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leport for the 105th Congress Wed, September 24, 1997 4:16pm (EDT)

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Congressional Record dated Tuesday, September 23, 1997
Senate Section

Se i i ai eee ee ee ae a i i Ele AE NR A TE SS ee i ee A el ie ie RE

Measure Debated by JEFFORDS (R-VT) and 3 others -~ $. 830
UNANIMOUS-CONSENT AGREEMENT [CR page $-9759, 247 lines]

Attributed to JEFFORDS (R-VT)

UNANIMOUS~CONSENT AGREEMENT

Mr. JEFFORDS. Mr. President, I have a unanimous-consent request which I
will offer.
I ask unanimous consent that immediately following the cloture vote with
respect to S. 830, if invoked, there be only the following time remaining in
the following fashion: 4 hours equally divided between the chairman and the
_ ranking minority member or their designee for use during today's session
only; 4 hours equally divided between the chairman and the ranking minority
member or their designee for use during the session of the Senate on
Wednesday, September 24, beginning at noon.

I further ask, notwithstanding rule XXII, that following the conclusion or
yielding back of time, the Senate proceed to vote on S. 830, as amended,
without further action or debate.

a

The PRESIDING OFFICER. Without objection, it is so ordered.
AMENDMENT NO. 1137

The PRESIDING OFFICER. Under the previous agreement, wé now have 20 minutes

equally divided on the Harkin amendment numbered 1137, 10 minutes under the

control of the Senator from Iowa and 10 minutes under the control of the
Senator from Tennessee.

‘The Senator from Iowa is recognized.

_ Mr. HARKIN. I yield myself 5 minutes.

Mr. President, there are many positive provisions in this bill that I am
pleased to support. However, I am disappointed that an essential element has

mot been included in this bill. A major goal of FDA reform is to ensure that
the public has access to medical innovations without compromising public
delay in moving to assure and improve and expand rigorous scientific review

safety. But the multimillion<dollar cost of obtaining FDA approval often
excludes from the review proceas all medical therapies not promoted by major
corporations, those that are nonpatentable or low cost.

Very few sponsors of alternative medicines and treatments have the
resources to go through this process. Unfortunately, this means that millions
of Americans are denied access to important alternative medicines and
treatments every day. In committee, I proposed and withdraw an amendment that
would improve the access to medical care. It was called the Access to Medical
Treatment Act. It was introduced this spring by Senator Daschle, “cosponsored”
by “the wayority leader, Senator Lott, Senators Hatch, Inouye, myself, and
many others. It would allow greater freedom of choice and increased access in oy .
the realm of alternative medical treatments, while preventing abuses-of fo. #
‘unscrupulous practitioners. °

 

Kemall

However, it appéars that we may not be ready to move om this important
consumer reform. Mr. President, while we may not be ready for this, we cannot

  

of alternative and complementary therapies. That is the purpose of my
amendment.

_ Mr. President, increasingly Americans are turning to alternative medicine.
A study done by Harvard University showed, in 1990, American consumers spent

over $14 billion on these practices. In that year, there were over 425
- million visits to alternative practitioners, more than visits to conventional

s “Practitioners.

ta light of that, in 1992, the Congress passed a bill setting up the Office
of Alternative Medicine at the National Institutes of Health. We now have 4 , oo

 
  

—

 

years’ experience with that office operating. It has done some good «
_ things, but it has been severely hampered by the fact that it must go. through |
the entire process at NIH, through the institutes at NIH, for its peer review |
and for its grant-making authority.

The amendment Io have before the Senate now would simply change the status
-of the Office of Alternative Medicine from an office under the Director to‘a
‘center for complementary and alternative medicine. It would not be an
institute but: a center. As such; that center could set up a peer review
process and: make its own. grants.

 

Now, why is chat important? Mr. President, every year since we established
the office, we put in the legislation that the office's: responsibility was to
investigate and validate treatments, practices and medicines. That has been
in there every year--to investigate and validate--because what we want is
scientific anabysis done of these.treatments. Now, I havé always heard,
“There are a lot of quacks out there practicing alternative medicine." While
that may be true, there are a lot of good people out there deing good things
with alternative medicine. We need the review and the science to let us know
what is good and what is working. —

I asked the Director of NIH a few months ago, who was in my office, how
many treatments, or practices, or medicines they had investigated and
validated since 1992. I was met with a deafening silence. ‘The answer is,
none. Yet, next year we are putting $13 million into the Office of
Alternative Medicine. One might rightly ask, where is it going? What is
happening? —

§o0.the purpose of my amendment ‘was to set up a center to elevate its status.
so that that center could do its own peer review and have its own grant-
making. authority. That. way; we can. cut through and save. a lot of money and
save a lot of ‘time, without in any way compromising rigorous Scientific
review. That is what this amendment does. It also incorporates within. that
center the Office of Dietary Supplements, which was also set up at NIH, to
bring the two of them together in a new center which would provide more
independence, assure economies of scale and efficiencies without in any way
denigrating good scientific research. That is the purpose of the amendment.

