National Institutes of Health

A Disease That Cries Out for Research as Many Suffer Silently

August 17, 2017 by Llewellyn King 5 Comments

Photo: Tom Camenzind, an ME/CFS patient, photographed at his home in San Ramon, Calif. / Credit: Linda Gasparello

All diseases are cruel, but some have a refined brutality all their own. One such is Myalgic Encephalomyelitis (ME), also known as Chronic Fatigue Syndrome (CFS). It is a monster, often hidden in plain sight; the suffering it inflicts is limitless.

Tom Camenzind is a handsome young man who should be in the joyous throes of youth. A popular and gifted student at Stanford University, Tom was clearing the hurdles of academia with ease and grace. In January of his sophomore year, he caught a cold on campus. ME walked through some door, and stole his promising life.

Today Tom lies conscious but prone in his parents’ home in San Ramon, Calif. He is totally paralyzed and can only communicate with his parents, Mark and Dorothy, by pressure from his fingers on sensors. He cannot tolerate everyday sounds, light or touch.

When the sensor-activated bell sounds, Tom’s parents come rushing to his side. Mark is an engineer and Dorothy is a physician, and the strain of their son’s affliction on them is palpable. Tom cannot do anything, anything whatsoever, for himself. At 23 years old, he is on the threshold of life, but he cannot cross it. He breathes and thinks, but he cannot live his life.

Recently, I filmed the Camenzinds for a special edition of “White House Chronicle,” a weekly program that I produce and host for PBS and other broadcast outlets. It was made in conjunction with the Solve ME/CFS Initiative, a Los Angeles-based charity.

Tom’s agony, and that of 1 million in America and 17 million around the world, predominantly women, cries out in terrible, silent eloquence for a national research effort with international cooperation on ME/CFS – so that those who suffer, like Tom, can dare to hope.

Tom’s paralysis is extreme, but others suffer daily with extreme fatigue, headaches, muscle pain, dysphasia and light and sound intolerance. Normal work is impossible, as is maintaining ordinary family life. Precious few ME/CFS patients make a full recovery. My files contain letters from sufferers who beg for death. Suicide is common.

Yet the United States has never put the effort — read dollars — into ME/CFS that it deserves, that it needs, that one would expect. Previous administrations have spent a paltry $5 million a year on research on the disease. While that amount was due to rise to $15 million, there is no guarantee it will under the Trump administration. The Office of Management and Budget has proposed deep cuts in funding for the National Institutes of Health, the research agency.

Even the diagnosis of the disease is a challenge. There are no conventional biomarkers that can be found in body fluids. One certain but clumsy way of diagnosing it is by asking patients who are ambulatory to walk on a treadmill. If they collapse for one or more days, the diagnosis is positive.

Many suffer for years and cannot find a doctor who knows anything about the disease. The disease is not part of the curriculum in medical schools.

Most patients see many doctors and get many wrong diagnoses before they find a specialist – if they find one at all. Most states have no specialists.

For patients, costs are huge and help is slight. Lovers drift away, spouses give up, children are often thought to be lazy and are criticized by parents, siblings and teachers. Schools are baffled when active kids fall apart from ME.

Over the years, there have been efforts by private charities, like the Solve ME/CFS Initiative, to fund the research gap. But still missing is the government, the big foundations and Big Pharma.

Sadly, ME has no celebrity champions. AIDS had Elizabeth Taylor, Muscular Dystrophy has Jerry Lewis and Parkinson’s Disease has Michael J. Fox.

For Tom to come back to his life one day, money and research are needed now. Oh, so needed.

Llewellyn King is executive producer and host of “White House Chronicle” on PBS. His e-mail is llewellynking1@gmail.com.

Cancer ‘Moonshot’ Has Paltry Dollars, Losers

February 6, 2016 by Llewellyn King 3 Comments

By Llewellyn King

Whenever the government wants to be seen to be doing something huge, it invokes the Manhattan Project or the moon landing. So the new cancer initiative of the Obama administration is called the “moonshot.”

But it’s neither the equivalent of the Manhattan Project, which developed the atomic bomb during World War II, nor President Kennedy’s ambitious program to land a man on the moon, after the Russians appeared to have stolen a march with the launch of Sputnik, the first satellite in space.

Those programs succeeded because they were tremendous national commitments without regard to funding. The $1 billion in proposed funding for the “moonshot” cancer initiative is somewhere between modest and paltry. In the world of biomedical research, $1 billion simply doesn’t buy much.

