25 Feb 2009

The cherry on top

One of the biggest challenges facing doctors, is getting patients to stick to their course of treatment. The bitter pill of malaria medication has just gone cherry-flavoured.

A fragile 2-year-old girl with malaria was sitting on the bed. The gathered journalists watched as she was given a watery pink liquid to drink. We stood about as the photographer from Time tried to get his perfect shot.

Outside, the Tanzanian air was sweltering. A foul smell hung between the old German buildings which now house the Ifakara Health Institute. The Indian Ocean lay dead, quiet, and inviting in the heat. It was a day like any other. And the girl in the ward was just a toddler like any other… just a child who happened to have been bitten by a mosquito carrying the plasmodium parasite.

Earlier that day, at the launch of a new cherry-flavoured malaria medicine called Coartem Dispersible (Coartem D) in the lush surroundings of the Moevenpick Royal Palm hotel in Dar es Salaam, the talk was abstract and political. It took the visit to the hospital in Bagamoyo to put it all in perspective. As with all public health issues, the boardroom discussions, theoretical models, and all the wheeling and dealing eventually has its outcome on the bodies of actual human beings.

In this case, it was about a girl drinking a cherry-lavoured drink – it tastes a bit like cherry tea – instead of fighting off the bitter adult formulations that children used to be given. And, as with the adult formulations, the odds are more than 97% that the artemisinin-based combination therapy contained in this drink would kill the malaria parasite in her blood and liver.

Coartem D is essentially a reformulation of the widely used malaria drug Coartem. The difference is that the original Coartem was bitter-tasting and tablets had to be broken or crushed before children could take them. Stories abound of parents forcing their children to swallow the bitter powder, only for the medicine to be vomited up soon after.

It is not surprising that parents relented once their children started looking and feeling healthier – even though the parasite was likely still to be lurking in their blood. This is why so many children who can access medication still suffer and die from malaria; and this is why Coartem D is significant: it is likely to mean that many more children will survive.

Almost didn't happen
This new, better-tasting malaria pill almost didn't happen, and this is where the story gets interesting. For one thing, malaria is a disease of the developing world, not a money-spinner like cholesterol or hypertension. And secondly, drug companies rarely make medicines especially for children, despite being urged to do so by the World Health Organisation (WHO).

Pharmaceutical giant Novartis nevertheless did develop Coartem D – and is selling it to the public sector at cost price.

Why?

Silvio Gabriel, executive vice president and general manager of malaria initiatives at Novartis, claims it is simply part of the company's corporate responsibility programme. In the light of Novartis' bruising battle with activists and Medicines Sans Frontieres (MSF) in India over the patent rights for the cancer drug Gleevec, I suggested, it might be very necessary PR? Gabriel didn't seem much taken with that interpretation. Still, Novartis certainly had some image problems to deal with, and vigorously courted the press with the launch of Coartem D. They flew in a PR team from New York, conducted launches in Dar es Salaam, Maputo and Dakar, and sponsored journalists from all over the continent.

In any case, the children are the winners, so it’s a happy ending.

Gabriel said Novartis would not have invested in the development of Coartem D had it not been for the Medicines for Malaria Venture (MMV) – a non-profit organisation created "to discover, develop and deliver effective and affordable antimalarial drugs through public-private partnerships". It was MMV which created the necessary conditions for bitter Coartem to be turned into sweet-tasting Coartem-D. In his turn, Chris Hentschel, president and CEO of MMV, says the project was only possible because governments and the world market of philanthropies backed it. Later, in the hotel lobby, he would tell me, with a broad sweep over the crowd waiting for the hotel buses to take us to the residence of the Swiss ambassador, that it is only when Bill Gates’ Gates Foundation came on board that other philanthropies and governments started chipping in as well.

MMV channelled significant amounts of that money into the project to cover costs external to Novartis – things like the difficult and risky business of conducting clinical trials. In this way, MMV, so to speak, sweetened the deal for Novartis, allowing them to focus on the things they do best: the actual development of the new formulation and setting up production. This saved Novartis a lot of trouble, and a lot of money. As a result, explains Hentschel, the total out-of-pocket cost for Novartis is far below the cost of a normal project.

If Bill Gates' goodwill hung over the whole launch event like some kind of divine presence, it was not the only one. On more than one occasion I was told that the malaria project was very close to the heart of Daniel Vasella, the chairman and CEO of Novartis. On both occasions, this was linked to his staunch Catholicism.

The Treatment Action Campaign
Apart from goodwill from Gates and Vasella, another factor mentioned more than once was the bad press pharmaceutical companies got during the battle between the Treatment Action Campaign (TAC) and GlaxoSmithKline and Boehringer Ingelheim in the early 2000s. That affair ended with a South African Competition Commission ruling in 2003 that the companies had abused their dominant position in their respective anti-retroviral markets. The thinking is that this forced pharmaceutical companies to rethink the ways in which they do business in Africa.

Whatever the motivation behind Coartem-D, it is a product that works. A study published In the Lancet found that Coartem D had a cure rate of over 97%, roughly similar to that of the original Coartem. And with a child in Africa dying of malaria every 30 seconds, the need for this kind of product is not trivial. An estimated 700 000 children under the age of five die annually of malaria, and in the worst affected areas, people can receive over 1 000 infectious mosquito bites per year.

What Coartem-D cannot do, is prevent reinfection. Particularly the East Africans seem convinced that the battle will turn only with the development of a vaccine, to be used alongside treatments, mosquito nets, and sprays.

Expanding the model
MMV is already using a similar public private model to explore other possible malaria medicines. And there is a strong suggestion the model might well be viable for other tropical diseases that are being neglected by the big pharmaceutical companies.

Spurring the development of new medicines for tropical diseases has been a public health headache. Hentschel suggests that the model that resulted in Coartem-D may be putting donor funds to better use than previous models. "The total out-of-pocket cost to the main donors is way below the cost that would be the case if you simply contracted, lets say, with a pharmaceutical company on a for-profit basis," says Hentschel.

But the little girl taking Coartem D at the hospital in Bagamoyo certainly doesn't care about multipronged approaches, the details of public private partnerships and what motivated who to get involved. All she knows is that the drink she's getting for her sickness really doesn't taste that bad. (A study was done to see what flavour kids prefer. Cherry won out over strawberry and orange.) The hope is that the public-private model could yield similarly pleasant health outcomes for other diseases.

(Marcus Low, Health24, February 2009)

Note: Low’s trip to attend the launch of Coartem D in Dar es Salaam was sponsored by Novartis and MMV.