“Using data for 2010 through 2019, Aubry and Carr looked at the relationship between prescription opioid sales, measured by morphine milligram equivalents (MME) per capita, and four outcomes: total drug-related deaths, total opioid-related deaths, deaths tied specifically to prescription opioids, and “opioid use disorder” treatment admissions. “The analyses revealed that the direct correlations (i.e., significant, positive slopes) reported by the CDC based on data from 1999 to 2010 no longer exist,” they write. “The relationships between [the outcome variables] and Annual Prescription Opioid Sales (i.e., MME per Capita) are either non-existent or significantly negative/inverse.”
Those findings held true in “a strong majority of states,” Aubry and Carr report. From 2010 through 2019, “there was a statistically significant negative correlation (95% confidence level) between [opioid deaths] and Annual Prescription Opioid Sales in 38 states, with significant positive correlations occurring in only 2 states. Ten states did not exhibit significant (95% confidence level) relationships between overdose deaths and prescription opioid sales during the 2010–2019 time period.””
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“Yet the CDC is still pushing the narrative that more opioid prescribing means more opioid-related deaths.”
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“In light of what has happened since 2010, Aubry and Carr say, relying on those outdated numbers is highly misleading. They say the CDC’s advice “should be corrected/updated to state no direct correlation has existed” between prescription opioid sales and drug-related deaths or treatment admissions since 2010, and “individualized patient care and public health policy should be amended accordingly.””
“Walgreens fills prescriptions. It is not in the business of drug enforcement. If some of the prescriptions filled by Walgreens were written by dirty doctors or went to people who abused them, it is not on individual pharmacists to figure that out.
Expecting pharmacists to be drug cops, too, ensures that more pharmacies will be hesitant to fill legitimate prescriptions, leaving patients in the lurch. It also threatens to worsen America’s pharmacist shortage.
In a number of recent cases, pharmacies and pharmacists have been sued for not filling prescriptions. including opioid prescriptions. It seems we’ve put them in a classic damned if you do, damned if you don’t situation.”
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“To sum it up: Walgreens filled prescriptions for a legal substance, but because some people went on to distribute or use the drugs in ways the government has forbidden, the company has to pay the government huge sums of money. Meanwhile, the inability of people to get prescription painkillers has given way to reliance on much more dangerous substances, like fentanyl, from which many more people are dying of overdoses. People keep taking opioids, and the government keeps making it harder for them to do so safely.”
“In 2018, the Trump administration issued an emergency order that would make it easier to prosecute people for selling so-called fentanyl analogues, drugs that share the same chemical structure of the powerful synthetic painkiller that has helped to fuel the nation’s opioid epidemic. Even as the Trump administration began embracing criminal justice reforms and opioid treatment elsewhere, the temporary order was part of a wider law-and-order crack down on new variations of the substance that had been flourishing in illegal drug markets.
The move was small, but significant. With little fanfare and debate, it gave federal prosecutors across the country sweeping new authority to charge people for federal drug crimes, triggering onerous mandatory minimums without the usual scientific process to determine whether the novel new drugs people peddled were even dangerous.
Yet, it wasn’t just a Trump phenomenon: On Thursday, Congress reauthorized the fentanyl copycat order for the sixth time — and the fifth time since Joe Biden’s inauguration — with broad bipartisan support, extending it to the end of this year. Instead of opposing the stricter enforcement, Biden favors making the order permanent — a move civil rights groups, public health researchers, criminal justice reform experts and other critics argue would further embolden federal law enforcement authorities and disproportionately affect low-income defendants of color. Opponents say it would usher in a remarkable change in drug law, one that criminalizes thousands of substances, some that haven’t even yet been developed, and set a precedent that could eventually extend to other drug categories.”
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“Federal authorities usually go through a multistep checklist to classify, or schedule, an individual drug into a certain category, which then determines how easily it can be researched and whether it merits criminal penalties. Some fentanyl analogues have already been individually tested and scheduled. But the 2018 order puts fentanyl copycats, which can include thousands of substances, into the government’s strictest drug control category — Schedule I, which also includes heroin, marijuana, LSD and ecstasy — without that scientific review. This represents the first time an entire category of drugs has been scheduled based on chemical structure alone.
In some cases, those fentanyl analogues can be more powerful than fentanyl, which is in the slightly less restrictive Schedule II category. But in other cases, analogues can be harmless or even potentially therapeutic. The FDA has testified that at least one new, potential overdose-reversal agent has fallen victim to the class-wide scheduling order.
