Patients Blame DEA for Drug Shortages, Not Monopolies or Middlemen

By Pat Anson, PNN Editor

Two federal agencies are getting more than they bargained for when they asked the public to comment on record shortages of prescription drugs.

In February, the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) made a joint Request for Information in the Federal Register, asking how wholesalers and other “middlemen” in the drug supply chain were contributing to persistent shortages.

“When you’re prescribed an important medication by your doctor, and you learn the drug is out of stock, your heart sinks,” HHS Secretary Xavier Becerra said in a press release. “This devastating reality is the case for too many Americans who need generic drugs for ADHD, cancer, and other conditions. (This) announcement is part of the Biden-Harris Administration’s work to tackle healthcare monopolies and lessen the impact on vulnerable patients who bear the brunt of this lack of competition.”

Nearly 10,000 comments have been received so far, with many blaming the federal government for the drug shortages -- not monopolies, middlemen or lack of competition. Drawing the most criticism is the Drug Enforcement Administration (DEA), which sets annual production quotas for opioids, stimulants and other controlled substances. The CDC and FDA also came under fire from frustrated patients.

“The heavy-handed failure of the FDA/DEA to properly and ethically manage the uptick in ADHD prescriptions is creating a crisis on par with their equally underhanded failure in managing the opioid crisis,” wrote Matti Dupre. “Hardworking Americans are left looking at the individuals leading these organizations as a source of pain rather than as a means of support.”

“Millions of people are having a hard time getting their prescription opioid medications filled at pharmacies now. Why? Because the DEA have cut production down so low, pharmacies can't get what they need to fill our prescriptions,” said Candi P. “Wake up! Stop playing with our lives!”

“The government has gone way too far, with their guidelines and regulations regarding opioids,” wrote Julie Anuskewic, who has a painful immune system disorder. “My pain is not controlled because the CDC has scared all doctors into not prescribing. It’s bad enough that they have destroyed the doctor-patient relationship. Now they are destroying the patient-pharmacist relationship.” 

Notably lacking in the FTC and HHS statement about drug shortages is any mention of the National Opioid Settlement, which has forced major drug wholesalers and big chain pharmacies to ration opioids and other controlled substances or risk losing their DEA licenses. Some manufacturers are also cutting back on production of generic opioids because the profit margins are low and the risk of further litigation is high.

A recent PNN survey found that 90% of patients with opioid prescriptions had trouble getting them filled, with one in five unable to get their pain medication even after contacting multiple pharmacies.  

“The FTC is looking in the wrong places for reasons for drug shortages, at least as far as opioids and stimulants are concerned,” wrote Andrea MacNary. “In those cases, the shortages are a direct result of the DEA's policies – with input from the FDA – that have seen annual reductions in the amount of drugs that manufacturers are allowed to produce.

”This results in patients being unable to obtain their legally prescribed medications in a timely manner. Because pharmacies have shortages, patients are then forced to call around to different pharmacies looking for their meds. This is extremely difficult, because not only do pharmacies not want to disclose whether they have the drugs in stock, but if the patient does find them, they must obtain a new prescription from their doctor.”

‘Broken Quota System’

One critic sees the public outreach by the FTC and HHS as a ham-handed attempt to coverup the DEA’s “crude and inadequate system” for regulating controlled substances   

“I believe the FTC is only trying to find cover for the Drug Enforcement Administration.The DEA is the only governmental agency that sets production and distribution quotas for every drug company manufacturing controlled medication,” William Dodson, MD, wrote in a recent op/ed in ADDitude. “This problem traces its roots and long tendrils back to the DEA alone. No other agency has the authority to create and prolong it. 

“The time has long since passed for the DEA to admit its fault and fix its broken quota system. There has already been too much needless suffering by innocent people who did nothing to cause the DEA’s restrictions.”

That’s not how the DEA sees it. This month a top DEA official compared the growing demand for Adderall and other ADHD stimulants to the early stages of the opioid crisis. Matthew Strait claimed the problem isn’t tight supplies, but excessive prescribing of stimulants.

“I’m not trying to be a doomsday-er here,” said Strait, deputy assistant administrator in the DEA’s diversion control division. “It makes me feel like we’re at the precipice of our next drug crisis in the United States.”

