DOCTOR, DOCTOR, GIVE ME THE NEWS

The International ME Association (IMEA) and patient advocate and IMEA member Keith Baker have nominated Dr. Joan Grobstein, a neonatologist with ME, to sit on the Chronic Fatigue Syndrome Advisory Committee (CFSAC).  A graduate of Harvard College and University of California at Davis Medical School, Grobstein was serving as a neonatologist at Children’s Hospital of Philadelphia and the University of Pennsylvania when she became ill with ME more than a decade ago.  She has testified before the CFSAC committee several times, most recently last spring (see clip at the bottom of this post).

Baker says that Grobstein’s experience both as a patient and a medical doctor is a good blend of attributes that no one else on the committee has.  “And that’s a perspective that the committee needs,” he says.

Grobstein says she decided she wanted to join CFSAC because the current government response has been “inadequate. Access to care is extremely limited, and there is little funding for research into the causes and potential therapies for the disease,” Grobstein explains. “Patients have waited far too long for progress.”

The deadline for CFSAC nominations is August 17^th. A former high-ranking government worker told CFS Central last spring that in his experience what gets the government’s attention is Facebook. In his view, the government has learned to ignore phone calls, faxes and emails. But Facebook campaigns, he said, “panic” them because they’re viral, embarrassing, and leave an indelible footprint.  Ideally, a campaign endorsing Grobstein’s bid could be started today.

BREAKING THE CODES

 Blood Working Group 

Results Expected in a Month

Dr. Michael P. Busch, director of the Blood Systems Research Institute, said today in a telephone interview with CFS Central that his institute began this week to break the codes for the Phase III study of the XMRV Blood Working Group.  “We expect in the next month to preliminarily disseminate the findings,” Busch said.  The Phase III study is evaluating the specificity and sensitivity of different assays in detecting the retrovirus XMRV, first discovered in ME/CFS patients in October 2009 by the Whittemore Peterson Institute.

How the Blood Working Group plans to publicize the results will be determined later this month, when the Blood Working Group scientists have their next phone conference.  Busch offered three possible ways of publicizing the preliminary findings:  in a peer-reviewed journal; at a conference; or in a press release.

“The Working Group will have to decide whether we put out a general public announcement summarizing the findings [making sure] that it would not undermine the scientific, peer-reviewed publication. Major journals are careful about embargoing findings. We’re working on a paper, pending the findings, so that we can plug them in and submit the paper.”

However, “definitive” dissemination will be through publication in a major journal, Bush clarified.

Researchers have examined whole blood, PBMC’s (peripheral blood mononuclear cells, which are cells with a nucleus, key players in the immune response), and serology (antibody testing).  Several labs participated, including those at the Whittemore Peterson Institute, the Food and Drug Administration, National Cancer Institute, and Centers for Disease Control, plus the commercial labs Abbott and Gen-Probe. 

The scientists examined the blood of ME/CFS patients who were positive in the Lombardi and Lo papers, as well as pedigreed negative control donor samples and spiked positives.  Several samples from about 70 different subjects were tested using at least 15 different assays.

“Our Phase IV and other planned studies of donor and recipient infection are contingent on results from Phase III documenting reproducible and specific detection of virus/antibody,” Busch said.

YOU DON'T DESERVE A BREAK TODAY

 

The bigger the lie, the more it will be believed

On the heels of the extraordinary documentary about cancer doctor Dr. Stanislow Burzynski, who’s been fighting the U.S. government  in court for 20 years to treat his patients with an effective cancer therapy, comes another equally powerful HBO documentary called Hot Coffee.  Documentary filmmaker Susan Saladoff paints a grim picture of the U.S. government, corporate America and the press stifling citizens from seeking justice through the courts. 

In the film, oilfield mega-corporation Halliburton prevents a woman from taking her abusers to court, even though she’s been brutally gang-raped and disfigured by Halliburton employees.  In another segment, malpractice caps--so called tort reform--prevent parents from collecting what the jury has awarded them to care for their son, born severely retarded and physically handicapped due to physician error.  And political mastermind Karl Rove, adviser to President George W. Bush, buys big-business judges and destroys judges intent on safeguarding the rights of ordinary citizens.

Bush himself makes a few appearances in the film, putting his foot in his mouth repeatedly. “In my line of work you have to keep repeating things over and over and over again for the truth to sink in, to kinda catapult the propaganda,” he explains.

The title Hot Coffee refers to a McDonald’s case brought by a 79-year-old woman, Stella Liebeck, who was burned by the restaurant’s coffee.  Excoriated by the media and big business as a money-hungry opportunist in search of "jackpot justice," she was, in reality, a hardworking recent retiree who sustained massive third-degree burns that required extensive skin grafts and surgeries.  All she wanted from McDonald’s was for the company to pay for what Medicare didn’t cover.  When McDonald’s refused, they went to court. 

McDonald’s had incurred more than 700 complaints and injuries that its scalding coffee—held at 180 degrees—was too hot, but never did anything about it until Liebeck sued and won.  Still, she remained the butt of jokes.  And given the severity of her injuries, it's not surprising that she never fully regained her strength and has since died.

At least the coffee’s 10 degrees cooler.

What does all this have to do with ME/CFS?  Nothing and everything.  It's the same story of desperate and deserving people being marginalized and abused by the government, big business and the press.  Different insults; same result.

Take a look at the trailer:

J'accuse!

Last week, freelance writer Nigel Hawkes penned a piece for the British Medical Journal called "Dangers of research into chronic fatigue syndrome." In the article, Hawkes argues that "threats to researchers" from the ME/CFS community are "stifling" the science.  In particular, he mocks patients who've accused British psychiatrist Simon Wessely of throwing a young boy into a swimming pool to check if his paralysis was genuine.  