Prosecutions for fentanyl-related substances soared during the Trump administration as the substance became more ubiquitous. The number of people prosecuted for and convicted of fentanyl-analogue crimes was nearly non-existent in 2016, but grew to 233 in 2019, according to data from the U.S. Sentencing Commission. Nearly 70 percent of those prosecutions targeted Black and Hispanic people, many of them street dealers rather than major drug kingpins, according to the government data.”
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“some defense lawyers worry the impact might be bigger than the data show. Based on her conversations with defense lawyers and independent research, Patricia Richman — national sentencing resource counsel at the Federal Public and Community Defenders, which represents indigent clients in federal cases — argues that many more people are likely being charged under the emergency order. Federal authorities have yet to release updated data on how the law has been used since 2020.”
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“Meanwhile, the opioid crisis has worsened: Drug overdose deaths have reached record levels, topping more than 100,000 in the 12 months ending in September 2021 with death rates among Black people catching up to rates among white people. By June of last year, synthetic opioids, which include fentanyl and related substances, accounted for 65 percent of all drug overdose deaths, representing a massive increase from just a few years earlier.”
“The revised and expanded pain treatment guidelines that the Centers for Disease Control and Prevention (CDC) published today mention “patient abandonment” eight times. They also include two occurrences of this admonition, in bold and italics: “Clinicians should not abandon patients.”
That gives you a sense of the disastrous impact that the original version of the CDC’s advice, published in 2016, had on medical care. Something clearly has gone terribly wrong when clinicians have to be reminded that they are not supposed to abandon patients. At the same time, the CDC’s acknowledgment of the problem signals its willingness to address the needless suffering caused by the 2016 guidelines, which resulted in undertreatment, reckless “tapering” of pain medication, denial of care, and procrustean policies that prioritize reductions in opioid prescribing over the interests of patients.
The original guidelines, which were aimed at primary care physicians and focused on “prescribing opioids for chronic pain,” included grave warnings about the dangers of exceeding 90 morphine milligram equivalents (MMEs) a day. Many physicians, pharmacists, insurers, regulators, and legislators read that threshold as a hard cap, meaning that it should never be exceeded and that chronic pain patients who were already above it should be forced to comply with this arbitrary limit.
Although the 2016 guidelines focused on chronic pain, they also touched on acute pain, because “long-term opioid use often begins with treatment of acute pain.” For acute pain, the CDC said, a prescription for “three days or less will often be sufficient,” while “more than seven days will rarely be needed.” As a result, the CDC notes in the new guidelines, “more than half of all states have passed legislation that limits initial opioid prescriptions for acute pain to a seven day supply or less,” while “many insurers, pharmacy benefit managers, and pharmacies also have enacted similar policies.”
Ostensibly, the guidelines were purely advisory. But in practice, many patients found to their dismay, they were mandatory.”
“The bulk of the illegal synthetic opioids that reach the U.S. are sourced in China by Mexico’s Sinaloa and Jalisco New Generation cartels. They buy from legitimate and illicit Chinese suppliers through “purchases made on the open market, smuggling chemicals hidden in legitimate commercial shipments,” the 2020 DEA National Drug Threat Assessment noted.
Successful bilateral cooperation in combating the fentanyl flow peaked in May 2019 when Xi responded to U.S. pressure by making all forms of fentanyl subject to production controls and anti-trafficking measures. That prompted a drastic reduction in direct shipments of fentanyl and related compounds from China.
But Mexican cartels and their Chinese suppliers quickly pivoted to the export and processing of unregulated chemicals that can be processed into synthetic opioids. The Chinese government moved to block that trade in June by adding six fentanyl precursor chemicals to the list of substances requiring government approval. Chinese suppliers responded by marketing the unregulated raw materials for precursors.
“Drug trafficking organizations adapted to the PRC’s [regulatory controls] of all fentanyl-related substances, and now appear to have increased the purchase of fentanyl precursors from the PRC to manufacture fentanyl in Mexico, indicating a pronounced shift in how fentanyl is trafficked into the United States,” a State Department spokesperson told POLITICO.
The response from Chinese chemical producers and exporters underscores the challenges of regulatory fixes that don’t keep up with the ability of the industry to skirt those laws.
“[Chinese suppliers] are acting like water, they’re just finding the gaps and cracks in the law,” said Bryce Pardo, drug policy researcher at RAND Corp. “They have gone on to [synthetic opioid component chemicals] that are used in all sorts of other medications and other commercial applications that can never be controlled because it would be way too burdensome for industry and genuine consumption purposes to control these other kinds of chemicals.”
On the Hill, China’s role as a drug chemical supplier for illicit synthetic opioids has become a political lightning rod, particularly for lawmakers from states such as Ohio that are suffering soaring increases in synthetic opioid-related overdose deaths.”
