WHO Issues Guidelines for Herbal Medicine: Press Exaggerates Warnings

The World Health Organization is engaged in a strategy of helping traditional medicine (TM) and complementary and alternative medicine (CAM) to emerge and gain recognition as a valid alternative to our pharmaceutically controlled western-style medical system. One of the steps in this WHO program is to develop a consumer information strategy.

A report released by WHO in January 2004 - "Guidelines on Developing Consumer Information on Proper Use of Traditional, Complementary and Alternative Medicine" informs governments what steps they should take to promote these relatively safe alternatives to pharmaceutical medicine.

Unfortunately the WHO's presentation of the report last week led to a spate of articles on the horrors of herbs, although the report itself says no such thing. We were treated to headlines like "WHO Warns on Unsafe Use of Alternative Medicines", "Who warns of Dangers of Traditional Medicines" and similar, although the report itself does hardly allow such a conclusion. How did the distortion come about?

Here is what I found:

In May 2002, the World Health Organization has launched a global strategic action to "provide a framework for policy to assist countries to regulate traditional or complementary/alternative medicine (TM/CAM) to make its use safer, more accessible to their populations and sustainable."

According to this WHO strategy document, about 80% of the people in Africa use traditional medicine as their normal everyday means of healthcare. In western countries, the use of herbal and other traditional alternatives is on the upswing. 75% of the population in France has used complementary medicine at least once; in Germany, 77% of pain clinics provide acupuncture; and in the United Kingdom, expenditure on complementary or alternative medicine stands at US$ 2300 million per year.

As a part of this strategy to help make complementary and alternative medicine more accessible to people everywhere, WHO has recently released "Guidelines on Developing Consumer Information on Proper Use of Traditional, Complementary and Alternative Medicine". That document is available for download as a PDF file from this page on the WHO site.

Press exaggerates warnings

Instead of reporting on what really happened - that the World Health Organization is working to help traditional medicine emerge and take its rightful place as a valid alternative to pharma dominated western-style medicine, the press seized on the wholly incidental warnings and came out with headlines such as "WHO Warns of Dangers of Traditional Medicines" (Voice of America) and "Who warns on Alternative Medicine" (BBC News). Reuters ran a piece titled "WHO Warns on Unsafe Use of Alternative Medicines" starting out with a screamer: The World Health Organization (WHO) wounded the alarm about the unregulated and often unsafe use of alternative medicines ranging from acupuncture to herbal medicines and food supplements.

Not without some help, I should add. One Dr. Vladimir Lephakin, the World Health Organization's assistant director-general for health technologies and pharmaceuticals, speaking from the WHO's Geneva headquarters, is extensively quoted as warning of interactions between the two kinds of medicines. He told a news briefing that "...it is not true that traditional medicines are good for everybody, every time in big quantities. This is a big mistake." He also said that "there are a lot of examples of people who not only suffer but die because of drug interaction or non-proper use of traditional medicine".

In Denmark and Sweden, reporters linked the WHO report with warnings against Ginkgo Biloba, a herb with anti-oxidant and memory enhancing properties that originally came to us from China, and the Swedish Expressen even headlined its article: "Two dead because of natural substance". The source quoted was one professor Ralph Edwards of the WHO's Uppsala Monitoring Center who, when asked by phone, categorically denied having warned against Ginkgo or cited deaths. the Danish Ekstrabladet and Danish TV carried similar warnings: "WHO warns after deaths" and "Natural substance can be life threatening".

Whether the false reports and exaggerations came from WHO's own strategically placed pharmaceutical people or whether the press is to blame is not quite clear yet, but for sure the opportunity was good for WHO's Lephakin to call for "strengthening control of food supplements in all countries".

What does the WHO report really say?

On page 2 and 3 of the report we find that

"TM/CAM therapies may cause fewer adverse events than conventional therapies such as treatment with conventional medicines (pharmacotherapy). For example, a National Institute of Health (NIH) panel issued a consensus statement on acupuncture issued a consensus statement on acupuncture stating that the incidence of adverse effects from acupuncture are extremely low and often lower than for conventional treatments."

"Another reason why patients turn to TM/CAM for complementary care is the increasing cases of chronic and debilitating diseases for which there is no cure. Scientific studies of several TM/CAM therapies show that their use is effective, e.g. for HIV/AIDS and cancer patients. As a result, UNAIDS is advocating collaboration with TM practitioners in AIDS prevention and care in sub-Saharan Africa."

