The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labelled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labelled as homeopathic.
The FDA is particularly concerned about unapproved injectable drug products labelled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defences against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labelled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”
No currently marketed drug products labelled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labelled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.
The FDA issued the warning letters to Hevert Pharmaceuticals, LLC; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labelled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.
Many of the drugs were labelled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream.
Drugs labelled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.
The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.
The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program. To report adverse drug events in animals, see How to Report Animal Drug Side Effects and Product Problems…
Hevert is of course well known to readers of this blog for their attempt to silence critics of homeopathy in Germany. The FDA’s warning letter refers to their following injectable products:
- “Calmvalera comp.,”
- “Gelsemium comp.,”
- “Hepar comp.,”
- “Lymphaden comp.”
The FDA referred to the following injectable homeopathic products from 8046255 Canada:
- “Systemic Detox,”
- “Neuro 3,”
- “Lymph 1,”
The FDA warning to World Health Advanced Technologies, Ltd referred to:
- “Enercel AM,”
- “Enercel Forte,”
- “Enercel Max,”
- “Enercel Mist-Nasal,”
- “Enercel Mist Nebulizer,”
- “Enercel PM,”
- “Enercel Plus,”
- “Enercel Plus IM.”
The FDA warning referred to the following products by MediNatura, and the claims made for them include:
- Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
- Traumeel Injection Solution: “… treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
- Engystol Injection Solution: “… support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
- Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
- Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
- Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”
The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.
Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”
Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”
As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.
People who use so-called alternative medicines (SCAM) tend to be more vaccine hesitant. One possible conclusion that can be drawn from this is that trusting SCAM results in people becoming more vaccine hesitant. An alternative possibility is that vaccine hesitancy and use of SCAM are both consequences of a distrust in conventional treatments. an International team of researchers conducted analyses designed to disentangle these two possibilities.
They measured vaccine hesitancy and SCAM use in a representative sample of Spanish residents (N = 5200). They also quantified their trust in three CCAM interventions;
and in two conventional medical interventions:
Vaccine hesitancy turned out to be strongly associated with (dis)trust in conventional medicine, and this relationship was particularly strong among SCAM users. In contrast, trust in SCAM was a relatively weak predictor of vaccine hesitancy, and the relationship was equally weak regardless of whether or not participants themselves had a history of using SCAM.
According to the authors of this paper, the implication for practitioners and policy makers is that SCAM is not necessarily a major obstacle to people’s willingness to vaccinate, and that the more proximal obstacle is people’s mistrust of conventional treatments.
This is an interesting study. Yet, it begs a few questions:
- Is it possible to reliably establish trust in SCAM by asking about just 3 specific therapies?
- Is it possible to reliably establish trust in conventional medicine by asking about just 2 treatments?
- Why those therapies out of hundreds of options?
- Could it be that here are national differences (in other countries distrust in conventional medicine is not a strong determinant of SCAM use)?
- Is trust in SCAM and distrust in conventional medicine perhaps the common expression of an anti-science attitude or cultist tendencies?
For complete newcomers to this blog, I should preface this post with four statements of fact (evidence to support them can be found in numerous previous posts on this blog or in my book entirely dedicated to homeopathy):
- Homeopathic remedies are usually so highly diluted that they do not contain enough active molecules to have any effect whatsoever.
- The evidence from clinical trials fails to show that homeopathic remedies are more than placebos.
- Boiron is the world’s largest manufacturer of homeopathic remedies.
- Therapeutic claims made for homeopathic remedies are bogus.
