CDC research funding scandal 2.0

Some of you ME/CFS readers might remember that ten years ago the Centers for Disease Control (CDC) got caught misusing money Congress had appropriated specifically for CFS research by using it for other diseases instead. At the time, CDC employee/CFS researcher Bill Reeves blew the whistle on his colleagues and went on to take the lead in CFS research, including reallocating the misspent money for the research it was intended.

But, alas, it is now Reeves who has been apparently caught misappropriating money. And this time, instead of the money going to other research, it's simply going to a pet contractor.

Kimberly McCleary, president of the CFIDS Association, testified (hat tip: Co-Cure) before the Department of Health Human Services CFS Advisory Committee at the end of last month about her outrage at having to confront serious funding issues at the CDC regarding CFS research yet again.

Based on information we have obtained directly from CDC officials (thank you to Sarah, Mike and Steve for the improved transparency over the past 5 months) and available on public information sites, the “boom” of CFS research that occurred during the “payback” phase from 1999-2005 has eroded to a “bust” of shameful scientific leadership, zero accountability, invisible outcomes and millions and millions of dollars stuck in suspended animation, if not wasted. At least in the 1998 scandal, science was being conducted that would aid discoveries in other diseases. This time, only the government contractors seem to be benefiting from millions spent for which there are no worthwhile outcomes for American taxpayers, or CFS patients.

Infuriating? Yes. I think many of us patients who have been following the current research at the CDC have felt like it was simply stagnating, and now we know why and how.

But I think there are a few hopeful things here. I've been glad to see the CFIDS Association back away from its relationship with the CDC in the last year and now forcefully and publicly confront it.

I also feel hopeful because last time the funding crisis brought an infusion of money into ME/CFS research, as well as a change in personnel. Reeves getting caught being naughty just might be the means of getting rid of him and his view of ME/CFS as a "mind-body condition." Indeed a few months ago at the cfs_research Yahoo group I said something to the effect that Reeves getting caught in a 1998-like scandal would probably be the best thing we could hope for in terms getting new leadership and research at the CDC.

I just didn't think it would actually happen.

Update: This comment from the NIH representative, Dr. Eleanor Hanna, was music to my ears:

NIH does not have confidence in the new definition for CFS being used by CDC and that it had resisted using the higher prevalence figures in its materials for that reason. She conveyed her concern that the use of different definitions made it difficult to compare results from CDC-funded research and NIH-funded research, and that this would present greater problems as treatments are studied.

Drs. Lucinda Bateman's and Nancy Klimas's comments are also spot-on.

Unfortunately, it sounds like the CFS Advisory Committee, and in particular, its research committee, did not share the urgency and dismay of McCleary, Hanna, and various clinicians and patients.

Sigh.

Guess that means we gotta keep pressing the issue. And perhaps the recent election presents us with new opportunities.

On track

I never fail to underestimate the depths of humiliation that illness continually takes me.

A few weeks ago I was having what I thought was a Good Walking Day. A day when I didn't hesitantly shuffle along the pavement as if my ankles were attached to two giant filing cabinets. A day when I felt, if not normal, then perhaps passable for normal.

My mom was suppose to pick me up from acupuncture, but after a quick cell-phone call, I discovered I had mixed up the time I gave her (as my damaged brain is apt to do on occasion) and would have to wait an hour and a half for her to pick me up. Not only did I find the sitting on the corner of 33rd and Belmont -- amusing as it can be at times -- wholly unappealing, but it would mean I would miss my daily call from A. on a day when I was more keenly aware of his absence. Since it was a Good Walking Day, I decided I'd hop a bus home. The downside to that is that the closest bus stop to my apartment on the return ride is about four and half blocks away downhill (or uphill from the bus stop). As I began that last, uphill leg of my journey, I thought to myself, yes, indeed, this really was a Good Walking Day. That is, until a tiny white-haired old lady in a light blue dress whizzed past me on my left.

This last Friday afternoon I had acupuncture again and walked to the bus stop departing for my acupuncturist's office just a block and a half away (with the usual plan that my mom would pick me up afterward). Again, as I meandered along, I thought that my walking ability seemed, maybe not quite on the level of a Good Walking Day, but pretty damn decent. Yet before I reached the end of the block, I kid you not, a man on crutches passed me on the left.

Crutches? Are ya fucking kidding me? For the love of God, does the humiliation never end?

