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First Meeting of New IOM Committee on Vaccines and Adverse Effects

Listen By Kelli Ann Davis

Today, Monday, April 20th  at 1:00 pm EST, the IOM Committee to Review Adverse Effects of Vaccines will hold its first meeting where representatives from Health Resources and Services Administration (HRSA) will discuss the official “Charge” and the public will have an opportunity to participate and issue a comment at the end of the meeting. 

Call-In Instructions: Please dial 1-800-508-7891 and the room number *1979783* to enter the meeting.  (Please note that the * star key is required before and after the room number. All phone lines will be muted during the meeting, but individual lines will be opened for the public comment session.) 

IMPORTANT: If you are participating via conference call and would like to speak during the public comment period, please send an e-mail with "PUBLIC COMMENT" in the subject line and your name and the phone number you are calling from in the body of the message to the project e-mail at vaccinesafety@nas.edu. The committee chair will alert individuals when it is their turn to speak and the conference call moderator will temporarily unmute the phone line so the committee and those on the call can hear the comment. (More information on the agenda HERE)

Background:

Health Resources and Services Administration (HRSA) has contracted with the Institute of Medicine (IOM) to review the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the Vaccine Injury Compensation Program.  The vaccines to be reviewed are varicella zoster vaccine, influenza vaccines, hepatitis B vaccine, and human papillomavirus vaccine.  Other vaccines could be added if additional funding is secured. The committee will author 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.

It is extremely important to understand the importance of this Committee and the impact that any consensus report could have in regards to cases in Vaccine Court.  In an effort to communicate our concerns to the IOM, I wrote an open letter to Drs. Fineberg and Salerno (HERE) and asked the community to submit comments to the IOM website (HERE).

In a follow up call with Dr. Kathleen Stratton on Friday, I was told they received many comments from the public in regards to our call to action!  Thanks to everyone who took the time to participate and GR will be implementing a more “formalized” call to action process in the coming weeks as we organize a grassroots network of warriors! 

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


Comments

Kelli Ann Davis -- To Kathy Blanco

"I was tempted to email my questions but figured it was like casting my pearls before swine. Apparently, I was right. So, the "open" meetings are just a farce heh? Why am I not surprised?"

Hey Kathy: You bet I wasn't about to let this Committee move forward without a challenge! Unlike you, I dive in when the stakes are high -- and this Committee falls into that category. (Think: 2004 IOM VSR Report -- you know, the one that still gets thrown in our face in every frickin news article!)

Considering the alternative -- sitting by and letting this Committee move ahead on the current course without a challenge and allowing them to issue another consensus report which can be used against families in vaccine court -- is quite frankly, a stupid move. (Sorry to be so blunt but that's the truth of the matter.)

If you want to bury your head (think Dan's piece today) go right ahead. But don't come on a piece I wrote to question my work on this issue.

Got it?

Kathy Blanco

I was tempted to email my questions but figured it was like casting my pearls before swine. Apparently, I was right. So, the "open" meetings are just a farce heh? Why am I not surprised?

I would love for someone to answer me, why they think ANY vaccine is safe, on a reduced schedule, later schedule, etc. Taking out one ingredient, putting another in. And how are you going to enforce that? How would that be marketed? And would that pas clinical trials? My answer is, hell will freeze over.

Then I found this litlte tidbit, which explains why our kids get numerous ear infections with vaccines soon after....and probably why a child who gets 9 different viruses in one day can essentially have chemical castration of the brain, by immune dysfunction.

Evidently there is a study published in the Journal of Infectious Diseases
which shows that the measles vaccine (yes, the single measles-the one that
most folk believe is safe if given alone) interferes with interferon
production. Big deal, you say?

Well, turns out interferon is a necessary chemical produced by lymphocytes (a
type of white blood cell). Interferon assists the host to be resistant to
infection and interferon's production is stimulated by infection with a
virus. Production of interferon is a good thing because its purpose is to
protect the body from superinfection by some other micro-organism.

