2013/11/17: Supplemental Request for Investigation by OIG: Did DHHS Violate its No-Bid-Contract Requirements for IOM Contract?
2014/01/08: After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded
2014/04/04: IOM-OCI-OIG … OMG!
2014/05/28: OIG Fails to Investigate IOM Conflict of Interest & Tells ME/CFS Patients to Buzz Off]
To use a poker analogy, I see your argument, PANDORA and a few others, that all ME/CFS experts who signed the open experts’ letter of October 25, 2013 are biased—merely due to signing that letter—and cannot, as a result, serve on the IOM ME/CFS committee and I raise you the claim that the IOM as an institution has a conflict of interest and bias—based on its report on Chronic Multisymptom Illness from earlier this year—that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS.
Today, I sent the following letter to Mr. Daniel R. Levinson Inspector General at the Office of Inspector General, U.S. Department of Health and Human Services calling for an investigation by the Inspector General of the IOM’s conflict of interest:
Jeannette K. Burmeister
[town, state, zip code]
November 11, 2013
Via Registered Mail and [Email]
Daniel R. Levinson
Office of Inspector General, U.S. Department of Health and Human Services
[town, state, zip code]
Re: Conflict of Interest of the Institute of Medicine With Respect to Its Contract with DHHS Regarding ME/CFS
Dear Mr. Levinson,
I respectfully request your review of a serious conflict of interest in a recently concluded $1 million contract (“IOM Contract”) between the Department of Health and Human Services (“DHHS”) and the Institute of Medicine (“IOM”) to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”).
I am a patient who has suffered from this disease since 2006.
The IOM Contract was announced on September 23, 2013. It was entered into on a rushed and alarmingly secretive basis despite a deafening outcry by the patient community against it. The IOM Contract has so far not been terminated despite the agreement of virtually all U.S. and a fair number of international ME/CFS experts to adopt the 2003 Canadian Consensus Criteria (“CCC”) as the case definition (or diagnostic criteria) for ME/CFS and the opposition to the IOM Contract by these experts (both also on September 23, 2013) and by over 170 representatives of the patient advocacy community (on November 9, 2013). The experts’ consensus negates the need for the IOM Contract and the waste of $1 million in taxpayer money. Nevertheless, Secretary Sebelius has, to this date, not had the courtesy to reply to the experts and advocates. To the contrary, the IOM Contract is being pushed through at an unprecedented speed.
The Federal Acquisition Regulations, an in particular 48 C.F.R. section 9.504, require the [government] contracting officer “to
(1) Identify and evaluate potential organizational conflicts of interests as early in the acquisition process as possible; and
(2) Avoid, neutralize, or mitigate significant potential conflicts of interest before contract award.”
48 C.F.R. section 9.505 sets up the underlying principles in avoiding or mitigating organizational conflicts of interests, including “preventing the existence of conflicting roles that might bias a contractor’s judgment.”
In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).
Just to give a few examples, the CMI Report unconditionally accepts antidepressants (page 119) as well as cognitive-behavioral therapy and graded-exercise therapy (page 99) as recommended treatments for ME/CFS even though these “treatments” are viewed by most if not all credible experts as not just unhelpful, but potentially quite harmful for most ME/CFS patients. Exercise is said, in the CMI Report, to have been shown to improve ME/CFS symptoms (page 99) when the potential harm of exercise to ME/CFS patients has been clearly established. At best, if you take into account “research” that has not followed the scientific method, this form of “treatment” is controversial, with most experts agreeing that it is harmful. But it is definitely not a “treatment” recommended by credible ME/CFS experts. This ties directly into the diagnostic criteria for ME/CFS because exercise triggers a post-exertional worsening of symptoms—the hallmark feature of ME/CFS—which is why it is even part of the current woefully inadequate 1994 CDC Fukuda case definition. The CMI Report also opines that there are no biomarkers for ME/CFS (page 203) when the IOM-contract study is to determine whether there are biomarkers and what they are. Furthermore, the CMI Report opines that ME/CFS is not “an organic disease” (page 22).
