Nielk
Senior Member
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Multitudes of ME/CFS advocates, including Eileen Holderman and Jeannette Burmeister, are sending letters of protest to HHS in opposition to the IOM and P2P. Below are statements from Holderman and Burmeister:
From Eileen Holderman:
In October, 2012, CFSAC made a recommendation to convene a workshop of ME/CFS experts (researchers, clinicians, advocates, and patients) to reach a consensus on a research and clinical definition starting with the Canadian Consensus Criteria (CCC). Instead of implementing the recommendation, HHS told Committee Members in subcommittee teleconferences, they would pursue new definitions their way: NIH would address (in part) a research definition with a workshop (called the EbMW, then called the P2P), and HHS and its agencies would pursue a clinical definition (later identified as the IOM Study). When 3 Committee Members sought information and expressed concerns about the proposed initiatives to redefine ME/CFS, HHS shut down the conversations, then called those 3 Committee Members and threatened to evict them from the Committee.
HHS continued their secrecy about the IOM and P2P, despite efforts from advocates, patients, and other stakeholders to uncover information about their redefinition initiatives.
Mass opposition to both IOM and P2P from CFSAC members, ME/CFS experts, advocates, patients, and caregivers sent a clear message to HHS that the majority do not want more Government-sponsored definitions for ME/CFS. Like so many advocates, I agree with our experts that HHS should adopt the CCC in all their agencies and use the money instead for biomedical research.
Therefore, I will restate and reaffirm, in writing, my opposition to both the IOM and P2P, and will send my letter to HHS for the public record. I will list my reasons for my opposition, without making any suggestions, so HHS is clear that I am protesting, and so they cannot claim stakeholder "buy-in" because I sent a letter.
Please click on the link to my June, 2014 CFSAC Written/Public Comment which enumerates the reasons for my opposition to IOM and P2P:
http://forums.phoenixrising.me/inde...holderman-cfsac-written-public-comment.31078/
If you wish to join the multitudes of advocates, patients, and stakeholders protesting the IOM and P2P, please send your letters of opposition (not suggestions - only your reasons for opposition) to the Government officials at HHS:
Sylvia.Burwell@hhs.gov (Secretary of HHS)
Francis.Collins@nih.hhs.gov (Director of NIH)
Tomfrieden@cdc.gov (Director of CDC)
From Jeannette Burmeister:
P2P: Don’t Buy the Hype! Protest!
The reason why I will not cooperate with, or participate or engage in, the P2P process is very simple. HHS and NIH have shown time and time again that they do not have ME patients’ interest at heart. This disturbing and indisputable fact has been confirmed again very recently in my FOIA lawsuit regarding documents relating to the IOM contract (the diagnostic equivalent of P2P), in which I won my motion for summary judgment against HHS and NIH in early September with a ruling by the court that the government violated federal law. The government, in turn, lost their motion for a summary judgment against me. HHS’s and NIH’s conduct in this matter has been dilatory, obstructionist and unlawful.
I initially filed my lawsuit pro se (meaning without engaging lawyers) because I was hoping that, when faced with a lawsuit, the government would finally comply with the law. I wanted to give them a chance to resolve the matter swiftly and without incurring any legal fees. Before filing my complaint, but sadly to no avail, I even gave them a warning that legal action was imminent, unless they complied. Even after filing my complaint, the government did not avail itself of the opportunity to moot the lawsuit (i.e., end it with a relatively small legal bill) by conducting a reasonable document search. Instead, the government filed a frivolous summary-judgment motion five months after I initiated litigation when they could have used all that time to remedy their prior FOIA violations. When faced with my opposition motion that clearly demonstrated that the government was in violation of federal law, they doubled down by filing another motion making frivolous and meritless legal arguments and misstating the law and the facts—the latter, under penalty of perjury. Even as late as in the oral-argument phase did they incorrectly cite the law, as noted by the court.
HHS and NIH have wasted the court’s time and energy and worse, they have directly caused my health to dramatically deteriorate as a result of their unreasonable conduct and stonewalling, as the case was factually extremely complex and required my close involvement in discussing strategy with my attorneys, reviewing documents, drafting and revising the motions, etc. This has predictably triggered an intense post-exertional crash, the hallmark symptom of ME. Ironically, HHS and NIH continue to boast of their commitment to our disease. It would follow that they knew about the post-exertional fall-out that their indefensible approach would have on my physical health and yet they passed on every opportunity to right their wrong. Instead, they have done everything to prolong this litigation and drive up my attorneys’ fees. Counsel for the government stated during oral arguments that he didn’t even understand the case until July of this year, six months into the litigation! Half a year! That is how seriously they take this patient population.
