Still #MillionsMissing

IMG_5469Today is another, larger #MillionsMissing protest, and I am missing it. I miss a lot of things.

One of the best things I ever did in my life was to drive cross country, camping in national parks. It changed my relationship with nature and exercise. I realized that I could be athletic, and enjoy it. My heart opened further with every gorgeous vista and soothing campground. I felt whole and complete.

I never did anything like that ever again. Those purple hiking boots in the photo were the ones I bought for that trip, and they are still not worn out more than twenty years later. ME arrived and kidnapped me from my life.

Good friends of ours recently made their own cross country trip. With every picture they posted from the road, I felt my sense of loss renewed. I belong out there on the road, and on the trail. But this is probably out of my reach, permanently.

For many years, I didn’t think about camping. I missed it too much. After twenty-two years of ME, I doubt I will ever camp again. That loss seems too big to handle.

How could a disease that ripped me from almost everything I loved in my life receive so little attention? How could I be sitting here twenty-two years later, without ever having had a treatment to try that was not off-label or hypothetical?

The lack of medical progress, which has sentenced me and millions of others to a life that is less than, is a direct result of our government’s failure to invest in ME/CFS research. The research dollars must flow. That is our only hope of escape from the life sentence that is this disease.

I am one of the Millions Missing. Don’t let me disappear.

 

 

 

 

Posted in Advocacy, Occupying | Tagged , , , , , , , , , , , , , , , , , | 13 Comments

RFA Ticker, 9/26/16

ticker

We are down to the wire, friends. The #MillionsMissing protest is on the 27th, and we have millions upon millions missing from ME research at NIH. Specifically, NIH issued 15 RFAs last week for $62 million, but ME did not get a damn thing. 

The end of the fiscal year is this Friday. Do not hold your breath. 

  • Total RFAs Issued by NIH: 343 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,776,271,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
9/19/16 15 $62,636,000 Zero
9/12/16 7 $31,150,000 Zero
9/5/16 3 $6,250,000 Zero
8/29/16 8 $11,250,000 Zero
8/22/16 5 $14,300,000 Zero
8/15/16 16 $130,685,000 Zero
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

Posted in Advocacy, Research | Tagged , , , , , , , , , , , , , | 3 Comments

PACE: Grossly Exaggerated

cartoon2On September 9, 2016, Queen Mary University of London released data from the PACE trial in compliance with a First Tier Tribunal decision on a Freedom of Information Request by ME patient Alem Matthees. The day before, the PACE authors had released (without fanfare) their own reanalysis of data using their original protocol methods. Today, Matthees and four colleagues published their analysis of the recovery data obtained from QMUL on Dr. Vincent Racaniello’s Virology Blog. These two sets of data reanalysis blow the lid off the PACE trial claims.

The bottom line? The PACE trial authors’ claims that CBT and GET are effective treatments for ME/CFS were grossly exaggerated.

Improvers

First, take a look at what the PACE authors’ own reanalysis showed. When they calculated improvement rates using their original protocol, the rates of improvement dropped dramatically.

pace-per-protocolAs shown in the above graph by Simon McGrath, the Lancet paper claimed that 60% of patients receiving CBT or GET improved. But the reanalysis using the original protocol showed that only 20% of those patients improved, compared to 10% who received neither therapy. In other words, half of the people who benefited from CBT or GET would likely have improved anyway. Remember, the PACE authors made changes to the protocol after they began collecting data in this unblinded trial. Those changes, used in the Lancet paper, inflated the reported improvement by three-fold.

One would think that the PACE authors would be at least slightly embarrassed by this, but instead they continue to insist:

All three of these outcomes are very similar to those reported in the main PACE results paper (White et al., 2011); physical functioning and fatigue improved significantly more with CBT and GET when compared to APT [pacing] and SMC [standard medical care].

