A Former Federal Peer Reviewer’s Analysis of the Draft CDC Guidelines

A Former Federal Peer Reviewer’s Analysis of the Draft CDC Guidelines

In my former life prior to chronic pain and illness I had many important and fascinating jobs.  One was as a peer reviewer for the United States National Institutes for Health (NIH), Center for Mental Health Services (CMHS), and Substance Abuse and Mental Health Services (SAMHSA); and New York State’s Education Department, Office of Mental Health, and Office of Alcohol and Substance Abuse Services.  I reviewed multi-million dollar grants, provided consumer input to agencies, and served on publication committees and focus groups.  When the opportunity arose to comment on the draft “CDC Guideline for Prescribing Opioids for Chronic Pain”, I looked forward to reawakening my peer reviewer skills to objectively identify the strengths and weaknesses of the document.

Unfortunately, I found it near impossible and beyond frustrating to review this document in an objective manner.  The guideline is not organized like a typical guideline or tool kit.  It is nothing more than a literature review of the harms and risks of opioids.  It is not objective, therefore, I found it impossible to be objective.  It was biased which made me completely biased (in the other direction).  Reading this document left me scared—really scared.  It left me wondering what happened to the United States and to the rights of patients?  How could this be?  No consumer groups or chronic pain patients were included in their peer review or “experts” process.  A huge no no.  Here is the comment I posted on the CDC site (I omitted my introduction):

As a consumer and citizen, I request you halt further activity regarding these guidelines until a consumer board can be developed—one that is solely made up of chronic pain patients who have experienced primary care access issues to opioid medication.  I also request you conduct focus groups of chronic pain patients who are on opioids.  Only then will you have guidelines that serve the public, the primary care doctors, and the chronic pain patients.

It is imperative a section in the guideline be created detailing how adequate pain control is a fundamental right of every patient.  Point to the Joint Statement from 21 Health Organizations and the Drug Enforcement Administration, “Promoting pain relief and preventing abuse of pain medications: A critical balancing act” which states “Effective pain management is an integral and important aspect of quality medical care, and pain should be treated aggressively… Preventing drug abuse is an important societal goal, but it should not hinder patients’ ability to receive the care they need and deserve” (http://www.deadiversion.usdoj.gov/pubs/advisories/painrelief.pdf).  In addition, in this section provide a thorough review of the risks of untreated chronic pain, i.e. suicides, depression, unemployment, lower quality of life, etc.

Throughout this document it is mentioned there are no adequate long term studies that prove opioid medication is effective, leading the reader to believe opioid medication never helps patients long term, which is not true.  If you conducted a focus group of chronic pain patients you would understand the complexities of opioid pain management and long term effect.  It became clear to me this document was written in a biased manner when I read the “Effectiveness of Alternative Treatments” section.  It boasted these treatments effective under 6 months.  Nowhere in this document did I see a similar positive citation for opioid treatment for short term use though hundreds exist.  The writers excluded the fact these alternative treatments, like opioids, had no proven long term benefits.  Furthermore, the alternative pharmacological agents, i.e. gabapentin, SSRIs, NSAIDs, etc. are touted as excellent treatments with little to no risks.  The writers should have included information on the hundreds of possible side effects, some very serious, each of these drugs carry.  The risk of death, overdose and suicide is very real for some of these medications and literature citations stating as such was discluded.

The statistics in the Background section do not delineate criminal activity from actual chronic pain patients in a pain management type setting.  It also does not define whether in overdoses there were additional drugs or alcohol contributing to the overdose (polydrug overdose) and whether these overdoses were legitimate pain patients or illegally obtained prescriptions.  These guidelines should not include such statistics.  This is not a paper about criminal activity and misuse.  Only statistics for actual pain patients should be included.

Information must be included describing the fact primary care doctors may be the only opioid prescriber in their area as most pain management doctors no longer manage chronic pain with opioids and specialists refuse to prescribe.  Primary care doctors have by default become pain management doctors.  As such, pain patients should not be punished for this trend.  I did like that you included a few sentences encouraging physicians to be compassionate.  Please expand on this.  Most of us are treated like a nuisance and criminal.  Include information on the difference between physical dependence, tolerance, and addiction/misuse of opioid medications.

