Friday, February 18, 2011

CBT & GET: The Studies, the Science and the Pseudoscience

I'm  more of a personal-experiences writer, definitely not a science writer, but for the sake of all my terribly ill friends who are being sent tripe by well-meaning persons, telling them to get well by pushing their limits and keeping a positive attitude, here are a few apt quotes and links.

To begin on a light note, here's an all-purpose reply for every one of those well-meaning efforts, from Sick Humor.

Fluff but not at all funny: the PACE Trials published yesterday in The Lancet, which ought to be ashamed for accepting such bad science for publication. Unfortunately this bad study is spawning the plethora of happy fluffy articles with which your friends and relations are cluttering your inbox.

Don't even click on those articles. What they say boils down to: "CBT and GET will make you well because we know what you really are is depressed and out of shape." Don't give them the satisfaction of a high hit volume. 

Instead, you can tell your well-wishers politely or otherwise that they ought to take a look at the more scientific study by Núñez et al, published 15 Jan 2011 in Clinical Rheumatology, which shows that treatment with CBT and GET actually makes ME worse. 

What's so unscientific about the study by White, Goldsmith et al in Lancet? To begin with, they aren't even studying patients with ME. They carefully selected their patient cohort to include only those likely to support the outcome they were looking for. They used the outdated Oxford Criteria which eliminate all patients with signs of neurological disease. Well guess what? ME is a neurological disease.

A patient describes the White, Goldsmith screening of subjects for their flawed study:

othersideofvenus (commenter to an article on the PACE study) wrote:

I took part in this study, and was randomised to the GET group, and I'd be very sceptical about its results.... My initial blood tests showed some signs of infection and inflammation so I was sent for another set which apparently didn't, so I could be accepted into the trial. The assessment/criteria forms which had to be filled out at the before and during the trial, did not mention symptoms after exertion or delayed onset fatigue, there was very little attention paid to pain and cognitive/mental issues were very blurred.
At the start of the trial, I had to wear an accelerometor thing for a week, presumably to measure activity levels. But at the end of the trial, this wasn't repeated. The fitness tests measured the number of steps I could do in a set amount of time, but paid no attention to the fact that I usually couldn't walk for 2 days after these assessments.
Why would scientists deliberately set out to create a flawed study? The entire approach to ME officially supported by the British health care system is based on treating the disease as psychological. It would cost a whole lot more money to treat the physical causes of the disease.  Further, the people currently in power, gaining salaries, royalties, speaking fees and study grants, want to stay in power. Conflicts of interest exist among those who make grant recommendations. Here's patient Siobhan McElwee's succinct take:
This is what happens when a wastebasket sort of diagnostic criteria is used. The Oxford Criteria which was used in this study does NOT differentiate between being chronically tired and depression and bonafide ME/CFS which has distinct neurological components. There seems to be an assumption that ME patients are professional, fear ridden couch potatoes with no vested interest in getting well. I find this almost funny. In the 80’s they told us it was because we were doing too much and type A personalities. Now they say we do too little and are afraid of moving about. Those who push the ‘psych’ theories on ME can’t even keep their stories straight over the long haul.

There is far more to ME/CFS than being chronically fatigued, a point that the powers that be seem to be conveniently overlooking.

Last time I checked a retrovirus could care less what one thinks. To date there’s not been a single retrovirus that does NOT cause immune, neurological and cancerous effect in humans. Gamma retroviruses (of which XMRV is one) in other species causes immune, neurological and cancerous effect in the species that they infect. Why is this so hard for the medical establishment at large to stomach?

Could it be that it just might require that money is going to have to be spent to actually TREAT millions of truly sick people worldwide? That money is going to have to be spent to screen the blood supplies? That careers are based on pushing this form of psychobabble on severely ill men , women and CHILDREN?

For shame.

But if "follow the money" works to explain why false solutions are pushed, it also can help lead to the real science. Siobhan further points out:

Big Pharma companies like Abbot Labs and Glaxo Smith Klein don't invest millions of their own $$ into virology studies based on a psych treatable disease.

That's right, the pharmaceutical giants are betting their dollars on the retroviral connection. And you can't fake for example results that show, as Singh et al have shown, that Raltegravir and Tenofavir are potent inhibitors of XMRV in vitro.

Further, those drugs are working not just in vitro but in patients. To follow the story of two patients experimentally taking the antiretrovirals with excellent results, see X Rx, the excellent blog of Dr. Jamie Deckoff-Jones. 