The pharmaceutical industry estimates that it costs well over $1 billion to bring just one new drug to market. Cancer needs many drugs.

The lead agency in this new iteration of the war on cancer, declared in 1971, is the National Institutes of Health. It has an annual budget of $32 billion on which there are demands from many deserving fields of biomedical research besides cancer.

President Obama has asked Vice President Biden to lead the cancer moonshot effort. I’ve been with the vice president when he has talked about his commitment to the cause of cancer research and the death of his son, Beau, from brain cancer. His sincerity and his commitment to cancer research is palpable, but he won’t have the dollars to get the job done.

The biggest contribution to the research for a cancer cure may be the stimulation the moonshot will give to extant cancer efforts, but it’s not without a downside.

Many other diseases fear they may be undercut by the cancer initiative. In the world of biomedical research, there is finite funding and talent — and a new initiative tends to draw the best research minds. The top magnets for good biomedical researchers these days are cancer and AIDS, and many other deserving diseases lose out. Biomedical research requires stability, so that decades of a scientist’s life can be devoted to a single line of endeavor.

I follow one of the more obscure diseases, one that that has been pitiably starved of public and private funds: Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome. Compared to any other disease affecting a large number of people (1 million victims of ME/CFS in the United States, according to the Centers For Disease Control), it has been funded so little by the government as to amount willful neglect. It receives a miniscule $5 million a year in funding.

Last year, after public and media pressure that has been applied for years, NIH Director Francis Collins announced that things would be rectified. But he didn’t mention a dollar figure; not when he made the announcement in October and not to date. No moonshot here, not even a Fourth of July firework.

Yet the suffering of those with ME/CFS is truly awful. I’ve been in the sick rooms and interviewed the few doctors who specialize in the disease, and the situation is one of unabated misery. Those who are the most affected can’t tolerate light or sound, and must pass their days in the silent dark. For years, one poor young man has had to take refuge from the disease in a modified closet. Others suffer from a world in which they’re punished for doing everyday things: A dinner with friends can mean days in bed for recovery.

There seems to be no light at the end of the victim’s physical pain and mental fog, despite decades of pleading from advocates and caregivers that some serious research be funded by NIH.

While we’ve been the world’s powerhouse in research in all sciences, biomedical is now being starved of research dollars. Recently America’s most revered virus hunter, Dr. Ian Lipkin, director of the Center for Infection and Immunity at Columbia University’s Mailman School of Public Health, has had to resort to crowdfunding. He and his deputy, Dr. Mady Hornig, can be found on YouTube eating red-hot chili peppers in an attempt to raise money for their ME/CFS research.

Dollars in across-the-board biomedical research are falling when they should be rising. Recently, NIH’s budgets have been 25 percent smaller in constant dollars than they were in 2003.

Research pays. Most of it doesn’t yield dramatic stuff, like a moonshot, but rather solid, incremental gain. In science, incremental gain is the equivalent of compound interest. But it needs sustained funding. Not rhetoric. — For InsideSources

In Search of the Real Elizabeth Warren

September 10, 2015 by Llewellyn King Leave a Comment

By Llewellyn King

I went to Boston this week in pursuit of the real Elizabeth Warren. You see, I don’t think the whole story of Warren comes across on television where she can seem overstated, too passionate about everyday things to be taken seriously.

Like others, I’ve wondered why the progressives are so enamored of her. Suffolk University, mostly known for its authoritative polls, gave her platform as part of an ongoing series of public events in conjunction with The Boston Globe. But whether the dearest hopes of the progressives will be fulfilled, or whether the senior senator from Massachusetts has reached her political apogee is unclear.

What I did find is that Warren has star power. She is a natural at the podium, and revels in it. At least she did at Suffolk, where the cognoscenti came out to roar their affirmation every time she threw them some red meat, which she did often.

Here’s a sampling:

On student loans: “The U.S. government is charging too much interest on student loans. It shouldn’t be making money on the backs of students.”

On the U.S. Senate: “It was rigged and is rigged [by lobbyists and money in politics]. The wind only blows in one direction in Washington … to make sure that the rich have power and remain in power.”

