first large-scale investigation that assesses the effects of different lifestyle profiles, APOE ε4 status, and their interactions on longitudinal memory trajectories over a 10-year follow-up period. The results show that lifestyle is associated with the rate of memory decline in cognitively normal older individuals, including in people who are genetically susceptible to memory decline. The authors are rightly careful to avoid causal inferences between lifestyle and memory decline. To demonstrate causality beyond doubt, we would need different study designs.
The authors also discuss several weaknesses of the study:
- Firstly, the assessments of lifestyle factors were based on self-reports and are, therefore, prone to measurement errors.
- Secondly, several participants were excluded due to missing data or not returning for follow-up evaluations, which might have led to selection bias.
- Thirdly, the proportion of individuals with an unhealthy lifestyle might have been underestimated in the study because people with poor health were less likely to have participated in the study.
- Fourthly, given the nature of the study design, it could not assess whether maintaining a healthy lifestyle had already started influencing memory by the time of enrolment in the study.
- Fifthly, the evaluation of memory using a single neuropsychological test that does not comprehensively reflect overall memory function. However, the Auditory Verbal Learning Test is an effective instrument for memory assessment, and a composite score was used based on four Auditory Verbal Learning Test subscales to represent memory conditions to the greatest extent possible.
- Sixthly, as participants might become familiar with repeated cognitive testing, a learning effect could have influenced the results.
- Finally, memory decline was studied solely among older adults; however, memory problems commonly affect young individuals as well.
The authors, therefore, state that further studies should be conducted to facilitate a more extensive investigation into the effects of a healthy lifestyle on memory decline across the lifespan. This approach would help to elucidate the crucial age window during which a healthy lifestyle can exert the most favourable effect.
Chronic kidney disease is common, often progressive, and difficult to treat or prevent. Effective interventions would therefore be more than welcome. This paper explored the relation of habitual fish oil use with the risk of chronic kidney diseases (CKD).
A total of 408,023 participants (54.2% female) without prior CKD and with completed information regarding their consumption of major food groups and fish oil in the UK Biobank were enrolled. Fish oil use and dietary intakes were assessed by touch screen questionnaire and food frequency questionnaire, respectively. Incident CKD was recorded from hospital inpatient records.
At baseline, 128,843 (31.6%) participants reported taking fish oil supplements. During a median follow-up period of 12.0 years, a total of 10,782 (2.6%) participants developed CKD. With adjustments for important confounders, habitual fish oil use was associated with a significantly lower hazard of incident CKD (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.87-0.95), compared with non-use. Consistently, participants reporting ≥2 servings/week of oily fish (HR, 0.86; 95% CI, 0.79-0.94) and nonoily fish (HR, 0.86; 95% CI, 0.77-0.97) consumption had a lower hazard of incident CKD compared to those reporting no consumption ever. Additionally, among the 97,914 participants with data on plasma fatty acid, there were significant inverse relationships of plasma omega-3 polyunsaturated fatty acid (PUFA) (per SD increment, HR, 0.89, 95% CI, 0.84-0.94) and eicosatetraenoic acid (per SD increment, HR, 0.91, 95% CI, 0.87-0.96) with incident CKD.
The authors concluded that habitual fish oil use was associated with a lower hazard of CKD, which was further confirmed by the consistent inverse relations between fish consumption and circulating omega-3 PUFA concentration with incident CKD.
I like this paper! It shows in an exemplary fashion how to interpret an association between two variables: fish oil consumption does not necessarily CAUSE the lower risk, it is merely associated with it and there might be a number of non-causal explanations for the link. Whether there is a true cause-effect relationship needs to be investigated in further, differently designed studies. The present paper does not overstate its conclusions but it is nevertheless important, as it hopefully will prompt others to clarify the crucial issue of causality.
Wouldn’t it be nice, if researchers of so-called alternative medicine (SCAM) finally learned this simple lesson?
Max Gerson is well-known to experts in so-called alternative medicine (SCAM). After all, he invented the famous alternative cancer regimen, the Gerson therapy (previously discussed here, here, and here). Not that this treatment works – in fact, it is not just ineffective but also dangerous – but it has prominent promoters, not least King Charles III
. As I say, Gerson is well known for his cancer quackery. What hardly anyone knows is that, before he dabbled in cancer, he invented an entirely different medicine.
Max was born as the 3rd of 9 siblings into a Jewish family on October 18, 1881. They lived in Wongrowitz, a part of Poland that at the time belonged to Germany. Max went to school in his hometown and studied medicine in Breslau (Wrocław, now Poland), Wuerzburg, Berlin, and Freiburg. In 1909, he graduated from the University of Freiburg and began practicing medicine at age 28 in Breslau. During WWI, Gerson worked as a surgeon in a military hospital in Breslau and was awarded the ’Iron Cross’ for his service. In 1916, he married Gretchen Hope; the two had three daughters and stayed together until his death.
In 1918, the Gerson family moved to Bielefeld (Germany), and Max specialized in internal medicine as well as neurology. During this period, Gerson developed an anti-inflammatory drug combination and made contact with a local pharmaceutical firm, ‘ASTA Medica’. On the occasion of the firm’s recent 100th jubilee, a German newspaper reported: “The company did business with the well-known Bielefeld physician and inventor Dr. Max Gerson. At the time, he owned the prescription and trademark for a painkiller called Quadronal. Dr. Gerson became a silent partner.”[1] Remarkably, Gerson who published >50 papers (most in German) seems to have no publication on Quadronal.
