Can conventional therapy (CT) be combined with herbal therapy (CT + H) in the management of Alzheimer’s disease (AD) to the benefit of patients? This was the question investigated by Chinese researchers in a recent retrospective cohort study funded by grants from China Ministry of Education, National Natural Science Foundation of China, Beijing Municipal Science and Technology Commission, and Beijing Municipal Commission of Health and Family Planning.
In total, 344 outpatients diagnosed as probable dementia due to AD were collected, who had received either CT + H or CT alone. The GRAPE formula was prescribed for AD patients after every visit according to TCM theory. It consisted mainly (what does ‘mainly’ mean as a description of a trial intervention?) of Ren shen (Panax ginseng, 10 g/d), Di huang (Rehmannia glutinosa, 30 g/d), Cang pu (Acorus tatarinowii, 10 g/d), Yuan zhi (Polygala tenuifolia, 10 g/d), Yin yanghuo (Epimedium brevicornu, 10 g/d), Shan zhuyu (Cornus officinalis, 10 g/d), Rou congrong (Cistanche deserticola, 10 g/d), Yu jin (Curcuma aromatica, 10 g/d), Dan shen (Salvia miltiorrhiza, 10 g/d), Dang gui (Angelica sinensis, 10 g/d), Tian ma (Gastrodia elata, 10 g/d), and Huang lian (Coptis chinensis, 10 g/d), supplied by Beijing Tcmages Pharmaceutical Co., LTD. Daily dose was taken twice and dissolved in 150 ml hot water each time. Cognitive function was quantified by the mini-mental state examination (MMSE) every 3 months for 24 months.
The results show that most of the patients were initially diagnosed with mild (MMSE = 21-26, n = 177) and moderate (MMSE = 10-20, n = 137) dementia. At 18 months, CT+ H patients scored on average 1.76 (P = 0.002) better than CT patients, and at 24 months, patients scored on average 2.52 (P < 0.001) better. At 24 months, the patients with improved cognitive function (△MMSE ≥ 0) in CT + H was more than CT alone (33.33% vs 7.69%, P = 0.020). Interestingly, patients with mild AD received the most robust benefit from CT + H therapy. The deterioration of the cognitive function was largely prevented at 24 months (ΔMMSE = -0.06), a significant improvement from CT alone (ΔMMSE = -2.66, P = 0.005).
The authors concluded that, compared to CT alone, CT + H significantly benefited AD patients. A symptomatic effect of CT + H was more pronounced with time. Cognitive decline was substantially decelerated in patients with moderate severity, while the cognitive function was largely stabilized in patients with mild severity over two years. These results imply that Chinese herbal medicines may provide an alternative and additive treatment for AD.
Conclusions like these render me speechless – well, almost speechless. This was nothing more than a retrospective chart analysis. It is not possible to draw causal conclusions from such data.
Because of a whole host of reasons. Most crucially, the CT+H patients were almost certainly a different and therefore non-comparable population to the CT patients. This flaw is so elementary that I need to ask, who are the reviewers letting such utter nonsense pass, and which journal would publish such rubbish? In fact, I can be used for teaching students why randomisation is essential, if we aim to find out about cause and effect.
Ahhh, it’s the BMC Complement Altern Med! I think the funders, editors, reviewers, and authors of this paper should all go and hide in shame.
This is the title of an editorial by Alan Schmukler. You probably remember him; I have featured him before, for instance here, here, and here. This is what was recently on Schmukler’s mind (I have added a few references referring to comments of mine added below):
England’s National Health Service (NHS) is proposing that NHS doctors no longer be permitted to prescribe homeopathic remedies … They claim lack of evidence for effectiveness. Anyone who’s been remotely conscious the last 10 years will see this as a pretext. Homeopathy is practiced by board certified physicians in clinics and hospitals around the world . The massive Swiss review of homeopathy, found it effective, safe and economical, and the Swiss incorporated homeopathy into their national health care system …
The reason given for banning homeopathy and these nutrients is a lie. Why would the NHS ban safe, effective and affordable healing methods?  Without these methods, all that is left are prescription drugs. Apparently, someone at the NHS has an interest in pushing expensive prescription drugs , rather than safer and cheaper alternatives. That someone, also wishes to deny people freedom of choice in medicine . I say “someone”, because organizations don’t make decisions, people do. Who is that someone? In looking for a suspect, we might ask, who is the chief executive of the organization? Who introduced this plan and is promoting it? Who at the NHS has the political clout? Who was it that recently declared: “Homeopathy is a placebo and a misuse of scarce NHS funds which could better be devoted to treatments that work”.
