Dr Robert Verkerk – dlaczego placebo działa? – polecamy Zespół MT

Posted on 29 października 2010. Filed under: ANH, ANH fight for true, ANH walka o prawdę, placebo, racjonalista.pl | Tagi: , , , , , |


Analysis of clinical trials reveals that placebo content is rarely described

A new paper entitled ‘What’s in Placebos: Who Knows? Analysis of Randomized, Controlled Trials’ was published in the Annals of Internal Medicine on 25th October 2010.

On reflection, it is surprising that a study such as this has not been carried out before now. With the concept of placebos so high on the public agenda, courtesy of the publicity given the revered randomised, placebo-controlled trial (RCT) by the mainstream media, it seems blindingly obvious that the placebos should also come under scrutiny.  At the very least the substances used as placebos should both be disclosed and established not to affect the outcome of the trial.

In fact, what these researchers have uncovered gives grave cause for concern, as trials that do report details of their placebo formulations are very unusual exceptions. The rule appears to be to say „You can trust us, we’re using inert substances that will have no bearing on the trial results”, while not disclosing any information on what those substances might be! While it may very well be true that the companies and organisations running clinical trials are whiter-than-white in terms of the substances given to patients as placebo, the potential for mistakes, invalid results and plain old medical fraud are huge.

Just think: it would be so easy for unscrupulous researchers to pollute their anonymous placebo with a substance that made those patients a little bit sicker – even if only on one or two clinical indicators – and thereby skew the results in favour of the trial drug. Placebos are often known as “sugar pills”, but what would be the effect of a real sugar pill in an RCT for a type II diabetes drug? It would be a black day indeed for the pharmaceutical industry if it turned out that decades of clinical trials were declared invalid, due to a lack of definitive evidence that their placebos were safe and inert.

These researchers have taken an important first step toward full disclosure of the true state of the science behind RCTs. We await further developments with interest.

Access the abstract and full paper.

Short summary of the abstract:

Background: No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting.

Purpose: To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials.

Data Synthesis: Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002).

Limitation: Journals with high impact factors may not be representative.

Conclusion: Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

Golomb BA, Erickson LC, Koperski S, Sack D, Enkin M, Howick J. What’s in Placebos: Who Knows? Analysis of Randomized, Controlled Trials. Annals of Internal Medicine 2010; 153: 532–535.

ANH-International homepage
ANH-Europe
Good Science campaign

Read Full Post | Make a Comment ( None so far )

FAO and ANH go head to head on Codex – Komentarz „MEDYCYNY TYBETAŃSKIEJ” i dr Enji

Posted on 1 kwietnia 2010. Filed under: ANH, ANH fight for true, ANH walka o prawdę, codex alimentarius, dr Enji, enji, kodeks żywnościowy, lekarz Enji, lekarz Enkhjargal Dovchin, Złe Prawo | Tagi: , , , , , , , |


By the ANH Team

Two scientists on opposing sides of the debate over how the global food supply is being regulated were brought together yesterday to argue and debate their respective positions in front of an audience of leading academics at Lancaster University. The unique debate was convened by the ESRC Centre for Economic and Social Aspects of Genomics (Cesagen) as part of the ESRC Festival of Social Science. The debate was entitled “The Future of Codex Alimentarius”. Leading academics from Lancaster, Edinburgh, Sussex and Sheffield Universities actively participated in a highly engaging debate following presentations by the two scientists.

Dr Ezzeddine Boutrif

Dr Ezzeddine Boutrif, Director of the Nutrition and Consumer Protection Division, Food and Agriculture Organisation (FAO), opened the debate by making a presentation on the claimed benefits, risks and opportunities brought by implementation of the international food code administered through the intergovernmental organization responsible for developing international standards for the global food trade, the Codex Alimentarius Commission (CAC). Dr Boutrif explained the complex procedures developed to facilitate the workings of the intergovernmental organization and argued that the process was now considerably more transparent than in earlier years.

