Lie: "The CDC didn't know their guidelines would cause harm."

Details: Hits: 780

LIE: "The CDC Guidelines were created with transparency using a wide range of experts with unbiased views. They were based on strong scientific evidence, and the CDC was unaware that the Guidelines could have a negative impact on pain patient outcomes."

Table of Contents:

Introduction
CDC was warned their guidelines would cause harm
2016 CDC Guideline docket comments
Opioid Work Group (OWG) comments
Conclusion

Introduction

We all know by now that the 2016 CDC Guidelines for opioid prescribing have been weaponized. The CDC claims they were never intended to be used the way they have been.They even issued a warning acknowledging the Guidelines have been misapplied. This was in response to a letter (Word) (pdf) a group of health care professionals, called HP3 (Health Professionals For Patients In Pain) sent to the CDC raising concern about the misapplication of the Guidelines. Around the same time, the FDA also issued a warning about forced tapers.

What many people don't know is that the CDC was warned that the Guidelines would hurt patients. Did they care? No. So when they say "we didn't know this would happen," just know they're lying.

In 2015 several organizations and groups tried to sound the alarm about the potential dangerous impact the Guidelines may have.

At the same time as the CDC Guidelines were being written, another government agency, Interagency Pain Research Coordinating Committee (IPRCC) was asked by HHS to oversee the creation of the National Pain Strategy. We will get into details about that report at another time, but the reason I'm mentioning it is because the IPRCC expressed grave concern about the CDC Guidelines and how they could have a negative impact on patient outcomes.

This IPRCC meeting took place in December 2015. Here is the link to the video for the meeting. Here is an amazing Twitter thread done by Carrie Judy, a researcher with The Doctor Patient Forum, regarding this meeting and comments made about the CDC Guidelines. Here are a few quotes:

"It’s naïve to think it won’t have an impact. (The CDC Guidelines) In fact, it flies in the face of everything the NPS (National Pain Strategy) stands for."
"There was no review of anybody doing well on opioids to understand whether there are any patient characteristics predictive of who might do well. So to me, that spoke to a kind of BIAS. So there we are.”

It's clear that the IPRCC had concerns about the potential negative impact of the CDC Guidelines as well as the bias that was clearly allowed. Not surprisingly, there was then an investigation done into the members of the IPRCC, calling them "industry funded," as shown in this article. Here are a couple of quotes discussing the IPRCC members and their comments about the Guidelines.

.A federal panel that has recently criticized efforts to cut back on painkiller prescriptions is studded with members who have financial ties to drug companies."
:The revelation comes after the committee last month bashed a federal plan to recommend doctors scale back on prescribing painkillers for chronic pain. The guidelines by the Centers for Disease Control and Prevention are intended to curb deadly overdoses tied to powerful but highly-addictive opioid drugs, including Percocet and Vicodin."

Notice they didn't address any of the IPRCC's concerns regarding the CDC Guidelines, instead they just attacked the members of the IPRCC, trying to discredit them. Ad-hominem, is what that debating technique is called. Remember that because it's not the only time they used that technique.

In addition to the IPRCC, there were many other organizations who expressed serious concerns about the upcoming CDC Guidelines. These concerns were not only regarding the content of the Guidelines, but the secretive manner in which they were crafted. The following are links and information about a few of those organizations who expressed concern about the Guidelines in 2015:

American Academy of Pain Management (AAPM) wrote a letter (pdf) on 10/20/15 to the Honorable Fred Upton, who was Chairman of the House Energy and Commerce Committee at the time. This letter included the following comments:

"While we have concerns about some of the content of the draft guideline that CDC has presented, the subject of this communication is the process that is being undertaken to develop that guideline. We are very concerned that this process is deeply flawed."
"It will certainly have negative impacts on patients."
“What was particularly striking to the panel was the realization that there is insufficient evidence for every clinical decision that a provider needs to make regarding the use of opioids for chronic pain, leaving the provider to rely on his or her own clinical experience.”
"Although CDC has not been transparent about the members of the Core Expert Group that helped it develop the initial recommendations, the Stakeholder Review Group, or the three experts who will assist it in developing a final draft, we are privy to this information because we are one of the stakeholder groups invited to review the draft. We find the makeup of these groups both puzzling and concerning."
"These groups, charged with developing a guideline on how best to use opioids to treat chronic pain, are overwhelmingly dominated by individuals with no apparent expertise in the subject, nearly devoid of groups representing and advocating for people with pain, and studded with a number of individuals who are publicly on record as opposing the use of opioids to treat most types of chronic pain."

