Are Singh and Bateman Afraid of Proof of Principle Studies? Why?

“Our findings do not support an association between CFS and MLV-related viruses including XMRV and off-label use of antiretrovirals for the treatment of CFS does not seem justified at present.^”

^{-Dr. Ila Singh et al}

^{http://jvi.asm.org/cgi/content/abstract/JVI.00693-11v1}

^{After yet another study purporting to look for HGRVs such as MLVs and XMRV in ME/CFS patients but not following the exacting protocols of the original Lombardi et al study published in Science in 2009, nor those of the Alter/Lo study, the scientific conclusions of this study were predictable. The question still unanswered: When will researchers actually replicate the original study they seek to refute? And how can they, in scientific honesty and in good conscience, keep claiming to refute the study they refuse to actually replicate?}

^{And why add the editorial and unscientific comment attempting to discourage proof of principle studies? Is it about your patent applications, Dr. Singh?  From April 7, 2011 publication of her patent application:}

Title:

COMPOSITIONS AND METHODS FOR TREATING MLV-INFECTION, AND PREVENTING AND TREATING MLV-INITIATED DISEASES

Abstract:

Compositions and methods for inhibiting infection by XMRV or other MLV are disclosed. Also disclosed are methods for treating cancers resulting from infection by XMRV or other MLV, and for preventing such cancers. The anti- XMRV/anti-MLV compounds are predominantly integrase inhibitors, such as globoidnan A, L-000870812, S/GSK1349572, S/GSK1265744, Raltegravir and Elvitegravir, and also reverse transcriptase inhibitors AZT, tenofovir, and tenofovir DF. The compounds are also useful for treating chronic fatigue syndrome or other diseases with neuroimmune symptoms resulting from an infection by XMRV or other MLV. The compositions can also include other therapeutic agents known for treating prostate cancer, breast cancer, lymphomas, and leukemias, such as anti-androgenic agents, radioisotopes, and conventional anti-cancer compounds.

^{What Is “Proof of Principle”?}

^{See my earlier post: http://biomedicalmecfs.blogspot.com/2011/01/xmrv-proof-of-principle-studies.html}

^{In short, proof of principle studies, in the case of ME/CFS, would treat a cohort of patients who have been diagnosed with the illness by competent physicians and, preferably, who have tested positive for XMRV and/or other MLVs/HGRVs, with antiretrviral drug “cocktails”, perhaps in combination with other antiviral drugs to treat some of the co-infections such as those found by Dr. Montoya at Stanford. Another possible combination might include Ampligen.}

^{Dr. Singh herself has already found that at least 3 of the ARVs considered safe enough for HIV/AIDS patients, are effective against XMRV in the lab. Is she afraid that ME/CFS patients will use this information to justify trying to save their own lives by trying those drugs? And if they come to harm, that they would blame her? That doesn't seem logical to me, but I'm trying to understand why she would come out against proof of principle trials and I can't think of any scientific reason. It has been obvious since the mid-1980s, from the brain scans of the Incline Village patients, that the disease is associated with a retrovirus and/or virus(es). Not knowing specifically which RV or virus is no excuse for not treating for them.}

^{She and her collaborators seem to have bought, or wish to promote, the establishment stereotype of ME/CFS patients as a bunch of uninformed fanatics, so desperate that they would harm themselves for no reasonable chance of improvement. Surely she is aware that any patient who tries “off-label” use of antiretroviral drugs to treat the retroviruses associated with ME/CFS are not getting these drugs without the support and assistance of their own physicians. Why accentuate the “risks”, which are acceptable for other patients with retrovirus-associated diseases such as AIDS, without acknowledging the potential benefits? The risks are well known and physicians are doing the tests and surveillance required, so they don't need to be cautioned by researchers. The cautions appended to this study create a murky atmosphere and lead to suspicions of ulterior motives by this group of researchers. At best, it only serves to support the CDC's mantra, there are no tests for ME/CFS, there are no treatments for ME/CFS. Chant three times for maximum inculcation.}

“...off-label use of antiretrovirals for the treatment of CFS does not seem justified at present.^”

^{-Dr. Ila Singh et al}

^Justified?

^{What a curious assessment and what an arrogant, giant leap of logic!}

^{Why should Dr. Singh, the Drs. Light and Bateman make this judgment for others who are equally, or better informed than they are on the subject?}

^{Does anyone actually think that Dr. Snyderman and Dr. Deckoff-Jones should have just accepted their “fate” while waiting for researchers to do the “science” in their own sweet time? See their takes on the subject on her blog: http://treatingxmrv.blogspot.com/}

^{Each of these physicians with personal knowledge of the disease, the research and the potential treatments and side effects came to the conclusion that intervention was and is “justified”. Each has experienced substantial improvement in quality of life. It may even be that Dr. Snyderman has saved his own life, or at least prolonged his survival.}

