July 12, 2019 10:22AM

Senators Manchin and Braun Are Attempting to Practice Medicine Without a License — And Fighting the Wrong War

Senator Joe Manchin (D-WV) and Mike Braun (R-IN) are still trying to address the fentanyl and heroin overdose crisis—soon to be joined by a methamphetamine and cocaine overdose crisis—by denying chronic pain patients access to pain relief. They have just introduced a bill they call The FDA Opioid Labeling Accuracy Actwhich would “prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of ‘around-the-clock, long-term opioid treatment’ until a study can be completed on the long-term use of opioids.”

Set aside the fact that most pain specialists agree that, in some cases, long-term opioid therapy is all that works for some chronic pain patients. The 2016 guidelines on opioid prescribing put forth by the Centers for Disease Control and Prevention have already been misinterpreted and misapplied by legislators and regulators, leading to forced and rapid tapering off of opioids in many chronic pain patients, causing many to resume lives immobilized by pain, and in many cases, seek relief in the black market or by suicide. It has gotten so bad that the CDC recently issued a “clarification” in April, reminding regulators that the guidelines were only meant to be suggestive, not prescriptive, and did not in any way mean to encourage the rapid tapering of patients on chronic opioids for pain management. Johns Hopkins bioethicist Travis Rieder, PhD delves deeply into this subject and relates his own experiences in his book, In Pain.

What the senators fail to recognize is that patients are not one-size-fits-all. Different patients respond to pain and to pain management differently. Their proposed legislation, if passed, will only serve to exacerbate the unnecessary suffering of patients in pain that the CDC is trying to undue with its guideline clarification.

Meanwhile, they should take a look at the government’s own numbers. The data show there is no correlation between the number of prescriptions written and the incidence of non-medical use of prescription opioids or prescription pain reliever use disorder. And less than 10 percent of opioid-related overdose deaths in 2017 involved prescription pain relievers unaccompanied by other drugs such as cocaine, heroin, alcohol, or fentanyl.

The continued war on patients by politicians and regulators will not get one IV heroin user to take the needle out of their arm. Senators Manchin and Braun need to recognize that the overdose crisis has been on a steady, exponential increase since the 1970s and shows no signs of stopping—and that its ultimate cause is drug prohibition

If they want to get serious about addressing the problem, they should switch their focus to harm reduction. A good way to start would be to repeal the “Crack House” statutes that prevent cities and states from establishing overdose prevention sites called “safe injection facilities.”

July 8, 2019 5:31PM

New Evidence From British Columbia Provides a Strong Case for Harm Reduction Strategies

A study published last month in the peer-reviewed journal Addiction by researchers at the British Columbia Centre for Disease Control and the British Columbia Centre on Substance Use found that harm reduction strategies were responsible for the province’s opioid-related overdose death rate being less than half of what it otherwise would have been between April 2016 and December 2017.

The researchers noted that 77 percent of opioid-related overdose deaths during that time frame involved illicit fentanyl. Vancouver has long been a major port of entry for fentanyl and fentanyl analogs, produced in China and other parts of East Asia, often using historic seaborn drug trade routes

During the 23 months ending December 2017 there were 2,177 overdose deaths in British Columbia, according to the British Columbia Centre for Disease Control. Using mathematical modeling methodology to estimate monthly overdose and overdose-death risk along with the impact of harm reduction interventions, the researchers concluded an estimated 3,030 overdose deaths were averted.

The three harm reduction strategies investigated were take-home naloxone kits, safe injection sites, and “opioid agonist therapy”— known in the U.S. as Medication Assisted Treatment (which includes methadone, buprenorphine, hydromorphone, and heroin assisted treatments in British Columbia). The researchers employed counterfactual simulations with the fitted mathematical model to estimate the number of deaths averted for each harm reduction strategy as well as the three strategies in combination. 

While the harm reduction strategies combined for more than 3000 deaths averted, the number of lives saved by each strategy taken in isolation broke down as follows: 

  • 1,580 (1,480-1,740) deaths averted by take-home naloxone
  • 230 (160-350) deaths averted by safe injection sites
  • 590 (510-720) deaths averted due to opioid-agonist therapy

All three interventions worked in synergy to greatly reduce the death rate, but the widespread distribution of naloxone saved the most lives. 

Michael Irvine, the study’s lead author, told Canadian Broadcasting Company reporters that in recent years the overdose crisis has been driven by a prevalence of fentanyl and fentanyl analogs. 

