Failure to Fund, Part One

Hillary Johnson

 

 

Minneapolis was my childhood playground, though I left for Berkeley the day of my high school graduation. I never imagined I would live there again until my mother fell ill with terminal cancer in 1989. I came back then, determined to help her.

 

Near the end of her life, Ruth kept asking me if she was in a movie. She found reality just too strange. Her terrible illness and its unalterable outcome could not possibly be true.

 

“Is this some kind of movie we’re in?” she often asked me, sincerely puzzled. She was 63.

 

Nearing 68, I feel a kinship with that sentiment. Could the spread of ME, this so-far irreversible disease, and our government’s submersion of it from public view, really have happened?

 

Could I have really lost more than thirty-three years of my life? All the beauty of the world, the work, the loves, the friends—they’re in a book I read long ago about someone else. I’ve been misplacing that book lately. Multiplying that story by millions of people requires courage that is hard to summon, especially when there is no resolution in sight, just people I don’t believe or respect moving their mouths. It’s especially rough when the barricades to resolution—most critically the government’s failure to fund academic research—remain in place and when millennials are asking the same incredulous questions that victims of my generation asked more than three decades ago, suggesting no progress has been made.

 

“And the worst part is, no one believes you!” appeared on my Twitter feed recently.  I stared with disbelief at the comment, addressed specifically to me. I thought suddenly of Johnny Carson, who was still on TV when my nightmare began, replying to the obvious with his classic fake surprise, “I did not know that!

Johnny Carson: "I did not know that!"

 

I was personally dressed down on that very issue in the most public way thirty-one short years ago. A few days after publishing two lengthy articles about the emergence of this disease in Rolling Stone, George Straight, ABC’s science reporter, brought his television crew into the small apartment where I was living. There, in a tiny abode where I felt I was struggling for my life, having dressed up for the first time in months in an exhausting effort to look like my old self, Straight pushed passed pleasantries to ask, “What makes you so sure you aren’t imagining this disease?”

 

I had just written 20,000 words explaining why that couldn’t possibly be the case. But I wasn’t going to be the journalist expert. I was going to be the loser patient. I realized Straight’s singular purpose had been to ask me this provocative question. He had a job to do, an agenda. He was adhering to his strategy, come what may.

I was jarred. “I don’t believe that,” I said, buying time while I marshaled my facts. “I just don’t believe that,” I quickly reiterated to fill the awkward silence. And that’s the part of our interview that made Nightline, even though I recovered in time to burden him with facts, too. I wondered if Straight would have asked the same question of a male journalist who had just spent six months researching a series for Rolling Stone. Probably.

George Straight, ABC News

 

And the worst part is, no one believes you.

 

In time, you discover there are parts that are magnitudes worse, but in the beginning, yes, that’s the first shock.

 

***

 

The contemporary calendar, the calendar of the unafflicted, might read 2018 but it’s still 1984 in the ME cosmos. What prescience inspired George Orwell to pick 1984 for the title of his book about totalitarianism? Orwell’s phrases, “Big Brother,”“thoughtcrime,” “newspeak,” “memory hole” and “perpetual war” all have application in the upside-down, opposite world of ME--a world that began with the government’s declaration that if a doctor could find anything wrong with you, then you couldn’t possibly have ME. Talk about being shoved into a corner. I tried to explain that twisted logic to my mother, who thought for a moment and remarked, "I see. A bit like, 'Have I reached the party to whom I am speaking?'"

 

The opposite world of ME was born in 1984 with the Incline Village epidemic. Since then, ME sufferers mostly have been the terrified, beaten-down citizens of Orwell’s imagination with little to go on but their faith in the U.S. government, most especially its health agencies. Interestingly, those few with insight, call them dissenters, I’m told are being accused by millennial-era ME “advocates” of being “conspiracy theorists.” In this century, if you want to imply someone is crazy, call them a conspiracy theorist. But, go ahead. Put them in the same category as Woodward and Bernstein, Sy Hersh, Erin Brockovich, and Karen Silkwood--and remember that staying silent or collaborating with the enemy can be a conspiratorial act, too.