In the study, one-year-old infants were vaccinated with the measles vaccine.
This caused a huge drop in the level of alpha-interferon produced by
lymphocytes. Not only that, this harmful reduction in interferon production
lasted for an entire year, at which time the experiment was ended.

Conclusion: The study showed that the measles vaccine produced a significant
long-term immune suppression.
J Infect Dis. 1989 Sep;160(3):543-4
: J Infect Dis 1988 Dec;158(6):1386-90 Related Articles, Books
this study showed that measles vaccine produced a significant long-term
immune suppression."

Theresa Cedillo

Thank you Kelli Ann and everyone who spoke! And thank you for the updates. I would LOVE to hear Jim Moody speak at one of these.

Kelli Ann Davis -- FIREWORKS AND THE MUTE BUTTON

Well, there you go! Now we have an idea of how "open" they are to the public.

Comments? No problem. An actual question that deserves an answer??? FORGET IT!

Here's what happened:

They had all of us muted while they waited for Rita Palmer, et.al.to show up. (It was almost like they were paranoid to end the meeting without giving them a chance to make a comment. So the Chair kept checking back every few minutes to see if they were on the lines and unmuted all of us to find out.)

Meanwhile, a bunch of us were e-mailing each other basically saying how lame it was they kept us on mute while we waited for two other parents to "show up"!
So, I decided to e-mail the IOM and ask why.

Here's the 1st e-mail I sent:

----- Original Message -----
From: Kelli Ann Davis
To: Vaccine Safety
Sent: Monday, April 20, 2009 11:14 AM
Subject: Re: NEED WEBINAR INFORMATION ANNOUNCED TO PUBLIC

“Why go on mute?? People coming on will think the meetings over. Why not take the time to discuss the possibility of having Tom Powers and/or Jim Moody present during the next meeting? Why not allow folks who are waiting on the lines now the opportunity to keep speaking?”

(No response...yet the Chair kept coming back on the line looking for Rita, et.al)

A few minutes later, my 2nd e-mail to the IOM:

“If you want to hear the public, why mute us and remain silence? Let's get some feedback from the Committee on some of the suggestions for transparency, etc.”

(No response)

Meanwhile, Sallie Bernard sent a great question for the Committee (and sent it our private thread as well) so when the Chair came back (yet AGAIN looking for Rita, et.al) I interjected myself and posed Sallie’s question (which was a zinger -- remember, she's "Blaxill in a dress"):

"For the HRSA representative: please respond to the comment on why the IOM was asked to review AEFIs when the ACCV already has a set of guiding principles and a recommendation for a committee to review this topic?"

Well, you would have thought I was asking for the combo to the US Mint. SILENCE. I wasn't sure I was being heard until a few other parents chimed in and told me they could hear me. And then another parent on the line said she'd like the answer to Sallie's question as well.

The Chair mentioned something about it being raised for the ACCV at their next meeting, and THIS meeting was for public comment (or something along those lines) and so I knew the full Committee could hear me. So I reiterated to them:

"I represent Generation Rescue, Jim and Jenny’s autism organization, this is a public comment period, HRSA relayed the charge to the Committee, and now I'd like an answer to Sallie's question."

Chair: "Someone will get back to you privately."

Me: "Again, this is a public comment time, and I'd like the HRSA official to respond PUBLICLY to this question now."

Suffice to say, I got muted in double time.

Guess this "public feedback with open lines" ain't so grand after all? (At least from an IOM perspective :-)

PS...Did I tell ya my name means "bold warrior?" Shy? NAH!

Angie

For those that spoke! GREAT job everyone! I was the email the moderator read (too loud to hear over our kids so I asked her just to read my email)...

I really want to know exactly what Clive from IOM meant when he said "extensive processes are used related to appointment" after Kelli and Teresa asked how this committee was choosen(thanks for letting the cat out of the bag Kelli)...exactly what ARE the 'extensive processes"...isn't this the same kind of 'lingo' used toi distract us about all of the "extensive safety studies" that have been done on vaccines? Gosh "Do they really think we at that stupid?"...

