Chronic Fatigue Syndrome

Underwear Goes on the Outside for Charity

April 28, 2016 by Llewellyn King Leave a Comment

By Llewellyn King

Ronald Davis is a respected professor of biochemistry and genetics at Stanford University, and director of its Genome Technology Center. So why is a picture of him wearing his underwear over his pants superhero-style circulating on social media?

Davis is not alone. Others are joining in making themselves look ridiculous every day.

Looking silly for a serious cause

The answer is that Davis is a research scientist whose son is severely afflicted with Myalgic Encephalomyelitis (ME), better known as Chronic Fatigue Syndrome — a name that dismisses the severity of this little understood and understudied disease that has devastated the lives of perhaps 1 million Americans, and what are calculated to be 17 million people worldwide.

Taking a selfie with underwear worn over outerwear is a new campaign, “Undies on the Outside,” to raise money — desperately needed money — for research on ME. This money possibly should have come through the government years ago, but the principal medical research arm of the United States, the National Institutes of Health, has been parsimonious in funding ME down through the years. Only $5 million a year is devoted to the affliction.

Yet the sick are almost inevitably sentenced to a lifetime of unspeakable suffering — often being confined to bed for months at a time and sometimes years — in pain and hideous isolation. They tell their story on ME/CFSAlert, the YouTube channel that I co-founded.

ME is an equal-opportunity monster: It strikes all ages and both sexes. Dr. Jose Montoya of the Stanford University Medical Center describes it as ordering a “parallel life.”

One of my close friends, who has suffered from the disease for 25 years, is fairly typical in her adversity. She was an athletic woman with a passion for squash and cycling. She said that when she was afflicted she became “like a car that had run out of gas.” That was on good days.

My friend’s life went from one of accomplishment and fullness in all the ways that a life can go right to one of surviving on the margins. For two years, she was bedridden. Every type of exertion is followed by a kind of unreasonable punishment for just trying to be normal. Recently, we spent a few hours together and had lunch in a restaurant. The price she paid was being so sick for two days that she had to stay in bed.

Normal family life, work and simple enjoyments are prescribed by ME. I have been writing and broadcasting about it for five years, during which I have come to think of those who suffer day in and day out, essentially without hope, as the children of a lesser god, alive but denied the joys of being alive. Suicide rates are high, and my e-mail box is full of e-mails from people who say they wish they could die.

Symptoms vary from a patient who told me her limbs seemed to be exploding to many who suffer mental fog, known as dysphasia, and need hours to write a few simple sentences.

The “Undies on the Outside” challenge was devised by an Australian woman. It came from a party game of residents at cheetah rescue center in South Africa, who relieved the tedium of an evening by dressing up with their underwear over their outerwear. Years later one of those revelers, Kate Booker, now living in London, suffering from ME for 18 years, and bitterly aware of the paucity of funding globally for the disease, was inspired to work up a challenge to raise money.

Everyone photographed wearing their undies over their clothes is sending $10 to the Open Medicine Foundation in the Los Angeles area, and challenging three other people to do likewise. Booker chose the foundation because it is raising money for pure research into ME and is concentrating initially on finding a biomarker, so that people can be diagnosed and not thrown into medical limbo.

The Open Medicine Foundation is run by Linda Tannenbaum, whose adult daughter has been afflicted since she was a teenager.

It is especially sad that this disease seems only to be known and understood by those who have a family member or close friend who has been, as it were, taken from them while still being there, shuttered away in plain sight. — For InsideSources

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

Holidays: The Pain in with the Glitter

December 17, 2015 by Llewellyn King 1 Comment

By Llewellyn King

We all know about the dark side of the holidays: the pain of the lovelorn; the stress for the recovering alcoholic; the torment of parents who cannot provide gifts, even homes, for their children. Then there are those who bear loss: loss of employment, loss of a parent, loss of a partner and, most sad, loss of a child. And there are those who are shut-in, alone, and possibly hungry; others are in pain, physical pain that defies amelioration.

In the holiday season, my thoughts are about those who suffer from Myalgic Encephalomyelitis (ME), also known as Chronic Fatigue Syndrome (CFS). Its sufferers are walled off in plain sight, jailed by a disease that has no known cure and promises only suffering — by the day, the month, the year, the decade.

