Wednesday, May 30, 2007

Traditional Medicine: Consumers, government and other stakeholders

Based on the growing interest in traditional medicine shown by
consumers, scientists and regulators, three important challenges
present themselves.
• The public and the users of traditional medicine request
safe, quality–controlled and effective remedies.
• Medical scientists request more scientifically sound
evidence before comfortably accepting many traditional
medicine practices. Many health professionals have
doubts about the usefulness of traditional medicine. In
many cases, they require more scientifically–based
evidence if they are to trust its safety and effectiveness.
Meanwhile, the involvement of the academic and
scientific community provides the opportunity to create
more evidence by means of modern science.
• Governments need to establish and update mechanisms
for the regulation of traditional medicine and its
practitioners and, in doing so, require more
scientifically–based evidence to support decision–
making. As traditional systems of medicine become
better documented, and more scientifically credible,
usage is only likely to increase further.
Consumers, of course, have many different reasons for using
traditional medicine, and may not require the same level of evidence
of practice that is espoused by medical scientists. Consumers may
have confidence in, for example, oriental herbal medicine because
of its existence in public hospitals and medical infrastructure in
China, Republic of Korea, and Japan, instituted by centuries of use,
scholarly writings and a formal tertiary education system.
Consumers may also be prepared to try an herbal formula that has
been used and documented in classical medical literature for many
centuries and may be less convinced by a clinical trial of a new drug
– having been applied only to a well–defined sample group.
Consumers’ awareness of these factors may generate more confidence
in terms of ‘evidence behind practice’ than any single
methodologically rigorous clinical trial. However, to the scientist
it’s the latter, and not the former, that represents the stronger evidence.

Source: www.who.int

Traditional Medicine: Changes in trends of usage

Traditional medicine exists in most countries and areas in the
Western Pacific Region and makes a significant contribution to the
health of the people of the Region. Interest in traditional medicine
has increased over the last decade and seems likely to continue.
People now are more prepared to look for alternative approaches to
maintain their health.
There are no solid data on the extent of usage of traditional
medicine in the Region. However, data from several countries and
areas in the Region show that around 40% to 60% of the population
of these countries and areas use traditional medicine. For example,
traditional medicine accounts for around 40% of all health care
delivered in China and in Hong Kong, approximately 60% of the
population has consulted traditional medicine practitioners at one
time or another.3
The use of traditional/complementary medicine in industrialized
countries has increased significantly. Studies conducted in the US
show that complementary therapy usage increased from 34% in 1990
to 42% in 1997.4 In Australia, research has indicated that 48.5% of
the population used at least one non–medically prescribed alternative
medicine in 1993. The estimated national expenditure on alternative
medicines and alternative practitioners is close to A$1 000 million
per annum, of which A$621 million is spent on alternative medicines.5
An Australian government report in 1996 estimated that there were
at least 2.8 million traditional Chinese medicine consultations in
1996, representing an annual turnover of A$84 million within the
health economy. This growth was also reflected in a four–fold
increase in the importation of Chinese herbal medicines since 1992.6
Clearly, traditional medicine is widely used by the public, and
in some countries its use has increased dramatically. Increased
demands from public lead to increased interest and involvement of
the academic and scientific community. Concurrently, more and
more governments from countries and areas within the Region have
shown their interest and willingness to promote the proper use of
traditional medicine.

Source: www.who.int

Traditional Medicine: Changes in trends of usage

Traditional medicine exists in most countries and areas in the
Western Pacific Region and makes a significant contribution to the
health of the people of the Region. Interest in traditional medicine
has increased over the last decade and seems likely to continue.
People now are more prepared to look for alternative approaches to
maintain their health.
There are no solid data on the extent of usage of traditional
medicine in the Region. However, data from several countries and
areas in the Region show that around 40% to 60% of the population
of these countries and areas use traditional medicine. For example,
traditional medicine accounts for around 40% of all health care
delivered in China and in Hong Kong, approximately 60% of the
population has consulted traditional medicine practitioners at one
time or another.3
The use of traditional/complementary medicine in industrialized
countries has increased significantly. Studies conducted in the US
show that complementary therapy usage increased from 34% in 1990
to 42% in 1997.4 In Australia, research has indicated that 48.5% of
the population used at least one non–medically prescribed alternative
medicine in 1993. The estimated national expenditure on alternative
medicines and alternative practitioners is close to A$1 000 million
per annum, of which A$621 million is spent on alternative medicines.5
An Australian government report in 1996 estimated that there were
at least 2.8 million traditional Chinese medicine consultations in
1996, representing an annual turnover of A$84 million within the
health economy. This growth was also reflected in a four–fold
increase in the importation of Chinese herbal medicines since 1992.6
Clearly, traditional medicine is widely used by the public, and
in some countries its use has increased dramatically. Increased
demands from public lead to increased interest and involvement of
the academic and scientific community. Concurrently, more and
more governments from countries and areas within the Region have
shown their interest and willingness to promote the proper use of
traditional medicine.

Source: www.who.int

Traditional Medicine: Background and Characteristics

Traditional medicine is the ancient and culture–bound medical
practice which existed before the application of modern science to
health. The practice of traditional medicine varies widely, in keeping
with the societal and cultural heritage of different countries. Every
human community has responded to the challenge of maintaining
health and treating diseases by developing a medical system. Thus,
traditional medicine has been practised to some degree in all cultures.
A workshop on development of national policy on traditional
medicine organized by WHO Regional Office for the Western Pacific
in October 1999 defined traditional medicine as the sum total of
knowledge, skills and practices of holistic healthcare, which is
recognized and accepted by the community for its role in the
maintenance of health and the treatment of diseases. Traditional
medicine, based on the theory, beliefs and experiences indigenous to
different cultures, was developed and handed down from generation
to generation1.
In some countries, remedies used by traditional medicine have
re–emerged. Such techniques are usually known as “alternative” or
“complementary” medicine, which as a form of medicine has evolved
recently as a reaction to high technology medicine2.
A traditional medicine practitioner is a person who is recognized
by the community where he or she lives as someone competent to
provide health care by using plant, animal and mineral substances
and other methods based on social, cultural and religious practices.
Traditional medicine practitioners are also recognized as experts on
community attitudes and beliefs related to physical, mental and social
well–being and the causes of disease and disability. Traditional
medicine practitioners include traditional healers, traditional birth
attendants, herbalists and bone–setters.
There are many traditional systems of medicine. However, many
traditional systems of medicine have some common characteristics.
• Traditional medicine is based on a belief that health is
a state of balance between several opposing aspects in
the human body. Illness occurs when an individual falls
out of balance, physically or mentally. The “causes” of
imbalance could be change of weather, intake of certain
food; external factors, such as magical or supernatural
powers; mental stimulation and societal reasons.
Traditional medicine tries to restore the balance using
different therapies.
• Traditional medicine is based on the needs of
individuals. Different people may receive different
treatments even if they suffer from the same disease.
Traditional medicine is based on a belief that each
individual has his or her own constitution and social
circumstances which result in different reactions to
“causes of disease” and treatment.
• Traditional medicine applies a holistic approach. It
considers a person in his or her totality within an
ecological context and usually will not only look after
the sick part of the body. Besides giving treatment,
traditional practitioners usually provide advice on
lifestyles and healthy behaviour.
• Traditional medicine precedes modern medicine. Most
traditional remedies have not been evaluated by sound
scientific methods. This means that, at this stage,
traditional medicine is not easily understood by modern
medicine. However, traditional remedies have been
“field–tested” by tens of thousands of people for
hundreds of years.
• Traditional medicine covers a wide scope and its
practices vary widely from country to country. In the
Region, the main therapeutic techniques are medicinal
plants and acupuncture.

