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Revised CDC guidelines on opioids are a step in the right direction, but much work remains

More restrictive opioid prescribing guidelines were put in place in a rightful effort to stop a devastating crisis. But this sudden and dramatic change negatively impacted chronic pain patients who were managing their pain through prescription opioids given few other effective options.

The recent CDC decision to amend the opioid prescription guidelines comes as a relief to millions of chronic pain patients and practitioners across the U.S.

Since the 2016 revisions encouraging doctors to avoid opioids where possible, people with chronic pain have been fighting to get proper access to necessary medicines and doses. While the regulations were put in place in a rightful effort to stop a devastating opioid abuse and overdose crisis, this sudden and dramatic change negatively impacted chronic pain patients who were managing their pain through prescription opioids given few other effective options.

The opioid crisis, along with the 2016 opioid prescribing guidelines and new state laws limiting opioid prescribing practices, forced many U.S. physicians and pain clinics to become more reticent to prescribe opioids for acute and chronic pain.

Opioids are most effective at acute pain relief. But they were also prescribed to chronic pain patients as a last resort, since the drugs can rapidly build opioid tolerance, requiring higher doses and increasing risk of abuse.

As a result of the change in guidelines, opioid prescriptions were nearly cut in half between 2012 and 2020. The decline in overuse and abuse of prescription opioids is a positive for society. But millions of chronic pain patients who were benefiting from the appropriate use of opioids were left suffering due to a lack of effective alternative treatments. 

Chronic pain patients speak of constant physical and mental exhaustion. They live with anxiety, depression and fear as they wait for their next pain episode — which can arise at any moment — or for their pain to worsen. Chronic pain sufferers also speak of the “side effects having side effects” as they take medicines for their pain that cause brain fog or leave them feeling exhausted. This, in turn, leads to inactivity and weight gain, which can contribute to comorbidities such as diabetes and cardiovascular disease.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The recent CDC revision of opioid prescription guidelines is a step in the right direction towards proper treatment for people with chronic pain. But there is still a long way to go before we can offer additional safe and effective therapies that they need and deserve.

In two decades of incredible advances in medicine, the treatment paradigm for chronic pain has not changed. Foundational treatments include NSAIDs, antidepressants and anticonvulsants that often have challenging side effects, such as dizziness, drowsiness, nausea and other gastrointestinal disturbances. Many chronic pain physician opinion leaders say that in clinical practice only about a third of patients can reduce their pain by 50% with currently available medications. That can drive clinicians and patients to turn to opioids as the only available alternative. 

The current dearth of products in R&D pipelines is largely due to our poor understanding of the complex pathophysiology and signaling pathways involved in chronic pain; the lack of preclinical pain models translating to efficacy in humans; and multiple clinical failures of compounds in development over the past two decades.

Despite groundbreaking science from researchers like Nobel Prize winner David Julius resulting in promising pain targets, the precision medicine approaches for pain have not proven successful to date. The lack of new scientific insights combined with these development failures has resulted in healthcare investors moving their money away from chronic pain investments to other disease categories.  

But chronic pain affects approximately 20% of our adult population.  As such, America needs investors, biopharmaceutical companies and researchers, as well as the U.S. government, to bring more focus, investment and incentives to address this issue. 

I applaud the CDC for revising their opioid prescription guidelines, recognizing the needs of people with chronic pain and respecting their autonomy to make decisions with their individual primary care teams. But I also recognize this is not enough for millions of chronic pain patients across our nation and around the world who struggle to manage their symptoms with current therapies, including opioids.

Therefore, I fully support the National Institutes of Health’s initiative, Helping to End Addiction Long-term (HEAL), which focuses on enhancing preclinical, translational and clinical research in pain management as well as on the prevention and treatment for opioid addiction. But we need additional measures to help cultivate more R&D in this area.

The NIH and U.S. government should support R&D in chronic pain through clinical grants, funding and tax incentives. Regulations also need to reflect the urgency of this issue, with the FDA instituting an accelerated approval program for chronic pain drugs and implementing “voucher programs” similar to their pediatric program to enhance investment in innovative chronic pain therapies.

We cannot continue to ignore the impact of this silent epidemic on our country while underinvesting in efforts to provide solutions. We need the power of the U.S. government, combined with the investment community, biopharmaceutical companies and the research community, to step up and give chronic pain patients the therapies they deserve.

Source: Prostock-Studio, Getty Images

Bob Azelby has worked in biopharma for more than two decades with significant experience in the pain management space. He is currently president and CEO of Eliem Therapeutics, a biotech company focused on developing therapies for neurological conditions. Over the course of his career, he has held executive and leadership positions at Alder Biopharmaceuticals, Juno Therapeutics and Amgen.

Bob is a member of the Clovis Oncology Board of Directors and was formerly on the Immunomedics and Cascadian Therapeutics Board of Directors.

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