KAVA KAVA

HISTORY AND USE
Kava is a member of the pepper family and is native to many Pacific Ocean islands. The rhizome (root stock) is used.  In early times, it was distributed eastward through tropical islands by migrating people, who valued the root broth as a drink and a medicine. In Hawaii, more than 15 varieties are known. In many islands of the Pacific, Kava has long played an important part in the life of the people, being used in ceremonies, festivals, and as a sign of good will. The root is used to prepare the ceremonial drink. The drink is reputed to be sedative, aphrodisiac, tonic, stimulant, diuretic, and diaphoretic. The root has a faint but characteristic odor, an aromatic, bitter, pungent taste, with a slight local anesthesia resulting.

Kava is used for Anxiety and Insomnia, also for nervousness, stress, and restlessness. Kava-lactones may have anti-anxiety, analgesic (pain relieving), and muscle relaxing, and anticonvulsant effects. Studies suggest that kava directly influences the limbic system, the ancient part of the brain associated with emotions and other brain activities. Kava improves mental functioning and mood and is not addictive. 

In a 1996 randomized, placebo-controlled, double-blind study, two groups of 29 patients with anxiety syndromes were treated with 100 mg of kava extract standardized to 70- percent kava-lactones three times a day for four weeks. The symptoms of anxiety were significantly reduced in patients taking kava as compared to placebo. No adverse reactions were observed in the kava group. 

EUROPEAN STUDIES LINK KAVA TO LIVER DAMAGE
Kava kava has come under scrutiny in Europe, Canada and the United States after the German government published studies on the herb's potentially hazardous effects on the liver.

In November, Germany's Federal Institute for Drugs and Medical Development (BfArM) reported 24 recent kava-related cases of liver damage, including one death. BfArM asked kava manufacturers to respond to the reports and stated that licenses to market the herb could be withdrawn.

Pharmaceutical giant Merck KGaA, based in Bonn, Germany, responded by pulling two kava-based products, Kytta-Kava and Kavadura, from German pharmacy shelves, despite other manufacturers' trust in the safety of this pepper plant known for its calming properties. Merck did, however, assert there have been no adverse effects from consumption of its products. Merck's annual kava sales in 2000 totaled about $443,000—a miniscule amount compared to its annual overall sales of $5.9 billion. U.S. kava sales in 2000 exceeded $30 million, reports the American Botanical Council in Austin, Texas.

Mark Blumenthal, executive director of the ABC, said that the German government is considering withdrawing the herb, "because kava is not approved as a herbal drug by the same standards as conventional drugs, the perception of its risk is increased because its benefits are not as strongly documented as [with] conventional drugs."

Although the German authority will not decide the herb's status until early 2002, the industry alert has already resulted in the ban of kava product sales in France and the suspension of sales in England.

"As a precautionary measure, we have asked all retailers and manufacturers to withdraw kava from sale," says Maurice Hanssen, director of the U.K.-based Council for Responsible Nutrition.

Despite the withdrawal, Hanssen is optimistic that the product will soon be back on the shelves, noting, "The German dosage seems incredibly high compared to other parts of the world." He says the situation is a result of unsubstantiated or inappropriate scientific evidence presented to authorities.

Canada is also considering pulling kava from the shelves, while the Belgian government has issued a warning about kava.

In the United States, the FDA responded by announcing an investigation into kava's potential liver toxicity. In December, the FDA requested the assistance of health care professionals in reviewing and reporting cases of liver toxicity to determine if any may be kava related.

Michael McGuffin, president of the Silver Spring, Md.-based American Herbal Products Association, said the FDA request will probably generate "hundreds of responses, a huge list of anecdotes, and a lot of it will be bad. I mean bad in both ways: Some will improperly implicate kava, and all of it will generate bad publicity." McGuffin said the AHPA supports stronger labeling, but not removing products from the market—unless reports come back that conclusively show kava is harmful to consumers.

"No reports of adverse liver effects of kava have been published in the U.S.," Blumenthal said. "Despite the relatively good safety profile that kava has in the U.S., we need to take this action by the German government seriously. An expert evaluation of the medical case reports and all relevant scientific literature is needed to determine the extent of the problem and the appropriate steps for the proper labeling of kava."

