Counterfeits Kill: Stronger Law Enforcement Needed
When one thinks of counterfeit goods, it can conjure up images of customers being duped into buying inferior quality designer bags or other fashion knockoffs. However, when it comes to the manufacturing, distribution and sale of counterfeit medications, the outcomes can be much more serious and life threatening.
Most consumers probably don’t realize that counterfeit medications have become a big and growing problem in the U.S. In recent years, cancer patients have received counterfeits that contained salt and starch with no active ingredient. In one instance, a counterfeit drug was discovered after a liver transplant patient had not responded to eight weeks of treatment. Counterfeit medications were also found that produced harmful interactions with patient medications. In another case, Chinese-sourced ingredients for a blood thinner were suspected to have resulted in as many as 81 deaths. There are endless examples of harmful counterfeit medications reaching patients, from heart, antibiotic, hair loss and arthritis medications to those for Parkinson’s and HIV-AIDS to injectable treatments such as Botox. The implications are clear – counterfeits can kill and increased law enforcement is necessary to protect the public.
Despite this alarming threat to patient health, just recently, the House Energy and Commerce Committee announced an investigation of the Food and Drug Administration’s (FDA) Office of Criminal Investigations, citing recommendations from two old reports dating back to 2010 and 2012 regarding mundane issues, oversight and performance measures. While insuring that taxpayer money is not wasted and looking for ways to improve government bureaucracy can be useful endeavors, the major mission of the House Committee’s investigation should be to protect public safety.
Enforcement is very difficult to carry out in practice, which makes it an easy target for criticism. Perpetrators are often moving targets, they are clever about creating an appearance of legitimacy, and they take sophisticated steps to make their products and packages appear nearly identical to the original manufacturer, thereby making it hard for patients and doctors to identify legitimate products from illegally imported or counterfeit products.
As consumers have turned to the Internet for discounts and deals, rogue distributors have found yet another opportunity for scamming patients. The results have given rise to Internet pharmacies that have made regulation and oversight appear more like a Whac-A-Mole game. For instance, so-called Canadian Internet pharmacies usually are not Canadian at all, and are based in such places as Belize, Russia and Vietnam, to name a few. Many illegal sellers have online presences that look authentic, claim to be an American-based company, and offer what appears to be a U.S. toll-free number. Yet, these phone numbers use Voice-over-Internet protocol that seamlessly reroute calls to the Philippines or another country out-of-reach from prosecution. Some use online advertising campaigns to sell and dispensed drugs to American’s without a prescription, adding what appears to be some level of legitimacy. Just Google it.
Detecting these counterfeit and illegally imported products is often difficult and time-consuming to do, since many of these goods are passed through a long and complicated distribution network, thereby creating opportunities for counterfeits to enter the supply chain completely undetected. The problem is complex, partly because most legitimate active ingredients are imported.
In some cases, drugs are reimported after changing hands seven or eight times among countries like in China, Bahrain, United Arab Emirates, Lebanon, Oman and elsewhere – all skirting FDA oversight. While some of these foreign drugs may turn out to be authentic, without FDA oversight, doctors and patients have no idea if these drugs were handled properly, contaminated in storage or shipped at unsafe temperatures. This, along with the sheer number of perpetrators, makes apprehension and prosecution more difficult.
How do consumers feel about the issue? According a 2014 survey of 1,000 adult U.S. citizens, 86 percent of respondents believe that the sale of counterfeit medicine and cosmetics pose health risks to U.S. consumers, and 83 percent want stronger criminal penalties to combat the online sale of these and other counterfeit products. Additionally, 89 percent see the sale of counterfeit and pirated goods as negatively affecting American jobs and 90 percent believe that it is bad for the U.S. economy.
Piracy and counterfeiting is costing the U.S. economy several hundred billion dollars each year at a loss of nearly one million jobs. For patients needing medications, the costs are immeasurably high. In addition to the harm to life, counterfeit and illegally imported medications impose costs on the medical system that result in higher costs for consumers. If cutting law enforcement dollars is the objective of the new House Committee probe, then it has misplaced its priorities and has failed its critical mission to protect American citizens.