^{As a cancer researcher, Dr. Singh ought to be more cognizant than she appears to be of the association of all known retroviruses with immune dysfunction and rare cancers, which turn out to be not so rare in ME/CFS patients. This is just one of many similarities that ME/CFS shares with HIV/AIDS. Surely Dr. Singh is not so young or so uninformed that she does not know that early drug interventions were trialed in AIDS before all researchers were convinced that HIV was the cause.}

^{To tell ME/CFS patients like Dr. Snyderman and Deckoff-Jones, and all the rest of us, that we should keep experiencing disease progression, the deterioration in quality of life, the impoverishment, degradation and premature death that comes with having a debilitating illness that has not been dealt with in a scientific, ethical or pragmatic manner for so many decades is incomprehensible to me. It seems like an underhanded swipe at the translational medicine and research of those scientists and physicians at WPI and the University of Nevada, who are collaborating to save lives right now, not in some distant future when “consensus” has arrived.}

<sup>I have to wonder if she would have said the same thing to my mother when she was pressured by her doctor to trial tamoxifen, an unproven cancer drug that patients had to pay for themselves since it was deemed “experimental”. Why is it OK for AIDS patients and cancer patients to try “experimental” or “off-label” drugs when the alternatives can only offer an earlier death or further disease progression?

Why is Singh's co-author, Dr. Bateman, getting involved in the pay-for-treatment study of Ampligen which could be described, in part, as an antiretroviral drug? Who but ME/CFS patients will participate in this study? Hemispherx has said that those who test postive for XMRV have a higher success rate than those who don't.</sup>

^{The conclusions of this study might as well have been “...treatment of CFS does not seem justified at present.”}

^{The only “advancement” of science this study provided: more proof that no one will find the retroviruses WPI found unless and until they actually REPLICATE the study. Just going through the motions without actually REPLICATING the original study does nothing but waste money and, more importantly for me, time.}

^{The ethical, moral and scientific questions I pose to Dr. Singh and her collaborators are these: Why didn't you replicate the WPI study? Why do you engage in this double standard of attitude and treatment of ME/CFS patients vs. those with other diseases?}

State of the Knowledge Workshop ME/CFS Research April 7-8, 2011

State of the Knowledge Workshop
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research
April 7-8, 2011

Building 31, Conference Room 6C10
National Institutes of Health, Bethesda, MD  20892

This NIH workshop will bring together subject experts who will discuss multiple aspects of ME/CFS, including epidemiology, etiology, pathophysiology, diagnosis and treatment.  The workshop panelists will identify gaps in knowledge and opportunities for new biomedical research. 

Workshop Agenda, Online Registration, and Visitor/Hotel Information.  This workshop is open to the public. Please note that attendance is limited, and we encourage registration for those attending in person. For those who are unable to attend, the workshop will be available via NIH VideoCasting (http://videocast.nih.gov/) both during and after the event. 

Individuals with disabilities who need reasonable accommodation should indicate your needs on the registration or contact Infinity Conference Group at (703) 925-9455 ext. 0 or by e-mail at icg@infinityconferences.com. Sign Language Interpreters can be provided if requested.

This workshop is sponsored by the NIH Office of Research on Women’s Health in collaboration with the Trans-NIH ME/CFS Research Working Group.

Preliminary Agenda  DAY 1 – THURSDAY, APRIL 7  8:00 – 8:05 WELCOMING  8:05 – 8:15 OPENING  8:15 – 9:15 PLENARY TALKS  9:15 – 10:45 INFECTIOUS DISEASES  10:45 – 11:00 Morning Break  11:00 – 12:15 SYSTEMS BIOLOGY  12:15 – 1:00 Lunch (On your own)  1:00 – 2:00 IMMUNOLOGY  2:00 – 3:15 NEUROLOGY  3:15 – 3:30 Afternoon Break  3:30 – 5:00 EXERCISE PHYSIOLOGY AND ENERGY METABOLISM  DAY 2 – FRIDAY, APRIL 8  8:00 – 8:15 Reconvene  8:15 – 10:20 DIAGNOSIS AND BIOMARKERS  10:20 – 10:35 Morning Break  10:35 – 12:30 TREATMENT  12:30 – 1:30 Lunch (On your own)  1:30 – 2:30 COMMUNICATION OUTREACH  2:30 – 2:45 Afternoon Break  2:45 – 4:45 SUMMARY AND CONCLUSIONS  4:45 – 5:00 CLOSING

Sponsored by The Office of Research on Women's Health, National Institutes of Health (NIH) In collaboration with The Trans-NIH ME/CFS Research Working Group

If you have any questions, call (703) 925-9455 ext. 0 or e-mail icg@infinityconferences.com **************************************************************************** Online registration needs to be done by March 30. https://www.infinityconferences.com/InfiniBase/Registration/Reg.aspx?ptguid=bf17bb1b-7df8-4ba5-b7a0-ba91edfbd56c Let us hope that the session called EXERCISE PHYSIOLOGY AND ENERGY METABOLISM will have real biomedical information, not the psychobabble from the UnumProvident controlled psychopuppets from UK and the CDC. More info: http://orwh.od.nih.gov/CSF%202011/newsEvents.htm

Reeves Strikes Again - "It's Your Uterus, Dearie!"