The ABC and a coalition of dietary supplements industry associations, including the AHPA, the CRN, the National Nutritional Foods Association and the Utah Natural Products Alliance, is currently evaluating the information released by the German government. The coalition is working with a university toxicologist to determine if there is a link between kava and liver problems.

Based on the German adverse events reports, the ABC recommends that kava consumers consider the following:

• Kava should not be taken by anyone with liver problems, by anyone taking drugs with known adverse liver effects, or by anyone who drinks alcohol regularly.
• Reports so far deal with chronic use, so Blumenthal suggests that kava not be taken daily for more than four weeks without professional supervision.
• Consumers should discontinue use if symptoms of jaundice (i.e., dark urine, yellow eyes) occur.
• Consumers should consult their health care provider if they have liver problems or suspect any new problems.

Shane Starling is a contributing writer for Functional Foods & Nutraceuticals.

SCHOLAR DISPUTES WARNINGS ON KAVA
LAWA'I, Kaua'i — A federal warning last month about the potential health hazards of kava slammed the industry in Hawaii’s and across the Pacific, but a prominent ethno-botanist has said he doubts the claims of liver damage. Paul Alan Cox, director of the National Tropical Botanical Garden on Kaua'i, will lead a team of physicians and botanists to Samoa next month to confer with native healers about its use. Many South Pacific islanders use the drug, made from the roots of the pepper relative Piper methysticum, recreationally and ceremonially. In the West, kava is sold as a food supplement to promote relaxation and ease insomnia, menopause symptoms and muscle discomfort.

During his extensive ethno botanical studies in island groups where the drug is used regularly, Cox said he has seen no evidence of liver problems. "When I heard of the problem, the first thing I thought was, what other things are these people taking?" he said. Growers in Fiji have suggested the problem may be with chemicals used to process kava for marketing. Native people generally use the roots of the plant simply pounded with water.

Concerns about the drug surfaced last year in Germany, where officials reported that as many as 25 people suffered liver ailments after using kava — 'awa in Hawaiian — ranging from hepatitis to cirrhosis and liver failure. The U.S. Food and Drug Administration issued a consumer advisory March 25 that recommended seeing a health professional at signs of liver damage, such as brown urine, yellowing of the skin and eyes, nausea, vomiting, abdominal pain and light-colored stools. The warning devastated the kava-growing industry. Some European nations removed kava products from stores, while others issued warnings. The drug company Merck announced a permanent halt to sale of its two kava products in Europe. Hawaii’s growers said prices and demand have plummeted. Fijian government officials are calling for an international medical inquiry into the claims of liver damage.

Cox said the indigenous people of the Pacific have used kava longer than anyone in Europe, and if there is a liver threat, they should be suffering from it. "I think the Polynesians would have figured this out if there were cases of severe liver failure," he said. "I have lived in indigenous villages, and I have not seen this kind of toxicity."

He said he would take a team of ethno botanists and physicians to talk to natives on Savaii in Western Samoa and the Manua island chain in American Samoa. "These people know more about kava than anyone in the world," he said. If there is a toxicity issue, indigenous people may have developed specific restrictions on kava use to minimize the risk, he said. "I find that indigenous people are very adept at excluding toxic compounds," he said. A recent study indicated as many as 50 farms on Hawaii’s growing kava, and a farm value of hundreds of thousands of dollars.

The FDA did not ban the product, but cited European restrictions and recommended that "persons who have liver disease or liver problems, or perhaps who are taking drug products that can affect the liver, should consult a physician before using kava-containing supplements."

Reach Jan Tenbruggencate at (808) 245-7825 or at jant@honoluluadvertiser.com.

TOXICOLOGIST CONCLUDES KAVA DOES NOT DAMAGE LIVER
A University of Illinois researcher is disputing recent claims that kava is linked to liver problems. Donald P. Waller, Ph.D., professor of pharmacology and toxicology, analyzed the same adverse event reports that led to the herb's safety being questioned throughout Europe as well as North America, Australia and New Zealand (see "European Studies Link Kava to Liver Damage," NFM, February 2002). In Report on Kava and Liver Damage, Waller concluded that there is "no clear evidence that the liver damage reported in the United States and Europe was caused by the consumption of kava."

