Saturday, August 21, 2010

Stop Blue Cross!

http://www.couragecampaign.org/page/m/4b660f0b/1ba4a3fd/dccdcc9/40ba226b/1585456015/VEsH/
My good friend Wendell Potter, a former head of corporate communications for CIGNA -- one of California's largest health insurance companies -- asked us to share this message with the Courage Campaign community. After many years defending the health insurance industry, Wendell is now an outspoken supporter for health care reform, testifying before Congress and appearing in the media often.

Rick Jacobs
Chair, Courage Campaign

http://www.couragecampaign.org/page/m/4b660f0b/1ba4a3fd/dccdcc9/40ba226a/1585456015/VEsE/

I'll bet you thought that the battle over health care reform ended last March when President Barack Obama signed the bill into law. That's exactly what Anthem Blue Cross wants you to think.

For 20 years, I worked in the health insurance industry. As head of corporate communications for CIGNA, I knew that insurance companies won when the public wasn't paying attention. That's when the real damage is done.

Anthem Blue Cross made headlines earlier this year when they proposed a whopping 39% rate increase for their health insurance policies. And now Anthem is going all-out to fight the implementation of the federal health care reform law here in California. While the public's attention is elsewhere, Anthem is fighting to kill the bills that would set up the state-based "exchanges" that are the heart of the health care law.

If Anthem gets their way, they'll stop you from getting affordable health insurance. They're counting on you to stay silent as they once again destroy reform.

I'm not going to let that happen. That's why I'm joining the Courage Campaign to deliver a letter to Anthem Blue Cross's new president, Pam Kehaly, to demand that she and her company stop trying to undermine the health care reform law in California. Will you add your name to the letter today? Click here to sign now:

http://www.couragecampaign.org/StopAnthem

Anthem is trying to block AB 1602 and SB 900, the two bills that would create the state-based "exchange" under the federal health care law. Anthem wants to instead control the exchange itself, and prevent the government from bargaining for the best price for consumers.

I decided to leave the insurance industry and speak out against these practices because I know that the only way to stop them from undermining your health care is by shining a light on their behavior and organizing the public to fight back.

That's why I need you to join me in stopping Anthem Blue Cross from gutting the health care law. Please add your name to the letter I will deliver to Anthem Blue Cross -- show the insurance companies you won't let them get away with it:

http://www.couragecampaign.org/StopAnthem

This is just the beginning of the Courage Campaign's effort to continue the fight for better, affordable health care for all Americans. While the federal law passed earlier this year will expand coverage considerably, it will still fall far short of universal coverage even when fully implemented. That's why we need to keep working together, until we finally succeed in fundamentally reforming our nation's broken health care system.

Thank you for joining me to stand up to Anthem's corporate greed.

Wendell Potter 


Courage Campaign California is a part of the Courage Campaign's multi-issue online organizing network that empowers more than 700,000 grassroots and netroots supporters to push for progressive change and full equality in California and across the country. Supported by thousands of small donations from our diverse community, Courage Campaign California holds politicians accountable to progressive values, works for fundamental reform to our state's broken government, and trains and organizes activists to change their communities.

To power our campaign to stop Anthem, please chip in what you can today:

http://www.couragecampaign.org/page/m/4b660f0b/1ba4a3fd/dccdcc9/40ba2269/1585456015/VEsO/
 


 

Depression is Painful. Advisory Panels more so.

 
Note: Eli Lilly markets it's anti-depressant Cymbalta saying
"depression is painful," however the research is mixed. The tagline is
mainly founded on the yet unproven assumption by psychiatrists that
pain is all in the mind if it cannot be proven otherwise. Detractors
suggest the hypothesis is all in the mind of psychiatrists.

The article below suggests another reason behind the push for Cymbalta
which was approved for fibromyalgia in 2008. Cymbalta ads are in direct contrast to ads for Lyrica which is prescribed for neuropathological pain in which fibromyalgia patients are portrayed as vibrant people who want to move past the pain and get on with living.

Depression Is Painful. Advisory Panels More So.
By Brian Orelli, Ph.D. |
August 20, 2010 |

Eli Lilly's (NYSE: LLY) date with the Food and Drug Administration
advisory committee was better than nothing. I guess. Certainly can't
make things worse, as was the case for its Alzheimer's drug earlier in
the week.

