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2:44 min BBC Business News segment: A pharmacist earnestly appears to make totally unfounded claims for echinacea and goldenseal, as well as unsubstantiated claims for treatment for menopausal hot flushes. An MHRA man evades the essential point - fraudulent labeling. Professor David Colquhoun points out that it is a disgrace that there is still no indication of whether treatments work. The UK government and MHRA apparently bend over backwards to support producers at the expense of consumers who get saddled with useless products.
"Safety issues related to herbal medicine are complex: possible toxicity of herbal constituents, presence of contaminants or adulterants, and potential interactions between herbs and prescription drugs." A critical look at the efficacy, safety, quality and cost issues involved in the prescribing of herbal medicines. Edzard Ernst, Md,PhD, FRCP, FRCPEd, The Journal of Family Practice (December 2004)
Useful safety information for anyone using herbal medicines and anyone operating in the herbal medicines sector, including manufacturers, herbal practitioners, suppliers and retailers. UK Medicines and Healthcare products Regulatory Agency (MHRA) [pdf]
“University of Adelaide professor of pathology Roger Byard, who was speaking at a conference in Perth said doctors and police officers investigating suspicious deaths should routinely check for herbal toxicity as well as the presence of drugs. He presented research at the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists annual meeting and called for a new research area to be set up in forensic herbal toxicology. Professor Byard said herbal medicines had mostly come from complex Chinese and Indian medical traditions. While many were effective there was now a problem with traditional village-based activities expanding into a global market, affecting the quality, composition and purity of supplies. He was aware of a recent case of a young man who died after injecting himself with what he thought was the drug ecstasy. But the dealer had substituted it with the Chinese herbal medicine, chan su, which contains venom from the skin of toads.” Australian news report (5th December 2011)
"Most of the adverse events were associated with herbal medications." European Journal of Paediatrics (February 2003)
"A third of us have tried herbal medicine, yet few have more than a vague idea about what it actually is." Edzard Ernst, The Guardian (17th August 2004)
NOTE: This link has been included as it is relevant to consumer health safety issues regarding supplements. It should not be confused with Herbal Medicine.
Concludes that systematic reviews are available on a broad range of herbal perparations prescribed for defined conditions. There is very little evidence on the effectiveness of herbalism as practised by specialist herbalists who combine herbs and use unconventional diagnosis. BMC Complementary and Alternative Medicine (2001)
“There is a big difference between using a scientifically proven herbal medicine for a specific condition and consulting a traditional herbalist, and thus receiving herbal therapy via this route. No good evidence exists to show that the latter approach does more good than harm. These individualized prescriptions are based on obsolete notions straight from the dark ages. In contrast, some herbal medicines are supported by sound evidence…The message for GPs is simple: the next time you are tempted to send a patient to a traditional herbalist, think twice.” Professor Edzard Ernst, Pulse (28th February 2011) [Free registration]
"…..there are structural problems in the way that herbalists work: they have failed to collectivise, so they do not work together on research, but rather as independent commercial traders. They tend not to move into university settings, where the culture of critical self-appraisal might infect them. And where alternative therapists do move into universities, they wall themselves off from the most valuable influences. They don't rub shoulders with colleagues from other disciplines, who could share ideas with them. The alternative medicine courses I have approached have flatly refused to tell me the most basic things, like what they teach and how. It's because of this culture, not funding, that the "research" on herbal remedies is inadequate. Huge numbers of "trials" are produced, at great expense, but they are inept, they are not fair tests, they have inadequate blinding and randomisation, positive results alone are cherry-picked, and worse." Ben Goldacre, MD, Bad Science (October 2007)
