Failure to Fund, Part Four

Hillary Johnson

People who fail to comprehend that a pandemic of ME occurred either because they weren’t born yet or were in high chairs flipping their mashed peas at the wall when it started seem particularly vulnerable to dubious scientific theories that have provided cover to the government for decades. Some seem unaware that the disease that has hobbled them was unknown to their parents and grandparents, though it is now among the most common chronic diseases in the world.

Scientists are fond of the philosophy of Occam's Razor, or the Latin phrase, lex parsimoniae, the law of parsimony. The first suggests that the simplest solution tends to be the correct solution. The second suggests that the more assumptions that are required to support a hypothesis, the less likely it is to be correct. In the case of ME, the disease cannot be explained by some sudden genetic shift, unless your knowledge of science comes from Marvel Comics. We know it cannot be explained by a large swathe of the population suddenly becoming mentally ill, even though the government tried hard to promote that for a generation. It can't be some new source of environmental pollution, since that would require every ME patient in the world to have been exposed to it. It can't be stress, since stress has been around since the beginning of time. As one who was alive and well in the early 1980s, I can avow life is no more stressful now than it was then. Plus, the actual science of the disease, the immunology in particular, refutes all of this propaganda. What's left? An epidemic of infectious disease. 

The ME story is a bit like the global warming story. When you contemplate global warming, the reality seems almost too dystopian to imagine. Climate deniers say, essentially, not to worry--it was ever thus. They produce a lot of spin and hype to explain away global warming. But the science is irrefutable no matter how uncomfortable the truth.

Below are a few of the most common theories and dubious hypotheses about ME that ignore reality:

There are subsets of ME

This theory probably derives from the fact that researchers can't seem to agree on a test for ME and from confusion among doctors who haven't seen enough patients. It remains popular in spite of that fact that groups continue to publish research in which they claim their findings can identify ME patients with anywhere from 70 to 90 percent or more certainty. But--wait--every ME patient is different! Every AIDS patient was different, too, depending on which co-infections were afflicting them. Additionally, scientific research has proven the subset theory wrong. Cornell scientist Maureen Hanson, for one, has noted more than once in presentations about her data that she finds no evidence for subsets. The subset theory continues to be a popular element of the effort to deconstruct ME, nevertheless. Though still promoted by any number of investigators, meticulous research like Hanson's may in time break through the fog. However, longtime students of this disease know how nonsensical theories can persist for decades, or disappear entirely, only to be revived by a new generation. Nevertheless, promoting subsets complicates unnecessarily any clear understanding of the disease. It props up the thirty-year-old cliche that ME is a "waste-basket" diagnosis and likely is one facet of the CDC's questionable claim that something like eighty percent of patients have not been diagnosed, which leads to the next fallacy:

Because there are subsets, there are numerous causes

In most scientific papers, the authors introduce their subject by describing ME as a "heterogenous" disease. According to Wikipedia (sorry), when used in the context of diseases, heterogeneous means: "...medical conditions which have several etiologies." In the absence of a single causative ME virus, subsets allow for another theory: multiple viruses (or other pathogens) are causing multiple subsets.

This theory helps the government hold fast to its claim that the disease is mysterious and hard to study. Yes, indeed, ME would be hard to study if you thought there were multiple subsets and each one had a different cause, or worse, causes. Granted, any disease that occurs in a sudden outbreak and reaches pandemic proportions--but can be shown to be caused by multiple pathogens--would be pretty mysterious. Has that been reported in medical history? It would be like discovering leprosy could be caused by any number of pathogens--maybe any pathogen at all. And if you really thought that, it's easy to see how you might get all hung up trying to figure out what is wrong with the host rather than hunting for the cause.

If you don't believe ME is infectious or a pandemic of a formerly rare disease, or a disease at all, then there is really no end to where your mind could take you. Currently, I am sensing a reboot of an effort that the CDC undertook about stress and childhood sexual trauma and the oh-so-scientific "allopathic load." Their effort ended in an embarrassing, best-forgotten 2006 press conference helmed by Suzanne Vernon and the late Bill Reeves. Instead of searching for the pathogen, Reeves and Vernon tried to figure out what was peculiar, or genetically maladaptive, about victims of ME. Their hypothesis fit their agency's bias to a T. Not a single scientific group even tried to replicate this research it was so ridiculous. (The agency also engaged in a dishonest PR campaign at the time, suggesting people get diagnosed and get treated. Under repeated questioning, a flustered Vernon eventually admitted to me there was no approved treatment to be had at the time, but then she asked me, "Aren't you glad we're (CDC) at least paying attention to CFS?" Not if you're pushing lies.)

