Written Testimony for Hearing on Varicella Vaccine Mandate:
September 14, 2000
From Connie Roux - IVAC Regional Coordinator

Dear Illinois Board of Health Member,

Whenever I've spoken with public health officials about the process of mandating vaccines, I've been assured that the process is rigorous, thorough, completely scientific and involves many thoughtful experts on both the federal and state levels.

My investigation of the process and the policies surrounding it shows quite the opposite. The process is 1) Money driven 2) Replete with conflicts of interest, on all levels and 3) Totally neglectful of the best interests of children. The science is sloppy and incomplete. The only rigorous part of the process is getting a new vaccine through the licensing phase as soon as possible and lobbying policy makers to make it mandatory.

I had assumed, as do most parents, that anyone on an advisory board, regarding vaccines, would feel that by accepting the advisory position, it is his/her solemn duty to seek out the results of pre-licensure studies on the vaccines; to check the statistics of the Vaccine Adverse Event Reporting System (VAERS) to determine what adverse reactions to the vaccine have , so far, been reported; to check the vaccine package inserts in order to study the vaccine ingredients ; to look at what areas the manufacturer studied and neglected to study, and what they reported and neglected to report: and to openly question and debate his/her findings.

What I found is that people chosen for advisory boards are most often chosen by the person they are supposed to advise. Very often those people have financial ties to the manufacturers of vaccines . Individual members generally do NO investigation and reporting of available information on the vaccines. Without question, they rely on the pro-vaccine propaganda we've all received over the years, and basically just function as "yes men" for vaccine manufacturers and unelected public health bureaucrats.

The conflicts of interest and lack of study of vaccine processes and effects, by advisory committees , is one of the most troubling aspects of the process.

I have attended and spoken at many public hearings. I have listened to the decision-making process of the Illinois State Board of Health when discussing and making final recommendations concerning the 1997-1998 Immunization Hearings. I am constantly appalled by how decisions made.

For example: 1) One board member,after supposedly having read all the written testimony , made the statement that he and his nurse-wife agree that chidren should receive all vaccines as young as possible, because the older they are, the harder it is to hold them down. 2) The Board of Health was to discuss the hearings and make recommendations to Dr. Lumpkin. Dr. McGee said, "Well, let's ask Dr. Lumpkin what he thinks", and of course, that's precisely what they advised. 3) The Board of Health was discussing whether or not to make a public statement that " when parents do not have their children vaccinated, it should not necessarily be considered a sign of neglect or abuse". Dave King, the keeper of the notes that day "inadvertently" deleted the statement. Dr. McGee said, "Oh well, I guess our decision is made. It wasn't that important, anyway.

Actually, It was important to alot of people, since the parents of an unvaccinated child in an emergency room is automatically , as hospital policy , in many hospitals, reported to the Department of Child and Family Services (DCFS).

More recently, I was appalled at the flip answer of Dr. Lumpkin to Sherry Wied when she asked him what studies he had read that convinced him that the varicella vaccine should be mandated. He answered, "None !. What the CDC and FDA recommend is good enough for me." What? No chance for an original thought there?

Dr. J. Anthony Morris, a staunch believer in vaccines, who spent 30 years processing vaccines for the government said, "......I have met no one in government who has the wisdom to mandate to another person what that person should do with himself or his children.......When I sat in the halls of those concerned with setting policies for vaccination procedures , I was never impressed that there was a repository of wisdom in the room."

Summary for Basis of Approval (SBA)
for Varicella Vaccine

The Summary for Basis of Approval (SBA) for the varicella vaccine, showed some interesting problems with the data.

1) All data on animal testing is withheld. (This data is not always withheld.)
2) Data concerning the safety of the vaccine vs. a placebo, in humans,
is withheld.
3) There is efficacy (how well the vaccine prevents the disease) data, at length:
safety data is concealed.
4) The long-term effects of the vaccine are not addressed.
5) Analysis of adverse events is limited to clinical complaints over a 42 day
period, of only 10,000 vaccine recipients.
6) The vaccine is stated to be safe, but
a) post-vaccine fatigue was reported by 27.4% of children and 29% of
children and adults.
b) post-vaccine chills reported by 4.8% children; 8.7% adolescents
and adults.
c) disturbed sleep: 24.1% children and 15.6% adolescents and adults.
d) abdominal pain: 8.2% children, and 7.7% adolescents and adults.
e) eye complaints: 6.2% children and 8.5% adolescents and adults.
7) The SBA found evidence that "vaccine recipients may transmit the
attenuated strain of varicella virus to close contacts". They urge vaccine
recipients to avoid contact with ....non-immune pregnant women for
several weeks".
ACIP's recommendation seems to push the interests of the vaccine maker and states the opposite: that children "living in a household with a susceptible pregnant woman should be vaccinated."

