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| Access to Medicines Campaign calls for ban on paracetamol national | miscellaneous | news report  Monday February 04, 2002 22:24 by Elizabeth OShea - Access to Medicines Campaign sastacht at gofree dot indigo dot ie 184 Stanaway Road Dublin 12 086 8719570 The Irish Medicines Board recently obtained the voluntary withdrawl of kava kava from Irish shops and chemists in response to cases of alleged associated liver damage in Germany and Switzerland. However, the IMB has not secured the withdrawl of paracetamol from shops and chemist even though 49 confirmed cases of paracetamol-associated liver damage occured in Ireland in 1999. The recenlty-convened Access to Medicines Campaign has called on the Irish Medicines Board to reverse the voluntary withdrawl of kava kava or to ban the prescription and sale of paracetemol. Kava kava is a plant found in the Polynesian highlands that was originally used in Melanesia as a ritual drink. The beverage calms the drinker while making the person more mentally alert. In the West, it is commonly sold as an over-the-counter stress reduction and relaxant medicine. The Irish Medicines Board (IMB) has secured ‘voluntary’ withdrawal of the herbal relaxant kava kava from health food shops and chemists. Kava kava has been withdrawn because 30 cases of liver damage allegedly associated with the herbal medicine have been reported in Switzerland and Germany. The IMB considers it ‘prudent’ to withdraw the product to protect people from possible liver damage. 'The IMB's prompt action on kava kava is curious because researchers in Germany and Switzerland have not yet determined conclusively that kava kava caused the 30 cases of liver damage reported,' said Sonya Mulligan, speaking for the Access to Medicines Campaign. 'However,' she continued, 'over 49 cases of liver damage as a result of paracetamol use were reported in Ireland in 1999 alone. But the IMB has only limited the number of paracetamol tablets you can buy at once. They have not ordered the withdrawl of a clearly dangerous medicine, and which is much more widely accessible.' The Access to Medicines Campaign want the Irish Medicines Board a answer some questions in relation to this latest withdrawl of a herbal medicine: •Why haven’t the IMB withdrawn paracetamol when it clearly threatens people’s health? The Access to Medicines Campaign seeks to ensure the public have equal access to conventional and alternative medicines and procedures by providing information about bias in medical and pharmaceutical practice. |
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Comments (19 of 19)
Jump To Comment: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19>Why, in general, does the IMB continue to act swiftly against herbal products
hmm, let me think, eh because they are fat old conservative balding men who sell themselves to the pharmaceutical companies who can't patent natural products?
Any thoughts on the withdrawal of geko and insam (ginseng)
Iva Pocock, Irish Times (Subscription)
Regulations: Controversial new controls on the sale of herbal medicines are to be implemented in Ireland by the semi-state body with responsibility for regulating medical and veterinary products, the Irish Medicines Board (IMB).
The new regulatory system marks another step in the Europe-wide move to limit the availability of herbal medicines and food supplements, say natural health campaigners. At present, there is no regulatory system for such medicines but a recently approved EU directive on traditional herbal medicines requires all member-states to implement a harmonised system.
The Department of Health has responsibility for transposing it into Irish law but it is understood the IMB will regulate the system.
The board has been considering the herbal medicines market for about three years so "it would make perfect sense" to take on this role, according to IMB chief executive Mr Pat O'Mahony. "There's an 18-month lead- in so in that time there will have to be a regulatory regime for herbal medicines in Ireland."
Unlike other medicines which require clinical trials, the new rules allow for the efficacy of herbal products to be established by the fact that they have been traditionally and successfully used for a particular condition for 30 years and at least 15 years in the EU. This time limit means that many herbs commonly used by people who have recently migrated into the EU will not be legal, according to Erica Murray, spokeswoman for the Irish Association of Health Food Stores.
"Herbal medicine is the chosen healthcare system for 80 per cent of the world's population, so this is severe restriction," she added.
Mr O'Mahony told The Irish Times that two of the IMB's key concerns - quality and safety - would have to be demonstrated by the herbal medicine producers.
Herbal medicines can be divided into two groups -
1. Those that do shag all, but are handy placebos
2. Those that have an actual effect on the body
1. I don't think people should be able to make claims about medicines that they can't back up with research. This applies to ancient Chinese herbs just as much as it does to snake oil and sugar pills. We would all be up in arms if Coca-cola said their product was a helath drink, or if McDonalds said Big Macs cured cancer. I don't think we should let smaller companies get away with making equally unsubstantiated claims.