Sure, twice as many people improved with CBT and GET compared to standard medical care. But 80% of the trial participants DID NOT IMPROVE. How can a treatment that fails with 80% of the participants be considered a success?

Not only that, but the changes in the protocol were like a magic wand, creating the impression of huge gains in function: 60% improved! The true results, however, are close to a failure of the treatment trial.

Recovery

Today’s publication on Dr. Racaniello’s blog presents the analysis of the recovery outcome data obtained by Alem Matthees. Once again, the mid-stream changes to the study protocol grossly inflated the PACE results.

screenshot-2016-09-20-18-20-19-1024x647

Source: Matthees, et al.

As the graph from the Matthees paper shows, the PACE authors claimed more than 20% of subjects recovered with CBT and GET. Using the original protocol, however, those recovery rates drop by more than three-fold. Furthermore, there is no statistically significant difference between those who received CBT or GET and those who received standard care or pacing instruction. In other words, the differences among the groups could have easily been the result of chance rather than the result of the therapy delivered.

Matthees, et al. conclude, “It is clear from these results that the changes made to the protocol were not minor or insignificant, as they have produced major differences that warrant further consideration.” In contrast, long time CBT advocate Dr. Simon Wessley told Julie Rehmeyer that his view of the overall reanalysis was, “OK folks, nothing to see here, move along please.”

Taken together, the reanalysis of data on improvement and recovery show that the changes in the protocol resulted in grossly inflated rates of improvement and recovery. Let me state that again, for clarity: the PACE authors changed their definitions of improvement and recovery and then published the resulting four-fold higher rates of improvement and recovery without ever reporting or acknowledging the results under original protocol, until now. Furthermore, the PACE authors resisted all efforts to obtain the data by outside individuals, spending £250,000 to oppose Matthee’s request alone.

Conclusions

Tuller’s detailed examination of the PACE trial and these new data analyses raise a number of questions about why these changes were made to the protocol:

  • Were the PACE authors influenced by their relationships with insurance companies?
  • Did they make the protocol changes after realizing that the FINE trial had basically failed using its original protocol?
  • Why did they change their methods in the middle of the trial? (Matthees, et al. note that changing study endpoints is rarely acceptable)
  • Were they influenced by the fact that the National Health Service expressed support for their treatments before the trial was even completed?
  • Since data collection was well underway when the changes were made, and because PACE was an unblinded trial, we have to ask if the PACE authors had an idea of the outcome trends when they decided to make the changes?
  • Was their cognitive bias so great that it interfered with decisions about the protocol?
  • Did the PACE authors analyze the data using the original protocol at any point? If so, when? How long did they withhold that analysis?

The grossly exaggerated results of the PACE trial were accepted without question by agencies such as the Centers for Disease Control and institutions such as the Mayo Clinic. The Lancet and other journals persist in justifying their editorial processes that approved publication of these grossly exaggerated results.

The voices of patients have been almost unilaterally ignored and actively dismissed by the PACE authors and by journals. We knew the PACE results were too good to be true. A number of patients worked to uncover the problems and bring them to the attention of scientists. Their efforts went on for years, and finally gained traction with a broader audience after Tuller and Racaniello put PACE under the microscope.

For five years, the claim that CBT and GET are effective therapies for ME/CFS has been trumpeted in the media and in scientific circles. Medical education has been based on that claim. Policy decisions at CDC and other agencies have been based on that claim. Popular views of this disease and those who suffer with it have been shaped by that claim.

But this claim evaporates when the PACE authors’ original protocol is used. Eighty percent of trial participants did not improve. Not only that, but we do not have any data on how many people in that group of 80% were harmed or got worse. CBT and GET may not be neutral therapies worth trying in case you fall in that lucky 20% who improved spontaneously or due to the treatment. We don’t know how many people got worse with these therapies, so we cannot assess the risks.

The end result is this: the PACE authors made changes to their protocol after data collection had begun, and published the inflated results. But when the original protocol is applied to the data, CBT and GET did not help the vast majority of participants. The PACE trial is unreliable and should not be used to justify the prescription of CBT and GET for ME patients.