Just when you thought the nightmare on Clifton Rd (location of the CDC) was over, Bill Reeves rises from the crypt to once again assert "It's your uterus, dearie."

A 19th Century medical myth, "hysteria" or the case of the wandering womb, has once against metamorphosed into what passes for research in the pretzel-logic and sham research tradition into "CFS" perpetuated by Bill Reeves and Co.

Gynecological History in Chronic Fatigue Syndrome:
A Population-Based Case-Control StudyRoumiana S. Boneva, M.D., Ph.D.,1 Elizabeth M. Maloney, M.S., Dr.P.H.,1 Jin-Mann Lin, Ph.D.,1James F. Jones, M.D.,1 Friedrich Wieser, M.D.,2 Urs M. Nater, Ph.D.,1,3Christine M. Heim, Ph.D.,4 and William C. Reeves, M.D., M.Sc


In the January 2011 issue of "Women's Health" (what else? we all know CFS is a woman's disease, right? Let's just ignore the fact that Dr. David Bell's practice finds 50 % of his ME/CFS patients are male and many of them are or were children when they first became ill.) Reeves and the usual suspects like Jones, Heim and Nater once again get it backwards.

They note, or just try to infer, that women with a lot of gynecological problems are more likely to have "CFS". Therefore, those gynecological "abnormalities" must be causing the "CFS", right? It couldn't be that what causes "CFS", like retroviral and viral infections and maybe bacterial co-morbidities could be causing those gynecological "abnormalities", could it?

Reaching back into the good old days when not many had yet noticed that the CDC's Viral and Chronic Infectious Diseases Branch had nothing biomedical to say about ME/CFS, Reeves cites papers from as far back as 1986 to support his latest paper's thesis, but includes not a mention of the recent biomedical research that is so pertinent.

 Reminds me of the map makers of long ago who believed that if you sailed far enough west you would fall off the edge of the Earth.

  He can't resist citing himself and his co-conspirators a few times as well. He's still hawking his psychological pseudo-theories in the footnotes:


44. Heim C, Wagner D, Maloney E, et al. Early adverse experience
and risk for chronic fatigue syndrome: Results from
a population-based study. Arch Gen Psychiatry 2006;63:
1258–1266.
45. Heim C, Nater UM, Maloney E, Boneva R, Jones JF, Reeves
WC. Childhood trauma and risk for chronic fatigue syndrome:
Association with neuroendocrine dysfunction. Arch
Gen Psychiatry 2009;66:72–80.

I'm sure it's comforting to the parents of children with ME/CFS to know that the CDC has determined they must have sexually abused their children and/or traumatized them in some way, to cause them to get the disease. Let's just ignore the family studies that show that children with ME/CFS often have parents, especially mothers, who either have ME/CFS or MS and the high rate of autism occurring in those same families. Let's just ignore all the viral, retroviral and infectious disease research that has accumulated over the last 25 years. Let's pretend that the 2009 Science paper never happened. Prescient as always, Bill predicted the CDC wouldn't find XMRV, and by golly, they didn't.

I'm still waiting for the CDC and/or Reeves, maybe with the sponsorship of CAA, to do a study of "CFS" in the boys sexually abused by Catholic priests over the decades. Seems like the perfect cohort for testing the sexual abuse hypothesis, doesn't it? Maybe Suzanne Vernon could help design the study.

There is nothing scientific about this whole paper, although its writers go to great length to give the impression that there is. They wedge the idea of mental illness into it by noting a third group of mainly depressives with "insufficient fatigue", into the narrative and in the illustrative figures, but then go on to say that this group was not considered in the "analysis". Then why mention it at all? I guess they just couldn't warp the science enough to find a way to include this group but tried to infer "guilt by association" somehow.

"Participants who met some but not all three criteria
for CFS constituted the ISF (insufficient fatigue), a separate group that is not
included in the current analysis."

Sort of like saying "In our study of pumpkins and gourds, we wanted to include some carrots, since they are orange, ("some, but not all the criteria"), but they didn't meet the criteria of being produced by a vine. We're including the attributes of the carrots just in case. But we didn't include those "participants" in our "analysis".

Their "cohort" was the notoriously unrepresentative Wichita cohort, obtained by the Publisher's Clearing House method: random digit dialing to households with telephone numbers in the current phone book database. They couldn't just contact the physicians who have patients with the disease, could they? No, those doctors are "contaminated", according to the CDC. This "contamination" is of the mental type, of course, in that they follow Sir William Osler's recommendation that they listen to the patients in order to diagnose. He liked to say, "He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all." His best-known saying was "Listen to your patient, he is telling you the diagnosis," which emphasises the importance of taking a good history.