The quote is from Simon Stevens, NHS England’s chief executive. He got the job in 2014, after ten years as a top executive at UnitedHealth, the largest health insurance company in America. His past work experiences and current activities show that he favors privatization . That would make him an odd choice to run a healthcare system based on socialized medicine. In fact, he has been moving the NHS towards privatization and the corporate, profit based American model.  The last thing a privatizer in healthcare would want, are non-proprietary medicines, for which you can’t charge exorbitant fees . Banning homeopathy on the NHS is just one small part of a larger plan to maximize corporate profits by letting corporations own and control the health care system . Before they can do this, they have to eliminate alternative methods of treatment.
Personally, I think Schmukler is wrong – here is why:
1 The current argument is not about what doctors are permitted to do, but about what the NHS should do with our tax money.
2 Argumentum ad populum
3 Oh dear! Anyone who uses this report as evidence must be desperate – see for instance here.
4 Why indeed? Except highly dilute homeopathic remedies are pure placebos.
5 Maybe ‘someone’ merely wants to use effective medications rather than placebos.
6 Freedom of choice is a nonsense, if it is not guided by sound evidence – see here.
7 No, that’s Jeremy Hunt! But in any case privatisation might be more profitable with homeopathy – much higher profit margins without any investment into R&D.
8 No, this is Hunt again!
9 Homeopathic remedies are ideal for making vast profits: no research, no development, no cost for raw material, etc., etc.
10 I am sure Boiron et al would not mind stepping into the gap.
I very much look forward to the next outburst of Alan Schmukler and hope he will manage to think a bit clearer by then.
We have discussed the NHMRC report on homeopathy several times – see, for instance, here, here and here. Perhaps understandably, homeopaths have great difficulties accepting its negative findings, and have complained about it ever since it was published. Now, a very detailed and well-researched analysis has become available of both the report and its criticism. Here I take the liberty to copy and (clumsily) translate its conclusions; if you can read German, I highly recommend studying the full document.
START OF MY TRANSLATION
The criticism of the NHMRC review is very voluminous and highlights many different aspects of the background, the methodology, the execution and the unwanted results from a homeopathic perspective. The very engaging discussions in the general public about this document and its flaws are, however, relatively meaningless: the NHMRC arrives at exactly the same conclusions as the employee of the Homeopathic Research Institute (HRI), Mathie, in his reviews of 2014 and 2017.
In both reviews, Mathie evaluated a total of 107 primary studies and found only 2 trials that could be rated as qualitatively good, that is to say constituting reliable evidence. Mathie did upgrade 2 further studies to the category of reliable evidence, however, this was in violation of the procedures proscribed in the study protocol.
The criticism of the NHMRC review was not able to make a single valid rebuttal. No condition could be identified for which homeopathy is clearly superior to placebo. This is all the more important, as Mathie avoided the mistakes that constituted the most prominent alleged criticisms of the NHMRC report.
- Since Mathie and most of his co-authors are affiliated with organisations of homeopathy, an anti-homeopathy bias can be excluded.
- Mathie conducted classic reviews and even differentiated between individualised and non-individualised homeopathy.
- Mathie did not exclude studies below a certain sample size.
Yet, in both reviews, he draws the same conclusion.
In view of the truly independent replications of an employee of the HRI, we can be sure that there are, in fact, no solid proofs for the effectiveness of homeopathy. The claim of a strong efficacy, equivalent to conventional medicines, that is made by homeopathy’s advocates is therefore not true.
END OF MY TRANSLATION
And here is the original German text:
Die Kritik an dem Review des NHMRC ist sehr umfangreich und beleuchtet sehr viele verschiedene Facetten über das Umfeld, die Methodik und die Durchführung sowie das aus Sicht der Homöopathen unerwünschte Ergebnis selbst. Die in der Öffentlichkeit sehr engagierte Diskussion um diese Arbeit und ihre möglichen Unzulänglichkeiten sind jedoch relativ bedeutungslos: Das NHMRC kommt zu genau dem gleichen Ergebnis wie Mathie als Mitarbeiter des HRI in seinen in 2014 und 2017 veröffentlichten systematischen Reviews:
Insgesamt hat Mathie in beiden Reviews 107 Einzelstudien untersucht und fand nur zwei Studien, die als qualitativ gut („low risk of bias“), also als zuverlässige Evidenz betrachtet werden können. Mathie hat zwar vier weitere Studien zur zuverlässigen Evidenz aufgewertet, was allerdings im Widerspruch zu den üblichen Vorgehensweisen steht und im Studienprotokoll nicht vorgesehen war.