If you’d like to make a comment in the Federal Register on the FTC and HHS Request for Information, click here. Comments will be accepted until May 30. 

FDA Finds ‘Credible Scientific Support’ for Marijuana as Pain Reliever

By Pat Anson, PNN Editor

It took a lawsuit to prompt its release, but the U.S. Department of Health and Human Services (HHS) has finally made public a lengthy FDA review explaining why it thinks marijuana should be rescheduled as a Schedule III controlled substance. Such a move would make it legal under federal law for marijuana to be used for medically approved purposes, such as pain relief.

The FDA review was completed last August, nearly a year after it was requested by President Biden. But the 252-page review was not released until Friday, after a lawsuit was filed by two pro-cannabis lawyers when HHS didn’t respond to Freedom of Information Act (FOIA) requests.

Medical marijuana is already legal in 38 states, but cannabis remains classified as a Schedule I substance by the Drug Enforcement Administration, making its sale or use illegal under federal law. The DEA is expected to make its decision on rescheduling soon.

The FDA looked at seven potential medical uses of cannabis: pain, anorexia, anxiety, epilepsy, inflammatory bowel disease (IBD), nausea, and post-traumatic stress disorder (PTSD).

After reviewing clinical studies of cannabis, and the views of academic and professional medical societies, the FDA said they found “mixed findings of effectiveness.” The strongest evidence was for pain relief, anorexia and nausea.

“The available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain.”

— FDA review

“The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain),” the FDA said. “On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting, with varying degrees of support and consistency of findings.”

Perhaps just as importantly, the FDA found no evidence of “unacceptably high safety risks” when marijuana was used therapeutically. That is a key finding for marijuana to be rescheduled by the DEA. The risk of marijuana being used nonmedically was also low, compared to substances like alcohol, heroin, cocaine, prescription opioids and anti-anxiety drugs.

“The rank order of the comparators in terms of greatest adverse consequences typically places heroin, benzodiazepines and/or cocaine in the first or immediately subsequent positions, with marijuana in a lower place in the ranking, especially when a utilization adjustment is calculated. For overdose deaths, marijuana is always in the lowest ranking among comparator drugs,” FDA said.

“These evaluations demonstrate that there is consistency across databases, across substances, and over time that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The FDA said the “vast majority” of professional medical organizations do not recommend marijuana, but they don’t specifically recommend against it either. The lone exception is the American Psychiatric Association, which warns that long-term use of marijuana can worsen psychiatric conditions, such as paranoia and hallucinations.

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – would certainly be historic, but it won’t resolve the many differences between federal and state regulation of cannabis.

Under federal law, legal access to Schedule III substances requires a prescription from a licensed doctor that is dispensed from a licensed pharmacy. Medical marijuana products would also have to go through the FDA’s lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would only be approved by FDA for certain conditions.  

HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.

Feds Warn About Rapid Opioid Tapers

By Pat Anson, PNN Editor

Federal health officials are once again urging doctors not to rapidly decrease or abruptly stop prescribing opioid medication to chronic pain patients.

In an editorial published in the Journal of the American Medical Association (JAMA), three federal health officials warn that sudden opioid tapering significantly increases the risk of harm to patients, resulting in increased hospitalizations and emergency room visits.

“There are concerning reports of patients having opioid therapy discontinued abruptly and of clinicians being unwilling to accept new patients who are receiving opioids for chronic pain, which may leave patients at risk for abrupt discontinuation and withdrawal symptoms,” the editorial warns.

The editorial was written by Deborah Dowell, MD, of the Centers for Disease Control and Prevention, Wilson Compton, MD, of the National Institute on Drug Abuse, and Brett Girior, MD, of the U.S. Public Health Service. Dowell is one of the co-authors of the CDC’s controversial opioid guideline, which has been widely used as an excuse by doctors, insurers and pharmacies to impose mandatory limits on prescribing.  

Even before its release in March 2016, pain patients and advocates warned the CDC guideline would result in rapid tapering, patient abandonment and suicide.