The NIH’s failure to fund is a quiet disaster of more than three decades duration. That history is notable for NIH’s lies, fraudulent science—including manipulation of data to arrive at false conclusions—and unequivocal thuggery at the highest levels of the agency toward patients and their representatives in Congress.

While I’m on the subject of 1984 (the year), I would like to clear something up because it’s an integral part of the failure-to-fund conundrum. Incline Village was never Ground Zero for the ME epidemic, as many have mistakenly imagined. Instead, the tony mountain resort where CDC made its stand was Ground Zero in an endless propaganda war that’s been going on since before millennials were in diapers. Beginning with the agency’s conclusion that ME was an “epidemic of a diagnosis” and alternately,“hysteria,” to the current CDC staff who give lip service to ME's existence but continue to allow the disease to spread without bothering to notify the public of the danger, the propaganda just keeps coming. Obsessed for decades with HIV transmission, which has slowed dramatically in the US and Western countries, CDC staff can’t even bring themselves to suggest that people with ME, at a minimum, practice safe sex. The agency would rather take a chance on the disease spreading than admit any danger of transmissibility exists, despite abundant epidemiological and biological evidence, not to mention simple logic, for ME’s infectious nature.

 

***

 

The NIH’s failure to fund is a quiet disaster of more than three decades duration. That history is notable for NIH’s lies, fraudulent science—including manipulation of data to arrive at false conclusions—and unequivocal thuggery at the highest levels of the agency toward patients and their representatives in Congress.  

 

CDC enters this story primarily because early decisions made at that agency after the Nevada outbreak gave NIH the ability to justify its failure to fund. I am referring to the CDC’s decision to rename the disease “chronic fatigue syndrome” and its refusal to perform epidemiology, the sole endeavor in which the CDC might be able to claim competence. Both crimes relieved the NIH of any responsibility to conduct basic research--it’s federal mandate--on the disease. The name branded patients as whiners and malingerers in the public mind up to the present. Next, in 2002, CDC’s director William Roper explained in a Trumpian way—that is, in the face of a plethora of evidence to the contrary—that there weren’t very many people who were ill when he was queried by members of a House appropriations committee. CDC’s first public estimate was ten thousand patients. As one sarcastic CDC insider told me at the time, “Off by several magnitudes. Nobody’s perfect!”

 

In reality, by the late 1980s, the agency was receiving ten thousand calls a month from frantic patients and alarmed doctors. People with this disease were showing up in the Atlanta lobby of the agency having come from places as far away as Maine, some of them middle-aged men who were in tears. They were routinely greeted by a secretary who counseled patience. I imagine most of them are dead now.

 

The NIH’s Stephen Straus was the dominant player in the re-naming of the disease; he also performed research at NIH on patients that ranged from abusive to dishonest, ultimately concluding ME sufferers (based on an unethical "study" of twenty-three of them) had a high incidence of mental illness. Never mind that the most perfunctory analysis of his data did not even come close to warranting that conclusion, he published his verdict in the Journal of Clincial Psychiatry anyway. Just in case the general public wasn't reading the Journal of Clincial Psychiatry, Straus' institute, NIAID, sent out a three-page press release trumpeting Straus' conclusion to 500 reporters and news organizations around the country, including television networks and the science and government writers for every major newspaper and wire service. The press release was headed in bold-faced, all-cap letters by the words, "LIFETIME HISTORY OF PSYCHIATRIC ILLNESS IN PEOPLE WITH CHRONIC FATIGUE SYNDROME." Virtually every metropolitan newspaper in the nation reported on the article in the obscure journal, cribbing their headlines from the press release. And then Straus never published on the disease again, nor did he ever once attend a medical conference on the topic--I'm told because he was afraid of patients physically harming him. Was the brain tumor that would kill him in 2007 already wreaking havoc on his thinking mechanisms? Or was it true? Would patients throw their coffee at him? Aim paper airlines at his head, perhaps? Knowing the ME crowd as I do, I doubt it.

He was a jovial man—and why not? He had just received a five-year NIH grant of $250 thousand per year to research AIDS.

