The authors suggest that the reluctance is "apparently motivated by the belief that the publicity will harm the sales of brand-name products in a fiercely competitive business."
Up to 15% of all drugs sold worldwide--worth over $35 billion--are fakes. In parts of Africa and Asia, the situation is even more serious--over half of purchased drugs are fakes.
The estimated 192,000 patients killed by fake drugs in China alone in 2001 gives an indication of the health consequences of counterfeiting. The recent discovery of fake HIV medicines in Central Africa "raises the prospect of a disastrous setback in the treatment of AIDS in sub-Saharan Africa, unless vigorous action is taken now," say the authors.
As the second Global Forum on Pharmaceutical Anticounterfeiting gets underway in Paris next week (March 15-17), the article outlines examples of counterfeiting around the world. The authors, who include tropical medicine experts Professor Nick White and Dr. Paul Newton from Oxford University, United Kingdom, and Mahidol University, Thailand, and drug regulators Dr. Dora Akunyili of Nigeria and Mr. Kyeremateng Agyarko of Ghana, will present their provocative findings at the Paris meeting.
The problem is enormous. The authors report, for example, that in December of 2000, Belgian customs seized 57,600 packs of fake GSK Halfan (anti-malarial) capsules en route from China to Nigeria. The counterfeiters in China were preparing to export 43 tons of counterfeits of 17 brands of drugs from seven international pharmaceutical companies.
Although drug companies have sometimes voluntarily issued public alerts when they have discovered that their drugs have been counterfeited or tampered with, Cockburn said that they have not found one country where companies have a legal duty to report such discoveries to public-health or trade authorities.
Professor White said, "The production of sub-standard and fake drugs is a vast and under-reported problem and seems to be increasing. It causes unnecessary deaths and illnesses and a loss of confidence in medicines. The pharmaceutical industry is a big benefit to our health but it is harming patients and itself by not warning the public of fake products when they arise."
Dr. Akunyili, the Director-General of Nigeria's National Agency for Food and Drug Administration and Control said, "We will issue a fake medicine warning even if we find it in only one shop. We don't defend companies. We are defending the people."
Cockburn believes that "the suffering of millions of patients could be eased by issuing public health warnings from available information that is currently kept confidential by the pharmaceutical industry."
"Our report urges a change to mandatory reporting by drug companies to governmental authorities, which should also have a legal duty to investigate, issue appropriate warnings and share information across borders."
The authors argue that a "multifaceted approach" is needed to control the global epidemic of counterfeit and substandard drugs. This approach should include:
Citation: Cockburn R, Newton PN, Agyarko EK, White NJ (2005) The global threat of counterfeit drugs: Why industry and governments must communicate the dangers. PLoS Med 2(4): e100.
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