ILADS conference 2010 - Dr. Marcus Conant

The Patient Advocate came to the ILADS conference in Jersey City, NJ to hear several talks. The ILADS organizers departed from past practices and invited five non-ILADS members to give presentations. In the PA’s estimation, this is in reaction to the changed ME/CFS topography since October 2009. There is no other explanation for it. Dr. Burrascano, a major lyme doctor, obviously engineered having these HIV/XMRV/Infection Disease doctors give presentations. Things are changing at the ILADS conference.

The Patient Advocate paid his conference fee to hear three presentations. Foremost among these was Dr. Marcus Conant, a relative newcomer to the ME/CFS field at the age of 73. If you want to learn more about Dr Conant look here. The Patient Advocate was not disappointed. This guy is great. We will be seeing more of Dr. Conant as XMRV moves relentlessly along.

Dr. Conant gave a talk entitled “Lessons - learned from HIV”. Dr. Conant, who was in the front lines of the AIDS diagnosis and treatment, is no shrinking violet. In the early 1980's he was one of a very few doctors in San Francisco who were willing to deal with doomed patients - often dead in weeks or months. Dr. Conant speaks his mind and he does not flinch. He began his talk by referencing the plague of 1348 and drew parallels, past and present, to it. He spoke in an impassioned fashion of the advocacy problems of trying to defeat ignorance, and how to move the agenda forward. His presentation had very humorous – even caustically absurd - moments to it, indicating the complex and emphathetic nature of his rangy personality. His central recommendation is to define the cause and to focus the research. In doing this Dr. Conant recommended not groveling, not fawning, not eliciting sympathy - just moving forward with clarity and determination. He encouraged activism and self-reliance regarding research, saying “Congress is your last resource, not the first”. Dr. Conant obviously does not get sidetracked or waste his time talking to non-helpful individuals. On the other hand he urges efforts toward inclusion - not fracturing - by trying to bring your adversaries to your side of the issues. The talk was deeply emotional and Dr. Conant, an unknown to most of the attendees, made a strong connection, as he was given a spontaneous standing ovation by the entire 200+ people in the hall.

The Patient Advocate has read on the internet that Dr. Conant has left his practice in San Francisco and come to New York because of an interest in this new retrovirus named XMRV. This was confirmed in conversation with him. The Patient Advocate surmises that Dr. Conant thinks that XMRV is a potential player in ME/CFS. Dr. Conant presents lyme and its affiliate, ME/CFS, as an infectious disease. With this in mind the Patient Advocate sees Dr. Conant as “an advocate for ME/CFS research and treatment”. At a minimum Dr. Conant’s expertise can be involved in upcoming treatment trials of antiretroviral drugs in ME/CFS patients.

The atmosphere of the ILADS conference was diametrically opposed to the CFSAC Science Day, which should be canceled. Much of this was due to the ILADS presentations of these four pro XMRV-related infectious disease physicians. There was none of the self-satisfied, politically-motivated vapors that filled the HHS conference room. The Patient Advocate saw Science Day as an attempt to put the breaks on further revelations about the connection of XMRV. The PA has to ask, why is this?

It becomes increasing obvious to the Patient Advocate that the FDA and others are really freaked out over the blood supply, and their responsibility for this. The FDA is going to be exposed to insurance claims coming from those who have been made sick through transfusions. This is a repeat of the AIDS epidemic. It is in their interest to string this out, until the Blood working group reports - and longer.

Other reasons for these delaying tactic were advanced to me by a knowledgeable and insightful friend:

“Where the money has not simply disappeared, or been poured down a rathole, it went to fund the amateur psychiatry of Stephen Straus or Bill Reeves. (Nobody seemed concerned at the time about them publishing work far outside their areas of expertise, except, as always Lenny Jason.) Avoiding exposure of this, with concomitant collateral damage to institutions, and future funding, is the first priority of those in charge. As second goal is to wrest control from WPI, so new research serves to provide more funding for the same institutions who screwed around, wasted time and treated funding for this subject as a kind of slush fund to cover miscellaneous expenses not covered by other allegations.

A third goal is to avoid committing the federal government to paying disability, or diagnostic and treatment costs, for another few million people. Current expenditures for HIV run around $1,000 per person per month -- for life. Since we are talking about another retrovirus and some of the same drugs, costs for treating ME/CFS are unlikely to be lower. Taking on a new $1,000,000,000/month liability was not in the Congressional plans for medical reform. Projected funding is already inadequate without this."

Yesterday was Conant, Montoya and Brewer. Today it is Mikovits.

Put this gal in charge - let her run the show.

The Patient Advocate listened to the public testimony at the CFSAC, many of which were inspired presentations.These testimonies are available on the internet. The ME/CFS patients and advocates are articulate, passionate and focused - each in a different way. Their collective testimony is the very best and strongest part of these meetings.

