fraud
The interest in the medicinal properties of honey is lively. A recent review, for instance, concluded that honey is a safe natural substance, effective in the inhibition of bacterial growth and the treatment of a broad range of wound types, including burns, scratches, diabetic boils (Skin abscesses associated with diabetic), malignancies, leprosy, fistulas, leg ulcers, traumatic boils, cervical and varicose ulcers, amputation, burst abdominal wounds, septic and surgical wounds, cracked nipples, and wounds in the abdominal wall. Honey comprises a wide variety of active compounds, including flavonoids, phenolic acid, organic acids, enzymes, and vitamins, that may act to improve the wound healing process. Tissue-engineered scaffolds have recently attracted a great deal of attention, and various scaffold fabrication techniques are being researched. 
But there is also reason to be cautious. The U.S. Food and Drug Administration (FDA) posted warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s laboratory testing found that product samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“Tainted honey-based products like these are dangerous because consumers are likely unaware of the risks associated with the hidden prescription drug ingredients in these products and how they may interact with other drugs and supplements they may take,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D., “Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that put their health at risk, and instead seek effective, FDA-approved treatments.”
Today’s warning letters outline how companies violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health. These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
The warning letters were issued to:
- Thirstyrun LLC (also known as US Royal Honey LLC),
- MKS Enterprise LLC,
- Shopaax.com,
- 1am USA Incorporated dba Pleasure Products USA
Companies marketing food products containing tadalafil and/or sildenafil violate federal law. Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. In some cases, product claims reference diseases that can only be diagnosed or treated under medical supervision. Additionally, some products cited in the warning letters are represented as dietary supplements even though tadalafil and sildenafil products are excluded from the dietary supplement definition.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
Consumers using or considering using any over-the-counter product marketed for sexual enhancement should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. The FDA’s health fraud products database can help consumers identify nearly 1,000 of these potentially dangerous products.
The FDA previously warned consumers about more than 10 honey-based products containing hidden drug ingredients. The FDA’s laboratory testing found that product samples contained undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart and other retailers. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.
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 also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
Look what I found on Facebook:
Learn how to offer the healing energy of Reiki to yourself, people, and animals while enhancing your animal connection skills!
From daily support for health or challenges during times of crisis, Reiki helps restore balance on physical, emotional, spiritual, and mental levels for all living beings, enabling the body to do what it does best—heal itself. These benefits extend to other people, animals, trees/plants, and self-healing.
Reiki offers so many benefits for animals and for their human caregivers that I call it the gift that keeps on giving!
Reiki also enables students to connect and communicate more deeply with animals. If you think animals like you now, wait until they discover you’ve got Reiki—you’ll become an animal magnet!
For 25+ years Reiki has blessed me, my animal companions, students, and as a teacher I love sharing those benefits with as many people and animals as possible.
AVAILABLE WORLDWIDE
For many years I’ve taught a LIVE personally-mentored 6-week audio class where students learn all the basic skills needed by a beginning Reiki practitioner in addition to foundational principles of energy healing. And you don’t even need to leave the comfort of your home!
TAKEN REIKI BEFORE but don’t feel confident? Students who have retaken Reiki with me share that the weekly calls, opportunities to practice, online community, and opportunity to ask questions and receive guidance have helped them make Reiki a part of their daily lives and feel confident in offering it to loved ones.
REIKI LEVEL 1 CLASS SERIES
August 3 – September 7, 2022
LIVE WEEKLY CALLS and PERSONAL MENTORING
Every Wednesday at 6:00 p.m. Pacific for six weeks. Each call will be recorded and available for replay for students, including those in other time zones/countries. You do not have to attend live to take this class.
In addition to the 60-90 minute weekly calls, each student receives handouts and personal guidance for practice sessions.
When the class concludes, and all requirements have been fulfilled, each student receives a Reiki Level 1 certificate.
To learn more or register:
AND NOW FOR THE IMPORTANT BIT:
Choose one payment for all six classes. Payment is available with Visa, MC, or PayPal (choose PayPal credit card option for payment with Amex or Discover). PayPal also offers a payment plan option. Confirmation will be sent after registration along with instructions on how to join the first call. If you were unable to register in time to attend the first class live you can very easily catch up with the replay. Final deadline for registration is the day of the second class.
