CDC Bows to Demands for Transparency and Public Input on Draft Opioid-Prescribing Guideline

cdc_logo(3)Over the past year, the Centers for Disease Control and Prevention (CDC) has been drafting a Guideline for Prescribing Opioids for Chronic Pain in relative secrecy, relying upon the input of a hand-picked group of advisers and a limited number of stakeholders. Such a stealth approach drew criticism from numerous interested parties, including Washington Legal Foundation, which explained in a November 17, 2015 letter to CDC that the agency’s drafting process ran afoul of the Federal Advisory Committee Act (FACA).

This week, CDC took several unexpected steps towards greater transparency for its prescribing guideline project, implicitly conceding its prior FACA violations. The director of CDC’s National Center for Injury Prevention and Control informed WLF on December 14 of its about-face in a letter responding to our November 17 missive. That same day, CDC published a notice in the Federal Register that seeks comments on the draft guideline and also directs the public to numerous previously-unreleased documents. In addition, CDC announced that it will ask a federal advisory committee, its Board of Scientific Counselors, to review the draft guideline and public comments and make recommendations to the agency.

In our November 17 letter, WLF argued the “Core Expert Group” that CDC’s National Center for Injury Prevention and Control selected to draft and review the guideline qualified as a federal advisory committee under FACA. In convening the Core Expert Group, CDC had failed to follow numerous FACA requirements, including formally filing a charter; announcing meetings in the Federal Register; holding meetings in public; and keeping and making public detailed minutes of those meetings. We also questioned whether the Core Expert Group complied with FACA’s requirement that advisory committees be fairly balanced in terms of the points of view represented.

Instead of holding meetings in public, for instance, the Core Expert Group met secretly in Atlanta in June to provide recommendations to CDC regarding the guideline. The first time that the public had access to even a general outline of the draft guideline occurred in September, when CDC convened a hastily-called webinar to discuss its plan. CDC agreed to receive comments by email for 25 hours after the webinar, which it later extended to 49 hours. Technical difficulties with the September 16 webinar limited stakeholders’ access, forcing CDC to re-run it the following day.

WLF’s November 17 letter also addressed the CDC’s seeming indifference to FACA’s fair-balance requirement. Numerous members of the Core Expert Group were on record as strongly supporting the need to tighten opioid-prescribing standards. The panel did not include physicians and others experienced with treating chronic pain, and featured only one pain-management expert, Dr. Jane Ballentyne. The group for which Dr. Ballentyne serves as President, Physicians for Responsible Opioid Prescribing (PROP), has, among other activities, petitioned FDA to curb opioid use and lobbied Congress for legislative limits (PROP’s Vice President is also a member of CDC’s Core Expert Group). In addition to her pre-existing ideological bias, Dr. Ballentyne suffers from a financial conflict of interest, having acted as a paid consultant to a law firm representing the State of California and the City of Chicago in novel lawsuits against opioid manufacturers—clients who stand to gain from a strict federal guideline.

We explained to CDC that if the final opioid-prescribing guideline relied on the Core Expert Group’s recommendations, the agency ran the risk of a legal challenge by stakeholders under the Administrative Procedure Act.

It is unclear whether these latest developments, and the involvement of a chartered federal advisory committee, will result in a fresh look at the draft prescribing guideline, or the release of a document that relies in any way on the advice of the tainted Core Expert Group. Stakeholders and other interested parties, such as WLF, will certainly continue to scrutinize the process to find out. We will also keep an eye on the makeup of the working group that the Board of Scientific Counselors will be appointing in January to review the draft guideline to see whether it is fairly balanced and free of conflicts of interest.

Congress adopted FACA in 1972 because it believed process matters, and because that process should be open to the public that regulators serve. The final Guideline for Prescribing Opioids for Chronic Pain may not constitute a formal regulation, but CDC intends it to be the federal government’s definitive statement on the topic. It will not only influence the work of thousands of public-health officials and private physicians, but directly impact millions of patients who suffer from chronic pain. Only a process that is transparent and informed by robust debate and discussion will provide the type of reasoned outcome that such patients deserve.