“The latest supplement toxic alert thankfully involves only two young soldiers who died suddenly, both reported to have the unregulated amphetamine-like dimethylamylamine, DMAA, aka ‘Jack3d’ and ‘OxyelitePro’, as the suspected death-dealing toxicant. Who knows how many other unexplained deaths and near-deaths can be attributed to the vast experiment foisted upon an unwary American populace by such drugs -- I mean, ‘supplements’? Thanks to 1994's Hatch Act, the Dietary Supplement Health and Education Act (DSHEA), pushed through Congress and released upon a then-unprotesting public by Utah's Sen. Orrin Hatch (R-UT), substances which may be benign, toxic, and everything in between, as long as they are sold as ‘dietary nutritional supplements’, get a virtual free pass. The supplement manufacturer can make "structure-function" claims, such as ‘supports sexual health’, but not health claims. Such assertions must clarify that the substance is not FDA approved ‘to diagnose, treat, cure or prevent any disease’. Part of the law mandates that ingredients brought to market after 1994, so-called ‘novel’ ingredients -- and only those -- be shown to have passed safety tests. Older ingredients got ‘grandfathered’ in without the need to be proven either safe or effective. How is that working out? There have been approximately 51,000 new ingredients brought to market since DSHEA passed, of which about 0.3% -- that's not a misprint, 170 out of 51,000 -- have documented safety tests. Who cares? ‘Why worry?’, perhaps under the delusion that some substance termed "natural" must be safe, seems to be the governing mantra of the American consumer on this subject, since about 100 million of us spend, at last tally, over $28 billion per year on these products -- vitamins, minerals, potions, herbals, biologicals, who-knows-what. If a shopper has a question about the efficacy or danger of a supplement, they may simply ask the health-food store employee. Obviously, trusting a sales clerk to be expert is pure foolishness.” George Lundberg, MD, Editor-at-Large, MedPage Today, President of the Lundberg Institute,consulting professor of pathology and health research policy at Stanford University School of Medicine anda member of the Institute of Medicine (5th March 2012)
"According to the Medicines and Healthcare Regulatory Agency (MHRA), this indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC. There have been 92 applications since the scheme began in March 06. The most important line is this one:
Under this scheme, the permitted indications for the medicine are based on traditional usage and not on evidence of effectiveness of the product.
So, as I wrote before with homeopathy, as long as the seller can demonstrate safety of the product and a history of use for the particular therapeutic indication, then it can receive the THR stamp and be sold legitimately, despite there being no investigation into whether it works or not…On a positive note, any product with this mark on it will single it out clearly and obviously to me as snakeoil - if it were a *real* medicine that, you know, actually had some effect, then it would be marketed as such and would have some evidence to back it up. So, perhaps we should look at this stamp as a victory for evidence-based medicine, as it singles out products without any provable efficacy for all to see." Thinking Is Dangerous blogspot (23rd October 2009)
“What follows is simple and in stark contrast to what many people seem to assume: today there is no good scientific evidence to demonstrate that traditional herbalists do more good than harm.” Professor Edzard Ernst, Pulse (18th August 2010) [Free registration]
This study demonstrates that health providers and consumers need to closely examine label ingredients of presumably the same or similar herbal products. Archives of Internal Medicine (2003)
Patients who are admitted to hospital for planned surgery without informing doctors about what herbal medicines they are taking may be placing themselves in danger of potentially serious complications, a team of Dublin anaesthetists has warned. They say: “Lack of scientific research on herbs, combined with the lack of regulation of herbal preparations can give consumers a false sense of security about the safety of herbal products”. Irish Health news report (26th July 2011)
“The Medicines and Healthcare products Regulatory Agency (MHRA) is warning people of the dangers of taking unlicensed herbal medicines containing aconite. Aconite has recently been portrayed in the media as 'herbal valium', however, it is actually an extremely poisonous plant that is toxic to the heart. It is also known as monkshood and herbal products containing this ingredient could be fatal or cause serious illness if consumed…MHRA Head of Herbal Policy, Richard Woodfield, said it was vital people did not confuse herbal medicines and omeopathic ones. "Registered homeopathic products that contain aconite are considered acceptably safe as the active ingredient, aconite, is sufficiently diluted," he said. "Herbal medicines are made from plants and so can have a very significant effect on the body. In certain cases, such as with aconite, the medicine can be extremely potent. "This is a classic case where 'natural' does not mean 'safe'."” Medical News Today (5th October 2009)