In his biography of Gerson, Howard Straus (Max’s grandson), explained that Max Gerson did, in fact, develop not just Quadronal for ASTA but also another drug, Quadronox, which however was not as successful as Quadronal. Crucially, Straus makes it very clear that the drug company defrauded Gerson and “never paid a penny to him or his family, nor honored his early ownership of the shares in the company”.[2]
When I was a young clinician in Germany, Quadronal was still quite popular, and I prescribed it regularly. It had been unquestionably the main success for the multi-million firm, ASTA. Today, it is less in use or even no longer available (I am not sure, perhaps someone can fill me in). Gerson’s second drug, Quadronox, seems to have disappeared a long time ago.
I find this story interesting and potentially relevant to the history of Max Gerson. His time in Bielefeld ended when he fled the Nazis (many of his family were killed during the Holocaust). Eventually, Max, his wife, and their three daughters ended up in New York where Gerson tried to establish his anti-cancer regimen. He became fiercely anti-pharma, and many of his followers even claim that he died by being poisoned by the medico-pharmaceutical establishment which allegedly was afraid that his ‘highly successful’ cancer therapy would put them out of business. It is hard to resist the temptation of suspecting a connection between Gerson’s pharma-phobia and the unfair treatment Max received from ASTA in Bielefeld.
Obviously, my knowledge about all this is incomplete, and I would love to hear from people who know more about it.
[1] ASTA-Erfolgsgeschichte startet vor 100 Jahren (westfalen-blatt.de)
[2] Dr. Max Gerson Healing the Hopeless: Amazon.co.uk: Straus, Howard: 9780976018612: Books
The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
The warning letters were issued to:
- Essential Elements (Scale Media Inc.);
- Calroy Health Sciences LLC;
- Iwi;
- BergaMet North America LLC;
- Healthy Trends Worldwide LLC (Golden After 50);
- Chambers’ Apothecary;
- Anabolic Laboratories, LLC.
“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”
Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
Camilla spent ten days at the end of October in a sophisticated meditation and fitness center in southern India. Life has recently been hectic for the Queen Consort: at 75, she has been in a non-stop succession of various ceremonies for the funeral of Elizabeth II, always one step behind her husband, not to mention her new status as sovereign… Enough to block her chakras in no time.
She came to the resort with her bodyguards and a handful of friends and was able to take advantage of the tailor-made treatments concocted for her by the master of the house, Dr Issac Mathai, who created this high-end holistic centre on a dozen hectares of scented gardens near Bangalore. The program includes massages, herbal steam baths, yoga, naturopathy, homeopathy, meditation, and Ayurvedic treatments to “cleanse, de-stress, soothe and revitalize the mind, body and soul”, as the establishment’s website states.
Guests are required to follow an individualized, meat-free diet, with organic food from the resort’s vegetable gardens, based on lots of salads or soups – Camilla is said to be a fan of sweet corn soup with spinach. Cigarettes and mobile phones are not allowed, although it is assumed that Camilla must have some privileges due to her status… and the basic rate for the suites, which starts at $950 a night – the price of the rooms varies between $260 and $760, the rate including a consultation with the doctors.
Charles and Camilla have been fans of the Soukya Centre in India for a decade. The place corresponds in every way to their deep-rooted convictions about health. Like her husband, Camilla is a follower of organic food, she also practices yoga and treats her face with creams made from nettle and bee venom. For his part, Charles has long been an advocate of alternative medicine, homeopathy, acupuncture, aromatherapy, and also hypnosis… He even set up a foundation to support complementary medicine by lobbying the British health service to include it in complementary therapies for certain patients, which caused an uproar among the pundits of traditional medicine.
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If you suspected I was (yet again) sarcastic about the royal couple, you are mistaken. The text above is only my (slightly shortened) translation of an article published in the French magazine LE POINT (even the title is theirs). I found the article amusing and interesting; so, I looked up the Indian health center. Here are some of the things I found:
The 1st impression is that they are not shy about promotion calling themselves THE WORLD’S BEST AYURVEDA TREATMENT CENTER. The doctor in charge was once a ‘Consultant Physician’ at the Hale Clinic in London, where he treated a number of high-profile people. As his professional background, he offers this:
M.D. (Homeopathy); Hahnemann Post-Graduate Institute of Homeopathy, London M.R.C.H, London; Chinese Pulse Diagnosis and Acupuncture, WHO Institute of Traditional Chinese Medicine, Nanjing, China; Trained (Mind-Body Medicine Programme) at Harvard Medical School, USA
The approach of the center is described as follows:
The fundamental principle underlying Holistic Treatment is that the natural defense and immune system of an individual when strengthened, has the potential to heal and prevent diseases. In the age of super-specialisation where human beings are often viewed as a conglomeration of organs, it is crucial to understand ourselves as multi-dimensional beings with a body, mind and spirit. These interconnected dimensions need to be in perfect harmony to ensure real well-being.
And about homeopathy, they claim this:
Homeopathy originated in 1796 in Germany, and was discovered by Dr. Samuel Hahnemann, a German scientist. Homeopathy is popular today as a non-intrusive, holistic system of medicine. Instead of different medicines for different parts of the body, one single constitutional remedy is prescribed. As a system of medicine, Homeopathy is highly scientific, safe, logical and an extremely effective method of healing. For over 200 years people have used Homeopathy to maintain their good health, and also to treat and cure a wide range of illnesses like allergies, metabolic disorders, atopic dermatitis, Rheumatoid arthritis, Auto-immune disorders.
At this stage, I felt I had seen enough. Yes, you are right, we did not learn a lot from this little exploration. No, hold on! We did learn that homeopathy is highly scientific, safe, logical, and extremely effective!
The question, however, is should we believe it?
