(This month we introduce a new periodic feature, a guest editorial on a research topic of high interest to our readers. Kurt Rowley, PhD, shares his view about the formal and informal process of achieving consensus in his essay. In it he represents his own views and not those of any other organization.)
Kurt Rowley, Ph.D.
Is XMRV a New Paradigm for CFS?
The Role of the Scientific Consensus Process in the XMRV Debate
Kurt Rowley, Ph.D.
Independent Researcher & Writer
In Thomas Kuhn's famous book The Structure of Scientific Revolutions  the term 'paradigm shift' was defined as a change in the basic assumptions and explanations for an entire field of science. The discovery of XMRV by PCR in CFS patient samples reported by Lombardi et al  suggests a possible paradigm shift. If the correlation between CFS and XMRV could be validated to the satisfaction of the scientific community and a causal model identified and proven, this would be a game changer in the science of CFS. The XMRV discovery then would have a dramatic effect on not only treatment options but also on the politics of CFS. These points have all been well noted by CFS researchers, patients, and advocacy groups. However early confirmation attempts have failed to find XMRV in several patient groups [3-5], and many more studies are reportedly in progress. The debate over who is right has begun both among scientists and the CFS community. How will this all play out, how and when will patients have an answer about XMRV? Where will the answers come from? In order to address those questions, I believe some background in the scientific consensus process is helpful, as only the science, and not the political or medical needs of any faction in the debate, will determine the validity of the XMRV hypothesis for CFS.
The Change Process in Science
Change in consensus views can be a slow process in science as the initiators of change must do more than just provide new data, they must persist in defending their data as other researchers work through and challenge the initial findings. This can be a long and arduous struggle, and groups of scientists with conflicting viewpoints are known to be slow to reach consensus. As a result, patients following the XMRV debate should be prepared for the roller-coaster ride of the scientific consensus process. Noted Harvard Biologist Edward O. Wilson  says this about game-changing discoveries in science.
“First rule of the history of science: when a big, new, persuasive idea is proposed, an army of critics soon gathers and tries to tear it down. Such a reaction is unavoidable because, aggressive yet abiding by the rules of civil discourse, this is simply how scientists work. It is further true that, faced with adversity, proponents will harden their resolve and struggle to make the case more convincing. Being human, most scientists conform to the psychological Principle of Certainty, which says that when there is evidence both for and against a belief, the result is not a lessening but a heightening of conviction on both sides.” (The Diversity of Life, p.26)
The dialogue among CFS researchers, patients and advocates over the past six months since the XMRV announcement has certainly supported Wilson's observations. He then continues with discussion of the inevitable battle over a new finding.
“Rule number two: the new idea will, like mother earth, take some serious hits. If good it will survive, probably in modified form. If bad it will die ...” (ibid, p.26)
At the present time the CFS world finds itself in the midst of a rare scientific debate. Simply having new researchers interested in our illness has raised hope of progress. Is this the paradigm shift for CFS that we have all been waiting and hoping for, a discovery that will not only increase awareness of CFS but also lead to better medical and social support for those afflicted with this maligned and devastating illness? Or is the XMRV finding only one part of a complicated picture, is there more to this, will the hypothesis require modifications to survive as Wilson suggests? Is XMRV simply a passenger virus, yet another dead end in the search for a cure? Of course we would all like answers to those questions, and certainly in time we will have answers. But how much time? What type of consensus process will the researchers follow? To answer all of these questions about XMRV the CFS community should be prepared for the gradual process of building up a new research literature, as part of the scientific consensus process.
The Scientific Consensus Process
The scientific consensus process is simply a way to describe the reaching of a consensus view by a majority of scientists for a new research finding, in essence it is the construction of a new paradigm on a given topic or sometimes an entire field. The consensus process is not a formal part of the scientific method, but often researchers, businesses and government agencies rely on a consensus opinion for policy and funding decisions. Therefore the reaching of consensus can be critical for helping a field move in new directions. Although consensus building may be a somewhat informal process, there are also formalized approaches that might present a model for a consensus process for XMRV or CFS. One of the more important consensus processes is sponsored by The US National Institute of Health. The NIH maintains a formal medical consensus committee and hosts regular conferences of experts for specific consensus development topics .
NIH Consensus Process
The NIH consensus process begins with a determination of whether a sufficient research base exists for a consensus view. If the committee determines the research literature is too shallow for a consensus, they may instead convene a 'state-of-the-science' conference on the topic, which will follow the same basic process as a consensus conference. For both types of conferences, NIH will convene a conference of experts and follow approximately the following procedure.
