The Specificity of the Crazy and A Cattle Prod to the Genitals

Have You Been Served?

Two years ago, when Science published the first study linking the retrovirus XMRV to ME, how many of us yearned to fast forward a few years to see if Dr. Judy Mikovits’s findings would be validated and the cause of ME finally nailed, as we hankered to do 20 years earlier when Dr. Elaine DeFreitas published her landmark study linking ME to another retrovirus?

This heady time around no one could envision the spate of nightmarish events that have been plastered in the media since October 2009: shouting contests on both sides of the Atlantic about the rightness of this study or that study and intimidating researchers in Europe and the U.S. for daring to research the retrovirus XMRV, until they switched sides, washed their hands of ME or were booted out of research altogether.

Blood Working Group

More recently was the failure to distinguish patients from controls in the Blood Working Group's XMRV study, and the relabeling of slides, which caused an uproar. That was followed by a spate of jaw-dropping disclosures, for which I've coined the phrase "the specificity of the crazy"—though that phrase applies to much of ME research during the past 30 years. As many readers know, according to court affidavits by Mikovits's research assistant Max Pfost, Mikovits asked him to take documents from the Whittemore Peterson Institute (WPI), which he stashed in a Happy Birthday bag.  His affidavits also state that Mikovits hid out on a boat to avoid being served with papers from WPI and that the duo created secret email accounts—an oxymoron if there ever was one.

Then, during Thanksgiving week, in a quintessential Upstairs, Downstairs moment, WPI gave public thanks for getting back most of its property.

British researchers Simon Wessely and Myra McClure, who published a negative XMRV study, and the CDC, which did the same, must be licking their lips as they watch the critical XMRV players implode in the media. Under extreme stress, many people become reptilian, but still…. To paraphrase singer Annie Lennox, how long can the ME community go on living in this same sick joke?

Pulling strings

Scientists are supposed to ask: What do we think, what do we know, what can we prove?

I don’t know what to think about most of these events—let alone reflect on what we know and what we can prove. At this point, there are far more questions than answers. Here are some of mine: After working several years on XMRV, did anyone at the Whittemore Peterson Institute know that there were reliability issues with the XMRV assays before the Blood Working Group began its studies? After all, when you conduct scientific experiments, you check known positives at the same time to make sure everything is copasetic.

Another question: Who was pulling the strings? Did Mikovits see a problem early on—perhaps even before the Science study was published? If so, did she share her concerns with Harvey and Annette Whittemore or Daniel Peterson, or did she sweep her disquiet under the proverbial carpet? And if Mikovits voiced unease, what was the response? Did they insist she soldier on, and they’d all figure it out in the rinse cycle—or could that have been, perhaps, Mikovits’s expectation? At any time was there deception? Was there self-deception?

Do the right thing

Contending that the retrovirus is hard to culture from blood is reasonable, but how long can you then confidently rely on that assay? You have to develop an antibody test that works consistently or a better way to find the virus—or something. You have to take a step back and figure it out—because if you don’t, the problem will bite you in the ass—and not in a good way. And with this disease the bite always seems to be particularly vicious, the kind that leads to, say, a methicillin-resistant staph infection, several years in the wilderness, and slashing ME’s already dangerously low street cred.

What should the key players have done if they knew there was a problem? A psychiatrist friend of mine is fond of saying: “Unless someone is planting a cattle prod to your genitals, you walk away when someone is pushing you to do something you find objectionable.” You stand up, you refuse, you do the right thing.

Could that be why Dr. Daniel Peterson left the Whittemore Peterson Institute so abruptly—back when things were ostensibly going along swimmingly, only a few months after the Mikovits study was published? He wasn’t a bit player in this yarn: He’s the Peterson in the Whittemore Peterson Institute. None of the explanations for his abrupt departure have made a whole lot of sense, at least to me.

