This Little Piggy Crashed the Market
Dr. Bernadine Healy on AAP, Paul Offit, Vaccine Schedule and Safety

IOM Meeting of National Vaccine Plan Discussing Safety Issues Meets Today

Listen Today, Tuesday, April 14, 2009 is the Fourth Stakeholder meeting of the IOM Committee on Review of Priorities of the National Vaccine Plan in Washington, DC.  The focus of this meeting will be Goal 2 of the National Vaccine Plan: Enhance the safety of vaccines and vaccination practices. For more information, and to view the agenda, please see the project website at: HERE 
This meeting will be audio webcast in real-time. To listen to the webcast, visit HERE and click "LIVE WEBCAST" (top-center of the webpage) on Tuesday, April 14th. The link will be activated at 8:00 a.m. EST and will be available until the meeting is adjourned at 5:30 p.m. Registration is not necessary for the webcast.

Those listening to the webcast may submit questions or comments during the meeting via email to Vaccine Plan. The committee chair or IOM staff will read the questions/comments to the meeting participants. Due to time constraints, questions most relevant to the day’s discussion (Goal 2 of the National Vaccine Plan: Enhance the safety of vaccines and vaccination practices) will be addressed first.
Registration for this meeting will close COB Friday, April 10; however, registration is not necessary to attend the meeting. As with all IOM meetings there is no charge to attend. Registration is not necessary to listen to the webcast.
Contact: Vaccine Plan
Website: HERE

****This IOM Committee is focused on addressing the National Vaccine Plan and should not be confused with the NEW IOM Committee that has been conveyed to Review Adverse Effects of Vaccines which I’ve written extensively about over the last two weeks. ****
Background about the National Vaccine Plan:

The NVPO, part of Department of Health and Human Services (DHHS), is coordinating the update to the 1994 National Vaccine Plan and DHHS agencies and other departments are contributing to the plan with advice from the National Vaccine Advisory Committee (NVAC). 

There are many important stakeholders whose input is needed.  IOM has been asked to get input from scientific, medical, public health, and private sector experts (meetings are open to the public).  NVPO will conduct a separate and extensive process to obtain input from the general public. 

The purpose of Stakeholder Meetings will be to: explore topics related to the five major goals of the draft National Vaccine Plan and; react to draft objectives being developed by DHHS agencies.

Overview of the Study Process: Charge to the IOM Committee

1. Review the 1994 National Vaccine Plan and then provide guidance on the development of the update to the plan.

2. The committee will hold five information-gathering meetings with stakeholders to explore areas of the developing plan and prepare a report about priorities in updated National Vaccine Plan:

• On July 24, 2008, the First National Stakeholder’s Meeting was held in Chicago, Illinois.

• On December 1, 2008, the Second National Stakeholder’s Meeting was held in Irvine, California and I wrote about it here:  (HERE)

• On February 2, 2009, the Third Stakeholder’s Meeting was held in Washington, D.C.

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



I'm curious to see how the IOM and Merck will try and weasel their way out of this little predicament. It might be a little tough to take back the statement that Merck had access to VSD data without permission. Great catch Kelli, and thanks for all you do to help all of our children.


Thank you so much to Kelli Ann for the up-to-the-minute reporting on the questions and answers (and lack of answers) and other issues. It has to be a headache to put oneself on the line and come up against that brick wall over and over but this amply demonstrates the flaws in the process.

Alison MacNeil

How dare they say (in regard to getting more peds to report to Vaers) 'the plural of anecdotes is not data. Everyone of the thousands and thousands of our children are both 'anecdotes' and they certainly are data and they are also our total heartbreak.

Kelli Ann Davis -- IOM's Response on Audio Files for Meeting

Ms. Davis,

The audio files for today's meetings should be available for posting by Monday, and the transcript will be placed in our Public Access Records Office ( when it becomes available in approximately 4 weeks.

I understand that Dr. Iskander will reply to your question in the next couple of days.

Thank you.

Alina Baciu

And my response back to the thread:


Also been told that a few folks from our community are also recording this meeting via Real Player but of course, I'd appreciate a copy of the audio file as soon as possible.




Well, my science question didn't get asked this time. It would have been out of place in that panel anyway. I don't know what the point of that one was.

Kelli Ann Davis -- Welcome to La La Land

This current conversation is ridiculous. There is no way you can continue to keep "uptake" and "safety" under HHS, period. Pretending that NVPO won't be "calling the shots" and directing everything from the top is not realistic as indicated by NIMH Director Tom Insel during the January 14, 2008 IACC Meeting:

I think one thing that didn't get discussed when we voted on this is a problem that didn't occur to me until after the meeting, which is that this is perhaps the only issue that we dealt with that is now part of litigation that involves the department, and it's a HRSA issue and I'm concerned about the optics, so the optics of having HRSA vote on issues related to autism and vaccines when they have a large court case, the optics of having people who have, could be perceived to have, um, or to represent those with a financial investment in this issue. It takes it out of the realm of a scientific question, a research question, and it raises the possibility that some could see whatever comments we make as being biased by nonscientific issues, and I understand that's a risk in lots of things that we do, this one really feels, since this is a court case that is soon going to become public, and I think it's fairly close to a large omnibus effort, um, I think that this one really does represent some jeopardy for this process, for this committee, almost any way in which it comes out. If we say, yes we think it's important to look at this, and to provide additional information, it implies that we believe that there is a relationship between autism and vaccines, and it suggests, um, that, um, in some way this runs opposite to what HHS may define through the HRSA process. If we say we don't think that this needs to be pursued it opens us up to the possibility, at least the optics, that we were trying to keep HRSA from having to go down this road legally.