Thirty years ago, in 1988, doctors and scientists met to discuss the disease during a weekend in Rhode Island. A few government scientists were present, including the National Cancer Institute epidemiologist Paul Levine, who I've described recently in this space, and Ann Schleuderberg, the NIH's administrator in charge of ME grants (which were, of course, nonexistent). Also present were some smart clinicians, two of them running clinics focused exclusively on ME. One was Paul Cheney, who was working at the Nalle Clinic in Charlotte. Most of his patients had read about his practice in Incline Village and found him at the Nalle. They came to him from all over the world; one patient was from Saudi Arabia. Another smart doctor present was Charles Carpenter, chief of staff of Miriam Hospital, the teaching hospital for Brown University's medical school. Carpenter and his colleagues at Miriam Hospital had a clinic where they saw only ME patients. The organizers of the Rhode Island meeting, who were patients, hoped this group of government and non-government scientists and doctors could, in the privacy of a rented mansion in Newport, achieve some common ground.

From Osler's Web:

"Carpenter and several of his colleagues had concluded that a discrete, if unknown, pathogen was abroad. Carpenter's certitude was such that when other researchers proposed hypotheses about multiple causes and multiple syndromes, he was quick to disagree. 'Most of us feel this is new. If this had been going on in the fifties and sixties, even if we had discarded it as pyschiatric, it would have been written about, and it's not in the literature. And that suggests there is a dominant agent that's driving the majority of cases.'"

More from Osler's:

"The private meetings were monopolized by efforts by Cheney, (David) Bell, and others to lead the government representatives to an understanding of the disease as a discrete entity with an infectious cause. 'I'd like to make the analogy,' Cheney gently interjected at one point in the discussions. 'Historically, in AIDS, we had a sign-symptom complex where in order to make the diagnosis we looked for evidence of Epstein-Barr, cytomegalo virus, toxoplasmosis and so on. But this heterogeneity was then thrown out the window when HIV was discovered.'  Brown's Carpenter, too, expressed his conviction that the disease was new and likely to be the result of what he called 'one dominant agent' spreading through the population. David Bell concurred, pointing out that as a result of his position as a pediatric specialist in the disease, he now had an opportunity to see children from all over the country. 'They are virtually indistinguishable from the children in Lyndonville,' Bell said. 'This is such a dramatic disease in children that if it existed in the days of rheumatic fever, it would have been described in the literature.'"

***

No one in the ME field seems particularly interested in finding the cause because, in their public lives, they ignore the possibility of a single cause. Although, if you scratch the surface, many ME investigators admit privately there is a high likelihood or certainty of a single Agent X causing the disease. Nevertheless, a majority are super interested in creating subsets and trying to figure out, as I mentioned, who is vulnerable to the disease and who isn't. But isn't the latter, in particular, the real Black Box of medicine? More than half a life-time ago, I used to work in offices. It was not uncommon for, say, five or ten people in an office to catch the cold virus that was flying around. The other 75, working alongside those ten, either didn't catch the cold, or, having become infected, their immune system tamped it down and they experienced no symptoms. 

We don't know why this occurs, but we aren't terribly concerned, either, because our life experience has taught us this is how infectious diseases work. Among people living in the same circumstances, some get tuberculosis but others never develop symptoms. We rush to get the TB patient on drugs that will wipe out their infection and allow them to survive and be unable to transmit the disease; we don't ignore those who are ill and worry instead about why one person fell ill and another didn't.

My point is, why worry about these phenomena in ME at this juncture when, say, one, two or more million people are incapacitated, unemployed and pondering suicide every day of their lives? If you want to know the answers, take some established disease for which the cause is known and study the Black Box issue--why some fall ill and many more do not. Don't waste precious time and money trying to figure this out in ME. There is no time. Look for the CAUSE. Perform epidemiology to discover how it spreads.

Something that's rarely if ever discussed: unless ME is a disease unlike any other, one that defies the laws of nature as we understand them, we must wonder how many people have been infected with the ME virus and remain healthy but are capable of infecting others. Are they more of a threat than the patient who is so sick they are confined to their house and unlikely to infect others? Is there an army of ME typhoid Mary's, in other words? And do housebound patients inoculate those around them, which protects family members from the disease? When scientists select controls for their studies from among family members and friends, are they true controls, or are they infected but healthy? With presumably millions infected, will it even be possible to find legitimate controls in the future? Only if the cause is known.

