Thursday, October 28, 2010

Fate of Earth's Living Beings Nears 'Tipping Point'

A new strategy to halt the loss of the Earth's diverse living beings is expected to emerge from a United Nations conference that opened Monday in Nagoya. As 2010 is the International Year of Biodiversity, there is an urgency to these negotiations because species are disappearing in unprecedented numbers.

Species extinction rates are now as high as a thousand times the natural rate, and the world is nearing a "tipping point" where there could be irreversible loss, warned Ahmed Djoghlaf, the executive secretary of the UN Convention on Biodiversity, in his opening speech to the delegates.

Of the world's 5,490 mammals, 78 are Extinct or Extinct in the Wild, with 188 Critically Endangered and 450 Endangered, according to the International Union for the Conservation of Nature. Habitat loss, over-exploitation, pollution, disease and human-induced climate change are the factors driving these extinctions, the IUCN says.

Although more than 16,000 delegates representing the 193 Parties to the Convention and their partners are attending, this is "not just another UN conference," said Djoghlaf, but "the most important meeting on biodiversity in the history of the United Nations."

He called on delegates "to address the unprecedented loss of biodiversity seriously compounded by global warming."

Although the world failed to meet its 2010 target of slowing the loss of global biodiversity, the delegates gathered at Nagoya are tasked with setting another target, to be embodied in the Aichi-Nagoya Strategic Plan for the next decade, with a vision for 2050.

"This is not another plan," said Djoghlaf. "It will be, as recommended by last month's historic New York summit on biodiversity, the overarching coordinated global biodiversity framework of the whole biodiversity family, including the United Nations system."

The Aichi-Nagoya Strategic Plan hammered out by delegates over the next nine days will be submitted October 27 to the high-level segment of the conference, which will be attended by several world leaders and more than 100 environment ministers.

"Here there is an opportunity to shape the landscape and the trajectory of humanity's response to the loss of its natural and nature-based assets in profound and transformational ways," Achim Steiner, executive director of the UN Environment Programme, told delegates on opening day. "Here and together we can begin to put in place the kinds of far sighted policy-responses and smart mechanisms that have been incubating for years in many countries and communities."

"The plants and animals, fungi and micro-organisms that produce and clean our air, generate drinking water, hydro-power and irrigation; provide food, shelter and medicines and also bring to many joy and a spiritual dimension to our daily lives need a big helping hand from this 10th Meeting of the Conference of the Parties - if not for their sakes, for ours," Steiner said.

BirdLife International, the world's foremost bird conservation group with partners in more than 100 countries and territories, outlined five essential goals the Nagoya conference must meet to be successful.

The conference must:

   1. adopt a comprehensive, ambitious and achievable strategic plan with associated 2020 targets that take us well beyond business as usual
   2. agree mechanisms to ensure that each country has access to the resources it needs for effective implementation of the Convention on Biodiversity
   3. conclude negotiations on the international Access and Benefit Sharing, ABS, regime resulting in a Protocol to the Convention with legally binding provisions
   4. agree to expand protected area networks, particularly in marine areas
   5. agree clear actions to promote synergies between the Convention on Biological Diversity and the UN Framework Convention on Climate Change at national and international levels

"The ongoing decline of the world's biological resources - such as rainforests, coral reefs and agricultural biodiversity - threatens to increase poverty and people's vulnerability to climate change," said Dr. Dilys Roe, a senior researcher at International Institute for Environment and Development and co-author, with BirdLife, of a new, free book, "Banking on biodiversity: a natural way out of poverty."

"These challenges must be tackled together rather than in isolation," said Roe.

Djoghlaf, Steiner and nongovernmental organizations appealed urgently to all government delegates in Nagoya to finalize a legally-binding protocol on access to genetic resources and sharing of the benefits of that access, known as Access and Benefits-Sharing or ABS.

The Convention establishes that a person or institution seeking access to the genetic material of a biological resource in a foreign country should seek the prior informed consent of that country. The person or institution seeking access must also negotiate and agree on the terms and conditions of access and use of this resource.

Genetic resources are used by research institutes, universities and private companies in pharmaceuticals, agriculture, horticulture, cosmetics and biotechnology for research and to develop products.

