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The Economic and Public Health Impact of Fentanyl Contamination in the United States’ Counterfeit Drug Industry

September 19, 2018
According to a July 2016 report by the Drug Enforcement Agency (DEA), fentanyl contamination of counterfeit drugs has become a global threat.[1] While virtually all pharmaceutical medications and medical products can be found either diverted, adulterated or completely falsified on the black market, in recent years counterfeit opioids containing the extremely potent substance fentanyl have emerged as an incredibly dangerous threat affecting United States consumers.

Fentanyl, a synthetic opioid originally created treat severe pain (often experienced by cancer patients), is 50 to 100 times more powerful than morphine and 50 times more potent than heroin.[2][3][4] While it’s origins are relatively innocuous and its correctly-prescribed use has definite medical benefits, Fentanyl has become the fastest-growing opioid to be diverted from the pharmaceutical industry, and abused by opioid addicts due to its potency. The CDC reports that from 2015 to 2016 alone, that overdoses from the abuse of illicitly used synthetic opioids like fentanyl and tramadol grew 100 percent.[5] It also reports that seizures of substances testing positive for fentanyl contamination rose by 426 percent from 2013 to 2014.[6] The same reports cited by the CDC show that the increases in synthetic opioid-related deaths “are being driven by increases in fentanyl-involved overdose deaths, which are likely the result of illicitly-manufactured fentanyl.This is supported by the 2016 findings of the Morbidity and Mortality Weekly Report, which found that while there was a strong correlation between synthetic opioid deaths and increased fentanyl-positive seizures in 27 out of 50 states, there was not a significant increase in legal fentanyl prescription rates.[7] The data suggests that these deaths and seizures are the unfortunate result of illicitly-manufactured fentanyl. This reflects a consequence commonly observed in the wake of the United States’ growing counterfeit drug industry made even deadlier by the potency of fentanyl: the risk of abuse and adulteration. In its most-commonly abused form, fentanyl, is usually illegally-made and laced with other opioids such as heroin and even other non-opioid addictive substances (such as cocaine). Due to the proliferation of the drug’s abuse and the insidious nature of America’s counterfeit drug industry, the current state of affairs is unfortunately poised for the rise in the abuse of counterfeit fentanyl.

In many ways, the contamination of counterfeit drugs with the powerful synthetic opioid fentanyl represents the convergence of two of the most deadly and ominous threats to the American healthcare system: the counterfeit drug industry and the opioid crisis. The counterfeit drug industry is certainly no stranger to the international black market. Counterfeit drugs are dangerous due to the lack of FDA regulation and quality control in their manufacturing.[8] Whoever takes counterfeit medicines runs the risk of a variety of dangers.[9] They may be taking the wrong dose, the drug may not be up to current potency standards, the drug may be laced with other drugs, etc. Recently, the sobering effects of counterfeit medicines on global relief efforts on international aid efforts. As recently as November 2017, the World Health Organization estimated that approximately 1 in 10 of all medical products in developing countries is either substandard or falsified.[10][11] Of these, antimalarials and antibiotics were the most common. These frightening findings are the result of 100 peer-reviewed surveys from 2007 to 2016 spanning across 88 countries. Of these surveys, the dire consequences are internationally known. In 2011, contaminated heart medications killed 200 people in Pakistan. And from 2014 to 2015, over a thousand people were hospitalized in the Democratic Republic of Congo after taking a fake drug. NPR interviewed Kristina Acri, an economist from Colorado College who has studied the effects of the counterfeit drug industry since 2000, who stated that there is indeed a tremendous incentive to manufacturing these deadly fakes: it is incredibly profitable. This incentive and global threat has now unfortunately coupled with the convenience and prevalence of the Internet to introduce mass quantities of illicitly manufactured fentanyls into the US market.