Information about actual pain conditions is slim, which is disconcerting.  The fact you include cataracts as a painful condition and not severely painful conditions like chronic pancreatitis, complex regional pain syndrome, shingles, back and spine issues, trigeminal neuralgia, endometriosis, adhesion pain, kidney stones, and more shows the lack of familiarity of the team of writers with true chronic pain populations.

Teach patients basic opioid safety—keeping the opioids locked away and out of teenagers’ hands.  Many patients are naïve to think their teens would never consider experimenting with their meds or visitors won’t snoop through a medicine cabinet.  Providing real-world information will prevent unnecessary overdoses NOT limiting chronic pain patients their pain medication.  Also, the naloxone section should be removed or limited to a sentence.  True chronic pain patients rarely experience overdose and should be dealt with by emergency personnel.

—End of comment—

The CDC is clearly not the appropriate agency to spearhead opioid prescribing guidelines.  They are good at authoring literature reviews on ebola and trying to find cures for diseases.  They are NOT equipped to publish guidelines of this manner.  This is not an epidemic and they are incapable of being objective.  A document like this must be objective and unbiased.

Brooke Keefer is a mom to three sons ages 28, 19, and 4 and has a 2 year old granddaughter. Brooke has a Bachelor of Science degree in Mathematics from the State University of New York at Albany. For over 15 years she worked as a not-for-profit director, lobbyist, advocate, and a grants writer, manager, and reviewer in the field of children’s mental health. Brooke suffers from several painful conditions—sphincter of oddi dysfunction (a defect in the pancreatic/biliary valves), chronic pancreatitis, and fluoroquinolone toxicity syndrome (long term adverse reaction of the nervous system to Levaquin). Though these have disabled her, she writes health articles, advocates for patient rights, and runs the Sphincter of Oddi Dysfunction Awareness and Education Network website, www.sodae.org.


3 Responses

  1. Amazing. No long term studies for chronic pain management and the annual influenza vaccine ritual either. What data there is seems better for pain than for the flu shot. You can quantity to some extent that when pain is controlled people can lead more productive lives and perform their own ADLs. According to this link there is little if any data to show that the flu shot prevents your from getting the flu. Much pressure is placed on pharmacists who do not administer enough flu vaccine.


    Flu Vaccine for All: A Critical Look at the Evidence
    Eric A. Biondi, MD, MS; C. Andrew Aligne, MD, MPH| December 21, 2015


    Does the evidence support the call for universal influenza vaccination?

    Response from Eric A. Biondi, MD, MS
    Assistant Professor of Pediatrics, Pediatric Hospitalist, University of Rochester Medical Center, Rochester, New York
    Response from C. Andrew Aligne, MD, MPH
    Assistant Professor of Pediatrics, Director of The Hoekelman Center, University of Rochester School of Medicine & Dentistry, Rochester, New York
    Influenza vaccination is a yearly ritual. The Advisory Committee on Immunization Practices (ACIP)[1] and the American Academy of Pediatrics (AAP)[2] recommend annual influenza vaccination for all healthy persons 6 months of age or older who are without contraindications.

    In an interview published in The Atlantic,[3] Tom Jefferson, head of the Vaccine Field Group at the Cochrane Database Collaboration (the world’s leading producer of evidence-based medical reviews), voiced serious reservations about the data supporting influenza vaccine recommendations, stating that “The vast majority of the studies [are] deeply flawed. Rubbish is not a scientific term, but I think it’s the term that applies.”

    A critical look at the evidence raises further questions about the flu shot recommendations. A 2012 Cochrane review[4] examining the efficacy of pediatric influenza vaccination noted that:

    …industry-funded studies were published in more prestigious journals and cited more than other studies, independent of methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favorable to [influenza] vaccines… reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies.

    And a 2014 Cochrane review[5] examining use of flu vaccine in healthy adults, including pregnant women, concluded that:

    [Influenza] vaccination shows no appreciable effect on working days lost or hospitalization.

