Q & A with CDC's STEVE MONROE

The CDC says it's found XMRV in prostate tissue but omits a crucial fact from its XMRV study on CFS patients

Below are the emailed answers to the questions I posed, by email, to Dr. Stephan Monroe, head of the CDC’s division of High Consequence Pathogens and Pathology.  More problematic than the non-answers to most of the questions on the CDC's present and future course for CFS research is that Monroe didn’t answer one of my questions on the CDC study.

That question was why did the CDC XMRV scientists omit in their paper that they had tested 20 samples that the Whittemore Peterson Institute found to be XMRV positive but didn't find any positives themselves?  Rather than answer it, Monroe simply ran up the next question—deleting its bullet point, thereby altering the questions as posed.  The CDC press office sent Monroe’s responses at 4:42 p.m. Friday, making a Friday follow-up unfeasible.  However, I’m resubmitting the question to Dr. Monroe and will report his reply on CFS Central.

Published in July, the CDC's study failed to find the retrovirus in any CFS patients the researchers tested, unlike the October 2009 Science study by the Whittemore Peterson Institute, the National Cancer Institute and the Cleveland Clinic that found 67 percent of CFS patients positive for XMRV, and the as-of-yet unpublished FDA/NIH study, which reportedly found 80 percent of CFS patients positive for the retrovirus.  The 2010 XMRV studies in Europe have failed to find the retrovirus in patients with either CFS or prostate cancer, the two diseases in which U.S. scientists have reported an XMRV link.

Here are the two questions on the CDC’s XMRV study that CFS Central submitted to Monroe:

• One of the CDC slides from this week’s Blood Safety Advisory Committee meeting showed that the CDC tested 20 samples from CFS patients that the Whittemore Peterson Institute found to be positive for XMRV. But, according to the slide, the CDC didn’t find any positives among those 20. Why was this piece of information— that the agency was unable to find positives in any of those 20 samples—left out of the CDC’s XMRV study? 

• Given that the CDC couldn’t confirm any of the Whittemore Peterson Institute’s 20 positive samples, why did the CDC scientists conducting the study conclude that the CDC’s methods were accurate? My sources have confirmed that three independent labs found these samples to be positive.

Here is the one question and answer back from Monroe.  I've highlighted his reply in red: 

• One of the CDC slides from this week’s Blood Safety Advisory Committee meeting showed that the CDC tested 20 samples from CFS patients that the Whittemore Peterson Institute found to be positive for XMRV.  But, according to the slide, the CDC didn’t find any positives among those 20.  Why was this piece of information— that the agency was unable to find positives in any of those 20 samples—left out of the CDC’s XMRV study?  Given that the CDC couldn’t confirm any of the Whittemore Peterson Institute’s 20 positive samples, why did the CDC scientists conducting the study conclude that the CDC’s methods were accurate?  My sources have confirmed that three independent labs found these samples to be positive. 

The information in the Retrovirology paper was consistent with the specifics of the study design. The results, and methodology, have been confirmed by three different independent laboratories.

Below are the rest of the questions and answers.  I've deleted the bullets because editing with bullets has proved too problematic in Blogger.

CFS Central: Who decides what research the CDC will pursue when it comes to Chronic Fatigue Syndrome?  Is it you, Dr. Monroe?  Is it Mr. Bill Switzer [principal investigator of the CDC XMRV study]?  Is it Dr. William Reeves [who has long held that CFS is a psychogenic illness and served as the former head of CFS research for 20 years until his transfer in February to Mental Health Surveillance]?  Is it Dr. Elizabeth Unger [acting head of CFS research]? Is it Dr. Thomas Frieden [the head of the CDC]?  Or is it from higher-ups in the HHS organization?  Who decides?

Dr. Steve Monroe: As there is still much to learn about CFS, CDC pursues a broad approach to research related to CFS. Decisions about the direction of CFS research are primarily guided by the insights gained from our continued scientific investigations. 

CFS Central: There are one million people with HIV/AIDS in the U.S. There are one million people with CFS in the U.S. (using the original 1994 Fukuda definition, not the Empirical definition).  The two diseases became widespread in the 1980s.  Some believe that the CDC pursued psychiatric research where CFS is concerned because the agency had its hands full with HIV and didn’t want to deal with another infectious epidemic in this country.  And now decades later, the agency remains in that mode and will continue in that mode.  Do you believe there’s validity to this argument? Why or why not?

SM:  The direction of CFS research has, and will continue to be, based on the best available scientific information and insights gained from our research and the findings of others.

CFS Central: On patient forums in the U.S. and abroad, many bloggers voice that they have no confidence in the CDC’s CFS policies and research.  Patients post on my blog, CFS Central, or address emails to me directly about their disappointment and outrage when it comes to the CDC.  One of the most important reasons CFS patients say that they have no confidence in the CDC is because the agency is pursuing a psychological cause, when much of the evidence, including 2,500 journal articles, points to a physiological cause. Is the CDC aware that many patients have no confidence in the agency when it comes to CFS research and policy?  Does the CDC care that patients have lost confidence in the agency?

SM:  CDC is deeply committed to reducing the morbidity and societal costs associated with CFS to enable a better quality of life for CFS patients. 

