More than 20 states sue CDC over federal mask mandate on public transportation

https://www.abc15.com/news/national/coronavirus/more-than-20-states-sue-cdc-over-federal-mask-mandate-on-public-transportation

TALLAHASSEE, Fla. — 20 states are joining the state of Florida in a lawsuit against the federal mask mandate on public transportation.

Attorney General Ashley Moody and Governor Ron DeSantis announced the lawsuit on Tuesday.

In a press release, Moody’s office called the mandate “unlawful” and said it “exceeds the authority of President Biden’s Centers for Disease Control and Prevention.”

The other states included in the suit are Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, Ohio, Oklahoma, South Carolina, Utah, Virginia and West Virginia.

In several instances, the lawsuit calls the mask mandate “arbitrary and capricious.”

Florida leaders claim there is no “high-quality data to support the efficacy of mask mandates, case numbers and hospitalizations experiencing a large downward trend, and 81.7% of the population having received at least one dose of the COVID-19 vaccine.”

The lawsuit doesn’t just call for an end to the mandate and a permanent injunction against enforcement, it also calls for the defendants to pay for attorney fees and other costs.

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How many pts have contacted the ACLU in their state about chronic pain pts being civil rights discriminated by the CDC prohibiting/limiting being prescribed medication to treat their chronic pain  and be told that the ACLU did not have the resources to deal with that issue ?

Department of Justice Finds PA Court System Violated Federal Law By Banning Medication for Opioid Use Disorder

https://www.aclupa.org/en/press-releases/department-justice-finds-pa-court-system-violated-federal-law-banning-medication

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This is not the first time that a member of a hospital system that has been convicted for the death of a pt because of a med error. The med error was made by a technician in preparing a IV.. and the pharmacist did not catch the fact that the tech used 26.3% NACl instead of 0.9% NACl in the IV.  This was a decade ago, and back then, many states did not require technicians to be registered or certified.  Because of that the technicality … the tech had no authority by the board of pharmacy… since they only have authority over those who are registered/certified and licensed by the Board of Pharmacy.  There are several related stories and hyperlinks in the hyperlink below.  Just like the issue with the nurse and a pt death, there was a number of “system issues” that contributed to the death of the little girl in Ohio.

Pharmacist Jailed for Fatal Medication Error

https://www.pharmacyerrorinjurylawyer.com/pharmacist_jailed_for_fatal_me_1/

An Ohio pharmacist spent six months in jail for a medication error that led to the death of a two year-old child. Emily Jerry’s parents took her to a Cleveland hospital in February 2006 for the last of a series of cancer treatments. Her doctors ordered an intravenous chemotherapy solution. A pharmacy technician prepared her medication with the incorrect dosage of saline, 23 percent instead of 1 percent, and supervisor Eric Cropp signed off on the technician’s work. The saline amount proved to be lethal. Emily slipped into a coma shortly after the solution was administered, and she died several days later.

Will Prosecuting Medical Errors Lead to a Culture of Silence?

— Healthcare workers fearful of repercussions from former nurse RaDonda Vaught’s conviction

https://www.medpagetoday.com/special-reports/exclusives/97911

Healthcare workers are alarmed by the conviction of former Nashville nurse RaDonda Vaught, who now faces prison time over a medical error.

“We could all and probably have been close to this situation because we’re continuously stretched too thin,” Kelsey Fassold, RN, an ICU nurse, said in a LinkedIn post. “We try so hard to do the best by our patients while the odds are stacked against us.”

Jeremy Faust, MD, MedPage Today’s editor-in-chief, said in an Inside Medicine post that the verdict “may contribute to a culture of silence around medical errors.”

“Such silence may make systemic problems less readily identified and rectified. This is the opposite of what we need,” Faust wrote. “We need to destigmatize human errors, acknowledge them, and learn from them.”

On Friday, Vaught was convicted of negligent homicide and gross neglect of an impaired adult, after she allegedly gave 75-year-old Charlene Murphey the paralytic vecuronium when she was meant to give her the anti-anxiety drug Versed. Vaught had been acquitted of a reckless homicide charge.

