Fake drugs and the plague that never lifts

To pharmaceutical firms, legitimate replicas and outright fakes are much the same: neither make them money. But to sufferers in the developing world, the difference is life and death. Charles Ebikeme on the big business of counterfeit medicine in the developing world.

Starch, wax most often found in the head cavities of sperm whales, and the flowering plant gentianae — these are the ingredients to a concoction that looks remarkably like the anti-malarial drug quinine. The difference being that it is cheaper and most definitely quite useless.

For much of its history, quinine has been seen as the drug of choice for malaria — the most expensive of the preparations that came from the cinchona bark (the peruvian tree with fever curative properties). And for much of history, there was still no discernible test to tell apart fake concoctions from the real thing — outside of a delicate taste that was hard to explain and only acquired by keen practice.

The late days of the British Raj in India, where colonial medicine was viewed as a tool of the empire, set the scene for a problem the officials at the time called “adulteration.” By 1939 it was estimated that 60% of all quinine on the subcontinent was fraudulent in one way or another. A unique set of circumstances — from weak indian productions combined with low imports failed to meet the needs of patients — planted the seeds for drug fraud and opening up the temptation for rogue trading. The problem of fake medicines only increased as the second world war drove up the price of imported drugs.

For as long as there have been medicines, there have been those that have sought to fake them. The editor of the Indian medical gazette wrote in 1932 “we can think of no more despicable act than selling to a malaria-stricken peasant as “quinine” a tablet containing nothing but chalk or some such inactive substance… If these are a fair sample of quinine tablets on the market, it is obvious that the most serious adulteration is going on within the country”.

It wasn’t until the interwar period that officials in India started to respond to the problem on a more serious level. At the time the testing for purity of medicines wasn’t a common occurrence, officials choosing to focus on narcotics and poisons instead. Officials were often more adept at keeping opium pure than it was at safeguarding quinine. It would take much of the 20th century to provide workable scientific tests to back legal standards for medicinal drugs.

Some of the drugs and devices often labeled "counterfeit" are actually faithful replicas of more-expensive brand names, produced so that patients in poor countries can have access to life-saving medication. Others, however, are out-and-out fakes, and it's not always easy to tell the difference.

Fake medicines are the winner on the dark side of globalisation, with a shadow market economy that is unprecedented, unknown, immense and outside any one organisation’s control. Certainly, the World Health Organisation has admitted that 30% of countries have “no drug regulations, or a capacity that hardly functions.”

Today, the Asian subcontinent is notorious for trafficking of illicit counterfeit medicines and medical devices. A large proportion of the world’s counterfeit medicines originate somewhere in Asia, with most ending up in Africa. Over 60% of malaria-endemic countries have no information on the quality of medicines used within their borders.

Since the British Raj, the main actors have changed but the story stays the same.

Qinghao (“blue-green herb”) is the Chinese name for a relatively common plant otherwise known as Artemisia annua or sweet wormwood. Chinese herbalists have known of its curative properties for more than 2,000 years. One of the earliest known records was in the book 52 Prescriptions, discovered in the Mawangdui tomb of the Han Dynasty in 168 BC, where it was first described for the treatment of hemorrhoids.

Artemisinin-based combination therapies (ACTs) have become the modern treatment-of-choice for malaria, with a three-day therapeutic programme curing more than 95% of patients. In countries where malaria is prevalent, antimalarials are the most widely taken drug and therefore ripe for adulteration (often described as “blockbuster” drugs for counterfeiters). The picture of the global counterfeiting trade amounts to somewhere in the region of 75 $ billion yearly. With a market that large, the incentive is there.

And with this also comes a new form of adulteration. Adulteration that is more sophisticated that simple starch tablets. In 2006, it was estimated that at least 12 different types of counterfeit antimalarials were in circulation within the Asian region. Concoctions of chalk, sugar, and washing powder have been found as imitation antimalarials. Outdated drugs are sometimes repackaged and resold. Other medicines, such as the antibiotic erythromycin, are passed off as antimalarials. Some fake tablets are a combination of too-small amounts of the active antimalarial and the pain-reliever paracetamol.

All this points to a counterfeit market system that possibly stems all the way to the source.

The south-east Asia region is home to the largest uncharacterized population at risk of malaria. Within the region sits the major suppliers of artemisia annua (the artemesia farmers). And it is estimated that close to 50% of the oral ACT market is supplied by five leading Asian manufacturers based in India. It is perhaps no coincidence that the Greater Mekong Subregion has been a focal-point for the emergence of drug resistant malaria. As the fakes that contain none or insufficient amounts of the active ingredient mean that the malaria parasite has a chance to adapt and build up a resistance (something that is of great worry as artemisinin is has a short half-life in the human body).

It is the extent that is worrying. With over 60% of malaria-endemic countries having no information on the quality of medicines used within their borders, the fear is the damage has already been done. And with only three laboratories in sub-Saharan Africa and five in South-east Asia pre-qualified by the WHO as capable of accurately analyzing the quality of antimalarials. The problem isn’t going to get any better any time soon.

A part of the problem is embedded in law. The Indian Drug and Cosmetic Act of 1940 was meant to be a central piece of legislation regulating the manufacture, sale, and quality of drugs and formulations, but for many years has proved ineffective. The definition it provides of "spurious drugs" makes no link to or defines the term "counterfeit drugs" — helping to confuse the issue between real-but-grey-market drugs and fake drugs The penalty for counterfeit drug manufacture in India is imprisonment for not less than 3 years and a fine of 5000 rupees (a size insignificant in comparison to the profits made). Even though laws exist, they are rarely implemented in letter or in spirit.

India, now the leading supplier of low-cost generic drugs to Africa and sometimes known as the pharmacy of the developing world, has begun fighting back to counter the confusion surrounding counterfeit drugs in the region. Recently, Nigeria threatened to ban the import of all drugs from India. Citing the high prevalence of counterfeits amongst their imports. It is issues such as these that impact "brand India". Some have even gone as far as to challenge this to allege that several other counterfeit companies are manufacturing "Made in India" drugs for sale in Africa.

The dramatic rise in reports of poor quality artemisinin malarials, which are currently the only line of defense against malaria, point to a losing battle. The speed at which parasites develop resistance means that the damage has most likely already been done. A man-made public health hazard in the waiting.

Photo illustration courtesy of Shutterstock

Published 8:45 am Mon, Jun 2, 2014

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