A review of the research is prepared by an NIH Agency Center knowledgeable of the target medical question(s) under consideration. Usually this review is completed by the Agency for Healthcare Research and Quality, a division of the US Dept of Health and Human Services.
- Four or five primary questions are usually prepared to define the scope of a panel conference. As an example, in 2008 the NIH convened a consensus conference for the treatment of Hepatitis B virus . In this case six questions were prepared for the panel as follows:
- What is the current burden of Hepatitis B?
- What is the natural history of Hepatitis B?
- What are the benefits and risks of the current therapeutic options for Hepatitis B?
- Which persons with Hepatitis B should be treated?
- What measures are appropriate to monitor therapy and assess outcomes?
- What are the greatest needs and opportunities for future research on Hepatitis B?
- A panel of unbiased experts is convened. The experts on the panel must be knowledgeable about the issue but they may not have a direct scientific or financial conflict of interest respecting the topic, and none may be involved in advocacy. The panel will include researchers, healthcare practitioners, methodology experts and public representatives. To continue the Hep B example above, for that conference the 12 panelists were mostly professors of medicine from university medical research hospitals, with varying specialties.
- Outside invited experts provide data for the panel in an open, public session that includes questions and answers.
- The panel meets in a closed, executive session to determine a statement that responds to the primary questions.
- An additional public (plenary) session of the conference is held to present and discuss the panel's statement and allow for final public inputs. The panel then makes final adjustments to their consensus statement.
- The resulting consensus statement (or a 'state-of-the-science' statement if the topic did not qualify for a consensus statement) is disseminated to the healthcare and research community. The consensus statement then becomes the basis for eventual healthcare decisions (diagnostic tests and treatments). Eventually this entire process will likely be revisited as the knowledge base for the topic continues to be expanded. A summary of the 2008 Hep B consensus conference is presented in the Sidebar "An Example Consensus Process."
An Example Consensus Process
Hepatitis B is a complicated and potentially life-threatening persistent viral liver infection that afflicts 1.25 million Americans. In 2008 the NIH convened a consensus conference for the management of Hepatitis B. The stated objective of the conference was:
“To provide health care providers, patients, and the general public with a responsible assessment of currently available data on the management of hepatitis B. “ 
This conference is an example of a formal scientific consensus process for a complex viral-mediated illness. The participants in the conference included:
“A non-DHHS, nonadvocate 12-member panel representing the fields of hepatology and liver transplantation, gastroenterology, public health and epidemiology, infectious diseases, pathology, oncology, family practice, internal medicine, and a public representative. In addition, 22 experts from pertinent fields presented data to the panel and conference audience. “ 
The Hepatitis B consensus conference followed the standard NIH consensus process including presentations by experts and presentation of a systematic literature review. The panel then drafted a statement based on the evidence presented and circulated that statement on the final day of the conference to the public (plenary session) for comment. A revised final consensus statement was released at the end of the conference.
The consensus statement was empirically-based and included diagnostic markers and predictors of serious disease (cirrhosis or carcinoma of the liver); risk factors; the goals of therapy; discussion of the lack of evidence for many therapies; a discussion of approved therapies (seven therapies were presented that lead to proven improvement in virological, biochemical and histological parameters); and identification of areas of greatest need for research including studies of patient monitoring practices, longitudinal cohort studies, the need for more controlled trials, and effects of therapies on long-term outcomes. The panel made recommendations for routine screening of the public and discussed vaccination.
As an example for an eventual consensus surrounding a CFS virus, such as proposed in the XMRV Hypothesis, this recent consensus conference illustrates the type of strong research base needed, including research narrowly focused on the known lines of evidence for XMRV and CFS epidemiology, diagnostic markers, pathology, and treatments.
The First Issue: Building a Research Base
While research supporting the XMRV Hypothesis for CFS has not yet achieved sufficient momentum for a consensus opinion, the above formal process illustrates some of the primary issues that researchers, health-care practitioners, and the patient community can expect to see addressed in any future consensus process for XMRV, and perhaps any formalized consensus process for CFS. The need for a strong research base is self-evident in this process. The research base must be sufficiently strong to convince a panel of experts who have no conflicts of interest in the areas in question. And given that this must include experts in the methodologies involved, certainly the studies leading up to a consensus process must have established their methodological validity beyond any reasonable scientific doubt. Also, the patient community and public have a role in this process, helping to frame the context of the discussion, and providing inputs on the final wording of formal consensus statements.