Stephen Straus, NIAID

 

Pole vaulting ahead to 2017, the NIH spent $7 million in extramural grants on ME, funding three research "centers." Patients were expected jump up and down with joy and many did. The money is a sum that NIH hands refer to as “fairy dust”—money so slim it’s used to round up or round down real grants. Certainly, I hardly need point out to this audience that $7 million is a negligible sum relative to the magnitude of the public health crisis of ME.

 

The AIDS funding story is remarkable by contrast. I’ll come back to it because it’s so extraordinary it deserves its own column, except to note that $7 million in AIDS World is akin to lunch money or taxi fare--maybe not even.

 

I interviewed Stanford infectious disease chief Tom Merigan in 1987 for Osler’s Web. He was a jovial man—and why not? He had just received a five-year NIH grant of $250 thousand per year to research AIDS. For perspective, in 2018 dollars that yearly sum would be $557,000, or half a million. All to a single lab.

 

Cornell University, where Professor Maureen Hanson has managed over a period of years to pull together an impressive coterie of scientists and labs ranging from her own sizable lab to Ithaca College to New York’s Weill Cornell medical school, is one of those centers and probably the most sophisticated, in my view. The Cornell group will receive $9.4 million over five years; another, at Columbia, will receive a similar amount for that period. The government’s desire to keep this disease within their ultimate control—it’s politicization of the disease—continues, as well. Cornell, Columbia and the Jackson Lab in Connecticut, the third recipient, are inextricably tied to NIH’s apron strings as a condition of their receipt of NIH grant money.

Tom Merigan, Stanford

 

“The grants will be managed by NIH’s National Institute of Allergy and Infectious Diseases and the [National Institute of Neurological Disorders and Stroke],” the press release promised. Everyone on the same page!  That would be NIH’s page, of course--the agency that claims after thirty-five years it does not have enough information to label ME a neurological disease. The lies told by NIH bureaucrats and scientists are so numerous one could never dream of keeping track of them, but that has to be one of most outstanding in recent memory.

 

***

 

You could say of Merigan’s 1987 $250-million-a-year Stanford grant: “Yes, but it was AIDS and it was early years!” Which is my point. I'm talking about ME, another disabling and sometimes deadly infectious disease that threatens the world’s population, already having taken down an estimated 17 to 35 million people, and it is very late years. And NIH is still blowing fairy dust at the problem and lying about what it is and what it isn't.

Let’s compare apples to apples--people who are actually sick as opposed to having seroconverted to a particular virus.

 

The epidemics of ME and AIDS began simultaneously--a remarkable coincidence no one in the federal government is willing to touch with a ten-foot pole, but some scientists I've talked to think about it all the time. Nevertheless, in 2018, ME is more common than HIV infection in this country. CDC claims there are currently 1.1 million HIV-infected people in the U.S. but some estimates put the number of ME sufferers at 2.5 to four million. Further, rates of HIV infection have been declining for years. In 2015, for instance, approximately 30,000 people, mostly homosexual men, became HIV positive, according to CDC. What they all have in common, unlike patients with ME, is a fix: drugs that keep HIV at bay and allow them a symptom-free, average life-span of 78 years.

 

In fact, is being HIV positive remotely equivalent to having ME? Let’s compare apples to apples--people who are actually sick as opposed to having seroconverted to a particular virus. In that equation, ME is equivalent to having AIDS. In fact, we know from morbidity studies that it's worse than having AIDS. The latter disease is increasingly rare in the US compared to ME. In 2014, approximately 6,500 hundred people died of AIDS, according to the CDC. The same year, 600,000—1,600 people per day—died of cancer.  

 

Would it be out of line to suppose that 6,500 people with ME may have died of their disease that year, too, whether prematurely, or from organ failure, starvation or suicide? Why is ME, which is often compared to a "living death" and which may last for decades and afflicts millions more people and remains uncontrolled--that is, it continues to spread--unworthy of an equivalent number of billions of dollars that have been spent on AIDS?

 

In spite of all this, federal AIDS money continues to roll out in staggering amounts even today. Money devoted to AIDS domestically this year alone amounts to $26 billion. That includes not only research but a multitude of social services.  