Dr Robert Verkerk, executive director of the Alliance for Natural Health, an international non-governmental organization, followed Dr Boutrif, questioning the independence of much of the science relied upon by Codex technical committees, providing evidence for the distortion of the process by large vested interests. Dr Verkerk also claimed that Codex’s work on genetically modified foods was inadequate to ensure consumer or environmental protection and that the basis for claiming that GM crops could alleviate hunger and poverty in developing countries was lacking. He advocated that agro-ecological models of agriculture that focused on the self-sufficiency of such agricultural communities—and not biotechnology—would be central to any resolution of the problems.

The global food system has transitioned massively over the last few decades, even since the CAC was formally established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) in 1963. Central to these changes are the industrialization of agriculture, the establishment of a truly global food trade, the increased consumption and availability of processed foods and accompanying use of food additives, as well as a dramatic adoption of GM crops destined for both the animal and human food chains.

The recommendations, guidelines and standards as established by Codex Alimentarius have become central to the way in which the global food trade is regulated. The over 10-year long dispute between the USA and the EU over growth hormones in beef in which the EU has been forced by the World Trade Organization, on the basis of evidence from Codex, to pay fines amounting to over $120 million annually for refusing import of hormone-treated US and Canadian beef provides an example of the significance of Codex. The EU, in contrast, has argued that some hormones may present a health risk to humans consuming produce from treated animals.

Dr Robert Verkerk

Commenting on the meeting, Dr Verkerk said, “The Cesagen meeting presented a rare opportunity for our views to be aired, not only directly to the FAO, but also to a clutch of leading academics in the genomics and social science fields. There is no doubt in my mind that the interests of consumers, as well as those of smallholder farmers and small businesses in the food trade, are not being adequately addressed by the present Codex structure. Big business and a number of governments have run away on their own track. We hold some hope that well argued positions from the NGO and academic sectors may help to positively shape the system to better deal with the demands of future generations. Developing foods and food production systems that are more compatible both with the environment and our bodies will involve a paradigm shift—and this is about going forwards not backwards. ”


ANH HomepageCodex campaign page

Say No to GM campaign page

Read Full Post | Make a Comment ( None so far )

FAO and ANH go head to head on Codex

Posted on 28 marca 2010. Filed under: 1 | Tagi: , , , , , , , , |


By the ANH Team

Two scientists on opposing sides of the debate over how the global food supply is being regulated were brought together yesterday to argue and debate their respective positions in front of an audience of leading academics at Lancaster University. The unique debate was convened by the ESRC Centre for Economic and Social Aspects of Genomics (Cesagen) as part of the ESRC Festival of Social Science. The debate was entitled “The Future of Codex Alimentarius”. Leading academics from Lancaster, Edinburgh, Sussex and Sheffield Universities actively participated in a highly engaging debate following presentations by the two scientists.

Dr Ezzeddine Boutrif

Dr Ezzeddine Boutrif, Director of the Nutrition and Consumer Protection Division, Food and Agriculture Organisation (FAO), opened the debate by making a presentation on the claimed benefits, risks and opportunities brought by implementation of the international food code administered through the intergovernmental organization responsible for developing international standards for the global food trade, the Codex Alimentarius Commission (CAC). Dr Boutrif explained the complex procedures developed to facilitate the workings of the intergovernmental organization and argued that the process was now considerably more transparent than in earlier years.

Dr Robert Verkerk, executive director of the Alliance for Natural Health, an international non-governmental organization, followed Dr Boutrif, questioning the independence of much of the science relied upon by Codex technical committees, providing evidence for the distortion of the process by large vested interests. Dr Verkerk also claimed that Codex’s work on genetically modified foods was inadequate to ensure consumer or environmental protection and that the basis for claiming that GM crops could alleviate hunger and poverty in developing countries was lacking. He advocated that agro-ecological models of agriculture that focused on the self-sufficiency of such agricultural communities—and not biotechnology—would be central to any resolution of the problems.