2. Some herbal medicines will have an effect on your body. What effect is that? Well, we don't know, because there haven't been any proper trials done. Again, if Glaxo or Smithkline-Beecham came out with a new pill we'd expect them to know exactly what it did, and whether it had any side-effects. We should apply the same standards to everyone.
And yes, BTW, I think 'applying the same standards' means that paracetamol should carry a big red warning label, saying not to combine it with alcohol, or even require people to get a prescription if they want paracetamol rather than aspirin.
that there should be more independent research carried out on herbal medicines. But, are you fully confident that there hasn’t been any proper research carried out on any herbal formulae to date?
The problem with this argument is that the sort of research needed to test any 'new' drug is very, very expensive. The drug companies fund research on things they own the patient on because they reckon future profits will outweigh the costs. But with herbal medicine there is no patent so no company is willing to fund such research.
The obvious answer is to do away with patents and have all such research funded by society at large (through the state in the here and now). But the corporations who fund the politicians won't be keen on this as no patent = no profit.
Yeah, I agree that testing costs are a high barrier to entry, and also about the problems with patenting.
The thing is, the people arguing the case for herbal medicines don't usually argue for a better, cheaper testing regime. Instead they argue that some medicines shouldn't be tested because they're traditional.
If something is a traditional medicine then its probably not immediately fatal. But it could be mildly toxic (or very toxic in some situations, like paracetamol) or completely ineffective (except as a placebo). I have a problem with people selling magnets to 'improve blood circulation', or special light to cure cancer, because all these 'cures' do is make money for the people selling them. I have the same problem with people selling homeopathic remedies, or acupuncture, or 'traditional Chinese medicine'.
As for whether they have been tested, Ray, well you tell me. I know that homeopathy and acupuncture have been tested, and they don't work. I have no objection to the sale of herbal medicines that have been through at least two controlled, double-blind tests, on reasonably-sized groups, and have been shown to produce better results than a placebo. Can you point to any such medicines?
Title: Ginger for nausea and vomiting in pregnancy: Randomized, double-masked, placebo-controlled trial
Teraporn Vutyavanich MD, MSc, Theerajana Kraisarin MDa and Rung-aroon Ruangsri BSc
Department of Obstetrics and Gynecology, Chiang Mai University, Chiang Mai, Thailand
Obstetrics & Gynecology, Volume 97, Issue 4 , April 2001, Pages 577-582
Abstract
Objective: To determine the effectiveness of ginger for the treatment of nausea and vomiting of pregnancy.
Methods: Women with nausea and vomiting of pregnancy, who first attended an antenatal clinic at or before 17 weeks’ gestation, were invited to participate in the study. During a 5-month period, 70 eligible women gave consent and were randomized in a double-masked design to receive either oral ginger 1 g per day or an identical placebo for 4 days. Subjects graded the severity of their nausea using visual analog scales and recorded the number of vomiting episodes in the previous 24 hours before treatment, and again during 4 consecutive days while taking treatment. At a follow-up visit 7 days later, five-item Likert scales were used to assess the severity of their symptoms.
Results: All participants except three in the placebo group remained in the study. The visual analog scores of posttherapy minus baseline nausea decreased significantly in the ginger group (2.1 ± 1.9) compared with the placebo group (0.9 ± 2.2, P = .014). The number of vomiting episodes also decreased significantly in the ginger group (1.4 ± 1.3) compared with the placebo group (0.3 ± 1.1, P < .001). Likert scales showed that 28 of 32 in the ginger group had improvement in nausea symptoms compared with 10 of 35 in the placebo group (P < .001). No adverse effect of ginger on pregnancy outcome was detected.
Conclusion: Ginger is effective for relieving the severity of nausea and vomiting of pregnancy.
Title: Ginger treatment of hyperemesis gravidarum
Fischer-Rasmussen W.; Kjaer S.K.; Dahl C.; Asping U.
