CDC Manipulated Data to Deceive

Durations of Opioid, Nonopioid Drug, and Behavioral Clinical Trials for Chronic Pain: Adequate or Inadequate?

This commentary presents the case that the CDC manipulated the data it used as a basis for its opioid prescribing guidelines.

By imposing an arbitrary non-standard constraint and excluding some studies that were included in earlier reports, the CDC created a different interpretation by using a different set of data.

Objectives. A recent US federal review and clinical guideline on opioids for chronic pain asserted that the literature contributes no evidence on efficacy because all trials had “inadequate duration.”

To explore the evidence, we examined durations of studies on opioid, nonopioid drug, and behavioral therapies for chronic pain.  

Methods. We retrieved Cochrane reviews of anticonvulsants, antidepressants, NSAIDs, opioids, or behavioral interventions for chronic pain. We also examined all opioid treatment studies retrieved for the federal evidence report but excluded due to “inadequate duration.”

Results. We graphed numbers of trials vs duration for the five treatments reviewed in the Cochrane Library, compared with durations of opioi12690d trials dropped from the federal evidence report. Most graphs were overdispersed Poisson distributions. Nearly all trials had active treatment durations of 12 weeks or less.

Conclusions. 

No common nonopioid treatment for chronic pain has been studied in aggregate over longer intervals of active treatment than opioids.

To dismiss trials as “inadequate” if their observation period is a year or less is inconsistent with current regulatory standards.

The literature on major drug and nondrug treatments for chronic pain reveals similarly shaped distributions across modalities.

Considering only duration of active treatment in efficacy or effectiveness trials, published evidence is no stronger for any major drug category or behavioral therapy than for opioids.

© 2016 American Academy of Pain Medicine.  

The full article details how the CDC’s conclusions are based on studies selected by using arbitrary non-standard standards of inclusion/exclusion.

Introduction

The use of opioids began in prehistory and is now standard practice in much of the world for the management of acute, chronic, and cancer-related pain.

Balancing the legitimate medical use of opioids for analgesia vs society-wide abuse, misuse, diversion, addiction, and mortality has become a major public health theme.

In March 2016, the US Centers for Disease Control and Prevention (CDC) published a guideline for prescribing opioids for chronic pain on the CDC website.

An important message communicated in the CDC guideline and related press releases is that the body of evidence addressing the effectiveness or efficacy of opioid therapy for outcomes of pain, function, or quality of life was insufficient to contribute any studies for their analyses.

In reaching this conclusion, the minimal duration for inclusion of a long-term study was set by the authors as “>1 year,” the same threshold employed by a 2014 evidence report that informed the 2016 CDC guideline.

The same consultant was the lead methodologist for both the 2014 evidence report and the 2016 CDC guideline.

However, earlier systematic reviews of the effectiveness or efficacy of opioids for chronic noncancer pain, co-authored by the same consultant and based upon the best available evidence, had identified dozens of clinical trials and systematic reviews of this topic.

Although their conclusions were guarded due to the poor overall quality of the literature, both earlier reviews concluded that selected, carefully monitored patients might benefit from such therapy.

Because the 2016 CDC literature review may be viewed as an update of the earlier reviews, it was striking that the 2016 review reached far more negative conclusions about the risk-benefit ratio for long-term opioid therapy than did the 2009 and 2010 reviews.

The 2014 evidence report and the 2016 CDC guideline relied upon the absence of studies of a year or greater duration to advance recommendations reflecting a low perceived benefit-to-risk ratio of opioid use for chronic pain.

And that is how they justified opioid prohibition.

We wondered whether a more standard approach to study retrieval and inclusion would confirm or refute this perception. Issues related to study inclusion also have implications for switching from or preferring one therapy to another

In addition, we examined studies cited in in the Cochrane Library of Systematic Reviews addressing opioids, antidepressants, anticonvulsants, NSAIDs, and behavioral treatments.

Our objective was to assess whether differences exist between the duration of treatment trials for chronic pain using each of these modalities, if analyzed without applying the one-year minimum threshold for inclusion newly introduced in the 2014 AHRQ and 2016 CDC reports.