The global food system has transitioned massively over the last few decades, even since the CAC was formally established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) in 1963. Central to these changes are the industrialization of agriculture, the establishment of a truly global food trade, the increased consumption and availability of processed foods and accompanying use of food additives, as well as a dramatic adoption of GM crops destined for both the animal and human food chains.

The recommendations, guidelines and standards as established by Codex Alimentarius have become central to the way in which the global food trade is regulated. The over 10-year long dispute between the USA and the EU over growth hormones in beef in which the EU has been forced by the World Trade Organization, on the basis of evidence from Codex, to pay fines amounting to over $120 million annually for refusing import of hormone-treated US and Canadian beef provides an example of the significance of Codex. The EU, in contrast, has argued that some hormones may present a health risk to humans consuming produce from treated animals.

Dr Robert Verkerk

Commenting on the meeting, Dr Verkerk said, “The Cesagen meeting presented a rare opportunity for our views to be aired, not only directly to the FAO, but also to a clutch of leading academics in the genomics and social science fields. There is no doubt in my mind that the interests of consumers, as well as those of smallholder farmers and small businesses in the food trade, are not being adequately addressed by the present Codex structure. Big business and a number of governments have run away on their own track. We hold some hope that well argued positions from the NGO and academic sectors may help to positively shape the system to better deal with the demands of future generations. Developing foods and food production systems that are more compatible both with the environment and our bodies will involve a paradigm shift—and this is about going forwards not backwards. ”


ANH Homepage

Codex campaign page

Say No to GM campaign page

Read Full Post | Make a Comment ( None so far )

New ANH study says EU vitamin laws must change track

Posted on 28 marca 2010. Filed under: dr Enji, enji, lekarz Enji, lekarz Enkhjargal Dovchin, lex nostrum | Tagi: |


ANH Press Release: New ANH study says EU vitamin laws must change track

Press Release
For immediate release

25th March 2010

NEW ANH STUDY SAYS EURO VITAMIN LAWS MUST CHANGE TRACK
Alliance for Natural Health study says risk-benefit approach needed for vitamin and mineral food supplements

Download a PDF of the press release

A study just published in a leading peer reviewed journal explains how the European Commission’s proposed approach to limiting maximum doses of vitamins and minerals in food supplements across Europe is not scientifically rational.

The study’s author Robert Verkerk PhD, executive and scientific director of international campaign organisation, the Alliance for Natural Health (ANH), „When you dig into the complexity of risk and benefit relationships for nutrients as I have in this study, proceeding with the kind of approaches the European Commission, the European Food Safety Authority and industry have been discussing over the last six or so years makes absolutely no scientific sense. The only rational way forward involves moving from the risk-only approach that has been considered up until now, to a risk-benefit approach. This means changing tracks.”

The study has been published in the journal, Toxicology, the official journal of the British Toxicology Society and the German Toxicology Society. It is published in the same journal just two months after an in-depth review of the scientific methods being considered by European authorities, co-authored by Dr Verkerk, along with Dr Steve Hickey of Staffordshire University, UK.

This latest study shows that the risk-based approaches under consideration by European authorities, if turned into law as proposed, will deny the majority of people from consuming beneficial quantities of vitamins and minerals.

Dr Verkerk explains, „The problem is that the risks and benefits for most nutrients actually overlap. If you exclude all risks in the majority through statutory limitation as planned under the second phase of the EU Food Supplements Directive, you literally prevent people from accessing products containing levels that are good for them. You might stave off deficiency diseases, but you would also prevent many people from managing their health naturally. If we applied the same approach to wheat, dairy or peanuts, governments would have to ban these foods.”

Using extensive examples and referencing to other published studies, the paper shows that any scientifically rational approach would need to be applied to individual forms of vitamins and minerals, rather than being developed as blanket levels applying to all forms of a given vitamin or mineral group.

