Topic: Health Care

Will Congress Finally X-Out the “X” Waiver?

Members of Congress are growing more appreciative of the benefits of Medication Assisted Treatment in addressing the overdose crisis. Two bills presently under consideration—one in the Senate and one in the House—are the latest evidence of that awareness. 

Medication Assisted Treatment for opioid use disorder is one of the most widely-accepted and least controversial of the tools in the harm reduction tool box. The strategy involves placing the patient on an orally-administered opioid that binds with enough opioid receptors to prevent painful withdrawal symptoms while, at the same time, not producing cognitive impairment or euphoria. The approach has been around since the 1960s and has greatly reduced overdose deaths as well as the spread of deadly infections from dirty needles.

One of the oldest and most well-known examples of MAT uses the synthetic opioid methadone, which is classified by the Drug Enforcement Administration as Schedule II (known medical use with a high potential for abuse or dependence). A more recent form of MAT uses the Schedule III opioid buprenorphine. Schedule III drugs have less potential for dependence or abuse than those in Schedule II. Like methadone, buprenorphine is permitted to be prescribed for the treatment of pain, but not for MAT without obtaining DEA permission.

As I have written here, federal policy regarding methadone MAT makes no sense. Health care practitioners have been permitted to prescribe methadone in oral or non-oral forms to treat pain for decades. Yet they are not permitted to prescribe methadone for opioid withdrawal management or for MAT for opioid use disorder outside of a DEA-licensed and regulated methadone clinic. These clinics must also obtain state licenses. Patients are required to take the methadone in front of a member of the clinic staff. 

These regulatory requirements have been great obstacles to providers wishing to establish methadone clinics, and even greater obstacles to patients seeking methadone MAT for their disorder. It also places onerous burdens on patients suffering from opioid use disorder who want treatment. The requirement to take the medication in the presence of clinic staff each day demands a certain amount of scheduling discipline that many addicts have difficulty achieving. It also implies that addicted patients cannot be trusted with an outpatient supply to take as directed —which is a further blow to the already shattered self-esteem that helps perpetuate substance use disorder. And patients living in remote areas underserved by methadone clinics are unrealistically expected to travel long distances each day to take their methadone in the presence of clinic staff. This problem can be alleviated by allowing health care practitioners who can already prescribe methadone for other reasons to prescribe it to outpatients for withdrawal management and MAT, as has been the case in Canada, the UK, Australia and other countries for decades.

Buprenorphine, on the other hand, may be prescribed on an outpatient basis for MAT. Research has been inconclusive with respect to the relative effectiveness of methadone versus buprenorphine for MAT. Most clinicians believe there is no one-size-fits-all answer. Depending upon the patient and the circumstances, one drug might work better than the other. In recent years buprenorphine has been combined with the overdose antidote naloxone in an oral form, commonly known by the brand name Suboxone. When taken orally, naloxone is inactive. If buprenorphine/naloxone is crushed and injected, the naloxone counteracts the buprenorphine, preventing the user from achieving any “high.” But most users of non-prescribed diverted Suboxone report they are self-medicating to avoid opioid withdrawal, and that the Schedule III buprenorphine is a poor substitute for the “high” they get from heroin and other more powerful opioids.

A major force behind the black market for buprenorphine is the fact that there is an acute shortage of practitioners to whom people with substance use disorder can go for buprenorphine MAT. Again, this is because of onerous federal restrictions. Under the Drug Addiction Treatment Act of 2000, practitioners wishing to treat substance use disorder with buprenorphine are required to obtain an “X waiver.” Providers must take an 8-hour course in order to have the ”X” added to their DEA narcotics prescribing license. There are also strict limits on how many patients a practitioner can treat at any given time, as well as restrictions on nurse practitioners or physician assistants wishing to obtain the X waiver. These have combined to create an acute lack of buprenorphine MAT providers. According to the Substance Abuse and Mental Health Services Administration, less than 7 percent of practitioners have jumped through the hoops and obtained X waivers. The shortage is particularly severe in rural areas. Nationally, only 1 in 9 patients with opioid use disorder are able to obtain buprenorphine MAT.

For this reason, health care practitioners interested in treating opioid use disorder, as well as other harm reduction advocates, have called for ending the requirement of an X waiver to use buprenorphine for MAT. In France roughly one-fifth of general practitioners treat people with substance use disorder in their offices without any further licensing or education requirements. It has contributed to a dramatic reduction in France’s overdose death rate.

