Guidelines Written and Manipulated by Insiders

Professional Societies Should Abstain From Authorship of Guidelines and Disease Definition StatementsJohn P.A. Ioannidis – Oct 2018

Guidelines and other statements from professional societies have become increasingly influential. These documents shape how disease should be prevented and treated and what should come within the remit of medical care.

Changes in definition of illness can easily increase overnight by millions the number of people who deserve specialist care. This has been seen repeatedly in conditions as diverse as hypertension, diabetes mellitus, composite cardiovascular risk, depression, rheumatoid arthritis, or gastroesophageal reflux.

Similarly, changes in prevention or treatment options may escalate overnight the required cost of care by billions of dollars.

For example, if we accept PROP’s argument that we’re all addicted to our “heroin pills”, we’d all suddenly need “addiction-recovery programs/clinics/residential treatment centers/resorts” for our  “substance abuse” instead of “chronic pain”. 

Should the specialists of the respective field be the developers for such influential articles?

Many influential professional society documents are written exclusively by insiders. Joining such guideline panels is considered highly prestigious and allocation of writing positions is a unique means to advance an expert’s visibility and career within the specific medical specialty

Hundreds and thousands of designated guideline coauthors share in the society-wide power game across a large portfolio of guidelines and statements that improve, fine tune, or manipulate disease definition and management.

Tens of thousands of society members then cite these articles. This creates a massive, clan-like, group self-citation network.

Eight of the 15 most-cited articles across all science published in 2016 are medical guidelines, disease definitions, or disease statistics.

Most (not all) citation superstars get bulk citations by coauthoring guidelines, industry trials, and nonsystematic expert reviews.

Stardom is the interwoven product of guidelines and industry links (Table below). Industry trials nurture opinion leaders who then solidify their clan power authoring guidelines that serve the industry.

Name of Author Articles that have
>2000 citations
Most-Cited Article Citations Type
Guide-lines Industry Trials Other
Abraham, William T 3 3 0 5355 Guideline
Achenbach, Stephan 7 0 0 8094 Guideline
Adams, Cynthia D 5 0 0 4115 Guideline
Albert, Nancy M 0 0 0 1551 Guideline
Angiolillo, Dominick J 0 0 0 1167 Industry trial
Anker, Stephan D 3 0 0 8094 Guideline
Antman, Elliott M 15 3 1* 6604 Guideline
Atar, Dan 7 1 0 6314 Guideline
Avezum, Alvaro 0 2 1* 10 812 Other*
Fagard, Robert H 12 0 1* 8809 Guideline
Feldman, Ted E 1 1 0 3344 Industry trial
Filippatos, Gerasimos S 17 0 0 19 293 Guideline
Fonarow, Gregg C 4 0 0 6295 Guideline
Fox, Keith AA 3 0 0 6604 Guideline
Fuster, Valentin 14 0 2 9997 Guideline
Halperin, Jonathan 8 1 0 6368 Industry trial
Harrington, Robert A 0 1 0 4953 Industry trial
Hochman, Judith S 5 0 1 4115 Guideline
Hohnloser, Stefan H 2 2 0 5686 Industry trial
Holmes, David R 0 2 1 5134 Industry trial
Huber, Kurt 5 0 0 4987 Guideline
Hunt, Sharon Ann 9 0 0 5101 Guideline
Husted, Steen E 1 1 0 4953 Industry trial
Wallentin, Lars C 4 3 0 8952 Industry trial
Wang, Thomas J 0 0 1 2347 Other
Webb, John G 0 2 1 4509 Industry trial
White, Harvey D 2 0 2 6604 Guideline
Widimsky, Petr 12 0 0 8802 Guideline
Wijns, William 9 0 0 8094 Guideline
Windecker, Stephan 15 0 0 8094 Guideline
Wiviott, Stephen D 0 4 0 5495 Industry trial
Wood, David A 1 0 0 8132 Guideline

 

…these guidelines writing activities are particularly helpful in:

  • promoting the careers of specialists,
  • building recognizable and sustainable hierarchies of clan power,
  • boosting the impact factors of specialty journals and in
  • elevating the visibility of the sponsoring organizations and their conferences that massively promote society products to attendees.

However, do they improve medicine or do they homogenize biased, collective, and organized ignorance?

Well-conducted unbiased guidelines can be useful. However, most published guidelines have one or more red flags that either make them overtly unreliable or should at least raise suspicion among potential users.

