Staff Report?

[Guest guest]

I was searching the house site to see if the audio hearing might still

be available that one of you said you caught on the house website.

Anyway, this was the search. Although I will not swear to it, it

appears to be the actual staff report that Waxman did not want released.

I am including the link and should it disappear...I am including the

text in this email.

I can see why Waxman was so protective of the information. The money

involved is INCREDIBLE!

http://www.house.gov/reform/hearings/healthcare/00.06.15/staff_report.htm

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Policy Making

Majority Staff Report

Committee on Government Reform

U.S. House of Representatives

June 15, 2000

Section I

Introduction

In August 1999, the Committee on Government Reform

initiated an investigation into Federal vaccine policy. Over the last

six

months, this investigation has focused on possible

conflicts of interest on the part of Federal policy-makers. Committee

staff has

conducted an extensive review of financial

disclosure forms and related documents, and interviewed key officials

from the

Department of Health and Human Services, including

the Food and Drug Administration and the Centers for Disease Control and

Prevention.

This staff report focuses on two influential

advisory committees utilized by Federal regulators to provide expert

advice on vaccine

policy:

1. The FDA’s Vaccines and Related

Biological Products Advisory Committee (VRBPAC); and

2. The CDC’s Advisory Committee

on Immunizations Practices (ACIP).

The VRBPAC advises the FDA on the licensing of new

vaccines, while the ACIP advises the CDC on guidelines to be issued to

doctors and the states for the appropriate use of

vaccines.

Members of the advisory committees are required to

disclose any financial conflicts of interest and recuse themselves from

participating in decisions in which they have an

interest. The Committee’s investigation has determined that conflict of

interest rules

employed by the FDA and the CDC have been weak,

enforcement has been lax, and committee members with substantial ties to

pharmaceutical companies have been given waivers to

participate in committee proceedings. Among the specific problems

identified in this staff report:

§ The CDC routinely grants waivers from

conflict of interest rules to every member of its advisory committee.

§ CDC Advisory Committee members who are not

allowed to vote on certain recommendations due to financial conflicts of

interest are allowed to participate in committee

deliberations and advocate specific positions.

§ The Chairman of the CDC’s advisory

committee until very recently owned 600 shares of stock in Merck, a

pharmaceutical

company with an active vaccine division.

§ Members of the CDC’s advisory Committee

often fill out incomplete financial disclosure statements, and are not

required to

provide the missing information by CDC ethics

officials.

§ Four out of eight CDC advisory committee

members who voted to approve guidelines for the rotavirus vaccine in

June 1998

had financial ties to pharmaceutical companies

that were developing different versions of the vaccine.

§ 3 out of 5 FDA advisory committee members

who voted to approve the rotavirus vaccine in December 1997 had

financial

ties to pharmaceutical companies that were

developing different versions of the vaccine.

A more complete discussion of specific conflict of

interest problems identified by Government Reform Committee staff can be

found in Sections 4 and 5 of this report. To

provide focus to the discussion, this report examines the deliberations

of the two

committees on one specific vaccine -- the Rotavirus

vaccine. Approved for use by the FDA on August 31, 1998, the Rotavirus

vaccine was pulled from the market 13 months later

after serious adverse reactions to the vaccine emerged. Financial

disclosure

forms and waivers granted to committee members who

participated in these meetings were analyzed, along with their votes and

actions taken during the meetings.

Section II

Laws and Regulations

Laws Governing Advisory Committees

Federal law requires that advisory committees be

balanced in terms of points of view of their members and that they

conduct their

business in public. The law also requires that

advisory committee members disclose their financial interests and recuse

themselves

from matters in which they have an interest. The

following is a brief description of the requirements of these laws:

1. Federal Advisory Committee Act

(FACA):

The FACA, signed into law by President

Nixon in 1972, regulates advisory committees, task forces and

councils established by either the President,

the federal agencies or Congress. These increasingly influential

advisory

bodies have been considered by many to be the

Afifth branch of government.@[ii] It is important to note, however,

that

the FACA does not address the conflict of

interest of committee members; these are addressed in a separate statute

and

dealt with by individual agencies in the Code

of Federal Regulations.[iii] The FACA=s most significant requirements

fall

into three basic categories:

a.) Scope of Committees: The

statute clearly states that the function of advisory committees is to be

Aadvisory only.@ They provide

advice and recommendations that may or not may be adopted.

The final determination is to be

made by the official or agency involved.[iv]

b.) Requirement of

Openness: The second important issue addressed by the FACA is the need

for

openness in the proceedings of

advisory committees. With very few exceptions, all advisory

committee meetings are to be open

to the public and the materials distributed at the meetings,

including working papers, studies

agendas, etc…, are to be made available to the public for

inspection.[v]

c.) Balanced Representation:

Perhaps the most controversial provision of the FACA is the need for

a membership that is Afairly

balanced in terms of the points of view represented and the

functions@ of the committee.[vi]

The statute specifically forbids the committees to be

Ainappropriately influenced@ by

special interests.[vii]

2. Conflicts of Interest Statutes

[viii]:

The ethics guidelines for the advisory

committees are set by the agencies in accordance with federal statute,

specifically

18 U.S.C. ''202-209. Under the statute,

advisory committee members are considered ASpecial Government

Employees@ (SGEs). SGEs provide temporary

services to the U.S. government, not to exceed 130 days a year. As

SGEs, advisory committee members must comply

with Federal conflict of interest laws. 18 U.S.C. ''202-209 broadly

prohibits employees, including SGEs, from

participating in a decision-making process when they have a personal

interest

in the matters discussed, absent a waiver from

the relevant parties .[ix] The types of waivers found in the statute

are:

a.) ((1) waivers: The employee

may participate when the appointing official determines that the

financial interest Ais not

substantial as to be deemed likely to affect the integrity of the

services

that the Government may

expect.@[x]

b.) ((2) waivers: Employee may

participate if the interest is so Aremote@ or Ainconsequential@

that it will not have a special or

distinct effect on the employee or his employer.[xi]

c.) ((3) waivers: specifically

applicable to advisory committee members, this waiver will allow

them to participate in matters for

which he would have been disqualified, if it is determined that Athe

need for the employee=s services

outweigh the potential conflict of interest created by the

employee=s financial

interest.@[xii] Factors that may be considered include: type of

interest,

identity of the person, uniqueness

of the individual=s qualifications, difficulty of locating a similarly

qualified individual without a

disqualifying interest, the dollar value of the interest- including its

value

relevant to the member=s assets,

and the extent to which the financial interest will be affected by the

actions of the committee.

3. Code of Federal Regulations (CFR) &

Office of Government Ethics (OGE):

Since most advisory committee members are

considered Aspecial government employees@, the provisions in 18

U.S.C. ''201-219 that address conflicts of

interest apply to them. However, the statute only provides broad

guidelines,

so that it is up to the individual agencies to

provide the specific rules governing conflict of interest.[xiii] In the

case of the

Department of Health and Human Services

(DHHS), these regulations can be found at 5 C.F.R. '' 2635 and in 5

C.F.R.

''2640. Under the DHHS regulations, an

advisory committee member may not participate, absent a waiver, in

matters in

which they have a financial interest. These

are divided into the following categories:

a.) Particular matter: Aincludes

matters that involve deliberation, decision, or action focused on the

interests of specific persons, or a

discrete and identifiable class of persons.@[xiv]

b.) Particular matter involving

specific parties: the code defines this term to include proceedings,

applications, requests for

determination, contracts, claims, controversies and/or investigations

involving specific

parties. AThe term typically involved a

specific proceeding affecting the legal rights of the parties, or

an isolatable transaction or related set

of transactions between identified parties.@[xv] This term will

generally refer to the particular issue,

vaccine and or company that will be directly affected by the advisory

committee discussions.

c.) Particular matter of general

applicability: the code defines this term as Aa particular matter that

is

focused on the interests of a discrete

and identifiable class of persons, but does not involve specific

parties.@[xvi] This definition becomes

relevant in the discussion of companies that may be indirectly affected

by the proceedings of an advisory

committee. In this report, the companies under this category will be

referred

to as Aaffected companies.@

d.) A direct and predictable effect on

their financial interest: a Adirect@ effect on a financial interest is

defined as Aa close causal link between

any decision or action to be taken in the matter and any

expected effect of the matter on the

financial interest.@[xvii] According to the CFR, the effect may

actually be considered Adirect@ even

though it does not occur Aimmediately.@ However, the CFR also

specifies that the link will not be

direct in instances where the Achain of causation is attenuated or is

contingent upon the occurrence of events

that are speculative.@[xviii] On the other hand,

Apredictable@ is defined in the code as

a situation where there is a Areal@ possibility that the matter will be

affected.

e.) Affected interests: according to

the CFR, the disqualifying financial interests include: salary,

indebtedness, job offer, or any other

similar interests that could be affected by the matter discussed.[xix]

It

also includes the interests of persons

other than the advisory committee members, such as a spouse, children,

general partner, place of employment,

organizations where the advisory committee member serves as officer,

director and/or trustee, and prospective

employers.[xx]

f.) Interests in securities: The CFR

specifically addresses the potential conflicts that may arise out of

interests in securities, such as stock

holdings. The guidelines provided for in the CFR include:

(1) De minimis exemption: This

exemption applies to publicly-traded or long-term

Federal/municipal securities. The

CFR states that persons having holdings in the specific parties

involved of $5,000 or less or

holdings in the affected companies of $25,000 or less will be allowed

to participate in the proceedings

of the advisory committee. (Exhibit 53) These financial interests

are deemed to be of Alow

involvement@ and do not require a waiver, but a simple disclosure on the

forms required by the particular

agency or department.

