Dangerous Liaisons: Terrorism and Pharma - Pharmaceutical Executive


Dangerous Liaisons: Terrorism and Pharma

Pharmaceutical Executive

US drug supply: The weak link

For decades, the production and sale of fake drugs were largely confined to the third world; the danger was mostly to solid dosage forms. Recently, fake solid and injectable brand drugs have penetrated the industrialized economies, exposing both the industry and its customers to more risks than might meet the eye.

Chronic shortages of generic injectable drugs have driven gray market prices up by thousands of percent—making them, for the first time, candidates for potential counterfeiting. Counterfeiters today may feel they have even greater latitude in picking from a whole panel of short-supply injectables, due to the shortages of many very basic drugs and their less complex generic labels and packaging. The potential "market" for fakes of generic injectable drugs extends to thousands of hospital and clinics—covering even more territory than the brand injectable drugs they've counterfeited to date.

The FDA has discovered fake injectable brand drugs in United States hospitals and clinics. First to appear were fake Procrit and Epogen, then fake Avastin. Some of these fakes originate with domestic criminals; others with as-yet unidentified foreign manufacturers.

Beyond the fake erectile-dysfunction and narcotic drugs sold on the Internet, investigators have found in US pharmacies near-perfect truly counterfeit Lipitor tablets containing atorvastatin, packaged along with diverted overseas-manufactured tablets of the genuine drug, assembled in counterfeit dose packs.

Baxter's tragic experience with long-trusted Chinese suppliers of heparin precursor—the substitution of that key ingredient with a toxic chemical was designed to fool the incoming US factory assay—demonstrated the vulnerability of both brand and generic companies to overtly criminal economically motivated adulteration by overseas vendors in their raw materials supply chain.

These criminal exploitations of gaps in the US drug system have been noted by terrorist groups and rogue states. A "failure of imagination" could result from companies failing to consider how committed criminal, political, and terrorist groups might seek to exploit gaps in their employment screening, computer networks, or supply chains to insert fake versions—even toxic fakes—into their distribution channels.

The global pharmaceutical industry has been specifically targeted by the leftist international hacking organization "Anonymous," whose sympathies appear closely allied with those of violent animal rights groups that have targeted pharma in the past, and with terrorist organizations known to finance their activities through the sale of counterfeit amphetamine Captagon and fake Western drugs.

Hackers of unknown origin or intent have successfully penetrated the computer networks of Pfizer, Abbott, and Boston Scientific. Those penetrations may have lasted a month or more until discovered.

Criminals hacked into the computers of America's largest security company, ADT, obtaining vital security data from companies which was then used to break in and steal from their warehouses and trucks. One of their targets was a drug supply warehouse for Eli Lilly, from which they stole $75 million in inventory covering a wide range of drugs. Other companies whose drugs were stolen and then resold include Glaxo SmithKline and Novo Nordisk, as thieves targeted both warehouses and long distance trucks.

The stolen Novo Nordisk cargo was insulin, which other criminals then sold to small distributors who resold it to the giant Kroger pharmacy chain, which inadvertently bought it even after an FDA warning. Fortune magazine claimed one patient in Ohio who took the insulin went into convulsions; another, in Texas, saw his blood sugar spike.

Counterfeit Avastin manufactured in the Middle East penetrated both European and United States gray-market distribution, and was discovered being administered to patients—after passing through the lawless conflict-zone in Syria.

Middle East terrorist factions of Hezbollah and HAMAS have been cited by the US Drug Enforcement Agency as manufacturing millions of dollars annually in counterfeit prescription drugs and amphetamines and selling them through criminal networks, both in the Middle East and Latin America. Nineteen Hezbollah operatives in Michigan who ordinarily specialized in dealing in untaxed cigarettes, were indicted in 2006 by a Federal grand jury for trafficking as many as 50,000 counterfeit Viagra tablets into the United States from Canada, and transmitting proceeds from their operations to Hezbollah. Four years earlier, the DEA discovered a similar operation smuggling large quantities of pseudoephedrine from Canada—destined for methamphetamine manufacturing in the Midwest and Mexico, with profits going to Hezbollah.

Hezbollah, HAMAS, and Iran have developed their own hacking teams, with evidence that they operate both alone and with the assistance of Russian criminal gangs. Hezbollah took responsibility for having hacked into the networks of the US banking giant Wells Fargo. Bank of America and CitiBank have also been hacked.


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