Instead they take their standards from the disability insurance industry which has a policy of declaring that doctors who actually see the patients can't possibly know more about them than their own on-staff doctors who only go through the files, never seeing the patient, but finding that the patient couldn't possibly have the disease since there are no "objective" findings.

Then they try to turn the weakness in their cohort selection into a positive, using the CDC's trademark pretzel-logic:

"A major strength of the study is its design as a population-based case-control
study, avoiding referral biases inherent to studies of CFS from
referral clinics and the use of convenience controls."

Uhhhhh..., right! Random digit dialing must be better than "referral biases" (what?) from "referral clinics". In other words, we're not going to let any patients with a bona fide diagnosis from a clinician who knows how to diagnose ME/CFS into any of OUR studies! Likewise, those damned "convenience controls". Our random digit dialing is inherently better!

There's one thing the CDC has been very effective at: keeping the disease "mysterious" and making sure that none of the tests, biological markers or treatments ever get tried and tested. Keeping them forever "experimental" means that no insurance, including Medicare, has to do the testing that would prove the biomedical abnormalities present. With no "objective" evidence of disease, the disability and health insurance companies usually don't have to pay up, neither for disability nor for treatment. Those who have the money to outlast them can win. It took Samuel Salomaa 8 years in court to win his disability claim against Life Insurance Company of America, despite having the support of CFS specialists, including Dr. Natelson. It took Clinton Merrick 13 years in the courts to win his CFS disability claim and punitive damages against the disability insurance companies that tried to rip him off. The infamous UnumProvident was a part of that case. Those who don't have the money to defend themselves are simply hung out to dry.

In addition to their bogus cohort, this study uses their bogus criteria/definition of the "syndrome". They say they used the "International Definition" and the "empirical definition". Both were invented to suit their purposes, with the input of the likes of Michael Sharpe from the psycho-quacks of UK. "International" actually means that the US and the UK got together and agreed on the best way to define the disease out of existence: by diluting it to include the depressed and the simply "fatigued".

Then they add a lot of boilerplate statistical mumbo jumbo, much ado signifying nothing. They make a big deal out of the "CFS cohort" having "significantly more" pregnancies that the controls. Actually the "CFS" women had 2.8 pregnancies each and the controls had 2. Why is having nearly 3 pregnancies "significantly more" than two? They go on to state that they didn't ask (it was all done with questionnaires) how many births, miscarriages, abortions or stillbirths any of these women had, essentially admitting that the number of pregnancies couldn't be interpreted to mean anything at all. Yet it was "significant".

None of their other "findings" were significant either, but they ended up concluding:

"In conclusion, the higher prevalence of gynecological conditions
and surgeries in women with CFS highlights the importance
of evaluating gynecological health in these patients." (Uhhhhh....wouldn't evaluating gynecological health be important for all women?)

Translation: "Give us some more money and we'll do some more bogus research" without ever seeing any patients who have the disease and without taking into consideration the Emory study that found XMRV in the reproductive organs of the female and male monkeys. It's not like they never heard of Emory. That's where they've done a lot of their "mind-body" "research", using money from the Chronic Viral and Infectious Disease Branch to not investigate the chronic viral and infectious aspects of the disease.

A little CYA and pseudo-humility amongst the hubris:

"Our findings are derived from a population-based study in
which most patients with CFS reported gradual onset of
symptoms and may not apply to women with sudden onset or
postinfectious fatigue. Participants in this study were somewhat
older than in other studies.8 A different participation
rate between cases and controls may also have introduced
selection bias."

 
Translation: After all that random dialing, they could only find 36 women with "CFS" in Wichita!

And where at CDC are the studies on "postinfectious fatigue"? Or "sudden onset", for that matter? No, no, no. No viral or infectious diseases here, folks. Just pre- and post-menopausal women who were sexually abused as children and are stressed out about it. That and their raging hormones, or hormones that don't rage enough.

Where are the studies of men who have this disease? Children? Maybe not enough men and children were home when the random digit dialing took place, hmmm?

The frosting on this rancid cake:
"We acknowledge Elizabeth Unger, M.D., and Daisy Lee of
the CDC and Suzanne Vernon, Ph.D., formerly of the CDC,
for their contributions to the study protocol."

About a year ago, in a public forum, Cort Johnson told me Suzanne Vernon, currently the "scientific advisor" for CAA, and Bill Reeves "hate each other" in one of Cort's many defenses and apologies for behavior disloyal and counter to the interests of ME/CFS patients by the CAA. I don't remember if that was before or after his editorial saying the CDC wasn't up to anything nefarious - they honestly believe they're right. Right! I didn't believe it then and I don't believe it now. I used to think Vernon was a "Trojan horse" in the CAA but now I realize she and Kim McCleary are in tandem harness, pulling in the same direction, in perfect harmony.

Now aren't all you guys with this disease happy to know your gynecological history is probably what caused your disease? Aren't we all glad that Bill Reeves, no longer at CDC, is still producing such wonderful research with the limited funds available?