As Matthees, et al., stated in their paper:

The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny. We therefore propose that a thorough, transparent, and independent re-analysis be conducted to provide greater clarity about the PACE trial results. Pending a comprehensive review or audit of trial data, it seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results.

 

Posted in Advocacy, Commentary, Research | Tagged , , , , , , , , , , , , , | 18 Comments

RFA Ticker, 9/19/16

teenage-girl-waiting-for-train-chicago-illinois-19601Imagine a woman waiting for a train. She has been waiting a long time, and the train is the only way to get to her destination. She waits as many other passengers get on their trains and proceed down the line. She waits with some impatience. She checks her watch, and checks with a ticket agent. She waits. She gets angry and raises hell with a conductor. Every other train is coming in, taking on passengers, and going out. Just wait, the conductor says. Your train is very very important to us. She waits, alone and with nowhere else to go.

ticker

  • Total RFAs Issued by NIH: 328 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,713,635,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
9/12/16 7 $31,150,000 Zero
9/5/16 3 $6,250,000 Zero
8/29/16 8 $11,250,000 Zero
8/22/16 5 $14,300,000 Zero
8/15/16 16 $130,685,000 Zero
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

Posted in Advocacy, Research | Tagged , , , , , , , , , , , , | 15 Comments

CFSAC Renewed

checkmarkAs expected, the charter for the CFS Advisory Committee has been renewed for another two years. This has become a routine operation, but the new charter makes some intriguing changes to the CFSAC. I also have new information on potential membership changes.

Purpose of CFSAC

Under the old charter, CFSAC made recommendations on the state of the knowledge of diagnosis and treatment, strategies for medical education, and partnerships to improve patient quality of life. This is still the case, but the new charter adds a new task for the committee:

The Committee shall advise and make recommendations to the Secretary, through the ASH, on a range of topics including:  . . . strategies to insure that input from ME/CFS patients and caregivers is incorporated into HHS policy and research.

You might remember that former Assistant Secretary Dr. Koh had told ME/CFS patients that CFSAC was their channel of input into HHS. This change formalizes and expands that. Not only does CFSAC receive input from patients, it now has been charged with recommending strategies for incorporating input from patients and caregivers into policy and research.

This lines up nicely with the working group formed at the last meeting to make recommendations on how HHS agencies can better receive input from stakeholders. This working group is chaired by Dr. Dane Cook, but has not yet begun its work.

Follow Through

During CFSAC’s long history, both voting members and the public have been frustrated by the fact that recommendations seem to go nowhere. Only recently have the agencies responded to recommendations in writing. But most recommendations were not adopted, and we never knew who was responsible for making those decisions and carrying them through. Now the new charter makes it explicit:

The ASH shall be given the responsibility to coordinate and monitor the implementation of those recommendations adopted by the Secretary.

This sounds almost czar-like, in that one person is responsible for monitoring implementation of recommendations across agencies. However, the wrinkle is that this only applies in the case of adoption of recommendations by the Secretary. Furthermore, this oversight responsibility is limited to CFSAC recommendations, NOT the work on ME/CFS as a whole.

Voting and Non-Voting Membership

The charter makes some significant changes to membership of CFSAC. The old charter specified eleven voting members, but this is now increased to thirteen. There will still be seven biomedical researchers, but only three members with experience in service delivery, insurance, etc. The new charter now states that there will be three voting members who are patients or caregivers affected by ME/CFS.

This is highly significant. CFSAC’s custom has been to appoint a single patient to the committee (although that was not a specific mandated quota). This placed a heavy burden on those individuals to try and represent the diversity of patients’ experiences and views. By increasing the number to three, CFSAC will benefit from a broader range of patient perspectives.