But not until April of this year – after three years of needless deaths and suffering -- did the FDA and CDC start urging doctors to be more cautious in their tapering.

It then took another six months for the Department of Health and Human Services (HHS) to produce a 6-page guide for doctors on how to taper patients.

“The HHS guide and current guidelines emphasize that tapering should be individualized and should ideally proceed slowly enough to minimize opioid withdrawal symptoms and signs. Physical dependence occurs as early as a few days after consistent opioid use, and when opioids have been prescribed continuously for longer than a few days, sudden discontinuation may precipitate significant opioid withdrawal,” the JAMA editorial warns.

The HHS tapering guide urges doctors not to dismiss pain patients and to share decision making with them when developing a taper program.

“If the current opioid regimen does not put the patient at imminent risk, tapering does not need to occur immediately. Take time to obtain patient buy-in,” the guideline cautions. “There are serious risks to non-collaborative tapering in physically dependent patients, including acute withdrawal, pain exacerbation, anxiety, depression, suicidal ideation, self-harm, ruptured trust, and patients seeking opioids from high-risk sources.”

The guide suggests tapers of 5% to 20% every four weeks, although slow tapers of 10% a month may be appropriate for patients taking opioids for more than a year.

A recent study of tapering in Vermont found only 5 percent of patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering. Many of those patients were hospitalized for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure.

Another recent study at a Seattle pain clinic found that tapered patients had an unusually high death rate, with some dying from suspected overdoses.

Meanwhile, not a single word of the CDC opioid guideline has changed since federal health officials finally acknowledged it was harming patients and needed clarification.

Feds Urge Doctors to Co-Prescribe Naloxone

By Pat Anson, PNN Editor

Pain patients taking relatively modest doses of opioid medication should be co-prescribed naloxone, according to a recommendation released this week by the U.S. Department of Health and Human Services.

Naloxone is an overdose recovery drug administered by injection or nasal spray that rapidly reverses the effects of an opioid overdose. It has been credited with saving thousands of lives, although recently there has been controversy over a company exploiting demand for the drug by raising the cost of its naloxone injector over 600 percent.

“Given the scope of the opioid crisis, it’s critically important that healthcare providers and patients discuss the risks of opioids and how naloxone should be used in the event of an overdose,” said Adm. Brett Giroir, MD, assistant secretary for health and senior advisor for opioid policy at HHS.

“Co-prescribing naloxone when a patient is considered to be at high risk of an overdose, is an essential element of our national effort to reduce overdose deaths and should be practiced widely.”

But the “guidance” released by HHS could involve millions of patients who are not necessarily at high risk and have been taking opioids safely for years.  It urges doctors to “strongly consider” prescribing naloxone to patients under these circumstances:

• Patients prescribed opioids at a dose of 50 morphine milligram equivalents (MME) or more per day

• Have respiratory conditions or obstructive sleep apnea (regardless of opioid dose)

• Have been prescribed benzodiazepines (regardless of opioid dose)

• Have a mental health or non-opioid substance use disorder such as excessive alcohol use

• Are receiving treatment for opioid use disorder

• Have a history of illegal drug use or prescription opioid misuse

The HHS guidance was issued days after an FDA advisory committee voted 12 to 11 in favor of adding language to opioid warning labels recommending that naloxone be co-prescribed.  Some panel members objected to the labeling because of the additional cost involved and because it does not address deaths caused by illicit opioids, which account for the vast majority of opioid overdoses.

The guidance notes that most health insurance plans, including Medicare and Medicaid, will cover at least one form of naloxone. For patients without insurance, the guidance suggests contacting a state or local program that may supply naloxone for free or at low cost.

Naloxone costs only pennies to make and syringes containing generic versions of the drug typically cost about $15 each. But formulated and branded versions that have a more sophisticated delivery system are much pricier. According to Health Care Bluebook, a package of two nasal sprays of naloxone sold under the brand name Narcan will cost about $135.  Evzio, a kit that contains two auto-injectors of naloxone, retails for about $3,700.   

A recent U.S. Senate report found that Kaleo, a privately-owned drug maker, jacked up the price of Evzio by over 600% to “capitalize on the opportunity” of a “well established public health crisis.” As a result, the report estimates the U.S. government paid over $142 million in excess costs to Kaleo for prescriptions covered by Medicare.  