Warren’s questioner, Globe political reporter Joshua Miller, led her through the predictable obstacle course of whether she was angling to be the vice presidential candidate, if Joe Biden runs and becomes the Democratic nominee. She waffled on this question, as one expected, admitting to long talks about policy with Biden and declaring herself prepared to talk policy with anyone. She said the subject of the vice presidency might have come up.

Short answer, in my interpretation: She would join the ticket in a heartbeat. This isn’t only for reasons of ambition — of which she has demonstrated plenty, from her odyssey through law schools, until she found a perch at Harvard as a full professor — but also age.

Warren is 66 years old and although her demeanor and appearance are of a much younger woman, the math is awkward. There are those in the Democratic Party who say she needs a full term in the Senate to get some legislative experience and to fulfill the commitment of her first elected office. But eight years from now, she’ll probably be judged as too old to run for president.

Clearly Warren didn’t fancy the punishment, and probable futility, of a run against Hillary Clinton. But the vice presidency might suit her extraordinarily well, given Biden’s age of 72.

Warren has stage presence; she fills a room. She is funny, notwithstanding that you can be too witty in national politics, as with failed presidential aspirants Mo Udall and Bob Dole. She reminds me of those relentlessly upbeat mothers, who were always on-call to fix things in the children’s books of my youth.

Although Warren comes from a working-class background, years of success at the best schools has left her with the patina of someone from the comfortable classes; someone for whom things work out in life. She counters this by stressing the plight of the middle class, the decline in real wages and her won passion for fast food and beer — light beer, of course.

Warren’s father was janitor in Oklahoma who suffered from heart disease and her mother worked for the Sears catalog. The young Elizabeth did her bit for the family income by waitressing.

However, it’s hard to imagine her at home at a union fish fry. My feeling is that she’d be more comfortable — the life of the party, in fact — at a yacht club.

Progressives yearn for Warren and she speaks to their issues: the lack of Wall Street regulation and federal medical research dollars, and the need for gun control, student loan reform, equal pay for equal work, and government contracting reform.

Less dour than Bernie Sanders, and less extreme, it’s no wonder they long for her to occupy high office; she’s a classic, untrammeled liberal.

All in all, I’d like to go to a party where Warren is the host: the kind where they serve more than light beer. — For InsideSources.com.

Buckets of Iced Water Are Fun, Not an Answer

October 5, 2014 by White House Chronicle Leave a Comment

Two seemingly unrelated items of medical news: Ebola is devastating West Africa, and may spread around the world, and the entertaining ice bucket challenge has raised $115 million for ALS research.

The linkage is that both diseases have needed and still need medical research. So do hundreds of other diseases and conditions.
The truth is that the amount of money the United States spends on medical research is falling precipitously. It has been hit by budget worries in Congress, sequestration, and the decline in research funding by corporations.

Leo Chalupa, vice president for research at The George Washington University, said on “White House Chronicle” last weekend that the National Institutes of Health budget for research grants has decreased by 20 percent since 2004. He said that five out of six research applications are now rejected by the NIH, the principal conduit for federal funding of medical research.

The George Washington University is a member of the Science Coalition, a group of more than 60 of the nation's leading public and private research universities. Since its establishment in 1994, the coalition has advocated for sustained federal investment in basic scientific research as a means to stimulate the economy, spur innovation and drive America's global competitiveness.”

The late David Fishlock, science editor of the Financial Times, wrote and spoke elegantly about the problem democracies have in sustaining scientific funding; how they tend to be heavy on the gas, and then heavy on the brakes.

The government funds research through its own network of institutes and laboratories, and through grants to universities and corporations. When it comes to capturing the energy and flair of young researchers, the universities are vital.

Jennifer Reed, associate professor in the Department of Chemical and Biological Engineering at University of Wisconsin-Madison, said on “White House Chronicle” that universities contract with graduate students for five years, but the federal grants for research, when they get them, can be for less time. Reed said this is devastating to the research and the lives of the young researchers. Her funding comes from the Department of Energy and is aimed at using renewable materials to make alternatives to fossil-based plastics; also energy storage.

The problem is acute in medical research, most of which has its genesis in grants made by the NIH. Contrary to popular belief that medical funding is shouldered in the private sector, Chalupa said pharmaceutical companies often have narrow interests in particular drugs for particular conditions. “They have shareholders to answer to,” he said.

But it is not just funding that bedevils research, it is politics as well. Good projects are canceled and bad ones are incubated, depending on their appeal to particular constituencies. For example, fusion research has been lavished with money compared to other nuclear research needs, including the increased use of nuclear medicine to save lives and suffering.