In short, HHS and NIH have acted like bullies vis-à-vis a disabled ME patient whose only “infraction” was to avail herself of her statutory rights. After all that litigating, the court ordered HHS and NIH to do what they should have done more than eight months ago, without a dime spent and without any additional damage to my health: to produce the requested documents. Does anybody honestly believe that the government is somehow—miraculously—going to conduct itself differently in this ludicrous and high-stakes jury-model P2P project when they don’t even take a very simple and straightforward FOIA request seriously and instead fight it tooth and nail contrary to explicit instructions by the US Attorney General for clear-cut cases like mine? Please see “P2P: ‘Patients to Purgatory’ or the Jury Model Stood on its Head” for an explanation of why the jury-model analogy of NIH is preposterous.
I urge patients and other stakeholders to voice their unambiguous opposition to the P2P in strong, but professional, terms. Opposing this effort means making our voices heard; quite obviously, it is the opposite of silence. Getting our opposition on the record is crucial because the government will try to claim that they had the support of the patient community for P2P when that is clearly not the case, as even most of those who suggest that patients should cooperate with the process are against the P2P in principle. Engaging the government allows them to claim that they took the community’s concerns into account when they have no intention of doing so. Their outreach to the patient community, the comment period, is a mirage.
The distinction between opposing/protesting and participating/cooperating/engaging is subtle, but very important. To clarify:
Do not participate or cooperate by making suggestions on how the P2P should be conducted or which areas it should focus on or by engaging regarding the seriousness of the disease, etc. Basically, do not make any substantive comments, in writing or in person at the workshop, because that will, without a doubt, be entirely ignored, as has been the case with the IOM and will allow the government to pretend that our concerns have been heard and will be reflected in the P2P outcome. Remember the changes that were made to the IOM panel in response to patients’ concerns about various suggested panel members’ conflict of interests? No? I don’t either. The make-up of the committee was not changed at all despite a few advocates researching the background of the proposed panel members and finding some troubling facts. The feedback of those advocates was entirely ignored. If the government wanted our input, they would have designed the whole process completely differently instead of merely having one token, hand-picked patient advocate at the P2P workshop purporting to speak for the entire community. Giving our input means legitimizing the farce. Don’t fall for it.
Opposing/protesting, on the other hand, is stating one’s unequivocal disapproval of this redundant, unscientific and ludicrous effort without making any substantive suggestions whatsoever. This effort is redundant because we already have a research definition that has been adopted by our experts, the Canadian Consensus Criteria. P2P is unscientific because it precludes anybody with ME/CFS expertise from being a member of the P2P panel. And it is ludicrous because the utilization of the jury-model approach in this context is, frankly, beyond comprehension. Therefore, I will send a letter protesting the entire effort in no uncertain terms, but without engaging substantively.
There is no doubt in my mind that P2P will harm patients greatly and I will have no part in that by being seduced into thinking that my engaging will result in any meaningful effect on the process.
From Eileen Holderman:
In October, 2012, CFSAC made a recommendation to convene a workshop of ME/CFS experts (researchers, clinicians, advocates, and patients) to reach a consensus on a research and clinical definition starting with the Canadian Consensus Criteria (CCC). Instead of implementing the recommendation, HHS told Committee Members in subcommittee teleconferences, they would pursue new definitions their way: NIH would address (in part) a research definition with a workshop (called the EbMW, then called the P2P), and HHS and its agencies would pursue a clinical definition (later identified as the IOM Study). When 3 Committee Members sought information and expressed concerns about the proposed initiatives to redefine ME/CFS, HHS shut down the conversations, then called those 3 Committee Members and threatened to evict them from the Committee.
HHS continued their secrecy about the IOM and P2P, despite efforts from advocates, patients, and other stakeholders to uncover information about their redefinition initiatives.
Mass opposition to both IOM and P2P from CFSAC members, ME/CFS experts, advocates, patients, and caregivers sent a clear message to HHS that the majority do not want more Government-sponsored definitions for ME/CFS. Like so many advocates, I agree with our experts that HHS should adopt the CCC in all their agencies and use the money instead for biomedical research.
Therefore, I will restate and reaffirm, in writing, my opposition to both the IOM and P2P, and will send my letter to HHS for the public record. I will list my reasons for my opposition, without making any suggestions, so HHS is clear that I am protesting, and so they cannot claim stakeholder "buy-in" because I sent a letter.
Please click on the link to my June, 2014 CFSAC Written/Public Comment which enumerates the reasons for my opposition to IOM and P2P:
http://forums.phoenixrising.me/inde...holderman-cfsac-written-public-comment.31078/
If you wish to join the multitudes of advocates, patients, and stakeholders protesting the IOM and P2P, please send your letters of opposition (not suggestions - only your reasons for opposition) to the Government officials at HHS:
Sylvia.Burwell@hhs.gov (Secretary of HHS)
Francis.Collins@nih.hhs.gov (Director of NIH)
Tomfrieden@cdc.gov (Director of CDC)
From Jeannette Burmeister:
P2P: Don’t Buy the Hype! Protest!