Vaught faces 1 to 2 years in prison for the negligent homicide charge, and 3 to 6 years on the gross neglect charge, according to Kaiser Health News. Her sentencing is scheduled for May 13.

Typically, serious medical errors are handled by licensing boards or civil courts — not prosecutors.

The American Nurses Association said in a statement that the “criminalization of medical errors could have a chilling effect on reporting and process improvement.”

“ANA supports a full and confidential peer review process in which errors can be examined and system improvements and corrective action plans can be established,” the statement said. “Transparent, just, and timely reporting mechanisms of medical errors without the fear of criminalization preserve safe patient care environments.”

Faust said that during his career, he witnessed a very similar error. Instead of confusing vecuronium with Versed, Faust said a nurse gave the paralytic rocuronium when she was meant to give the antibiotic Rocephin.

“Fortunately, the mistake was immediately recognized, and the patient suffered no immediate or long-term consequences,” Faust wrote. “In fact, the patient was informed as to what was happening in real time, given a play-by-play narration of what had just happened and what would happen next,” which included giving Sugammadex to reverse the effects of rocuronium.

“The nurse who made the mistake was experienced, respected, and every bit as caring as the very best healthcare colleagues I have worked with over the years,” Faust wrote. “In other words, this was not some green, distracted, or emotionally detached bad apple. In my mind, all of that added up to one thing: this could have happened to anyone.”

“If honest errors lead to criminal convictions, every incentive will be to sweep things under the rug,” Faust added. “If we don’t learn from both our successes and our failures, things will get worse, not better.”

Fassold noted in her LinkedIn post that she considered Vaught’s mistake a “systemic error” and that “when something bad happened, the nurse took the heat.”

“Nurses are constantly put in unsafe and harmful conditions that can and will hurt patients. Not because they’re not trying, but because they’re working themselves to death trying to keep up with what the system demands from them,” she wrote — a sentiment that has echoed throughout the nursing world as it struggled to provide care through the COVID-19 pandemic.

“Nursing ratios are far worse now than they ever have been,” she continued. “How many more situations will occur just like this? It’s time nurses stand up for themselves, their license, and their life. It’s time nurses say no to unsafe assignments. It’s time nurses tell administration that what [they’re] demanding is unsafe and harmful. It’s time we all stand together and demand change.”

Vanderbilt University Medical Center, Vaught’s former employer when the error occurred, said via an email from a spokesperson that it did not have a comment on the verdict.

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Can You Be Held Liable for Prescribing Opioids in Good Faith?

https://www.medpagetoday.com/opinion/second-opinions/97904

The Supreme Court is considering this question in Ruan v. United States

Earlier this month, the Supreme Court heard oral arguments in a case that will impact how doctors can treat patients where opioids are involved. The threshold question in Ruan v. United States, which came to the Supreme Court from the U.S. Court of Appeals for the Eleventh Circuit, is when the care a doctor provides patients crosses the line into a criminal act where the doctor is prescribing opioids.

Xiulu Ruan, MD, practiced medicine as a board‐certified pain specialist in Alabama, and was indicted in 2016 for unlawful distribution of opioids. The jury in the trial court convicted Ruan and other physicians in his practice based on a ruling that did not allow doctors to claim a defense of “good‐faith” where they honestly prescribed opioids under the belief that it was the right thing to do medically. Once the case reached the Eleventh Circuit on appeal, Ruan was essentially doomed, as that federal appellate circuit does not recognize a good-faith defense in cases such as this. He lost and appealed to the Supreme Court on a writ of certiorari, a court process to seek judicial review of a decision from a lower court.

John Brennan, JD, a New Jersey criminal defense lawyer, explains that the heart of the question presented to the Court in this case is what is and isn’t reasonable medical judgment:

“The argument of the doctors involved in the case was that the Supreme Court should look at the good faith of the doctors prescribing opioids. In a situation where a doctor genuinely believes that writing an opioid prescription falls within their normal course of practice, that this should not be viewed as a criminal act and they shouldn’t be convicted of unlawful distribution under the Controlled Substances Act.”