A coalition of dietary supplements industry associations, including the American Herbal Products Association, National Nutritional Foods Association, American Botanical Council, Council for Responsible Nutrition and Utah Natural Products Alliance, commissioned Waller to evaluate 26 kava-related AERs received by the FDA between May 1998 and September 2001, as well as 30 Swiss and German AERs gathered in the last 11 years.

"We wanted to know, from an unbiased and qualified scientific perspective, whether the case reports that emerged are evidence of an actual association between kava and liver damage," said Michael McGuffin, AHPA president. "If that is the case, we need to know that to carry out our mission to promote responsible commerce; if that is not the case, we need to know that so we can be prepared to respond appropriately."

Although all of the German AERs reported liver problems, only five U.S. cases involved liver effects. Waller reported "no scientifically supported association of liver disease with the use of kava ... using the FDA AERs." Further, when Waller reviewed the nonliver-related FDA AERs, he found two cases of excessive kava consumption that, "from a toxicological perspective ... provide some evidence that kava itself is not a direct hepatotoxin, even in extremely high concentrations."

In the report, delivered to the FDA on Feb. 19, Waller criticized the German and Swiss case reports as lacking in "specific clinical and historical information" and recommended they be "revisited where possible to obtain further information." Waller concluded: "Kava when taken in appropriate doses ... has no scientifically established potential for causing liver damage." But he warned that any pharmacologically active agent can interact with drugs, pre-existing conditions and hypersensitivity reactions, possibly affecting the substance's toxicity.

Waller also said taking kava may not be appropriate with "concomitant intake of prescription drugs associated with liver damage, excessive alcohol consumption and pre-existing liver disease with compromised liver function." This advice matches industry recommendations, including AHPA's suggested label statement for kava products, NNFA's position on the herb (www.nnfa.org/services/science/background.htm) and ABC's recommendations to kava consumers ((see "European Studies Link Kava to Liver Damage," NFM, February 2002).

The industry coalition is awaiting a response from the FDA and "will continue to evaluate the situation," said Loren Israelsen, UNPA executive director. "We want to work closely with the FDA to find the best solution where everybody is in agreement that the goal is to protect consumer safety. But [the goal is] also to not preemptively remove a product from the market unless there is a good reason to do so."

—With additional reporting by Sue Blanchard and Shane Starling  

NOW EXAM THIS CONTROVERSIAL EVIDENCE
Kava has been known and used for centuries throughout the islands and during the last half of this century throughout the western world, so why all of a sudden has this product caused concern with reports of liver damage? And why has liver damage only been reported in Germany? If we look at the sales figures for Kava in Germany for the year 2000 we see a dollar value of $443,000, but compare this to the annual Kava sales in the U.S of $30,000.000 and with no liver damage reported!

The Pharmaceutical giant Merck had overall sales figures of 5.9 billion for the year so letting go of Kava for them means nothing. Could there be more to this story than we are reading, maybe there is an underhanded plot brewing to remove the freedom of choice to the consumer regarding health care supplements. Germany which is the head office to some of the most powerful drug manufactures in the world, (Bayer, Boehringer-Ingelheim, Byk-Gulden, Hermal GmbH, Hoffman-La Roche, Krueber GmbH, Lichtwer Pharma GmbH, Merck KGaA, Pharmacia & Pfizer, Losan, Shering-Plough, Schwarz, SmithKline Beecham Pharma GmbH, and Steigerwald) plus many, many more by association. So for Merck to remove Kava a non-patented, low profit item would only allow greater sales in prescription drugs? And Germany is behind Codex, the movement wanting to take away over the counter supplements and place all items as prescription only, all concerned with money. Remember the scenario that happened when the amino acid L-Tryptophan caused a few isolated deaths due to a contaminated batch. Instead of preventing this from happening again they removed the product from over the counter sales to prescription only, this I am sure helped sell many more sleeping pills by prescription. And now another relaxer is being questioned and removed from public access. 