Yes, I know. I should shut my mouth now and be grateful I haven't lost my ability to use the toilet on my own.

It's funny, though, just how much my ability to walk is mediated by this illness. While there are the Good Walking Days when my gait is natural, if slightly deliberate (who am I kidding? I make great-grandmas look like Jamaican gold-medalists!), I have other days when I feel almost hemiplegic. I walk with a very distinct, if inexplicable limp on my right side, as if I were dragging it along like a heavy suitcase. And, of course, I always walk with a cane, Good Walking Day or no, though I suspect on those bad days I should probably be using a walker.

A study back in May suggested that perhaps gait characteristics could be used to monitor the disease process of ME/CFS. And when I went to look for that paper, I was surprised to find some studies back in the 1990s suggesting the same thing. All three studies insisted this suggested central nervous system pathology. But I suppose James Jones at our esteemed CDC would tell me that I just need to see a therapist and Peter White of the UK would tell me I just need work harder at walking.

Yet I couldn't help but thinking of my walking difficulties while I read this paper this afternoon that insisted ME/CFS was really caused by an enterovirus, the genus that contains the polio virus. While polio itself may have been eradicated, other forms of enterovirus have "filled the vacuum" its absence has created. I was particularly struck when the author, Dr. J. Irving Spur, mentioned labyrinthitis as a trigger, as getting that was the proverbial straw that broke the camel's back for me. Gait abnormalities are mentioned in a symptom catologue located in the appendix.

He, of course, is not the first to discuss enterovirus. Dr. John Chia began the year with a study finding an enterovirus in stomach biopsies of 83% of 165 ME/CFS patients and 20% of healthy controls. Much more suggestive than some of the early muscle biopsy studies of the 1990s.

Yes, there are all kinds of viruses linked to ME/CFS. And Chia or Spur need a lot more research to verify their work. And even if they are right, we have no way yet to treat an enterovirus. But, damn, I couldn't help but feel that they are on the right track.

You know, so that someday my feet will always stay on track and everyday will be a Good Walking Day. And when that day comes, those great-grandmas and guys on crutches will be eating my dust.

Buddy, can you spare a paradigm?: Media, paradigm shifts and ME/CFS

A Tale of Two Conferences

This spring there were two conferences about ME/CFS in the UK. One was hosted by the Royal Society of Medicine and was widely derided by ME/CFS patients because it focused exclusively on this disease being psychiatric in origin. It was closed to both the public and the press.

The second was held in Cambridge a week or so later, was open to patients and the press, and focused on the disease as a biomedical phenomenon.

Which one was later featured in the Economist? Yep, that's right. The Cambridge conference.

It makes sense. I mean, first of all, the Cambridge conference was open to the press. But it makes economic sense for the Economist (as well as all the other papers that covered this conference). People with ME/CFS are not going to buy a magazine with an article telling them their disease is all in their head. A magazine with an article that focuses on what new research is showing about their disease, on the other hand, will be eagerly bought and read.

It made me wonder, will capitalism be what finally saves us patients?

The biggest difficulty patients with ME/CFS face is that despite over twenty years of research showing a multitude of biological abnormalities, the primary scientific organizations that define our disease (CDC, NHS, NIH, etc.) are still stuck in the psychiatric "Yuppie Flu" paradigm.

Philosopher Thomas Kuhn argued that science does not work in a straight line where scientists do a study, collect knowledge, and then do another study, collect knowledge, etc. Rather, science works within a central paradigm (for our disease that's "it's all in your head") and scientists do research that further enlarges our understanding of that paradigm.

However, there are some scientists who question the central paradigm and do research that looks at other possible paradigms. By doing so, they are being "bad" scientists -- or, at the very least, are considered to be marginal -- because they are not doing research to broaden our understanding of the current central paradigm. But eventually all the research of these "bad" scientists piles up to a point that it seriously questions the current central paradigm and a crisis occurs. Eventually the paradigm of the "bad" scientists takes over in a "paradigm shift" and they become the "good" scientists and the former "good" scientists become the bad ones.

The question I keep pondering is how do we shift the current paradigm from the psychogenic paradigm to the biomedical paradigm when the psychogenic one has all the money and power behind it? Because ME/CFS IS a biomedical disease, I know the shift WILL come. But, well, I'm impatient. Is there anything that can speed the process along?