For example, an appetite suppressant has been derived from species of Hoodia, succulent plants indigenous to southern Africa and long used by the San people to stave off hunger and thirst. One brand of Hoodia pills includes a San-approved certification process.

In February 2006 an agreement was signed between the San and the Southern African Hoodia Growers, empowering the SAHG as the exclusive, legal, approval body for growers and purveyors of natural Hoodia gordonii grown in South Africa. The San receive six percent of the revenue from Hoodia sales made through this group.

The certification process allows traceability of the San-endorsed Hoodia with all legal documents in place under the national Nature Conservation Ordinance and Biodiversity Act and international rules under the Convention on International Trade in Endangered Species, CITES.

An ABS protocol could include these elements.

Djoghlaf explained to delegates how their work at the conference would shape biodiversity conservation at all levels of government.

"The Aichi Nagoya Strategic Biodiversity Plan will need to be translated before the New Delhi Biodiversity Summit [in 2012] into national biodiversity strategies and action plans tailored to the needs and circumstances of the Parties and their partners," he said.

"It will be also translated into action plans at the municipal level. This is the objective of the first-ever City Biodiversity Summit to be held at the end of this week," Djoghlaf explained. "The expected 300 mayors from all over the world will have before them the Urban Biodiversity Index specially designed with the support of Singapore and test-bedded by 34 cities."

"Based on the experience gained by Aichi Prefecture and Ishikawa, prefectural strategies and action plans will be also promoted," he said. "Based on the experience of our host, biodiversity basic law will be encouraged. This is the objective of the summit on Parliamentarians and Biodiversity to be held in partnership with Globe International."

On October 25-26, just before the opening of the high-level segment at Nagoya, 122 legislators from around the world will convene a forum co-hosted by GLOBE International, GLOBE Japan and the CBD Secretariat. It will focus on the concept of natural capital as a means to mainstream biodiversity and ecosystems services into policy making.

Monday, October 25, 2010

Traditional Chinese medicine hopes for global approval

When Sun Xinsheng learned that a domestic traditional Chinese medicine maker had managed to acquire the necessary US Food and Drug Administration (FDA) certification to enable him to sell his wares in the United States, his first response was "unbelievable".

Sun is vice-chairman of the China Quality Association for Pharmaceuticals and his response is a reflection of the difficulties facing Chinese patent medicine makers seeking markets abroad.

Zhimingde International, a Beijing-based company engaged in bio-medicine production, spent nearly two years undergoing the demanding application process. Eventually, its products were registered by the FDA under the category of healthcare rather than medicines on July 20.

Under the terms of the FDA registration, Zhimingde's products cannot be sold in US drugstores as medicine or prescribed by doctors at higher prices. They have to be sold in supermarkets and drugstores as nourishments.

"The number of made-in-China traditional medicines now registered as medicine in the US and European markets is zero," said Luo Yang, head of the traditional Chinese medicine department of China Chamber of Commerce for the Import & Export of Medicines & Health Products.

FDA rules require three phases of clinical trials before new drugs receive approval to be available on the market. Last month, the Compound Danshen Dripping Pill, a herbal treatment for angina and coronary heart disease made by Beijing Tongrentang Health Pharmaceutical Co Ltd (TRT), became the first Chinese traditional drug to pass the second phase, but it will be 2013 before it can enter the US market.

Domestically, traditional Chinese medicine (TCM), focusing on remedying underlying causes rather than treating symptoms, is supported by a strong culture and consumer trust.

A recent survey of TCM use in China conducted by the Horizon Research Group found almost 90 percent of the 100,000 respondents use it. Nearly 50 percent of them said they chose TCM over Western medicine because it cost less and had fewer side-effects, according to the survey.

Last month, TRT signed a five-year contract to import high-quality ginseng from the US to cater to the increasing domestic demand for traditional herbal medicine. Yu Jun, president of the healthcare products division with TRT, said that the company will double the number of its drugstores "very soon" in China.

But still, Chinese manufacturers "have a long way to go" to branch into overseas markets, Luo said, adding that the country's export of traditional Chinese medicine largely focuses on herbal products, rather than the more value-added Chinese patent medicines.

So far, extracts, prepared slices and other herbal ingredients account for the bulk of China's traditional Chinese medicine export. The more value-added Chinese patent medicine, which consists of herbs and other ingredients, mixed and formed into pills, accounts for only a fraction.