„A good example of this, considered in detail in the paper, is that of folate”, continues Verkerk. „There are more and more data pointing to health risks from long-term supplementation with more than 1000 micrograms daily of the synthetic form of folate, folic acid, that’s widely used in cheaper supplements. But the natural, non-reduced forms as found in green-leaved vegetables have a much wider range of benefits, and are known to exert their greatest benefits when consumed in significantly larger amounts.”

The paper also looks in detail at the anomalous case of fluoride and shows that the European legislative approach to fluoride in supplements, or indeed government approaches to the water fluoridation programmes specific to Ireland and parts of the UK, are contrary to the principles of risk management applied elsewhere. Given the risks of fluoride to young children, Verkerk argues that it is remarkable that mass treatment of public drinking water is still allowed while the European Food Safety Authority continues to green light various forms of fluoride in supplements.

Verkerk’s study argues forcefully that legislation on maximum levels of vitamins and minerals should not proceed until new methods involving consideration of both risks and benefits of individual forms of vitamins and minerals are developed. Accordingly, the paper ends with the following advice to European authorities, given around 200 years ago by the third President of the United States of America, Thomas Jefferson, „delay is preferable to error”.

ENDS.

CONTACT

For further information, please contact ANH Campaign Administrator, Sophie Middleton, tel +44(0)1306 646 600 or email info@anhinternational.org.

EDITOR’S NOTES

About the article

The full reference to the ‘Epub ahead of print’ article is as follows:

Verkerk, R.H.J., The paradox of overlapping micronutrient risks and benefits obligates risk/benefit analysis. Toxicology (2010), doi:10.1016/j.tox.2010.02.011

The article can be accessed here

About ANH International
www.anhinternational.org
www.anh-europe.org
www.anh-usa.org

Alliance for Natural Health International is an internationally active non-governmental organisation working towards protecting and promoting natural approaches to healthcare. ANH-Intl campaigns across a wide range of fields, including for freedom of choice and the use of micronutrients and herbal products in healthcare. It also operates campaigns that aim to restrict mass fluoridation of water supplies and the use of genetically modified foods. Through its work particularly in Europe (www.anh-europe.org) and the USA (www.anh-usa.org), the ANH works to accomplish its mission through its unique application of ‘good science’ and ‘good law’. The organisation was founded in 2002 by Dr Robert Verkerk, an internationally acclaimed expert in sustainability, who has headed the organisation since this time. ANH-Intl is working collaboratively with a wide range of scientists, lawyers, medical doctors, health practitioners, politicians and consumers, to help facilitate the development of scientific and legal frameworks appropriate to natural and sustainable healthcare.

Additional Press Release

The following (related) release has been issued simultaneously by Voice of Irish Concern for the Environment (VOICE):

‘Fluoride risks to children in Ireland highlighted by new review in Toxicology journal’


Health Choice campaign

Clean Drinking Water campaign

Good Science campaign

Read Full Post | Make a Comment ( None so far )

ANH Press Release: ANH set to challenge EU herb law

Posted on 28 marca 2010. Filed under: dr Enji, enji | Tagi: |


Press Release
For immediate release

22nd March 2010

ANH SET TO CHALLENGE EU HERB LAW
Alliance for Natural Health International announces its intention to initiate a legal challenge to the European directive on traditional herbal medicines

Download a pdf of the press release

An expert’s workshop in Budapest, sponsored by the Indian government and convened by the European Ayurvedic Association, provided the venue for the Alliance for Natural Health International to announce its intention to initiate legal proceedings against the European Directive on Traditional Herbal Medicinal Products (THMPD) (EC Directive 2004/24/EC).

The directive poses a major obstacle for the continued use and practice of long-standing traditions of healthcare involving herbal products in Europe, including those of Ayurveda and Unani from the Indian sub-continent and that of traditional Chinese medicine (TCM).