With the proliferation of the Internet, the threat of counterfeit medicines has now become a perfect storm in the United States. The domestic counterfeit drug market has converged these factors into a situation that exploits vulnerable American consumers. The proliferation of the Internet in the late 90’s to early 2000’s led to a boom in the number of online pharmacies in existence. The availability of buying drugs (counterfeit or otherwise) had never been greater. Since the internet pharmacy boom of that time, there has been a steady stream of counterfeit drugs infiltrating the global market. Initially “designer drugs” like Viagra and diet drugs were the most popular, and a large portion of these drugs were diverted from the legal pharmaceutical industry. By 2009, the estimated amount of Internet pharmacy sales in the US had totaled $11 billion.[12] For example, in the case of United States v. Vincent Chhabra, et al. (E.D. Va.), one subject in the case owned at least 50-websites for his Internet pharmacy business, was affiliated with hundreds of other Internet pharmacy websites, and sold at least $155 million in sales diverted from the pharmaceutical industry. This subject business garnered a lot of clientele due to the convenience it provided its customers and the fact that it circumvented the need to physically see a doctor for these drugs. In this particular case, the drugs weren’t illegally made. They were obtained via prescriptions hastily written by co-conspirator doctors. However, in the years that have followed, the Internet’s use as a platform for the proliferation of the counterfeit drug industry has grown to be more toxic than large-scale prescription drug diversion.

While Internet pharmacies certainly still do exist, the Internet is utilized in every stage of the industry. In 2016, the DEA published its report entitled Counterfeit Prescription Pills Containing Fentanyls: A Global Threat in which it claims that “hundreds of thousands of counterfeit prescription pills, some containing deadly amounts of fentanyls, have been introduced into U.S. drug markets.”[13] The CDC reported in 2017 that the approximate “economic burden” of prescription opioid abuse in the US has reached $78.5 billion a year.[14][15] This figure includes “the costs of health care, lost productivity, addiction treatment, and criminal justice involvement.” Of the hundreds of thousands of counterfeit prescription pills, the DEA also reported that the from August 2013 to the end of 2015, US law enforcement agencies seized approximately 239 kilograms of illicitly manufactured fentanyls. The danger of such a quantity is heightened when one considers that a small lethal dose of fentanyl is thought to only be 2 milligrams. This amount doesn’t just threaten opioid addicts, an amount that small is also a threat to law enforcement officers who run the risk of accidental overdoses via skin contact or accidental inhalation.[16] Additionally, fentanyl contamination of counterfeit drugs doesn’t only affect drug abusers who misuse opioids. Fentanyl has also been found in counterfeit benzodiazepines such as Xanax and other kinds counterfeit drugs sold on the streets. This increases the risk of Fentanyl overdoses to encompass not only opioid addicts but a broader consumer base of users of commonly-prescribed drugs for non-drug addiction related purposes. American consumers looking for cheaper drug prices are also at risk of Fentanyl overdose via contaminated counterfeit drugs.

Image: Map depicting the flow of illicitly manufactured fentanyls from China to North America. Source: DEA.

Image: Map depicting the flow of illicitly manufactured fentanyls from China to North America. Source: DEA.

This influx of both illicitly-manufactured fentanyls and the materials needed to make them has created a multifaceted and international supply chain which starts in Chinese black markets, passes through Canada and Mexico and eventually makes its way into the hands of vulnerable American consumers.[17] China has emerged as the leading source of fentanyl-powder, the main chemical ingredients in commonly-abused prescription drugs like benzodiazepines and opioids, and the technology required to make them (pill presses). Once purchased from China, illicitly manufactured fentanyls make their way into the USA through two major venues.[18] They are made in Canada and Mexico and smuggled across the border into the US, or the manufacturing materials are bought by American domestic pill manufacturers and made in the US. While the US Government’s Drug Enforcement Agency requires all purchased pill presses be registered with the Agency, there are loopholes in that regulation that is frequently exploited. Pill presses ordered from Chinese online retailers are often mislabeled or shipped in parts, thus escaping the detection of the government surveillance.

Image: Google Search Results for the phrase “buy pill press”, 8/27/2018.Image: Google Search Results for the phrase “buy pill press”, 8/27/2018.

In summary, the current risk of fentanyl overdose due to contaminated counterfeit medications presents the American public with a multi-faceted and insidious danger. This crisis puts opioid addicts, counterfeit prescription pill buyers, law enforcement, emergency response personnel, children, healthcare providers and more at risk of fentanyl exposure and overdose. While authorities are learning all they can about the different manifestations of illicitly-made fentanyls both sold on the streets, via the Internet and across national borders, the economic and social impact of this public health crisis is proving to have become America’s fastest growing and most difficult public policy obstacle.

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