[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
FACA: CONFLICTS OF INTEREST AND VACCINE DEVELOPMENT--PRESERVING THE
INTEGRITY OF THE PROCESS
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
JUNE 15, 2000
__________
Serial No. 106-239
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
73-042 DTP WASHINGTON : 2001
_______________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government Printing
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Mail: Stop SSOP, Washington, DC 20402-0001
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH-HAGE, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Lisa Smith Arafune, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on June 15, 2000.................................... 1
Statement of:
Glynn, Marilyn, general counsel, Office of Government Ethics;
and James Dean, Director, Office of Governmentwide Policy,
U.S. General Services Administration....................... 26
Suydam, Linda A., D.P.A., Senior Associate Commissioner, Food
and Drug Administration; and Dr. Dixie Snider, Jr., M.D.,
executive secretary, Advisory Committee on Immunization
Practices, Centers for Disease Control, accompanied by
Kevin Malone, Jennie Slaughter, Bill Freas, and Nancy
Cherry..................................................... 59
Letters, statements, etc., submitted for the record by:
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 9
Chenoweth-Hage, Hon. Helen, a Representative in Congress from
the State of Idaho, prepared statement of.................. 122
Davis, Hon. Danny K., a Representative in Congress from the
State of Illinois, prepared statement of................... 21
Dean, James, Director, Office of Governmentwide Policy, U.S.
General Services Administration, prepared statement of..... 36
Gilman, Hon. Benjamin A., a Representative in Congress from
the State of New York, prepared statement of............... 107
Glynn, Marilyn, general counsel, Office of Government Ethics,
prepared statement of...................................... 28
Snider, Dr. Dixie, Jr., M.D., executive secretary, Advisory
Committee on Immunization Practices, Centers for Disease
Control, prepared statement of............................. 89
Suydam, Linda A., D.P.A., Senior Associate Commissioner, Food
and Drug Administration, prepared statement of............. 62
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 18
FACA: CONFLICTS OF INTEREST AND VACCINE DEVELOPMENT--PRESERVING THE
INTEGRITY OF THE PROCESS
----------
THURSDAY, JUNE 15, 2000
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 1 p.m., in room
2154, Rayburn House Office Building, Hon. Dan Burton (chairman
of the committee) presiding.
Present: Representatives Burton, Gilman, Ros-Lehtinen,
Waxman, Norton, Kucinich, and Davis of Illinois.
Staff present: Kevin Binger, staff director; James C.
Wilson, chief counsel; David A. Kass, deputy counsel and
parliamentarian; Mark Corallo, director of communications; S.
Elizabeth Clay and Nat Weinecke, professional staff members;
Robert Briggs, clerk; John Sare, staff assistant; Robin Butler,
office manager; Michael Canty, legislative aide; Toni Lightle,
legislative assistant; Leneal Scott, computer systems manager;
Lisa Smith Arafune, chief clerk; Corinne Zaccagnini, systems
administrator; Phil Barnett, minority chief counsel; Sarah
Despres, minority counsel; David McMillen, minority
professional staff member; Ellen Rayner, minority chief clerk;
and Jean Gosa and Earley Green, minority assistant clerks.
Mr. Burton. The hearing will come to order.
Before we begin, I ask unanimous consent that statements
from members of the committee and witnesses before the
committee may be included in the record as well as an other
materials they may submit.
Mr. Waxman. I reserve the right to object. I would
certainly withdraw my objection to those particular documents,
but I think that I, at this point, have to object to that
blanket request, have to object.
Mr. Burton. So you are reserving your right to object on
that?
Mr. Waxman. I do object at this point.
Mr. Burton. Well, all right. I had one more unanimous
consent request as well, Mr. Waxman, which I believe you will
object to as well, so why don't we get them all together here.
I ask unanimous consent that a set of exhibits which have
been shared with the minority prior to the hearing be included
in the record without objection.
Mr. Waxman. I reserve the right to object to that. These
are--Mr. Chairman, I'm reserving my right to object and I'd
like to be recognized on my reservation.
The reason I do not plan to object is not out of concern
that we would in any way fail to disclose conflicts of
interest, but because of the Ethics in Government Act. People
submitted their own private financial information under a law
that said once they make this submission, it will not be made
public. And on that basis, those were the rules under which
they have volunteered to serve on various Government panels and
have given this information to the appropriate agencies.
The reason they give this information is that if there's a
conflict of interest, the agency will know about it, because it
will be disclosed. If it's a conflict that goes to a narrow
point, they may not be able to vote on that point. If it's a
broader conflict, they shouldn't be serving on the advisory
committee or any other commission at all. That's the Ethics in
Government law.
But for us to in any way disclose what was, here today in
the Congress, what was given to an agency with the
understanding under the Ethics of Government law that it not be
made public seems to be an inappropriate thing to do. So I
don't think we ought to be making anything public that was
given to our committee with the expectation that the Ethics in
Government law would have prevented us as it would any other
agency of Government from making that information public. So on
that basis, I will object to your unanimous consent request.
Mr. Burton. Well, I have one more unanimous consent request
which you may want to object to, too, and then I'll respond. I
also ask unanimous consent that a staff report by majority
staff be included in the record, and without objection----
Mr. Waxman. Mr. Chairman, I do reserve the right to object.
The staff report, as I understand it, refers to some of the
documents that were part of the financial disclosures that
under the Ethics in Government law were not to have been made
public by anyone. And on that basis, I don't think the staff
report, insofar as it incorporates that kind of information,
should be made public, and I wouldn't agree to it. And
therefore, wouldn't want to go along with the unanimous consent
request.
And I particularly wouldn't want to go along and give a
unanimous consent request to a report that we have not even
seen. We haven't even seen this report, we who are on this
committee. So we don't know what's in it. So until I know
what's in it, I'm not going to agree to release it, if it has
information that may be improper to release. So I do object.
Mr. Burton. Well, I understand that in the case of our
majority report and your minority reports, we very rarely see
yours either. So I disagree, Mr. Waxman, with your
interpretation of the law. I've had our lawyers review it. It's
clear to us that your interpretation is incorrect. I have a
letter that I've sent to you explaining our views, and I think
you have that.
It's clear from a reading of the entire section that the
provisions refer to the agency in question and particularly
their ethics officials. As you know, Congress guards its rights
to conduct oversight and make information public very
jealously. It doesn't make any sense to suggest that Congress
would pass a law that would stop it from making public
information about conflicts of interest and undue influence of
special interests. Nowhere in this entire section is Congress
referred to.
However, I will withdraw my unanimous consent request. I
will not issue our staff report today. I believe that every
place where we have referred to financial disclosure form
information, that information is publicly available. For
instance, at the beginning of every advisory committee meeting
at the CDC, the Centers for Disease Control, the members go
around the table and disclose their conflicts in public.
It is my intention, however, to use documents during the
hearing. Under the rules, the committee documents are available
for use by all Members during hearings. I think that it's
pretty clear that drug companies do have influence on these
advisory panels and these committees, and I don't think it's
proper. I think the public needs to know about that. They have
a right to know about that.
And we will proceed in the proper manner.
Mr. Waxman. Mr. Chairman, I'd like to make a point of
order.
Mr. Burton. The gentleman will state his point of order.
Mr. Waxman. Under Rule 11(2)(k)(8), which refers to
documents that could be disclosed, you already indicated you
plan to refer to and therefore in the course of this hearing
make public these very same documents that I think should not
be made public. And I want you to rule, under the rules of the
House, that it would not be pertinent to our hearing to release
those documents.
I want to read the section of the law. The section of the
law, the Ethics in Government law, says, any information
required to be provided by an individual under this subsection
shall be confidential and shall not be disclosed to the public.
Now, as I understand your argument, you think the Congress can
make the disclosure to the public, even though the law says it
shall not be disclosed to the public.
When the Republicans took control of the House of
Representatives in January 1995, we adopted rules saying that
we will be subject to the same rules that outside groups have
imposed upon them, whether it be OSHA rules or civil rights
laws or anything else. Under the spirit of that notion that we
should be guided by the same rules that apply to others, I
think that the Congress of the United States should not be
permitted to make available to the public or disclose to the
public that which no other agency of Government, no one working
for any of those agencies of Government, no one else would be
permitted to do without violating the law.
And in fact, I would submit that even this committee would
be violating the law should we disclose this information. So I
make at this point a point of order that the Chair rule that
the information that he appears to be willing to disclose, not
be disclosed based on these arguments, and the rules of the
House that would prevent disclosure of information under Rule
11(2)(k)(8).
Mr. Burton. First of all, before I rule on your point of
order, there was never any agreement with Health and Human
Services that these documents would not be made public. I have
a copy of a letter that I sent to Dr. Shalala, and I'll read
from that. It says, the documents produced to the committee in
response to the October 1st request will be treated as
committee documents. Committee rules state that all committee
documents shall be available for use by members of the
committee during committee meetings.
Beyond this, if there is a determination that committee
documents should be made public, it has been the practice of
this committee to do so only upon agreement between the
chairman and ranking minority member, or by vote of the
committee. When and if committee documents are made public,
appropriate redactions are made to delete personal information
such as home phone numbers and addresses, social security
numbers or bank account numbers. It's my intention that these
documents referred to above shall be treated in this manner.
Now, the documents, the documents are pertinent to this
hearing, and therefore the point of order is overruled.
Mr. Waxman. Mr. Chairman, before you make your decision,
which I fully expect to be contrary to my argument, I do want
to point out in that letter that you wrote to Donna Shalala,
the Secretary of HHS, you said when and if committee documents
are made public, appropriate redactions are made to delete
personal information, such as home phone numbers and addresses,
social security numbers or bank account numbers. It's my
intention the documents referred to above shall be treated in
this manner.
As I understand, what you plan to do today is to refer to
financial disclosures. It seems to me that in the spirit of
this letter, some of those things could be redacted. But all of
the information will be made public about individuals who
submitted these financial disclosures with a clear
understanding, because the law spells it out for them, that in
doing so, when they volunteer then to serve on a committee,
that their financial holdings and information about their
financial personal situation would not be made public.
So I want to point that out, and I don't know if that will
persuade you differently on the ruling on my point of order,
but I think it's important to put on the record.
Mr. Burton. Well, we have said that we're not going to make
those documents public today. However, the committee can use
all documents that we have in the course of discussion of the
hearing and will do so. And your point of order is overruled.
We'll now proceed with, let's see, I have one more thing. I
also ask unanimous consent that questioning under this matter
proceed under clause 2(j)(2) of House rule 11 and committee
rule 14, in which the chairman and the ranking minority member
allocate time to members of the committee as they deem
appropriate for extended questioning, not to exceed 60 minutes
equally divided between the majority and the minority. And
without objection, so ordered.
Today we're going to continue our series of hearings on
vaccine policy. For the last few months, we've been focusing on
two important advisory committees. The Food and Drug
Administration and the Centers for Disease Control and
Prevention rely on these advisory committees to help them make
vaccine policies that affect every child in America. We've
looked very carefully at conflicts of interest. We've taken a
good, hard look at whether the pharmaceutical industry has too
much influence over these committees.
From the evidence we've found, we believe that they do. The
first committee is the Food and Drug Administration's Vaccine
and Related Biological Products Advisory Committee. This
committee makes recommendations on whether new vaccines should
be licensed.
The second committee is the CDC's Advisory Committee on
Immunization Practices. This committee recommends which
vaccines should be included in the childhood immunization
schedule.
To make these issues easier to understand, we're going to
focus on one issue handled by these two committees, the
rotavirus vaccine. There are other vaccines that we may get
into later, but today we're going to use this as the primary
example.
It was approved for use by the FDA in August 1998. It was
recommended for universal use by the CDC in March 1999. Serious
problems cropped shortly after it was introduced. Children
started developing serious bowel obstructions. The vaccine was
pulled from the U.S. market in October 1999.
So the question is, was there evidence to indicate that the
vaccine was not safe, and if so, why was it licensed in the
first place? How good a job did the advisory committees do?
We reviewed the minutes of the meetings. At the FDA's
committee, there were discussions about adverse events. They
were aware of potential problems. Five children out of 10,000
developed bowel obstructions. There were also concerns about
children failing to thrive and developing high fevers, which as
we know from other vaccine hearings, can lead to brain injury.
Even with all of these concerns, the committee voted
unanimously to approve it.
At the CDC's committee, there was a lot of discussion about
whether the benefits of the vaccine really justified the cost.
Even though the cost benefit ratio was questioned, the
committee voted unanimously to approve it.
Were they vigilant enough? Were they influenced by the
pharmaceutical industry? Was there appropriate balance of
expertise and perspective on vaccine issues?
We've been reviewing their financial disclosure statements.
We've interviewed staff from the FDA and the CDC. The staff has
prepared a staff report summarizing what we found. At the end
of this statement, while I won't ask unanimous consent to enter
this report in the record today, I've already agreed not to do
that, we've identified a number of problems that need to be
brought to light, and we will be discussing those.
Families need to have confidence that the vaccines that
their children take are safe, effective and very necessary.
Doctors need to feel confident that when the FDA licenses a
drug, that it's really safe and that the pharmaceutical
industry has not influenced the decisionmaking process. Doctors
place trust in the FDA and assume that if the FDA has licensed
a drug, it's safe for use.
Has that trust been violated? How confident in the safety
and need of specific vaccines would doctors and parents be if
they learned the following: One, that members, including the
chair of the FDA and CDC advisory committees who make these
decisions own stock in drug companies that make the vaccines.
Two, that individuals on both advisory committees own patents
for vaccines under consideration, or affected by the decisions
of the committees.
Three, that three out of the five of the members of the
FDA's advisory committee who voted for the rotavirus vaccine
had conflicts of interest that were waived. Four, that 7
individuals of the 15 member FDA advisory committee were not
present at the meeting. Two others were excluded from the vote,
and the remaining five were joined by five temporary voting
members who all voted to license the product.
Five, that the CDC grants conflict of interest waivers to
every member of their advisory committee a year at a time, and
allows full participation in the discussions leading up to a
vote by every member, whether they have a financial stake in
the decision or not. So they're discussing it, influencing
other members possibly, whether they have a financial stake or
not.
Sixth, that the CDC's advisory committee has no public
members, no parents have a vote in whether or not a vaccine
belongs on the childhood immunization schedule. The FDA's
committee only has one public member.
These are just a few of the problems we found. Specific
examples of this include Dr. John Modlin. He served for 4 years
on the CDC advisory committee and became the chair in February
1998. He participated in the FDA's committee as well. He owns
stock in Merck, one of the largest manufacturers of the
vaccine, valued at $26,000. He also serves on Merck's
immunization advisory board.
Dr. Modlin was the chairman of the rotavirus working group.
He voted yes on eight different matters pertaining to the
ACIP's rotavirus statement, including recommending for routine
use and for inclusions in the Vaccines for Children program. It
was not until this past year that Dr. Modlin decided to divest
himself of his vaccine manufacturer stock.
At our April 6th autism hearing, Dr. Paul Offit disclosed
that he holds a patent on a rotavirus vaccine and receives
grant money from Merck to develop this vaccine. He also
disclosed that he is paid by the pharmaceutical industry to
travel around the country and teach doctors that vaccines are
safe. Dr. Offit is a member of the CDC's advisory committee and
voted on three rotavirus issues, including making the
recommendation of adding the rotavirus vaccine to the Vaccines
for Children program.
Dr. Patricia Ferrieri, during her tenure as chair of the
FDA's advisory committee, owned stock in Merck valued at about
$20,000 and was granted a full waiver.
Dr. Neal Halsey, who serves as a liaison member to the CDC
committee on behalf of the American Association of Pediatrics,
and is a consultant to the FDA's committee, has extensive ties
to the pharmaceutical industry, including having solicited and
received startup funds from industry for his Vaccine Center. As
a liaison member to the CDC committee, Dr. Halsey is there to
represent the opinions of the organizations he represents, but
was found in the transcripts to be offering his personal
opinion.
Dr. Harry Greenberg, who serves as chair of the FDA
committee, owns $120,000 of stock in Aviron, a vaccine
manufacturer. He also is a paid member of the board of advisors
of Chiron, another vaccine manufacturer, and owns $40,000 of
stock. This stock ownership was deemed not to be a conflict,
and a waiver was granted. To the FDA's credit, he was excluded
from the rotavirus discussion, because he holds the patent on
the Rotashield vaccine.