The government estimates that as many as 1 million Americans and another 17 million people worldwide are imprisoned by ME. Little is known about it, and nothing about the causes. It is understood to be a disease of the immune system, but there are those who want to believe, and have convinced some governments, that it is a psychiatric affliction. It is easier for government institutions, like Britain’s National Health Service, to believe in psychiatric nostrums than to treat and research the terrible suffering of the sick, the physically sick.

ME patients can be bedridden for years, unable to tolerate light or sound, and must rely on families or friends for basic needs. Sometimes they may seem a little better, but they cannot do the things of normal life. They are vulnerable to collapse after exercise or just normal activity.

Patients tell me that they know too well what my friend, colleague and ME sufferer Deborah Waroff says is the excruciating loneliness that comes with the induced isolation. It is the kind of loneliness that moved the 17^th-century English poet John Milton to say, “Loneliness is the first thing which God’s eye named, not good.”

How often can a caregiver ask, “How are you feeling?” when the answer is known; was known yesterday, last year, and the year before, going back decades.

One sufferer told me she thought, in the height of her suffering, that she was already dead and was in limbo. Many sufferers have written to me saying they pray that they will not wake in the morning.

Suicide rates are high. Surely, suicide must be preceded by a loneliness that cannot be imagined? ME victims – and I have interviewed or had correspondence with hundreds — feel that not only do they suffer from symptoms which vary from pain in the joints, a sense that their limbs are exploding, headaches and mental fog, but they also have debilitating fatigue. Deborah Waroff, who has suffered since 1989, says it is like being a car that has no gas: You press the accelerator and nothing happens.

She, like other victims, has to ration her social life: a dinner with friends will result in collapse, and two or more days in bed. Likewise, going to a movie or a family gathering. Sometimes just making a simple meal is too much, and results in a return to one’s lonely bed.

Doctors, once they have decided that a patient has the disease, and if they have any knowledge of it, prescribe a variety of drugs from antivirals to large doses of vitamins. Some help with some symptoms, some do not. Ryan Prior, a young man who has made a documentary movie about ME, “Forgotten Plague,” takes as many as 19 pills a day. He was a star athlete in high school before being stricken. Now he manages his activities with stringent care. He is one of the lucky ones.

My correspondents from around the globe write to me about many things, but the most constant is their loneliness, exacerbated by the holidays. Marriages fail, love affairs go by default, and one is terribly, awfully alone.

There is aching aloneness for them each day, while others laugh and love. Mother Teresa said, “Loneliness is the most terrible poverty.”

That poverty is part of this disease. — For InsideSources

The Cruelty of the Holidays

November 23, 2014 by Llewellyn King Leave a Comment

T.S. Eliot may have had it wrong: The cruelest months are November and December, when the holidays are upon us, not April. For those who are broken – broken in all the ways that people can be broken — the holidays are a special hell.

The bedridden, the incarcerated, the mourners, the maimed from accidents, disease or wars, the heartbroken – either those who have had their hearts broken by lovers or others, or those who have had no one in their lives — endure the holidays in anguish, hurting even more than the permanent hurt that has become their lives.

You may find the broken in the corners at parties, sitting glumly at the table. But the real suffering is unseen; the real sufferers cannot make it to the table – or dare not for fear that the outing will cost them later. The brave face can mask the deepest hurt. They are the permanently sick. Those who will be sick today, sick tomorrow and sick in the next holiday season as they were in the last.

There are people who suffer constant illness in all the myriad ways that a body can be afflicted or fail. No afflicted cohort is more deserving of understanding than another; none has a greater call for science to redouble its efforts for a cure than another.

But the effort to find cures is woefully skewed by the institutions of medicine, by the pharmaceutical companies and by those diseases that have celebrity champions, informing the public and the politics of research institutions. Yes, there is always politics and so there are winners and losers. Celebrities can help: Elizabeth Taylor did so for AIDS, Jerry Lewis for Multiple Sclerosis, and Michael J. Fox is doing so for Parkinson’s disease.

I write and broadcast about one disease in particular, Myalgic Encephalomyelitis (ME), also called Chronic Fatigue Syndrome. It is a disease largely orphaned by the medical community which has no test for it — cannot say with assurance that a patient has it until months of debility validate that it is ME. In medical parlance, there are no biological markers. What is known is that it is almost certainly a disease of the immune system, and that there is no cure. It also has no celebrity benefactors and no lobby in Washington.