The Vaccine Adverse Event Reporting System
(VAERS) statistics show:

So far, the use of varicella vaccine has been fairly limited. Even so, between 1995 and 1999 ,VAERS has received 9,018 reports of adverse reactions, including some deaths.
Since the CDC admits that only about 1% of adverse reactions is reported, this translates to over 900,000 adverse reactions , with limited usage. Yet this is termed a very SAFE vaccine? I don't see it that way. Have there been over 900,000 children admitted to hospital , in that same time period, with Chicken Pox disease? Certainly not.

Pharmaceutical Companies earn billions of dollars in excess profits, and spend millions to lobby and buy special access to legislators and vaccine decision makers.

I have enclosed a chart demonstrating how much the top 10 drug companies spent to buy congressional access in the years 1997-1998.
Examples: Pfizer: $3.3 billion in profits; $19.8 million to buy congress.
Merck: $5.2 billion in profit: $10.6 million lobbying congress.

When a vaccine manufacturer buys enough influence to have a vaccine MANDATED, for EVERY child, that manufacturer is guaranteed billions of easy dollars over the years.

Additionally, by influencing Congress, these manufacturers have already persuaded lawmakers to exempt them from liability for physical or neurological damage done to children by their vaccines. Now, isn't THAT a heck of a deal !!!!?? Every time a parent pays for a vaccine, 15% of it goes into a fund to compensate parents of vaccine damaged children. Why do you suppose vaccine manufacturers lobbied for such a law. Because they know their vaccines are SAFE ? Over $1 billion has so far, been awarded to parents of children damaged by vaccines.

Just this spring , here in Illinois, we saw another way that vaccine manufacturers spend money in an attempt to influence the process, in an underhanded way. A representative from the "Children's Health Coalition" attended at least one Immunization Advisory Board Meeting, to speak "on behalf of the organization ," in favor of mandating the varicella vaccine. Upon investigating this new coalition, it was discovered that there was no Children's Health Coalition. It was a public relations front, funded by Merck, to influence the process. They used the same technique, to get the vaccine mandated in Ohio.

Vaccine Safety

Vaccine safety doesn't seem to be a major federal concern. Of the Centers for Disease Control (CDC) budget, less than one half of one percent is put aside for safety research. The rest of the budget is designated for vaccine purchase and promotion.

Recommendations to policy makers are based upon studies of the very pharmaceutical companies that profit from the vaccines. Their studies are normally done over a very short time (generally 3-14 days), on a very limited number of participants. As with all drugs, long-term effects do not show up until taken over a long period of time , post-licensure and release, by tens of thousands of people. This puts children in the position of being research subjects in vaccine experiments.

According to the Government Accounting Office (GAO), at least 50% of drugs approved as safe and effective by the FDA show some negative, and usually dangerous side effect, not detected in clinical trials.

When the CDC is questioned about the rationale behind vaccine recommendations, which we would presume to be public information, it is found that the agency treats formulation of vaccine policy as "top secret", and hides behind an obscure provision in the Freedom of Information Act that exempts it from releasing such material.

Likewise, much important information on vaccine studies done by manufacturers, pre-licensure is exempt from study, even by the advisory committees, and is considered "proprietary information." It seems they consider it to be essential that they keep that information from being scrutinized.

Conflicts of Interest
The FDA's Vaccines and Related Biological
Products Advisory Committee (VRBPAC)
and the CDC's Advisory Committee
on Immunization Practices (ACIP)

On Thursday, June 15, 2000, federal Representative Dan Burton, of Indiana, Head of the Committee on Government Reform, held a hearing on " Conflicts of Interest in Vaccine Development." The full text of his opening speech can be found on the Internet at,

www.house.gov/reform/hearings/healthcare/00.06.15/index.htm

To illustrate, Burton's committee focused on how the two committees, the (VRBPAC) and (ACIP) handled approval of the since- withdrawn Rotavirus Vaccine. From minutes of the committee meetings, they discovered that:
1) At the (VRBPAC) meeting, there were discussions of pre-licensure
adverse events.
5 of 10,000 children had developed bowel obstructions.
There were concerns about "failure to thrive" .
There were concerns of high fevers which could lead to brain injury

The committee voted unanimously to approve it.

2) At the CDC's , ACIP meeting, there was much doubt expressed about
the cost -benefit ratio of mandating the vaccine.

