Richard A (Red) Lawhern, Ph.D. is the spouse of a chronic pain patient. He has supported pain patients and family members for twenty years with online research, physician referrals, authoring of websites and critical commentaries.
Lawhern is calling for the immediate withdrawal of the US Centers for Disease Control and Prevention guidelines on prescription of opiates to adult non-cancer chronic pain patients. The grounds for this challenge include exceptionally poor science, professional bias, and known harms to patients and doctors in the arbitrary withdrawal of care.
The CDC Recommendations for Chronic Opioid Use are “Neat… Plausible… and Generally Wrong”
Excerpts from Address to the Rally Against Pain
Washington DC, October 22, 2016
The Big Ideas
Papers in science and medicine are generally begun with a short summary called an “abstract”. This is where the authors record their “take away ideas” before getting into details. The first two paragraphs of Martin, Poteet, and Lazris’ paper are really eye-opening. So let’s read them aloud:
“The American crisis of opioid addiction and overdose compels our strongest efforts toward successful prevention and treatment. Recommendations from the Centers for Disease Control and Prevention (CDC) for chronic opioid use, however, move away from evidence, describing widespread hazards that are not supported by current literature. This description, and its accompanying public commentary, are being used to create guidelines and state-wide policies.
“These recommendations are in conflict with other independent appraisals of the evidence or lack thereof and conflate [confuse] public health goals with individual medical care. The CDC frames the recommendations as being for primary care clinicians and their individual patients. Yet the threat of addiction largely comes from diverted prescription opioids, not from long-term use with a skilled prescriber in [an ongoing] clinical relationship. By not acknowledging the role of diversion and instead focusing on individuals who report functional and pain benefit for their severe chronic pain, the CDC misses the target.
This is a startling summary. What it tells us is that the CDC screwed up BIG TIME last March when they issued guidelines for prescribing opioids – medicine that literally millions of people need in order to maintain any quality of life in the face of chronic pain.
Now let’s turn to the details.
The CDC Narrative
Again to quote from Martin, Potee, and Lazris, the basic premises of the CDC standards are these:
‘People in chronic, severe pain are readily provided unproven opioids in ever-increasing doses, get easily addicted and die of overdose either from the opioids prescribed to them or from a switch to lethal heroin.’
As these authors and many others are increasingly writing in popular literature, while such notions might seem plausible to uninformed readers, they are unfortunately just plain wrong.
As those of us gathered here can testify, opioid medication is by no means “readily provided”. It is almost always a last resort after many other therapies have been tried and failed. Moreover, it is quite unusual for someone who has chronic pain to “switch” to street drugs, if their medical needs are being met by prescriptions.
The CDC claims that there is no evidence that people who have pain get benefits from opioids that are used for many months or years. The problem with this assertion is that long-term studies simply haven’t been done. So the CDC doesn’t actually know that opioids don’t provide benefit. They simply assume that it doesn’t.
From my own observations, this assumption is contradicted by tens of thousands of patient reports in social media that the CDC made no effort to sample or to understand. As Martin and his colleagues mention,
“The CDC, in telling patients that “the benefits are transient and generally unproven,” is essentially telling patients they are wrong about their pain and function.”
Ignoring Their Own Research
Whatever happened to the patient being the best source of information on their own symptoms and conditions? This principle has gotten thoroughly lost in the CDC’s so-called research for its new prescription guidelines. The consultants’ working group even ignored published work from the NIH itself, including the 2014 National Institutes of Health “Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain”. These quotations appear in the Martin et al paper, as follows:
“Patients, providers, and advocates all agree that there is a subset of patients for whom opioids are an effective treatment method for their chronic pain, and that limiting or denying access to opioids for these patients can be harmful.
[O]ur consensus was that management of chronic pain should be individualized and should be based on a comprehensive clinical assessment that is conducted with dignity and respect and without value judgments or stigmatization of the patient.
… Biased media reports on opioids also affect patients. Stories that focus on opioid misuse and fatalities related to opioid overdose may increase anxiety and fear among some stable, treated patients that their medications could be tapered or discontinued to “prevent addiction.”