You the reader must decide and open your eyes to the real reasons behind all the control over health supplements. Now regarding Kava formulate your own opinion, and when new reports are released on natural supplements question the source and ask yourself why!

Read On:

Bribery of German docs by drug companies reported
BERLIN, Mar 11 (Reuters Health) - At least 1,000 alleged cases of corruption of doctors by large pharmaceutical firms have been cited in Germany. The companies are allegedly encouraging doctors to prescribe more expensive drug treatments.

Many doctors have received offers of free trips for training seminars in glamorous places that happened to coincide with Formula One races or football World Cup championship games--with entry tickets often included in the hospitality, according to Bild am Sonntag, the German newspaper that carried the story on its front page this weekend.

One doctor, Hans-Peter Meuser from Langenfeld in the west of the country, told the medical newsletter Arzneitelegramm that in 1998 he had been invited along with a companion to attend a workshop in Paris, and the offer included tickets to the football World Cup final.

He said he would have been expected to treat at least 20 patients with a new high blood pressure drug and send the drug company short notes on the patients' progress. The new medication cost about seven times as much as similar drugs at that time.

The Munich public prosecutor, which is leading the overall investigation, confirmed Monday that around 100 clinics and hospitals across Germany were involved. Of those institutions, 23 are in Munich.

Munich's public prosecutor spokesman Manfred Wick said the case started in 1999 when a complaint was made against the firm SmithKline Beecham Pharma GmbH on suspicion of bribery and tax evasion.

Various offices of the pharmaceutical giant were raided on May 10, 2000, in Munich as well as some of Saechsisches Serumwerk in Dresden and Hoechst Marion Roussel in Frankfurt.

Around 600 files were taken from the SmithKline Beecham group while further raids were conducted on travel agent offices.

Wick said in a statement, "After evaluating the files, it showed up that the firm SmithKline Beecham had laid on many training seminars, meetings and congresses in Germany as well as abroad for doctors, which hospital doctors and companions had taken part in, where the travel costs were paid by SmithKline Beecham.

"The evaluation of the circa 600 files confiscated from SmithKline Beecham in Munich, as well as the files from various travel agents showed that around 5,800 single payments were made through the pharmaceutical firm to doctors in hospitals or public institutes."

The payments ranged from several thousand deutschmarks to up to 50,000 DM, he said.

Initially, more than 3,000 investigations were launched but these were narrowed down to around 1,000. Around 380 investigations have been opened against the staff of SmithKline Beecham.

On Monday, GlaxoSmithKline released a statement that stressed the structural changes that had taken place since the company's merger on December 27, 2000.

"As far as we can find out, the allegations concern the time between 1997 and 1999," the statement reads. "The fusion of Glaxo Wellcome and SmithKline Beecham prompted a restructuring and many positions have been redefined and re-staffed; responsibilities have changed."

The firm said in the statement that it had no further information beyond that which had been given to the media.

Doctors have been outraged by the allegations. The Federal Doctors' Association issued a statement suggesting that its members had before--and were now being--targeted in order to take attention away from a party political funding scandal currently being uncovered in the media.

The Association's president Professor Joerg-Dietrich Hoppe said in the statement, "Fraud and bribery should not just be investigated by the public prosecutor but also and initially by the doctors' association. We have no doubt about that. We wrote that in the professional code of conduct. But it is frivolous to compare the alleged acceptance of advantages by a number of individual doctors to the fraudulent practices of the political parties, and looks like a cheap diversionary tactic."

But Dr. Ellis Huber, former president of the Association's Berlin branch, told Bild am Sonnag, "A third of doctors are cynical and unscrupulously oriented, a third keep to the ethical rules, and a third sway somewhere between the two. Moral principles have been mislaid in this profession. The power of the marketing people has overgrown the power of the medics and researchers."

The country's biggest health insurer AOK said Monday night it would try to reclaim any charges it had paid that could be traced to additional costs incurred by bribed doctors.