P57 Hoodia Gordonii The San Tribe and Pfitzer in South Africa

Traditional Knowledge of the Hoodia Gordonii Cactus

The San Tribe of South Africa has for thousands of years used the Hoodia cactus as an

appetite suppressant. Over the course of this period of time, the San Tribe has acted as

custodians for the preservation of the cactus. With knowledge of its traditional purpose, the

National Council for Scientific and Industrial Research (CSIR) developed and patented the active

ingredient in the cactus, known as P57. The ingredient eventually made its way into a

commercially viable appetite suppressant drug manufactured by Pfizer, which could generate

revenue in the millions.

Despite the CSIRs reliance on the Sans TK of the Hoodia cactus, no agreement

concerning compensation for this knowledge was ever established between the San Tribe and

CSIR. Foreclosed from any benefits derived from the patented drug and realizing its potential

commercial success, the San Tribe threatened to bring suit against the CSIR. Prior to any

litigation however, a dialogue between the CSIR and the San Tribe was opened and on April 9.

2002, the San Tribe and the CSIR announced that they had concluded a Memorandum Of

Understanding (MOU), which would serve as the basis for benefit sharing negotiations.

This announcement comes at a time when developments in a number of international fora

have brought the issue of TK to the forefront of intellectual property policy making. For

instance, working groups within the Convention on Biological Diversity, the United Nations

Food and Agriculture Organization and the World Intellectual Property Organization all have

dealt with TK and the development of international norms handling TK within their respective

context. The final outcome of these norm-setting processes has significant economic

implications for many large multinational corporations, especially pharmaceutical and

biotechnology conglomerates, since the research and development of their products is often

based on TK and genetic resources cultivated by indigenous populations.

Both in and outside these fora, most developed countries have resisted the establishment

of sui generis systems to protect TK, arguing instead that TK can be protected within the

existing intellectual property system. Many developing countries however have explored the

possibility of a sui generis system for TK, arguing that the current intellectual property system is

ill suited for the particular needs of indigenous communities and other holders of traditional

The MOU between the San Tribe and the CSIR presents a middle of the road option that

may prove to be the most effective course of action for the protection of TK. Under the MOU,

the CSIR recognised the San as the custodians of TK associated with the uses of a large variety

of plant materials, including the Hoodia cactus plant. The San, in turn, acknowledge that it was

necessary for the CSIR to protect the work that had been done in isolating the active ingredient

in the plant and that the CSIR had a right to patent it.

The terms of the final benefit sharing agreement between the San and the CSIR have not

yet been established, but the MOU is an encouraging step towards the recognition of the value of

TK and the equitable distribution of benefits among all the parties that have contributed to the

development of P57. It is important to point out though, that the MOU was reached despite the

absence of national legislation governing the use of TK. In the context of the international

debate over TK protection, the MOU thus demonstrates that national legislation implementing

sui generis TK protection is not necessary to ensure that holders of TK are appropriately

compensated for their contributions and that recourse to present legal mechanisms, including

those beyond intellectual property, can serve the same objectives as a sui generis regime. Along

these lines, IIPI has advocated that developing countries explore various methods of protecting

their traditional knowledge resources, including revision of their visa policies and the

establishment of national clearinghouses to secure rights in traditional knowledge.

Intellectual Property Needs and Expectations of Traditional Knowledge Holders, WIPO Report on Fact-Finding

Missions on Intellectual Property and Traditional Knowledge (1998-1999), 2001 at 25.

Sui generis is Latin for of its own kind. A sui generis system thus is a system specifically designed to address the

needs of a particular issue.

Although not much has been mentioned about this Kalahari Desert cactus in the mainstream media to date, the day Pfizer launches what it now perceives to be the obesity solution of all time (in about 2007, but possibly as early as 2004), it expects an unprecedented rise in stock value.

An Internet search for "Hoodia", "Xhoba" (the name given the cactus by the San Bushmen) and "P57" (so named because it was the 57th compound that Phytopharm spent money to develop) turns up some very interesting information.

Hoodia cacti are native to the semi-deserts of South Africa, Botswana, Namibia and Angola. There are about 20 species in this family but the gordonii is the one that contains a natural appetite suppressant. The Hoodia cactus is quite common and varieties can be purchased for your garden, although growing gordoniis for your own use is not the answer since they are slow growing, bitter tasting and produce odiferous flowers that attract flies which pollinate them.

The reason it has taken so long to bring this natural compound to the marketplace has to do with modern research methodology since the effects were first observed in 1937 by a Dutch anthropologist studying the San Bushman of the Kalahari Desert. He noticed that they munched on the stem of a certain variety of Hoodia plant as an appetite suppressant and thirst quencher before and during nomadic hunts through the sandswept and sparsely vegetated area.

Interestingly, the San, who can trace their heritage back 27,000 years based on rock paintings, are one of the world's oldest and most primitive tribes. They have known about the properties of Xhoba for thousands of years.

Besides alleviating hunger and thirst, Xhoba also provides a state of alertness but without the jittery feeling produced by the current Western diet remedy of ephedra stacked with caffeine. Thus it is an ideal choice for days' long hunts where prey is tracked over hundreds of miles.

