An Open Letter to the CDC Center for Injury Prevention

By Richard “Red” Lawhern, Guest Columnist

Dear Dr. Robert Redfield and Dr. Debra Houry,

By its passive refusal to conduct a thorough review of the impact and outcomes of its 2016 opioid prescribing guideline, the CDC’s National Center for Injury Prevention and Control is actively causing harm to hundreds of thousands of pain patients.   

Deserted by their doctors in a hostile regulatory environment, many are going into the streets seeking pain relief.  Possibly hundreds may already be dead of illegal fentanyl poisoning or suicide.  Military veterans, in particular, face draconian restrictions on the availability of safe and effective opioid medication therapy.   

And all for no good reason!

I suggest with every intention of professional and personal courtesy, that government organizations can no longer stand aside from this centrally important issue.  Such a stance will make you and other federal agencies accessories to state-sanctioned torture and negligent homicide.  That is unacceptable.   

As a former military officer, I respect a well-tried motto that I urge each of our regulators to take on as their own:   

      Lead, follow, or get out of the way! 

It has become clear that the CDC guideline must be immediately withdrawn for a major rewrite.  In its present form, the guideline is unjustifiably biased against opioid pain relievers, factually incomplete, in error on basic science, and founded on untested assumptions that do not hold up under any degree of careful scrutiny.   

The guideline is directly responsible for a vast regulatory over-reach by DEA and state authorities that is driving doctors out of pain management and denying safe and effective pain treatment for hundreds of thousands of patients.  

The CDC guideline has been publicly repudiated by no less an authority than the American Medical Association. Over 300 medical professionals have called for a rewrite of the guideline from the ground up. And a recent draft report by a federal task force calls for a reorientation of the guideline towards individualized patient-centered care, not the one-size-fits-all approach of the CDC. 

Multiple published papers have conclusively invalidated the guideline’s contention that there is a maximum dose threshold of risk for opioid addiction and overdose.   

Likewise, contrary to assertions in the guideline, there are presently no validated long-term studies to support the use of non-opioid analgesics and NSAIDs, or the off-label prescribing of anti-seizure and anti-depressant drugs to treat pain. No Phase II or Phase III trials have been published on "alternative" techniques such as acupuncture, massage or meditation.  And there are no trials which directly compare these techniques to opioid therapy under documented protocols.  Alternative treatments can at best be regarded as adjuncts to be added to analgesic or anti-inflammatory treatment.  

Published papers also demonstrate that criteria used by CDC and other federal agencies to identify risk of opioid abuse or overdose have very limited predictive accuracy. These faulty criteria are now being used by Prescription Drug Monitoring Programs (PDMP’s) to "flag" patients presumed to be at risk, who are in fact not at risk but are being denied pain treatment due to false alarms.  

Opioids, Overdoses and Demographics 

We can now take this narrative a step further.  I have compiled overdose data directly from the CDC Wonder database and from the Agency for Healthcare Research and Quality Data. This data focuses specifically on deaths directly attributable to opioid-related overdoses or suicide. The chart below shows rates of mortality by age group from 1999 to 2017.

GRAPHICS BY RED LAWHERN

Note that the highest rates of opioid-related mortality are among youth and young adults, while the lowest rates are among people over age 55.  Moreover, mortality in youth has skyrocketed by 1,800% over 17 years, while remaining relatively stable in people 55 and older.

The chart below documents the contrast in opioid prescribing by age group in 2016.  Unsurprisingly, older adults and seniors are much more likely to experience chronic pain and are prescribed opioids at a rate nearly double that of young adults. These two demographic trends contradict the idea that opioid overdoses are linked to prescribing.  They’re not and the evidence proves it. 

An updated analysis report further summarizes major themes we found in the overdose data.  The report reveals that “over-prescribing” of medical opioids was never a significant driver in opioid overdoses. There is no cause-and-effect relationship between rates of opioid prescribing versus rates of opioid overdose. In fact, it can be argued that in states where prescribing rates are highest, the trend may be in the opposite direction. 

The downward sloping red line in the chart below is called a "regression" line.  This is the trend line for the overdose and prescribing data from all 50 states in 2016. If there were a connection between high rates of opioid prescribing and overdoses, we’d expect the regression line to be pointing upward, not downward.

Overdose mortality rates are actually lower in high-prescribing states! 

One plausible explanation for the downward sloping line is that in states where prescribing has been more suppressed, patients are being driven into unsafe street markets or are committing suicide when overwhelmed by pain.   

These findings have previously been published in the blog of Dr. Lynn Webster, former President of the American Academy of Pain Medicine and author of "The Painful Truth." 

The implications of this analysis are glaring: the National Center for Injury Prevention and Control has created a fatally flawed guideline which actively increases injury rather than reducing it.   

