PHARMACIST STEVE

This is the third of a three-part series on the nation’s struggle to address its crippling opioid crisis, and the unintended victims left in its wake. Read Part 2 here: Doctors caught between struggling opioid patients and crackdown on prescriptions

Many Americans today will attend several funerals before they get their first gray hair.

That’s in large part because of drug overdoses, now the leading cause of death among Americans aged 50 and younger. More than 70,000 people in the U.S. last year died from overdoses, most of which involved illegal opioids.

The overdose problem – and a rise in suicides, another byproduct of the drug epidemic — is so pervasive it’s being blamed for a drop in U.S. life expectancy.

The crisis has led to a rush of public health and law enforcement initiatives at all levels of government. The federal government has vowed to cut prescription opioids by a third. More than 30 states have passed some type of legislation aimed at attacking the opioid epidemic.

“Defeating this epidemic will require the commitment of every state, local, and federal agency,” President Donald Trump said in a March speech in New Hampshire. “Failure is not an option. Addiction is not our future. We will liberate our country from this crisis.”

We’re targeting the most vulnerable and sickest people who have been on opioids a long time.

— Dr. Stefan Kertesz, addiction specialist and professor at the University of Alabama at Birmingham School of Medicine.

The government response to the epidemic has many medical professionals, patients and their families welcoming the long overdue debate about the risks vs. benefits of opioid use. But it has also set off alarm bells for many of the millions of Americans with chronic pain who legally take opioids, under their doctor’s supervision, and are suffering a range of unintended consequences that have left them undertreated, ignored, and desperate for alternatives.

The root of the problem, according to dozens of pain patients, doctors, scholars, and others who spoke to Fox News for this story, are the Centers for Disease Control and Prevention (CDC) guidelines for opioid prescribing that were issued in 2016. While the guidelines are credited with focusing attention on prescribing practices, critics say they’ve been adopted by too many as hard and fast rules that must be enforced across the board, rather than serve their intended advisory purposes.

“We’re targeting the most vulnerable and sickest people who have been on opioids a long time,” said Dr. Stefan Kertesz, an addiction specialist and professor at the University of Alabama at Birmingham School of Medicine.

TOUGH NEW OPIOID POLICIES LEAVE SOME CANCER AND POST-SURGERY PATIENTS WITHOUT PAINKILLERS

Striking the right balance between getting control of the overdose epidemic and protecting access to treatment that brings relief to pain sufferers is a public health imperative.

The failure to do so threatens to exact a heavy price on the tens of millions of Americans whose pain is severe and disabling, and who are not driving the drug overdose epidemic.

Neglect of this large population of patients has the potential to prompt many to seek illegal opioids, or to become another statistic in the crisis of the rising U.S. suicide rate. Some have told Fox News that they have traveled, or plan to go to another country to obtain prescription opioids from doctors or pharmacies — a risky move for manifold reasons.

So what’s the solution? Medical professionals, patients and others familiar with the opioid crisis and the fallout from the government crackdown have offered a variety of ideas.

RESETTING CDC GUIDELINES

Many believe the most urgent need is to address misunderstandings about the CDC guidelines. Clinicians and health experts say the CDC needs to make clear, in a high-profile way, what the guidelines were – and were not – meant to address. A letter signed by more than 300 health professionals, including former drug czars in the Clinton, Nixon and Obama administrations, calls on the CDC to examine the impact of the guidelines and publicly clarify them.

“Many doctors and regulators incorrectly believed that the CDC established a threshold of 90 MME as a de facto daily dose limit,” the letter said. “Soon, clinicians prescribing higher doses, pharmacists dispensing them, and patients taking them came under suspicion.”

The letter said that because the guidelines do not offer alternative pain care options, “patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use. Others have experienced preventable hospitalizations or medical deterioration.”

The letter added: “We urge the CDC to issue a bold clarification…particularly on the matters of opioid taper and discontinuation.”

Richard A. Lawhern, a prominent advocate on behalf of chronic pain patients and co-founder of the Alliance for the Treatment of Intractable Pain, goes even further, suggesting the CDC should scrap its guidelines, and write new ones.

“The resulting document is fatally flawed,” Lawhern said, “and needs to be withdrawn for a major revision in an open public process by qualified experts in community practice for chronic pain treatment, assisted by representatives or advocates from chronic pain communities.”

CLARITY ON LEGAL PAINKILLERS

Many have acknowledged the need for better data about opioid use, on everything from the precise role that legal vs. illicit drugs have played in the national overdose crisis to more accurate information on the effect of dosage changes.

Over the summer, a U.S. Health and Human Services special task force on pain management formulated a draft report of recommendations for the guidelines and noted muddled data on deaths involving illegal opioids vs. prescribed drugs.

