White House Chronicle

News Analysis With a Sense of Humor

The Strange Case of the NIH and an Elusive Disease

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The federal government has a mostly open dialogue with those it serves and those who serve it. This happens pretty well across government agencies, from the Pentagon to the Department of Transportation to the Department of Agriculture.
 
So it is troubling that the National Institutes of Health, an arm of the Department of Health and Human Services, appears to have no communication with a critical but ignored patient cohort: those suffering from Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome, and often referred to only as ME/CFS. The NIH does not appear to hear the cries of the petitioners at its door; it seems to be interested only in classifying and defining the disease.
 
According to the Centers for Disease Control, ME/CFS afflicts 1 million people in the United States, and 17 million people around the world. While those numbers of victims are disputed, their suffering is not; they are ill in a terrible way.
 
ME/CFS takes healthy — often athletic — people and casts them into a shadow world of physical incapacity, mental fog, loneliness and relentless dependence on others. The suffering is measured in years and decades. Suicide is common.
 
It is a disease of the immune system, but what triggers it is unknown. Physicians who treat ME/CFS have told me that they would rather have cancer than this disease. One epidemiologist said, “With cancer, you are cured or you die. ME/CFS just goes on and on. You live the life of a zombie.”
 
From a physician devoted to treating and researching ME/CFS, this is not only a terrible admission, but also a de facto indictment of the national effort to find a cure, or even a therapy, for alleviating the suffering.
 
One of the problems affecting ME/CFS treatment is diagnosis. There are no biological labels, known as markers, that enable doctors to easily identify ME/CFS; it cannot be picked up in a blood tests or a urine sample. It is a ghostly manifestation, and doctors fall back on what is known as wastebasket diagnosis. In its simplest form, this means testing for a lot of diseases and if it does not turn out to be one of them, it could be ME/CFS.
 
But one case definition has satisfied the ME/CFS community in recent years, and it is endorsed by specialists in the field. Established in 2001, it is called the Canadian Consensus Criteria.
 
Yet, incomprehensibly, the NIH is spending some of the paltry $6 million devoted to ME/CFS, on a study to come up with a new case definition for the disease; something that no one wants and which could do real harm.
 
To do this work, the NIH selected the Institute of Medicine (IOM), which has no expertise in ME/CFS and which had drawn opprobrium with its clumsy attempt to do a case definition of Gulf War Syndrome.
 
The NIH, which has failed to explain itself in plain English, has ignited incandescent rage in the patient community and from patient advocates. In a unique outpouring of objection, 50 of the world's top doctors and clinicians wrote to Secretary of Health and Human Services Kathleen Sibelius, pleading with her not to muddy the waters and to stay with the definition which is working well. The NIH went ahead with the IOM contract.
 
So lacking is government support, moral as well as financial, that the research community, including dedicated physicians such as Andreas Kogelnik of Mountain View, Calif., Daniel Peterson of Incline Village, Nev., and Derek Enlander of New York City, feel they have to raise funds privately to continue their work. Even celebrity virus hunter Ian Lipkin of Columbia University has abandoned hope of getting his seminal work funded by the NIH and has joined the researchers who have had to hold out begging bowls to the public to do their research.
 
Judging by social media, the entire patient community is in a state of metaphorical war with the NIH.
 
There is a cry from and on behalf of the pitiable sick for action, sympathy and even courtesy from the bureaucrats in Bethesda, where the NIH is headquartered. The Hippocratic Oath says, “first do no harm.” When people are in pain and despair, inaction is palpable harm.
 
A congressional hearing is needed to investigate decision-making in the NIH, find out about its budget request to the Office of Management and Budget, and to demand that it listen to those who suffer and those who are trying to help them. — For the Hearst-New York Times Syndicate

David and Goliath, or, the Sick and the Bureaucracy

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Malcolm Gladwell, the New Yorker writer, has grown rich with a series of books exploring the sociological dimensions of success and failure. In his latest, “David and Goliath: Underdogs, Misfits and the Art of Battling Giants,” Gladwell celebrates the many Davids who triumphed over the odds because they were nimble and resourceful.
 
If he wants to observe a classic David-versus-Goliath rumble, Gladwell might want to go to Washington on Tuesday (Dec. 10). He will see a frail woman go up against the federal government with a humble petition and a small following of mostly very sick people.
 
Her name is Susan Kreutzer and she suffers from the debilitating and mysterious disease Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis, which is the name patients favor.
 
Kreutzer and others will begin their demonstration at 9a.m. outside the headquarters of the Department of Health and Human Services on Independence Avenue, where she will hand over a petition. Then she will move up the street to Capitol Hill to demonstrate and hand-deliver petitions to members of Congress. She will end her day of petitioning her government outside the White House.
 
Kreutzer has no idea how many, if any, demonstrators will join her, but she assures me she has the required permits to demonstrate. Another time, only six demonstrators turned out,, but they unfurled a huge banner and stood on he street telling the oft-ignored story of their suffering to anyone who would listen.
 
Telling your story in Washington without a big-bucks lobbying firm or celebrity friends is not an easy assignment. Not only is there the high chance of being ignored but there is also the chance of being discounted as one of the apocalyptic “end of days” proselytizers, or those who believe the CIA has it in for them and who habitually assemble at the White House and elsewhere. In other words, it is easy to be dismissed as a “crazy.”
 