(2) Employment exemption: Under

the DFR, SGEs may participate in the advisory committee

discussions on matters of general

applicability so long as the otherwise disqualifying financial interest

arises only from the committee

member=s non-Federal employment or prospective employment and

so long as the matter does not

have a special or distinct effect on the employee or employer other

than as part of a class. In other

words, under these circumstances, employees will be granted an

automatic waiver.

g.) Teaching, speaking and writing on

subject of meeting: SGEs are prohibited from receiving

compensation for teaching, speaking, and

writing on subjects Arelated to the employee=s official duties@ in

the advisory committee.[xxi]

The Code also stipulates that an SGE may not

participate in matters that are Alikely to have a direct and predictable

effect on the financial interests of ...a

person with whom he has a covered relationship, @ including members of

his household, close friends or

employer.[xxii] This type of conflict requires that the member disclose

the potential

conflict and that said conflict be waived by

the agency designee.

Section III

The Rotavirus and the Rotashield Vaccine

A. What is Rotavirus?

Rotaviruses cause acute gastroenteritis. Rotavirus

gastroenteritis is a self-limiting, mild to severe disease characterized

by vomiting, watery

diarrhea, and low-grade fever. Infantile diarrhea, winter

diarrhea, acute nonbacterial infectious gastroenteritis, and acute viral

gastroenteritis

are names applied to the infection caused by the most

common and widespread “Group A rotavirus.”

Person-to-person spread through contaminated hands is

probably the most important means by which rotaviruses are transmitted

in close

communities such as pediatric and geriatric wards, day

care centers and family homes. Group A rotavirus is endemic worldwide.

It is the

leading cause of severe diarrhea among infants and

children, and accounts for about half of the cases requiring

hospitalization.

It is estimated that over 3 million cases of rotavirus

gastroenteritis occur annually in the United States. In temperate

areas, it occurs primarily

in the winter, but in the tropics it occurs throughout the

year.

Group B rotavirus, also called adult diarrhea rotavirus or

ADRV, has caused major epidemics of severe diarrhea affecting thousands

of

persons of all ages in China. Group C rotavirus has been

associated with rare and sporadic cases of diarrhea in children in many

countries.

However, the first outbreaks were reported from Japan and

England.

The incubation period ranges from 1-3 days. Symptoms

often start with vomiting followed by 4-8 days of diarrhea. Temporary

lactose

intolerance may occur. Recovery is usually complete.

However, severe diarrhea without fluid and electrolyte replacement may

result in

severe diarrhea and death.

Childhood mortality caused by rotavirus is relatively low

in the U.S. Estimates of death resulting from complications of rotavirus

are from

20[xxiii] to 100 deaths per year. From 1979 through 1985,

an average of 500 children died annually from diarrhea disease in the

United

States; an estimated 20% of these deaths were caused by

rotavirus infection. Death rates for diarrhea disease were highest in

the South and

among black children less than 6 months of age. Many

deaths and hospitalizations may be prevented by the aggressive use of

oral

rehydration therapy, which is underused. Children 6

months to 2 years of age, premature infants, the elderly, and the

immuno-compromised

are particularly prone to more severe symptoms caused by

infection with Group A rotavirus. Outbreaks of Group A rotavirus

diarrhea are

common among hospitalized infants, young children

attending day care centers, and elder persons in nursing homes.[xxiv]

B. Rotavirus Vaccine Development

Wyeth Lederle Vaccines and Pediatrics, a subsidiary of

American Home Products was the first pharmaceutical company to come to

market

with a rotavirus vaccine. The Rotashield was approved by

the Food and Drug Administration on August 31,1998. It was a Rhesus

monkey-based live oral vaccine. Merck was also developing

a rotavirus vaccine that was based on bovine cells. The National

Institute of

Allergy and Infectious Diseases was conducting research in

rotavirus vaccine development. Kline Beecham was also working on

a

rotavirus vaccine.

Wyeth-Lederle Vaccines and Pediatrics first filed their

Investigational New Drug Application in August of 1987 for the

Rotashield vaccine.

This vaccine had an overall relative efficacy of 49% to

83% for four strains of rotavirus.

C. Timeline for Vaccine Approval and Universal

Use Recommendation

Date

Individual or Organization

Action

August 1, 1987

Wyeth Lederle

Filed Investigational

New Drug (IND)

Application to the FDA

December 9, 1994

Fred , Offit, Stanley

Plotkin (Inventors); Wistar

Institute of Anatomy and

Biology and Children's Hospital

of Pennsylvania (Assignees)

Filed U.S. Patent for

Rotavirus reassortant

vaccine. Application

number 353547

June 1, 1995

Fred , Offit, Stanley

Plotkin (Inventors); Wistar

Institute of Anatomy & Biology

and Children's Hospital of

Philadelphia (Assignees)

Filed U.S. Patent for

rotavirus reassortant

vaccine. Application

number 456906

May 6, 1997

Fred , Offit, Stanley

Plotkin (Inventors); Wistar

Institute of Anatomy and

Biology and Children's Hospital

of Pennsylvania (Assignees)

Awarded U.S. Patent #

5,626,851 for

Rotavirus Reassortant

vaccine.

December 12, 1997

VRBPAC (FDA)

The committee voted to

recommend that the

FDA license the

Rotashield vaccine.

February 11, 1998

ACIP (CDC)

The committee voted to

include the statement

“Routine Vaccination”

in the ACIP statement.

June 25, 1998

ACIP (CDC)

The committee voted to

include the short

version of the ACIP

statement regarding

post-marketing

surveillance.

August 31, 1998

FDA

FDA approved the

Rotashield vaccine.

October 1, 1998

Wyeth-Lederle

Distribution of the

Rotashield began.

October 21-22, 1998

ACIP (CDC)

The committee voted to

add the rotavirus

vaccine to the

Vaccines For Children

Program.

January 15, 1999

CDC

ACIP published its

recommended

immunization schedule

in the Morbidity and

Mortality Weekly

Report (MMWR).

February 17-18, 1999

ACIP (CDC)

The committee voted in

favor of

recommending

immunization of infants who

have diarrhea at the

time presented for

immunization.

February 17-18, 1999

ACIP (CDC)

The committee voted to

include infants born

prematurely under

guidelines for routine

immunization with a

precaution to insure the

infant was at least

six weeks of age, leaving a

nursery or no longer

hospitalized, and

clinically stable.

March 19, 1999

CDC

CDC officially adopted

recommendation for

routine use of

rotavirus vaccine as published in

MMWR.

May 1999

FDA

Ten cases of

intussusception reported through

the VAERS System.

June 17, 1999

ACIP (CDC)

The ACIP discussed

intussusception reports

to the Vaccine Adverse

Event Reporting

System (VAERS)

July 16, 1999

CDC

MMWR published request

to suspend use of

Rotashield until

further analysis of existing

reports of

intussusception.

October 15, 1999

Wyeth-Lederle

A subsidiary of American Home

Products

Manufacturer

voluntarily removed Rotashield

from the U.S. market.

October 22, 1999

ACIP (CDC)

The Committee voted to

rescind the

Recommendation of the

Rotashield Rotavirus

Vaccine.

D. Severe Bowel Obstructions Tied to Rotashield

Vaccine

A little more than one year after the Rotashield rotavirus

vaccine was licensed by the Food and Drug Administration as a safe and

effective

vaccine, it was removed from the market due to adverse

events. More than 100 cases of severe bowel obstruction, or

intussusception, were

reported in children who had received the vaccine were

reported.

Rotashield was licensed by FDA on August 31, 1998.

Distribution began on October 1, 1998. On January 1, 1999 there were

zero cases

of intussusception on the Vaccine Adverse Events Reporting

System (VAERS). In May 1999 there were ten cases of intussusception

reported in the VAERS. Data was received from the

Northern California Kaiser active surveillance system and from statewide

data case

control in Minnesota in early June that supported a

relationship between the Rotashield vaccine and intussusception. Dr.

Jeffery P. Koplan,

Director of the CDC was briefed for the first time on June

11, 1999. A subsequent meeting was held with Dr. Koplan and the CDC at

which a decision was made to postpone any further use of

the vaccine until further analysis was conducted. This was published in

MMWR

on July 16, 1999.

As of October 15, 1999, 113 cases of intussusception had

been received. Nine of these reported cases were determined not to be

intussusception. Of the remaining 102 cases of

intussusception, 57 had received the vaccine. Of these, 29 required

surgery, seven

underwent bowel resection, and one five-month-old infant

died after developing intussusception five days after receipt of the

vaccine.[xxv]

A case study was conducted that estimated that the risk of

intussusception was increased by sixty percent among children who

received the

Rotashield.

It is alarming that it was known during clinical trials

and the licensing process that there were increased incidences of

intussusception in

vaccinated infants. The topic was raised at a VRBPAC

meeting and a reference to intussusception is listed in the ACIP

recommendation,

however, the committee apparently determined that the

reported rate of 1 in 2010 was not to be statistically significant. The

CDC continues

to provide inconsistent information on their web site.

One fact sheet, the Rotavirus Q & A, has not been updated since July 16,

1999 and

does not provide a link to a more recent fact sheet. The

fact sheet significantly plays down the seriousness of the adverse event

and asserts

that no association has been made.[xxvi] Another

Rotavirus Vaccine Fact Sheet was updated on February 2, 2000 that

indicates that the

FDA and CDC confirmed the association between Rotashield

and intussusception.

During the clinical trials, five children out of a total

of 10,054 subjects suffered intussusception.[xxvii] If confirmed, the

rate of

intussusception would be 1 in 2010 children. According to

the manufacturers package insert, the adverse event was considered

statistically

insignificant at 0.05%. Intussusception had not

previously been associated with natural rotavirus infection.

Rotashield rotavirus vaccine was removed from the U.S.

market in October 1999. Development of other rotavirus vaccines

continues by

Merck and others.