Changes were also made to the ex officio members representing HHS agencies. The Centers for Medicare and Medicaid services will no longer be represented. This is odd, since care reimbursement is such a big issue for ME patients. Two non-HHS members will be added. The Department of Veterans Affairs and the Department of Defense will both be represented on CFSAC, a first for involving Departments outside of HHS. This change is especially intriguing because the Department of Defense funds a great deal of biomedical research. It would be fantastic if ME researchers could tap into that on a greater scale than they have so far.

A New Roster

There are multiple vacancies on CFSAC. Rebecca Collier’s term expired in May, and Dr. Lisa Corbin’s expired in June (although she is still listed on the roster). Dr. Adrian Casillas and Dr. Mary Ann Fletcher will finish their terms at the end of December. In addition, the new charter added two additional members, both of whom will be patients or caregivers. A total of six new members will be needed by the end of 2016, with four of those chairs being vacant right now. Another three members (Dr. Sue Levine, Dr. Dane Cook, and Dr. Gary Kaplan) will reach the end of their terms in May 2017.

This creates a conundrum for HHS. The call for nominations resulted in only four nominees from the public. They are all terrific: Dr. Cindy Bateman, Dr. Nancy Klimas, Dr. Lenny Jason, and Mary Dimmock. My information is that appointments are working their way through the approval process, but I don’t know how many people (or who) have been put forward for approval. Given the roster situation, HHS should issue another call for nominations very soon. Approvals take far too long – about nine months – and so the process must begin now.

Will It Matter?

Most of the changes to the CFSAC charter are positive. If the new members have the right experience and skills, then recommendations from CFSAC should improve. But is HHS ready to accept these recommendations?

The other issue is urgency. CFSAC meets only twice a year, and one meeting is by webinar. As far as I know, the three work groups formed at the May 2016 meeting have not begun their work yet. Six months is plenty of time for a work group to come up with well-supported recommendations, but if they have not met yet then I doubt we will hear much from the work groups at the next meeting (perhaps in November). If CFSAC continues to do its work at the same pace, and in the same way, then the charter changes are more tweaks than substantial improvements.

Posted in Advocacy | Tagged , , , , , , , , , , | 11 Comments

RFA Ticker, 9/12/16

ticker

I have to admit, maintaining this RFA Ticker is a bit like watching a train wreck in slow motion. As the fiscal year winds down, and the RFAs slowly shrink in size and number, I keep asking “Will they or won’t they? Will they or won’t they?”

There are three weeks to go. Will they or won’t they get the RFA done for us in time?

  • Total RFAs Issued by NIH: 321 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,682,485,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
9/5/16 3 $6,250,000 Zero
8/29/16 8 $11,250,000 Zero
8/22/16 5 $14,300,000 Zero
8/15/16 16 $130,685,000 Zero
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

Posted in Advocacy, Research | Tagged , , , , , , , , , , , , , | 6 Comments

Pretty Much the Worst

One of the worst things someone said to me recently about my disability was:

With all the stuff you’re doing, you work just as hard as someone working full time.

The charitable and loving way to interpret this statement is: “You’re really doing a lot. I’m worried that you are hurting yourself and not getting enough rest. Please take care of yourself.” An even better follow up statement would be, “What can I do to help you?”

But there’s another way to interpret this statement: “You are apparently able to work, since you’re basically doing as much as that already. You must not be disabled any more.”

Whether this second message was intentionally sent or not, it is deeply offensive to me as a person disabled by ME.

mjaxmy0wodg5ogq5odflm2jizmm1I know I don’t look sick or disabled. I know that I have a lot on my plate, between my advocacy and dealing with the realities of our two disability household. But to say that I could work full time?  That’s basically gaslighting or willful ignorance.

Since my husband had a stroke more than a year ago, I have been balls to the wall every day. That doesn’t mean eight hours of some kind of productivity, by the way. It’s more like a frantic few hours trying to get urgent tasks done, then triage everything else. People might see the effort I expend, but they don’t see what it costs.