Throughout the CMI Report, the IOM references ME/CFS and, in particular, its case definition, symptoms and treatment modalities. These are all used as critical building blocks in reaching the IOM’s conclusion regarding treatment of Chronic Multisymptom Illness. The case definition and symptoms and possibly treatments of ME/CFS are at the heart of the IOM Contract. The conflict here is obvious. The IOM is wedded to the CMI Report’s conclusions from just earlier this year that is based in part on its assumptions and conclusions about ME/CFS. That represents a substantial bias in favor of not contradicting its prior assumptions and findings and prejudices the IOM against adopting findings that are inconsistent with the CMI Report.
When you furthermore take into account the tremendous backlash the CMI Report has triggered in the Gulf-War-Illness population, including congressional hearings and serious accusations of the CMI Report being tainted due to an undue influence on the report by the Department of Veterans Affairs, it becomes even more obvious that the IOM cannot afford to backtrack on any of its findings in the CMI Report regarding ME/CFS because the CMI Report rests largely on those.
In a much less significant conflict situation, your office has determined that a conflict of interest exists if a member of an IOM committee under a DHHS/IOM contract has previously stated a position on the issues to be analyzed under the contract (Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health, regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments). In that case, the contract with the IOM was to study the adverse consequences of the Pertussis and Rubella vaccine. The committee member in question had stated his position on this issue in a deposition.
If a position on the contract issues stated in a deposition creates a conflict of interest for an IOM committee member, then surely when the organization itself, the IOM, has publicly stated such a biased position in an official report, the entire organization is unavoidably tainted by a conflict of interest.
The IOM might argue that their prior position regarding ME/CFS does not represent an organizational conflict of interest because the CMI Report was authored by a committee convened specifically for that report. That argument is not tenable because the CMI Report expressly states that the IOM along with the IOM committee assumes entirely all responsibility for the content of the CMI Report (page vii of the CMI Report). It cannot escape responsibility for statements by an IOM committee that the IOM, as an organization, has fully and unconditionally endorsed.
This bias towards the nature of ME/CFS creates an organizational conflict of interest that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS. The positions on ME/CFS previously stated by the IOM pre-judges any IOM conclusions at the very heart of the IOM Contract.
I specifically request that your office investigate this serious conflict of interest as soon as possible, so that government funds will not be unnecessarily expended on an unavoidably tainted contract.
I would be pleased to respond to any questions you may have.
Jeannette K. Burmeister
Open Letter to Secretary Sebelius by 50 ME/CFS Experts of October 25, 2013
Open Letter to Secretary Sebelius by ME/CFS Advocates of November 9, 2013
Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments
Senator Harry Reid, Majority Leader in the U.S. Senate
Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Adam Trzeciak, Inspector General, U.S. Government Accountability Office
Secretary of Health and Human Services Kathleen Sebelius
That’s an amazingly good and insightful letter, Jeannette! I hope that the powers that be take it seriously.
Thank you so much for expending all the effort it took to write that!
Excellent! I was just starting to dig into this. Awesome to tie it to the FAR in order to get in front of the OIG, and also awesome to find that previous COI issue!
Thank you so much for your intelligent, aggressive, herculean effort!!
NOW THAT IS RIGHT ON THE BUTTON!! EXCELLENT!!! IOM supplies their own evidence to be viewed and disected under the microscope; thank you for speaking UP to this, Jeanette!!!
Once again brilliant Jeannette! And thank you, I know the work that must have gone into this when you’re feeling as sick as you have been. Wouldn’t it be great to have THIS signed by a large group also to show how many are in agreement? Just a thought. Now can you rest? 🙂
What a great idea! The Office of the Inspector General is the one who should be investigating this fiasco of a contract–a waste of money if there ever was one. Thank you for doing this, Jeannette.