Die Kritik am Review des NHMRC hat keinen einzigen Punkt fundiert widerlegen können. Man konnte keine Indikation finden, bei der sich die Homöopathie als klar über Placebo hinaus wirksam erwiesen hätte. Diese Punkte sind umso bedeutsamer, weil Mathie die am NHMRC hauptsächlich kritisierten Fehler nicht gemacht hat:
- Als Mitarbeiter des HRI und mit Autoren, die überwiegend für Homöopathie-affine Organisationen arbeiten, ist eine Voreingenommenheit gegen die Homöopathie auszuschließen.
- Mathie hat klassische Reviews ausgeführt, sogar getrennt zwischen einzelnen Ausprägungen (individualisierte Homöopathie und nicht-individualisierte Homöopathie).
- Mathie hat keine Größenbeschränkung der Studien berücksichtigt.
Er kommt aber dennoch zweimal zum gleichen Ergebnis wie das NHMRC.
Angesichts der wirklich als unabhängig anzusehenden Bestätigung der Ergebnisse des NHMRC durch einen Mitarbeiter des Homeopathy Research Institute kann man sicher davon ausgehen, dass es tatsächlich keine belastbaren Wirkungsnachweise für die Homöopathie gibt und dass die von ihren Anhängern behauptete starke, der konventionellen Medizin gleichwertige oder gar überlegene Wirksamkeit der Homöopathie nicht gegeben ist.
I do apologise for my clumsy translation and once again encourage those who can to study the detailed original in full.
My conclusion of this (and indeed of virtually all criticism of homeopathy) is that homeopaths are just as unable to accept criticism as an evangelic believer is going to accept any rational argument against his belief. In other words, regardless of how convincing the evidence, homeopaths will always dismiss it – or, to put it in a nutshell: HOMEOPATHY IS A CULT.
The title of this post is a statement recently made in an article by Mike Adams in ‘Alternative Medicine News’:
The cancer industry goes to great lengths to deny patients access to any information that they might use to prevent, treat or cure cancer without requiring expensive (and highly toxic) medical interventions. That’s what makes the BMJ documentation of this curcumin cancer cure so astonishing: In years past, the BMJ never would have even tolerated the publishing of such a scientific assessment. So what changed? In truth, the evidence of natural cures for cancer is now so overwhelming that even the BMJ cannot remain in a state of denial without appearing to be hopelessly out of touch with scientific reality.
The story is based on one single patient who apparently was cured of cancer using curcumin (turmeric). The case was also recently (3/1/18) featured on BBC’s ‘YOU AND YOURS’ (http://www.bbc.co.uk/programmes/b09k0ng7) in a similarly uncritical way: no expert was asked to provide an evidence-based assessment and bring some reason into the discussion. Even the DAILY FAIL reported about the story, and predictably, critical assessment had to make way for sensationalism.
We hear about such nonsense almost every day!
True, but this case is different; it is based on a publication in the highly-respected BMJ (well, actually, it was the ‘BMJ CASE REPORTS’ and not the BMJ, as reported). Here is the article:
START OF QUOTE
A woman aged 57 years was initially diagnosed with monoclonal gammopathy of undetermined significance (MGUS) in 2007 following an incidental finding of M-protein (18 g/L) during investigation for hypertension.
Within 15 months, the patient had rapidly progressed to ISS stage 3 myeloma with M-protein 49 g/L, urinary protein 1.3 g/24-hour, Bence-Jones protein 1.0 g/24-hour, Hb 9.7 g/dL and increasing back pain. She initially declined antimyeloma treatment but 6 months later, following vertebral collapse at T5 and T12, started cyclophosphamide, thalidomide and dexamethasone (CTD) treatment. However, after a week, the patient was admitted with idiosyncratic syndrome including hyponatraemia, a fall in albumin and worsening of blood counts. She received red cell transfusion and her electrolyte abnormalities were carefully corrected.
Although there was evidence of a response to CTD (M-protein 34 g/L), bortezomib and dexamethasone treatment was initiated as an alternative, but this was discontinued after three cycles due to progressive disease (M-protein 49 g/L). The patient was then treated with lenalidomide and dexamethasone with the aim of reducing disease burden prior to high-dose therapy and autologous stem cell transplantation. Treatment was frequently interrupted and dose adjusted to account for neutropenia and despite a minor response after six cycles (starting M-protein 47 g/L, finishing M-protein 34 g/L), in October 2009, she proceeded with stem cell mobilisation. However, neither cyclophosphamide nor plerixafor/GCSF priming were successful. A bone marrow biopsy revealed 50% myeloma cells and a course of CTD was restarted with cautious titration of thalidomide.
The patient achieved a partial response with CTD retreatment over the course of 17 cycles (M-protein 13 g/L) with no further episodes of idiosyncratic syndrome. However, attempts to harvest stem cells in February 2011 and again there months later, both failed. By then, her M-protein had risen to 24 g/L and the patient was too neutropenic to be considered for a clinical trial.