Section IV

Food and Drug Administration

Vaccines and Related Biological Products Advisory

Committee

A. Vaccines and Related Biological Products Advisory

Committee:

1. Description of the Committee:

The Vaccines and Related Biological Products

Advisory Committee (VRBPAC) advises the Commissioner of the Food

and Drug Administration Ain discharging her

responsibilities as they relate to helping ensure safe and effective

biological

products,@ including vaccines.[xxviii] It

reviews and evaluates the data concerning the safety, effectiveness, and

the

appropriate use of vaccines and related

biological products. In short, the VRBPAC advises the FDA on whether or

not

to license new vaccines for commercial use.

2. Membership of the Committee:

The VRBPAC has 15 voting members, including the Chair, who

are selected by the Commissioner of the FDA or her designee. The FDA

seeks members who are “authorities” in the fields of

immunology, pediatrics, infectious diseases and related fields. The

charter also suggests

that there be a member who is identified with consumer

interests. VRBPAC meets approximately 6 times a year.

3. Terms:

VRBPAC members serve overlapping terms of four

years. A member may serve after the expiration of the member=s

term until a successor has taken office.

Under the DHHS policy, members may not serve continuously for more than

four years or more than eight years within a

twelve year period. Additionally, members may not serve on more than

one

committee within the agency at the same time.

Vacancies are announced at least once a year in the Federal Register.

The selections are made by Dr. Suydam,

Senior Associate Commissioner of the FDA, who also considers and

grants all conflict of interest waivers.

4. Temporary voting members:

Members of other scientific and technical FDA advisory

committees -- not to exceed 4 members (Exhibit 54) -- may vote on the

VRBPAC

when: a.) expertise is required that is not available

among current voting members or, b.) their presence is needed to

comprise a quorum.

B. Conflict of Interest Review and Waivers by the

FDA

1. Scope:

As discussed in Section I of this report,

conflict of interest statutes and regulations generally prohibit the

participation of

advisory committee members in official matters

where that person has a financial interest and their participation will

have

a direct and predictable effect on that

interest.[xxix] Many factors are considered by the Department in

determining

whether a conflict of interest exists and, if

it does, whether it may be waived to allow participation. A conflict

may either

be an actual or apparent conflict. An actual

conflict is the situation where a direct, identifiable conflict exists.

An

apparent conflict is where there is an

appearance of a lack of impartiality.[xxx]

2. Procedure:

There are many steps in the FDA=s procedure to

clear potential conflict of interests in VRBPAC. They include:

a. Prior to a scheduled

VRBPAC meeting, FDA officials will review the agenda and other

assignments. Entities with a

financial interest in the matter to be discussed are identified by the

staff

of the Center for Biologics

Evaluation & Research, as are the products to be used in conjunction

with the product being reviewed,

and competing products.

b. Advisory committee members

are required to fill out a Confidential Financial Disclosure Statement

(FDA form 3410) prior to each

meeting.

c. FDA staff compares

financial disclosure information compiled for each VRBPAC member with

the

issues on the agenda for the

upcoming meeting to determine who has conflicts. Based on the

information provided, the member

can be found to have: a.) no conflict of interest, b.) a conflict of

interest that is minimal and thus,

justifiable, or c.) a conflict of interest so substantial than recusal

or a

waiver is the only course of

action. If there is a substantial conflict of interest, it must be

detailed.

Some of the factors and criteria

used in determining whether a waiver is appropriate include:

(i.) Agenda topic: Where the

subject of the meeting is of Ageneral scientific presentations@ and

not of particular products or to

review research with no direct or predictable effect on outside

interests, waivers are not

needed.[xxxi]

(ii.) Net worth of member: The

amount of the financial interest will be considered in relation to the

net worth of the SGE.[xxxii]

(iii.) Employment: Situations

where the SGE=s university employer has a grant or a contract with

either the sponsoring company or

any other affected companies will be taken into consideration

during the waiver process.[xxxiii]

(iv.) Amount of grant or contract:

The amount of the grant or contract given to the university

employer of a member, as well as

the member=s involvement (i.e. principal investigator, department

chair) will be considered in

whether the financial interest arises to the point of conflict.

(Exhibit 53).

(v.) Competing products: The

member=s financial interest in competing products or otherwise

affected companies will be taken

into consideration by the agency in determining whether a waiver

may be granted.[xxxiv]

(vi.) Potential effect of

committee recommendation: Members may not vote on any matter

where a committee recommendation

could benefit financially either the member or his/her immediate

family. A waiver may not be

granted where the member=s own research is involved.

(vii.) Industry consultant or

advisor: The level of involvement of the member with either a

sponsoring or an affected company,

as measured by the amount of compensation received, will also

be considered. (Exhibit 53).

(viii.) Patents, royalties and

trademarks: As in the previous categories, the level of involvement

of the particular member will be

measured by the amount of compensation received from the

sponsoring or affected companies.

(Exhibit 53).

b. If the Director of the

division determines that the member=s services are too important,

despite a

substantial conflict of interest,

he must provide the necessary justification for a waiver. AWhere the

financial interest is relatively

large it is essential that the justification be particularly

strong.@[xxxv]

c. If a waiver is

contemplated, it must be reviewed by FDA=s ethics staff who will make a

recommendation to the approving

official regarding the waiver. They may also consult with the

Office of General Counsel in the

Department or the Office of Government Ethics.

d. Final approval of

waivers is given by Dr. Suydam, Senior Associate Commissioner

of the FDA. In addition to a full

participation waiver, the Department may also grant:

i.) Limited Waivers: This waiver

places restrictions on the member=s participation, such as no

right to vote.[xxxvi]

Potentially, a limited waiver could also restrict a member=s

participation to

answering factual questions about

the matter being discussed by the committee.

ii.) Disclosure: In cases where

the financial interest is not deemed to be substantial, it will be

disclosed in the public record

with the expectation that other participants will take them into

consideration as they evaluate the

opinions expressed by the member. The Agency in some cases

deems that such disclosure is

sufficient in addressing the potential for an actual or apparent

conflict of

interest.[xxxvii]

iii.) Recusal: Finally, members

are expected to recuse themselves from the committee proceedings

in cases where they deem that the

financial interest may interfere with their ability to be impartial.

C. Problems identified with VRBPAC:

The Committee conducted an in-depth investigation of

the VRBPAC from 1995 to present. As noted above, the approval and

recommendation of the Rotashield vaccine for the

treatment of rotavirus was chosen as a good example of the concerns that

arise

from the use of waivers by advisory committees.

For the purposes of this report, we chose the VRBPAC=s December 12,

1997,

meeting, at which the Rotashield vaccine received

its initial approval.

This meeting was attended by 5 VRBPAC committee

members, 5 temporary voting members and at least 3 consultants, in

addition to both the FDA and the sponsor company=s

representatives. Although Wyeth-Ayerst Laboratories (Wyeth Lederle

Vaccines and Pediatrics) was the sponsoring company

for the Rotashield vaccine, several other companies were deemed to be

AAffected Companies@ by the FDA. These include:

Merck, Virus Research Institute, and National Institute on Allergy and

Infectious Diseases (NIAID). Advisory committee

members, temporary voting members and consultants were screened for

potential financial conflicts of interest with

either the sponsoring or the affected companies. The decision to

recommend approval

of the license for the Rotashield was unanimous.

The Government Reform Committee=s investigation of the VRBPAC=s

Rotashield vaccine approval meeting raised several

concerns:

1. Unanimous vote despite

concerns raised: At the VRBPAC meeting, several members raised concerns

about adverse effects that occurred at

the rotavirus clinical trials. These included: intussusception,

infant=s

failure to thrive, and febrile reactions

among others.

A statement by Dr. Fleming, a temporary

voting member, summarizes the statements of many of the other

voting members. He stated: " And as a

result, I would ask the FDA to work with the sponsor to further

quantitate what these serious side

effects are -- specifically the adverse effects, driven in particular by

febrile illness -- is inducing

hospitalizations and what is that level of access. I still don't feel

like I have

a good grasp of that at this point. "

He proceeded to vote for the approval recommendation.[xxxviii]

2. Potential conflicts of interest of

VRBPAC members: Four out of five members had conflicts of interest that

necessitated

waivers. Perhaps one of the major problems contributing

to the overall influence of the pharmaceutical industry over the vaccine

approval

and recommendation process may be the loose standards that

are used by the agency in determining whether a conflict actually

exists.

(Exhibit 53). In many cases, significant conflicts of

interest are not deemed to be conflicts at all.

For this particular meeting, two members of the VRBPAC

were excluded from the committee deliberations:

a.) Dr. Harry Greenberg: Dr. Greenberg

was excluded from the deliberations as he is a patent holder of the

Rotashield, the actual vaccine discussed

at the meeting. He may have been present at the VRBPAC meeting,

but it is not apparent that he

participated in any way, including the open public session.

b.) Dr. Clements-Mann: It is not clear

from the waiver process why she was excluded from participating in

the proceedings.[xxxix] However, while

Dr. Clements-Mann did not vote, she was present and did participate

in the public session of the committee

deliberations. Dr. Clements-Mann works for the s Hopkins

University.

Five members out of fifteen members of

the advisory committee were present in the deliberations:

c.) Dr. Ferrieri, Chair: She

directed the discussion on the Rotashield vaccine. At the time of the

proceedings, Dr. Ferrieri owned at about

$20,000 of stock in Merck, an affected company and manufacturer

of an upcoming rotavirus vaccine. This

conflict was waived by the FDA as it was deemed to be of Alow

involvement@ (Exhibit 56). Also, Dr.

