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Message
Posted by margaret on June 20, 2000 at 03:16:38:

PLEASE WRITE A LETTER! LET THEM KNOW THIS ISSUE IS IMPORTANT TO YOU. IT
DOES NOT HAVE TO BE LONG...JUST WRITTEN AND SENT!

Connecticut Vaccine Newsletter #10 June 16, 2000

Urgent Action required before Wednesday, June 28, 2000!!! See below
for details on sending letter to Congressional Committee. Take a moment
and tell them you care!!
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Any information obtained here is not to be construed as medical or legal
advice. The decision to vaccinate and how you implement that decision
is yours and yours alone.
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National News:
On Thursday, June 15, 2000 the Congressional Committee on Government
Reform held a hearing at 1 PM entitled, "FACA: Conflicts of Interest
and Vaccine Development - Preserving the Integrity of the Process." The
hearing was postponed from Wednesday, June 14, 2000, when it was
originally scheduled.

Rep. Dan Burton, R-Indiana, chaired the Committee hearing. Rep. Waxman,
D-California, Rep. Danny Davis, D-Illinois, and Rep. Benjamin Gilman,
R-New York, were all present at the hearing. Rep. Shays, R-Connecticut
was not present.

There were parents from Ohio, Virginia, Connecticut, Pennsylvania, and
Illinois who were present for the hearing. This hearing was not as well
attended by parents and was only taped by CNN. Nonetheless, the hearing
yielded some very interesting information.

After arriving at 6:15 AM and standing outside the building, prior to it
being opened, I was able to be the first person in line for the hearing
so that I could attended the almost 4 hours of testimony.

There was considerable debate at the beginning of the hearing regarding
releasing and including a staff report on this issue by Rep. Burton's
staff into the record. It was strongly objected to by Rep. Waxman due
to privacy concerns.

FACA stands for Federal Advisory Committee Act. This act deals with
conflict of interest for advisory committees and a waiver provision for
"special Government employees" or SGEs. According to Marilyn L. Glynn's
written testimony, General Counsel, Office Of Government Ethics, SGEs
"are defined as any officer or employee who is selected to perform
temporary duties for no more than 130 days during any 365 day period."

SGEs are people, such as doctors, who are asked to sit on advisory
committees to make certain recommendations. This is all relevant to the
vaccine issue because the Center for Disease Control (CDC) and the Food
and Drug Administration (FDA) both have advisory committees that make
recommendations on which vaccines to approve and which vaccines should
be added to children's recommended vaccine schedule. The CDC's
committee is called the Advisory Committee on Immunization Practices
(ACIP) and the FDA's committee that pertains to vaccines is called
Vaccines and Related Biological Products Advisory Committee (VRBPAC).
These committees meet several times per year.

The VRBPAC suggests to the FDA which vaccines should be licensed for
public use. The ACIP works for the CDC and the Department of Health and
Human Services (HHS) by suggesting which vaccines should be recommended
for children and adults through the vaccine schedules that many doctors
and states adopt as law.

According to Ms. Glynn's written testimony, "Under this provision
[referring to FACA], enacted 1989 as section 208(b)(3), an agency now
has broad discretion to grant an individual waiver based on a written
determination that the need for the individual's services outweighs the
potential for a conflict of interest created by the financial interest
involved (my italics)." When she cites 'an agency' she refers to
agencies such as the FDA and CDC.

Ms. Glynn's testimony continued. "Such a waiver mechanism was deemed
appropriate for several reasons: FACA itself includes a fair balance
requirement that helps to protect against disproportionate influence by
a particular interest; FACA similarly requires that most advisory
committee meetings be open, thus subjecting them to "the most exacting
public scrutiny;" and advisory committee members typically are not
ultimate decisionmakers, but only advisors."

As a result, the question became whether or not some officials, most of
them doctors, who sit on these two advisory committees, ACIP and VRBPAC,
have a conflict of interest due to many of their ties to the
pharmaceutical companies or whether they are sitting on the committees
with no ethical conflicts since they had reveled their potential
conflict of interests previously and were granted a waiver by the
agency. Further questions were raised as to whether someone who simply
exposes their conflict of interest and gets a waiver can really function
in the best interest of the American children and citizens.

Ex officio members, often government employees, are given voting status
when regular voting members have to remove themselves from a vote due to
a conflict of interest. The use of ex officio members is highly suspect
because these members are suppose to represent their agencies point of
view, not their own, and be non-voting. The following are some of the
agencies that have ex-officio members for the ACIP: FDA, CDC, Health and
Human Services Department, and the Department of Veterans Affairs to
name a few.

