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SOURCE: Financial Times

DATELINE: 14 - November, 1999 - Weekend Section

BYLINE: David Pilling

The Drug They Couldn't Give Away


Glaxo inherited Malarone when it took over Wellcome. Too expensive to put into commercial production, the company determined to offer it free to Kenya. But it was not as simple as that. David Pilling reports.

A child-size mound draped in a dirty blanket lies motionless on a broken metal bed. Flies circle around one end of the heap. A tiny foot protrudes from the other. The body appears to have been abandoned. Nobody, not a nurse nor a relative nor a friend, is in attendance.

The setting is a grim, mustard-coloured hospital ward in Siaya, a steamy, malaria-ridden district of Kenya on the shores of Lake Victoria. The pathetic mound is another statistic, one more victim of the mosquito-borne disease that is ravaging East Africa.

Yet suddenly, miraculously, the blanket twitches into life. A little boy, perhaps nine months old, twists round from his prostrate position and stares up with wide-eyed interest. Later we learn that the baby -- no one seems to know his name -- has responded to quinine, an anti-malarial of last resort.

Many of his compatriots have been less fortunate. Each day in Kenya, 72 children below the age of five die of malaria -- one every 20 minutes. The disease kills about 1 m Africans each year and destroys the livelihood, through prolonged incapacity, of millions more.

The situation is getting worse. In much of East Africa, chloroquine, the cheap and widely available drug that has kept malaria at bay for decades, has become almost useless as disease-bearing parasites have learnt the art of resistance.

It is against this bleak background that, in 1996, executives at Glaxo's headquarters in faraway London discovered they were in possession of a wonderdrug: an anti-malarial that was 98 per cent effective against even the most virulent strains.

The drug was Malarone, a clever combination of an old compound called proguanil and a new anti-viral known as atovaquone. Glaxo had inherited the miraculous drug when it took over Wellcome, a British company with a distinguished tradition of research into tropical diseases.

There was a problem. Glaxo was more commercially driven than Wellcome, which had its roots in the charitable sector. Malarone was an extremely expensive drug to produce; its estimated retail cost was GBP 24 for a course of treatment. For desperately poor countries such as Kenya, it might as well have cost GBP 24,000.

"Malaria simply isn't a commercial opportunity for a big research based company," says Andrew Bulloch, managing director of Glaxo Wellcome Kenya, with a hint of sadness.

If the project had been at an early stage, Malarone might have been quietly killed off. Because they offer little commercial prospect, very few drugs for tropical diseases make it on to the market.

But Malarone was not just a gleam in a scientist's eye. It was only months away from regulatory approval and had a fiercely loyal follow- ing inside the company. Glaxo felt morally obliged to do something with it.

That is why, in November 1996, the company took an unprecedented decision: it would give Malarone away. It pledged to donate 1 m treatments every year, indefinitely. Starting with a pilot programme in Kenya, Malarone would fan out across East Africa transforming people's lives as it went. The hope was to have the programme up and running in three months.

"Here was Glaxo with this fantastic drug," recalls Bulloch, one of the driving forces behind the donation. "Perhaps we were a bit naive, but we felt that people would be falling over each other to make use of it."

Three years later, things have not worked out like that. Instead of the 3 m Malarone doses Glaxo could theoretically have distributed, the grand total is somewhat smaller -- about 100. Most of those have been dispensed at Siaya where, after years of arguing, a pilot project finally got under way in April.

"I would never have believed it could be so difficult to give something away," says Bulloch. So why has it been so difficult? Why is the drug gathering dust in Glaxo's Nairobi warehouse while malaria rips a swathe through Kenya?

The first, and arguably main obstacle, has been a suspicion of Glaxo's motives. Although many have gradually come to believe in the sincerity of the company's gesture. the initial reaction was one of outright disbelief.

"I had never heard the word 'donation' before," says John Ouma, a lookalike of US boxing impresario Don King and head of the Department of Vector Borne Diseases in Kenya's Ministry of Health. "The word 'donation' was not in my vocabulary . . . You had to wonder what the hell they were talking about."

The suspicion in Kenya was that Glaxo was mounting a dastardly marketing ploy by weaning the country off existing drugs -- which cost pennies -- in favour of GBP 24-a-go Malarone. When it was hooked, so the theory went, Glaxo would pull the plug on the donation and start charging.

Such suspicions reflect a deep distrust in much of the developing world of pharmaceutical companies, regarded by many as serving only the interests of western patients and their share-holders. Glaxo, a company that had grown fabulously wealthy by selling drugs for peptic ulcers, herpes and migraine, seemed to fit the stereotype.

"People do ask why here," says Annette Alcock, a Nairobi-based aid worker. "They don't want something new foisted on them. They think it's imperialism all over again. There are still people here who see condoms as a western plot to stop Africans reproducing."