At this point, the patient began a daily regime of oral curcumin complexed with bioperine (to aid absorption), as a single dose of 8 g each evening on an empty stomach. A few months later, she also embarked on a once-weekly course of hyperbaric oxygen therapy (90 min at 2 ATA) which she has maintained ever since. Her paraprotein levels gradually declined to a nadir of 13 g/L, her blood counts steadily improved and there was no evidence of further progressive lytic bone disease.
Outcome and follow-up
The patient continues to take oral curcumin 8 g daily without further antimyeloma treatment. Over the last 60 months, her myeloma has remained stable with minimal fluctuation in paraprotein level, her blood counts lie within the normal range and she has maintained good quality of life throughout this period. Repeat bone imaging in 2014 identified multiple lucencies <1 cm in the right hip and degenerative changes in both hips, but these were attributed to osteoarthritis rather than the myeloma. Recent cytogenetic analysis revealed she had no abnormal cytogenetics by fluorescent in situ hybridisation.
A small but significant number of myeloma patients consume dietary supplements in conjunction with conventional treatment primarily to help cope with the side effects of treatment, manage symptoms and enhance general well-being. Few, if any, use dietary supplementation as an alternative to standard antimyeloma therapy. Here, we describe a case in which curcumin has maintained long-term disease control in a multiply-relapsed myeloma patient. To the best of our knowledge, this is the first report in which curcumin has demonstrated an objective response in progressive disease in the absence of conventional treatment.
Curcumin is a polyphenol derived from the perennial herb Curcuma longa (turmeric) and has, for centuries, been used as a traditional Indian medicine. Several reports published over the two decades have claimed various health benefits of curcumin and this has led to its increasing popularity as a dietary supplement to prevent or treat a number of different diseases.
The biological activity of curcumin is indeed remarkable. It is a highly pleiotropic molecule which possesses natural antioxidant, anti-inflammatory, antiseptic and analgesic properties. More recently, it has demonstrated antiproliferative effects in a wide variety of tumour cells including myeloma cells and exerts its antiproliferative effects through multiple cellular targets that regulate cell growth and survival.
In vitro, curcumin prevents myeloma cell proliferation through inhibition of IL-6-induced STAT-3 phosphorylation and through modulation of the expression of NF-kB-associated proteins such as IkB〈,Bcl-2, Bcl-xL, cyclin D1 and IL-6 and apoptosis-related molecules including p53 and Bax. In other studies, curcumin was shown to circumvent resistance to dexamethasone, doxorubicin and melphalan as well as potentiate the effects of bortezomib, thalidomide and lenalidomide. Furthermore, curcumin-induced cell death was not influenced by myeloma molecular heterogeneity.
The antimyeloma effects of curcumin in the clinical setting however are less clear. Only one phase I/II study has evaluated curcumin treatment in myeloma patients. These patients were either asymptomatic, relapsed or had plateau phase disease. Treatment with curcumin downregulated the expression of NFkB, COX-2 and STAT3 in peripheral blood mononuclear cells, but no objective responses were observed in any subgroup of patients. This may be as a result of small sample size in this study, follow-up was limited to 3 months and clinical responses may have been observed with longer follow-up. However, downregulation of NFkB, COX-2 and STAT3 expression may not correlate with the clinical activity of curcumin and there may be further mechanisms of action that remain unclear, possibly through the modulation of another target. We would not be able to identify any patient-specific mechanisms of activity in this case study, as the patient has been taking curcumin for some time now and baseline bone marrow or peripheral blood samples are not available. However, in the setting of a clinical trial, it may be possible to use next-generation sequencing to help identify a mutation that may be a potential target for curcumin.
Another study examined its effects in preventing the progression of MGUS and smouldering myeloma to myeloma. The results showed that curcumin exerted a trace of biological activity with modest decreases in free light chain and paraprotein levels and a reduction in a marker of bone resorption with curcumin treatment, suggesting the therapeutic potential of curcumin in MGUS and smouldering myeloma. However, more studies are needed to address this further.
Whether such effects are observed in patients with active disease remains to be seen. The fact that our patient, who had advanced stage disease and was effectively salvaged while exclusively on curcumin, suggests a potential antimyeloma effect of curcumin. She continues to take daily curcumin and remains in a very satisfactory condition with good quality of life. This case provides further evidence of the potential benefit for curcumin in myeloma. We would recommend further evaluation of curcumin in myeloma patients in the context of a clinical trial.
END OF QUOTE
What should we make of this?
I think that much of the reporting around the story was grossly irresponsible. It is simply not possible to conclude that curcumin was the cause of the remission. It could be due to a whole host of other factors. And a case report is just an anecdote; it never can prove anything and can only be used to stimulate further research.