Ferrieri received a $135,000 NIAID grant for unspecified research on

rotavirus[xl] for 1998-1999, after the

committee voted to approve the Rotashield vaccine. It is not certain

whether this grant was in negotiations

at the time of the VRBPAC vote on Rotashield. Dr. Ferrieri received a

full participation waiver.

d.) Dr. Caroline Hall: At the time of

the VRBPAC meeting for approval of Rotashield, Dr. Hall=s employer,

the University of Rochester, had a

$9,586,000 contract with the NIAID for a rotavirus vaccine. As the

original developer of the rotavirus

vaccine, the NIAID subsequently licensed to Wyeth the rights to further

develop the Rotashield vaccine.

According to the conflict of interest waiver forms, Aneither Dr. Hall

nor the

principal investigator of the NIAID

contract have evaluated the specific Rotashield vaccine.@

However, the same form states that it is

unknown which rotavirus vaccine was licensed to Wyeth from NIAID.

Dr. Hall was allowed to fully

participate in the meeting.

e.) Ms. Cole: The consumer

representative on the VRBPAC committee at the time, Ms. Cole has

been an ardent advocate for increased

vaccinations after her son died of complications from his asthmatic

condition and the chicken pox. As an

advocate for vaccines, she has received both travel expenses and

honoraria from Merck, the developer of

the chicken pox vaccine, to appear in discussions advocating its use.

Under the FDA standard, Ms. Cole did not

need a waiver for participation.

f.) Dr. : Dr.

received a contract from Wyeth Lederle for $255,023 per year

from 1996 to 1998 for the study of

pneumococcal vaccines. She also had numerous grants and contracts with

the NIAID, an affected company, for the

following amounts: $206,750 per year from 4/1/95 to 3/1/98 to

study TB vaccines; $673, 373 a year from

1996-2003 to study mucosal vaccines; and $86,279 from

1997-1998 to study acellular

pertussis/cell mediate immunity. These contracts and grants were deemed

to

potentially >appear= to be a conflict,

but were subsequently waived. Dr. was allowed full

participation in the meeting.

g.) Dr. Estes: At the time of the

Rotashield approval meeting, Dr. Estes= employer, Baylor College of

Medicine, was receiving a large amount

of funds for the development of rotavirus vaccines, including a

$75,000 grant from American Home

Products, the parent company of Wyeth-Lederle Vaccines and

Pediatrics, and from the NIAID for

$404,000 from 8/93 to 7/98. The FDA determined that the Aamount of

funding is not large and represent[ed] a

small portion of the University=s research budget.@ (Exhibit

61) Accordingly, this conflict was

waived. Dr. Estes was also listed as the principal investigator for a

grant

from Merck for the development of a

rotavirus vaccine. This conflict was also waived and Dr. Estes was

given

a full participation waiver for the

meeting.

3. Use of temporary voting members:

An additional concern was raised by the

liberal use of temporary voting members, particularly in the Rotashield

approval

meeting of VRBPAC. Of the ten (10) members

allowed to vote in this meeting, only half (5) were standing members.

The other half were temporary voting members.

The VRBPAC charter states that the number of temporary members is

Anormally not to exceed four members.@[xli]

This is bothersome as a meeting where a quorum cannot be

constituted from the duly appointed members

should be canceled until the quorum can be achieved. The temporary

voting members appointed for this meeting

were:

a.) Dr. Broome: Senior Advisor

to the Director for Integrated Health Information Systems at the

Centers for Disease Control.

b.) Dr. Dixie Snider: Associate

Director for Science at the Centers for Disease Control. Dr. Snider

was, at

the time, the Executive Secretary of the

CDC=s Advisory Committee on Immunization Practices (ACIP).

c.) Dr. Karzon: Professor at

Vanderbilt University. Dr. Karzon is a frequent consultant and/or

temporary voting member to the VRBPAC,

voting on a variety of issues. While no apparent conflicts of

interest were reported by Dr. Karzon,

his employer, Vanderbilt University, receives extensive grants and

contracts from pharmaceutical companies.

d.) Herbert DuPont: Professor at the

University of Texas in Houston. No apparent conflicts of interest were

reported.

e.) Fleming: Chair of

Biostatistics at the University of Washington, Dr. Fleming has also been

a

frequent temporary voting member or

consultant to the VRBPAC.

4. Conflicts of interest of consultants:

At least three consultants participated in the

discussion of the Rotashield vaccine on December 12, 1997. They were:

a.) Dr. Neal Halsey: Dr. Halsey has

been one of the leading investigators and advocates in the area of

vaccines. In addition to numerous

grants and contracts from different vaccine manufacturers, Dr. Halsey

has

received frequent reimbursements for

travel expenses and honoraria from companies such as Merck.

Importantly, at the time of the

Rotashield approval meeting, Dr. Halsey was seeking start-up funds from

most

of the vaccine manufacturers for the

establishment of an institute for vaccine safety at s Hopkins

University, where he works. He has

already received $50,000 from Merck and was awaiting funds from

Wyeth Lederle (Exhibit 56). Dr. Halsey

also participated in the rotavirus working group of the ACIP.[xlii]

Also, Dr. Halsey was the Chair of the

Committee on Infectious Diseases and representative of the American

Academy of Pediatrics which, in

conjunction with the CDC, sets and advertises the recommendations for

schedules and dosages of immunizations.

He was granted a waiver for participation,[xliii] participated during

the morning session and then recused

himself at the beginning of the afternoon session due to conflicts that

were not disclosed in the minutes for

the meeting. Finally, Dr. Halsey=s employer, s Hopkins University,

is also the employer of Dr.

Clements-Mann, who was excluded from the discussions.

b.) Dr. Maldonado- No apparent

conflicts were listed for Dr. Maldonado.

c.) Dr. Modlin: At the time of the

Rotashield approval meeting, Dr. Modlin owned approximately

$26,000 in Merck stock, an affected

company. He has also served on Merck=s Immunization Advisory

Board from 1996 to the present. These

financial interests were waived and he was allowed to extensively

participate in the meeting although, as

a consultant, he was not allowed to vote. Also, Dr. Modlin was at the

time the Chairman of the ACIP and its

rotavirus working group.

5. Balanced representation:

As previously discussed, the statutory

requirement of balanced representation is one of the most controversial

provisions

of the FACA. The FDA has interpreted

“balance” as diversity of geography, ethnicity, disciplines and gender.

While it

is questionable whether this standard

guarantees the balance of Apoints of view represented@ expressly

required by

the statute, it was interesting to see the

high concentration of professors in pediatrics represented on the VRBPAC

committee, particularly during the Rotashield

discussion (Dr. Ferrieri, Dr. Karzon, Dr. , Dr. Modlin, and Dr.

Halsey). Also, two of the voting members work

for Vanderbilt University (Dr. & Dr. Karzon), while one

member Dr. Clements-Mann (who, although

excluded from voting, was able to participate in the open public hearing

part of the meeting) and Dr. Halsey, both come

from s Hopkins University. Two of the voting members (Dr.

Broome and Dr. Snider) are CDC Federal

employees. The overwhelming majority of members, both voting members

and consultants, have substantial ties to the

pharmaceutical industry.

6. Recurrent membership:

A troubling pattern is the recurrence of

members, temporary voting members and consultants, year after year,

despite

term limits, which greatly limits the

diversity of opinion that is sought in this type of committee.[xliv]

After reviewing the

VRBPAC rosters of members and consultants for

the past few years, it becomes apparent that many of the members

have frequently participated in committee

proceedings for many years. Also, it is evident that there is a

significant

number of people who frequently participate in

proceedings at both the FDA and the CDC, despite a policy that

prohibits the simultaneous participation of

members in more than one advisory committee within the agency.[xlv] In

this

particular meeting, at least four of the

members (Dr. Broome, Dr. Snider, Dr. Modlin and Dr. Halsey) were

intrinsically

involved in the development of recommendations

for the CDC. In other words, these persons influence the process of

vaccine approval and recommendation. Dr.

Halsey also chaired the American Academy of Pediatrics committee which

helps set and advertise the schedule and

dosage of recommended vaccines. Also, several of the temporary voting

members frequently participate in VRBPAC=s

meeting, without actually becoming members, thus severely limiting the

diversity of participation and opinion.[xlvi]

Other members are retained as temporary voting members and/or

consultants

once their four year term on the advisory

committee has expired.[xlvii]

7. Timing of the proceedings:

A particularly troubling aspect of the

deliberations on the Rotashield vaccine is the sequence of events. The

ACIP

Committee voted to recommend universal

vaccinations of infants before the FDA licensure of the vaccine.

Officials of

the CDC acknowledge that they knew of no other

instance where this has happened. As discussed before, during the

December 12, 1997, VRBPAC vote to recommend

the licensure of the Rotashield vaccine, a number of concerns were

raised by some of the members with regard to

the vaccine and its possible adverse effects. Although the VRBPAC

unanimously approved the vaccine

recommendation, some of the committee members= votes were conditioned on

the

FDA=s ability to successfully resolve the

areas of concern. However, before the FDA final licensure of the

Rotashield

vaccine in August 1998, the ACIP committee -

as will be discussed in the ACIP section of this report- had already

voted to recommend the mandatory universal use

of the vaccine. This is troubling, not only because the vaccine had

not

yet been approved by the FDA, but because

there were several areas of concerns that may not have been successfully

addressed by the FDA, at the time of the ACIP

vote.

Section V

Centers for Disease Control and Prevention

The Advisory Committee on Immunizations Practices

A. Practices and Procedures of the

Advisory Committee on Immunization Practices (ACIP)

1. Purpose of the ACIP

ACIP provides advice and guidance on vaccine policy

to the Secretary of DHHS, the Assistant Secretary for Health, and the

Director of CDC. The ACIP develops written

recommendations, subject to the approval of the Director of the CDC, for

the

routine administration of vaccines to the pediatric

and adult populations, along with schedules regarding the appropriate

periodicity,

dosage, and contraindications applicable to the

vaccines.