I think of it as a terrorist disease, which takes its patents hostage and confines them in an alternative world of muscle pain, headaches, diarrhea, dizziness, brain fog and almost permanent collapse. Some are adversely affected by light, others by sound.

One sufferer says that having ME is like being an engine without fuel: Your tank is empty and you hurt in new and refined ways almost daily. Sufferers go through long periods of disability where they cannot function at all. “I thought I was already in my coffin,” another told me.

The joys are few and sometimes from little things, like a pet or nature observations. One sufferer, Elisabeth Tova Bailey, wrote a wonderful book, “The Sound of a Wild Snail Eating.” It is about the habits of a snail in a terrarium next to her bed, during two years of sustained collapse.

This is a disease that steals lives, chains them up in dungeons of despair where loneliness and suffering reach “excruciating proportions,” according to my colleague, Deborah Waroff, whose life was snatched by this disease 25 years ago. Together Waroff and I established a YouTube channel on ME, mecfsalert.

The loved ones, and the caregivers – if there are any — are enslaved by this disease, seeing those they care about in a place where neither love nor medicine can reach them. Literally and figuratively, they must fluff the pillows once again and mouth the empty words — lies really — of encouragement that we all utter in the face of hopelessness. Those who live on their own, often in poverty and sloth they cannot ameliorate for themselves, suffer what one woman told me was such sustained loneliness that she prayed nightly for death.

Thanksgiving, Christmas, Hanukkah, Kwanzaa and New Year's Eve are on the way. Sadly, while the rest of us are suffused with joy, the permanently ill take stock and find their lives are terribly wanting and isolated on the holidays. — For the Hearst-New York Times Syndicate

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

May 8, 2014 by whchronicle 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 whchronicle 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 Shame of Biomedical Research in the U.S.

January 19, 2014 by whchronicle 4 Comments

When the dark shadow of incurable disease settles across a life, it is brightened only by the hope that science is on the job: The cavalry will come.

Horribly the cavalry — researchers in the big pharmaceutical companies and the government-run National Institutes of Health and the Centers for Disease Control — may not even have mounted.

New drug development is a murky business governed by huge risks, inertia, bureaucracy and politics.

I've been looking at the role of biomedical research and the development of new therapies and drugs through the lens of one disease, Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis. But it is symptomatic of the whole struggle for cures, which means funds. It is a peephole into a system in chaos; where good intentions, economic reality, public pressure, politics and bureaucratic apathy play a role in where the research dollars go.

I've been writing about CFS for several years now, so I understand the dilemmas those who are in charge of biomedical research in government and private industry face. It is a disease of the the immune system, like AIDS, but it is mostly a medical enigma. It is hard to diagnose because there are no normal markers in blood or urine. It prostrates its victims essentially for life. In its severest form, patients lie in bed in darkened rooms, often feeling that their bones are going to explode. It cries out for more research, as do many other little understood diseases.

A very small coterie of physicians — maybe not many more than 50 in the United States — specialize in CFS and have developed private clinics for research into alleviating therapies. None of them are set up to do major drug research in the way that pharmaceutical companies do.

Big Pharma — as the drug behemoths are known collectively — is at the heart of new drug development, aided by preceding biomedical research that takes place through government grants to researchers in universities, teaching hospitals and private clinics. It is a complex matrix.

A new drug can cost over $1.2 billion to develop. It is a very high-risk undertaking — maybe the riskiest investment decision made in the private sector is developing a new drug. It is also a tortuous undertaking.

First a target has to be selected where there is a large enough patient cohort to establish a market. Then the science begins. Diseases that are straightforward, in medical terms, edge out those where the causes may be multiple and the resolution may require a cocktail of drugs. Understandably, a rifle shot is more appealing than a shotgun blast. Eight out of 10 drugs fail and are abandoned at some point. The winners have to pay for the losers.

If, after years of research, a compound that may work is discovered, the laborious business of testing it on animals must precede human trials with control groups and years of analysis. Finally the drug must be approved by the Food and Drug Administration which looks for efficacy, safety, risk benefit and manufacturing stability.

Into this already difficult world of new drug development, enter the politicians.