I fully agree with the authors of the case report: curcumin seems worthy of further investigation. But recommending it to patients for self-medication is vastly premature and quite simply dangerous, unethical and naïve bordering on stupid.
And, of course, the above-cited drivel of Mike Adams is just beyond the pale – the evidence for ‘alternative cancer cures‘ is very, very far from ‘overwhelming’; and the ‘cancer industry’ is doing what they can to determine whether turmeric or any other natural remedy can be used to treat cancer and other diseases.
If they are ever successful, the Adams of this world will shout ‘EXPLOITATION!!!’
If their endeavours are not successful, they will complain ‘CONSPIRACY!!!’
The question whether chiropractic is a truly valuable option for people suffering from back pain has been addressed repeatedly on this blog. My answer was usually negative, but proponents of chiropractic tended to argue that I am biased. Therefore I find it constructive to see what an organisation that hardly can be accused of bias says on this topic. An article by ‘SHOW ME THE EVIDENCE’ has recently provided a comprehensive overview of treatments for back pain. This is what they wrote about chiropractic:
START OF QUOTE
Spinal manipulation, the cranking and tweaking on offer when you visit a traditional chiropractor, is among the most popular approaches to back pain. Practitioners lay their hands on the patient and move their joints to or beyond their range of motion — a technique that’s often accompanied by a pop or crack.
There is some evidence the approach can help people with chronic back pain — but not any more than over-the-counter painkillers or exercise, and you need to take precautions when seeking out a chiropractor.
First, a quick look at the evidence. There are two recent Cochrane reviews on spinal manipulation for low back pain: one focused on people with acute (again, episodic/short duration) pain and the other on chronic pain. The 2011 review on chronic low back pain found that spinal manipulation had small, short-term effects on reducing pain and improving the patient’s functional status — but this effect was about the same as other common therapies for chronic low back pain, such as exercise. That review was published in 2011; UpToDate reviewed the randomized trials that have come out since — and also found that spinal manipulation delivered modest, short-term benefits for chronic back pain sufferers.
The Cochrane review on acute pain found that spinal manipulation worked no better than placebo. So people with a short episode of back pain should probably not bother seeing a chiropractor.
“Based on the evidence,” University of Amsterdam assistant professor Sidney Rubinstein, who is the lead author on the Cochrane reviews, told me, “it would appear [spinal manipulation] works as well as other accepted conservative therapies for chronic low back pain, such as non-prescription medication or exercise, but less well for patients with acute low back pain.”
As a chiropractor himself, he had some advice for patients: They should avoid chiropractors who routinely make X-rays or do advanced diagnostics for low back pain because this adds nothing to the clinical picture, particularly in the case of nonspecific low back pain. Patients should also beware chiropractors who put them on extended programs of care.
“Patients who respond to chiropractic care traditionally respond rather quickly,” he said. “My advice is those patients who have not responded to a short course of chiropractic care or manipulation should consider another type of therapy.”
While the risks of serious side effects from spinal manipulation for back pain are rare — about one in 10 million — the risks associated with chiropractic therapy for neck pain tend to be slightly higher: 1.46 strokes for every million neck adjustments.
The issue is the vertebral artery, which travels from the neck down through the vertebrae. Manipulating the neck can put patients at a higher risk of arterial problems, including stroke or vertebral artery dissection, or the tearing of the vertebral artery (though Rubinstein noted that people in the initial stages of stroke or dissection may also seek out care for their symptoms, such as neck pain, which makes it difficult to untangle how many of health emergencies are brought on by the adjustments).
END OF QUOTE
This all seems fairly reasonable to me – except for the following not entirely unimportant points:
- I am not sure where the evidence about risks of spinal manipulation comes from. In my view, it is not entirely correct: as there is no effective post-marketing surveillance, we cannot possibly name the incidence figures.
- Neck manipulations are clearly more risky than manipulations lower down. But this does not necessarily mean that back patients are safer than those with neck pain. Chiropractors view the spine as a whole organ and will regularly manipulate the neck (if they sense ‘subluxations’ in this area), even if the patient comes with low back pain.
- There are also indirect risks with consulting a chiropractor; for instance, they often give incompetent advice about healthcare. This can include discouraging immunisations or treating serious diseases, such as asthma, colic etc., with chiropractic.
- I think the article should point out that exercise is not just as effective (or as ineffective) as chiropractic, but it is much safer and less expensive.
- What Rubinstein says about responders is debatable, in my view. In particular, most chiropractors will convince their patients to continue treatment, even if they do not ‘respond’. And ‘responding’ might be simply the natural history of the condition and therefore totally unrelated to the therapy.
The bottom line: Chiropractic is not the best treatment for back pain!