Source: http://www.who.int

Tuesday, May 29, 2007

Prohibited or restricted herbal ingredients

The use of some herbal ingredients in medicines are restricted or prohibited due to their toxicity or potency.

A list of herbal ingredients which are prohibited or restricted in medicines is available here. PDF (new window) This table provides a consolidated and complete list of herbal ingredients which are subject to various restrictions.

Source: http://www.mhra.gov.uk

Safety issues associated with poor quality

In September 2001 the MHRA issued a press release about the poor quality of some traditional Chinese medicines found on the UK market.

The release gave examples of potentially dangerous and illegal ingredients found in herbal remedies and publicised the concerns expressed by the Committee on Safety of Medicines. It included comments from the then Chairman of CSM, Professor Breckenridge:

"We recognise that many people value herbal remedies, such as traditional Chinese medicines and are keen that people carry on having the choice to use them. However, there is clear evidence that standards used in the production of some TCMs on the UK market are, at best, unreliable. While many individual remedies are unlikely to pose any threat to public health, I am concerned that we continue to find further examples of TCMs containing potentially dangerous and often illegal ingredients.

There is no reliable way for the public to identify those TCMs which could be unsafe. In the light of this evidence we are unable to give the public any general assurances as to the safety of TCMs on the UK market. That is why the MHRA has called upon, and are working with, the UK traditional Chinese medicines sector to improve the quality and safety standards of its medicines.

When buying TCMs people should always be aware of the possibility of low quality or illegal products. They should not take them if they are not labelled and include a list of ingredients in English. Even then, clear labelling is not in itself a guarantee of good quality standards. When seeing their doctor or pharmacist people should always inform them that they are taking a herbal remedy."


Source: http://www.mhra.gov.uk

Mistaken identity of herbal ingredients

The MHRA is aware of a number of incidents over recent years where herbal ingredients used in herbal remedies have been mis-identified by someone manufacturing or making up remedies.

This has led to risk or, in some cases, actual harm to people. Such incidents have affected a variety of countries. Wherever such an incident is reported, however, it is of potential concern to the UK. This is because there is an international trade in herbal remedies and herbal ingredients, with a consequent risk that such products or ingredients may find their way on to the UK market. Also, where evidence has emerged of similar looking ingredients becoming confused this may be an indicator that a similar problem could recur elsewhere.

Incidents of this kind emphasise the need for rigorous control through the supply chain to ensure that all ingredients used in the manufacture of herbal remedies are properly authenticated by someone with the necessary expertise and using validated methodology.

Intended ingredient Ingredient used Notes
Stephania, Clematis and others
Aristolochia species

Aristolochic acids associated with cancer and kidney failure; repeated incidents have been identified in various countries including the UK.

Gentian
Podophyllum

Cases of Podophyllum poisoning have been reported from Hong Kong following inadvertent use of Podophyllum root instead of Gentian. Internal use of Podophyllum can cause serious toxicity and may be fatal.

Scutellerai
Teucrium

Substitution of Scutellaria by Teucrium species has been known to occur in the UK, Teucrium species have been linked with cases of liver toxicity.

Plantain
Digitalis

Cases of serious cardiac arrhythmia (abnormal heart rhythm) were reported in the US in 1997 following the accidental substitution of plantain with Digitalis.

(Chinese) Star Anise
Japanese Star Anise

Japanese Star Anise contains compounds not present in Chinese Star Anise and known for convulsant effect; affected several European countries in 2001



Source: http://www.mhra.gov.uk

Side effects and interaction with other medicines

When the MHRA receives reports that herbal medicines, for example St John's wort, may interact with other medicines, we look carefully at the evidence and seeks the advice of the Committee on Safety of Medicines (CSM) . The objective is to take a balanced and proportionate approach.

Use of herbal medicines in patients prior to surgery

It is important for patients to discuss their herbal medicines with their doctor before they undergo surgery. In some cases it may be necessary to discontinue the herbal medicine several weeks before surgery.

Concerns have been raised that some herbal medicines should be discontinued prior to surgery. This is because it is thought that some herbal medicines could cause complications by interfering with anaesthetics, anticoagulants and other substances used before, during or after surgery.

There are also concerns that some herbal medicines may themselves interfere with blood clotting and blood pressure. For example, garlic, ginseng and ginkgo have been reported to interfere with blood clotting mechanisms and may increase the risk of bleeding during surgery.

Because of the limited information available on herbal medicines it is difficult to give specific guidance on when they should be discontinued prior to surgery.


Source: http://www.mhra.gov.uk

Using herbal medicines: Advice to consumers

This section provides advice on using herbal medicines.


General advice to consumers

  • Remember that herbal remedies are medicines. As with any other medicine they should be used with care.
  • Any medicine – herbal or otherwise – has the potential to have adverse effects.
  • Before you take any herbal medicine you need to be sure it is the correct product for you.
  • Remember that natural does not mean safe. Many plants can be poisonous to humans. Many pharmaceutical medicines have been developed from plants because of the powerful compounds they contain.
  • Herbal remedies can interact with other medicines. This could result in the other medicines having reduced or enhanced effects, including side-effects. When consulting your doctor or pharmacist about your health always tell them about any herbal medicines you are taking.
  • As with all medicines, keep herbal medicines out of the sight and reach of children.


Are any particular groups at risk?

  • In many cases the safe use of herbal medicines has not been established in:
    • pregnant women
    • breastfeeding mothers
    • children
    • elderly.

  • Therefore caution should be taken about use of herbal medicine in pregnancy, when breast feeding or in children/elderly.
  • If you are due to have a surgical operation always remember to tell your doctor about any herbal medicines you are taking. Some herbal medicines could alter the effects of anaesthetics or other medicines during surgery.
  • Anyone with a history of liver complaints or any other serious health condition is advised not to take any herbal medicine without speaking to their doctor first.


Which herbal medicines have been assessed by the Regulator?

  • Look for PL or THR on the product labels. Herbal medicines licensed in the UK have a PL (product licence) number on the label.
  • Traditional herbal medicines registered in the UK have a THR (traditional herbal registration) number on the label. The first registered products under this new scheme are expected to reach the UK market in the coming months.
  • Both these kinds of medicines are regulated by the MHRA and meet assured standards.
  • Other herbal medicines on the UK market have not been assessed by the MHRA.


How can I tell if an unlicensed medicine is made to acceptable standards?

  • Consumers should be aware that unlicensed herbal medicine on the UK market have not been assessed by the MHRA as to their safety, quality or patient information.
  • There is evidence that standards vary considerably in the unlicensed sector. It is likely that some companies manufacture products to good standards. However, there is also evidence of poor or patchy standards in parts of the sector. Information about this is regularly published on the MHRA’s website in 'Herbal Safety News'. I
  • It is not generally possible for consumers to identify which unlicensed medicines are made to acceptable standards. However, there are a number of pointers, in particular from the product information, which may be indicative of poor or unreliable standards.


Advice for consumers when buying unlicensed herbal medicines

  • Treat with caution claims about safety that are not backed by credible evidence. Be wary of products making claims such as :
    • The herbal remedy is “100% safe”
    • Herbal remedies are “safe because they are natural”
    • This herbal medicine “has no side effects”
    • “Chinese medicines will not interfere with the effects of any western medicine”
    • You can avoid Chinese medicines interfering with other medicines if you take them an hour apart.

