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The Rise of "Creative Capitalism": Tackling Malaria

February 4, 2009

According to Steve Hamm, the term “creative capitalism” was coined by Microsoft co-founder Bill Gates [“‘Creative Capitalism’ Versus Malaria,” BusinessWeek, 2 February 2009 print edition]. Hamm writes that the concept of creative capitalism has brought together “an unlikely alliance” that has led “to a low-cost treatment [for malaria] that Bill Gates hopes will inspire similar projects.” Hamm writes:

“When Bill Gates coined the phrase ‘creative capitalism’ at the World Economic Forum a year ago, he said the world’s deepest problems could be solved only if corporations joined nonprofit organizations, governments, and philanthropists in the fight. ‘Diseases like malaria that kill over a million people a year get far less attention than drugs to help with baldness,’ the Microsoft billionaire told his audience in Davos, Switzerland.”

For more on what Gates said at last year’s World Economic Forum, see my post Profit-backed Social Philosophy. Hamm continues:

“One of the Bill & Melinda Gates Foundation’s pet projects is now emerging as evidence that creative capitalism can work. The Artemisinin Project is an unconventional effort by Big Pharma’s sanofi-aventis, biotech upstart Amyris Biotechnologies, a University of California researcher, and the first nonprofit drug developer in the U.S., the Institute for OneWorld Health, to take on malaria. ‘If this works, there will be a lot of people piling on,’ says Christopher Whitty, a professor of international health at London School of Hygiene & Tropical Medicine. ‘If not, people may well shy away from this kind of approach.'”

The approach is unique in several ways. First, as described above, it involves a novel partnership between NGOs, academia, and commercial enterprise. To be fully successful, it will also require the participation of governments. Second, the “cure” could actually bring financial benefits to areas affected by malaria because the plant containing a key ingredient is grown in Asia and Africa. Finally, the ultimate goal is making effective medicine at prices low enough that they can help the globe’s bottom billion — a group that is still not a preferred target group for many products. Hamm goes on to describe how the Artemisinin Project got started and where it has progressed.

“Artemisinin is a chemical found in a plant—sweet wormwood—that grows in temperate parts of Africa and Asia. It’s used to help cure malaria, mostly as a component in artemisinin combination therapies, or ACTs, which are the only truly effective treatment today. Two problems exist. One is that volatile weather and market conditions result in unreliable supplies and wild price swings. The other is ACT costs $3 to $20 per patient, well beyond the reach of many victims. Jay Keasling, a biology researcher at the University of California at Berkeley, came up with a potential supply solution in 2003: producing artemisinin semi-synthetically, using a process similar to what biotech companies employ to make drugs for everything from anemia to cancer. But Keasling could not find a corporate sponsor to underwrite his work. So late that year he took it to the Gates Foundation, which already had teamed up with OneWorld Health to combat so-called neglected diseases such as malaria. Backed by a $42.6 million grant from the foundation, OneWorld Health began working with Keasling and Amyris, a startup he had created along with his lab associates. After sounding out big drug companies, OneWorld Health picked sanofi-aventis last March to find a way to mass-produce the chemical. The drugmaker has its own ACT treatment, so it needed an inexpensive and plentiful supply of artemisinin. And it also saw an opportunity to sell the compound to other drug manufacturers. ‘We want to become a leading pharmaceutical company in the fight against malaria,’ says Philippe Farabolini, a director in the company’s Access to Medicines department. The company now aims to get ACTs containing semi-synthetic artemisinin into poor countries in Africa and Asia in 2012. With government subsidies, the treatment’s cost should come closer to the $1-per-patient target.”

The Artemisinin Project is being carried out on a “not for profit” basis, although there are hopes of creating concomitant financial benefits for those involved.

“Neither Amyris nor sanofi-aventis will make a profit from this project. But it has provided revenues, technology, and, for Amyris, a launchpad for a different product—the startup has raised $120 million in venture capital. For sanofi-aventis, the project should yield good PR and expand sales of its ACT products. Besides, the company isn’t motivated by profits in this market, says Farabolini. Money from selling drugs to the wealthy customers in the developed world underwrites products for the have-nots. ‘We say the rich pay for the poor,’ he says.”

If successful, the Artemisinin Project still won’t replace on-going efforts to prevent victims from contracting malaria in the first place. Programs to reduce mosquito numbers and distribute low-cost anti-mosquito bed-nets will continue to play an important role. Unfortunately, there are indications that the plan might not work because artemisinin appears to be losing its potency against malaria [“Spread of Malaria Feared as Drug Loses Potency,” by Thomas Fuller, New York Times, 26 January 2009]. Fuller reports:

“Combination treatments using artemisinin, an antimalaria drug extracted from a plant used in traditional Chinese medicine, have been hailed in recent years as the biggest hope for eradicating malaria from Africa, where more than 2,000 children die from the disease each day. Now a series of studies, including one recently published in The New England Journal of Medicine and one due out soon, have cemented a consensus among researchers that artemisinin is losing its potency [in Cambodia] and that increased efforts are needed to prevent the drug-resistant malaria from leaving [Cambodia] and spreading across the globe.”