The Patient Advocate would like to highlight one testimony and make a suggestion. Let's get rid of all the people on the CFSAC committee and put Dr. Joan Grobstein in charge. Let her pick the new members. Dr. Grobstein, 11 years ill with ME/CFS, can run things from her couch in her home. The HHS can hire as many assistants as necessary - and they can be trained to deal with the new ME/CFS committee head in a manner that is conducive to her illness.

Watch how much clarity and direction that Dr. Grobstein packs into the measly five minutes that they give her.

CFSAC - Day 2

Dr. Grobstein is "Public comment - Speaker 2". Take the time to watch this. (Hopefully it will be posted soon on youtube for more easy access.)

The Patient Advocate also presents Dr. Grobstein's written 2010 testimony, which includes some important suggestions not included in her oral presentation. It is worth reading.

CFSAC Written Testimony October, 2010
Joan Grobstein, M.D.

I am a former neonatologist who had to retire from practice in 2000 due to illness. I have had ME/CFS since 1999. Before retiring I worked at the Neonatal Intensive Care Units of Children’s Hospital of Philadelphia and the Hospital of the University of Pennsylvania.

At this Committee’s meeting a year ago, I spoke about science and MyalgicEncephalomyelitis/Chronic Fatigue Syndrome, or ME/CFS. Specifically, I addressed the negative impact of the CDC’s “empirical” definition of CFS on scientific research into the causes of and potential treatments for ME/CFS. A resolution was passed at that meeting stating that the “CFSAC rejects the empirical definition” of CFS. Despite this recommendation, the CDC has published 3 papers in the past year using the “empirical” definition, including a paper which was unable to find any evidence of XMRV in blood from a cohort of patients with “empirically” defined CFS or in healthy controls, and another paper which discussed personality features and personality disorders in the same group of patients. At the last CFSAC meeting six months ago, Dr. Unger stated that she stood by the CDC’s estimate of the number of people affected by CFS in the United States, a number based on the “empirical” definition. There is no evidence that the CDC has paid any attention to the expressed views of this Committee about the “empirical” definition. Communication with the leadership of the CFS program at the CDC about the definition and other issues has been next to impossible for other professionals involved with ME/CFS as well.

At the same CFSAC meeting six months ago, I confined my comments to the

Committee’s charter, at the Committee’s request. At that meeting, an amendment was made to the Function section of the charter to include the statement “the current state of knowledge about the epidemiology, etiology(s), biomarkers, and risk factors relating to Chronic Fatigue Syndrome and identifying potential opportunities in these areas”. The words etiology(s) and biomarkers are not in the current version of the charter on the Committee’s website.

It must be frustrating to members of the Committee to have their recommendations ignored so blatantly. Taxpayers are spending a reported $130,000 each year on this Committee. We do expect effectiveness. I’m sure the dedicated experts who take the time to serve on the Committee also expect that their recommendations will be implemented, especially the ones that are revenue-neutral.

These are big issues: (1) that the Center for Disease Control of the United States of America is continuing to use a discredited definition in publications about CFS, and (2) that the charter of this Committee ignores the importance of a search for the cause of a disease that affects one million Americans and their family members. But today I want to move on from discussions of science and bureaucracy and talk about medicine.

Medicine is an applied science. Doctors take scientific facts and apply them in real world situations in order to improve the lives of real people. Part of the reality of medical practice is that sometimes doctors don’t yet have all the information we need to make a fully informed decision. And yet we must act. For example, a patient arrives in the emergency room in shock and we may not initially know why. But we have to act. We draw tests to clarify the cause of the patient’s low blood pressure at the same time that we start IV infusions to treat the low blood pressure. We may give antibiotics for the most likely infections before we know what the infection is, or even if infection is the cause of the patient’s condition. We act.

At the present time, there is no action for patients with ME/CFS. We know, for example, that many patients have low blood pressure and orthostatic intolerance, yet there is no recommendation to treat the low blood pressure, or even to do tests to establish its cause, in the CDC’s CFS “toolkit” for professionals. We know many patients have chronic viral infections, yet there is no recommendation to treat those infections. The CDC “tool kit” for CFS does not recommend testing for any infections. We know that many patients have abnormalities of immune function yet there is no recommendation to treat those abnormalities. We know a lot about Canadian Consensus Criteria-defined ME/CFS, but we don’t apply that knowledge to treat the disease.

In the past year we have learned a lot about MLVs, including XMRV, which present an attractive, although as yet unproven, hypothesis about the underlying cause of ME/CFS: a newly identified family of retroviruses may affect the immune system causing patients to be susceptible to various new or re-activated viral infections, as well as other possible infections, and perhaps themselves are causing much of the diverse symptomatology of the disease. It is time to act. Despite the incompleteness of our knowledge, we can treat. We must treat.