Excellent letter. Is there a petition for the rest of us to sign to back it up?
Anyone who is on Twitter, please tweet this:
@Sebelius #MECFS patient advocate calls for #OIG investigation of #IOM contract for bias http://tinyurl.com/OIGInvestig
we’ve experienced some serious petition fatigue and i don’t want to take away from the petitions that are already out there. let me think about it.
Good plan to sit back and think about it in terms of the other petitions and the serious petition fatigue–still little trickles coming in, but verrrrry slowly.
wow Jeannette! Who needs a lawyer!? So so brilliant … I have no words for it.
Thank you so much on behalf of the entire ME-community (also those who – at this moment – do not see or recognize the importance of your efforts. xoxo
hehe. i am a lawyer 😉
and thank you!
aha! that explains it! 🙂
psst, don’t tell anybody 😉
Yeah, who needs lawyers!
Every time I read one of your letters i can feel how much energy you have used to formulate such a powerful, insightful and knowledgable letter. I thank you for this x x Sarah, UK
Masterful, once again! Thanks!
Now this is a letter I can support. (I have no energy to repeatedly send long letters to unelected people who have no responsibility to respond.) This letter requires action! It’s a great first draft; make it shorter and more concise and get it to the media and Congress. It hits the target!
Well, this is more of an excellent final draft than a good first draft! But I agree a concise version would work very well for media and congress.
Hello and thank you, Jeannette. I just discovered your blog but look forward to reading and learning more. Given your legal knowledge, I wanted to ask if you think there could be anything in the federal court case earlier this year, Secretary of Health and Human Services 0, 04-1593V (Fed. Cl. 2013)?
A backup copy of the awarding damages (right lingo?) can be viewed here: https://www.courtlistener.com/uscfc/5s5B/id-v-secretary-of-health-and-human-services-0/?stat_Non-Precedential=on&stat_Relating-to+orders=on&court_ccpa=on&sort=score+asc&stat_Precedential=on&stat_Errata=on&page=43
And a random news article here: http://www.examiner.com/article/hepatitis-b-vaccine-has-been-ruled-to-cause-chronic-fatigue-syndrome#disqus_thread
I didn’t know if we-the-people are privy to any of the arguments in this case? HHS lost though. How do we know they aren’t seeking to re-define ME/CFS, so they (and SSA) can’t lose again? Could something in this case perhaps be used as part of the ME community’s conflict-of-interest argument? Thank you!
Ren, this is most likely not helpful for our purposes. A federal law set up something called the National Vaccine Compensation Program (VICP). This law sets up a fund financed by a federal excise tax on vaccines to compensate, on a no fault basis, damages from vaccines. Claims under this program are filed with the Federal Claims Court in D.C. There is typically no trial, so the Court determines that the alleged damages fall under the program and the case is referred to a special master who determines damages. Only very recently has a case gone to trial in the Claims Court. On November 8, 2013, a case involving Gardasil vaccine for HPV is going to trial. So the case you cite had no trial and no opinion on the issues regarding the Hep B vaccine and CFS, only the damages decision by the special master.
But keep digging, guys.
let me add to the above comment: there was no trial, but rather simply a claim under the no-fault law for damages due to the vaccine, which then went to a special master to determine damages, which resulted in the reported decision as to the amount of damages. The DHHS did not “lose” a case. That is simply the procedure under the National Vaccine Injury Compensation Program (VICP) established under the National Childhood Vaccine Injury Act of 1986. The Secretary of DHHS under the law must be named as the respondent in any such claim. They are not a defendant in any accepted understanding of that term. They are simply the one that must be named in any such claim under the program. Hence, a special master determining the amount of damages for the” CFS,” which followed receipt of the vaccine does not represent any loss by DHHS or finding of fault on its part.
Absolutely BRILLIANT letter! Thank you so much!
UMMM–WHAT a mine field!! Good detective work, Ren!!
Well done! Thank you so much.
Well done, counselor!
