Fake pharmaceuticals offer fast profits for their unscrupulous manufacturers, at the expense of the health of the unwitting victims but, reports Russ Swan, technology may hold the answer
The pharmaceutical business can be enormously profitable for those companies that hit on a 'blockbuster' drug with a large market.
Their reward for their vast investment in research and development, keeping many of the world's laboratories busy and providing a stimulus to manufacturers of lab automation equipment, is the profits to be made on sales while a drug remains on patent and - in theory at least - protected from copying.
But those profits lure the criminal element to create fake versions of the real drugs - often with little or no active ingredient - and pass these off as the real thing.
The World Health Organization, WHO, estimates that around 10 per cent of the global drug supply is counterfeit, although for obvious reasons it is impossible to obtain accurate figures.
What is beyond dispute is that, as the global pharmaceutical trade continues to grow (prescriptions in the USA rose over eight per cent in 2006, for instance), the pirates will be trying ever harder to steal some of that trade.
Indeed, the fake drug trade is actually expected to grow faster than the legitimate: a study by the Center for Medicine in the Public Interest, cited by WHO, predicts that the counterfeit drug trade will be worth US$75 billion by 2010 - a 92% increase from 2005.
WHO estimates the current value of the sale of counterfeit pharmaceutical at about $32 billion - or about $5 per year for every person on the planet.
The human cost is often higher: during a meningitis epidemic in Niger in 2000, up to 60,000 patients were treated with a worthless counterfeit vaccine.
About 200 unwanted pregnancies resulted from a fake contraceptive pill in Brazil in 1998.
In Haiti, 75 children died in 1996 after being given counterfeit anti-fever medicine containing the industrial solvent ethylene glycol.
The problem is certainly most pressing in developing countries, but it would be a mistake to assume that it is confined to them.
In late 2007 as many as 5000 counterfeit heart drugs were found to infiltrated the supply chain the the world's largest health provider, the UK's National Health Service (NHS).
And anybody with an email account will be familiar with the daily opportunities offered to buy drugs of dubious provenance and doubtful efficacy.
New technologies to the rescue.
Two new techniques intended to help identify legitimate drugs from their fake counterparts have recently been launched.
Xstream Sysxtems, in Florida, USA, has developed an X-ray diffraction technology which it says can verify the contents of a container without breaking the seal, while DataLase (Widnes, UK) has invented a laser system which can scribe onto individual tablets as an anti-counterfeit technique.
Xstream's technology is the XT250, which the company says enables the testing of powders, pills and entire sealed bottles.
The equipment's sample penetration ability, using energy-dispersive X-ray diffraction (EDXRD), is said to be good enough to allow the identification of contents inside opaque plastic, cardboard, and even metal packaging.
When placed at distribution checkpoints or warehouse facilities, the unit is able to determine fake medications from legitimate inventory, preventing counterfeits from penetrating any further into the supply chain.
DataLase takes a different approach with its laser marking system for tablets.
The technique - completely edible - allows information like product identification numbers and markings (human readable or barcodes) and logos to be recorded directly onto the tablet.
Even patient details, dosage information, use-by dates, and serial numbers can be, ensuring no two tablets are identical, and every one is fully traceable.
The company points out that the technique, which involves use of a colour-changing chemical in the tablets' coating, is completely edible and meets US Food and Drug Administration (FDA) requirements on drug labelling.
These state that human drug and biological product labels must contain numbers that allow healthcare professionals to administer the correct drug, in the right dose, to the right patient, at the right time.
Even better, says Datalase, to put this information directly on the drug instead of simply on the packaging - where it is more vulnerable to tampering.
Further investigation.
The Counterfeit Pharmaceuticals Initiative is a movement coordinated by ICC Commercial Crime Service, a specialised division of the International Chamber of Commerce, which sets out to highlight the growing issues of rogue medicines and provide rapid contact with law enforcement and other authorities who can take action on identified issues.
Its brief is wide-ranging, from the collection and disemination of information to providing independent third-party advice to industry.
In the meantime, June 2008 sees the 4th Global Forum on Pharmaceutical AntiCounterfeiting, to be held in Washington DC.
The conference aims to focus on the issues, strategies and solutions for pharmaceutical anticounterfeiting between the principal stakeholders in pharmaceutical protection (drug regulators, healthcare professionals, manufacturers and anti-counterfeiting technology and service providers) from both developing and industrialised countries.
