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Safety of drug supply: Tougher laws needed to stem counterfeit drug rings

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The FDA has warned that the U.S. drug supply is a potential target for terrorism. On March 29, 2006, the federal Joint Terrorism Task Force unsealed an indictment charging 19 people with operating a global crime and terrorism ring spanning Lebanon, Canada, China, Brazil, Paraguay and the United States. The ring sold counterfeit drugs and other contraband materials, directing its profits to support the criminal terrorist group Hezbollah. This federal announcement is another example of the growing trend linking international crime, terrorism and the drug supply.

Critical stakeholders in the industry must be engaged to combat these crimes with new laws and tougher punishments for violators. Drug supply issues will be addressed at the San Diego health law conference hosted by the Institute of Health Law Studies this June. The conference will bring together intelligence personnel, such as the FBI, Homeland Security and U.S. Customs officials, as well as international and pharmaceutical agencies and health policy experts, to discuss what action policymakers must take to ensure that prescription drugs are packaged and distributed safely.

The drug supply chain

While the traditional drug supply chain is often considered safe, vulnerabilities, such as the gray market and Internet, provide opportunities for criminals and terrorists to exploit the drug supply for their own nefarious purposes.

With 3.5 billion U.S. prescriptions filled annually, approximately 350 million prescriptions are affected by the gray market, where drugs change hands many times between small wholesalers, pharmacies and repackagers before reaching the patient. Furthermore, Internet sales operations have been found manufacturing 500,000 fake pills a day and selling them around the world. Patients have been harmed with fakes, cheating them out of treatments for cholesterol, cancer, HIV and transplantation.

Major drug supply vulnerabilities

Selling fake drugs is the perfect crime. Health care providers have almost no suspicion of fakes, attributing therapeutic failure to the patient's disease, condition or age. Diseases like hypertension and high cholesterol are "silent," thus fakes cannot easily be detected by symptom changes. Packaging is thrown away, the "drug" metabolized, and few lab tests are available to determine the presence of the actual drug. Finally, patients often do not wish to tell doctors they bought prescriptions over the Internet or in another country, fearing provider reproach. Hence, no one suspects, no one tells and no one detects the fake drugs.

Selling fake drugs is also the perfect crime because of weak penalties. In South America, illicit cocaine and heroin peddling is penalized by 15 years incarceration; yet, fake licit drug production and sale results in only six months with perpetrators out in days on bail. In the United States and United Kingdom, faking a trademark can result in 10 years incarceration; faking a drug only up to three years, and often no time at all. In Asia, faking licit drugs usually results in no more than six months -- and can be avoided through payment of a fine. With high profits, low detection risk and low penalties, selling fake drugs is indeed the perfect crime.

Solutions

This trade is high-profit and low-risk. While there has been recognition of terrorist and international crime organization presence in drug piracy and its risk to the world drug supply, there have been limited efforts to provide a solution to prevent these crimes.

In an effort to better facilitate discussion on the issue and educate stakeholder groups, the aforementioned conference entitled "Terrorism, International Crime and Medicine Security: Issues in a Global Marketplace" will propose interdisciplinary ideas and solutions to protect patients and better engage law enforcement, provider, industry and patient cooperation.

Solutions to drug supply crime and terrorism must be multidimensional. First, technology investment is key. Radio-frequency ID (RFID) tags are being developed and pilot-tested to track and authenticate medicines. But technology cannot be the only solution, since RFID, as well as holograms, tamper-proof labels, embossing, thermo-reactive ink and DNA markers, only track packaging, not product. Hence alone, they are necessary but not sufficient.

Technology must be coordinated with intelligence activities, including FBI, U.S. Customs and Border Protection investigations and international data sharing efforts. A reporting system that integrates Web, e-mail and other means of data entry available to these agencies -- and to patients and providers to report suspect drugs -- would be ideal for GIS thematic mapping and investigation purposes.

Most importantly, patient and provider awareness is critical. Patients must understand the risks associated with suspect sources, and providers must have suspicion if and when therapeutic failure occurs for no apparent reason.


Liang is a professor at California Western School of Law in San Diego, where he directs the Institute of Health Law Studies. For more information on the June 9 conference, go to www.CaliforniaWestern.edu/ihls.>

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