Please, Bill, sail west and fall off the edge of the Earth. Take Suzanne, Kim and Elizabeth with you.

"... cheaper than chimpanzees." Experimenting on mental patients & prisoners.

"In widely covered congressional hearings in 1973, pharmaceutical industry officials acknowledged they were using prisoners for testing because they were cheaper than chimpanzees." - AP story on Yahoo

"ATLANTA – Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates. Such experiments included giving hepatitis to mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in Maryland, and injecting cancer cells into chronically ill people at a New York hospital." - Michael Stobbe

If you think the psychiatric industry's push to have ME/CFS categorized as "medically unexplained" and a "psychosomatic" illness has no meaning for you who have this neuroimmune disease or care about someone who has it, think again. Institutionalized mental patients are, for all intents and purposes, prisoners. They become prisoners of mental institutions without the due process of law that those who are accused of crimes are afforded under the law.

In some US states, psychologists and psychiatrists are advocating a change in laws that now require two doctors to sign legal papers authorizing the commitment "for observation" of those who might be "a danger to themselves or others". They want to be able to commit people on the signature of one doctor.

Imagine that you or your loved one goes to a physician who diagnoses the ME/CFS patient as depressed or as somatizing. Imagine the prescription for exercise, talk therapy, drugs. If the patient, knowing her own body and her own experience, refuses this "treatment", she could be committed to a mental institution to enforce "compliance", "for her own good". The death of Sophia Mirza is one of the results of this policy already in force in UK. The men in white coats came to her door, with her mother present and objecting, forced their way in and took her away against her will. It could happen in the US.

Mental hospitals do not have the capacity or the knowledge needed to treat a neuroimmune disease and the multisystem dysfunctions that result from it. To the person with a hammer, everything looks like a nail. ME/CFS patients committed to a mental institution can expect to be pounded into the perceived holes dreamed up for them by psychiatrists, psychologists and physicians who collude with them.

Once committed, patients no longer have the right to "refuse" treatment or even give consent to treatment. They can be, and are, injected with psychotropic drugs against their wishes. And if the psychiatric industry so declares it, the "treatment" for ME/CFS can be GET, CBT and antidepressant and antianxiety drugs. These drugs have generally proven unhelpful for those with ME/CFS. They can have side effects that are permanent. As for exercise as a "treatment", ME/CFS patients are already doing all they can physically, so urging them to increase physical activity is unnecessary and can be damaging.

And what if "resistant" mental illness "requires" ECT - electro-convulsive "therapy"? You thought that went out in the era of "One Flew Over the Cuckoo's Nest"? No, it comes back around in fashion every so often. It's the treatment of last resort in the minds of some psychiatrists, rather like sending the patients to a psychiatrist was in the first place, for the physician who couldn't correctly diagnose ME/CFS in the first place. For the ME/CFS patient already experiencing seizures, being convulsed by electricity as a "treatment" for a CNS that is already fragile could be the last shock it could not withstand.

Research by scientists and clinicians who actually treat biomedical ME/CFS, not the watered-down version invented by the CDC and the NHS in UK, but the Canadian Consensus definition of CFS, has shown that exercise and talk therapy are no more "treatments" for this neuroimmune disease than they would be for other diseases, such as HIV/AIDS, polio, MS, malaria or hepatitis C.

Of course, any sufferer of debilitating disease might benefit from counseling on how to cope, but coping strategies are not treatments for the disease itself.  Any researcher or clinician who acquiesces to this emotional and intellectual manipulation is colluding with the school of propaganda that seeks to inculcate the disinformation that "illness beliefs", present stress from previous childhood abuse, or any other thoughts cause or sustain this disease.

If you don't apply this standard to other neuroimmune diseases, you can't apply it to ME/CFS. Period.

The race is on. Will biomedical researchers be able to prove, create and market a reliable test for the biomarkers already found for ME/CFS before the psychiatric cabal can change the involuntary commitment law and the DSM to suit themselves?

This is why it is such a big deal when the likes of Kim McCleary, Suzanne Vernon and CJ do and say things that chip away at the real biomedical research and those researchers. Delaying and sabotaging biomedical research give the psychiatric lobby, supported by the disability insurance lobby, time to get their plans into place.

For a glimpse into how disability insurers such as Unum operate, read the case of a man disabled with CFS and how many years of harassment, appeals and fighting it took for him to win. Read the judge's list of 13 illegal tactics several insurers and reinsurers regularly use to avoid paying legitimate disability claims. Mr. Merrick was a millionaire and had the means to fight and to survive the fight, unlike the vast majority of those who have already been impoverished by the disease before they try to get disability benefits.

It would shortcut the process a great deal to just have those with ME/CFS labeled as mentally ill, to prescribe GET, CBT and cheap drugs and to then put them away if they don't or can't comply.

Sophia Mirza.....it could happen here. And Kim McCleary regrets that CBT and GET are "not available treatments" in the US, no thanks to her and her cronies.