Some believe private enterprise will shoulder all the risks and is the right place for research. Others don't understand the vital role that government research grants — administered by NIH and CDC — play in the development of biomedical knowledge: the essential precursor to new drugs and therapies. Its funding is on a see-saw; it was down under sequestration and funding is restored but not boosted under the new budget deals. It tops out at $29.9 billion, a decline of 25 percent since 2003, according to The Atlantic magazine.

Chronic Fatigue Syndrome — which has 1 million Americans suffering hopelessly every day — gets about $6 million a year from NIH. What's wrong with that largesse? Well, remember, it costs $1.2 billion to develop a new drug once the biomedical case is made. As they say, you do the math – and don't expect the cavalry to ride to the rescue anytime soon.

Across the board, researchers are dependent on government funds augmented by foundations and charitable giving. Yet biomedical research pays as a national investment. American drugs are an export commodity, the cost of healthcare is contained and, yes, the suffering is reduced even as life is extended. China, by the way, has said it will surpass the United States in actual biomedical research dollars in five years. — 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.”

A Drug Goes Down in a Perfect Storm

February 7, 2013 by whchronicle Leave a Comment

A man you have never heard of is on a hunger strike in Reno, Nev., in a desperate petitioning of the government to do something to help bring a drug you have never heard of to some very sick people.

The man is Robert Miller, a former miner and bartender, who suffers from Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis (ME). And the drug, which stimulates the immune system, is Ampligen.

Miller and the drug are at the heart of a perfect storm involving bureaucratic procedures, corporate ineptitude and a community of patients who have no Washington presence and therefore no strident voice.

Instead of a lobby, there are individuals — many of them very sick — who form a rag-tag pressure group, a small irregular army, who speak out on behalf of what is believed to be a million CFS sufferers in the United States.

The problems start with the disease itself, which like AIDS is a dramatic compromise of the immune system. It is hard to diagnose: There are no biological markers; there is no way to quickly identify it. Instead, it is what doctors call a waste-basket diagnosis: If it is not any of a list of ailments, then it must be CFS.

Some suffers report flu-like symptoms at the onset, building to a total collapse. Others simply collapse after exercise. Recovery is very rare — and only men. The disease undulates; good days and bad days, good years and bad years. In bad days and years, the victims are bedridden with intolerance of light and sound; restricted to bed and darkened rooms. Suicide is common, the suffering endless and severe.

I have talked to dozens of sufferers — the most heartrending are the teenage girls who are denied schooling, social life and the prospect of marriage by their ghastly affliction.

Enter Ampligen. It is an anti-viral compound developed in the 1970s and administered intravenously. Every patient is not helped by Ampligen, but many are restored to mobility after being bedridden. Robert Miller is one of these.

Last December, the Food and Drug Administration (FDA) heard from more than 700 patients praising Ampligen, with accounts of the choice it presented for them between functioning or being dependent on others.

Yet this month, the FDA rejected certification of the drug. The agency acknowledged the patient support, but castigated the company that makes Ampligen for incomplete data, a lack of scientific evidence of its efficacy and the way that it had handled the clinical trials.

There is a more-in-sorrow-than-in-anger tone in the FDA’s rejection of application for the drug by its maker Hemispherx Biopharma, Inc. of Philadelphia.

The FDA said: “As evidenced by the hundreds of letters, emails, and testimonies submitted to FDA, Myalgic Encephalomyelitis (ME) Chronic Fatigue Syndrome (CFS) is a devastating disease with a serious impact on quality of life. We are acutely aware of the seriousness of this disease, that no FDA approved treatments are available, and of the community's strong desire to see rintatolimod injection (Ampligen) approved.”

The bottom line is that the patients are to be denied a drug which helps some of them. Dr. Daniel Peterson of Simmaron Research in Incline Village, Nev., estimates that 70 percent of his patients are helped. Dr. Nancy Klimas of Nova Southeastern University in Florida, a dedicated supporter, puts the success rate lower.

For the patients, the dispute of methodology is irrelevant. What is relevant is that methodology has triumphed over humanity — and medicine.

Miller is continuing his hunger strike in the hope that the National Institutes of Health can be persuaded to conduct its own trials as, they can and do sometimes. But even if they do, it will be years before the FDA will rule again. — For the Hearst-New York Times Syndicate