CDC Report ‘Likely Underestimated’ Deaths Linked to Counterfeit Drugs

By Pat Anson, PNN Editor

A new report from the Centers for Disease Control and Prevention found that fatal overdoses in the U.S. from counterfeit medication more than doubled in recent years, with 93% of those deaths involving illicit fentanyl.

Deaths from counterfeit pills rose from 2% of all overdoses in the third quarter of 2019 to 4.7% of drug deaths in the last quarter of 2021, according to the CDC’s Morbidity and Mortality Weekly Report (MMWR). The overdose rate from fake medication was three times higher in western U.S. states (14.7%). 

However, due the unreliability of death certificates, witnesses and coroner investigations, as well as other flaws in the study’s methodology, the MMWR report acknowledges that the number of deaths involving counterfeit medication is “likely underestimated.”

CDC researchers only looked at overdose data from 34 states and the District of Columbia, identifying 2,437 deaths linked to counterfeit pills during the 30-month study period.

Nearly 106,700 people in the U.S. died from drug overdoses in 2021, so if the 4.7% death rate was applied to that year alone, that would suggest there were over 5,000 deaths nationwide involving counterfeit medication.

Even that estimate is probably on the low end, because CDC researchers focused on counterfeit pills made to look like oxycodone and the anti-anxiety drug alprazolam (Xanax).

While “Mexican Oxy” – blue tablets that look like 30mg oxycodone – are favored by counterfeiters, fake pills are also designed to look like Vicodin, Norco, Adderall, and many other medications. Deaths from those pills were not counted.  

Importantly, whether a death was even linked to fake medication “depended largely on scene or witness evidence of pill use” and other anecdotal evidence, rather than toxicology tests on the pills or the actual people who died.

And while pills are obviously designed to be taken orally, the MMWR report only includes “noningestion routes of drug use,” such as smoking, snorting or injection, which require the pills to be ground into powder or liquefied. CDC researchers considered data on the oral ingestion of counterfeit pills so unreliable, “that information is not presented” in the report.

Many of these details on the study’s strange methodology are buried in the footnotes of the MMWR report, which a casual reader could easily miss. 

Not surprisingly, given the limitations on data, smoking was found to have an outsized role in overdose deaths. According to the MMWR, nearly 40% of the deaths linked to counterfeit medication involved smoking – a misleading statistic, given the study’s flaws. But that didn’t stop researchers from drawing conclusions or recommending “safer smoking practices.”

“The higher percentage of deaths with evidence of drug use by smoking might reflect recent general shifts from injecting drugs to smoking them in western states or could be specific to counterfeit pill use methods,” wrote lead author Julie O’Donnell, PhD, an epidemiologist at the CDC’s National Center for Injury Prevention and Control.

“Harm reduction services that expand outreach to persons using drugs by methods other than injection, such as smoking, and provide education about safer smoking practices and risks related to smoking, might be most successful at addressing diverse drug use patterns.”

There’s a safer way to smoke illicit fentanyl?

This is the CDC’s first MMWR report to look exclusively at deaths caused by fake pills, a public health crisis that the agency has been slow to acknowledge. The DEA started warning about a “fentanyl crisis” as far back as 2016, a time when the CDC was preoccupied with its guideline to reduce opioid prescribing.

There were major flaws in CDC research even back then. The agency eventually admitted that thousands of overdose deaths linked to illicit fentanyl and other street drugs were misclassified as deaths caused by prescription opioids. Some deaths that involved more than one drug were counted multiple times.

Mexican Pharmacies Sell Counterfeit Drugs to U.S. Tourists

By Pat Anson, PNN Editor

With opioid pain medication increasingly harder to obtain in the United States, a growing number of Americans are heading south of the border to get painkillers and other prescription drugs in Mexico.  That’s a risky activity, according to UCLA researchers, who found it was fairly common for Mexican pharmacies to sell counterfeit medication to unsuspecting tourists.