Now, I -understand that the Senator from Tennessee is going to raise a point
of order that this amendment is not germane. Under the rules of cloture, I
admit that it is not germane. That doesn't mean it is not important. It is
very important. It is critically important. It should be passed.

Mr. President, I understand my 5 minutes are up. I yield 2 minutes to one
of my chief cosponsors, the Senator from Maryland.

The PRESIDING OFFICER. The Senator from Maryland is recognized.

3 “
ones,

, MS. MIKULSKTI. Mr. President, I rise te cosponsor Senator Harkin's amendment
establish the Center of Alternative Medicine. I helped him establish the
Office of Alternative Medicine in 1993 at NIH. Why did I do that? One,
because I want everyone who is sick in the United States of America to have
access to all possible means of treatment that are safe and have efficacy. At
the same time, I wanted to prevent quackery. I alse was aware of the Harvard
study by a Dr. Eisenberg that said one out of three Americans was using
alternative or complementary medicine, but we were not aware of scientific
investigation to establish its efficacy or its safety. Yet, many of us have
enjoyed those practices,

 
 
  

Some years ago, I had some very severe illnesses. Western medicine was of
limited utility for me and I turned to acupuncture, Acupuncture helped me get
well and has helped me stay Wéliv-t~am-pleased@ about that. But there are many
other modalities out there being utilized by the American consumer. I want to
make sure they are safe. I want to make Sure they have efficacy. Twant NIH
to investigate it, and then I want them to validate it. I believe there is emi

“aioe

merit in this” “manana spear

 
I. am puzzled why NIH wants to continually try to submerge this Office of
Alternative or Complementary Medicine. The hallmark of NIH is to have an open
mind and to pursue scientific investigation. I believe Senator Harkin is on
the right track. Though this amendment might not be germane, it is certainly
relevant to the American people. If we don't find a way to move it on this
bill, let's explore other ways.

I yield back such time as I might have.
The PRESIDING OFFICER. Who yields time?
Mr. JEFFORDS. I have a unanimous-consent request, Mr. President.

The PRESIDING OFFICER. The Senator from Vermont is recognized.
UNANIMOUS-CONSENT AGREEMENT

Mr. JEFFORDS. Mr. President, I ask unanimous consent that following debate
and disposition of the Harkin amendment, Senator Murray be recognized for §

minutes to offer her amendment No. 1161, and that following her remarks, her
“amendment be agreed to.

I further ask unanimous consent that the following amendments be called up,
considered en bloc and agreed to: A Jeffords amendment No. 1174; a Jeffords
amendment No. 1175; a Kennedy amendment No. 1152; a Wellstone amendment No.

-2156, and Senator DeWine's amendment No. 1136, as modified in the amendment I
send. to the desk.

The PRESIDING OFFICER. Is there objection?
Mr. HARKIN. Reserving the right to object, Mr. President. I was hard-
pressed to hear the numbers. Was amendment No. 1131 included in that?

Mr. JEFFORDS. There are no nongermane amendments in the unanimous=congsent
request.

Mr. HARKIN. I appreciate that.

The PRESIDING OFFICER. Without objection, it is so ordered.
Who yields time?

Mr. FRIST. Mr. President, I yield myself 9 minutes.

Mr. President; I rise today to respond to my colleague from Iowa with
regard to an améndment to the Food and Drug Administration [FDA] reform bill,
to establish a new national center for complementary and alternative medicine
at the National Institutes of Health [NIH].

Again, remember the debate today and the past several days, and maybe
through tomorrow, is on the FDA. Yet, we have introduced an amendment on
another agency-~the NIH. I oppose the offering of this proposal as an
amendment to the FDA bill for that very reason.

Comments have been made earlier about the importance of complementary and
alternative medicine to the public and to this country, the importance of
science, and the importance of peer review--all of which I support. I have
been in the field of medicine, in a broad sense, for the last 20 years. I
have been involved in many medical fields, including a great part of which
has been designated as alternative therapies~-at least initially, because
when I first. started doing lung transplants, very few had been done in the
history of this country before. Therefore, I, as a scientist, a medical
prefessional, and a U.S. Senator, do feel that alternative medicine and
complementary medicine is vitally important to the health and the well-being
of Americans and people throughout the world.