I’m going to be bare bones honest, here. I don’t have the capacity to see my friends. I’ve had multiple near-fainting episodes in recent weeks. We rely almost exclusively on pre-prepared meals. We can’t keep up with laundry and other household tasks. I’m afraid to lie down for rest breaks because that usually turns into unintentional three hour naps. The pain and post-exertional malaise feels like I’m carrying a five story building on my back and shoulders. Every evening I collapse onto the couch, barely able to pay attention to the television. Most days, I’m barely making it.

Almost everything I do, I do out of a sense of obligation. Family obligations. Adults-have-clean-houses-and-healthy-food-in-the-fridge obligations. Maintaining this blog and participating in advocacy. Offering emotional support and patience as my husband continues to kick stroke rehab ass. Supporting my friends in their difficulties. Oh, and attempting to manage my own health.

My husband has no problem setting aside obligations in order to heal. A saner person than me would have given more things up a long time ago, and I don’t really understand why I haven’t. But if you look at me or my life and think, “She could be working,” then you are not SEEING me.

You are not seeing the physical pain I deal with every day. You are not seeing the fog that replaces my brain as the day goes on. You are not seeing the force of will that is required for me to remain upright most of the day. You are not seeing that every task, every routine activity, every action that you apparently take for granted, requires intense concentration and determination to track and ultimately complete.

It is so very tempting to imagine singing my theme song (NSFW language) as I exit stage right. But I choose, every day, to live a life that is bigger than the four walls of my house. That’s why I stay in advocacy, and why I try to stay on top of all the obligations and aspects of living a normal life.

But if you think that translates into being healthy enough to work full time? Please. You are not paying attention.

55a1e-invisible-illness1

Posted in Occupying | Tagged , , , , , , , , , , , | 42 Comments

RFA Ticker, 9/5/16

ticker

Another light week – a mere $11 million for diseases that are not ME.

Cort Johnson reported that NIH is preparing two RFAs, one for collaborative research centers and one for a Data Management Coordinating Center. Marian Emr told me, “The RFAs are working their way through the NIH process, with many people and ICs involved, so it difficult to predict the timing. We will certainly keep the community posted, however, as this is important to all of us.”

Obviously, neither of these replies indicate how big the RFAs will be or when we can expect to see them. I do still think there is a chance it could happen before September 30th, but that remains to be seen.

  • Total RFAs Issued by NIH: 318 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,676,235,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
8/29/16 8 $11,250,000 Zero
8/22/16 5 $14,300,000 Zero
8/15/16 16 $130,685,000 Zero
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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RFA Ticker, 8/29/16

ticker

Last week was surprisingly light for RFAs. NIH issued five RFAs, setting aside $14.3 million for those projects.

One of the RFAs may be of particular interest to the ME community. The National Institute of Neurological Diseases and Stroke issued an RFA for a Parkinson’s Disease Center of Excellence. What is interesting about it is that the RFA offers $1.5 million for one Center of Excellence for one year. Does this suggest parameters for the ME/CFS research consortium RFA?

Speaking of which, there is no word on the research consortium RFA except that it is currently in process. We have no indication of whether it will be issued before the end of the fiscal year, or how much money might be set aside for it.

  • Total RFAs Issued by NIH: 310 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,664,985,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
8/22/16 5 $14,300,000 Zero
8/15/16 16 $130,685,000 Zero
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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Reality Checking, Dr. Nath

This is the second of a two part series. Part One described the controversy and my fact checking. Part Two presents my analysis of the potential danger to the Clinical Care study.

As part of the renewed focus on ME/CFS at NIH, the National Institute of Neurological Diseases and Stroke is conducting an intramural study of ME/CFS at the NIH’s Clinical Care Center. Dr. Avi Nath is the Clinical Director of NINDS and the Principal Investigator on the study. Some of Dr. Nath’s remarks on the more controversial aspects of the study gave me pause, and I set out to understand the reality and context of those comments. What I found not only confirmed my initial reaction, but exposes a danger to the quality of the study because ME advocates and federal employees are failing to effectively communicate with each other.

reality-checkThe Reality Check: Does Bias Matter?