BOIRON USA, seem to employ someone who does little else but tweet irresponsible advertisements that mislead and endanger the public. On 5/5/2020, for instance, I saw within a matter of just hours in my Twitter timeline dozens of advertisements by Boiron USA . I copied a few examples:
- Oscillococcinum USA Clinical studies show that Oscillococcinum reduces the duration and severity of flu-like symptoms such as body aches, headache, fever, chills, and fatigue.*
- Boiron USA Ignatia amara relieves a lump in throat, hypersensitivity or intolerance to light, noise, or smells, frequent sighing, difficulty breathing, spasms, & cramps related to stress. It may help those who feel moody or emotional from added #stress. Claim basis: bit.ly/2VaVt0o
And here are four more from 6/5/2020:
- #Homeopathic Sabina relieves profuse and painful periods with red blood clots and pain spreading to the tops of the thighs. Dosage: Dissolve 5 pellets under the tongue 4 times a day. Decrease frequency with improvement. Claim basis: bit.ly/2I1L3sN
- Colocynthis 6C relieves abdominal & menstrual cramps improved by bending over, strong pressure and heat. Dosage: Dissolve 5 pellets under the tongue every 30 minutes. Decrease frequency with improvement. Claim basis: bit.ly/2oMa9RX
- Caulophyllum thalictroides 30C relieves menstrual cramps occurring at the onset of periods, with scanty flow. Dosage: Dissolve 5 pellets under the tongue 4 times a day. Decrease frequency with improvement, Claim basis: bit.ly/2q7Ea2Q
- #Homeopathic Cimicifuga racemosa 6C relieves cramps associated with #PMS and aggravated by cold and humidity. Dosage: Dissolve 5 pellets under the tongue twice a day. Decrease frequency with improvement. Claim basis: bit.ly/2Kj57Yk
(Please do click on the links for ‘claim basis’ and be surprised!)
As far as I can tell, Boiron USA have been doings this sort of thing incessantly since years. Why does someone not stop them? All of these advertisements make claims that are bogus, unethical, and potentially harmful for many consumers. How can this be legal? Should there not be some sort of consumer protection?
But perhaps there is something all of my US readers can do quite effortlessly: on their website, Boiron USA state that they are
committed to providing top-quality products to our customers. Subject to the Terms, Conditions and Limitations below, if within 30 days of purchase, you are not completely satisfied with our medicines for any reason, we’ll give you your money back.
To receive your refund, please send us the following items within 30 days of purchase at the address below:
- Your name, address and telephone number
- The original UPC from the Boiron product purchased
- The original dated cashier register receipt with the purchase price circled
Boiron Information Center
4 Campus Boulevard
Newtown Square, PA 19073
So, how about buying the preparations advertised and then insisting on a refund, if they did not achieve what was promised in their advertisement on Twitter? That might soon stop them misleading the public!
There are uncounted different forms of bogus so-called alternative medicines (SCAMs), and many have been discussed on this blog. What do I mean by ‘bogus’? A bogus SCAM is one, in my view, that is being promoted for conditions for which it does not demonstrably generate more good than harm.
Ten popular examples are:
- alternative cancer ‘cures’,
- applied kinesiology,
- Bach Flower Remedies,
- detox treatments,
- paranormal or energy healing techniques,
- slimming aids.
These treatments are diverse in many ways: history, basic assumption, risks, etc. But they nevertheless tend to have certain features in common:
- Most SCAMs originate from the ideas developed by a single, often charismatic individual who proclaimed to have seen the light. Think of Gerson, Bach, Palmer, Hahnemann, Still.
- They are recommended by enthusiasts as a panacea, a ‘cure all’.
- They are heavily promoted by celebrities, hyped by the press and marketed via books or the Internet, but they are far less or not at all supported by published studies in the peer-reviewed medical literature.
- The clinical trials of SCAM that have been published are flimsy, lack independent replication, yet are celebrated by proponents as though they represent robust evidence.
- SCAMs target either the most desperately ill patients who understandably tend to cling to every straw they can find. Or they go for the ‘worried well’ who have nothing truly wrong with them and plenty of cash to waste.
- Proponents of SCAM use scientific-sounding terminology, while simultaneously displaying a profoundly anti-scientific attitude.