"The advantages of TM/CAM include its diversity and flexibility; its availability and affordability in many parts of the world; its widespread acceptance in low- and middle- income countries; its comparatively low cost; and the relatively low level of technological input required. As a result, TM/CAM therapies have the potential to contribute to a better health care system in many countries."

Does that sound different from the press reports? It gets better. When talking about the risks involved in TM/CAM, the report states, among other things

"It is important to note that while TM/CAM procedure-based therapies are relatively safe, accidents do occasionally occur, for example when TM/CAM practitioners are not fully trained; when practitioners do not follow the professional code of ethics; or when the treatment is not adjusted or modified according to the condition or constitution of the patient."

The report advocates (page 7 to 9) that some important aspects should be given further consideration:

Quality control of herbal medicines

Development of reliable treatment guidelines

Training and qualified practice for TM/CAM practitioners

Collaboration between conventional health care providers and TM/CAM practitioners

Communication between TM/CAM consumers and their conventional health care providers and TM/CAM practitioners as well as

Organization of TM/CAM practitioners.

In chapter 2, Development of Consumer Information, the report says that "it is important that information strategies provide a well-balanced message containing reliable, well-supported information tailored to the specific local context." Well - the press reports about this WHO project on TM/CAM could hardly have been more distorted.

At a time when people get sick in droves from the neurotoxic sweetener aspartame, when mercury in vaccines has led to an epidemic of autism, when the pharmaceutically controlled western medical system has become the major cause of death in the US, it is hardly proper to look for the splinter in the eye of alternative medicine, while the beam in western medicine's own eye is so appallingly evident that we have hundreds of thousands of deaths every year caused by conventional medicine and its pharmaceutical remedies, not to speak of bankrupt health budgets to pay for the mayhem.

See related articles:

Aspartame and Multiple Sclerosis - Neurosurgeon's Warning

Mercury: Toxic Amalgam 'Unsuitable for Dental Restoration'

Hormone Heresy's 'Final Nail in the Coffin'

EU Commissioner Byrne: No Zero Risk Society

Lipitor: Side Effects And Natural Remedy

CDC Knew: Mercury in Vaccines Induces Autism

Risk Free Vitamins - How Safe is Safe Enough?

Medical system is leading cause of death and injury in US

Here is a very informative comment on the WHO reporting from Jenny Thompson of the Baltimore Health Sciences Institute:

WHO Let the Dogs Out

Health Sciences Institute e-Alert

July 6, 2004

*************************************

Dear Reader,

You have to love synchronicity. Sometimes it provides good theater.

Just a few days ago, for instance, the World Health Organization (WHO) let the metaphorical dogs out with the release of new guidelines for developing consumer information on the "proper use" and regulation of complementary and alternative medicine (CAM).

Meanwhile, the very same week, some unsettling new information about the world's best selling prescription drug was published in the Archives of Neurology. Too bad WHO didn't offer some ideas about the "proper use" of this very popular but potentially harmful "miracle" drug.

---------------------------------------
High drama
---------------------------------------

My favorite coverage of the WHO guidelines came from BBC News, which spruced up the dry WHO language with lurid warnings that people may "not only suffer but die" as a result of using CAM treatments. I would say, "Spare me the dramatics," but it gets even better.

The BBC article quotes WHO officials whose comments make it clear that they think of the public as naïve children, in constant need of bureaucratic protection. For instance, Xiaorui Zhang (the WHO coordinator for traditional medicines) told the BBC that most countries don't regulate herbal formulas, and: "More than 90 countries sell them over-the-counter."

I guess this is supposed to sound shocking, as if 90 countries are running amok and out of control. And that includes the U.S., where you can buy extracts from plants that may be growing in your back yard. And, yes, you can purchase them with ease, over-the-counter (OTC), just as you can with many drugs, such as acetaminophen and pseudoephedrine.

The BBC article states that this past December, the FDA issued a warning about supplements that contain ephedra. Actually, the FDA didn't just issue a warning - it issued a BAN of ephedra, which took effect in the spring. Meanwhile, you can still buy decongestant medication that contains pseudoephedrine - the hyped-up pharmaceutical cousin of ephedra, which is much more dangerous than herbal ephedra in its unadulterated form.

And of course, these decongestants are all available over-the-counter in more than 90 countries.

-----------------------------------------
Giving and taking
-----------------------------------------

The same week that WHO officials released their new guidelines for regulating dietary supplements, a study appeared in the Archives of Neurology with this title: "Atorvastatin Decreases the Coenzyme Q10 Level in the Blood of Patients at Risk for Cardiovascular Disease and Stroke."