I wrote a letter to Hawkes to set the record straight, as I interviewed the parents of that boy last summer for one of the first articles I wrote for this blog, "Hard Cell."  I waited a few days for a response from Hawkes, but he's not replied, so it's time to post the letter:  

 
Dear Mr. Hawkes,

I’m an investigative reporter in the States. Last summer, I interviewed the parents of Ean Proctor for an article I was writing. Nearly 25 years ago, when he was 12, Ean, who was wheelchair-bound with a severe case of ME, was put facedown in a swimming pool without water wings.  He sank underwater and had to be rescued.  He endured other Dickensian tactics while he was sectioned.  For instance, the doctors and nurses, according to Mrs. Proctor, believed Ean was faking his illness and forced him to feed himself, which took hours because his arms were so weak.  He sat in soiled clothing because the nurses wouldn’t take him to the bathroom.

Although Dr. Simon Wessely didn’t personally do any of this to Ean, he did sign papers that led to Ean being separated from his parents where he was abused—there is no other word for it than abuse—for five months before his parents finally succeeded in getting him out.

I wrote a piece on his ordeal called “Hard Cell” for my blog, CFS Central.  In it, I referenced the documents Wessely wrote about Ean back then.  You can read three of them in full.  In addition, I interviewed Dr. Wessely, who did not deny the incident.  Moreover, there is a link to a youtube video where Ean is interviewed about his sectioning.

I’ve interviewed many other ME patients who’ve been subjected to similar abuses at the hands of British doctors and live in fear that they’ll be sectioned again. After 30 years of abuse at the hands of many in the British health system, patients have rightfully had enough. I believe that you’ll better understand what patients are really dealing with from Dr. Wessely and others like him if you get all the facts.

I welcome a dialog with you toward more accurate reporting on this issue.

DUSTY MILLER REDUX

Second Email Exchange Between 

Dusty Miller and CFS Central

CFS Central:  You wrote: "Regarding the data in Lombardi et al., I was initially convinced by their extensive analysis, in particular, their ability to grow virus from patient materials. Indeed, we entered the CFS/XMRV field largely on the basis of these data. However, published and unpublished data now indicate that all of these methods were flawed.”

 
As far as I'm aware, no published or unpublished data indicates that the methods of Lombardi et al. were flawed. To what studies are you referring? 

Dr. Dusty Miller:  In the recent Science Express paper by Knox, ..., and Levy, the authors used three techniques to detect XMRV and related retroviruses in humans with CFS, and found none.  These techniques included nested PCR, an assay for infectious virus, and assays for neutralizing antibodies and other inhibitory factors in blood.  Importantly, many of the CFS subjects they studied came from Dr. Peterson's practice in Incline Village, and represent some of the same patients that Lombardi et al. studied.  Therefore, this is a close replication of the Lombardi et al. study.  The Knox study is in addition to many other negative studies cited in this paper (refs. 7-12).  

Lastly, the XMRV viral sequences deposited by Lombardi et al. in GenBank all are very closely related the VP62 XMRV sequence (see the supplemental material in Knox et al.), and the VP62 plasmid from Robert Silverman was apparently present in the labs of Lombardi et al., strongly indicating contamination of the Lombardi et al. PCR assays by VP62 plasmid DNA.  Putting all of this together leads me to conclude that the methods of Lombardi et al. must have been flawed.

CFS Central:  You also wrote: "Regarding the constant accusation that no one has carefully replicated Lombardi's methods, this is not true as far as most scientists are concerned. Initial reports attempting to replicate the study did have flaws, but many later studies are convincing.”

The problem with these later studies as I see it is that not one of the so-called replication studies was a bona fide replication. The patient cohorts and/or methods used were not identical. I learned in 9th grade science that being identical in cohort and methods are necessary for a true replication—otherwise you’re introducing variables that may account for the different findings. In your view, could the different methods/cohorts account for the differences in the findings? Why or why not?
 

Miller:  Please see my response above.  It is difficult to perform an exact replication study, which would involve going to the Mikovits lab and watching whoever did the previous study repeat it with the same patient samples.  Besides which, you may have also learned in 9th grade science that scientific results must be generalizable, that is, competent scientists must be able to repeat the experiments under somewhat different conditions and obtain similar results.  If the claimed result can only be obtained by performing the experiment in one spot in the Mikovits lab, perhaps while singing a particular song, then the results are not generalizable and should be looked on with suspicion. 

DUSTY MILLER'S XMRV STUDY

Dr. Dusty Miller gave this statement to CFS Central about his XMRV study:

"Our paper is in press in the Journal of Virology, and should be available online through the Journal website on Wednesday this week.  We performed our study independently of the Paprotka et al. (including Coffin) study recently published in Science, but the results do overlap.  Essentially, we found an endogenous retrovirus (mERV-XL) in NIH/3T3 cells, a commonly used mouse cell line, that is virtually identical to what Paprotka et al. are calling PreXMRV-2.  You can find both sequences on the NCBI website.  One of the points we make is that all of the PCR primers used to detect the XMRV gag region can amplify a sequence identical to XMRV from NIH/3T3 cells, which are present in many labs.

"Unfortunately, we did not find an intact copy or the right half of XMRV in any of the mouse cell lines or tissue that we analyzed, but clearly we did not look hard enough.  Paprotka et al. firmly established the origin of XMRV from nude mice.  We were pursuing the same hypothesis, but could not get early samples of the cell lines and tissues from which the XMRV-carrying 22Rv1 cells were derived."

The Geniuses and the Other Guys

 Burzynski's Cure and Coley's Lost Cure

The extraordinary documentary on Dr. Stanislow Burzynski has been making the rounds the past few days. Born in Poland, Burzynski now practices medicine in Houston, Texas, where he pioneered cancer therapy with antineoplastons, nontoxic peptides in the human body that prevent cancers. Burzynski discovered that cancer patients were deficient in antineoplastons and has been successfully treating patients with them for two decades.  His nontoxic treatment is far more successful that most current toxic chemotherapies and radiation, particularly for patients with brain cancer who haven’t had prior chemo and radiation.

Burzynski versus the government
While Burzynski has recorded phenomenal success treating patients, the FDA has tried to shut him down repeatedly.  The agency has taken him to court several times and tried—unsuccessfully —to haul him off to jail, while the National Cancer Institute initiated antineoplaston drug trials using too-low dosages to discredit Burzynski’s discovery, and the government managed to secure patents for antineoplastons, which Burzynski had already secured years earlier. 