How confident can we be in the process when we learned that
most of the work of the CDC advisory committee is done in
``working groups'' that meet behind closed doors, out of the
public eye? Members who can't vote in the full committee
because of conflicts of interest are allowed to work on the
same issues in working groups, and there is no public scrutiny.
I was appalled to learn that at least 6 of the 10 individuals
who participated in the working group for the rotavirus vaccine
had financial ties to pharmaceutical companies developing
rotavirus vaccines.
How confident can we be in the recommendations for the Food
and Drug Administration when the chairman and other individuals
on their advisory committee own stock in major manufacturers of
vaccines?
How confident can we be in a system when the agency seems
to feel that the number of experts is so few around the country
that everyone has a conflict and thus waivers must be granted?
It almost appears that there is an ``old boys network'' of
vaccine advisors that rotate between the CDC and FDA, at times
serving simultaneously. Some of these individuals served for
more than 4 years. We found one instance where an individual
served for 16 years continuously on the CDC committee. With
over 700,000 physicians in this country, how can one person be
so indispensable that they stay on a committee for 16 years?
It's important to determine if the Department of Health and
Human Services has become complacent in their implementation of
the legal requirements on conflicts of interest and committee
management. If the law is too loose, we need to change it. if
the agencies aren't doing their job, they need to be held
accountable. That's the purpose of this hearing, to try to
determine what needs to be done.
Why is this review necessary? Vaccines are the only
substances that a government mandates a U.S. citizen receive.
State governments have the authority to mandate vaccines be
given to children prior to admission to day care centers and
schools. State governments rely on the recommendations of the
CDC and the FDA to determine the type and schedule of vaccines.
I am not alone in my concern about the increasing influence
of industry on medicine. Last year, the New England Journal of
Medicine learned that 18 individuals who wrote drug therapy
review articles had financial ties to the manufacturer of the
drugs they were discussing. The Journal, which has the most
stringent conflict of interest disclosures of medical journals,
had a recent editorial discussing the increasing level of
academic research funded by the industry. The editor stated,
``What is at issue is not whether researchers can be `bought'
in the sense of a quid pro quo, is that close and remunerative
collaboration with a company naturally creates goodwill on the
part of the researchers and the hope that the largesse will
continue. This attitude can subtly influence scientific
judgment.''
Can the FDA and the CDC really believe that scientists are
more immune to self-interest than anybody else?
Maintaining the highest level of integrity over the entire
spectrum of vaccine development and implementation is
essential. The American people have to have trust in the
system. The Department of Health and Human Services has a
responsibility to the American public to ensure the integrity
of this process by working diligently to appoint individuals
that are totally without financial ties to the vaccine industry
to serve on these and all vaccine-related panels.
No individual who stands to gain financially from the
decisions regarding vaccines that may be mandated for use
should be participating in the discussion or policymaking for
vaccines. We have repeatedly heard in our hearings that
vaccines are safe and needed to be protecting the public. If
the panels that have made the decisions on all vaccines on the
childhood immunization schedule had as many conflicts as we
have found with rotavirus, then the entire process has been
polluted and the public trust has been violated. I intend to
find out if the individuals who have made these recommendations
that affect every child in this country and around the world
stood to gain financially and professionally from the decisions
of the committees on which they served.
The hearing record will remain open until June 28th for
those who would like to submit a statement for the record.
I now recognize the ranking minority member, Mr. Waxman,
for his opening statement.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Waxman. Thank you very much, Mr. Chairman.
This hearing is about conflicts of interest and vaccine
decisionmaking. This is an issue I take very seriously. I have
probably done more than any other member of this committee to
identify and oppose genuine conflicts of interest in Federal
decisionmaking.
In 1991, I held a hearing on conflicts of interest in Vice
President Quayle's Council on Competitiveness. These hearings
revealed that the executive director of the council owned 50
percent of a chemical plant subject to regulation under the
Clean Air Act at the same time that he was chairing biweekly
interagency meetings on Clean Air Act regulations, including
regulations that dealt with toxic substances that may have
affected his chemical plant.
In 1998 and 1999, I was the only member to question what
role a key NIH official played in selecting Rezulin in a
diabetes drug trial when he was consulting for Rezulin's
manufacturer, Warner Lambert. My question led directly to an
ongoing inspector general review of NIH's management of its
conflict of interest policies.
In 1997, when the Supreme Court ruled that the Federal
Advisory Committee Act applied to the National Academy of
Sciences, some members wanted to exempt the Academy from those
requirements. I insisted that we put in place a system to
examine conflicts of interest in the membership of those
advisory groups. In 1997, when the Republican Congress wanted
to privatize medical device approvals and farm out product
reviews to for-profit entities, I was one of the members who
fought hard to ensure that conflicts of interest were
prohibited and that the public interest was protected.
If indeed a real threat to objective decisionmaking by our
health agencies is identified during these hearings, I will
call for a full investigation, as I have done in the past. I
know that conflicts can be dangerous, not only because of the
possibility that a financial interest could exert undue
influence on critical policy decisions, but also because they
can lead to loss of public confidence in the system.
But there's a right way and a wrong way to investigate
conflicts of interest. The right way is to investigate first
and then reach conclusions later. The wrong way is to accuse
first and then investigate later. Unfortunately, our chairman
has a propensity to investigate in the wrong way, not just in
this issue, but in other issues. He has made unsubstantiated
allegations that smear people's reputations but turn out to
have no basis in fact.
The chairman made his latest allegation last Sunday on Meet
the Press. On national TV, he accused the President, the Vice
President and the Attorney General of obstruction of justice
and other crimes. But when he was asked to provide evidence to
back up these accusations, the chairman refused, stating, ``I
can't give you the specifics of it right now.''
My fear is that the chairman has reached a predetermined
conclusion that vaccines are dangerous. It is difficult for him
to persuade others to agree with his conclusion because it is
so far out of the scientific and medical mainstream. But rather
than accept the fact that he may be wrong, the chairman has
decided that those who disagree with him must be part of a drug
company conspiracy.
I intend to keep an open mind as I review the evidence we
hear today. The chairman didn't share with us the report that
he planned to release today. As a result, I've had no time to
review what his staff has written, and cannot comment on the
findings.
But from what I've seen, I have my doubts that the chairman
will be able to demonstrate that vaccine decisions have been
tainted by scandal. CDC and FDA should follow the highest
possible standards in applying conflict of interest rules.
There may be questions about whether these rules have been
properly applied in every instance. But lapse in the
application of these rules, if there are any, does not mean
that vaccine decisions have been made improperly.
Unfortunately, CDC and FDA face a difficult challenge in
assembling together expert advisory panels on vaccines. Vaccine
decisions have major public health implications. For this
reason, it's important, in fact it's essential, that the
individuals serving on the vaccine advisory panels be the
world's leading experts on vaccine issues.
But some of these experts also have varying ties to the
pharmaceutical industry, such as working with the industry to
develop new and better vaccines. After all, their field is
vaccine research. CDC and FDA have the responsibility of
ensuring that the public benefits from the expertise of these
individuals, while at the same time ensuring that appropriate
precautions are taken against conflicts of interest.
That's why those disclosures were required of all of those
people that serve voluntarily on advisory committees, so CDC
could see if there's a conflict, FDA could see if there's a
conflict. But to get those disclosures, people are promised
that their financial holdings are not going to be made public,
which is why I objected to the release of this information,
which I gather will be made public indirectly today.
Let me give you an example. The chairman referred to Dr.
John Modlin and said, he must have a conflict of interest
because he owns $60,000, I think it was, maybe $40,000, of
shares in Merck Pharmaceutical. Maybe it's $100,000, I don't
remember the number. But the point I want to make is that this
man served on an advisory committee and approved a drug by
another company. It wasn't a Merck rotavirus vaccine that he
voted to approve. It was a Wyeth product.
Now, he was later asked, did he know that Merck was also
working on a rotavirus vaccine. And he said he didn't even know
that they were working on a rotavirus vaccine. Maybe if he
knew, he would have voted against the competitor's product
because he had a financial interest in Merck.
Well, the fact of the matter is, Merck is involved with
many products, as is Wyeth, as is every other pharmaceutical
company. If we want to say that anybody who works as an advisor
cannot own these stocks, then let's say it. But you know what?
We don't say that of Members of Congress. The Roll Call
newspaper today has an article about all the Senators that have
stocks in high tech. Now, that's not wrong or illegal. And we
even vote on issues that affect those industries.
If we're going to have a requirement that no one own stocks
in companies that may benefit from our decisions indirectly,
then we ought to say it. But we have not said that, and
therefore, people have not violated any rule because they
simply have financial holdings.
This hearing will serve a useful purpose if it provides an
opportunity to explore objectively how good a job CDC and FDA
are doing in meeting their obligations. But let's be ready to
look at the evidence first, before we reach conclusions that
could scare people into thinking that vaccines that are on the
market are going to hurt their children, and have them run away
from getting their children immunized, when one thing we do
know is that those diseases that can be prevented can take an
enormous toll on the lives of children.
I also want to point out that rotavirus, which is the
example used by the chairman, is not a vaccine that is mandated
by the Federal Government to be used by children. As I
understand it, the CDC had put it on its list of recommended
vaccines for infants. They recommended it. They later took it
off that list. But it is not required by law that children be
immunized. Some States have laws that require that before
children can go to school, they be immunized. This particular
product, as I understand it, was never mandated to be used.
But when the Centers for Disease Control says that they
recommend a product, it's a very serious matter. If FDA
approves a product, they're saying to the American people that
this product has undergone scrutiny and is safe and effective.
As I also understand in this particular case, FDA asked that
they continue to monitor after the approval to be sure that if
there are problems, we know about those problems.
Those of us who looked at the FDA issues on the committee
that has jurisdiction, the Health and Environment Subcommittee,
which I once chaired, know very well that there is pressure
from Congress and the American people to get drugs approved as
quickly as possible. And when we press to get these products
approved as quickly as possible, it means we've got to make
sure that we monitor any adverse impacts so we can respond if
we learn about problems.
With this particular vaccine, there was an advisory that it
be monitored. After it was monitored, they found that there was
a problem, because adverse event reporting requirement for
vaccines, and they acted to take this vaccine off the market.
That appears to me to be appropriate. We wish they would have
been able to catch it before it was ever used. But we want to
be able to make sure that we catch it after it's being used and
the decisions that are made to make a vaccine available be the
decisions that are based on the science, by the leading
scientists and make sure that if they are acting on these
advisory panels that they not have genuine conflicts of
interest.
Let's be mindful of the way things work and explore the
evidence before we jump to conclusions. I will do that with an
open mind today as we hear from various witnesses, and hope
that we can reach some conclusions based on the facts.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Henry A. Waxman follows:]
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Mr. Burton. I would like to add or correct one thing that
the gentleman from California said. Merck was listed as an
affected company in the documents provided by the FDA to Dr.
Modlin. So he was aware of that.
Mr. Davis, do you have a comment you'd like to make, sir?
Mr. Davis of Illinois. Yes, Mr. Chairman.
Thank you very much, Mr. Chairman, and I'd like to commend
you for holding this oversight hearing to examine the
implementation of the Federal Advisory Committee Act and to
examine the operation of the Department of Health and Human
Services.
Mr. Burton. Excuse me, Mr. Davis, I don't mean to interrupt
you. We have 7 minutes on the clock. Would you like to continue
now or----
Mr. Davis of Illinois. I'll be done in 2.
Mr. Burton. OK, Mr. Davis.
Mr. Davis of Illinois. And to examine the operation of the
Department of Health and Human Services Advisory Committee on
Immunization Practices of the Centers for Disease Control and
Prevention and the Vaccine Related Biologic Products Advisory
Committee of the Food and Drug Administration.
A strong and prosperous America needs healthy people.
Healthier people will build a stronger America. It is crucial
that we provide the best health care to all Americans. And in
order to ensure the health of all Americans, the two advisory
committees have critical roles to recommend the kind and dosage
of vaccinations that our children and adult populations
receive.
There is a tremendous amount of interest in this subject,
as is evidenced by the numbers of people who are at this
particular hearing, and in my community, especially, Mr.
Chairman, there is a great deal of interest. And I note the
presence of Barbara Malarkey, a representative of the Illinois
Vaccine Awareness Coalition, who happens to live in my
neighborhood. She is indeed a fighter, a hard worker, and has
raised the level of awareness locally where we live. I simply
want to commend her for taking time out to come all the way
from Chicago to just simply be here today and participate and
hear the information as we discuss this important subject.
[The prepared statement of Hon. Danny K. Davis follows:]
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Mr. Waxman. Would the gentleman yield to me just to use
this opportunity?
Mr. Davis of Illinois. Yes.
Mr. Waxman. Because you have a minute left. Dr. Modlin was
a non-voting member on this panel. If there was a document
given about Merck being an affected company, he claims he did
not know about it. And the reason I say he claims that is that
my staff talked to him and asked him about it. I don't know if
Mr. Burton's staff talked to him and asked him that question.
He said that when he served in this advisory capacity, he
did not know that Merck was listed as one of the affected
companies. He didn't know Merck was working on a rotavirus
vaccine as well. He was looking at a Wyeth product, and used
his best scientific judgments with regard to that Wyeth
product.
Thank you for yielding.
Mr. Burton. We have a vote on the floor. We will be back
very shortly. The Chair stands in recess.
[Recess.]
Mr. Burton. We will now proceed with the statements of Mr.
Dean and Ms. Glynn. Would you please stand and raise your right
hands.
[Witnesses sworn.]
Mr. Burton. Ms. Glynn, would you like to go first with your
prepared statement?
STATEMENTS OF MARILYN GLYNN, GENERAL COUNSEL, OFFICE OF
GOVERNMENT ETHICS; AND JAMES DEAN, DIRECTOR, OFFICE OF
GOVERNMENTWIDE POLICY, U.S. GENERAL SERVICES ADMINISTRATION
Ms. Glynn. Sure. I'm pleased to be here today to talk
briefly about the Federal ethics and conflict of interest
statutes and regulations and how they apply to members of
Federal advisory committees generally.
The core conflict of interest statute is Section 208 of
Title 18 of the U.S. Code. This law prohibits employees from
participating personally and substantially in any particular
matter which to their knowledge has a direct and predictable
effect on their financial interest. It also applies when the
matter would affect the financial interests of certain other
persons or organizations with whom they have some connection,
such as an outside employer.
The law contains waiver and exemption provisions that would
permit an employee to participate in a matter notwithstanding a
potential conflict of interest. Section 208 applies to regular
employees of the executive branch as well as to so-called
special Government employees, or SGEs, as we call them. Many
members of Federal advisory committees are SGEs, in fact,
probably most are.
The SGE category was created by Congress as a way to apply
an important but limited set of conflict of interest
requirements to a group of individuals who provide important
but limited services to the Government. Some members of Federal
advisory committees are not employees of the Government at all.
These individuals serve as representatives of outside interest
groups. It is understood by the Government that they represent
a particular bias and they aren't covered by any of the rules
that apply to regular employees or to these SGEs.
There is a wavier provision in Section 208 for SGEs who
serve on Federal advisory committees within the meaning of the
Federal Advisory Committee Act [FACA], I think as it's known.
It permits the agency employing the SGE to grant an individual
waiver based on a written determination that the need for the
individual services outweighs the potential for a conflict of
interest created by the financial interests involved.
In contrast, the waiver provision for regular Government
employees under Section 208, and these employees typically
provide a range of services of course far broader than those
provided by SGEs, that other waiver for regular employees
focuses on the size of the employee's financial interest, and
the likelihood that the financial interest would affect the
integrity of the employee's services.
OGE has issued regulations interpreting Section 208.
Included in our regulations is guidance concerning the issues
of waivers and various procedural criteria required by the
statute. OGE has also issued regulations granting general
exemptions from the disqualification requirement in Section
208.
Many of these exemptions apply to SGEs as well as to
regular employees. For example, there are de minimis exemptions
for ownership of publicly traded securities. Some other
exemptions apply only to SGEs serving on FACA committees. The
most significant of those exemptions exempts certain financial
interests arising from the SGEs' outside employment.
Beyond the criminal conflict of interest laws, OGE has
promulgated regulations prescribing standards of ethical
conduct for employees of the executive branch, including these
SGEs. One of those rules provides a mechanism for dealing with
potential appearances that an employee make lack impartiality
when dealing in certain matters. The rule provides a balance to
be struck between concerns about appearances of partiality and
the Government's interest in having the employee participate in
the particular matter.
Most SGEs serving on advisory committees have to file
financial disclosure reports with their agencies. Financial
disclosure helps protect the integrity of the advisory
committee process by providing the agencies an opportunity to
determine whether an SGE may have any potential conflicts of
interest that must be addressed.