- Entrepreneurs of SCAM are efficient at selling false hope at excessive prices.
- SCAMs sometimes seem to work because many of the therapists are skilled at maximising the placebo-response.
- SCAM is awash with conspiracy theories, for instance, the notion that ‘the establishment’ is supressing SCAM. (If a SCAM ever showed real promise, it would rapidly scrutinised by researchers and, if effectiveness were confirmed, adopted by conventional medicine. The notion of an alternative cure for any disease is idiotic, because it presupposes that conventional healthcare professionals shun a potentially valuable treatment simply because it emerged from elsewhere.)
- Most SCAMs can do direct harm. For instance, oral treatments can be toxic or interact with prescription drugs. Or spinal manipulations can cause a stroke. Or acupuncture can cause a pneumothorax.
- SCAMs are dangerous even if they do not cause direct harm. There are many examples of people who died needlessly early because they used SCAM as an alternative to conventional medicine (Steve Jobs is a prominent example).
- Moreover, SCAMs cause harm by undermining the principles of EBM and, more importantly, by undermining rational thinking in our society.
- SCAM practitioners violate fundamental rules of medical ethics on a daily basis. One could even argue that the ethical practice of SCAM is rarely possible.
When I first saw this press-release, I thought it was a hoax. After all, it came from a most dubious homeopathic source. Then I read it again and was no longer sure.
What do you think?
Here it is in full:
Santa Clara, Cuba, April 3,2020 (Prensa Latina) The homeopathic medicine Prevengho-VIR began to be administered as a measure to confront the Covid-19 in this province of central Cuba.
Dr. Mirtha Rosa Hernandez, head of the Department of the Elderly in Villa Clara, reported that the supply of the preparation began in the Grandparents’ Homes and Elderly Homes of the territory, which has 184,000 people over 60 years old, 23.9 percent of the local universe. The medicine is administered by doctors and nurses of the basic working group where the Grandparents’ Homes and Nursing Homes are located in the 13 municipalities of this province.
This homeopathic medicine comes in a 10-milliliter bottle, and the daily dosage is 5 drops, thrice a day; while on the tenth day a reactivation of the initial dose is performed. It is aimed at preventing the respiratory diseases in this risk group, in addition to other medical conditions, such as dengue.
In the upcoming days it will be extended to the Maternal Homes. It is administered by the doctors and the nurses from the basic work group of the senior homes.
She said, that besides avoiding the new coronavirus the formula is also aimed at preventing respiratory diseases in this risk group, in addition to others such as dengue fever.
This medicine can also be administered to children under 10 years old, pregnant women, nursing mothers, and patients with liver disorders.
Anas berberiae 200
Baptisia tinctora 200
Eupetorium perf 200
Arsenicum Album 200
As I said, I was not sure whether this was for real. Is it possible that even officials are so stupid, brainwashed or gullible to go for homeopathy in such a serious situation?
In an attempt to find out, I did a little search and quickly found that the story has been reported by multiple media. This, for instance, is what the Miami Herald reported:
As scientists around the world speed up clinical trials to find a cure or vaccine for the coronavirus, the Cuban government will begin distributing a homeopathic remedy to the elderly and other vulnerable people to “prevent” the spread of the disease, a top health official said.
Dr. Francisco Durán, national director of Epidemiology at the Ministry of Public Health, said in a press conference on Sunday that “sublingual drops” of the compound PrevengHo-Vir “prevent different diseases such as influenza, the common cold, dengue, and emerging viral infections such as this one.”
On Monday, Durán tried to correct his statements and said that the product “does not prevent contagion” but rather “increases resistance, the body’s defenses against a certain virus.”
Several state media outlets reported that PrevengHo-Vir is already being used in various Cuban provinces to treat the elderly and other groups vulnerable to the coronavirus. There is no internet record of PrevengHo-Vir, other than press reports about the announcement of its distribution in Cuba.