Among the developed nations, Canada has been one of the hardest hit by the overdose crisis on a per capita basis, with overdose deaths in Vancouver, BC approximating those of some of the worst-hit states in the U.S. as recently as 2017. This recent study gives us reason to conclude that, had British Columbia not embraced harm reduction strategies, the per capita overdose rate would have far-exceeded that of the U.S.

Canadian policymakers are being urged to curtail the prescription of opioids to patients in pain, despite the fact that more than three-quarters of overdose deaths involve fentanyl and, as in the U.S., the majority of overdose deaths involve multiple other drugs as well, including cocaine, heroin, benzodiazepines, and alcohol. This approach is driven by the failure to recognize there is no correlation between the number of prescriptions written for patients and the incidence of non-medical use of prescription opioids or prescription opioid use disorder. 

The Canadian government has also given in to pressure by the U.S. government to double down on its war on drugs. But in the U.S., researchers have learned that overdoses from the non-medical use of licit and illicit drugs has been on a steady exponential increase since the 1970s--the only variation being which particular drug is in vogue in any particular era--with no evidence of any slowing. It appears to be a result of sociocultural and psychosocial factors. There is no reason to believe things are much different in Canada.

Efforts to approach this problem by doubling down on supply-side interventions and the War on Drugs are doomed to fail—and will only cause more people to die. Fighting a war on drugs is like playing a game of “Whac-a-Mole.”

If the British Columbia experience should teach policymakers anything, it should be that harm reduction is the most effective way to end the overdose crisis. Ending prohibition would be the most consequential form of harm reduction.

June 26, 2019 10:49AM

CDC Provisional Drug Death Numbers Show Slight Improvement. Credit Harm Reduction.

Provisional data released by the Centers for Disease Control and Prevention suggest the annual overdose death rate may be levelling off or even slightly declining. The data predict a drop in the death rate to 69,096 for the 12-month period ending November 2018, down from 72,300 predicted deaths for the 12-month period that ended November 2017. These provisional findings represent a 4.4 percent drop in the national overdose rate. 

The drug overdose death numbers include deaths due to natural and semi-synthetic opioids, synthetic opioids other than methadone (fentanyl and its analogs), methadone, methamphetamines and other stimulants, cocaine, and benzodiazepines. For example, opioid-related deaths accounted for 47,600 of the 70,237 overdose deaths reported by the CDC for the year 2017. The final report for the year 2018 should be available in December of this year.

The possible slowing or decrease of the overdose rate is likely due to the fact that many state policymakers have begun to recognize the wisdom of harm reduction, a realistic acceptance of the fact that there will never be a “drug-free” society, that seeks to reduce the risks associated with non-medical use of licit and illicit drugs. As I have written here, harm reduction has long been an approach employed by health care professionals in modern and developed societies. 

The provisional report from the CDC shows the most dramatic improvements in states that have expanded the availability of the opioid overdose antidote naloxone, allowed for the expansion of needle exchange programs, and increased the licensing of Medication Assisted Treatment (e.g., methadone, buprenorphine) programs. In fact, the greatest improvement was seen in Ohio, which has aggressively promoted these harm reduction measures. Ohio had been an epicenter of opioid-related overdose deaths. The provisional numbers for the year ending November 2018 show a 23.3 percent decrease in overdose deaths. The states that have made the most progress are those that have increased the focus on harm reduction strategies.

Despite these encouraging signs, the overdose rate continues to and is likely to remain high. As researchers at the University of Pittsburgh have discovered, overdoses related to the non-medical use of licit and illicit drugs have been on a steady, exponential increase since the 1970s. The only changes that have occurred over that time period pertain to which drugs came in and out of vogue for non-medical users. 

Despite policymakers obsession with doctors prescribing pain medication to their patients, the government data show no correlation between the number of prescriptions and non-medical use or substance use disorder. In recent years deaths from fentanyl and heroin have come to represent the majority of fatalities reported by the CDC with cocaine, methamphetamines, and other stimulants showing a recent surge as well. And benzodiazepine-related deaths are also on the rise.

The driving force behind these deaths has always been drug prohibition. Ending the endless and unwinnable war on drugs would be the greatest exercise of harm reduction.

June 18, 2019 12:17PM

The War on Meth Is Back. Big Time

Today’s Seattle Times reports on the surge in methamphetamine-related deaths, noting there are more meth-related deaths than at the height of the last “meth wave” in the early 2000s. 