In closing, I want to emphasize, of course, that OGE shares
the committee's belief that Government decisions should not be
tainted by an employee's conflicts of interest. At the same
time, the Government needs the services of SGEs who can
contribute relevant outside expertise and perspectives to the
work of an advisory committee.
Balancing these two considerations is frequently a
difficult task. Nevertheless, we believe that the current
statutory and regulatory system that applies to advisory
committees provides an appropriate framework for accommodating
both objectives.
Thank you, and I'd be happy to answer any questions you may
have.
[The prepared statement of Ms. Glynn follows:]
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Mr. Burton. Thank you, Ms. Glynn.
Mr. Dean.
Mr. Dean. Good afternoon, Mr. Chairman, Mr. Ranking Member,
members of the committee. Thank you for the opportunity to
discuss with you today the important role played by Federal
advisory committees in achieving the missions assigned to the
executive branch.
The Federal Advisory Committee Act [FACA], operates within
the body of statutes that promote access to Federal
decisionmaking and information. For example, policy related to
the accessibility of Government records was revised in 1966,
following the enactment of the Freedom of Information Act. And
the two remaining cornerstones of Federal access policy, the
Privacy Act, and the Government in the Sunshine Act were
enacted by the Congress in 1974 and 1976 respectively.
FACA seeks to accomplish two important objectives. First,
to establish the means for providing congressional and
executive branch oversight over the number and costs of the
advisory committees, and second, to ensure that the advisory
committees operate in plain view of the public. Simply stated,
the act's purpose is to illuminate how agencies make decisions,
based upon advice and recommendations from individuals outside
of Government, while also making sure that the costs as
reported by the advisory committees are commensurate with the
benefits received.
Although advisory committees do not make or implement
decisions, they are used by over 60 agencies to provide advice
on issues that reflect the complex mandates undertaken by the
Government. During fiscal year 2000, almost 50,000 committee
members will serve on 1,000 committees and provide advice and
recommendations on such matters as the safety of the Nation's
blood supply, steps to address the management of natural
resources, and the country's national defense strategies.
In our full testimony, Mr. Chairman, we have provided a
complete listing of the act's most significant provisions. To
summarize, the Secretariat is responsible for issuing policy
and providing a framework for Government oversight. Agencies
have joint responsibility for implementing the act and for
issuing additional guidelines that are needed to address their
unique requirements.
At the agency level, committee management officers [CMOs]
as we know them, are responsible for implementing FACA on
behalf of the agency head. Each committee has a designated
Federal officer [DFO], who must work with the CMO to manage the
committee's operations day to day. Together, the CMO and DFO
are responsible for ensuring compliance with FACA, the agency's
internal operating procedures, regulations issued by the
Secretariat, and any other applicable statutes or regulations
such as those issued by the U.S. Office of Government Ethics,
the National Archives and Records Administration, or the Office
of Personnel Management, just to name a few.
Mr. Chairman, in your letter inviting us to testify before
the committee today, you asked us to address how the Federal
Advisory Committee Act deals with issues relating to balancing
an advisory committee's membership and conflict of interest
issues relating to individual members. The act does not include
provisions addressing committee member conflicts of interest.
The applicability of conflicts of interest laws and various
ethical requirements for members of advisory committees who
serve as special Government employees are covered by other laws
and regulations issued by OGE.
The act, however, does include two important provisions
designed to promote the objectivity of advisory committee
deliberations. First, FACA requires that ``the membership of
the advisory committee be fairly balanced in terms of the
points of view represented and the functions to be performed by
the committee.''
Second, the act requires ``provisions to ensure that the
advisory recommendations will not be inappropriately influenced
by the appointing authority or by any special interest, but
will instead be the result of the advisory committee's
independent judgment.'' Thus, while the act addresses the
importance of assuring an advisory committee's independent
judgment, it also requires that at a minimum, the composition
of the advisory committees reflect the expertise and interests
that are necessary to accomplish a given committee's mission.
The act does not, however, define those factors that should
be considered in achieving balance. The Secretariat's
regulations provide in part that ``in the selection of members
for the committee, the agency will consider a cross section of
those directly affected, interested and qualified as
appropriate for the nature and function of the committee.
Committees requiring technical expertise should include persons
with demonstrated professional or personal qualifications and
experience relevant to the functions and tasks to be
performed.''
In their efforts to balance a committee's membership,
agencies focus primarily on the subject matter to be addressed.
Nevertheless, other factors may be appropriate in relation to a
committee's function, such as geographical representation,
racial or ethnic diversity, occupational affiliation or the
need to consult with State, local or tribal governments.
Similarly, the act does not outline specific steps that
must be taken to ensure that advice or recommendations offered
by an advisory committee are free from inappropriate influence
by the appointing authority or special interest. Accordingly,
each agency is responsible for developing specific operating
procedures, consistent with the act and the Secretary's
regulations to promote the advisory committee's independent
judgment and to achieve a balanced committee membership.
Although the act is quite detailed in the specific
procedures agencies must follow--I see I have the stop sign.
Mr. Burton. If you're close to concluding, go ahead.
Mr. Dean. Probably about a minute and a half.
Mr. Burton. OK.
Mr. Dean. Although the act is quite detailed in specific
procedures agencies must follow with respect to the
establishment of advisory committees, the conduct of meetings
and the availability of records, it provides substantial
flexibility to agency heads in other areas such as membership
selection, tenure and procedural issues such as voting. This is
appropriate given the diverse needs of the executive branch and
the necessity for agencies to quickly adopt new operating
procedures where conditions warrant.
This flexibility is balanced by a variety of procedural
safeguards to ensure that the advice or recommendations
tendered by an advisory committee are properly obtained by an
agency through a public process prior to final agency action.
In particular, the act's provisions require opening meetings
and a summary of closed or partially closed meetings, the
ability of the public to provide written or oral statements to
a committee and access to committee minutes and records
reinforce the act's goals of maintaining committee independence
and freedom from inappropriate influence. These checks and
balances, rooted firmly in the principle of Government in the
Sunshine, have contributed greatly to the success of advisory
committees over the past 28 years.
Mr. Chairman, that concludes my statement.
[The prepared statement of Mr. Dean follows:]
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Mr. Burton. Thank you very much.
I think the one thing that was significant, or one of the
things that was significant about your statement is the
Sunshine aspect, that the public and the American people have a
right to know where major decisions are being made.
I wish Mr. Waxman was here. I see that his staff has put in
his desk there a copy of a document. And so for the record, I'd
like to show that Dr. Modlin was aware that Merck was involved
in producing a rotavirus. He was a consultant to the FDA, he
got this notification on December 12th. And it was voted on
December 12th, was it? He got it on November 4th and he voted
on December 12th. So he knew about this for over a month.
And so I wanted to correct the record, and correct what Mr.
Waxman said. Mr. Modlin did know that Merck, and he had a
financial interest in Merck, he did know that Merck was
involved in that process.
Mr. Dean, you just said, and Ms. Glynn can comment on this
as well, the whole idea we've been talking about behind the
advisory committee law is openness. Do either one of you think
it's appropriate for an advisory committee to do a lot of their
work through working groups behind closed doors?
Mr. Dean. Mr. Chairman, the act provides that most advisory
committees should be open to the public. However, it does
provide the opportunity to close meetings that are consistent
with Government in the Sunshine Act. Many agencies find that it
is necessary from time to time, in particular the agencies such
as the Department of Defense, for example, with----
Mr. Burton. Well, let's confine our remarks to the health
agencies.
Mr. Dean. Oh, sure. Within HHS, then, many meetings are
closed where necessary to discuss proprietary information, to
protect material that contains information subject to the
Privacy Act and other issues that are exempted under the
Sunshine Act, sir.
Mr. Burton. Should advisory committee members who have
conflicts and financial interests, and can't vote at public
sessions, be allowed to work on or in working groups on the
same subject on which they have a conflict of interest?
Mr. Dean. I think that OGE may want to comment on that as
well. But I can address that from a structural standpoint. It
is very common, and the act provides that agencies may
establish working groups or subcommittees to support parent
committees. All working groups and subcommittees must report to
the parent, and only the parent may vote on issues before the
committee. In other words, the deliberation on matters that are
normally prepared at the subcommittee level or working group
level are fully vetted, or are to be vetted under FACA in the
parent committee.
So the normal way of business is done is that the work done
at the lower level will come up to the higher level.
Mr. Burton. Do you have a comment?
Ms. Glynn. Yes, I do. As to your question about whether
it's appropriate to work sort of behind the scenes when you
have a conflict of interest, I would say that it's not
necessarily inappropriate if the agency has been made aware of
the conflict of interest in advance, has had an opportunity to
weigh whether they want that person to work behind the scenes
in that capacity and has gone through the necessary procedural
steps of issuing a waiver as required under the law.
Mr. Burton. Let's say you have a child, and there's a new
vaccine that's coming on the market. And let's say that there's
an advisory committee that's going to be making a decision on
whether or not that should be put in the marketplace and into
your child's body.
Do you think they should be totally unbiased and without
any financial conflicts?
Ms. Glynn. I have to say that I think, given the breadth of
the criminal conflict of interest statute, it might be
difficult to find someone who has the requisite expertise, that
has absolutely no financial conflict at all.
Mr. Burton. How many doctors did we say we had in the
country? We have 700,000 physicians in America, probably a
couple hundred thousand scientists as well. Now, the rotavirus,
we found that many of those people that were on the advisory
committees that dealt with that were on the committees year
after year after year, had financial conflicts of interests and
were making decisions on this vaccine knowing full well that
the company that they had stock in or had financial interest in
was making, was going to make a profit, which in turn would be
beneficial to them.
Ms. Glynn. Yes, sir, I understand.
Mr. Burton. The vaccine had not been, to our knowledge,
thoroughly tested, and yet they went ahead and approved it.
Don't you think if you were a parent you'd be a little bit
concerned about that?
Ms. Glynn. Well, I am a parent, and I do have----
Mr. Burton. Would you be concerned about that?
Ms. Glynn. I think with the type of knowledge that I have,
having worked for many years in the ethics field and
understanding that some of these conflicts of interest could
really be characterized as technical. For example, the
ownership of stock, I think is a good example. Remember, in
evaluating your financial stake in the matter when you own
stock, it's not the value of the stock you own.
Let's say you own $40,000 or $50,000 worth of stock,
whatever those numbers were that you were discussing earlier.
The value of your financial interest in the matter is the
potential for gain or loss to you. And when you own stock in a
large publicly traded company such as, I think Merck was the
example, you really own a billionth of an interest in the
company.
So the likelihood that your personal financial interest in
the matter is going to be affected I think is pretty remote. So
I really don't think it's inappropriate for agencies to issue
waivers in those situations.
Mr. Burton. What if you were getting paid to go around and
make speeches for that company and you were on that payroll?
Would that be a conflict, do you think?
Ms. Glynn. You know, it might very well not be a conflict
under the criminal conflict of interest statute. It would only
really amount to that level if you were actually an employee of
the company or if the honorarium or whatever it is you're
receiving was dependent on the matter which was under
consideration.
But believe me, of course there are certainly appearance
concerns in a situation like that. And so that's why my office
has issued a regulation which requires the employee to consider
whether his impartiality would be questioned in such a
situation. And the agency can of course go ahead and make its
own determination that they don't want an employee to act in
such a situation, if they think the appearance is so great that
the benefit of having him participate is outweighed by the
appearance of a conflict of interest.
Mr. Burton. Do you know that there were some serious side
effects from the rotavirus and they took it off the market
shortly after it was put on the market? And one child, I think,
died?
Ms. Glynn. I don't----
Mr. Burton. Did you know that?
Ms. Glynn. No, sir, I'm not--I'm not involved in the
details of this.
Mr. Burton. Well, I guess the point I'm trying to make, and
the question I'm trying to make is that, I have a grandchild, I
have two grandchildren. One of them almost died from a vaccine,
the other one is now autistic, we believe, from vaccines. And I
think that I, like most people who have children or
grandchildren that are having these things put into these
bodies, need to be assured that they've been thoroughly tested
and that the people who are making the decisions on whether or
not those should be mandated, mandated by law, don't have a
conflict of interest.
And so what you're telling me is that the regulations, the
updated regulations that you're talking about, still would
allow these people, even though there are 700,000 people in
this country, other physicians, and probably a couple hundred
thousand scientists, that could be taking a look at these
things besides a select group that continues to do it over and
over again who don't have financial interests?
Ms. Glynn. Yes, sir, I'm saying the statute that Congress
passed gives the discretion to the agency involved to decide
whether that particular individual is so important to the
process that they should----
Mr. Burton. Well, do you think that it should be reviewed,
the statute?
Ms. Glynn. I don't think there's ever anything
inappropriate about Congress reviewing a statute that they've
passed. But I have to say that from the information that OGE
gets from agencies that operate advisory committees, we've been
led to believe that it's working well and that they feel that
the exemption provision in the statute is necessary for them to
continue to operate their advisory committees.
Mr. Burton. Oh, me. The immunization process takes place, a
vaccine has not been thoroughly tested, an advisory panel on
which people serve that have financial interests in the
company, some children are maimed for life or die, and you're
saying that you don't think there's a problem with a conflict
of interest, where they're mandating, mandating that those
vaccinations be given to these children, and these people who
are making the decisions do have an interest in the company?
And you did say if there's an appearance of impropriety, they
should recuse themselves. But you don't see any problem with
the current regulations?
Ms. Glynn. No. I do not. I think the regulations do
provide, as our testimony says, an appropriate framework for
making those decisions.
Now, I'm certainly not in a position to say whether any
individual serving on any particular committee was the right
person to be serving, and whether the need for that particular
individual was so great that that outweighed a potential
conflict of interest. But I think the appropriate framework is
in place for making those decisions by the agency.
Mr. Burton. OK. The Code of Federal Regulations, 5 C.F.R.
2640.202(a), by the Office of Government Ethics, states that
stock holdings not exceeding $5,000 on a specifically affected
company or $25,000 on an affected company is considered to be a
low involvement and thus is generally waived. How did OGE
decide the acceptable parameters of what constitutes an
acceptable financial interest?
Ms. Glynn. In the particular regulation at issue, we issued
a proposed regulation, proposing that figure. We got comments,
I'll tell you truthfully, all over the place. Some commenters
thought we should raise the amount to $100,000 I would say
generally the comments that we got thought the amount was too
low. We took a ballpark guesstimate at what we thought was
something that would appear to be acceptable across the board.
Remember, that regulation is an exemption for every Government
employee, whether they're a regular Government employee or a
special Government employee, acting in any type of matter.
Mr. Burton. How did you arrive at that amount?
Ms. Glynn. A ballpark guesstimate----
Mr. Burton. A ballpark guesstimate.
Ms. Glynn [continuing]. Of what we thought would be
appropriate.
Mr. Burton. Did you consult with the Department of Health
and Human Service officials about this policy?
Ms. Glynn. I believe they commented on our regulation.
Mr. Burton. What did they say?
Ms. Glynn. I don't recall their specific comments.
Mr. Burton. You don't remember?
Ms. Glynn. No.
Mr. Burton. The Food and Drug Administration has a document
entitled Waiver Criteria Document 2000 which lists additional
classifications for financial interests, mainly medium
involvement and high involvement. The standard amounts shown in
these categories are quite broad and range, for example, stock
holdings in a company directly affected or more than $5,000 but
less than $100,000 are deemed to be of medium involvement. Most
likely to be waived.
In other words, an advisory committee member could have
owned $100,000 worth of stock in Wyeth Lederle, and most likely
would be allowed to vote on the Rotashield vaccine, is that
correct?
Ms. Glynn. I don't know. I have not seen the document
you're reading from.
Mr. Burton. Did the FDA consult with the OGE in setting the
policy I just mentioned?
Ms. Glynn. I don't know if they did or not. I don't
personally recall them doing it.
Mr. Burton. Are you aware of who set the criteria for all
of the different classifications listed in the FDA's Waiver
Criteria Document 2000?
Ms. Glynn. At the Department of Health and Human Services,
I don't know. I think you would have to ask them.
Mr. Burton. Does the OGE generally agree with the standard
policy set forth in that document?
