CDC: Opioid Guideline Should Not Be Used to Taper Patients

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).


The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.
— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

Steep Decline in New Opioid Prescriptions

By Pat Anson, PNN Editor

The number of doctors writing new prescriptions for opioid pain medication has fallen by nearly a third in recent years, according to a large but limited study that documents a dramatic shift in opioid prescribing patterns in the U.S.

Researchers at Harvard Medical School studied health data for over 86 million patients insured by Blue Cross Blue Shield from 2012 to 2017, and found that first-time prescriptions for patients new to opioids – known as “opioid naïve” patients -- declined by 54 percent.

At the start of the study, 1.63% of Blue Cross Blue Shield patients were being treated with new opioid prescriptions. Five years later, only 0.75% were.


The study also found a shrinking pool of doctors willing to start opioid treatment. The number of doctors who prescribed opioids for opioid naive patients decreased by nearly 30 percent, from 114,043 to 80,462 providers.

The research findings, published in The New England Journal of Medicine, do not provide any context on the patients’ health conditions or the severity of their pain and injuries. As such, it is a data-mining study that provides no real information on the harms or benefits of opioids.

"The challenge we have in front of us is nothing short of intricate: Curbing the opioid epidemic while ensuring that we appropriately treat pain," lead investigator Nicole Maestas, PhD, an associate professor of health care policy at Harvard Medical School, said in a statement. "It's a question of balancing the justified use of potent pain medications against the risk for opioid misuse and abuse."

First-time prescriptions for opioids are usually used to treat short-term acute pain caused by trauma, accidents or surgery. They rarely result in long-term opioid use or addiction, but have become a major target for healthcare policymakers and anti-opioid activists. Several states have adopted regulations that limit the initial supply of opioids to 7 days or less.

While the number of doctors starting opioid therapy has fallen dramatically, Harvard researchers say many are still engaged in “high-risk prescribing” – which they defined as new prescriptions for more than 3 days’ supply or a daily dose that exceeds 50 morphine milligram equivalent (MME).

More than 115,000 of these “high-risk prescriptions” were written monthly for Blue Cross Blue Shield patients. Over 7,700 of the prescriptions exceeded 90 MME per day, a dose that researchers say puts patients at a substantially higher risk of an overdose. The study did not identify whether any of those high-dose patients experienced an overdose.

Opioid prescriptions in the U.S. have fallen sharply since their peak in 2010, but have yet to slow the rising tide of overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl and heroin, not prescription opioids.

Heart Transplants Surge as Overdoses Increase

By Pat Anson, PNN Editor

One of the more ghoulish and yet beneficial aspects of the overdose crisis is that it has led to a surge in organ transplants. In 2000, only about 1 percent of organ donors were overdose victims. By 2017, when over 70,000 Americans died from drug overdoses, over 13 percent of organ donors were overdose victims.

A new study by researchers at Brigham and Women’s Hospital has documented how the number of hearts available for transplant has increased dramatically, particularly in states like Pennsylvania that have been hard hit by the overdose crisis.  

"In the U.S., the drug crisis is clearly not uniform, and neither is the rate of recovered hearts from drug-intoxication-related deaths," said lead author Mandeep Mehra, MD, the medical director of Brigham's Heart and Vascular Center.

Mehra and his colleagues analyzed CDC data on overdose deaths and from the Organ Procurement and Transplantation Network, and reported their findings in The New England Journal of Medicine.

They found major increases in drug-related deaths and organ harvesting in Pennsylvania, New York, Ohio and other Northeast states, and in Florida and Texas. Overall, the team estimated that 6.24 hearts were recovered for every 1,000 lives lost due to drug intoxication.



Among the 37,232 donors whose hearts were transplanted from 1999 through 2017, the percentage of those who died from overdoses rose from 1.5% to 17.6 percent. And as the number of hearts available for transplant grew, the waiting list for donated hearts began shrinking in 2016. According to the United Network for Organ Sharing, there are currently 45 people in the U.S. waiting for a heart transplant.

"This is a very important outcome indicating that people are now adopting organs from drug-intoxication-related deaths as a viable source for lifesaving donor organs," said Mehra. "Although we support organ donation recovery from this source, those of us in the transplant community also strongly support effective efforts to combat the drug overdose crisis. We must pursue ways to target the crisis while simultaneously looking for new ways to increase the availability of viable donor organs."