As the first step in any regular consensus process is to review the literature base, for XMRV a new research literature must be constructed study by study. The number of studies required for a consensus view to be reached depends on the complexity of the research issue. In virology where testing processes can be complex, several different test designs can often be equally valid. As a result, a large number of studies may be required, to test alternate test assays and validate findings. Discovery of multiple ways to achieve the same results lowers the risk that some of the tests are producing false results (false negatives or false positives).
Each study in a new research area may produce new technical questions, requiring further research. Thus the literature may grow like a tree, with early concepts supporting many later discoveries. When there is a lack of agreement among multiple studies, then the tree may need to be pruned, then produce new branches. So it is with the development of a new literature, many studies may be required before a scientific consensus is even possible. In many previous cases in medicine hundreds and sometimes thousands of studies have been run before a sufficient literature base existed for consensus to be reached and widely accepted. This is particularly true for complex illnesses such as the Hepatitis B example. However, if there is significant agreement between most of the early studies, and methodological issues are easily managed, a smaller number of studies may be sufficient for an early consensus opinion to be reached in the scientific community.
Reasons For A Consensus Process for XMRV
Do we need a consensus process for XMRV in CFS? The history of retrovirus searches for other diseases suggests a consensus process will be important. Although the XMRV study reported by Lombardi et al.  was unusual for the CFS world, the idea of a retroviral explanation for disease has been explored repeatedly in many other conditions including multiple sclerosis, lupus and breast cancer, and even previously for CFS [9-14]. Proving retroviral involvement in these and other conditions has been very slow and deliberate, including hundreds of studies, with most retroviral hunts being eventual failures, often due to interference from endogenous retrovirus contaminants . However, there are a few exceptions. New studies of retroviral involvement in multiple sclerosis suggests the involvement of endogenous retrovirus forms , and there is new evidence of an MLV type endogenous retrovirus in some types of psoriasis . Therefore, consistent with Wilson's views quoted above, early views suggesting retroviral involvement in some of these illnesses have been modified over time. This illustrates how the challenge of proving retroviral infection as the cause of CFS, and suggests that given the early mixed findings, some type of consensus process may be very important in the search for answers about XMRV in CFS.
There are good reasons to pursue the long-term goal of a formal consensus process for XMRV in CFS, even if the initial studies all seem to agree on the major findings. The use of outside experts, as in the NIH approach to consensus-building, can help give credibility to the findings. Additionally, the NIH approach to including public comment may be particularly relevant in CFS, as the body of health-care providers and experts is so small. Public comment through blogging and online patient and researcher forums has already begun, producing rapid feedback to the CFS community. Therefore, the debate over XMRV is already underway and may be viewed as an informal attempt at consensus-building. But even with an informal consensus-building process, the NIH approach may be a useful model in the evolution of an informal and eventually a formal scientific consensus. Given that patients and researchers and advocacy groups are already following an informal consensus-building approach, some familiarity with the language and pathway of the scientific process as it relates to developing a common view of a topic should be helpful. The Sidebar "The Vocabulary of Consensus Building" presents a relevant vocabulary for discussion of the XMRV scientific consensus-building process.
The Vocabulary of Consensus-building
Here are a few useful terms often used in the process of reaching scientific consensus in medical or general scientific research. Some of these terms have been used in reports of the XMRV studies for CFS. These terms may not always be used properly, even by researchers, so the reader of research reports should understand the general principles and processes behind the terms:
Original Finding / Discovery: One or more scientifically controlled experiments that provides evidence for a novel hypothesis, or makes a new connection between disease processes and proposes correlation between causal or contributing factors in a given population. A good original finding study includes sufficient controls to ensure that each run of the test is 'working' correctly.
Replication Study: A study to determine the reliability of the methods used in the original discovery of a new finding. This is not generally considered a validation of the finding, but rather a verification that the procedures and methods work as claimed. This is also sometimes called a 'Verification Study'. By itself a replication study is not proof that a finding is valid, but only that an experiment can be repeated. The Lombardi et al XMRV study  included its own replication effort, a small number of samples run at two outside labs (Cleveland Clinic and the National Cancer Institute).