In his webinar comments, Dr. Nath said, “If you’ve got to eliminate all kinds of [scientists], you’re never going to be able to study anything. Rather, you do as you’re designing your study whereby you don’t have to worry about people’s biases.” After reviewing the emails I obtained through my FOIA requests and speaking with Marian Emr of the NINDS Communications Office, I was left with the question: were advocates’ criticism of Dr. Walitt’s involvement in the study scientifically sound, or is Dr. Nath correct that the study can be designed to make bias irrelevant?

Everyone has biases, and it is a continuing challenge in science. I agree with Dr. Nath that one cannot eliminate all bias from all researchers, and so studies must be designed to control that bias as much as possible. This is why studies use control groups, blinding, and other design elements to keep human error and influence to a minimum.

Dr. Walitt denied that he has a bias towards the psychogenic view of ME/CFS when he spoke at the March telebriefing, but that is hard to square with his previous multiple public statements to the contrary. Dr. Nath argued in the webinar presentation that a well-designed study can make investigator bias irrelevant. In an email on February 26, 2016, Dr. Nath wrote that he was “absolutely certain that no such bias can or will occur in our study.”

I described the Walitt/bias controversy to two scientist sources, one of whom is not in a biomedical field and another who is in a biomedical field unrelated to ME/CFS. The first scientist just stared at me open mouthed, aghast that Nath would claim Walitt’s bias didn’t matter. The other said it was “insane” for Walitt to be on the study if he thinks ME/CFS is a psychological disorder.

In the webinar, Dr. Nath used an analogy about AIDS researchers being biased against homosexuals to show that bias is unavoidable and immaterial. He said that screening researchers for “adverse views about gay people” would have prevented progress in AIDS research. He said, “we know that people have all kinds of biases and we shouldn’t worry about those kind of things.”

I don’t think Dr. Nath made the right analogy. The issue that advocates have with Dr. Walitt is not his personal view about whether he likes his research subjects or their behavior. The issue is whether someone who holds the negated and pseudoscientific view that ME/CFS is a psychological disorder should work on the study. I assume that Dr. Nath would screen his collaborators for their opinions on HIV as the cause of AIDS. I can’t see Nath allowing Dr. Peter Duesberg to collaborate on an HIV/AIDS study, since Duesberg claims that HIV is a harmless passenger virus. That is a bias that Nath would never countenance on an HIV study, and I agree that he should not.

The same should hold true in our case. The psychogenic theory of ME/CFS is wrong. We know this. ME is not a psychosomatic illness. Anyone who holds that view is clinging to a disproven and unfounded scientific theory. There is no good reason or excuse for selecting a scientist for this ME/CFS study who blatantly rejects the scientific evidence. Why would it be reasonable to keep Duesberg off an HIV study, but unreasonable for ME advocates to reject the participation of Walitt and others who have said that ME/CFS is a somatoform illness? This is an unacceptable double standard.

The potential bias of investigators on the Clinical Care study is scientifically relevant. Anyone who believes that ME/CFS is a psychological disorder (in whole or in part) should be disqualified from participating in the study. Such a bias represents a significant risk to the quality of the study, especially because of the harm the psychogenic theory has caused over many decades. In my view, ME advocates have raised legitimate and scientifically sound criticisms of the potential bias of Dr. Walitt and other investigators, and NIH must address these criticisms directly. Dr. Nath should not simply brush them aside as irrelevant.

The Reality Check: Are We Antagonizing Scientists?

