On their website, the US Food and Drug Administration (FDA) has recently published a statement on homeopathy which, I think, is important enough to get cited extensively:
… Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…
The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients… The FDA intends to focus its enforcement authorities on the following kinds of products:
- products with reported safety concerns;
- products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- products for routes of administration other than oral and topical;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- products for vulnerable populations; and
- products that do not meet standards of quality, strength or purity as required under the law.
Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.
While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public…
Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.
In September 2016, the FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, after the products were associated with serious adverse events, including seizures and deaths, in infants and children. An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna. A similar issue occurred in 2010 when Hyland’s Teething Tablets were found to contain varying amounts of belladonna. An FDA inspection of that product’s manufacturing facility indicated substandard control of the product’s manufacturing.
The FDA has issued warnings related to a number of other homeopathic drug products over the past several years. These include certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and various homeopathic drug products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine (a highly toxic, well-studied poison often used to kill rodents).
“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”…
The FDA is not alone in reexamining its approach to homeopathy. In November 2016, the Federal Trade Commission (FTC) announced a new enforcement policy explaining that they will hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as other products making similar health claims. Notably, the FTC said that companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions…
END OF QUOTE
US homeopaths were quick to respond, as reported here:
The National Center for Homeopathy’s board of directors stated:
The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.
Of course, the unique aspect of homeopathic medicines undoubtedly is that they usually contain no active molecules and therefore do not work. But somehow, I doubt that the NCH was thinking of telling consumers the truth.
The NCH statement is tame in comparison with the NCH’s response to the FDA’s actions during the homeopathic teething investigation last year. Prior to the recall, the FDA issued a warning to consumers, which the NCH dubbed as “arbitrary and capricious.” The NCH went on to say that the FDA’s warning led to “exaggerated fear mongering” in the media and a “public scare” that threatened access to homeopathic products. “[G]roups interested in seeing homeopathy destroyed continue to hammer away at the system—making exaggerated claims that create misunderstandings about and limit consumer access,” the NCH wrote [emphasis theirs].
And this response is tame compared to what a prominent US homeopaths claimed at the time:
“It’s time to hold these people accountable. There are laws in every country against officials taking bribes and malfeasance in office. Write to your legislators and demand that they investigate and bring these criminals to justice. Send them the links to hundreds of homeopathy studies, including disease prevention with homeopathy, at the end of this article. Tell them that the regulatory agencies are protecting Pharma profits, not the public.
Meanwhile, let us insist that pharmaceutical drugs be labeled honestly, like this:
“This drug was tested by the same company that profits from it, and which company has been fined millions of dollars in the past for lying about test results. This drug does not cure any medical condition, but only suppresses symptoms which may ultimately make the patient sicker. This drug has already killed or injured X number of people.”
The outrage is understandable for two reasons, I think:
- even homeopaths cannot deny that the days of unchecked claims are counted;
- against rage of this sort homeopathic remedies are obviously not working.
Will President Donny Fartpants follow recent science-hating form and lay down what language can and can’t be used by the FDA and others in this matter(e.g. ‘evidence- based’)?
Apparently, Trump has been wrongly maligned over this: Editorial: It’s Not 1984
A move in the right direction, but I will continue to say that homeopathy should be made illegal and its practice criminalised. But there is no ‘exit strategy’, and that is the problem. Nevertheless, here is some satire regarding homeopathy to lift the spirits;
The mainstream U.S. reaction to homeopathy is always interesting to observe. First, it is criticized as being nothing but a placebo, because the remedies have been diluted to the point where they contain no measurable active ingredient. However, when it is convenient the FDA will say the remedies contain toxic substances. Would be nice if people made up their minds, do homeopathic remedies contain something, or nothing? Beyond that, the fact is that with the exception of the U.S., where Big Pharma with the help of the FDA looks to ward off any threats to its profitable businesses, homeopathy is in fact very well received in many European countries, and not only by holistic advocates but by licensed doctors as well. A little healthy skepticism rather than across the board acceptance is always good, however, tossing out homeopathy because there could be some tainted remedies on the market is akin to dismissing all of Western medicine because medical error has been acknowledged as the third leading cause of death in the U.S. An interesting article if you are inclined:
Cheers and happy New Year!
“Would be nice if people made up their minds, do homeopathic remedies contain something, or nothing?”