My mother's cancer
Back in 1995, my mother was suffering from colon cancer.  My father, a physician, contacted Burzynski, who said that his treatment didn’t work for colon cancer—at least at that time.  So my mother endured the standard chemo—the aptly named 5FU—and died in 1998.

After she died, I started researching chemo drugs like 5FU and realized how useless most standard chemotherapy was for most tumors (the exceptions are testicular cancer, leukemia, lymphoma and Wilms’ tumor).  Boy, was I pissed; I realized how duped I had been. (My father knew 5FU wouldn't cure my mother, but what else was there?)  Reading cancer studies—not just the abstracts—I learned that most chemo and radiation shrink tumors but don't extend life, and when the tumors grow back, they’re often far more virulent.  That certainly was the case with my mother’s cancer.

William Coley
In my research, I came across the pioneering cancer research in the late 1800s of Dr. William Coley, a brilliant, handsome New York doctor at Memorial Hospital, which is now called Memorial Sloan Kettering.  His cancer research began in 1890, when Elizabeth Dashiell, a delicate young woman of 17, was diagnosed with bone cancer in her right hand. William Coley, a graduate of Harvard Medical School, was her 28-year-old surgeon.  Since her diagnosis had come early in the course of the disease, amputation of her afflicted arm below the elbow was swift.  Yet she died a few months later. 

Distraught over her death, Coley began poring over old patient records—for what, he wasn’t sure.  As Coley read the dusty charts, he saw that most cancer therapies failed; most of the patients died.  But curiously, one patient who was severely afflicted with sarcoma, a cancer of the connective tissue, did recuperate.  Hospitalized and near death in the fall of 1884, he experienced two outbreaks of a severe skin infection called erysipelas.  Caused by a strep bacterium, the infections resulted in high fevers and roused his sleepy immune system.  The bumpy, plum-sized tumor below his left ear began to shrink and the patient rallied, recovering completely.  When the tenacious Coley tracked the man down, he was well with no cancer recurrence some seven years later.

Uncharted territory
Because Coley’s discovery transpired more than a century ago when the immune system was uncharted territory, the scientist didn’t understand how the patient’s strep infection could bring about a cancer remission.  Nevertheless, the prescient physician thought perhaps he had stumbled across something important—a novel way to treat cancer—and began a series of experiments, injecting first live strep bacterium and later killed strep, as it was safer, into patients with sarcomas.  The first patient he treated recovered completely, many more followed, and the young surgeon soon published his first paper.  

But because scientists didn’t understand how the toxins worked, the treatment was never fully embraced. When Coley’s boss at Memorial, Dr. James Ewing—a snappish widower who liked his chicken rare, his lamb overcooked, and his clothes dated and baggy— decided to champion a new cancer treatment—radiation—the fix was in.  Radiation soon eclipsed Coley's toxins, Coley and Ewing became fierce rivals, and Coley's discovery was relegated to a footnote in cancer research.  In 1965, in what now seems an incredible lapse of judgment, the American Cancer Society consigned Coley’s vaccine to the list of “unproven” cancer drugs, where it joined the crooked ranks of coffee enemas and laetrile.  In fact, his toxins were a more effective cancer treatment than most current chemotherapy and radiation.

Book proposal
After reading about this extraordinary man, a century ahead of his time, I decided to write a book about him, with the working title The Genius and the Other Guy. My agent loved the book proposal but not the title, which he changed to The Lost Cure.  But the publishing houses didn’t go for it in any event.  “Who cares about a failed cancer treatment?” was the common refrain.

Ah!  If only the sheep didn’t dictate what books were sold, what drugs were approved and what scientific discoveries were embraced, we’d all be so much better off, wouldn’t we?

-----------------------------

This article is copyright CFS Central 2010. All Rights Reserved. You may quote up to 150 words from this article as long as you indicate in the body of your post (as opposed to a footnote or an endnote) that the excerpt is by Mindy Kitei for CFS Central. You may not reprint more than 150 words from this article on blogs, forums, websites or any other online or print venue. Instead, refer readers to this blog to read the article. 


Public service announcement:  People interested in being treated with the experimental ME/CFS drug Ampligen in the San Francisco Bay area and can afford the circa $2,500 a month that the drug and infusions will cost, please contact: samp511@comcast.net

ANIMAL FARM

The culture medium for the vaccines that many of us have received over the years includes cells from animals. It’s possible that these cells have harbored animal viruses or retroviruses, which subsequently piggybacked their way, via the vaccines, into humans.  Here are some of those vaccines:

Polio vaccine:  Monkey kidney tissue

Polio vaccine:  Mouse brain

Japanese encephalitis vaccine: Mouse brain

Rabies vaccine:  Rhesus fetal lung tissue

Rotovirus vaccine: Monkey kidney tissue

Vaccinia (smallpox) vaccine: Monkey kidney cell

Yellow fever vaccine; flu vaccine; rabies vaccine:  chicken embryo

JAY LEVY: Got Some 'Splainin' to Do

I sent this email to Dr. Jay Levy, co-author of the recent XMRV-negative paper published in Science last week:

I’m a science reporter and blogger on CFS Central.  I read this quote by you on Bloomberg today [Tuesday, May 31], and have a few questions about it:

“When that paper came out I was totally surprised and suspicious,” Levy said today in a telephone interview.  “Who knew there would be pressure on the government to do these expensive studies? I’ve never been around anything quite so dramatic and misleading and misunderstood for so long. There are financial ramifications, and medical and health ramifications.”

• Why were you “surprised and suspicious” when the 2009 Mikovits study was published?
  

• What do mean by “dramatic and misleading and misunderstood”?  Are you talking about CFS or XMRV or something else?
  

• What financial, medical and health ramifications are you referencing?
  

• On another note, the groups that funded your study are not listed by name. Sources have informed me that the HHV6 Foundation helped fund the study. Is that correct?
  

I would appreciate a response by end of business Friday.

Levy didn't reply.

 

SAVE ME FROM STEVEN SALZBERG (Part 2)

It's not going to stop
'Til you wise up 

Yesterday, I responded to Dr. Steven Salzberg's diatribe in Forbes against XMRV and Dr. Judy Mikovits.  Today Salzberg responded to me, and then I to him.