Intellectual property

Why did Mikovits want her notebooks and other data that research assistant Max Pfost allegedly took at her request? Did Mikovits believe the materials belonged to her? Indeed, Mikovits attorney Lois Hart told Science reporter Jon Cohen, “She [Mikovits] is entitled to a copy of the information she created.”

According to law, does that data legally belong to Mikovits or WPI or to both? In the U.S. and Europe, the institution usually owns the intellectual property, though every contract is different. (In Japan, it’s usually a 50/50 split between the institution and the inventor.) Is keeping a copy of the material different from owning the material?

Did Mikovits or WPI want the material to continue the current research, or to foster other important scientific discoveries and to help patients? Did Mikovits want the data to prevent WPI from continuing its research? Does the WPI want to prevent Mikovits from continuing her research? Where, exactly did the XMRV research go wrong—and is the key to it all in those notebooks? What role did money have in all of this? What role did fame play?

Who the hell knows.

Versions of the truth

In a November 11th post on the Wings of Hope blog, Annette Whittemore wrote: “WPI immediately asked to have the materials returned, but to no avail.” If the Whittemores made that request, how did Mikovits and her lawyers respond? What other options could the Whittemores and their lawyers have utilized short of humiliating Mikovits and leaving her to stew in jail for five days without the possibility of bail? Did the Whittemores need to resort to Draconian measures?

Or did the Whittemores have the fiduciary duty to report to the police that property was taken from its institution and once they did, was the chain of events that followed pretty much out of their hands? Did the Whittemores consider the negative repercussions of putting Mikovits in jail on scientists interested in studying this disease, in the press and on the patients?

I want to know the answers to these questions, instead of blindly pledging allegiance to anyone’s version of the truth. As I’ve commented on this blog in the past, and with apologies to Voltaire for messing with his quote, reason consists of seeing things as they are, not how we want things to be.

However you cut it, the last few months have been a terribly sad coda to such a promising start. I think of all the excitement, good will and hope that floated up the day the prestigious journal Science published Judy Mikovits’s study. Judy Mikovits, Daniel Peterson and the Whittemores seemed an invincible team. But most relationships end, and many end badly—though most not as badly as this. As Dr. Phil is fond of saying, “The person you marry isn’t the same person you divorce.”

JUDY MIKOVITS TURNS HERSELF IN

Neuropsychiatric Versus Multisystem

In an interview on the Cure Talk website,  Chronic Fatigue Initiative and Columbia University researchers Dr. Ian Lipkin, who's a neurologist, and Dr. Mady Hornig, a  psychiatrist, stated that ME is a "neuropsychiatric" disorder because it affects concentration, memory and the autonomic nervous system.  However, Lipkin and Horig don't consider the disease psychosomatic.

Labeling ME a neuropsychiatric disease is problematic for three reasons. First, Parkinson's, MS and other neurological diseases can affect concentration and memory. Yet no one calls them "neuropsychiatric" disorders; they're called neurological disorders.

Second, invariably some researchers--particularly CDC scientists and British psychiatrists--will gleefully misinterpret the term neuropsychiatric and continue to relegate ME patients to the psychiatric arena.

And third, ME is more than just a neurological disease.  For starters, ME also affects the heart, kidneys and the immune system.  In other words, it's a disease that attacks more than the brain.  It's a multisystem disease.  Here's an idea:  Why not just call ME a multisystem disease? 

Rituximab, Genentech, Tony Fauci and Pertinent Pop Culture References

As many readers are aware, a small, newly released Norwegian double-blind study found that rituximab—an IV medication used to treat lymphomas, leukemias, organ rejection and refractory arthritis—is also very effective in treating ME.  And now a bigger rituximab study is under way in Norway.

In the U.S., Genentech markets rituximab (trade name Rituxan).  In Canada, it’s Hoffmann-La Roche. And in Japan, it’s Chugain Pharmaceuticals. Unfortunately, as of this week, Genentech doesn’t appear interested in doing a study on ME. Joseph St. Martin, a spokesperson for Genentech, wrote CFS Central in an email on Tuesday: “We cannot comment on the external data you mentioned [the Norway study], but I can say that Genentech has never studied Rituxan in CFS and currently have no plans to do so in the future.”