The Committee on Oversight and Government Reform, a House Oversight Committee wrote a letter (pdf) to Dr. Tom Frieden on 12/16/15. This letter included the following comments:

Some groups have raised concern that the proposed guideline may be insufficient to treat those suffering from chronic pain."
"We expect CDC's guideline drafting process to seek an appropriate balance between the risk of addiction and the need to address chronic pain."
"We have questions about why a 'Core Expert Group' established by CDC to assist with drafting these guidelines is not considered an advisory committee under the FACA (Federal Advisory Committee Act)."

The American Cancer Society wrote a letter (pdf) to Dr. Frieden and Dr. Houry on 10/1/15. The letter included the following comments:

"We are concerned that the emphasis on how to reduce inappropriate use of opioids has paid very little attention to how these efforts may impede medically necessary access to these products."
"We have concerns about the lack of evidence on which the guidelines were based, the methodology used to develop the guidelines, and the transparency of the entire process. Our concerns are so serious that we cannot endorse the proposed guidelines in any way and suggest suspending the process until the methodological flaws are corrected and more evidence is available to support prescribing recommendations."
Unfortunately the guidelines drafted by CDC, by its own admission, are based on weak or nonexistent evidence."
"In fact, the CDC imprimatur makes it more likely that these guidelines become de facto requirements through adoption by state health departments, professional licensing bodies or insurers. CDC even acknowledges that this is one of the goals of this process."
"We are concerned that the draft document does not reflect the appropriate weighing of benefits and harms at the individual and population levels, a fundamental element of rigorous guideline development."

The Washington Legal Foundation wrote a letter (pdf) to Dr. Tom Frieden on 11/17/15. This letter included the following comments:

The WLF is writing to express extreme concern with the flawed procedures being employed by the CDC in connection with its proposal to issue a Guideline from prescribing opioids for chronic pain."
The overly secretive manner in which the CDC has been developing the Guideline serves the interest of neither the healthcare community nor consumers."
Government standards for the prescription of opioids to treat chronic pain are highly controversial, as evidenced by the considerable number of protests that have been raised in connection with the CDC's draft Guidelines."
WLF went on to express concern that the CDC was not abiding by the Federal Advisory Committee Act (FACA)

I'll briefly explain FACA, and why WLF questioned the process CDC was using to write these guidelines.

The government's website defines FACA as "The Federal Advisory Committee Act that was enacted in 1972 to ensure that advice by the various advisory committees formed over the years is objective and accessible to the public. The Act formalized a process for establishing, operating, overseeing, and terminating these advisory bodies and created the Committee Management Secretariat to monitor compliance with the Act." If you're interested in reading more about it, here is the link.

The CDC responded to the WLF in a letter, and announced they'd have their Board of Scientific Counselors (BSC) as the Federal Advisory Committee (thus complying with FACA) , to review the draft guidelines and published this announcement about an upcoming public commenting period. Richard Samp, the lawyer at WLF, wrote this article explaining this information. Although this appeared to be a step in the right direction, looking back it was really just lip service, making things look like they were trying to create balanced guidelines, when in fact they needed to push these unscientific guidelines through to be used as evidence in opioid litigation. This is what you'll hear us call the "litigation narrative."

Remember how CDC's response to IPRCC's concerns was an ad-hominem attack instead of addressing the actual concerns they had? Well, they did the same thing with the concerns of these organizations.