Towards the end of the April webinar, Dr. Nath said, “people have to be a little bit careful as to how critical you become. . . . And we want to really try and help, but we can’t do that if the very people you want to help become antagonistic towards you.” I filed FOIA requests for the emails to determine whether ME advocates were antagonizing the scientists working on the study and provoking some of them into withdrawing or stepping back. Was the broader context of criticism on social media so huge and unreasonable that scientists would be justified in refusing to work on the study?

My investigation showed that Drs. Nath and Walitt (combined) received fewer than 20 critical emails over the first four months of 2016. A few are strongly worded or confrontational, but most are thoughtful and well-reasoned. In my view, only one can fairly be classified as antagonistic (the self-described “scornful and contemptuous” one). There were no abusive or harassing emails.

Looking beyond the emails to social media, as Marian Emr suggested, shows that criticism was quite high on blogs, Twitter, and discussion forums. However, it’s not clear how closely any of the NIH scientists personally tracked this. Dr. Nath declined my request to speak and Dr. Walitt declined Julie Rehmeyer’s interview request. We haven’t been able to have a conversation about the sources of the antagonism Dr. Nath was referring to, and so our ability to analyze how reasonable his comments were is limited.

In the absence of direct evidence of personal attacks and the like, Dr. Nath’s admonishment that our criticism would “end up antagonizing all these people” implies that we shouldn’t criticize the study, or at least we should do it very nicely. Even though no one sent nasty or abusive emails to NIH scientists, even though we raised legitimate criticisms in our social media space, even though Marian Emr could not confirm that anyone had withdrawn from the study, Dr. Nath is saying we risk insulting scientists who will now withdraw from the study and not want to help us.

One scientist I consulted said that Dr. Nath’s comment about antagonism was unacceptable and outrageous. Patients have to speak out and be part of the process. Scientists must put patients first, not their own feelings. This scientist noted that many researchers are not used to public engagement, and that outspoken patients can be shocking to researchers who have not dealt with it before. They may not be prepared for the justifiable anger of people who have been sick and neglected for years.

My scientist source said it’s also true that there are some nasty people among advocates, and their behavior can taint the whole community. But he pointed out that HIV/AIDS activists are much more intense than ME advocates. As just one example, look at all the protests at the 1996 International AIDS Conference. ACT UP brought the opening ceremonies to a halt, and protested in multiple parts of the conference. Dr. Nath, having worked on HIV/AIDS, should be used to that. But Dr. Nath says ME advocates are too critical, which deflects attention from the substance of those criticisms to the way in which the criticisms were made.

ME advocates have an obligation to point out the flaws in science and policy that affect our lives. We have the right to be angry about how we have been treated, and the ongoing failures to fix the situation. I wholeheartedly agree that we should not harass, abuse or threaten anyone, but there is no evidence of that in the context of the Clinical Care study. Angry or strongly worded emails and tweets are unpleasant to read, but do not automatically equal abuse. Sarcasm does not equal harassment.

ME advocates’ tactics pale in comparison to HIV/AIDS activists. We are not as numerous, as loud, as omnipresent, as angry, or as bold. But Dr. Nath seems to think that our substantive criticisms of the study and a few confrontational emails are enough to risk antagonizing scientists. I don’t understand why.  In my experience, scientists generally have robust egos. If HIV/AIDS researchers can deal with AIDS activists, and even partner with them in meaningful and substantive ways, then the same kinds of partnerships should be possible in ME.

Failing to Communicate is Dangerous

Advocates and NIH are talking past each other. Advocates are expressing strong, substantive, and scientifically sound criticisms of a highly significant and long awaited study. Dr. Nath says we’re antagonizing scientists and should be nice. These are two different conversations. Our failure to succeed in having these conversations poses a risk to the ultimate quality of the Clinical Care study results.

Advocates and NIH should have a substantive discussion about the design and conduct of the Clinical Care study. Patients are entitled to a seat at the table. We have things to teach NIH, and NIH has things to teach us. That process is overdue. Both advocates and NIH would also benefit from discussing how we express and receive criticism. But this must be a two-way conversation between equals. Scientists can’t claim they want to take their test tubes and go home because advocates are being mean if they haven’t actually listened to and considered what the advocates are saying. Advocates, on the other hand, can’t claim that their suffering automatically makes them right.