US Republican Senator Hatch from Utah (born March 22, 1934) has announced that he is retiring after having been a Senator since 1977. When he leaves, the Senate “will lose its most ardent supporter of alternative medicine“. His decision comes after ‘The Salt Lake Tribune’ published a Christmas Day editorial calling on him to do so. The editorial stated that he has an “utter lack of integrity” that comes from “his unquenchable thirst for power.”
For advocates of alternative medicine, Hatch’s retirement comes as a blow: for decades, the senator has been one of the most powerful defender of quackery. As a young man, Orrin Hatch sold vitamins and supplements. As an old man, he takes them every day—including. “I really believe in them. I use them daily. They make me feel better, as they make millions of Americans feel better. And I hope they give me that little added edge as we work around here”, he was quoted stating.
And his love was returned: Between 1989 and 1994 Herbalife International gave Hatch $49,250; MetaboLife, $31,500; and Rexall Sundown, Nu Skin International, and Starlight International a total of $88,550. In addition, according to his financial disclosures for 2003, Hatch owned 35,621 shares of Pharmics, a Utah-based nutritional supplement company. In the early 1990s, Hatch’s son Scott began working for lobbying groups representing vitamin and supplement makers. Kevin McGuiness, Hatch’s former chief of staff, was also a lobbyist for the industry.
The NYT reported in 2011 that Hatch “was the chief author of a federal law enacted … that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable…
“Mr. Hatch has been rewarded with hundreds of thousands of dollars in campaign contributions, political loyalty and corporate sponsorship of his favorite causes back home.
“His family and friends have benefited, too, from links to the supplement industry. His son Scott Hatch, is a longtime industry lobbyist in Washington, as are at least five of the senator’s former aides. Mr. Hatch’s grandson and son-in-law increase revenue at their chiropractic clinic near here by selling herbal and nutritional treatments, including $35 “thyroid dysfunction” injections and a weight-loss product, “Slim and Sassy Metabolic Blend.” And Mr. Hatch’s former law partner owns Pharmics, a small nutritional supplement company in Salt Lake City…”
Further information is provided by Wikipedia:
Hatch’s son Scott Hatch is a partner and registered lobbyist at Walker, Martin & Hatch LLC, a Washington lobbying firm. The firm was formed in 2001 with Jack Martin, a staff aide to Hatch for six years, and H. Laird Walker, described as a close associate of the senator. In March 2003, the Los Angeles Times reported that the firm was formed with Hatch’s personal encouragement and that he saw no conflict of interest in working on issues that involved his son’s clients. In 2009, the Washington Times reported that Hatch said “My son, Scott, does not lobby me or anyone in my office”.
In March 2009, the Washington Times reported that the pharmaceutical industry, which has benefited from Hatch’s legislative efforts, had previously unreported connections to Hatch. In 2007, five pharmaceutical companies and the industry’s main trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), donated $172,500 to the Utah Families Foundation—a charitable foundation which Hatch helped start in the 1990s and has continued to support since. Walker, Martin & Hatch LLC was paid $120,000 by PhRMA in 2007 to lobby Congress on pending U.S. Food and Drug Administration legislation.
We should not have to repeat this! But, as it is currently topical and certainly true, let me tell you again:
DETOX IS BUNK!
After the season of gluttony, it seems that half the population has fallen victim to the legion of alternative practitioners and entrepreneurs who claim that their particular form of quackery is ideally suited for detoxifying the body – and, sure enough, rid their clients of money instead of poisons. I have pointed out again and again why detox, as promoted in alternative medicine. is bogus and occasionally even harmful – see for instance here, here and here. And years ago, I published a review of the evidence on ‘alternative detox’ (AD); it concluded that “the principles of AD make no sense from a scientific perspective and there is no clinical evidence to support them. The promotion of AD treatments provides income for some entrepreneurs but has the potential to cause harm to patients and consumers. In alternative medicine, simplistic but incorrect concepts such as AD abound. All therapeutic claims should be scientifically tested before being advertised-and AD cannot be an exception.”
But I have, of course, many readers who do not trust a word I am putting on paper. So, please don’t take it from me, take it from others; read for example this recent article:
Detox diets are popular dieting strategies that claim to facilitate toxin elimination and weight loss, thereby promoting health and well-being. The present review examines whether detox diets are necessary, what they involve, whether they are effective and whether they present any dangers. Although the detox industry is booming, there is very little clinical evidence to support the use of these diets. A handful of clinical studies have shown that commercial detox diets enhance liver detoxification and eliminate persistent organic pollutants from the body, although these studies are hampered by flawed methodologies and small sample sizes. There is preliminary evidence to suggest that certain foods such as coriander, nori and olestra have detoxification properties, although the majority of these studies have been performed in animals. To the best of our knowledge, no randomised controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans. This is an area that deserves attention so that consumers can be informed of the potential benefits and risks of detox programmes.