The CDC, in contrast, highlights that prescription opioids are “really dangerous medications which carry the risk of addiction and death.”
Numerous published studies find that prescription of opioids is simply indispensible at our present state of knowledge. And while opioids can have negative side effects, there is real doubt that many patients rapidly develop tolerance for these medications, or seek ever-increasing doses to control their pain. One published source indicated that fewer than one in ten chronic pain patients who haven’t used opioids before, show such a pattern of spiraling use.
I’ve personally communicated with thousands of patients over 20 years, of whom several hundred were managed on opioids. From that background, I’d be inclined to estimate the numbers of problem patients even lower. I cannot recall more than three patients who needed to go through drug rehab because of developing tolerance and losing the pain relieving effects of opioids. This isn’t a scientific or inclusive sample, of course. But it’s suggestive of a larger phenomenon.
Arbitrary Limits on Pain Relief
Yet another pernicious outcome of the CDC’s labors is that they have attempted to enforce an upper limit on the daily dose which a chronic pain patient may receive from a general practitioner of medicine. The guidelines direct that doses should be increased above 90 Morphine Milligram Equivalent per Day (MMED) only after careful consideration of the benefits and risks of such treatment – as if any medical doctor would do otherwise.
There are multiple problems with this one-size-fits all policy. High on that list is that pain is not a one-size-fits-all problem. Due to genetic factors, many patients respond poorly or not at all to low doses of opioid medication, and require much higher doses to get pain relief. But we know from thousands of patient reports that many people are stable and do well on high dose levels – well above those recommended in the CDC guidelines.
Likewise, it is very difficult to compare the effects of different opioids on any common scale. Some researchers go so far as to call the concept of MMED itself not a method, but a mythology of pseudo-science and opinion.
There are also problems with the science which is said to justify CDC warnings on high dose rates. Starting from a January 2016 interim briefing on recommendations of the consultants’ working group, I have reviewed the studies which were applied in arriving at the 90 MMED limit. My findings were published on the National Pain Report.
The CDC could find only four studies that examined risk of drug toxicity or overdose versus dose rates. However, one of these papers shows only a small increase in risk of drug toxicity when prescribed doses are increased from 50 MMED to 90 MMED or higher. There is also a variation in estimated risk of more than 400%. Moreover, there is no clear trend in outcomes beyond a generally higher estimated risk of bad outcomes at higher doses.
The nature of risk was also different between the four (comparing overdose to hospital admission for drug toxicity). Thus the CDC used four studies that do not compare well to each other, and whose results are understandably self-contradictory. My own intuition is that if a study supported the conclusions that the writers wanted to present, then it was used. In any other context, this practice is called “cherry picking”. It is scientifically invalid.
This is more than a quibble over numbers. As Martin and his colleagues note, the CDC guidelines are being used as justification for reducing the medication available to thousands of chronic pain patients. They have also been enshrined as mandatory restrictive standards of practice in multiple State laws. And such restrictions may be falling especially hard on military veterans. As of December 2015 – and despite CDC attempts to make their guidelines voluntary for physicians – Congress in its debatable wisdom has made conformance to CDC practice guidelines legally mandatory for the US Department of Veterans’ Affairs.
Understanding the Real Risks of Treatment
One of the remarkable services that Dr. Martin and his colleagues have done for us, is to put together data from multiple sources which the CDC has ignored, to estimate the real risks of drug overdose from prescription opioids . What they found is a major contradiction to the hysteria which led CDC writers to mention “overdose” 144 times in their recommendations.
The US Institute for Medicine estimates that more than 115 million people in the US suffer from chronic pain lasting more than 90 days. Dr Martin and his colleagues show us that about 16 million people are prescribed opioids in any given year – for all reasons combined. The great majority receive medication for only a few days after a surgery or other injury. Out of 16 million, an estimated 2.8 to 3.4 million are prescribed opioids for long periods to manage chronic pain.