My Letter to the SEP: Dr McClure's Appointment Is Inappropriate

Subtitle: Sending the Fox to Guard the Hen House.

I sent this letter:

To:

kathleen.sebelius@hhs.gov,francis.collins@nih.gov,dennis.mangan@nih.gov,toni.scarpa@nih.gov,hoshawb@csr.nih.gov,AskDrH@ostp.gov

Cc:

m.mcclure@imperial.ac.uk

I will post any responses I get.

******************************** 

 

My fellow Americans, Myra McClure, Ph.D. has been appointed to membership on the Center For Scientific Review, Special Emphasis Panel, ZRG1 CFSH80 2/22/2011-2/23/2011 meeting. This appointment is inappropriate for the following reasons: 　 1 - From the NIH Scientific Center For Review: How Scientists are Selected for Study Section Service : "Fairness and objectivity are the most important criteria for a reviewer." Dr. McClure, of UK, has demonstrated that she is neither fair nor objective when it comes to research on the neuroimmune disease "CFS", better known as ME/CFS.   She has personally denigrated the discoverers of XMRV, a novel retrovirus recently found in ME/CFS patients and she has declared she is "1000% sure there is no XMRV in UK". Other researchers have found it in abundance all over UK & Europe.   After she was criticized for poor specimen selection, poor cohort selection and poor laboratory procedures, she declared "I wash my hands of any further CFS research." And: "Nothing on God’s Earth could persuade me to do more research on CFS." 2 - She received her 14 year old lab specimens, in the one XMRV/CFS study she did, from a UK psychiatrist who has made a career out of promoting his idea that "CFS" is a mental disorder. Using pretzel-logic, he distorts every biomedical finding in this area of research into an "illness belief". 3 - She has since toured the world in a speaking campaign promoting the unsupported contention that all CFS reseach into XMRV, and the related MLVs that Drs. Alter & Lo of NIH/FDA and Dr. Komaroff of Harvard found in CFS patients, (concluding that their work supports the findings of the original work at WPI) - that all this work is merely "lab contamination". The WPI researchers are former NCI researchers with decades of experience in HIV and cancer research and are therefore knowledgable about lab contamination possibilities, so it is clear that this in nothing more than a "marketing" approach to squelch more research into the viral and retroviral cause(s) of ME/CFS. I contend that it is the mission of Dr. McClure to see to it that there is no more research into the viral/retroviral cause(s) of ME/CFS. More specifically, she will vote against funding any research by WPI and anyone else who wishes to research viral causes in CFS, unless they have her agenda - to disprove viral involvement. Background information: The Department of Works and Pensions in UK (equivalent to the SSA in the US) is under the influence of the giant disability insurance company, Unum (also called UnumProvident), the biggest seller of disability insurance in the US and the UK. This insurance company has a history of malfeasance in the denial of insureds' disability claims. Since about 2007, it has been advising DWP in UK on how to deny disability claims most effectively. It has targeted such diseases as ME/CFS, fibromyalgia, Gulf War Syndrome and MCS for claims denial. It has a "five year plan", ending in 2012, to "re-educate" those doctors who find in favor of the disabled, in UK.To that end, NHS has suspended or harassed doctors who treat ME/CFS biomedically. There, the National Health Services deny patients with CFS any biomedical testing or treatments, in favor of counceling and drugs for "mental health". In the US, Unum has an ongoing campaign to harass doctors who see and treat CFS patients so that doctors will drop those patients. See the judge's comments in this 2008 case of a CFS patient denied and harassed by Unum: http://scholar.google.com/scholar_case?case=3736254457285322723&hl=en&as_sdt=2&as_vis=1&oi=scholar The psychiatrist Dr. McClure got her "CFS" specimens from is deeply involved with the Unum effort and she has been unduly influenced by him. Together, they have their minds made up not to ever acknowledge the biomedical basis of ME/CFS and to deny funding of any research that would move the science forward. Again, I say, Dr. McClure is incapable of being either fair or objective when it comes to voting on ME/CFS research. I would also like to say, as an aside, that there are too many psychologists and dentists on this panel, as well. It appears to be stacked against funding any research that is actually relevant to the biomedical disease processes in ME/CFS. This idea is born out by the history of NOT funding the many biomedical studies that have passed through this panel's process and have NOT been funded. It's past time that that attitude is changed. Appointing professionals with better qualifications in virology, retrovirology and neuroimmune diseases would a step in the right direction. There are many American scientists who would be a better choice. Sincerely,

********************************************

Response from Sebelius:

Thank you for your email

 

While we will respond to the specific issues you raise as soon as we can, I wanted to let you know that your message has been received and that I appreciate your taking the time to write.

The mission of the Department of Health and Human Services (HHS) is to protect the nation’s health and provide essential human services, and, as part of that mission, we are at the forefront of the federal government’s efforts to address a wide range of critical issues and challenges.  I wanted to take this opportunity to update you on our work.

First, on March 23, after more than a year of extensive debate, the President signed into law health reform legislation that brings down health care costs for American families and small businesses, expands coverage to millions of Americans and ends the worst practices of insurance companies. As a result of the new law, Americans will begin to see significant benefits take effect this year, with other important reforms following shortly after.  In the weeks, months, and years ahead, our department will be responsible for implementing many of these reforms.  You can be assured that we are firmly committed to explaining these changes to the American people clearly, and to enacting them carefully and effectively.  For information about the new law, I would encourage you to visit www.healthcare.gov.

Meanwhile, thanks to the American Recovery and Reinvestment Act, we’ve made hundreds of millions of dollars available as part of a comprehensive prevention and wellness initiative, Communities Putting Prevention to Work.  This new initiative supports local efforts to reduce obesity, increase physical activity, improve nutrition, and decrease smoking – the four most important things we can to do to fight chronic diseases and improve public health.  And it’s right in line with the First Lady’s “Let’s Move” campaign, which calls on Americans to work together to solve childhood obesity in a generation.  You can learn more about these and other Recovery Act initiatives at www.hhs.gov/recovery.

In addition, it is a core responsibility of HHS, through the Food and Drug Administration (FDA), to ensure the food we eat is safe.  Toward that end, I am firmly committed to working with my colleagues at the Department of Agriculture to achieve the President’s goal of upgrading and strengthening our food safety system; restoring trust in the FDA as the leading science-based regulatory agency in the world; and fulfilling our obligation to the American people to ensure that the food they purchase and serve to their families is safe to eat.  For more information, please visit www.foodsafety.gov.

Finally, HHS plays a vital role in getting our children ready to learn and thrive in school, helping low-income working families struggling to make ends meet in this difficult economy, and meeting the basic needs of vulnerable populations, such as abused and neglected children, refugees, and individuals with disabilities.  As the Administration works to turn around our economy, we recognize that the economic downturn has had its greatest impact on the most vulnerable among us – low-income families with children.  Through child care, child support, energy assistance, and other efforts, the Department helps low-income parents and their communities weather this economic storm.  We will continue to work hard to improve these programs through evidence-based approaches that make a difference for these families and children.

Again, thank you for writing. [END]

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Perhaps we need to begin each communication with HHS/NIH, et al, with the statement that we are among the "vulnerable populations" of "individuals with disabilities", since it Ms. Sebelius's statement that they are "working hard" to improve those programs through "evidence-based" approaches.

Alter, Lo and Gill Live Webcast, February 22, 3pm CST: CFS: Is There a Virus?

Demystifying Medicine - Chronic Fatigue Syndrome: Is there a virus?

The NIH is airing a live webcast and the event can be viewed live at: http://videocast.nih.gov/

Air date:           Tuesday, February 22, 2011, 4:00:00 PM EST

Description:     This event will include the presentation of patients, pathology, diagnosis and therapy context of major disease problems and current research. The course is designed to help bridge the gap between advances in biology and their application to major human diseases. Each session includes clinical and basic science components presented by NIH staff and invitees. These seminar series are primarily directed toward PhD students, clinicians and program managers. All students, fellows and staff are welcome, as well.

For more information, visit http://www1.od.nih.gov/oir/DemystifyingMed

Author:            Shyh-Ching Lo (FDA), Fred Gill (NIDDK) and Harvey Alter (NIDDK)
Runtime:         120 minutes

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Maybe this time we can get the straight talk without the interference and insinuations of smoke screeners and denialists like Dr. Stoye and others of his ilk we suffered at the Blood Products production.

Still no new info on this as of 2/15/2011.

Here's the NIH profile of Dr. Gill:

Biosketch
After receiving his medical degree from Northwestern University Medical School, Dr. Gill trained in internal medicine as an intern and resident at New York University-Bellevue Hospital followed by research training as a research associate of the National Institute of Allergy and Infectious Diseases (NIAID). He completed his clinical training as a medical resident and infectious disease fellow at Cornell-New York Hospital. Dr. Gill is an elected fellow of the American College of Physicians and the Infectious Diseases Society of America.
 

After many years of private practice in Bethesda, Maryland, Dr. Gill initiated the Internal Medicine Consultation Service for the Clinical Center in 1998. His practice in the Bethesda community combined primary care in internal medicine and consultation in infectious diseases. He served as chief of the Division of Infectious Diseases, Rheumatology and Allergy and chair of the Infection Control Committee at Suburban Hospital and as attending physician on the Consultant Service of NIAID’s Laboratory of Clinical Investigation. During this time, he participated as a co-investigator on research projects in the NIAID, the CC Clinical Pathology Department (now the Department of Laboratory Medicine), and the National Cancer Institute.

Dr. Gill led the development of the AIDS clinic for the Montgomery County Health Department and has chaired the AIDS Committee of the Medical and Chirugical Faculty of Maryland. He has served on many committees, including the Maryland Governor’s Advisory Council on AIDS, NIAID’s Advisory Council for Lyme Disease and Suburban Hospital’s Board of Trustees.

At NIH, besides heading the internal medicine consult service, Dr. Gill is chair of the CC Ethics Committee, principal coordinator for clinical education for the NIH Clinical Research Training Program, and an attending physician for NIAID’s Infectious Disease Consultation Clinic. He is a co-investigator on protocols of the National Human Genome Research Institute, National Eye Institute and NIAID. and served as the medical monitor for a National Human Genome Research Institute study. He is a member of data and safety monitoring boards for other institutes and of several CC and NIH committees.

And Dr Alter:

Biosketch
Dr. Harvey Alter earned his medical degree at the University of Rochester Medical School, and trained in internal medicine at Strong Memorial Hospital and at the University Hospitals of Seattle. In 1961, he came to the National Institutes of Health as a clinical associate. He then spent several years with Georgetown University, returning to NIH in 1969 to join the Clinical Center's Department of Transfusion Medicine as a senior investigator becoming Chief of the Clinical Studies and Associate Director of Research in the Department of Transfusion Medicine at the NIH Clinical Center.

Dr. Alter is also a clinical professor at Georgetown University.

Dr. Alter co-discovered the Australia antigen, a key to detecting hepatitis B virus. Later, Dr. Alter spearheaded a project at the Clinical Center that created a storehouse of blood samples used to uncover the causes and reduce the risk of transfusion-associated hepatitis. He was principal investigator on studies that identified non-A, non-B hepatitis, now called hepatitis C. His work was instrumental in providing the scientific basis for instituting blood donor screening programs that have decreased the incidence of transfusion-transmitted hepatitis to near zero.


In 2000, Dr. Alter was awarded the prestigious Clinical Lasker Award and in 2002, he became the first Clinical Center scientist elected to the National Academy of Sciences (NAS) and in that same year was elected to the Institute of Medicine. Only a small number of scientists nationally are elected to both these scientific societies.

FDA Assigns CFS Treatments to DPARP

DPARP stands for Division of Pulmonary, Allergy, and Rheumatology Products.

The first question that comes to mind: What do lung problems, allergies and rheumatology have to do with viral myalgic encephalomyelitis, morphed into chronic fatigue syndrome by the CDC, with NIH complicity? 

I have emailed them to inquire whether treatments for HIV/AIDS are also reviewed by DPARP, and if not, why not. I also asked whether antiretroviral drugs being used to treat XMRV and MLVs, and the drug Ampligen, will be reviewed by this division.


The announcement: (notice that the headline says "drugs" but the body of the article says "products".)

Assignment of Drugs Developed to Treat Chronic Fatigue Syndrome (CFS)

"The Office of New Drugs (OND) recently announced a jurisdiction decision for products to treat chronic fatigue syndrome (CFS).

Applications for products being developed to treat chronic fatigue syndrome had previously been assigned to at least six different review divisions within OND. Across these applications, a variety of different endpoints have been evaluated in assessing products for CFS. More recently there has been interest in the development of endpoints such as instruments that rely upon patient reported outcomes. Developing such tools may help facilitate development of new products to treat patients with CFS and allow for a better means for assessment of the benefits such products provide to patients.
The search for an underlying etiology or etiologies for CFS continues. Further research to understand the underlying etiology of CFS and the pathophysiology of the condition may also help in the development of new products.

In order to work effectively with internal and external stakeholders on developing clinical trial endpoints (e.g., PRO instruments designed for assessing patient symptoms and response in CFS) and clinical trial designs, OND leadership have agreed to assign all CFS applications to a single OND review division, the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). This will allow for a coordinated and consistent process for review of products being developed for the treatment of CFS. In addition, consolidation to one division should allow for efficient and effective review, development of expertise within this area, and provide a single point of contact for CFS applications for stakeholders external to FDA.

Effective immediately, all new applications for drug and therapeutic biologic products for CFS, regardless of the proposed mechanism for the therapeutic product or primary endpoint, will be assigned to DPARP. Existing active applications (NDAs and INDs) will be transferred to DPARP in an orderly manner (timing to be mutually agreed between the DPARP and the currently assigned division)." [end of statement]

It could be good news: at least now FDA is admitting there may be drugs and "therapeutic biologic products" developed for the treatment of "CFS". Let's hope that won't include the latest antidepressant or antianxiety drugs, developed especially to treat the "personality disorders" and "depression" due to "childhood sexual abuse" that the CDC has been foisting off on a gullible public and compliant medical industry for decades. (I can't bear to call it a "profession" anymore although I readily admit there are still some professionals in the industry.)

The announcement says they will take into consideration patient reports of efficacy. This could be good news, too, if they should begin to listen to patients like Kelvin Lord and Mary Schweitzer on Ampligen.

The (possibly) bad news: Well, what do lung problems, allergies and rheumatology have to do with viral myalgic encephalomyelitis, morphed into chronic fatigue syndrome by the CDC?

I emailed them. You can, too. Their comment form:
http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

This is their email address:
druginfo@fda.hhs.gov