Single Pay Plan: $249.00
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This seems like a good little earner to me!
Congratulations to whoever invented it.
Yet I do feel that something has been forgotten:
the evidence.
If you search for Reiki on Pubmed, you find a baffling array of papers many of which arrive at positive conclusions. If you then check out the primary studies, you realize that most of them are of extremely poor quality, published by members of the Reiki cult (often in 3rd class journals for the nursing professions). If you search for independent systematic reviews that adequately account for the quality of the primary studies, you discover that, in fact, the evidence does not support the notion that Reiki is effective for anything. Here are a few examples:
- There is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.
- The serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness.
- In total, the trial data for any one condition are scarce and independent replications are not available for each condition. Most trials suffered from methodological flaws such as small sample size, inadequate study design and poor reporting.
And what about Reiki for animals?
As far as I can see, there is no good evidence at all.
So, does this render the above and similar courses fraudulent?
I let you answer this question for yourselves.
It took two years, but now it is done: I am a German again after more than 20 years!
The process started over two years ago when I went to the German embassy in London. When it was my turn, the official asked me what I wanted, and I handed her my lapsed passport and asked to get it renewed. She looked at it, then at me, then at the passport again. What happened next took me by surprise: she confiscated my old passport and told me in no uncertain terms that I was not a German anymore. If I wanted to become a German, I would need to start from scratch and get re-nationalized. Unbeknown to me, I would have had to apply for dual citizenship back in 1999 when I took British nationality. By not doing it, I lost my German nationality.
Now followed a two-year process of application. This meant retrieving and supplying documents over documents over documents. I would have hardly been surprised if they has asked me for the fingerprints of my grandmother. Yes, the Germans are still the world champions of bureaucracy, if you ask me.
But why did you want to become a German again?
Glad you asked!
People who know me well are aware of the fact that I was never really proud of being German. As I grew older, I was often even ashamed. One of my research subjects had long been medicine during the Third Reich, and it was this topic that disenchanted me with Germany. Therefore, it seemed entirely right to become a Brit. In fact, I felt proud – the UK was my chosen home, and the decision was meant to be for life.
Never in my wildest dreams did I think in 1999 that Britain would one day succumb to the collective death wish of leaving the EU. After the deeply dishonest referendum in 2016, I was still convinced that this act of extraordinary self-harm would be prevented. But then it did happen, not least due to the lies of the right-wing of the Tory party and the two-faced incompetence of Jeremy Corbyn and his followers. I remember the morning that I heard it being announced on the radio; I was in tears.
Brexit itself would have been bad enough but the way it changed the atmosphere in Britain was even worse, in my view. With the nationalists in power, every halfwit seemed to feel entitled to let out his xenophobic vomit at will. Lying and corruption in politics became the new norm. The press remained largely silent or even supportive of those who claimed that Brexit would bring back the great British empire. The few who had the courage to object were declared to be ‘enemies of the people’. Britain, I felt, was fast becoming a banana republic.
Most of what had made me once aspire to be British had vanished in a matter of months. It was time to reconsider my position. The first step my wife and I took was to move to Cambridge. We felt it was an enclave of sanity in a country that seemed to destroy itself. The second step was to spend more time in Brittany, my wife’s place of birth. Without exception, our French friends felt that the UK had lost its senses and had become the laughing stock of Europe. The third step was to apply to become a German citizen again.
Now that all this is done, I feel both happy and sad. Happy to be a member of the EU again, and sad to see what has become of the country I so loved.
Yes, it is hot! Very hot. Where I live – Cambridge, UK – we expect records to be broken today and tomorrow, and we are predicted to reach as much as 40 degrees Celsius.
But do not despair – there is help!
As so often, homeopathy comes to our rescue.