I was excited about this panel. I thought they were going to talk science, but they are talking about nothing. Just themselves.

Kathy Blanco

Seriously addressing this issue would call upon people to not lie about their are you going to do that? Especially when their careers, jobs and reputations, and even jail time are on the line...get real people, there is no safe vaccine, that is the real issue. The only way we can overcharge this industry is to give the fright of their lives, and that is, that we are not beholden to their products, in any form, on any schedule, or any "so called" green vaccine. How do you make the viruses safe folks?

There is no incentive to tell the american people the real story. Stock holders perhaps need to be told the real story (did we ever think about that one?), shouldn't we be focusing on their reliances of a "good story" about vaccines/pharmacetuical products worth, OR NOT? Routinely, they lie about the side effects that are "tolerable" to risk? We are the tolerable, acceptible losses folks, get that in your heads, quick.

I don't put my stock holdings (the few that they are), in industries that harm our environment, sicken our children etc. That means I am not that wealthy, because of all the industries that does sicken people, pharma is number one, food corporations number two, and chemical and pesticide corporaitons number three.

Why aren't we focusing on the securities holders in these companies? Why don't we send them what they are promoting? An AUTISM EPIDEMIC, A SICKNESS and EUGENICS MOVEMENT? A picture of our children and the hell we have been through? After all, I don't think our government runs us, it is our multi national corporations (our founding fathers would be rocking in their graves).

Maybe then, when things start collapsing will the real truths be told. Of course, who am I to say that would ever happen (hell will freeze over). This industry is too enboldened/philosophised/mezmorised into human psyche by deliberate secretive constant lies, and cemented to political wranglings and underpinnings of national security,..let's get real... it won't ever be unraveled...and all the work we have done...will barely scratch the surface while we have a handful of children at home who are damaged. Don't you think THEY know we are caught up in the rush of autism? How that debilitates the family in general? That we don't have time to protest? That we don't have the resources? That we don't represent a majority voice or that our runs and walks are only blips on the scheme of things? That we have no way in heck, to sit in their financial board meetings to tell them they are no better than Herod of old?

I say, the only issue is our uncourageous stance that vaccines have value in our society. If you believe different, that is your right, but my right/science is equally as weighty if not proportionally true. I am sorry for our population, still thinking that someone, just someone will listen to us? The only thing they listen to is BOTTOM LNES and profit margins.

I guess I will be slammed for this, but you have a right to slam me for thinking my is from years of experience with these people.


Kelli Ann,
Thank you so much for all your work on this. I can't listen to the call today, but when you are able to get info on the transcripts (audio and written) please post it. I would love to be able to go through it later. Also, transcript info on prior stakeholder meetings.

Kelli Ann Davis -- Panel 3 Pitts "Parents" vs "Scientists"

My Question on Panel 3 (where they are trying to pit the "parents" against the "scientists"):

Question: Do you consider Bernadine Healy a "lay person" when she says the proper safety studies haven't been done in regards to the link between autism and vaccines?

Bottom Line: We are NOT idiots because we are parents -- many of us have degrees in science, medicine -- and the message that there is somehow a "gut" vs. "science" argument going on is irresponsible and will do absolutely nothing in terms of seriously addressing this issue!

Kelli Ann Davis
DC Political Liaison
Generation Rescue

PS....This is NOT an "emotional" issue -- it is a "scientific" issue and needs to be addressed as one. Please stop pitting the "parents" against the "scientists"!!

Kelli Ann Davis -- IOM Response to My E-mail to Fineberg/Salerno

Response from IOM on e-mail to Fineberg, Salerno, et. al (bottom up):


Patricia Saddier specifically said that Merck had already started accessing the VSD in regards to a Rotavirus project prior to rec'ing permission and then had to stop when they didn't get it (for whatever reasons).

THAT is the point. I'd like the transcripts to this meeting as soon as possible since there are conflicting "versions" of what was said. I KNOW what I heard and it stood out because access to the VSD is a HUGE issue for our community.

In addition, I'd like to have the audio transcript as soon as possible. Can you tell me when both of those will be available to Generation Rescue??

Thank you,

Kelli Ann Davis
DC Political Liaison
Generation Rescue

PS...I'm including Stan Kurtz (President of Generation Rescue) and JB Handley (Co-founder of Generation Rescue) to this thread.

----- Original Message -----
From: Geller, Amy
To: Kelli Ann Davis
Cc: Fineberg, Harvey ; Salerno, Judith ; Stratton, Kathleen ; Matthews, Sandra ; Evans, Jody ; Dr. John Iskander ; Vaccine Plan
Sent: Tuesday, April 14, 2009 10:53 AM
Subject: RE: Merck Uses VSD WITHOUT Prior Approval

Dear Ms. Davis,

As you heard, we raised the question during the public comment period and Dr. Iskander responded.