We know from past clinical trials that some patients improve, if not recover completely, when treated with antivirals appropriate for the viral infections that they have as demonstrated by appropriate lab tests. These clinical trials include, but are not limited to: enteroviruses, as shown by Dr. Chia, various herpesviruses, as shown by Dr. Lerner, and HHV-6, as shown by Dr.Montoya. Other infectious agents that have been shown to be common in ME/CFS patients include chlamydia, mycoplasma, and parvovirus, among others. I propose a randomized controlled trial of XMRV positive patients in which patients are randomly assigned to two groups: half the patients receive treatments for the infections that they are shown to have, and the other half receive treatments for the infections that they are shown to have and, in addition, are given the three antiretrovirals that have been shown by Dr. Singh to be active against XMRV: raltegravir, zidovudine and tenofovir. The primary outcome measure should be Karnofsky score, i.e., patient functionality. This is what patients care about: what they are able to do in their daily lives. Appropriate measures of the other, non-retroviral, infections should also be followed as secondary outcome measures. There is no currently accepted measure of XMRV activity, but it is not necessary to follow viral counts or to have an accepted immunological marker to establish efficacy of anti-retroviral treatment. Improved patient functionality or a more rapid eradication of other infectious agents will establish efficacy. Raltegravir, zidovudine and tenofovir have been used in thousands of AIDS patients, and their safety profiles are well understood.

I’m sure some will argue that there should be a third group in this trial, a group that receives no treatment for the infections that they have. I personally think that it would be unethical to include a group that receives no treatment. The word Tuskegee comes to mind. Although, ME/CFS patients were not deliberately infected, unlike the men in the Tuskegee experiment, it
is, in my opinion, unethical not to offer treatment to patients with known infections. However, I do realize that the current standard protocol for ME/CFS at this time is not to test for other infections, and, even if found, not to treat them. As a physician, this is unacceptable to me.

One could also argue that a third group should receive antiretrovirals alone. I am not opposed to this. I suspect all infections will need to be treated, but, since this is not documented, it is a reasonable question to research.

People with ME/CFS have been extremely patient with the medical and scientific community. However, our patience is not inexhaustible. Despite the cautionary mumbling of some physicians and scientists, people want to be treated for this serious, debilitating illness. We read the scientific papers on the internet. Despite our intermittent brain fog, we are not stupid. We will seek treatment. We will not wait for scientists to satisfy their intellects and establish who is “right”. If clinical trials are delayed too long it may be impossible to find untreated patients to enroll. At a certain point, it will also be impossible to claim therapeutic equipoise, because the mass of anecdotal evidence will be impossible to ignore.

Research cannot be done without funding, and funding for ME/CFS research at the NIH has been abysmally low. The NIH website gives an estimate of 5 million dollars, or about 5 dollars per patient, for 2010. ME/CFS received no ARRA funding for 2010. It is time to establish designated funding levels for ME/CFS.

I have spent my life working primarily as a clinician, not a researcher. I am therefore not particularly familiar with different types of grants or the mechanism of organizing randomized controlled trials with NIH funding. I have neither the time or the energy to get that information now, and it is not my job to do so. A request for proposals should come from the NIH for the necessary projects. More research dollars are urgently needed for this significantly underfunded, serious illness. It is time to act.

Many thanks to all the people who serve on this Committee and support this Committee. It is my hope that the future will soon be much brighter for people with ME/CFS.


References:

http://www.cdc.gov/cfs/toolkit/diagnosis.html

http://www.cdc.gov/cfs/toolkit/treatment.html

Switzer WM, Jia H, Hohn O, Zheng H, Tang S, Shankar A, Bannert N, Simmons G, Hendry RM, Falkenberg VR, Reeves WC, Heneine W., Absence of evidence of xenotropic murine leukemia virus-related virus infection in persons with chronic fatigue syndrome and healthy controls in the United States., Retrovirology. 2010 Jul 1;7:57.

Maloney EM, Boneva RS, Lin JM, Reeves WC, Chronic fatigue syndrome is associated with metabolic syndrome: results from a case-control study in Georgia. Metabolism. 2010 Sep;59(9):1351-7. Epub 2010 Jan 27.

Nater UM, Jones JF, Lin JM, Maloney E, Reeves WC, Heim C, Personality features and personality disorders in chronic fatigue
syndrome: a population-based study, Psychother Psychosom. 2010;79(5):312-8. Epub 2010 Jul 28.

John K. Chia, Andrew Y. Chia, Ribavirin and Interferon-a for the Treatment of Patients with Chronic Fatigue Syndrome Associated with Persistent Coxsackievirus B Infection: A Preliminary Observation, The Journal of Applied Research, Vol. 4, No. 2, 2004

A Martin Lerner, Safedin Beqaj, James T Fitzgerald, Ken Gill, Carol Gill, James Edington, Subset-directed antiviral treatment of 142 herpesvirus patients with chronic fatigue syndrome, Virus Adaptation and Treatment 2010:2 47–57

Singh IR, Gorzynski JE, Drobysheva D, Bassit L, Schinazi RF., Raltegravir is a potentinhibitor of XMRV, a virus implicated in prostate cancer and chronic fatigue syndrome., PLoS One. 2010 Apr 1;5(4):e9948 http://report.nih.gov/rcdc/categories/