Hoodia sat on the back shelf in a lab for almost another thirty years when South African scientists at the Council for Scientific and Industrial Research (CSIR) began studying it. Lab animals fed the flesh of the cactus lost weight, but otherwise suffered no ill effects.

It was during these tests that CSIR researchers discovered the plant contained a previously unknown molecule, which has since been christened P57. CSIR, which patented the compound in 1997, sold the license to a Cambridgeshire, England bio-pharmaceutical company by the name of Phytopharm plc, which in 1998, subleased it and the marketing rights to U.S. pharmaceutical giant Pfizer Corporation for US$32 Million plus royalties from future sales.

CSIR has been accused of selling something that didn't belong to it in the first place although it claims to have the best interests of the San at heart. The San and their attorneys have a different opinion, however. As for the Bushmen, the unhappy current situation finds many of them smoking large quantities of marijuana, suffering from alcoholism, and having neither possessions nor any sense of the value of money. The San in Botswana and Namibia are often regarded as a nuisance by authorities and herded into towns where they have few skills with which to earn a living. They were also persecuted by the apartheid regime in South Africa. The current Mandela government has granted them ownership of more than 40,000 hectares, (roughly 400 square kilometers or 155 square miles) although quality of the land is marginal.

Dr. Richard Dixey, a Buddhist convert and current Chief Executive Officer of Phytopharm, claims he wishes to see the San given their fair share of what could possibly produce profits in the US$3 Billion range. However, he initially claimed the San who discovered Xhoba had died out!

Eventually that same San clan, now 100,000 members strong and very much alive, found out about the patent and became as thorny in the sides of the usurpers as the cactus itself.

In June of 2003, Business Day reported that "The San people and the Council for Scientific and Industrial Research (CSIR) have finally come to a royalty agreement for a potentially lucrative new obesity drug."

HYPERLINK "http://health.iafrica.com/healthnews/200899.htm"Health News states that, "Details of the agreement have not yet been released. However a CSIR spokesperson told Business Day that profits would be shared equally between all San."

If their gods are with them (they regard the one that doesn't provide enough food as a "trickster") the San living along the edge of the Kalahari will become overnight millionaires on royalties negotiated by their South African lawyer, Roger Chennells. Even so, it appears they will need all the help they can get to secure their money, agreement or no agreement.

According to Dixey, the hypothalamus is the organ affected by the P57 molecule because it's the location of the "nerve cells that sense glucose sugar. . . .When you eat, blood sugar goes up because of the food, [and] these cells start firing [so you feel full]. What the Hoodia seems to contain is a molecule that is about 10,000 times as active as glucose. It goes to the [hypothalamus] and actually makes those nerve cells fire as if you were full. But you have not eaten. Nor do you want to."

Phytopharm performed the first animal trials, choosing rats because they are "creatures who will eat literally anything." When fed the cactus, they stopped eating completely.

When the first human clinical trial was conducted, a morbidly obese group of volunteers were placed in a Phase 1 Unit. In this controlled environment, where subjects were literally incarcerated, all they did was read, watch television, and eat. Half were given Hoodia and the other half, a placebo. Fifteen days later the Hoodia group had reduced their caloric intake by 1000 a day and suffered no ill effects. The stuff clearly seemed to work.

Of course that is just one study, but if P57 works in Phase II Clinical trials, now underway at Pfizer, it may be the answer to a great many problems although it could also cause as many as it cures.

It's one thing to REDUCE someone's appetite but eliminating it altogether is dangerous. There is the distinct possibility that people with eating disorders will somehow con their physicians out of it or possibly it will become available on the black market.

On the other hand, there is no doubt it would be preferable to current thermogenics and diuretics for athletes who need to make weight but who understand nutrition well enough to return to their normal, and usually healthy, eating habits once their competition or event is over.

The one thing it will not do is correct the choice of foods. All those fat folks who eat fast food will still eat it. Granted, they will eat much less of it, but unless they are also given vitamins and anti-oxidants and counseled in good nutritional practices, they could very well continue to compromise their health.

Thus P57 is not a compound to be taken lightly and the reason why even those who can abide the stench of the Hoodia cactus flowers should not indiscriminately partake of the cactus. Remember, the San only ate Xhoba for specific survival purposes, not because they had eating disorders or some body image problem. In fact, they find the idea that anyone would not eat on purpose ludicrous.

At present, one can find various over the counter products that purport to contain Hoodia. Interestingly enough, they also contain ephedrine and caffeine (ThinPhetamine™) and ephedrine/yohimbine combinations (Lipodrene™).

According to a January 4, 2003 article in The Guardian (UK), "Some [San] elders attribute aphrodisiac qualities to the plant, though Pfizer, which also makes Viagra™, has not marketed that angle."

This produces an interesting conundrum for Pfizer since the FDA now grants only single-use patents. (For more information on this subject visit http://www.lef.org). It is estimated that approximately 30 percent of the U.S. male population uses Viagra™ which is contraindicated for those with heart and circulatory problems. This is purportedly not true of Hoodia. With time running out on Viagra's patent (the drug giant can apply for an extension), which will be more lucrative: a fat-loss pill or a male potency enhancer?

One way to circumvent the problem is simply to apply for separate patents for the same compound using different trade names, thus reaping double profits.