The era of the American meth lab is over a decade gone, yet pure, cheap meth is back and bigger than ever in Western Washington. When Seattle residents point to needles proliferating on sidewalks, they usually say heroin’s to blame; however, a bigger proportion of those needles in recent years is actually from people injecting meth, according to King County syringe exchange surveys.

Death rates in King County have increased four-fold between 2005 and 2017. As I have written here, this is a nationwide phenomenon. In 2005 Congress passed the Combat Methamphetamine Epidemic Act, which moved behind-the-counter the effective decongestant pseudoephedrine (Sudafed), often converted into meth by local meth labs, and limited the amount one can purchase per month. Law enforcement led an all-out assault, often with S.W.A.T. teams, on local meth labs. The Seattle Times report states that the 2005 crackdown dramatically reduced the number of “mom and pop” meth labs in the state of Washington. But this only created an opening for Mexican drug cartels.

Since 2011, there have been just 212 meth-lab sites reported statewide, according to the state Department of Ecology. But drug cartels south of the American border stepped in to fill demand, making more and more meth in “superlabs” in Mexico and shipping it, along with heroin and fentanyl, up Interstate 5 — hidden away in tires, paint cans and hidden compartments in semi-trucks — according to Keith Weis, special agent in charge of the Drug Enforcement Administration’s Pacific Northwest division.

Shilo Jama, a harm reduction activist in King County, told the Seattle Times that for the last several years harm reduction sites have been treating more stimulant users than opioid users. 

I pointed out in a recent blog post, “The overdose crisis is the byproduct of psycho-sociocultural trends seen among many developed countries intersecting with the dangerous world of drug prohibition—where the content and dose of the substance being sold is never reliable, and where users take otherwise avoidable risks.” 

The War on Drugs is like a game of “Whac-a-mole.” We’ve gone from meth crisis to opioid crisis and now a meth plus fentanyl crisis. If the goal of public policy is to reduce the deaths and disease that result from underground drug use, the solution is to end the war, as Portugal decided to do in 2001, and switch the focus to harm reduction.

May 21, 2019 10:57AM

The Coming “Stimulant Crisis?”

Earlier this month the Centers for Disease Control and Prevention, in the Morbidity and Mortality Weekly Report (MMWR), reported that from 2015-2016 deaths from cocaine and psychostimulants (such as methamphetamine, Ritalin, dextroamphetamine) increased 52.4 percent and 33.3 percent respectively. In 2017, the CDC reported a total overdose rate of 70,237, and cocaine was involved in 19.8 percent of those deaths while other psychostimulants were involved in 14.7 percent. Opioids, primarily synthetic (fentanyl and fentanyl analogs), were found in 72.7 percent of the cocaine deaths and 50.4 percent of the other psychostimulant deaths. The report mentioned that provisional 2018 data indicate deaths involving cocaine and other psychostimulants are continuing to increase.

As I have written here and here, deaths related to cocaine, methamphetamine, and other psychostimulants have been on the rise for several years now, despite legislation in 2005 that was supposed to address the problem, and recently fentanyl has replaced heroin as the drug with which they are combined to make a “speedball”—a mixture aimed at reducing the negative “come-down” effects after the rush from the stimulant.

The most important sentence in the CDC report was this: “Increases in stimulant-involved deaths are part of a growing polysubstance landscape.” This should be viewed in the context of a recent study from the University of Pittsburgh that concluded:

The U.S. drug overdose epidemic has been inexorably tracking along an exponential growth curve since at least 1979. Although there have been transient periods of minor acceleration or deceleration, the overall drug overdose mortality rate has regularly returned to the exponential growth curve. This historical pattern of predictable growth for at least 38 years suggests that the current opioid epidemic may be a more recent manifestation of an ongoing longer-term process. This process may continue along this path for several more years into the future…Indeed, it is possible that a future overdose epidemic may be driven by a new or obscure drug that is not among the leading causes of drug overdose death today. Understanding the forces that are holding multiple sub epidemics together onto a smooth exponential trajectory may be important in revealing, and effectively dealing with, the root causes of the epidemic.

Policy makers and the media remain focused on pain pill prescriptions and blame the overdose crisis on unethical pharmaceutical manufacturers. They continue to miss the big picture and they are harming patients in the process. The overdose crisis is the byproduct of psycho-sociocultural trends seen among many developed countries intersecting with the dangerous world of drug prohibition—where the content and dose of the substance being sold is never reliable, and where users take otherwise avoidable risks. 

