[e-drug] Fake prescriptions are flooding the US

[Kirsten Myhr <myhr@online.no>]

E-drug: Fake prescriptions are flooding the US
-------------------------------------------------------------------------

BMJ 2001;322:1446 ( 16 June )
News extra
Fake prescription drugs are flooding the United States
Fred Charatan Florida
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/commerce

--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Information and archive http://www.healthnet.org/programs/edrug.html
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to:  `owner-e-drug@usa.healthnet.org'.