Fortunately, members of Congress seem to be getting the message. Senators Lisa Murkowski (R-AK) and Maggie Hassan (D-NH) have introduced a bill that would eliminate “the separate scheduling requirement for dispensing narcotics in Schedules III, IV, and V for maintenance or detoxification treatment.” In the House, Representative Paul Tonko (D-NY) introduced HR 2482 in May which does the same. HR 2482 has 75 co-sponsors, 15 of whom are Republicans.

It should be a lot easier for providers to help the many patients seeking help from their disorder but are are unable to find it. This legislation should help. Congress should also look at reforming laws surrounding methadone, so it can be prescribed in practitioners offices as well. But first things first.

 

 

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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.”

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.

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A Startling Development on the ObamaCare Front

The U.S. Court of Appeals for the 5th Circuit — the court that would hear any appeal of the Texas v. Azar decision overturning the entire Patient Protection and Affordable Care Act (ACA) — has just issued a request that does not bode well for ObamaCare.

In NFIB v. Sebelius, Chief Justice John Roberts reasoned the Supreme Court could view the ACA’s otherwise-unconstitutional individual mandate as a constitutional use of the Taxing Power. See my criticisms of Roberts’ reasoning here. In Texas v. Azar, a district-court judge ruled that since Congress zeroed-out the individual-mandate penalty, the courts could no longer uphold the mandate as a use of the Taxing Power, ergo the ACA must fall.

I oppose the ACA but disagree strongly with Texas v. Azar. At the time, I wrote, “federal judge Reed O’Connor did exactly what Chief Justice John Roberts did at the high court: jettison the rule of law to achieve a politically desired outcome.”

In an interesting twist, President Trump decided not to defend the ACA but instead to embrace the district court’s ruling, thereby depriving the overturned statute of its most obviously legally cognizable appellant — the government. Fortunately for the ACA, several states and the House of Representatives appealed the lower-court ruling to the 5th Circuit. Which brings us to yesterday’s development.

Yesterday, the 5th Circuit asked the states and the House (1) to justify why they have standing to appeal the lower-court ruling, (2) to explain, if they do not, whether the court can even hear an appeal of that ruling, and if not (3) what they think should happen then. See the court’s language below.

The request could mean the ACA and its would-be intervenors could have a harder slog than anyone thought. It means at least one judge on the 5th Circuit panel is skeptical that the court can even hear this appeal in its current form.

I think a higher court should, and ultimately will, overturn the lower court’s ruling in Texas v. Azar. But there are rules. Courts need a legitimate case or controversy in order to act. Today, it became less certain that they will.

The probability that Texas v. Azar will stand may have only risen from 0.5 percent to 5 percent, but I never would have thought it would reach even that high.

For more, see Nick Bagley.

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.

New Genetics Evidence Should Help Quell “Reefer Madness”Mongering

A team of Australian and Dutch researchers (Gillespie et al), writing in the June 2019 issue of the British medical journal The Lancet, criticized a March 2019 study by British researchers (Di Forti et al) in the same journal that suggested variations in cannabis use and potency may be responsible for variations in psychotic disorders. Opponents of cannabis legalization have used the Di Forti study as evidence to support their position. 

The criticism rests on the fact that the authors of the March study “assume that cannabis causes psychosis or psychotic symptoms without acknowledging compelling, alternative hypotheses.” 

Gillespie and colleagues point out that most studies looking at associations between cannabis and psychosis don’t adjust for “confounding” that arises from correlated genetic and environmental individual differences. They point to their own findings as well as those of other researchers showing cannabis use may be higher among individuals with a genetic liability that predisposes them to both cannabis use and the development of psychotic disorders. 

To address the shortcomings of the March study, they specifically point to the results of their recent meta-analysis of the largest genome-wide association study of lifetime cannabis use to date. The study indicated that genetic risk factors for cannabis use and schizophrenia are positively correlated. The meta-analysis applied bidirectional randomization and found a “consistent pattern of evidence supporting a causal effect of schizophrenia risk on lifetime cannabis use.” The study “found little evidence for any causal effect of cannabis use on schizophrenia.” While conceding their analyses were not based on cannabis use frequency or potency but rather genetic risk factors, they felt confident making the following statement:

Nevertheless, our findings strongly suggested that associations between measures of cannabis use and psychosis or psychotic disorders are far more nuanced than Di Forti and colleagues assume. In addition to correlated genetic liabilities, indirect and bidirectional processes are likely to affect the associations between cannabis use, misuse, and psychotic disorders. By not acknowledging the alternative, compelling and plausible mechanisms, Di Forti and colleagues’ conclusion regarding the harmful effect of high-potency cannabis use on mental health is likely to be overestimated.

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.

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