Ms. Glynn. Well, sir, as I said, I haven't seen the
document. But I don't think it's inappropriate for an agency to
set forth general parameters of the type you describe. I guess
we could argue about the numbers. But I guess one of the things
you have to remember is that there are a lot of employees,
regular and special Government employees, who own stock. It's
not uncommon, and it's not unusual, I think, for agencies to
develop a sort of internal policy in which they say, OK,
interests in this sort of ballpark can be waived, interests in
another ballpark would typically not be waived, and use that as
a sort of standard operating procedure.
I don't think there's anything inappropriate about that.
Mr. Burton. I understand that the Food and Drug
Administration employees cannot own stock in pharmaceutical
companies of which they are maybe making determinations on. Is
that correct?
Ms. Glynn. You would have to ask the Food and Drug
Administration. I believe that they have a statute prohibiting
ownership of stock, and I know they have regulatory provisions
related to it.
Mr. Burton. Why do you think they have that kind of a
statute?
Ms. Glynn. I think you have to ask them.
Mr. Burton. Well, let me just ask, because they're afraid
that there would be a conflict of interest?
Ms. Glynn. Well, of course they are a regulatory entity,
and they deal with all these companies.
Mr. Burton. What's the difference between FDA and CDC and
the other agencies that are involved in the decisionmaking
process on vaccines and the advisory panels?
Ms. Glynn. Sir, I think these questions are more properly
addressed to the FDA and to the CDC. We were invited to talk
generically this morning. Our letter of invitation asked us to
speak generically about the framework for conflict of interest.
Mr. Burton. OK.
Ms. Glynn. I have given a cursory review to waivers issued
by CDC and FDA in preparation for this hearing, and we received
an invitation only 1 week ago. So we haven't had much time to
prepare.
Mr. Burton. Well, is it your interpretation of the (b)(3)
waiver under 18 U.S.C.A. Section 208 that any kind of financial
interest, no matter how great, could potentially be waived if
the agency determines that the need for the individual is so
unique and so important to the agency that it outweighs the
potential conflict of interest? In other words, Wyeth Lederle
CEO could potentially be allowed to participate in the
decisionmaking process, if it was deemed by the agency that he
had some expertise that no one else in the United States has?
Ms. Glynn. Yes.
Mr. Burton. And can you think of a situation where this
could actually happen?
Ms. Glynn. Yes, I think theoretically, your reading of it
is correct that that could happen. In practice, I think that
agencies do not issue waivers where they really think there is
the potential the person will be actually biased in the advice
that they give.
Mr. Burton. Can liaison members be considered de facto SGEs
if they contribute substantially in the decisionmaking process
of an advisory committee?
Ms. Glynn. I think not, sir. They're actually called there
to provide a kind of biased opinion. It's understood that their
point of view is going to be representing an industry view or
an organization view, and presumably, people involved in the
decisionmaking process know how to weigh that in. They
understand that it's not going to be an objective point of
view. In fact, that's why they're there, to provide that. I
don't think they would become SGEs because they're involved in
the discussion.
It's important, though, I mean, you're making a good point,
which is that it's important to determine in advance whether
the person serving is in fact an employee or not. The agency
should determine, in advance whether they want that person
there to represent the biased industry view, so to speak, or to
provide a service to the Government as an employee.
Mr. Burton. It's my understanding if those people have a
role in the decisionmaking process in these private meetings,
that the public doesn't have any access to it, is that correct?
Ms. Glynn. I don't know, sir.
Mr. Burton. So you're not familiar with that in your
capacity?
Ms. Glynn. No, sir.
Mr. Burton. So I'd have to ask the FDA or CDC or those
people about that. OK.
Mr. Waxman.
Mr. Waxman. Ms. Glynn, I know you're going to answer some
questions generically about the ethics of Government law and
how it applies across the board, and we'll have a chance to ask
FDA and CDC about their specifics. But has the Office of
Government Ethics reviewed CDC and FDA conflict of interest
policies recently?
Ms. Glynn. Our office has a component that does agency
reviews, reviews of agency programs. And we do them on a 4-year
cycle. I believe the last time we reviewed the FDA was about 3
years ago. We recently reviewed CDC; perhaps we've just issued
a report in this past year.
Mr. Waxman. Can you tell us what you found with regards to
these two agencies?
Ms. Glynn. I can. In preparation for this, I did a cursory
review of documents relating to these specific agencies. And
we'd be happy to provide copies of those reports for the
record, if you'd like them. As to the FDA, generally I can say
we gave it what you might call a clean bill of health. We found
that their ethics program, which examines things such as
financial disclosure, counseling and advice, ethics training
and so on, we found that they had a very good program and that
it was operating quite well.
As to CDC, we found that they had what we call a sound
ethics program. But we frankly found that they were somewhat
understaffed and we recommended that they devote more staff
resources to their ethics program.
Mr. Waxman. What's the standard for determining whether
there's been a violation of the conflict of interest law?
Ms. Glynn. The law prohibits an employee from acting in a
matter that affects as financial interest. The standard is very
broad. And so arguably, using the stock case as an example,
again, if you own one share of stock in a company and the
matter affects that company, you have violated, in the absence
of a waiver or exemption of course, you have violated the
conflict of interest clause.
The Congress created a law, as we see it, Congress created
a law that was very broad that sweeps in a lot of interests.
And they tempered that broad law by creating these exemption
and waiver provisions--so that the agency would have the
opportunity to examine the potential conflict of interest
either across the board for groups of people, or on a case by
case basis in individual waivers, and make its own
determination about whether they want the employee involved.
Mr. Waxman. Isn't the standard to determine whether an
advisory committee member is acting in a particular matter that
will have a direct and predictable effect on the financial
interest of that employee, his spouse, his children, or an
organization which he serves as an officer, director or general
partner and so on? Isn't that the standard, whether there's a
direct and predictable conflict?
Ms. Glynn. There has to be a direct and predictable effect
on the financial interest for the statute to be violated.
Mr. Waxman. So the financial interest that would arise in a
conflict, can't be speculative?
Ms. Glynn. That's right.
Mr. Waxman. It has to be an actual conflict of interest?
Ms. Glynn. That's right.
Mr. Waxman. So if somebody owns stock in Merck and they're
voting on another company's drug?
Ms. Glynn. There may or may not be a violation of the
statute, depending on the facts of a particular case. You can
theorize about situations where you act in a matter involving a
competitor and it has the effect of virtually driving the other
company out of business. It would be probably easy in a
situation like that to establish the direct and predictable
effect on the competitor. But oftentimes, it's a little bit
more difficult.
Mr. Waxman. It seems to me there are two goals that
agencies should have when they put together an advisory
committee. First, they should try to have the best possible
experts, and second, they should try to have individuals on the
committee who are without conflicts of interest. Now, if you're
trying to achieve those two goals, those two goals may be in
conflict at times.
For example, in the case of vaccines, often the best
researchers, those people with the most expertise, have had
some relationship with a vaccine manufacturer, such as a
research funding or honoraria from participation in a
conference. Do you find that this is often the case with
advisory committees?
Ms. Glynn. From the copies of the waivers--remember, we
don't issue the waivers at our office, the waivers are issued
by the individual agencies and copies are provided to our
office--from the copies of the waivers we have seen, that seems
to be the typical kind of conflict of interest that is waived.
I can't really say how many members of advisory committees
receive waivers. We just don't keep that kind of information.
Mr. Waxman. Well, the chairman said that there are 700,000
physicians in America. I presume by that statement he means,
why should we rely on these people who know the most about
vaccines, when we can get just another physician. I don't know
that any of us would want to have brain surgery done by a
physician who's licensed and his general practice is podiatry.
Ms. Glynn. I believe that's why Congress gave discretion to
the agencies involved in deciding which particular individuals
are those that are so needed that it's reasonable to issue a
waiver under the conflict of interest statute. Only the agency
really is in that position to decide whether the qualifications
the individual possesses are so special that a waiver is
appropriate.
Mr. Waxman. Mr. Dean, do you agree with the comments on
these questions?
Mr. Dean. Yes, I do. I would just add, Mr. Waxman, that the
process that's established by the Federal Advisory Committee
Act provides yet another level of protection potentially in
that much of what an advisory committee does, and certainly the
final recommendations issued by a parent committee, are subject
to, I think, to a very public process, and at times a very
intense public review by any number of people, whether it be
the general public, the media, interest groups and so forth and
so on. The Federal Advisory Committee Act provides a great deal
of access to what advisory committees do.
Mr. Waxman. And is it, in your experience, uncommon for
agencies to seek waivers for its advisory committee members so
they can participate in committee meetings?
Mr. Dean. Mr. Waxman, I don't have any experience with the
waiver process at all. I do know anecdotally that our customers
do talk about the difficulty in finding qualified people to
serve on advisory committees. And you alluded earlier to our
hearing regarding the National Academy of Sciences, and that's
certainly one of the issues that we discussed then.
And I just might note that the NAS and similar
organizations I think by and large use procedures that are very
similar to those used in the executive branch in terms of
screening for conflicts of interest, balancing advisory
committees, providing access to committee deliberations and so
forth.
So it's not a problem that's unique to Government. I would
point out that it's a problem that is, I think that we face,
that universities face, that the NAS faces, that any
organization that does research I think faces that very same
problem.
Mr. Waxman. Ms. Glynn, what's your experience? Is it
uncommon for an agency to seek waivers for its advisory
committee members? And do you think waivers are inappropriate
if there's apparent conflict of interest?
Ms. Glynn. To answer your second question first, no, I
don't think it's inappropriate to seek waivers. And whether
it's uncommon or not is a little hard for us to judge from OGE.
We are told anecdotally by agencies, I have to support what Mr.
Dean said, we are told anecdotally by agencies that they have
difficulty obtaining the services of expert advisors for
advisory committees, in that they would be unable to obtain the
services they need in the absence of some type of waiver
provision.
Provided that the process is not actually tainted by bias,
I don't think it's inappropriate to issue waivers at all. And I
tend to think that some of these conflicts of interest tend to
be more technical and it's reasonable to waive them.
Mr. Waxman. Well, let me go back to Dr. Modlin. I have his
CV. It's extensive. He's clearly one of the leading experts in
his field. Just to cite a little bit about him, he was the
medical director of the Clinical Virology Laboratory of the
Mary Hitchcock Memorial Hospital in Lebanon, NH. He sat on
several editorial boards. He's been a reviewer for over 20
medical journals. He's participated in numerous conferences and
workshops on various vaccine issues.
He's an expert. He knows more than the other 700,000
physicians in the country. So he's an expert. And he owns, as I
understand it, 600 shares of Merck stock.
Now, he doesn't remember getting a notice that when he
looked at a Wyeth Lederle vaccine product, that another company
that might have been affected by his decision might have been
Merck. He doesn't recall. Mr. Burton put in the record that he
was given some notice that one of the affected companies was
Merck, affected products, all investigational, Merck, Virus
Research Institute, NIAID, Wyeth, obviously Wyeth. So he was
given that information.
Is that an apparent conflict, if a man owns 600 shares of
Merck? How important is a decision on this one issue going to
affect the bottom line of Merck and therefore his stock price?
How should we evaluate that conflict?
Ms. Glynn. I'm not in a position to comment on the facts of
an individual case. And I think we made clear before the
hearing that I wouldn't be commenting on individual----
Mr. Waxman. Well, let me ask you a generic question. If a
man owns stock in a drug company, let's say he was voting on
that company's product. Would that be a conflict?
Ms. Glynn. If he owns stock in a company, I'm speaking
hypothetically now, if he owns stock in a company and he was
voting on that company's product, yes, that would be a conflict
of interest. He couldn't vote, in the absence of a waiver or
some exemption applying.
Mr. Waxman. Now, he's voting on another company's product,
and that company may be in a competition with a company where
he owns some stock. Is that an actual conflict of interest?
Ms. Glynn. That may potentially be a conflict of interest,
depending on whether the matter would have some sort of effect
on the competitor in which he owns stock.
Mr. Waxman. So just those facts alone wouldn't leap out as
saying that people throughout this country should be wary that
vaccines are not safe, because they're being approved by people
like that example?
Ms. Glynn. I certainly wouldn't be in a position to say
that. But I think it's important in situations such as you
described for the agency to examine these potential conflicts
of interest in advance and make a determination whether they
think the person should go forward acting or should be issued a
waiver to permit them to go forward and act.
Mr. Waxman. I presume that Dr. Modlin had to file a form or
disclosure about his own financial holdings. Isn't that
required of people who want to serve on these advisory
committees?
Ms. Glynn. Our regulations require that members of advisory
committees--or I should say require that the so-called special
government employees--file confidential financial disclosure
forms.
Mr. Waxman. And on that confidential financial disclosure,
would a person have to list stock holdings?
Ms. Glynn. Yes.
Mr. Waxman. How about if they received compensation from
that company?
Ms. Glynn. Yes.
Mr. Waxman. For whatever purpose?
Ms. Glynn. Yes. They have to list all their assets, outside
employment, typically outside consulting arrangements of any
type, honoraria received or other forms of income of that type,
liabilities, membership in certain organizations. It's
relatively extensive.
Mr. Waxman. Why isn't this public? Why can't the American
people or the press go and look at all these disclosures, the
way they can look at our disclosures?
Ms. Glynn. Certain people in the executive branch, of
course, do file public financial disclosure forms. They're the
higher level employees or people who have political
appointments. For the vast majority of other employees, a
balance is struck that you don't want to put too many
roadblocks in luring them into Government service.
And for people who serve on advisory committees, they don't
serve in the kind of positions that Congress has deemed
appropriate for filing public forms. The criteria for filing
public forms is set out in statute. And they just don't meet
those criteria unless they're so highly paid by the Government
and they work a certain number of days, then they would file a
public form.
Mr. Waxman. So the law is that that is not made public?
Ms. Glynn. That's right.
Mr. Waxman. Furthermore isn't the law that it can't be made
public by anyone?
Ms. Glynn. The law is that they may not be made public,
that they're meant to be held as confidential.
Mr. Waxman. Do you think that applies to the FDA?
Ms. Glynn. Yes, sir.
Mr. Waxman. HHS?
Ms. Glynn. Yes.
Mr. Waxman. CDC? How about the Congress of the United
States?
Ms. Glynn. I'm not in a position to comment on that. I
think you would have to go to your own Ethics Committee.
Mr. Waxman. But the spirit of the law that Congress passed
was that that information is not to be made public. It doesn't
say not to be made public only by FDA, CDC, HHS, and everybody
else at Congress is--it doesn't say one way or the other. It
just says shall not be made public.
Ms. Glynn. The provision does not--it says it shall not be
made public. When we provide confidential financial disclosure
forms to Congress, for example, occasionally as part of
financial disclosure review of people being nominated to
certain positions, we alert Congress to the fact that they are
confidential, that we're not making any public release of the
form, and that Congress in effect has to make its own decision
about whether they think they should.
Mr. Waxman. Now, let me ask both of you, if Congress
through its investigative committee started making public all
these disclosures, what impact would that have on people's
desire or willingness to serve in advisory committees?
Ms. Glynn. My own view is I think it would have a chilling
effect. What I understand from agencies is they have difficulty
attracting people to these advisory positions to begin with,
because they're typically low paying. And for the type of
people they're trying to attract--very expert, well-known
people--they're at a point in their careers where maybe isn't
that much in it for them to be serving on these committees any
more. And if they thought that they were giving their forms to
the Government with a pledge of confidentiality, only to
discover that wasn't being honored, I think it could have a
chilling effect.
Mr. Waxman. Mr. Dean, what do you think?
Mr. Dean. I would tend to agree with that, Mr. Waxman.
Mr. Waxman. So Congress ought to be very careful if we're
going to start making public information that people were told
was not going to be made public, not just because we're maybe
violating the rights of those individuals, but we could have a
chilling effect on people being willing to come in and serve on
these advisory committees.
Mr. Dean. I think it ought to be looked at very carefully
before we make them public.
Mr. Waxman. Mr. Chairman, I'm going to yield back the
balance of my time.
Mr. Burton. I'll just take a couple of minutes to make a
couple of comments. We're talking about, what's the gentleman's
name, Dr. Modlin, is that how you pronounce his name? He was a
paid consultant for Merck. When the rotavirus was approved, it
had a positive impact on other companies who were producing the
rotavirus, because it showed that it has been approved for one
company, and if it was a similar product, it would be approved
for the other company.
So Merck was going to be the beneficiary of that. Not only
that, he was a paid consultant for Merck. Now, we don't know
how much he was paid by Merck, but we know he was a paid
consultant in addition to owning stock in Merck.