Fuller notes that researchers believe that the drug-resistant malaria is in the initial stages of spreading and that provides them with some hope that they can develop a plan to delay its spread.

“Though the studies show relatively early signs of resistance to artemisinin, the drugs were judged to have failed in only two patients in the recently published study. Even they were eventually cured. But malaria experts note that several times in the past, this same area around the Thai-Cambodian border appears to have been a starting point for drug-resistant strains of malaria, starting in the 1950s with the drug chloroquine. Introduced immediately after World War II, chloroquine was considered a miracle cure against falciparum malaria, the deadliest type. But the parasite evolved, the resistant strains spread, and chloroquine is now considered virtually useless against falciparum malaria in many parts of the world, including sub-Saharan Africa. It took decades for this resistance to spread across the world, so by the same token artemisinin-based drugs are almost sure to be useful for many years to come. To protect against artemisinin resistance, the global health authorities are trying to assure that it is sold only as a combination pill with other antimalaria medicines that linger longer in the blood, mopping up any artemisinin-resistant parasites.”

The greatest worry, Fuller notes, is that “there are no new drugs to take the place of artemisinin-based combinations and no immediate prospects under development.”

“Scientists have documented how malarial parasites that were resistant to chloroquine in the 1950s spread across Thailand, Burma, India and over to Africa, where a vast majority of the nearly one million annual malaria-related deaths occur. To prevent a recurrence with artemisinin therapies, the United States has put aside political considerations and approved a malaria monitoring center in military-run Myanmar, formerly Burma. The Bill and Melinda Gates Foundation, one of the largest donors to malaria research, is giving $14 million to the Thai and Cambodian governments to help pay for a containment program.”

The only way to stop malaria from becoming drug-resistant is to eradicate the disease. That, of course, is easier said than done. The Economist reports that there are also efforts to create a malaria vaccine [“A jab of hope,” 13 December 2008 print edition]. The article discusses a vaccine trial taking place in Tanzania.

“For much of the 19th century, Bagamoyo was a dreadful place, at the heart of the east African slave trade. The very name of the Tanzanian port means ‘lay down your heart’ in Swahili. But that tragic association may be supplanted by a happier one, thanks to an important new study done in the city that shows how to tackle a killer that has long outlasted Bagamoyo’s trade in human beings. Most malaria experts have pinned their hopes of tackling that disease with new drugs, such as artemisinin-combination therapies, and the use of bed-nets impregnated with long-lasting insecticides. However, the Bagamoyo study suggests that vaccination deserves a serious look. “

The reason that the vaccination deserves a serious look, according to the article, is that it has demonstrated significant effectiveness against malaria and researchers believe that its effectiveness can be improved even more.

“Joe Cohen of GlaxoSmithKline, a British drugs giant, and his colleagues present their case for the speedy development of a malaria vaccine in [a December 2008 issue of the] New England Journal of Medicine. In earlier studies, researchers have shown that RTS,S (as the vaccine is known) showed promise, although doubts remained. Christian Loucq of the PATH Malaria Vaccine Initiative, a charity that co-sponsored the study, says some naysayers have pointed to historical difficulties in getting African governments to accept and distribute new vaccines as grounds for scepticism. Which is why the work in Bagamoyo tested whether the malaria vaccine could be integrated into African countries’ existing system for inoculating infants with a group of established vaccines. It showed that giving all the jabs simultaneously did not affect the safety or efficacy of any of the vaccines and that the malaria vaccine reduced the risk of infection by over 60%. Dr Cohen points to novel adjuvants (ingredients that increase the body’s response to vaccines) as one of the reasons why the vaccine works when many earlier versions failed. A second study in the same journal was conducted in both Tanzania and Kenya, and it shows the vaccine is indeed improved by using a better adjuvant.”

The bugaboo of the vaccine trials is the same hurdle faced by most challenges in the developing world — money. “The researchers are keen to push ahead with this improved version of RTS,S early next year, but Dr Loucq worries about funding a big final-stage clinical trial that may cost $500m or more.” Even if the money for new trials can be found, finding the money for a full-blown vaccination program in affected areas creates a much larger challenge. The important thing is that strides are being made to help those who are too poor to help themselves — even during the current financial downturn (for another example, see my post entitled Limiting the Spread of AIDS). Diseases that devastate the developing world eventually have some impact on the developed world as well. Thus, helping those who desperately need our help is also a matter of enlightened self-interest.

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