We're sick but we're not stupid. We patients aren't lazy or crazy---jumping jacks and chummy chats are not going to kill the retrovirus and the possibly numerous additional opportunistic infections that are wreaking havoc with our immune systems, our central and peripheral nervous systems and our circulatory systems.

Back as far as the 1980s, Doctors Peterson and Cheney were finding the CFS patients in their practice had minute, punctate lesions in brain myelination consistent with the cognitive losses they exhibited and that these lesions diminished and even disappeared with use of the experimental drug Ampligen, with patients showing simultaneous dimunition of the cognitive symptoms. Sorry I don't have a link for a study on this but it's documented in Hillary Johnson's excellent expose', Osler's Web, which I not only recommend you read, but I recommend you give a copy to each and every one of your beloved well-wishers who insult your integrity and intelligence with fluff pseudoscience promises of full recovery via the jumprope and the sharing circle.

In my last post, I used my beautiful, brilliant, tough and determined daughter as an example of one patient who needs real medicine, not CBT or GET. There are millions like her, waiting, while the grant money gets wasted on bad jokes like the PACE Trials.

Again, please appeal to your elected officials and write letters to editors, and blog and share, demanding real science. We need funding for studies on XMRV and other MLV pathogenesis, and on treatment with Ampligen, Raltegravir and Tenofavir, because what we have is infectious and debilitating retrovirus XMRV, not DUMB or LAZY. And work on convincing your well-wishers to help us with some real support for real science.


Please note: no offense is intended toward patients with, or doctors treating, real clinical depression, nor towards any reputable program of physical fitness or mental health. Yeah, I got a little scathing, but the scathe is directed at those who deliberately misdiagnose, mistreat and malpractice upon neuroimmune patients. 

Thursday, February 17, 2011

Rocky Works Hard: a Good News/Bad News Story Inspired by the PACE Trial

We were working up a sweat in the garden, turning the soil one warm spring afternoon, preparing for planting. My kid Rocky paused for a moment and leaned on her shovel, its handle reaching higher than her head, and proclaimed, "I love working hard," and she dug in once again.

That's how she was at age 7, and that's how she stayed. No matter what she took on, Rocky dug in with a will. No turning back halfway on a hike or a kayak trip. No leaving half the dishes soaking and the counters dirty. No letting go of a research question until she had found not one but several answers. Rocky was a fighter and was delighted to conquer the rock she was climbing, the math problem she was solving, the new programming language she was teaching herself, the tough goals she habitually set.

At least, that's how she was, until one day, when she was fourteen, and she got horribly sick.

Well, everyone slows down when they have the flu. We all three got sick that spring, both of my kids and me, and we all slowed waaay down. That spring, we couldn't plant even a small garden.

When we'd been sick for nearly a month I got more worried. Every time we thought we were bouncing back, tried a school activity, a family outing, even a walk, slam, down we'd go again with the aches and sore throats and tremendous exhaustion. So off I took us to the local health clinic.

The doctors said it was a flu, maybe a respiratory infection. They checked for strep or fevers and sent us home advising the usual rest and liquids. And the sickness continued.

Months went by. We rescheduled activities, tried to pick up and keep going, but with each effort, slam, down we'd go. Rallies were followed by relapses. Bess was pale and listless, I couldn't concentrate on work, and Rocky, rarely out of bed, was in awful pain almost constantly. We were referred to rheumatologists, neurologists, infectious disease specialists.

The diagnosis after six months was "mononucleosis." After nine months it was "post-viral fatigue syndrome." We had been sick for a year and a half before a doctor said, "chronic fatigue syndrome and fibromyalgia." All that time we had been pushing ourselves, thinking a little exercise would help. "Try a five minute walk each day for a week," one doctor advised, "and then increase that to seven minutes, then ten...."

After one five-minute walk Rocky wasn't able to move for days. But she was determined. Up she'd get as soon as she was able, and try another walk. This kid who loved to hike and kayak, dance and research, write quirky stories and do tricky math, Rocky who loved to work hard, tried to take a five-minute walk and ended in pain and tears, barely able to get out of bed to take care of basic needs.

Nearly eighteen months into our illness, we had to move house. As we packed and carried boxes we felt like our arms would fall off. Again, a relapse to even more profound pain and exhaustion. And then we got the diagnosis of chronic fatigue syndrome and fibromyalgia, and began to research what that meant.

When we learned about Post-Exertion Malaise, it sounded so familiar. And when the Lights' study on exercise in CFS came to my attention, stating that "symptoms are often exacerbated following even mild exercise in CFS patients," I couldn't follow the medical jargon in detail but I could see that the study was a vindication, confirming with scientific evidence something we patients already knew. Exercise, body or brain, work or play, hurts. It hurts.