The recommendation for routine use of a vaccine is

tantamount to a Federal mandate for vaccine use. HHS regulations

require that

all grants for childhood immunizations are subject

to the States’ implementation of procedures to ensure routine

vaccination. To

receive federal funding the States must, among other

things, require a plan to systematically immunize susceptible children

at school

entry through vigorous enforcement of school

immunization laws.[xlviii]

Additionally, the ACIP has been given a mandate from

Congress by the Omnibus Budget Reconciliation Act of 1993, to establish

and periodically review and, as appropriate, revise

a list of vaccines for administration to children in the Vaccine For

Children

Program (VFC), along with schedules regarding the

appropriate periodicity, dosage, and contraindications applicable to the

pediatric vaccines.[xlix] The VFC program provides

for public purchase of vaccines for children without health insurance

coverage. Under the VFC program, $474 million has

been obligated to pay for the purchase of vaccines in fiscal year 2000.

2. Membership of the ACIP

The ACIP has three different categories of

membership consisting of voting members, ex-officio members and liaison

representatives.

a. Voting Members of the ACIP

The ACIP has twelve voting members, including

the Chair, all approved by the Secretary of DHHS or his designee.[l]

The ACIP members are selected based upon their

expertise in the field of immunization practices.[li] The membership

consists of U.S. citizens that have

multi-disciplinary expertise in public health, and expertise in the use

of vaccines and

immunologic agents in both clinical and

preventive medicine. The ACIP membership is required by FACA and agency

guidelines to be fairly balanced in terms of

point of view represented and the committee’s function. Specifically,

the

CDC attempts to select members from diverse

backgrounds including geographic areas, gender, ethnic and minority

groups, and the disabled.

(i.) Procedure for nomination

to the ACIP

New members are nominated to the ACIP on

an annual basis. Suggestions for membership to the committee

are sought from a variety of sources

including current and former ACIP members, professional societies,

vaccine manufacturers and the general

public. A panel of government officials screens the candidates for

nomination to the committee and submits

a slate of possible nominees to the director of the CDC. With

approval of the CDC director, a

nomination package is prepared for the Secretary of DHHS who makes the

official appointments to the committee.

Committee members are nominated to serve

for overlapping four-year terms. Members may serve after the

expiration of their terms until their

successors have taken office.[lii]

b. Ex Officio Members of the ACIP

The ACIP charter designates seven non-voting

ex officio members to the committee from the following federal agencies:

1. Deputy Director, Division of Vaccine

Injury Compensation, Bureau of Health Professions, Health Resources and

Services Administration

2. Deputy Director for Scientific

Activities, Office for the Assistant Secretary of Defense

3. Under Secretary for Health,

Department of Veterans Affairs

4. Director, National Center for Drugs

and Biologics, Food and Drug Administration (FDA)

5. Medical Advisor, Medicaid Bureau,

Health Care Financing Administration (HVFA)

6. Director, Microbiology and Infectious

Diseases Program, National Institute of Allergy and Infectious Diseases,

HHS

7. Director, National Vaccine Program

Office, CDC[liii]

Generally, designees of the officials listed

above hold the ex officio positions. In contrast to regular voting

members, who

are expected to voice their personal opinions,

ex-officio members are expected, to the extent possible, to represent

the

position and views of their sponsoring

organizations.[liv]

c. Liaison Members:

In addition to the voting members and

ex-officio members, the ACIP charter specifies 16 additional non-voting

liaison

representatives from professional societies

and organizations responsible for the development and execution of

immunization programs for children and

adults. Like ex officio members, liaison members are expected, to the

extent

possible, to represent the positions and views

of their sponsoring organizations. Liaison members are expected to

contribute to committee discussions when

issues of importance to their organizations are being discussed. These

members can serve as appointed consultants to

working groups and subcommittees to provide expert advise and apprise

the working group of the position their

organization endorses.[lv]

The liaison representatives to the ACIP

consist of representatives from the following organizations:

1. American Academy of Family Physicians

2. American Academy of Pediatrics

3. American Association of Health Plans

4. American College of Obstetricians and

Gynecologists

5. American College of Physicians

6. American Hospital Association

7. American Medical Association

8. Association of Teachers of

Preventative Medicine

9. Canadian National Advisory Committee

on Immunization

10. Hospital Infection Control Practices

Advisory Committee, CDC

11. Infectious Diseases Society of America

12. National Medical Association

13. Pharmaceutical Research and

Manufacturers of America

14. National Vaccine Advisory Committee

15. Biotechnology Industry Organization

16. Secretario de Prevencion y control de

Enfermedades, Mexico

3. Decision-Making Process of the ACIP

a. Working Groups of the ACIP

When deemed appropriate by the Executive

Secretary and the Chair of the ACIP, working groups may be formed to

prepare draft policy recommendations to be

submitted to the full ACIP for its consideration. The working groups

must:

1) include one or more regular voting members,

2) include CDC staff members, 3) may include ex officio members and

liaison representatives and other consultants.

Vaccine manufacturer’s official representatives may not serve on working

groups but, at the discretion of the chair,

may be consultants to a working group.[lvi]

Generally, working groups range from six to

fifteen members.[lvii] The working group is charged with reviewing all

pertinent information relative to the

recommendation for use of a vaccine. No notice is given to the public of

working

group meetings and discussions of the group

are held in private. No minutes are taken at the meetings.

Upon drafting a proposed recommendation, the

chair will submit the draft proposal to the ACIP for consideration. The

ACIP members review the proposal and suggest

revisions to the working group. This process is generally repeated

numerous times. The process for making a final

recommendation to the full ACIP generally takes eighteen to twenty-four

months. The work that the working group does

contributes in large part to the recommendations for use of a vaccine

submitted to the Director for approval.

b. Full Meetings of the ACIP

Regularly scheduled meetings are usually held

three times a year, at the discretion of the CDC, with meeting dates

announced six to twelve months in advance.

Notices of each meeting, along with agenda items that may be discussed,

are published in the Federal Register in

accordance with the requirements of FACA. Potential topics for ACIP

consideration can be suggested by anyone, but

are most often proposed by CDC program staff, ACIP members, and

vaccine manufacturers.[lviii]

The meetings of the ACIP are held in public

and are widely attended by representatives from government, industry,

and

other interested parties. Frequent votes are

taken to decide on a given policy matter at hand. Whenever six or more

members are not eligible to vote by reason of

financial conflict or interest, the Executive Secretary has the

authority to

temporarily designate the ex-officio members

as voting members.

c. Final Recommendations for

Vaccine Use

ACIP recommendations are submitted to the

agency for approval. Upon acceptance by the agency, ACIP

recommendations are published in the Morbidity

and Mortality Weekly Report Recommendations and Report

published by the CDC. While the

recommendations by the ACIP to the CDC are subject to agency approval,

longtime

CDC officials do not remember an ACIP

recommendation that was not approved by the agency.[lix]

B. The ACIP Conflicts of Interest Resolution

Process

1. Disclosure Requirements for ACIP

Members

As an SGE, every member of the ACIP is required to

file the standard OGE form 450 confidential financial disclosure report

once

a year.[lx] New members of the ACIP must file a new

entrant report no later than 30 days after assuming their position. All

reports must cover the 12 months preceding the date

of filing.

Members must report specific sources of earned

income over $200 for the filer and $1,000 for the filer’s spouse. ACIP

members

must report all honoraria received in excess of

$200, along with the date services were provided. The $1,000 threshold

for

spousal earned income does not apply to honoraria,

because of special concerns about that form of income.[lxi] They must

also

report all assets held for investment or the

production of income with a fair market value greater than $1,000 at the

end of the

reporting period. The filer does not have to report

the dollar amount or values for any asset or income.[lxii]

2. Reviewer’s Responsibilities

The ACIP Deputy Ethics Officer, Mr. ph ,

is responsible for ensuring that the OGE 450 is completely and properly

filled out. Specifically, the reviewer is

required by the OGE to check for the completeness of

the financial disclosure form and that each asset and source of income

are listed separately.

3. ACIP Waiver Process

Waivers are granted to each and every member of the

ACIP whether or not they have conflicts of interests listed on their OGE

450. The ACIP issues “limited” 208 ((3) waivers

on an annual basis to members who have potential conflicts of interest.

The

waivers allow members to participate in all matters

that come before the ACIP, with the provisos that: (1) members recuse

themselves from voting on matters involving

vaccine-related entities where they have a current direct financial

interest and (2) that

they publicly disclose all relevant financial

interests at the beginning of each ACIP meeting.

The waiver states that under Section 208(a) the

members are under statutory obligation to refrain from participating in

any

deliberation that involves a particular matter

having a direct and predictable effect on a financial interest

attributed to them. They

provide that the deputy ethics counselor has the

authority under 18 U.S.C. §208((3) to grant a waiver permitting the

ACIP

member to participate in such matters as deemed

appropriate.[lxiii]

Waivers are requested by the Executive Secretary of

the ACIP, Dr. Dixie Snyder, Jr. CDC Legal Counsel Malone concurs

that the waiver is appropriate and the Deputy Ethics

Counselor, Mr. ph R. , is responsible for approving the

waiver. In

interviewing these individuals, the Committee staff

was told, “we generally give them to everyone…we give them out freely.”

The

CDC representatives explained, it is “the nature of

the industry that they will have conflicts…we will allow you to

participate if you

disclose your conflicts…we will let you discuss but

not vote.”[lxiv]

4. Work Sheets

The Executive Secretary prepares a work sheet prior

to every ACIP meeting detailing the conflicts of interest that members

may

have pertaining to the topics on the agenda. The

work sheet is only for his use and is not disclosed to the public. The

documents

are considered informal and are not saved by the

CDC.