The new HHS guidance mirrors that of the 2016 CDC opioid guideline, which encourages physicians to consider prescribing naloxone to pain patients on “higher opioid dosages” of 50 MME or more.

“I’m personally against it, because I don’t think most patients who require opioids for pain management are at risk of overdose,” said Andrea Anderson, Executive Director, Alliance for the Treatment of Intractable Pain (ATIP).  “I also don’t think naloxone helps unless you’re with other people, which makes more sense for those who are using illicit opioids rather than those who rely on opioids for routine pain relief. 

“I don’t think the government should require patients to buy medications for which they do not have a proven need. This sounds like another one of those good ideas in theory but poor in practice.”

New Federal Task Force to Address Opioid Prescribing

By Pat Anson, Editor

The federal government is forming another advisory panel to study and develop "best practices" for treating acute and chronic pain. And for the first time, the feds are seeking nominations from the public for members to serve on the panel, who would represent pain patients and pain management experts.

The Pain Management Best Practices Inter-Agency Task Force was authorized by the Comprehensive Addiction and Recovery Act of 2016 – also known as the CARA Act – a landmark bill signed into law last year to address the nation's addiction and overdose crisis.

While much of CARA is focused on preventing and treating opioid addiction, the law also calls for the Department of Health and Human Services (HHS) to form a task force to recommend solutions to “gaps or inconsistencies” in pain management policies among federal agencies.

Currently, the Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, and the Department of Defense all have different regulations and guidelines for opioid medication.

“This Task Force represents a critical piece of HHS’s five-point strategy to defeat the opioid epidemic, which includes advancing the practice of pain management,” HHS Secretary Tom Price said in a news release.

“Top experts in pain management, research, addiction and recovery can help us reassess how we handle the serious problem of pain in America.”

The task force could have as many as 30 members representing a broad spectrum of interests in pain management, according to a notice being published in the Federal Register:

The members of the Task Force shall include currently licensed and practicing physicians, dentists, and non-physician prescribers; currently licensed and practicing pharmacists and pharmacies; experts in the fields of pain research and addiction research, including adolescent and young adult addiction; experts on the health of, and prescription opioid use disorders in, members of the Armed Forces and veterans; and experts in the field of minority health.

The Members of the Task Force shall also include… representatives of pain management professional organizations; the mental health treatment community; the addiction treatment community, including individuals in recovery from substance use disorder; pain advocacy groups, including patients; veteran service organizations; groups with expertise on overdose reversal, including first responders; State medical boards; and hospitals.

Members will also be appointed to represent Veterans Affairs, Department of Defense, Office of National Drug Control Policy, and “relevant HHS agencies.” The latter most likely includes the FDA and CDC. The Drug Enforcement Administration, an agency in the Department of Justice, will apparently not have a representative on the task force.

Pain patients and pain management experts have been poorly represented – and in some cases excluded – from previous federal advisory panels that addressed opioid prescribing and addiction. Some panel meetings were also closed to the public.

President Trump’s opioid commission, for example, includes three governors, a former congressman, and a Harvard professor who has been a longtime critic of opioid prescribing. No patients, pain management experts or practicing physicians were appointed, and the commission only heard testimony from addiction treatment advocates during its one public meeting.

That was better than the CDC, which held no public hearings while preparing the initial draft of its opioid prescribing guideline in 2015. As PNN has reported, the “Core Expert Group” and various stakeholders that advised the CDC were dominated by special interest groups and addiction treatment specialists, including five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Only after a public outcry and threats of a lawsuit did the agency delay the release of the guideline, seek public comment and form a new advisory panel.

Are you interested in becoming a member of the new task force on pain management or know someone who might?

Information on how to nominate individuals – including self-nominations -- can be found by clicking here. Applications are due by Wednesday, September 27. All nominations must be submitted via email to the attention of Vanila Singh, MD, Chief Medical Officer at PainTaskforce@hhs.gov.

Members of the task force who are not government employees will receive per diem pay and reimbursement for travel expenses. All task force meetings will be open to the public.