What if AIDS scientists had claimed there were multiple subsets of AIDS, each caused by different pathogens and a vast range of stressors? Ultimately, they accepted that there were myriad infections in AIDS, but their interpretation of the numerous other infections in AIDS was that the causative virus was wreaking havoc on the immune system allowing once dormant viruses to reactivate. A refusal to even consider this model for ME is yet more evidence of the government seeking to dominate the direction of the science and spin the "mysterious" and "hard to study" memes that have been prominent since the 1990s. It has also allowed for the walling off ME from mainstream science, which has allowed the government to avoid funding ME, which allowed the disease to spread.

ME is an autoimmune disease

This doesn't really work as an explanation for outbreaks or a pandemic. Hardly anyone had heard of ME before the 1980s. In 2018, however, it's among the most common diseases. Autoimmune diseases, by definition, do not occur in epidemics or pandemics because in theory they are perpetuated by an immune system that has become "confused" and is attacking cells of the body as if they were antigens, or viruses. On the other hand, what is today considered to be autoimmune might tomorrow be identified as a viral infection. After all, what if the target of the attack actually is a virus?There are indications MS is moving in that direction.

Another common theory: “hit and run," which proposes that a virus “triggers” ME, then forever disappears from the body even though the disease and its accompanying inflammation persists for years and decades and in many cases grows worse over time. Amy Proal, a microbiologist with a strong interest in ME, finds the hit and run theory nonsensical. "Can a pathorgen really 'trigger' a life-long inflammatory disease?" she asked recently, then explored that theory in a YouTube presentation. Proal will be featured in a Q&A in Eye View Exclusive on this and related subjects, so I fear you must await Proal's dissection.

***

 

As long as you've been reading and hearing about AIDS, that's how long ME has been shoved aside, mischaracterized as psychiatric, ridiculed and, most critically, starved for research funding by the U.S. government. Time is running out for millions of people while the jaded, ill-informed speculation I've listed above continues. For me, certainly, and perhaps for others who have suffered from ME for years, it's becoming harder and harder to sit silently by while doctors and scientists who have just discovered ME debate and theorize and make up explanations for the disease that bear remarkable similarities to the claims emanating from the CDC in the 1980s. It's as if for them, ME is a super-fun Rubik's cube and there is all the time in the world to examine it, when the obvious explanation will do: people with ME are suffering from an infection. What is that infection?

There are 40 different drugs for AIDS and more in the pipeline. Although a few worrisome side effects continue, most work marvelously well at keeping patients alive and functioning into their 70s and beyond. I recently read that Columbia's Ian Lipkin, who was paid by NIH to de-discover XMRV as a cause of ME, commented that it would be ten years or so before ME was solved. 2028? I'm too vain to reveal how old I'll be in ten years, assuming I've not died from ME before then, but ten years is an intolerable, unacceptable amount of time to me. I blame the loss of more than half my life entirely on government negligence. Among other failures, my government has failed to investigate and failed to fund this disease with anything but fairy dust since the epidemic began--and by all indications is planning to do so indefinitely.

A great crime has occurred; hundreds of thousands of lives have been lost as a result. Are women, who reportedly comprise at least 80 percent of ME sufferers, who fight in wars, give birth, raise children, run companies, write plays, sing in operas, discover cures, lead nations and do much of the worlds’ grunt work allowing men to pursue their interests—really that unimportant?

“If we had developed a drug that men could rub on their heads to grow hair, (Ampligen) would have been approved years ago.”

 

As long as ME is portrayed as a mysterious disease that is unlike any disease known to exist in the natural world there will continue to be paltry funding.

***

 

NIH veteran Tony Fauci, who has held his job in Bethesda since the Reagan Administration and is considered by some to be the de facto head of the NIH by virtue of his multi-billion dollar, thirty-five year AIDS program, has played an influential role in ME funding priorities for decades. For twenty years, NIH devoted approximately $5 million annually—let’s call that a nickle—to ME, famously equivalent to the amount the agency devoted to male pattern baldness.

 

Tom Equels, CEO of Hemispherx Biopharma told me recently, “If we had developed a drug that men could rub on their heads to grow hair, Ampligen would have been approved years ago.”

 

As it happens, Fauci’s infectious disease institute, NIAID, is currently the largest donor to ME extramural researchers. But when you’re talking about a few million dollars for a disease afflicting millions, a disabling, sometimes fatal disease that’s almost certainly infectious and has been spreading uncontrolled for decades, the money is a pittance, an insult.

 

The NIH and the CDC, especially Fauci, have demonstrated repeatedly that they do whatever they want regardless of what Congress asks of them. If necessary, they lie about their efforts and in the past, at least, have distorted the reality of the disease to congressional committees. Once, in the 1990s, a senate appropriations subcommittee member asked Fauci if his agency needed more money to investigate the disease. No, Fauci replied. Given the state of the science, which he deemed poor, no one at NIH knew how to proceed. On his say so, one to two million or so lay in their beds in emotional and physical agony for yet another decade.