C. Problems Identified During the Committee’s

Investigation

The Committee staff’s review of the ACIP’s

consideration of the rotavirus vaccine identified serious weaknesses in

the CDC’s

policing of conflicts of interest on this advisory

committee. On June 25, 1998, the ACIP voted to recommend the rotavirus

vaccine for routine use in infants. In reviewing

the minutes of ACIP meetings and the financial disclosure forms of the

ACIP

members, the Committee staff identified a number of

troubling issues:

1. ACIP Members Do Not Fully Disclose Conflicts

of Interest

Examination of ACIP members’ financial disclosure

forms reveals that many members do not fill them out completely. CDC

ethics

officials conceded to Committee staff that they have

been lax in compelling the ACIP members to provide complete and thorough

information.[lxv]

a. Dr. (Mimi) Glodé (Exhibits 3-15)

Dr. Glodé lists reviews of medical legal cases on her OGE

450 for 1996, 1997, 1998, 1099 at 5 per year for her and her spouse,

but does

not detail the law firms or clients for whom they do the

legal work. She only discloses that the maximum income allowed by

University of

Colorado is $10,000 per year.

Dr. Glodé and her spouse have attended

numerous conferences and received honoraria for their attendance.

However,

she does not list who the sponsors were in

1995, 1996, 1997, 1998, 1999. She states only that the honoraria given

was

from $500-$750 Per occurrence and were limited

to five per year; her spouse does 5-10 per year as well.

On her 1996 FDA financial disclosure form she

lists that she was a co-principal investigator on an $84,500 grant from

Chiron to study the MGNIN C Vaccine, $10,000

of which was a part of her salary. The study lasted for fifteen months

from 10/96-3/98. But on her CDC financial

disclosure forms for 1997, 1998, and 1999, this funding was not

mentioned

as required. Furthermore, the conflict was

not mentioned on the waivers granted to her by the CDC for the same

years.

According to the Federal conflict of interest

statutes she would not be able to participate in any deliberations

regarding

Chiron before the ACIP.

b. Dr. Marie

Dr. doesn’t fill out a new form each

year. She references previous year’s forms instead and adds any new

items

to the current year’s form. (Exhibit 18)

She lists “publicly traded stock,” but not

the specific companies on her 10/6/94, 2/95, 6/9/96, and 10/20/97 OGE

450.

This is not sufficient under the law. (Exhibit

16)

c. Dr. Offit

Dr. Offit lists that he is a consultant to

Merck on an attachment to his OGE 450, but does not disclose whether or

not he

received any remuneration for his services.

(Exhibit 39)

d. Dr. Clover

Dr. Clover lists legal fees paid by the law

firm of O’, Brown, and Toner, but not their client. (Exhibit 1)

The CDC informed the Committee staff that they

have been unhappy with the OGE 450 and are working on a

supplemental form. They stated that they

wanted a form that was more specific and easier to fill out. Two years

ago at

the June 24-25, 1998, ACIP meeting, CDC Legal

Counsel Malone stated his concerns to the ACIP:

“The 450 is a very frustrating form. All of

us use the same form too and it is very difficult to even figure out

what it is you should be disclosing. One of

the things we’ve talked about is producing a supplementary form

that would more explicitly lay out types of

issues because certainly if we’re going to be in a position that we

have to be announcing these interests, we

would also need to feel a little bit more confident, I think that

everything is being reported.”[lxvi]

However, two years later, the

supplemental form has yet to be put into use.

2. Every Member of the ACIP is

Granted a 208 ( Waiver for the Entire Year

The CDC grants blanket waivers to the ACIP

members each year that allow them to deliberate on any subject,

regardless of their conflicts, for the entire

year. In contrast, the FDA grants waivers on a meeting by meeting

basis,

taking into consideration the issues on the

agenda and the affected companies discussed. Moreover, the FDA provides

a list of parties that will be affected by

their vote so their members clearly understand when they can not

participate.

The CDC’s policy of issuing annual waivers

creates an environment where people do not take the conflict of interest

issue as seriously as they should. This

policy, in concert with sloppy monitoring of the completeness of

members'

financial disclosure statements, allows for a

clubby environment where ethical concerns are downplayed.

3. ACIP Members are Allowed to Vote

on Vaccine Recommendations, Even When They Have Financial Ties

to Drug Companies Developing Related or

Similar Vaccines

Members of the ACIP are allowed to vote on a

recommendation for one company’s vaccine even if they have financial

ties to a competing firm developing a similar

vaccine. For example, in the case of rotavirus vaccine, the vaccine

before

the advisory committee was developed by

Wyeth-Lederle. However, Merck and kline-Beecham had rotavirus

vaccines under development. A recommendation

for Wyeth-Lederle’s vaccine would help pave the way for future

recommendations for the products of Merck and

kline-Beecham.

While ACIP members with ties to Wyeth-Lederle

were not allowed to vote on recommendations for the rotavirus

vaccine, those with ties to Merck and

kline-Beecham were allowed to vote. This stands in stark contrast

to the

policies of the FDA. In discussions with FDA

staff on this specific issue they informed the Committee staff that when

the

VRBPAC is deliberating the licensure of a

vaccine, a company is considered affected [an affected company is one

with a

direct interest] if they are direct

competitors of the manufacturer of the vaccine being considered. They

further clarified

that that this policy was in place because of

the competing interest of the affected company and not because of

concerns

about the release of proprietary information.

Moreover, if a VRBPAC member has a direct interest with a competing

firm they are automatically disqualified from

participation.

At ACIP meetings from February 11, 1998,

through June 17, 1999, there were eight votes related to the their

approval

of the rotavirus vaccine for routine use.

Three of these votes were particularly notable. They include: (1) June

25, 1998

– The ACIP approved the statement recommending

the rotavirus vaccine for routine use, (2) October 22, 1998 – The

ACIP recommended the rotavirus vaccine be

added to the Vaccines for Children Program, and (3) October 22,

1999—the ACIP rescinded its earlier decision

to recommend the rotavirus vaccine.

a. Dr. Modlin—Chair beginning 2/11/98

(Exhibits 35-37)

Dr. Modlin owned 600 shares of stock in Merck

as listed on his OGE 450. He serves on Merck’s Immunization

Advisory Board but receives no remuneration.

Dr. Modlin informed committee staff that he divested his shares in Merck

some time in 1999.

Dr. Modlin was the Chairman of the Rotavirus

working group. He voted yes on eight different matters pertaining to

the

ACIPs rotavirus statement, including

recommending for routine use and for inclusion in the VFC program.

b. Dr. Offit (Exhibits 38-41)

Dr. Offit shares the patent on the Rotavirus

vaccine in development by Merck and lists a $350,000 grant from Merck

for

Rotavirus vaccine development. Also, he lists

that he is a consultant to Merck.

Dr. Offit began his tenure on ACIP in October

of 1998. Out of four votes pertaining to the ACIP’s rotavirus statement

he voted “yes” three times, including, voting

for the inclusion of the rotavirus vaccine in the VFC program.

Dr. Offit abstained from voting on the ACIP’s

rescission of the recommendation of the rotavirus vaccine for routine

use.

He stated at the meeting, “I’m not conflicted

with Wyeth, but because I consult with Merck on the development of

rotavirus vaccine, I would still prefer to

abstain because it creates a perception of conflict.”[lxvii]

c. Dr. Guerra (Exhibits 30-31)

Dr. Guerra lists a Contract with Merck Vaccine

Division from 2/99-8/99 on his OGE 450, and a donation of $25,000

by Merck, Pasteur Merieux Connaught, and

Medimmune (5/11/99 supplement to OGE 450). Also, he has a Contract

with kline-Beecham as a Principal

Investigator (pending 7/99).

Dr. Guerra voted yes on eight different

matters pertaining to the ACIP’s rotavirus statement, including

recommending for

routine use and for inclusion in the VFC

program.

d. Dr. Marie (Exhibits 16-29)

Dr. lists consultant fees (3/21/97)

and a salary from Merck relating to her position as Chair of Merck’s

Endpoint

Monitoring Committee on her OGE 450 (5/12/98 &

1/22/98).

She also lists consulting fees and travel

expenses paid by Merck. (Exhibit 22)

Her spouse is a consultant for American

Cyanamid (5/12/98 disclosure). American Cyanamid and Wyeth-Lederle are

Subsidiaries/divisions of American Home

Products Corporation.

Dr. voted on seven different matters

(yes six times and no once) pertaining to the ACIPs rotavirus statement,

including recommending yes for routine use and

for inclusion in the VFC program.

d. Dr. T. Chinh Le (Exhibits 32-34)

Dr. Le’s employer, Kaiser Permanente, is

participating in vaccine studies with Merck, Wyeth-Lederle, and

kline-Beecham. Additionally, Dr. Le owns

stock in Merck as reported on his OGE 450. Dr. Le abstained from

voting on all but one issue related to the

Rotavirus.

e. Dr. Clover (Exhibits 1-2)

Dr. Clover lists educational Grants from Merck

and kline-Beecham on his OGE 450. He voted on seven different

matters (six times and no once) pertaining to

the ACIPs rotavirus statement, including recommending voting yes for

routine use and for inclusion in the VFC

program.

4. Members Who are Not

Allowed to Vote on a Recommendation Due to Financial Conflicts are

Allowed to

Fully Participate in the Discussion Leading up

to a Vote

The “limited” 208((3) waiver process enacted

by the CDC allowing for discussion in all matters before the ACIP by

conflicted members appears to be in direct

contradiction to common practice at other DHHS agencies.