“The national crisis of illicit drug use along with overdose deaths are confused with the appropriate therapy of patients who are being treated for pain,” the draft report said. “This confusion has created a stigma that contributes to barriers to proper access to care.”

Federal data on overdose deaths generally do not offer specific statistics on how many involved patients who were prescribed opioids, though other data – such those compiled by states – indicate they account for a small minority.

AS DOCTORS TAPER OR END OPIOID PRESCRIPTIONS, MANY PATIENTS DRIVEN TO DESPAIR, SUICIDE

In November, a data and software company serving emergency medical services, fire departments and hospitals, released national opioid overdose data based on approximately 15,000 records collected between January and October of this year, and found that 94 percent of opioid overdoses involved illicit drugs, with only 4 percent being prescribed.

But that hasn’t stopped political leaders from developing policies and initiatives around cutting prescriptions as well as the supply of opioids. Trump vowed to cut opioid prescriptions by 30 percent over three years.

And many state and government officials are boasting about opioid prescription reductions, giving a misleading impression, Kertesz said, that progress is taking place in the drug overdose epidemic.

The [CDC opioid guideline] document is fatally flawed and needs to be withdrawn for a major revision in an open public process by qualified experts in community practice for chronic pain treatment, assisted by representatives or advocates from chronic pain communities.

— Richard Lawhern, co-founder of the Alliance for the Treatment of Intractable Pain

Many medical groups and health researchers also are calling for the CDC to address the fallout – such as reports of pain patients suffering withdrawals — from misguided implementation of its guidelines.

Kertesz, a lead author of the letter to the CDC, said that the many anecdotal reports of suicides and suicidal plans coming from pain patients who are being undertreated or cut off by doctors must be studied by the agency.

“It’s a large number of anecdotes,” he said, adding that if forcibly tapering or cutting off patients from opioids is leading to suicidal thoughts, “who will stand up to defend that policy, would we be ethically comfortable with that?”

The American Medical Association (AMA) recently released a resolution critical of the CDC guidelines that said: “We urge the CDC to follow through with its commitment to evaluate the impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation.”

In an interview with Fox News in 2017, Richard Baum, then-acting director of the Office of National Drug Control Policy, said the dialogue about the opioid epidemic has been misleading.

“This is framed as an opioid epidemic. But when you look under the hood at the report of people who overdose on fentanyl and heroin, they often have other drugs on board – cocaine, methamphetamine, other pharmaceuticals,” Baum said. “So we have a multi-drug threat that’s complicated. It means people often aren’t using [just] heroin, fentanyl, they’re also using cocaine.”

“Sometimes we inadvertently simplify it,” Baum said, “[saying] that it’s only one drug that’s causing the problem, but a lot of drug users use multiple drugs so we absolutely have to focus and are focusing on heroin and fentanyl and the opioids as the number one threat.”

LOOKING BEYOND DOSAGES

Health experts say the Drug Enforcement Administration (DEA) and state authorities must not be so narrowly focused on quantity and dosage when looking at prescribers who might require disciplinary action.

“No entity should use [morphine milligram equivalent] – thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guidelines for Prescribing Opioids,” according to the AMA.

The DEA and other authorities told Fox News they are judicious when taking action against prescribers, stressing the number who face punitive measures are just a small part of the more than 1 million registered with the agency to handle controlled substances.

Ronald Chapman II, a Michigan attorney who represents doctors accused of overprescribing, said sometimes a prescribing problem doesn’t rise to the level of a crime, and should be addressed administratively. Many prescribers trigger so-called “red flags” by errors or omissions in pain patients’ medical records, he said, and shouldn’t automatically be treated as sinister.

“We have a lot of hammers out there looking for a nail,” Chapman said.

Physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guidelines for Prescribing Opioids.

— American Medical Association

John Martin, the DEA’s administrator of the Diversion Control Division, said his agency has taken steps to reach out to pharmacists and clarify how investigators go about opening cases.

“I’m sure there are doctors … out there that are afraid” to prescribe opioids now, Martin said, “but that’s part of our responsibility in communication. We had that issue with pharmacists over the years.”

Martin said DEA officials have met with more than 15,000 pharmacists and pharmacy technicians “to educate them on proper prescribing on the regulations, diversion and so forth.”

Martin said the agency is undertaking a similar effort aimed at doctors.

“We’re making them aware of what we’re actually looking for, so ways that they can reduce diversion and education so they understand the different regulations out there, what they can and can’t do,” he said.