The CDC opioid prescribing guideline is a case study of a guideline corrupted by the special-interests (addiction/recovery) of non-specialists (chronic pain). The opioid guideline raised every red flag mentioned [my comments are within square brackets like this]

The list of red flags includes

  • sponsoring by a professional society with substantial industry funding, [recovery industry, medication for addiction treatment]
  • conflicts of interest for chairs and panel members, [recovery and anti-addiction industries are interested in classifying more people as addicted and needing their product]
  • stacking,  [many guideline writers are PROP memebers]
  • insufficient methodologist involvement,  [used low quality evidence to generate “strong” recommendations]
  • inadequate external review, and [no time was given for external review]
  • noninclusion of nonphysicians, patients, and community members.  [no pain specialists or patients were included]

After mounting pressure from the 2011 Institute of Medicine report (Clinical Practice Guidelines We Can Trust. http://www.nationalacademies.org/hmd/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx),  several societies have succeeded in part to ameliorate the composition of their chosen panels to avoid florid financial conflicts and preclude direct industry funding in guideline development.

Prioritizing more the role of methodologists with expertise on evidence assessment and biostatistics and excluding content experts with conflicts (both financial and nonfinancial) is still uncommon across medical specialties.

Moreover, stacking of the panels with specialists who have overt preferences (even without overt conflicts) is more difficult to avoid

Some professional societies are behemoth financial enterprises. Efforts are made to minimize the influence of this funding.

However, securing objectivity is difficult when industry-manufactured interventions also procure much of the specialty income. Would a society advise its members to change jobs, if evidence proved their medical services a waste?

An overspecialized worldview is a major disadvantage in making sound recommendations. Specialists cannot compare their merchandise against the merchandise of other healthcare providers.

However, diverse specialists and societies compete for the same pie of healthcare resources.

Proponents of evidence-based medicine have recognized early the need to be critical toward guidelines.

Yet evidence-based medicine and professional societies have had a mutually suspicious relationship.

Grading of Recommendations Assessment, Development and Evaluation (http://ww.gradeworkinggroup.org and http://www.gradeworkinggroup.org/#pub) [more this in a future post], an important initiative on evidence appraisal, has tried to improve standards of guidelines and secure their objectivity and methodological strength

Especially when guideline authors choose to give strong recommendations on the basis of the week evidence, as we see in the cc guidelines

Guideline development also needs to consider the sociopolitical context.

The CDC guidelines are a special case of guidelines that bow to the demands of the cultural moment. Such biased guidelines would never have passed muster before the drug war focused on prescription opioids.

in the United States, the US Preventive Services Task Force is convened by the Agency for Health Research and Quality, but most powerful guidelines are issued by professional societies; these typically place less attention on cost containment. With skyrocketing healthcare expenditures, largely cost-unconscious guidelines make little sense.

This makes it sound like all these groups create “Guidelines to Generate the Most Profit for our Speciality”.

This is certainly what happened when anti-opioid zealots wrote a guideline to restrict opioids for pain management, blaming prescription opioids for the increasing numbers of opioid overdose deaths, even though those are usually from illicit fentanyl supplementation.

An alternative approach to the current situation would be to avoid having specialists assume any major role in guidelines that pertain to their own fields

Especially when they are writing guidelines outside of their field of expertise.

A good example is how the PROP folks, who are in the business of “drug rehab”, were writing a misdirected guideline restricting medication for pain patients. They can “see” opioids only as street drugs that are killing people, not as essential medications to alleviate human suffering.

A more realistic solution would be to have professional societies and their members abstain specifically from writing their own guidelines.

Another good idea that will never be implemented. There’s too much money at stake when some drug or device is “recommended” in one of these guidelines.

Instead of having mostly or exclusively specialists write the guidelines and occasional nonspecialists consult or comment on them, guidelines could be written by methodologists and patients, with content experts consulted and invited to comment. This approach has been proposed also for systematic reviews and meta-analyses that synthesize the evidence feeding into guideline development

What may seem crucially important to a field expert, may appear as minutiae to a less personally involved outsider.

Like the pain levels associated with the opioid use that’s being studied: Opioids Blamed for Consequences of Chronic Pain

Methodologists, patients, and different field specialists add to guideline teams more methodological rigor, patient-centeredness, and impartiality.

Professional societies should consider disentangling their specialists from guidelines and disease definitions and listen to what more impartial stakeholders think about their practices. Professional societies could still fund these efforts without their own experts authoring them.

Author: John P.A. Ioannidis MD, DSc, Stanford Prevention Research Center, Meta-Research Innovation Center at Stanford (METRICS), and Departments of Medicine, Health Research and Policy, Biomedical Data Science, and Statistics, Stanford University, CA. E-mail Address: jioannid@stanford.edu
(I posted a slightly different version of this in Oct 2018)

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