The researchers visited 40 pharmacies in Northern Mexico and purchased samples of oxycodone, hydrocodone, Xanax and Adderall, most of which were obtained without a prescription. Immunoassay testing strips were then used to check each pill for the presence of fentanyls, benzodiazepines, amphetamines and methamphetamines.

Eleven of the 40 pharmacies were found to be selling counterfeit drugs. Of the 27 “oxycodone” tablets purchased, 11 were made with either illicit fentanyl or heroin. One pill sold as “Vicodin” only contained lactose and the weaker opioid tramadol.

Nine of the 11 “Adderall” pills contained methamphetamine, while none of the Xanax pills were found to be counterfeit.  

The study findings were first reported online in medRxiv, a website that publishes new medical research before it is peer-reviewed.

FAKE OXYCODONE PILLS

“It is not possible to distinguish counterfeit medications based on appearance, because authentic and counterfeit versions are often sold in close geographic proximity and are visually and otherwise indistinguishable from one another. Nevertheless, US tourists may be more trusting of controlled substances purchased directly from pharmacies,” the UCLA researchers said, noting that overdoses are poorly monitored in Mexico, making it difficult to know how many people have died from taking counterfeit pills.

Researchers say the growing trade in counterfeit drugs – both north and south of the border – is due in part to a decade-long crackdown on prescription opioids. Since 2010, opioid prescriptions in the U.S. have fallen by nearly 50 percent.

“These decreases have been shown to have affected many patients with known painful chronic conditions, including terminal cancer, and other palliative care patients. Many patients have been rapidly tapered off opioid regimens, which has been associated with increased rates of suicide and drug overdose. A large unmet demand for diverted and legitimate prescription opioids has led to widespread consumption of counterfeit opioids in the US by witting and unwitting consumers,” researchers said.

One such case involves Jessica Fujimaki, a 42-year-old intractable pain patient, who lost access to opioids after the DEA suspended her doctor’s license to prescribe controlled substances last November. Desperate for relief and going into withdrawal, Fujimaki and her husband made two trips to Mexico from their home in Arizona to buy opioids, but were uncertain of the quality of drugs they purchased. She died in December.   

‘These Are Really Strong!’

Perhaps the most widely available counterfeit drug is “Mexican Oxy” – small blue pills that are designed to look like 30mg oxycodone pills. One of the UCLA researchers asked for oxycodone when he visited a Mexican pharmacy:

“We head into the pharmacy and ask for Oxy. The pharmacy employee flashes us a smile and says ‘I have Mexican Oxy or I have American Oxy. American Oxy is 35$ for 20mg, and Mexican Oxy is 20$ for 30mg.’

‘Why is the Mexican Oxy stronger and cheaper?’ I ask.

‘Oh the Mexican oxy is very strong, but it’s cheaper because they give it to us for cheaper,’ he says. ‘You should only take half, and even that’s going to be a lot. The full one might be too dangerous.’

I say, ‘Okay, we’ll take the Mexican Oxy.’ He goes under the counter and pulls out a cardboard box full of syringes. He reaches underneath the needles, and pulls up this false bottom on the box, and the bottom is full of these little blue pills, just loose in the box.

He takes one out of the pile and puts it in a little plastic bag for us. As he hands it to me. He’s says, ‘Okay guys, these are really strong! Please be careful.’”

When that “Mexican Oxy” pill was analyzed later, it tested positive for fentanyl.  

Two reporters for the Los Angeles Times recently found how easy it is to get counterfeit medication in Mexico when they visited pharmacies in Tijuana, Cabo San Lucas and several other northwestern cities. The reporters found that 71% of the 17 pills they purchased were fake. The “oxycodone” and “hydrocodone” pills tested positive for fentanyl, while pills sold as “Adderall” tested positive for methamphetamine.

Asked to comment on the Times investigation, the U.S. State Department, DEA and the White House Office of National Drug Control Policy failed to respond to repeated inquiries. Local and national government agencies in Mexico also ignored requests for comment.

Most of the drug experts interviewed by the Times said they’d never before heard of pharmacies selling counterfeit pills.

