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Why synthetic artemisinin is a bad idea.

June 21, 2013 - 10:20 -- Irene Teis

WE are astonished that only 50 of the 7917 malaria experts on www.malariaworld.org have an opinion on synthetic artemisinin production and the impact this may have on farmers in poor countries. Somebody sent us yesterday the blog “Why Synthetic Artemisinin Is Still a Bad Idea “ from Jim Thomas of the ETC Group. Hereafter a few excerpts which deserve consideration

*….The ‘story’ of semi-synthetic artemisinin has changed over the years: Jay Keasling first claimed that it would overcome environmentally damaging means of producing artemisinin, but dropped that argument quite quickly. He then claimed it would fill in the shortfall in artemisinin production, but dropped that argument when it became apparent there was overproduction of botanically-derived artemisinin. He and Amyris then claimed synthetic artemisinin could be used to smooth out the boom and bust cycle – which was a bit more nuanced an argument, but not ultimately convincing since it imagined a pharmaceutical company refraining from 'firing up its bioreactors' in years when botanical production was assured…... Finally, just recently Jay Keasling has admitted that, yes, the aim (his aim anyway) is to replace all of the botanical production ….. That’s the way a drug company argues, ie, if you hand us control of the entire market we can stamp out less savory practices and the price you pay for that is that we, the drug company, end up with a monopoly.

There is no evidence that synthetic artemisinin is or will be any cheaper than botanical artemisinin. Its real advantage to drugmakers is not so much price as the fact that it can be more easily controlled when it is brewed from a single source, so the drug companies don't have to maintain complicated sourcing arrangements. The average price of natural artemisinin is actually quite low. If you take the 745 metric tons of artemisinin that has been imported into India over the last 10 years for processing by the large Indian generic pharmaceutical companies, the average price of the last 10 years is $370 per kg… Consider what happens to the growers, extractors etc who formerly sold to Sanofi but have just discovered Sanofi no longer wants their product – where do you think they are likely to sell to now that Sanofi is no longer buying their product? You talk about 'a few thousand farmers'.

The most knowledgeable people in the artemisinin supply chain peg the number of farmers at about 100,000 and point out that the social impact of lost livelihoods is about 3-5 times that (account for families). That farmers … could switch to potatoes was used by Jay Keasling in his talk in Cambridge in the absence of context. ….Artemesia is a cash crop ON TOP of food production – it’s the crop that keeps them out of poverty. Take away artemisia and they will still have some food but little to no cash.

What is perhaps most worrying is that Jay's pronouncements about intending to take over the entire supply of artemisinin and claiming to undercut botanical production may already be driving farmer planting decisions right now as well as investment decisions. As Malcolm Cutler warns in the Nature article : “If it’s brought in too fast it could create huge shortages, because people will stop producing the natural stuff.” If farmers decide not to plant because they fear they can't compete, we may be in for shortages in 2015 – that really would be a tragedy. If there isn't enough artemisinin for ACTs people may die. Introducing synthetic artemisinin the wrong way will not only hurt the farmers who lose their livelihood, but could also hurt malaria sufferers.. Indeed I’m told there seem to be some lessons from previous misguided communication led by CHAI (Clinton Health Access initiative) a few years ago when their unrealistic attempt to lower ACT prices led to a complete stoppage of Artemisia plantations , and in fact, contributed to the more recent shortage and price surge “-

Comments

Submitted by Lutgen Pierre (not verified) on

How legal is bio-engineered artemisinin ?

The FDA-CDER regulation from 2004 on Botanical Drug Products states that : the term botanicals includes plant, materials, algae, macroscopic fungi, and combinations thereof.
It does not include: fermentation products (i.e., products produced by fermentation of yeast,bacteria, and other microscopic organisms…and products produced by fermentation of plant cells), even if such products are previously approved for drug use or accepted for food use in the United States

It is also the regulation followed by EFSA (European Food Safety Agency) and EMA (European Medicin Agency).

Which would mean that artemisinin produced by the bio-engineered synthesis of California, South Africa or Berlin may not be considered for antimalarial drugs, unless it has previously been approved by these authorities ?
Who knows more ?