From this smaller group, the number who develop opiate use disorder (also called opiate addiction) is much lower. Five different studies put the risk at 10%, 6%, 4%, 2% or 1.3%, depending on whom you believe. The statistics don’t even mention how difficult it is to determine whether someone is addicted and unstable, versus physically dependent and stable under medical management.
The real risk of overdose death among people prescribed opioids at high doses is estimated in the range of 0.06 to 0.2 percent. In one large study, a total of 59 deaths occurred among 32,449 patients taking opioids for longer than three months.
How in the world can anybody in their right mind call this an “epidemic” of death from prescription opioids? Death rates attributed to many non-opioid medications in other conditions are significantly higher. And for that matter, the death rate due to medical errors during hospital treatment is now over 440,000 deaths per year – the third highest cause of death in this country!
For families who have lost someone to drug addiction or overdose, street drugs are a genuine crisis. And prescription drugs do indirectly play a part. But not in the manner suggested by the prevailing narrative of hysteria. There is a genuine problem of drug diversion – where pills unused by an acute pain patient are given to or stolen by a family member or otherwise wind up on the street sold to drug abusers. There is evidence that quite a few heroin addicts start out as abusers of pain pills – particularly teens. But trust me on this – a suffering chronic pain patient is the LAST person in this world who is going to sell their medications on the street or give them away. And there are straightforward solutions to reduce much of the diversion, if we ever get serious about doing so.
None of this seems to matter to the medical policy makers at CDC, FDA and the Surgeon General’s office. In fact, the Surgeon General has added insult to injury by circulating a letter to all US general practitioners, urging that doctors reduce or withdraw opioid medications from their patients, across the board.
Ironically, the Surgeon General has very likely never treated a chronic pain patient in his career. Likewise, none of the members of the CDC consultants’ working group which wrote the prescription guidelines was Board Certified or had regularly treated or pain patients. The people who wrote this standard were instead addiction specialists with a sprinkling of psychiatrists and doctors from emergency medicine (hospital ERs).
These medical professionals quite literally had no first-hand knowledge of what they were talking about.
The Bottom Lines
This brings us full circle to the primary ideas which this rally is about.
The CDC practice guidelines are causing doctors to leave pain management practice all over the US, for fear of DEA malicious prosecution if they exceed an arbitrary and unscientific “one size fits all” policy while trying to treat their patients effectively and as individuals.
Patients are being deserted by their doctors, in some cases without assistance in drug withdrawal, after they have used opioids as directed, safely and effectively for years to maintain the quality of their lives. Almost certainly some patients have already died and more will suicide as a result. Our government is aware of this problem, but chooses to do nothing.
The guidelines are also being embedded in State laws that reinforce restrictions on opioids. Major areas of several US States are now without pain management centers, and remaining specialists are seeing ever-heavier patient loads and higher risk of prosecution.
The best predictors for people falling into addiction are their age (teens are particularly vulnerable), and their status as unemployed or poor. Restriction of opioid medications to pain patients won’t solve these problems. If anything, we should anticipate increases in deaths due to street drugs, as desperate people are forced to seek them out against their own wishes, just to maintain a marginal quality of life.
The CDC needs to withdraw its unscientific and damaging opioid guidelines. Revisions should acknowledge that at the present state of medical knowledge, opioids are an indispensable part of managing agonizing pain, and trained doctors are the best decision makers on how much is needed to relieve pain in each individual patient.
Standards of practice and doctor training are needed. But the present CDC guidelines are a poor basis for such standards. Re-writing should be accomplished by professionals who actually understand chronic pain and its management, and not by addiction specialists who have a financial self-interest in diverting limited government resources away from proven pain treatments.
For the longer term, the US National Institutes for Health needs to allocate far more research and resources to the study and treatment of chronic pain. At present, less than 1% of NIH research funds are directed to chronic pain – for one quarter of the US population.
It is time to STOP THE WAR AGAINST PAIN PATIENTS!
Richard A (Red) Lawhern, Ph.D.
Check out the Lawhern Files, a collection of Red’s writings on behalf of pain patients.