Taken in sum, the evidence reveals that key assumptions on which the CDC guideline is based are simply and conclusively wrong.  Continued refusal to reevaluate the guideline is morally, ethically, medically and legally wrong. The 2016 CDC guideline on opioids must be retracted.  NOW! 

(Editor’s note: Dr. Redfield is CDC Director and Dr. Houry is Director of the CDC National Center for Injury Prevention and Control. A longer version of this open letter has been sent by email to other federal agencies and officials.)

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder and Director of Research for The Alliance for the Treatment of Intractable Pain.

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

CDC: Painkillers No Longer Driving Opioid Epidemic

By Pat Anson, Editor

A top official for the Centers for Disease Control and Prevention has acknowledged that prescription painkillers are no longer the driving force behind the nation’s so-called opioid epidemic.

In testimony last week at a congressional hearing, Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, said that heroin and illicit fentanyl were primarily to blame for the soaring rate of drug overdoses.

“Although prescription opioids were driving the increase in overdose deaths for many years, more recently, the large increase in overdose deaths has been due mainly to increases in heroin and synthetic opioid overdose deaths, not prescription opioids. Importantly, the available data indicate these increases are largely due to illicitly manufactured fentanyl,” Houry said in her prepared testimony before the House Energy and Commerce Committee's Oversight and Investigations Subcommittee.

The CDC blamed over 33,000 deaths on opioids in 2015, less than half of which were linked to pain medication.  

While painkillers may be playing less of a role in the overdose epidemic, Houry believes pain medication is still a gateway drug for many abusers. She cited statistics from Ohio showing that nearly two-thirds of the people who overdosed on heroin or fentanyl received at least one opioid prescription in the seven years before their deaths.  

"The rise in fentanyl, heroin, and prescription drug involved overdoses are not unrelated,” Houry said. “While most people who misuse prescription opioids do not go on to use heroin, the small percentage (about four percent) who do account for a majority of people recently initiating heroin use.”

Houry also disputed reports that efforts to reduce opioid prescribing have led to increased use of illegal drugs. It was her office that oversaw the development of controversial CDC guidelines that discourage doctors from prescribing opioids for chronic pain. 

DEBRA HOURY, MD

“Some have suggested that policies meant to limit inappropriate opioid prescribing have led to an increase in heroin use by driving people who misuse opioids to heroin,” Houry testified.  “Recent research, however, has indicated otherwise. One study found that the shift to heroin use began before the recent uptick in these policies, but that other factors (such as heroin market forces, increased accessibility, reduced price, and high purity of heroin) appear to be major drivers of the recent increases in rates of heroin use.”

The “recent research” Houry cited was a report published in the New England Journal of Medicine in January, 2016 – a full two months before the CDC opioid guidelines were even released. She offered no evidence to support her claim that the guidelines were having no impact on heroin use.

Some Patients Turning to Illegal Drugs

According to a recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation, the CDC guidelines have reduced access to pain care, harmed many patients and caused some to turn to illegal drugs for pain relief.

Over 70 percent said their opioid doses have been reduced or cutoff by their doctors in the past year. And one out of ten patients (11%) said they had obtained opioids illegally for pain relief since the guidelines came out. 

“The one person I know who says the recent guidelines have helped (is) my neighbor who is a heroin dealer. He says business has quadrupled since doctors have started becoming too afraid to help people in pain,” one patient wrote.

“This has caused me far more pain and suffering in my life, and increased my stress and anxiety, and depression, because nobody seems to care that I suffer like this,” said another patient. “This has also caused me to turn to using heroin, because I have nothing left now at this point and cannot suffer like this.”

“Because people are unable to get adequate pain relief from prescribed medications due to the fear instilled to doctors by these ‘guidelines,' most people, in my experience, are turning to heroin. This explains not only an increase in overdoses but also an increase in suicide from chronic pain patients,” wrote another.

“I found it easier to get medications through the black market than through my doctor. I spend about $1,000 per month in medications through the black market, but in the end that is less than the deductible on my insurance. And they deliver to my house!” a patient said.  

“My fear right now is that I've been using medications I buy from a dealer. They appear to be real and thus far I've been OK, but I'm afraid that I may eventually hit a bad batch laced with fentanyl,” said a patient. 

Houry’s testimony came on the same day the Drug Enforcement Administration warned that counterfeit painkillers made with fentanyl have killed dozens of people in the Phoenix area.

The DEA said at least 32 deaths in the last 18 months in Maricopa County, Arizona have been linked to fake pills laced with fentanyl that were disguised to look like oxycodone tablets. In nearly 75% of the overdoses, examiners also found dipyrone (Metamizole), a painkiller banned for use in the U.S. since 1977. 