But when prescribers are targeted by authorities, sometimes they lose access to their patients’ medical records, and either are forced to stop treating them because they lose their controlled substance prescribing rights or their medical license through suspension or revocation. Often, their patients are left to scramble, with nothing to fill the void of a doctor taken out of commission, and an abrupt loss of a medical treatment plan. Pain patient advocacy groups, and health care experts, say that authorities undertaking an investigation or disciplinary action  must have a plan in place for patients who are under the care of such health care providers.

Health professionals also argue that regulators and law enforcement authorities must stay in their lane, so to speak, and not interfere in the doctor-patient relationship in an effort to address the largely illegal opioid crisis.

“The key is to get the government out of medicine entirely,” said Dr. Kenneth W. Fogelberg, who specializes in obstetrics and gyneacology. “Let the politicians and lawyers do what they do and let us practice medicine. We have licenses and DEA certificates and most of us know what we’re doing.”

“In 2006, we were required to take a course in pain management. The thrust of the course was that we were underprescribing and our patients were in pain. If a patient said she had pain  I was expected, by the patient and the hospital nurse, to medicate. If I did not, I was written up. She might be sitting in bed reading a comic book but, if she said, ‘my pain is an 8’ (out of 10) she was to be medicated.”

“Now, MDs are blamed for overprescribing,” Fogelberg said. “Pain is subjective and I only can judge by what a patient tells me, but we are pretty good at separating legitimate pain from drug-seeking behavior. If the governments, both state and local, would let doctors doctor, we could handle this, but with their insatiable thirst for control of everything, the situation just keeps getting worse.”

MORE RESEARCH ON RISKS – AND BENEFITS

Most health experts agree more studies are needed on the effectiveness and dangers of opioid use.

“In medical school in the 1990s, it was taught that dosage does not matter if you go up slowly,” Dr. Deborah Dowell, lead author of the CDC guidelines, told Fox News. “Now we know there is an increased risk of opioid overdose.”

In an editorial in the “Annals of Internal Medicine,” Dowell noted “little evidence has been available to help weigh the benefits and harms of reducing or discontinuing opioids in patients already receiving long-term therapy or to guide clinicians in how to taper opioids safely and effectively.”

Other agencies, such as the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), are moving ahead with their own guidelines on opioid prescribing and pain management. In August, FDA Commissioner Scott Gottlieb referred to the CDC guidelines as a commendable initial step, and said that his agency was working on developing evidence-based guidelines that would look at opioid prescribing.

In a rare acknowledgment of the depth of desperation among pain patients whose long-time opioid treatment had been abruptly cut down or cut off, Gottlieb expressed concern about suicides.

“In select patients and for certain medical conditions, opioids may be the only drugs that provide relief from devastating pain,” Gottlieb said in a statement on the agency’s website. “We’ve heard from some of these patients, and listened carefully to their concerns about having continued access to necessary pain medication. We’ve heard their fear of being stigmatized as a person with addiction, and the challenges they face in finding health care professionals willing to work with patients with chronic pain.”

“Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide,” Gottlieb said. “This is unacceptable.”

Little evidence has been available to help weigh the benefits and harms of reducing or discontinuing opioids in patients already receiving long-term therapy or to guide clinicians in how to taper opioids safely and effectively.

— Dr. Deborah Dowell, lead author of the 2016 CDC guidelines on opioid prescribing

And this fall, Trump signed into law a bipartisan measure that calls on the FDA to assess “existing opioid…guidelines, examine how these guidelines were developed and any potential gap” in data.

Some experts say more should be done in the classroom to help better educate health professionals on treating pain.

“We have to look at our culture and attitude toward people with pain – and people with addiction – but mostly with pain,” said Dr. Lynn Webster, former president of the American Academy of Pain Medicine and author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” “In our medical schools, there are less than seven hours on average of education about pain. Even though it affects more people than any other problem, it is the number one public health problem. But we’ve spent little on research to try to find a solution to this. We need to make pain and addiction a core of our medical education curriculum.”

RESEARCH INTO NON-OPIOID ALTERNATIVES

Webster has called for major funding in alternative pain treatment, which could offer relief with fewer risks and side effects. There’s also a need for quicker treatments for patients in urgent need of relief.

Stricter pre-authorization policies for prescription and non-opioid treatments, such as physical therapy, many times mean delays that leave patients in pain.

Several physicians told Fox News they’ve had to wait several days, or longer, for prescription pre-authorization. They also said there is much more paperwork required now in connection to pain management, leaving more room for error and, by extension, more potential for red flags that could lead to disciplinary action.

Most people interviewed by Fox News agreed there should be a concerted move toward a multi-faceted, more comprehensive way to treat pain. And, they stressed, because severe, unrelenting pain can lead to anxiety and depression, mental health must be an important part of treating the condition.

