Tag: Opioids

Fentanyl as a WMD? The War on Opioids Reaches a New Level of Misinformation

“This is like declaring ‘ecstasy’ as a WMD,” an anonymous source from the Department of Defense counter-WMD community commented incredulously. This source was quoted by a Task and Purpose reporter investigating a Department of Homeland Security internal memo discussing designating the synthetic opioid fentanyl as a weapon of mass destruction. This is just the latest example of how misinformation and hysteria inform federal and state policy regarding the overdose crisis. 

Policy makers maintain their state of denial about the role of prohibition in the overdose crisis. Denial fosters vulnerability to misinformation and “alternative facts” to prop up falsely held views. Denial that the war on drugs is responsible for most of the death and destruction surrounding illicit drug use makes policymakers susceptible to claims about fentanyl that are not based in reality.

Misinformation about fentanyl leads to avoidable stress and overreaction among first responders. But misinformation about the causes of the opioid overdose crisis causes much more harm. 

Lawmakers and policy makers continue to believe the overdose crisis was caused by doctors too liberally prescribing pain pills. This ignores the government’s own data that shows there is no correlation between the number of pills prescribed and the incidence of nonmedical use or pain reliever use disorder. It ignores evidence that nonmedical drug use was on a steady exponential increase well before the doctors began prescribing more liberally, and is showing no signs of letting up. As I have written before, the main driver of the overdose crisis has always been prohibition. Policies that fail to recognize this and focus on reducing prescriptions only serve to drive nonmedical users to more dangerous drugs and make patients suffer in the process.

The WMD hypothesis probably derives from a lone instance in 2002 when fentanyl was pumped into a Moscow theater by Russian police to end a hostage crisis, resulting in nearly 200 deaths. The means by which it was aerosolized have never been made public. Much remains secret. American authorities believe a second disabling substance might have been mixed in with the fentanyl. And Russian doctors complained that delays in entering the building and the failure to have naloxone available contributed to the deaths. 

However, a 2017 position statement from the American College of Medical Toxicology states, “At the highest airborne concentration encountered by workers, an unprotected individual would require nearly 200 minutes of exposure to reach a dose of 100 mcg of fentanyl… evaporation of standing product into a gaseous phase is not a practical concern.” 

The urban myth that even minimal skin contact with fentanyl or an analog can cause a drug overdose has been difficult to eradicate. Because it not easily absorbed through the skin it took years of research before pharmaceutical companies finally devised a means to deliver fentanyl trans-dermally using a skin patch, now one of the most common ways it is prescribed in the outpatient setting. In its position paper, the ACMT also affirms that even extreme skin exposure to fentanyl “cannot rapidly deliver a high dose” of fentanyl.

Yet reports abound of first responders being rushed to emergency rooms after manifesting overdose symptoms upon exposure to fentanyl, only to be cleared and released upon evaluation. This may be attributable to the nocebo effectan exquisite example of the power of suggestion that has a neurochemical explanation. Guidelines on preventing occupational exposure from the Centers for Disease Control and Prevention and first responder alertsfrom the Drug Enforcement Administration that state, “Exposure to an amount equivalent to a few grains of sand can kill you,” only serve to enhance the nocebo effect and feed the hysteria.

The DEA states almost all of the fentanyl it seizes is “illicit fentanyl“—fentanyl and fentanyl analog powders made in clandestine labs in Asia and now in Mexico. It is often purchased on the “dark web” and shipped to the US in the mail. Fentanyl’s appearance in the underground drug trade is an excellent example of the “iron law of prohibition:” when alcohol or drugs are prohibited they will tend to get produced in more concentrated forms, because they take up less space and weight in transporting and reap more money when subdivided for sale. 

Licit fentanyl is an excellent drug, not usually produced in powdered form, and is used in many different clinical settings, not the least of which is in the operating room as an anesthetic adjunct. 

Illicit fentanyl is mainly used to enhance the strength of heroin and as an additive to cocaine (for “speedballing”). Drug dealers also use pill presses to press fentanyl into counterfeit prescription pain pills and sell them to unsuspecting drug users. 

The Drug Enforcement Administration recently moved several illicitly produced analogs of fentanyl to Schedule 1 (no known medical use), thus banning them.

This will do nothing to stop the fentanyl trade. The DEA already claims that almost all of the fentanyl seized is illicit fentanyl. Making it schedule 1 will not cause these labs to shut down or the cartels to stop their already lucrative trade. Dozens of fentanyl analogs have been developed and more are on the way. They are as easy to make in the lab as making meth from Sudafed or P2P. 