Additionally, questions were raised as to whether someone who has a
clear conflict of interest should be allowed to participate in the
discussion that will lead to a vote on whether a vaccine should be
recommended. For example, at an ACIP meeting Dr. T. Chinh Le was not
allowed to vote due to conflict of interest but he was allowed to
participate in the discussion and try to push forth his interests.
During discussions of the rotavirus vaccine he stated, "if I were to
vote for this, I would vote for this routine immunization". At a June
1998 ACIP meeting, which is when they approved the rotavirus vaccine
recommendation for routine use, Dr. Le stated that he "feels very
privileged to be able to participate in a discussion that he cannot vote
on. Hopefully, that perhaps what I will say will influence the people
who can vote [referring to ex officio members] for me if I cannot
vote." Remember the ex officio members are government employees on the
ACIP.

This hearing used the Rotavirus Rotashield vaccine as just one example
where conflict of interest potentially existed. The FDA approved the
Rotavirus Rotashield vaccine in August 1998. The CDC made a universal
recommendation for the Rotavirus vaccine in March 1999. It soon became
apparent that there were serious problems regarding this vaccine when 2
children died from it and many more experienced serious bowel problems.
In the end the Rotavirus Rotashield vaccine was pulled off the market in
October 1999.

The following excerpt is taken from Rep. Burton's opening statement. I
am including this specific excerpt because it speaks to the whole issue
of conflict of interest, or at a minimum an appearance of such. It is
critical because this deals with who is making decisions regarding which
vaccines should be recommended for our children. Many of these examples
and references to meetings refer to the Rotavirus vaccine.

"How confident in the safety and need for specific vaccines would
doctors and parents be if they learned the following:

1. That members, including the Chair, of the FDA and CDC advisory
committees who make these decisions own stock in drug companies that
make vaccines.
2. That individuals on both advisory committees own patents for vaccines
under consideration or affected by the decisions of the committee.
3. That three out of five of the members of the FDA's advisory committee
who voted for the rotavirus vaccine had conflicts of interest that were
waived.
4. That seven individuals of the 15 member FDA advisory committee were
not present at the meeting, two others were excluded from the vote, and
the remaining five were joined by five temporary voting members who all
voted to license the product.
5. That the CDC grants conflict-of-interest waivers to every member of
their advisory committee a year at a time, and allows full participation
in the discussions leading up to a vote by every member, whether they
have a financial stake in the decision or not.
6. That the CDC's advisory committee has no public members - no parents
have a vote in whether or not a vaccine belongs on the childhood
immunization schedule. The FDA's committee only has one public member.

These are just a few of the problems we found. Specific examples of
this include:

Dr. John Modlin - He served for four years on the CDC advisory committee
and became the Chair in February 1998. He participated in the FDA's
committee as well owned stock in Merck, one of the largest manufacturers
of vaccines, valued at $26,000. He also serves on Merck's Immunization
Advisory Board. Dr. Modlin was the Chairman of the Rotavirus working
group. He voted yes on eight different matters pertaining to the ACIP's
rotavirus statement, including recommending for routine use and for
inclusion in the Vaccines for Children program. It was not until this
past year, that Dr. Modlin decided to divest himself of the his vaccine
manufacturer stock.

At our April 6 autism hearing, Dr. Paul Offit disclosed that he holds a
patent on a rotavirus vaccine and receives grant money from Merck to
develop this vaccine. He also disclosed that he is paid by the
pharmaceutical industry to travel around the country and teach doctors
that vaccines are safe. Dr. Offit is a member of the CDC's advisory
committee and voted on three rotavirus issues - including making the
recommendation of adding the rotavirus vaccine to the Vaccines for
Children's program.

Dr. Patricia Ferrieri, during her tenure as the Chair of the FDA's
advisory committee, owned stock in Merck valued at $20,000 and was
granted a full waiver.

Dr. Neil Halsey, who serves as a liaison member to the CDC committee on
behalf of the American Association of Pediatrics, and as a consultant to
the FDA's committee, has extensive ties to the pharmaceutical industry,
including having solicited and received start up funds from industry for
his Vaccine Center. As a liaison member to the CDC committee, Dr.
Halsey is there to represent the opinions of the organization he
represents, but was found in the transcripts to be offering his personal
opinion as well.

