Bad pharma

Andrew Smyth
Opinion - Books Thursday, 28 June 2018

Researching his novel brought home to Andrew Smyth the scale of criminal trading of fake drugs

Researching plots takes the writer up many blind alleys, so when I started looking into the pharmaceutical industry, I thought I'd hit the jackpot. The healthcare industry worldwide is huge, and the researcher doesn't have to look far to find murky goings-on. In 2010 GlaxoSmithKline paid out $750m to settle civil and criminal charges that it manufactured and sold adulterated drug products, while a year earlier Pfizer paid out a settlement of $2.3 billion.

But there was a snag. Although these cases involved cover-ups, no one would seriously believe that a publicly quoted pharmaceutical company would deliberately set out to adulterate its products. (Despite looking for a big company as the "baddie", I don't really believe in conspiracy theories.) But I was reluctant to abandon the idea, and I thought about it some more. While a pharmaceutical company doesn't set out deliberately to make fake drugs, a criminal organisation might.

I started to look into the world of counterfeit drugs, but soon discovered that the pharmaceutical companies, although committed to stamping out fakes, don't like to give publicity to the fact that some drugs might not be what they seem. The general feeling appeared to be that it would undermine confidence in the marketplace if there were too much emphasis on the issue.

The other problem in researching the subject is that once the medicine has been administered, it's gone, and there's no way of telling whether it was full strength or just a variant on talcum powder. That means that all the research on the subject is limited.

The main source of information is from international agencies. What I found out from the World Health Organisation (WHO) absolutely staggered me. The WHO estimates the world market for fakes and substandard drugs is worth $30 billion annually, representing 15% of the market in developed countries. In the rest of the world, where detection is more difficult, the problem is even worse. The WHO suggests that one in 10 drugs sold in Africa is "falsified or substandard", and results 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.

This is an astonishing statistic, suggesting that fake drugs may account for almost as many deaths as the diseases they are supposed to be curing. But how to get it to the attention of the world? I thought that writing a thriller about counterfeit pharmaceuticals might help spread awareness of the scale of this criminal trade.

The problem has got worse since drug manufacturing has moved from Europe and the United States to plants mainly in India and China. Supervision has become more difficult, and the absence of oversight is one the main reasons why India's pharmaceutical industry is so profitable. They export over $15 billion annually, yet the WHO estimates that one in five of the drugs is fake. The profit margins can be so huge that Italian police estimate that criminal gangs make more money out of fake drugs than they do out of "traditional" drugs such as heroin.

One investigator reported on a business that in one warehouse was turning out fake pills using 1950s technology, while next door there was a large, state-of-the-art machine, printing the packaging. Unless you open up the package and analyse the contents, how can you possibly know what's inside?

If you buy a Rolex watch for £100 you know it's a fake, but when a fake medicine's packaging is identical to the real thing, it's impossible to tell. And that tells only part of the story, because if the counterfeits contain only reduced quantities of the essential active ingredients, they not only fail to help, but can make the situation worse by increasing drug resistance.

Charities such as the Gates Foundation estimate that 1.5 million children die every year from vaccine-preventable diseases, and that part of the problem is the high cost of vaccines. This leads people to seek out cheaper alternatives, which are often fakes with few or no active ingredients. Part of the foundation's efforts are in reducing the cost and making genuine vaccines more widely available. Micro-chipping is one method of testing authenticity, and there is increasing use of hand-help analysis machines such as the Truscan, which features in my book.

This is a huge problem, and I hope my book starts discussions about how to address it.

Grave Island by Andrew Smyth is out today, 28 June (Bloodhound Books, £8.99).

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