And that is when the Economist article and my speculation about the role of capitalism in saving us comes in.

Now we do have plenty of "bad" scientists who are questioning the current central paradigm: Jonathan Kerr, Daniel Peterson, Kenny DeMeirlier, Vance Spence, Leonard Jason, Andrew Lloyd, Benjamin Natelson, Nancy Klimas -- to name just a few. But they need money. And they aren't getting it -- at least not in the sums needed -- from government agencies. That's where private foundations become very important as they are the ones providing the capital to fund the research that is making the big breakthroughs. Craig Maupin at the CFS Report has put together a wonderful list of foundations supporting good ME/CFS research (hat tip to Tom Kindlon). Any one of them would be a great place to send money. Another excellent organization would be the IACFS/ME, which announced recently that it is beginning a capital campaign to raise money for it's outreach programs to physicians, as well as for other programs, particularly a professional journal -- all the more important now that the Journal of Chronic Fatigue Syndrome will soon be defunct due to the sale of its publisher.

Frankly, there are times I actually want tell my congressman to simply quit funding the CDC and NIH so at least their bad research won't be out there mudding the waters. But then, it's not ALL bad (indeed many of the researchers listed above get funded -- albeit only in tiny bits -- by organizations like the NIH) and I wouldn't want to do anything to cut the good stuff. And in the meantime, letting your congressman/woman know that you want to see the federal Chronic Fatigue Syndrome Advisory Committee charter renewed so that the Department of Health and Human Services is kept up to date on research and the needs of patients would be a good thing.

As people like Jonathan Kerr or Nancy Klimas do more and more science that challenges the central paradigm, more magazines, newspapers, and even television news report the breakthroughs they are making. And my experience has been that your average doctor reads and watches these sources of information as much as (and perhaps even more than) medical journals (which a lot of this research is being published in as well -- though generally not the more prestigious ones).

So, could this be the way forward to our paradigm shift -- the media's hunger for profits that come from selling magazines with articles about ME/CFS research breakthrough's? I dunno. There are also structural and bureaucratic barriers that stand in our way, as Cort Johnson's recent interview with Ken Friedman points out. Yet I can't help but wonder if it might be a step forward and a sign of hope in an otherwise dismally slow process -- though a step that is not without its problems.

The Double-edged sword

While media attention of various research breakthroughs helps to demonstrate that ME/CFS is indeed a biomedical illness, it can also raise false hopes and even scare the bejeezus out of people unnecessarily.

Quite awhile ago on one of the ME/CFS Yahoo group I used to read frequently, I remember how someone posted links to news stories about how the drug Coumadin was going to be black-boxed by the FDA in an effort to show people how dangerous it is. "Coumadin can cause fatal bleeding!" shouted the headline posted to the group. Now it's quite true that Coumadin can cause fatal bleeding. That's why when you take this medication, you have to go in at least once a month or more to be tested to make sure you're not in too much danger of it causing that fatal bleeding. Indeed, when you first start the medication your doctor or nurse will explain in great detail the dangers associated with this drug and what you should avoid to make sure you don't start bleeding uncontrollably. So, in other words, we already know the medication causes fatal bleeding. But I tell you the truth, several people on the group became afraid to take the medication after hearing this from a news report even though this should not have come as any sort of surprise to them.

It works the other way too. Two years ago there were reports about a physician down at Stanford who started using a herpes drug on his ME/CFS patients. "A herpes drug may make energy soar for Chronic Fatigue Syndrome patients," read one headline. It sounded like we at the entrance of the Promised Land. Nine out of twelve patients reported "great improvement." And a former ice skater who had been bedridden from ME/CFS was practically cured. However, the results after a much larger study were not nearly so promising. According to this summary by Dr. David Bell, while the recent study showed some improvement in cognitive function, levels of fatigue did not improve substantially.

I've seen this happen time and time again in the ME/CFS community. One study comes out showing one thing, but when another study tries to recreate the results, we end up rather disappointed. Now there are a number of reasons for this, the biggest being that ME/CFS is defined so broadly it makes it difficult to know if we're studying the same disease process from one study to the next. But that's not the only reason. As Maggie Mahar pointed out recently at her blog, Health Beat, the media hypes the good news because, well, they know it will sell more papers, magazines, and air time.

What may be a big help in getting the word out about ME/CFS, may also get our hopes up far higher than they ever should.