So, it’s not a hoax!
In this case, let me try to predict what will happen next:
- When the pandemic is over, the Cubans will publish mortality rates achieved with their homeopathic prevention [A].
- They will compare them to data from a cohort that did not receive the homeopathic treatment [B].
- Neither of the data-sets will be transparent and nobody will be able to check its reliability.
- The comparison will yield a significant difference in favour of homeopathy.
- The Cubans will use this to market their remedy.
- The world of homeopathy will use it as a proof that homeopathy is effective (it wouldn’t be the first time).
Nothing wrong with that, some will say. Others who understand research methodology will, however, point out that these data are less than convincing.
In such case/control studies, one large group of patients [A] is compared to another group [B]. Group A has been treated homeopathically, while group B received no homeopathy. Any difference in outcome between A and B might be due to a range of circumstances that are unrelated to the homeopathic treatment, for instance:
- group A might have been less ill than group B,
- group A might have been better nourished,
- group A might have benefited from better hygiene,
- group A might have received better care,
- group B might have received treatments that made the situation not better but worse,
- the researchers might have prettified the data to make group A look better.
Such concerns are not totally unfounded; after all, Cuba seems to have a long history of making irresponsible claims for their homeopathic products.
Guest post by Richard Rasker
Almost two years ago, in March 2018, a group of 124 doctors and other medical professionals published an article in the French newspaper ‘Le Figaro’, warning the general public for the false promises, unproven claims and dangers of alternative medicine.
Homeopathy in particular is denounced as an unscientific belief in magic, utterly lacking in plausibility as well as in evidence of efficacy for any condition. Subjecting people to these kinds of unproven treatments is unethical, and may result in serious harm by delaying proper medical treatment. Also, homeopaths and other alternative practitioners often express anti-vaccine sentiments, endangering children by dissuading their parents from vaccination.
For these and several other reasons, these 124 medical professionals made an appeal for alternative and esoteric treatments to be excluded from the field of science-based medicine, and to stop reimbursement of homeopathic and other alternative treatments under France’s national health care insurance system.
In a somewhat belated response, French homeopaths are now filing no less than 63 disciplinary complaints with the French Medical Council against the signatories of the appeal in Le Figaro, apparently for “uncollegial behaviour” and “defiling medical ethics”. The homeopaths are represented by homeopathic doctor Daniel Scimeca, president of the French Federation of Homeopathic Societies, who also has close relations with Boiron laboratories, the biggest manufacturer of homeopathic products in the world.
At the time of this writing, 11 complaints have been adjudicated, resulting in 7 warnings, and 4 releases or dismissals. It is unclear how serious such a ‘warning’ should be taken, but it is clear that homeopaths are trying to punish real doctors for supporting and expressing an overwhelming scientific consensus, i.e. that there is no evidence whatsoever that homeopathy is actually good for anything.
And even though these French homeopaths do not resort to the sort of vile, underhanded media smear campaign perpetrated by the late Claus Fritzsche against Dr. Ernst, there are certain parallels – the most important of which is that proponents of unproven ‘medicine’ attempt to silence science-based criticism by unscientific means, instead of open discourse about the merits (or more precisely: the lack thereof) of their chosen profession.
I personally find it rather worrying that almost two-thirds of the complaints resulted in a slap on the wrist for the medical professional involved. Especially in a field that is so strongly dependent on both science and trust, well-founded criticism should be encouraged and made public, not punished and silenced.
According to WebMed, the shark cartilage (tough elastic tissue that provides support, much as bone does) used for medicine comes primarily from sharks caught in the Pacific Ocean. Several types of extracts are made from shark cartilage including squalamine lactate, AE-941, and U-995.
Shark cartilage is most famously used for cancer. Shark cartilage is also used for osteoarthritis, plaque psoriasis, age-related vision loss, wound healing, damage to the retina of the eye due to diabetes, and inflammation of the intestine (enteritis).