The committee voted 8-6 in favor of expanding the use of its
depression-turned-pain-drug Cymbalta into patients with chronic pain.
That's not exactly a resounding endorsement.
And it only gets more ambiguous from there. Eli Lilly used studies in
patients that had back pain and those with osteoarthritis to support
the chronic pain indication. The committee voted 8-5 that the data
supported Cymbalta's use in back pain but with a 4-9 vote, found that
the data didn't support its use in osteoarthritis.

This is normally where I'd point out that the FDA usually -- but not
always -- follows the advice of the committee, but with mixed advice,
it seems that the FDA is pretty much on its own here. It's not clear
exactly when the agency might make its decision since the PDUFA date
came and went many months ago.

What is clear is that Eli Lilly could use the additional sales.
Pending appeal, the company is at the losing end of patent fight over
attention-deficit-disorder drug Strattera. If it can't convince a
court otherwise, generic competition from Teva Pharmaceutical (Nasdaq:
TEVA), Mylan (Nasdaq: MYL), Novartis (NYSE: NVS), and Dr. Reddy's
Laboratories (NYSE: RDY) will be on its way shortly.

If the FDA does give Eli Lilly the green light to market Cymbalta for
the expanded indication, they seem to have a tag line all set up. The
advertisements for Cymbalta say that "depression is painful". Flip it
around -- "pain is depressing" -- and you've got one drug that can
treat both.
That's something Pfizer's (NYSE: PFE) Celebrex and Johnson
& Johnson's (NYSE: JNJ) Tylenol can't say. But for now, they're the
ones that can advertise to patients with pain.

http://www.fool.com/investing/general/2010/08/20/depression-is-painful-advisory-panels-more-so.aspx


Lilly Moves Closer to Approval to Market Cymbalta for Chronic Pain
By DUFF WILSON
Published: August 19, 2010

A federal panel on Thursday voted narrowly to recommend allowing Eli
Lilly to market its blockbuster antidepressant Cymbalta for some
chronic pain conditions like lower back ailments that affect millions
of Americans.
Sales of Lilly's antidepressant Cymbalta are $3 billion a year.

The scientific advisory panel to the Food and Drug Administration
voted 8-6 in favor of expanding approved uses of Cymbalta. If approved
by the agency, the drug would compete with Tylenol, aspirin and other
anti-inflammatory drugs, and opioids like codeine and morphine.

F.D.A. officials at the meeting assured the panel they would draft
warnings against the overuse of Cymbalta for pain, if they did finally
approve a label change. Advisory committee votes are often, but not
always, followed by the agency.

"I think it will be a very useful drug for a significant number of
patients," Dr. Jeffrey R. Kirsch, the chairman of the advisory panel,
said after the vote.
But while the committee, in a series of votes, approved the drug's
effectiveness for lower back pain, it voted against the drug's use for
osteoarthritis. The F.D.A. staff earlier in the week opposed Lilly's
broader proposal that would have allowed Cymbalta to be used for
chronic pain on a host of issues.

Dr. Robert Baker, Lilly's global development leader for psychiatry and
pain disorders, said the company would continue seeking F.D.A.
approval to market Cymbalta to treat all chronic pain.
In an interview, he said Lilly learned only this week that the agency
had limited votes to just two conditions. "While we'd have been happy
to move right to chronic pain, we are also understanding and
interested in helping them capture this for doctors as they work for
patients for individual subsets of pain such as osteoarthritis or
lower back pain," Dr. Baker said.

"If you think of how many people have lower back pain, it's an
extraordinarily large opportunity," C. Anthony Butler, a Barclays
analyst, said. The Barclays note predicted Lilly, which is based in
Indianapolis, would invest heavily in promotion because it was relying
on Cymbalta for sales growth from next year, when its patent expires
on its best-selling drug, Zyprexa, to 2013, when its patent expires on
Cymbalta.

But Lilly also was criticized Thursday by the F.D.A. panel members for
its advertising campaign for Cymbalta. The ads say "depression is
painful." Dr. Kirsch, who is chairman of the department of
anesthesiology at the Oregon Health Sciences University, said he was
perturbed at what he termed an attempt to "premarket" the drug for a
pain use that had not yet been approved.