While most homeopathic remedies prescribed and sold tend to be at high dilutions (Hahnemann was particularly fond of 30C or a dilution of 10^60), many are not. You can see here a list of 80 remedies sold by Helios Homeopathy as ‘mother tinctures’, i.e. undiluted extracts of (mostly) plant materials. These may contain potentially toxic substances at (relatively) high concentrations.
Homeopathists refer to such extracts and the first dilutions made from them as ‘low potency’ preparations, because they’ve not been diluted and succussed out of existence to raise their medical potency. But it’s with the ‘low potency’ products that homeopathy meets herbalism and creates the confusion in which many folk think the two terms mean the same thing.
The magic of homeopathic dilutions is simply the inverse of every known law of chemistry and physics, which is one reason most rational people regard homeopathy as a pseudoscience. (The other is the concept of ‘like cures like’ which the past 200 years of increasingly sophisticated understanding of physiology, biochemistry, microbiology and pathology has rendered obsolete.) Like all government regulatory authorities, the FDA is stuck somewhere in the middle, forced to deal with the detail of individual products without offending anybody.
Good point about the extracts and first dilutions. Indeed, it does sometimes blur the line between homeopathy and herbalism. Nonetheless, I think the FDA and others greatly exaggerate the potential threat from homeopathy or herbal preparations, despite the lack of regulation. According to Harvard University (2014 article), in the U.S. each year there are “…a total of 2.74 million serious adverse drug reactions. About 128,000 people die from drugs prescribed to them. This makes prescription drugs a major health risk, ranking 4th with stroke as a leading cause of death.” (https://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages).
I don’t have numbers, but I would imagine the percentages for the safe administration of herbals and homeopathic preparations is better globally than pharmaceuticals, and given the numbers on adverse reactions and deaths from prescription drugs, the FDA’s efforts directed at homeopathy seem a bit misplaced. As you can see from the article I linked in my original comment, many European doctors, as well as their patients who use homeopathic preparations and get well, don’t really care that it’s labeled pseudoscience. Our conventional medical understanding may be sophisticated, but we still manage to kill an awful lot of people with our pharmaceuticals.
What you’re overlooking is the benefit:risk ratio. If the benefit is zero, then any risk becomes unacceptable. Prescription drugs usually offer real benefits for properly diagnosed diseases: without them patients’ conditions are likely to worsen or the patient may die. Proper doctors have to weigh the benefit of a drug vs. the risk in the context of the seriousness of the disease.
We know the risks of prescription drugs and detailed data on adverse events because there are well validated systems in place for monitoring them. Practitioners of Big Snakeoil don’t have anything comparable, so the risks of herbals, homeopathy, chiropractic, etc. are unquantified.
Alan Henness, in his comments on this thread, has really covered this ground more comprehensively than I’m doing. Please do read his link on Death By Medicine. If you’ve any kind of open mind it should help.
This is the ethical dilemma of the times, I’m afraid.
Let them all die or try to save as many as possible and risk losing some in the process.
In special cases, a third option also exists, Kill them actively or passively, because of ignorance or passionate beliefs. It merges with the first option however, so it’s still a dilemma, not a trilemma.
The effort of the FDA is not misplaced, conventional medicine being imperfect is no reason to (usually) passively expose people to health risks. Homeopathy is equal to doing nothing, which is equal to negligence in cases of significant illness.
Oh, and by the way:
They don’t get well because of the homeopathic preparations. But they never see what would happen if they didn’t use the homeopathic preparations. When that is accounted for (in proper trials), it becomes evident that homeopathic preparations are just there for the amusement.
Jay Howard said:
Bizarre. You use the word ‘tainted’ later on, but this still seems a mystery to you… I’ll let you ponder on that.
An oft-repeated accusation, but just as frequently, unevidenced.
But if Big Pharma thought they homeopathy was a real threat to there profits, would it not be far easier and quicker to simply buy up the homeopathy manufacturers? Homeopathy is a highly profitable big business but I’m sure they could do it with little more than the loose change in their pockets.
I suspect Kanye West is very well received in many European countries, but that doesn’t mean he’s a great musician. In fact homeopathy isn’t really even all that popular in many European countries. In the UK, for example, only about 1% of the population had used homeopathy in the 12 months prior to 2014.
My GP is holistic – many quacks try to steal the term as if it was a facet missing from conventional medicine and that somehow replaces the need to provide evidence homeopathy actually works. Quacks can offer whatever they like, but it can never replace evidence of what they do: it is simply an attempt to paper over the cracks in their evidence.