The committee voted unanimously to approve it.

3) Members of these committees, including the Chair, who make the
decisions about the vaccines own stock in the drug companies that
make vaccines.

4) Some individuals, on both advisory committees own patents for vaccines
under consideration, or affected by the decisions of the committee.

5) 3 out of 5 members of the VRBPAC who voted for the rotavirus vaccine,
had conflicts of interest that were waived.

6) 7 of the 15 VRBPAC members were not present at the meeting; 2 others
were excluded from the vote; 5 "temporary members" voted.

All voted to license the product.

7) CDC grants "Conflict of Interest Waivers", for a year at a time to every
advisory panel member. They are allowed full participation in discussions
whether they have a financial stake in the vaccine or not.

8) The VRBPAC has no public members: The ACIP has only one.

Dan Burton's Opening Statement has specific examples of conflicts of interest on these two major committees. In shortened version, the following are only 2 examples, of many given.

Dr. Paul Offit - ACIP Committee member
- Holds a patent on Rotavirus vaccine
- Receives money from Merck to develop the vaccine
- Paid by Merck to travel the country and teach physicians that vaccines
are safe.
- Voted on 3 Rotavirus issues-including recommendation of adding
rotavirus vaccine to the Vaccines for Children program.

Dr. John Modlin - Chair of VRBPAC
- Owned Merck stock, valued at $26,000.
- Serves on Merck's Immunization Advisory Board
- Chairman of Rotavirus Working group
- Voted Yes on 8 different matters in ACIP's Rotavirus Statement
- Voted for Rotavirus inclusion in Vaccines for Children Program

Conflicts of Interest
on the Illinois Immunization Advisory Board

The following members of the Illinois Immunization Advisory Board, have conflicts of interest.

Susanna Roberts, R.N. - Has stock in two companies who manufacture vaccines.

Alicia Strauss - Receives a $10,000 unrestricted grant for the activities of the Chicago area Immunization Campaign from the Merck Vaccine Division.

Lawrence D. Frankel, M.D.- Receives compensation from Merck for speaking , 6 times per year, on Varicella Vaccine, and vaccines, in general.

Nancy Khardori, M.D. - Speaks for medical education programs for Merck and Smith Kline Beecham.

Lisa Keitz - Consultant to IDPH on strategic planning. (She is being paid by the same department, whose head, Dr. Lumpkin, she is advising on immunizations.)

Tina Q. Tan, M.D. - On her inventory she lists under "Speaking and Writing": Pasteur-Merieux, Connaught, Pfizer, Wyeth-Lederle, Smith-Kline-Beecham--Pertussis, Polio, Hib, Pneumococcal vaccines, Antibiotic Resistance.

Kevin Sherin, M.D. - May or may not have a conflict of interest. He lists "Rakel's
Textbook of Family medicine Chapter on Alcohol Abuse", but
not who pays him for this.

Robin Gabel - Receives a $20,000 grant from Merck.

Most participants, with financial connections to vaccine manufacturers , state that the issues are unrelated to issues of the committee. However, on April 19, 2000, Alicia Strauss, made her first appearance at an immunization board meeting, voted for the chicken pox mandate, and was widely quoted in the media. She gets an unrestricted $10,000 grant from Merck. Was she not functioning as a shill for the vaccine company? It would be interesting to see members with financial connections to Merck vote against mandating the varicella vaccine and see how much longer they get to speak or work for Merck or other vaccine companies. Ms. Strauss, and anyone else with any financial tie to Merck, should not have been allowed to vote on the issue.

Conflicts of Interest on the State Board of Health

It had been extremely difficult to get financial information on this group. For several months, Freedom of Information requests were "lost or ignored. Final information was quite sketchy.

The Freedom of Information Act Guidelines, in Illinois state that the government can charge a "copying fee", which cannot be so high as to discourage information seekers. In the past there has been no charge for a certain number of pages, and 25 cents per page thereafter. For this particular information, however, they want 50 cents per page.........$11. I believe that this fee is excessive, and meant to be discouraging.

I encourage each and every one of you to be curious, as well as courageous. I encourage you to do research on both sides of the vaccine issue. You, personally, are partly responsible for each and every injury done by a vaccine that you have recommended be given to every child. Ignorance of the subject is no excuse. Information on the problems with vaccines abounds, in your own medical journals.

Thank you for taking the time to read this.

Sincerely,

Connie Roux

cc: Representative Rick Winkel
Senator Stanley Weaver
Candidate Tod Satterthwaite

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