Now, I don't know how the bureaucracy in Washington feels,
but I think I can speak for an awful lot of parents around the
country who want to have confidence that the vaccinations their
kids are getting have been tested, and that there's been an
unbiased judgment made as to whether or not they're going to be
safe as well as effective.
And the problem with the bureaucracy is, you keep saying,
well, we can't do this because we might not be able to attract
people to these advisory committees. Look, there are 700,000
doctors. There must be somebody else out there in that vast
mass of humanity that has the expertise to be able to be on
these advisory boards.
And if a parent knew that there was a financial interest,
possible conflict of interest from the person making the
decisions on the vaccination, especially if we find out after
the fact that kids died or are ruined for life, then I think
the parents would say, you know, maybe we ought to make
absolutely sure there's no conflict before we allow these
people to be on these advisory panels making these decisions.
Now, you know, you may disagree because you serve in a
position in the bureaucracy where these decisions are made, and
you think that that's the way it ought to be. I speak from a
little bit of experience. I have two grandchildren, two. One
got a hepatitis B shot and within 3 hours she was dying. She
wasn't breathing any longer. They had to rush her to the
hospital and she survived.
Now, there's a lot of parents who have had that kind of
problem with other drugs and other vaccinations. My grandson
got nine shots in 1 day. He was a perfectly normal child. And
within about 3 or 4 or 5 days, a week, he became autistic. Now,
it may be a coincidence. A lot of people say that's
coincidental.
But the one thing I want to make sure of as a grandparent
or as a parent is that the guys making these decisions or the
ladies making these decisions, these doctors, these experts,
don't have some kind of a conflict of interest that skews their
judgment in one direction or the other. And the American
people, well, you can say, we shouldn't be making this stuff
public. Let me tell you something. Everybody in American who
has a child who's had this kind of a problem wants this stuff
made public, because they want to know if the people making
these decisions do have a conflict of interest.
We go to the doctors and we get these shots for our kids,
and we do it believing that the health agencies are above
reproach, that there's no danger to our children, or at least
it's minimal. And we put great confidence in CDC and FDA and
all of our health agencies. And if we find out after the fact
that our child has had a terrible, serious problem, and then we
find out after the fact that people on that advisory committee
that made those decisions did have a conflict of interest, it
will weigh on us very heavily, because we'll wonder, always
wonder, if that conflict of interest led to the problem that we
have in our family.
And that's why the people on these advisory committees need
to be above reproach. They need to be above reproach. If they
have a conflict of interest, if they're a paid consultant for a
company that has an interest in that product, if they have a
large amount of stock in that company, and they're going to
benefit from that product, or if they have some other reason to
be tied to that company, they're getting grants from that
company for scientific research, whatever it might be, they
should not be on those advisory committees. And if they are, it
should be made known at the outset so that people can make a
decision based upon information, total information.
And I just think it's wrong. You may shade this one way or
the other, based upon what you feel is being with the
Department of Ethics in this country. But if that's the way it
is right now, I think the law should be reviewed and changed.
There's got to be people out there that can serve on these
advisory panels that don't have conflicts, who may have their
judgment skewed in one direction or another. And there's got to
be people out there that are going to make decisions based upon
what's best for the people of this country and the kids of this
country without any bias whatsoever.
And that's what the American people, I believe, want. And I
know as one who's been affected by this, that's what I want.
Mr. Waxman. Mr. Chairman, my heart goes out to you, for
your personal family tragedy. I don't know whether it was
connected to the immunization or not. I just don't know the
answer to that. I think you feel that it was connected, and I
understand your strong feelings about it.
But I don't think we ought to pick on Ms. Glynn and say
that she believes something because she's part of the
bureaucracy. After all, we're talking about laws that were
adopted by the Congress. She didn't vote on these laws, we did.
And under the law that we voted there is a whole mechanism to
try to avoid against conflicts of interest. The disclosure had
to be made by each of these people who wanted to be on an
advisory committee, or we tried to get on advisory committees,
and we told them, we want you on, you have to make a
disclosure.
So they made a disclosure, the agencies had the
information. We'll find out when we hear from the next panel
whether they had disclosures. But I presume they had
disclosures about everybody on the advisory committee.
Second, they may or may not have had waivers if they
thought that it was important to allow these people to continue
to serve, notwithstanding the fact that they may have had a
conflict, such as owning shares.
But what would gall me the most, as a parent and as a
grandparent, was to think they got people who didn't have
expertise in the science and started having them sit on these
committees and approve drugs or vaccines that later turn out to
be a problem. Now, it turned out there was a problem with this
particular rotavirus vaccine. The fact that there was a problem
with the rotavirus vaccine, and I don't know why they didn't
foresee it, but it seems like from what I understand, they had
some concerns about it and they were watching to see if this
problem might develop that they feared might result from this
vaccine. I have not heard any evidence that anybody, even if
they had no conflict of interest to even talk about, made any
decision that wasn't completely proper, scientifically and
otherwise proper in terms of their evaluation of this
particular vaccine.
So, to say that because there's an apparent conflict with
some of the people on the advisory committee, that that
apparent conflict meant that the vaccine might have had a
problem, is a huge leap. It is a huge leap, and we ought to
have a lot more evidence before we make that kind of a
statement publicly, because it does tend to scare people into
thinking that decisions are made at FDA on drugs and vaccines
or at the CDC on public health issues, by people who are
sitting there thinking about how they're going to enrich
themselves, and they're not evaluating the science.
If they've evaluated the science, that's the first thing
that's important. And we have no evidence that they didn't do
that which was necessary.
I don't want people who are beyond reproach. I don't want
saints. I want people who know what they're doing and if
there's a problem or a possible conflict, I want that disclosed
and dealt with. And as I understand it, in the case of each and
every one of these people who served on these advisory
committees, their holdings, their income, were all disclosed to
the people who were having them serve on the committee.
So I don't think, notwithstanding the frustration that you
and others may feel, that we ought to leap to conclusions based
on what we have heard so far about some of the individuals that
served on the advisory committee. Look at how Members of
Congress are dealt with. We disclose our information and we
assume therefore there's no conflict. Look how we handle our
campaign finance laws. We disclose--we thought, except for some
loophole that's now come up in the form of these non-profit
organizations that are now being used to subvert the disclosure
laws--but we worked under the assumption that we disclosed from
whom we get the campaign money and therefore we've done what's
necessary to show that if we act, people can judge whether
we've acted in a conflict.
These people who serve on advisory committees had to make
that disclosure, and therefore for those who work in the
agencies and handle the ethical questions, they can evaluate
whether there was a breach of ethics. From Ms. Glynn's
testimony, FDA seems to have a good record in ethics. CDC
apparently has a good record in ethics. You're not talking
about agencies that have a bad record on how they handle their
ethics. And I think we need to get more information before you
reach some of those conclusions that you've mentioned.
Mr. Burton. I'd like to just ask my colleague one question,
because I don't want to prolong this. The rotavirus that we're
talking about, before the advisory committee made its
recommendation, they already knew that there were adverse
events, 1 out of 2,000 children had severe side effects. And
yet they went ahead and approved this rotavirus anyhow. And it
was put on the market and then withdrawn in less than a year
because of severe side effects and problems.
That's the thing I have concerns about.
Mr. Waxman. I understand, and I share that concern as well.
But without knowing more, it could well have been a judgment
that was a mistaken judgment on the scientific evaluation of
whether they thought that this was a likely result and
therefore they should have foreseen it, or whether it was an
unlikely result and they didn't know about it in the instance
in which they reviewed it, and thought maybe these were
isolated cases, and let the vaccine go forward.
After all, vaccines can prevent a virus that is a killer
all around the world of children and of infants. And you have
to evaluate, with all products, the risk benefit calculation.
Mr. Burton. I want to thank this panel for being here.
We'll now go to our next panel. Our next panel consists of
Linda Suydam, Dixie Snider, Kevin Malone, Jennie Slaughter,
Bill Freas, and Nancy Cherry. Would you please come forward.
Would you please stand. As I understand it, one person from
each agency is going to be the principal spokesman, and the
others will be there to help you, to assist you. So I guess you
don't need to come forward, as long as you're sworn in.
[Witnesses sworn.]
Mr. Burton. Please be seated.
Ms. Suydam, do you have an opening statement?
Ms. Suydam. I do, Mr. Chairman.
Mr. Burton. You're recognized.
STATEMENTS OF LINDA A. SUYDAM, D.P.A., SENIOR ASSOCIATE
COMMISSIONER, FOOD AND DRUG ADMINISTRATION; AND DR. DIXIE
SNIDER, JR., M.D., EXECUTIVE SECRETARY, ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES, CENTERS FOR DISEASE CONTROL,
ACCOMPANIED BY KEVIN MALONE, JENNIE SLAUGHTER, BILL FREAS, AND
NANCY CHERRY
Ms. Suydam. Thank you. Mr. Chairman, members of the
Committee, I'm Linda Suydam, Senior Associate Commissioner of
the Food and Drug Administration.
I'm pleased to have the opportunity to be here today to
discuss with you FDA's advisory committees. FDA is committed to
selecting the most qualified members for our advisory
committees, and to rigorously complying with the statutes and
regulations governing those committees. FDA is a science based
regulatory agency with regulatory responsibility for
approximately 25 percent of the gross national product,
including food, drugs and medical devices.
FDA's mission is to protect and promote the public health
by promptly and efficiently reviewing clinical research and
taking appropriate action on the marketing of regulated
products in a timely manner. FDA's advisory committees play a
critical role in this public health mission. FDA's decisions
must be based on the highest clinical and scientific standards.
To provide this critical scientific base, FDA has over 1,500
outside experts who provide FDA with essential expertise in
highly specialized areas.
Many of these experts serve as members on or consultants to
our advisory committees. These members are public servants in
every sense of the word. While they are compensated for their
time at meetings, the amount of time and effort these members
and consultants put into the public health needs of this Nation
is a true public service.
Currently, FDA is administratively responsible for a total
of 32 advisory committees. Each has a core membership
identified with each committee's charter. This membership is
developed based on the complexity of the issues to be
considered and the assessment of the issues by the agency as to
the types and degrees of expertise needed.
FDA's advisory committee system assists FDA's mission in
the following seven ways: by providing independent expertise
and technical assistance related to the development and
evaluation of products regulated by FDA; by lending credibility
to the product review process; by speeding the review of
products by providing visible sharing of the responsibility for
the evaluation and judgment of these products; by providing a
forum for public discussion on matters of significant public
interest; by allowing sponsors and consumers to stay abreast of
trends in product development by reviewing process and changes
in regulations and guidelines related to FDA-regulated
industries; and providing external review of FDA's internal
research projects.
Committee members with voting status vote on substantive
scientific and policy matters. It is extremely important to
note, however, that these advisory committee recommendations
are not binding and that panel members are not asked approval
or disapproval questions. The agency retains all final
decisionmaking authority. Thus, FDA alone decides to approve a
product for marketing as safe and effective.
The standing membership of advisory committees includes
academicians, clinicians, consumers, and in some cases industry
reps and patient or patient caregivers. In addition to the
standing membership, temporary voting members and consultants
may be needed to provide specific expertise.
FACA requires that committee memberships be fairly balanced
in terms of points of view represented to the committee
function, and DHHS policy requires that the committee
membership be composed of as equitably as possible of
geographic, ethnic and gender representation. In screening
nominations for prospective standing committee members, FDA has
a thorough and consistently applied process. This ensures that
we obtain qualified members who are able to provide the agency
sound advice. Final appointment of all advisory committee
members is done by me, the senior associate commissioner.
If permitted by a committee's charter, the committee's
standing voter membership will be supplemented by the
appointment of temporary voting members. These members are
important, as they have specialized expertise often necessary
for the consideration of particular issues.
While FDA has a great need for scientific advice, it is
critical that that advice be as free as possible from conflict
of interest and potential bias. If the advice FDA receives is
biased or perceived as biased, it is of little value to the
agency and only diminishes the credibility of agency decisions.
Studies have shown that academic and biomedical research is
increasingly supported by industry. For that reason, outside
experts in research centers where they work frequently have
research grants from and contracts with regulated industry.
Thus, most active researchers in the private sector have some
ongoing or past relationship with the regulated industry.
This by itself does not preclude them from becoming SGEs.
If this were the case, FDA would not have the top scientists in
the field and the recommendations of the committees would not
be of the highest scientific nature, with a likely impact on
public health.
Prior to each advisory committee meeting, each SGE
completes an FDA conflict of interest disclosure form. Types of
interests that are screened are stocks, investments, primary
employment, consultant work, contracts, patents, grants,
trademarks, expert witnesses activity, speaking engagements and
other information. FDA has the authority to allow an advisory
committee member to participate in the review of a new therapy,
even if there is a potential conflict, as long as FDA applies
with applicable legal standards. And FDA may provide for this
by granting a waiver.
In the 1990's, the Institute of Medicine recommended to FDA
that it formulate a written guidance document. And an FDA task
force with DHHS did create that waiver criteria document. And
in 1997, the Office of Government Ethics audited the FDA ethics
program, including the advisory committee programming,
concluded that it was impressed with FDA's program for
protecting SGEs from conflict of interest, and that it was a
model for other agencies to use in developing their own systems
and procedures.
In conclusion, Mr. Chairman, let me assure that the agency
has met every effort to rigorously comply with the applicable
statutes and regulations in appointing outside members to the
FDA advisory committees. Multiple, independent and sometimes
redundant views, taken together ensure FDA, the medical
community, industry, consumer and patient groups and most
importantly, the American public, that advisory committee
recommendations are based on the best possible science and are
free from bias.
Thank you. I'll be happy to answer any questions.
[The prepared statement of Ms. Suydam follows:]
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Mr. Burton. Thank you, Ms. Suydam.
Dr. Snider, do you have an opening statement?
Dr. Snider. Yes, sir, I do.
Dr. Snider. Thank you, Mr. Chairman, and good afternoon.
I'm Dr. Dixie Snider, Jr., Associate Director for Science
at the Centers for Disease Control and Prevention. As executive
secretary for CDC's Advisory Committee on Immunization
Practices, I'm pleased to be here to discuss the policies and
procedures of the committee and its role in developing
recommendations for vaccine use.
The ACIP develops written recommendations subject to the
approval of the Director of CDC for routine administration of
vaccines for the pediatric and adult populations, along with
schedules regarding the appropriate periodicity, dose and
contraindications applicable to the vaccines. In addition, as
provided by statute, the ACIP designates vaccines for
administration in the Vaccines for Children program.
The overall goal of the ACIP is to provide advice that
assists CDC, HHS, and indeed the whole Nation, in reducing the
incidence of vaccine preventable diseases and increasing the
safe usage of vaccines and related biological products. The
ACIP consists of 12 regular voting members, many of them
parents, selected by the Secretary of the Department, from
authorities who are knowledgeable in the field of immunization
practices, have multidisciplinary expertise in public health,
and have expertise in the use of vaccines and immunologic
agents in both clinical and preventive medicine.
In addition to required technical expertise, consideration
for ACIP membership is given to representation from diverse
geographic areas, both genders, ethnic and minority groups and
the disabled. In addition to regular voting members, the ACIP
has ex officio members from other Federal agencies who are
involved in vaccine issues. And we have non-voting liaison
representatives from professional societies and organizations
responsible for the development and execution of immunization
programs for children and adults. These people do not vote.
The representation of these ex officio members and liaison
representatives does contribute toward a better understanding
of the position and views of their sponsoring organizations and
results in better informed decisions, in our view. Open public
ACIP meetings are held three times a year with meeting dates
announced 6 to 12 months in advance. Notices of each meeting
are published in the Federal Register in accordance with the
requirements of the Federal Advisory Committee Act. ACIP
meetings are open to the public, as I said, and public comments
are solicited during the ACIP meetings.
Federal advisory committees inherently have members who may
have potential financial conflicts of interest. Experts in the
field frequently have affiliations with or may be engaged in
research conducted by academic institutions or other
institutions which may receive funding by vaccine
manufacturers. The situations which produce immunization
expertise also may result in potential conflicts of interest.
And Congress has recognized the need for service on Federal
advisory committees by these experts by providing the authority
to issue waivers of conflicts of interest when the need for the
individual's services outweighs the potential for a conflict of
interest created by the financial interest involved. The work
of the ACIP necessitates significant immunization expertise.
One of the purposes of this advisory committee is to
provide additional scientific expertise beyond what may be
known and presented to the committee. Experts are more likely
to be familiar with the published scientific literature, with
its strengths and weaknesses, than non-experts. But in
addition, experts are more likely to know cutting edge research
information, including unpublished information, that may not be
generally available. And if this expertise were not available
to us, members would be limited to decisionmaking based solely
on selected information presented at the ACIP meetings.