Salzberg:

"Ah, the Galileo gambit! Thanks Mindy, for illustrating a classic logical fallacy. You compare Mikovits to Galileo – the implication being that if the “establishment” disagrees with a scientist, then that scientist much be a brilliant revolutionary thinker. At the same time you would imply that those of us who disagree with Mikovits are just too dumb or too stubborn to understand her new ideas. Sorry, not falling for it. (See Orac’s discussion, http://scienceblogs.com/insolence/2006/08/the_galileo_gambit_1.php, or the RationalWiki, for more on this gambit.)

"And about replications: yes, there are multiple studies that attempted to replicate Mikovits’ result, and they all failed. Neither Mikovits nor you gets to dictate what a “replication” is. The whole point is that these are independent studies, which means the scientists conducting them get to decide how best to test the original claims. The peer-review process then evaluates whether or not the follow-up studies are worth publishing."

CFS Central reply:

No, Steven, that’s not what I was implying. I’m not saying that Judy Mikovits is right and the other researchers are wrong. What I am saying is that no one will know the truth until her study is replicated precisely.

What I’m also saying is that the history of science–and everything else for that matter–is filled with outside-the-box thinkers who were right but who were excoriated by a myopic status quo. Could this be the case with the Mikovits finding? Only time will tell.

That is one reason why, in my view, people shouldn’t be so quick to judge. The late physicist and science historian Thomas Kuhn, who authored the groundbreaking book The Structure of Scientific Revolutions in 1962, believed the lag between the emergence and acceptance of new ideas is natural and inevitable. Change, he postulated, can come about only after long periods of stasis because “frameworks must be lived with and explored before they can be broken.”

Compounding the inertia, and contrary to popular belief, Kuhn held that most scientists are not objective and independent thinkers. Rather they are rigid conservatives who do their best to implement exactly what they’ve been taught.

As far as these XMRV “replications,” clearly you haven’t read these studies carefully. Not one has been a bona fide replication. I’ve interviewed many of the authors of these studies for my blog, CFS Central, and they agreed that their studies weren’t replications.

For instance, Dr. Kate Bishop, the principal investigator of one of the British studies, said that a key reason her cohort didn’t adhere to the Mikovits protocol is that she believes it’s tougher to get a paper published when the experiment is conducted in exactly the same way as the original study.

Dr. Myra McClure, the principal investigator of the first British study, said that her study “was never designed to replicate [the Mikovits] study or to say, ‘Look how clever we are, and they’re wrong,’ she says. “It was simply an investigation to see if we in this country could detect this virus in our CFS patients that were homegrown here.”

To your point that “neither Mikovits nor you gets to dictate what a ‘replication’ is,” consider cracking open a 9th grade science book. In Biology, by Stephen Nowicki, published by McDougal Littell in 2008, the author explains what a replication is:

“Scientists repeating another person’s experiment must be able to follow the procedures exactly and obtain the same results in order for the experiment to be valid. Valid experiments must have

• a testable hypothesis
• a control group and an experimental group
• defined independent and dependent variables
• all other conditions held constant
• repeated trials”

Got it? All conditions must be held constant for the experiment to be valid. That’s the definition of a replication, not what you decide, or what I decide or what any researcher on the planet decides.

And a replication is certainly not, as you claim, a free-for-all in which “scientists conducting them get to decide how best to test the original claims.” When you change things up, you introduce variables that may account for a different result.

Once again, I urge you to sit down and read the XMRV studies carefully before making judgments.

Scene from the movie Magnolia. Aimee Mann wrote the accompanying song, "Wise Up."

STEVEN SALZBERG'S PSEUDOSCIENCE

You look like a perfect fit
For a girl in need of a tourniquet

Today Forbes' Dr. Steven Salzberg joined the XMRV naysayers, penning the piece "Chronic fatigue syndrome: virus hypothesis collapses further."  Salzberg took a step further, labeling Dr. Judy Mikovits a "pseudoscientist." He's the same Steven Salzberg who doesn't believe there's an autism epidemic but does believe that acupuncture is nonsense. Surely a front-runner for columnist Keith Olbermann's Worst Person in the World award, Salzberg is not exactly an outside-the-box thinker. 

Below is my letter to the editor:

As a science reporter and blogger, I was disappointed to read Steven Salzberg’s article. Dr. Salzberg, if you’d sit down and read all the “replications” of the 2009 Science study in their entirety, you’d realize they’re not replications. 

The essence of the scientific method is reproducing precisely the methods and patient cohort of the original study, something most of us learn in 9th grade science. 

None of these so-called replications meet that standard. The Levy study didn’t replicate the methods of the 2009 Science study.  The Centers for Disease Control's study and the British XMRV studies examined patients with idiopathic fatigue and depression, not CFS, which is a neuroimmune disease that causes acquired immune abnormalities, including natural killer cell dysfunction--the CFS counterpart to HIV’s T-cell depletion.

CFS also causes seizures, abnormal brain scans, rare cancers and autonomic dysfunction, leading to abrupt drops in blood pressure upon sitting or standing.

Both the CDC’s study and the British studies weeded out anyone with neuroimmune or autonomic dysfunction. The work of Dr. Leonard Jason at DePaul University has established that the CDC and the British scientists are studying the wrong cohorts. 

Moving on, the Mikovits study found antibody reactions to XMRV in patients. You don't get an antibody reaction to a contaminant.  Morever, only 4 percent of controls in the Mikovits study tested positive for XMRV, while 67 percent of patients tested positive. If XMRV were contamination, one would expect an equal distribution. 

Science seems hell bent on consensus, but as Harvard-educated physician and medical thriller writer Dr. Michael Crichton once pronounced: “Let’s be clear: The work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right....”

Sadly, the history of science is replete with investigators who were discredited by the status quo but who were eventually proved right:  Galileo, Semmelweis, Pasteur, Ohm, Nott, Zweig and Rous, to name a few.

In 1982, Drs. Barry Marshall and Robin Warren discovered that H. pylori was the cause of stomach ulcers. In the early 20th century, there had been interest in an ulcer link to the spiral-shaped bacterium until a large 1954 U.S. study failed to find it in stomach biopsies, delaying the discovery for 28 years.