Even when Glaxo -- which operates the donation through the Atlanta- based Task Force for Child Survival and Development overcame initial suspicion, progress was hampered by a further doubt: was 1 m doses sufficient? After all, this was a global donation, not just aimed at Kenya.

"It is quite obvious that 1m doses is not enough," says Caroline Sergeant of the UK's Department of International Development in Nairobi. "So how do we ration it? Who decides who gets it and who does not?"

It struck many at Glaxo as surreal that experts should be worrying about the 1m dose ceiling before even a single tablet had been do- nated.]

But, argues Bob Snow, a malaria epidemiologist and adviser to Kenya's health ministry, such concerns are legitimate. New drugs, however effective, cannot be given out like sweets. They must be woven into the fabric of a country's existing drugs policy, which has often been painstakingly stitched together over years. Adding a new drug can throw the whole thing off killer.

Snow says there is a role for Malarone, but that a GBP 24 drug -- even with the assurance that it will remain free can never be central to a poor country's health strategy.

"It is putting quite a bit of pressure on the Ministry of Health to make its existing drugs policy even more complicated," says Snow. "Yet it would be a bit churlish for them to turn round and say No to a rather significant donation of free drug."

There is yet another problem: parasite resistance. The malaria plasmodia, which hitch mosquito rides between their human victims, are virulent and fast mutating.
Webmaster's note:"Evolving Resistance through natural selection is a more accurate way of describing drug resistance spreading in a population of malaria parasites. Give them a chance and they will learn how to sneak past a drug's defences. If Malarone is to last more than a few years, Glaxo's scientific advisers decided, it had to be kept in reserve, given only when first-line therapy failed.

Preventing abuse means keeping close tabs over how it is used. In poor countries, patients resist taking a full course of medicine, preferring to save precious tablets for future bouts of illness or to share with family members.

As a result, Olukayode Oyediran, director of the Malarone Donation Programme in Africa, has drawn up what for Kenya is a highly complex "protocol", a list of strict guidelines governing the use of the drug.

These include a urine test to determine whether a patient has actually been treated with first-line therapy (the temptation is to lie in order to qualify for free drugs) and microscopy to verify the type of infection. Children below 11 kg and pregnant women are, for the moment, excluded because sufficient research on these categories of patient has not been carried out.

To prevent Malarone leaking on to the black market, tablets are kept under lock and key. And to ensure full dosing, they must be swallowed in front of the physician on each day of the three-day course.

For Oyediran, strict guidelines are vital. "One hopes and prays hard that we'll have Malarone with us as an effective drug for a very long time," he says. "But those plasmodia are wretched, horrible things. This is why we are firm there should be no messing about with the drug."

That's fine in theory, says Snow. But in practice, if Malarone is really to make a difference, it must be administered at village, not district, level. In the countryside, microscopes and trained clinicians are a faraway dream. Thus, even if the drug is free, with such a strict and costly protocol, it is unaffordable.

Snow has a different proposal. "I would make Malarone available as quickly as possible with the knowledge that it won't last for ever, that you're maybe just buying a few years."

That would shorten Malarone's effective life. It would also undermine any plans Glaxo has to make a little money by selling it as a prophylaxis to western travellers. But it might, says Snow, bridge the gap until a more affordable drug, or combination of drugs, comes along.

David Nabarro, of the World Health Organisation's Roll Back Malaria Programme, says Snow's strategy makes sense for Malarone at GBP 24. But if Glaxo slashed prices -- say by four-fifths -- he believes Malarone could be used far more effectively.

"It's been great of Glaxo to start out with a donation, but in the long run you can't operate like that. If you could bring the price right down, we would have a lifesaver on our hands. Otherwise, it re- mains attractive, but it will probably stay on the shelf."

Is that to be the fate of Malarone? Has the donation programme, for all the goodwill and millions of dollars lavished upon it, been a failure?

Far from it, say the optimists. From the agony of its birth could come a model of how to forge a public-private partnership. The Siaya pilot programme is up and running and, having thrashed out their differences, the various actors are building trust and a fragile consensus about how best to move forward. At a meeting in London last month, it was decided to press ahead with more pilot projects and to extend the use of Malarone as aggressively as possible to children and pregnant mothers. There is, says Glaxo, an absolute determination to make it work.

Back in Siaya -- where few are aware of Malarone, let alone the hooha it has unleashed -- anxious mothers are lining up in the hospital's open courtyard. Many of the children clutching their skirts have malaria.

Inside the hospital, unbeknown to them, is a box of closely guarded Malarone, one of the world's most effective anti-malarials. Yet, for the moment at least it is being strictly rationed.

For some of the most vulnerable children waiting patiently in the courtyard, Malarone -- the wonderdrug will come too late.

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