Discussion

We conducted an investigation of the nature of the evidence for five frequently used interventions for chronic pain recommended in the 2016 CDC guideline for opioids in chronic pain:

pharmacotherapies (anticonvulsants, antidepressants, NSAIDs, and opioids) and nondrug, behavioral interventions

Our motivation for doing so was curiosity as to why the 2014 AHRQ evidence review and 2016 CDC guideline for the use of opioids in chronic pain declared that no suitable studies of opioid therapy qualified for inclusion.

Earlier systematic reviews in which one or more coauthors of the 2014 AHRQ evidence review and 2016 CDC guideline had participated, had identified sufficient studies to conclude, albeit guardedly, that selected patients carefully followed might benefit from such therapy.

Because the principal reason for the 2014 and 2016 documents’ exclusion of all retrieved effectiveness and efficacy trials was stated as “inadequate duration,” we focused our analysis upon the durations of active treatment in published clinical trials of all six modalities for chronic pain

Is it justified to state, as did the 2014 AHRQ evidence report and the 2016 CDC guideline, that there are no trials of opioid therapy whose duration is adequate to inform clinical guidelines on chronic pain treatment?

No.

Both the AHRQ and Cochrane opioid literatures have longer durations than corresponding literatures for anticonvulsant, antidepressant, NSAID, and behavioral therapies

Thus we found no evidence for the statement that currently available literature on opioid efficacy and effectiveness are inadequate to provide clinical guidance

Further, if a one-year minimum threshold for duration of active treatment were required to justify using any of the major typical therapies for chronic pain, then none of these nonopioid therapies could be recommended.

Insofar as strength of the recommendation to switch from an opioid to a nonopioid therapy was based upon the durations of active treatment in the corresponding clinical trials, the published literature is insufficient to recommend any switch from one modality to another.

Conclusion

To categorize analgesic trials as of “inadequate duration” if their observation period is a year or less is a major departure from existing standards for the duration of published treatment trials for chronic pain, the vast majority of which are 12 weeks or less.

However, basing therapeutic decision-making upon durations of published clinical efficacy or effectiveness trials does not support choosing any drug or nondrug therapy over another.

In fact, the opening words of the first recommendation of the CDC guideline (“Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain”) and the rationale presented directly below it make no mention of the overwhelmingly strong evidence for significant morbidity and mortality risk from the most likely nonopioid alternatives to opioid therapy for chronic pain: NSAIDs, coxibs, and acetaminophen.

The morbidity and mortality likely to result from an increased population-wide consumption as a consequence of following this recommendation are difficult to estimate but likely to be of the same magnitude as from opioids.

Safety concerns about these nonopioid alternatives are sufficiently compelling as to have prompted the US FDA to issue its latest of many NSAID safety warnings in a 2015 “Drug Safety Communication”.

In the future, as more population-based information becomes available to fill existing research gaps, clarifying the selection and maintenance of patients who may benefit from opioid therapy or other drug or nondrug interventions to control chronic pain must be a high priority.

See more on this problem: CDC Scientists Expose Agency Corruption


Addendum 12/5/16

At that time of this post, this full article was online and freely accessible, so I was dismayed to hear from a comment that as of Dec 5, the full article was behind a paywall.

I verified that my annotations from the full version of this article were collected on Nov 28 from the link at the top of this post: http://classic.painmedicine.oxfordjournals.org/content/17/11/2036.full

Now the price to see the full article is astonishingly high, making it virtually inaccessible to most of us:

A subscription (12 issues) to the “Pain Journal” where it was published costs $1047.00, but you may access the article for 1 day for US$40.00.

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36 thoughts on “CDC Manipulated Data to Deceive

    1. Zyp Czyk Post author

      …continued

      Scientific types can no longer tolerate the blatabt manipulation of drug-war data and feel compelled to speak up.

      Bravo to the authors who dared publish a challenge to the mighty CDC!

      Liked by 2 people

      Reply
  1. Lis

    The cynical pessimist in me thinks they purposely overlooked the risk of long-term NSAID use because, deep down, they just want us dead so we’re not burdens on the government and healthcare system anymore.

    Liked by 2 people

    Reply
    1. Zyp Czyk Post author

      I already have that very article scheduled for tomorrow’s post!

      These 2 articles belong together, showing the same problem (deceit) from two sides (statistician and researcher/employee). I’m so glad that scientific people are starting to push back against the outrageous anti-opioid claims of the CDC and PROP.