As they develop scenarios and contingency plans for weaponized fentanyl, policymakers refuse to see that the actual weapon of mass destruction is America’s endless war on drugs.

 

 

The AG’s Position on Marijuana Legalization a Welcome Contrast to That of His Predecessor

Lost in all of the media frenzy over the Mueller Report, redactions, and alleged improprieties within the Department of Justice and FBI, was Attorney General William Barr telling the Senate Appropriations Committee yesterday that he favors a more federalist approach to marijuana laws.

In response to a question from Senator Lisa Murkowski (R-AK), Barr said that allowing the states to set their own marijuana policy and removing the federal government from the matter would be an improvement over the present situation, which he called an “intolerable” conflict between state and federal laws. Senator Murkowski is a sponsor of the Strengthening the Tenth Amendment Through Entrusting States (STATES) Act, which would give immunity from federal action against business and people engaged in the manufacture, sale, purchase, or consumption of marijuana in states where it has been legalized. President Trump has signaled in the past that he would sign the bill if it was passed and sent to his desk.

Unfortunately, Barr still opposes federal legalization, but his approach to the issue is a stark and welcome contrast to that of his predecessor Jeff Sessions, and would amount to de facto federal decriminalization—at least in the states that have decided to legalize marijuana. 

It also signals a realization that the march toward state-by-state legalization continues to gather momentum. It may be just a matter of a few years before federal decriminalization of marijuana becomes a reality and, as is the case with alcohol, it will be a matter left up to each of the states and the District of Columbia.

Decriminalization should be a welcome change for all who are concerned with the growing rate of opioid-related overdose deaths. There is growing evidence that marijuana reduces the need for opioids to relieve pain and numerous studies have shown lower opioid-related overdose death rates in states where access to marijuana is legal. Furthermore, marijuana has great potential as a harm reduction strategy. At the recent conference on harm reduction held at the Cato Institute, Dr. Adrianne Wilson-Poe, a nationally recognized cannabis clinical researcher at Washington University School of Medicine, gave a detailed and enlightening presentation on the potential role for cannabis in Medication Assisted Treatment (MAT) as well as opioid withdrawal management. You can see that presentation here. Dr. Wilson-Poe was also interviewed on a Cato Daily Podcast here.

They Still Call It An “Opioid Epidemic.” Why’s That?

The Cleveland Plain Dealer recently reported that, while overdose deaths have come down slightly over the past year in the Cleveland metropolitan region, a new killer has emerged on the scene: cocaine mixed with fentanyl.

The Cuyahoga County Coroner’s Office informs the public that cocaine was involved in 45 percent of overdose deaths last year, the highest rate in ten years. It reports that cocaine is being found in combination with fentanyl with increasing frequency, and it is believed that many cocaine users are either unaware of the presence of fentanyl or, if they are, they are uncertain as to the amount that is present. The highly potent fentanyl (roughly 100 times more potent than morphine) causes them to asphyxiate and die.

This phenomenon was reported a year ago in Massachusetts and the New England region. According to the Drug Enforcement Administration, fentanyl has been supplanting heroin as the narcotic often combined with cocaine to affect “speedballing”—a dangerous technique designed to minimize the negative effects of the “come-down” after the rush from cocaine. 

The rise in cocaine-related overdose deaths is also associated with a change in the demographic mix of overdose victims. The Plain Dealer report states:

Historically in Cuyahoga County, opioid deaths have had the most severe impact among white people, and in suburban communities, Gilson said. Cocaine, on the other hand, has largely been linked to overdose deaths among African-Americans, and in urban communities…

“We’re starting to see a rise in fentanyl deaths among African-Americans, but we’re also seeing more cocaine in the fentanyl deaths among the white, suburban residents,” Gilson said. “Now, as those two interface, we start to see more deaths, period.”

One encouraging part of the Plain Dealer story is that the overall overdose rate in Cuyahoga County came down slightly in the past year. Credit has been given to the more liberal distribution of the overdose antidote naloxone as well as the distribution of fentanyl test strips. Originally approved by the FDA for urine drug testing, they are now being used “off-label” to test for the presence of fentanyl in a drug bought on the black market. Distributing naloxone and fentanyl test strips are two harm reduction strategies. 

A Canadian firm, BTNX, manufactures the test strips and has neither sought nor gained approval for their use in this context. The test strips work well for IV heroin users, who adjust their heroin dose or even discard the heroin according to the amount of fentanyl detected. Public health officials are concerned that it might be more difficult to use the test strips with cocaine, because the substance must be liquified in order to test it. In most cases, the heroin is already in liquid form because it is intended for injection.