I found this source giving us advice about “BEST HOMEOPATHY MEDICINE FOR SUMMER HEAT“:
Homeopathic remedies are non-toxic and a safe way to help the body to replenish its store of the cell salts and nutrients it needs in warmer periods and help to relieve cramps, aches, and fatigue. Some of the most common homeopathic medicines to deal with summer heat are:
-
- Calendula: This is an all-purpose medicine for many kinds of skin damage that many of us face during the summer season. When the skin gets damaged due to wounds, infection, prolonged sun exposure, and even excessive pollution and dirt, one can try using calendula.
- Arnica: All that running around on the beach can easily give you sore muscles, while the heat can sap up your energy and leave you fatigued. In such cases, Arnica is the perfect homeopathic answer to your maladies. This homeopathic remedy can be used for topical application if bought in its cream or gel form.
- Belladonna: Sun strokes, dehydration, and over-exposure to the sun, in general, can give you a host of problems and conditions including heat headaches. In order to treat such conditions, one can use homeopathic medicine Belladonna used for sun-stroke related ailments and symptoms.
- Rhus Toxicodendron: This Homeopathy remedy used for Hot Weather Symptom is also known as Rhus Tox. It is made from poison ivy extracts and is an effective drug when it comes to dealing with itchy rashes. These rashes may be caused because of exposure to oak, sumac, and even poison ivy.
- Ledum: Ledum or Ledum Palustre is one of the best homeopathic drugs when it comes to treating insect bites during summers.
- Euphrasia Officinalis: This homeopathic medicine is most commonly used for eye-related problems that may come about due to sun exposure or excessive sweating in prickly heat and other heat-related factors.
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So, now we know. All you need to do is go to a homeopathic pharmacy and buy the remedies (please do not run, this might aggravate your symptoms!).
Which potency?
Good question!
The author of the advice – Dr. Bela Chaudhry, BHMS, MD – Homeopathy, Homeopathy Doctor, Delhi, India – does not disclose this important information. As some of these ingredients are toxic, I would urge you to buy an ultra-molecular dilution – a C30, for instance – this way, you are sure that not a single molecule of what is printed on the package is contained in the actual remedy.
Alternatively, you could save quite a bit of money by staying where you are, taking a cool drink of water (put a pinch of salt in it, if you think you are getting dehydrated), and considering the evidence. It clearly shows that homeopathic remedies are pure placebos. They do not work against the symptoms of overheating nor against anything else.
PS
I suspect, there will be some who disagree with me. To them, I say: please show me the evidence that any of the above-listed homeopathic remedies are effective against the named conditions. If you do that, I promise that I will change my post accordingly. Thank you.
The US Food and Drug Administration created the Tainted Dietary Supplement Database in 2007 to identify dietary supplements adulterated with active pharmaceutical ingredients (APIs). This article compared API adulterations in dietary supplements from the 10-year time period of 2007 through 2016 to the most recent 5-year period of 2017 through 2021. Its findings are alarming:
- From 2007 through 2021, 1068 unique products were found to be adulterated with APIs.
- Sexual enhancement and weight-loss dietary supplements are the most common products adulterated with APIs.
- Phosphodiesterase-5 inhibitors are commonly included in sexual enhancement dietary supplements.
- A single product can include up to 5 APIs.
- Sibutramine, a drug removed from the market due to cardiovascular adverse events, is the most included adulterant API in weight loss products.
- Sibutramine analogues, phenolphthalein (which was removed from the US market because of cancer risk), and fluoxetine were also included.
- Muscle-building dietary supplements were commonly adulterated before 2016, but since 2017 no additional adulterated products have been identified.
The authors concluded that the lack of disclosure of APIs in dietary supplements, circumventing the normal procedure with clinician oversight of prescription drug use, and the use of APIs that are banned by the Food and Drug Administration or used in combinations that were never studied are important health risks for consumers.
The problem of adulterated supplements is by no means new. A similar review published 4 years ago already warned that “active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”
These papers relate to the US where supplement use is highly prevalent. The harm done by adulterated products is thus huge. If we focus on Chinese or Ayurvedic supplements, the problem might even be more serious. In 2002, my own review concluded that adulteration of Chinese herbal medicines with synthetic drugs is a potentially serious problem which needs to be addressed by adequate regulatory measures. Twenty years later, we seem to be still waiting for effective regulations that protect the consumer.