Validation Study: A study using different but accurate measures to validate that an original study found what it said it found. A validation study ideally should use alternate methods and measures, providing outside evidence for the original finding. In other words, for validation purposes outside labs should find the same effects or pathogens using different testing processes, different laboratories, and different cohort groups (that match the original criteria). The purpose of a validation study is to provide a 'second opinion' regarding whether the newly reported phenomenon really exists. In biological studies successful validation studies prove that the original finding was not due to measurement error, contamination, problems with reagents, problems with test designs, etc.
When validation studies repeatedly fail using measures that are capable of finding similar phenomenon, the original finding is seriously weakened. However, a failed validation study is not proof the original study is false. Often many different types of validation studies must be attempted before the original phenomenon is found in yet another way, and sometimes validation studies lead to a modification of the understanding of the original phenomenon.
Confirmation Study: This is often a nebulous term that can refer to either replication or validation studies. Sometimes this is used interchangeably with 'replication study.' Occasionally this term is used to denote a study that confirms just one aspect of a previous study.
Scientific Criticism & Debate: This is an essential part of developing a consensus view. While not a formal process, various journal articles, panel debates, blog discussions, and special conferences may all host discussions of the various datasets, including interpretation of the lines of evidence from various studies. Over time the original hypothesis is often refined due to acceptance or rejection of various criticisms in the scientific debate.
Causal Model Study (Theoretical and/or Evidence-based): At some point one or more theoretical or evidence-based studies must propose causal models. Eventually theoretical causal models must be tested through measurement of a known disease pathology in humans or animal models over time (a 'longitudinal' study). During these types of studies the researchers must take measurements that are capable of revealing whether the proposed causal model is accurate. Causal model theories and studies are critical parts of the eventual treatment studies. This is a particularly important type of study in the process of finding effective treatments.
Treatment Study: A treatment study tests proposed treatments under carefully-controlled conditions. Generally at least two groups are required, one for the primary treatment and another using placebo (if possible) and having no treatment. Ideally treatment studies are not conducted until a finding has been validated, early consensus reached, and causal models tested. Treatment studies should be blinded or double blinded although in some cases that is impractical, or even unethical (when treatments are deemed essential for patient welfare).
Epidemiological Study: After diagnostic testing has advanced sufficiently and early consensus is available regarding standardized testing procedures, a survey of the prevalence of the pathology in the general population is often conducted. Sometimes this happens early in the process, before testing is standardized, which can lead to debates over time if later testing shows a different incidence of the condition in the population.
Meta-analysis: A meta-analysis is the review of the detailed findings of a large number of prior studies on the same general topic. Usually a meta-analysis will survey all studies on a topic using a selective criteria, then choose a smaller number for close comparison of results. Sometimes a 'meta-statistic' is generated by averaging the research findings from all the qualifying studies to show a global effect size for a given treatment or other finding. Meta-analysis can be controversial due to the difficulty in evaluating subtle differences between multiple study designs in the group of studies selected.
Literature Review: Another type of review study is to review of all available literature on a given topic. Often during a review specific themes occurring in the literature are identified, and those recurring themes are sometimes presented as the findings of the review. A literature review is not as analytical as a meta-analysis, although 'counts' of studies supporting various positions may be included. Literature reviews are commonly used during formal consensus processes, to help panelists determine the underlying issues and identify the results of a preponderance of studies.
Consensus Statement/Opinion: This is usually the final step in a formalized scientific consensus process. A consensus statement (sometimes called a 'consensus opinion') is generally a document produced by a major research group, association or government agency in a given scientific field. This type of statement is ideally written by experts who are well-published on the topic and have conducted or extensively reviewed evaluation and/or meta-analysis studies. When produced for or by a government agency a consensus statement sometimes will have a strong influence on policy at all levels of practice and governance in the respective field. A consensus statement can guide practitioners and protect consumers.
Evaluation Study: A study that evaluates the experience of practitioners and sometimes challenges the assumptions of prior studies, including previous consensus statements. Occasionally the term 'evaluation study' is used in other ways, synonymous with meta-analysis. However, in most scientific fields 'evaluation studies' analyze outcomes, which in medicine means evaluating common patient results due to practitioners following a consensus opinion and applying recommended treatments over time.
An Example Consensus Process for XMRV
Based on my own experimental research experience, as well as the general scientific consensus process discussed above, including the NIH approach, I have outlined a hypothetical consensus process for the XMRV finding in CFS. Note that while this appears as a linear list, some elements of this type of hypothetical approach would be worked on simultaneously.