According to Chinese customs statistics released last month, China's export value of TCM touched $910 million in the first half of this year, up 26 percent year-on-year, with plant extracts, prepared slices and other raw materials accounting for 78.8 percent of the total volume. Patent medicines took up only 12.9 percent of the total volume.

The export volume of Chinese patent medicines reached $160 million in 2009, up 30 percent from $125 million in 1996, according to customs figures.

The small increase over the 13 years would be erased if inflation and exchange rate changes were taken into account, industry experts said.

"The current growth model of Chinese traditional medicines' export is not sustainable," said Fang Shuting, head of the China Association of Traditional Chinese Medicine.

"The growth is based on massive consumption of natural resources, some of which are already on the precipice of extinction. More research and development efforts should be made to develop patent medicines," Fang said.

China's export growth is largely driven by a rise in volume rather than by added value, he said.

Fierce competition among exporters may force the prices of raw materials, which already offer thin profit margins, to drop further, according to industry analysts.

The export price of biloba extracts, for instance, was $500 a kilogram in 1995. This year it is $25 amid fierce price wars among domestic exporters.

Japan and South Korea are the two major players in the global TCM market, making up more than 80 percent of market share last year, according to a People's Daily report. In contrast, China only has a 5 percent share in the market.

However, Japan imports 75 percent of raw material of its Chinese patent medicines from China and resells them at much higher prices after processing, the report said.

Wu Zhendou, head of the international cooperation department with the State Administration of Traditional Chinese Medicine, was recently quoted by People's Daily as saying that Japan and South Korea imported at least 50,000 tons of traditional Chinese medicinal materials from China annually.

To cope with the problem, the Ministry of Health in August launched an industry-university alliance to promote TCM in the global market.

The alliance aims to introduce international standards to the domestic manufacturers of TCM to pave the way for easier registration in overseas markets.

"Registration and consumer acceptance are key for the country's traditional Chinese medicine to enter Western markets," said Luo Yang of the China Chamber of Commerce for the Import & Export of Medicines & Health Products.

She said there is an inherent prejudice against TCM in Western countries, where most patients still don't believe they are real drugs and have concerns about the use of animal parts in them.

"But if their doctors give out traditional Chinese medicines in prescriptions or they are on sale in drugstores, it is very likely that the patients will give the medicines a shot," she added.

No more sibutramine - what now?

The writing has been on the wall for any weight loss medications containing the compound sibutramine since January of this year. On 21 January Lisa Richwine published a report on “EU Agency Urges Ban on Diet Drug” in Reuters Health. The drug in question was sibutramine, the active ingredient in products such as Reductil, Ectiva, Ciplatrim and Meridia. Recently Simply Slim, an over-the-counter (OTC) herbal slimming pill, was found to contain high levels of sibutramine. The product was withdrawn from the South African market and recently relaunched without sibutramine (Pretoria News, 2010).

The latest developments

Last Monday it was announced in the press that Abbott Laboratories, who manufacture Reductil and Ectiva, were voluntarily withdrawing these sibutramine-containing slimming drugs from the South African market after consultation with the Medicines Control Council (MCC). According to the report, Abbott have also withdrawn these slimming pills in the USA, Australia, and Taiwan. The use of sibutramine for slimming purposes is banned in Europe.

The article in the Pretoria News (2010) also pointed out that the MCC has said that it intends taking “appropriated action” against generic versions of sibutramine-containing drugs such as Ciplatrim. A weight loss programme combining Ciplatrim and Weigh-Less was launched at the beginning of September 2009 and many of Health24's users reported that they were using it with varying degrees of success. In view of the MCC statement, Cipla may also be asked to withdraw Ciplatrim in the near future.

Reasons for the withdrawal

The Reuters report published in January 2010, said that a study called SCOUT, which compared Meridia (sibutramine) against placebo (dummy treatment) in 10 000 patients, had found an increased risk for heart attacks or stroke in subjects receiving the active drug.

Preliminary data indicated that 11.4% of the subjects receiving sibutramine had died, or had a heart attack, a stroke or cardiac arrest compared to 10% for subjects who were given the placebo treatment (Richwine, 2010).