The F.D.A. approved Cymbalta for major depression and diabetic nerve
pain in 2004, generalized anxiety disorder in 2007, and fibromyalgia
in 2008.
Approval for lower back pain alone could add as much as $500 million
in annual sales of Cymbalta, on top of its $3 billion current sales,
an investor note from Barclays Capital said Thursday.

Full story at: http://www.nytimes.com/2010/08/20/health/20drug.html?src=me&ref=health


 

Check out Wong's Virology - Slide Sets

 
Since many PWCs have co-infections, this website may be of interest.



Going Viral with ME/CFS: Letter to the WPI

 


Video of the WPI Opening

http://imedia.unr.edu/cmm/CMM_Grand_Opening.html


Thursday, August 19, 2010

Name Change for XMRV in the works

  I just received the following message from Dr. Joe Burrascano.
I checked

  with him, and he responded that this information can be made public.  I don't have any additional information about this, so won't be able to answer questions, but it sounds like a major development, and I think people  here will want to know about it.

Best regards,

Rich Van Konynenburg, Ph.D.
richvank@aol.com

__________________



Hello all from Dr. B.
I just returned from the first official scientific symposium of the Whittemore-Peterson Institute on the topic of XMRV.  We formed a working group to be in constant touch and we plan to meet regularly because advances are coming so rapidly.  Big news that everyone should know and adopt is that we have proposed a name change for the virus.

This virus is a human, not mouse virus, and it is the first and so far only gamma-retrovirus known to infect people. Also, it is clearly not an "endogenous" retrovirus (one that is present in all genomes due to ancient infection).

Because of all of this, and because of the desire to begin on the right track, the new name of the virus is HGRV- Human Gamma Retro Virus. The illness caused by this infection is named HGRAD- Human Gamma Retrovirus Associated Disease.

We plan to announce this at the upcoming NIH retroviral conference this September.

Definitely stay tuned- the volume of new and important information about this virus and its disease associations is increasing rapidly and in my opinion should be a concern to every patient with chronic neuro-immune diseases, including those with chronic Lyme.

Joseph J. Burrascano Jr. M.D.
Water Mill, NY, USA

Clinical trial of Droxidopa

Chelsea Therapeutics Announces Initiation of Investigator-Led Phase II
Study of Droxidopa (Northera)  in Chronic Fatigue Syndrome

CHARLOTTE, N.C., Aug 19, 2010 (GlobeNewswire via COMTEX) -- Chelsea
Therapeutics International, Ltd.
/quotes/comstock/15*!chtp/quotes/nls/chtp (CHTP 3.59, +0.04, +1.13%)
announced that a new investigator-led phase II clinical study of
Droxidopa, an oral synthetic precursor of norepinephrine, has been
initiated in chronic fatigue syndrome (CFS).

CFS is a complex and crippling disorder characterized by extreme
fatigue that is not improved by rest. In addition to fatigue, patients
with CFS experience symptoms, similar to that of fibromyalgia
including, weakness, muscle pain, impaired memory and concentration.
Droxidopa has been shown to improve symptoms of fatigue, weakness and
concentration in neurogenic orthostatic hypotension associated with a
variety of conditions including Parkinson's disease, multiple system
atrophy and pure autonomic failure. Droxidopa is also being studied in
an ongoing Phase II trial in fibromyalgia
where, during an interim
analysis, an independent data monitoring committee saw meaningful
efficacy in multiple treatment arms.

Dr. Charles Lapp, a former board member of the American Association
for CFS and medical advisor to the American Fibromyalgia Syndrome
Association, is conducting this single-center Phase II study at the
Hunter-Hopkins Center in Charlotte, North Carolina. The trial will
evaluate up to 600 mg TID of droxidopa
and assess the clinical
efficacy using changes in Patient Global Impression of Improvement
(PGI-I). In this open-label trial, approximately 20 patients will be
titrated to optimal therapeutic benefit over a two-week period after
which they will continue treatment for 12 weeks. The primary outcome
measure will be changes in PGI-I scores from baseline to the end of
the 12-week treatment period. Secondary measures include changes in
the Multidimensional Fatigue Inventory (MFI), Clinical Global
Impression of Severity (CGI-S), Hospital Anxiety and Depression Scale
(HADS), blood pressure before and after a tilt table test.