DOCTORS CAUGHT BETWEEN STRUGGLING OPIOID PATIENTS AND CRACKDOWN ON PRESCRIPTIONS

“There is a lack of multidisciplinary physicians and other health care providers who specialize in pain,” the AMA noted. “These physicians and other health care providers include pain specialists, addiction psychiatrists, psychologists, pharmacists, and others who are trained to be a part of the pain management team.”

Among the AMA recommendations was “Expand graduate medical residency positions to train in pain specialties including adult pain specialists, pediatric pain specialists, behavioral health providers, pain psychologists, and addiction psychiatrists,” and “expand availability of non-physician specialists including, but not limited to, physical therapists, psychologists, and behavioral health specialists.”

Some physicians and pain patients would like to see medical marijuana legalized in more states, and on the federal level. Military veterans who get their medical treatment from Veterans Administration health facilities say that even if they reside in states where cannabis is legal for health reasons, they cannot get a prescription because it is not legal on a federal level.

“My patients have benefitted by many opiate alternatives,” said Montana-based Dr. Mark Ibsen, who stopped prescribing opioids after running into trouble with state medical officials and the DEA over allegations, which he said were untrue, that he was unjustifiably giving high doses to pain patients. “Eighty percent of my patients on opiates got off with cannabis.”

Ibsen, whose license was reinstated, and who was never charged, said: “The key is to create a context for healing, which empowers the patient to interact with pain and their life in the most effective manner possible, and let go of what no longer works.”

Dr. Daniel Alford, the associate dean at Boston University’s School of Medicine’s Office of Continuing Medical Education, is on a mission to ensure that the next generation of doctors are better equipped to make decisions about safe opioid prescribing.

“We’ve been over-reliant, too opioid-centric in terms of our prescribing for chronic pain,” Alford said. “Opioids shouldn’t be the first choice, they should really be the last choice. But if opioids are to be prescribed, how do you do it in a way that maximizes risk to that patient. We should try to minimize dose escalation.”

A prioirty, Alford said, is to improve the patient’s quality of life.

“It’s important to acknowledge and appreciate a person’s pain, for them it’s real,” Alford said. “Until we have some method to say ‘This is exactly where [the] pain is, our responsibility is to say ‘I believe you.'”

Most of the time, he said, there’s “zero percent risk” of being deceived by the patient.

“Based on their risk profile, to the best of your ability, you think about what treatment is best for them,” he said.

If tapering is necessary, “I’m going to taper over a long period of time, I’m going to try to keep the patient engaged and I’m going to try to do what’s really really hard, I’m going to try to get the patient into other forms of treatment,” Alford said, adding that multi-modal treatment plans, combining medication and other therapy, often are successful.

But the approach won’t go very far if insurers won’t cover non-opioid or multidisciplinary treatments, health experts said.

“Insurance won’t pay for many evidence-based treatments,” said Michael Schatman, a clinical psychologist who runs Boston Pain Care, which uses an array of programs – including exercise, psychotherapy as well as prescription painkillers—to treat pain. “My program loses money every year.”

“Some patients need to be tapered, some need to be taken off opioids, they’re not good for everyone, but there’s a void because of our health care system,” he said.

At Boston Pain Care, patients go through multiple treatments simultaneously. Shatman claims it is more effective than the status quo approach, which often involves trying one treatment, perhaps two, which may not work. Often, patients are pressed to try different therapies, one at a time, until one offers some improvement.

“Sequential pain management is an incredible failure,” Schatman said. “As long as we have a for-profit insurance agency, it’s not going to get much better. We’re seeing the devolution of the profession of pain medicine to the business of pain medicine.”

MORE DIVERSE VOICES IN DISCUSSIONS ABOUT SOLUTIONS

The debate over opioids and pain management has become emotional, with the overdose crisis and the dearth of reliable data fanning the flames.

Some of the leading voices on different sides of the debate are calling for unity toward working on finding solutions to both pain management and the overdose crisis.

Schatman said he would like to see health experts who are firmly opposed to opioids sit at a table with peers who are supportive of them as a beneficial treatment and bat around ideas.

Many pain experts and health researchers say that committees for agencies such as CDC should include specialists in pain and pain patients.

Dr. Stephen Gelfand, a rheumatology consultant from South Carolina, was quoted in OpioidInstitute.org saying that forced tapering is concerning. But, he added, “there is also a significant percentage of these patients who actually have the disease of addiction and need addiction treatment services including medication-assisted therapy.”

And so, he said, “we also need to have victim advocates who have survived and overcome the scourges of addiction as the result of opioid overprescribing to sit on these patient advisory boards at every level of decision-making.”