I actually missed the beginning (I walked away from the phone when everyone was saying their name and intrests and only half listened, it was just too egotitical for me :), so if anyone has a list (or knows a link to find a list) of the committee members?

Did anyone get anthing from them saying they are woeking towards transparacy? I mean, if they did want that, shouldn't they be doing a public deliberation, at LEAST where we could just listen in live, AND also download at anytime from their site? Hmmm...one can only wish right? Anyone sense they will/will not?

Thanks again for everyone who spoke! Great job!

Angie
Mom to Ethan, Alex, and Megan

Katie Wright

Many, many thanks to all the Moms who spoke. You were all so amazingly articulate,courageous and well informed. In speaking about your child's descent into autism you also spoke for my son. Thank you.

nhokkanen

Uh-oh, the moderator used the power of the MUTE button to cut off Kelli and other parents who chimed to support her request.

Over now -

The Powerpoint will go up on this website later today:
http://www.iom.edu/vaccineadverseevents

Send your comments to:
vaccinesafety@nas.edu

Lisa Hunter Ryden

Thank you Kelli Ann, Theresa, Teri Poling and other who were so eloquent and spoke on our behalf.

Tanners Dad

Kelli Ann you rock. I wish I could see video of the room.

Tanners Dad

Did anyone get the website with the graphics?

nhokkanen

Kelli just said that HRSA is conflicted. Thanks, gal!

nhokkanen

"We are in dire need of updating this [vaccine injury] table."

Well, that's an encouraging statement....

Lisa in Texas

Wow--the first 10 minutes they want to make sure we understand the very high credentials of all of the panel and reiterate that there is no connection between vaccines autism. I can hardly wait for the next 3 hours!

dolores jackson

response to paula -p

You can view/search Vaccine/VAERS data (as well as drug adverse event data) here:

e.g., here's a search for VAERS data mentioning influenza:

http://www.fdable.com/vaers/query/ba1ace9fcfaf

paula p prfit merckelous

Parental anecdotal evidence is used in this study for trivalant influenza vaccine. Hmm I guess the parent report system street only runs one way.
Immunogenicity and reactogenicity of 1 versus 2 doses


Immuno
genicity and reactogenicity of 1 versus 2 doses
of trivalent inactivated influenza vaccine in vaccine-naive 5-8-
year-old children
- Neuzil K.M., Jackson L.A., Nelson J. et al.
[Dr. K.M. Neuzil, PATH, 1455 NWLearyWay, Seattle, WA 98107,
United States] - J. INFECT. DIS. 2006 194/8 (1032-1039) - summ
in ENGL
Background. Two doses of trivalent inactivated influenza vaccine
(TIV) are recommended for children9 years old receiving vaccine
for the first time, but compliance is suboptimal. This study assessed
the need for a second dose of TIV in this age group. Methods. In
this prospective, open-label study, 232 influenza vaccine-naive 5-
8-year-olds enrolled in a health maintenance organization received
2 doses of TIV in fall 2004. Serum for antibody titer measurement
was obtained at 3 time points (n = 222). Parents completed diaries
for 5 days. Results. Both doses of vaccine were well tolerated. The
strongest predictor of a protective antibody response (1:40) after
1 dose of TIV was baseline seropositive status. In multivariate
analysis adjusting for age, sex, and baseline serostatus, the proportion
of childrenwith protective antibody responses was significantly
higher after 2 doses than after 1 dose of TIV for each antigen (P



.001, for A/H1N1; P = .01, for A/H3N2; P .001, for B). Age
and sex were not independently predictive of a protective antibody
response. Over one-third of children had antibody responses1:40
for the type B vaccine component, even after 2 doses. Conclusions.
The present study supports the need for 2 doses of TIV in 5-8-yearolds
receiving TIV for the first time. Efforts to increase compliance
with the 2-dose recommendation are warranted. © 2006 by the

Infectious Diseases Society of America

enter picture of one way

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