Instead of addressing the actual issues brought up by the various organizations, they published an investigation into the 158 groups themselves, claiming they were all industry funded. These claims can be seen in this article by PROP (Health Professionals for Responsible Opioid Prescribing) member Adrienne Fugh-Berman. This is ironic considering Fugh-Berman herself is "industry funded" by the endlessly lucrative opioid elimination industry. She, Andrew Kolodny, Jane Ballantyne, and other PROP members have received millions of dollars as "expert witnesses" in opioid litigation. Two of the authors of the paper about this investigation were Andrew Kolodny and Caleb Alexander, both have been expert witnesses in opioid litigation. Caleb Alexander also owns a compliance company, hence making more money off of the opioid elimination industry.

Looking back, it's easy to see that the purpose of the CDC Guidelines was to be used as evidence for opioid litigation. This was the end-game. Their main reason for creating this litigation narrative. Billions of dollars made off of litigation. Peter Pitts, former FDA employee, discussed this very issue in an article in 2015.

When Kolodny was pressed on why Ballantyne working for a law firm with a financial interest in the guidelines is different than input from doctors with financial ties to pharmaceuticals, he said: “I’m not sure how I would understand that to be a conflict if somebody is an expert and they’re asked for their expertise.” He then went on to make millions as an expert witness in litigation that used the CDC Guidelines as evidence.

Washington Legal Foundation predicted in 2016 that the Guidelines would be used in opioid litigation. Read Richard Samp's prediction in this article called "CDC's New Opioid Guidelines Will Be Used By Plaintiffs Bar, WLF says." '“Will the plaintiffs bar use these guidelines in their pending litigation? I have no doubt that, yes, they will,” Samp told Legal Newsline.'

Read more about the litigation narrative and the CDC Guidelines in this article called "Plaintiffs firm consultant helped develop CDC's controversial opioid guidelines."

Now, Listen to this podcast from 2019 with Tom Frieden, who was the head of the CDC at the time the Guidelines were written, and hear his account of the WLF complaint.

The interviewer, who lost a son to heroin, asked Dr. Frieden about the Guidelines. He said how shocking it was that "pain forums" pressed Congress to investigate the CDC to uncover any influence from special interest groups. He then went on to say that the CDC took a very strict view on conflicts of interest (COI's). Listen to this quote "People's opinions change for reasons they might not be aware of. And, if you're getting a paycheck from someone, or might be in the future, you might in ways you didn't even realize have a different opinion. He then said if anyone had a COI, CDC didn't allow them to be there. I guess the millions Kolodny, Ballantyne, Alexander, etc made as expert witnesses in litigation doesn't count as a "paycheck." Right? Certainly, someone being paid by a lawyer to convince a jury that prescription opioids are fueling this crisis, wouldn't ever want to influence Guidelines that would help them win. Right?

The following letters were written by organizations commenting on the docket of the proposed CDC Guidelines:

American Academy of Family Physicians (AAFP) wrote a letter (pdf) to Dr. Tom Frieden on 1/13/16, commenting on the proposed Guideline. This letter included the following comments:

"The AAFP certainly wants to promote safe and appropriate prescribing of opioids; however, we recommend that the CDC still adhere to the rigorous standards for reliable and trustworthy guidelines set forth by the Institute of Medicine (IOM). The AAFP believes that giving a strong recommendation derived from generalizations based on consensus expert opinion does not adhere to evidence-based standards for developing clinical guideline recommendations."
"All of the recommendations are based on low or very low quality evidence."
"The patient voice and preferences were not explicitly included in the guideline. This raises concerns about the patient-centeredness of the guideline."

American Academy of Pain Medicine (AAPM) wrote a letter (pdf) to Dr. Tom Frieden on 1/12/16, commenting on the proposed Guidelines. This letter included the following comments:

"We are disappointed that despite our and others’ raising this fundamental concern, no substantive changes have been made in the methodology that remedies the biases of the current draft guideline."
"In the current era of personalized, “precision” medicine, we should be mindful that some patients do well on chronic opioid therapy for noncancer pain, and conduct evidence reviews that seek to identify such subgroups."
"We believe it is wrong to quote an arbitrary dose despite scientific evidence documenting individual genetic and environmental factors that produce variability of individual responses to opioid medications."