As Portuguese policy makers discovered, ending prohibition is an effective way to reduce the deaths—that plus a strategic shift to harm reduction.

May 13, 2019 3:16PM

An Encouraging Sign for Harm Reduction Advocates

A New Hampshire high school student who is remarkably knowledgeable about the various harm reduction strategies that are underused to address the overdose crisis engaged Senator Cory Booker (D-NJ) in a discussion of the subject during a campaign stop in Littleton, NH. The video of the exchange is here.

Senator Booker, who is seeking the Democratic nomination for President in 2020, is a former mayor of Newark, NJ, a city with major drug overdose problems. He had a sophisticated conversation with the student and agreed with her on the need for safe syringe programs. At about 1:50 into the video Booker was asked if he would support needle exchange programs and safe injection sites. He responded that as mayor of Newark he established the needle exchange program in that city and “fully supports” establishing safe injection sites.

As I detail in my Policy Analysis on harm reduction, both needle exchange programs and safe injection sites have been shown for decades to reduce the spread of HIV and hepatitis, reduce overdoses, and increase the number of addicts obtaining rehab. 

While needle exchange programs are legal in the US, and are even promoted by the Surgeon General, the Centers for Disease Control and Prevention, and the American Medical Association, many states have anti-paraphernalia laws that inhibit their creation.

Safe injection sites exist in over 120 cities in Europe, Canada, and Australia, and have been in use for over 30 years. One even operates in the US clandestinely, because federal law prohibits safe injection sites in this country. Several cities are attempting to establish safe injection sites in the US, including Seattle, San Francisco, Boston, and New York. In Philadelphia, a nonprofit that includes former Pennsylvania Governor Edward Rendell on its board is attempting to establish a “Safehouse” in that city, funded entirely with private money, but is being thwarted by the Department of Justice.

While the Senator seemed to wrongly accept the mistaken narrative that the opioid manufacturers are to blame for much of the problem, it is gratifying to learn that Senator Booker has an appreciation for harm reduction in general, and needle exchange and safe injection sites in particular. And, to his credit, he has also expressed enlightened views regarding cannabis legalization

As more members of Congress join the growing ranks of mayors of major US cities in endorsing safe syringe programs, momentum will hopefully build for states to remove any remaining obstacles to needle exchange programs and for Congress to remove the federal obstacles to safe injection sites.

April 24, 2019 10:15AM

As Seattle Reels From An HIV Outbreak, Safe Consumption Sites Make More and More Sense

The US Centers for Disease Control and Prevention’s latest Morbidity and Mortality Weekly Report (MMWR) alarmingly reports a 286 percent increase in cases of HIV among heterosexual persons injecting drugs in King County, Washington from 2017 and mid-November 2018. The report recalls a similar outbreak for similar reasons in rural Indiana that took place between 2011 and 2014, and ultimately led the state to enact legislation permitting needle-exchange programs to operate there. 

As I explain in my policy analysis on harm reduction strategies, needle exchange programs have a more than 40 year track record reducing the spread of HIV, hepatitis, and other blood-borne diseases, and are endorsed by the CDC and the Surgeon General, but are prohibited in many states by local anti-paraphernalia laws. But such laws are not the problem in the state of Washington. Needle exchange programs have operated legally there for years.

Safe Consumption Sites have been shown to be even more effective in reducing the spread of HIV and hepatitis, as well as preventing overdoses. The nearby city of Vancouver, BC has found they dramatically reduced cases of HIV as well as overdoses since 2003.

Recognizing this, the Seattle city council voted in 2017 to permit the establishment of two safe consumption sites, which are obstructed by federal law, in particular the so-called “Crack House Statute” passed in the 1980s, which makes it a felony to “knowingly open, lease, rent, use, or maintain any place for the purpose of manufacturing, distributing, or using any controlled substance.” A non-profit group in Philadelphia is attempting to set up a “Safe House” there, and has already been met with the threat of prosecution from the Department of Justice. Former Pennsylvania Governor Edward G. Rendell, a principal of that non-profit, spoke about this at a recent conference on harm reduction held at the Cato Institute.

With safe consumption sites working in more than 120 major cities throughout the developed world, including several in neighboring Canada—and with outbreaks of HIV developing across the US—lawmakers who claim to be deeply concerned about the plague of disease and overdoses afflicting the country should put their money where their mouth is and repeal the outdated “Crack House Statute” so cities and towns can get to work saving lives.