  • Be wary of any unlicensed medicine suggesting the consumer should stop taking, or change the dosage of, a prescribed medicine. The MHRA advise you not to follow such advice - you should always consult your doctor about making changes to your prescribed medication
  • Treat with caution any unlicensed herbal medicine that makes medicinal claims for the product (that is claims to prevent, treat or cure illnesses). These claims will not have been assessed by the MHRA and could be misleading
  • Be wary of any product if:
    • It is not labelled in English
    • It does not have information about safe usage
    • The herbal practitioner cannot or will not give a list of ingredients.

  • Apparently similar unlicensed herbal medicines may be accompanied by different patient information. Do not assume that the medicine with fewer warnings is necessarily safer to use.

Buying herbal medicines over the Internet

  • There is an international trade in poor quality unregulated herbal products. Unlicensed “herbal” products in the UK and elsewhere have been found containing banned pharmaceutical ingredients, heavy metals. Products may contain harmful herbs that are not permitted in the UK. Be aware that unlicensed herbal medicines manufactured outside the UK may not be subject to any form of effective regulation.
  • If a product refers to licences granted in other countries there may be no guarantees that the product actually complies with requirements or that standards applied in other counties match those that a UK consumer would expect from regulated products.


What to do if you think you have had an adverse reaction to your herbal medicine?

  • All medicines, including herbal medicines, may cause side effects or unwanted reactions.
  • If you think you have had a reaction to your herbal medicine, you should discontinue use and tell your doctor or pharmacist.
  • If you think you or someone else has had an unwanted or harmful reaction after taking a herbal medicine (commonly referred to as a suspected adverse drug reaction), we would like to know. This will help us give advice to other patients and healthcare professionals - and will help us make sure herbal medicines in the UK are safe.
  • You can report a reaction yourself directly to us using a system called the Yellow Card Scheme.
  • This can be done online or by filling out a paper yellow form which is available upon request by calling 020 7084 2000.
  • Alternatively, you can ask your doctor or pharmacist to report the reaction us on your behalf.
  • Any information received by us will be held in complete confidence and your personal details will not be given to anyone else without your permission.
Source: http://www.mhra.gov.uk

Monday, May 28, 2007

FDA attempting to regulate supplements, herbs and juices as "drugs"

When it comes to health freedom, this is the FDA's end game. A new FDA "guidance" document, published on the FDA's website, reveals plans to reclassify virtually all vitamins, supplements, herbs and even vegetable juices as FDA-regulated drugs. Massage oils and massage rocks will be classified as "medical devices" and require FDA approval. The document is called Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

The FDA is accepting public comments on the docket until April 30th. They tried to sneak this under the radar, but word got out and now the natural health community is up in arms over this rule. If you wish to protect your access to nutritional supplements, herbs, essential oils, homeopathic medicine or any other "complementary" or "alternative" modality, it is crucial that you take action to post your comments with the FDA right now and write your representatives in Washington to put a stop to this outrageous effort to destroy natural medicine. (And be sure to really write them. Just sending an email has virtually no impact compared to writing a physical letter in your own words.)

Click here for the direct link to the FDA's comment posting page for this docket.

This move by the FDA is designed to once and for all destroy the 1994 DSHEA law that has made supplements "legal" while eliminating nutritional supplements and natural medicine from the United States, ensuring monopoly profits and control by drug companies and the FDA. It is the latest action item by the FDA / Big Pharma conspiracy that will not stop until health freedom has been abolished, drug companies rule the nation, and every citizen is diagnosied with a fictitious disease and drugged up on monopoly-priced pharmaceuticals.

FDA "experts" will decide what's a drug or medical device

Under these proposed guidelines, FDA "experts" (the same corrupt officials who reapproved Vioxx after it killed over 50,000 Americans) will decide whether herbs, supplements, vitamins or simple devices like massage stones are to be regulated as drugs and medical devices. If the FDA experts, in their infinite wisdom, decide that these things are to be reclassified, they will essentially be outlawed, stripped from the shelves, and regulated out of existence. Anyone who dares to manufacture, promote or sell such products may be branded a criminal and rounded up by armed FDA agents who have a well established history of suppressing natural medicine.

I've documented much of the criminal history of the FDA in my recent book, Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them, which suddenly seems even more relevant today than when I wrote it. In that book, I documented the FDA ordered book burnings, the raids on vitamin shops, the kidnapping of natural health practitioners, the threats, intimidation and oppression tactics that have been used to suppress natural medicine for nearly a hundred years now. And now, with this CAM Products Regulation effort, the FDA is about to deal a final, fatal blow to the alternative medicine industry, outlawing nutritional supplements, functional foods, homeopathy and natural therapies all at once.

This is not a drill. It really is time to be alarmed. Nothing else I've written about this year is as important as this sinister plot to destroy natural medicine and force the American population to resort to dangerous prescription medications sold at monopoly prices under a system of medical tyranny.

Your access to vitamins, supplements, herbs, and even energy medicine modalities is now directly threatened, and you have until April 30 to make your voice heard.

Action items

First, read the document yourself. Click here for the PDF version.

Take special care to notice the following text, taken directly from the FDA's own document: (italicized text is from the FDA, with my own translation following)

"...a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the act or the PHS Act. Second, neither the act nor the PHS Act exempts CAM products from regulation."

Translation: Anything used in any system of medicine may now be regulated as a drug or medical device by the FDA. This includes a biofeedback machine, acupuncture needles, a cup of herbal tea, massage oil, a glass of vegetable juice or even a bottle of water.

"...if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health... [and] if the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act."

Translation: Raw vegetable juice will be regulated as a drug and must be FDA approved as a drug if it has any health effect whatsoever. Handing a cup of raw vegetable juice to someone and telling them it's good for the detoxification of their liver will get you arrested for practicing medicine without a license and promoting an "unapproved drug."

..."biologically based practices" includes, but is not limited to, botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, proteins, prebiotics and probiotics: whole diets, and "functional foods". ...a botanical product intended for use in treating a disease would generally be regulated as a drug." ..."functional foods" may be subject to FDA regulation as foods, dietary supplements, or drugs under the Act.

Translation: All foods, supplements, superfoods and functional foods may be reclassified as drugs by the FDA, then regulated off the market.

If... the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act."

Translation: Massage oils and creams will be regulated as "drugs" and acupuncture needles as "medical devices." Taking this absurdity one step further, massage therapists who use their fingers to touch patients may have their fingers regulated as "medical devices" and be accused of practicing medicine for merely touching patients.

Things that will be regulated out of existence

It is very clear that the FDA is intending to regulate and ultimately destroy the entire CAM industry (Complementary and Alternative Medicine). Based on the explanations in the FDA's own document, the following things are likely to occur:

  • All vitamins, nutritional supplements and functional foods will be stripped of their structure & function claims, reducing them to empty labels where virtually nothing at all is allowed to be stated.

  • Vegetable juice will be regulated as a drug. Raw juice retreats will be raided or shut down.

  • Growing and selling common garden herbs will get you arrested as a drug dealer.

  • Massage oils and handheld massagers will be regulated as "medical devices."
  • Yoga props, pilates machines and weight machines will be regulated as "medical devices" and require FDA approval before being sold or used.

  • Raw sprouts and other anti-cancer foods will be regulated as drugs.