As stated succinctly by the Congressional

Research Service, “Clearly, the influence on Government policy from

advice

and persuasion during a “discussion” of a

particular recommendation, immediately preceding a vote on that

recommendation, is significant and is equal

under the law, to participating in a particular recommendation by way of

voting for or against that

recommendation.”[lxviii]

a. Inappropriate Statements by ACIP Members

Undoubtedly Influence the Process

This is evidenced by several exchanges between

Dr. T. Chinh Le and members of the ACIP. At one point during

deliberations on the rotavirus vaccine, he

said, “if I were to vote for this, I would vote for this routine

immunization” and

went on to encourage a two-dose regimen for

the vaccine.[lxix] Moreover, at the June 1998 ACIP, meeting during

which they approved the statement for routine

use of the rotavirus vaccine, he said 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.” When Committee staff queried CDC ethics officials

regarding these statements, they acknowledged

that they were inappropriate, and that they had discussed the issue with

Dr. Le.

Dr. Le abstained from all but one vote related

to the rotavirus vaccine because of significant conflicts of interest as

stated

earlier in this report. He did, however

participate extensively in deliberations on the rotavirus vaccine and

was a member

of the rotavirus working group.

CDC conflict of interest policies are contrary

to those of both the FDA, as cited earlier in this report, and that of

the

National Institutes of Health (NIH). The

Office of Federal Advisory Committee Policy (OFACP) at NIH clearly

states

that a 208 ((3) waiver “is considered a

‘general’ waiver, in that it allows participation in matters that affect

all

institutions, or types of institutions,

similarly. Even with a general waiver, however SGEs must disqualify

themselves from

participation in all matters that specifically

and uniquely affect their [particular] financial interest.”[lxx]

5. Liaison Representatives

Don’t have to Disclose Financial Conflicts of Their Organizations

Liaison representatives to the ACIP are not

considered SGEs by the CDC.[lxxi] As such, they are exempted from the

Federal conflict of interest statues the

financial disclosure process. In the process of investigating events

leading up to the

approval of the rotavirus vaccine, the

Committee staff has learned that the relationship between liaison

members and the

ACIP is substantially more formal than

described by the CDC.

ACIP liaison members provide more than the

just the opinions of their organization to the advisory committee’s

process.

Their role of the liaison representatives is

more like that of a de facto SGE than an advisory representative. They

are

central to the process of creating

recommendations for vaccine use by the ACIP. As official voting members

of working

groups that write draft recommendations for

the committee’s consideration, they are under routine supervision by CDC

staff and have meetings in government

offices. Moreover, their advice is solicited frequently by CDC

personnel on issues

where their organization has a financial

interest.

In a cursory review of publicly available

references and an internet search, the Committee staff was able to find

that the

following organizations that the ACIP liaison

representatives represent have ties to numerous vaccine manufacturers.

a. American Academy of Family

Pediatrics

Abbott Laboratories, American Home Products

Corporation, Aventis, Bayer Corporation, bioMerieux, Boehringer

Ingelheim Chemicals Co., Bristol-Myers Squibb

Company, Eli Lilly and Company, Forest Laboratories, G.D. Searle &

Co., Glaxo Wellcome plc, Janssen

Pharmaceutica, Lederle Laboratories, Merck & Co., Muro Pharmaceuticals,

Novartis, Novo Nordisk A/S, Ortho-McNeil

Pharmaceuticals, Otsuka America Pharmaceutical, Inc., Pasteur Merieux

Connaught, Pfizer, Inc., Pharmacia, Schering

AG, Schwarz Pharma, Inc., Kline Beecham, Solvay S.A.,

Warner-Lambert Company, and Wyeth-Ayerst

Laboratories .[lxxii]

b. American Academy of Pediatrics

Abbott Laboratories, Astra, Merck & Co.,

Pasteur Merieux Connaught, Pfizer, Inc., and

Kline Beecham.[lxxiii]

c. American College of Obstetricians and

Gynecologists

Berlex Laboratories, Eli Lilly and Company,

Novartis, Ortho McNeil Pharmaceutical,

Pharmacia, Schering AG, and

Wyeth-Ayerst.[lxxiv]

d. American Medical Association

Aventis, Glaxo Wellcome plc, Merck & Co.,

Pfizer, and Shering AG.[lxxv]

e. Infectious Disease Society of America

Aventis and Bristol-Myers Squibb

Company.[lxxvi]

f. Biotechnology Industry Organization

Merck & Co., Wyeth-Ayerst and many other

pharmaceutical companies.[lxxvii]

g. Pharmaceutical Research and Manufacturers

of America

6.The Use of Working Groups is Contrary to the FACA

(Exhibit 71)

a. Members of the Rotavirus Working

Group of the ACIP

The ACIP rotavirus work group was responsible

for creating the statement recommending universal use of the rotavirus

vaccine. The working group has ten members,

seven of whom have identifiable conflicts of interest with vaccine

manufacturers or vaccine interest groups. The

group’s meetings were held in private with no minutes or records of the

proceedings taken. It appears that members

who were not allowed to vote because of conflicts of interest with

Wyeth-Lederle, such as Dr. Le, were allowed to

work extensively on the recommendation for a long period of time in

the working group.

The broad ability to grant waivers from the

federal conflict of interest statutes was specifically enacted because

of the

statutory requirements and safeguards of the

FACA. FACA requires that advisory committees hold public meetings,

except in unusual circumstances. As such,

deliberations of advisory committees are open to the most exacting

public

scrutiny. These requirements are to ensure

public scrutiny of advisory committees operations and ensure that it is

not a

secretive or hidden vehicle for special

interest influence.[lxxviii] The ACIPs prolific use of working groups

to draft

vaccine policy recommendations outside the

specter of public scrutiny opens the door to undo special interest

access.

i. Modlin, M.D., Chairman

Chinh T. Le, M.D.

W. Fleming, M.D

ACIP Voting Members

Dr. Le has conflicts with Wyeth Lederle

and kline-Beecham and Dr. Modlin has a conflict with Merck as

described in this report.

ii. I. Glass, M.D., Ph.D.

ph S. Bresee, M.D.

Centers for Disease Control and

Prevention

National Center of Viral and Rickettsial

Diseases

National Center for Infectious Diseases

iii. Margaret Rennels, M. D.

Department of Pediatrics, University of land

Her employers website states that she

participated in virtually all phases of the testing of the licensed

rotavirus

vaccine[lxxix] Also, she is affiliated

with U.S. Rotavirus Efficacy Group[lxxx]

iv. Zimmerman, M.D.

American Academy of Family Physicians (AAFP)

The AAFP has conflicts with numerous

vaccine manufacturers as described in this report.

v. Neal A. Halsey, M.D.

American Academy of Pediatrics

At the time of the rotavirus approval meeting,

Dr. Halsey was seeking start-up funds from most of the vaccine

manufacturers for the establishment of an

institute for vaccine safety at s Hopkins University, where he

works. He

has already received $50,000 from Merck and

was awaiting funds from Wyeth Lederle. (Exhibit 56) He has received

frequent reimbursements for travel expenses

and honoraria from companies such as Merck.

Dr. Halsey Serves on the advisory board to the

Immunization Action Coalition, an advocacy group funded by vaccine

makers including: Aventis Pasteur, Chiron

Corporation, Glaxo Wellcome, Merck & Co., Nabi, North American

Vaccine, Kline-Beecham, Wyeth-Lederle

Vaccines.[lxxxi]

vi. Paradiso, Ph.D.

Lederle-Praxis Biologicals Division

Wyeth-Lederle Vaccines and pediatrics

vii. Florian Schodel, M.D.

Office for Clinical Vaccine Research

Merck Research Labs

7. ACIP is not Fairly

Balanced in terms of the Points of View Represented

According to section 5 of FACA, membership on

an advisory committee must be “fairly balanced in terms of points of

view represented and the functions to be

performed . . . ” and the advice and recommendations of the advisory

committee cannot be “inappropriately

influenced by the appointing authority or by any special interest.”

The absence of any consumer advocates on the

ACIP has resulted in an advisory committee that is inherently not

“fairly

balanced.” It is clear to the Committee that

the intent of the FACA was for individuals who are affected by the work

of

the ACIP, in this case vaccine recipients, to

have significant representation on the committee.

The ACIP’s use of ex officio members, who are

all government employees, in a voting capacity contradicts the notion of

an advisory committee. Advisory committees

are intended to provide independent information and advice to the

government. In discussions with CDC staff,

the Committee was informed that there are no records of an ex officio

member ever voting no on an issue before the

ACIP. This policy encourages a system where government officials make

crucial decisions affecting American children

without the advice and consent of the governed.

Congress sought to eliminate “the danger of

allowing special interest groups to exercise undue influence upon the

Government through dominance of advisory

committees which deal with matters in which they have vested

interests.”[lxxxii] However, the extensive

use of working groups, in which conflict of interest procedures do not

appear

to be implemented, and the automatic waivers

given to every advisory committee member, along with the absence of

consumer representation, appear to thwart this

goal.

Section VI

Recommendations

As a result of the review of the ACIP and VRBAC practices,

the following Committee has the following recommendations to the

Department of Health and Human Services:

1. Individuals who serve on advisory

committees involving vaccines should have no financial ties to vaccine

manufacturers.

2. Public participation on ACIP and VRBAC

needs to be increased substantially.

3. Conflict of Interest waivers should be

used more stringently.

4. A balance of policy perspectives

should be incorporated into consideration of appointments of committee

members.

5. Any level of stock ownership in

vaccine manufacturers should not be allowed by committee members.

6. Department personnel need to insure

that all documentation is fully and adequately completed.

7. Full explanation of participation as

expert witnesses in legal cases needs to be a part of financial

disclosures.

8. Individuals who have patents for

vaccines for the same disease under discussion should not be allowed to

participate in the

discussion or vote of ACIP or VRBAC.

9. Individuals who are developing

vaccines for the same disease under discussion should be not be allowed

to participate in the

discussion or vote of ACIP and VRBAC.

