As an advocate for people in pain, I have long been a critic of opioid prescribing guidelines of the US Centers for Disease Control and Prevention (CDC), published in 2016 and revised in 2022. I have found these guidelines to be fatally flawed and actively dangerous to US public health. And I have publicly advocated for immediate repudiation and recall without replacement.
Understandably, some U.S. government officials have become rather unhappy with me. I hadn’t realized just how unhappy until I tried in early October of this year to register my concerns with serving senior officials in the US Department of Health and Human Services. I looked up email addresses in their HHS online directory, and informed the officials of several new publications:
US Opioid Guidelines 2022. More and Less Than Meets the Eye
Everything the Government Thinks It Knows About the Opioid Crisis is Wrong
Reshaping Opioid Policies – A Patient Advocate’s Call [Podcast]
Oversight on Revision of US CDC Guidelines – A Process Predestined to Fail
Taken in combination, this research demonstrates fundamental and fatal flaws in the CDC opioid guidelines, particularly these:
1. The guidelines fundamentally misconstrue the implications of their repeated direction to clinicians that they must balance “risk versus benefits” in prescribing decisions for individual pain patients. Risk is a predictive demographic measure that applies only to large cohorts of patients. Clinicians understand that a past history of opioid exposure or mental health issues may prompt more frequent oversight of their patient’s response to pain treatment. But at the present state of science, it is impossible to assess risks in specific individuals.
2. It has been known for 25 years — and was known to the CDC guideline writers — that minimum effective opioid dose is strongly affected by the genetics of individual opioid metabolism. Genetics cause a wide range of minimum effective dose levels for individuals, perhaps as large as 15-to-1.
None of the present clinical trials literature uses protocols that account for individual variation in minimum effective dose. Randomized double-blind trials also fail to incorporate the extensive titration and clinical monitoring necessary to determine the effective dose for each individual. These omissions effectively invalidate the entire clinical trial literature on the safety and side effects of opioid analgesics.
The literature needs to be burned to the ground and done over.
Both of these realities were known to the writers of the revised CDC opioid guidelines in 2022. But if CDC had embraced the science, then they could not have published their guidelines. Thus they chose instead to ignore reality in favor of “publish or perish”. They chose to commit fraud and to grievously harm millions of US citizens as a result.
I’ve sent the narrative above repeatedly by email to senior officials in the Department of Health and Human Services, with a request that they convene a timely senior staff review of CDC performance in the resulting issues of science and public health.
It’s reasonable to ask what their response was: a crashing silence!
Both the Office of the Secretary of Health and Human Services (HHS) and key figures within CDC, FDA, Agency for Healthcare Research and Quality (AHRQ) and others have chosen to stone-wall the message that CDC has committed fraud. Moreover, I’ve seen evidence that their Info Tech administration has red-flagged all of my correspondence as trash, denying me public access to their officials.
With this record in mind, I called the Immediate Office of the Secretary and asked to speak with the Chief of Staff. I was informed that he was unavailable. When I asked to be routed to his voicemail, I was told that the public is not allowed to leave messages. I could do so only through an email address: [email protected].
I then attempted to make this malfeasance known to key legislative staff in the U.S. House and Senate, using their published phone directories. I quickly ran into similar patterns of avoidance and exclusion. I then recruited several citizen advocates for an email campaign to reach out to legislator Chiefs of Staff and Legislative Directors. Again, many of us saw the same pattern. Some were informed that their emails had violated administrative rules of the House mail processing system and would not be delivered. However, the specifics of such rules were never explained. I seriously doubt that they ever will be.
The unwillingness of U.S. legislators to hear their constituents is becoming legendary. Ask anyone who has tried to communicate with legislators on key committees of the Congress, through their online websites. If your telephone and zip code aren’t in the legislator’s District or State, then you won’t be able to send an inquiry about the public’s business. Even if you do get through the maze, the letter you get back over the legislator’s signature will almost never substantively address your concerns. The only message that our legislators seem willing to hear is money. And money talks loudly.
As an advocate on behalf of people in pain, I would remind legislators of two inconvenient realities of their jobs:
The First Amendment of the US Constitution guarantees citizens the right to petition their government for redress of grievances. When legislators set up administrative rules to deny us that right, they are violating that Amendment and revealing their disinterest in the problems of the people who elected them.
We live in contentious times. But as Former President Harry S. Truman reminded us, “if you can’t stand the heat, then get out of the kitchen.” Over 100 million US citizens experience pain every day. Thousands of them are killing themselves because they can’t get safe and effective care. Either legislators will engage with this issue or they will be required to LEAVE!
We are a Nation in pain and we will not be silenced!
#Dr. Lawhern is a member of the ACSH Scientific Advisory Board.
