Politics and Policy in Medicine

Over the past ten years or so, patients, advocates and medical professionals have repeatedly sent requests for help to government officials regarding the struggles and suffering that chronic/intractable pain patients have incurred as a result of the proclamation of the “opioid crisis”-only to be left waiting for a response that apparently isn’t coming any time soon.

This is a crisis that is just as legitimate and important. Millions of people are experiencing severe medical complications, medical collapse, complete despair and even taking their own lives because of the consequences of the [other side of the] “opioid crisis”.

We hear politicians tout “Medical Freedom” and “Women’s Rights” but nobody seems to want to help the tens of millions (most of whom are women) with incurable, painful conditions who require round-the-clock pain relief.

The more I met with and corresponded with elected officials and/or their staff, the more I was left with unanswered questions rather than offers for help or solutions.  This made me wonder: perhaps there is more than meets the eye as to why the pleas for help pertaining to millions of their constituents with chronic pain are blatantly being ignored?

The anti-opiate attitude has been present in our country for a very long time, going back to the opium dens in the early 20th century. Opiate-based medications have been used safely and effectively for decades…how do we explain the sudden change? Most of us are aware of the 2016/2022 CDC Guidelines, but that’s only part of what has contributed to the destruction of pain management. Let’s look at how things have unfolded against the use of prescription opioids more recently.

In 2010, The National Institutes of Health (NIH) and The Institute of Medicine (IOM) implemented the National Pain Strategy https://www.iprcc.nih.gov/national-pain-strategy-overview  and included in the agenda list was to identify  “Treatments that are ineffective, whose risks exceed their benefits, or that may cause harm for certain subgroups need to be identified and their use curtailed or discontinued”.  There it is. Recent publications have over-emphasized the risks of opioid pain relievers.

Senator Sheldon Whitehouse (D-RI) introduced the Comprehensive Addiction and Recovery Act (CARA) in 2015 and it became law in 2016.  There were 44 co-sponsors which you can review here: https://www.congress.gov/bill/114th-congress/senate-bill/524/cosponsors.

Passed into law that same year was the Cures Act, which according to greenwayhealth.com: “[The bipartisan legislation] seeks to increase choice and access for patients and providers. It contains provisions to streamline development and delivery for drugs and medical devices, accelerate research into serious illnesses, address the opioid crisis, and improve mental health services”.  Increase choice and access?  How’s that working out for everyone?

The first few lines of the Cures Act document are as follows: TITLE I—INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects. Sec. 1002. FDA innovation projects. Sec. 1003. Account for the state response to the opioid abuse crisis. Sec. 1004. Budgetary treatment. TITLE II—DISCOVERY Subtitle A—National Institutes of Health Reauthorization.

Two years later, in October of 2018, The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT), became Public Law 115-271. According to the Department of Labor, it is a “bipartisan effort to address the country’s opioid and substance misuse epidemic. This law includes critical provisions to standardize the delivery of addiction medicine; expand access to high-quality, evidence-based care; and address the impacts of the epidemic by increasing and strengthening our workforce”.

The official proclamation was made under the Trump administration in 2017, with Attorney General Jeff Sessions (R) advising former President Trump (R) on the issue and laying out a very detailed plan to sanction, persecute and/or prosecute clinicians for treating pain conditions with controlled medications. Included are instructions to create media reports in order to taint the court of public opinion.  Click bait headlines like “doctor charged with illegally prescribing a million pills” have become common. The cases are often similar and the CDC’s 90 MME is typically used by the prosecution to claim “overprescribing without a legitimate medical purpose “.

Law and policy makers are essentially “practicing medicine without a license” (US Code 42,SS 1395) with bill proposal after bill proposal that typically consist of restricting dosage based on morphine milligram equivalents (MME) and calling for sanctioning, persecution and/or prosecution of providers who dare to prescribe controlled substances.

The Supreme Court has ruled that clinicians are the ones who should decide what their patients’ needs are, as determined by clinical findings (Ruan vs. United States, June 2022), but most of the lower court judges are blatantly ignoring the unprecedented 9-0 decision.  The DEA and DoJ have “doubled down” their efforts and continue to use the “overprescribing “ claim-often using Medicare and Medicaid fraud as a sort of back up charge.

According to his X account, Secretary of Health and Human Services Xavier Becerra (D) is a “fighter for underserved communities, healthcare, and justice”.  He has also said “No American should be denied the healthcare they need”. Additionally, and maybe more importantly, he served as the attorney general for California from 2017-2021.  California was one of 46 states to join the opioid lawsuits against opioid manufacturers and subsequently received $2.05 billion from the suit. Per his Facebook post on December 19, 2020: “As Attorney General, I’ve gone after the drug manufacturers responsible for the opioid crisis, and when I’m HHS Secretary, our administration will work together to take this on”.