 

***

 

What millennials may not realize about the NIH grant system as it applies to ME is that everything old is new again. In the 1980s and well into the 1990s prestigious scientists like Jay Levy in San Francisco, Seymour Grufferman, a cancer epidemiologist and non-Hodgkin's lymphoma expert at the University of Pittsburgh, Hilary Koprowski, the director of the Wistar Institute in Philadelphia and his mentee, immunologist Elaine DeFreitas and other scientists of their ilk wanted to pursue this disease aggressively. All had all been recipients of millions of dollars in grants from NIH throughout their careers, but when they proposed to study ME—specifically to search for the virus causing it--their grant applications were deemed unworthy by NIH ad hoc grant review panels staffed by people who knew nothing about ME. Or, if they knew anything, they knew it was a psychiatric problem a few trouble makers were insisting was real.

Hilary Koprowski, Wistar Institute

 

Koprowski, who died in 2013 at 96, was a member of the National Academy of Sciences. (It's rumored that Columbia's Ian Lipkin was such a Koprowski fan he named his dog after the Wistar director.) In conversation and in large, public meetings, Koprowski never missed a chance to refer to ME as “an infectious disease of the brain.” At ME conferences, where patients and their relatives were in attendance, Koprowski’s phrase would inevitably incite an audible gasp from audience members. But infectious central nervous system diseases were among Koprowski’s areas of expertise.  He knew one when he saw one. He developed the first polio vaccine; he engineered a way to immunize wild animals from rabies. He once explained to me, in the starkest terms, that the emerging threat of infectious neurological diseases was so great that NIH needed to create a new institute specifically to tackle them. Enormous sums of money, Koprowski said, should be poured into that effort much like Nixon’s War Against Cancer. He was talking about Alzheimer’s, Parkinson’s, ALS, MS and ME. In recent weeks, researchers have provided tantalizing evidence that Alzheimer's might be caused by Human Herpes Virus Six. Will NIH start funding big, AIDS-like grants to allow scientists to pursue that finding? Why am I dubious? Larry Kramer, writer and AIDS activist, called NIH "a cesspool of mediocrity," in a recent interview. "Has it never occurred to anyone how few cures have come out of the NIH?" he added. (He also called Francis Colllins "a wimp.")

 

As regards ME in 2018, funding continues to be barely there and the same excuses that have been recycled for over thirty years are being employed even today. One gets the feeling NIH bureaucrats are reciting and recycling statements from some twisted equivalent of the Dead Sea Scrolls. “The science isn’t there,” and some variation of, “We aren't receiving enough grants,” are the critical phrases. The names and faces change, the excuses don't. I heard the phrase, “The science isn’t there,” (verbatim) first from Ann Scheluderberg in 1987. She was the original NIH grant officer for ME. Our conversations were difficult because she wouldn't allow me to call ME a disease. She agreed to let me interview her if I drove her from her hotel in downtown Los Angeles to LAX--at seven a.m. I felt like death warmed-over at that hour; I could barely walk--something she never saw because I was always seated in a car. She didn't know the late-model vehicle was rented because I could no longer afford a car of my own. But she wouldn't allow me to call the disease a disease. "We don't know that!" she would interject sounding more schoolmarm than scientist. We settled on the amorphous "It." Afterward, I came home and slept forty-eight hours.

ME wasn’t “something into which you could probably pour a lot of money.”

 

Over a decade, CDC stole (is "re-purposed" easier to swallow?) approximately $150 million dollars Congress appropriated to the agency to identify the cause of ME and perform epidemiology on it. Less well known is the fact that NIH, too, deliberately steered money away from the disease, often turning down offers of money from Congress for intramural and extramural research.

 

During an interview in the early 1990s, I was told by Tony Fauci’s top deputy, James Hill, that I should be “grateful” Stephen Straus was working on ME because “Straus is the only person we have in our institute who is interested in this particular subject.” Hill also noted, nevertheless, that ME ranked “number two in time consumption, at least, in terms of our responses politically and to the public,” after AIDS. When I asked about the absence of extramural funding, which might reasonably be expected to generate hypotheses and answers to this malady that was inconveniencing his institute, Hill let me know that “the state of the science” was so poor—“the disease, the diagnosis,” he continued, waving his hand to illustrate how absurdly vague it all was—well, he concluded, ME wasn’t “something into which you could probably pour a lot of money.”

