Tag: Opioids

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.

Today’s Drug Abusers Did Not Derive From Yesterday’s Patients

We learned last week that the 2017 drug overdose numbers reported by the US Centers for Disease Control and Prevention clearly show most opioid-related deaths are due to illicit fentanyl and heroin, while deaths due to prescription opioids have stabilized, continuing a steady trend for the past several years. I’ve encouraged using the term “Fentanyl Crisis” rather than “Opioid Crisis” to describe the situation, because it more accurately points to its cause—nonmedical users accessing drugs in the dangerous black market fueled by drug prohibition—hoping this will redirect attention and lead to reforms that are more likely to succeed. But the media and policymakers remain unshakably committed to the idea that the overdose crisis is the product of greedy pharmaceutical companies manipulating gullible and poorly-trained doctors into over-prescribing opioids for patients in pain and ensnaring them in the nightmare of addiction.

As a result, most of the focus has been on pressing health care practitioners to decrease their prescribing, imposing guidelines and ceilings on daily dosages that may be prescribed, and creating surveillance boards to enforce these parameters. These guidelines are not evidence-based, as Food and Drug Administration Commissioner Scott Gottlieb seems to realize, and have led to the abrupt tapering of chronic pain patients off of their medication, making many suffer desperately. An open letter by distinguished pain management experts appeared last week in the journal Pain Medicine criticizing current policies for lacking a basis in scientific evidence and generating a “large-scale humanitarian issue.” 

Current policy has brought high-dose prescriptions down 41 percent between 2010 and 2016, another 16.1 percent in 2017, and another 12 percent this year. Yet overdose deaths continue to mount year after year, up another 9.6 percent in 2017.

One might expect the obvious prevalence of heroin and illicit fentanyl among overdose deaths would make policymakers reconsider the relationship between opioid prescribing, nonmedical use, and overdose deaths. The data certainly support viewing the overdose crisis as an unintended consequence of drug prohibition: nonmedical users preferred to use diverted prescription opioids and, as supplies became tougher to come by in recent years, the efficient black market responded by filling the void with cheaper and more dangerous heroin and fentanyl.