“Since 2014, state and local governments have filed thousands of lawsuits against pharmaceutical companies they blame for causing the “opioid crisis” by exaggerating the benefits and minimizing the risks of prescription pain medication. The theory underlying these cases is pretty straightforward: Drug manufacturers lied, and people died.
Two recent rulings—one by a California judge, the other by the Oklahoma Supreme Court—show how misleading this widely accepted narrative is. Both decisions recognize that undertreatment of pain is a real problem and that bona fide patients rarely become addicted to prescription opioids, let alone die as a result.”
“Between 2002 and 2019, according to the federal government’s survey data, the number of Americans who had a “substance use disorder” involving heroin roughly doubled. During that same period, according to the CDC’s data, the annual number of heroin-related deaths septupled, while the total number of opioid-related deaths quadrupled. The war on drugs helps account for that disparity, since it has made opioid use more dangerous”
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“Nowadays fentanyl is showing up in black-market pills sold as hydrocodone or oxycodone and even in stimulants such as cocaine and methamphetamine. Its proliferation is a response to the very supply control measures that were supposed to reduce drug-related deaths. To the extent that the government succeeds in exerting pressure on the supply of illegal intoxicants, it encourages traffickers to distribute more-potent drugs, which are easier to conceal and smuggle.
Since fentanyl is far more potent than heroin, a package weighing less than an ounce can replace one that weighs a couple of pounds. Synthesizing opioids is also a less vulnerable and much cheaper process than production that relies on poppy crops. Researchers at the RAND Corporation estimate that heroin is at least 100 times as expensive to produce as fentanyl, adjusting for potency.
Black-market drugs were already iffy because of prohibition; the prohibition-driven rise of fentanyl has made them even more of a crap shoot. And these are the substitutes nonmedical opioid users resorted to after drug warriors succeeded in driving down prescriptions of analgesics such as hydrocodone and oxycodone. That shift replaced legally produced, reliably dosed pharmaceuticals with illegal drugs of unknown provenance and composition. The result was predictable (and was in fact predicted): As opioid prescriptions fell, opioid-related deaths rose.”
“Although prescription pain medication is commonly blamed for the “opioid epidemic,” such drugs play a small and shrinking role in deaths involving this category of psychoactive substances.”
“Medications like methadone, as well as buprenorphine and naltrexone, are considered the gold standard of care for opioid addiction. Studies show that the medications reduce the mortality rate among those patients by half or more, and keep people in treatment better than non-medication approaches.
Yet rehab facilities in the US often treat medications with skepticism or even scorn, while embracing approaches with little if any peer-reviewed scientific evidence”
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“Medication isn’t the only effective way to treat opioid addiction. Other approaches, including cognitive behavioral therapy, motivational interviewing, and contingency management, also have evidence backing up their ability to treat addiction.
Still, for opioid addiction, medications “should be the first-line option,” Keith Humphreys, a drug policy expert at Stanford, told me. “Not forced, but every single person should be offered that in any decent program treating opioid addiction.””
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“despite their effectiveness, the available medications are often stigmatized with a common trope that they “replace one drug with another.” On its face, this is literally true: The medications do substitute, say, heroin or alcohol.
But the context matters. The issue with addiction is not just drug use. Most people use some kind of drug — caffeine, alcohol, or medications. Some people are even dependent on these drugs, whether someone needs coffee to get going in the morning or insulin to survive.
What makes addiction a medical disorder is not just drug use or even dependence, but continued, compulsive use despite negative consequences. So someone would be unable to stop using heroin even when it poses serious risks to his health, career, or family. It’s only then that drug use becomes a drug use disorder.
The medications alleviate those problems, turning a drug use disorder back into just drug use. That’s why they reduce all sorts of drug-related problems, including the risk of death.”
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““No other medication is prescribed in this way,” Sue, of the Harm Reduction Coalition, said.
Buprenorphine can be prescribed in a traditional health care setting, but it too faces unique restrictions. Doctors have to go through an eight-hour training course to get certification to prescribe it, and nurse practitioners and physician assistants have to go through a 24-hour training course. The restrictions are one reason that, according to the White House opioid commission’s 2017 report, 47 percent of US counties — and 72 percent of the most rural counties — had no physicians who could prescribe buprenorphine as of 2016.
Since methadone and buprenorphine are opioids themselves, the rules are meant to make it harder to get and illegally sell the medications for misuse. (Naltrexone, the non-opioid option, doesn’t face similar restrictions.) But the laws and regulations have also helped create an environment in which rehab facilities are more likely to try unproven methods than medication-based treatments with decades of scientific evidence.”