{"id":107604,"date":"2016-09-23T08:13:23","date_gmt":"2016-09-23T16:13:23","guid":{"rendered":"http:\/\/lukeford.net\/blog\/?p=107604"},"modified":"2016-09-23T08:13:50","modified_gmt":"2016-09-23T16:13:50","slug":"bad-science-misled-millions-with-chronic-fatigue-syndrome","status":"publish","type":"post","link":"https:\/\/lukeford.net\/blog\/?p=107604","title":{"rendered":"Bad science misled millions with chronic fatigue syndrome"},"content":{"rendered":"

Julie Rehmeyer writes<\/a>:<\/p>\n

If your doctor diagnoses you with chronic fatigue syndrome<\/a>, you\u2019ll probably get two pieces of advice: Go to a psychotherapist and get some exercise. Your doctor might tell you that either of those treatments will give you a 60 percent chance of getting better and a 20 percent chance of recovering outright. After all, that\u2019s what researchers concluded in a 2011 study published in the prestigious medical journal the Lancet, along with later analyses.<\/p>\n

Problem is, the study was bad science.<\/p>\n

And we\u2019re now finding out exactly how bad.
\nUnder court order, the study\u2019s authors for the first time released their raw data earlier this month. Patients and independent scientists collaborated to analyze it and posted their findings<\/a> Wednesday on Virology Blog, <\/em>a site hosted by Columbia microbiology professor Vincent Racaniello.<\/p>\n

The analysis shows that if you\u2019re already getting standard medical care, your chances of being helped by the treatments are, at best, 10 percent. And your chances of recovery? Nearly nil.<\/p>\n

The new findings are the result of a five-year battle that chronic fatigue syndrome patients \u2014 me among them \u2014 have waged to review the actual data underlying that $8 million study. It was a battle that, until a year ago, seemed nearly hopeless.
\nWhen the Lancet study, nicknamed the PACE trial, first came out, its inflated claims made headlines around the world. \u201cGot ME? Just get out and exercise, say scientists,\u201d wrote the Independent, using the acronym for the international name of the disease, myalgic encephalomyelitis. (Federal agencies now call it ME\/CFS.) The findings went on to influence treatment recommendations from the CDC<\/a>, the Mayo Clinic<\/a>, Kaiser<\/a>, the British National Institute for Health and Care Excellence<\/a>, and more.<\/p>\n

But patients like me were immediately skeptical, because the results contradicted the fundamental experience of our illness: The hallmark of ME\/CFS is that even mild exertion can increase all the other symptoms of the disease<\/a>, including not just profound fatigue but also cognitive deficits, difficulties with blood pressure regulation, unrestorative sleep, and neurological and immune dysfunction, among others.<\/p>\n

Soon after I was diagnosed in 2006, I figured out that I had to rest the moment I thought, \u201cI\u2019m a little tired.\u201d Otherwise, I would likely be semi-paralyzed<\/a> and barely able to walk the next day.<\/p>\n

The researchers argued that patients like me, who felt sicker after exercise, simply hadn\u2019t built their activity up carefully enough. Start low, build slowly but steadily, and get professional guidance, they advised. But I\u2019d seen how swimming for five minutes could sometimes leave me bedbound, even if I\u2019d swum for 10 minutes without difficulty the day before. Instead of trying to continually increase my exercise, I\u2019d learned to focus on staying within my ever-changing limits \u2014 an approach the researchers said was all wrong.<\/p>\n

A disease ‘all in my head\u2019?<\/strong><\/h2>\n

The psychotherapy claim also made me skeptical. Talking with my therapist had helped keep me from losing my mind, but it hadn\u2019t kept me from losing my health. Furthermore, the researchers weren\u2019t recommending ordinary psychotherapy \u2014 they were recommending a form of cognitive behavior therapy that challenges patients\u2019 beliefs that they have a physiological illness limiting their ability to exercise. Instead, the therapist advises, patients need only to become more active and ignore their symptoms to fully recover.<\/p>\n