"As we continue to work towards an approval for droxidopa for the
treatment of neurogenic orthostatic hypotension, we are eager to
expand the body of clinical research supporting potential indications
that could be effectively treated with norepinephrine replacement
therapy," said Dr. Simon Pedder, president and CEO of Chelsea. "We
welcome the opportunity to support Dr. Lapp's efforts to characterize
the therapeutic role of norepinephrine in chronic fatigue syndrome and
believe that a favorable outcome from this study, combined with data
being generated by our ongoing Phase II trials in fibromyalgia and
adult attention deficit hyperactivity disorder, will further highlight
the integral role of norepinephrine as a neurotransmitter central to
the etiology of a host of disorders."

About Droxidopa

Droxidopa, the lead investigational agent in Chelsea Therapeutics'
broad pipeline, is currently in Phase III clinical trials for the
treatment of symptomatic neurogenic orthostatic hypotension (NOH) in
patients with primary autonomic failure -- a group of diseases that
includes Parkinson's disease, multiple systems atrophy (MSA) and pure
autonomic failure (PAF). Droxidopa is a synthetic catecholamine that
is directly converted to norepinephrine (NE) via decarboxylation,
resulting in increased levels of NE in the nervous system, both
centrally and peripherally. Droxidopa is also being studied for the
treatment of fibromyalgia and adult attention deficit disorder in two
ongoing phase II trials and completed a phase II in intradialytic
hypotension (IDH) study with positive results.

Chelsea Therapeutics is a biopharmaceutical development company that
acquires and develops innovative products for the treatment of a
variety of human diseases. Chelsea's most advanced drug candidate,
Northera(TM) (droxidopa), is an orally active synthetic precursor of
norepinephrine initially being developed for the treatment of
neurogenic orthostatic hypotension. In addition to Northera, Chelsea
is also developing a portfolio of metabolically inert oral antifolate
molecules engineered to have potent anti-inflammatory and anti-tumor
activity to treat a range of immunological disorders, including two
clinical stage product candidates: CH-1504 and CH-4051. Preclinical
and clinical data suggest superior safety and tolerability, as well as
increased potency versus methotrexate (MTX).
 
 

Fibromyalgia Pain at Night

 

For Advocates: The One Reason Your Facebook Page Strategy Doesn’t Work

 
One of the comments is quite to the point:

"Having a lot of followers that don't read or care about your content is useless.  Try instead for quality, not quantity. I can get you a million fans in a day, and not one of them will be beneficial to you. On the other hand, 500 fans acquired over a couple of months through natural methods can bring you far, far more business and value."

And that's true.  I'm a "fan" of a friend who's a real estate agent.  The odds of him ever getting a sale because I'm a fan are slim and none, because my friends locally fall into two categories: those who already own houses and those who will never own one (disabled people can't afford to buy in this town, where a household income of $100,000 might get you a starter home).  Mostly, I'm a fan so that if he's doing an open house in my neighborhood, I can pop in and say hello.  If he had 1000 fans who are all like me, he'd be in financial trouble.

When I started a FB page for my editing business, I didn't invite all my friends -- only those who might reasonably have a need for the service.  It's not about the numbers.  The stuff I'm posting there would be of no interest to most of my friends, so I don't want to spam their pages with my updates any more than I like them spamming my page with their Farmville stuff.  The numbers are climbing slowly, from posting that link to various professional groups.

So, no, I'm not going to waste space in this blog inviting a bunch of disabled people to become fans of a business they're not likely to use.  But I will invite you to join  Facebook | CFS Facts  which will be of interest to you.

 

 

 

Wednesday, August 18, 2010

A Chronic Fatigue Cover-Up? - Newsweek

 
How much -- and how little -- has changed since 1996.


 

Vote for the Science Idol | Union of Concerned Scientists

 
 The Scientific Integrity Editorial Cartoon Contest, UCS asked 12 artists to draw humorous attention to the not-so-funny issue of political interference in science. This year, we focused on how the private sector can inappropriately influence how science is used to make decisions about our health, safety and environment.