Whether Dr. Mikovits is right is anyone’s guess. But asking her to withdraw her paper before the truth is known is the antithesis of science.  Doing “replications” that aren’t bona fide replications is the antithesis of science. 

As far as patients taking anti-retrovirals, all drugs have risks, but several CFS patients I’ve interviewed have been helped by these medications.  Their natural killer cell numbers, for instance, have normalized and a few have largely recovered. Patients responding to anti-retrovirals would put a serious kink in the XMRV contamination theory, which is one reason some believe that these researchers are determined to get patients off them.

Given that physicians are now prescribing anti-retrovirals to healthy HIV-negative people in high-risk groups, I find it particularly unsettling that the researchers who’ve conducted these non-replication XMRV studies are admonishing desperate and dying CFS patients that they have to be wait for treatment. In fact, CFS patients have been waiting for decades; many have died waiting. There is not one approved drug for CFS--and none in the offing.  The government spends only $6 million a year on CFS, a million more than it spends on hay fever. 

Approximately one-third of the parents with CFS whom I’ve interviewed have children with autism. This is not chimera; there is a connection here.

Twenty years ago, the first evidence of a retrovirus in CFS patients surfaced at the Wistar Institute at the University of Pennsylvania.  Back then, the CDC refused to replicate the methods of Wistar’s Dr. Elaine DeFreitas. When the CDC couldn’t replicate her findings, the research died. Two decades later, it’s deja vu all over again.

I believe, Dr. Salzberg, that you’d do your readers a greater service if you would read the studies in their entirety and learn about the history of this disease, instead of spinning misinformation.

Letter in Response to WSJ Article

Last night the Wall Street Journal published Amy Marcus's article "Chronic-Fatigue Paper Called Into Question."  Here is my response:

As a science reporter and blogger, what I find most perplexing about the Science editors asking Dr. Mikovits to withdraw her study is that the jury is clearly still out. While some laboratories haven’t found XMRV in CFS patients, others have. The ones that haven’t found XMRV failed to replicate the methods and patient cohort of the original Science study, making their findings questionable. The laboratories that have found the retrovirus include a study by National Institutes of Health Lasker Award winner Dr. Harvey Alter and the FDA’s Dr. Shyh-Ching Lo. Their study found variants of XMRV in 86 percent of patients and 7 percent of apparently healthy controls. All the controls were blood donors, signaling a contamination of the blood supply.

In addition, the original Science study was coauthored by the Cleveland Clinic and the National Cancer Institute, both of which also found the retrovirus in CFS patients. Moreover, other laboratories have found the retrovirus in CFS patients but have not yet published their findings. And, finally, respected laboratories have found the retrovirus in prostate cancer patients as well, making the contamination theory less than likely.

Given that others have replicated Mikovits’ findings, given the high stakes in a population that has no treatment after 30 years of government neglect, given that many CFS patients have died from the disease and many others experience a living death, I find it problematic that Science has asked Dr. Mikovits to withdraw the paper.

Some see this move as the first step to shutting down current NIH-sponsored XMRV CFS studies, as the government did 20 years ago, when the first evidence of a retrovirus in CFS patients surfaced at the Wistar Institute at the University of Pennsylvania. Back then, the Centers for Disease Control refused to replicate the methods of Wistar’s Dr. Elaine DeFreitas. When the CDC couldn’t replicate her findings, the research died. Twenty years later, it’s deja vu all over again.

Science seems to be hell bent on consensus, but as Harvard-educated physician and medical thriller writer Dr. Michael Crichton once pronounced: “Let’s be clear: The work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right....”

Whether Dr. Mikovits is right is anyone’s guess. But asking her to withdraw her paper before the truth is known is the antithesis of science.

Round 3 for WPI and Chase; Healkick's New Features

From ME/CFS patient Justin Reilly:

There is a silver lining in winning less than $100K in that we are eligible for the $200K discretionary spending prize. (There is also an additional $300K in discretionary spending for which I believe all the charities in round 2 are eligible).

I sent the following letter in case anyone wants any ideas. Thanks to Ann from whom I borrowed some wonderful phrasing!

Dear Chase Community Giving,

I am a Chase customer. I support Whittemore Peterson Institute in the CCG contest. I am writing you to let you know how great WPI is and urge you to award them some of the discretionary contest funds.

I have had ME/CFIDS for ___ years. 17 million people worldwide have this devastating neuroimmune disease, with virtually no viable treatment options and little bona fide research.

That is, until the Whittemore Peterson Institute recently came along. One family, fighting for their daughter's life, footed the bill and opened a state of the art Institute to research neuroimmune disease. As the New York Times noted, comparing WPI to Michael J. Fox's Foundation and others, "Harvey and Annette Whittemore were not the first to start a research foundation out of desperation to find answers for an incurable disease... But few if any of the private groups have produced notable results as quickly as the Whittemore Peterson Institute has."

Unfortunately, the Whittemore family can no longer cover all of the Institute's costs alone. WPI needs help raising money that will all go toward desperately needed research for a cure. This is where you can help. Please award this most deserving of charities as much of your discretionary funding as possible!

Thank you for your consideration.

Sincerely,

http://apps.facebook.com/chasecommunitygiving/rules

(Charities awarded a Round 2 grant of $100,000 or more in the current program are not eligible to receive the $200,000 Advisory Board grant)

 ***

Healkick, the forum for ME/CFS patients under 40, has added new features:

• IM Chat (private and public). "Many patients have said it’s the first time they’ve actually talked to another patient," says Cari Lea, who co-founded Healkick with Joey Tuan. 

• Language friendly. You can choose the language of your choice to read posts. No more struggling to read the forum in English.

• Patient Map.  "Every member that joins the site enters where they live," explains Cari Lea.  "It all gets put on our Patient Map. So patients can see who lives near them, and find patients they can meet up with or at least find some local support--something that is very hard for most of us to find."