Sadly, in many states with anti-paraphernalia laws, such as my home state of Arizona, fentanyl test strips are illegal for distribution because they are considered a form of drug paraphernalia. Last June the Maryland legislature removed fentanyl test strips from that state’s drug paraphernalia list.

As public health and law enforcement authorities more openly discuss the prevalence of cocaine, fentanyl, heroin, and methamphetamines in the overdose statistics, it is reasonable to ask why they and the media continue to refer to this as an “opioid epidemic” when it is obviously a “prohibition crisis.”

 

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From “Meth Crisis” to “Opioid Crisis” to “Fentanyl and Meth Crisis” to…

Today’s Wall Street Journal reports that, just as overdose deaths related to prescription pain relievers are showing signs of leveling off, officials worry that the surge in methamphetamine-related deaths is joining the surge in fentanyl-related deaths to fuel the total drug overdose rate. 

There were 1887 meth-related deaths reported in 2011. By 2017 more than 10,000 deaths were reported related to meth and other chemically-similar psychostimulants.

The Drug Enforcement Administration has seen a 118 percent increase in meth seizures by law enforcement between 2010 and 2017. The meth is cheap and abundant and flooding the US mainly from Mexico, according to the agency. The Mexican cartels have taken up the meth trade to compete with cocaine coming up from South America. 

The Journal article quotes a spokesman from the Phoenix office of the DEA as saying the meth is smuggled through tunnels, through ports of entry, and between ports of entry. 

As I wrote here, the meth trade became the domain of the Mexican cartels after the US cracked down on homegrown meth labs and made Sudafed (a decongestant converted to meth in those labs) more difficult to obtain. 

I pointed out elsewhere that waging a war on drugs is like playing a game of “Whac-a-mole.” The war should be drawn to a close and attention should turn to ameliorating the death and other harms that prohibition has wrought. 

In 2005 Congress acted to address the “Meth Crisis.” Shortly thereafter it turned its attention to the “Opioid Crisis.” Now it is dealing with a fentanyl crisis and a replay of the meth crisis. How many more will die or suffer needlessly before lawmakers wise up?

 

Will US Drug Policymakers Blow It Again—This Time With Benzodiazepines?

In a recent column, Maia Szalavitz reports on the rise in overdose deaths related to benzodiazepines (a class of tranquilizers including Xanax, Valium, and Ativan). According to a recent study in JAMA, the number benzodiazepine prescriptions doubled in the US  from 2003 to 2015. And benzodiazepines are found in the bloodstream of almost a third of all opioid overdose victims—a nearly ten-fold increase since the beginning of this century. Szalavitz reminds us that the US is not the only developed country with an overdose problem from the nonmedical use of prescription drugs: Scotland has been contending with this problem for years, and the city of Dundee has been dubbed the “drug death capital of Europe.” 

Unlike the US, where fentanyl was found in 40 percent of overdose deaths in 2017, the main ingredients of Scotland’s overdoses are benzodiazepines, involved in more than half the drug deaths in Scotland. Like the US, most of Scotland’s overdose deaths involve multiple drugs, including heroin, cocaine, fentanyl, and alcohol.

US policy focused on decreasing opioid prescribing (high dose opioid prescriptions are down 58 percent in the US since 2008). Likewise, Scottish policy emphasized and succeeded in reducing benzodiazepine prescribing. In both cases, the goal was to reduce the amount of the drug available for diversion to the black market for nonmedical users. And in both cases, the efficient black market filled the vacuum with illicit and more dangerous substitutes.

Illicit benzodiazepines like phenazepam (originally developed in the USSR in the 1970s) and etizolam are much more potent and dangerous. Many are made in local clandestine labs and pressed into counterfeit Xanax or Valium pills.

Benzodiazepine overdoses are manifested by the victims growing stuporous, lapsing into a coma, hypoventilating from respiratory depression, developing bluish fingernails from decreased oxygenation and, ultimately, dying. Benzodiazepine withdrawal can last much longer than opioid withdrawal, sometimes taking months or years, often featuring seizures, and is much more likely to result in death. The potentially lethal consequences of acute withdrawal make Medication Assisted Treatment of benzodiazepine dependency or addiction essential.

It seems the Scots sowed the same (failed) supply-side policies towards benzodiazepine overdoses that the US did towards opioid overdoses. And they reaped the same results. Szalavitz explains:

“People who once had access to drugs that were of known dosage and purity suddenly did not. Drug dealers stepped in to meet the demand, and the global supply chain of illegally-manufactured pharmaceuticals provided the products users wanted.”wareness of the growing role of benzodiazepines in the US overdose crisis, US policymakers should learn from Scotland’s mistakes in addressing nonmedical benzodiazepine use so as not to repeat them. But that requires them to recognize that Scotland was merely emulating US policy towards opioids.