    How Did We Get Here? The History of Influenza Vaccines

    If the data supporting widespread influenza vaccination are weak, then why do such organizations as the AAP, ACIP, and the US Centers for Disease Control and Prevention (CDC) support a widespread influenza vaccination policy? As is so often the case, to understand the present, we must examine the past.

    The 1918-1919 influenza pandemic, which occurred concurrently with World War I, killed approximately 50 million people around the world.[6] Despite little understanding of the etiology of the pandemic, physicians began administering various vaccines to soldiers in an attempt to stop the spread of the disease.

    During World War II, the US Army, eager to prevent a recurrence of 1918, supported influenza vaccine development efforts by such scientists as Jonas Salk.[7] This early flu vaccine was studied in the military in 1944 and found to decrease episodes of illness with a temperature above 99°F[8]—a promising result, but not evidence of an impact on serious clinical outcomes. A subsequent evaluation in 1947 found that “the incidence of disease was no different in vaccinated and unvaccinated individuals.”[9]

    In other words, by the late 1940s a vaccine for influenza had been developed, but there was no evidence that it prevented serious outcomes. Nevertheless, the vaccine was released for use in the general population.

    Then, in 1957, a new pandemic struck. The “Asian flu,” although not as severe as the 1918 pandemic, would eventually cause 1-2 million deaths worldwide.[10] A vaccine was manufactured, and millions of doses were administered in the United States in response.[11] The vaccine had no appreciable effect on the trend of the pandemic.[12]

    When Vaccination Became Routine

    Vaccine proponents felt that the failure of the vaccine was explained by the immunization campaign being too little, too late. As a result, in 1960, national health experts recommended, for the first time, routine annual vaccination, with emphasis on high-risk groups, including those over the age of 65 years and individuals with chronic illness.[13] By the early 1960s, routine influenza vaccination was generally adopted as a policy, with very little supporting evidence.

    After several years of this policy, the CDC decided to evaluate its impact. In 1964, Alexander Langmuir, MD, MPH, then the chief epidemiologist at the CDC, published a paper[13] that “reluctantly concluded that there is little progress to be reported. The severity of the epidemic of 1962-1963…demonstrates the failure to achieve effective control of excess mortality.” The paper questioned whether widespread influenza immunization “should be continued without better evidence to justify the major costs to the general public.” Despite this, annual vaccination campaigns were continued.

    In 1968, the CDC finally performed a randomized, double-blind trial[14] to examine the effect of vaccination on morbidity and mortality. The authors concluded that “Despite extensive use of influenza vaccines…attainment of [improved morbidity and mortality] has never been demonstrated.” Nevertheless, flu immunization continued.

    In 1976, H1N1 “swine flu” appeared, and a large-scale effort to immunize as many Americans as possible was launched.[15] However, the anticipated levels of disease did not appear, and an epidemic of paralytic Guillain-Barré syndrome in recipients of vaccine led to the program’s cancellation. An analysis in 1977[16] by the CDC concluded that influenza control had been “generally ineffective” and that statistically valid community trials were needed.

    In 1995, a major review from the US Food and Drug Administration acknowledged the ongoing “paucity of randomized trials” and warned about serious methodological flaws in many existing flu vaccine studies.[17]

    In 2000, the CDC performed a placebo-controlled trial and found that “vaccination [when compared to placebo] may not provide overall economic benefit in most years.”[18]

    Nonetheless, in 2004, the AAP recommended annual influenza immunization for young children, household contacts, and healthcare providers.[19]

    Vaccination coverage recommendations continued to expand, and now during every flu season, we watch commercials by retail pharmacies telling us about the importance of getting the flu shot. The fact that the AAP recommends “mandatory” flu vaccination for healthcare providers[20] means that eventually clinicians could be fired for not getting vaccinated.

    Summing Up the Data

    A 2012 systematic review and meta-analysis[21] examined the efficacy and effectiveness of licensed influenza vaccines in patients with confirmed influenza illness. The authors confirmed that the original “recommendation to vaccinate the elderly was made without data for vaccine efficacy or effectiveness.” The main message was that we need a better vaccine and better studies to demonstrate its effectiveness.