A more realistic picture is pained by this abstract:
The promotion of crude shark cartilage extracts as a cure for cancer has contributed to at least two significant negative outcomes: a dramatic decline in shark populations and a diversion of patients from effective cancer treatments. An alleged lack of cancer in sharks constitutes a key justification for its use. Herein, both malignant and benign neoplasms of sharks and their relatives are described, including previously unreported cases from the Registry of Tumors in Lower Animals, and two sharks with two cancers each. Additional justifications for using shark cartilage are illogical extensions of the finding of antiangiogenic and anti-invasive substances in cartilage. Scientific evidence to date supports neither the efficacy of crude cartilage extracts nor the ability of effective components to reach and eradicate cancer cells. The fact that people think shark cartilage consumption can cure cancer illustrates the serious potential impacts of pseudoscience. Although components of shark cartilage may work as a cancer retardant, crude extracts are ineffective. Efficiencies of technology (e.g., fish harvesting), the power of mass media to reach the lay public, and the susceptibility of the public to pseudoscience amplifies the negative impacts of shark cartilage use. To facilitate the use of reason as the basis of public and private decision-making, the evidence-based mechanisms of evaluation used daily by the scientific community should be added to the training of media and governmental professionals. Increased use of logical, collaborative discussion will be necessary to ensure a sustainable future for man and the biosphere.
To be clear: there is no good evidence that the supplements commercially available currently are effective for any condition.
Now, there is more news on this topic:
The objective of this study was to analyse labelling practices and compliance with regulatory standards for shark cartilage supplements sold in the United States. The product labels of 29 commercial shark cartilage supplements were assessed for compliance with U.S. regulations. Claims, including nutrient content, prohibited disease, and nutritional support statements, were examined for compliance and substantiation.
Overall, 48% of the samples had at least one instance of non-compliance with labelling regulations. The most common labelling violations observed were:
- missing a domestic address/phone number,
- non-compliant nutrient content claim,
- missing/incomplete disclaimer,
- missing statement of identity,
- prohibited disease claims,
- incomplete “Supplement Facts” label.
The use of prohibited disease claims and nutritional support statements without the required disclaimer is concerning from a public health standpoint because consumers may delay seeking professional treatment for a disease.
The authors concluded that the results of this study indicate a need for improved labelling compliance among shark cartilage supplements.
In summary, it seems that shark cartilage supplements are bad for all concerned:
- Patients who rely on them might hasten their death.
- Sharks are becoming an endangered species.
- Consumers are being mislead and misinformed.
There is just one party smiling: the supplement manufacturers who make a healthy profit destroying the health of gullible consumers and patients.
Leah Bracknell, started raising funds ~3 years ago for alternative cures of her stage 4 lung cancer. Bracknell who, after her acting career, had become a yoga teacher said at the time that, in the UK, she was given “a fairly brutal and bleak diagnosis, but one I am determined to challenge”. Her partner, Jez Hughes, who helped with the fund-raising said the money would be used for “immunotherapy and integrative medicine, which are seeing previously ‘incurable’ cancers going into complete remission”.
The team thus raised over £50 000 and went to Germany, a country that is well-known for its liberal stance on quackery. In Britain, there are just a few physicians who are devoted to this or that alternative medicine. In Germany, there are thousands of them. In addition, Germany has a healthcare profession called the ‘Heilpraktiker’, a poorly-regulated left-over from the Third Reich. A Heilpraktiker has not studied medicine, yet is legally permitted to make all sorts of unsubstantiated claims and treat many serious diseases, including cancer, with unproven therapies.
