April 10, 2008

Bogus Medicines Responsible for Half a Million Deaths a Year

Fake pharmaceutical drugs are fast becoming a major threat across the world. Mostly they are sold over the internet but they are also infiltrated into the neighbourhood pharmacies or local hospitals.

While the bogus medicines are responsible for half a million deaths a year, the death merchants themselves rake in billions of dollars, it has been estimated.

Bogus pharmaceuticals come in all combinations - some with no active ingredient, some with too little active ingredient, others with too much, some with toxic constituents. One seized consignment of phoney Ponstan, a non-steroidal anti-inflammatory, had no active ingredients at all; but it did contain boric acid, a pesticide that can cause renal failure. (The pills' colour came from leaded road paint.) Fake antibiotics have been intercepted that are made of talcum powder, as well as birth-control pills made of rice flour. Other ingredients have ranged from floor polish to rat poison.

The developing world records the majority of such deaths. In China, between 200,000 and 300,000 people are estimated to die each year because of counterfeit or substandard medicines. The WHO estimates that 200,000 of the one million malaria deaths a year would be prevented if all the drugs were genuine.

Fake vaccines killed 2,500 during a meningitis epidemic in Niger in 1995. Eighty-nine children died in Haiti the same year after swallowing paracetamol cough syrup that had been made with cheap, toxic diethylene glycol. In Nigeria in 2003, three children died during open-heart surgery because the adrenaline and suxamethonium, a muscle relaxant, used were fake. Prof Dora Akunyili, the director of the country's food and drug agency, said, 'The evil of fake drugs is worse than the combined scourge of malaria, HIV/Aids, armed robbery and illicit drugs.'

But it is no longer only the developing world that is being duped. In Canada, 58-year-old Marcia Bergeron died just after Christmas 2006 after buying fake Zolpidem, a prescription sleeping pill, on the internet. The pills had been laced with traces of a medley of dangerous metals including uranium, strontium, selenium, arsenic and aluminium.

In 2004 in Chicago, Craig Schmidt, a salesman, bought the anxiety drug Xanax and the painkiller Ultram. He took one of each, and woke up in hospital three weeks later. The 'Xanax', it was found, contained quadruple the usual amount of active ingredient. He suffered a heart attack, coma and brain damage.

It is a huge process keeping track of the death merchants. At its London headquarters, close to the MI6 headquarters on the Thames, Medicines and Healthcare products Regulatory Agency (MHRA) detectives use web-crawling software to continuously search the internet for drugs most likely to be counterfeited at any given time.

There are currently 14 drugs on the 'watch list', which is updated every six months. 'We look for sites with a UK base, selling in sterling - something that brings them into our jurisdiction,' Malik, a senior operator, explains. Test purchases are made from suspicious sellers. 'Sometimes the card is ripped off and nothing arrives,' Malik says. 'Or you can get something different from what you ordered, or a drug that's counterfeit or unlicensed.'

Internet security experts believe that nearly 25 per cent of all emails - 15 billion messages a day - are spam advertising drugs. According to the WHO, more than 50 per cent of medicines offered by websites that conceal their physical addresses are fakes.

'It's front room and back room with the internet. You'll go to the site and there will be an image of a bloke with a white coat and a stethoscope hanging round his neck; they'll be offering all sorts of medicines. When we go round, it's a garage, filthy dirty, mucky, horrible. There are no people in white coats with stethoscopes,' says Mick Deats, a former detective chief super¬intendent who now heads the MHRA's intelligence and enforcement unit.

'There is far less risk [than with cocaine and heroin] and when you look at the money you can make you are going to make more out of this,' he adds.

Steve Allen, a former officer with the National Crime Squad (now the Serious and Organised Crime Agency) and senior director of global security at Pfizer, the world's biggest pharmaceuticals company whose drugs Viagra and the cholesterol-reducing Lipitor top lists of counterfeited medicines, says, 'The chances of detection are pretty low and the penalties don't really fit the crime. If you are bringing in cocaine or heroin, you are going to go to prison for the rest of your life. At the moment if you are smuggling in Viagra you may get a slap on the wrist and a fine.'

The trade extends far beyond Viagra and other 'lifestyle' drugs. Virtually all medicines have been counterfeited - increasingly, criminal gangs have moved into lifesaving medicines including antibiotics, antiretroviral drugs for Aids, and expensive cancer and infertility drugs. At the height of the bird-flu scare, fake doses of the antiviral drug Tamiflu were unleashed on to the world market that contained just vitamin C and lactose.

