Drug companies 'stay silent about fakes to protect profits'

Pharmaceutical companies in Britain are covering up the discovery of fake versions of their products and contributing to thousands of deaths across the world, an investigation into counterfeit drugs has found.

Pharmaceutical companies in Britain are covering up the discovery of fake versions of their products and contributing to thousands of deaths across the world, an investigation into counterfeit drugs has found.

Fake versions of antibiotics, antimalarials and lifestyle drugs such as slimming and sex aids are flooding the market in some countries but manufacturers of the genuine medicines are reluctant to publicise the problem for fear of harming sales of their branded products, doctors say.

The World Health Organisation (WHO) estimates that fake drugs account for more than 10 per cent of the global medicines market. In parts of Africa and Asia more than half of all drugs are fake, according to the US Food and Drug Agency. Yet few warnings are issued to enable consumers to spot the counterfeit versions.

Researchers from Britain, South-east Asia and Nigeria say annual criminal sales of counterfeit drugs exceed US$35bn. It is estimated that fake drugs led to the deaths of 192,000 patients in China in 2001 who were given ineffective treatments.

In South-east Asia between a third and a half of packets of artesunate, a life-saving antimalarial drug, were found to contain no active ingredient and had no effect against the disease.

"We suggest that the pharmaceutical industry, which is such a benefit to our health, is harming both patients and itself by not vigorously warning the public of fake products when they arise," the authors write in the open access online journal Public Library of Science Medicine.

They warn that companies could be liable to the charge of "corporate killing" if they failed to take steps to warn the public of a fake product.

The researchers wrote to 21 of the more than 70 major pharmaceutical companies with offices in the UK. They received replies from only six, of which three - GlaxoSmithKline, Bristol-Myers Squibb and Novartis - said they would inform local health regulators if they found one of their drugs was being counterfeited.

Nicholas White, one of the authors and a professor of tropical medicine at Oxford University, said yesterday: "The companies have no obligation to do this [report fake versions of their drugs] other than for the public good. Their priority is to their shareholders. In a market economy it is clearly wrong for them to do anything that might damage their products.

"Our solution is to take the responsibility away from the companies. Given the gravity of the situation we think it should be taken up by governments and pursued with vigour. Everyone knows about the problems of heroin and crack cocaine, and even about counterfeit CDs, but they don't know about the problem of fake drugs."

The reluctance of companies to report cases of counterfeiting was highlighted by the WHO in 1999. It recommended compulsory reporting but between 1999 and 2002 the WHO received only 84 reports and since 2002 it has received none.

At the International Conference of Drug Regulatory Authorities in Madrid in February last year, the WHO said "the drugs industry had a great deal of data but was very reluctant to make them available".

The Pharmaceutical Security Institute, set up by drug manufacturers in the US and Europe to combat counterfeiting, said in an e-mail to the researchers: "It is necessary to keep fake drug information confidential for commercial reasons ... If a patient came to harm as a result of a counterfeit product, the company's good reputation is in danger of disappearing."

Professor White said counterfeiting "undoubtedly led to deaths". In Cambodia 70 per cent of the antimalarial drug artesunate sold in shops and markets - which accounts for 90 per cent of the total supply in the country - was fake.

Professor White said: "I was on the north-west border of Thailand with Cambodia two weeks ago and a man came into the clinic with severe malaria and the tablets he had with him were fake. He died the next day."

There are at least one million deaths from malaria annually and the WHO estimates that 200,000 of these might be avoided if the medicines were "effective, of good quality and used correctly".

In the US, pharmaceutical manufacturers agreed in 2003 voluntarily to report cases of counterfeiting to the Federal Drug Agency within five days of discovery. The researchers say this is an advance but "it should be mandated by law and become a global standard".

A spokesman for the Association of the British Pharmaceutical Industry said: "It is not true that companies are covering up cases of counterfeiting. We are very keen on reporting cases as soon as possible and co-operating fully with the regulatory authorities.

"How companies would discover something happening in a country thousands of miles away I don't know. Whether it would be appropriate for an office in this country to take action I don't know. These companies have offices around the world."

Bad medicines

Counterfeiting medicine is a lucrative business. Most counterfeiters caught have been small-scale producers who package worthless ingredients to look like the real thing. Incidents of counterfeit drugs include:

• More than 100,000 malaria tablets bought by a charity in south-east Asia turned out to be fake.
• In Haiti, Nigeria, Bangladesh, India, and Argentina, more than 500 patients, mainly children, died from the use of anti-freeze in the manufacture of fake paracetamol syrup.
• A fake meningitis vaccine distributed in Niger in 1995 is estimated by the World Health Organisation to have led to the deaths of 2,500 people.
• Antidepressants were repackaged as antiretroviral Aids drugs and sold in the Democratic Republic of Congo.
• In the US bottles of Ziagen, an Aids medicine, were relabelled as Combivir. Both are used in combination regimens in Aids treatment and can cause life-threatening reactions.
• In the UK, the Royal Pharmaceutical Society in 2004 found half of all drugs for erectile dysfunction sold online were fake. Customs and Excise seized 231,151 counterfeit Viagra tablets in a single year.
• Serono, an injected growth hormone to prevent muscle-wasting in Aids patients, is targeted by counterfeiters who sell it to bodybuilders. Fake versions have sold online for £900 for seven vials.