To the best of our knowledge, no randomised controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans. I think that says enough; and it applies not just to detox diets, it applies to all detox methods promoted in alternative medicine.
DETOX IS BUNK!
Save your hard-earned money for stuff that is proven to work.
How often have we heard the claim from proponents of alternative medicine that one strength of their approach is disease prevention (see for instance my previous post or this, this and this) and that conventional medicine neglects prevention almost completely? Such claims annoy me because they are demonstrably false.
I know, to some readers, this may seem like a bold statement; let me therefore try to justify it.
- So far, I have seen no good evidence that any alternative therapy might be effective in preventing any disease.
- Practically everything we know today about disease prevention originates from conventional medicine and science.
- There are thousands of papers that address prevention and, as far as I can see, they all originate from the realm of conventional medicine. Below is a list of just 7 recent reviews on the subject.
This paper is an update of the evidence for exercise as a prevention of heart failure. It concluded that exercise provides protective benefit in preventing HF (primary prevention). With HF present: exercise improvement with training provides benefits in HF (secondary prevention). The prediction of future in HF patients: exercise impairment, as a leading characteristic of HF, is used as a prognostic factor.
The aim of this review was to update evidence for the US Preventive Services Task Force on the benefits and harms of hormone therapy in reducing risks for chronic conditions. The authors found that hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms. The available evidence regarding benefits and harms of early initiation of hormone therapy is inconclusive.
This paper reviewed the evidence for Implantable Cardiac Defibrillators (ICDs). The authors stated that individuals with stable ischemic heart disease (no recent myocardial infarction), especially those with inducible arrhythmias, seem to derive the highest mortality benefit from prophylactic ICD use.
These authors investigated whether neuromuscular and proprioceptive training is effective in preventing knee and anterior cruciate ligament (ACL) injuries. They concluded that neuromuscular and proprioceptive training appeared to decrease the incidence of injury to the knee and specifically the AC.
Other researchers summarized current evidence about real-world studies on apixaban for stroke prevention in atrial fibrillation. They concluded that the use of apixaban in real-life is associated with an overall similar effectiveness in reducing stroke and any thromboembolic events when compared with warfarin. A better safety profile was found with apixaban compared with warfarin, dabigatran, and rivaroxaban.
Finally, a review assessed the evidence of blood pressure (BP) lowering treatments as a means of reducing cardiovascular morbidity and mortality. The authors concluded that primary preventive BP lowering is associated with reduced risk for death and CVD if baseline SBP is 140 mm Hg or higher. At lower BP levels, treatment is not associated with any benefit in primary prevention but might offer additional protection in patients with CHD.
Testing preventative treatments is, of course, far from easy. Ideally, one would want to do an RCT, but often this is not possible, for instance, because the sample size would need to be prohibitively huge and the observation period prohibitively long (think of cholesterol-lowering for reducing cardiovascular risks, or smoking cessation for preventing cancer). Thus we rely frequently on other types of investigations such as epidemiological studies. This type of research is, however, rarely undertaken in alternative medicine, and when it does cover subjects related to this area, it is almost never done by proponents of alternative medicine.
The long and short of all this is depressingly simple: the often-heard claim that alternative medicine is strong on prevention is quite simply false. Proponents of alternative medicine like to talk about prevention (presumably because it is good for business), but when it comes to applying prevention and showing that their preventative interventions are effective, all this talk turns out to be little more than hot air.
I am sure – even hope – that some readers will disagree, and I look forward to their evidence proving me wrong.
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.
Electrohomeopathy is a version of homeopathy few people know about. Allow me to explain:
Cesare Mattei (1809–1896), an Italian count, was interested in homeopathy. Mattei believed that fermented plants gave off ‘electrical’ energy that could be used to cure illness. He also believed that every illness had a cure provided in the vegetable kingdom by God. He began to develop his system from 1849. The large bottles are labelled ”Red”, ”Green”, “White”, “Yellow” and “Blue” so the actual ingredients remained a secret. Ointments were made up with ingredients from the small and large bottles. The vial labelled “Canceroso 5” was used for bruises, cancers, chilblains, hair loss, skin diseases and varicose veins, among other conditions. Although dismissed by the medical profession as quackery, Mattei’s system was popular. It formed part of the treatment at St Saviour’s Cancer Hospital in London from 1873.
