Letter to Congress, from Americans affected by chronic pain
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November 2021 UPDATE: We have amended this letter to add new bills of concern to our community, introduced in the 117th Congress.
Dear Senators and Representatives,
We are patients, families, friends, and caregivers affected by chronic pain. We advocate for access to all forms of pain treatment. Today we hope to start a dialogue regarding pain and opioid policy, as Congress considers new addiction legislation.
Several bills introduced in 2020-2021 raise concerns for our community. Whether or not these bills are heard in the 2021-2022 session, any future legislation addressing addiction must take great care not to harm the (approximately) 8 million Americans with disabilities who benefit from opioid medication for chronic pain. We hope to work with the new Congress to remedy grave harms that have befallen patients since 2016, due in part to misapplication of the CDC Guideline for Prescribing Opioids for Chronic Pain.
As one example, we raise concerns about the Budgeting for Opioid Addiction Treatment (LifeBOAT) Act (introduced in 2021 as S.1723). The LifeBOAT Act would require a per-milligram stewardship fee on opioid medication, similar to the tax in the Addiction Prevention and Responsible Opioid Practices Act (introduced in 2020 as S. 4242/H.R. 7701). While the LifeBOAT Act allows a process for some patients to claim exemptions, this fee could restrict the legitimate pharmaceutical supply chain, and any delay at the pharmacy seriously threatens patients’ health.
We are also concerned about unintended consequences of the IMPROVE Addiction Care Act (introduced in 2021 as S.1575). This bill would require state Medicaid programs to identify patients who have experienced fatal or non-fatal overdose, then contact clinicians who prescribed opioid medications to those patients in previous years. The California Medical Board attempted a similar plan with the California Death Certificate Project, which has now been revised due to ineffectiveness; very few of the prescribers targeted for intervention were found to have prescribed unethically.
The Prescription Monitoring Act of 2021 (introduced in 2021 as S.889/ H.R.2344) requires PDMP reporting similar to the Comprehensive Addiction and Recovery Act (introduced in the 117th Congress as S. 987) and the Safer Prescribing of Controlled Substances Act (S. 2354). All of these bills raise the same concerns about patient privacy, improper use of data, and definitions of “outlier prescriber” based on arbitrary numbers.
We have some concern regarding the current wording of the Block, Report, and Suspend Suspicious Shipments Act (passed the House in 2021 as H.R.768). As written, this bill would require the Office of the Attorney General to identify criteria for suspicious shipments of controlled substances. These criteria would be decided without input from medical professionals experienced in pain medicine, oncology, or palliative care. This could result in delays or shortages for patients attempting to fill necessary prescriptions.
The FDA Accountability for Public Safety Act (introduced in 2021 as S.1439), the Protecting Americans from Dangerous Opioids Act (introduced in 2021 as S.1434), and FREED of Opioids Act (introduced in 2021 as S.1634) would change the way opioids are marketed and approved, with a goal of fewer formulations available on the market. Different patients respond best to different medications. Some patients benefit from one particular medication for years, and removing that medication from the market results in grave harm. Congress should not micromanage FDA drug approvals, especially since opioid prescribing is already down to a 15-year low, and opioid medications are no longer marketed in the ways they once were.
Finally, we strongly oppose the Addiction Prevention and Responsible Opioid Practices Act (introduced in 2020 as S.4242/H.R.7701). While this bill has sections we can support, including expanded access to addiction treatment, as written this bill would have unintended and devastating consequences for Americans living with severely painful diseases and injuries.
Over many years, pill mills and scams by dishonest physicians have fueled addictions and fed them illegally. This does not mean that capping dose limits for all patients across the board has any potential to be prudent or helpful. Nor is it clear how patients benefit from taxing every milligram of their medication to pay for addiction costs.
The Addiction Prevention and Responsible Opioid Practices Act would establish a cautionary dosage threshold from the CDC Guideline for Prescribing Opioids for Chronic Pain as de-facto law for the entire country, though the Department of Health and Human Services (HHS) and CDC have both clarified the Guideline was never intended to legislate maximum dosage.  The bill would require the Food and Drug Administration (FDA) to withdraw approval for opioid medications above dosages mentioned in the CDC Guideline, even after CDC clarified in April 2019 that strict dosage limits actually contradict the Guideline and threaten patient safety.
As defined by the bill, “the term ‘ultra-high-dose opioid’ means an opioid drug for which the daily dosage provided for in the approved label exceeds the morphine milligram equivalents per day outlined in the report entitled ‘CDC Guidelines for Prescribing Opioids for Chronic Pain,’ published by the Centers for Disease Control and Prevention in 2016 (or any successor document).”
Because patients differ in genetics, size, underlying conditions, and metabolism, even some vocal advocates for reduced opioid prescribing acknowledge that higher dosages are medically necessary for certain patients, especially in exceptional cases where other treatments have failed.  
Some of us are those exceptional cases. Our health should not be sacrificed.