Facebook and the Government

A former high-ranking government worker has told CFS Central that in his experience what gets the government’s attention is, yes, Facebook. In his view, the government has learned to ignore phone calls, faxes and emails. But Facebook campaigns, he said, “panic” them because they’re viral, embarrassing, and leave an indelible footprint.  Ideally, a campaign could be started directly on the government's own Facebook pages.

MONEY AND JUSTICE

Ailing biologist Dr. Alfred Kinsey pleaded to A & P supermarket heir George Huntington Hartford II in the 1950s for a research grant to cover his groundbreaking research into human sexuality. “We need money,” Kinsey told Hartford in the film Kinsey.  “We need someone to give us money.  You have no idea what I’ve had to endure just to obtain the same rights other scientists take for granted.  My funding has been slashed, my name has been dragged through the mud in every newspaper and magazine across this country…. We’re broke.  I’m not sure how much time I have left.  Help me.  I have to get it all on the record.”

Hartford refused to give Kinsey the grant:  He found the subject matter too scandalous and controversial.

Sound familiar?

If enough ME/CFS patients vote in round two of the Chase Community Giving contest, they can help ensure that WPI gets the money it needs for ME/CFS research.  

1. Go to facebook: http://www.facebook.com
2. Copy and paste this URL: http://www.facebook.com/ChaseCommunityGiving?ref=ts
3. Click the "like" button (to the right of "Chase Community Giving" at the top. If you’ve  already "liked" Chase Community Giving, you won’t see the “like” button, and you can skip to the next step.
4. Copy and paste this URL: http://tinyurl.com/wpiround2  Click the big green "Vote & Share" button to cast your vote.

ZOMBIE APOCALYPSE NOW

  Sounds Like ME/CFS to Me

 

One of the CDC's polite press guys, David Daigle, whom I've had the pleasure of speaking with on several occasions, posted this how-to manual to prepare for the Zombie Apocalypse, on the CDC's Public Health Matters Blog.  Curiously, what causes folks to transmogrify into zombies appears to be, according to Daigle, an infectious agent passed in a bite or bodily fluids that causes a neurodegenerative syndrome.  Does David Daigle know something we don't know?  Not to mention that patients describe both being a zombie and ME/CFS as "a living death," "death warmed up" and "I feel like such a zombie!" 

Below, in purple, is an excerpt from Daigle's post, which drew a whopping 23,000 readers to the lonely CDC blog--a record--causing the site to crash. 

Preparedness 101: Zombie Apocalypse

There are all kinds of emergencies out there that we can prepare for. Take a zombie apocalypse for example. That’s right, I said z-o-m-b-i-e a-p-o-c-a-l-y-p-s-e. You may laugh now, but when it happens you’ll be happy you read this, and hey, maybe you’ll even learn a thing or two about how to prepare for a real emergency.

A Brief History of Zombies

We’ve all seen at least one movie about flesh-eating zombies taking over (my personal favorite is Resident Evil), but where do zombies come from and why do they love eating brains so much? The word zombie comes from Haitian and New Orleans voodoo origins. Although its meaning has changed slightly over the years, it refers to a human corpse mysteriously reanimated to serve the undead. Through ancient voodoo and folk-lore traditions, shows like the Walking Dead were born.

A couple dressed as zombies - Danny Zucco and Sandy Olsson from the movie Grease walking in the annual Toronto Zombie Walk.

In movies, shows, and literature, zombies are often depicted as being created by an infectious virus, which is passed on via bites and contact with bodily fluids. Harvard psychiatrist Steven Schoolman wrote a (fictional) medical paper on the zombies presented in Night of the Living Dead and refers to the condition as Ataxic Neurodegenerative Satiety Deficiency Syndrome caused by an infectious agent. The Zombie Survival Guide identifies the cause of zombies as a virus called solanum. Other zombie origins shown in films include radiation from a destroyed NASA Venus probe (as in Night of the Living Dead), as well as mutations of existing conditions such as prions, mad-cow disease, measles and rabies.

The rise of zombies in pop culture has given credence to the idea that a zombie apocalypse could happen. In such a scenario zombies would take over entire countries, roaming city streets eating anything living that got in their way. The proliferation of this idea has led many people to wonder “How do I prepare for a zombie apocalypse?”

Well, we’re here to answer that question for you, and hopefully share a few tips about preparing for real emergencies too!

Disaster or Blackout Emergency Supplies

Some of the supplies for your emergency kit

Better Safe than Sorry

So what do you need to do before zombies…or hurricanes or pandemics for example, actually happen? First of all, you should have an emergency kit in your house. This includes things like water, food, and other supplies to get you through the first couple of days before you can locate a zombie-free refugee camp (or in the event of a natural disaster, it will buy you some time until you are able to make your way to an evacuation shelter or utility lines are restored). Below are a few items you should include in your kit, for a full list visit the CDC Emergency page.

• Water (1 gallon per person per day)
• Food (stock up on non-perishable items that you eat regularly)
• Medications (this includes prescription and non-prescription meds)
• Tools and Supplies (utility knife, duct tape, battery powered radio, etc.)
• Sanitation and Hygiene (household bleach, soap, towels, etc.)
• Clothing and Bedding (a change of clothes for each family member and blankets)
• Important documents (copies of your driver’s license, passport, and birth certificate to name a few)
• First Aid supplies (although you’re a goner if a zombie bites you, you can use these supplies to treat basic cuts and lacerations that you might get during a tornado or hurricane)

SHOAH TESTIMONY

A Few of the Speakers at this Week's Chronic Fatigue Syndrome Advisory Committee Meeting at the Department of Health and Human Services in Washington, D.C.

Dr. Mary Schweitzer delineates what's problematic about the CDC when it comes to ME/CFS:



Dr. Joan Grobstein, a neonatologist, discusses transmission and treatment of ME/CFS and what the government needs to do in the next six months to end the inertia:

Lori Chapo-Kroger, the founder of CFS Solutions of West Michigan, talks about the death of three friends from ME/CFS:



Attorney Charlotte von Salis speaks on disability benefits, the problematic definition, and why many patients want to dissociate from the CFIDS Association:



Respiratory therapist Meghan Shannon, who's had ME/CFS for 35 years, gives her moving testimony and explains what's wrong with the CDC website:



Demonstration by playwright Rivka Solomon, who is joined by other patients, outside HHS:



Too ill to testify in person, 22-year-old patient Ben Di Pasquale was filmed by a local TV station.

