Drug companies accused of ignoring counterfeits

LONDON - 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 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 ever issued to enable consumers to spot the counterfeit versions.

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

In southeast 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 major pharmaceutical companies of the more than 70 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 discovered one of their drugs was being counterfeited.

Nicholas White, professor of tropical medicine at the University of Oxford in the UK and Mahidol University in Bangkok, Thailand, one of the authors, 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 World Health Organisation in 1999. It recommended compulsory reporting but between 1999 and 2002 WHO received only 84 reports and since 2002 it has received none, the researchers say.

At the International Conference of Drug Regulatory Authorities in Madrid in February 2004, 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 email 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.

"I was on the northwest 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 World Health Organisation estimates 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 to voluntarily report cases of counterfeiting to the FDA 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."

- INDEPENDENT