In reaction to these findings, the EU elected to ban all sibutramine-containing medications immediately. Other countries, including South Africa, first evaluated the results of the study to assess the risk posed to persons using sibutramine for slimming purposes. Abbott Laboratories who produce Reductil and Ectiva in South Africa have now voluntarily withdrawn these two slimming products in South Africa.

What now?

Sibutramine was used for weight loss because it acts as an appetite suppressant and also stimulates metabolism. Many healthy individuals did benefit from using sibutramine to assist them with weight loss and did not develop any negative side-effects.

Now slimmers in this country will have to lose weight without the aid of Reductil or Ectiva, and possibly also Ciplatrim. Needless to say, Health24 users are starting to panic and I receive frantic postings on the DietDoc Message Board from people who are totally stymied in their attempts to lose weight.

One by one even those slimming medications which were developed over many years under stringent scientific conditions and were subjected to extensive safety tests are now proving to be dangerous and possibly fatal to health.

This is indeed a problematic situation especially in a country like South Africa where the latest statistics show that up to 67% of adult women are obese, 61% of adults are overweight, obese, or morbidly obese and 17% of children under the age of 9 years are overweight (Joubert et al, 2007; Skade, 2010).

While many people do lose weight successfully with the aid of appropriate slimming diets and regular exercise, some individuals need assistance to curb their appetites and give them support to achieve their weight loss goals.

Some tips for desperate slimmers

a) What not to do

The first and most important fact to keep in mind is that you need to preserve your health and not expose yourself to the risk of developing heart attacks and strokes. In view of the worldwide concern about the safety of sibutramine-containing pharmaceutical products, I would advise Health24 users as follows:

    * If you are at present taking any slimming medication purchased in South Africa that contains sibutramine (i.e. Reductil, Ectiva or Ciplatrim), please contact the prescribing doctor or your pharmacist and discuss the risks associated with taking the remaining pills in your possession. If you experience any side-effects or have any doubts, stop taking these medications immediately. Rather safe, than sorry.
    * Do NOT order any pharmaceutical products that contain sibutramine over the Internet (i.e. product such as Reduxane and Zelium from Europe, and Meridia from the USA or other parts of the world).
    * Be aware of the fact that some OTC slimming products may be illegally laced with sibutramine. The Pretoria News article published last Monday warned that a product called Beauty Bitter Orange Slimming Capsules, which is reputedly “100 percent herbal”, was found to contain excessive amounts of sibutramine when tested by the FDA of America (Pretoria News, 2010).
    * Avoid using OTC slimming pills, capsules, potions, liquids, and patches because they could contain undisclosed high levels of sibutramine, or be a waste of money or cause other undesirable side-effects like addiction, dehydration or loss of normal bowel function.
    * Never give children or teenagers slimming pills of any kind as they may damage their metabolism and have serious side-effects.

b) What you can do

Use safer options for weight loss such as a balanced, energy-reduced low-fat, low-glycaemic index (GI) diet and regular exercise. It may take longer and you may need to exercise greater self-control, but this is one way of losing weight safely and sensibly.

If the 3 top Losers in the SA Biggest Loser show on etv in 2008, were able to lose between 45 and 62 kg in 12 weeks, you too can lose weight if you set your mind to it and stick to your diet and exercise regimen.

Anyone struggling to lose weight, should consider consulting a registered dietician to help you with a tailored slimming diet that meets your special needs. You may have insulin resistance which requires the use of a low-fat, low-GI diet to promote effective weight loss. Having the support of a dietician to explain the details of such a diet and to give you encouragement as you lose weight may make the difference between success and failure.

Visit the website of the Association for Dietetics in SA to find a dietician in your area. Consulting a dietician for a slimming diet is particularly valuable if you suffer from health problems such as heart disease, diabetes, kidney disease, or metabolic syndrome. The dietician will take your medical conditions and any medications you may be taking for these conditions into account when working out a slimming diet for you.

The use of a low-GI diet should also prevent cravings that often cause attempts at slimming to fail. If you do not have constant cravings for sweets and carbohydrates because you are eating low-fat, high-fibre and low-GI carbohydrates as part of your slimming diet, you won’t need all kinds of pills to see you through your weight loss journey.

The withdrawal of sibutramine-containing slimming pills is therefore not the end of the line for slimmers, because you do have other options which are safe and sensible.