However, there are certainly some doctors who in thrall of homeopathy, but that can’t replace evidence either. But even there, in the UK, the numbers are dropping and we know that the number of prescriptions for homeopathy on the NHS dispensed in community pharmacies in England have plummeted 95% in the past 20 years.
Indeed. You should try it sometime…
First, provide evidence that homeopathy has specific effects over placebo…
Also, you say medical error is the third leading cause of death in the US – and provide no evidence – but the Center for Disease Control give the top ten causes of death (2015) as:
1 Diseases of heart . . . . . . . . . . . . . . . . . . 633,842
2 Malignant neoplasms . . . . . . . . . . . . . . . . 595,930
3 Chronic lower respiratory diseases . . . . . . 155,041
4 Unintentional injuries . . . . . . . . . . . . . . . . 146,571
5 Cerebrovascular diseases . . . . . . . . . . . . . 140,323
6 Alzheimer’s disease . . . . . . . . . . . . . . . . . 110,561
7 Diabetes mellitus . . . . . . . . . . . . . . . . . . 79,535
8 Influenza and pneumonia . . . . . . . . . . . . . 57,062
9 Nephritis, nephrotic syndrome, and nephrosis 49,959
10 Suicide . . . . . . . . . . . . . . . . . . . . . . . . 44,193
Are they wrong?
There really is very little Ullman get right in that article – and much he conveniently omits – but if there is something specific you’d like to draw our attention to, please do. But remember that Ullman is not an expert in homeopathy! You may find what the Honorable Bryan F Foster in Rosendez v. Green Pharmaceuticals, Case No. CIVDS 1108022 (Cal. Super. Ct., San Bernardino Nov. 25, 2014)  said of Dana as an expert witness for homeopathy:
At last, something we can agree on…
Not inclined to get into the long and often fruitless debate of conventional vs. non-conventional, placebo vs real drug, or science vs pseudoscience, as I am sure neither of us will convince the other.
The only thing I will note however is that the statistic on deaths from prescription drugs came from the Harvard University article I linked in my comment. Not necessarily medical error, but death from prescription drugs. JAMA has also published statistics showing medical error specifically as the third leading cause of death in the U.S. Easy to search online or on their website.
If you don’t want to back up your claims or acknowledge they were wrong or misleading, that’s fine by me. I never mentioned placebos anyway.
However, you may like to read this: Death By Medicine”. You might just find it illuminating. Or not.
Why not use correct data for a change.
“Death By Medicine”.
Perfect circular referencing! Who are you misleading?
Use real data for a change.
About 90,000 deaths/year in USA based upon study in 1994.
These total to 225 000 deaths per year from iatrogenic causes. Three caveats should be noted. First, most of the data are derived from studies in hospitalized patients. Second, these estimates are for deaths only and do not include adverse effects that are associated with disability or discomfort. Third, the estimates of death due to error are lower than those in the IOM report.
If the higher estimates are used, the deaths due to iatrogenic causes would range from 230 000 to 284 000. In any case, 225 000 deaths per year constitutes the third leading cause of death in the United States, after deaths from heart disease and cancer.
Study year 2000.
“Analyzing medical death rate data over an eight-year period, Johns Hopkins patient safety experts have calculated that more than 250,000 deaths per year are due to medical error in the U.S. Their figure, published May 3 in The BMJ, surpasses the U.S. Centers for Disease Control and Prevention’s third leading cause of death—respiratory disease, which kills close to 150,000 people per year.
The Johns Hopkins team says the CDC’s way of collecting national health statistics fails to classify medical errors separately on the death certificate. The researchers are advocating for updated criteria for classifying deaths on death certificates.
Almost 400,000 deaths every: year 2014
Is Europe different? NO. SAME MEDICINE SAME RESULTS.
“For example, the United Kingdom Department of Health, in its 2000 report An organization with a memory, estimated about 850 000 adverse events a year (10% of hospital admissions). Spain (in its 2005 national study of adverse events) and France and Denmark have published incidence studies with similar results.”
“Infections associated with health care affect an estimated 1 in 20 hospital patients on average every year (estimated at 4.1 million patients) with the four most common types being: urinary tract infections (27%), lower respiratory tract infections (24%), surgical site infections (17%) and bloodstream infections (10.5%). Multi resistant Staphylococcus aureus (MRSA) is isolated in about 5% of all infections associated with health care. The United Kingdom National Audit Office estimates the cost of such infections at £1 billion per year.”
Can India be different? NOT FOR PATIENTS WHO GO TO THE SCIENTIFIC HOSPITALS/ DOCTORS.
Larger the sample, bigger the quantity of error.