In the recent oral arguments, the Supreme Court Justices seemed to be leaning towards overturning the Eleventh Circuit and siding with the convicted doctors. However, the notion of reasonable belief and subjective intention are going to be difficult to agree upon because they can be a little slippery.

Three Justices — Brett Kavanaugh, Neil Gorsuch, and Chief Justice John Roberts — each expressed concerns for doctors who would be on the wrong side of a close professional judgment call, pointing out that doing so could result in decades in prison. When Justice Clarence Thomas asked whether the standards regulators set forth on this issue were insufficiently clear, counsel for Ruan replied that the elements of knowingly and intentionally misprescribing are left to states and administrative boards, as there is no clear federal guidance on this issue.

For the Justices, this will essentially come down to a question of reasonable professional practice, which can be difficult to pin down in medicine. At least from the nature and tone of the questioning at the oral argument, the Justices seem unwilling to look at the Controlled Substances Act in as restrictive a manner as the Eleventh Circuit did. While pinning down a reasonable good-faith defense is going to be a real challenge for the Court, the outcome here relies upon it, as does intelligent and balanced enforcement of the Controlled Substances Act.

The importance of this case and the underlying issue — the opioid crisis — cannot be overstated. A recent position paper by the American Medical Association made it clear that the nation’s opioid and drug overdose epidemic continues to worsen with metrics far beyond earlier projections. The ruling in this case could impact its trajectory.

While both the Alabama Federal Court jury and the Eleventh Circuit convicted Ruan for violating provisions of the Controlled Substances Act, among other laws, the larger question goes far beyond the wrongdoing of any doctor who may have been motivated to prescribe opioids for financial gain.

Simply put, a doctor’s ability to practice medicine properly would be limited by an inability to make judgment calls. If doctors fear huge penalties for honest mistakes, they will err on the side of not treating. So, if the Court’s ruling sets forth an overly restrictive policy aimed at the small number of physicians motivated by their own self-interest, it may be patients in pain who suffer in the long run.

Will the Supreme Court overturn the Eleventh Circuit here? In my opinion, they absolutely need to. While ensuring the availability of opioids may seem counterintuitive in a national opioid crisis, this is neither the legal nor medical issue presented in this case. Having the Controlled Substances Act without a good‐faith defense makes no sense from a legal or practical perspective. If the Supreme Court doesn’t overturn the Eleventh Circuit, they are essentially saying the binary between good doctors and those who run illegal pill mills is always crystal clear.

We can still be against pill mill doctors but agree that, in all jurisdictions, doctors need the legal ability to follow their best medical judgment to prescribe or not to prescribe as they see fit. If doctors are overly fearful of the legal consequences of perceived misprescribing — which may be the result of the current ruling in the Eleventh Circuit — patients in chronic pain will suffer unnecessarily. Beyond being fundamentally unfair, it is also a specious medical argument for any court to hold that physicians should still be convicted for unlawful distribution of controlled substances if they sincerely believe they were prescribing the drugs under acceptable standards of practice.

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FDA authorizes 2nd booster shot for Americans over 50

https://abc7.com/covid-booster-2nd-for-seniors-fda/11689371/

WASHINGTON — U.S. regulators on Tuesday authorized another COVID-19 booster for people age 50 and older, a step to offer extra protection for the most vulnerable in case the coronavirus rebounds.

The Food and Drug Administration’s decision opens a fourth dose of the Pfizer or Moderna vaccines to that age group at least four months after their previous booster.

Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot.

The latest expansion, regardless of people’s health, allows an extra shot to millions more Americans – and the question is whether everyone who’s eligible should rush out and get it. The Centers for Disease Control and Prevention is expected to weigh in.