American Academy of Anesthesiologists (ASA) wrote a letter (pdf) to Dr. Tom Frieden on 1/13/16, commenting on the proposed Guidelines. This letter included the following comments:

"ASA and ASRA support the federal government’s efforts to reduce opioid overdose deaths, and support the majority of recommendations in the CDC Guideline. However, we are concerned that the Guideline would curtail perioperative physicians’, which includes physician anesthesiologists, surgeons, and co-managing internists or hospitalists, ability to treat patients’ acute pain after surgery, and any recommendations made by CDC need to balance the overprescribing of opioids for acute pain with perioperative physicians’ imperative to treat post-surgical pain."
"In the Guideline, CDC emphasizes that evidence on long-term opioid therapy for chronic pain is insufficient to determine long-term benefits. However, we would like to note that physicians can assess functional improvement when considering whether opioids are effective."

Of course there were organizations and people who wrote letters in support of the CDC Guidelines. Since those profiting from this false narrative want you to believe that anyone who opposed the Guidelines did so because they were bought by pharma, let's look at those who supported the Guidelines. Attorneys General. Now, why do you think they would care to give their input on the Guidelines? Could it be because this was all part of their plan to get billions of dollars from the pharmaceutical industry in opioid litigation? All you have to do is look at the cases currently in court to see these Guidelines are added as evidence. There are approximately 3,000 cases across the USA.

Let's look at some of these letters. When reading these letters from lawyers, keep in mind the comments physicians and actual pain experts made about the lack of evidence, the tremendous bias, the secretive manner in which the Guidelines were created, and the potential harm the Guidelines could cause on people in pain.

Letter written (pdf) by the Attorney General of NY regarding the Guidelines, written on 1/13/16. This letter included the following quote:

"The nonbinding Guideline is based on solid clinical evidence and contains recommendations that promote the effective treatment of pain and may prevent inappropriate prescribing of opioids, thus saving lives."

Letter written (pdf) by the Attorney General of Massachusetts regarding the Guidelines, written on 1/13/16. This letter included the following quotes:

"While there have been various efforts from state officials and other organizations to memorialize best practices for opioid prescribing, the Guideline would provide prescribers with a single, nationwide, evidence-based standard."
"Our national opioid-related overdose deaths are the result of years of overprescribing of prescription painkillers."

Letter written (pdf) by 36 Attorneys General regarding the Guidelines, written on 1/13/16.This letter included the following quote:

By better informing and guiding prescribers, these Guidelines will not only provide a strong framework for providers, but they will also improve the access to opioids for patients for whom they are the best choice. For these reasons, we urge the CDC to promptly adopt these Guidelines.

Remember that after WLF pushed the CDC to abide by FACA, they opened up a comment period. These comments are listed here (pdf) in the minutes of a Board of Scientific Counselors (BSC) meeting on 1/28/16. The comments start on page 38. Look at the people who commented. Gary Mendell, Gary Franklin, Judy Rummler, Steve Rummler's fiancé, Caleb Alexander, David Juurlink, Jane Ballantyne, and Andrew Kolodny, So you have the same biased anti-opioid zealots who helped create the Guidelines, making comments supporting the Guidelines. Where are all the pain patients and pain doctors? Well, the comment period was not well publicized, so many pain patients and doctors didn't have a chance to comment.

Here are some quotes:

"In this regard, he urged CDC to disregard all comments made by individuals with financial conflicts of interest and to issue as quickly as humanly possible the guideline that has been prepared for months" "apart and “shattered” as his was. Those who have died cannot be present to testify. CDC can wait for years for further research, but if it does, tens of thousands of people will die" ~Gary Mendell
"Contrary to what some have claimed, the recommendations provide sufficient scientific support to justify their strength and the derivation of “strong” recommendations is entirely consistent with best practices in guideline development" ~Dr. Caleb Alexander
"Much of the opposition to the guideline has been based on a faulty premise; namely, that the recommendations will somehow jeopardize the care of those living with pain." ~Dr. Caleb Alexander
"The guideline was created using the best available evidence, expert review, and input from a broad and balanced group of stakeholders." ~Dr. Jane Ballantyne
"Appropriate pain care is not jeopardized by the guideline: it demands it." ~Dr. Andrew Kolodny
"FED UP! applauds CDC for creating this draft guideline which will lead to more cautious opioid prescribing and reverse the trend of ever-increasing overdose deaths." ~Judy Rummler