So consistent with these provisions of law, limited waivers
are issued to ACIP members who have potential conflicts of
interest, so that the Government may benefit from the
scientific and public health expertise of each member. And
under these waivers, each member with a potential or actual
financial conflict of interest is granted a limited waiver to
allow participation in all committee discussions, with the
conditions that the member publicly discloses relevant
interests at the beginning of every ACIP meeting and abstains
on votes involving entities with which the member has a current
direct financial interest when that vote could potentially
result in a significant financial impact on the entities.
This public disclosure, which is fairly unique to the ACIP,
ensures that the agency, their fellow members and the public
are aware of each member's interests, which then can be weighed
in the deliberations of the committee.
CDC is continuing to review its policies related to its
advisory committees to achieve the highest level of scientific
integrity in obtaining external expertise. We welcome any
suggestions to improve the process. And I'd be happy to respond
to any questions you may have, Mr. Chairman.
[The prepared statement of Dr. Snider follows:]
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Mr. Burton. Dr. Snider, when a person decides that they may
have a conflict of interest and they decide not to vote, does
anybody vote in their stead at these advisory committee
meetings?
Dr. Snider. In most cases, they do not. We do have a
provision that if we do not have a quorum, which is six
members, available, that is not conflicted, that is able to
vote, then in the most recent charter, I have the authority to
appoint the ex officio members as voting members.
Mr. Burton. And who are those ex officio members?
Dr. Snider. The ex officio members are representatives from
other Federal agencies.
Mr. Burton. So you appoint somebody to go in and take the
place of the people who aren't there or who have disqualified
themselves on that issue?
Dr. Snider. I'm able to appoint ex officio members as
voting members under certain circumstances, yes, sir. On some
committees, ex officio members are routine voting members.
Mr. Burton. Now, these people that you appoint to go in, do
they discuss the issue at hand with the people who are in the
meeting, including the person who may have said they have a
potential conflict of interest before they vote?
Dr. Snider. I'm sorry, I don't quite understand the
question.
Mr. Burton. Well, let me explain it again. You've got a
meeting, you've got say six or eight people there, and a couple
of them say, you know, that I have a financial interest in this
company. And they say to you that in order to make sure we have
a vote today, because we've come a long way, can you send a
couple of people in to vote in our stead. Now, when they go in
there, do those people discuss the issue with the people in the
meeting?
Dr. Snider. All right, Mr. Chairman, let me explain the
process. I understand the question now.
In the meetings, as I mentioned, there are these potential
conflicts of interest that are disclosed at the beginning of
the meeting. When we arrive at a point in the meeting at which
a vote needs to be taken, we do another ascertainment to
determine who is able to vote and who is not able to vote among
the regular voting members.
Also in the room during the whole meeting are the ex
officio members. And so they have been participating and
listening to the discussions. Therefore, they are well equipped
to participate in the vote.
Mr. Burton. So the people who have a financial interest who
have disqualified themselves, do they participate in the
discussion about the vaccination or the product at hand?
Dr. Snider. As was indicated earlier, Mr. Chairman, these
individuals have been granted waivers. Of course, we could
allow them to vote on the issue if we wanted, under those
waivers.
Mr. Burton. I know, but let's get----
Dr. Snider. But we have decided, to answer your question,
sir, we have decided that because of their expertise, we would
like them to participate in the discussion.
Mr. Burton. So they participate in the discussion.
Dr. Snider. But they do not vote.
Mr. Burton. But they do not vote. But the people that you
have appointed to come into the room hear all of the arguments,
and they are persuaded to vote either for or against it, based
on the discussion in the room, correct?
Dr. Snider. The individuals who are ex officio members
participate throughout the meeting.
Mr. Burton. I understand.
Dr. Snider. They are active participants. They are
representatives from FDA, a representative from NIH and so
forth. They understand these issues on their own.
Mr. Burton. OK, I don't understand. We don't need a long
dissertation.
Dr. Snider. They're vaccine experts.
Mr. Burton. The question I asked is this. They sit in the
room, the people who are not going to vote, in whose place
these people from your agency are going to vote, they hear the
discussion. And after they hear the discussion, which includes
the people who are not going to vote, then they vote in their
stead, is that correct?
Dr. Snider. It's not--we don't view it as in their stead.
But they do vote, yes, sir.
Mr. Burton. OK, but they have heard the discussion, which
includes the people who do have a potential conflict of
interest, they participate in the discussion and then they
don't vote after they participate in the discussion?
Dr. Snider. That's correct. The other people do vote after
hearing those people who are conflicted, and also knowing that
those people are conflicted.
Mr. Burton. Do you think that the people who are conflicted
expressing their opinion and how they feel about the potential
product, do you think that they have any persuasiveness to
them? Obviously they're there to tell how they feel about the
product.
Dr. Snider. People vary in their persuasiveness. And just
because individuals have conflicts of interest does not
necessarily mean that you can predict what position they will
take. And individuals may or may not be very persuasive.
Mr. Burton. Would you say that they're in a de facto, they
are de facto participants in the decisionmaking process,
because they're actually giving their views to the people who
are going to vote in their stead?
Dr. Snider. As are members of the public and as are
representatives from professional societies.
Mr. Burton. How many members of the public do you have in
there?
Dr. Snider. In many meetings we have maybe 60, 70, 80
people present at the meeting. And we'll have 10, 15, 20
members of the public.
Mr. Burton. How many of those people vote?
Dr. Snider. I'm not suggesting they vote. My point was that
there are many people who are recognized by the chairman who
are able to comment on these issues throughout the discussions.
If a member of the general public gets up to the microphone,
Dr. Modlin, our current chair, will recognize that individual
and allow them to influence the committee as much as anyone
else can.
Mr. Burton. As much as the person who has the conflict of
interest who's on the committee who's not voting?
Dr. Snider. To the extent that they have those persuasive
powers.
Mr. Burton. How many recommendations by advisory committees
are not followed? How often does that occur, by the FDA?
Ms. Suydam. It's very rare when, the recommendations are
generally related to specific questions that the advisory
committee is asked. For example, they're asked, is there enough
data to support the safety of this product, is there enough
data to support the efficacy of this product. So when you say
follow, the decision that whether the product is allowed on the
market is FDA's alone.
Mr. Burton. I understand that. But how often does a
recommendation by an advisory panel of this type, how often is
that rejected?
Ms. Suydam. It is very rare.
Mr. Burton. Very rare. I mean, can you give me a number in
the last 2 or 3 years how many times it's happened?
Ms. Suydam. I don't believe I can, Mr. Chairman. I'll be
glad to provide that for the record.
Mr. Burton. Can you list all the instances where the FDA
has not licensed a vaccine product recommended for licensure by
the VRBPAC on the basis that it did not agree with the findings
of the committee from January 1990 to the present? Can you give
me some examples?
Ms. Suydam. Mr. Chairman, I don't believe there are any.
Mr. Burton. So for the past 10 years, the recommendations
of the advisory panels have pretty much been followed 100
percent?
Ms. Suydam. With some delay in some cases. For example, it
may be 5 years before a product is brought onto the market.
Mr. Burton. The Supreme Court, when they were talking about
additions to 18 U.S.C. 208, said ``The statute is thus directed
not only at dishonor, but also at conduct that tempts dishonor.
This broad proscription embodies a recognition of the fact that
an impairment of impartial judgment can occur in even the most
well-meaning men or women when their personal economic
interests are affected by the business they transact on behalf
of the Government.''
Now, I want you to bear that in mind, because I have some
questions that bear upon that. The committee, one of these
committees, VRBPAC, for the VRBPAC meeting where Rotashield was
approved for recommendation, an advisory committee member, Dr.
Mary Estes, her employer had received a $75,000 grant from
American Home Products, the parent company of the sponsor,
Wyeth Lederle. In addition, the member herself was the
principal investigator on a grant from Merck, an affected
company, for the development of its rotavirus vaccine. This
member was given a waiver and fully participated and voted on
the recommendation.
Another member, Dr. Catherine Edwards, was receiving a
grant for research on another vaccine of $163,000 from Wyeth
Lederle. And yet another member, in fact the chairwoman of the
committee, Dr. Patricia Ferrieri, owned close to $20,000 worth
of stock in Merck, an affected company whose rotavirus vaccine
was already in the pipeline. This person as chair leads and
conducts a discussion on the approval recommendation of a
vaccine that, by the FDA's own admission, will make it easier
for other similar rotavirus vaccines in the pipeline to be
approved.
Now, I know you can't comment on specific cases. But
generally speaking, should a person who is getting large grants
of money from a company that makes the vaccine under
consideration be able to get a waiver and vote for its
approval?
Ms. Suydam. Mr. Chairman, as you know, the Government
Ethics Act and the Privacy Act prohibit me from talking about
specifics.
Mr. Burton. I'm not asking about specifics.
Ms. Suydam. I would suggest that----
Mr. Burton. Generally speaking.
Ms. Suydam. We have a procedure in place whereby we have
eight levels of review that looks at the financial disclosure
statements for every member of our advisory committees,
including temporary members. And those eight levels of review
would weigh whether the benefit of having a particular expert
is necessary for that committee in order to have them on the
committee, if they had and did own some stock.
Mr. Burton. Generally speaking, generally speaking now, you
have one that got a $75,000 grant from American Home Products,
and was the principal investigator on a grant from Merck, which
was an affected company. And this person was given a waiver.
Another member received a grant for research for a vaccine from
the company in question, Wyeth Lederle, for $163,000. Another
who was the chairwoman had $20,000 worth of stock in Merck, an
affected company. And she led and conducted the discussion on
the approval of the recommendation of the vaccine that by the
FDA's own admission will make it easier for other similar
rotavirus vaccines in the pipeline to be approved.
Now, generally speaking, don't you think the American
public would consider these to be a possible conflict of
interest, if they saw that?
Ms. Suydam. Mr. Chairman, they are considered a conflict of
interest, but they were waived after considerable thought and
review. And we've gone back and reviewed all of the members of
those committees. So I won't speak about each one individually.
But I will tell you that we believe that the decision was made
in a way that made the committee the most effective for the
American public.
Mr. Burton. So if a decision was made like that, then
obviously you would not consider that to be a real conflict of
interest problem.
Ms. Suydam. We consider it a conflict of interest that
could be waived based on the needed expertise of those
particular individuals.
Mr. Burton. And this rotavirus that went on the market,
even though there had been 1 in 2,000 adverse events, which was
withdrawn after substantial problems by people who took the
vaccine, within a year, so would you say that maybe there was a
mistake made? And what about those people who suffered as a
result of that mistake? Do you think they might think there was
the possibility that there might have been a conflict of
interest by these people that had a financial interest, even
though you folks didn't?
Ms. Suydam. Mr. Chairman, I think the injuries that were
suffered are a great tragedy for the people and for the parents
of those children. I do believe that those kinds of injuries
happen when you bring a product onto the market. I think we put
protections in place so that we could pull off that product as
quickly as possible.
And when we saw that the incident rate was higher than we
had anticipated, we did take action and the product was
withdrawn.
Mr. Burton. They knew at the outset that there were adverse
events. They knew at the outset. And yet it was a unanimous
decision, I guess, by the advisory panel, to go ahead and put
that product on the market. And people did have conflicts of
interest, it was very, very clear, substantial conflicts of
interest. And you felt that their expertise was substantial
enough that you waived.
Ms. Suydam. Yes, sir, we did.
Mr. Burton. At the very least, don't you think that a
person who's receiving substantial amounts of money, either for
his or her research or as a consultant is likely to be biased
toward that company?
Ms. Suydam. I believe that the bias is one that has to be
weighed in terms of what is the person's scientific abilities
and whether that person can participate in a way that is
unbiased. Clearly, if the person had an interest that was
specifically related to the product that was being reviewed,
they would not be granted a waiver. And in fact, that was the
case in the Rotashield meeting. We excluded a number of people
from those meetings.
Mr. Burton. Well, you have waived a lot of people who have
these conflicts. And we have a lot of cases. We've been doing a
lot of research. So I won't go into all those, we just took
this one example today.
But let me go back to what the U.S. Supreme Court said. And
I want you to listen to this, and think maybe you're waiving
these things too often. It says, the statute is thus directed
not only at dishonor, where a person intentionally does it, but
also at conduct that tempts, tempts dishonor. This broad
proscription embodies a recognition of the fact that an
impairment of impartial judgment can occur in even the most
well-meaning men and women when their personal economic
interests are affected by the business they transact on behalf
of the Government.
Now, the reason I bring that up again is the Supreme Court
said that even the best of us, when put in that position, may
have our judgment tainted because in the back of our minds,
they know we have a financial interest. And yet you waive
continually on these products people who have substantial
financial interests.
And in the case of the rotavirus, even though there were 1
in 2,000 side effects that were substantial, they voted to put
that on the market, and in less than a year, it was taken off.
They knew there were side effects. They knew they had a
conflict of interest. You waived on it and people suffered and
it went out into the marketplace.
You don't see that as a problem?
Ms. Suydam. It certainly is a problem when people suffer
from products that cause harm. I understand that. But Mr.
Chairman, I waive conflict of interest when we feel and the
scientists in FDA feel that they need the expertise of those
particular people to make the decisions that they have to make.
Mr. Burton. Dr. Snider, for the VRBPAC meeting on
Rotashield on December 12, 1997, only seven advisory committee
members were in attendance. Two of them had strong financial
conflicts of interest that prevented them from even
participating in the proceedings. That meant that only five
members were available for the meeting, and five people were
brought in as temporary voting members.
Why wasn't this meeting postponed when it became evident
that there would not be a quorum of advisory committee members?
Ms. Suydam. That's my question, I think.
Mr. Burton. Yes, that's a question for you, go ahead.
Ms. Suydam. It is my question. At the time, we had two
other topics on the committee agenda as well. And we felt it
was important to go forward with the meeting as such. And we
have used and have authority to use temporary members and bring
those in as temporary voting members. And we did that in this
case.
Mr. Burton. Well, wasn't it inappropriate, and this is when
the rotavirus was approved, wasn't it inappropriate not to say
against the Department policy that states that a meeting will
generally not have more than four temporary voting members? I
guess in your charter it says that you have to have, you can't
have 50 percent of the voting members being temporary members.
So why would you have more?
Ms. Suydam. I think the operative word, Mr. Chairman, is
generally. And we felt that it was important in this case, the
meeting for other issues we had individuals at that meeting and
we went ahead with the meeting and had the rotavirus
discussion.
Mr. Burton. That was because there was a deadline coming
up?
Ms. Suydam. We felt it was important to have the advisory
committee at the time when we set it up, there were more people
attending, we had hoped there would be more people attending.
Mr. Burton. If the concerns were related to deadlines or
getting this job done that the FDA had to comply with, why
didn't the FDA get an extension to make sure that the members
were there? Didn't feel like you needed to do that?
Ms. Suydam. No, Mr. Chairman, I think we initially thought
there would be more members at the meeting, and then at the
last minute, some people had things that came up and they were
not able to attend.
Mr. Burton. After reading, and we read the VRBPAC
Rotashield approval transcript, it became obvious that members
voted unanimously to recommend the approval of the vaccine,
even though many expressed serious concerns about the efficacy
and the safety of the vaccine. I mean, they expressed concern
about the safety of the vaccine at the hearing.
For example, one of the temporary members asked, and as a
result, I would ask the FDA to work with the sponsor to further
quantify 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.
And yet, even though he had serious concerns, he worked for
the agency, he voted, along with everybody else, for the
approval of this vaccine that was jerked off the market.
Now, doesn't it concern you that these members are voting
unanimously to approve a product that they have serious
concerns about, like this person from the agency?
Ms. Suydam. I think you're quoting from the transcript, is
a scientist who is speaking out and talking about some of the
issues that he still thinks need to be resolved, because they
know that FDA makes the final decision and that FDA will in
fact be able to followup with the company. So they're giving us
a signal, they're sending us a signal that says, FDA, go ahead
and talk to the company about this particular issue. And I
assume that the FDA did.
Mr. Burton. But you said in the last 10 years, there hasn't
been one time that the advice of these committees has been
rejected by the FDA, in 10 years. Isn't that correct?
Ms. Suydam. In the case of the VRBPAC, yes.