I had some hope that these conversations and others would be made possible by NIH’s publicly stated intention to create a patient advisory panel of some kind. Many advocates have made a strong case that we should not only be involved in all stages of the Clinical Care study, but also in devising NIH’s research strategy for ME/CFS. But the creation of this panel seems to have stalled.

In the April 21st webinar, Dr. Nath said that it “turns out to be much more
complicated than I originally imagined.” He said that the details of who and how many should be selected, and what their role should be, were unclear. Dr. Nath said the “extramural folks” were approaching people for the panel. Dr. Vicky Whittemore confirmed to me that there was nothing to share at that time. Dr. Whittemore later suggested that the CFS Advisory Committee form a working group to examine how patients could be engaged in the agencies’ work, but the group has yet to meet.

Science requires criticism. It’s part of the process, at every single stage. In the case of ME, patients and advocates know far more about this disease than scientists who are new to the field. This is exactly what happened in HIV/AIDS. Those patients were extremely critical, extremely vocal, and extremely active in standing up to the way government scientists wanted to do things. They also secured patient participation in AIDS research at all stages and at all levels, working alongside scientists to improve their research and to learn information that they could take back to their community. Those combined efforts are what accelerated progress in HIV/AIDS.

I wonder if Dr. Nath has missed the point that vociferous criticism is part of our job as advocates. We are obligated to speak out about our disease, our experiences, and the science needed to find answers. We are fully qualified to participate in the scientific enterprise, and our perspectives are necessary.

Without meaningful participation by patients with a diversity of perspectives, the Clinical Care study is at risk. The controversies over the Reeves criteria and functional movement disorder control group are two examples, and the potential bias of Dr. Walitt is another. These controversies might have been avoided if advocates were involved at the early stages of protocol design. I think there are a variety of other ways we could assist as well. For example, the series of tests planned in the study will be quite grueling. We could help adjust the design to make it easier on participants. In addition, I suspect that the team has not thought through the full spectrum of effects that the study will have on patients – before, during and after participation. Again, adjustments to design could collect those data and augment the study’s impact.

I don’t think NIH’s refusal to engage with us as equals, or scientists’ dislike of our criticism, is a nefarious conspiracy. An essay by Kameron Hurley (about a different topic) explains why:

When the internet loses its shit over what, to many, looks like a single insignificant incident unrelated to anything else, it’s easy to say they’re fucking nuts. They’re raging over some perceived slight that’s been blown waaaaay out of proportion. That, in truth, is the easier narrative . . . . It’s easier to say people are crazy than to try and figure out why.

. . . .

Change is messy. It’s angry. It’s uncomfortable. It’s full of angry people saying angry things, because they’ve been disrespected and forgotten again and again and again and again, and they’re tired of being fucking nice because it makes you uncomfortable if they act in any way that is not deferential or subservient to you and your worldview.

This is exactly the situation we are in with NIH and other federal agencies. They seem to think we’re crazy, we’re antagonistic, and we’re overreacting. They want us to tone down the anger, and criticize in a more polite and quiet way. In Dr. Nath’s comments, I hear: “Just go away and let us do the science. We’re the experts here.”

There is no question that Dr. Nath is a world-renowned expert who is capable of designing an excellent and elegant study. But some of the scientific decisions made by NIH, including the involvement of Dr. Walitt, are worthy of criticism. Our criticisms, even the angry ones, deserve a fair hearing.

The appropriate response to our criticisms is not, “You don’t know what you are talking about. Sit down and speak softly, or not at all.” It is not to dismiss us all as antagonistic and crazy because someone received a couple of critical emails. The appropriate response is to listen, and to consider our points. Then we can partner and learn from each other. And that is essential to producing good science.

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