Progress in medicine, they say, is made funeral by funeral!
In 2007, we published a systematic review summarizing the efficacy of homeopathic remedies used as a sole or additional therapy in cancer care. We have searched the literature using the databases: Amed (from 1985); CINHAL (from 1982); EMBASE (from 1974); Medline (from 1951); and CAMbase (from 1998). Randomized and non-randomized controlled clinical trials including patients with cancer or past experience of cancer receiving single or combined homeopathic interventions were included. The methodological quality of the trials was assessed by Jadad score. Six studies met our inclusion criteria (five were randomized clinical trials and one was a non-randomized study); but the methodological quality was variable including some high-standard studies. Our analysis of published literature on homeopathy thus found insufficient evidence to support the clinical efficacy of homeopathic therapy in cancer care.
Meanwhile, more trials have emerged, not least a dubious study by Frass et al which is currently under investigation. This means that a new evaluation of the totality of the available evidence might be called for. I am pleased to report that such an assessment has just been published.
In this systematic review, the researchers included clinical studies from 1800 until 2020 to evaluate evidence of the effectiveness of homeopathy on physical and mental conditions in patients during oncological treatment.
In February 2021 a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL, and Medline) to find studies concerning the use, effectiveness, and potential harm of homeopathy in cancer patients.
From all 1352 search results, 18 studies with 2016 patients were included in this SR. The patients treated with homeopathy were mainly diagnosed with breast cancer. The therapy concepts include single and combination homeopathic remedies (used systemically or as mouth rinses) of various dilutions. Outcomes assessed were the influence on toxicity of cancer treatment (mostly hot flashes and menopausal symptoms), time to drain-removal in breast cancer patients after mastectomy, survival, quality of life, global health and subjective well-being, anxiety, and depression as well as safety and tolerance.
The included studies reported heterogeneous results: some studies described significant differences in quality of life or toxicity of cancer treatment favoring homeopathy, whereas others did not find an effect or reported significant differences to the disadvantage of homeopathy or side effects caused by homeopathy. The majority of the studies have low methodological quality.
The authors concluded that, for homeopathy, there is neither a scientifically based hypothesis of its mode of action nor conclusive evidence from clinical studies in cancer care.
I predict that, if we wait another 15 years, we will have even more studies. I also predict that some of them will be less than reliable or even fake. Finally, I predict that the overall result will still be mixed and unconvincing.
Why can I be so sure?
- Because homeopathy lacks biological plausibility as a treatment of cancer (or any other condition).
- Because highly diluted homeopathic remedies are pure placebos.
- Because homeopathy has developed into a cult where one is no longer surprised to see studies emerging that are too good to be true.
I have previously reported that a Canadian naturopath, Jason Klop, is under investigation for selling fecal Microbiota transplants to treat autistic children. Now, there is a new twist in this story.
On Twitter, J.N. Stea summarized it nicely:
This naturopath is fighting a judge so that he can charge parents about $15,000 to give his nephew’s poop to children as a treatment for autism. His lawyer argues that he should be allowed to since naturopathy isn’t scientific anyway.
Klop’s lawyer defends the naturopath against an investigation into his business of selling fecal microbiota transplants to families of autistic children. The College of Naturopathic Physicians (CoN) had banned Klop for selling, advertising, and manufacturing pills made from human feces claiming that Klop has been engaging in conduct not acceptable for a naturopathic physician. Klop’s lawyer, Jason Gratl, argued this was difficult to prove in a field that has a few restrictions and some ambiguous boundaries.
“What does it take to be a naturopath and do something that is not appropriate in a field so wide-ranging and open to interpretation?” the lawyer, Gratl, asked the court suggesting that the lack of scientific evidence supporting the use of fecal Microbiota Transplants (FMT) to treat autism is not necessarily relevant in this instance.
