Three counterfeit prescription drugs have reached the shelves of American pharmacies and in some cases have been given to patients. Some phials contained cheap generic versions of the drugs named on the packaging; others contained liquids with no active ingredients.
The drugs involved, all three of which are injectable, are filgrastim (Neupogen), an anticancer drug sold by Amgen; and two versions of the human growth hormone somatropin, Serostim, made by Serono, and Nutropin, which is sold by Genentech.
Genentech issued a warning to patients, physicians, pharmacies, and wholesalers that the counterfeit drug may pose a serious health risk to patients. It also showed how closely the packaging of counterfeited Nutropin AQ resembled the genuine version.
All three drugs are expensive, which could be why the counterfeiters selected them. A 12 week course of Serostim, for example, which is used to treat wasting associated with AIDS, costs $21 000 (£15 000). In the case of Serostim, some patients complained last year of a slight swelling or a skin rash after injections.
All three companies immediately informed the US Food and Drug Administration (FDA), who launched its own investigation in May.
Officials of the US Customs Service said that their seizures of counterfeit and other prescription drugs had risen sharply in recent years. The service seized 9725 parcels of prescription drugs in 1999 compared with 2145 the year before. Most of the seizures were of drugs purchased by Americans from websites operating in foreign countries, but some of the seizures were commercial shipments that were intended for resale.
Alarmed at the public health risk, the US House of Representatives' oversight and investigations subcommittee of the House energy and commerce committee last week held a hearing on the issue. In an opening statement the chairman, Pennsylvania Republican James C Greenwood, said, "We must be aware of the latest threats in the global pharmaceutical market and deal with them."
An array of expert witnesses from the FDA, the Office of National Drug Control Policy, the Drug Enforcement Administration, the United States Custom Service, the National Institute on Drug Abuse, and pharmaceutical companies Novartis, Bristol-Myers Squibb, and GlaxoSmithKline submitted prepared testimony.
The committee found that the counterfeit drugs, produced and packaged to look like the genuine products, presented a danger to citizens because the FDA was unable to monitor the products for quality and safety. It was impossible to know for certain what the medications contained, how they had been produced, where they had been stored, or what the potential side effects were.
Counterfeiters use state of the art technologies, such as desktop publishing, to produce labels that are indistinguishable from the original labels. These labels put false "new" expiration dates on expired products and make adulterated or ineffective drugs look like the real thing. Counterfeiters have the ability to make and stamp tablets with company logos and even to package them in blister packs.
Counterfeiting is prevalent outside the United States and is growing at an alarming pace. A joint workshop of the World Health Organization and the International Federation of Pharmaceutical Manufacturers Associations concluded in 1992 that in some countries as much as 60% of all drugs may be counterfeit.
The WHO has estimated that between 5% and 8% of the worldwide trade in pharmaceuticals is in counterfeits, and that the problem is worse in developing nations than in developed nations such as the United States. The 5-8% range is only an estimate since no one has conducted a systematic study of the worldwide problem of counterfeit medicines.
Factories in China and India are the source of most of the bulk active ingredients used in counterfeit pharmaceuticals worldwide. It is believed that some products are sourced in India, fraudulently labelled in the area around San Diego, California, and then shipped into Mexico for sale to unsuspecting Americans. A 1997 seizure by US customs officials of more than $60m worth of misbranded and counterfeit pharmaceuticals that were destined for drugstores in Tijuana supports this theory. The active ingredients seemed to have originated from India.
The US Customs Service, the Postal Service, and the FDA are struggling to cope with the growing flood of counterfeit drugs that threatens the health of Americans and the integrity of their pharmaceutical companies.
The FDA has recommended that US customs agents at mail inspection sites be required to send back all small foreign drug shipments they find, the only exception being those for "compassionate use," so that seriously ill patients could order drugs from overseas that are unavailable in the United States.
Globally, national laws are often inadequate, and international shipments are not searched or verified in free trade zones. There is also a lack of dedicated enforcement personnel and resources, no specific treaty or set of uniform international obligations, and no staff dedicated to monitoring compliance.
The US House oversight and investigations subcommittee hearing can be accessed at http://www.house.gov/commercewww.house.gov/commerce