Mr. Burton. So in 10 years, they haven't rejected it. And
yet this gentleman or gentlelady that made this comment who had
reservations, went ahead and voted for it, I presume because he
was persuaded by everybody else, or maybe because he worked for
the agency, and nothing was done. They went ahead and approved
it and put it on the market.
Ms. Suydam. Well, I can assume, Mr. Chairman, that the
agency, if they also take the advice of the committee, would
also go ahead and followup with the company and resolve that
issue, resolve that question that the scientist was raising in
the transcript.
Mr. Burton. Does anybody know if that was resolved? Do you,
Ms. Suydam? Do you know if it was resolved?
Ms. Suydam. I believe it was. Otherwise the product would
not be on the market.
Mr. Burton. Well, it wasn't on there very long.
As I understand it, the very concerns that were expressed
here were the reason they pulled it from the market. So maybe
it wasn't addressed.
Are most of the votes of the VRBPAC unanimous votes?
Ms. Suydam. I believe most of them area. The majority are.
Mr. Burton. Can you give me an idea of how many aren't
unanimous?
Ms. Suydam. Well, occasionally, they will be seven to one
or something like that on some issues.
Mr. Burton. Can you give me a number that have not been
unanimous?
Ms. Suydam. I don't believe I can, no.
Mr. Burton. Is there anybody that's with you that can give
us a number of the recommendations that have not been unanimous
in the last 5 to 10 years? Do you know of any that have not
been unanimous?
Ms. Suydam. I do. I do know of some.
Mr. Burton. How many do you know of?
Ms. Suydam. I know that even on some of the questions we
have asked for the Rotashield, for example, they were not
unanimous.
Mr. Burton. So you know of some vaccines where they were
not unanimous?
Ms. Suydam. Yes.
Mr. Burton. But it's rare?
Ms. Suydam. It's probably in the range of 20 percent.
Mr. Burton. Now, if you have somebody that doesn't agree,
let's say you have four, do you normally have more than one or
two or how many?
Ms. Suydam. It's hard for me to say. The numbers of the
committee members that are voting changes. Sometimes it could
be two, sometimes it could be three, sometimes it could be one.
Mr. Burton. According to the time line of the approval and
recommendation of the Rotashield vaccine, the ACIP committee
voted on a recommendation before the vaccine had been approved
by the FDA. Do you feel that it's appropriate for the ACIP
committee to vote on a recommendation of a vaccine when that
vaccine has not even been approved by the FDA?
Ms. Suydam. I would not be able to speak for the ACIP.
Mr. Burton. Doctor.
Dr. Snider. I think it's appropriate for the committee to
give the working group some guidance on how they would foresee
the recommendation going. The recommendation is not an
established recommendation until it's published in the
Morbidity and Mortality Weekly Report. But there's a lot of
scientific work that goes into developing these
recommendations. So votes have been taken prior to licensure to
give guidance. I think some people have misunderstood the
purpose of those votes, and have mistook those votes as being
final votes. But a recommendation is not final until it's
accepted by the Director of CDC.
Mr. Burton. So you think it's appropriate for the ACIP
committee to vote on a recommendation when a vaccine has not
even been approved by the FDA?
Dr. Snider. I think it's appropriate, again, to give their
opinions about what populations it should be used in and give
general guidance to the working group that's working on the
recommendations. And that is what we attempt to do in our
policies and in our procedures. To the extent that others have
been misled about any votes, we apologize and will take steps
to try to ensure that never happens in the future.
Mr. Burton. At the ACIP meeting on February 18th, 1999, Dr.
Modlin stated, ``Just when everybody thought we were finished
with rotavirus, in fact, we were really almost there. The
statement was approved in June of last year and in fact the
statement is very close to going to the printers.'' And it was
approved on June 25th, prior to it going to the FDA, is that
correct? That's----
Dr. Snider. And then subject to licensure, there was more
discussion at the ACIP meeting and further revisions were made.
Mr. Burton. But it was already approved, though, was it
not?
Dr. Snider. That was my point, that the recommendations
remain fluid and dynamic until they are published in the MMWR.
I think if you'll check the record of the ACIP meeting, you'll
find that I made statements to that effect to the committee in
1999.
Mr. Burton. Are you aware of any other instances when this
has happened?
Dr. Snider. I think there are other instances where people
have gotten the impression that because the committee has
expressed a preference for a particular policy option, let's
say it has to do with what age children should be recommended
for this vaccine, that that's a final decision. But again, the
decisions are not final until CDC accepts them and publishes
them in the MMWR.
They may go back to working groups for further revision.
After some people may have thought their work was over, it
wasn't.
Mr. Burton. Can you give us specifically another instance
when this has happened, specifically?
Dr. Snider. I'd have to look through the minutes, Mr.
Chairman.
Mr. Burton. I thought you just said that it happened quite
frequently. If it happened frequently, can't you just think of
one?
Dr. Snider. In which we have had numerous drafts of the
recommendations?
Mr. Burton. Votes on a vaccine that had not yet been
licensed. Can you think of another instance when that happened?
Dr. Snider. Again, I think there were perceptions that we
had votes on other vaccines in which there were not final
votes.
Mr. Burton. I think the answer's no, you can't think of
any, is that correct, right now?
Dr. Snider. I can't think of any that I want to say to the
chairman that I'm certain about.
Mr. Burton. If you would just wait 1 minute, Mr. Gilman,
I'll be through with my questioning, and if Mr. Waxman doesn't
mind, we'll let you make your statement. Because he has to
leave, is that all right with you?
Mr. Waxman. When your time is up, I'm taking my time.
Mr. Burton. Mr. Gilman, Mr. Waxman has said that he will
not yield to you for your statement until he takes 30 minutes.
Mr. Gilman. I have to get back to the floor.
Mr. Waxman. I've been sitting here a whole half hour
waiting for my turn. I'm not going to yield my time.
Mr. Burton. OK, Mr. Gilman, we'll submit it for the record.
Mr. Waxman. Ben, I'm going to let you do it.
Mr. Gilman. Thank you very much.
Mr. Burton. Just 1 second, Ben, we'll be finished here.
The VRBPAC is the advisory committee that reviews the
vaccine efficacy and safety data and then makes recommendations
to the FDA as to the approval of the vaccine. Can and does the
FDA license a vaccine without a VRBPAC recommendation?
Ms. Suydam. Yes, Mr. Chairman, it can and it does.
Mr. Burton. How does the FDA decide when vaccine data
should be reviewed by the VRBPAC?
Ms. Suydam. Well, for the most part, if it's a new or novel
product, if it's the first of a kind of a particular kind of
vaccine, if it's a combination vaccine that hasn't been seen
before. So I would say that the examples of those that are not
are those that are more second time.
Mr. Burton. OK, my time has expired. Mr. Gilman, you're
recognized for your statement and we'll go to Mr. Waxman.
Mr. Gilman. Thank you very much. I want to thank Mr. Waxman
for yielding. I'd like to welcome the panel and thank our
chairman of the committee for investigating Federal vaccine
policy and any conflicts of interest on the part of Federal
policymakers that may exist.
This committee has encountered many aspects of Government
in need of reform due to weak enforcement of Federal policy.
However, the committee's current investigation attracts
particular attention, for not only is our Federal vaccine
policy a governmental issue but a humanitarian issue that
affects every American family. Any possible links between
industry and Federal policy enforcers inevitably results in a
question of ethics.
However, the apparent ties between the pharmaceutical
industry and the Federal Drug Administration and Centers for
Disease Control advisory committee members results in more than
an ethical question. It results in personal injury and possible
death for innocent children and adults. Previous investigations
have revealed that the conflict of interest rules employed by
the FDA and the CDC are weak and are not strictly enforced.
Advisory committee members who have personal or financial ties
to pharmaceutical companies have been granted waivers to
participate in committee deliberations and many committee
members have incomplete financial disclosure statements which
may conceal their financial ties to a pharmaceutical company.
The breach of integrity in vaccine development has
culminated in the serious need for reform. The urgency for
reform can be exemplified by the unethical development of the
Rotashield rotavirus vaccine and its subsequent removal from
the U.S. market. Rotashield was developed to combat rotavirus,
which symptoms are vomiting, diarrhea, low grade fever.
However, it was pulled from the market following reports of
serious illness in over 100 babies. The Rotashield vaccine
intended to cure these symptoms, instead, caused 2 deaths, 53
cases of surgery and 47 cases of required medical care, all in
babies.
The FDA and its advisory committee approved the vaccine in
1999, overlooked the 1989 tests of a similar vaccine in China
in which a number of babies suffered identical bowel problems
to those caused by rotashield known as intussusception, a bowel
obstruction so severe that the intestine swallows itself.
Moreover, at least one of the researchers involved in that
China test is now working at the CDC, was also involved in
Rotashield.
Therefore, the data from the earlier China test was
available to the advisory committee members who approved the
Rotashield vaccine but was overlooked or ignored. Regardless of
the reason why this information was disregarded, American
babies suffered, underwent surgery and some even died. The FDA
and CDC advisory committee members do have the responsibility
of abiding by all regulations to ensure the safety of our
public health.
Human life should not be undermined or compromised for
personal or financial ties that advisory members may have to
the pharmaceutical industry. It's essential to uphold the
integrity of the vaccine development process and to ensure that
the Federal Advisory Committee Act requirements are strictly
enforced. And it's for that reason that I commend our chairman
for pursuing this issue with both the FDA and the advisory
committee administrator.
Mr. Chairman, of recent date, in the last 2 days, it's come
to my attention that our whole anthrax vaccine program is in
severe problems. And I would hope that the FDA would take
another look at that program. The GAO has given us some very
serious information that requires, I think, further review. And
I hope, Mr. Chairman, that our committee would take a further
look at that.
And I thank you for permitting me to make this statement at
this time, and I thank Mr. Waxman again.
[The prepared statement of Hon. Benjamin A. Gilman
follows:]
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Mr. Burton. Thank you, Chairman Gilman. And we will look at
that.
Mr. Waxman, you're recognized for 30 minutes.
Mr. Waxman. Thank you, Mr. Chairman. I want to commend Mr.
Gilman on his statement. I thought that was a good addition to
this hearing. It could have been permitted to be reported by
Mr. Gilman a half hour ago, and I was frustrated by the
minority having to wait 30 minutes before we could even pursue
questions.
Mr. Gilman raised an interesting point. He talked about,
the first time I've heard about it, some Chinese study of this
rotavirus. Dr. Snider, are you familiar with that Chinese
study?
Dr. Snider. Mr. Waxman, I'm not an expert in rotavirus. I
do know that there were other studies done. There are different
rotavirus vaccines. And they may have different properties.
But one thing I would want to say is that having observed
the process and to a certain extent participated in the
process, the issue of whether or not there was an association
between intussusception and Rotashield was something of great
concern and long debate, both in the FDA advisory committee
meeting and at the ACIP meeting. And I think the best
scientists were brought in to look at the situation. I think
that they were quite objective in the way they looked at this.
And the pros and cons of whether there was an association
or was not an association was not a no-brainer call. There was
not a statistical difference between those who received vaccine
and those who received placebo in terms of the incidence of
intussusception. And in contrast to what we observed once
Rotashield went on the market, the rotavirus vaccine studies
observed intussusception occurring after the second and third
doses. There were none after the first dose.
So I guess the bottom line is that it was not an issue that
was passed over, swept under the rug or was not of great
concern. But at the same time, although there perhaps are only
20 deaths from rotavirus in the United States, there are
approximately 50,000 hospitalizations, parents who are very
concerned about that, lots of money is spent on that. And an
estimated half a million kids who get rotavirus each year who
are sick enough that often their parents have to stay home and
take care of them. And that's, as someone has said, not a
trivial issue.
So again, the risk-benefit was considered. Human judgment,
as you know, is not entirely perfect. But I believe people made
the best judgments they could under those circumstances. And as
you know, we put measures in place to monitor, because of our
concern, that there just might be something there. We caught it
very, very early and reacted quite rapidly to it and quite
vigorously, as you know, using all of our EIS officers at CDC
to gather this information, to assess whether there was a true
risk.
In fact, there are some people who still don't think there
is a risk from Rotashield vaccine, although we are convinced of
it, and as you know, we're so convinced that we withdrew the
recommendation.
Mr. Waxman. I'm pleased you went through that discussion,
that at the time the vaccine was being considered by
scientists, both at FDA and at CDC, there was a discussion
about this issue.
Dr. Snider. Many discussions.
Mr. Waxman. Because I think the most telling point I've
heard in this hearing as I waited for my 30 minutes, to get a
chance to ask some questions, which is frustrating for those of
us in Congress as we like to do the talking, but those are the
rules, was the chairman saying to you, Ms. Suydam, people
suffered as a result of conflict of interest. I don't get it.
We know that some people had a conflict of interest who had
enormous expertise, and they disclosed that. And waivers were
given because their expertise outweighed in some cases a very
minor conflict of interest.
And then they used their best scientific judgment and came
to a conclusion that a year later was reversed. But it seems to
me that, I've heard no evidence, and you were there, both at
CDC and at FDA, that those who might have had a conflict of
interest tried to sweep it under the rug or tried to get this
product out there, even though they knew there was a side
effect from it. Is there any evidence of that?
Dr. Snider. No, sir, I know of no evidence.
Mr. Waxman. As I understand the record, there was a Dr.
Rennels who was paid by Wyeth to study this vaccine and she
presented data at the VRBPAC, what would that stand for?
Ms. Suydam. That's the VRBPAC, that's FDA's advisory
committee.
Mr. Waxman. OK, that she went to that meeting and despite
the source of her funding, she presented this advisory
committee data on the intussusception as a possible adverse
event associated with the vaccine. Is that your understanding
as well?
Ms. Suydam. Yes, that's correct.
Mr. Waxman. Now, if we believe people only act in their own
self-interest, you would think that as a representative of the
company, she wouldn't have pointed that out. The other issue is
Dr. Modlin who had some interest in stock at Merck. So you
would think that if he knew that Merck was working on a rival
vaccine, if he were going to vote in his financial interest, he
would have voted no on a product that was going to get to
market before Merck's vaccine. That would seem to me the
conclusion, if you think people only operate on the basis of
conflicts of interest.
But people also operate on the basis of integrity and
professionalism and based on science and using their expertise
and not wanting their reputations in any way tarnished by
trying to do something that might potentially improve the stock
potentially that they might own of a company, a drug company.
The committee felt there was no data, as I understand it,
that definitively showed a connection between the vaccine and
intussusception. Is that the situation in the advisory
committees?
Ms. Suydam. Yes, that's correct.
Mr. Waxman. Nonetheless, isn't it true that the committee
agreed that it would be necessary to include this information
about the possibility of intussusception in the package insert?
Ms. Suydam. Yes, that's correct.
Mr. Waxman. And the committee agreed that careful post-
marketing monitoring was necessary once the vaccine was
introduced into the general population, isn't that correct?
Ms. Suydam. Yes.
Mr. Waxman. Now, why wouldn't those people with a conflict,
if they're driving this thing forward, try to not put some
label warning? Why wouldn't they say we shouldn't monitor it in
the future? After all, if we monitored it in the future, we
might find that there's a problem with it, and that might hurt
their stock.
And the FDA did carefully monitor Vaccine Adverse Events
Reporting System to look for possible side effects. And after
about 15 cases of intussusception that were identified in the
VAERS, the FDA and the CDC moved quickly to remove this
rotavirus vaccine. Is that a correct statement for the record?
Ms. Suydam. Yes, sir, that's correct.
Dr. Snider. Yes, sir.
Mr. Waxman. How do you deal with conflicts of interest,
because people are concerned about it. Dr. Snider, I understand
that in 1998, ACIP voted to recommend that the rotavirus
vaccine be added to the immunization schedule for infants. This
was after several meetings, but you voted to add it to the
schedule for infants?
Dr. Snider. Yes, sir.
Mr. Waxman. Why was that decision taken?
Dr. Snider. Why?
Mr. Waxman. Yes. Why did you decide to do that? Why did you
recommend that for parents to have that for their infants
vaccinated against rotavirus?
Dr. Snider. First of all, I should say that the committee
considered a whole range of options, from no recommendation to
a recommendation for high risk groups all the way to a
universal recommendation. And I think there were several
reasons why a universal recommendation was made. One is that
rotavirus does not respect socioeconomic or race--ethnic or any
other boundaries. So that virtually every child is infected
with rotavirus some time before their 7th birthday and usually
much earlier.
So it seemed that every child in the country was
susceptible to this potentially.
Mr. Waxman. And this vaccine could prevent that?