Unfortunately most hometown clinicians don't have tools or time to measure the pain we feel. We look fine. They can assume we're depressed or that the whole phenomenon is due to some misfiring of neurons. Following the best practices they were taught, they'll give us painkillers and antidepressants, cognitive behavioral therapy and graduated exercise therapy, and when we refuse to get well the poor beleaguered doctors throw their hands up in frustration.

Rocky is 17 now. Nearly four years have passed since she got ill. Sometimes, sitting up is too much. Looking at a screen to watch a video or play a game can be too much. Sometimes all she can do is lie in bed in a darkened room, trying to be as still and quiet as possible, because light and motion exacerbate the agony.

And it's agonizing to know that the friends she used to climb trees with and swim with, visit museums with and play D&D with, play hard and work hard with, can all continue busy lives full of education and recreation, while she lies quiet, waiting for a treatment that will actually help.

The hardest work Rocky ever did: putting up with ME/cfs day after painful day.

And now, some good news/bad news. 

The good news is that research like the Lombardi study, Science, Oct 2009 and the confirming study by NIH and FDA scientists Alter and Lo are narrowing in on a possible trigger for all the many physical processes, the neurological and cardiac damage and viral symptoms, everything that is ME/cfs. Turns out there's a strong link to a retrovirus also found in prostrate cancer. Identifying this retrovirus and how it works may be the key to effective treatment for ME/cfs patients; a return to life and normal hard work for Rocky and all of us who work so hard at surviving.

But it's good news/bad news. We just recently learned that Rocky tests positive for that retrovirus, XMRV. This means we probably all three are infected. That's bad news because nobody wants to be infected with a retrovirus. An infection with XMRV, same as with related retrovirus HIV, is an infection for life. But it's also good news because again, it might at least point our way towards treatment. Then again, more bad news is that the treatment is liable to be very expensive and it might take years for it to be FDA approved and hence covered by insurance.

And finally, a piece of bad news, but I'm hopeful it will blow over soon. All this while that we struggle to understand and cope with the disease that destroyed our lives and took Rocky's entire high school years away, millions of dollars have been wasted on research that persists in trying to pin the clearly-neuroimmune illness on psychological causes and/or suggest psychological and exercise-based treatments.

The latest waste, as I write this, is the PACE Trial out of the UK (where ME/cfs is notoriously snake-pitted, with patients like Sophia Mirza, a bright and passionate young woman like my Rocky, getting malpracticed to death with psychiatric mismanagement of a physical illness). The Pace Trial is claiming that we can get well with positive thinking and good healthy exercise. That's bull.

Yes, it's bollocks in UK parlance, and Malcolm Hooper Ph.D.,B.Pharm.,C.Chem.,MRIC isn't afraid to say so. He points out that the patients selected for the PACE study don't even have the disease being studied. Patients with neurological disorders were excluded from the PACE study, but ME is a neurological disorder. He quotes Dr. Klimas who stated that, to set against the PACE nonsense, " have a publication, written by a psychologist and well-regarded CBT expert to use when you want to argue that CBT helps people with this illness (as it does in every chronic disease model ever tested) but does not cure the illness.” He points to conflict of interest, a clear motivator for the sponsors and conductors of studies like PACE, seeing that they stand to benefit financially. I'll let Dr. Hooper's excellent article show you in detail why PACE is nonsense. Of course, a part of me dearly wishes it were not. I wish it helped.
If only it really were as simple as CBT and GET. Rocky would love to be back at work, and so would I. But we can meditate and be mindful, try one recommended therapy after another, exercise only to relapse and make therapy appointments only to have to cancel them because we're too sick to see the therapist. Millions of dollars are poured into studies while we remain ill, and the super bad worst news of all is, all those dollars are diverted from the serious, valuable, biological research that should be done now, to follow up on the exciting findings of Lombardi, Mikovits, Alter and Lo.

Rocky has XMRV and ME, and no matter what the PACE Trial may say, CBT and GET won't get her on her feet and into the garden again.

This is not the first time that the medical establishment has relegated an illness to the psych snake pit, only to later learn the biological causes. Polio and MS are cases in point. But the biological research has got to get funded or in the snake pit we stay.

We would appreciate it if readers would take a moment to call or write their elected officials, urging support for research into biological causes and treatments for ME/cfs. A letter to the editor or a mention in your blog would be great, too. HIV research turned a corner when people who were not infected took an interest. If you could devote some time to our cause, that would be very good news. The best.