Nigerian health authorities found a fake
version of a meningitis A vaccine, branded Mencevax, on March 15th after
the Niger’s health department launched a campaign to inoculate 6 million
children against the disease. The bogus drugs were discovered during a routine
inspection of a private pharmacy located in the capital of Niger. During
another outbreak in 2017, Nigerian officials found vials alleged to be the
Mencevax vaccine, but which contained only water. In early February, Geramil
Trading in the Philippines was closed for selling and administering a fake
rabies vaccine. And in July of 2018, Chinese vaccine makers Changsheng
Biotechnology and Wuhan Institute of Biological Products was discovered to have
produced substandard rabies and diphtheria-pertussis-tetanus vaccines.
Counterfeit vaccines, and counterfeit medications in general, are
a significant and nefarious challenge that the healthcare community faces.
Counterfeit medicine has been around about as long as medical science, and the
market for fake medications is an incredibly profitably business on the black
market. Indeed, the counterfeit medicine business is often more lucrative than
that of illicit drugs: according to the International Anti-Counterfeit
Medicines Institute, an estimated US$1,000 invested in falsified drugs results
in a US$500,000 profit. Further, the World Health Organization
estimates that roughly €73 billion of illegal counterfeit
medications are traded annually. And, according to the WHO, more than 30 percent of medicines in
circulation in areas of Africa, Asia, and South America are counterfeit. (By
comparison, the United States of America and Western Europe see less than 1
percent of counterfeit medications in circulation.) To compound the issue,
counterfeit drugs can be made anywhere and shipped to any country in the world,
a process facilitated by the anonymous internet – and one that makes justice
much more challenging for authorities.
The black market for counterfeit medications at once undermines
legitimate drug-making businesses and policy-making, and can place the public
directly in harm’s way. For example, if a counterfeit drug contains the correct active agent at an
incorrect dosage a busy healthcare professional might
accidentally overlook the discrepancy. Unwitting patients, especially in a
developing country, may simply place too much trust in a “licensed” pharmacy
and unknowingly purchase a medication that has negligible, or at worst, harmful
or fatal, effects on the patient. As such, victims might come to mistrust
healthcare providers and the treatments they provide – an understandable
reaction, but one that has potentially disastrous long-term consequences.
From a biopharmaceutical company’s perspective, fake medications
serve to directly undermine the millions of dollars and man-hours invested into
the development of the copied drug or vaccine. These biopharmaceutical
companies normally turn a profit from selling viable patented drugs, and when
counterfeit copies are smuggled into the market those companies suddenly find
themselves competing with their own brand. Further, counterfeits can drive
generic drugs off the market altogether as companies and providers find their
manufacturing prices skyrocket due to anti-counterfeiting legislation.
Companies will thus look to cut costs by removing their least profitable drugs
from production, which in turn drives up the cost of that drug – and the
subsequent demand, if not met by a legitimate manufacturer, might allow for an
enterprising but fraudulent provider to fill the gap.
Many countries have little to no regulation to effectively
minimize counterfeiting activities to begin with. Those countries that do have some form of legislation often
do not establish sufficiently severe forms of punishment to dissuade
counterfeiters, or do not effectively apply proper countermeasures to deter
them. Even countries that do enact good legislation, however, still face the
task of implementing the law – a challenge made more difficult by porous
borders and vulnerable supply chains, a lack of transnational jurisdiction or
agreement, and the internet. Furthermore, drugs are expensive, and
counterfeiters know it. They take advantage both of the high costs of medicine
and of faulty health coverage systems so as to illicitly distribute counterfeit
medicine to unwitting patients. Medications comprise a significant percentage
of medical costs, and if a patient in an emerging country – or any country, for
that matter – faces huge costs, they will invariably look for cheaper prices.
Unfortunately, without the regulation required to mitigate counterfeit
medications, the search for cheaper drugs can often turn into a dangerous
gamble for the patient.
To be sure, counterfeiting medications threatens worldwide global health initiatives. If the world’s most vulnerable are vaccinated with an ineffectual or toxic knockoff, the consequences for that person, family, or community could be fatal. Even if they were to survive the poorly-made treatment the disease against which the medication was supposed to mitigate could kill the patient, and herd immunity throughout the community would be weakened.
The good news is, awareness of counterfeit medication scandals
ultimately leads to better treatment and less harm done to patients and
communities. Healthcare organizations around the world are working to actively
combat the counterfeit medication threat and cooperate with other organizations
and governments to curtail counterfeiting activities. Ultimately, education and
information are key. National and international governments and organizations
are responsible for relentlessly uncovering illegal activities and pursuing
fraudsters. Further organization and infrastructure are certainly needed to win
this battle, though, and every member of the healthcare community should become
involved in protecting patients against the dangers of counterfeit medications.
Jon Hamilton earned his Master’s Degree in Biohazardous Threat Agents and Emerging Infectious Diseases from Georgetown University. He was briefly involved in Healthcare Association of Hawaii’s Ebola Virus Disease Prevention working group during the 2014 EVD outbreak. He has also worked with and done research for infectious disease physicians in Honolulu and at the National Institutes of Health in Washington, D.C. When Jon is not researching or writing, he can be found surfing in sunny San Diego, California, where he currently resides. Jon can be reached on LinkedIn or at firstname.lastname@example.org.