Everyone eligible for a first booster who hasn’t gotten one yet needs to, FDA vaccine chief Dr. Peter Marks said. But the second booster is only for these higher-risk groups because “current evidence suggests some waning of protection” for them.

The move comes at a time of great uncertainty. COVID-19 cases have dropped to low levels after the winter surge of the super-contagious omicron variant. Two vaccine doses plus a booster still provide strong protection against severe disease and death, CDC data show.

But an omicron sibling is causing a worrisome jump in infections in Europe — and spreading in the U.S. – even as vaccination has stalled. About two-thirds of Americans are fully vaccinated, and half of those eligible for a first booster haven’t gotten one.

Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults “to provide flexibility” for the government to decide who really needs one. The FDA set age 50 as the threshold for both companies. As for the immune-compromised, only the Pfizer vaccine can be used in those as young as 12; Moderna’s is for adults.

There’s limited evidence to tell how much benefit another booster could offer right now. FDA made the decision without input from its independent panel of experts that has wrestled with how much data is required to expand shots.

“There might be a reason to top off the tanks a little bit” for older people and those with other health conditions, said University of Pennsylvania immunologist E. John Wherry, who wasn’t involved in the government’s decision.

But while he encourages older friends and relatives to follow the advice, the 50-year-old Wherry – who is healthy, vaccinated and boosted – doesn’t plan on getting a fourth shot right away. With protection against severe illness still strong, “I’m going to wait until it seems like there’s a need.”

None of the COVID-19 vaccines are as strong against the omicron mutant as they were against earlier versions of the virus. Also, protection against milder infections naturally wanes over time. But the immune system builds multiple layers of defense and the type that prevents severe illness and death is holding up.

During the U.S. omicron wave, two doses were nearly 80% effective against needing a ventilator or death – and a booster pushed that protection to 94%, the CDC recently reported. Vaccine effectiveness was lowest – 74% – in immune-compromised people, the vast majority of whom hadn’t gotten a third dose.

U.S. health officials also looked to Israel, which during the omicron surge opened a fourth dose to people 60 and older at least four months after their last shot. The FDA said no new safety concerns emerged in a review of 700,000 fourth doses administered.

Preliminary data posted online last week suggested some benefit: Israeli researchers counted 92 deaths among more than 328,000 people who got the extra shot, compared to 232 deaths among 234,000 people who skipped the fourth dose.

What’s far from clear is how long any extra benefit from another booster would last, and thus when to get it.

“The ‘when’ is a really difficult part. Ideally we would time booster doses right before surges but we don’t always know when that’s going to be,” said Dr. William Moss, a vaccine expert at the Johns Hopkins Bloomberg School of Public Health.

Plus, a longer interval between shots helps the immune system mount a stronger, more cross-reactive defense.

“If you get a booster too close together, it’s not doing any harm – you’re just not going to get much benefit from it,” said Wherry.

The newest booster expansion may not be the last: Next week, the government will hold a public meeting to debate if everyone eventually needs a fourth dose, possibly in the fall, of the original vaccine or an updated shot.

As for updating vaccines, studies in people – of omicron-targeted shots alone or in combination with the original vaccine – are underway. The National Institutes of Health recently tested monkeys and found “no significant advantage” to using a booster that targets just omicron.

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It is pretty simple answer…  Law firms … like all other businesses is a FOR PROFIT BUSINESS. Just look at all the “ambulance chasing “ personal injury law firms that advertise on TV…   Most claim… you don’t pay … unless YOU WIN… They don’t take every case that someone comes to them with…. they weigh their chances of winning or losing… basically there is a handful of well worn paths to a pot of money – mostly from insurance companies.  What they don’t regularly share is that most settlements are done by exchanging letters – or mediation – between the insurance company the law firm until a $$$ sum is agreed upon… very few go to court.

With law firms that take a case on contingency basic… I would expect those that are settled with negotiating by letter that the law firm will probably get rewarded at least ten times what the exchange of negotiation  costs them.

