GOING VIRAL

Of Bats and Pigs and the CDC

Contagion is the new virus thriller from director Steven Soderbergh about MEV-1, a vicious, spanking-new hybrid virus—part bat, part pig—that spreads worldwide like the flu and is often fatal within a few days, usually after the victims spike a high fever, then experience seizures and, finally, frothing at the mouth. The film spans more than four months, and once the virus invades the HIV/AIDS population, it becomes even more virulent. 

The fast-paced movie makes coughing scarier than Kathy Bates in Misery and sports a great cast.  Gwyneth Paltrow is pale, wan patient zero in the U.S., having been infected on a business trip to Hong Kong; Matt Damon is well cast as her beleaguered husband; Kate Winslet and Marion Cotillard portray dedicated epidemiologists; Laurence Fishburne imbues his role of the hardworking Centers for Disease Control deputy director with gravitas; Jennifer Ehle plays a fearless CDC vaccine researcher and the film’s number-one heroine; Elliott Gould has fun as an intrepid non-government scientist defying CDC orders; and Jude Law sinks his teeth into the juicy role of an unscrupulous blogger who sets the world into an early panic and screams “Print media is dying” to a newspaper editor who won’t give him an assignment. Later, when the number of unique visitors to "Truth Serum Now"—his doom-and-gloom blog of fake cures and misinformation—exceeds the mounting death toll, he becomes positively gleeful.

As MEV-1 and panic spread, food becomes scarce, stores are looted and fires set, streets and airports empty out, and undertakers won’t bury the dead as Earth morphs into a gigantic ghost town. To increase their chances of survival, people don masks and gloves and practice what’s called “social distancing” while CDC scientists risk their lives in a race to come up with an effective vaccine.  Oddly no politicians weigh in during the movie, and the President is soon whisked to a secure underground bunker; that's the last time he's mentioned.  Contagion is all about weary scientists who spout phrases like "chimeric," "revert to wild type" and "attenuated."

The film’s only obvious misstep is the disappearance of Marion Cotillard’s character.  She's kidnapped by Chinese who claim first dibs on a vaccine for their nearly wiped-out village—and use her for collateral.  But so much is happening round the globe that when the film finally pivots back to Cotillard, someone in the audience called out:  “I thought she was dead already.” 

Contagion effectively pieces together the casual connections of the first victims.  Even more satisfying is witnessing how the two virus halves first met.  Both are the most gratifying and eerie aha! moments since the critical instant in The Sixth Sense when you realize that Bruce Willis’s character has been dead for most of the movie.  

Why am I giving a mini review of Contagion on CFS Central?  

1. Is it because I snickered and threw popcorn at the screen every time another brave government official appeared?

2. Is it because I wondered how the CDC’s Beth Unger would fare in the role Jennifer Ehle played? See photos, below.

3. Is it because another worldwide plague is already here and it’s not MEV-1, but rather ME?

4. Is it because I’m wondering where the heck are all the intrepid non-government researchers like Elliott Gould’s character, who’d defy government orders for the sake of mankind?

5. Is it because the film gives bloggers a bad name?

6. Is it because the scientist that Kate Winslet portrays believably utters the word “fomite”?

7. Is it because a frightened big brown bat flew inside my house during hurricane Irene, and I had bacon in the refrigerator? 

8. Is it because what’s missing in the film is a cameo from British psychiatrist Simon Wessely in which he’d call MEV-1 a biosocial construct and complain that MEV-afflicted patients were sending him nasty emails and trying to breathe on him?

9. Is it because the film mentions Dr. Barry Marshall, who drank a Petri dish of H. pylori in 1984 because he was convinced the bacterium caused ulcers, but nobody believed him?

10. Is it because Jude Law’s character, Alan Krumwiede—pronounced “Crum-weedy,” in the most hyperbolic illustration of nominative determinism ever—bemoans the pathetic lack of information on the CDC website? 

All of the above are true, except for number one: I don’t like popcorn.

Postscript: Patient advocate Lilly Meeham emailed that virus hunter Dr. Ian Lipkin, who's overseeing the big XMRV study, served as an adviser to Contagion.  In fact, Elliott Gould's character is based on Lipkin!  Thank you, Lilly.  Lipkin explained in an interview that MEV-1 is not that big a stretch from the truth and is similar to the Nipah virus, which was discovered during an encephalitis outbreak in Malaysia among Chinese pig farmers. "The pigs had been infected by bats," Lipkin said.  "In outbreaks in Bangladesh where people don't farm pigs, the virus went directly from bats to man via palm sap collected in trees and sold as a beverage. What was different in Bangladesh is that there were reports of human-to-human transmission."

            Ehle                                   Unger

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."