The CDC put together an OWG (Opioid Workgroup) to discuss the proposed guidelines. Here is a pdf of their comments made at the meeting on 1/28/16. Some of the members actually did express concern with some of the guidelines, but it appears that these concerns were not addressed. Here is one of their comments:

"One member of the Workgroup strongly opposes Guideline Recommendation #5 ( which discusses limits of 50 and 90mme) as it is written. This member stated repeatedly that the current recommendation clearly suggesting dose limits is not supported by any data showing a decrease in benefit/risk ratio at the arbitrary numbers stated in the recommendation." Since changes weren't made, it appears that this warning was not taken seriously.

As you know, the Guidelines were published without any consideration of the concerns raised about them. Regardless of the fact that they're "just guidelines," they have since been used in opioid litigation and have been cited as the reason for cutting people off opioids. Read this White Paper by National District Attorneys Association. "This working group recommends that the CDC’s guidelines or a similar evidence-based guideline be adopted that would be standard around the country. Prosecutors should familiarize themselves with the CDC standards and advocate for their legislatures to adopt them in the irrespective states." Prescribing is down, 44%, and overdoses have skyrocketed. We need to get these rescinded if we have any hope of returning to individualized pain care. Please read this article written by AMA Opioid Task Force member and palliative care physician, Dr. Chad Kollas, called PROP's Disproportionate Influence on U.S. Opioid Policy, The Harms of Intended Consequences. The Guidelines are being updated and due to be released the end of 2022.This process was also done in a very shady manner with conflicts of interest.

Conclusion

Now that we've gone through the timeline of the creation and the concerns about the 2016 CDC Guidelines, if you're interested in hearing more about it, here is an excellent talk discussing this topic called "If 6 were 9: The CDC's Prescribing Guidelines and the Veil of Secrecy In this discussion, you'll hear the explanation about the Core Expert Group and how it was originally a secret. They discuss this in some detail, including information about the complaints filed by WLF (that we discussed earlier in this article). It is clear that the Core Expert Group (which includes PROP members Ballantyne and Franklin) was originally secretly working on the CDC Guidelines, and their names were not released until pressured to do so. As we mentioned earlier, when their names were released, they didn't properly disclose conflicts of interest such as already having been hired as expert witnesses in litigation.

The CDC explained the role of the Core Expert Group saying "CDC sought the input of experts to assist in reviewing the evidence and providing perspective on how CDC used the evidence to develop the draft recommendations. These experts, referred to as the “Core Expert Group” (CEG) included subject matter experts, representatives of primary care professional societies and state agencies, and an expert in guideline development methodology. CDC identified subject matter experts with high scientific standing; appropriate academic and clinical training and relevant clinical experience; and proven scientific excellence in opioid prescribing, substance use disorder treatment, and pain management. CDC identified representatives from leading primary care professional organizations to represent the audience for this guideline. Finally, CDC identified state agency officials and representatives based on their experience with state guidelines for opioid prescribing that were developed with multiple agency stakeholders and informed by scientific literature and existing evidence-based guidelines."

Interestingly, Andrew Kolodny has been quite outspoken about things he refers to as myths or conspiracy theories. He gave a presentation about this on Marcy 29, 2021., which was sponsored by Pharmed-Out, a group started by Adriane Fugh-Berman-also a PROP member. One of these myths, Kolodny claimed was that "CDC Opioid Guidelines was secretly written by PROP." Kolodny called this idea a conspiracy theory in a Justice article about our protest we sponsored at Brandeis, where he works. His said "One conspiracy theory Kolodny rejected is that he and PROP secretly wrote the CDC guideline calling for more cautious prescription of opioids."

Now that you have the facts, you can decide for yourself. Did PROP secretly assist with the 2016 Opioid Guidelines? We've given you evidence and explanations from experts who claim they did. Kolodny claims that's a conspiracy. What is your conclusion?

This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum.

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