If someone is bold enough to try and sue the DEA.. they are not going to get any $$$ from the FEDS… if one wins… ideally the win will mean that they change their policies and hope that they don’t find a work around for what they were sued for and start doing a similar thing again. I suspect that most law firms would take on a case that person wants to sue over… if they can come up with enough cash to cover all the anticipated hours they will bill for… in trying to suing the Fed government…  that could involve several million

I know a person that was an employee of and sued a large corporation over violations of  EEOC, ADA, and whistler blower. The law firm that  took the case on a contingency basis and the case was settled via mediation – never went to trial –  my understanding is that the law firm tracked the number of billable hours for this case and at the rate they charge.. the total was NORTH of ONE MILLION…   I don’t know what the final settlement was, but it is my understanding is that the attorney that was the “lead” on this case… was MADE A PARTNER of the firm after this case was settled.  One can only imagine what the total settlement was, to make the lead attorney a partner in the firm… meaning that this attorney will share in the profits of the law firm going forward on top of what the attorney is paid for their billable hours.

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Cannabis Linked to Less Opioid Use in Back Pain, Osteoarthritis

Usage fell by almost 40% in 6 months, although it’s not clear if medical pot was the reason

https://www.medpagetoday.com/meetingcoverage/aaos/97887

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This is what no pain management looks like in the state of Washington

call their bluff with a letter from attorney ?

I am hearing from more and more pain pts whose pain is under managed or not managed at all.  Because many large healthcare corporations have adopted a “no opiate pain management policy”

Anything above 135/85 is considered “high” and most healthcare professionals will consider BP above 200/100 being in stroke/heart attack territory.

The hyperlink above is a fairly long post that I created some time ago…  that gives some suggestions as to a pt’s option in dealing with such issues.

These large healthcare corporations, hospitals, chain pharmacies, insurance/pbm are behaving much like the criminals that we see in some of our large cities.  You know the ones who are going into retail stores and cleaning the shelves off and walk/run out the door without paying…  Some district attorneys, in some of these large cities won’t even prosecute a person unless they steal > $950.00… and some of these cities have a “no bail” policy… so the criminals are back out on the street in a matter of hours…

Mostly likely, they go right back to stealing more merchandise from another store … because they know that they will have no consequences to deal with.  Apparently these large healthcare corporations are functioning under a similar mindset.  If they provide no controlled substances to pts…. they have no worry about the DEA coming and screwing with them and fining them for exceeding some -undefined – standard of care and best practices.

To date, none of these healthcare corporations have suffered any financial consequences for establishing corporate  no opiate – policies that stop their employees from prescribing controlled meds to any pts. 

I would suspect that until those healthcare corporations has to deal with consequences from their “no-opiate policies” things will not change or even more of those corporations will join them with implementing no-opiate policies.

Unless some law firm gets involved and/or pts get some lawsuit started… IMO … the community’s future may closely look like what can be seen in the rear view mirror today.

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“CVS Ousts Executives After Probe”

http://pharmacistactivist.com/2022/March_2022.shtml

As if CVS pharmacists and pharmacy technicians did not already experience enough anxiety, panic attacks, and other mental health challenges from the management-imposed metrics and policies that result in understaffed, stressful, and error-prone workplaces, the occurrence and mishandling of sexual harassment complaints has now become public. The title for this commentary is the one used for a recent Wall Street Journal story* (WSJ; Sharon Terlep, Suzanne Kapner; March 12-13, 2022; page B3).

Based on allegations and an internal investigation, CVS dismissed a regional manager who oversaw hundreds of stores, the executive who supervised him, a human-resources executive, and others. In a communication to staff, Karen Lynch, the CEO of CVS stated: “I want to be crystal clear: this company does not tolerate harassment or hostile, abusive or discriminatory behaviors of any kind from any employee – regardless of position…We also will not tolerate inaction from leaders who are responsible for escalating concerns or allegations raised by our colleagues.” The communication continues in noting that the company would improve its internal reporting and investigation processes, and had created a confidential communications channel to bring concerns to the attention of senior leaders.