“I haven’t seen anything like that,” said Cecilia Farfán-Mendez, a researcher at UC San Diego’s Center of U.S.-Mexican Studies. “I think it speaks to the lack of law enforcement monitoring what’s happening in the pharmacies.”

9.6 Million Counterfeit Pills Made with Fentanyl Seized in 2021

By Pat Anson, PNN Editor

Seven years after the Drug Enforcement Administration issued its first nationwide alert about the emergence of illicit fentanyl in street drugs, the fentanyl crisis continues to escalate and overdose deaths keep rising.

A new study by the National Institute of Drug Abuse (NIDA) estimates that 2,416 kilograms (5,326 pounds) of illicit fentanyl powder were seized by U.S. law enforcement agencies in the last three months of 2021. According to a DEA estimate of fentanyl’s lethality, that’s enough to kill 1.2 billion people.  

That’s not the worst part, according to researchers. The number of counterfeit pills made with fentanyl is also growing and now make up about 29% of all seizures. Over 9.6 million counterfeit pills were seized by law enforcement last year.

“An increase in illicit pills containing fentanyl points to a new and increasingly dangerous period in the United States,” NIDA Director Nora Volkow, MD, said in a statement. “Pills are often taken or snorted by people who are more naïve to drug use, and who have lower tolerances. When a pill is contaminated with fentanyl, as is now often the case, poisoning can easily occur.”

In the last quarter of 2021, over two million counterfeit pills laced with fentanyl were seized – a 4,850% increase from the same period in 2018.

Counterfeit pills are particularly worrisome because they are easy to manufacture, transport and sell -- and most people who buy them have no idea if they’re getting a potentially lethal dose of fentanyl. Counterfeit pills known on the street as “Mexican Oxy” or “M30” look nearly identical to 30mg oxycodone pills.

Because fentanyl is up to 100 times more potent than morphine and 50 times more potent than heroin, it doesn’t take much to kill someone. The DEA estimates that nearly half of counterfeit pills contain at least 2mg of illicit fentanyl, a potentially lethal dose.

“What is particularly concerning is that fentanyl is now often pressed into counterfeit pills which resemble oxycodone (e.g., blue “M30″ pills), hydrocodone, or benzodiazepines such as alprazolam. This is alarming because a large portion of people who misuse psychoactive prescription pills such as opioids or benzodiazepines obtain them from nonmedical sources, thus increasing the likelihood of users unintentionally ingesting fentanyl through counterfeit pills,” lead author Joseph Palamar, PhD, a drug epidemiologist at NYU’s Grossman School of Medicine, reported in the journal Drug and Alcohol Dependence.

Illicit fentanyl was first detected in cocaine, heroin and other U.S. street drugs in 2014. Two years later, counterfeit pills made with fentanyl also began appearing, around the same time the CDC released a guideline that discourages doctors from prescribing opioids for chronic pain.

Faced with pressure from Congress to crackdown on painkillers, the DEA began reducing the legal supply of opioids in 2017. The agency has reduced opioid production quotas for five consecutive years, cutting the supply of hydrocodone and oxycodone in half.

In 2021, the DEA quietly acknowledged that drug cartels were actively targeting pain sufferers as potential customers.  A DEA report said nearly two-thirds of people who misused pain medication “identified relieving pain as the main purpose” of their drug use.

Cutting back on legal opioid medication has clearly backfired. The CDC recently reported that over 105,000 Americans died of drug overdoses in the 12-month period ending October 2021, a record number. About two-thirds of those deaths involved synthetic opioids such as fentanyl.

The risks of fentanyl and counterfeit pills should be well-known by now, but Palamar and his colleagues say a surprising number of people are oblivious to the danger. They cited a recent study of nightclub attendees – a group at high risk of illicit substance use – which found that only half were aware that pills obtained from family, friends or dealers may be counterfeit versions made with fentanyl.

“Public education about the risk of non-pharmacy-sourced pills containing fentanyl needs to be more widespread,” they wrote. “These findings suggest that a substantial portion of people who use illegal drugs appear to be aware that non-pharmacy-sourced pills can contain fentanyl, but less experienced people who may be at risk for use require more education.”

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