In other words, while the illness might have been triggered by a virus or other physiological stressor, the problem was pretty much all in our heads.
\nBy contrast, in the American research community, no serious researchers were expressing doubts about the organic basis for the illness. Immunologists found clear patterns in the immune system<\/a>, and exercise physiologists were seeing<\/a> highly unusual physiological changes in ME\/CFS patients after exercise.<\/p>\n

I knew that the right forms of psychotherapy and careful exercise could help patients cope, and I would have been thrilled if they could have cured me. The problem was that, so far as I could tell, it just wasn\u2019t true.<\/p>\n

A deeply flawed study<\/strong><\/h2>\n

Still, I\u2019m a science writer. I respect and value science. So the PACE trial left me befuddled: It seemed like a great study \u2014 big, controlled, peer-reviewed \u2014 but I couldn\u2019t reconcile the results with my own experience.<\/p>\n

So I and many other patients dug into the science. And almost immediately we saw enormous problems.<\/p>\n

Before the trial of 641 patients began, the researchers had announced their standards for success \u2014 that is, what \u201cimprovement\u201d and \u201crecovery\u201d meant in statistically measurable terms. To be considered recovered, participants had to meet established thresholds on self-assessments of fatigue and physical function, and they had to say they felt much better overall.<\/p>\n

But after the unblinded trial started, the researchers weakened all these standards, by a lot. Their revised definition of \u201crecovery\u201d was so loose that patients could get worse over the course of the trial on both fatigue and physical function and still be considered \u201crecovered.\u201d The threshold for physical function was so low that an average 80-year-old would exceed it.<\/p>\n

In addition, the only evidence the researchers had that patients felt better was that patients said so. They found no significant improvement on any of their objective measures, such as how many patients got back to work, how many got off welfare, or their level of fitness.<\/p>\n

But the subjective reports from patients seemed suspect to me. I imagined myself as a participant: I come in and I\u2019m asked to rate my symptoms. Then, I\u2019m repeatedly told over a year of treatment that I need to pay less attention to my symptoms. Then I\u2019m asked to rate my symptoms again. Mightn\u2019t I say they\u2019re a bit better \u2014 even if I still feel terrible \u2014 in order to do what I\u2019m told, please my therapist, and convince myself I haven\u2019t wasted a year\u2019s effort?<\/p>\n

Many patients worked to bring these flaws to light: They wrote blogs; they contacted the press; they successfully submitted carefully argued letters<\/a> and commentaries<\/a> to leading medical journals. They even published papers<\/a> in peer-reviewed scientific journals.<\/p>\n

They also filed Freedom of Information Act requests to gain access to the trial data<\/a> from Queen Mary University of London, the university where the lead researcher worked. The university denied most of these, some on the grounds that they were \u201cvexatious<\/a>.\u201d<\/p>\n

Critics painted as unhinged<\/strong><\/h2>\n

The study\u2019s defenders painted critics as unhinged crusaders who were impeding progress for the estimated 30 million ME\/CFS patients around the world. For example, Richard Horton, the editor of the Lancet, described<\/a> the trial\u2019s critics as \u201ca fairly small, but highly organised, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients.\u201d<\/p>\n

Press reports also alleged<\/a> that ME\/CFS researchers had received death threats, and they lumped the PACE critics in with the purported crazies.<\/p>\n

While grieving for my fellow patients, I seethed at both the scientists and the journalists who refused to examine the trial closely. I could only hope that, eventually, PACE would drown under a<\/a> slowly<\/a> rising<\/a> tide<\/a> of<\/a> good<\/a> science<\/a>, even if the scientific community never recognized its enormous problems.<\/p>\n

But with the National Institutes of Health only funding $5 million a year of research into chronic fatigue syndrome, it seemed like that could take a very long time. Read on<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Julie Rehmeyer writes: If your doctor diagnoses you with chronic fatigue syndrome, you\u2019ll probably get two pieces of advice: Go to a psychotherapist and get some exercise. Your doctor might tell you that either of those treatments will give you … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[9250],"tags":[],"class_list":["post-107604","post","type-post","status-publish","format-standard","hentry","category-cfs"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t