Also the government funds research through many agencies, and this often reflects local or political pressure. Some researchers have found that they have to shop for funding, from NIH to the Pentagon to the National Science Foundation. Others have turned to crowd-funding, including the famed virus hunter Dr. W. Ian Lipkin, who directs the Center for Infection and Immunity at Columbia University's Mailman School of Public Health. Dr. Lipkin is now in high demand because of the Ebola crisis. But if there had been more work on viruses since the discovery of Ebola in 1976, there might now be a vaccine or other therapy to deal with the epidemic.

The United States is still the creative engine of the world. But without steady expenditure, it won't be firing on all cylinders. Chalupa and Reed warned China is increasing its funding for research rapidly, and is set to overtake the United States.

One (or more) patient launched the iced water caper that has been so successful out of frustration with the ALS research effort. It has been creative, but it will not keep the United States as the preeminent home of brave discoveries. Or to help the sick. — For the Hearst-New York Times Syndicate

Buckets of Iced Water Are Fun, Not an Answer

October 5, 2014 by White House Chronicle Leave a Comment

Two seemingly unrelated items of medical news: Ebola is devastating West Africa, and may spread around the world, and the entertaining ice bucket challenge has raised $115 million for ALS research.

May 12: A Disease Gets Its Day, but Who Cares?

May 8, 2014 by White House Chronicle 22 Comments

May 12 is not a day that is written into history. It is not a day when there will be, like clockwork, a presidential proclamation, or a moment of silence. Yet, for some, it is a day of recurring infamy.

Since 1992, it has been the day on which Myalgic Encephalomyelitis (ME) sufferers — and those who care for them– have marked the disease. It is, for these people, a day of sorrow, of remembrance and of yearning. They remember those who have died, or committed suicide.

They are angry — often too angry to be persuasive — that ME is not on the national radar. They are angry that after more than three decades, the federal government is still seeking to define the disease, which afflicts about 1 million people here and 17 million worldwide; that research funding, at $5 million, is so low that in the world of Washington expenditures, you practically need an electron microscope to find it; and that the suffering goes on unmitigated.

They are angry that the government, through the Centers for Disease Control, abandoned the old name, Myalgic Encephalomyelitis, in favor of the dismissive new name, Chronic Fatigue Syndrome. They believe this trivializes the disease, and favors those who want to define it as a psychological affliction rather than a real disease.

They are angry that distinguished researchers, like the virus hunter Dr. Ian Lipkin of the Columbia University Medical Center, has had to resort to crowdfunding to continue his work that might help ME patients.

Why does the ME community observe May 12? It is the birthday of Florence Nightingale, who may have suffered at the end of her life from a variant of ME.

So this May 12, Mary Dimmock, a mother of a suffering son, will endeavor to unfurl a banner made of pillowcases on the grass outside the U.S. Capitol. Her goal: Get recognition for the disease, so the long work of finding answers and a cure can be accelerated.

What is known is that ME is a disease of the immune system, and it starts with flu-like symptoms or with collapse after exercise. In extreme cases, as with Dimmock's 26-year-old son, Matt, the patient becomes almost totally incapacitated with mental fog, painful joints, terrible headaches, intestinal upset, and extreme sensitivity to sound and light. Matt Dimmock has to spend his days on a bed set up in a closet.

Patients go through periods of extreme debilitation for two or more years, sometimes recovering enough to function for several hours a day. What a healthy person would consider to be normal activity — like going to dinner or a movie with friends — can result in two days in bed for a ME patient.

Doctors, on the whole, know very little about the disease.

Mary Dimmock is an unlikely protester. She has presence: tall and distinguished. She is a scientist, who took early retirement from a large drug company to care for her son and has become an advocate for this disease, which has confiscated so many lives.

Although ME knows no age or gender, the National Institutes of Health (NIH) has lodged what little effort it makes under “women's health.” One patient said, “Maybe they think we are hysterical women, who are just making a fuss.”

Dimmock is the antithesis of an hysterical woman. She became an activist when she found, after her son fell ill four years ago, that where ME is concerned, the system is broken. She told me, “It has been profoundly disturbing to watch the world around my son, especially the medical community, ridicule and even brutalize him for believing that his disease is real and serious.”

