Taking on the negative studies

The negative studies - they've sufficed at discrediting good research over the last year - several researchers are finding it difficult to get their XMRV studies published.  Rather it seems who you are matters - the CDC, the Wessley group in Britain.  The time has come to put politics aside, and put the issue to rest for good.  There is a rule in science that in order for a confirmation study to be valid, it means copy exactly!!!

In order to do that, it would mean taking a modest amount of samples, using different methods in the same laboratory.  So if we have replica A using the method described by Mikovits et. al, B using the CDC method, C using the Wessely study, and only the first method shows positivity, then contamination can be ruled out.

CDC Damage Control: ME/CFS Research Group Relieved of Duties

In a stunning move, responsibility for XMRV research has been taken away from the ME/CFS working group within the CDC, and re-assigned to the division of HIV/AIDS prevention.  This group will be in charge of replicating findings of the Whittemore-Peterson Institute, rather than the group under the control of Dr. Reeves.  The move is highly significant: it appears that the CDC is now acknowledging the serious nature of XMRV.

The CDC will be part of an interagency working group on XMRV, led by Dr. Jerry Holmberg.  A three-part study will be initiated:

1. The first part will consist of standardizing and validating laboratory methods and reagents for XMRV testing.  This stage will use samples provided by samples collected by Dr. Judy Mikovitz.  The intention is to create an FDA approved test.
2. The second part will test a much larger sample than the initial study, trying to determine the prevalence of XMRV in the general population, and the blood supply.
3. The third part will consist of how XMRV is transmitted, how it causes disease, and how it affects various subgroups of the population.

The forceful demotion of Dr. Reeves is a sign that the CDC is in damage control mode.  The HIV/AIDS prevention group in the CDC has many capable retrovirologists, who can provide years of expertise.  In my opinion, this turn of events should lead to balanced, common sense research.

Is it time for CFS/FM/Gulf War Syndrome patients to wage a legal battle?

The cat is out of the bag: it can be said with reasonable certainty that XMRV is the single agent that sets the wheel in motion for the immune disturbances associated with XMRV.  According to a CDC insider which I have spoken to, the CDC long knew back in the late 1980's that a single viral agent would be capable of causing the perturberences seen in ME/CFS.  I've also heard from a patient in Toronto, Ontario who developed CFS 3 months after receiving a blood transfusion after a motor vehicle accident in 1994 - it's more than a co-incidence.  More information keeps surfacing each and every day about the CDC hanky-panky.

For patients, there is enough there to start looking at litigation against the CDC and other parties.  This would not come at a small price - going against the CDC would require hiring a law firm that specializes in high stakes litigation.  The CDC would not be the only defendant - the Social Security Administration and the American Red Cross likely share some liability.  How much is at stake - Billions.  Each CFS/ME/FM/Gulf War Syndrome patient costs $35,000 a year in lost productivity - that's $595 Billion!  It's also $595 Billion that the Social Security Administration does not have to pay out in disability costs, HMO's and PPO's don't have to pay in drug treatments, and that pension plans don't have to pay out!

Such a lawsuit is perhaps what is needed to "Stimulate" the CDC into recognizing that these disease have an infectious etiology, that they are not some idiopathic fire of unknown origin like they want us lemmings to believe.  They will be forced to admit that CFS/ME/FM/Gulf War Syndrome is another acquired immune deficiency syndrome, and that they've been covering up this silent pandemic for just too long.  Likely if a judgment was won, it would be an egg in the face of the CDC, but they would exhaust all appeals.  Likely other lawsuits would follow in other countries.  Perhaps even a movie by the name of Osler's Web, done with an A list director and Cast might embarrass the CDC enough to change  their ways.

Dr. William Reeves - Another Mark Whiteacre? Criminal Negligence Perhaps?

For those of you who don't know, Mark Whiteacre was a biochemist at Archer Daniels Midland, who is most famously remembered as one of the highest level corporate whistleblowers in the history of corporate America.  He got the inside scoop on a price fixing scandal on Lysine and other products, and got his bosses in trouble, while he himself had his own embezzlement scheme going on within the company.  A similar thing can be said about Dr. Reeves at the CDC - he blew the whistle on his bosses, and yet he continues to be hypocritical to the extreme by stating that the retroviral program at the CDC was taking the lead in an attempt to replicate the WPI XMRV results.

Reeves acted unethically by stating to the press that he did not expect the agency (CDC) to replicate the WPI findings of XMRV in ME/CFS patients.  He acted unethically in that he pre-judged someone else's findings, before doing any research of his own.  He put his credibility, and quite possibly his career on the line - and he will be watched very closely.  Falsifying data won't go over this time.

But why would the CDC engage in such sinister behavior?  Their mission is to protect the public from emerging infections, and in this case they've failed miserably.  The pharmaceutical companies rely on them to lay out their research roadmaps for the future - if they put out junk science, how is the pharmaceutical industry to develop new treatments?  And why would they want to intentionally try and deny scientific facts???

It's certainly not in the interest of the drug companies, CFS/ME/FM/Gulf War Syndrome patients.  It seems the CDC's motto is if it isn't a deadly disease, then feed them Thorazine, Zyprexa, and Amitriptylline, and keep them so sedated they can't think straight - something that's already difficult enough for these patients - now we'll turn them into living zombies!  For the drug companies this would only represent five or six dollars a day - so it wouldn't contribute much to their bottom lines - Amitryptilline and Thorazine are off patent and cheap.  But anti-retrovirals would be a potential goldmine for the pharmaceutical industry - rather than sell just to HIV patients, now they could quadruple their sales to CFS/ME/FM/Gulf War Syndrome patients.