The statements of the CVS CEO are commendable and seemingly unequivocal. However, the situations that occurred and her comments raise additional questions:

1. Would this situation have become publicly known if it were not for the discovery of WSJ reporters, or would it have been buried in confidential CVS corporate files? My long-term observations have been that CVS will take any action necessary to suppress information that could result in negative publicity.
2. Why have the individuals who have been terminated not been identified? In addition to CVS management, their identities are known to the WSJ reporters who reached out to them but did not receive a response or they refused to comment?
3. Although some will consider termination from an executive position to be a strong action, have these experiences and individuals been reported to law enforcement or regulatory agencies, or to organizations that accredit components of CVS operations? Might it be expected that the terminated individuals may be hired in executive positions at companies such as Walgreens, Walmart, or Rite Aid who may be impressed with their executive responsibilities at CVS but not be aware of the reasons for their departures?
4. What took so long for these experiences to be discovered by top management and for action to be taken? Although a thorough investigation takes time, there have been rumors and allegations on social media for many months from CVS employees who are familiar with these experiences but can’t report them for fear of retaliation. Could the high-level executives of CVS have been completely ignorant/oblivious to situations that were apparently known to numerous employees?
5. Are the situations reported in the WSJ story just the “tip of the iceberg?” In the short period of time since the story was published there have been social media posts from CVS employees about other experiences that seem similar or even worse.
6. Although the word “harassment” is commonly applied to inappropriate sexual comments or behaviors, it is also applicable to other situations such as intolerable and dangerous workplace conditions that are widely known. Are these not abusive behaviors that are among those that the CVS CEO indicates will not be tolerated? Now that a confidential channel of communication has been established for employees to bring concerns to CVS senior leaders, every CVS employee who is concerned that working conditions increase the risk of harmful and even fatal errors for customers, or jeopardize their own personal mental and physical health should document these experiences and communicate them through the confidential channel that has been established.
7. Will anything actually change at CVS?

Pharmacist Steve Ariens often brings to my attention pharmacy-related experiences of which I may be unaware. Last fall he shared with me the tragic news of the death of pharmacist Ashleigh Anderson who collapsed and died in the CVS store in which she worked in Indiana. My tribute to and commentary regarding Ashleigh is in the November 2021 issue of The Pharmacist Activist. Steve just forwarded to me a photo of a large billboard sign at the Scottsburg, Indiana northbound exit of I-65. The billboard includes an excellent photo of Ashleigh next to a heart that includes her first name and the dates of her birth and death. It also includes the designation #SHEWAITED, and the important message, “Your job can wait. Your heart can’t.” I highly commend and thank those who designed and posted this fine tribute to Ashleigh.

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A couple of things that remain the same when comparing the 2016 guidelines and the 2022 proposed guidelines…  neither carries the weight of a law and the CDC has no legal authority to challenge any entity that refuses to honor any specific carve outs in treating chronic pain pts.  They also reference the MME system… which has no science nor any double blind clinical studies behind it to support the opiate to opiate ratios that are “theoretically therapeutically equivalent”. I cannot find any reference to MME system in any printed FDA professional prescribing information.  I find it interesting that we have all seen the back lash that many practitioners received when treating COVID-19 pts with FDA approved meds that were off label – which is a very common practice in medicine and practitioners seldom/never received any push back.. and here we have the CDC proposing new opiate dosing guidelines that recommends using the MME system … that is not FDA approved nor even recognized.

