Health

Imagine the outcry if 500 people in a developed country such as the US or UK died after being given a fake medicine. Then consider that in the early 1990s a similar number of children died of kidney failure in India, Haiti, Bangladesh and Nigeria after taking fake paracetamol syrup contaminated with a toxic solvent. Barely anyone noticed bar their families and a few doctors.

Their deaths represent just one documented case of a trade in illicit pharmaceuticals that claims countless lives each year. Victims, mostly among the world's poorest, unwittingly buy fake medicines that often contain toxic substances or little or no active ingredients, yet purport to combat the most common preventable killers, including malaria, tuberculosis and typhoid.

The scale of the problem is laid bare this month in a review published in The Lancet Infectious Diseases (vol 6, p 602). In south-east Asia, for example, half of all medicine sold is thought to be fake, much of it counterfeit versions of new anti-malaria drugs based on the molecule artemisinin, which many believe will be vital in curbing the spread of the disease. In Cambodia, a survey revealed that 71 per cent of the artemisinin-derived drug artesunate sold is fake, while across south-east Asia, 53 per cent of artesunate packs sold in 2002 and 2003 were faked, says lead author Paul Newton of the University of Oxford.

"We're desperately worried that these counterfeit derivatives will follow the real ones into Africa," Newton says. "The very high prevalence of counterfeit artesunate in Asia has emphasised the importance of tackling this trade." Unless it can be stopped, he warns, there is little point in spending vast amounts of money developing new drugs, as they will only be immediately undermined by ineffective or toxic counterfeits.

The World Health Organization is so worried by the trend that this November in Bonn, Germany, it will launch an International Medical Products Anti-Counterfeiting Taskforce, or IMPACT. The aim is to unite all parties involved in tackling in the problem, from pharmaceutical companies, drug regulators and distributors through to Interpol and customs officers.

Experts fear the trade in counterfeit pharmaceuticals kills more people and causes more harm than the trade in illegal narcotics. And it isn't a great deal less lucrative. In 2005, the US Food and Drug Administration estimated that worldwide sales of fake drugs exceeded $3.5 billion, but other estimates suggest the figure is 10 times as high. The Center for Medicines in the Public Interest, a charity backed by the US pharmaceutical industry, predicts that global sales of fake drugs will reach $75 billion by 2010 unless the trade is curtailed.

However, no one can yet be sure how many fake drugs are sold. The pharmaceutical industry first raised the alarm 20 years ago, but law enforcement agencies, governments and charities that donate medicines have paid scant attention. As too have researchers. In his review, Newton found that just 43 academic papers have been published on fake drugs, only one of which used scientifically acceptable methodology.

What's more, a survey he conducted in Laos revealed that two out of three pharmacists and four of five consumers didn't even realise fake drugs existed. The reality is that this trade threatens to undermine global attempts to combat infectious diseases that kill 14 million people, 90 per cent of them in developing countries.

IMPACT will initially focus its efforts in five areas: anti-counterfeiting technology; harmonising legislation; tougher enforcement; strengthening regulatory agencies; and better publicity warning consumers about fakes, says co-founder Howard Zucker, who is the WHO's assistant director-general for health technology and pharmaceuticals.

Strengthening regulatory agencies is key, argues Newton, especially in the one-third of countries worldwide where they barely function. "If you don't have a functioning drug regulatory agency, you can't inspect the drug supply, enforce border checks, prosecute counterfeiters or root out bribes and corruption."

Zucker agrees this is a priority. "If there's no enforcement, nothing else has any teeth," he says. So too does the Global Fund to Fight AIDS, Tuberculosis and Malaria, which spends millions of dollars each year providing drugs to treat these major diseases. Spokeswoman Rosie Vanek says the Global Fund has already approved requests for technical assistance to improve national drug quality-control labs and bolster regulatory authorities. Vanek also stresses that the Global Fund has established measures to "ensure to the greatest possible degree the authenticity of commodities purchased with Global Fund resources".

But Valerio Reggi of the WHO, who will coordinate IMPACT from Geneva, Switzerland, says it won't be easy to root out corruption, especially in countries where inspectors are paid so little that it is worth the risk of taking bribes to turn a blind eye to the trade.

Newton also says that donor agencies must subsidise life-saving drugs so that the real versions price counterfeiters out of the market. "The key is to beat them at their own game." This strategy is supported by the Global Fund, which provides drugs either free or at a small fee.

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