CDC: Guideline ‘Not Intended to Deny Any Patients Opioid Therapy’

By Pat Anson, PNN Editor

A top official with the Centers for Disease Control and Prevention says the agency’s controversial opioid guideline was never intended to deny prescription opioids to chronic pain patients.

Deborah Dowell, MD, is one of the co-authors of the 2016 guideline and the chief medical officer for the CDC’s National Center for Injury Prevention and Control. In a February 28th letter made public this week, Dowell attempted to dispel the widespread belief that the guideline is a mandatory policy for all pain patients.  

“The Guideline is not intended to deny any patients who suffer with chronic pain from opioid therapy as an option for pain management. Rather, the Guideline is intended to ensure that clinicians and patients consider all safe and effective treatment options for payments,” Dowell wrote. “CDC encourages physicians to continue to use their clinical judgement and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Dowell’s letter was addressed to three medical associations – the American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH) and the National Comprehensive Cancer Network – which were concerned that the CDC guideline was being misapplied by insurers to patients with cancer and sickle cell disease.

In February, the three groups sent a joint letter to Dowell asking the CDC to release an immediate clarification that the guideline was not intended for patients in active cancer treatment.

“Although the CDC guideline clearly states that the guideline is not intended to apply to this population, many payers are still inaccurately applying the CDC guidelines to patients in active (cancer) treatment,” the letter said.

Dowell responded a few days later with her own letter -- stating that the guideline was never intended to deny “any patients” opioid medication, but that alternate pain therapies should be considered.

Her letter also noted that two clinical practice guidelines for cancer pain (here and here) have been published or updated since the release of the CDC guideline.

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“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” ASCO Chief Executive Officer Clifford Hudis, MD, said in a statement.

“People with sickle cell disease suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal to the insurance companies every time a pain crisis hits and the initial request is denied,” said ASH President Roy Silverstein, MD. “We appreciate CDC’s acknowledgement that the challenges of managing severe and chronic pain in conditions such as sickle cell disease require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered.”

The CDC guideline is voluntary and only intended for primary care physicians treating chronic non-cancer pain. But after its release in March 2016, the guideline quickly metastasized throughout the U.S. healthcare system and became a mandatory policy for many insurers, pharmacies, states and practitioners.

‘Even Cancer Patients Suffer’

Many cancer patients who responded to PNN’s recent survey on the CDC guideline said they were denied opioid medication or not given enough for pain control.

“I'm fighting cancer a second time and I'm not being properly medicated, can't find a pain management (doctor) that will take me on. I have days where I am suffering and have no quality of life!” one patient wrote. 

“I'm a brain cancer patient and the CDC guideline has scared every doctor and oncologist in Connecticut. Even cancer patients suffer and they don't care because that's the law,” another said. 

“I was told two weeks ago that I have lung cancer and still cannot get anything for pain,” wrote another patient. 

“I had to go a year without pain meds and I am a stage 4 head and neck cancer survivor. The sudden withdrawal almost killed me,” said one patient. “Thank God I found a pain management doctor that understands head and neck cancer and the devastating effects it leaves forever. But even he is limited.” 

“I went through 6 weeks of chemo and radiation. My treatment caused muscle and joint pain that on some nights and days are so bad I wish I would have never survived my cancer. They have me on gabapentin. It is okay but does not stop the pain,” wrote another cancer survivor.

None of this is news to the CDC. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “some doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.” In a joint letter to the CDC, hundreds of healthcare providers also warned the agency that within a year of the guideline’s release “there was evidence of widespread misapplication” of its recommendations.

But except for an occasional letter -- like the one from Dowell -- there has been no systematic, publicized effort by the CDC to remind insurers, pharmacies and providers that the guideline is voluntary and exempts cancer patients. The agency has also failed to keep its pledge to study the impact of the guideline on patients and to revise it in future updates.

CDC Releases More Faulty Research About Opioids

By Pat Anson, Editor

A new study by researchers at the Centers for Disease Control and Prevention estimates that opioid overdoses have shaved two and a half months off the average life span of Americans – a somewhat misleading claim because the study does not distinguish between legally obtained prescription opioids and illegal opioids like heroin and illicit fentanyl.

The research letter, published in the medical journal JAMA, looked at the leading causes of death in the U.S. from 2000 to 2015. Overall life expectancy rose during that period, from 76.8 years in 2000 to 78.8 years in 2015, largely due a decline in deaths from heart disease, cancer, stroke, diabetes and other chronic health conditions.

But deaths due to Alzheimer’s disease, suicide, liver disease, drug poisoning and opioid overdoses rose, collectively causing a loss of 0.33 years in life expectancy – most of it due to opioids.

“This loss, mostly related to opioids, was similar in magnitude to losses from all the leading causes of death with increasing death rates,” wrote lead author Deborah Dowell, MD, of the CDC’s National Center for Injury Prevention and Control.

“U.S. life expectancy decreased from 2014 to 2015 and is now lower than in most high-income countries, with this gap projected to increase. These findings suggest that preventing opioid related poisoning deaths will be important to achieving more robust increases in life expectancy once again.”

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Dowell was also one of the lead authors of the CDC’s 2016 opioid prescribing guidelines, which discourage physicians from prescribing opioids for chronic pain. She and her two co-authors in the JAMA study --  both of them CDC statisticians -- do not explain why they failed to distinguish between black market opioids and legal prescription opioids, a dubious use of statistics akin to lumping arsonists in the same category as smokers or Boy Scouts learning to build campfires.  

They also fail to even mention the scourge of heroin and illicit fentanyl sweeping the country, which now accounts for the majority of opioid overdoses in several states.  

But Dowell and her co-authors don't stop there. The say the actual number of deaths caused by opioids is “likely an underestimate” because information on death certificates is often incomplete and fails to note the specific drug involved in as many as 25% of overdose deaths. This is another disingenuous claim, because it fails to explain why the data on the other 75% of overdoses is faulty too. 

Epidemic of Despair

Other researchers have also tried to explain the disturbing decline in American life expectancy – which began over adecade ago for middle-aged white Americans. Princeton researchers Anne Case and Angus Deaton were the first to document that trend,  when they estimated that nearly half a million white Americans may have died early because of depression, chronic pain, suicide, alcohol and drug abuse, and other health problems – an epidemic of despair linked to unemployment, poor finances, lack of education, divorce and loss of social connections.

The evidence was right there for Deborah Dowell and her co-authors had they looked for it. The JAMA study found that over 44,000 Americans committed suicide in 2015, a 66% increase from 2000, and over 40,000 died from chronic liver disease or cirrhosis, another 66% increase. Opioid overdoses during that same period rose to 33,000 deaths. 

Which is the bigger epidemic?

As PNN has reported, the CDC ignored early warnings from its own consultant that the agency’s opioid guidelines were being viewed as “strict law rather than a recommendation,” causing many doctors to stop prescribing opioid pain medication. Chronic pain patients also feel “slighted and shamed” by the guidelines, and are increasingly suicidal or turning to street drugs. We’ve also reported that the CDC has apparently done nothing to study the harms or even the possible benefits the guidelines have caused since they were released 18 months ago.

Instead of going back in time and selectively mining databases to fit preconceived notions about opioids, perhaps it is time for the CDC to take a giant step forward and see what its opioid guidelines have actually done.