We have a national election just around the corner… and our Declaration of Independence states: We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness. ——

Maybe it is time to talk to politicians, especially with politicians talking about  EQUITY  – especially those against abortion about the QUALITY of “your life” and your lack of EQUITY to proper pain management.  Ask them what is their definition of LIBERTY – if you have had your pain management taken away and you are basically “house bound” to a chair or bed, and the PURSUIT OF HAPPINESS… – if you are being forced to live in a torturous level of pain, causing you to be house bound, has all your options off pursuing happiness – been taken away ?  The CDC guidelines is nothing more than a PSEUDO LAW/RULE/REGULATION. Who believes that when this guideline is approved and published that just like the previous 2016 guideline, that various bureaucratic agencies and others will develop their own interpretation of these guidelines and apply them to part or all of the community. Is it time for the community to get their $$$ together and engage law firm(s) to go after those large healthcare corporations for all the discrimination and harm that is being done to the community. I expect that the CDC will publish these guidelines right after Labor Day, because that is primary time frame for those running for federal office to be “out on the campaign trail” Those in Congress will not get much done … and once the election is over… Those in Congress that are leaving will be busy packing up, those who move up in seniority will be jockeying for their new offices, then there is Congress’ Christmas break… Then the first couple of weeks of 2023, all the new “Freshman” members of Congress will be getting orientation, hiring staff and getting their new office organized.

How Rochelle Walensky Can Improve the CDC’s Pain Guidelines

https://washingtonmonthly.com/2022/03/24/how-rochelle-walensky-can-improve-the-cdcs-pain-guidelines/

The agency has issued draft guidance on opioid prescribing. It’s an improvement over a 2016 version that left too many patients in pain—but the director needs to make it even better.

For millions of Americans with chronic pain, the new draft guidance on opioid prescribing, issued by the Centers for Disease Control and Prevention, could not have come soon enough.

We, too, have a vested interest. One of us, Kate Nicholson, used prescribed opioids so she could continue working as a civil rights attorney at the U.S. Justice Department. (A surgical injury had left her bedridden from the early 1990s through the late 2010s.) The other, Sally Satel, is a psychiatrist who understands the risks of addiction—and how those risks have often been overplayed when it comes to treating patients with long-term pain.

The CDC’s 2016 “Guideline for Prescribing Opioids for Chronic Pain” wrought havoc. Regulators, insurers, pharmacies, clinicians, and law enforcement misinterpreted the document as a government mandate that limited doctors’ use of opioid painkillers for pain or directed them to stop prescribing opioids completely. While the guideline, written amid the opioid crisis, did recommend limits on prescribed painkillers, it was issued only as guidance, and not the near ban many interpreted it as being. Yet the result was (and still is) that tens of thousands of Americans who were in agony because of medical conditions could not get essential pain medication or treatment. 

Patients who had functioned well for years became couch bound because they could not get the necessary medication. Others suffered withdrawal from abrupt opioid discontinuation, sometimes turning to street drugs for pain relief. Many “pain refugees,” as the media called them, searched desperately for care when their doctors abandoned them. Some even died by suicide. 

We have spent the past few weeks reading every word, table, and citation in the CDC’s draft “Clinical Practice Guideline for Prescribing Opioids,” updated guidance on the treatment of pain. (Full disclosure: Nicholson was a member of the Opioid Workgroup that reviewed an earlier version of the new guideline.)

Fortunately, the CDC’s 211-page update explicitly recognizes the harms that emerged from its previous version and contains significant improvements. Foremost, the new guideline espouses the bedrock philosophy of humane care—strikingly absent from the 2016 guideline—namely, that doctors should rely on their clinical judgment, not on fixed directives. The new document, its drafters firmly state, “should not be used as inflexible standards of care [nor] be implemented as absolute limits of policy or practice.”

Wisely, too, the new recommendations remove the earlier warning against prescribing more than 90 MME—morphine milligram equivalents, a standard dosage measure—per day and omit the prior directive that prescriptions should rarely last more than three to seven days. These are two commonly misapplied provisions from the 2016 guideline. 

The value of these changes cannot be overstated, and yet other aspects of the update are troubling and threaten to sabotage them. 

For example, the CDC update sends mixed messages. The update’s welcome and overdue emphasis on individualized care is undermined, for example, by a sweeping pronouncement that opioids are “not the preferred treatment” for non-acute pain. Deeming the medication “not preferred” gives insurers a convenient reason to deny opioid coverage for those with severe conditions. For some patients and conditions, opioids are the appropriate choice. A patient might have exhausted other options, experienced bad side effects from them, or derived such great benefit from opioids that the value clearly outweighs the risks.  