I sent a follow-up email yesterday: “Given the success of this small double-blind study, and given the fact that CFS is a serious and sometimes fatal disease that afflicts 1 million Americans and 17 million people worldwide, I find it surprising that Genentech would have no interest in doing a study. Why is there no interest? Is there someone at the company who’d be able to enlighten me on this issue?” 

St. Martin kindly emailed back that he'd track down the right person for me to interview, but then emailed today after I followed up: “As mentioned, Genentech has never studied Rituxan in CFS and currently have no plans to do so in the future. We will not be disclosing [any] additional information on this topic.”

CFSAC
In my five minutes testifying before the Chronic Fatigue Syndrome Advisory Committee (CFSAC) meeting last spring, I asked for, among other things, a meeting with Dr. Tony Fauci, head of the National Institute of Allergy and Infectious Disease (NIAID), the same Tony Fauci who has said many times that ME is a psychological disease. 

I’d love to report that the two of us met over saketinis, where we chatted sotto voce about ME and then braided each other’s hair, during which time the NIAID director finally had the light-bulb epiphany patients have been dreaming about for decades:  ya know, that ME is a devastatingly serious and sometimes fatal disease.  

Alas, however, I heard bupkas from Dr. Fauci.

As Gordon Gekko might say, summer is over and business is business. I’ve been hearing the usual fretting about the toothless CFSAC committee meetings, the semi-annual snorefest of how to accomplish absolutely nothing while spending beaucoup taxpayer dollars, as suspicious guards eye patients who can barely move as if the patients are Al Qaeda operatives and the guards are Claire Danes in Homeland.

There has been some debate where to hold the CFSAC protest this year, and I say wouldn’t it be great if people could protest everywhere—the hotel where the meeting has been moved, Health and Human Services, at the homes of all government officials involved in the disease, from CDC’s Dr. Beth Unger on up. But since that’s not feasible, in my view a protest outside Tony Fauci’s office is what’s needed most to shake things up.  After all, he’s the one who dictates policy; Beth Unger et. al. comprise merely the foot-soldier battalion.

As I’ve blogged before, ACT UP patients addressed Fauci’s indifference to HIV/AIDS 25 years ago; for a time, activist Larry Kramer affectionately dubbed Fauci a “murderer.” Those strong-arm tactics changed everything for the better.  Fauci was just one of the government officials ACT UP gutted and served with fava beans and a nice Chianti. 

Dr. Stephen C. Joseph, the Health Commissioner of New York City from 1986 to1989, was another. After proposing that physicians be required to report HIV/AIDS patients to the state, Joseph became a favorite target of ACT UP. According to the Wall Street Journal, he also reduced by 50 percent the estimate of the number of New Yorkers carrying the HIV virus, a momentous shift ACT UP believed would result in diminished funding.  ACT UP staged sit-ins in Joseph’s office, tortured him with telephone calls, marched outside his house and threw paint on his house.  And, in keeping with Godwin’s Law—in which the probability of a comparison to Nazis/Hitler in a heated debate eventually approaches 1—ACT UP denounced Joseph as a Nazi.

And what did Stephen Joseph do?  When he resigned at the end of 1989, he told the New York Times that he credited ACT UP with helping change aspects of a system that had been “unfair and constraining.”

When you stand up to bullies, they back down. Eventually. Most recently, we’ve seen this caving in occur with the Occupy Wall Street protests, as the republicans began dialing back their disdain and even showed on-camera sympathy as the number of protestors and media coverage grew.

Rituximab redux
Which brings me back to rituximab. Pushing for a study on rituximab now is paramount for four reasons: one, the drug appears to work for ME, which after 30 years still has no drug to treat it; two, drug approval for a disease garners respectability for the disease—and if there’s one thing this disease needs it’s respectability. Three, figuring out exactly how rituximab works on ME may shed insight into the immune abnormalities in the disease and generate more research and effective treatments. And four, at circa $20,000 a year, the drug is prohibitively expensive and insurance won’t cover it for most ME patients, unless they also happen to have cancer, an organ transplant or arthritis.

