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.
The pharmaceutical industry is less convinced, however. "As long as the cost per unit of a counterfeit is lower than the street price of the real thing, there will be counterfeits," says Harvey Bale, director of the International Federation of Pharmaceutical Manufacturers. He points out that paracetamol (acetaminophen) and the antibiotics ampicillin and amoxycillin are the most widely counterfeited drugs in developing countries, even though they are also the cheapest.
A number of initiatives are to be unveiled in Germany. One option IMPACT will pursue is to give each packet of drugs a code number that can only be read when the seal is broken. The consumer can phone the factory with the number to check their medicine is genuine. Zucker says the precise details are secret for now, but will be revealed in Bonn.
Others include off-the-shelf legislation that nations could adopt to combat counterfeiting, while IMPACT will launch a study to assess the growing threat of fake medicines sold on the internet, and another to gauge the scale of counterfeiting in Africa.
Newton warns not to underestimate the counterfeiters, as their production techniques have become increasingly sophisticated. Often they include small amounts of the real drug to make them more difficult to spot than if they contained no active drug. This practice that promotes the development of drug resistance. "It means that bacteria or parasites see very low concentrations of the active ingredient, enough to select for resistance," says Newton. That could mean future generations of drugs could become obsolete.
Fake packaging is also increasingly sophisticated, says Newton. Some of the artesunate packs he found in Asia even carried holograms like those on the originals. "At the moment, the counterfeiters are winning." But Zucker is more upbeat, and sees the creation of IMPACT as evidence that there is at last the political and international will to do something. "My perception is that there's momentum."
In 1995 in Niger, some 60,000 people were inoculated with fake meningitis vaccine after authorities received a donation of 88,000 doses of purported Pasteur Merieux and SmithKline Beecham vaccines from neighbouring Nigeria. The vaccines contained no traces of the true active ingredient.
192,000 patients in China reportedly died over the course of 2001 after taking fake drugs. In the same year Chinese authorities closed 1300 factories while investigating 480,000 cases of counterfeit drugs worth $57 million. In 2004 they arrested 22 manufacturers of grossly substandard infant milk powder and closed three factories after the death of more than 50 infants.
In North America, there have been recent reports of various counterfeits: human growth hormone; atorvastatin, which is used to lower cholesterol and treat heart disease; erythropoietin, used to alleviate anaemia; filgrastim, used to treat people who have had either leukaemia or a bone marrow transplant; and the anti-cancer drugs germcitabine and paclitaxel.
Antiretrovirals, a long-term drug therapy that helps stop people with HIV from developing AIDS, are already being faked in central Africa. So far, counterfeit versions of the drug combinations stavudine-lamivudine-nevirapine and lamivudine-zidovudine have been identified.
From issue 2568 of New Scientist magazine, 08 September 2006, page 8-9
The Medicines that could Kill Millions
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