“Naturopaths can rely on science in certain aspects, but they are not bound to science,” Gratl said. He explained that naturopathic practices could be based on anecdotes and historical knowledge. Later, he pointed out that the field also includes homeopathy, which, some believe, involves magical thinking. It is definitely not scientific in its core.” After describing the case as a “tragedy”, Gratl called the allegations against his client “entirely unverfounded and scurrilous.”
I suspect it is nothing new to most readers, yet I find it gratifying to hear from a lawyer that naturopathy
- is not science,
- relies on anecdote instead of evidence,
- and involves magical thinking.
I do think, however, that despite all this, naturopaths should not be allowed to do any odd nonsense that comes to their minds and fills their bank accounts quickly.
In India, the homeopathic remedy, Arsenicum Album 30C (prepared from arsenic trioxide) is widely prescribed and publicly supplied to adults and children for preventing COVID infections. Inorganic arsenic, known as the “king of poisons” is a highly toxic substance with the potential to cause acute as well as chronic injury to multiple organ systems, mainly skin, lung, liver, and kidneys.
Indian researchers present three cases of acute liver injury, leading to the death of one patient with underlying non-alcoholic steatohepatitis (NASH) cirrhosis, after consumption of the homeopathic remedy AA30 for COVID-19 prevention.
Case one
A 70-year-old man with compensated non-alcoholic steatohepatitis (NASH)-related cirrhosis and diabetes mellitus consumed the homeopathic IB AA30 as prescribed for 12 weeks prior to the onset of symptoms. He presented with jaundice and abdominal distension within four weeks after the onset of loss of appetite and well-being. The patient was not on any other hepatotoxic agents, over-the-counter medications, or herbal and dietary supplements. Investigations revealed the presence of conjugated hyperbilirubinemia, ascites, and abnormal coagulation, suggestive of acute-on-chronic liver failure (ACLF). Further investigations to identify known causes of acute deterioration of underlying cirrhosis were performed, including a transjugular liver biopsy. All competing causes for acute liver injury were meticulously ruled out. These included infections-tests for immunoglobulin M (IgM) for viral hepatitis A and E; hepatitis B surface antigen and IgM antibody to hepatitis B core antigen; nucleic acid tests via polymerase chain reaction for hepatitis C; IgM for herpes zoster and herpes simplex, cytomegalovirus, parvovirus, Epstein-Barr virus. Complete auto-antibody testing for autoimmune hepatitis (AIH) was negative. The Roussel Uclaf Causality Assessment (RUCAM) demonstrated “probable” (score 7) drug-induced liver injury (DILI) and simplified AIH score was less than 5, revealing the cause of acute liver injury leading to ACLF as the homeopathic remedy, AA30. The liver biopsy revealed multiacinar hepatocyte necrosis, lymphocytic, neutrophilic, and eosinophilic inflammation in the absence of interface hepatitis, which were predominantly portal-based in the background of cirrhosis, suggestive of DILI. Analysis of drugs consumed could not be performed in view of inadequate sample availability. The patient and family consented to arsenic analysis in nail and hair samples which revealed extremely high levels of the heavy metal, supportive of arsenic toxicity and associated liver injury in the patient. Evaluation of hair and hair samples of two family members (below detection limits, method detection limit being 0.1 mg/kg), staying in the same household did not reveal levels signifying cluster arsenic poisoning from water or soil sources. The patient succumbed to complications related to ACLF, nine months after the initial diagnosis.
Case two
A 68-year-old male with systemic hypertension controlled on telmisartan who ingested AA30 as prescribed for four weeks prior to the onset of symptoms. There was no associated jaundice or cholestatic symptoms, but liver tests revealed acute hepatitis with an elevation of liver enzymes. The patient was not on any other hepatotoxic agents, over-the-counter medications, or herbal and dietary supplements. Further investigations did not reveal the presence of underlying chronic liver disease or portal hypertension. All competing causes for acute liver injury were meticulously ruled out similar to the extensive workup that was done in case one. The RUCAM demonstrated “probable” (score 8) DILI and simplified AIH score was less than 5, revealing the cause of acute non-icteric hepatitis as the homeopathic remedy, AA30. The liver biopsy revealed perivenular hepatocyte necrosis, with predominantly portal-based mixed cellular inflammation consisting of plasma cells, eosinophils, lymphocytes, and scattered neutrophils. Additionally, ballooning of hepatocytes was marked with scattered rosettes and moderate interphase hepatitis in the presence of mild portal and sinusoidal fibrosis suggestive of DILI. Acute hepatitis resolved after drug withdrawal and finite course of steroids within three months, without any recurrence on follow-up.