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply and because drug addicts are more likely to be infected with HIV, hepatitis and other communicable diseases. But those risks have been minimized with modern testing.

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are over 113,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.

Should Rx Opioids Be Limited for Cancer Patients?

By Pat Anson, PNN Editor

At a time when many chronic and acute pain patients are losing access to opioid medication, patients suffering from cancer pain are treated differently. They’re usually exempt from opioid guidelines that typically focus on limiting prescriptions for “noncancer pain.”

But some oncologists are starting to question whether opioids should be routinely prescribed to cancer patients.

“As an oncologist, I cannot help but reflect on that qualifier. It suggests that a cancer diagnosis gives us permission to prescribe opioids with impunity. Patients with cancer can become addicted, like anyone else. Yet oncologists use these potent, seductive drugs freely, perhaps without sufficient regard for the risk of dependence and abuse,” writes Alison Loren, MD, in an op/ed published in The New England Journal of Medicine.

“Treating patients who are terminally ill from cancer is an important indication for these drugs. But what about patients with cancer who aren’t dying, the ones we hope to cure? Woven into our language about the opioid epidemic is an implication that oncologists can hand out opioids as if there were no tomorrow. But for many people with cancer, there is now indeed a tomorrow.”

Loren, who is a professor at the Perelman School of Medicine at the University of Pennsylvania, says many patients whose cancer was once thought incurable are living for a decade or longer. Thanks to advances in cancer treatment, there are more than 15 million cancer survivors in U.S. and their ranks are growing

“With this progress comes new challenges. Especially poignant — albeit rare — is the one I face when I see a patient who is cancer-free but addicted to medications I’ve prescribed,” wrote Loren. “I am responsible for this predicament, and it feels monstrously cruel — second only to allowing the dependence to continue. Sometimes, like those with ‘noncancer pain,’ our patients veer into abuse.”


A new study by researchers at the University of Colorado School of Medicine found signs of opioid abuse in a small percentage of cancer patients. Out of 811 patients given opioids after treatment for oral or oropharynx (neck) cancer, 68 patients (7%) were still using opioids six months later.

"You shouldn't need opioids at the six-month point," says Jessica McDermott, MD, an investigator at the CU Cancer Center. “We felt like (opioid misuse) was a long term problem for some of our head and neck cancer patients, but didn’t know how much of problem.”

McDermott doesn’t advocate taking opioids away from cancer patients, but says doctors should know which patients are more at risk of opioid misuse, such as those having a previous opioid prescription or a history of smoking and alcohol use.

"If a patient needed opioids for pain, I wouldn't keep them away, but especially if they have risk factors, I might counsel them more about the risks of addiction and misuse, and keep an eye on it," McDermott says.

Loren would take opioids away from a cancer patient at risk of misuse. She shared the story of a leukemia patient with a long history of substance abuse who was found dead in her hospital bed.

“Her leukemia was in remission. The possibility that she may have overdosed haunts me,” Loren wrote. “Oncologists are accustomed to giving opioids, but we must also be comfortable taking them away, and sometimes giving them in limited doses or not at all.”

Is Addiction or Untreated Pain Causing Patient Suicides?

By Pat Anson, Editor

A new op/ed in The New England Journal of Medicine focuses on an aspect of the overdose crisis that’s rarely discussed – how opioids are a “silent contributor” to the nation’s rising suicide rate. But critics say the article misses the mark on why a growing number of pain patients are having suicidal thoughts and taking their own lives.

Most people already know that drug overdoses are soaring in the United States, but few recognize that suicides are at their highest level in nearly 30 years. In 2016, more Americans died from suicides (44,965) than from opioid overdoses (42,249).

“The significant increases in both opioid-overdose deaths and suicide rates in our country have contributed to reduced life expectancy for Americans. These two epidemics are intermingled, and solutions to address the opioid crisis require that we tailor interventions to preventing opioid-overdose deaths due to suicidal intent,” wrote co-authors Maria Oquendo, MD, and Nora Volkow, MD.

Volkow is the longtime director of the National Institute on Drug Abuse, while Oquendo is a Professor of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania and past president of the American Psychiatric Association.

Volkow and Oquendo believe many suicides are misreported as “undetermined” or accidental drug overdoses, and that “the true proportion of suicides among opioid-overdose deaths is somewhere between 20% and 30%, but it could be even higher.”