Now, you have the chance to pick the winner, which will be featured on the cover of the 2011 scientific integrity calendar.

* * *

Gracious me!  Politics trumps science?  Who'd'a thunk it?

Oh, wait ... that's what PWCs have been dealing with for years.

Tuesday, August 17, 2010

Dear Cort, Please Get Your Facts Straight

 
Thanks, Heidi!

Numerous Trials Reveal the Scope of Unum Misdeeds

Numerous Trials Reveal the Scope of Unum Misdeeds
News
August 16, 2010. By Gordon Gibb

    San Diego, CA: Unum is working to distance itself from its
unsavory past, but it's hard to escape the details that are emerging
from various lawsuits brought by disgruntled and distraught Unum
insurance policyholders who allege to have been wronged by the massive
insurance provider.

    Numerous Trials Reveal the Scope of Unum MisdeedsTrial lawyer
William Turley of San Diego, who sits on the Board of Governors of
Consumer Attorneys of California, notes that Unum, UnumProvident,
Provident Life, and Paul Revere companies have been named in nearly
5,000 civil actions concerning insurance from 2000 to the present.

    In one recent trial in Federal Court, Unum Provident was found to
have addressed a concern in the early 1990s that claims against
occupational insurance policies threatened to put the company at risk.
It was found that the company moved from maintaining a claims payment
policy to one of claims management.

    The firm adopted a variety of tactics to manage claims, including
discouraging the use of independent medical examinations in favor of
using its own medical staff, who might be persuaded to toe the company
line.

    Round table reviews involving medical staff, claims personnel,
vocational staff, legal counsel and management personnel focused on
high indemnity claims and how to manage them to the company's
advantage. Notes taken at the meetings were destroyed.

    Turley notes that in some cases Unum put the burden on the insured
to prove that their claims were valid—even though it is an insurer's
responsibility to investigate the validity and accuracy of a claim in
a reasonable and fair manner without becoming adversarial and without
basing decisions on mere speculation.

    According to facts uncovered from one trial, Unum targeted claims
based on emotional or nervous disorders, Fibromyalgia or Chronic
Fatigue Syndrome—conditions that are subjective and difficult to prove
with hard medical evidence.

    The company viewed such conditions as affording high potential for
resolution in the company's favor, based on the vulnerability of the
claimants, and a hoped-for cancellation of a Unum long-term disability
insurance claim or similar claim against Unum.

http://www.lawyersandsettlements.com/articles/14786/unum-insurance-provident-first-25.html

Check out Chronic Fatigue Syndrome (ME/CFS) News From Phoenix Rising - An Alt

 
"Three drugs have been able to stop XMRV in the lab and Dr. Lombardi felt many more were potential candidates"

BREAKING NEWS: Dr. Judy speaks

Dr.  Mikovits broke whatever embargo was present on the study by the FDA stating  
in an interview with RGJ.Com, what has seemed to be more and more  obvious -
that the FDA paper in  press is going to confirm the WPI's findings  when it is
released. While  no one yet had directly said so, the news  seemed to be in the
air....check out more on what Dr. Mikovits and Annette and Andrea Whittemore are
saying about XMRV in


Vindication? Dr. Mikovits Breaks the News on the FDA XMRV Paper

http://www.forums.aboutmecfs.org/content.php?207
 

Findings by Reno scientists confirmed by U.S. government

Findings by Reno scientists confirmed by U.S. government
LENITA POWERS - lpowers@rgj.com  - August 16, 2010

http://www.rgj.com/article/20100816/NEWS/100816069/1321


Two Reno scientists, who last year discovered a new infectious human
retrovirus they linked to Chronic Fatigue Syndrome, said Monday that
their findings have been replicated and confirmed by the U.S. Food and
Drug Administration.

Dr. Judy Mikovits, one of the lead researchers with the Whittemore
Peterson Institute for Neuro-Immune Disease in Reno, said the FDA's
review of their findings is scheduled to be published in September.

"There has been an issue over whether anybody could replicate our
study, and it will not only confirm our findings but extend our
findings, which is really exciting for us," she said.