Dr. Harry Greenberg, who serves as the Chair of the FDA committee, owns
$120,000 of stock in Aviron, a vaccine manufacturer. He also is a paid
member of the board of advisors of Chiron, and other vaccine
manufacturer and owns $40,000 of stock. This stock ownership was deemed
not to be a conflict and a waiver was granted. To the FDA's credit, he
was excluded from the rotavirus discussion because he holds the patent
on the rotashield vaccine."

Essentially, the whole debate becomes a matter of interpretation. For
some, if the advisory committee members (of either ACIP or VRBPAC)
disclose their conflict of interest and obtain a waiver from the agency,
either CDC or FDA respectively, then there is not a conflict of
interest. For those who believe this, they support their argument by
saying that there are not enough qualified physicians who are
knowledgeable about vaccines and the associated subjects. Hence, they
feel that if the doctors who often sit on the advisory committees, as
'special government employees', knew that their financial records could
possibly be disclosed publicly then no one would want to sit on the
committees. Rep. Waxman, D-California, showed support for this
interpretation.

The other interpretation of the conflict of interest debate is one,
which was supported by Rep. Burton, R-Indiana. This position is
essentially that although certain laws were not broken the people on
these advisory committees "need to be above reproach". Essentially,
there should not even be an appearance of a conflict of interest. Rep.
Burton noted that there are 700,000 doctors in the U.S. and questioned
why the CDC could not locate other individuals with expertise to serve
on the 15-person committee. Rep. Burton went so far as to say in
reference to the Rotashield vaccine that "You knew there were problems,
you waived the conflicts of interest and people suffered."

The debate particularly between Rep. Waxman and Rep. Burton occurred
frequently. Toward the end of the hearing, Rep. Waxman wanted to assure
the people that from his point of view he sees no conflict of interest.
Upon hearing Rep. Waxman's position, Rep. Burton replied that, "There is
none so blind as those who will not see."

It was explained during the hearing that individuals with financial
interests that are between $5,000 and $25,000 should be allowed to
participate on these advisory committees because this amount of money is
considered to be a low involvement. Ms. Glynn went justified this
conflict of interest by explaining that it could be seen technically but
that it was important to understand the potential for gain and loss in
regard to conflict of interest. She explained that if someone owns
stock, even a lot, in a very large corporation then the individual
actually owns just a billionth of the company and as such she did feel
that the stock ownership would sway an individual's opinion.

It was also interesting to note that before the Rotavirus Rotashield
vaccine was even approved for use in public by the FDA, the ACIP
committee was already recommending it for infants.

It is very clear that there are serious questions regarding the current
system in which individuals participate on these advisory committees.

To see the written testimony please visit:
http://www.house.gov/reform/hearings/healthcare/00.06.15/index.htm

To see the majority staff report please visit: (this is very
informative)
http://www.house.gov/reform/hearings/healthcare/00.06.15/staff_report.htm
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Sending letter to Government Reform Committee:

The committee is accepting written testimony (letters) until June 28,
2000. It is VERY critical that they receive letters expressing your
concern. As you can tell, there are considerably different views on
what is and is not considered conflict of interest in regard to a highly
personal topic. Your letter will make a difference. It does not need
to be long or fancy but it DOES need to be written and sent! Below is
the mailing/fax and contact information. Below that are possible
suggestions on what to include in your letter.


HOW TO SUBMIT YOUR LETTER (TESTIMONY):
Mail your letter to Chairman Daniel Burton and request that your letter
be included in the official record for the hearing. Send your letter
to:

Chairman Daniel Burton Or you can fax your
testimony to (202) 226-1274. Government Reform Committee
2157 Rayburn House Office Building
Washington, DC 20515
Attn: Autism Hearing Testimony

Or you can submit your testimony by e-mail. Send your testimony to Beth
Clay, Staff, Committee on Government Reform at: beth.clay@mail.house.gov
Insert "Vaccine Conflict of Interest Testimony-June 15,2000" in the
"Subject:" line.

If you have questions about submitting testimony, contact Beth Clay at
the e-mail address listed above or by phone at (215) 225-5074. **Due to
the incredible amount of work that Beth Clay handles, you may also call
me, Lisa Reiss at 860-493-9147, if you have any questions.

You may choose to include the following items in your letter. The
letter does not have to be long. just written and sent!!!
1. The public, including parents, should be allowed to participate as
voting members of the ACIP and VRBAC. (If the science is sound any
person will understand. Furthermore, it is the public who is forced to
live with these committee's decisions.)
2. Voting members on the advisory committees should have NO financial
ties to the vaccine manufacturers.
3. No voting committee members should be allowed to own st

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