TCS Daily

New Malaria Drugs to Be Approved, But Do They Work and Are They Safe?

By Roger Bate - September 5, 2007 12:00 AM

The market for treatments of malaria - which kills over one million people a year -- is of almost no commercial value: Although patients seek over 300 million treatments a year, and perhaps as many suffer without treatment, few legitimate drug companies make any money from the business. It is for this reason that one would typically be excited that new drugs to treat the disease, produced by Chinese firm Guilin Pharmaceutical, and Indian firm Ipca Laboratories have been approved by the World Health Organization. But recent history suggests that caution is very much in order.

The two largest companies still engaged in any meaningful way in malaria research are Novartis and Sanofi Aventis. Novartis signed an agreement with the World Health Organization in May 2001 to provide Coartem at cost to patients in malarial countries. Coartem, the first artemisin combination therapy (ACT), is the best anti-malarial since chloroquine, which was once the gold standard, effective for 50 years saving millions of lives. But with resistance to chloroquine accelerating in the past decade, alternatives like Coartem have become essential.

As with HIV, another fast-changing pathogen, it makes sense to give drugs in combination. This forces the pathogen (in this case, the malaria parasite) to simultaneously develop resistance to all combined medicines at once in order to survive—statistically unlikely, at least assuming drugs were stored and administered correctly.

The problem with combination therapies is that they are necessarily more expensive, since they involve at least two drugs, and ideally have gone through entirely new development to allow both drugs to work correctly in a single formulated pill.

Now that more funding has been dedicated to the prevention and treatment of malaria with the inception of the Global Fund to Fight AIDS TB and Malaria, and President Bush's Malaria Initiative, demand has soared for new drugs. But Coartem is still the only ACT on the market that has been tested by a high-quality regulatory agency - both the Swiss and EU agencies, which are equivalent to US Food and Drug Administration. Last year Novartis provided 62 million treatments—all at cost, as per their agreement.

Like Novartis, Sanofi has a long tradition working on malaria and has developed a new ACT, Coarsucam. Some evidence suggests that the malaria parasite may have developed resistance to one of the drugs, amodiaquine, in the Coarsucam combination. But the drug is potentially very useful, adding to the arsenal of weapons that health departments in malaria countries can use against the disease.

But unlike Coartem, Coarsucam has not yet passed approval by a western drug safety agency or even the WHO's historically dubious prequalification process. Three years ago, the WHO approved 18 anti-HIV medicines produced by several Indian companies, which were subsequently withdrawn because they could not be demonstrated to work as well as the branded drugs they copied. Coarsucam must be tested properly to ensure it is truly effective.

With so much funding flooding the market and so many counterfeit products in the market, it is important to have some level of certainty about supply. In the past two weeks the Government of Kenya announced that it was demanding a recall of large amounts of fake anti-malarials. The legitimate Chinese manufacturer Holley-Cotec is having to take part in the recall because a counterfeiter, possibly also Chinese, has been making fake versions of its drugs.

So far funders have been slack about ensuring quality. The Global Fund has spent many millions on medicines of uncertain quality. From data I have seen 56% (5 of 9) of purchase orders sent out by the Global Fund went to suppliers neither approved by WHO or a stringent agency. Privately some Global Fund staffers tell me they are unhappy that their board approved the purchase of these drugs, apparently to deny Novartis a monopoly of supply.

Given these facts it is with both hope, but mainly concern, that WHO has prequalified three of the copycat medicines that the Global Fund is already buying. Guilin is producing amodiaquine and a version of Coarsucam (amodiaquine plus artesunate). And Ipca is producing artesunate. It is surprising that WHO, which has fought against approving monotherapies, would approve single chemicals. One of the treatments already has resistance problems in certain countries while the other is the best product on the market but should only be used in dual therapy to prevent resistance. Guilin is capable of producing good chemicals but it is a shame that it has chosen to ask for prequalification for anything using amodiaquine. Ipca is more of an unknown quantity, but given a recent Wall Street Journal story about corruption in Indian drug supplies to the World Bank, one should be skeptical.

Having more high quality suppliers in the market would be great. But it will be interesting to see whether the WHO's testing is up to the mark, or whether these products will have to be withdrawn at a later date, if it is found that they're substandard - as happened with HIV medicines before.

WHO's approval of these copy drugs provides vindication to the Global Fund since it was already buying them. I imagine that Novartis will also be a little relieved since it has been obliged to satisfy a surging demand for ACTs, something that was very poorly predicted by the international health community over the past few years. Since ACTs take at least 14 months to produce due to the growth cycle of the sweet wormwood plant from which the product is derived, which in turn requires agreements with farmers, inaccurate forecasts mean over- or under-supply of ACTs. And given the attendant bad press companies would expect from undersupplying the market, both Sanofi and Novartis have overproduced drugs in previous years, leading to product destruction and millions in losses.

It will be interesting to see whether Guilin and Ipca will be able to provide consistent as well as safe supply of the product. Somehow I doubt it. The WHO has a difficult job to do and is woefully under-funded to do it. Until its budget is increased in order to test drugs properly and forecast their demand with any accuracy, Novartis will continue to bear the brunt of its agreement with WHO. It is enough to make them want to tear it up.

Roger Bate is a Resident Fellow of the American Enterprise Institute.



the UN? Puhleeze ! !
Bate sounds as if he thinks it's possible that the UN could possibly do anything efficiently, or even right. Or is he just testing us to see if we're paying attention, or perhaps making a great joke.

Malaria was on the run in the 1970s, millions of lives were being saved and improved all over the world, especially in Africa, by a cheap, effective insecticide. The head of the EPA, Bill Ruckleshaus(sp?), over-ruled his own department's studies, which showed that DDT was both safe and effective, and banned it in the US. The UN, NGOs, envirofreaks and dogooders all over the world joined in the ban. The result was a resurgence of malaria's terrible curse of suffering and death, which is still with us. Ghengis Khan, Stalin, Hitler, etc. combined, pale in comparison to the death and suffering wrought by one American bureaucrat.

DDT, the UN and Malaria
DDT was actually banned without much objection for reasons other than environmental. Resistance to DDT, especially among mosquito populations, was rampant because of mis-use and over use. While it was and is a tool that would help control malaria, almost solely as a surface spread around housing, no pesticide can be used as DDT was in the 1950s and retain its efficacy.

The UN is indeed incapable of fulfilling its roll. Most of the UN organization like the FAO are all but bankrupt and will require infusions of probably American dollars to save them. The UN's health mission is faced with corrupt governments, especially in the malaria and filarial belt and also its own bureaucratic inefficiencies.

While DDT could help in a integrated pest control program, permithrin treated bed netting reduces childhood malaria by considerably more thant 50%. That is assuming the national and local governments even allow their distribution.

Of course the single biggest problem with the UN is the USA pays most of the bills while at the same time allowing other countries to control how the money is spent. The left in the USA acts like anyone suggesting that the USA actually have a say over how it money is spent are evil. We aren't evil, since it is to our benefit that malaria be eliminated; we are just stupid for not demanding more accountability.

Is it irony?
Looney liberals want companies like Novartis to develop, then give away drugs, then they complain that the same companies have a monopoly on losing money?

No Subject
Follow the money. Someone is getting paid off to approve this.

following the money
Yeah, they don't want the drug companies to make any money, but the functionaries at outfits like WHO, etc do make a lot of money themselves. Those parasitic beaurocrats keep trying to think up schemes for themselves to benefit. So I avoid investing in companies like Novartis, that are expected to give away their products.

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