“Have you seen the unbelievable profits the insurance, hospital, pharmaceutical, and drug store chains are now making? To keep up the gravy train, the big players have to continue to reduce patient benefits and physician payments. There is no question in my mind. Patients and their families and advocates have to speak loudly, firmly, and progressively going forward.”

Patients and their advocates have played only a minimal role in the development of the CDC guidelines. The only two patient advocacy groups invited to the webinar were the American Chronic Pain Association and the American Cancer Society.

One group that was well represented at the webinar were non-profits focused on fighting addiction and drug abuse, includingThe Partnership at Drugfree.org, Safe States, Community Anti-Drug Coalitions of America, Harm Reduction Coalition, ShatterProof, and Physicians for Responsible Opioid Prescribing (PROP).

As Pain News Network has reported, PROP has played a significant role behind the scenes in the development of the CDC’s opioid prescribing guidelines. At least five PROP board members, including President Jane Ballantyne, MD, Vice-President Gary Franklin, MD, and PROP founder Andrew Kolodny, MD, are on CDC panels that developed the guidelines. Kolodny is chief medical officer for Phoenix House, a non-profit that operates a chain of addiction treatment clinics.

Was CDC "Hoodwinked" by Experts?

“I am surprised that the CDC would secretly align with PROP and others with conflicts, especially since many, if not most of their proposed guideline statements are not scientifically based,” said Jeffrey Fudin, PharmD, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“CDC should be ashamed at their approach, as they were obviously hoodwinked by the presumed experts, most of whom have no formal training in pain management whatsoever. I am surprised that participants were not required to disclose potential conflicts. It disgusts me that the very stakeholders that are paying for opioids are on a panel with an agenda to save money by denying opioid use.”

The CDC said it selected a “diverse” panel of experts for its various committees, including the "Core Expert Group" (CEG) that apparently played the largest role in developing the guidelines. A list of CEG members and peer reviewers will be listed at the end of this article.

"For a guideline to be credible, it is important to eliminate or effectively manage sources of bias. These sources of bias might include financial relationships with industry, intellectual preconceptions, and previously stated public positions. Prior to participation, CDC asked CEG members to reveal potential conflicts of interest. Members could not serve if they held conflicts that could be anticipated to have a direct and predictable effect on the recommendations," the agency said in internal documents obtained by Pain News Network.

According to those documents, CEG members Ballantyne and Franklin did not disclose they were PROP office holders or indicate they had a conflict of interest as members of PROP.

Ballantyne did disclose that she served as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies. Ballanytne also disclosed that she serves on a special advisory committee reviewing opioid abuse deterrence for the Food and Drug Administration.

"There is strong evidence that increased prescribing for chronic pain has produced increases in dependence, overdose and death without improving pain relief, function or quality of life for many individuals with common chronic pain diagnoses," wrote Ballantyne in a recent letter on behalf of PROP to an official with the National Institutes of Health, which is developing the National Pain Strategy.

Franklin did not disclose any conflicts, although he played a significant role in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation. For that, Franklin was honored by the workers compensation industry for "his pioneering research and outspokenness on the overprescribing of opioid pain medications."

“Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction,” wrote Franklin in a position paper published last year in Neurology, the journal of the American Academy of Neurology.

The CDC said it carefully reviewed the financial relationships and "intellectual preconceptions" of CEG members --- and "determined the risk of these types of activities to be minimal."

A request for an interview with Debra Houry, Director of the CDC’s National Center for Injury Prevention and Control, which selected the panels, vetted the members, and oversaw development of the guidelines, was declined.

Guidelines "Bad News" for Pain Patients

Patient advocacy groups are only now waking up to the fact that they’ve had little role or voice in the CDC guidelines -- which are scheduled to be released in January. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

"The CDC's draft guidelines regarding pain therapy are bad news for thousands of patients living with daily pain. They ignore the needs of patients and offer no real solutions to help physicians manage patients' pain. In addition, these guidelines were developed behind closed doors and have not been made publicly available. It is imperative that the CDC be transparent as they develop these guidelines," said Srinivas Nalamachu, MD, a member of the Alliance for Patient Access.