  • Bottled water that "treats" dehydration will be regulated as a drug.

  • Massage therapists who use hot rocks as part of their therapy will have the ROCKS regulated as medical devices! (It's true. The FDA will actually look at a pile of rocks and declare, "Those are medical devices!")

  • Functional foods, supplements, vitamins and homeopathic remedies will disappear from store shelves, pending FDA "review." (The only things remaining will be processed junk foods and pharmaceuticals, which is exactly what Big Business wants.)

  • Therapeutic tea products, such as green tea, will be outlawed and confiscated.

  • Vitamin store owners will be arrested and prosecuted for "practicing medicine without a license."

  • Citizens owning personal inventories of "unapproved drugs" (vitamins and herbs) may have their homes raided at gunpoint and their inventories confiscated by armed law enforcement agents.

  • The importation of herbs and functional foods from all countries may be banned.


Keep in mind that the FDA is the same agency that:

  • Wants to label irradiated foods as "pasteurized."

  • Voted to put the deadly drug Vioxx back on the market after tens of thousands of deaths, even after its own manufacurer pulled it from pharmacies.

  • Raided a church at gunpoint, confiscating biofeedback machines and charging that they were "practicing medicine" by counseling church members on issues like depression.

  • Openly allows corrupt, "on the take" experts to vote on new drug approvals, even when those experts are taking money from the same companies impacted by their votes.

  • Refuses to legalize stevia, the safe, natural herbal sweetener that's used virtually everywhere else in the world. The agenda? Protect the profits of aspartame and other chemical sweeteners.

  • Openly allows the mass poisoning of the public with cancer-causing food additives such as sodium nitrite.

  • Refuses to enforce its own laws regarding unsafe chemical toxins in personal care products, allowing perfume and lotion companies to continue poisoning the public with cancer-causing chemicals that don't even have to be listed on the label, nor proven safe.

  • Ordered the destruction of recipe books that mentioned stevia. (A campaign to keep the public ignorant of the herb.)

  • Does everything in its power to protect drug company profits, including discrediting herbs, supplements and alternative medicine.


Does anyone honestly believe that this criminal organization has any capacity whatsoever to act in the public interest? Even many Senators are fed up with the FDA's unprecedented level of corruption and criminal behavior.

Action items, continued...

Read Jon Barron's comments on this rule at the JonBarron.org website

Next, lodge your complaint against the FDA by commenting on this docket through the FDA's docket comment form.

And finally, write your Senator or Congressperson about this issue and let them know, in blatant language, that you will not stand by and allow the criminals running medicine today to take away your access to vitamins, supplements, herbs and homeopathic medicine. Write the letter in your own words, even if it's just two sentences. Individual letters have a hundred times the impact of form letters.

Medical wasteland USA

Everything is at stake here. If the FDA gets its way, the United States will become a medical wasteland, dominated by corporate drug company interests, where the naturopaths are imprisoned and their products destroyed. Supplements and herbs will become contraband, and gardeners who grow their own medicinal herbs may be raided and arrested by DEA agents wielding assault rifles. Simply selling dried broccoli sprouts as being "good anti-cancer foods" may land you in prison, and running a vitamin shop could result in you being arrested for "practicing medicine."

Imagine a nation where Whole Foods stores are stripped of all herbs and supplements, where vitamin shops are emptied and abandoned, where books that promote herbs are bulldozed into large piles and burned, where natural healers are rounded up and "disappeared" into incarceration centers. This is the future that will become reality if the FDA has its way. The plan has been explained to us in plain language. Any agency that openly states "vegetable juice will be regulated as a drug" has quite simply lost its marbles. We're are now clearly being regulated by clinically insane bureaucrats.

With this desperate proposal by the FDA -- clearly designed as a last-ditch effort to save the failing conventional medical industry from a massive public shift towards natural medicine -- the war against health freedom has reached our shores, and the FDA is plotting a 9/11-style attack to bring down the towers of health freedom in one swift motion.

This is the same agency that currently represents the greatest threat to the health and safety of the American people, far outweighing the threat of real terrorism. This agency, we have seen, will do ANYTHING to protect the profits and power of drug companies. It will lie, steal, accept bribes, hide scientific evidence, distort statistics, commit scientific fraud, break federal laws, threaten its own drug safety scientists, conspire with drug company executives, intimidate American citizens and use terror-style tactics to achieve its goals of complete domination over foods, drugs and health.

Why do Americans tolerate terrorism in their own government?

It is time we put a stop to this home-grown tyranny. We have fought too hard for freedom in the United States to allow us all to be steamrolled by a criminal front group covertly working for Big Pharma. The FDA has declared war on natural medicine and the American people, and we will lose our family members, children, brothers and sisters as casualties of this war if we don't stand up now and demand radical changes. It's time to stop this terrorist organization from destroying the lives of yet more U.S. citizens.

Make your voice heard now, or forever surrender your access to supplements, herbs, superfoods and functional foods. By the time the FDA is done with this country, we'll all be eating medication for breakfast, lunch and dinner.

Action reminders:

1. Lodge a complaint with the FDA by clicking here. MAKE SURE you include the docket number 2006D-0480. But don't trust this to be enough. The FDA will probably simply delete half the complaints it receives, so don't trust your complaint to actually count. It's important to continue...

2. Send a strongly-worded letter to your representatives in Washington. Be sure to cite Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Tell them you support open access to vitamins, herbs, and supplements, and you do not want CAM to be regulated by the FDA.

3. Send this story to everyone you know. Spread the word. Raise the alarm. With enough public support, the FDA will be forced to back off this insane proposal.

And stay tuned to NewsTarget for more news, analysis and action alerts on health freedom. Even though we're under constant attack by criminal organizations trying to disrupt our servers and take us off line, we're still here, beating the drum for health freedom, and hoping that we have enough sane-minded Americans remaining to save this country from its government.

Actual FDA quote is gobbledygook

Here's an actual FDA statement from the CAM Guidance report:

For example, naturopathic cranberry tablets might be labeled for use to maintain the health of the urinary tract. In this example, the cranberry tablets generally would be regulated as "dietary supplements" ...if they were labeled for use to "maintain the health of the urinary tract" rather than "prevent urinary tract infections." The cranberry tablets would be regulated as "drugs" ...if they were labeled for use to "treat urinary tract infections" even if they were labeled as dietary supplements.

Additional phone numbers as listed in the FDA document

Sheryl Lard-Whiteford at 301-827-0379
Daniel Nguyen at 301-827-8971
Ted Stevens at 301-594-1184
Wayne Amchin at 301-827-6739

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About the author: Mike Adams is a consumer health advocate with a strong interest in personal health, the environment and the power of nature to help us all heal He is a prolific writer and has published thousands of articles, interviews, reports and consumer guides, reaching millions of readers with information that is saving lives and improving personal health around the world. Adams is an independent journalist with strong ethics who does not get paid to write articles about any product or company. In 2007, Adams launched EcoLEDs, a manufacturer of mercury-free, energy-efficient LED lighting products that save electricity and help prevent global warming. He also launched an online retailer of environmentally-friendly products (BetterLifeGoods.com) and uses a portion of its profits to help fund non-profit endeavors. He's also a noted technology pioneer and founded a software company in 1993 that developed the HTML email newsletter software currently powering the NewsTarget subscriptions. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501(c)3 non-profit organization, and pursues hobbies such as Pilates, Capoeira, nature macrophotography and organic gardening. He's also author of numerous health books published by Truth Publishing and is the creator of several consumer-oriented grassroots campaigns, including the Spam. Don't Buy It! campaign, and the free downloadable Honest Food Guide. He also created the free reference sites HerbReference.com and HealingFoodReference.com. Adams believes in free speech, free access to nutritional supplements and the ending of corporate control over medicines, genes and seeds.

Source: http://www.newstarget.com/021789.html

Natural Herbs & Vitamins During Pregnancy

Although medicine has replaced most natural supplements with a synthetic substitute, there are many who still look to natural herbs and vitamins to provide essential nutrition to pregnant women as well as aid in the relief of some common discomforts.


Many herbalists believe that herbs are often better, cheaper, and healthier than their medical counterparts. However, many medical professionals do not recommend herbal remedies for pregnant women, since safety has not been established through extensive research.


Unlike prescription drugs, natural herbs and vitamin supplements do not go through the same scrutiny and evaluation process by the FDA. As a result, the quality and strength of an herbal supplement can vary between two batches of the same product and between products from different manufacturers. Consumers have little way of knowing if a product will do what the label claims and how safe the product may be. Reliable information about the product may be hard to find, which makes researching these products’ effectiveness more challenging.

What are the risks of using natural herbs during pregnancy?

Although herbs are natural, not all herbs are safe to take during pregnancy. The FDA urges pregnant women not to take any herbal products without talking to their midwife or doctor first. Women are also urged to consult a trained and experienced herbalist (or other professional who is trained to work with herbs) if they want to take herbs during their pregnancy. Some herbal products may contain agents that are contraindicated in pregnancy.


Herbs may contain substances that can cause miscarriage, premature birth, uterine contractions, or injury to the fetus. Few studies have been done to measure the effects of various herbs on pregnant women or a developing fetus.

What are some herbs I should be cautious about during my pregnancy?

Depending on the source, some information will list an herb as safe to consume during pregnancy, whereas another source may list the same herb as unsafe. Therefore, it is best to consult with your health care provider or someone trained in using herbs before taking any natural medicine or herb during pregnancy.


Some organizations that specialize in herbs have done extensive testing on their safety. Often these organizations will list herbs with their safety ratings for the general population and also safety during pregnancy and lactation. These ratings can often be confusing and hard to interpret; this is why speaking with a professional who is familiar with using herbs during pregnancy is recommended. One key thing when understanding the safety ratings is to pay attention to what type of use the rating is for.

For example, the rating for Rosemary is considered Likely Safe ...when used orally in amounts typically found in foods. (Rosemary has a Generally Recognized as Safe (GRAS) status in the US.) But in pregnancy, Rosemary is considered Possibly UnSafe ...when used orally in medicinal amounts. Rosemary might have uterine and menstrual flow stimulant effects; avoid using. There is insufficient reliable information available about the safety of the topical use of rosemary during pregnancy.1


This is a prime example of how the method of use of the herb changes its safety rating. We know that rosemary sprinkled in your tomato sauce is not a risk to you and your baby. If you were to use Rosemary in a large dose, like that used in medicinal amounts, it could be dangerous for your pregnancy. The same goes for herbs such as Garlic, Sage, Ginger and Tumeric. All of these herbs could be contraindicated in pregnancy when used in large or concentrated doses, but are considered safe when used in amounts found in food. 2

Herbs to Avoid during Pregnancy


The following herbs are considered Likely UnSafe or Unsafe during pregnancy : 3


  • Saw Palmetto - when used orally; has hormonal activity
  • Goldenseal - when used orally may cross the placenta
  • Dong Quai - when used orally due to uterine stimulant and relaxant effects
  • Ephedra - when used orally
  • Yohimbe - when used orally
  • Pay D’ Arco - when used orally in large doses; contraindicated
  • Passion Flower - when used orally
  • Black Cohosh - when used orally in pregnant women who are not at term
  • Blue Cohosh - when used orally; uterine stimulant and can induce labor
  • Roman Chamomile - when used orally in medicinal amounts
  • Pennyroyal - when used orally or topically

Are there any herbs that are Recommended in pregnancy?


Depending on what type of health care provider you see, they may recommend using herbs to help promote the health of your pregnancy. Remember, never try to self dose or diagnose with any medications, including herbs. Because each pregnancy is different, with its own specific details, the best way to use herbs is under the care of a midwife, physician, herbalist, naturopathic or homeopathic doctor.


Choosing to use herbs during pregnancy is a personal choice, but to ensure the best outcome for you and your baby, you should be well educated on the types of herbs, parts of the herb (root, leaf, etc…) and the way that it could be used (caplet, tonic, tea). The herbs that are considered safe to use during pregnancy are often food or tonic herbs. These often will be found in either tablet form, tea, or infusion form.

Herbs used in Pregnancy


The following herbs have been rated Likely Safe or Possibly Safe for use during pregnancy:4

  • Red Raspberry Leaf - Rich in iron, this herb has helped tone the uterus, increase milk production, decrease nausea, and ease labor pains. Some studies have even reported that using red raspberry leaf during pregnancy can reduce complications and the use of interventions during birth.5 You may see “Pregnancy Teas” that are made from Red Raspberry leaf to help promote uterine health during pregnancy. (Read about Herbal teas for more information)
    • There is some controversy about whether this should be used throughout pregnancy or just in the second and third trimester, so many health care providers will remain cautious and only recommend using it after the first trimester.
  • Peppermint Leaf - Helpful in relieving nausea/morning sickness and flatulence
  • Ginger root - Helps relieve nausea and vomiting
  • Slippery Elm Bark - (when the inner bark is used orally in amounts used in foods) Used to help relieve nausea, heartburn, and vaginal irritations
  • Oats & Oat Straw - Rich in calcium and magnesium; helps relieve anxiety, restlessness, and irritated skin

Additional Herbs rated Likely Safe or Possibly Safe:
  • Blond Psyllium - when used orally and appropriately
  • Black Psyllium - when used orally with appropriate fluid intake
  • Garlic - when used orally in amounts commonly found in foods
  • Capsicum (Cayenne, hot pepper) - when used topically and appropriately

The following herbs have been rated as having Insufficient Reliable Information Available by the Natural Medicines Database, although many are recommended by homeopathic physicians, herbalists, and midwives who treat pregnant women. More extensive research and discussions with your treating health care provider will help you make the decision about what herbs are safe for you to use.

  • Dandelion - Rich in Vitamin A, calcium, and iron; dandelion root and leaf can also help relieve mild edema and nourish the liver
  • Chamomile (German) - High in calcium and magnesium; also helps with sleeplessness and inflammation of joints
  • Nettles (Stinging Nettles) - High in vitamins A, C, K , calcium, potassium, and iron. Used in many “Pregnancy teas” because it is a great all around pregnancy tonic. Note on the safety of Nettles: Natural Medicines Database gives Nettles a rating of Likely Unsafe, even though it is used in countless pregnancy teas and recommended by most midwives and herbalists. This may be in relation to which part of the Nettles plant is used (the root or the leaves) and how much is used. According to other sources, the use of Nettles is encouraged during pregnancy because of all its health benefits.6

Other Popular Herbs that are used


The following are commonly used herbs which have a safety rating of Possibly Unsafe when used orally. Again, these are herbs you would want to do more extensive research on and discuss with your health care provider before using.