The reason why I will not cooperate with, or participate or engage in, the P2P process is very simple. HHS and NIH have shown time and time again that they do not have ME patients’ interest at heart. This disturbing and indisputable fact has been confirmed again very recently in my FOIA lawsuit regarding documents relating to the IOM contract (the diagnostic equivalent of P2P), in which I won my motion for summary judgment against HHS and NIH in early September with a ruling by the court that the government violated federal law. The government, in turn, lost their motion for a summary judgment against me. HHS’s and NIH’s conduct in this matter has been dilatory, obstructionist and unlawful.
I initially filed my lawsuit pro se (meaning without engaging lawyers) because I was hoping that, when faced with a lawsuit, the government would finally comply with the law. I wanted to give them a chance to resolve the matter swiftly and without incurring any legal fees. Before filing my complaint, but sadly to no avail, I even gave them a warning that legal action was imminent, unless they complied. Even after filing my complaint, the government did not avail itself of the opportunity to moot the lawsuit (i.e., end it with a relatively small legal bill) by conducting a reasonable document search. Instead, the government filed a frivolous summary-judgment motion five months after I initiated litigation when they could have used all that time to remedy their prior FOIA violations. When faced with my opposition motion that clearly demonstrated that the government was in violation of federal law, they doubled down by filing another motion making frivolous and meritless legal arguments and misstating the law and the facts—the latter, under penalty of perjury. Even as late as in the oral-argument phase did they incorrectly cite the law, as noted by the court.
HHS and NIH have wasted the court’s time and energy and worse, they have directly caused my health to dramatically deteriorate as a result of their unreasonable conduct and stonewalling, as the case was factually extremely complex and required my close involvement in discussing strategy with my attorneys, reviewing documents, drafting and revising the motions, etc. This has predictably triggered an intense post-exertional crash, the hallmark symptom of ME. Ironically, HHS and NIH continue to boast of their commitment to our disease. It would follow that they knew about the post-exertional fall-out that their indefensible approach would have on my physical health and yet they passed on every opportunity to right their wrong. Instead, they have done everything to prolong this litigation and drive up my attorneys’ fees. Counsel for the government stated during oral arguments that he didn’t even understand the case until July of this year, six months into the litigation! Half a year! That is how seriously they take this patient population.
In short, HHS and NIH have acted like bullies vis-à-vis a disabled ME patient whose only “infraction” was to avail herself of her statutory rights. After all that litigating, the court ordered HHS and NIH to do what they should have done more than eight months ago, without a dime spent and without any additional damage to my health: to produce the requested documents. Does anybody honestly believe that the government is somehow—miraculously—going to conduct itself differently in this ludicrous and high-stakes jury-model P2P project when they don’t even take a very simple and straightforward FOIA request seriously and instead fight it tooth and nail contrary to explicit instructions by the US Attorney General for clear-cut cases like mine? Please see “P2P: ‘Patients to Purgatory’ or the Jury Model Stood on its Head” for an explanation of why the jury-model analogy of NIH is preposterous.
I urge patients and other stakeholders to voice their unambiguous opposition to the P2P in strong, but professional, terms. Opposing this effort means making our voices heard; quite obviously, it is the opposite of silence. Getting our opposition on the record is crucial because the government will try to claim that they had the support of the patient community for P2P when that is clearly not the case, as even most of those who suggest that patients should cooperate with the process are against the P2P in principle. Engaging the government allows them to claim that they took the community’s concerns into account when they have no intention of doing so. Their outreach to the patient community, the comment period, is a mirage.
The distinction between opposing/protesting and participating/cooperating/engaging is subtle, but very important. To clarify:
Do not participate or cooperate by making suggestions on how the P2P should be conducted or which areas it should focus on or by engaging regarding the seriousness of the disease, etc. Basically, do not make any substantive comments, in writing or in person at the workshop, because that will, without a doubt, be entirely ignored, as has been the case with the IOM and will allow the government to pretend that our concerns have been heard and will be reflected in the P2P outcome. Remember the changes that were made to the IOM panel in response to patients’ concerns about various suggested panel members’ conflict of interests? No? I don’t either. The make-up of the committee was not changed at all despite a few advocates researching the background of the proposed panel members and finding some troubling facts. The feedback of those advocates was entirely ignored. If the government wanted our input, they would have designed the whole process completely differently instead of merely having one token, hand-picked patient advocate at the P2P workshop purporting to speak for the entire community. Giving our input means legitimizing the farce. Don’t fall for it.
Opposing/protesting, on the other hand, is stating one’s unequivocal disapproval of this redundant, unscientific and ludicrous effort without making any substantive suggestions whatsoever. This effort is redundant because we already have a research definition that has been adopted by our experts, the Canadian Consensus Criteria. P2P is unscientific because it precludes anybody with ME/CFS expertise from being a member of the P2P panel. And it is ludicrous because the utilization of the jury-model approach in this context is, frankly, beyond comprehension. Therefore, I will send a letter protesting the entire effort in no uncertain terms, but without engaging substantively.
There is no doubt in my mind that P2P will harm patients greatly and I will have no part in that by being seduced into thinking that my engaging will result in any meaningful effect on the process.
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