Case three
A 48-year-old overweight woman consumed homeopathic AA30 pills as COVID-19 preventive for one week prior to the onset of her symptoms of cholestatic jaundice. Prior to the development of jaundice, she had nonspecific gastrointestinal symptoms such as nausea and progressive loss of appetite. Liver tests revealed conjugated hyperbilirubinemia with highly raised liver enzymes. The patient was not on any other hepatotoxic prescription drugs, over-the-counter medications, or herbal and dietary supplements. Further investigations did not reveal the presence of underlying chronic liver disease or portal hypertension. All competing causes for acute liver injury were meticulously ruled out similar to the extensive workup that was done in case one. The RUCAM demonstrated “probable” (score 7) DILI and simplified AIH score was less than 5, revealing the cause of acute cholestatic hepatitis as the homeopathic remedy, AA30. The liver biopsy revealed spotty, focal hepatocyte necrosis, with predominantly portal-based neutrophilic and eosinophil-rich inflammation, moderate steatosis, and mild interface hepatitis with underlying mild perisinusoidal fibrosis, suggestive of DILI. The acute cholestatic hepatitis resolved after drug withdrawal and a finite course of steroids within six months, without any recurrence on follow-up.
The chemical analysis and toxicology (inductively coupled optical emission spectroscopy and triple-quadrupole gas chromatography with tandem mass spectroscopy method) on two sets of AA30 samples retrieved from case three revealed D-mannose, melezitose, and arsenic respectively, demonstrating batch-to-batch variation due to poor manufacturing practices.
The authors draw the following conclusions: Health regulatory authorities, physicians, general and patient population must be aware of the potential harms associated with the large-scale promotion of untested, alternative medical systems during a medical emergency so as to prevent an “epidemic” of avoidable DILI within the ongoing pandemic. Even though ultra-diluted homeopathic remedies, found ineffective as shown in large-scale meta-analysis, are considered safe for use due to the absence of any active compound beyond 12C dilution. Nonetheless, poor manufacturing practices, use of concentrated tincture formulations, and adulteration and contamination of homeopathic remedies can still pose considerable toxicity in predisposed persons. From a scientific and evidence-based standpoint, it is imperative that the general population and at-risk persons understand that vaccination, and not untested, misleading IBs, remains the best available armamentarium against COVID-19 which helps in fighting back the pandemic.
Alan Gaby, the assistant editor of the journal Integr Med has written an interesting commentary about widespread fraud in natural health products research. Here is an excerpt of his article:
During the past 49 years, I have reviewed and analyzed more than 50 000 papers from the biomedical literature, most of which were related to the field of nutritional medicine. Doing this work has given me some understanding of how to assess the reliability of a study. Over the past 10 to 15 years, an uncomfortably large and growing number of published papers related to my area of expertise have left me wondering whether the research was fabricated; that is, whether people were writing papers about research that had not actually been conducted. If the studies were not actually conducted, the publishing of this research is an affront to all who value integrity in science, and it has the potential to harm practitioners and patients who rely on its findings.
The studies that have raised concerns have come primarily from Iran and to a lesser extent from Egypt, China, India, Japan, and a few other countries. Characteristics of these concerning studies typically include one or more of the following:
- The study comes from an investigator or research group that has published an enormous number of randomized clinical trials in a relatively short period of time.
- The number of participants in the trial is unusually large, when considering the resources that appear to be available to the researchers.
- The recruitment period for the trial is unusually short.
- The paper is submitted to a journal unusually rapidly after the study is completed, or in some cases before it would have been possible to have completed the trial.
- A randomized double-blind trial is conducted before there is any preliminary evidence of efficacy in humans (such as case reports or uncontrolled trials). Because double-blind trials are expensive to conduct, such trials are generally reserved for treatments for which there is some evidence of efficacy.