  • Aloe
  • Ginseng (American & Korean)
  • Evening Primrose
  • Feverfew
  • Kava Kava
  • Senna

Your Next Steps:

Source: http://www.americanpregnancy.org/pregnancyhealth/naturalherbsvitamins.html

WHO traditional medicine strategy

The main objectives of the WHO Traditional medicine activities are:

  • To facilitate integration of traditional medicine into the national health care system by assisting Member States to develop their own national policies on traditional medicine.
  • To promote the proper use of traditional medicine by developing and providing international standards, technical guidelines and methodologies.
  • To act as a clearing-house to facilitate information exchange in the field of traditional medicine.

The objective of the strategy is to discuss the role of traditional medicine in health care systems, current challenges and opportunities and WHO's role and strategy for traditional medicine. Many Member States and many of WHO's partners in traditional medicine (UN agencies, international organizations, nongovernmental organizations, and global and national professional associations) contributed to the Strategy and have expressed their willingness to participate in its implementation. The Strategy was reviewed by the WHO Cabinet in July 2001 and, based on Cabinet comments, has since been revised. The Strategy was printed in January 2002. Since this is at present a working document, the proposed objectives and activities have started to be implemented in early 2002 and the Strategy will be widely disseminated. We understand that the situation in the use of traditional medicine is quite different from country to country and region to region. For example, in AFRO and in WPRO, the Member States consider that traditional medicine is a priority for health care in their regions, but in other regions the role of traditional medicine is treated as complementary or alternative medicine.

For more information contact:

Dr Xiaorui Zhang
Traditional Medicine, Essential Drugs and Medicines Policy (EDM)
WHO/Geneva
Fax: +41 22 791 4730
E-mail: trm@who.int


Source: http://www.who.int/medicines/publications/traditionalpolicy/en/index.html

How safe is traditional medicine?

Q: How safe is traditional medicine?

A: Traditional medicine includes many different practices and remedies, and varies from one country to another. While some practices seem to offer benefits, others remain questionable.

In 2002, WHO launched a strategy on traditional medicine to help countries explore its potential for people’s health and well-being, while minimizing the risks of unproven or misused remedies. The main aim of the strategy is to encourage further research.

There is some evidence that seems to support the use of traditional and complementary medicine – for example, acupuncture in relieving pain, yoga to reduce asthma attacks, and tai ji techniques to help elderly people reduce their fear of falls. WHO does not currently recommend these practices, but is working with countries to promote an evidence-based approach to addressing safety, efficacy and quality issues.

Unfortunately, the misuse of certain herbal remedies can cause harm – even death – in some cases. The herb Ma Huang (ephedra) is traditionally used in China to treat short-term respiratory congestion. In the United States of America, the herb was marketed as a dietary aid, whose long-term use led to at least a dozen deaths, heart attacks and strokes. In Belgium, at least 70 people required renal transplants or dialysis for interstitial fibrosis of the kidney after taking the wrong herb from the Aristolochiaceae family, again as a dietary aid.

In developing countries, where more than one-third of the population lack access to essential medicines, the provision of safe and effective traditional and alternative remedies could become a important way of increasing access to health care. One way to ensure this is to integrate traditional medicine into the formal health system, thus ensuring better safety and adequate follow-up for patients.

Traditional medicine is also becoming more popular in industrialized countries, where many products can be bought over the counter.

In addition to concerns over safety and quality issues, traditional medicine also raises questions of protecting biodiversity (through over harvesting of the raw material for herbal medicines and other products), and protecting the traditional knowledge of communities.


source: http://www.who.int/features/qa/20/en/index.html

What does WHO say about nature/natural herbal medicine?

WHO (World Health Organization) has a research about nature medicine. It's called Collaborating Center for Traditional Medicine. We can see what WHO says below:

Traditional medicine

What is traditional medicine?

Traditional medicine refers to health practices, approaches, knowledge and beliefs incorporating plant, animal and mineral based medicines, spiritual therapies, manual techniques and exercises, applied singularly or in combination to treat, diagnose and prevent illnesses or maintain well-being.

Countries in Africa, Asia and Latin America use traditional medicine (TM) to help meet some of their primary health care needs. In Africa, up to 80% of the population uses traditional medicine for primary health care. In industralized countries, adaptations of traditional medicine are termed “Complementary“ or “Alternative” (CAM).

Increasing use and popularity

TM has maintained its popularity in all regions of the developing world and its use is rapidly spreading in industrialized countries.

  • In China, traditional herbal preparations account for 30%-50% of the total medicinal consumption.
  • In Ghana, Mali, Nigeria and Zambia, the first line of treatment for 60% of children with high fever resulting from malaria is the use of herbal medicines at home.
  • WHO estimates that in several African countries traditional birth attendants assist in the majority of births.
  • In Europe, North America and other industrialized regions, over 50% of the population have used complementary or alternative medicine at least once.
  • In San Francisco, London and South Africa, 75% of people living with HIV/AIDS use TM/CAM.
  • 70% of the population in Canada have used complementary medicine at least once.
  • In Germany, 90% of the population have used a natural remedy at some point in their life. Between 1995 and 2000, the number of doctors who had undergone special training in natural remedy medicine had almost doubled to 10 800.
  • In the United States, 158 million of the adult population use complementary medicines and according to the USA Commission for Alternative and Complementary medicines, US $17 billion was spent on traditional remedies in 2000.
  • In the United Kingdom, annual expenditure on alternative medicine is US$ 230 million.
  • The global market for herbal medicines currently stands at over US $ 60 billion annually and is growing steadily.

Safety and efficacy issues

Scientific evidence from randomized clinical trials is only strong for many uses of acupuncture, some herbal medicines and for some of the manual therapies. Further research is needed to ascertain the efficacy and safety of several other practices and medicinal plants.

Unregulated or inappropriate use of traditional medicines and practices can have negative or dangerous effects.

For instance, the herb “Ma Huang” (Ephedra) is traditionally used in China to treat respiratory congestion. In the United States, the herb was marketed as a dietary aid, whose over dosage led to at least a dozen deaths, heart attacks and strokes.

In Belgium, at least 70 people required renal transplant or dialysis for interstitial fibrosis of the kidney after taking a herbal preparation made from the wrong species of plant as slimming treatment.

Biodiversity and sustainability

In addition to patient safety issues, there is the risk that a growing herbal market and its great commercial benefit might pose a threat to biodiversity through the over harvesting of the raw material for herbal medicines and other natural health care products. These practices, if not controlled, may lead to the extinction of endangered species and the destruction of natural habitats and resources.

Another related issue is that at present, the requirements for protection provided under international standards for patent law and by most national conventional patent laws are inadequate to protect traditional knowledge and biodiversity.

Tried and tested methods and products

  • 25% of modern medicines are made from plants first used traditionally.
  • Acupuncture has been proven effective in relieving postoperative pain, nausea during pregnancy, nausea and vomiting resulting from chemotherapy, and dental pain with extremely low side effects. It can also alleviate anxiety, panic disorders and insomnia.
  • Yoga can reduce asthma attacks while Tai Ji techniques can help the elderly reduce their fear of falls.
  • TM can also have impact on infectious diseases. For example, the Chinese herbal remedy Artemisia annua, used in China for almost 2000 years has been found to be effective against resistant malaria and could create a breakthrough in preventing almost one million deaths annually, most of them children, from severe malaria.
  • In South Africa, the Medical Research Council is conducting studies on the efficacy of the plant Sutherlandia Microphylla in treating AIDS patients. Traditionally used as a tonic, this plant may increase energy, appetite and body mass in people living with HIV.