JUDY MIKOVITS' NEW STUDY

Xenotropic Murine Leukemia Virus-related Virus-associated Chronic Fatigue Syndrome Reveals a Distinct Inflammatory Signature 

Published IN VIVO

VINCENT C. LOMBARDI, KATHRYN S. HAGEN, KENNETH W. HUNTER, JOHN W. DIAMOND, JULIE SMITH-GAGEN, WEI YANG and JUDY A. MIKOVITS

Abstract. Background: The recent identification of xenotropic

murine leukemia virus-related virus (XMRV) in the blood of

patients with chronic fatigue syndrome (CFS) establishes that a

retrovirus may play a role in the pathology in this disease.

Knowledge of the immune response might lead to a better

understanding of the role XMRV plays in this syndrome. Our

objective was to investigate the cytokine and chemokine

response in XMRV-associated CFS. Materials and Methods:

Using Luminex multi-analyte profiling technology, we

measured cytokine and chemokine values in the plasma of

XMRV-infected CFS patients and compared these data to those

of healthy controls. Analysis was performed using the Gene

Expression Pattern Analysis Suite and the Random Forest tree

classification algorithm. Results: This study identifies a

signature of 10 cytokines and chemokines which correctly

identifies XMRV/CFS patients with 93% specificity and 96%

sensitivity. Conclusion: These data show, for the first time, an

immunological pattern associated with XMRV/CFS.

HAVE YOU NO SENSE OF DECENCY?

Here is my testimony at the Chronic Fatigue Syndrome Advisory Committee meeting on Wednesday at Health and Human Services in Washington, D.C.  Below the written testimony is the video clip.

My name is Mindy Kitei.  I’m a science reporter who’s covered ME/CFS for twenty years.  Last June, I began my blog, CFS Central, in honor of my friend Nancy Kaiser.

I met Nancy in 1994, while working on an investigative piece for Philadelphia magazine called “The AIDS Drug No One Can Have” about the experimental HIV and ME drug, Ampligen.

Nancy had a severe case of ME. She had multiple seizures every day. When she tried to sit or stand, her blood pressure plummeted; she often crawled instead. She tried many experimental treatments to get well.

Nancy died on June 15, 2008.  I naively thought she’d never succumb to the illness, as if by sheer will she’d keep herself alive.

Three other ME patients whom I interviewed in 1994 have also died of the disease.

Despite its gravity, despite ample evidence that ME is an infectious disease, the government treats it like a joke. The CDC and parts of the NIH have been playing a shell game:  studying patients with simple fatigue or chronic fatigue or depression—but labeling them CFS patients. 

Even when the CDC conducted its XMRV study, it studied the wrong cohort and refused to do an actual replication of the Science study.  It’s just a different kind of shell game from the bogus psychological CFS studies that are the agency’s trademark.

To the CDC and NIH scientists who’ve been doing this ludicrous research for three decades and sweeping a worldwide human catastrophe of 17 million people under the carpet, I say to you:  Have you no sense of decency at long last?

ME patients are suffering from a serious infection— most likely a retrovirus—but are told by charlatans to exercise and have a positive attitude. 

Researchers in government and at universities, as well as the CFIDS Association, admonish desperate patients that taking anti-retroviral drugs is medically indefensible.  When the healthy reprove the sick that they’re impatient and reckless and foolish and need to wait for treatment, I say there is no treatment, and where are the drug trials?  Thirty years and not one approved drug and none in the offing.

ME patients should have the same freedom to try medications that AIDS patients had in the early days.  The AIDS patients became their own advocates because there was no one advocating for them.  The same holds true for ME patients now. Patients are gravely ill, and they have the right to treatment.  To say that they don’t—that’s what is medically indefensible.

The U.S. government conducted the Tuskegee Syphilis Experiment from 1932 to 1972.  The study tracked the progression of untreated syphilis among poor African American men but didn’t tell them they had syphilis. The men got sicker and many died.

In 1997, President Clinton apologized to the remaining Tuskegee men.  Clinton said:  “What was done cannot be undone. But we can end the silence. We can look at you in the eye and finally say on behalf of the American people, what the United States government did was shameful, and I am sorry.”

The United States government has watched ME patients suffer and die for 30 years, and has done nothing, and that is shameful.

In less than a year, more than 125 thousand patients from 108 countries and territories have found my blog, CFS Central.  Patients write to me asking for help every day.  Toward that end, I request a meeting with Kathleen Sebelius, Howard Koh, Francis Collins, Tony Fauci and Thomas Frieden to discuss how to turn this situation around, by funding good studies and finding effective medications.

About funding ME, Dr. Dennis Mangan said during this meeting:  “We’ll use one dollar and try to make two.”   I’m sure Dr. Mangan means well, but it isn’t enough.  As AIDS activist Larry Kramer said years ago about HIV patients:  “We are not crumbs.” After thirty years of neglect, ME needs research parity with HIV. We also need a czar who will oversee ME and report directly to President Obama. 

Finally, we need to enact the ME/CFS Care Act.  Much like the Ryan White Care Act for HIV patients, the ME/CFS Care Act will provide health coverage to needy patients.

In closing, I ask you, Dr. Wanda Jones, to ensure that this meeting occurs.  Dr. Jones, will you help me? 

BLOGGER LOST ALL THE COMMENTS ON THE POST.  SHOULD ANY OF YOU WANT TO COMMENT AGAIN, I WILL OF COURSE POST THEM AGAIN.

BLOOD VERSUS TISSUE

4generations commented on yesterday’s post on Dr. Ila Singh's XMRV-negative ME/CFS study: 

Singh's primate study found that XMRV left the blood of the infected primates after a few weeks (6, I believe). Isn't that finding plus the finding of XMRV in prostate cancer patient tissue good enough evidence to justify a study looking for XMRV/MLV in the tissues of patients with ME/CFS?