They also engage in a familiar pattern of demonizing opioid pain medication, citing studies showing that patients with “opioid use disorder” (OUD) from prescription opioids are more likely to have suicidal thoughts and “whose motivation to live might be eroded by addiction.” 


“Notably, two populations that are more likely than others to receive opioid prescriptions — patients with chronic pain and those with mood disorders — are also at greater risk for suicide,” they wrote.

That may all be true. The suicide rate among chronic pain patients is probably increasing. But what’s puzzling is that Volkow and Oquendo never acknowledge the role that the federal government has played in contributing to that trend. Anecdotal evidence is building that suicides started climbing after the CDC released its 2016 opioid prescribing guidelines and pain medication became harder to get. 

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide,” Stefan Kertesz, MD, a professor of medicine at the University of Alabama at Birmingham School of Medicine, recently told PNN.

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or even acknowledged by government bureaucrats like Volkow, who was an early supporter of the CDC guidelines.

In a survey of over 3,100 pain patients on the one-year anniversary of the guidelines, over 40 percent told PNN they had considered suicide because their pain was poorly treated. Many patients feel the healthcare system has turned its back on them.

“Even though I can barely function my doctor wants to stop my meds completely. With no hope, suicide seems like the best and only choice to get relief from the pain. I never thought doctors would be so uncaring, along with the government,” wrote one patient.

“I never thought I would even consider suicide, but death looks good when every move you make is painful, 24 hours a day, 7 days a week. The guidelines are not fair to me, my husband, and my children. No one can judge anyone else's pain level,” said another patient.


“I frequently contemplate suicide. I lay in bed on many nights crying because there is no comfortable positions and the spasms are relentless,” said a disabled nurse in Maine who is no longer able to obtain opioids.

“In the past year, six chronic patients I know who were no longer able to get their pain medication have committed suicide. I personally have researched the quickest and surest way of ending my own life. And no, it doesn’t include opioids,” wrote another patient.

“I nearly committee suicide last summer and again last November because of undertreated pain,” said one woman. “It is ridiculous beyond belief when my neighbor’s dog gets prescribed pain meds for a torn claw and I get treated like a criminal for having a chronic pain condition.”

Undertreated Pain

Patient advocates say these suicidal thoughts are often not the result of addiction or OUD, but because chronic pain is increasingly untreated or undertreated.

“The diagnosis of OUD is overwhelmingly made by physicians who are untrained in making the diagnosis,” says Stephen Nadeau, MD, a Professor of Neurology and Clinical Health Psychology at the University of Florida College of Medicine. “Most patients in chronic pain are under-dosed and/or suffer from inadequately treated depression. We don’t know the exact figures on prevalence of under-dosing but we do have studies that suggest that depression is detected only 20% of the time.”

“There is emerging data to suggest that increasing numbers of opioid overdose-related deaths may be a consequence of undertreatment of both pain and depression.  But the dominant public narrative is demanding even less treatment of pain when opioids are the chosen therapy,” says Red Lawhern, PhD, co-founder of the Alliance for the Treatment of Intractable Pain, a patient advocacy group.    

Lawhern believes many suicides can be attributed to the “epidemic of despair” first documented by Princeton researchers Anne Case and Angus Deaton.  They believe that the reduced life expectancy of Americans is not just due to substance abuse, but linked to unemployment, poor finances, lack of education, divorce, depression and loss of social connections – issues that Volkow and Oquendo fail to address.

“Their article is seriously deficient for failure to mention that both substance abuse and suicide generally are closely associated with depression and isolation -- both of which are consequences of economic hard times.  It is simply wrong to imply that opioid use disorder (itself an incorrect term) is the ‘cause’ of suicide, when both are driven jointly by socio-economic factors,” Lawhern wrote in an email.

What can be done to prevent suicides in the pain community? Volkow and Oquendo say more doctors should be trained to recognize the warning signs of suicide and patients should be screened for suicide risk and then referred for addiction treatment. Nowhere do they suggest better pain management.   

Getting the Story Right About Opioids

By Pat Anson, Editor

Many chronic pain patients feel they are wrongly portrayed in the media as malingerers and addicts – and that the growing difficulty they have just getting their pain treated is being ignored by the medical profession.

There’s a fair amount of truth to that.

