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Continued from page 25 – Case Study- Microbial Productionof Artemisinin to Treat Malaria(Since 2000, the biotech industry has used the promise ofGolden Rice in public relations campaigns designed towin moral legitimacy for its genetically engineered crops– but the controversial product is not yet available.)Though they’ve produced only tiny quantities ofartemisinic acid so far, Jay Keasling’s bacterial factoriesare already churning out copious amounts of priceless PRfor the fledgling synbio industry.The December 2006 issue of Discover names theBerkeley professor its first-ever Scientist of the Year andthe magazine’s editors ooze with admiration: “Throughhis significant synthetic biology advancements, Keaslingis changing the world, making it a better place with everynew discovery he makes.”But will betting on synthetic biology’s medicinalmicrobes to tackle malaria (backed by $42.5 million fromthe Bill and Melinda Gates Foundation) divert attentionand resources from other approaches that are less frontpagefriendly, but nonetheless sustainable and decentralised?Will promising options for addressingmalaria be cast aside in single-minded pursuit of synbio’ssilver bullet?The current situation: WHO requires that artemisinin bemixed with other malaria drugs (a drug combinationknown as Artemisinin Combination Therapies or ACTs)to prevent the malaria parasite from developingresistance.Novartis’s proprietary ACT drug (known as Coartem) isthe only one that has received pre-clearance from WHO(meaning that it is approved for procurement by UNagencies), giving Novartis a virtual monopoly on ACTdrugs. According to a 2006 study on artemisia conductedby the Royal Tropical Institute of the Netherlands: “Thismonopoly-like situation has created an imperfect marketdefined by scarcity of raw materials, speculation andextremely high retail prices.Under contract to WHO, Novartis provides Coartem atcost (US$ 0.90 to treat infants; US$ 2.40 to treat adults)to the public sector in malaria-endemic countries in theSouth.A two-tier pricing system allows Novartis to sell theirACT compound for ten times the cost to Northernmarkets and international travelers. Other drugcompanies are developing ACT drugs, with Sanofi-Aventis closest to having a marketable product.Novartis currently buys almost all of the world’swormwood crop, sourcing from thousands of smallfarmers across China, Vietnam, Kenya, Tanzania, India,Uganda, Gambia, Ghana, Senegal and Brazil.-26- Traditional African Clinic July/August 2007In East Africa, an estimated 1,000 small-scale farmers(average 0.3 hectares) and 100 larger scale farmers(average 3 hectares) currently grow artemisia. In light ofglobal demand and recent campaigns to reinvigorate thefight against malaria, that figure is expected to grow toapproximately 5000 smallholders and 500 larger-scalefarmers.The report by the Royal Tropical Institute of theNetherlands concludes that the current Artemisia shortfallcould be met solely by increasing cultivation ofwormwood, especially in Africa. Increasing localproduction is attractive as a sustainable and decentralisedapproach.“From a technical point of view, it is possible to cultivatesufficient artemisia and to extract sufficient artemisininfrom it to cure all the malaria patients in the world. AnACT could be made available at an affordable pricewithin just 2-3 years.”The report estimates that between 17,000-27,000 hectaresof Artemisia annua would be required to satisfy globaldemand for ACT, which could be grown by farmers insuitable areas of the South.The Institute’s report warns, however, that the prospect ofsynthetic artemisinin production could destabilize a veryyoung market for natural artemisia, undermining thesecurity of farmers just beginning to plant it for the firsttime: “Growing Artemisia plants is risky and will not beprofitable for long because of the synthetic productionthat is expected to begin in the near future.”Sold on synbio’s synthetic vision:Keasling’s team believes that using synthetic microbes tomanufacture artemisinin could increase supplies morequickly and reliably than planting new crops. “Youwould need to plant the state of Rhode Island to meetdemand,” quips Jack Newman, co-founder – along withKeasling – of Amyris Biotechnologies, the company thatwill bring synthetic artemisinin to market.Amyris predicts that microbial production will lower thecost of artemisinin to 25 cents per dose.The company’s non-profit partner, OneWorld Health,will steer the product through the regulatory process andconduct preclinical studies to determine the safestartemisinin derivatives.However, large-scale production of synthetic artemisininstill faces significant technical difficulties. OneWorldHealth explains that “the yield of artemisinic acid wouldneed to be improved several hundred fold to beeconomically acceptable for large-scale manufacturing.”Continued on page 27