Around the world, the ME story is the same: Doctors who do not know anything about the disease and governments that do not want to know anything about it, or want to believe, for economic reasons, that it is a psychosomatic affliction, when there is ample evidence that it is an immune system disease.

I have interviewed many patients, and some of the small coterie of doctors who are working on the disease. They all wish the Department of Health and Human Services would take a proactive role through its agencies, the NIH and the CDC. More and more dedicated researchers have been forced to turn to crowdfunding because the agencies of government, charged with the public health, have turned out to be selective in their sense of who is sick. — For the Hearst-New York Times Syndicate

A Bold Proposal for a Suffering Community

April 30, 2014 by White House Chronicle 8 Comments

I consider this a manifesto for the ME/CFS community. These are my thoughts, after nearly five years of watching the anguish and the neglect that surrounds this disease. The manifesto states what I think should be done now.

And “now” is an important word.

There is a story that Winston Churchill, when he was very old and sick, summoned the gardener at his beloved country home in Kent, Chartwell, and asked him to plant an oak tree in an open space.

The gardener, looking at his enfeebled employer, swallowed and said, “But, sir, an oak tree takes a hundred years to grow.”

“Then you’d better plant it now, hadn’t you?” said Churchill.

During World War II, Churchill used this same execution imperative approach to work. Churchill used to stick little, pre-printed notes — long before the days of Post-it notes — on his paperwork for staff that read, “Action This Day.”

One of the first things that struck me about ME/CFS, when I started writing and broadcasting on the subject, was how slow the pace of progress was, even as the suffering suggested the need for immediate action. The second was how stingy public and private funding for research was then and is now.

I want my friends and loves, who are in the grip of a relentless affliction, whose days are torn from the calendar of hell, to be cured in my lifetime — and I am 74. I want to be able to hold them as whole happy people; the people they were before they were struck down by an enemy they did not provoke, a monster they do not deserve, an unseen captor, a malicious jailer that takes daily life and makes it into a tool of torture and punishment.

One year, the CFIDS Association of America was able to declare proudly that it had raised $2 million. The National Institutes of Health, a federal agency that should be pushing research, granted a paltry $5 million for ME/CFS in 2013. By comparison, in that same year, I learned that a consortium of foundations was sponsoring a green power marketing initiative at $6 million a year.

I have spent nearly 50 years writing about federal funding for energy, science and technology, and the sums of money spent has been in the tens of billions of dollars. One company gets more than $60 million year-in and year-out for nuclear fusion research — and I see nothing wrong with that.

But when I look at the federal funding for ME/CFS research, I am aghast: It is not funded at a level that can be expected to produce results. It is, to my mind, a crime against the sick; morally, if not criminally, indictable. To allow the scale of suffering that attends ME/CFS, without making research on the disease a national priority, is close to willful neglect; an abrogation of the high purposes of Hippocrates’ calling.

Other governments are not free of guilt for the suffering – and the United Kingdom stands out among the many offenders. These governments have been seduced by the fraudulent blandishments of the psychiatric lobby. If a ME/CFS patient refuses to accept a psychiatric diagnosis, he or she can either be imprisoned or forced to suffer the insinuation that they are not physically sick, even if they cannot get out of bed. There are cases in Europe where patients refusing the prescribed psychiatric treatment have been imprisoned, as happened most recently to Karina Hansen in Denmark.

The United States is experiencing a boom in natural gas production and the deployment of solar panels on rooftops. These successes are the manifestation of substantial research money committed in the 1970s, and sustained since then. Science needs certainty of support, both political and financial, to triumph.

The key is sustained funding; a splash here and a dash there just won’t do — it won’t do anything. ME/CFS researchers need to concentrate on their work, wherever that work takes them, free from the stress of insecure funding.

ME/CFS deserves the level of effort that might lead to success. It is not getting it now, and it never has had it.

It is appalling that Dr. Ian Lipkin, the highly respected virus hunter, is trying to raise $1.27 million through crowdfunding to investigate the role of microbiome in ME/CFS. What we are seeing is a scientist forced to beg. Yet this fundamental research, with application for diseases beyond ME/CFS, is at the frontier of biomedical science.

If we, as a nation, are to believe that we are in the forefront of science, we must be in the forefront of biomedical research as well as the forefront of computers, telecommunications, materials and physics. We almost humbled polio, and developed powerful drug therapies for AIDS. We can transplant vital organs and gave hope to the leper. The advances came neither cheaply nor easily, but they have saved lives beyond counting and eased suffering beyond enumeration. Why not for ME/CFS? Why not?

