New approach needed in fight against deadly diseases

The growing threat of antimicrobial resistance should concern us all. Our ability to battle basic infections has fueled massive leaps in medical, social and economic progress worldwide throughout the 20th century.

But treating this problem as a failure of the pharmaceutical industry is a mistake. Combating infectious disease is challenging even when effective medicines are cheaply available. For diseases like TB (caused by a bacterial infection) and malaria, access to medicines involves a complex interplay of private sector development and government implementation. When new products finally hit the market, inadequate public health infrastructure-and downright bad government policies-undermine distribution efforts and feed the emergence of medicine resistance as people receive incomplete or substandard treatments.

{mosads}In short, it’s not just about producing cheap drugs, but also making sure that they get to those who require them. Unfortunately many governments prevent the latter while championing ever cheaper medicine production.

Take India, where almost a thousand people die from TB every day. Government authorities require that all new medicines undergo locally conducted clinical trials before approval, even if the drug has already been approved in the U.S. or Europe. This practice is designed to increase clinical trials within India, even when such trials are financially wasteful, and cost lives by delaying treatment.

In the past 18 months, for example, two new medicines have been approved to treat multidrug-resistant TB. But in 2013, Delhi denied approval for one of these medicines, bedaquiline, because it hadn’t gone through local trials. This, despite the fact that the drug already undergone clinical trials elsewhere and had been approved by the U.S. Food and Drug Administration.

India’s drug evaluation process is corrupt, providing opportunities for graft for Indian officials, something India’s own Parliamentary Committee on Health acknowledged in two reports in 2012 and 2013. So while pointless clinical trials may be undertaken, businesses routinely bribe authorities to speed up approval. One investigation found that the country’s regulators have approved at least 31 drugs that have never undergone adequate testing.

These drugs are often of low quality. My research team found that at least 7 per cent of Indian medicines to treat malaria and TB failed basic quality control. More broadly The American Journal of Hygiene and Tropical Medicine recently reported the pervasiveness of low-quality medicines with particular focus on HIV/AIDS, TB and malaria drugs. It found that over 40 percent of the 17,000 medicines studied fail basic quality standards (many of which will have been made in India).

Even when drugs are properly approved, India has failed to establish effective distribution channels. Doctors-often the final and most crucial point of distribution-aren’t receiving proper certification and training.

A 2010 study conducted in Mumbai examined the prescription practices of 106 doctors. Just six-about 5 percent-prescribed the correct TB treatment regimen. And in many instances pharmacists and patients will decide treatment regimens-they are unlikely to do a better job.

These lapses fuel the spread of drug-resistance, especially for TB which typically requires a six-month course of treatment. If a person receives substandard medicine, drug resistance can emerge and spread even faster.

Unfortunately, these problem aren’t confined to India. Many health activists overlook government failures across Africa and Central Asia and reflexively blame drug developers for the lack of treatment for TB and malaria in such locations. They claim the chief problem is
price-developers are simply charging too much for their products.

Obviously more people can be treated with cheaper drugs, but nothing is so expensive as a drug that doesn’t work. Most innovators make no profit from malaria and TB. Novartis even signed an agreement with WHO not to make a profit on its malaria drug Coartem. And while generic makers can often make older drugs cheaper, some (notably Indian manufacturers) cut corners, further driving drug resistance.

Constant focus on drug pricing and criticism of lack of access can discourage developers from investing in new treatments. As Bill Gates, one of the pre-eminent champions for expanding drug access in the developing world, recently put it: “You have some pharma companies
that choose never to do medicines for poor countries because they know that this always just becomes a source of criticism.”

TB and malaria are being combated in poor countries, but drug resistance is rising and controlling such strains is vital. We need better management of existing treatments and the careful deployment of new ones. Rather than complain about drug prices, governments should help developing countries reform their drug approval regulations and strengthen distribution channels so proven drugs get to patients quickly and safely.

Bate is a scholar at the American Enterprise Institute and the author of a new paper “Rational Roll Out of New Medicines for Diseasesof Poverty.”


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