On the down side, hobbling pieces of the immune system with a drug like rituximab may prove more Band-Aid than magic bullet.  It may thrust ME into the autoimmune world that quashes symptoms with immune suppressors rather than address the underlying disease process. That’s the world in which lupus, MS and rheumatoid arthritis currently reside. And it’s also possible that if enough ME patients improve on the drug, no one will devote much energy to searching for a cure—not that anyone does now, but one can always hope. Moreover, rituximab isn’t benign. It can be toxic to the kidneys and leave patients vulnerable to infections and cancers, as it depletes the B cells, key players in the immune system. 

Most problematic is that it can, in rare instances, reawaken the JC virus, which infects most people in childhood and is benign in healthy people, but in rare instances in immunocompromised patients it can attack the brain and cause progressive multifocal leukoencephalopathy (PML), which leads to death or brain damage. The best way to detect the presence of the JC virus is through spinal-fluid PCR and an antibody test prior to beginning therapy.  However, negative tests don't ensure that patients won’t develop PML due to the drug. For now, it's the jumbled luck of the draw.

All that being said, there’s always a risk-reward ratio for medications, and for some patients rituximab may restore life to their lives. After a disappointing summer, rituximab is huge news and certainly worthy of a bigger study. How do you convince a disinterested drug company or the disinterested U.S. government to conduct a rituximab study on ME?  Perhaps this would work: Patients could contact Genentech, Hoffman-LaRoche, Chugain Pharmaceuticals, their congressman and Tony Fauci with a clear and singular message: ME patients need and want a drug study on rituximab. Period. That could be a key message at the November CFSAC meeting and at the demonstration outside Tony Fauci’s office. 

Which brings me to my final point, Peter Weir’s amazing 1982 film The Year of Living Dangerously, with Sigourney Weaver, Mel Gibson (before he got creepy) and Linda Hunt.  It takes place in 1965 during the political upheaval in Indonesia under then-President Sukarno. Hunt, who plays a male news photographer (and won an Academy Award), plasters a huge banner outside a hotel window at the movie’s climax.  It screams in red letters: “Sukarno, feed your people.”

Tony Fauci, help ME patients.  Fund a rituximab study.

*** 

Rebel Satori Press has just published the novel Beatitude by writer extraordinaire (and my good friend) Larry Closs. The book has nothing to do with ME, but it is a great read. You can purchase the book on the CFS Central Amazon.com store.  Click on the book's yellow book jacket on the right-hand column on this page.  

Larry is also a filmmaker and created a terrific 1 minute 13 second trailer for the novel.  If you look closely, you’ll see a quick shot of the Beat poet Allen Ginsberg and a few shots of actor Johnny Depp (in the goatee): 

From the book jacket: 

New York City, 1995: Harry Charity is a sensitive young loner haunted by a disastrous affair when he meets Jay Bishop, an outgoing poet and former Marine. Propelled by a shared fascination with the unfettered lives of Jack Kerouac and the Beat Generation, the two are irresistibly drawn together, even as Jay’s girlfriend, Zahra, senses something deeper developing.

Reveling in their discovery of the legendary scroll manuscript of Kerouac’s On the Road in the vaults of the New York Public Library, Harry and Jay embark on a nicotine-and-caffeine-fueled journey into New York’s thriving poetry scene of slams and open-mike nights.

An encounter with “Howl” poet Allen Ginsberg shatters their notions of what it means to be Beat but ultimately and unexpectedly leads them into their own hearts where they’re forced to confront the same questions that confounded their heroes: What do you do when you fall for someone who can’t fall for you? What do you do when you’re the object of affection? What must you each give up to keep the other in your life?

Beatitude features two previously unpublished poems by Allen Ginsberg.