Breakthrough / Original Discovery of a new retroviral connection with CFS is reported by Lombardi et al .
- A few full replication studies that follow the WPI outlined process precisely, by outside labs unaffiliated with WPI, collecting new samples and using reagent mixes that follow the identical formulas used by Lombardi and his research team. This would prove that the WPI test is reliable (full replication may be underway but is not reported yet as of this writing).
- Multiple validation attempts that use different assays with equivalent or superior sensitivity to the Lombardi team. If a majority of early validation attempts agree with the original findings, meaning that the finding can be proven to exist in the target cohort by multiple measures at outside labs, then in most cases the original study would be considered validated by the scientific community. However, when early validation attempts fail, more detailed testing is usually required. In the case of the XMRV hypothesis, every one of the tests in the original study becomes a candidate for further outside validation studies. This includes the PCR, antibody, Western Blot, antigen, culture, EM and sequencing studies.
- Discussion of the findings of the validation studies by outside, unbiased experts must be complete and include analysis of known possible confounding factors, for example, possible cross-reactivities of antibodies, any evidence of false positives or false negatives by any of the studies (including the original finding), etc.
- Additional studies would be run as indicated including causal model studies, and eventually treatment studies. These would help determine whether XMRV is pathogenic or merely a passenger virus for CFS.
- Once sufficiently qualified studies have shown the presence (or lack) of XMRV in a reliable sample population, then an early review of literature or meta-analysis may be helpful.
- After literature is collected, discussions by outside experts are important, whether formal or informal.
- When the experts agree that the data supports a given conclusion about XMRV in CFS, an early consensus is reached and discussed by the public. Eventually a consensus statement would be created.
- If XMRV is a confirmed finding and a consensus view is reached, a standardized XMRV testing (and treatment if relevant) process whould be developed. This is an extension of the early consensus and allows future research to extend the original finding reliably.
- If XMRV is confirmed, and testing is standardized, large-scale epidemiological studies whould be conducted to determine the extent of XMRV infection in the CFS and also in the general population. This would provide the scientific basis and economic motivation for major policy decisions, including funding of large-scale research efforts.
- If XMRV is confirmed and testing standardized, multiple treatment approaches would be designed based on the various causal models, and then tested. During early treatment efforts new and important details about the XMRV hypothesis and/or causal models might be discovered, requiring re-consideration of earlier views and consensus statements.
- After early treatment trials, an additional consensus opinion about treatment would be formalized by a relevant agency or research association. This opinion then would be disseminated to any and all medical professionals who see patients with CFS.
- Over time doctors gain experience with the consensus diagnostics and treatment in clinical settings, evaluation studies would be conducted. This would allow the general consensus view to be updated, through publication of evaluation studies, further meta-analysis studies, and updated consensus opinion documents.
As should be apparent to the reader by now, the consensus process in science is slow and methodical. Given the complexity and uncertainty surrounding CFS, and the difficulties inherent in retrovirus searches, there is no reason to expect a rapid consensus about the XMRV hypothesis. Even if early studies all seem to point in the same direction, developing sufficient research literature for consensus about diagnostic and treatment methods could take many years and will require significant investment into multiple major research programs, allowing them to run the types of studies discussed here.
Regardless how the XMRV hypothesis turns out, additional details about CFS should be revealed as researchers work through the evidence. Those details can then contribute to an eventual consensus opinion about the causes of CFS. In my opinion, simply setting the goal of achieving a scientific consensus could foster significant change, helping researchers focus on an eventual paradigm shift for CFS. Even a preliminary consensus on a new research topic might foster change, raising awareness of the need for better social response to CFS patients, better government policies, more insurance coverage for CFS, and validated medical treatment options for patients. Therefore regardless of the outcome, working toward a scientific consensus about the XMRV hypothesis should be helpful at several levels in the quest for an eventual solution to CFS.
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About the Author
Kurt Rowley, Ph.D. is a CFS patient and independent researcher and writer. Kurt has worked as an adjunct University professor, systems consultant, and advanced training systems researcher for the Dept. of Defense. This article is based on both his experimental background as a human systems scientist (training applications), as well as independent study and interviews with a biomedical expert in retrovirology. Kurt holds a Ph.D. in Instructional Systems from Florida State University. These viewpoints are his alone and not the position of any outside organization.
Article updated April 9, 2010
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