There is eloquence in the voices of the community. But they are widely distributed and, sadly, they fall mostly on ears of those who already know them — the sick, their families and their advocates.

The voices need to be heard widely, need to be channeled and need to be focused. A million points of light won’t do it. A laser, a great beam, will do it.

There are three principal reasons why these voices are not heard by those who need to hear them:

1. ME/CFS is a hard story for the media to grasp.

2. ME/CFS has no celebrity doing what Elizabeth Taylor did for AIDS, what Jerry Lewis did for Multiple Sclerosis, or what Michael J. Fox is doing for Parkinson’s Disease.

3. ME/CFS has no presence in Washington.

Of the three, the last is the most critical to act on, and it is the one that would produce the most measurable result. Simply stated: Being on the ground in Washington every day is the essential step the community has to take.

To get results in Washington, you need to-see-and-be-seen in the daily life there. Letters and petitions do not have nearly the impact as a Washington denizen talking to a decision-maker in person.

Happily this would amount to one very visible person, who strolls the halls of Congress, lunches at the clubs and restaurants, like the Cosmos or Metropolitan clubs, or the Monocle Restaurant on Capitol Hill. Once, I was mentioned in the Wonkette blog because I was spotted entering Bistro B, a favorite restaurant of the powerful, and those who think they are powerful.

If your children attend one of the power schools, like St. Alban’s or Sidwell Friends, contacts can be made and deals can be done at the events. A friend of mine enlisted President Bill Clinton’s help for a cause because their children went to the same school.

It may strike you as banal, but it is the Washington political game. Learn to play it.

Washington is a society of people who are impressed with each other. It is important to be known. If you are invited to the annual White House Correspondents’ Association or Alfalfa Club dinners, you are known. The next step is to be known for ME/CFS advocacy.

Once known, the perfect advocate/lobbyist will morph into a resource, a voice for others in Washington: a source of information for congressional aides trying to understand the budget requests of agencies, and a source of information for reporters writing about diseases of the immune system.

A voice in Washington puts pressure on government agencies to do the right thing, and on members of Congress to authorize and appropriate money. The advocate/lobbyist can learn, through the hearing process, about the diligence and transparency of the agencies and the quality of their operations; to see if they are doing the job or treading water, to see how transparent their operations are and the quality of professionals operating programs.

Another salutary source of pressure in Washington is the press corps. It covers not just politics but also the functioning of government. The pinnacle of power in the corps are still The Washington Post, The New York Times and The Wall Street Journal. But the news agencies, The Associated Press, Bloomberg and Reuters, followed by a veritable media army that cover politics and programs, including Politico, The Hill, Roll Call, National Journal, and the specialized medical publications also play important roles.

Fifty years ago, the center of media activity was New York. Now it is Washington. A professional advocate for ME/CFS needs to cultivate the media and to be comfortable with the currency of Washington and to trade in it. That currency is information.

Washington is a great information market. The successful lobbyist/advocate is, by the nature of the city and its functioning, an information broker.

The sums of money that will be needed to accelerate research cannot be calculated and could be very substantial. Research funding, above all, needs to be sustained at predictable levels.

The pharmaceutical industry figures that a new drug can cost upwards of $1.2 billion. I mention it only to hint at the vast amount of money needed for drug research and development.

How much ME/CFS will need and for how long is an existential question. Money stimulates research, attracts new young minds to the field and leads to success. Right now, there is so little money funding so few researchers in ME/CFS.

In the United States, that success may be a long time in coming – too long for those for whom today will be a living hell, as yesterday was and tomorrow will be.

I figure that for as little as $1 million, a start toward a Washington presence can be made. That would cover one advocate/lobbyist, one office and one assistant for one year; not a smidgeon of attention from a giant lobbying firm, but a dedicated ME/CFS standard-bearer. Funding should grow within a year, as the ME/CFS cause comes out of the shadows.

I operated a small business in Washington for 33 years, and I am confident that a new ME/CFS presence there will reverse the disease’s funding fortunes at NIH, increase media awareness, and cause the big foundations to sit up and take notice. It would give ME/CFS the kind of presence that other diseases with active advocates – COPD, ALS, MS and others — have in Washington and the nation.