Department of Obstetrics and Gynaecology 537, University of Copenhagen, Hvidovre Hospital, 30 Kettegaard Alle, DK-2650 Copenhagen-Hvidovre, Denmark
EUR. J. OBSTET. GYNECOL. REPROD. BIOL. Volume 38, Issue 1 , 1990, Pages 19-24
Abstract
Thirty women participated in a double-blind randomized cross-over trial of the efficacy of a natural product, the powdered root of ginger (Zingiber officinale), and placebo in hyperemesis gravidarum. Three patients had to be withdrawn. Each woman swallowed capsules containing either 250 mg ginger or lactose q.i.d. during the first 4 days of the treatment period. Interrupted by a 2 days wash-out period the alternative medication was given in the second 4-day period. The severity and relief of symptoms before and after each period were evaluated by two scoring systems. The scores were used for statistical analyses of possible differences. Subjectively assessed, 19 women (70.4%) stated preference to the period in which ginger, as was later disclosed, had been given (P = 0.003). More objectively assessed by relief scores a significantly greater relief of the symptoms was found after ginger treatment compared to placebo (P = 0.035). No side effects were observed. The possible mutagenic and antimutagenic characters of ginger reported in a study of E. coli have not been evaluated with respect to any significance in humans. Powdered root of ginger in daily doses of 1 g during 4 days was better than placebo in diminishing or eliminating the symptoms of hyperemesis gravidarum.
Controlled, double-blind experiments (and repeated by an unconnected group of researchers). Based on research like that, I would be happy to see ginger pills in chemists or health food shops sold for the relief of nausea during pregnancy. If similar experiments were conducted for each claim made by each herb, then we could assess whether or not they worked as they claimed, and discard the ones that didn't work.
(The same experimental process can also be used to test other claims. The claims for dowsing, astrology, and arse-bouncing have yet to pass any such tests)
Studies in rats found that prostaglandins are decreased during pregnancy by aspirin which in turn seems to affect brain development resulting in lower libido in male offspring. Sort of off-topic, but .....
That would be up to independent researchers to carry out the research. However, the research carried out so far has passed the criteria for it to be published in peer reviewed journals. None of the published articles have yet to be formally disputed.
Here are some comments by non TM Movement (or most likely non meditators) scientists and researchers.
" I was initially sceptical, but having studied the research completed to date, I have concluded that these studies on the Maharishi Effect have subjected theory to proper empirical tests. They have shown sound results which demand serious interest."
Ken Pease, Professor of Criminology at the University of Huddersfield, Chairman of the Belfast based Centre for the Independent Research and Analysis of Crime, and Home Office adviser
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"I think the claim can be plausibly made that the potential impact of this research exceeds that of any other on-going social or psychological research programme. The research has survived a broader array of statististical tests than most research in the field of conflict resolution; I think this work and the theory that informs it deserve the most serious consideration by academics and policy makers alike."
David Edwards, Ph.D, Professor of Government, University of Texas, Austin, USA.
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"Home Office figures show that crime-related costs such as insured and uninsured losses, prison, courts and police expenditures, fraud, etc. amount to £5,000 per crime. Analysis of the effectiveness of Transcendental Meditation demonstrates that a 15% reduction in crime can be achieved within a short period. A 15% reduction in the current annual crime rate of 5.1 million crimes would save £3.8 billion each year. This contrasts with the present, costly largely ineffective government policies, including a prison construction programme which hasn't delivered any long term reductions in crime."
"I have been following the research on the Maharishi Effect as it has developed over the last twenty years. There is now a strong and coherent body of evidence showing that the Transcendental Meditation and TM-Sidhi programme provide a simple cost-effective solution to many of the social problems we face today. This research and its conclusions are so strong that it demands action from those responsible for government policy."
Huw Dixon, Professor of Economics at the University of York and Associate Editor of the prestigious Economic Journal
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"This research is of the highest methodological quality, and has added to a large body of published research undertaken in many different countries using a wide variety of research designs over the last 20 years. The point is rapidly being reached at which these findings, and their far-reaching implications for how we deal with social problems, can no longer be ignored by policy makers."
Dr Jim Kemeny, Reader in Social Policy at the University of Plymouth
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"In the studies that I have examined on the impact of the Maharishi Effect on conflict, I can find no methodological flaws, and the findings have been consistent across a large number of replications in many different geographical and conflictual situations. As unlikely as the premise may sound I think we have to take these studies seriously."
Ted Robert Gurr PhD, Professor of Government and Politics, University of Maryland.
