Originally appeared in TheJournalNews.com, February 16, 2004
(Original publication: February 16, 2004)
(The writer, a New Rochelle resident, is anattorney representing Timothy Fagan.)
Westchester County is launching a discount drug program that allows residents to import drugs from Canada. In doing so, we step into the Wild West of the pharmaceutical drug trade, endangering the health of program participants by exposure to counterfeit drugs, and subjecting county taxpayers to liability when counterfeits injure or kill the participants.
According to the Food and Drug Administration, there were about five investigations per year in the late 1990sof domestic counterfeiting of prescription drugs. There are now more than 20.
Westchester and other localities that have engaged in similar conduct are doing so without comprehending the scope of the problem or the ramifications of its action.
Counterfeit medications in this country are a silent, deadly and underappreciated public-health risk. These “drugs “will often target the people most at risk in our society because they are the ones that use the most expensive drugs, the ones most often counterfeited. Since counterfeits may be almost impossible to detect, and they already flow through some of the largest pharmacies and wholesale drug distributors in the country, local officials are naive if they believe they can protect us merely by being careful with the pharmacies they select in Canada.
A single incident of counterfeit drugs may affect tens of thousands of people, such as the counterfeiting and recall last year of the popular cholesterol drug Lipitor (200,000 bottles)and the injection of the expensive anemia drug Procrit into an estimated25,000 high-risk people. Recently, federal drug and customs officials seized 2,000 packages of foreign versions of American pharmaceuticals imported from Canada. Nearly all of them, officials said, might not be safe.
How does this happen? Usually, pharmaceuticals in the United States travel a direct path from manufacturer to authorized wholesaler to pharmacy. But this is not always the case. Sometimes, the drugs travel a circuitous path from manufacturer through multiple middlemen to a pharmacy.
In February 2003, a Florida grand jury stated that “an alarming percentage of the drugs flowing through the wholesale market have been illegally acquired. That is, they have been stolen from shipments, pharmacies, clinics, and hospitals; purchased on the black market from recipients and health care professionals who are defrauding insurance companies or Medicaid with bogus prescriptions; or illegally imported from overseas.”
Because drugs can be purchased for less on this secondary market, filled with thousands of smaller, unauthorized dealers selling goods of sometimes dubious quality, larger wholesalers may buy them to save money. Essentially, these middlemen, unseen by the public, are playing Russian roulette with the health, safety and well-being of the public by gambling that the drugs they purchased on this secondary market are legitimate. The drugs are then sold to your pharmacy. In effect, there are some who are gambling without lives by engaging in willful blindness to the counterfeiting activity for the sake of profit. By doing so, they enable counterfeiters to thrive.
Timothy Fagan, now an Iona College freshman, is symbolic of this badly flawed distribution system. Tim had an emergency liver transplant in February 2002. Afterwards, he was prescribed weekly injections of Apogent, a costly anemia drug. For two months, Tim was injected with a counterfeit version. He received his drugs from a division of a large, reputable pharmacy chain. The pharmacy received the counterfeits from the largest drug wholesaler in the country. The counterfeits he was injected with apparently had their original labels stripped off and were re-labeled. Tim could not possibly have discovered the counterfeits on his own. In addition to painful side effects, he remained anemic.
If the largest drug companies in the country cannot, or will not, control the vulnerabilities of the U.S. drug distribution chain because it’s cheaper to buy from the gray market, how are local governments to oversee Canada’s distribution chain, which itself imports drugs from many other countries? If our local governments dabble in outside drugs, we exponentially increase the risks of bogus drugs flowing in and causing injury or death. We also expose local government, and therefore taxpayers, to liability for facilitating the introduction of the bad drugs and the damage they cause.
Many local governments are grappling with how to make medications more affordable. While the goal may be laudable, and the remedy suggested may, in fact, decrease the cost, it comes at a steep and unappreciated price: Neither the consumer nor the local government will know where the drugs originated or the hands they passed through. Do local officials really want to further openour medicine chests to suspect medications?