If this is not done the government will continue to ignore the case for ME/CFS. Worse, the new billionaires who are beginning to throw real money into biomedical research will not know about ME/CFS. It will be hidden in plain sight much as it has been from the wider public.

ME/CFS needs a place on the national agenda if it is to be understood and cured in reasonable time, and if the very best minds are to be attracted to the task and to stay with it. That Churchill oak needs to be planted now, and in sight of the U.S. Capitol.

Llewellyn King is the creator of ME/CFS Alert on YouTube, which he co-hosts with Deborah Waroff. Their video work is being supported through donations on the fundraising Web site GoFundMe.

The Strange Case of the NIH and an Elusive Disease

March 3, 2014 by Llewellyn King 40 Comments

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

December 6, 2013 by Llewellyn King 10 Comments

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

A Young Man, a Big Disease and a Big Idea

June 17, 2013 by Llewellyn King 14 Comments

We expect big ideas to come from young people in computers, social networking and music. In medicine, less so.

So meet Ryan Prior, age 23, of Atlanta, Ga. He suffers from a little understood but ghastly disease of the immune system known in the United States as Chronic Fatigue Syndrome (CFS), and in the rest of the world as Myalgic Encephalomyelitis (ME).

The disease is mostly incurable; affects men and women, but more women than men are recorded; and the Centers for Disease Control (CDC) in Atlanta says there are 1 million victims in the United States and 17 million worldwide.

Its impact is horrific; confiscating lives, wrecking homes, sundering love affairs and grinding down caregivers and families. For the most part, the sick are sick until they die. Some are bedridden for years. Advocacy groups say suicide is high. I have received many letters from patients who say they can't take the pain, the helplessness and the stigma any longer, and beg for a quick release.

Despite all this, the disease gets short shrift from the National Institutes of Health and the CDC, although patients say they get a better hearing at the Food and Drug Administration.

Enter the over-achieving young patient, Ryan Prior. His story begins on Oct. 22, 2006. Like many victims he knows exactly when he was felled, when normal life had to be abandoned. He entered a dark world where good times are marked in hours; where bad times are days, weeks or months in darkened, silent rooms.

Prior was student president at Warner Robins High School in Warner Robins, Ga. (about 90 miles south of Atlanta), captain of the cross-country team and was taking three advanced placement courses. “My goal was to attend Duke University or West Point with the ultimate goal of becoming an Army Ranger,” he said.

By Nov. 15, 2006, Prior had to quit school. Under a Georgia plan for educating sick students, “my physics teacher taught me heat transfer while I was lying on the couch,” he said. But he slept through calculus.

Ryan still hoped to make it as an athlete. During a brief respite, he was back on his soccer varsity squad. But it was a disaster. He had been put on a drug that provided a short energy boost. “I went to a practice and played for about five minutes. I did OK for the first minute. After five minutes, I realized I had to stagger off the field as soon as possible. If I didn't get off voluntarily, I knew I would have to be carried off soon after.”

After seeing 15 doctors, who knew little or nothing about the disease, Prior found one who has helped him. Now, he says, he functions 90 percent of the time if he takes 15 to 20 pills a day and avoids overdoing it. Ultimately, he graduated Phi Beta Kappa from the University of Georgia.

But it's the almost complete ignorance of CFS by most doctors that has set Prior on his big idea project. He is making a documentary film about the disease with young filmmakers, and with a $12,000 budget. He hopes the film will lead to $50,000 in funding to create “an eight-week summer fellowship program” for medical students, between their first and second years, to study with recognized experts in CFS. They would, according to Prior, provide each student with a stipend of $5,000 for the eight weeks.

Prior has compiled a list of nine doctors or clinics preeminent in the field who he believes would accept the fellows. The end result: a flow of young doctors with a knowledge of CFS and new ideas.

I can attest that this is desperately needed. As far as I have been able to determine there are many states, including West Virginia and Rhode Island, where there are no doctors with specialized knowledge of the disease. One woman travels from Delaware to Manhattan for treatment with Dr. Derek Enlander, and many have moved Nevada to be near Dr. Dan Peterson in Incline Village and the Whittemore-Peterson Clinic in Reno.

If Prior's plan works, it may lead to a much larger training effort in the United States and across the world.

“The message is simple: American history has progressed in a logical line from women's rights, through civil rights, then to gay rights,” Prior says, adding, “Medical history has a similar process of ridicule, repression and ultimate acceptance: MS, AIDS, and now we want CFS to be the next step.”