WHO efforts in promoting safe, effective and affordable traditional medicine

The World Health Organization launched its first ever comprehensive traditional medicine strategy in 2002. The strategy is designed to assist countries to:

  • Develop national policies on the evaluation and regulation of TM/CAM practices;
  • Create a stronger evidence base on the safety, efficacy and quality of the TAM/CAM products and practices;
  • Ensure availability and affordability of TM/CAM including essential herbal medicines;
  • Promote therapeutically sound use of TM/CAM by providers and consumers;
  • Document traditional medicines and remedies.

At present, WHO is supporting clinical studies on antimalarials in three African countries; the studies are revealing good potential for herbal antimalarials.

Other collaboration is taking place with Burkina Faso, the Democratic Republic of the Congo, Ghana, Mali, Nigeria, Kenya, Uganda, and Zimbabwe in the research and evaluation of herbal treatments for HIV/ AIDS, malaria, sickle cell anaemia and Diabetes Mellitus.

In Tanzania, WHO, in collaboration with China, is providing technical support to the government for the production of antimalarials derived from the Chinese herb Artemisia annua. Local production of the medicine will bring the price of one dose down from US $6 or $7 to a more affordable $2.

In 2003, WHO support has so far facilitated the development and introduction of traditional and alternative health care curricula in seven tertiary education institutions in the Philippines.

Training workshops on the use of traditional medicines for selected diseases and disorders have also been organized in China, Mongolia and Vietnam.

Priorities for promoting the use of traditional medicines

Over one-third of the population in developing countries lack access to essential medicines. The provision of safe and effective TM/CAM therapies could become a critical tool to increase access to health care.

While China, the Democratic People’s Republic of Korea, the Republic of Korea and Vietnam have fully integrated traditional medicine into their health care systems, many countries are yet to collect and integrate standardized evidence on this type of health care.

70 countries have a national regulation on herbal medicines but the legislative control of medicinal plants has not evolved around a structured model. This is because medicinal products or herbs are defined differently in different countries and diverse approaches have been adopted with regard to licensing, dispensing, manufacturing and trading.

The limited scientific evidence about TM/CAM’s safety and efficacy as well as other considerations make it important for governments to:

  • Formulate national policy and regulation for the proper use of TM/CAM and its integration into national health care systems in line with the provisions of the WHO strategies on Traditional Medicines;
  • Establish regulatory mechanisms to control the safety and quality of products and of TM/CAM practice;
  • Create awareness about safe and effective TM/CAM therapies among the public and consumers;
  • Cultivate and conserve medicinal plants to ensure their sustainable use.

For more information contact:

Ms Daniela Bagozzi
Telephone: +41 22 791 4544
Mobile phone: +41 79 475 5490
E-mail: bagozzid@who.int

WHO Media centre
Telephone: +41 22 791 2222
E-mail: mediainquiries@who.int

Source: http://www.who.int/mediacentre/factsheets/fs134/en/

Sunday, May 27, 2007

A lifestyle

Oh, Your Aching Back!

By Bill Gottlieb

Peter Gulke, a screenwriter from Hollywood, was a guy who really used—and abused—his back. In high school and college he competed as a gymnast. After graduation, he picked up cliff diving and surfing. But it wasn’t the sports that did him in, at least not directly. One day in his late twenties, while raking the lawn, he reached for some leaves and felt an ominous twinge in his lower back. In that swift moment, he became one of the millions of people in this country who suffer from lower back pain.

He had to stop surfing, then jogging, then golfing. The pain would plague him for a few weeks, go away, then come back again. He tried chiropractic, acupuncture, herbs, muscle-relaxing drugs, mind-body techniques. Everything helped a little, but not for long.

Gulke’s story is so typical as to be almost a cliché. No doubt you’ve heard the statistics. Eighty percent of Americans will suffer a bout of debilitating back pain at some point in their lives, with a full 80 percent having one or more recurrences. Back pain sends more people to the doctor than any other illness except colds. For Americans between the ages of 30 and 50, medical costs to treat back pain are higher than they are for any other health problem.

And how is that money spent? On thousands of operations—even though some studies show that four years after back surgery, patients fared no better than those who hadn’t gone under the knife— and on millions of prescription drugs, like anti-inflammatories and narcotics, that only temporarily ease pain. Of course, some of the alternative remedies that didn’t help Gulke, like acupuncture and chiropractic, do have good track records. But the moral of the back story seems to be that no single treatment works for all people all the time.

That’s why alternative and conventional healers alike have been hard at work seeking new solutions. Some are based on a new understanding of how the back works and why it starts hurting; others involve new approaches to pain relief. The following treatments are three of the most promising to gain credibility in recent years.

Exercises
to stabilize your spine
Until two years ago, Anne-Marie Howard*, a 32-year-old laboratory technician in Halifax, Nova Scotia, considered herself lucky. She had spondylolisthesis, a congenital condition in which the front half of a vertebra separates from the back half, but she never experienced any pain.

Then her luck changed. By the time she walked into the office of Rick Jemmett, a physical therapist in Halifax and author of Spinal Stabilization: The New Science of Back Pain, she hurt every day. At work she spent most of her time standing. By noon she was usually in pain. By quitting time, she was in agony.

Jemmett didn’t give Howard the standard exercises prescribed by most physical therapists. Instead, he instructed her in highly specific but subtle move- ments involving the transversus abdominis muscle of her abdomen and the multifidus muscles of her lower back; he calls these “spinal stabilization” exercises. After two weeks of daily practice, Howard’s symptoms improved. After a month, she was pain free—and remains so, as long as she sticks with her exercise program.

Spinal stabilization is the first regimen to show an actual decrease in recurrence rates among sufferers of back pain, according to a study published recently in the journal Spine. The study compared a group of back patients whose treatment consisted of counseling and medication with a second group who received instruction in spinal stabilization.

After one year, 80 percent of the people receiving conventional methods had a recurrence of back pain compared to 30 percent of the spinal stablization group. After three years, the recurrence rate was 75 percent among the conventional group and 35 percent among the group taught the spine-stabilizing exercises.

What’s the secret to this unusual approach? Nothing less than a new understanding of what causes a back to start hurting in the first place. Traditionally, experts thought that strained ligaments and degenerating disks were the main problem, so they prescribed exercises to strengthen the muscles supporting those structures, which are the big muscles close to the skin.

But in 1992, Manohar Panjabi, professor and director of the biomechanics laboratory of the department of orthopedics and rehabilitation at Yale University School of Medicine, challenged this notion.

Based on research with cadavers, he concluded that the spinal column alone isn’t strong enough to support the body’s weight. Other researchers later demonstrated that most of the back’s stabilizing force is, in fact, provided by the small, deep muscles of the lower back and abdomen—the multifidus and the transversus abdominis.

Since then, experts have built on Panjabi’s research and discovered that regardless of the cause of spinal damage—whether it’s trauma, arthritis, or congenital problems like Howard’s—the underlying effect is the same. The signals between the central nervous system and these deep stabilizing muscles become impaired. As a result, it takes longer for the nervous system to activate the muscles, and at times it may do so in the wrong order.

Researchers have also found that the multifidus muscles tend to atrophy after an injury; believe it or not, they can shrink by as much as 25 percent within 24 hours of a back injury—and stay that way for years. Once these small muscles are damaged, the central nervous system compensates by relying on the larger ones to stabilize the spine. But they don’t quite get the job done, so back pain recurs.