Mikovits said they also have new, unpublished data concerning the
retrovirus, XMRV, that could lead to treatment of Chronic Fatigue
Syndrome.

"We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage," she said. "So we could have a diagnostic test to follow clinical treatment and show that people's
immune systems go back to normal. That's the latest data that's really
amazing. That's what we're after."

That data will be published by the end of the year, probably in a
clinical immunology journal, she said.

Lombardi said clinical trials could begin soon at the Whittemore
Peterson Institute, which is relocating from its tiny laboratory on
the University of Nevada, Reno campus to the university's newly opened
Center for Molecular Medicine.

"Actually, we already have been contacted by people who are sending us
tests, perceiving that they may be asked to be part of the clinical
trials," he said.

"I think once the (FDA) paper comes out and once the controversy is
put to rest, the pharmaceutical companies will realize that this is
some very low-hanging fruit for them to make the next transition,"
said Lombardi. "There are so many drugs that have been developed for
HIV, and it's a retrovirus. So there's probably a ton of HIV drugs
that they can go back and re-screen that could be used."

There also are three published drugs that work against XMRV, Mikovits said.

"We totally expect at least one clinical treatment trial before the end of the year," she said. "That is our goal and that's what this new facility is for."

XMRV findings replicated by Government Scientists

Two Reno scientists, who last year discovered a new infectious human
retrovirus they linked to Chronic Fatigue Syndrome, said Monday that their
findings have been replicated and confirmed by the U.S. Food and Drug
Administration.

Dr. Judy Mikovits, one of the lead researchers with the Whittemore Peterson
Institute for Neuro-Immune Disease in Reno, said the FDA's review of their
findings is scheduled to be published in September.

http://www.rgj.com/article/20100816/NEWS/100816069/1321
 

Monday, August 16, 2010

Lyndonville News, August 2010

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LYNDONVILLE NEWS

 

XMRV Update

There is so much to update, while at the same time almost nothing is happening on the outside. Except of course the CDC can't find XMRV in CFS, and it is directing the NIH XMRV conference in early September on how to find it. It seems that Dr. Harvey Alter can find it, but his paper was held after being accepted by the very prestigious journal PNAS. Very strange happenings, and I hope that someone is keeping a very accurate diary of all this.

 

Of those persons who read this, most of you follow the news carefully, so I will not dwell on it too much. But it has been publicly announced that the NIH is funding an XMRV grant on the Lyndonville outbreak. So we will stay busy.

 

In case you missed some of the news….lets see...New York Times article by David Tuller on July 14, 2010 quotes Hillary Johnson as saying, "A cabal of top government administrators" with a habit of "heavy-handed, anti-science manipulation of peer-reviewed science" ordered the delay of Dr. Harvey Alter's study. It is always exciting to see what is on Hillary Johnson's web site: Osler's Web.

 

Look up Dr. Suzanne Vernon's comments about the CDC study at the CFIDS Association web site. She blasts the CDC study as being poor. She used to work for them.

 

Having no inside information whatsoever about the CDC, here are my speculations. On the overly optimistic (lets give them a break side), maybe the CDC did several studies. First was a simple PCR study just like the three other negative studies involving hundreds of tired people gained from a telephone interview or two, and no XMRV is to be found. Note: of the four published studies, none have tried to replicate Mikovits' work. This is very important. It is now clear that if they do several thousand more PCR studies without trying to replicate the WPI work, they will not find it. Time to move on. Try replicating the WPI study and learn something.

 

But maybe the CDC is also doing other studies, open minded as they are, and finding it all over the place. Finding it in some controls, the blood supply, and in lots of persons with CFS. Maybe they are stalling in order to gear up for a major assault on CFS and XMRV with clinical trials, serious research, and so on. Maybe just maybe...

 

On the negative side, perhaps there is an organized effort to marginalize XMRV, even if it is the cause of CFS, because it may be expensive to treat. We know that this has been done before, with the excuse being "good science". Personally, I would insist on good science, but not political science. Lets find out what is there. If XMRV is marginalized, it will be no more visible to mainstream medical practitioners than the 2'-5' A synthetase, RNAse L, blood volume, isoprostanes, IVRT, natural killer cell data, immune upregulation, and the many other good science that has been done on CFS. It is all meaningless if the patients never get to see the benefit of this science.

