When people pay £200 for a Rolex, they know it’s going to be fake and substandard. Counterfeit pharmaceuticals, on the other hand, are virtually undetectable yet they represent a huge and almost unknown market.
The extent of the problem is quite staggering. At a recent conference in London, estimates made by the World Health Organisation (WHO) suggest that one in ten drugs sold in Africa are “falsified or substandard”, and result in the deaths of hundreds of thousands annually. Up to 72,000 deaths from childhood pneumonia can be attributed to substandard or fake drugs, while ineffective antimalarials kill over 100,000. When I thought of basing my thriller, Grave Island, on this subject, I was amazed that no one had covered it before – it is one where the truth is almost always more surprising than any fiction.
The pharmaceutical market is labyrinthine in its complexity; manufacturers and distributers try to juggle their products to orientate them to get the highest price in each market, but the manufacturing has changed significantly over the past decade as manufacturing has shifted to low-cost bases such as India, and this in turn means that supervision is weakened. In 2008, adulterated heparin, an anti-coagulant manufactured in China, caused dozens of deaths around the world. But this is the exception, not because it is rare – quite the opposite – but because it was discovered. A vaccination programme against malaria, however, could involve fake vaccines and who would know? Once the medicine has been taken, it’s gone. “China alone has more than 700 firms making drug products for the US,” a US Food and Drug Administration (FDA) commissioner reported to a House hearing, “yet the FDA has resources to conduct only about 20 inspections a year.”
The pharmaceutical industry works across borders and no one country is able to police it effectively which is why we rely on regulatory agencies from numerous countries to share their resources. The FDA is one such, while the Medicines and Health Regulatory Agency (MHRA) is its equivalent in the UK – both feature in Grave Island.
The FDA is now carrying out inspections in India, but it will take some years before this has much effect. The absence of oversight is one the main reasons why India’s pharmaceutical industry is so profitable, Manufacturers reckon that FDA inspection adds 20% to the cost. Ranbaxy, one of their biggest drug companies, was fined $500 million by US authorities for the manufacture and marketing of sub-standard antibiotics and epilepsy medications. The drugs industry is one of India’s most important and they export over $15billion annually but the WHO estimates that one in five are fakes. Counterfeit medicines in a paediatric hospital in Kashmir are suspected to be the cause of hundreds of infant deaths in recent years.
The FDA is trying to increase its staff in China but the government has failed to provide the necessary visas, despite an announced agreement made during Vice-President Joe Biden’s visit there in 2013. But the US negotiating position is limited since most of the ingredients for antibiotics, steroids and other life-saving drugs are now made exclusively in China.
No one can be sure of the exact extent of the illicit trade but estimates by the WHO put it at a market worth £30 billion representing more than 15% of the world market, rising to up to 60% in developing countries. Fake drugs have a high value per unit and one study by the Italian government showed that organised crime groups made several times more from fraudulent medicines as they did from drugs such as cocaine or heroin.
One of the most commonly faked drugs are artisemisinins – antimalarials. In one survey, which analysed the drugs bought randomly in SE Asia, 35% were counterfeit. But the situation is even worse in sub-Saharan Africa where anti-malaria programmes are more widespread. In samples taken in Senegal, 44% were sub-standard. In a recent study, anti-tuberculosis medicines were taken randomly for testing from pharmacies and while overall the failure rate was 9.1% the failure rate in Africa was 16.6% - one in every six pills. But that only tells part of the story because if the counterfeits only contain reduced amount of the essential active ingredients, it not only fails to help the patient but actively make the situation worse by increasingly drug resistance.
A sweep carried out in West Africa in 2012 seized more than 82 million doses of illicit medicines estimated to be worth over $40 million. A former director of the Nigerian Food and Drug Administration agency set out to destroy the country’s counterfeit industry. Firing corrupt officials and blacklisting manufacturers, she drastically reduced the proportion of fakes over an eight year period but it almost killed her. The counterfeiters fought back burning the agency’s laboratories and attempting to kidnap her son. She was ambushed and shot at and a bullet grazed her temple. “Armed robbery may kill a few at a time, but fake drugs kill en masse,” she said.
Such wild-west scenes are not typical, however, since most counterfeiters hide behind respectable fronts. Packaging is an essential part of concealing the origin of counterfeits. In one raid in China the investigator reported that the “warehouse was essentially a dirty shack with a pill press turning them out at 1,000 an hour with 1950s technology, while next door there was a large, shiny machine printing the packaging in pristine conditions. The effort they spend on the pill is nothing, but the level of detail they spend on the packaging is phenomenal.”
My thriller, Grave Island, starts in Afghanistan, where it was found that half of the drugs in the country were smuggled in, with a value approaching $350 million. They entered the main supply chain in Jalalabad where they became impossible to identify. So lucrative is the market that there are some 450 foreign pharmaceuticals companies registered with the health ministry in a country whose total population is just 31 million.
But detection is also improving. Micro-chipping packaging with links to an international database to confirm authenticity is one route. In Grave Island, the protagonist is armed with a hand-held analyser called a Truscan and the technology behind these has made rapid advances to produce a highly portable and relatively inexpensive testing machine.
With the AIDS epidemic in Africa, antiretroviral treatment has become increasingly important. In Tanzania alone the government estimates it has 1.4 million people living with AIDS or HIV, out of a population of 45 million and its free drug programme has had great success in extending lives, but fakes are a huge problem when they are expertly packaged to look exactly like the real thing. But increasing use of portable analysis machines as had remarkable success with the government estimating that it has reduced fakes by three quarters.
People in Africa are buying fake medicines because they can’t afford the real ones. Part of the answer undoubtedly is being able to buy generics at a reasonable price, but there is still a certain amount of ambivalence from the pharmaceutical industries on the issue. But if organisations such as the Gates Foundation can subsidise the cost then the main motive for the counterfeiters – profit – disappears.
But even if detection is increasing, so is the world market with huge vaccination programmes being launched around the world. It is still a highly profitable fraud with little risk of discovery. Grave Island is the story of just one programme that was stopped in time.