      Liked by 2 people

      Reply
  2. Pingback: CDC Scientists Expose Agency Corruption | EDS Info (Ehlers-Danlos Syndrome)

  3. david becker

    Zyp- you already know about how shoddy medical research tends to be- why should research on pain care be any better.
    The issue here, for me is for people to realize government and industry dont have what it takes to do what is right for people in pain. People in pain need to be more involved in government and health care- if they are to hope that pain care research and practice will imprive enough to meet their needs.

    Liked by 3 people

    Reply
      1. Red Lawhern

        The article is now behind a pay wall. I have sent the publishers a petition to make the article public as a public service, but I much doubt they will do so. Be aware, please that the article is copyrighted. Publishers may have objection to re-publication here without fee.

        Liked by 1 person

        Reply
        1. Zyp Czyk Post author

          This article was publicly available when I wrote this post with annotations from it. I’m so disappointed that this information is being “hidden”, though I agree researchers should be paid.

          However, when our tax dollars are used, the research should be publicly available. We (the public) pay for research that end up generating profit for private industry.

          Liked by 1 person

          Reply
          1. david becker

            That explains and justifies the importance of what you are doing for the pain community. As Jefferson wrote Confidance is everywhere the parent of despotism. We knw we can no longer afford to be confident in government or industry research or plans or policies. We are the 4th branch of gvernment that needs to keep them in check or they will continue their careless despotism.

            Liked by 2 people

            Reply
            1. Zyp Czyk Post author

              The facts coming out about corruption in the CDC frighten me. By twisting and misusing scientific facts themselves, this agency becomes a danger to the health of all citizens.

              Liked by 1 person

          1. Zyp Czyk Post author

            Thanks for letting me know!

            I looked recently and noticed it was available again – it was just inaccessible at the time I posted it. I’m glad this one is out there for all to see.

            Please show it to others too who you know still believe that what the CDC is doing is impartial science.

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  4. Angela M. Oddone LCSW, Resiliency Strategies LLC

    That’s true because we have a public health data-driven health care “system” where diagnostic & treatment decisions when paid for by Medicare, Medicaid & insurance are controlled by that data & what’s decided to be “evidenced-based” care. Doctors & other health care professionals whose practices are insurance-driven lack clinical professional autonomy that’s based on public health data rather than patient-centered care.

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    1. david becker

      Agreed. Its interesting that a calculus of probabilities and chances- Bayesian decisionmaking is used for treatment of individuals when it is not designed for individuals.. And the irony is that “personalized” medicine- based on omics of the individual still suffers from the same failure to address the individual. The Problem Oriented Medical Record would be a cnceptual improvement. But let us face the facts- medicine is medicine and doctors focused. They will not take the time to carefully and comprehensively assess the needs of any one individual-and all too often disrespect the views of individuals seeking their care.

      Liked by 1 person

      Reply
      1. W H

        “let us face the facts- medicine is medicine and doctors focused.”
        As a physician, I am tired of hearing this oft-stated, largely erroneous, and frankly offensive statement. More accurately today, so much of medicine is corporate profit-focused. Physicians who give a hoot for their patients are subject to another facet of that same pressure the frustrated patients feel. Your doctor is simply either fearful of running up against a police-state regulatory system (eg: DEA, or FDA or CDC “guidelines”) carefully crafted by the owners of that system (the major insurors, Big Pharma, the giant hospital chains), or he/she works for them and had better stay in line and be guided by the 28 year-old MBA in finance, or he/she is out on his/her butt. “It is difficult to get a person to understand the truth when their salary depends on them not understanding the truth.” Look around a bit. There is a large number of doctors frustrated, hamstrung and fearful of the same system that screws the patient for the profit of the Power Elite. They own your legislators in Washington and in every state capital as well.