CFS Central: As a follow-up to this question, three CFS patients whom I interviewed in 1994 for an investigative article on the experimental [HIV and CFS] drug Ampligen called “The AIDS Drug No One Can Have” for Philadelphia magazine have since died of the disease, including one at age 43, and another at 59 from mantle cell lymphoma, a rare cancer in the general population but one that’s remarkably common in CFS patients. While some patients are dying and many others are bed-bound or house-bound and experiencing seizures, chronic infections, heart failure and short-term memory loss, the CDC is advocating cognitive therapy, antidepressants and “sleep hygiene.”

These mild interventions may help the 38 percent of patients  with major depression who were misdiagnosed as having CFS under the Empirical definition, according to studies done by Dr. Leonard Jason.  These mild interventions, however, aren’t helping most patients who meet the original 1994, including three CFS patients whom I interviewed in 1994 who have since died of the disease: Nancy Kaiser, Jerry Crum and LeAnne Hyneman.  Does the CDC see the disconnect in what the CDC is advocating—antidepressants, “sleep hygiene” and cognitive therapy—and what patients, at least those who meet the original 1994 Fukuda definition—are experiencing? What should the CDC do to help these patients now and over the next five years?

SM: Unfortunately, there are very few double-blind, placebo-controlled studies of interventions for alleviating symptoms of CFS. CDC recommends that people with CFS work with a healthcare professional to develop a treatment plan that is highly individualized and addresses their particular constellation of symptoms. 

CFS Central: At the first international workshop on XMRV in September, the CDC’s William Switzer will be speaking on assay development to test for XMRV.  Has he ever found XMRV in any blood or tissue from any patients? 

SM: CDC has detected XMRV in samples from patients with prostate cancer.  Preliminary results were reported at a scientific conference and the findings are being prepared for publication in a peer-reviewed journal.

CFS Central: As I understand it from the CDC website, the foster-care study, which will begin in late 2010 and continue to 2013, will explore whether foster children are at higher risk for CFS than the general population of youths. 

What happens if a child doesn’t want to participate? What rights do the children have?

Who is advocating for these children? 

Will there be a court-appointed lawyer for these children? 

Or will it be only the state? 

Or will it be the foster parents plus the state? 

On the CDC website, it discusses “pharmacologic intervention trials” with these children. What kind of medications will be used? 

SM: The 5-year strategic research plan for CFS was developed in 2009 and is periodically updated. The foster-care study is not included in the current plan. 

CFS Central:  Dr. William Reeves, who was transferred from the head of CFS research to senior adviser for Mental Health Surveillance in February, is still authoring studies on CFS. His latest, released last week, is “Personality Features and Personality Disorders in Chronic Fatigue Syndrome.”  Will Dr. Reeves continue to do research into CFS over the next few years? 

SM:  CFS research will continue to be inclusive of many scientists, including those within and outside the agency, whose expertise can help us learn more about this illness.

CFS Central: The CDC says the revised 1994 Fukuda definition is the equivalent of the original 1994 Fukuda (AKA Empirical) definition. The CDC has been using the revised definition in its studies since 2005.  The CDC reported in 2003 that the estimated occurrence of CFS under the original definition in the U.S. was .23 percent.  In 2007, the CDC reported the occurrence with the new definition broadened to 2.5 percent, a 10-fold increase.  Likewise, Dr. Leonard Jason’s studies found the same 10-fold increase in the new definition over the old definition.  In addition, Jason found that in contrast to the original definition, 38 percent of patients characterized as having CFS under the revised definition actually had “major depression.”  Therefore, how can these two definitions of CFS be equivalent? 

SM:  The CDC uses quantitative assessment tools to reproducibly identify those individuals who meet the 1994 international research case definition of CFS.  The defining symptoms and criteria for exclusion have not changed. 

CFS Central:  The CDC devised the 1988 name Chronic Fatigue Syndrome to describe the symptoms of patients in the outbreak on Lake Tahoe, Nevada, among other clusters. Many of those patients had neurological symptoms and all had physical symptoms.  In the CDC’s XMRV study, it says: 

“The Lombardi et al. study [AKA the October 2009 Science study that found XMRV in 67 percent of CFS patients] specifies that samples were selected from patients fulfilling the 1994 international CFS case definition and the 2003 Canadian Consensus Criteria for CFS/ME…. Most notably, the Canadian Criteria include multiple abnormal physical findings such as spatial instability, ataxia, muscle weakness and fasciculation, restless leg syndrome, and tender lymphadenopathy. The physical findings in persons meeting the Canadian definition may signal the presence of a neurologic condition considered exclusionary for CFS and thus the XMRV positive persons in the Lombardi et al. study may represent a clinical subset of patients.”

Dr. Monroe, not only the Canadian Criteria, but the 1994 Fukuda definition—listed on the CDC’s website as the agency’s official definition for the disease—includes multiple physical findings.  Indeed “tender lymph nodes” is listed as a diagnostic criterion for CFS on the CDC website.  In addition, “difficulty maintaining upright position, dizziness, balance problems or fainting” are neurological findings listed as common CFS symptoms on the CDC website. 

Is the CDC now saying that the patients who exhibit these physical and neurological symptoms may no longer meet the CDC definition of the Chronic Fatigue Syndrome?

If the patients with physical and neurological symptoms who meet the original 1994 Fukuda definition of Chronic Fatigue Syndrome don’t have CFS, what, then, do they have?

SM:  People with CFS generally experience a variety of symptoms, many of which are consistent with other health conditions. 

Similarly, people who do not meet the diagnostic criteria for CFS may experience symptoms that are common among people who suffer from this illness.

Dr. Mary Schweitzer contributed to this post.

 

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