 

And perhaps most importantly, the Whittemore-Peterson Institute will open next week. For anyone who has been discouraged in the past about the lack of progress, this should be a shot in the arm.

 

Research Group News

I would like to thank the research group for its work and all of you for supporting the group financially. As I mentioned above, we have an NIH grant, and I am a consultant to this grant. As such, I will receive no funds from the NIH for this, and I am perfectly OK with that. All the preliminary data accrued came from your generosity. Your contributions, through Connecticut CFIDS Assn or otherwise, have paid for mailing of questionnaires, blood collection supplies, travel to conferences for myself, statistical help, and pizza for the meetings. So far I have not embezzled funds for a new kidney-bean swimming pool, and i have no intentions to do that in the future. The expensive stuff, meaning the XMRV assays, have been paid for from other sources. So we here in Lyndonville are doing just fine. If there are a lot more conferences, that will be good, because it means that there is positive news to report. If that happens, we may need some support.

 

Are there new studies in the works? At this point we are quite busy although nothing has shown to the outside world. We did get an NIH grant and that requires pilot data however. My hopes for the future would be to do a comprehensive pediatric study with many of the known researchers sending samples from children and adolescents as well as controls, and possibly a comprehensive neurologic study on the neurological symptoms present in persons positive for XMRV. These studies are way off in the future, and the NIH funding process, if it happens at all, is very slow. These studies cannot be done by the research fund's petty cash. They are major cash. So if anyone has $100,000 and wants to do one of these, let me know...

 

Diagnostic Criteria for XAND

Assuming that research on XMRV really gets going, and it is found to be at the root of CFS in a majority of cases, listed below is my version of the Cadillac diagnostic work-up for CFS or rather, XAND, XMRV Associated Neuro-immune Disease.

 

1. History and Physical Examination

 

As the basis for all good clinical medicine, the starting point is a good history and clinical exam. It is also the starting point for a constructive, provider-patient relationship. At some point effective treatments will be more widely known, but they cannot take place without a good relationship with your provider.

 

2. Test for XMRV

 

At this point in history we do not know the best and most accurate test for XMRV, and it has not been proven to my satisfaction that XMRV is the cause of CFS. However, it is my educated guess that XMRV can be found and that it will turn out to be the cause of this disease. The decision here is based upon how you will use the information, and the expense, as medical insurance will not pay for it.

 

3. Blood levels of 3 enzyme system to neutralize ROS (reactive oxygen species)

 

Superoxide dismutase (SOD) catalase (Cat) and the ratio of reduced to oxidized glutathione are three enzyme systems that are tasked to treat oxidative stress. If XMRV is the cause of CFS, FM and other related illnesses, it does so by creating massive oxidative stress by knocking out one or more of these enzymes. Their levels can be measured with a blood test in several laboratories. However, again, insurance will not pay for them and your provider may not have heard of them. While still not proven, it is my guess that levels of these enzymes will turn out to be an effective future marker to have if treatment should be attempted.

 

4. Blood, urine levels of Isoprostanes

 

Isoprostanes are a measure of oxidative stress and may be the link with the proven reduction of circulating blood volume.

 

5. ATP production

 

ATP production is the bottom line, and we need more studies like the Myhill, Booth, McLaren-Howard study which showed abnormalities in ATP production. Like the other suggestions above, a clinically practical test which will be covered by insurance is not available at the present time.

 

6. Echocardiogram with cardiac output while standing and IVRT interrogation with oxygen

 

While not published yet in the medical literature, Dr. Cheney's work here should be replicated. The echocardiogram is available, cheap and readily available.

 

There are many other tests that can be used to prove the organic nature of CFS: 2'-5'A Synthetase, RNAse L, Natural Killer Cell analysis, cytokine profiles, anaerobic threshold exercise testing. The fact that persons are still told that there are no approved tests for CFS (see CDC website) is intolerable. Many people with severe CFS are deprived of disability because courts are following the suggestions of the CDC. Thus you become unable to "prove" that you are ill, even if you are bedridden.   