In Britain between August 2004 and the end of last year there were nine recalls of counterfeit medicines where there was clear evidence that fakes reached pharmacies and patients (four of them last year). In 2004 there were recalls for Cialis, an erectile-dysfunction drug, and for Reductil, an anti-obesity drug.

The following year, 120,000 packs of Lipitor 20mg tablets were withdrawn when counterfeit stocks bearing a valid batch number were discovered in the legitimate supply chain. Half of all the retrieved stocks were proved to be fake.

Last year 10mg tablets of Zyprexa, an anti¬psychotic medication for the treatment of schizophrenia and acute bipolar mania, were withdrawn after a worker, repackaging the tablets (legitimately) for the UK market, became suspicious. The bogus tablets contained only 60 per cent active ingredient; some of these tablets reached patients.

Also last year there were two alerts concerning bogus 75mg tablets of Plavix, an anti-platelet drug given after heart attacks or stroke. In one instance, the fakes had been mixed in with genuine packs.

Worldwide, according to figures collected by the pharmaceutical giant Eli Lilly, customs seized more than three million counterfeit or suspected counterfeit tablets in more than 1,000 separate actions in the two years up to January, writes Eric Clark in an exhaustive article on the issue in the UK newspaper Telegraph.

Counterfeit medicines are easy to produce, low risk and vastly profitable. A drug costing a fraction of a penny can be sold for 50 times as much and more. In one case investigated by the MHRA, 100,000 fake tablets supplied by a Chinese manufacturer for about 25p each were being sold for up to £20 each in the UK, worth £1.6 million in total.

Britain is on the front line, both as Europe's prime target for counterfeiters (medicine prices are high compared with most other EU countries) and as a staging post between producers in the Far East and the medicine-hungry buyers of the United States.

Although the World Health Organisation (WHO) began collecting data on counterfeit drugs in the early 1980s, until about 10 years ago they were regarded as a problem only in countries such as China. The situation has changed quickly: by 2001 counterfeit versions of major prescription medicines were appearing all over Europe.

The WHO estimates the business to be worth £18 billion, a figure that some forecast will more than double in the next two years, to represent about 10 per cent of all pharmaceutical sales worldwide. The WHO also believes that up to 30 per cent of medicines in Russia and in some countries in Africa, Asia and Latin America are counterfeit.

The temptation for counterfeiters to attack the legitimate chain in preference to selling direct to the public is huge. 'Why sell a single packet to John Smith when I can sell 400,000 to John Smith and Company?' Graham Satchwell of the MHRA notes.

Production is not difficult. 'You really don't need a huge amount of skill,' one pharmaceutical company investigator says. Most counterfeiting takes place in south Asia and the Far East, with China the biggest source. The scale varies from small-time entrepreneurs turning out 100 tablets a day to vast factories. Both producers and distributors have become more expert. 'It's a cat-and-mouse game, permanently escalating,' Thomas Thorp, the manager of government affairs for Eli Lilly, says.

'Ten years ago it might take a counterfeiter six months to copy your product once it had come on the market, and the quality of that counterfeit would probably be very poor. We're now seeing counterfeit product in some markets where we haven't even launched the legitimate one. They are getting more and more sophisticated.' Manufacturers of the anti-malarial drug Atesunate added a hologram to the blister foil to differentiate it from fakes: the counterfeiters followed suit in less than a month.

Nearly a third of all counterfeit drugs confiscated in Europe in 2006 came via the United Arab Emirates where free trade zones can be used to muddy the trail. Dubai is especially favoured because of its position between Asia, Europe and Africa. In July last year more than 500,000 fake Plavix tablets were seized near Dubai airport. Some contained cement powder.

The MHRA and the Royal Pharmaceutical Society collaboratively conduct spot checks at pharmacies and distributors. The number has been stepped up and concentrates on the 'hot list' of much-faked drugs, but the total number of batches examined is still in the low thousands - tiny compared with the 750 million prescription items dispensed in each year.

Pharmacists get advice, such as: 'Look for signs of a removed or switched product label.' As counterfeiters use a solvent such as lighter fuel, there may be a tacky residue or fading or discolouring around the edges of the label.

London is a major transit point. London postmarks add reassurance for buyers, and packages carrying them are less likely to attract attention. In one recent case pharmaceutical company investigators found that counterfeits went from the Chinese mainland to Hong Kong, then to the United Arab Emirates and the Bahamas, where individual prescriptions for American internet buyers were filled and put into packets and addressed. These packages then came to the UK where they were stamped and mailed to the US, all to hide tracks and to add credibility.

The situation is indeed alarming, and agencies across the West are gearing up before counterfeits swamp the developed countries.

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