So who would not want that?  The first that come to mind are HMO's PPO's, publicly funded health plans.  Having to pay $1000 or more for XMRV treatments for an indeterminate period of time is something they would not take sitting down.  The second that comes to mind is blood banks - now they've got to worry about tainted blood on an unprecedented scale - making HIV and Hep C look like child's play.  Then comes the issue of liablity and lawsuits - like in Canada after the Canadian Red Cross was found negligent.  If they can keep it as a neuropsychiatric illness, then they can keep putting off liability.  It's criminal negligence at it's finest - the CDC knew of a viral link for twenty years, and they failed to act on it, and thousands more people became ill!

Chronic Fatigue Advisory Committee Meeting

This week, the Chronic Fatigue Advisory Committee will meet, and listen to the findings of Dr. Daniel Peterson.  The advisory committee has representation from the FDA, CDC, NIH, HRSA, and Social Security Administration.  The event is essentially a make-or-break event - will the evidence be strong enough to persuade the various agencies to start paying more attention to Chronic Fatigue Syndrome, that is the question that remains to be asked.

Over the years, the CDC has finally begun to realize that this disorder is reaching alarming proportions.  However, the system failed patients - the CDC essentially works hand in hand with the NIH - if the CDC doesn't believe something, the NIH does not grant research funds to institutions into that particular field of interest.  Precisely, this is what happened with the findings of Defreitas et. al years back - no research dollars flowed to anyone wanting to search for a virus responsible for CFIDS.  Without this, no drug companies are willing to invest in something that is unproven.

The current findings basically confirm earlier findings from research done be Dr. Elaine Defreitas.  This time, the difference is that Dr. DeFreitas did not actually isolate and characterize the virus, but found clues to its existence - this time we have a virus.  Hopefully, millions of dollars in research grants will flow to studying XMRV, rather than studying various neurological phenomena.

The CDC Failed CFS Sufferers in 1991 And Continues to do so Today.

In a landmark paper written by DeFreitas et. al, "Retroviral sequences related to human T-lymphotrophic virus type II in patients with chronic immune dysfunction syndrome", the authors stated that an association had been made by a yet unidentified retrovirus, and Chronic Fatigue Syndrome. It was during my tenure with the CDC in Atlanta that the CDC quickly jumped to the occasion and refuted the findings in the paper, pouring cold water on the retrovirus link. For the next 18 years, many theories surfaced about Chronic Fatigue Syndrome, with no answers - the phrases "hypothalmic dysregulation", "Neuropsychiatric disorder", "Neurally mediated hypotension" being all too common.

Meanwhile, a scandal was unfolding with our neighbors to the north where just two years ago the Canadian Government announced $150 million in compensation for those infected with HIV through blood products, and around the time the paper written by DeFreitas, details began to emerge about persons contacting Hepatitis C from tainted blood. A similar blood scandal like those of our Canadian neighbors was the last thing the CDC wanted - when the word "Retrovirus" was uttered, fear struck among the top brass of the CDC - notably Dr. Brian Mahy, prompting director William Roper to convene an emergency meeting with Louis Sullivan, then Secretary of US Department of Health and Human Services, and the director of the National Institutes of Health.

The result was simply scandalous.  Dr. William Reeves became installed as the head of the CFS/ME research program where under the command of his superiors namely Dr. Brian Mahy, many sinister things began to happen to the CFS/ME research program.  The experiment done by Dr. DeFreitas had essentially been rigged, and the CDC sent Dr. James Gow a standardized primer solution containing a fixed concentration of magnesium - so his lab would report a similar result.  During my tenure at the CDC during my research fellowship, we were told we would not be flying to Philadelphia because there was a lack of funds to buy airplane tickets.  It later turns out that $12.9 million dollars earmarked for CFS/ME research had been misappropriated and funneled to other projects, $8.8 Million was granted to pharmaceutical companies who sat on the money and did nothing with it, and $4.1 million dollars unaccounted for.  The Inspector General of the Department of Health and Human Services confirmed that $13 million in CFS/ME research money was either mismanaged and/or embezzled.  Following this report, the General Accounting Office noted research had declined on CFS at the NIH since 1996, there was a lack of communication between the CDC, and NIH about CFS research, and the leadership of the DHHS was ineffective in leading the CFS coordinating committee.

What ensued would have a profound effect on Chronic Fatigue Syndrome research for the next 15 years. Research funds for the disorder literally dried up overnight, and research came to a standstill. Shortly after the paper authored by Defreitas et. al. came out, the CDC was quick to refute their findings, and no further studies were made to isolate a virus. Basically, after the CDC has published their findings and used Dr. Gow to manipulate the results to appear as inconclusive, the NIH would no longer provide the research team of DeFreitas et. Al with further research funding on the matter or anyone else for that matter - it was case closed - NO RETROVIRUS! Now according to the CDC, CFS was a symptom of unknown etiology that had both psychiatric and neurological influences, and the NIH granted funding to find a neurological basis for the disease, which for the next decade would offer us some insights, but still no answers.

The fact is that we had our man 18 years ago, but we were too quick to rule him out as a suspect, and he's been out on the lam for the last 17 years. Rather than face the music, the CDC chose to stick their heads in the sand, and have it all come back in their at a later time. It begs the question of just how many people have been infected with XMRV through blood products , when we could have been testing our blood supply for at least the last 16 years? Lest not forget that antiviral drugs targetting XMRV would likely be available now had research been pursued.