Europe to ban hundreds of herbal remedies
Posted 30 December 2010 - 03:48 PM
Safety concerns sparked drive to outlaw products
By Jeremy Laurance, Health Editor
Thursday, 30 December
Hundreds of herbal medicinal products will be banned from sale in Britain next year under what campaigners say is a "discriminatory and disproportionate" European law.SPONSORED LINth four months to go before the EU-wide ban is implemented, thousands of patients face the loss of herbal remedies that have been used in the UK for decades.
From 1 May 2011, traditional herbal medicinal products must be licensed or prescribed by a registered herbal practitioner to comply with an EU directive passed in 2004. The directive was introduced in response to rising concern over adverse effects caused by herbal medicines.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued more than a dozen safety alerts in the past two years, including one over aristolochia, a banned toxic plant derivative which caused kidney failure in two women.
Herbal practitioners say it is impossible for most herbal medicines to meet the licensing requirements for safety and quality, which are intended to be similar to those for pharmaceutical drugs, because of the cost of testing.
According to the Alliance for Natural Health (ANH), which represents herbal practitioners, not a single product used in traditional Chinese medicine or ayurvedic medicine has been licensed. In Europe, around 200 products from 27 plant species have been licensed but there are 300 plant species in use in the UK alone.
The ANH estimates the cost of obtaining a licence at between £80,000 and £120,000 per herb. They say this is affordable for single herbal products with big markets, such as echinacea, a remedy for colds and flu, but will drive small producers of medicines containing multiple herbs out of business.
Under EU law, statutorily regulated herbal practitioners will be permitted to continue prescribing unlicensed products. But the Coalition Government and the previous Labour administration have delayed plans to introduce a statutory herbal practitioner register.
This means thousands of patients who rely on herbal treatments face being denied access to them. Medical organisations, including the MHRA, have warned the measures may drive patients to obtain herbal medicines over the internet – where risks are much greater.
Michael McIntyre, the chairman of the European Herbal and Traditional Medicine Practitioners Association, said: "The problem is you can't get a licence for many herbal medicines because they are grown in people's back gardens and you can't patent them. The implications are very serious. Patients want to receive treatment from trained and qualified practitioners but unless we have regulation they can't have confidence in who is treating them. The worst outcome is that patients will end up going to the internet for their herbal medicines where there are no controls."
Dr Rob Verkerk, of the ANH, said: "Thousands of people across Europe rely on herbal medicines to improve their quality of life. They don't take them because they are sick – they take them to keep healthy. If these medicines are taken off the market, people will try and find them elsewhere, such as from the internet, where there is a genuine risk they will get low quality products, that either don't work or are adulterated."
The MHRA said it had received applications for licences for 166 herbal products, of which 78 had been granted. Sir Alasdair Breckenridge, chairman of the MHRA, said a register of herbalists was essential. "Just because something is natural doesn't mean it is safe," he said. "It is terribly important to have responsible people who have undergone training prescribing these products."
Edzard Ernst, professor of complementary medicine at the University of Exeter, said proposals for regulation would be worthless unless they required practitioners to follow best evidence for the effects of their remedies. "It is in danger of regulating nonsense – and that must result in nonsense," he said.
A review of the codes of conduct by which alternative practitioners were bound found the "vast majority" did not include an obligation to report adverse effects, he said. The only exception was the Chinese Herbal Medicine Code which advised members to report "cases of industrial poisoning or accident".
A spokesman for the Department of Health said no decision had been made on a statutory register of herbal practitioners. "The Government is aware of the strength of feeling on this issue and is actively exploring options."
Remedies under threat
Cascara bark (Cascara sagrada, Rhamnus purshiana)
Helps stimulate a sluggish bowel.
Pau D'Arco (Tabebuia impetiginosa)
Anti-inflammatory, used for infection control.
Ashwagandha (Withania somnifera, or winter cherry)
Anti-inflammatory, for arthritis and boosting the immune system.
Skullcap (Scutellaria baicalensis/Chinese skullcap)
For anxiety, headaches and pain relief.
Meadowsweet (Filipendula ulmaria)
For stomach acidity, diarrhoea, headache.
Horny goat weed (Epimedium grandiflorum)
Used to enhance libido.
[Please note: Lupus Patients should never take any herbal preparations without consulting their own physicians. Certain herbal preparations, including Chinese herbal preparations, can cause serious problems, particularly for those with lupus nephritis, involving the kidneys. Admin]
Herbal Medicines Can Be Lethal, Pathologist Warns
09 Feb 2010
A University of Adelaide forensic pathologist has sounded a worldwide warning of the potential lethal dangers of herbal medicines if taken in large quantities, injected, or combined with prescription drugs.
A paper by Professor Roger Byard published in the US-based Journal of Forensic Sciences outlines the highly toxic nature of many herbal substances, which a large percentage of users around the world mistakenly believe are safe.
"There's a false perception that herbal remedies are safer than manufactured medicines, when in fact many contain potentially lethal concentrations of arsenic, mercury and lead," Professor Byard says.
"These substances may cause serious illnesses, exacerbate pre-existing health problems or result in death, particularly if taken in excess or injected rather than ingested."
Professor Byard says there can also be fatal consequences when some herbal medicines interact with prescription drugs. "As access to such products is largely unrestricted and many people do not tell their doctor they are taking herbal medicines for fear of ridicule, their contribution to death may not be fully appreciated during a standard autopsy."
An analysis of 251 Asian herbal products found in United States stores identified arsenic in 36 of them, mercury in 35 and lead in 24 of the products. In one documented case a 5-year-old boy who had ingested 63 grams of "Tibetan herbal vitamins" over a period of four years was diagnosed with lead poisoning. Another case involved a young boy with cancer of the retina whose parents resorted to a traditional Indian remedy that caused arsenic poisoning.
A herbal medicine known as Chan su, used to treat sore throats, boils and heart palpitations, contains the venomous secretions of Chinese toads, which can cause cardiac arrests or even comas, according to Professor Byard.
Other side effects of herbal medicines can include liver, renal and cardiac failure, strokes, movement disorders, muscle weakness and seizures. "Herbal medicines are frequently mixed with standard drugs, presumably to make them more effective. This can also have devastating results," Professor Byard says.
In his paper he cites the case of an epileptic patient on prescription medicine who had also ingested a Chinese herbal preparation and lapsed into a coma. Cushing syndrome, a hormonal disorder, has also been linked to the ingestion of steroids and herbal cures mixed together.
Some herbal medicines may also have a variety of effects on standard drugs, according to Professor Byard. St John's Wort can reduce the effects of warfarin and cause intermenstrual bleeding in women taking the oral contraceptive pill.
Gingko and garlic also increase the risk of bleeding with anticoagulants and certain herbal remedies such as Borage Oil and Evening Primrose Oil lower the seizure threshold in epileptics.
Professor Byard says the American Society of Anesthesiologists has recommended its patients discontinue using herbal medicines at least two weeks before surgery because of the risks of herbal and drug interaction, including an increased chance of hemorrhaging.
Herbal medicines have become increasingly popular in western countries in recent years, with an estimated 30% of United States citizens using them, often without their doctor's knowledge.
"Forensic pathologists the world over need to become more aware of the contribution that herbal medicines are playing in a range of deaths, that is not currently recognised," Professor Byard says.
Roger Byard is the George Richard Marks Professor of Pathology within the School of Medical Sciences at the University of Adelaide.
University of Adelaide
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