Proposed Brief of Pub. Health Scholars as Amici Curiae in Support of Pl.’s Motion for Temporary Restraining Order & Prelim. Injunction
Joshua M. Sharfstein
Brendan Saloner, PhD
Colleen Barry, PhD
Noa Krawcyzk
Jenny Wen
SimpleOriginal

Summary

Johns Hopkins public health scholars say methadone is a safe, effective treatment for opioid use disorder. Jails should not force withdrawal but continue methadone to prevent relapse and overdose.

2018 | Federal Juristiction

Proposed Brief of Pub. Health Scholars as Amici Curiae in Support of Pl.’s Motion for Temporary Restraining Order & Prelim. Injunction

Keywords methadone; opioid use disorder; MOUD; medication-assisted treatment; overdose deaths; depot naltrexone; withdrawal management; correctional settings; standard of care; Johns Hopkins

Amici—public-health scholars from Johns Hopkins—argue that methadone is a safe, FDA-approved, evidence-based medication for opioid use disorder (OUD) with the strongest track record of any MOUD (a.k.a. MAT): it lowers overdose deaths, infectious-disease risk, illicit use, and crime, and helps patients function normally without euphoria. They say defendants badly mischaracterize methadone as “continuing addiction” and exaggerate its risks; physical dependence is not addiction, and methadone-related fatalities are rare in OUD treatment and mainly tied to pain prescribing. Best practice is to offer all MOUD options and individualize care; forcing withdrawal from a successful methadone regimen to give a single depot-naltrexone shot is not recommended by medical authorities, has a weaker evidence base than methadone/buprenorphine, and exposes patients to unnecessary pain and elevated relapse/overdose risk. “Detox only” or withdrawal-management meds are not OUD treatment and can be dangerous. Concerns about diversion in correctional settings are overstated; jails can and do run MOUD programs effectively. Because the plaintiff’s methadone treatment is working, terminating it to impose forced withdrawal and depot naltrexone would contravene modern science and standard of care. Amici urge the Court to require continued access to methadone (and other MOUDs as clinically appropriate) rather than the defendants’ proposed regimen.

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Summary

Johns Hopkins public-health scholars, serving as amici curiae, assert that methadone is a safe, FDA-approved, and evidence-based medication for opioid use disorder (OUD). This medication, recognized as a medication for opioid use disorder (MOUD), demonstrates the most robust track record among available treatments. Its documented benefits include reducing overdose fatalities, mitigating infectious disease risk, decreasing illicit substance use, and lowering crime rates. Furthermore, methadone facilitates normal patient functioning without inducing euphoria. The amici contend that the defendants' characterization of methadone as "continuing addiction" is inaccurate, and their portrayal of its risks is exaggerated. It is emphasized that physical dependence is distinct from addiction. Fatalities associated with methadone are rare within the context of OUD treatment and are primarily linked to its prescription for pain management. Best medical practice dictates the provision of a comprehensive range of MOUD options, with individualized care tailored to patient needs. Medical authorities do not recommend discontinuing a successful methadone regimen to administer a single dose of depot naltrexone. Such an intervention possesses a weaker evidence base compared to methadone and buprenorphine, and it subjects patients to unnecessary pain and elevated risks of relapse and overdose. Withdrawal management or "detox only" protocols are not considered comprehensive OUD treatment and may pose significant dangers. Concerns regarding medication diversion within correctional facilities are deemed overstated, as jails have successfully implemented and managed MOUD programs. Given the efficacy of the plaintiff's current methadone treatment, its termination for the purpose of forced withdrawal and subsequent depot naltrexone administration would contradict contemporary scientific understanding and established standards of care. The amici therefore urge the Court to mandate continued access to methadone and other clinically appropriate MOUDs, rather than endorsing the regimen proposed by the defendants.

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Summary

Public health experts from Johns Hopkins University assert that methadone is a safe, FDA-approved medication for opioid use disorder (OUD). This treatment is supported by strong evidence and has the most successful history among all medications for OUD. It helps to reduce overdose deaths, lower the risk of infectious diseases, decrease illegal drug use, and lessen crime. Methadone also allows patients to function normally without causing feelings of euphoria.