Also published by at WLF’s contributor page

4 thoughts on “CDC Bows to Demands for Transparency and Public Input on Draft Opioid-Prescribing Guideline

  1. jojordan

    Thank you Washington Legal Foundation! So many in the world of pain have enough battles to fight just to get through the day. I’m not a pain patient but I think it would be inhumane not to sympathize with them and help them fight this unfair battle that has been waged against them. We all need to keep in mind that some day we may hurt too.
    That being said I find it extremely frightening that the CDC proceeded with guidelines, that will have such a profound effect on so many Americans, in such a shady fashion. What scares me even more is the motivation behind PROP a group that claims to have the best interest of the people at heart but clearly this is not the case. They have much to gain financially by these restrictions on opioid prescribing. They have no place in advising the CDC. I’m afraid if PROP gets what they want there will be more coming just around the corner. This organization needs to be investigated by those in power to do so before it’s too late.

  2. Thank you Washington Legal Foundation! The CDC is out of line here and their involvement with PROP is suspicious to say the least. PROP needs to be investigated. They have much to gain financially by these restrictions and they formed this group using MD etc. as a power symbol. They clearly have no interest in the good of the people as they claim. Their actions to date have been very shady and underhanded.
    People in pain have enough trouble just getting through their day. They do not have the wherewithal to go up against organizations such as PROP and the CDC which is being influenced by PROP.
    Again I say thank you for keeping watch and preventing this type of behind closed doors activity that can have such a profound effect on so many innocent and hurting people.

  3. Dee Green

    Do chronic pain patients have any rights concerning their access to care or the affects that a Prohibitionist groups involvement in restricting or rationing that care? Do patients have any recourse when care is impacted by the “chilling affect” that these “guidelines” will have once medical boards, health agencies and insurance companies adopt them as standards of care? It seems that 100 million people who suffer with chronic pain (NIH-IOM report) are being singled out and vilified for chronic conditions that they have no control over & only seek something to provide for some quality of life 😔 Thank you for speaking up- They have long since (beginning with PROPs denied FDA petition in 2011) silenced and vilified the physicians who treat chronic pain and now seek to further vilify and marginalize the chronic pain community 😥 Thanks again!

  4. Laura Lima

    Thank you WLF – you are only advocate. I have Multiple Sclerosis and suffer from debilitating chronic pain . I am prescribed opioid medications and other medications as part of my treatment plan. My doctor is a Neurologist, pain Management Specialist and Qualified Medical Examiner . I have been his patient for 5 years. I learned about the “Opioid Issue” 3 days ago when Wal-Mart pharmacy announced that “In accordance with Guidelines For opioid prescriptions” provided by the CDC, Walmart Pharmacies will limit Opiod prescriptions to a 7 duration & a 90mg per day maximum. I am absolutely stunned that this could even happen-how is it possible that a government agency Has the right or is more qualified than my doctor to determine my treatment? And do it without my knowledge?
    I’ve done some research in the last couple of days and discovered a HHS Strategic Plan for 2012 through 2018 on CDC’s website. The mission and goals outlined conflict absolutely with the statements in the “Guidelines” recently issued. It states that “trauma” is a serious underlying risk factor for ….substance abuse disorders. This factor certainly isn’t addressed by the restriction of opioid analgesics needed by chronic pain patients. The American Medical Association has also produced a statement for dealing with the “Opioid Epidemic”. People with incurable diseases or conditions that result in debilitating, chronic pain aren’t even mentioned. While they state that patients’ treatment should be at the discretion of their physician, they also state that they support the medication limits put forth by the CDC; which nullifies physician determined treatment. AMA also quotes a ridiculous statement by the CDC that opioid treatment is not effective, adding a footnote that there is no evidence to support this statement. What in he world am I going to do? What about the millions of people like me that are going to be unable to get the medication they need to make our pain manageable? Do we not have any rights whatsoever? I truly hope that the Washington Legal Foundation will take up our cause and advocate for us as you have always done. I hope that you can fight this latest indecency and get us the right to have treatment back.
    Thank you so very much- what you do truly makes a difference.

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