In 2010, the Affordable Care Act (ACA) established a 15 person council within the Department of Health & Human Services to be known as the National Prevention, Health Promotion and Public Health Council. This action resulted in a number of strategic plans to move forward at the Federal level to address pain as a public health problem.
In 2011, the Institute of Medicine (IOM) published a report "Relieving Pain in America" which was to act as a blueprint for addressing the public health issues as they relate to pain management and the creation of opioid-sparing policies to be tested in the general public via pragmatic clinical trials.
In response to the IOM report, a coalition of over 3 dozen organizations lobbied the federal government to change the standard of medical care from a biomedical approach to a biopsychosocial approach.
Subsequently, the IOM's Report was used to create the "National Pain Strategy" in 2016, which has outlined ambitious goals to address the social and economic issues surrounding pain care in America. The recommendations laid out in the National Pain Strategy have been moving forward at the various federal agencies, including but not limited to: AHRQ, CDC, FDA, NAM and PCORI; as well as numerous private-public partnerships.
In 2017, the FDA issued an IRB Waiver for Informed Consent for Human Clinical Trials under the condition, it was deemed minimal risk and/or an emergency. The opioid crisis was officially declared a federal emergency in 2018, which permitted the waiver for human clinical trials to be used to pursue new and innovative treatments via human clinical trials.
Since the implementation of these federal programs, there have been sharp increases in patient suffering, increased disability rates and increased suicide rates. Meanwhile, there has been no marked improvement for those suffering with substance use disorder. Overdoses continue to rise while the availability of treatment has remained scarce. There continues to be a lack of both in-patient and out-patient rehabilitation facilities as well as lack of access to necessary medication assisted therapy and mental health/social services these individuals desperately need.
CIAAG is working with the patient community and public-private stakeholders to ensure proper representation of those in need of pharmacological management of their painful diseases and conditions are provided without undue barriers including the numerous "try and fail/step therapy" recommendations outlined in the HHS Pain Management Inter-Agency Task Force report in 2019.
NIH through the HEAL Initiative and the NIH Reporter are providing billions of dollars in funding to clinical researchers to study "pain" and "opioids." Unfortunately, we have seen serious abuses taking place under the name of these federal programs. Particularly by the Organizations that were appointed to represent people with pains interest in the public health policy arena.
We have witnessed a great failure of the systems that were put in place to help improve public health and well-being. CIAAG seeks to restore ethics and transparency in regard to the public health changes taking place to address both pain and opioid use in America.
While research is of vital importance to address the complexities of pain care and drug abuse, we must ensure that human rights, civil rights, personal autonomy and informed consent are preserved in the process.
CIAAG 8-Point Strategy
The United States is working to address healthcare disparities to ensure equitable access to necessary services. As this work began to take form, it exacerbated existing disparities as well as created new ones.
In particular, people with disabilities, women, physicians/patients, and racial minorities are experiencing difficulty in accessing care. Overall, there is an increasing incidence of patient abandonment, denial of care, stigma, and patient abuse.