Patients seem to be waking up: Get ready to work harder to sweep scientific medical issues under the carpet until there is no space left.
Iqbal Krishna said:
Jay Howard made the claim: I provided a source that contradicted the claim. We can await his response to see if he can substantiate it to see who was misleading.
Well, your link doesn’t work, so that’s not much use.
Iqbal! We are getting rather fed up with your playing with your glue and scissors, making incoherent collages out of clippings that you think support your amateurish aversion of scientific medicine..
Here is the document you seem to be referring to in the broken link of your first clipping: http://www.library.armstrong.edu/eres/docs/eres/MHSA8625-1_MCADAMS/862510McAInstitute.pdf
This is not a study, this is not data. This is simply an article expressing opinion in support of another opinion piece (your next clipping, Barbara Starfield’s article form 2000) which is also not a ‘study’ as you call it but a critical look at the rather problematic health care system in the US (compared to other countries with better situation). The figures in there are largely based on “guestimation”.
You cannot even compose your own thoughts but clip and paste texts that literally contradict your own erroneous interpretation. Did you actually read the articles you are pasting references to? Did you actualy try to understand and put into perspective the texts you clip and past?
No one denies there are problems with health care, mistakes are inevitably made in all complex systems and complications occur. That is not because scientific medicine is wrong. It is because of the complexity and variability and the limitations of human abilities. Not because of lack of homeopathy.
Mistakes and errors of judgement are part of doctor’s everyday life. Just like they are part of a fighter pilots everyday life. Here is an article that describes another complex system and how the task is not to eliminate mistakes, which is impossible, but to prevent them from ruining the day.
I am not hopeful that you will understand this parable dear Iqbal, it is just as much put here for the audience who might be interested.
There is a constant effort within medicine to prevent errors and mistakes from causing harm. Barbara Starfield’s article was part of this effort. What she was saying was not that people should stop going to hospitals or doctors. Her input was an effort to push progress, which incidentally is non-existent in homeopathy if you discount the discovery of the remedy made from the common housefly 😀
No one is surprised that there are many errors and mistakes made in the Indian health care system. Try dividing the figure with how many doctor visits, operations and interventions are made in the area.
Indian health care is on a global scale sub-standard, to put it mildly. Regulation and oversight are a joke.
I would not want to be admitted to a hospital in India with a serious injury or disease. That someone writes about this and tries to “guestimate” how many errors are made and so on, does not corroborate the idiotic ideas the Indian government seems to be having these days. The solution is not in letting outdated, ineffective relics like Ayurveda and homeopathy into real health care.
Even in Europe people recognise problems and try to figure out ways to improve patient safety. The figures that frighten you so much should be seen as rough estimates and interpreted in relation to how many actual interventions there are and the relative benefit from modern medicine. The risk/benefit ratio is something we constantly mention here on this blog. Try looking the term up and contemplate how it relates to the figures in your clippings.
Poor old Iqbal – he doesn’t know better.
Fellow Iqbal, once again you prove that science-based medicine extensively documents its errors and actively tries to improve itself by examining them, making them public and scrutinizing the context to find space for corrections and avoidance in the first place.
Your next mission is to create a collage with official documents recording the number of active or passive (e.g. by negligence) deaths due to use of alternative medicine. I know it will be a bit tough because homeopaths only like to remember positive anecdotes and make formal case studies out of them. I have faith in you, though. I know you will not respond to anything relevant, but keep serving us your trademark copypasta specialty. Though your dishes here used to be eaten for breakfast, you ended up serving hardly an appetizer, which is bad. You have to try harder…
Listen fellow Iqbal, take some homeopathic pill and walk behind a moving truck, just touch with your hands and walk along… Then you can come in here and tell all of us how homeopathy gave you the strength to push an entire truck with your bare hands… This is precisely how homeopathy works in your mind. You need to practice your fantasy a bit more…
An article written by Donald Light. Who is not a scientist, not a statistician, not an epidemiologist. He’s an osteopath. A quack. With a massive personal agenda to batter the pharmecutical industry. His witterings are of no consequence.
There is no “debate”. Alternative, non-conventional medicine is a, per modality, random synthesis of make-believe claims, which somehow seemed reasonable at the time of contrivance, but were clearly disproved in later times. Anything goes in alternative medicine, urine drinking, effects stemming from lack of substances, poking your ass to improve liver function, just name your dream! In today’s world, claims don’t even need to seem reasonable at the time of contrivance. You name it, you believe it!