Which is why two recent articles in Politico and The New England Journal of Medicine – both written by doctors – are worth highlighting for PNN readers. They help dispel many of the myths about pain patients and the role they played in the so-called opioid epidemic.

“As an addiction psychiatrist, I have watched with serious concern as the opioid crisis has escalated in the United States over the past several years, and overdose deaths have skyrocketed,” Sally Satel, MD, wrote in Politico. “I have also watched a false narrative about this crisis blossom into conventional wisdom: The myth that the epidemic is driven by patients becoming addicted to doctor-prescribed opioids, or painkillers like hydrocodone.”

Dr. Satel practices at a methadone clinic, lectures at the Yale University School of Medicine and is a resident scholar at the American Enterprise Institute, a conservative think tank.  She has also done her homework about the opioid crisis, recognizing that the nation’s growing scourge of overdose deaths is “overwhelmingly attributable” not to prescription opioids, but to illegal ones like heroin and illicit fentanyl.

Satel also acknowledges that opioid prescriptions in the U.S. have been declining for years and that only a small percentage of pain patients become addicted. Yet insurers, pharmacies and regulators continue to tighten access to opioid medication, and anti-opioid activists rant about pain patients getting hooked after taking a few “heroin pills.”

“We must be realistic about who is getting in trouble with opioid pain medications. Contrary to popular belief, it is rarely the people for whom they are prescribed. Most lives do not come undone, let alone end in overdose, after analgesia for a broken leg or a trip to the dentist,” Satel wrote.


“We need to make good use of what we know about the role that prescription opioids plays in the larger crisis: that the dominant narrative about pain treatment being a major pathway to addiction is wrong, and that an agenda heavily weighted toward pill control is not enough.”

That narrative clearly has been harmful to patients. Satel cites a PNN survey of over 3,000 patients, which found that over 70% were no longer prescribed opioids or had their dose cutback after the CDC’s opioid prescribing guidelines were released in 2016.  Nine out of ten patients said the guidelines had worsened the quality of pain care in the United States, and 60 percent said it had become harder or impossible for them to find a doctor willing to treat their pain.

The Story of Mr. P

Patient abandonment and the growing lack of access to pain treatment is presented in the story of “Mr. P” – as told in the NEJM by Drs. George Comerci, Joanna Katzman and Daniel Duhigg, who are colleagues at a pain clinic in Albuquerque, New Mexico. Mr. P was prescribed opioid medication for two years when his doctor adopted a no-opioids policy in his practice.

“Mr. P. was given a prescription for a month’s worth of oxycodone and advised to find another prescriber in the future.  Not unexpectedly, six other physicians refused to prescribe him opioids, and he ended up in our pain clinic, sobbing in the exam room, terrified that he’d end up ‘back in my old life’ if he had to buy his pain medications on the street,” the doctors wrote.

“In the past year, our university-based interdisciplinary pain clinic has seen a flood of cases like Mr. P.’s. The increase in opioid-related mortality fueled by injudicious prescribing and increasing illicit use of both prescription and illegal opioids has led some clinicians to simplify their lives by discontinuing prescribing of opioid analgesics. The fallout is a growing pool of patients who are forced to navigate their transition off prescribed opioids, often with little or no assistance or guidance, with the potential for disastrous results.”

What is happening to these abandoned patients who can’t find adequate treatment?

“We fear that an injudicious approach involving blanket refusals to prescribe opioids and adoption of unreasonable prescribing and dispensing regulations will increase patient suffering. Furthermore, the worst-case scenario is for patients to obtain prescription opioids illegally and eventually transition to more dangerous drugs, such as heroin,” the doctors warned.

The opioid crisis continues to spiral out of control. Government efforts to intimidate doctors and dictate prescribing levels are not only harming patients, they may be making things worse. A recent report from the CDC found that illicit fentanyl – not prescription pain medication -- was responsible for over half the overdoses in ten states.

As Dr. Satel points out, if we ever hope to fix the problem and find the right solutions, we need to stop focusing on patients and doctors.

“We cannot rely on doctors or pill control policies alone to be able to fix the opioid crisis. What we need is a demand-side policy. Interventions that seek to reduce the desire to use drugs, be they painkillers or illicit opioids, deserve vastly more political will and federal funding than they have received,” she wrote. “If we are to devise sound solutions to this overdose epidemic, we must understand and acknowledge this truth about its nature.”

