"By J. Burmeister: Keep an Eye on Your Walitt: NIH Study Poses Dramatic Risk to Long-Term Disability

[Valentijn]

There are hundreds of studies that have found physical abnormalities so I am not so concerned as some seem to be about a single noninterventional study.

How many of those studies had three control groups and made dozens of comparisons?

I'd bet the answer is "zero", because such a study design makes it very very hard to achieve statistical significance, after the results are corrected to take into account the number of comparisons being made.

 

[A.B.]

A few mind over matter fanatics have used CFS as their playground and posed as experts because the rest of medicine has largely ignored the disease. So now we have people like Walitt that are viewed as being experts in CFS.

 

[Seven7]

The problem is, comments at the end of the study might be too late, if the patient selection is poor. No amount of replication or comments will help us stop the madness AGAIN.

 

[acer2000]

It is my recollection that what they did in the previous studies looking at XMRV, and then subsequent data for further studies by Columbia was use ME/CFS centers to diagnose and select well known patients. It included Dr Peterson's practice, Dr Klimas, and a few others. They should probably use the same process for this. Although limiting the duration of illness to 5 year might make it somewhat more challenging because many established ME/CFS practices have long standing patients ill for more than 5 years. OTOH, the study is only looking at 40 subjects, so they should be able to diagnose/find 40 people < 5 years in.

 

[halcyon]

So I'm concerned that too much opposition about something like this could affect such momentum.

If the study is done poorly with negative results then you can bet extramural NIH funding for ME research will not be increased any time soon.

I don't get the sense that the majority want the study called off full stop. We want the current incarnation stopped, and replaced with that we feel comfortable with (no Walitt/Gill/..., no Reeves questionnaires, no bogus controls, etc.)

 

[Dolphin]

There are hundreds of studies that have found physical abnormalities so I am not so concerned as some seem to be about a single noninterventional study.

How many of those studies had three control groups and made dozens of comparisons?

I'd bet the answer is "zero", because such a study design makes it very very hard to achieve statistical significance, after the results are corrected to take into account the number of comparisons being made.

There are only 2 control groups now.

There are probably one or more hundred types of findings that won't be tested so this study won't be able to nullify those findings.

 

[Dolphin]

I don't get the sense that the majority want the study called off full stop. We want the current incarnation stopped, and replaced with that we feel comfortable with (no Walitt/Gill/..., no Reeves questionnaires, no bogus controls, etc.)

If the Reeves criteria were used on their own, I would be very concerned. However, given that patients will have to satisfy other stricter criteria, and have had an infection, I'm less concerned.

There are 2 control groups now. Control groups are useful to isolate where abnormalities arise. Also they mean greater expenditure on the study that would be difficult to pay for privately. The more individuals involved, the greater the power of the study (if the control groups were combined to compare as one group with the ME/CFS patients).

I'm not hopeful that we would get a veto on particular staff members' involvement.

 

[Valentijn]

There are only 2 control groups now.

Someone mentioned that they were going to try to find a new group to replace the FMD group, I think.

 

[Sasha]

The more individuals involved, the greater the power of the study (if the control groups were combined to compare as one group with the ME/CFS patients).

I can't think of a kind of study where it would make sense to do that. The point of the two control groups is that they themselves are expected to be different to each other.

 

[Sasha]

Someone mentioned that they were going to try to find a new group to replace the FMD group, I think.

I haven't seen that anywhere. Surely it makes no sense to replace a control group that didn't make scientific sense? The point of control groups is to control for things that need controlling for. If there was something else that needed controlling for, there should have been such a control group in the first place, surely?

 

[Dolphin]

I can't think of a kind of study where it would make sense to do that. The point of the two control groups is that they themselves are expected to be different to each other.

Given that the post-Lyme are seen as a healthy group, I think it would make sense if they have normal results on particular tests to combine the results with those of healthy controls (if their results are different to healthy controls on certain tests, that is a different matter).

I imagine even if not formally combined, statistical tests are more powerful if it is 40-20-20 versus 40-20 (if the 2 groups of 20 have similar scores)

 

[Sasha]

Given that the post-Lyme are seen as a healthy group, I think it would make sense if they have normal results on particular tests to combine the results with those of healthy controls (if their results are different to healthy controls on certain tests, that is a different matter).

That would be a post-hoc comparison by its very nature and wouldn't make sense to do. It would be like saying, "whatever results my 20 healthy controls have, I'll treat them as though they were 40 people".

 

[Dolphin]

It would be like saying, "whatever results my 20 healthy controls have, I'll treat them as though they were 40 people".

No it wouldn't. What you describe is actually making up data for 20 people. This isn't making up data.

Post-hoc analyses can also give useful information.