It was reported that Leah Bracknell went to the ‘Hallwang Private Oncology Clinic’, an institution which claims that “Healing-oriented and individualised medicine considers all aspects of lifestyle and not only relies on conventional treatments and recent cutting-edge developments in medicine, but also takes into account our experience in natural remedies and is open for alternative treatment options in order to work in synergy with conventional treatment strategies. We always try to be as natural as possible and as conventional as needed to achieve the best results. Integrative Health Concepts are successfully used in many diseases including malignant diseases, neurological disorders as well as in prevention and rehabilitation.” The SCAMs used there include homeopathy, micronutrients, natural supplements, whole body hyperthermia and ozone therapy.
The evidence does not support these or other alternative cancer ‘cures’. In fact, the very notion of an alternative cancer cure is nonsensical: if an alternative cancer therapy showed even the slightest shimmer of promise, it would get investigated and, if shown to work, become part of routine oncology. The suggestion that there are treatments out there that are effective, yet shunned by oncologists because they originate from nature or from some exotic tradition is insulting and utterly barmy.
Yet cancer patients can easily fall for such claims. They are understandably desperate and listen to anyone promissing a cure. Therefore, they all too easily believe in weird conspiracy theories of ‘Big Parma’, the evil ‘establishment’ etc. who allegedly suppress the news of an effective therapy, as it might threaten their profits. If they do fall for such lies, they not only lose pots of money but also their lives.
Last Wednesday, it was reported that Leah Bracknell had died of cancer.
On Twitter, I recently found this remarkable advertisement:
Naturally, it interested me. The implication seemed to be that we can boost our immune system and thus protect ourselves from colds, the flu and other infections by using this supplement. With the flu season approaching, this might be important. On the other hand, the supplement might be unsafe for many other patients. As I had done a bit of research in this area, I needed to know more.
According to the manufacturer’s information sheet, Viracid
- Provides Support for Immune Challenges
- Strengthens Immune Function
- Maintains Normal Inflammatory Balance
The manufacurer furthermore states the following:
Our body’s immune system is a complex and dynamic defense system that comes to our rescue at the first sign of exposure to an outside invader. The dynamic nature of the immune system means that all factors that affect health need to be addressed in order for it to function at peak performance. The immune system is very sensitive to nutrient deficiencies. While vitamin deficiencies can compromise the immune system, consuming immune enhancing nutrients and botanicals can support and strengthen your body’s immune response. Viracid’s synergistic formula significantly boosts immune cell function including antibody response, natural killer (NK) cell activity, thymus hormone secretions, and T-cell activation. Viracid also helps soothe throat irritations and nasal secretions, and maintains normal inflammatory balance by increasing antioxidant levels throughout the body.
This sounds impressive. Viracid could thus play an important role in keeping us healthy. It could also be contra-indicated to lots of patients who suffer from autoimmune and other conditions. In any case, it is worth having a closer look at this dietary supplement. The ingredients of the product include:
- Vitamin A,
- Vitamin C,
- Vitamin B12,
- Pantothenic Acid,
- L-Lysine Hydrochloride,
- Echinacea purpurea Extract,
- Acerola Fruit,
- Andrographis paniculata,
- European Elder,
- Berry Extract,
- Astragalus membranaceus Root Extract
Next, I conducted several literature searches. Here is what I did NOT find:
- any clinical trial of Viracid,
- any indication that its ingredients work synergistically,
- any proof of Viracid inducing an antibody response,
- or enhancing natural killer (NK) cell activity,
- or thymus hormone secretions,
- or T-cell activation,
- or soothing throat irritations,
- or controlling nasal secretions,
- or maintaining normal inflammatory balance,
- any mention of contra-indications,
- any reliable information about the risks of taking Viracid.
There are, of course, two explanations for this void of information. Either I did not search well enough, or the claims that are being made for Viracid by the manufacturer are unsubstantiated and therefore bogus.
Which of the two explanations apply?
Please, someone – preferably the manufacturer – tell me.
It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).
Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”
But is this always interpretation correct?
I seriously doubt it.
Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.
Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).
This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”
When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?
The answer is YES and NO.
YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?
NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.
So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.
I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.
I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!
The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.