Atorvastatin is the chemical name for Lipitor, the cholesterol-lowering statin drug that's currently the biggest selling drug in the world. And this new study is simply confirmation of what scientists have known for some time: Statin drugs may lower levels of Coenzyme Q10 (CoQ10).

In the e-Alert "Power to the Powerhouses" (6/28/04), I told you that CoQ10 is a superior antioxidant, essential for the production of energy in every cell of the body. Through many years of research, CoQ10 has been shown to be effective in protecting the cardiovascular system and helping to prevent heart disease.

Just a little ironic, isn't it? Millions of heart patients who need CoQ10 supplements are taking a drug that depletes CoQ10. Yet if WHO officials have their way, dietary supplements will face stricter regulations. Meanwhile, the UK has decided to reclassify Zocor (another best selling statin drug) as OTC, in spite of the fact that Zocor may cause muscle pain or weakness, as well as liver problems (according to the Zocor web site).

I would ask, "What's wrong with this picture?" but the better question would be: Is there anything that's NOT wrong with this picture?

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One part harmony
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In August 2005, a new European Union (EU) directive will come into effect, which will ˆ according to the BBC - "harmonise" the regulation of dietary supplement sales within the EU. (To give you an idea of how significant this is, all you need to know is that there are more citizens in the EU than in the U.S.)

Harmony. Sounds nice, doesn't it? In this case, however, this "harmonising" will severely restrict the sale of supplements, putting ridiculously low upper limits on the dosages of vitamins and herbal products. This scheme is designed to "protect" consumers, as if getting too much vitamin C is a dire problem that needs solving.

That's an idea only a drug company executive - or a WHO official - could love.

 

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posted by Sepp Hasslberger on Wednesday June 30 2004
updated on Monday December 13 2010

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Readers' Comments

Here is an e-mail I received recently from India asking about the WHO's consumer guidelines publication on TM/CAM, and my reply, which I believe is interesting in the context of this article.

Dear Mr. Hasslberger

The science and environment fortnightly magazine "Down To Earth" is carrying an article on World Health Organisation's guidelines on developing consumer information for proper use of traditional medicines.

I would be grateful if you would comment on the feasibility of implementing these guidelines. How would they help the consumers? Do you think that the industry would accept these? Would these help promote international trade? Is there a chance that market for some products would be lost? How do these guidelines compare with EU's directives on traditional herbal medicines - is there a linkage?

Date: Thu, 1 Jul 2004

To: Vibha Varshney

From: "Sepp (Josef) Hasslberger"

Subject: World Health Organisation - Traditional medicine

Dear Vibha Varshney,

thank you for contacting me on the matter of the World Health Organisation's guidelines on developing consumer information for proper use of traditional medicines. Just yesterday, I published an article on my site

WHO Issues Guidelines for Herbal Medicine: Press Exaggerates Warnings

which discusses problems inherent in the press reporting about these guidelines. It appears that the report has been misrepresented in the press, possibly due to comments from pharmaceutical operators slanting the content to appear negative towards traditional and complementary medicines.

It should be noted that these consumer related guidelines are part of a larger WHO initiative to help traditional medicines emerge as a real alternative to pharmaceutically based western medicine. That initiative comprises the making of monographs for certain herbs, suggestions for quality control of products, suggestions for the training and the quality control of practitioners of traditional and alternative medicine and in general the promotion of these medicines to consumers and - more importantly - to countries which do not as yet recognize them. The overall initiative therefore appears to be a valid program directed towards achieving pluralism in medicine in those countries where western-style pharmaceutical medicine is dominating and where often the traditional and alternative forms of medicine are merely tolerated or are even subject to open persecution.

To answer your questions:

1) How would the guidelines help the consumers?

If the guidelines and the successive consumer information initiatives were impartial and supplied reliable information to consumers, they could benefit consumers by allowing a conscious choice between types of medicine and types of preventive strategies each one of us could adopt.

2) Do you think that the industry would accept these?

This is very much a problem in countries where pharmaceutically based medicine has a strong position. In those countries, industry is synonymous with pharmaceutical manufacturers, and there is a real possibility that regulations would meet resistance. In countries like India and China however, and in parts of Africa, where traditional medicine was never replaced by the pharmaceutical paradigm, I believe industry as a whole would welcome regulations that are directed to ensure high quality of products.

3) Would these help to promote international trade?

I believe that regulations which help traditional forms of medicine gain a certain measure of respectability would be positive for international trade, bringing some balance to the flow of goods. The largely one-way flow of trade of pharmaceutical as well as dietetic products from industrialized countries to the developing world would be re-balanced where developing countries could compete in furnishing the products needed for traditional forms of medicine to the industrial nations.

