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Scientists, Police Lift Lid on Life-Threatening Fake Malaria Drugs

Malaria is an enormous problem around the world, annually affecting an estimated 500 million people and killing about one million of them. For decades, doctors and scientists have watched helplessly as first-line medications became ineffective against the disease. That's because malaria parasites have evolved resistance to quinine-based medications such as chloroquine. But, as we hear from reporter Rose Hoban, the latest public health enemy is not so much a mutating microbe as it is human greed.

One great hope in the treatment of malaria is a new class of drugs known as artesunates, derived from artemisinin, a medication Chinese herbal doctors have used for millennia. More recently, Chinese scientists altered these traditional medicines to create modern anti-malarial compounds.

Infectious disease doctor Paul Newton from Oxford University says these compounds have been extremely effective. "They kill the malaria parasites very quickly, more quickly than any other group of anti-malarials."

Older and more conventional drugs, such as choloroquine and fansidar, which have been used to treat the most deadly form of the disease, were losing their effectiveness, because parasites had become resistant to them.

Several years ago, Newton says, doctors in Southeast Asia began to see what they suspected were counterfeit artesunate drugs.

Newton says, at first, it was easy to recognize that pills and their packaging were fake. But as time passed, it became harder to tell counterfeit artesunate medications from real ones. Surveys done in the past few years have indicated that between one third and half of the pills sold in South East Asia are fake.

"The counterfeiters have become increasingly sophisticated," Newton explains. "They have evolved their packaging. Now it's extremely hard, without a hand lens and a UV light, to tell that a packet of artesunate is fake or genuine."

And these fake pills contain little or no active medication at all.

Newton says that in one hospital in Laos, where he does work, all of the anti-malarial medications were fake.

Dallas Mildenhall calls what's happening "bloody-minded murder." He's a scientist in New Zealand who has done chemical analysis on some of these counterfeit pills.

"Essentially, it means that patients are dying, and particularly the women and children," Mildenhall says. "I would suspect that over the last 5 to 10 years, the number of deaths as a result of people taking sub-therapeutic and counterfeit artesunate would be in the thousands, if not the millions."

Mildenhall is part of an international team Paul Newton assembled to examine fake artesunate medications. Scientists in the U.S. did chemical analyses. They found the pills contained some illicit drugs and some carcinogenic chemicals, but mostly, they were chalk and starch.

In New Zealand, Mildenhall performed sophisticated forensic analyses of the pills. He was able to determine the counterfeits were manufactured in southern China.

Newton gave the gathered evidence to the head of INTERPOL, the international police agency, who went to Chinese authorities with the evidence. After their own investigation, Chinese government officials confiscated tens of thousands of phony pills and arrested some of those responsible for trading in fake artesunate in Hunan Province.

But Mildenhall says these are not the only people making and distributing counterfeit anti-malarials.

"One of the problems that we foresee is the anti-malarial counterfeit drugs getting into Africa," he says. "In fact, we do know that they are in Africa, but getting into Africa at the level that it currently is in Southeast Asia, then deaths per year will, well, will be in the millions."

Newton says fake artesunates have been detected in Kenya, Tanzania, Cameroon, the Democratic Republic of Congo and Chad. Both he and Mildenhall say the level of counterfeiting is so good, it's impossible to identify them without scientific analysis.

"If the hospitals can't tell the difference between the counterfeit and the real thing, then you can't expect a person in the street to be able to tell the difference," Mildenhall observes, adding, "And no, you can't tell the difference. "

Newton suggests that if a patient doesn't respond to treatment, doctors should suspect that the medication might be phony.

Both Mildenhall and Newton also fear that patients, doctors and nurses - not knowing the difference between real and fake drugs - will lose confidence in all artesunate medications and stop using them.

They say the only way to get rid of this problem, is to make it un-profitable for people to make counterfeit anti-malarial drugs.

Mildenhall says, in fact, the anti-malarial drugs are relatively cheap already. "If you make them cheaper… or if you make them free, then there's no profit," he says.

Newton and Mildenhall's paper detailing this problem and the investigation appears in the online journal PLoS Medicine.