Anyway, as I said, I imagine even if not formally combined, statistical tests are more powerful if it is 40-20-20 versus 40-20 (if the 2 groups of 20 have similar scores).

 

[Sasha]

No it wouldn't. What you describe is actually making up data for 20 people. This isn't making up data.

I think it's exactly the same as making up data because you're suggesting filtering out data post-hoc if it turns out to be different.

 

[Valentijn]

Anyway, as I said, I imagine even if not formally combined, statistical tests are more powerful if it is 40-20-20 versus 40-20.

No, results are weaker, because twice as many comparisons are being made between the patients and control groups.

 

[Dolphin]

No, results are weaker, because twice as many comparisons are being made between the patients and control groups.

What I had in mind is using F-tests (for example) for 3 samples rather than more t-tests and the like that are used for 2 samples.

Intuitively, more data (that is different to ME/CFS scores but similar to each other) should make ME/CFS abnormalities stand out more.

 

[duncan]

They need to shelve the psychs.

They need to clearly articulate what they mean by post-Lyme. They need to spell it out. Their statement that the Lyme patients are cured of Bb, and free of all TBD's, must be unequivocal.

And I think they need to tighten up the mechanisms to ensure the patients recruited are true ME/CFS patients.

We should not pretend this isn't a potential catastrophe just because we wish the NIH to be sincere. If the NIH were really on the up and up, they would see how justified our concerns are, and resolve them.

 

[Jonathan Edwards]

What I had in mind is using F-tests (for example) for 3 samples rather than more t-tests and the like that are used for 2 samples.

Intuitively, more data (that is different to ME/CFS scores but similar to each other) should make ME/CFS abnormalities stand out more.

Sadly I think Valentijn is right here. The more comparisons you are able to make the more you have to adjust your significance levels. And increasing groups increases comparisons combinatorially. More control groups may answer new questions but will weaken power. With small group sizes like these power is the problem. You can get around it by declaring primary analyses, as you do for primary outcome measures in trials, but nobody ever does that as far as I know.

 

[jamie]

Another angle we could take to get rid of Walittt and the others who gave a history of dismissing us and have a psych problem is the fact that the lead investigator role includes overseeing the well being of the patients making sure they do not come to harm.

Enter Klimas..( god bless her and the others real ME experts. I posted on another thread that now might be a good time for a letter from patients thanking all our real experts for their thankless work in the face of so much opposition over the years. It would be something positive all groups could get behind and would NOT include any of these NIH experts.)

"Klimas witnesses this anger and frustration time and again in her work treating and studying CFS patients. Each week she hears another story of a physician who told a patient the symptoms were all in his or her head.

Klimas discovered just how contemptuous some health-care providers are about CFS almost by accident. Following Hurricane Andrew in 1992, she and her colleagues launched a study to investigate whether post-traumatic stress disorder (PTSD)was more common among people with chronic diseases. As expected, she found higher rates of PTSD in people with chronic illness, including among people with chronic fatigue syndrome (Psychosomatic Medicine, 1995).

Yet compared with people with other chronic diseases, CFS patients, even those who hadn't lived through the trauma of a hurricane, had notably higher PTSD rates, she found. Digging deeper, she found that CFS patients had actually been distressed by their medical experiences.

"A common theme in the trauma was an exposure to a health-care situation that was demoralizing and demeaning," she says.

That discovery pushed her to focus her career, in part, on studying CFS. "It was a pivotal moment for me. In a culture where we're supposed to ‘first do no harm,' we saw harm happening time and time again by doctors who tried to put it back on the patient."

Klimas understands why her colleagues can be dismissive. "The reason why primary-care doctors still look at our patients and don't believe they're ill is because [researchers] haven't told them otherwise," she says. "It's not in their textbooks."

 

[jamie]

Here is a former patient who was involved in a Walitt in the comment section o the Jeanette Blog we are discussing.

"Thank you for this article. I met Dr. Walitt years ago when he opened the Fibromyalgia Center at Georgetown University Hospital and was recruiting patients for his research. I was referred over from my rheumatologist at the time and very excited to be a part of the research. Then I went to the first day, which involved interviews, an exam, and a lecture. I couldn’t wait to leave and never went back. I was not impressed with the doctor or the program. Mostly I was offended by the continuous lecturing from Dr. Walitt which can be summed up as “you probably did too much and caused fatigue and pain and now you’re depressed and anxious and can’t ever get better because your depression and anxiety make you think you’re sicker than you are.” He was cold, direct, and impatient. I was exhausted, confused, and upset by the whole experience and cried the whole way home. It baffles me that he’s involved at the NIH level and frustrates me to no end to know that he’s involved in anything at all related to CFS/ME and FM."