Is it true that the drugs produced by American pharmaceutical companies have fostered a foreign, often illegal, drug counterfeit business and substandard or counterfeit drugs? Can such a global epidemic that involves over 124 countries be placed on the doorstep of Big Pharma?
While the North American and European pharmaceutical sales make up “two-thirds of the entire world sales of pharmaceuticals”, it’s noteworthy that only one-fourth of falsified drug sales are made to citizens of these two continents. (1) This reflects that the other three-fourth of sales are to other countries. Unfortunately, the counterfeit drugs are far inferior and often are nothing more than a placebo.
Economics is the leading reason people turn to unregulated pharmaceutical markets. The other is an act of desperation to find a silver bullet cure for diseases conventional medicine cannot cure. Unregulated markets are just as life-threatening as many diseases.
An inside look at these counterfeit drug seller inventories reveals volumes of loose pills and broken-up packs of medications that are easily misidentified. Beyond these significant reasons why people should avoid such markets, potential customers should consider that non-regulation means that not only are the manufacturing practices up for grabs, there is no guarantee of proper handling and storing of the drugs. In fact, these factors could make the drugs either no longer viable or worse, dangerous to take.
Addressing Counterfeit Drugs
In September, 2012, under the direction of Interpol, agencies in over 100 countries responsible for law enforcement, customs and regulatory oversight participated in an international raid on online pharmacies. The results were a staggering arrest of more than 4,100 online sellers. This was a good start, but is like trying to close a gushing wound with a piece of adhesive tape. (2)
How can such a rampant problem be resolved? Many countries don’t have testing facilities to identify whether or not a drug is counterfeit. They are forced to rely on inadequate field kits. In addition, recognizing an imitation illegal drug requires not only expensive equipment, but also specific training; both of which are often out of the reach of impoverished countries.
According to a 2011 report by The Institute of Medicine (IOM), the 124 countries involved in the selling of “illegal medicinal products” are classified as low to middle income nations.
Those purchasing these drugs don’t have insurance co-pays. The IOM stated that 90% of the drugs purchased are paid out-of-pocket.
The IOM placed the blame for this illegal industry on the doorstep of countries’ “poor manufacturing practices…aided by lax regulators or domestic pressures to turn a blind eye to such problems in order to promote local industry”. (1)
The report acknowledged that even with good manufacturing practices, there is still room for poor product control. The example given was the September 2012 pharmaceutical compounding company in Massachusetts and its poor manufacturing practices that was responsible for the death of 44 Americans.
The IOM concluded that policing was also another component of enforcing regulations and it would require a global effort to overcome the current situation. The IOM recommended, “a voluntary international agreement to share systems for surveillance, regulation and law enforcement”. (1)
The US FDA (Federal Drug Administration) currently working with the WHO (World Health Organization) on the issue of falsified pharmaceuticals endorsed the report and requested that the IOM “assess the global public health implications of false medicines”.
IOM suggested that the infusion of more generic medicines and upgraded manufacturing equipment would help lower the current cost of most medicines. These less expensive drugs would then be affordable to those currently purchasing from counterfeit drug manufacturers. (2)
Public Health Concerns
The problems created by falsified medicines and substandard drugs are more than just monetary and purchasing drugs that aren’t good quality or simply don’t perform against illnesses. The use of inferior drugs often creates a form of drug resistance. This in turn means a bigger threat to public health since there is the potential for epidemics with the spread of illnesses.
In addition to a larger number of people becoming infected, there’s also a greater number of untreatable patients. For many people, this drug resistance becomes a death sentence.
Drugs used to treat malaria are a prime example of this ineffectiveness due to drug resistance. The patients are resistant from having previously taken inferior drugs.
Falsified malaria drugs are a $400 million annual business. The UNODC (United Nations Office of Drugs and Crime) compares falsified drug empires to those of oil and cocaine. West African law enforcement has begun seizing counterfeit medicines, but this is just a drop in a very large global bucket.
For example, in Pakistan, the lax drug oversight and poor manufacturing regulations spawned a company that produced heart medication with antimalarial active ingredients. This drug was directly responsible for 120 deaths. (1)
While the IOM, WHO and FDA are all committed to finding a solution to this growing crisis, it often seems an insurmountable issue. The economics that have spawned such a market and the large illegal business machine that runs it create a separate set of problems that must be effectively resolved.
In addition, regulations, manufacturing practices and oversight are vital components to such a global solution. It will require concentrated effort and cooperation between countries, which many of these countries have long-standing politic differences. Another hurdle is regional and ethnicity differences. Until this issue is resolved, the citizens of these countries will continue to suffer.