Tony Fauci (left)

In 2002, NIAID’s director (and Straus’ boss) Fauci and other top DHHS officials appeared before the House appropriations committee. When a committee member asked Fauci if NIAID needed more money to fund extramural ME grants, “Fauci said that his institution did not, because the pool of experienced investigators in the CFS field remains small. We are trying to attract new researchers by stimulating interest through workshops, publications and program announcements. As the number of investigators increases,’ Fauci added, ‘the availability of resources will become more important.’ The committee followed up by asking Fauci if his institute needed more money for its intramural investigations. ‘We have expanded our intramural program to a level that we feel is appropriate given the state of the science and staff commitments in this area.”

(Fauci's quote above excerpted from Osler’s Web, 1996)

 

The intramural program Fauci referenced was comprised of one man and his nurse: Stephen Straus and Janet Dale. When Straus died, Fauci sent ME to the janitor's closet at NIH known as the Office of Research on Women's Health, where it sat for years and years with the brooms and mops. ORWH has no labs, no scientists, and no money for ME, certainly, but it does have a website!

So, after turning down grant applicants Levy, Grufferman, DeFreitas, Koprowski and numerous others, Fauci told Congress that the NIH was not funding grants because there weren’t enough scientists who were interested in ME. He also turned down Congress' offer of money to pay for more extramural ME research.

Jay Levy, UCSF

By the time Fauci testified on the matter, word of the NIH’s refusal to fund was spreading widely throughout academia, from UC Berkeley to Harvard: why should scientists at universities who were trying to support entire labs knock themselves out writing grants they knew had zero chance of being funded? I knew these excuses were false in the 1980s and they’re false now. Nevertheless, it seems that with renewed patient interest in the process today, NIH is doubling down on them. After all, it worked in the past. As recently as last May 2018, the NIH's Vicki Whittemore told ME scientists who had convened in Montreal that NIH would fund more ME grants if they were to receive more applications. "There isn't that much interest," she rued. 

And yet, word on the the grapevine is that NIH just turned down another major ME grant that was important and should have been funded. I was unable to learn the name of the researcher because, I was told, the researcher would be embarrassed to be named. Maybe someone among my ultra-sharp, in-the-know subscribers list knows. Personally, I think the researcher should be shouting from the rooftops about her or his turn down by NIH. Patients need to know worthy proposals continue to be shot down at NIH in spite of the institute's pretense--from Francis Collins to Avindra Nath to Vicki Whittemore--that it is committed to resolving this disease. There is no other conclusion possible: the NIH is NOT committed to resolving this disease. I will address the "WHY" in my next column.

 

***

 

In addition to Fauci’s choice to withhold NIH research grants from ME investigators over the years, there have been additional institutional systems in place at NIH to deter money from being routed to ME. For instance, a “standing” grant review committee has never existed at NIH for ME, as is common for most other diseases. These permanent “study” committees, comprised of presumed specialists in the disease, come together routinely to read and rate grant proposals. When the scientists they fund come to the end of their grants, the original standing committee remains intact. Which grants were successful? Which were not? Committee members are compelled to hold one another accountable for their decisions.

 

In contrast, from the start, ME grant committees have been ad hoc: an NIH bureaucrat pulls together a group that is unlikely to meet again (and rarely if ever meets in person since they conduct their meetings by telephone). These days, two to three members from a committee of six, including a chairperson, report their opinions of a grant to their colleagues. If these two to three reviewers deem that a grant needs additions, subtractions, or other changes, it’s sent back to the authors. When scientists resubmit their re-tooled proposals, their grants are read by a different group with new and different biases. It can waste a year, two years, if the grant is funded at all.

 

“One person can sink you,” an ME investigator told me recently.

