Efforts to identify and intercept phony medication have taken on a greater urgency amid increased concerns that tampering and counterfeiting may become an attractive vehicle for organized crime rings and even terrorists.
The profitability of expensive new drugs used to combat cancer and other diseases along with the growth of Internet and cross-border purchasing appears to have raised the potential for exploitation motivated by both greed and politics.
"There is a concern about potential vulnerability, but its an issue that requires responsible analysis and not hysteria," said Lewis Kontnik, J.D., a spokesman for Reconnaissance International, a Colorado-based consulting firm that specializes in anti-counterfeiting measures.
"Counterfeiting is motivated primarily by greed ... . So far its been an economic motivation although there is the potential for political motivation such as terrorism. Right now its a footnote issue but one that people are concerned about," Kontnik said.
Biotech Drug Targets
In addition to producing outright copies of popular and expensive drugs, there have been cases of diluting or otherwise adulterating pharmaceuticals with worthless "filler," affixing high-potency labels on lower-potency products, changing expiration dates, reselling expired medication, and even substituting worthless or harmful compounds as brand-name or well-known pharmaceuticals.
"Over the last 2 years theres been a real spate of tampering with or copying high value drugs that were largely injectables; now the trend seems to be more in changing labelsbuying low potency materials then affixing high potency labels," Kontnik said.
In early May, vials of the anti-anemia drug Epogen were discovered with phony lot numbers. After analyzing the contents, the drugs manufacturer, Amgen, sent letters alerting pharmacists and distributors that the vials each contained 2,000 units of the drugfar less than the 40,000 claimed on the labels.
A month later, manufacturer Ortho Biotech Products issued a warning to health care professionals that counterfeit lot numbers of their anti-anemia drug Procrit had been uncovered in Texas. Discovered during the Epogen investigation, the Procrit vials were also found to contain concentrations of the active ingredient 20 times lower than the amount listed on the labels.
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Nevertheless, according to U.S. Food and Drug Administration spokesman Jason Brodsky, counterfeit drugs currently make up a low percentage of all drugs purchased in the United States. The perception that cases of counterfeiting and tampering are growing comes from better reporting, from manufacturers increasingly "going public" with alerts, and from reports that counterfeit drugs have been unwittingly purchased online from foreign sources.
Foreign Sources
Thus far, the counterfeiting targets discovered in the United States have been largely the popular and expensive "high-value pharmaceuticals"cancer drugs, performance-enhancing growth hormones, drugs used to treat AIDS, and Viagra. In other parts of the world, however, anti-malaria drugs, antibiotics, and even common analgesics have become counterfeiting targets.
According to the international police agency Interpol, at least 5% of the world pharmaceutical trade involves counterfeit drugs, and up to 60% of medicines in the developing world may be counterfeit. Not only has this cost the drug industry more than $12 billion annually, but it has also resulted in an untold number of deaths. This vulnerability was recently illustrated when 109 Nigerian children died after taking counterfeit paracetamol (acetaminophen) syrup.
Although manyif not mostcounterfeit drugs are manufactured and distributed in India, China, Brazil, South Africa, and Russia, they are poised to make their way to the U.S. market. That is because they are increasingly turning up at pharmacies in Mexico and other intermediary countries and through difficult-to-trace online pharmacies. As a growing number of Americans attempt to save money by purchasing their medication in Canada, Mexico, and other foreign countries or through the Internet, the number of counterfeit or adulterated drugs making their way into the U.S. market is potentially staggering.
"Once the consumer leaves this country to purchase drugs via the Internet or otherwise, they are forgoing U.S. protections and putting themselves at risk for receiving a counterfeit or expired product. We encourage them not to purchase their products from online pharmacies operating outside U.S. law," Brodsky said.
But not all online pharmacies are suspect. A substantial number serve rural areas or provide lower-cost services under insurance or other plans. Tips for identifying online pharmacies that are based in the United States and fall under FDA scrutiny are available from local FDA offices or through the FDAs Web site (www.fda.gov), Brodsky said.
Meanwhile, 14 U.S. and European pharmaceutical manufacturers have backed a relatively new organization that assists in coordinating various anti-counterfeiting initiatives. Headquartered in Vienna, Va., the Pharmaceutical Security Institute (PSI) is a nonprofit clearinghouse that monitors counterfeiting operations in the U.S. and abroad by collecting, analyzing, and sharing intelligence information.
At the same time, lawmakers, regulatory officials, manufacturers, and security experts are discussing the potential for pharmaceuticals to become a target for terrorists. They are moving quickly to develop and launch a plethora of anti-tampering and anti-counterfeiting measures.
For example, PSI, FDA, U.S. Customs, and the Federal Bureau of Investigation are working together to assess pharmaceutical security during manufacturing, distribution, and dispensing. Even federal lawmakers took on the problem during a series of hearings in June on drug importation.
And at the end of September (after this issue of the Journal went to press) officials from the World Health Organization, FDA, PSI, the humanitarian group Doctors Without Borders, the Russian Association of Pharmaceutical Manufacturers, and more than 100 other global drug industry representatives met in Geneva, Switzerland, at the First Global Forum on Pharmaceutical Anti-Counterfeiting.
According to Thomas Kubic, PSIs executive director and a former FBI agent, there is general agreement that counterfeit pharmaceuticals would be "a very attractive target for terrorists" both as a way to generate money as well as a way to wreak havoc.
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Both Kontnik and Kubic point out that manufacturers are pursuing new technologies that would make counterfeiting more difficult, if not impossible. According to the FDAs Brodsky, these efforts include the design of new packaging techniques such as blister packs, holograms, package inserts, and other "innovative" but secret new anti-tampering measures.
Alertness is Crucial
Ultimately, experts agree that the responsibility for identifying and reporting tampering and counterfeiting will continue to rest with alert consumers, pharmacists, and other health professionals.
"Alertness is a key element; right now this [drug counterfeiting] is an issue but not an epidemic," said Kontnik. "In a number of cases, counterfeits were spotted by the patients and not pharmacists or distributors. Its often consumers who notice [that] something theyve been taking is now a different shape or color or theyve had a different reaction to their medication."
Kubic advised that patients should bring any discrepancies to the attention of their pharmacists. Consumers can also report suspicions to the manufacturer, the local FDA office or national Web site (http://www.fda.gov/medwatch), or even their local law enforcement authorities.
"At present, the incidence of counterfeiting at the corner pharmacy is fairly low in the U.S. but is a bigger concern in developing countries. Unless youre ordering pharmaceuticals online where you dont have face-to-face contact with a pharmacist or buying in a foreign country, you can be fairly confident in a high degree of safety," Kubic said.
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