These experts explain that critics often incorrectly describe methadone as "continuing addiction" and overstate its dangers. They clarify that physical dependence is not the same as addiction. Deaths related to methadone are rare when the medication is used to treat OUD; such fatalities usually occur when methadone is prescribed for pain management.

The best practice for OUD treatment involves offering all available medication options and tailoring care to each patient's specific needs. Medical authorities do not recommend stopping a successful methadone treatment to replace it with a single injection of extended-release naltrexone. This approach has less evidence to support it compared to methadone or buprenorphine, and it exposes patients to unnecessary pain and a higher risk of relapse and overdose. Additionally, "detox only" programs or medications used solely for managing withdrawal symptoms are not considered full treatments for OUD and can be dangerous.

Concerns about methadone being diverted for illegal use in correctional facilities are often exaggerated; jails are capable of and do effectively manage medication for OUD programs. Since a patient's methadone treatment is proving successful, ending it to force withdrawal and provide extended-release naltrexone would go against current medical science and accepted standards of care. Therefore, the experts urge the Court to ensure continued access to methadone, and other appropriate medications for OUD, rather than implementing the alternative plan proposed by the defendants.

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Summary

Scholars from Johns Hopkins explain that methadone is a safe, FDA-approved, and evidence-based medicine for opioid use disorder (OUD). It has the strongest history of success among all medications for OUD (MOUD). Methadone helps lower overdose deaths, reduce the risk of infectious diseases, decrease illicit drug use, and lower crime rates. It also allows patients to function normally without causing euphoria.

These scholars argue that claims mischaracterizing methadone as "continuing addiction" or exaggerating its risks are incorrect. Physical dependence on a medication is not the same as addiction. Fatalities related to methadone are rare in OUD treatment settings and are mostly linked to when it is prescribed for pain.

The best approach is to offer all MOUD options and tailor treatment to each person's needs. Forcing someone to withdraw from a successful methadone treatment to instead receive a single naltrexone shot is not advised by medical experts. This approach has less scientific backing than methadone or buprenorphine and can expose patients to unnecessary pain and a higher risk of relapse and overdose. Programs that only offer "detox" or withdrawal management are not considered full OUD treatment and can be dangerous.

Concerns about methadone being misused in correctional facilities are overblown, as jails can and do run effective MOUD programs. Because a patient's methadone treatment is working, stopping it to force withdrawal and administer naltrexone would go against current medical science and accepted standards of care. The scholars urge the Court to ensure continued access to methadone and other appropriate MOUDs, rather than the alternative treatment proposed by the defendants.

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Summary

Experts from Johns Hopkins say that methadone is a safe medicine. The FDA has approved it, and it has been proven to help people with opioid use disorder (OUD). It has the best history of all medicines for OUD. Methadone helps stop people from dying from overdoses, lowers the risk of infections, and reduces illegal drug use and crime. It helps people live normal lives without feeling a "high."

These experts say that some people wrongly call methadone "continuing addiction" and make its dangers seem bigger than they are. A body depending on a medicine is not the same as being addicted. Deaths from methadone are very rare when used for OUD. Most methadone deaths happen when it is given for pain, not OUD.

Doctors should offer all types of medicine for OUD and pick the best one for each person. If someone is doing well on methadone, doctors do not suggest making them stop. Forcing someone to stop methadone to get a different shot (depot-naltrexone) is not what medical groups advise. This shot does not have as much proof of working as methadone or buprenorphine. It can cause people unnecessary pain and raises the chance of them using drugs again or overdosing. Medicines that only help with "detox" or withdrawal are not real treatments for OUD and can be risky.

Some people worry that methadone will be misused in jails, but this worry is too big. Jails can, and do, offer OUD medicine programs that work well. If a person's methadone treatment is working, stopping it to force withdrawal and give a different shot would go against current science and good medical care. The experts ask the Court to keep letting people use methadone and other OUD medicines when they are right for the person, rather than following a different plan.

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Footnotes and Citation

Cite

Proposed Brief of Pub. Health Scholars as Amici Curiae in Support of Pl.’s Motion for Temporary Restraining Order & Prelim. Injunction, Pesce v. Coppinger, 355 F. Supp. 3d 35 (D. Mass. 2018) (No. 18-11972-DJC).

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