Opioid crisis fix attracts foreign counterfeit pharmaceutical drugs


The recent Arizona seizure of 73,000 counterfeit pills containing fentanyl by the U.S. Drug Enforcement Administration (DEA) is a microcosm of what is fueling the nationwide opioid crises. President Trump recently touted that 17 percent fewer opioid prescriptions were written this year compared to last year. With the reduction of opioid prescriptions, one would conclude there would be a corresponding reduction of prescription opioid abusers. To the contrary, opioid addiction and overdose incidents continue at epidemic proportions, with no end in sight.

As part of a national strategy, DEA’s tactical diversion squads pursued pharmaceutical manufacturers, distributors, pharmacies, pharmacists, and doctors, whom the DEA determined were abusing their DEA registration when marketing and over-prescribing opioid medication. Criminal, civil, and administrative sanctions have, and continue to reign in the industry. Gov. Doug Ducey signed Arizona’s “Opioid Epidemic Act” enacting stricter controls on the medical industry’s prescribing of opioids, mandatory participation in a prescription monitoring program, limiting the number of prescription opioid pills for first-time patients, and educating the medical industry on opioid addiction.

Douglas Hebert
Douglas Hebert

It appears government successes in reducing available “legal” pain medication generated an unintended consequence. Mexican drug trafficking organizations filled the void, flooding America with foreign counterfeit prescription drugs, fueling the opioid crises. According to the Center for Disease Control and Prevention, U.S. prescription drug overdoses reached a record 72,000 deaths in 2018. What is disturbing is that more than half of the opioid overdose deaths were from fentanyl, a synthetic heroin manufactured in China.

Fentanyl contained in foreign counterfeit medications, sourced in China and smuggled across the Southwest border by Mexican drug trafficking organizations, supplies millions of addicted Americans. With the precipitous reduction of legal prescription pain medication, patients have turned to the black market to get their pain medications. Patients unwittingly purchase foreign counterfeit drugs disguised as low-level pain medication, unaware of the dangers – they end up as an overdose statistic. There is no question, foreign counterfeit opioid drugs are responsible for thousands of deaths. Despite what we are experiencing with the counterfeit opioid crisis, there are proposals to “legally” allow foreign prescription medications to be imported and sold in the U.S.

We are fortunate the U.S. Food and Drug Administration and the DEA have strict policies and controls over the U.S. pharmaceutical industry. From the manufacturer to the end-user, the FDA and DEA ensure Americans their prescription drugs are legitimate, free from contamination, and safe. These government and industry safeguards in the U.S. do not apply to pharmaceutical drugs of foreign origin. According to the World Customs Organization, pharmaceutical drugs are the No. 1 counterfeited item in the world – a $200 billion a year industry.

International drug trafficking organizations have exploited substandard quality management, unwitting suppliers, and corruption to infiltrate international pharmaceutical supply chains and pharmacies. In many countries, patients risk taking prescription medication with the wrong ingredients, no ingredients, or harmful formulations.

While the impulse of lawmakers to search for ways to address prescription drug availability and costs is understandable, policies allowing foreign prescription drug importation fail to address the bureaucratic complexities of creating an international supply chain; requiring large-scale changes in vetting, screening, packaging, labeling, storing, and security practices.

Not unlike the situation with counterfeit opioid drugs, the unwitting public will gravitate to what is most affordable and available, unaware of the risks that “legally” imported pharmaceutical drugs may be counterfeit.

Introducing legal access to foreign pharmaceutical drugs are not solutions, but vulnerabilities easily exploited and viewed by international criminal organizations as new opportunities to expand their counterfeit drug trade in the U.S. market. Americans are experiencing the realities of insufficient border security and addictions fueled by smuggled foreign counterfeit opioid medications.

Based on our counterfeit opioid drug crises, it’s important to “know your source” when it comes to your medication and beware of advertisers offering large discounts on foreign prescription drugs. Lawmakers and citizens should be skeptical of any proposals to “legally” allow the foreign importation of prescription drugs into the U.S. and placing Americans at risk.

— Douglas Hebert is a retired special agent in charge with the Phoenix bureau of the U.S. Drug Enforcement Administration and a senior investigator with the Arizona Department of Economic Security. Hebert wrote this commentary as a private citizen.

Scottsdale researcher sues U.S. government over quality of marijuana for studies

Sue Sisley
Sue Sisley

A federally-licensed marijuana researcher is suing the government agency that grants her a license to conduct research.

Dr. Sue Sisley has asked the District of Columbia Circuit of the United States Court of Appeals to compel the U.S. Drug Enforcement Agency to allow researchers to use cannabis from sources other than the feds, thereby ending the government’s monopoly on manufacturing the plant for studies.

“Simply put, this cannabis is sub-par,” Sisley’s attorney, Shane Pennington, wrote in the complaint filed in court.

Sisley a few months ago completed her research on the effects of marijuana for veterans with Post Traumatic Stress Disorder, but the results have yet to be published. The DEA had approved that study – the first time the agency has done so for this kind of research.

She said her suit, which she filed in June, is finally getting some traction.

“Groups are offering to submit amicus briefs … we are in good shape to succeed here,” she said, adding that her lawyers even took the case pro bono.

Under the Controlled Substances Act, anyone seeking to manufacture and distribute marijuana must apply to the DEA, but Sisley said for almost 50 years, the only legal source of cannabis for research comes from the University of Mississippi, which she has openly complained about before. Sisley said she just wants the DEA to follow through on its pledge to end the cannabis monopoly at Ole Miss.

“When they announced that [pledge], they were announcing other growers they invited applications in to become a DEA Schedule 1 bulk manufacturer,” she said.

Sisley said she applied to be one about three years ago, but her application has just been sitting there, even though the DEA accepted her application fee.

“My attorneys think it’s unlawful and maybe even unconstitutional,” Sisley said.

She noted that Congress amended the Controlled Substances Act to require the U.S. Attorney General to publish a notice of application no later than 90 days upon receiving an application to manufacture a Schedule I drug, and argued that the DEA is violating the law. But she doesn’t even blame the DEA, speculating that it goes much higher than them.

“We are also suing the Attorney General, not just the DEA because my gut tells me that the DEA is not responsible for impeding this,” she said.

Sisley also said that her research company, Scottsdale Research Institute, has a “great relationship with the DEA.”

“The local office here has been wonderful to work with. They’re very supportive of our work and I’ve never gotten the impression they were ever trying to block anything,” Sisley said.

It’s the national office that has to deal with federal politics, she said.

Sisley said she is not even asking the DEA to accept her application, just to process it, which she believes would open up processing for the other 30 or so applications also sitting there.

She argued that the cannabis Mississippi uses is “suboptimal.”

“Scientists need access to options and we are handcuffed by a government-enforced monopoly that has only allowed me to study this really suboptimal study drug from Mississippi,” she said, claiming the drug provided for studies is moldy, and contains sticks and seeds.

“They are providing this standardized green powder that is just cannabis ground up,” she said, adding that it also is not being tested like it should.

She says by grinding it up into this powder substance is an “overzealous effort to standardize the study drug batches for clinical trials” and the most optimal substance would just be the marijuana flower.

But right now, Sisley says the efficacy research has been systematically impeded by the government ever since the monopoly was put in place and that it’s the final barrier to cannabis research.

“If we don’t end this monopoly and license other growers, we will continue to see cannabis research sabotaged by this low quality study drug, and we will never be able to do real world studies,” Sisley said.