The only way to really cure back pain, according to this theory, is to help the central nervous system regain control of the transversus abdominus and multifidus muscles. That’s where the spinal stabilization program—originally created by Carolyn Richardson of the University of Queensland in Brisbane, Australia—comes in. When a patient learns to control the small stabilizing muscles, he or she can then proceed to the standard strengthening exercises taught by most physical therapists.

Unfortunately, the techniques to stimulate the muscles are difficult to learn by yourself, says Jemmett, and they’re not yet well known by many physical therapists. You can get a general list of therapists in your area from the American Physical Therapy Association at 800.999.2782; check with those on the list to see if any have been trained in spinal stabilization.

Supplements
to nourish your disks
What baby boomer hasn’t heard of glucosamine and chondroitin, the wonder-workers for aging knees? But did you know that these popular supplements, which nourish and rebuild cartilage, can also help with a certain kind of back pain? Many back sufferers have the same kind of osteoarthritis that people more commonly associate with knees and hands, only this time it’s in their disks. (Cartilage is the main material of the spongy disks that cushion the vertebrae.)

“When the disks are damaged, either by injury or the wear and tear of age, they lose their ability to hold water and absorb shock,” says Luke Bucci, a clinical nutritionist and adjunct faculty member in the department of nutrition at the University of Utah and author of Healing Arthritis the Natural Way.

To compensate, vertebrae grow new bone, which rubs against pain receptors, squeezes nerves, and can make life close to unbearable for some sufferers. The key to treating this condition, also known as degenerative joint disease, is to rebuild the cartilage of a damaged disk. That’s where glucosamine and chondroitin can help.

Many studies show that these supplements relieve arthritis, but one in particular looked at their power to ease back pain. Reporting in the journal Military Medicine, scientists gave 1,500 milligrams (mg) of glucosamine and 1,200 mg of chondroitin to Navy SEALs with low back pain; another group got a placebo, or fake pill. Those who took the two-nutrient combination had a 41 percent reduction in the level of back pain; the placebo group had a 19 percent reduction. The dose they got is considered standard. But you could safely take two to three times that amount for faster relief, Bucci says.

“You should get substantial pain relief in a week or two, and then you can start the more standard dosage,” he says. He also recommends looking for a product that contains both substances in a single supplement and taking it once a day rather than in divided doses. “You need to get blood levels of the substances to the highest possible level, so they get into the disk,” he says.

Natural Injections
to rebuild ligaments
“The fact that modern medicine attempts to relieve back pain by reducing inflammation is absolutely wrong.” That’s the strongly held opinion—which might strike some as rather inflammatory itself—of Marc Darrow, an assistant clinical professor at the University of California at Los Angeles School of Medicine and director of the Joint Rehabilitation and Sports Medical Center, also in Los Angeles.

“Anti-inflammatories are antihealing,” he says. When the body is injured, he explains, the injury triggers an immune response, starting with inflammation, which sends white blood cells to the site to clean up the damage. Other cells called fibroblasts also travel to the affected area, where they help create new collagen, the connective tissue necessary for healing. The standard anti-inflammatory medications—like aspirin, ibuprofen, and Celebrex—interrupt this process.

“When inflammation is reduced, a person does get temporary pain relief. But because healing is blocked, the person can end up with a long-term injury that causes chronic pain,” Darrow says. “True healing of back pain means working with inflammation, not against it.”

He and several hundred other physicians in the United States today are working with a technique, called prolotherapy, that follows this rationale. The “prolo” in prolotherapy is short for proliferation, because the idea is to use the inflammation to produce collagen and strengthen ligaments in areas where they have become weak.

In a typical treatment, says Darrow, whose clinic specializes in prolotherapy, the therapist first numbs the sore area with lidocaine. He or she then injects it with a dextrose solution. (Some prolotherapists use other solutions, such as sodium morrhuate, a cod liver oil extract.) The dextrose draws water from the cells, damaging a small layer in the area.

This sparks an inflammatory response at the site, calling in fibroblasts, which produce collagen to strengthen the ligaments. Studies show that after eight sessions of prolotherapy, ligaments are 50 percent thicker and two to four times stronger. These stronger ligaments stabilize the spine, reducing or even eliminating back pain.

Prolotherapy may also have a neurological effect, says Jeff Patterson, an osteopath and professor in the department of family medicine at the University of Wisconsin Medical School in Madison. He thinks the injections may quiet pain by altering nerve function in the area. In this respect, the technique is similar to a widely accepted approach to pain relief called trigger point therapy, in which a therapist uses finger pressure to release knots of tension and constricted nerves.

Studies show that on average, 90 percent of prolotherapy patients with back pain get significant relief, Darrow says. Prolotherapy may briefly make the pain worse before it gets better, since it’s creating more inflammation. But according to Darrow, it’s gentler than surgery and many of the pharmaceuticals commonly used in treating back pain.

Some orthopedic surgeons aren’t convinced. They say prolotherapy works by creating scar tissue, not inflammation, and that the results are only temporary. But Darrow disagrees. “A study of post-prolotherapy tissue of a spinal ligament shows fresh layers of collagen and no scar tissue,” he says.

Usually a prolotherapy session consists of four to six injections, with one to two weeks between sessions to allow time for the growth of new tissue. Some patients may need more treatments. Costs range from $100 to $500 a visit. If prolotherapy is billed as trigger point therapy, insurance may cover it, and worker’s compensation will usually pay if it’s a work-related accident.

For Peter Gulke, the money was well spent. “I can surf again,” he says. “I can play golf again. Prolotherapy makes more sense than any other therapy I’ve had. I feel like I have a new back.”

How to Get Over a Back Injury:
Don’t be afraid to move

If you hurt your back and you’re not getting any better, your back may not be the problem: It could be your psyche.

That’s the conclusion of a recent study in the medical journal Pain. Surprisingly, researchers found that the best predictor of whether a person returns to work within one month of a back injury is whether or not the person suffers from “fear-avoidance behavior.” The notion is pretty self-explanatory. It means you fear your back pain, so you avoid any movement you think might make it worse. But this behavior pattern itself, by keeping your muscles tense and tight, might keep you on the couch.

“The spine and back are not frail structures you need to coddle during your recovery,” says Steven George, one of the authors of the study and a fellow at the Brooks Center for Rehabilitation Studies at the University of Florida in Gainesville. In fact, for most people who are under 55 and whose backs have generally been in good shape, he says, the best way to get better after an injury is keep moving and confront the pain.

No, this isn’t about telling your back to back off. It’s about knowing what it takes to recover. First, understand that you must stretch and strengthen your muscles to heal a back injury and that pain is an expected and normal part of the process. “With your doctor’s okay, start your recovery program two to three days after the injury,” says George. “Exercise or stretch about 10 percent beyond your pain threshold,” he adds, “and don’t take off from exercise more than two days in a row.”

Deep breathing can also help you overcome anxiety and relieve muscle tension, says Bruce Kodish, a physical therapist in Pasadena, California, and author of Back Pain Solutions. Any time you feel anxious about reinjuring yourself, take five deep breaths, holding the inhale to a count of five and exhaling as slowly as possible.

In some instances, though, confronting pain is not a good idea. If you’ve tried it and your aching is worse 24 to 48 hours later, if your pain moves from your back into your buttocks or leg, or if your symptoms change—from pain to numbness or weakness, for example—stop exercising and see your doctor