Infectious brain disease expert and Wistar Institute director, the late Hilary Koprowski, once told me NIH should have an entire division working on ME as they have for AIDS now and in past decades. Instead, we have Avindra Nath at the National Institute for Neurological Disorders and Stroke, moving at a snail's pace to study 40 newly-afflicted patients by examining everything about them. We may have Nath's results in the years ahead. Nath's credentials are excellent assuming he can remove any bias he may have about ME. Unfortunately, he is not assigned to this study full-time; he's got other projects on his plate. For me, the diffuse and broad study that the NIH claims will unveil anything that might be wrong, smacks of a typical "prove it to me" exercise by NIH. "Prove to me that people with ME have something wrong with them, because right now we don't necessarily believe that." It seems a waste of money given how much is already known about the disease, but Nath and others may not take seriously findings unearthed by academic researchers. On the other hand, if there's anything to be discovered, like the pathogen--is it mere coincidence that Nath's expertise lies in brain infections? If there is something to discover, NIH certainly would prefer to have the bragging rights--and the lucrative patents that will follow. NIH can help withhold pathogen discovery because it controls not only the purse strings, but freedom of speech among those who would like an NIH grant.

At NIH, Brian Wallitt, a medical officer at the National Institute of Nursing Research at NIH who thinks Canadian pop historian Ed Shorter is a distinguished thinker in this disease, has been given the task of selecting people he believes merit enrollment in the NIH’s tiny study that began more than two years ago. Perhaps it shouldn’t be surprising that the study has collected six patients in two years at last count, or three patients per year. Let’s not get ahead of ourselves, NIH--I'm getting the whirlies! 

Given the history of ME patients who traveled to Bethesda to be examined and studied by NIH scientists, it's hard to sustain optimism. In 1987, when NIH imported ME patients from Incline Village to study, I interviewed most of them. Virtually everyone had a horror story to tell, including a young woman who described sexual molestation. Straus was in charge of those "studies." He never released any data, though I tried for years to force him to do so with an FOIA request. After the Assistant Secretary of Health ordered him (my win on appeal) to release those records to me, Straus sent me a worn brown envelope filled with taxi and restaurant receipts from a trip to Brussels. So--that was the data from Tahoe? Straus' old taxi receipts from Belgium? I think the kindest assumption is that he had no data. If he did have data, then he was lying at every hopsital grand rounds he ever gave when he 1) made fun of Tahoe patients and 2) insisted he had found nothing wrong with them and inevitably suggested "...they need our help to get behind the wheel of their BMWs."  Boy, did that get laughs from the healers, the doctors on the front lines.

 

Pardon my cynicism but does anyone feel particularly confident Wallitt would know an ME patient if he fell over one? Reportedly, he’s getting help from a few non-NIH researchers who count themselves as specialists in the disease. So it's taken a team-effort and two years to identify six NINDS-approved patients--one whom is a former NIH public relations specialist--out of the reported 271 who have offered themselves? What more do you need to know about ME’s priority in the NIH cosmos?

For perspective, consider that the National Institutes of Neurological Disorders and Stroke's budget was $1.4 BILLION this fiscal year. So far, all we know about what NINDS is spending on this study, on which so many have pinned their hopes, is that NINDS staffers have said they will not say what they are spending on this study.

In 2017, NIH spent slightly less than $17 million on ME extramural funding. This year, the amount actually dropped by $2.3 million. Thirty-five years of Ground Hog Day. ME may be heading into male pattern baldness and hay fever territory again at the nation’s largest funder of bio-medical research. No wonder scientific consortiums, even those with NIH money, continue to ask patients--repeatedly and often--for donations.

 

What is a reasonable sum to expect the government to invest on research into this unprecedented epidemic thirty-five years after it began? A clue: it’s not the $250 million Mary Dimmock and Leonard Jason suggest, but more on that in Part Five.

 

Keep in mind the NIH received $37 BILLION for fiscal 2018, an historical high. Trump may be a terrifying train wreck of a president, but he seems to like the idea of generously funding NIH, possibly as a result of former Tea Party leader Newt Gingrich, one of Francis Collins' best friends and a guy who likes science, whispering in Trump's ear. Just a guess.

Correction: In the original version of this story I identified Brian Wallitt as a nurse. His correct title is "medical officer" at the National Institute of Nursing Research, reflected above.

Next: A Contrarian Report on AIDS Spending (circa 1992), or, What Changes when You have a Bug

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