In a letter sent to CDC Director Tom Frieden, a coalition of patient groups said they were “deeply concerned” that the prescribing guidelines are “inconsistent with established best practices” and show an “extreme imbalance” in the agency’s views about opioids.

They also complained about the webinar.

“The CDC slides presented on Wednesday were not transparent relative to process and failed to disclose the names, affiliations, and conflicts of interest of the individuals who participated in the construction of these guidelines. The presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines,” the letter states.

It’s not the first time pain patients have been largely excluded from an issue that’s important to them, according to David Becker, a patient advocate and longtime critic of regulators and leaders in pain care.

“Until people in pain work together in common cause to have a real voice in pain care, then the designs of others in government and industry will continue to impose inhumane, degrading, and ineffective treatment on them - without their advice or consent,” Becker said.

Interestingly, the only media outlet invited to the CDC webinar was Consumer Reports, which last year did a cover story and special report on “The Dangers of Painkillers.”

Groups and organizations invited to the CDC webinar:

American Academy of Family Physicians

American Academy of General Physicians

American Academy of Neurology

American Academy of Pain Management

American Academy of Pediatrics

American Academy of Physical Medicine and Rehabilitation

American Board of Internal Medicine

American Cancer Society

American Chronic Pain Association

American College of Obstetrics and Gynecology

American College of Occupational and Environmental Medicine

American College of Physicians

American College of Preventive Medicine

American Geriatrics Society

American Hospital Association

American Insurance Association

American Medical Association

American Pain Society

American Pharmacists Association

American Physical Therapy Association

American Public Health Association

American Society of Addiction Medicine

American Society of Anesthesiologists

American Society of Clinical Oncology

American Society of Health-System Pharmacists

American Society of Hematology

American Society of Interventional Pain Physicians

Association of American Medical Colleges

Blue Cross/Blue Shield(s)

Brandeis PDMP Center of Excellence

Cigna

Clinton Global Initiative

Colorado Department of Regulatory Agencies

Community Anti-Drug Coalitions of America

Consumer Reports

CVS Caremark

Federation of State Medical Boards

Harm Reduction Coalition

Kaiser Permanente Southern California

MaineCare

National Association of Boards of Pharmacy

National Association of State Alcohol/Drug Abuse Directors

National Association of State Medicaid Directors

National Comprehensive Cancer Network

National Conference of State Legislatures

National Governors Association

National Safety Council

Pew Charitable Trusts

Physicians for Responsible Opioid Prescribing

Safe States

ShatterProof

Trust for America’s Health

The Partnership at Drugfree.org

American Association for the Treatment of Opioid Dependence

Appalachian Regional Commission

Association of State and Territorial Health Officials

American College of Emergency Medicine

National Association of County and City Health Officials

Society of General Internal Medicine

Core Core Violence & Injury Prevention Program (VIPP) grantees

CDC Prevention for States grantees

Core Expert Group members:

Pam Archer, MPH; Oklahoma State Department of Health

Jane Ballantyne, MD; University of Washington/PROP President

Amy Bohnert, MHS, PhD; University of Michigan

Bonnie Burman, ScD; Ohio Department on Aging

Roger Chou, MD; Oregon Health and Sciences University

Phillip Coffin, MD, MIA; San Francisco Department of Public Health

Gary Franklin, MD, MPH; University of Washington/PROP Vice-President

Erin Krebs, MD, MPH; Minneapolis VA Health Care System/University of Minnesota

Mitchel Mutter, MD; Tennessee Department of Health

Lewis Nelson, MD, New York University School of Medicine

Trupti Patel, MD; Arizona Department of Health Services

Christina A. Porucznik, PhD, MSPH; University of Utah

Robert Rich, MD, FAAFP; American Academy of Family Physicians

Joanna Starrels, MD, MS; Albert Einstein College of Medicine of Yeshiva University

Michael Steinman, MD; Society of General Internal Medicine

Thomas Tape, MD; American College of Physicians

Judith Turner, PhD; University of Washington

Peer Reviewers: