Sunday, May 15, 2011

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

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:

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”?

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. use of antiretrovirals for the treatment of CFS does not seem justified at present.
    -Dr. Ila Singh et al

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:

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.

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.

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?