There are new developments in the continuing saga that is the NIH’s Office of Disease Prevention’s mismanagement of public comment on the P2P report. When I last wrote about this on April 3rd, ODP had acknowledged that yes indeed, they had failed to send an unspecified number of comments to the Panel. In an attempt to reassure us, ODP said that publication of the report would be delayed so the Panel could review the missing comments and decide if they should change anything in the report.
On April 7th, I received a second release of documents under my FOIA request, described as consisting of all the remaining comments. But that was not true. I carefully reviewed the documents and compared them with what was submitted to me for the P2P Library. I asked another advocate to double check my work. There are still comments missing – I can document at least six. I filed a second appeal on April 13th, but then on April 16th, ODP announced that the final report would be published on June 16, 2015.
There are several possibilities:
- Maybe those six comments were not received by NIH. But I was copied on the actual emails to NIH in several cases, so that is not likely to be the case.
- Maybe those six comments were sent to the Panel, but not sent to the FOIA office for release to me. This would represent a continuing and disturbingly lax approach to document management.
- Maybe those comments were not sent to the Panel when the rest of the missing “set” was sent to them after I uncovered the problem. This is the worst possibility of all.
We are left with difficult questions about the integrity and validity of the process:
- Has the Panel received all the comments, or are there still some missing?
- How much time was the Panel given to consider the set of comments sent to them a few weeks ago?
- Did the Panel take the time to reconsider all the public comment? Or did they simply read the new ones?
- Whatever is in the final report, how can we be sure it is the best version that would have resulted if ODP had not screwed up the public comment process to begin with?
The mishandling of public comments is not a technicality, nor is it an insignificant matter. This goes to the heart of NIH’s stewardship of a process that depends upon the opinions of five people who have no expertise in ME/CFS. The federal government cannot play fast and loose with public comment, no matter what that final report looks like.
On April 19th, I sent a letter to the Office of the Inspector General for the Department of Health and Human Services to request an investigation and intervention to remedy the problem. After describing the facts of the situation, I wrote:
ODP’s failure to forward over 200 pages of public comment to the P2P panel for consideration is a clear violation of the public trust, NIH’s document retention policies, and public comment administrative procedures. The proposed “fix” of asking the panel “to consider the new information and determine if changes are needed before the release of the final report” is completely inadequate.
The purpose of collecting public comment is for the panel to have the benefit of outside views. By design, the P2P process selects non-subject matter experts for the panel. In order to produce useful recommendations on the future needs of ME/CFS research, the panel is completely dependent on the multi-component process of presenting evidence, particularly the public comment submitted on the draft report.
However, the success of the process requires that all public comments on the P2P report be considered equally. They should be compared and contrasted, and given equal weight. By failing to provide the Panel with all of the comments at the same time, NIH has created a situation in which the missing comments will automatically be considered differently than the comments sent to the Panel in January. This error is only compounded by the apparent failure to find all of the misplaced comments and produce them under FOIA. Finally, only two weeks elapsed between ODP’s acknowledgement of its failure to provide the comments to the panel and the announcement of the new publication date. It remains unknown whether the panel has received all the comments, how much time they have had to review the comments, and whether all the comments have been given the same level of scrutiny and consideration.
Given ODP’s admission that the panel did not receive all of the public comment, the very legitimacy of the P2P process and final report is undermined. This report is highly relevant to the planning and conduct of future ME/CFS research at NIH. There is a strong public interest in ensuring that NIH takes every appropriate corrective step, and that new procedures are in place to prevent the repetition of these errors.
Therefore, I ask that your office investigate the handling of public comment by ODP. I further ask that you act immediately to intervene, given the imminent publication of the panel’s final report. The report should not be published until the panel has received and given due consideration to every single comment submitted by the public in response to NIH’s invitation.
I will keep you posted on the status of my FOIA appeal and on any reply I receive from the OIG.