Excellent and very important find by you on page 22, that “CFS” is not an “organic disease”, but instead a somatoform disorder!! We need to keep this particular point prominent which so clearly shows their extremely strong bias!
That assertion was backed by a cite to Sharpe, 2001, btw. On the same page they cite Wessely for the proposition that GWI is just a bunch of non-organic (psychological) symptoms that do not even rise to the level of a syndrome, because there is no particular cluster of symptoms!! They say medically unexplainable symptoms from combat were previously known as “psychoneurosis.”
God, this is even worse than I thought. This is like Wessely circa 1990.
They as say Fibro and IBS are somatoform disorders with no organic basis. We need to rally the fIbro and IBS patients to help us (as well as the Gulf Veterans), because, the way this is going, they’re going to be the next victims of the full IoM treatment!!
I am a fibro sufferer, and I’ve been doing my best to spread the word! I truly believe that if this contract is fulfilled, that ME, Fibro, and many other “invisible illnesses” will be grouped into CMI. We can’t let this happen!
Once again, a government controversy (or anything for that matter), sadly, isn’t real/legitimate until it hits the media. If anyone has any contacts with national press covering government please help! Thank you!
Thanks, Ess. I don’t recall where I first learned about the HHS case, but at least one of the links I listed was first (I believe) shared by Ecoclimber on PR when the story first came out (I believe). So as much as I enjoy the praise, I can’t take credit. 🙂 I wondered about its greater context in regard to current events, but others planted and shared the seeds, so to speak. Cheers!
Don’t forget that, according to ecoclimber, every one of the nine numbered volumes of the GWI reports takes the same psychogenic-and-CBT/GET-as-the-treatments approach to “CFS” as this last GWI report to which Jeannette refers. So it’s not just a matter of it would make IoM’s one last GWI report look bad, but that all nine of their numbered GWI reports (there are additional unnumbered IoM GWI reports and I don’t know if they also say ME is somatoform disorder) would be made to look unscientific at best, anti-scientific and predatory at worst if the ME redefinition report didn’t say ME was a somatoform disorder.
Fwiw, I have seen volumes one and nine and they are both as Eco describes- “CFS” as medically unexplained or unexplainable symptoms to be treated with CBT and GET.
the inspector general is most likely not familiar with the history and the idiosyncrasies of our disease. let’s not give them an excuse not to take us seriously because they don’t understand what we are saying. we need a simple case/argument and we’ve got that. everything on top of that complicates matters and that hurts us.
i had to strike a balance between giving the OIG enough information to investigate without bogging them down with too much information. Remember that the inspector general is is a neutral party here. he’s not our enemy and we want to keep it that way. if, all of a sudden, he gets a ton of similar complaints. he will most likely be put off and that will definitely work against us.
Also, remember that the inspector general is unfamiliar with the symptoms and other specifics of our disease. if we give him too much to sift through, too many details, it may work against us because the main argument will get lost. sometimes, less is better. this is often hard to understand for lay people. but there are tactics involved here. and i did think it through.
The OIG has more than enough info to dig into this. I believe it would be a mistake to bombard them with more. there is no upside to going with more than the recent report, unless the other reports have significantly different, helpful statements by the IOM. in fact, going with older reports sets up an argument by the IOM that they have evolved as science has advanced. the report from earlier this year is by far our strongest argument.
True. Take your word for it, Counselor. Often, less is more, If we had to argue out in court or legal briefs and answer 10 points, our side would and could do it. But for now, it’s best to keep it simple and direct and deal with a modest agenda, as laid out by our the attorney here, which stick to the points at hand.
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Wow, Jeannette! I just read this from the Co-Cure message, and I’m overwhelmed with gratitude that you knew what the IOM report on GWI said and who to contact within HHS to request official attention to this conflict of interest. I’m also grateful for your artful articulation of the myriad problems with the contract. Thank you SO much!
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This is a fabulous letter, Jeanette, as are all your other letters. Thank you.
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