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Is the IOM in Compliance With FACA?

Toe the line By Kelli Ann Davis

If you’ve been reading Age of Autism on a daily basis over the last week, then you’ve most likely read several of my pieces regarding the new IOM Committee to Review Adverse Effects of Vaccines which Health Resources and Services Administration (HRSA) funded for $1.7 million in September 2008.  And if you are an avid, daily reader of AoA and have been following the Interagency Autism Coordinating Committee (IACC) meetings over the last 2 years, then you know about the multiple FACA violations (one example here (HERE) which finally cumulated in the January “surprise revote” to withdraw two vaccine studies that had been inserted into the Strategic Plan at a previous meeting.  At that time, Generation Rescue announced it had consulted with a prominent DC law firm to assess possible legal recourse for the multiple violations and that process is still on-going. (HERE)

Ever since the Subcommittee on Investigations and Oversight held the 3 ½ hour FACA meeting last July, I’ve noticed a lot of changes in how agency meetings (NIMH, NVAC) have been conducted (open telephone lines, comment boxes for instant feedback, posted transcripts, updated websites, etc) until of course, the IACC debacle in January.   
So imagine my surprise a few weeks ago when I heard FACA and the IOM mentioned in the same sentence.  I wrote about it last week (HERE) and  purposely highlighted the following 1997 FACA amendment which establishes criteria that the IOM must follow in order for government agencies to use any of their advice or recommendations:

• The Academy shall make its best efforts to ensure that (A) no individual appointed to serve on the committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable, (B) the committee membership is fairly balanced as determined by the Academy to be appropriate for the functions to be performed, and (C) the final report of the Academy will be the result of the Academy's independent judgment. The Academy shall require that individuals that the Academy appoints or intends to appoint to serve on the committee inform the Academy of the individual's conflicts of interest that are relevant to the functions to be performed.
In an effort to find out more about this new IOM Committee, I accessed the transcripts from the November 18, 2008 Advisory Commission on Childhood Vaccines (ACCV) and was quite surprised to read the following statements by Dr. Kathleen Stratton:

• “The Institute of Medicine works under the processes of the National Academy of Sciences, which have developed over the years to protect the scientific integrity of the work. That has to do with the peer-review process and it has to do with some of the exemptions that we have by Congress from the Federal Advisory Committee Act to allow committees to deliberate, as well as our processes for how we select the committee members. We can talk about some of that.”

Sure, there were exemptions regarding the IOM and that is why FACA was amended in 1997, BUT the preceding FACA paragraph is in effect and must be followed if the government intends to use any of IOM’s advice or recommendations.  And since HRSA is contracting for “a consensus report with conclusions on the evidence bearing on causality and the evidence regarding the biological mechanisms that underlie specific theories for how a specific vaccine is related to a specific adverse event” my guess is they are going to want to use that Report for determination decisions in VICP.

FACA – (A) no individual appointed to serve on the committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable.

• “The Academies’ official policy is that only current affiliations matter. Because this was such a controversial and sensitive issue, the Academies looked at past relationships and considered them.”

The following two individuals definitely have “current affiliations” that create a conflict of interest problem and they need to be removed from the Committee immediately since there are plenty of other qualified individuals and so therefore, the current appointments are not “unavoidable”:

Huge A. Sampson, a vaccine patent holder; and Anthony L. Komaroff, the founding editor of Journal Watch which is produced by the publishers of the New England Journal of Medicine – a publication which receives advertising funds from pharmaceutical companies.
Although conflicts of interest regarding membership on the Committee were discussed in detail during the ACCV meeting, I found this following statement by Dr. Stratton to be quite troublesome as well:  
• “There is the possibility, should resources be found, whether from the government or from private sources -- and we are talking to some nonprofit foundations -- of getting additional funds to be able to include in the review other vaccines of importance to the program.” 

Private sources?  Non-profit foundations?  And what exactly would this additional funding provide?

• “Should that money become available within some reasonable period of time, they can be added to the task of the committee. I believe the order in which the program feels they have needs is meningococcal, hepatitis A, DTaP and others -- what that really means is currently administered tetanus toxoid-containing vaccines, DTaP being one of vaccines of great interest. The last time we worked, the whole-cell vaccine was what was being used. So it would be DTaP, Tdap, DT, and tetanus toxoid. So that “and others” means any tetanus toxoid-containing vaccine -- as well as MMR.”

(Question: what exactly does $1.7 million cover if the only expense the IOM has is to fly, feed, and lodge the Committee members during meetings?)

FACA – (B) the committee membership is fairly balanced as determined by the Academy to be appropriate for the functions to be performed.

• “The specific adverse events that the committee will review have not yet been determined. That will be determined -- and Geoff or Rosemary would have to answer the process questions about this -- those will be decided by HRSA or the compensation program, with advice from the Advisory Commission on Childhood Vaccines. Obviously, they are to be adverse events that are of importance to the program, determined by the nature of the claims that you have in front of you.”

Since there are thousands of autism cases “in front of” the Vaccine Court and autism is a major concern cited by parents in their refusal to vaccinate, I suspect it will come up multiple times during Committee deliberations – even if it doesn’t end up on the official adverse events list.  Therefore, incorporating individuals who view, study, and/or treat autism as a whole-body biological disorder is not only advisable but falls within the parameters of FACA.

Additionally, her following remarks further highlight the need for balance in Committee membership and adherence to the FACA guidelines since the overwhelming nature of claims in front of the program are autism cases:     

•  “With regard to the input about adverse events, I think we have the general nature of the types of claims that are in front of the program and the types of adverse events that are of concern to the program and to parents and to vaccine recipients. So I think that we can put together a committee with the proper scientific, medical, and technical expertise, without knowing every single adverse event that is going to be in front of us.”

• “Our first work will be general in nature, which is this general framework for thinking about biologic mechanisms. So, although just to be settled I wish I knew now what those adverse events were that the committee was going to ask to be reviewing, it’s not stopping us from moving forward as we need to.”

How can you possibly pick the best Committee members for the “functions to be performed” – as FACA outlines – if you aren’t clear on what adverse events are to be studied before you comprise the roster?  Seems to me you need to specify the adverse events first, and then pulls the Committee together. 

FACA – (C) the final report of the Academy will be the result of the Academy's independent judgment.

• “I think there is a lot of work to be done to make that part of the report clearer. The process for identifying the literature and how it’s weighed and how it is reviewed -- we could be more transparent about that. After 1994, when the 2001 and 2004 immunization safety review series began, I think that committee became more transparent in terms of the words they used to describe biologic mechanisms. But it could definitely be improved upon -- the language that we use, the way we describe how that literature is collected and reviewed, and what is considered to be important in understanding the theory.”
And yes, I agree.  The Report process should be transparent and having a public comment component to the report drafting phase would be a logical step to ensure this happens.  In addition, terminology and definitions (biological mechanisms vs. biological plausibility for example) should be well established beforehand and in accordance with the legal standard used in the VICP.

In conclusion, it is my hope the IOM will seriously consider the FACA issues raised in this piece and incorporate Generation Rescue’s suggestions as outlined in our original letter to Drs. Fineberg and Salerno last week. 

Please read the article and follow the directions for submission of comments (HERE)

Thanks, I’ll keep you posted on developments.

Kelli Ann Davis is the D.C. Political Liaison for Generation Rescue   


Theresa Cedillo

Thank you Kelli - I just left my comments.


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