There is nothing to convince a proponent of such claims of. In most cases, it is natural for beliefs to persevere, despite clear evidence, it’s just a natural weakness. Thankfully, robust scientists, who are the kind of people that discover how this world actually functions, are always fond of robust evidence, and are always ready to reformulate their models in the face of such robust evidence. This is what makes those models of reality robust.
Don’t mention debates as if there were one. This is just reality versus imagination.
“We are getting rather fed up with your playing with your glue and scissors, making incoherent collages out of clippings that you think support your amateurish aversion of scientific medicine.”
There is no requirement to be fed up. You all should be worried. These are unfolding of “Chapters of the Scientific Medical Horror stories” written by icons of the Scientific medical world:
Dr Lucine Leape, Dr. B Starfield, Drs Martin Makary / Michael Daniel…. the list is becoming longer by the day. How ever you prefer to quote Gorski; a paid writer. What does he know about public health compared to the listed names?
“The figures in there are largely based on “guestimation”. You cannot even compose your own thoughts but clip and paste texts that literally contradict your own erroneous interpretation. Did you actually read the articles you are pasting references to?
Then make sense of the outcome of studies below, as these read in context with above provide confirmation about mess that Edzard avoids to write about.
“A 2015 study led by Harvard’s Dr. Anupam Jena echoes this observation. It is a large investigation looking at deaths in hospitals across the United States when the American Heart Association and the American College of Cardiologists are in session — measuring patient health when most of America’s cardiologists are away from their home institutions. In the outcomes it considers, the study finds that patient death rates either stayed the same or significantly improved when doctors were away at the conferences.”
“The only report of increased mortality associated with strike action was from South Africa, where the odds of death increased at one hospital during a 20-day strike in 2010. However, this strike included both doctors and nurses who withdrew all services from patients, and left only one hospital open to serve a population of 5.5 million people.”
‘Around 70-75,000 diabetic patients die every year. The study estimated that a third of them were dying from causes that could be avoided if their condition were better managed. “
Where does so much diabetes come from?
Makes sense if heard with:
“…..If both “paroxetine” and “pravastatin” are present in the query, it goes up to 10 percent, a huge three- to four-fold increase in those searches with the two drugs that we were interested in, and diabetes-type words or hyperglycemia-type words.”
“Nick went on; he’s a professor at Columbia now. He did this in his PhD for hundreds of pairs of drugs. He found several very important interactions, and so we replicated this and we showed that this is a way that really works for finding drug-drug interactions.”
“We don’t just use pairs of drugs at a time. As I said before, there are patients on three, five, seven, nine drugs. Have they been studied with respect to their nine-way interaction? Yes, we can do pair-wise, A and B, A and C, A and D, but what about A, B, C, D, E, F, G all together, being taken by the same patient, perhaps interacting with each other in ways that either makes them more effective or less effective or causes side effects that are unexpected? We really have no idea.”
“WE HAVE NO IDEA.” Read this in context of doctors killing patients/making them chronicly sick and it makes a lot of sense.
This is the EVIDENCE in medicine that Edzard peddles?
Have you seen any doctor consult a list of drug interaction before he writes a prescription? Do you even have such a list? What is the outcome when a patient consults 3/4 “specialists” around the same time and gets prescription from each? First create diabetics and then kill them on the pretext of complexity and complication.
I would have thought healthy people would use less medicine. Here, it is exactly the opposite. Americans spend $3.2 trillion on 323 million people for health care. A proper sick population. This is the outcome of scientific medicine.
“No one denies there are problems with health care, mistakes are inevitably made in all complex systems and complications occur. That is not because scientific medicine is wrong.”
If this is the understanding you have about the medicine you practise, what is the end result difference between you and a blood letting doctor? You think the issue of medicine is too complex and complicated to understand and your predecessor did not understand medicine? With docotrs like you running amok, the outcome is exactly on expected lines: As WHO report says: “While 23% of European Union citizens (one in EACH family) claim to have been directly affected by medical error, 18% claim to have experienced a serious medical error in a hospital and 11% to have been prescribed wrong medication.”
If this is not developimg into a horror story, what is additional information?
Iqbal’s comments could simply be an essay titled: “Doctors – A useless profession”.
Fellow Iqbal, you are successfully trolling this blog. I’m sorry to say that it’s been quite a long time since your irrationality and deluded perceptions were, at least slightly, original. You have not been original for quite some time now. Will you please try harder?
What’s your opinion on surgical interventions?
What is your advice to heal diabetes?