Dear Sir or Madam:
I am writing to you as a representative of an organization that includes U.S. armed services veterans to make you aware of an issue that will have a significant impact on the members of your organization. The issue is the Centers for Disease Control and Prevention's (CDC) proposed "Guideline for Prescribing Opioids for Chronic Pain". The CDC is in the process of drafting this Guideline and it is expected to have a significant impact on all Americans who have been, or will in the future be, prescribed pain medication. Indeed, the Omnibus spending bill that was recently passed by Congress and signed by President Obama (H.R. 2029, MILITARY CONSTRUCTION AND VETERANS AFFAIRS AND RELATED AGENCIES A PPROPRIATIONS ACT, 2016) directs the Veteran's Administration to implement the CDC Guideline once it has been finalized.
I have taken a keen interest in the Guideline for a variety of reasons, and have followed the process in the news, and via information provided by the CDC and other agencies. I do not represent any parties that would be affected by the Guideline and the views that I express are my own, personal opinions. The process that the CDC has taken to develop the Guideline is very controversial, as is the draft Guideline itself. My purpose in writing is to make you aware of the development of the Guideline so that you can ensure that your members' voices are heard and their positions are included in the debate.
You can review the Guideline at www.regulations.gov/#!documentDetail;D=CDC-2015-0112-0002
Additional information is available at www.cdc.gov/drugoverdose/prescribing/guideline.html
and related documents, including public comments, are available at www.regulations.gov/#!documentDetail;D=CDC-2015-0112-0001.
The Guideline has a noble stated purpose: "Improving the way opioids are prescribed through clinical practice guidelines [that] can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose from these powerful drugs." However, the Guideline has been widely criticized as an veiled attempt to strictly limit the availability of opioid medication based on weak or insufficient scientific evidence. In short, it is biased toward placing arbitrary restrictions on physicians who prescribe opioids to the millions of Americans who rely on them for pain relief, in order to reduce the amount of opioids that are diverted to illegal, non-medical use, assist the DEA in prosecuting physicians who prescribe opioids and ultimately eliminate the use of opioids for medical purposes.
My concern is the way that the CDC has gone about developing the Guideline and the way that it can be misused. Although the CDC has stated that the Guideline is "voluntary" and does not carry the weight of regulation, as noted above, it has already been adopted by Congress for implementation by the Veteran's Administration. Because of the stature of the CDC, this Guideline will very likely be widely adopted by state medical associations, health care providers and insurers, and will likely be used by the Drug Enforcement Agency and courts in criminal and civil proceedings to deny or limit prescription of opioids. But the unilateral way that the CDC developed the Guideline is not the way that our federal government is supposed to work.
Some of the circumstances that concern me about the process the CDC has used to develop the Guideline are:
· The CDC does not have the regulatory authority to promulgate regulations on this issue, but has cloaked the Guideline with the trappings of rulemaking, such as publishing the draft Guideline in the Federal Register. Many people will believe the Guideline is mandatory.
· The CDC acted in secrecy to review literature related to the use of opioids by forming an illegal advisory committee that met behind closed door meetings and whose membership was not disclosed until it was leaked. The secrecy violates both the spirit and the letter of our government's requirement for open meetings and transparent government activities.
· The CDC's advisory committee repeated reviews of medical literature by the National Institutes of Health (NIH) that had been completed little more than a year ago and another comprehensive review completed by the National Institute of Medicine (NIM) in 2011, yet arrived at very different conclusions and recommendations. Many of the "strong" recommendations in the Guideline are based on evidence the CDC, NIH and NIM acknowledges to be insufficient or of low quality.
· The CDC did not consult the FDA, NIH, DEA, state medical boards or medical associations for input into the Guideline. These organizations and agencies – not the CDC -- are the ones that are actually delegated by Congress and state legislatures with the responsibility for developing and enforcing rules prescribing medication.
· The CDC is well-known for its role in infectious disease control, but has very little expertise in pain management and possibly less about pharmacology. It is not the correct agency to be preparing guidelines on issues it is not well-informed about.
· The CDC excluded important stakeholders from discussions leading to the formulation of the Guideline, such as the actual physicians that the Guideline is directed to, experts in pain management, pain patients, disabled patients, veterans and even people who have become addicted to opioids. The Guideline has significant ramifications for activities in which many excluded stakeholders have strong interests.
· The CDC committee was loaded with individuals primarily on the addiction treatment side of the issue without a balance of those with opposing views: the committee included individuals who were known to be vigorously opposed to the use of opioids for any purpose as well as individuals with ethical and financial conflicts of interest.
· The CDC did not acknowledge or incorporate guidelines that have recently been developed by other organizations, such as state medical boards and pain treatment organizations. In 2011, the Institute of Medicine of the National Academy published a comprehensive, 383 page document entitled "Relieving Pain in America" which was ignored by the CDC.
Following an outcry from pain organizations, the public and other government agencies (e.g., a top official in the Department of Health and Human Services told an NIH research committee the CDC's guidelines were 'shortsighted' and there was a rush to judgment; The American Medical Association, stated its concern that the guidelines lack "a patient-centered view and any real acknowledgement of the problems chronic pain patients may face"), the CDC reluctantly opened a small crack in the process to increased participation by other stakeholders. The CDC discussed the Guideline at a webinar on December 7, 2015, with only 2 days notice and before the Guideline was available for review; published the Guideline in the Federal Register on December 14, 2015, but gave the public only 30 days to comment. As of this writing, the CDC has received and posted 4,369 comments received from individuals and organizations representing healthcare providers, professional associations, state medical boards, law enforcement, pharmaceutical companies, patients and victims of addiction. I have read many of the comments and although a handful of individuals have identified themselves as veterans suffering from chronic pain, notably absent are comments from organizations representing veterans.
Even though the comment period is now closed, the Guideline has not been finalized, so there may still be time to have the voices of veterans heard. I urge you to investigate this important issue, particularly as it affects veterans, and state your position and perspectives on opioid prescribing and pain management by writing to the CDC, Congress, the President of the United States, the Department of Health and Human Services, the FDA, DEA, the Veterans Affairs Administration, state and local lawmakers.
In addition, the CDC has published a Notice in the Federal Register (81 FR 1191) that it anticipates a workgroup tasked with reviewing public comments will present its observations in a report to the CDC's Board of Scientific Counselors at a January 28, 2016 public meeting. There will be 90 minutes allotted for public comment during the meeting. Details of the meeting and instructions for calling in and delivering comments are available at www.federalregister.gov/articles/2016/01/11/2016-265/board-of-scientific-counselors-national-center-for-injury-prevention-and-control-bsc-ncipc. Due to the blizzard in Washington, D.C., I suspect this meeting may be postponed. I recommend contacting the CDC for an updated meeting date and time.
With so much at stake, your members need to be part of the discussion!!
Sincerely,
Jane K. Babin, Ph.D., Esq.