4generations, the primate study at Emory University wasn’t Singh’s. But your point is well taken, as XMRV quickly left the blood and settled in the tissues in the macaques. In addition, in the CDC’s new XMRV study on prostate cancer this week, the three patients who tested PCR positive to XMRV in tissue had no virus in plasma by PCR or Western blot.  

If that can occur in prostate cancer, perhaps that can occur in ME/CFS as well.  Moreover, as some readers have pointed out, Dr. Kenny de Meirleir in Belgium is taking tissue samples in the gut of ME/CFS patients and finding them positive for XMRV.

DR. ILA SINGH:

She believes XMRV isn't in ME/CFS patients but that there's evidence for the retrovirus in prostate cancer

CFS Central emailed University of Utah's Dr. Ila Singh about her new XMRV study, which found no evidence of XMRV in ME/CFS patients. In 2009, Singh found evidence of the retrovirus in prostate-cancer tissue.

CFS Central:  Will you revisit your prostate-cancer XMRV findings in light of this XMRV negative CFS study?  From what you’ve learned in this latest CFS study, do you now believe that the XMRV that you found in prostate cancer is a human infection or just contamination?

Dr. Ila Singh: Prostate cancer and chronic fatigue syndrome are completely different illnesses.  I recognize that recent studies have cast doubts on the prostate cancer association as well, but there is still considerable data supporting the link to prostate cancer that cannot be easily explained by contamination. We will present some of this work at the Cold Spring Harbor meeting later this month.  But clearly more work needs to be done before that question can be settled. 

CFS Central:  Do you believe scientists should be looking for XMRV in CFS patients’ tissues instead of blood?
 

Singh: The original study by Mikovits' group reported finding XMRV only from blood.  They did not examine other tissues.  So blood is where the focus should be. Now if one found it in blood, then of course you'd be interested in finding out where else the virus is.  And then it would be interesting to look at tissues.  But looking at tissues is not trivial and not something to be attempted without good evidence of the virus being present in the body first. 

CFS Central: Did you test the new assays/methods used in the new study against any XMRV positive samples from your prostate-cancer study?

Singh: Our prostate cancer study was entirely on prostate tissues. These were archived in tissue banks in a de-identified manner, so there was no way to go back to those patients and obtain blood samples.  So, we could not test some of the new tests we developed on our material from prostate cancer patients. 

CFS Central:  In your new study it says that “2 positive controls were also included” (line 349 of your study). Were the two positive controls clones or clinical samples from prostate-cancer studies or from Mikovits’s positive CFS patients? 

Singh:  The samples from Mikovits' patients were all tested in a completely blinded fashion.  We did not know which of them were positive, so could not use them as positive controls.  But more accurately, there are no real patient 'positive controls' for XMRV.  In order to use patient samples as controls, you'd have to first be absolutely certain that these patients have XMRV.  How could you do that right now?  So we used what you call a 'clone' for our PCR studies.  But remember, this clone was isolated from a patient (a prostate cancer patient).  And this is over 99% identical to the isolates from CFS patients described in Lombardi et al.  For the viral culture studies, we used very small amounts of titrated virus that was grown in the lab as positive controls. And all of these positive controls were always positive. 

CFS Central:  You grew XMRV in the prostate-cancer cell line LNCaP and the breast-cancer cell line MCF-7 in your study “Raltegravir is a potent inhibitor of XMRV, a virus implicated in prostate cancer and chronic fatigue syndrome.”  It’s unclear to me why the new study didn’t culture XMRV from those two positives. 

Singh:  Yes, we did.  And these grew just fine.  Apologies for not being clearer in the paper.  None of the patient samples tested positive, but the positive controls were always positive. 

CFS Central:  Some patients on the forums find this sentence from the new study problematic:  “We are forced to conclude that prescribing antiretroviral agents to CFS patients is insufficiently justified and potentially dangerous.”  The Science and the Alter/Lo studies have reported XMRV and related MLVs in CFS patients.  CFS patients are very ill, many for decades, and there are no approved treatments. They believe the decision to try antiretroviral drugs should be between a patient and his or her doctor. Why did you feel the need to put that statement in the study and press release? 

Singh:  The patient and their doctor did not make the decision to try antiretroviral drugs in a vacuum.  It was based on reports of finding XMRV in CFS patients.  We are now convinced that there is no XMRV in CFS patients--so the reason for starting those drugs does not exist.  And there is no good evidence for continuing to use drugs that could lead to serious side effects of liver or bone-marrow failure.

****

I wrote to Singh to ask her to clarify two of her answers:
 

CFS Central:  In your prostate-cancer study, “XMRV is present in malignant prostatic epithelium and is associated with prostate cancer, especially high-grade tumors,” you found 4 percent of healthy controls with evidence of XMRV.  If you’re finding a background rate in controls in your prostate-cancer studies, why do you think you didn’t find a background rate in CFS patients and controls?  

Singh:  Not entirely sure, but there were different assays (e.g. immunohistochemistry) and different sample types (blood vs prostate tissue).

CFS Central: To clarify one of my previous questions, beginning on line 347 of your new study, it states: “We inoculated LNCaP cells with 100 [microliters] of plasma from 31 patients and 34 healthy volunteers, and passaged the cells weekly for 6 weeks. 13 negative controls and 2 positive controls were also included. Only one culture was handled at a time to prevent any cross-contamination. After weeks 2, 4 and 6, cultures were lysed and analyzed by Western blots (Fig. 4) and by qPCR for XMRV. No XMRV protein or DNA was detected in any of the cultures. [emphasis added]  

My question is this: Is the bolded sentence correct, or did the 2 positive controls grow in these cultures and/or did the positive samples continue to test positive in culture?  If the positive controls didn’t grow or if the positives controls didn’t test positive in culture, why didn’t they?  You grew XMRV in the prostate-cancer cell line LNCaP and the breast-cancer cell line MCF-7 in your study “Raltegravir is a potent inhibitor of XMRV, a virus implicated in prostate cancer and chronic fatigue syndrome.”

Singh:  That was our poor wording in the paper (the words in bold).  All positive controls grew XMRV--as one would expect.  None of the samples from the healthy controls or CFS patients grew any virus in culture.  And of course the negative controls did not grow any XMRV.