Fwd: Conflict of Interest Hearing

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> Subj: Conflict of Interest Hearing

> Date: 6/16/00 2:55:45 PM Eastern Daylight Time

> From: ppva@... (Carolyn Morelli)

> Sender: ppva@...

> To: ppva@...

>

> Conflict of Interest Hearing June 15, 2000 From my notes: Kathi

>

> On June 15, 2000,Dan Burton Chairman of the Government Reform Committee

held

> a hearing: FACA: Conflicts of Interest and Vaccine Development: Preserving

> the Integrity of the Process

> (FACA- Federal Advisory Committee Act)

>

> The hearing opened with a discussion between Cong. Dan Burton and Cong.

> Waxman over whether the personal financial disclosures made by federal

> advisory committee members could be released to the public. When a person

is

> appointed to a committee they are asked to disclose any conflicts of

> interest they may have and they are told that this information will be kept

> confidential.

>

> Cong. Burton agreed to NOT release his staff report until they could get

> further clarification on the legalities of releasing the information.

>

> Burton moved on to his opening statement that discussed the rotavirus

> vaccine and its' licensure. Burton brought up Dr. Modlin who was the

> head of the ACIP and was the chair in February 1998. He participated in the

> FDA committee as well and owned $26,000 in Merck stock, serves on Merck's

> Immunization Advisory Board and was chairman of the rotavirus working

group.

>

> Burton and Waxman went back and forth on whether or not Modlin could have

> known at the time he voted on rotavirus that Merck was also working on a

> rotavirus vaccine. If Wyeth's product got licensed, it would make it easier

> for Merck. Memos were shown that had been given to him but of course he was

> not there to speak for himself.

>

> Congressman Burton raised the point that there are 700,000 doctors in this

> country and why couldn't we find 15 to serve on a CDC committee that did

not

> have conflicts of interest.

>

> The CDC and FDA argued that it is all right because all the conflicts are

> disclosed and then there are waivers that are given on a case by case

basis.

> When certain members are not allowed to vote they are still allowed to be

> part of all discussions and use whatever powers of persuasion they may have

> to influence other voting members.

>

> In discussing the pre-licensure problems with the rotavirus vaccine with

the

> FDA, Cong Burton said, " You knew there were problems, you waived the

> conflicts of interest and people suffered. "

>

> The FDA said they waive them when they believe the expertise of the person

> voting is more valuable to the discussion than not having him vote.

>

> Cong. Burton said there were 5 voting members on the FDA committee the day

> they voted on rotavirus, 5 were temps. Their charter says they should not

> vote without a quorum.

>

> The FDA responded with, " our charter says " generally " we should not vote

> without a quorum. "

>

> Burton also brought up the fact that ACIP voted before the FDA had licensed

> the vaccine. The CDC responded by saying their job is to give guidance on

> how they would foresee the recommendations going and it is not established

> until it is published in the MMWR. He felt it was OK to give their opinions

> in what populations it should be used in. Their recommendation remained

> fluid until it was published.

>

> The FDA considers it a low impact if the financial interests are less than

> $25,000.

>

> The hearing ended with Cong. Burton reading from a transcript where Dr. Lee

> said, he could not vote but if he could he would vote for routine

> immunization and he hoped his participation in the discussion would

> influence the people who voted in his stead.

>

Conflict of Interest Hearing June 15, 2000 From my notes: Kathi

On June 15, 2000,Dan Burton Chairman of the Government Reform Committee held

a hearing: FACA: Conflicts of Interest and Vaccine Development: Preserving

the Integrity of the Process

(FACA- Federal Advisory Committee Act)

The hearing opened with a discussion between Cong. Dan Burton and Cong.

Waxman over whether the personal financial disclosures made by federal

advisory committee members could be released to the public. When a person is

appointed to a committee they are asked to disclose any conflicts of

interest they may have and they are told that this information will be kept

confidential.

Cong. Burton agreed to NOT release his staff report until they could get

further clarification on the legalities of releasing the information.

Burton moved on to his opening statement that discussed the rotavirus

vaccine and its' licensure. Burton brought up Dr. Modlin who was the

head of the ACIP and was the chair in February 1998. He participated in the

FDA committee as well and owned $26,000 in Merck stock, serves on Merck's

Immunization Advisory Board and was chairman of the rotavirus working group.

Burton and Waxman went back and forth on whether or not Modlin could have

known at the time he voted on rotavirus that Merck was also working on a

rotavirus vaccine. If Wyeth's product got licensed, it would make it easier

for Merck. Memos were shown that had been given to him but of course he was

not there to speak for himself.

Congressman Burton raised the point that there are 700,000 doctors in this

country and why couldn't we find 15 to serve on a CDC committee that did not

have conflicts of interest.

The CDC and FDA argued that it is all right because all the conflicts are

disclosed and then there are waivers that are given on a case by case basis.

When certain members are not allowed to vote they are still allowed to be

part of all discussions and use whatever powers of persuasion they may have

to influence other voting members.

In discussing the pre-licensure problems with the rotavirus vaccine with the

FDA, Cong Burton said, " You knew there were problems, you waived the

conflicts of interest and people suffered. "

The FDA said they waive them when they believe the expertise of the person

voting is more valuable to the discussion than not having him vote.

Cong. Burton said there were 5 voting members on the FDA committee the day

they voted on rotavirus, 5 were temps. Their charter says they should not

vote without a quorum.

The FDA responded with, " our charter says " generally " we should not vote

without a quorum. "

Burton also brought up the fact that ACIP voted before the FDA had licensed

the vaccine. The CDC responded by saying their job is to give guidance on

how they would foresee the recommendations going and it is not established

until it is published in the MMWR. He felt it was OK to give their opinions

in what populations it should be used in. Their recommendation remained

fluid until it was published.

The FDA considers it a low impact if the financial interests are less than

$25,000.

The hearing ended with Cong. Burton reading from a transcript where Dr. Lee

said, he could not vote but if he could he would vote for routine

immunization and he hoped his participation in the discussion would

influence the people who voted in his stead.

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