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"The peer-reviewed literature provides statistically highly significant support for the claim that a marked, socially beneficial influence can result from large gatherings practising the Transcendental Meditation and TM-Sidhi programmes. Moreover, the speed at which it is experienced would seem to rule out the explanations based on personal contacts."
James Lawton, Ph.D., Visiting Professor of Chemical Engineering, Imperial College; and former Research Director, CEGB, UK.
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"The hypothesis definitely raised some eyebrows among our reviewers, but the statistical work was sound. The numbers were there ..... When you can statistically control for as many variables as these studies do, it makes the results much more convincing."
Raymond Russ, Professor of Psychology, University of Maine, USA; Editor of Journal of Mind and Behaviour.
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"This research shows a great deal of promise. It is a non-traditional approach, but the methodology of these studies is sound and the statistical significance is high. In a world as unstable and dangerous as ours, I believe that any approach with such consistent objective support deserves careful attention."
Ved Nanda, PhD, President World Association of Law Professors, Director International Legal Studies Programme, University of Denver College of Law, Colorado.
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"I want to express my support for this research. What we are really looking at here I think is a new paradigm of viewing crime and violence, and the new paradigm says, look to the individual acting in concert with other individuals to reduce crime constructively.... Having worked extensively on social problems in the District of Columbia for some 24 years at the University of the District of Columbia ..... I'd like to encourage taking this new idea very seriously ... I would like to recommend that this new model that is being offered and advanced here, after a number of exhaustive and very carefully controlled studies, be considered, and that we think about ways that it might be implemented in the inner city with youth and community people who live here."
Anne Hughes, PhD, Professor of Sociology and Government, University of the District of Columbia.
Out of the nine cited reviewers one of them is a Psychologist. The rest are all sociologists, criminologists, economists. Peer-review should be accomplished by people within the area of expertise.
And I would hope that Ray Mc would agree that an aeronautical engineer should validate claims of yogic flying. To prevent cheating tests should be carried out in a wind tunnel.
A priceless image Pat C! Saffron robes flapping in smoke trails! However, I'm not adding information now and this isn't a bulletin board so I'll shut up and content myself with laughing.
I wouldn't think any of them would be experts in explaining how group practice of TM and TM-Sidhi programme has on society. But they would be competent enough to analysis the findings i.e. accident and crime statistics.
Dessie O' Hare for the experiment as he should be a Yoga Master by now.
1. As R Isible pointed out, only one of the ten people you list is even a psychologist.
2. None of these people are talking about studies they've conducted themselves. All are reacting to what they've been told by studies carried out by TMers.
So they're not even in a position to say whether the results claimed are true, let alone assess their validity.
How do you know the studies carried out so far have passed the criteria to be published in real (not TM) journals. Do you know what those criteria are? Have you first-hand experience of these studies? Or are you just repeating stuff you read on a TM website?
In another thread, you made a specific claim that within a matter of months TM would be making headlines all over the world. Do you stand by that claim?
A number of your TM websites claim that terrorism, crime, or some other bad thing dropped after mass meditation. Can you point to any case where such a claim was made _in advance_, and the criteria that would be used to test the claim were also made _in advance_ (in public, to credible witnesses, etc, etc). Or are you like Uri Geller who, when Big Ben stopped one day, phoned the newspapers to claim responsibility?
Why not try to disapprove that the articles are not cited in any of the journals listed in the link?
'not try' 'disapprove' 'not cited'
You seem to be asking 'what about these journals'?
These journals include "Scientific Research on Maharishi's Transcendental Meditation and TM-Sidhi Program: Collected Papers" !
The main problem with all but one of the articles cited (none of which I could find online, BTW, so I'm basing this judgement on the abstracts - if you can dig one up you can prove me wrong) is that none of them describe an actual experiment. They don't say "We took two cities, set up a TM centre in one of them, and waited to see what would happen". They don't describe predictions, and then see how those predictions measured against reality.
What those papers do is try to define a measure of improvement that can be connected, retrospectively, with some TM event. That is completely unscientific. It is exactly the same as Uri Geller claiming retroactive responsibility for stopping Big Ben. The statistics they contain may be correct, but as evidence for the effectiveness of TM they are laughable.
In all of the articles listed on the TM web-page, there was only one that looked half-way intriguing, the article in Social Indicators Research. That's the only one that says predictions were made in advance. Unfortunately its not online.