Many such products, including those from Western herbal traditions, have up until now been sold in the EU as botanicals under the food supplement regime. But most Member States are anticipating narrowing the regime when the directive’s 7-year transition phase expires on 31 March 2011. Legally, the directive requires that the same pharmaceutical standards applied to conventional, synthetic drugs are applied to herbal products. This requirement is the main reason for the technical difficulties and very high costs of compliance.

Dr Robert Verkerk, executive director of Alliance for Natural Health International (ANH-Intl), said, “Getting a classical herbal medicine from a non-European traditional medicinal culture through the EU registration scheme is akin to putting a square peg into a round hole. The regulatory regime ignores and thus has not been adapted to the specific traditions. Such adaptation is required urgently if the directive is not to discriminate against non-European cultures and consequently violate human rights.”

The ANH-Intl has been working alongside its lawyers, Cheyney Goulding of Guildford, UK, and has sought advice from a leading London-based barristers’ chambers, 11KBW, which specialises in European competition and human rights law.

ANH-Intl has been working for several years towards creating the necessary changes to the directive to prevent discrimination against smaller herb producers and non-European healthcare cultures.

Referring to ANH-Intl’s legal advice, Verkerk stated: “We are now confident that our legal counsel has found a solid way forward that will be in the long-term interests of European and non-European citizens alike. Given the challenges facing the health of the people of Europe, especially as a result of the burden of chronic diseases, the EU should be welcoming—not locking out—these very long-standing, multi-faceted and effective healthcare traditions. We are now assured that a diverse range of interests are willing to work with us to initiate the judicial review process.”

ENDS.

CONTACT

For further information, please contact ANH Campaign Administrator, Sophie Middleton, tel +44(0)1306 646 600 or email info@anhinternational.org.

NOTES TO THE EDITOR

About the EU Directive on Traditional Herbal Medicinal Products

For further information about the EU directive on traditional herbal medicines (THMPD) and concerns over its implementation, please download the following ANH briefing paper:

http://www.anhcampaign.org/files/080630_ANH-Briefing_Paper_THMPD.pdf

· The European directive provides a simplified registration scheme for herbal medicines, whereby evidence of traditional use is accepted in place of the clinical trials used for conventional drugs that aim to prove their effectiveness for given indications. The directive, which is restricted to products indicated for mild ailments (without the intervention of a practitioner), still requires that conventional pharmaceutical standards are met to verify quality, purity and stability of herbal medicines. These standards are either technically not feasible for many multi-herb products common to non-European healthcare traditions, or they are prohibitively and disproportionately expensive.

· Less common traditional healthcare cultures dependent on herbal products, such as those from other regions of Asia (such as Tibet, Mongolia and South-East Asian countries), Africa and South America will be impacted to an even greater extent given the technical hurdles and costs of the European licensing regime provided by the directive.

· Both Ayurveda and TCM have over many years developed very specific approaches to maintaining the quality and consistency of herbal medicines and these are detailed in their respective pharmacopoeia. While there have been a small number of well-publicised instances where exports from both India and China have been found to be sub-standard in quality or contaminated, this has been through failure to adopt standards set by the tradition-specific pharmacopoeia. Enforcement in both India and China has improved in recent years and the directive’s requirement for licensing of overseas manufacturers by EU authorities provides a control against sub-standard operators.

· The ANH argues that the EU authorities should respect the equivalence of non-European standards as set by their respective pharmacopoeia, rather than force non-European herbs through western scientific standards that are neither appropriate nor relevant.

· To-date, not a single product from either the Ayurvedic or Chinese tradition has been registered. Restrictions on eligibility, including the general requirement to demonstrate 15 years of use of the product in a European Member State, out of a total of 30 years, provide further obstacles to successful registration of products from non-European traditions under the EU scheme.

· The traditions of Ayurveda and TCM have evolved over more than 4,000 years. These traditions alone are common to over one-third of the world’s population. They represent multi-faceted approaches to whole body healthcare that include detailed attention to diet and lifestyle, as well as the use of natural products and specific mental or spiritual practices.