4) Is there a chance that market for some products would be lost?

Yes, definitely, there is a chance that market for some products could be lost, but in my view this is not due to the initiative of the World Health Organisation.

Rather, products could be lost because of restrictive international legislation (giudelines) being considered in the Food and Agriculture Organization's Codex Alimentarius. This legislation is not directly concerning herbs and traditional medicines, but is restrictive with regard to what may be marketed as food supplements, which in many western nations include not only vitamins and minerals but also traditional healthy foods used in alternative medicine. These discussions are taking a very restrictive bent and you can see some specific articles reporting on that on my site:

Meet Codex Alimentarius

South Africa breaks ranks at Codex Nutrition Committee

Codex 2003 - Grossklaus and Mathioudakis: Nutrition not relevant to Health

Codex Alimentarius - Optimizing Nutrient Intakes

South Africa Opposes Codex Rule on Food Health Information

While Codex Alimentarius is dealing with foods and in this context majorly with nutrients, restrictive rules in that area would definitely influence the fields of traditional and alternative medicines - making it much harder to introduce the products needed by these practices in western countries where the pharmaceutical paradigm has a close grip on what may be registered as a medicine and with what kinds of scientific proof.

5) How do these guidelines compare with EU's directives on traditional herbal medicines - is there a linkage?

The WHO guidelines could conceivably provide a counter-balance to the EU's quite restrictive directives, both on food supplements (already passed) and on traditional herbal medicines, which is under consideration. There is also a third EU directive, which is the medicinal laws directive, where the newly revised definition of a medicine promises to be so restrictive that theoretically, it is up to the EU health authorities to declare ANYTHING a medicine and require onerous registration procedures to be followed. This requirement for pharmaceutical registration is almost guaranteed to keep the various traditional medicines out of European markets.

The traditional medicines directive of the EU, which is still under consideration, limits the acceptability of products that may be registered under the directive to products that have a EUROPEAN tradition of a minimum of 30 years, 15 of which in Europe and 15 years in another market - products in other words, that have been legally on the European market for between 15 and 30 years. This would automatically exclude most of the products of non-European herbal traditions from registration under the provisions of the directive and would erect a one-way trade barrier discriminating against products from developing countries.

The European Union is also the major driving force for the restrictive Codex Alimentarius regulations on supplements mentioned previously. With now 25 countries, which practically have to act as one compact bloc of votes, and with the European Commission's Basil Mathioudakis leading the EU voting power in shaping the restrictive Codex rules on supplements in the exact image of the European directive on that same subject, there is a very real possibility that the EU can impose its restrictive view on these products on the world through Codex.

To overcome this barrier being erected, there are two possible courses of action:

a) The World Health Organisation's guidelines would have to be considerably strengthened to become binding on the western nations, eventually overriding the European laws. This is a course of action which for obvious reasons does seem to have little chance of success.

b) The European directives would have to be challenged in court (for the food supplements directive) and during the legislative process (for the traditional herbal directive) to encourage a more open approach by the European Union to the concept of healing traditions in the food area. This is necessary because the pharmaceutical area in Europe is under an exceedingly strict control by huge commercial interests, which slant the field in favour of pharmaceutical products and against traditional and food-based remedies.

Conclusion:

I would like to conclude with a suggestion.

If traditional medicines are to be allowed and in fact promoted to become a real alternative to pharmaceutical medicine, the developing world will have to throw its weight behind actions that are already in progress to achieve this aim:

i) The WHO initiative to increase the stature of traditional and alternative medicine and make it a real alternative to pharmaceutically controlled western medicine.

ii) The efforts
of South Africa in the deliberations of Codex Alimentarius, to open the way to a food-based health strategy, both in regards to the Codex guidelines on vitamin and mineral supplements and to the guidelines on claims, that is, the possibility to inform consumers of positive health properties of foods and traditional and alternative remedies that do not have full pharmaceutical registration as intended in western countries.

iii) The ongoing efforts to legally challenge the European food supplements directive and to influence the legislative course of the traditional herbal medicines directive as well as the pharmaceutical directive of the European Union. This effort is being spearheaded by the Alliance for Natural Health, an alliance of consumers, retailers, traditional medicine practitioners and producers of natural remedies. The Alliance for Natural Health has a website which can be accessed at http://www.alliance-natural-health.org/ It should be strongly supported as it is currently the only initiative working in the direction of changing the European mind towards allowing health traditions from all cultures access in the European market and allowing European consumers a meaningful and wide choice in health matters.

Posted by: Sepp on July 2, 2004 08:03 PM

 

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