10. Working groups should be replaced by

fully constituted Subcommittees on both the VRBAC and ACIP.

11. Individuals should not be allowed to

participate on two DHHS advisory committees at the same time.

12. Individuals should not serve excessively

long terms on a committee.

13. The FDA should reconsider its policy on

using temporary voting members.

14. ACIP should not consider making a

recommendation on a vaccine until it has been licensed by the FDA.

15. CDC should follow the same policy in

identifying affected companies for vaccine discussions as the FDA does

and exclude

participation of any individual who has a conflict.

16. Organizations who send liaison members to

participate in council meetings, should offer full disclosure of ties to

the pharmaceutical

industry.

17. The Department should review its policies

and practices regarding conflicts of interest, participation on advisory

committees, and

terms of service, public participation, and balance

of views and expertise.

5 U.S.C. app. II (1994).

[ii]Ensuring Coverage, Balance, Openness and Ethical

Conduct for Advisory Committee Members Under the Federal Advisory

Committee Act, 5 Admin. L.J. 231, Palladino,

Spring, 1991.

[iii]5 U.S.C. app. II '7©. The guidelines for

the Food and Drug Administration=s advisory committee are set forth in 5

C.F.R.

'2640 (1994)

[iv]5 U.S.C. app. II '2((6) (1994).

[v]5 U.S.C., '10 (.

[vi]5 U.S.C., '5 ((2).

[vii]5 U.S.C., '5((3).

[viii]18 U.S.C. ''202-209.

[ix]18 U.S.C. '208.

[x]18 U.S.C. '208((1).

[xi]18 U.S.C. '208((2).

[xii]18 U.S.C. '208((3).

[xiii]FACA amendments of 1989

[xiv]5 C.F.R. '2640.103(a)(1).

[xv]5 C.F.R. '2640.102(l).

[xvi]5 C.F.R. '2640.102(m).

[xvii]5 C.F.R. '2640.103(a)(3).

[xviii]Id.

[xix]Id. at (.

[xx]Id. at ©(5).

[xxi]5 C.F.R. ' 2635.807.

[xxii]5 C.F.R. '2635.502.

[xxiii] Minutes of ACIP meeting, October 22, 1999 at

51.

[xxiv] Bad Bug Book, U.S. Food & Drug

Administration, Center for Food Safety & Applied Nutrition, Foodborne

Pathogenic

Microorganisms and Natural Toxins Handbook, Chapter 33

http://vm.cfsan.fda.gov/~mow/chap33.html.

[xxv] Minutes of ACIP meeting, October 22, 1999,

56-57.

[xxvi] CDC’s Rotavirus Q & A

http://www.cdc.gov/nip/Q & A/genqa/Rotavirus.htm.

[xxvii] Rotashield Package Insert, Wyeth-Ayerst, 13.

[xxviii]VRBPAC charter, DHHS, 12/21/99.

[xxix]5 C.F.R. '2640.103(a).

[xxx]Waiver Criteria Document 2000, FDA, 2.

(Replacing the AWaiver Criteria Document (1994).@)

[xxxi]Id. at 19.

[xxxii]Id. at 23.

[xxxiii]Id. at 20. Where the grant or contract

relates to the subject matter of the committee discussion, an actual

conflict may

arise. In situations where the grant or contract is

unrelated to the product at issue, an appearance problem may arise. In

either situation the

conflict of interest may be waived and the member allowed

to participate.

[xxxiv]Id. at 17.

[xxxv]Policy and Guidance, Handbook for FDA Advisory

Committees, 12.

[xxxvi]Waiver Criteria Document (2000), FDA, 19.

[xxxvii]Id.

[xxxviii] VRBPAC " Rotashield " rotavirus vaccine

approval meeting transcript, page 210, December 12, 1997.

[xxxix]A copy of the waiver forms have not been

provided to the Committee.

[xl]The NIAID is the original developer of the

Rotashield and other rotavirus vaccines. According to the FDA, as

stated in Dr.

Caroline Hall=s AConflict of Interest Waiver@ form, Wyeth

received the rights to further develop the Rotashield from NIAID and it

is

unknown which rotavirus vaccine was licensed to Wyeth by

the NIAID.

[xli]Please see VRBPAC Charter. Exhibit 54

[xlii]See further discussion of the ACIP rotavirus

working group in the ACIP section of this report. Section IV

[xliii]Consultants may be allowed to participate in

the committee=s discussion, but may not vote, unless designated a

temporary

voting member in advance of the meeting.

[xliv]According to the DHHS policy, members cannot

serve for more than eight combined years within a period of 12 years.

[xlv]Letter from Mr. Doleski, FDA, to the

Government Reform Committee (March 30, 2000), stating that the DHHS

policy

states that AFederal advisory committee members will not:

...serve on more than one committee within an agency at the same time.@

[xlvi]Some of the frequent temporary members and

consultants in the past few years include: Dr. Fleming (at least 4

meetings from

7/96 to 12/97); Dr. Karzon (at least 5 meetings between

4/96 until 9/99); Dr. Snider (at least 4 meetings in 1997, before

becoming a

standing member in 1998); Dr. Broome ( 8 meetings from

4/96 to 12/97); Dr. Diane Finkelstein (consultant in at least 5 meetings

from 4/96

to 12/97, when she became a standing member); Dr.

Theodore Eickhoff (consultant on at least 8 meetings from 4/96 to 9/99);

Dr. Rob

Breiman (4 meetings from 11/98 to 9/99).

[xlvii] For example, Dr. Ferrieri (at least 4

meetings past her appointment ); Dr. Poland (at least 2 meetings

past his

appointment); Dr. Alison O=Brien ( at least 3 meetings

past her appointment) and Ms. Cole (1 meeting past her

appointment).

[xlviii] 42 C.F.R. §51b.204

[xlix] Section 1928 of the Social Security Act (42

U.S.C. § 1396s), as added by Section 13631 of the Omnibus Budget

Reconciliation Act of 1993

[l] ACIP Charter, May 3, 1998 as approved by

Broome, Acting Director CDC (Exhibit 72)

[li] ACIP Charter, May 3, 1998 as approved by

Broome, Acting Director CDC, 2

[lii] ACIP Charter, May 3, 1998 as approved by

Broome, Acting Director CDC, 3

[liii] ACIP Charter, May 3, 1998 as approved by

Broome, Acting Director CDC, 2

[liv] The Advisory Committee on Immunization

Practices, Centers for Disease Control and Prevention, Policies and

Procedures for

Development of Recommendations for Vaccine Use and for the

Vaccines for Children, January 2000, 4 (Exhibit 73)

[lv] ACIP Charter, May 3, 1998 as approved by

Broome, Acting Director CDC, 4

[lvi] The Advisory Committee on Immunization

Practices, Centers for Disease Control and Prevention, Policies and

procedures for

Development of Recommendations for Vaccine Use and for the

Vaccines for Children, January 2000.

[lvii] Telephone interview of Dr. Modlin (June

9, 2000).

[lviii] The Advisory Committee on Immunization

Practices, Centers for Disease Control and Prevention, Policies and

Procedures

for Development of Recommendations for Vaccine Use and for

the Vaccines for Children, January 2000.

[lix] Interview of Dr. Dixie Snider, Mr.

Malone and Mr. Joe (June 1, 2000).

[lx] 5 C.F.R. § 2634.904(.

[lxi] OGE Form 450: A review Guide, U.S. Office of

Government Ethics, 15 (September 1996).

[lxii] OGE Form 450: A review Guide, U.S. Office of

Government Ethics, 15 (September 1996).

[lxiii] Cited from a several examples of waivers

provided by the CDC to the Government Reform Committee.

[lxiv] Interview of Dr. Dixie Snider, Mr.

Malone and Mr. Joe (June 1, 2000).

[lxv] Interview of Dr. Dixie Snider, Mr.

Malone and Mr. Joe (June 1, 2000).

[lxvi] ACIP Meeting June 24, 1998, 41.

[lxvii] ACIP Meeting, October 22, 1999.

[lxviii] Conflicts of Interest and the

Disqualification of Federal Advisory Committee Members, Congressional

Research Service

Memorandum, June 6, 2000.

[lxix] ACIP Meeting Minutes, February 11 and 12,

1998.

[lxx] Ethics Rules for Advisory Committee Members,

for committee members appointed to serve on HHS advisory committees as

SGEs, NIH Office of Federal Advisory Committee Policy

(OFACP), 4, http://www1.od.nih.gov/cmo/sge.htm.

[lxxi] Interview of Dr. Dixie Snider, Mr.

Malone and Mr. Joe (June 1, 2000).

[lxxii] http://www.aafp.org.

[lxxiii] http://www.aap.org.

[lxxiv] http://www.acog.org;

http://www.figo2000.com/sponsors.cfm.

[lxxv] http://www.ama-assn.org.

[lxxvi] http://www.idsociety.org/pd/grants_toc.htm.

[lxxvii] http://www.bio.org.

[lxxviii] Conflicts of Interest and the

Disqualification of Federal Advisory Committee Members, Congressional

Research Service

Memorandum, June 6, 2000.

[lxxix] http://som1.umaryland.edu/research.html.

[lxxx] ACIP Meeting, February 13, 1997.

[lxxxi] http://www.immunize.org/admin/funding.htm.

[lxxxii] FAC Standards ACT, supra note 10, at 6,

reprinted in FACA Source Book, supra note 2, at 276, citing Hearings on

H.R.

4383 Before the Legal and Monetary Affairs Subcommittee.

Of the House Comm. On Government Operations, 92 Cong., 2d Sess., at

13-55 (1971), reprinted in 1972 U.S. Code Cong. & Admin.

News 3434-76.

Committee on Government Reform

2157 Rayburn House Office

Building

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