Becerra certainly isn’t the only politician who has misplaced blame on manufacturers, distributors, pharmacies, clinicians and patients. Forty five other attorneys general joined the suits and they all settled based on a deadline, not proven guilt of the accused parties.

Josh Stein (D) of North Carolina and Herbert Slatery (R) of Tennessee were assigned to lead an executive committee of 14 attorneys general who led the lawsuits. Stein, currently a North Carolina senator, is campaigning for Governor for the 2024 race. He has eight years of previous experience working with the Department of Justice.

Florida’s attorney general, Ashley Moody (R) is married to a DEA agent. On December 5, 2023 she posted “Thank you, @GovRonDeSantis, for prioritizing our law enforcement heroes and the opioid crisis in your Focus on Florida’s Future Budget” to her X account. In October there were over 33,000 lbs of cocaine seized at the coast of Port Everglades- yet that story didn’t make her X page.

Committee member Josh Shapiro (D) is Pennsylvania’s current Governor.  Preceding his election to position as state attorney general in 2016, he campaigned on the promise to “combat the drug crisis” and launched “Operation Outfoxed”, calling it a “million dollar heroin ring”. He seemed to have the right idea, as to focus on illicit drugs; but his focus quickly shifted to pharmaceuticals.

Next door in Ohio, the current Governor is Richard Michael “Mike” DeWine (R), a “career politician” since 1976. Prior to being elected Governor, DeWine led the state’s opioid litigation process as state attorney general, which has led to more than 100 doctors and pharmacists losing their licenses for “improper prescription practices”.

In 2018, New York elected Barbara Underwood (D), who only served as AG for one term that year.  She was married to Martin Halpern who was a professor at Brandeis.  She returned to her job as solicitor and Letitia James (D) took her place. She has scored over 2.6 billion dollars for New York from the opioid settlements.

Attorney General Warren Kenneth “Ken”  Paxton (R) of Texas began his political career as a State Representative in 2002.  He kept that position until being elected as the state’s AG in 2015. His wife Angela is a state senator. Paxton has said “The health and safety of the people of Texas will always be my number one priority”.  Why don’t the health, safety and well-being of people who are suffering in tremendous pain matter?

Other attorneys general who were on the committee: Phil Weiser (D) of Colorado, William Tong (D) of Connecticut,  Kathy Jennings (D) of Delaware, Christopher Carr (R) of Georgia, Jeff Landry (R) of Louisiana, and Maura Healy (D) of Massachusetts.

Josh Hawley (R) is currently a Missouri Senator who was Attorney General from 2017-2019 and led the state’s opioid pursuit. He has been called out for criticizing others for being “career politicians” while he is on that path himself.

The settlements have clauses that are affecting all other scheduled medications, too. There is a ten year injunction included that restricts what manufacturers, distributors, pharmacies, pharmacists, providers and patients can do.

People with PTSD, ADHD, anxiety and even SUD/OUD (substance/opioid use disorders) cannot obtain their medications either…yet the DEA has decided to cut production of several scheduled medications for the eighth consecutive year.  Where is the logic in that decision? Why would production quotas be cut amongst shortages? Why isn’t there oversight with the agency and why aren’t actual medical professionals and patients (the real experts) involved in this decision making?

To save face and follow procedure, the agency asked for comments before the proposals to make additional cuts for 2024, but completely ignored the concerns brought before them.  Many who’ve been following this disaster for the past eight years or so have said that the decision was already made and the cuts were going to happen regardless of public input. It sure seems as though that’s the case.

The lawsuits aren’t over either. According to the National Association of Attorneys General, “This settlement resolves litigation against [these] four companies based on opioid-related misconduct. It does not release other companies. Investigation and litigation will continue against other companies”.  Additionally, the other states that weren’t part of the settlement are working on their own litigation. It wasn’t that they didn’t join because they felt there was no blame, it’s that they feel they can get more than what the original suit settled on.

With elections just around the corner, it’s time we pay close attention and recognize who refuses to acknowledge the pain crisis.  No longer can they claim they aren’t aware of what’s happening-especially those who’ve held their position for at least two years. It’s time we use our voices and votes-even if we have to cross party lines-to send a message.

The failure to address both crises in a way that is logical, effective, impactful and life-saving is harming too many people. A new approach is needed, continuing to target pharmaceuticals hasn’t brought the overdose numbers down, we need some folks who can see that. New policies are needed; and for that, new politicians are also.  Politicians who will openly listen to their constituents, new ideas and who do not have interest in monetizing others’ suffering, nor have close ties to the universities or media companies that are fueling the disinformation campaigns that keep the narrative going may be the only way we will solve the illicit drug and pain crises.