 

Responsible and Irresponsible Medicine

The above suggestions as to criteria to diagnose XAND are easily dismissed as irresponsible, bad medicine. Modern medicine is based upon good, proven science - not speculation. Placebo therapies are no longer acceptable. And it is not acceptable to falsely raise people's hopes with bogus science. I agree with this 100%. But this process in CFS has gone off track.

 

Science will be done only if it is adequately funded. A researcher has to feed his or her family. And the funding agencies generally will fund those studies that prove what they already believe. If you believe that CFS is not "real," you will not vote to fund a study that investigates a hypothesis regarding medical physiology in CFS. It would be a waste of money.

 

Medical politics can and will marginalize and stigmatize certain areas in order to keep control of the process. Furthermore, while an open mind is the goal of a scientist, it is rare.

 

We need to change the scientific process. We should not discipline providers who, in good faith, treat their patients differently than "mainstream" providers do. Patients are not stupid. We need to loosen our grip on those advances that fall outside of the convenient. The good studies on CFS need to be shared in medical education conferences. Now you only see conferences talking about diabetes and high blood pressure. And this is because the conferences are meant to be easy and are funded by drug companies.

 

I once found that a medication I was using to treat CFS had a placebo effect. I found it by doing an inexpensive double blind trial. My patients did feel better but only because I was taking them seriously and trying to help. That is not false hope. After the study, I told them that the medication wasn't helping them. They managed to deal well with the news.

 

But the process of proven-only treatments has gone overboard. There are some things that probably help. But we do not know because the process has discarded patients with CFS. It is too expensive, it is difficult to define, what subtypes do you want to study? And so on. No industry is going to fund a study on high dose vitamin B12, because that drug is generic and not patent protected.

 

Attempting seriously to get to the bottom of CFS is not false hope. I challenge those who discriminate against and disrespect CFS to make accusations of irresponsible medicine.

 

Question and Answer

 

Question: Oh, and my vertigo story has taken an interesting turn.  Last week I saw a new doctor who was filling in for my family physician.  He suspected I have migraine-associated-vertigo and gave me a Maxalt in his office.  Within twenty minutes my nausea was gone and most of my balance was restored.  It felt like a miracle.  He also gave me a referral to a neurologist to talk about preventative medications.  I've been struggling with bouts of vertigo since 1995, so this is good news.

 

Comment: There is an old paper establishing the link between vertigo, CFS, and migraine (Ash-Bernal R, Wall C, Komaroff A, Bell D, Oas J, Payman R, et al. Vestibular function tests anomalies in patients with chronic fatigue syndrome. Acta Otolaryngol. 1995;115:9-17.) It is quite reasonable to try migraine meds in this situation.

 

Question: I have had several episodes of shingles but my doctor will not test them, but suggests the vaccine.

 

Comment: I feel that repeated episodes of shingles do occur in CFS and may be related to reduced number or function of natural killer cells. I do not know how CFS patients respond to the vaccine for shingles. But here is what I would do.
            a) ask for a referral to an infectious disease specialist.
            b) without being arrogant, ask during the visit if he or she would be willing to follow you if XMRV turns out to be the cause of CFS. If the specialist says no, then you have not lost anything. If the specialist says yes, then you wait. But wait respectfully and patiently.
            c) See the specialist regularly so he or she can get to know you. Maybe when the time is right a treatment will be offered. If XMRV turns out to be the cause of CFS, the infectious disease specialists will embrace it and lead in the treatment efforts.

 

 THE SOUND OF A WILD SNAIL EATING

 

It is a great pleasure for me to encourage everyone to buy and read this book. While it seems trite to say, this book really is a triumph of the human spirit. If you thought you understood something about ME/CFS, read this and it is possible you will realize that you understood very little. I learned huge amounts and want to give a copy of it to the family of every patient I have ever had. The writing is magnificent. 

 

And also, congratulations to D. Lark.


FREE BY D. LARK

Sculpture "Free" by D. Lark (LarkBrickArt@gmail.com)

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Disclaimer Any medical advice that is presented in the Lyndonville News is generic and for general informational purposes only. ME/CFS/FM is an extremely complex illness and specific advice may not be appropriate for an individual with this illness. Therefore, should you be interested or wish to pursue any of the ideas presented here, please discuss them with your personal physician.

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© 2010 David S. Bell
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