The growing role played by benzodiazepines in US drug overdose deaths is gaining more attention. US policymakers should learn from and avoid the mistakes Scotland made in dealing with nonmedical benzodiazepine use. That means recognizing that Scotland was emulating US policy toward nonmedical opioid use. 

(Maia Szalavitz will be a featured speaker at the Cato Institute day-long conference on harm reduction on March 21.) 

Add Hepatitis C to the List of Unintended Consequences of Abuse-Deterrent Opioids

One year ago Cato published my policy analysis, “Abuse-Deterrent Opioids and the Law of Unintended Consequences,” which provided strong evidence that reformulating opioids, so that they could not be crushed for snorting or dissolved for injecting by nonmedical users, only served to drive nonmedical users to more dangerous, readily available, and cheaper heroin provided by the efficient black market. 

The evidence included a RAND study that found “a substantial share of the dramatic increase in heroin deaths since 2010 can be attributed to the reformulation of OxyContin” which replaced regular OxyContin in 2010. It also included a study from researchers at Notre Dame and Boston Universities that found:

When we combine heroin and opioid deaths together, we find no evidence that total heroin and opioid deaths fell at all after the reformulation—there appears to have been one-for-one substitution of heroin deaths for opioid deaths.

Now comes a new RAND study that finds the abuse-deterrent reformulation of OxyContin led to an increase in cases of hepatitis C from IV drug use. As nonmedical users switched from OxyContin to injectable heroin, more became exposed to hepatitis C, transmitted by needle sharing.

The study compared states with above-median misuse rates of OxyContin to states with below-median misuse rates before and after the drug’s reformulation—from 2004 to 2015. Prior to the reformulation there was almost no difference in hepatitis C infection rates between the states. After the reformulation, states with above-median misuse rates saw a 222 percent increase in hepatitis C infections, while the below-median states saw a 75 percent increase during the same period. 

Add hepatitis C to the list of unintended consequences from abuse-deterrent reformulation of opioids.

Despite mounting evidence that abuse-deterrent reformulation of opioids has done nothing to reduce overdoses but may in fact be adding to them, the Food and Drug Administration continues to encourage pharmaceutical manufacturers to bring more abuse-deterrent formulations to market. As was the case with OxyContin, reformulation often results in extension of existing patents, reducing competition from generics and allowing patent holders to charge and profit more from their product. So opioid manufacturers are answering the FDA’s call for more abuse-deterrent reformulations.

Now that we have strong evidence that abuse-deterrent formulations spread disease as well as death, perhaps the FDA will reconsider this ill-advised policy.

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The FDA Bends Over Backwards To Get Drug Makers To Ask Them To Make Naloxone OTC

Press reports have created the impression that the opioid overdose antidote naloxone is now available over the counter. But in fact, the drug is still classified in the US as prescription only, so states have developed workarounds to make it easier for patients to obtain it without going to a doctor for a prescription. In most states, patients can get naloxone by going up to the counter and asking the pharmacist, who is legally authorized by the state to dispense it. 

But some states prohibit third parties from obtaining a prescription for another person, so people in those states who wish to have the antidote available because they have a friend or relative who uses opioids cannot obtain it. And experience shows that many pharmacists choose to not stock naloxone or participate in any distribution program. Furthermore, the stigma now attached to opioid use has deterred many patients from going up to the pharmacy counter and explaining to a pharmacist why they need naloxone.

To get around such obstacles, Australia and Italy have designated naloxone as a truly over-the-counter drug. People can discreetly buy it off the shelf and check out at the cash register.

The Food and Drug Administration is on record since at least 2016 as believing that it is probably appropriate for naloxone to be rescheduled as OTC and has encouraged manufacturers to petition the FDA to that end. Yesterday  FDA Commissioner Gottlieb announced the FDA has even gone to the trouble of designing Drug Facts Labels (DFL) required of manufactures for their products to be sold over the counter, and has even tested these labels for “consumer comprehension” in front of focus groups. The Commissioner stated in the announcement that this represents an unprecedented effort to facilitate and speed up the reclassification of naloxone from prescription-only to OTC.

This is commendable. But as I have written herehere, and here, the Commissioner does not have to wait for manufacturers, who may lack the incentive, to request the move to OTC. Under FDA regulations, the FDA can undertake reclassification review at the request of “any interested person,” or the Commissioner himself. States may petition the FDA for reclassification. Finally, if all else fails, Congress can order the reclassification.

The FDA should no longer wait for manufacturers to ask them to make this lifesaving drug more accessible to those in need.

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