- The magnitude of the reported improvement is much larger than is typically seen in trials using just one or two nutrients.
- No funding source is listed or the study is listed as self-funded. This is of particular concern when the sample size or study design suggests that the study was expensive.
- The design of the study raises ethical issues, such as participants not being permitted to use treatments that are known to be effective.
- One or more baseline characteristics of the study group appear to be implausible.
- The research was conducted by a student as part of a graduate school thesis, and the magnitude of the project seems to have been beyond the capabilities and resources of a student.
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What Gaby alludes to is a problem indeed. I have previously posted about the Chinese aspect of this story. What Gaby does not mention is the fact that even many studies of so-called alternative medicine (SCAM) which seem to be not overtly fraudulent are nevertheless highly suspect. I am referring to trials that are fatally flawed and/or studies that draw unwarranted conclusions. These are, of course, the types of studies that are the main target of this blog. Because they are so numerous, I feel that the damage they do is much bigger than that of the more overtly fraudulent papers.
Prof. Fabricio Benedetti is one of the world’s leading experts in the study of placebo effects. I have mentioned his excellent work before, for instance, here where he cautioned that quackery has today one more weapon on its side, which is paradoxically represented by the hard science–supported placebo mechanisms. Now he has expressed his concerns even more clearly in an article entitled “Alternative and natural medicine quackery is on the rise. Here’s why the placebo effect is part of the problem”. Here are a few excerpts from this excellent paper:
For several decades now, many scientists, including me, have been working hard to reveal the full power and scope of the placebo effect — the amazing ability of a simple sugar pill or other non-pharmaceutical “fake intervention” to improve someone’s quality of life. This research has been crucial to giving scientific credibility to a powerful psychological effect. But the advances of science have also backfired, spawning an alternative industry that preys on the vulnerable…
All this means that some alternative medicines can indeed have positive outcomes for patients, though not necessarily through the mechanisms that the therapy’s inventors supposed, but rather through a placebo effect. This holds true for treatments ranging from strange talismans to acupuncture — studies have shown that pain relief is about the same for patients receiving true acupuncture with needles, for example, as for those receiving sham acupuncture with trick needles.
The scientific advances in understanding placebo are fascinating. But one unfortunate outcome of all this work is that profit-seeking companies and individuals now have a new weapon: It is no longer necessary to demonstrate the effectiveness of their proposed therapies; it is enough to assert that these work because of the placebo effect. I receive myriad eccentric proposals for new therapies, ranging from talismans and concoctions to mascots and weird rituals. Their inventors claim that these are capable of inducing substantial health benefits and often seek my endorsement. These proposals have stepped up sharply in recent years. Sadly, the science of the placebo effect is fueling this new breed of pseudoscience…
So, if a salesperson says: “This concoction (or ritual or talisman) will reduce your pain,” it is not necessarily a lie, as the placebo effect may indeed stimulate pain-relieving circuits in the brain. But anyone could truthfully use these words, within limits.
These marketers often overstate the size of the possible response, claim to provide a “cure” rather than pain relief or incorrectly suggest that only their own expensive products will have this effect. Even worse, they may present the products as an alternative to more effective traditional medications for serious conditions such as cancer. In other words, they prey on the vulnerable by making undeliverable promises, purportedly backed by the science of placebo.
Even if taking a placebo can reduce symptoms such as pain, this isn’t always the best course of action. An apparently trivial pain may, for example, be the first sign of something far more serious. Treating the pain alone may prevent diagnosis by a physician or delay important medical treatments…
…Education, communication and honesty are the best friends of medical practice. Patients and health care professionals deserve to know what placebos can and cannot do.
The research and medical communities must be more transparent about the efficacy of many conventional pharmacological and nonpharmacological treatments, by acknowledging that some of them are useful whereas some others are not. Many over-the-counter products have doubtful efficacy, for example. Honesty will boost patients’ trust and confidence in medicine, which are the best antidotes to quackery.
BRAVO PROF BENEDETTI!