Wikipedia offers more informing us that:
“… Mattei, a nobleman living in a castle in the vicinity of Bologna studied natural science, anatomy, physiology, pathology, chemistry and botany. He ultimately focused on the supposed therapeutic power of “electricity” in botanical extracts. Mattei made bold, unsupported claims for the efficacy of his treatments, including the claim that his treatments offered a nonsurgical alternative to cancer. His treatment regimens were met with scepticism by mainstream medicine:
The electrohomeopathic system is an invention of Count Mattei who prates of “red”, “blue”, and “green” electricity, a theory that, in spite of its utter idiocy, has attracted a considerable following and earned a large fortune for its chief promoter.
Notwithstanding criticisms, including a challenge by the British medical establishment to the claimed success of his cancer treatments, electrohomeopathy (or Matteism, as it was sometimes known at the time) had adherents in Germany, France, the USA and the UK by the beginning of the 20th century; electrohomeopathy had been the subject of approximately 100 publications and there were three journals dedicated to it.
Remedies are derived from what are said to be the active micro nutrients or mineral salts of certain plants. One contemporary account of the process of producing electrohomeopathic remedies was as follows:
As to the nature of his remedies we learn … that … they are manufactured from certain herbs, and that the directions for the preparation of the necessary dilutions are given in the ordinary jargon of homeopathy. The globules and liquids, however, are “instinct with a potent, vital, electrical force, which enables them to work wonders”. This process of “fixing the electrical principle” is carried on in the secret central chamber of a Neo-Moorish castle which Count Mattei has built for himself in the Bolognese Apennines… The “red electricity” and “white electricity” supposed to be “fixed” in these “vegetable compounds” are in their very nomenclature and suggestion poor and miserable fictions.
According to Mattei’s own ideas however, every disease originates in the change of blood or of the lymphatic system or both, and remedies can therefore be mainly divided into two broad categories to be used in response to the dominant affected system. Mattei wrote that having obtained plant extracts, he was “able to determine in the liquid vegetable electricity”. Allied to his theories and therapies were elements of Chinese medicine, of medical humours, of apparent Brownianism, as well as modified versions of Samuel Hahnemann‘s homeopathic principles. Electrohomeopathy has some associations with Spagyric medicine, a holistic medical philosophy claimed to be the practical application of alchemy in medical treatment, so that the principle of modern electrohomeopathy is that disease is typically multi-organic in cause or effect and therefore requires holistic treatment that is at once both complex and natural.”
END OF QUOTE
If one would assume that electrohomeopathy is nothing more than a bizarre and long-forgotten chapter in the colourful history of homeopathy, one would be mistaken; it is still used and promoted by enthusiasts who continue to make bold claims. This article, for instance, informs us that:
- Electro Homeopathic remedies tone up the brain and the nerves through which overall body processes are controlled and strengthen the digestion process.
- The tablets provide food for the red blood cells and provide nourishment for the white corpuscles of the lymph and the blood.
- They provide the useful elements to the plasma of the blood and provide required nutrients for the cells of which tissues are made.
- They enhance the eviction through the skin and other modes and unnecessary substances which disturb the function and health of the body.
- They cure the diseases and are helpful to the patients who use them.
- They are curative as well as palliatives.
- They are helpful in curing the serious diseases whether it is acute or chronic, non-surgical or surgical, for women, men, and children. They provide 100 percent cure.
- They cure diseases such as tuberculosis, cancer, fistula, and cancer. They can cure these diseases without operation.
- They cure all type of infectious diseases with certainty and are also helpful in prophylactics in the epidemics.
This article also provides even more specific claims:
Here are the 5 best Electro Homeopathic medicines for curing kidney stones –
- Berberis Vulgaris – is the best medicine for left-sided kidney stones
- Cantharis Vesicatoria– is one of the best medicine for kidney stones with burning in urine
- Lycopodium – is the best remedy for right-sided kidney stones
- Sarsaparilla – is the best medicine for kidney stones with white sand in urine
- Benzoic Acid – is best homeopathic medicine for renal calculi…
The aforesaid homeopathic medicines for kidney stones have been found to be very effective in getting these stones out of the system. It does not mean that only these medicines are used.
What all of this highlights yet again is this, I think:
- There are many seriously deluded people out there who are totally ignorant of medicine, healthcare and science.
- To a desperate patient, these quacks can seem reasonable in their pretence of medical competence.
- Loons make very specific health claims (even about very serious conditions), thus endangering the lives of the many gullible people who believe them.
- Even though this has been known and well-documented for many years, t here seems to be nobody stopping the deluded pretenders in their tracks; the public therefore remains largely unprotected from their fraudulent and harmful acts.
- In particular, the allegedly more reasonable end of the ‘alt med community’ does nothing to limit the harm done by such charlatans – on the contrary, whether knowingly or not, groups such as doctors of ‘integrative medicine’ lend significant support to them.