 

Over the years, members of these ME grant study committees have included dentists, a man whose specialty was hypnotizing rats and not unexpectedly an endless parade of psychologists and psychiatrists. In recent years, NIH is seeking out scientists with some experience in ME research to assign rankings to grants their peers submit. Generally, having been published at least once on the disease will give you leave to be selected by an NIH scientific review officer.

“We need better reviewers. New researchers are not going to come into this field and commit professional suicide with this system as it is.”

 

If a researcher has been listed on a paper with another investigator, NIH considers that a conflict of interest and she or he is not chosen to review the grant under consideration. But the system isn't running as smoothly as some would like. It turns out some ME researchers who sit on grant review panels are sabotaging each other on occasion.

 

At an ME conference in Montreal last May, exercise and sports sciences professor Betsy Keller from Ithaca Collage spoke up publicly on this delicate subject.

 

“It’s clear that you’re not supposed to know who reviewed your paper,” she said, but she indicated that it’s often crystal clear who did the reviewing based on their comments and biases. “It’s a small field. People on the grant review committees can support the grant, or they can micromanage the grants and force them not to be funded. When you see these reviews, you can see there are overt biases. Whether these reviewers think they’ll lose their own grant if your grant gets funded is uncertain.

 

“None of this will change until experts in the field start playing nice in the sandbox,” Keller added.

 

Another researcher who has submitted grants said he was frustrated by perennial NIH staff assertions that they will fund more grants when they get “better grants,” another way of saying, "The science isn't there," or that funding will be available when there is more interest in the disease.

 

“No,” he said. “We need better reviewers. New researchers are not going to come into this field and commit professional suicide with this system as it is.”

 

Columbia’s Ian Lipkin and Stanford’s Ron Davis have had grants turned down by review panels who pointed out in one case that ME was a psychiatric disease. Another reviewer killed a grant saying that the cause of the disease had already been established--it was Epstein-Barr virus. Wow. 

One difference between Davis and new scientists who may be curious to explore hypotheses in ME is that Davis, whose son is severely ill, has more than a passing interest in the disease and is willing, so far, to keep trying. Indeed, after filing a formal complaint with NIH over his last grant review, Ron Davis recently was awarded an NIH research center grant--$745,000 for the first year, or $2.5 million over five years. Taxi fare from the world’s richest bio-medical research facility. Notably, Davis has been able to raise more money for himself and his many collaborators at Stanford by developing a highly competent social media campaign than by seeking grants from NIH, a success that has not gone unnoticed.  All the NIH center grant recipients continue to ask for donations on their websites. My guess is that philanthropic money, drummed up by super-rich patients or their relatives, exceeds what's been spent on ME over the years by NIH. 

Ampligen manufacturer Hemispherx's CEO Tom Equels has stated his belief that Hemispherx, over the last three decades, likely has spent more on ME research than the U.S. government, as well. To no avail. Further, I'll note that not a single NIH researcher or grant recipient is conducting research on Ampligen and ME. To me, that fact reflects the impact of allowing the NIH to exert control over--to politicize--what scientists may study about ME. Ampligen cures a lot of newly-ill ME patients and it improves the health of others to the degree that their suffering is knocked back significantly. But drug development would not be part of the NIH's research agenda, would it? God forbid a powerful immune-modulator and antiviral like Ampligen be proven efficacious in ME by academic, NIH-funded scientists. Might some citizens start to wonder if ME is an infectious disease? Better to drag out the confusion and "mystery" for as long as possible. You know--study the microbiome for the next decade. NINDS' director Walter Koroshetz can claim ignorance about the bewildering, mysterious ME right up to his retirement, at which point, it will be someone else's problem.

Thirty years of wheel-spinning is one reason Hemispherx's new priority is to see Ampligen approved for use in oncology. Once that approval comes, doctors can write off-label Ampligen prescriptions for ME sufferers who can afford it. That's one  scenario, anyway. Until then, Equels jokes, ME sufferers should stage a "sleep-in" in the Food and Drug Administration's parking lot in Rockville, MD. If ordered out, patients could set their mattresses on fire before leaving. He adds, "Get a permit first!"

Now that's advocacy.

Stay tuned for my second installment of Failure to Fund. Until then....

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