        Liked by 1 person

        Reply
        1. Zyp Czyk Post author

          I agree completely. Doctors are NOT the problem. Money is the problem, and the financial incentive to standardize everything and replace doctors with algorithms. This is completely irrational, as has been acknowledged outright by the push toward “Precision Medicine” which tailors treatment to individual differences.

          https://edsinfo.wordpress.com/2016/06/06/professional-managers-bleeding-the-healthcare-system-dry/
          https://edsinfo.wordpress.com/2016/10/04/this-version-of-health-care-is-purely-a-business/
          https://edsinfo.wordpress.com/2016/06/01/employed-physicians-contracts-may-threaten-their-patients/
          https://edsinfo.wordpress.com/2016/07/16/million-dollar-plus-exec-compensation-at-non-profit-hospitals/

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        2. jane

          I appreciate your comments. I will say as a trained ethicist, that in this situation, although most people do understand the incredible pressure on doctors, they have an ethical obligation to follow the Hippocratic Oath they took. Since the doctors lobby is huge, many patients and their families are honestly wondering why doctors have not, as a large group, stood up loudly and used their lobbying power to protect the patients like my daughter who are dying from refusal of pain treatment and have been SEVERELY abused by doctors, ERs, hospitals and EMTS, all who refuse to treat the unliveable pain and agony and instead, verbally abuse patients, while not even giving them care based on their own protocols. I had abdominal surgery in 2015 and my surgeon left and went on vacation thinking the OR post op team would manage my pain. I woke up in AGONY and the nurses refused mine and my husbands numerous pleadings for a surgeon to see me. ( I should have been admitted it turns out) I was related within hours and spent 3 days in agony, unable to get into bed and was vomiting continuously. I need up in the ER again. Im terrified now of hospitals and medical personnel. The hospital CYA’d themselves and despite 2 escalations of complaints” Found themselves not guilty” of refusing me proper pain relief even though my SAT levels were dangerously low ( I couldn’t breathe post operatively from being UNDER medicated for pain) I worked in hospice and chronic care and told them I was in a level 9 pain. They didnt care. My poor daughter: We have to fly her OUT of the state to her old PCP in CA to save her life and give her fentanyl patches. 45 days of unending agony has destroyed us all. We are forever traumatized and still , 2 years later, cannot find ONE PCP, ONE PM doctor or ONE ER to help her here in CO. We wonder when she will have more Central pain attacks and die. She had a baby last year as well………. will we be taking care of him when his poor disabled 25 year old mother dies from refusal of treatment????

          Liked by 1 person

          Reply
          1. Zyp Czyk Post author

            Yes, I’m very disappointed that the AMA didn’t push back against this intrusion of government into the exam room for the sake of their own professionalism and also how they ceded control over their patients’ pain control. When these guidelines came down, they just rolled over and piddled, like frightened puppies.

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  5. Denise

    Zyp- Thanks for another great article & ALL you do on behalf of the millions of chronic pain patients everywhere! I have a question for you in the midst of this ongoing circus regarding the CDC & the Guidelines for opioid prescribing. Isn’t the FDA the Governmental Dept who should be the one in charge of the regulating & dosing limits on opioid medications to begin with?? And if so, WHY on earth is the FDA allowing the CDC to overstep it’s boundaries, like this especially, with all this talk of not only weak & tainted data in addition to the corruption now surfacing from within its own staff!

    Liked by 1 person

    Reply
    1. Red Lawhern

      I have referenced this article in a piece published today by the American Council on Science and Health, titled “CDC Opioid Malfeasance – Guess Who Is Getting Hurt”. This paper has potential to reach a readership of over 100,000. The paper that Zyp discovered is figuratively a smoking gun which establishes that the CDC writers of the opioid standards violated their own protocols by cherry-picking studies to support a false reading of the medical evidence on effectiveness and risks of opioid prescription. See http://acsh.org/news/2016/12/05/opioid-malfeasance-cdc-guess-who-getting-hurt-10531

      Liked by 2 people

      Reply
      1. Zyp Czyk Post author

        Thank you, Red!! I’ll be blogging about that article very soon.

        It’s gratifying to see the real truth seeping out of the secrecy veiling the CDC’s unscientific workings. Thanks to people like you, these stories will find their way into more mainstream media – not just pain patient blogs.

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    2. Angela M. Oddone LCSW, Resiliency Strategies LLC

      The Federal government has been serving corporations (big pharma, Phoenix House, etc.) over people/citizens/voters for quite some time. Citizens United just sealed the deal. That’s why FDA & other HHS agencies fail to speak out. The FDA sold out to big pharma long ago. Federal emoloyees fear retaliation if they speak out. Check out the documentary “The War on Whistleblowers.” I think it might still be on YouTube for free. It’s eye opening. The bottom line is corporations have succeeded in buying our government. We’re seeing the completion of a corporate coup d’etat. Look for more privatization in health care for sure.