It seems to me that there was a lack of clarity in the comments that were made by the panelist from Merck. Her subsequent statement was that Merck was told by VSD that they should not do a study at a VSD site because that site was already participating in a similar VSD study, and that therefore Merck had to approach a different health plan.

It is my understanding, and I imagine Dr. Iskander from the Immunization Safety Office could clarify even further, that Merck does not have access to VSD data and that pharmaceutical companies do not have access to VSD data. Vaccine Safety Datalink sites are housed in HMOs that may undertake any array of other studies, including phase IV studies required by FDA of industry sponsors, but those studies are different and have nothing to do with VSD studies or data.

Thank you.

Alina Baciu

Kelli Ann Davis -- My E-Mail On VSD Question to Fineberg and Salerno

I just sent the following e-mail to the President and Executive Director of the IOM with Kathleen Stratton and John Iskander carbon copied:

Drs. Fineberg and Salerno,

I've submitted this same question 3 times to the IOM Committee on the National Vaccine Plan to have answered and they've managed to "hedge and haw" around it without answering a basic, simple question:

How did Merck manage to access the VSD BEFORE getting the prior, proper approval?

I'd like Patricia Saddier (Merck) to explain how they did that since she originally brought it up during Panel Session 2.

Thank you for helping to get clarification on this question BEFORE this Committee adjourns for today.

Kelli Ann Davis
DC Political Liaison
Generation Rescue
Jenny McCarthy's Autism Organization

Kelli Ann Davis -- Panel Back Peddles on My Question -- AGAIN

To the IOM:

Again, they didn't answer the question: HOW DID MERCK ACCESS THE VSD WITHOUT PRIOR APPROVAL??? (I know they do studies from the VSD, but the point is they DIDN'T HAVE PERMISSION to access the database BEFORE they went in)

I'd like the MERCK representative to answer the question since she brought it up.


Kelli Ann Davis
DC Political Liaison
Generation Rescue

Kelli Ann Davis -- MERCK Back Peddles on My Question



Patricia said they were conducting the study with the VSD without permission and then had to stop because they didn't get it.

Please re-ask the question because this is not going to sit pretty with our community!


Kelli Ann Davis
DC Political Liaison
Generation Rescue

Kelli Ann Davis --  My Question to IOM on Merck VSD Use

According to Patricia Saddier (Merck) they used the VSD before getting prior approval for a study on Rotavirus and when they didn't get the approval, they had to stop the study.

Question: How did a pharmaceutical company get access to a government funded, database without going through proper approval channels??

Kelli Ann Davis
DC Political Liaison
Generation Rescue

PS....I would like this question raised and addressed during this meeting. Thank you.

Kelli Ann Davis --  MERCK Uses VSD Without Permission

Patricia Saddier/Merck:

“Which signals deserve to be studied? expeditions…..large scale databases not large enough to look at rare adverse effects….VSD….started working with VSD on Rotavirus study before they got approval and then had to stop…"

I thought I was going to roll out of my chair!!! Merck used the VSD without prior approval!!!!

Yet, we get the 3rd degree on privacy issues.

Oh and Merck....EVERY signal deserves to be studied!!!!

Kelli Ann Davis --  A Huge Medical Experiment

Tracy Lieu (Harvard, VSD): “No data mining going on….reasons for it….HPV….cautions…don’t want to produce “false signals lots of work but nice for employment issues”…..long-term safety studies…..have to wait for many years….start with hypothesis first…..”

So there you go. It’s official – the federal government is conducting a huge medical experiment on the population.

Kelli Ann Davis --  CDC -- "Vaccines not Drugs"

Art (Chair of Panel 2) made a remark:

"Don ‘t know if we know about long-term safety of any vaccines”....

John Iskander -- CDC countered by stating:

"the state of science of vax safety continually improving” “overall better in terms of breathe of study and potential to do more studies” “at same time vaccines are different from drugs because of 'mandating' and they are “different medical products”

Kelli Ann Davis --  An Individual on Panel 2 Conducting Vaccine Study for Pharma

Art -- Chair on Panel 2

Brought up a few questions they will address because of "perception of adverse events":

HPV, Vax/Unvax (he already brought up that there may not be enough children to study)

Hey, one guy on the panel is working on a vaccine study for a pharma company but heck, no problem - yet not one individual representing a vaccine injured child with autism on the panel. UNBELIEVABLE.


Excellent point Jack. My comment was probably too long but I had to comment on pediatrician education which is disgustingly inadequet. I couldn't believe the comment that they needed to be educated because they didn't know who Wakefield was! Basically they were saying they need to educate pedis in order to debunk Wakefield. That's their priority???? UMMMMM, how about educating them in recognition, and treatment?????!!!!


Great question by Vikki Debold.

Of course, they won't test vaccines in at-risk populations because they know they might get a bad result.

If it is unethical to do vaccine safety trials on premature infants, why are we then vaccinating them as if all was normal???

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