About ANH International
www.anhinternational.org
www.anh-europe.org

Alliance for Natural Health International is an internationally active non-governmental organisation working towards protecting and promoting natural approaches to healthcare. ANH-Intl campaigns across a wide range of fields, including for freedom of choice and the use of micronutrients and herbal products in healthcare. It also operates campaigns that aim to restrict mass fluoridation of water supplies and the use of genetically modified foods. Through its work particularly in Europe (www.anh-europe.org) and the USA (www.anh-usa.org), the ANH works to accomplish its mission through its unique application of ‘good science’ and ‘good law’. The organisation was founded in 2002 by Dr Robert Verkerk, an internationally acclaimed expert in sustainability, who has headed the organisation since this time. The ANH brought a case against the European directive on food supplements in 2003, which was successfully referred to the European Court of Justice in early 2004. The ruling in 2005 provided significant clarification to areas of EU law affecting food supplements that were previously non-transparent.

Budapest workshop convened by European Ayurvedic Association

The workshop entitled “The future of Ayurveda in Europe” was convened at the Marriott Hotel, Budapest on 19th and 20th March 2010 by the European Ayurvedic Association (EUAA) (www.euroayurveda.com). The workshop was sponsored by AYUSH, the arm of the Indian government responsible for Ayurveda and other Indian systems of medicine.

The workshop was opened by the Indian Ambassador to Hungary, Mr Ranjit Rae. Speakers at the workshop, other than Dr Robert Verkerk of ANH, included:

·      Ms Jalaja, the Secretary of AYUSH, Government of India

·      Dr Sharma, scientific expert with AYUSH, Government of India

·      Dr Péter Medgyessy, the former Prime Minister of Hungary

·      Dr Harsha Gramminger of EUAA

·      Edit Herczog, a former European Member of the Parliament

·      Dr Werner Knoess, responsible for registrations of traditional herbal medicines in the German regulatory agency BfArM (Federal Institute for Drugs & Devices, Germany)

·      Paolo Vergano, Brussels-based lawyer and specialist in WTO dispute resolution

ANH Homepage

Nurture Traditional Medicinal Cultures campaign page

Read Full Post | Make a Comment ( None so far )

  • Google Translator

  • STOP kłamstwu tvn!

    STOP TVN, TVN24, POLSAT I WYBIÓRCZEJ - stop zakłamaniu w mediach masowych
  • Chroń medycynę naturalną/ Protect natural medicine all over the world
  • Podpisz petycję w obronie medycyny naturalnej i tradycyjnych systemów medycznych
  • Medycyna Tybetańsko-Mongolska, Akupunktura, Moksa, Ziołolecznictwo na PINTEREST.COM
  • Polub nas na FB

  • Instagram prof Enji

    There was an error retrieving images from Instagram. An attempt will be remade in a few minutes.

  • Artykuł o nagonce

  • Czwarty Wymiar o nagonce medialnej

    Artykuł w "CZWARTYM WYMIARZE" o nagonce medialnej na lekarkę Enkhjargal Dovchin "ENJI"
  • Artykuły w „ZC”

    Znaki Czasu - to obecnie jedyne czasopismo, które ma odwagę pisać jawnie o najważniejszych sprawach dotyczących zdrowia ludzkiego czyli Kodeksie Żywnościowym, Szczepieniach oraz alternatywnych metodach leczniczych.
  • MTM in Poland

    Mongolska Tradycyjna Medycyna w Polsce - MTM in Poland
  • LIST OTWARTY

    LIST OTWARTY PUBLICYSTÓW W OBRONIE TOLERANCJI I WOLNOŚCI WYKONYWANIA ZAWODU
  • Chmurka kategorii

  • Ankiety

  • Szybkie menu

Liked it here?
Why not try sites on the blogroll...