Stem Cell Regulation and a Rule Too Many

By A. Rahman Ford, Columnist

The New England Journal of Medicine recently published an op/ed rather benignly entitled “Rejuvenating Regenerative Medicine Regulation.”  

The authors, R. Alta Claro and Douglas Sipp, argue that the Food and Drug Administration did not go far enough in regulating stem cell therapies in its recently released final guidance, and that further restrictions need to be placed on Americans seeking to use their own cells to heal themselves. Both authors are affiliated with RIKEN, a Japanese research institute that is developing stem cell technology.

Although clothed in the flowing garb of humaneness, medical ethics and protecting the sick and disabled, the authors’ posture reveals itself to be strikingly paternalistic.  Rather than “rejuvenate” regenerative medicine with ideas that would invigorate and fertilize a forward-thinking, democratic regulatory regime, Claro and Sipp instead articulate positions so extreme that they operate as more of a death knell to stem cell innovation.  Indeed, the authors seem to have issued a eulogy for a promising and precocious corpus of medicine that has barely attained its infancy.

In their view, the FDA guidance is “a positive step,” but more needs to be done.  To assist in the effort, they urge institutions at the state level to “crack down” on malfeasant clinics and agitate for state legislatures to pass stricter informed consent laws, as was recently done in California. 

To justify further restrictions on the availability of stem cell therapies, they claim that the “explosion of stem cell marketing in the United States” has led to “predatory” clinics offering “untested stem cell treatments [that have] exposed patients to unjustifiable risks.” 


They further claim that the FDA has fallen short in in its staged approach to enforcing the new rules against clinics deemed to be in violation.  The authors even go so far as to assail the 21st Century Cures Act because it created “a pathway to approval that is at risk of putting cell and tissue products on the market before they have been adequately tested.”

A bare endorsement of the FDA’s “minimal manipulation” and “homologous use” tests would have been troubling enough, and the authors do endorse those tests in their article.  As I wrote in an earlier column, the agency’s guidance is unduly burdensome when it comes to autologous therapies – which involve stem cells that are extracted from a person and administered to the same person to relieve conditions such as chronic pain. 

In Clara and Sipp’s view, those suffering from pain and other chronic illnesses are part of the problem, because it was largely “patient demand” that helped “drive the growth of unproven therapies.”  Such a placing of blame upon chronically ill patients is disappointing. 

Equally disappointing is the authors’ disregard of those same patients’ constitutionally-protected privacy interest in their own bodies and their own cells, an interest which – as with abortion rights – would require a compelling interest on the part of the federal government to justify excessive regulation.  Unfortunately, an uncited reference to “numerous documented reports of medical accidents” involving stem cells does not a compelling interest make.

Texas Should be the Model

However, the authors are correct that states must be more involved in setting stem cell policy.  The problem is that they chose the wrong example.  Rather than emulate the restrictive policies of California, the Texas example should be the model that other states follow.  Texas has passed legislation making autologous stem cell therapies more accessible to its residents and has even buttressed it with “right to try” legislation.  

The Texas effort was spearheaded by tireless patient advocates who were able to communicate to state lawmakers their truly human stories.  Lawmakers heard and felt that pain – some personally because of their own experiences with pain and disability.  The result was stem cell choice, in a state-led regulatory model that can hopefully be a nationwide blueprint, as Washington state was for marijuana legalization.

Stem cell policy-making must not be a strictly elite enterprise.  It must be democratic process, as embodied by the Congress when it overwhelmingly passed the Cures Act and its provisions which help expedite stem cell cures.  The people’s voice must be preponderant, and bolstered by thoughtful, reasonable rules that privilege choice, promote fairness, and protect us from physical and legal injury.

We should not seek rules that only preserve a place for the status quo in a rapidly advancing medical technology landscape that threatens to make a dusty relic out of old ways of thinking.  The orthodox "clinical trial" medical regulatory paradigm favored by the FDA simply does not work for regenerative medicine and stem cell therapies.  So rather than fear-mongering by focusing on a conjured-up phantom of rampant medical malfeasance, we should embrace the future. 

Fear of change is understandable and expected from certain quarters.  But the millions of Americans in chronic and intractable pain are not the ones who are afraid, and are not as docile and ignorant as they may be portrayed.

Although their argument is flawed, the title Charo and Sipp selected is resounding.  Regenerative medicine and stem cell policies must indeed be about rejuvenation, not more regulatory entanglement.

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.