    Despite the lack of high-quality data supporting the value of the flu shot, widespread vaccination policy might still be reasonable if observational studies consistently showed a benefit. However, the observational studies cited by flu shot proponents are frequently flawed.[22-28] In many studies, relevant clinical outcomes are ignored in favor of immunogenicity (ie, the ability to elicit an antibody response). “Influenza-like illness” (ie, cold symptoms) is frequently measured instead of serious outcomes, such as pneumonia or death. When these more serious outcomes are examined, there is often a failure to control for healthy user bias—the propensity for healthier people to do such things as receive annual check-ups, eat healthier foods, and get the flu shot. So, although it’s true that people who get flu shots live longer, it may have nothing to do with actually getting the flu shot.

    A 2005 study of a 33-season, national data set attempted to reconcile the reduced all-cause morbidity and mortality found in some observational studies of influenza vaccination with the fact that “national influenza mortality rates among seniors increased in the 1980s and 1990s as the senior vaccination coverage quadrupled.”[29] In this study, the authors conclude that:

    “[Our] estimates, which provide the best available national estimates of the fraction of all winter deaths that are specifically attributable to influenza, show that the observational studies must overstate the mortality benefits of the vaccine…[even during two pandemic seasons] the estimated influenza-related mortality was probably very close to what would have occurred had no vaccine been available.”

    The rationale for flu immunization as a national health priority is that influenza is a disease with serious complications, such as pneumonia, hospitalization, and death.[5,13,28] If the reason for influenza vaccination is that flu is such a serious disease, then the relevant outcomes are whether vaccination improves morbidity and mortality from flu. However, after decades of vaccine use, it is hard to detect any public health impact. This is in stark contrast to other routine vaccinations, such as polio andHaemophilus influenzae type b, where introduction of the vaccine led to obvious decline of the disease.

    We are pediatricians, and we believe in childhood immunizations. Many vaccines have provided immense public health value. We simply question whether the policy of routine influenza vaccination has outpaced the data supporting its use.

    Influenza vaccination now supersedes many other priorities of public health (such as obesity, illiteracy, and high school dropout), and we question whether so much time, effort, and money should be dedicated to flu vaccination while these other national healthcare priorities remain on the back burner.

    Consult original link for references.

  2. An exceedingly well-written critique. This was a power grab by CDC. Addiction is not an infectious disease. You can’t catch it from watching a TV program, in which the actor on camera happens to suffer addiction. Because addiction is not an infectious disease, the investigative methods of epidemiology are unhelpful. Exposure is not causation.

    There are a number of shyster lawyers, emboldened by large settlements made in the 1990’s, that in exchange for vast sums of money paid to politicians, granted immunity to tobacco companies for falsely advertising that cigarettes could kill us but it was a risk worth taking. Those shyster lawyers would have the public believe that people in pain should be forced to suffer worse pain, so that they can engineer ways of bleeding money out of the healthcare system, along the same patterns as the 1990’s tobacco litigation.

    This bogus application of epidemiological principles to the non-contagious condition of addiction, provides those lawyers a valuable cover story. The PROP organization’s founders, whose illegal secret meetings with CDC staff to construct the studies that make it appear there is an opioid overdose “epidemic”, then constructed the policy documents to capitalize on the perceived epidemic in further illegal secret meetings, stand to make a small fortune in expert-witness fees, when the shyster lawyers call them to testify in court cases brought against the healthcare system.

    There is nothing remotely legitimate about the CDC’s illegal secret meetings with PROP. This was a conspiracy for unjust enrichment, that would swindle the taxpayers and has already killed patients. It demands criminal investigation and indictments, trials and imprisonments.

    One hundred million Americans with chronic pain, are being misled to fear the drugs that can rescue them from a pain crisis, because a few lawyers and crooks want money they do not deserve. All 100 million of us deserve to be angry and deserve retribution for the harm we’ve already suffered.

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