      Liked by 1 person

      Reply
      1. david becker

        The government is prejudiced toward market fundamentalism- and is partial to producers and not consumers. And when it comes to pain care governments position is unjustifiable for market failure is nly too evident with missing markets, underdeveloped markets andterrible externalities. Government suffers from moral and mental blindness in this regards- as do their friends in the marketplace.

        Like

        Reply
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  13. Candi S WI

    This war on “opioids” is actually a war on chronic incurable diseases. A war on chronic pain disease patients who benefit from opioid medications. Medications that enable millions of Americans relief of chronic debilitating pain associated with these diseases.
    The fiction, widespread hysteria and distorted truths about this “opioid epidemic”, is killing legitimate chronic pain disease patients who use their medications responsibly.
    100 million Americans have one or more chronic incurable pain Disease. As the CDC, DEA, FDA, Medicaid and Medicare, and numerous other government agencies, are blaming Doctors for the over prescribing of opioid medication. NOBODY, is looking at or reading the statistics from chronic pain disease patients. How about NOT addressing these drugs as dangerous and addictive. When all else fails: physical therapy, exercise, over the counter medications and numerous injections etc, we chronic pain disease patients, are left with one option to help us cope, opioid pain medication. Lets address this medication as lifesaving and medically necessary for the million of Americans with chronic diseases. Chronic pain is a disease. Chronic pain disease patients are now the epidemic. The addiction rate of chronic pain disease patients is .02-.6 %. We do not misuse or abuse our medications.
    No other disease medication is scrutinized. We, as patients, are being denied, dismissed, overlooked and discriminated against, by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications. Our Dr’s are afraid to treat us humanely and adequately. We have a disease that medication is readily accessible and beneficial to us and we are being denied. We, pain patients, are being discriminated against, due to people who abuse illegal heroin and illegal fentanyl. This is a direct hunt for Doctors who prescribe life saving medication, for pain disease patients, that benefit from them. We have our privacy invaded, we no longer are able to have doctor/patient confidentiality. We now have insurance agencies, pharmacists, and other government agencies in our physicians offices, monitoring, prosecuting and policing our physicians.
    Though the statistics show a reduction in, opioid medications distributed, due to the CDC guidelines, death rates of overdoses from illegal opioids is rising.
    The specific causes of deaths also needs to be closely investigated. The opioid in the person’s system needs to be specified. Was it an illegal opioid, was it opioid medication specifically for that person, was there other drugs or alcohol involved? These statistics need to come out. These Government agencies do not want that information out, due to the fact that this “opioid epidemic”, would then be debunked.
    Let’s put the shoe on the other foot. Restricting or taking away our medications is like FORCING people who do not want this medication to take it. One day those against these medications will need them but they will be denied.
    We have a chronic disease. We want to be able to take care of our homes, our children, our selves, as much as possible, but without access to these life saving medications, we are unable to do so. We want to live, not just exist in pain 24/7.
    We need the government agencies to look at the real statistics, not the hand picked. These agencies are not physicians. They are trying to doctor us, patients, without a medical license. They are also trying to police our physicians. This is a war on a disease, medications, physicians and patients.
    We chronic pain disease patients need help. All the headlines, topics and stories on how opioids are bad and how people are abusing, misusing, overdosing, becoming addicted or dying from them. We need to look at the good they do and how they help our disease of chronic pain and the million of Americans who use them for some relief.
    The government needs to put the focus on illegal drugs coming into, being manufactured and distributed in this country, illegal fentanyl, illegal heroin, methamphetamine, cocaine and all other ILLEGAL DRUGS. Not the legally prescribed and medically necessary medications we patients need. We chronic pain disease patients need help, but we are helpless due to the government and government agencies. There is stigma, scrutiny and discrimination against us due to a category of medications we desperately need and benefit from, opioid medications.

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      Actually, I believe the main problem is that addiction isn’t being treated. Just trying to remove access to opioids (or other psychoactive drugs) doesn’t solve anything for anyone.

      Both addicts & pain patients need proper treatment. Focus on the people, not the substance!

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