The CDC Guideline is undergoing revision, and we hope to see extensive revisions as recommended by the American Medical Association.
For instance, the CDC Guideline distinguishes between cancer and non-cancer pain, though FDA has found no evidence that the painful mechanisms cancer patients experience are different from other types of pain. Cancer is only one of many conditions that cause pain via pressure on nerves and surrounding tissues, bones, visceral organs, muscles, and other areas. Other painful conditions can benefit from opioid medication, especially when other therapies have failed: graft versus host, trigeminal neuralgia, post-herpetic neuralgia, adhesive arachnoiditis, CRPS, ankylosing spondylitis, multiple sclerosis, rheumatoid and other arthritic conditions, interstitial cystitis, osteogenesis imperfecta, Ehlers-Danlos Syndrome, and hundreds of other rare and disabling diagnoses.
It is reasonably clear that the vast majority of overdose deaths are not from compliant patients with painful conditions who use opioids safely and as prescribed. Instead, the increase in overdose deaths is due to a poisoned, rapidly-shifting illicit drug supply, as CDC officials testified in a 2017 congressional hearing.
A study in Massachusetts found that the vast majority of overdose deaths from 2013-2015 resulted from illicit and counterfeit drugs; only 1.3% of opioid overdose deaths involved an opioid prescription legally prescribed to the decedent. A Canadian study from 2015-2017 found that only 2% of opioid overdose deaths were caused by prescription opioids alone. Opioid prescription rates continue to drop and are currently well below 2004 levels, yet overdose rates continue to climb.
We know from Center from Medicare and Medicaid Services (CMS) data that prescribed dosage does not accurately predict overdose risk. Studies have also found dose change is a greater risk factor than high dose alone.  Paradoxically, the Addiction Prevention and Responsible Opioid Practices act would increase overdose risk for many patients, by requiring harmful dose changes.
Furthermore, oversight measures in the Addiction Prevention and Responsible Opioid Practices Act duplicate regulations from the 2018 SUPPORT Act. Under the SUPPORT Act, Medicare and Medicaid are already required to report aggregate trends and individual outlier prescribers.
The Addiction Prevention and Responsible Opioid Practices Act would require HHS to add new federal “[w]arning letters and enforcement mechanisms, for addressing outliers in opioid prescribing practices.” Physicians already receive warnings from insurers, state health departments, medical boards, and Department of Justice offices. In many of these initiatives, reduced opioid prescribing is the only outcome being tracked, with no mention of whether the affected patients are doing better or worse. 
The CDC Guideline does not endorse disciplining physicians for prescribing above cautionary thresholds, absent evidence of illegal activity. The Addiction Prevention and Responsible Opioid Practices Act would add even more barriers for prudent prescribers who specialize in pain management and palliative care, a specialty already laden with administrative and regulatory barriers.
Finally, this bill would authorize direct access to information from the PDMP (prescription drug monitoring program) to all State law enforcement agencies. This is a massive intrusion into patient privacy, allowing unfettered, uncontrolled access to anyone who could potentially use the information for theft, impersonation, or other harm. Many states have limited such access, following high-profile cases of improper use by law enforcement officers. 
Today, every opioid prescription in America is tracked by multiple sources. Patients are graded by outside proprietary algorithms and ranked according to risk. (These are flawed algorithms, and proprietary, so cannot be seen by the patient or corrected - but that’s another important topic for another day.) Pharmacists and staff are also privy to these databases and risk rankings, and may deny patients prescriptions based on that analysis or their own personal comfort. Patients undergo urine or buccal testing at every visit (at great expense), and pills are counted randomly to make sure one has not taken one extra tablet on a bad day, or skipped one on a good day, as both of these actions are characterized as misuse.
Studies and news reports suggest that patients, in losing access to safe and measured prescribed opioid medications, have been forced to take the risks of seeking illicit medications to treat their pain.  Many people with serious pain cannot benefit sufficiently from non-opioid treatments. Some require medications to work, and thus to feed and house their families. Some may be trying to mitigate unrelenting agony from incurable medical conditions and/or avoid suicide, their only other remaining option.
The Addiction Prevention and Responsible Opioid Practices Act would prevent physicians from treating patients according to their training and experience. In crafting future legislation, we invite you to review this letter to Congress, signed by 100 disability rights organizations. These and other experts stand ready to advise on a federal response to opioid addiction that also balances the medical needs of people in serious pain:
We thank you for taking the time to hear our knowledge and perspective on this issue.
 Kurt Kroenke, Daniel P Alford, Charles Argoff, Bernard Canlas, Edward Covington, Joseph W Frank, Karl J Haake, Steven Hanling, W Michael Hooten, Stefan G Kertesz, Richard L Kravitz, Erin E Krebs, Steven P Stanos, Mark Sullivan, Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report, Pain Medicine, Volume 20, Issue 4, April 2019, Pages 724–735, https://doi.org/10.1093/pm/pny307
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