But Kreutzer, who will have a warm-up demonstration on Dec. 9 in San Francisco at the HHS offices there, believes in the strength of small voices, of a murmur in the cacophony of Washington petitioning. “I feel I have to do this,” she said.
 
This year, the victims of CFS are particularly upset with HHS and its dependent agency the National Institutes of Health. They are fuming at the decision of NIH to seek a new clinical definition of their disease, supplanting the Canadian Consensus Criteria, which has been the diagnostic gold standard for researchers who are deeply committed to finding a cure for a disease that affects as many as 1 million Americans and another 17 million people worldwide.
 
It is a disease that simply confiscates normal life and substitutes an existence in purgatory, where victims can be confined for decades until death. Sometimes they will be so sick they must lie in darkened rooms for months or years; sometimes they can function for a few hours a day, usually followed by collapse. Dysphasia — word confusion — increases. Lovers leave, spouses despair and the well of family compassion runs dry.
 
The first and major complaint of all those in researching the disease and those suffering from it is that NIH spends a trifling $6 million on this circle of hell that could have been invented by Dante.
 
The second and immediate source of anger laced with despair is that NIH has, apparently arbitrarily, decided to have the clinical definition of the disease reclassified by the Institute of Medicine and has diverted a precious $1 million to this purpose. Thirty-six leading researchers and physicians from the United States, risking retribution in funding, protested the move but were ignored. They were joined by colleagues from abroad, bringing the blue-ribbon protesters to 50.
 
Still nobody knows why the move to reclassify the disease. One school of thought is that NIH would like to abandon the current and well-accepted diagnostic criteria, known as the Canadian Consensus Criteria, in order to treat the disease as more of a mental one rather than a physical one.
 
I approached HHS for a comment and for a word with Dr. Howard Koh, the assistant secretary in charge, but have received no response.
 
Will this David, Susan Kreutzer, fell this Goliath, HHS? — For the Hearst-New York Times Syndicate
 

Getting a Seat at the Table

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Think of this as a primer for all of those, like the sufferers of the awful disease Chronic Fatigue Syndrome, who need to be heard in Washington and aren't. Silence has a price.
 
There are two branches of lobbying in Washington. The first is big lobbying, with big money making big campaign contributions. The second is everyday lobbying, which is quietly effective, scarcely organized and part of the fabric of decision-making. Call it "informational lobbying."
 
Congress cannot expected to be knowledgeable about a myriad of issues, and this is where the lobbyists perform their often more innocent function. Simply, they know stuff. Their advice isn't always objective, but it's informed.
 
Certainly, Congress has the best research available through the Congressional Research Service of the Library of Congress and all the executive branch agencies. But it's a lot easier to call a friend, where a question can be asked and answered in the vernacular: “Joe, what's the story on the helium shortage?” It can be argued that, at this level, lobbying is not suspect but efficient.
 
Proximity is a force in Washington, familiarity a lever. There are no fingerprints; it's how the system works. A chance meeting in a restaurant can change the course of policy; influence a congressional opinion about something obscure but important, like the Endangered Species  Act, which is now receiving attention on its 40th anniversary.
 
The indictment of this informal lobbying regime is not that it exists and works, but that if you aren't at the table, you won't be heard. Woe betide those who don't have a lobbying operation, however modest, in Washington.
 
The lobby-less must suffer in obscurity: no lobby means no input. No conversation after church or at a kid's soccer game means no information is spreading about actions and decisions that will have impact down the line.
Make no mistake, proximity means a lot in the informing of government. A few casual words will often trump a great academic study.
 
For the past several years, I've taken a keen interest in Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis. It's a disease associated with the suppression, for reasons unknown, of the immune system. To get it is to contract a life sentence of daily suffering, often so severe that patients can be bedridden for years. They think of themselves as “the damned.”
 
This community has issues with the federal government; specifically with the Department of Health and Human Services, which has oversight of the National Institutes of the Health. Yet the advocates for CFS — many of them superbly articulate – aren't heard in Washington.
 
This is very clear, at the moment, when the department, acting through the NIH, has signed a contract with the Institute of Medicine to, according to NIH, to develop “clinical diagnostic criteria” for CFS.
 
This has so enraged the top tier of 35 doctors and researchers in the field that they — risking good relations and future research funding — have written to HHS Secretary Kathleen Sibelius, imploring her to halt this folly. The Institute of Medicine doesn't have expertise in this field, according to the CFS doctors.
 
Most CFS specialists agree that an effective definition of the disease, known as the Canadian Consensus Criteria, is working fine and should be retained. Confusion and expense from Washington aren't needed. A wrong definition can be destructive to research, treatment and patient well-being. It will have consequences.
 
But the protests may have come too late, as knowledge of what the NIH was up to came too late.
 
To me, this bureaucratic shuffle by HHS is an example of the dangers of not having a presence in Washington. Government responds to pressure. No presence, no pressure, no result — or worse, a bad result.
 
You don't need huge money to lobby. Effective lobbying is often a case of simply being there and being known to be there: walking the halls of Congress catches the attention not only of Congress, but also wayward federal departments and the media. — For the Hearst-New York Times Syndicate