Fentanyl is a synthetic opioid 100 times more potent that morphine. It is sold legally in sprays, patches and lozenges to treat severe chronic pain.

counterfeit oxycodone (dea photo)

The DEA says illicit batches of fentanyl are being made in China and exported to Mexico, where drug dealers mix it with heroin or turn it into counterfeit medication before smuggling it into the U.S.

The DEA released detailed demographic information on the age, sex and ethnicity of the people who overdosed in Arizona. It did not say how many of the dead were patients looking for pain relief.    

CDC: Opioid Guidelines 'Not a Rule, Regulation or Law'

By Pat Anson, Editor

It’s no secret in the pain community that many patients are being taken off opioid pain medication or weaned to lower doses because of an overzealous reaction by doctors to the CDC’s opioid prescribing guidelines.

Those guidelines – which discourage opioid prescribing for chronic pain -- are meant to be voluntary and are intended only for primary care physicians. Yet they are having a chilling effect on many doctors and their patients.

One such patient, a retired Nevada pharmacist who took high doses of opioids for years for chronic back and hip pain, refused to be silent when his pain management doctor abruptly lowered his dosage to 90 mg (morphine equivalent) a day – the highest dose recommended by the CDC.  

Richard Martin wrote 27 letters to the CDC and didn’t mince words, saying doctors in the Las Vegas area “are scared shitless that the DEA will get them” and that their malpractice insurance rates would skyrocket if they didn’t follow the guidelines to the letter.

“All of you at the CDC and like-minded groups, individuals, etc. are causing hundreds of thousands if not millions of people to suffer in pain needlessly,” wrote Martin.

“The medical community has failed me. I was stable on my opioid regimen for over 6 years. No tolerance, no cheating, no hyperglasia and a pretty good quality of life. Last year my primary MD up and told me to go to a pain specialist. He would no longer provide me with opioid prescriptions. The first thing the pain doctor did was decrease my opioids. Of course I am in much more pain now. Due to my decreased level of activity my blood sugar levels have spiked. I used to be able to walk up to 3 miles every other day. Now I can’t go walking. I may have to start taking insulin.”  

To see all of Martin’s letter, click here.

Martin received two responses from the CDC. One appears to be nothing more than a form letter, in which a CDC official blandly wrote, “We are sorry to hear about your health problems.”

The other letter was from Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention, which oversaw the guidelines’ development. In her letter, Houry appears to acknowledge that the guidelines are being too widely implemented by doctors.

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain,” wrote Houry.

“Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

To see Houry’s letter in its entirety, click here.

Martin wrote back to Houry and challenged her to address the issue of patients being abruptly weaned from opioids more publicly.

DEBRA HOURY, MD

“My pain management doctor and his group are quoting your guidelines and more or less cowardly blaming you for the problem. Personally, I think they may be using this as an excuse to get rid of Medicare patients and perform more interventional injections or procedures,” he wrote in his follow-up letter, which you can see by clicking here.

“The CDC, in my opinion, should change the dosing guideline… The CDC should EMPHASIZE as you stated ‘The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication.’”  

Martin has yet to receive a response from Houry. When Pain News Network contacted the CDC about the letters, we were encouraged to post them. But the agency declined an offer to explain its position further.

Martin’s letter writing campaign hasn’t ended. He’s written to the American Association of Retired Persons (AARP) about the “huge tragedy unfolding across America” and has been contacted by Pharmacy Today magazine about having one of his letters published.

Patient Survey about CDC Guidelines

Another pain patient who is fighting back is Lana Kirby, a 60-year old retired paralegal who suffers from chronic back pain and several other chronic illnesses. Kirby and her husband recently moved to Florida, but found she can't find a doctor in that state willing to prescribe the pain medication she needs. So every three months, Kirby drives back to her home state of Indiana to see a doctor and get her prescriptions filled.

“In all my years as a paralegal, I've never seen anything like this,” she told PNN.  “Quite frankly, if an attorney were to take this to Federal Court, it would be a slam dunk due to the damages occurring on an ongoing basis and the ‘avoidable decline.’ We all know it costs a lot more to take care of a bedbound person than someone who can take care of themselves.  And if that means using opioids, that is the way it should be.  But as far as I know, no one has found an attorney with the resources to take on a case like this.”

Kirby is conducting an online survey of pain patients, asking if their opioid doses have been lowered since the CDC guidelines came out or if they have been discharged or abandoned by their doctors.

“The reason I did the survey was because I was talking to hundreds of pain patients everyday online and they all were saying the same thing,” she said. “Having a legal background, I felt that the damages needed to be documented and quantified in order to prove what was going on and the volume of people affected.”

To take Kirby’s survey, click here.