Dr. Snider. This vaccine can prevent at least 50 to 70
percent of episodes. But most importantly, 80 to 95 percent of
severe cases, which are the ones that can lead to dehydration
and death.
Mr. Waxman. So the decision was based on scientific
judgment by all the people involved that it ought to be on this
recommended list. If it's on the recommended list, is it
mandated that rotavirus vaccine be used?
Dr. Snider. CDC does not mandate vaccines for anyone. The
States make their own determinations about what vaccines will
be required. As was pointed out, this is not one of those
vaccines that would be on the list of required vaccines for
school entry, because it's given at 2, 4 and 6 months of age,
although some States may have elected to require it for child
care.
But that again would not have been a Federal decision. That
would have been a State decision.
Mr. Waxman. Now, Chairman Burton issued a press release
yesterday about this hearing. And in this press release he said
four out of the eight advisory committee members who voted on
the Wyeth rotavirus vaccine had financial ties to the
pharmaceutical companies that were developing different
versions of the vaccine.
My staff has gone through these documents and has
identified those four members. One of them is Dr. Modlin, and
we talked a lot about him. He owns 600 shares of Merck stock.
Because Merck does not have a licensed rotavirus vaccine, this
did not constitute a conflict, is that correct?
Dr. Snider. That is our interpretation, our view and
practice, as I understand it, since the mid-1960's, when the
ACIP was created, is that conflicts of interest are determined
based on licensed vaccines, not on vaccines that might be in
the pipeline and may or may not ever be marketed.
Mr. Waxman. Ms. Glynn testified earlier that if you own a
stock in a huge company, you really own only an infinitesimal
amount of that company. Do you agree with that?
Dr. Snider. It's my understanding that for the
pharmaceutical industry in general, the figure I heard at a
meeting earlier last month was that vaccines account for
approximately 1.3 percent of the revenues of pharmaceutical
companies. So that for a large firm like Merck, one would
anticipate that a decision one way or another about a single
vaccine wouldn't have much impact on the stock price one way or
the other.
Mr. Waxman. The chairman made mention of Dr. Modlin's
membership on a Merck advisory board. Are you aware that while
he does serve on that board, he no longer takes any honoraria
for that service?
Dr. Snider. Yes, sir.
Mr. Waxman. So he doesn't have a financial interest in that
service. He owns some stock.
Dr. Snider. He did own. My understanding is that he has
divested himself.
Mr. Waxman. Well, there are two other members of the ACIP,
there's a Dr. Griffin and Dr. Clover, who had relationships
with Merck in the form of consulting fees, honoraria and
educational grants. It is possible that these two members were
unaware of Merck's work on a rotavirus vaccine. Is there any
evidence that either of these members knew about Merck's
rotavirus vaccine that you know of?
Dr. Snider. Not that I am aware of.
Mr. Waxman. Mr. Chairman, do you have any evidence that
either Dr. Griffin or Dr. Clover knew about Merck's rotavirus
vaccine? They had consulting fees, honoraria, educational
grants from Merck.
Mr. Burton. You can proceed. I'll get you an answer to
that.
Mr. Waxman. I'd be interested in that.
If there is no evidence, then I think it would be wrong to
accuse them of a conflict without actually knowing whether or
not they knew that Merck was working on this vaccine. And let's
assume they did know. Would that be considered a conflict for
purposes of the ACIP's vote on the Wyeth rotavirus vaccine?
Dr. Snider. No, sir.
Mr. Waxman. Why does the CDC tolerate a certain level of
conflicts, both actual and perceived, on its advisory
committees?
Dr. Snider. I think for some of the same reasons that have
already been expressed. It's extremely important that people
who serve on advisory committees understand more than just the
cursory science that might be presented to them during the
course of the meeting. They need to have an in-depth knowledge
of some area that is pertinent to vaccination, whether it has
to do with the delivery side, how do you deliver vaccines in
the public sector, or how to do research properly, the
immunology of vaccines and so forth.
Mr. Waxman. Well, there are 700,000 physicians the chairman
has told us. Why couldn't we pick somebody else who didn't have
any possible conflict of interest?
Dr. Snider. Well, we do have members, we've talked so much
about conflicts, Mr. Waxman, that we haven't had an opportunity
to say that we do have members on the ACIP who do not have
conflicts. And of course, on any given issue, we may have
several members who have no conflicts with a particular matter
that's under consideration.
Just because someone fills out a 450 and indicates a
conflict does not mean that they have a conflict with the issue
at hand. So that most of the time, we have a large number of
members who are eligible to vote.
Mr. Waxman. And just because they have no conflict doesn't
mean they always make the right decisions?
Dr. Snider. Well, I guess that's true of all of us.
Mr. Waxman. But I know for myself, if I'm having FDA make a
decision or the CDC make a decision on a vaccine or FDA make a
decision on a drug, I want people on the advisory committee
that know the science, that have an expertise, that understand
when these drug companies come in, and they present their reams
of documents, on why FDA should approve a drug, I want them to
be able to scrutinize it pretty carefully. Not somebody who
happens to be a physician educated at a medical school.
Dr. Snider. We attempt to get the best scientific expertise
we can, Mr. Chairman. It requires a broad range of expertise.
And there are a limited number of people. We do rotate members,
we don't just recycle people who have always been on the ACIP.
But the expertise is difficult to find, and as was mentioned
earlier, even when you find it, people are not always willing
to serve.
Mr. Waxman. Ms. Suydam, when FDA has an advisory committee,
they're making a recommendation to FDA, which is usually
accepted by the FDA. And they vote to determine whether the
application a company submitted for licensure supports the
safety and efficacy of the product. But their recommendation is
non-binding. They don't vote to license or not to license.
There are other issues FDA considers in addition to what the
advisory committee tells them as they go about approving a
product, isn't that correct?
Ms. Suydam. Yes, that's correct, Mr. Waxman.
Mr. Waxman. I must say, I've had a lot to do with FDA, as a
Member of Congress. And I get reports that scare me more about
the conflicts of interest by the companies who want to give the
best appearance of their drug. And they sometimes don't want to
present the possible side effects. And they may have it buried
in the documents supporting their up-front top page documents
with the hope that maybe an advisory committee won't read all
the way through it. You obviously have busy people. Their
conflict is that sometimes they're busy.
Ms. Suydam. That's why it takes a very thorough review on
the part of the FDA to make sure that all the information
that's provided is reviewed.
Mr. Waxman. So when you're trying to select advisory
committee members, what are you looking for?
Ms. Suydam. Well, Mr. Waxman, in the VRBPAC alone, we look
for expertise in infectious diseases, immunology, virology,
bacteriology, molecular biology, pediatrics and biostatistics.
We look for people who understand the research in those areas,
people who have been researchers themselves. We try to find the
very best scientific experts.
And in fact, in the VRBPAC itself for the last 5 years,
we've used 82 different experts, either as members, temporary
voting members or consultants. And we think that's a fairly
representative sample of the experts available to the FDA, when
a vaccine expert is not a typical physician. A vaccine expert
is one who has had a lot of experience in the research of
vaccines.
When you go to an international vaccine meeting, you don't
have thousands of people there like you do at the chemistry
meetings or the microbiology meetings. You may have 500 at the
most. And that's an international meeting. So we're talking
about a very limited pool of people that we can actually
attract to our committee in this particular area.
Mr. Waxman. You try to reach out and get people who are
geographically and ethnically diverse?
Ms. Suydam. We have a process, and in fact, we do have
people on our committee who are not conflicted or do not have
any conflicts. Every year we publish in the Federal Register a
notice of vacancies for our committees. We advertise in the
Academic Physician, which is the document that most physicians
read, all the members of the teaching hospitals across the
country are members of the AAMC, and that's their magazine.
We go out to our experts on the committee and ask for other
recommendations. We ask for public input, and we usually have a
pool of about 50 people that we can select 3 or 4 people from
for a membership on the committee.
Mr. Waxman. Is there a difference in the conflict of
interest screening between agency employees and the special
Government employees that serve on these committees?
Ms. Suydam. The same statute applies, but the standards are
different, the waivers are not granted to FDA employees. FDA
employees meet the statutory standards. We have waivers for FDA
employees but they're very, very limited. And those are done on
an ad hoc, individual basis.
In this case, we look for scientific advisors who have had
expertise in a particular area. And they may have, as I
mentioned in my testimony, they may in fact be people who have
worked in the industry. And so we have to make the decision
that the expertise they provide is important enough for us to
actually waive that potential conflict.
Mr. Waxman. The majority of this committee issued a press
release yesterday and they claimed three voting members of the
advisory committee for FDA had some kind of relationship with
``affected companies.'' I'd like to walk through each of these
situations with you. Let's begin with Dr. Patricia Ferrieri,
the committee chair, who owned about $17,000 in Merck stock.
Under FDA criteria, this constitutes a low involvement with an
affected company, isn't that correct?
Ms. Suydam. That's correct, Mr. Waxman.
Mr. Waxman. Can you explain how the determination that
$17,000 in stock is low involvement?
Ms. Suydam. We have a waiver criteria document which has
been, was established in 1994 and has been updated, was updated
once in 1997 and then again this year. The waiver criteria
document was established to provide to all of our committee
executive secretaries a guidance document and to all our
committee management staff on how you could look at an
individual's conflicts of interest. And it was decided that
less than $25,000 was in fact a low involvement.
Mr. Waxman. I have the memorandum of the Department of
Health and Human Services dated November 18, 1997, from Diana
Widener, SGE programs officer about this subject. And they go
into this document, I hope that's the right document, but I
have some FDA document I'll make part of the record, probably
the chairman already has it, where these issues of conflict
came up.
And for example, they talked about Dr. Ferrieri. This was a
letter signed by David Kessler, who was the Commissioner of the
Food and Drug Administration. It says, as a member of the
Vaccines and Related Biological Products Advisory Committee on
the temporary voting member of another FDA committee, Dr.
Ferrieri could potentially become involved in matters that
could affect her or her employer's financial interests. And
they go through the code section and they say, first, although
Dr. Ferrieri has a financial interest in a competing firm, she
is not involved with the specific products at issue. Further,
the financial interest is insubstantial in that it represents
only a small percentage of her total income.
Second, the Federal Advisory Committee Act requires that
committee members be fairly balanced in terms of point of view.
It's intended purpose would be significantly impaired, the
committee's intended purpose would be significantly impaired,
if they couldn't call on experts that become eminent in their
field, notwithstanding the financial interest. Dr. Ferrieri is
board certified in pediatrics, she's got both extensive
experience in pediatric infectious disease, both in research
and clinical practice. And on and on and on.
Ms. Suydam. That's the waiver document, yes.
Mr. Waxman. A very well qualified person.
So far, these situations have not been particularly
troubling. There are a couple members whose involvement at
least on the surface raise some questions, specifically I'd
like to ask you about Dr. Estes, and why, given her level of
involvement with NIAID, Merck and Wyeth, you went ahead to give
her a waiver to participate in this meeting.
At the time of the FDA advisory committee meeting, Dr.
Estes was a principal investigator on several grants associated
with Wyeth and NIAID to study rotavirus, and she was in
negotiations with Merck for a grant to study the rotavirus
vaccine. These connections seem to be a little close to the
issue at hand, Wyeth's rotavirus vaccine.
Can you explain to us why you gave her a waiver?
Ms. Suydam. We actually went, and I was personally not
involved, but the Office of Committee Management went to Dr.
Estes. And I would suggest that I probably have to deal with
this in the hypothetical as well, since her conflict of
interest, I mean, since her financial disclosure statement is
something I have to deal with in terms of the Privacy Act.
But we went to her and asked about the specifics of her
expertise and her involvement. And they are very different than
the issue that was being discussed. So there was a difference
in terms of the kind of research she was doing.
And if I could, Dr. Estes' expertise is in bacteriology,
immunology and virology. She has experience with reovirus, with
gastroenteritis virus, with viral pathogenesis. She is in fact
an expert in all of the areas that we needed of that committee.
Mr. Waxman. Mr. Chairman, I wouldn't want people to think
that if their children are going to get immunized that in some
way the CDC or the FDA has not been as attentive as they need
to be and we expect them to be on the merits of whether a
vaccine ought be made available. After all, we're talking about
diseases that can cause death, disability, and disease from
which many children do suffer.
And if we can prevent these, we hope we can do it without
side effects. But sometimes we find out, as we did in this
case, there are side effects. I just don't want people to be
scared. I don't think we've shown here, because of some
conflicts of interest which were all disclosed and for which
their supervisors under the law made a decision to allow them
to serve, should in any way discredit the immunizations that
are available.
And I want to say that I speak from the point of view of
someone who at times has been very critical of FDA. I recently
criticized NIH and FDA for the gene therapy patients. Here's a
headline that says ``Waxman; FDA has done little to merit
confidence in this particular area.'' I will criticize FDA or
CDC or NIH if I think there's a reason for it.
But I think that it doesn't appear to me that a case has
been made to criticize either agency. It appears that they
acted reasonably, in the public interest, to try to protect our
children. And it's unfortunate that the result was one that
meant that the vaccine was taken off the market within a year,
because we found out the problems.
But I was glad we found out about those problems and that
everybody acted in the best way possible. It would have been
better if we'd known about it before, but sometimes science
doesn't allow us to know in advance with certainty what the
results are going to be.
My time is expiring. I want to thank the two witnesses for
your testimony and to assure people, from my point of view,
that we always have to monitor vaccines and drugs and make sure
that they're safe. I would hope we would monitor a lot of these
other products that are on the market that get no scrutiny at
all from FDA. People use them and think they are going to
improve their health but they can do damage. From this hearing,
I've seen no evidence to change my view that you've acted
responsibly and under the best expectations of the Congress and
from the American people.
Mr. Burton. Well, I have a little different opinion, and
I'll take a little bit of my time now and say there's none so
blind as those who will not see. If you look at Dr. Modlin, Mr.
Waxman mentioned that he had some stock, but he failed to
mention that he was a consultant for Merck and got paid
consultant's fees, and that was not in his financial disclosure
form. So we don't know how much money Merck was paying him. And
he was the chairman of the panel. I mean, come on, unbiased?
Give me a break.
And he was talking about the recommendations by the
advisory committee, I think you said, Ms. Suydam, that they
haven't rejected the advisory committee's recommendations in 10
years. So it's a fait accompli. If they say it's OK, it's OK,
it's going to be done.
He mentioned Mary Estes. Gee, this is all going to be
public eventually, it's going to be out there. Her employer had
grants of $75,000 from American Home Products for rotavirus,
$404,000 from NIAID, a number of grants for rotavirus, NIH,
$355,000 for rotavirus, $55,560 fee from Merck for rotavirus
vaccine, Wyeth Lederle, $10,420 fee for rotavirus, and $5,400
for Norwalk virus vaccine. Come on.
And the Supreme Court said it's not just people knowingly
doing something wrong. It's having this in the back of their
mind that there's a financial interest to what they do.
I have a number of questions. We have votes on the floor
and I don't want to keep you here all night. I think basically
I've made my points and Mr. Waxman has made his. There's a lot
of other questions I have. I'd like to submit to you both
questions for the record. Bear in mind when you answer the
questions they will be made public. But we want complete and
accurate answers, because you were sworn in and the documents
that you send us will be considered under oath.
With that, anything else I need to go into?
I'd like to read Dr. Chen Lee, he was one of those who
couldn't vote, he said during the discussions, deliberations
when he was talking to the people who you had appointed
evidently to come in and vote in his stead and others' stead,
he said at one point, he would vote for routine immunization if
he was eligible to vote, and he went on to encourage a two dose
regimen for the vaccine. 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 for me if I cannot vote.
Now, that makes the point. He's there saying to the people,
you know, you're voting in my stead, I'd vote for it and I hope
I'm influencing you to vote for it. That isn't right, folks. We
have to be above reproach or even the appearance of
impropriety. And I hope that CDC and FDA and the other agencies
will take into consideration what we've said today.
You probably don't like me for what I've done, and I
understand that. But I want you to know we're going to be
watching, we're going to be having more hearings on this. And
if people are appointed to these advisory panels, it's going to
be made public and if there's a conflict, it's going to be made
public. And I think it would be better to err on the side of
safety, so that the agencies which you represent will not get a
black eye. Because I'd rather you didn't get a black eye and
everybody would feel a little bit safer.
And with that, thank you very much. We stand adjourned.
[Whereupon, at 4:52 p.m., the committee was adjourned.]
[The prepared statement of Hon. Helen Chenoweth-Hage and
additional information submitted for the hearing record
follow:]
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