Another problem with the new draft guideline is that the updated text instructs clinicians to “pause and carefully reassess” (bold in original) if they are raising a dose above 50 MME per day. (A 10 milligram tablet of oxycodone is equivalent to about 15 milligrams of morphine, or 15 MME.) While not bad advice in theory, specifying a dosage threshold is a set-up for clinicians and policy makers to adopt it as a ceiling and not a suggestion.

This is precisely what happened when the 2016 guideline asked clinicians to justify prescribing more than 90 MME a day. Instead of explaining their decisions, nervous clinicians, fearful of law enforcement or lawsuits, seized on the 90 MME dosage as a decree to reduce all amounts below that threshold. A hard limit of 50 MME in the updated guidance threatens to create an even worse outcome. 

Finally, in reviewing evidence for opioid treatment of long-term pain, the drafters omitted studies that did not last more than a year, which bizarrely flouts the CDC’s own definition of chronic pain, which is pain lasting three months or longer, not one year or more. Further, discounting those studies removes from the draft the existing evidence that opioids can reduce pain lasting more than three months.

The guidance does suggest alternatives to opioids such as acupuncture, laser therapy, and massage, which may well be beneficial to some patients. But many insurers do not cover these options, making them effectively unavailable for some patients, as the CDC itself acknowledges. 

But what concerns us most is that clinicians, health care entities, states, and law enforcement are likely to ignore the guideline’s stern injunctions against patient abandonment, rigid dosage cutoffs, and involuntary tapering. 

We have already seen doctors and pharmacies deny opioid medication to patients with cancer and sickle cell disease as well as those receiving palliative care, even though the 2016 guideline explicitly exempted them from its recommended restrictions. 

In 2019, we urged the CDC to clarify its guidance—Nicholson in cooperation with Human Rights Watch, and Satel through a widely publicized letter that was signed by more than 300 concerned physicians. To its credit, in April 2019 the CDC published a corrective in The New England Journal of Medicine, cautioning doctors and health care systems against “inflexible application” of the guideline.

We were thrilled—and then nothing happened.

Nicholson, who is the executive director of the National Pain Advocacy Center, an organization that fights for getting available pain treatments to those who need them, continued to receive scores of messages each week from patients who were in unbearable pain from cancer or late-stage multiple sclerosis or amputated limbs. Each story of suffering that lands in her in-box is as heartbreaking as it is needless. 

If the CDC’s bold clarification in a leading medical journal had little effect on regulations and practice, will the agency’s new exhortation against patient abandonment be enough? 

With the benefit of hindsight, we are skeptical. 

Here’s what could really help this time: The CDC needs to draft its final guideline in a way that anticipates and mitigates the potential for policy misapplications. It’s not enough to say that the guidance is voluntary, when we know it will be interpreted as a national prescribing mandate. This is especially important because the new guideline is much broader; it will apply to the treatment of virtually all pain, not just chronic pain. The agency should underscore in unmistakable terms to clinicians, health systems, insurance companies, and government entities that, because pain varies greatly in severity and underlying condition, individualized care is paramount. 

The CDC should also be proactive when it comes to the bureaucratic jousting that is likely to ensue. It must pointedly discourage other federal agencies, such as the Centers for Medicare and Medicaid Services and the Drug Enforcement Administration, from imposing blanket prescribing thresholds on doctors. This is a chance for CDC Director Rochelle Walensky to get beyond the various feuds over COVID-19 policy. As a physician on the front lines of the HIV/AIDS epidemic, Walensky has been witness to human suffering and to the stigma that can cause those at the center of public health crises to be denied what they likely need most: appropriate and humane access to care. 

With its updated guideline, the CDC has the potential to correct significant, if unintended, harms. But this will only happen if the practical wisdom it now endorses is put into practice. 

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