What I do oppose, however, is dealing with this issue of elevating an
office to the level of a center when most of our colleagues do not even know
what a center in the NIH really means. What are the responsibilities of a
center? What. are. the authorities? What is the difference between an office
and a center and an institute? As I talk to my colleagues, they do not know.
Why? Because we have not addressed the issue in: the appropriate environment--~
that is, through. the. committee structure.

_ --I am the chairman of the Subcommittee on Public Health: and Safety, which
oversees. the reauthorization of the NIH. We are, right now,: looking at..the
reauthorization of the NIH. We have held two hearings in the past. examining
- how -you set. biomedical and medical. research priorities. It is a process where
‘we have people come in and testify, and we discuss: and debate back and forth.
This amendment, as proposed ‘by. the Senator from Towa,. has not been taken
through that process. It is being brought to the floor on a bill that does
not have anything to do with the NIH; but’ rather the FDA bill. Therefore, 1
@o believe it is not germane.

~T believe we should not be placing NIH authorizing legislation on an FDA

- bill. Rather, the more appropriate process would be. to take. it through the
committee structure. I should also add, for the benefit of my colleagues,
“most of whom have not. addressed this issue at all because it has not been
through the. committee process, that no legislative bill to establish a center
of alternative medicine has been introduced into the Senate. Therefore,

bila: has not been referred to the appropriate committee, it has not been.

vetted, it has not had hearings. There has been no formal debate. This would
create a huge center within thé NIH without that debate. Therefore, I object
“to bypassing this process, again, witha tremendous amount. of respect. for
alternative medicine.

My colleague from Towa is a senior member of the subcommittee, and he and I
have had the discussion that we do need to look at the appropriate role for
alternative medicine at the NIH. We have scheduled a hearing in early
October. It has been mentioned on the floor of the Senate that ene of the
panels should address the issue of alternative medicine.

We have a 4-year history with the Office of Alternative Medicine. Let's
debate and look at the results of that history. Let's see the results of peer
review and see what advances have been made.

_ The issue of whether to elevate an office to a center-~again, as I»talked
to my colleagues over the last few weeks about taking an office at the NIH
and elevating it to a center--is one that I think we need to discuss, but not
today on the FDA bill, not over the course of a few minutes, but look at it
through the appropriate hearing process. What does it mean to elevate an
office to center status? What is a center at the NIH? 1 hope my colleaques
ask themselves right now, do I really know what a center at the NIH is? Mest
Will say no. The role of the current Office of Alternative Medicine, the
office-~as outlined by the Senator from Iowa, my colleague, who basically
defined what the office is --is to coordinate and foster the conduct and
support of alternative medicine research at the NIH. Right now, the office
provides a central focus for a research area that is germane to all NIH
components. In other words, the office can work with all the various
institutes.

I understand that the majority of complementary and alternative research is
performed and Supported by those 24 centers and institutes and divisions

“within. the NIH, and it is integrated within the scientific research portfolic

of each of those institutes. My colleague is arguing--and he may be right,
-and that is why we need to discuss it--that we must consider alternative
medicine being a center in and of itself. But that would mean that the
‘scientists and researchers who are responsible for broad areas of science may
not have the opportunity to integrate alternative medicine into their
respective research portfolios as they do today. It needs to be discussed. It
needs to be debated in the appropriate forum.

i recognize that the Senator from Iowa has concerns about whether the
current approach is working or not. Again, I look forward, through our
reauthorizing committee, to the Subcommittee on Public Health and Safety, on
which he serves, to address this very issue.

I do know that when you elevate an entity like an effice to an institute or
to center status, the scientific potential of the field should be .
sufficiently demonstrated so that the new institute or center can support a
thriving intramural and extramural program. Are we at that point today? I do
net know. I daresay that most of my colleagues have not studied this specific
issue yet.

Twill have to say that as I have reached out to people, many others in the
scientific community have raised concerns about establishing a new center at
the NIH. Let me read to you a portion of a letter sent to me from the
Association of the American Medical Colleges expressing their concerns:

This is the AAMC, Association of the American Medical Colleges:

Any change in the organizational structure of the NIH of this magnitude
raises significant scientific and administrative questions. ..

‘Further, the AAMC believes allo members of the research community should

have the Opportunity to address these issues in a full and public manner
during a hearing conducted by the subcommittee.
Mr. President, I ask unanimous consent that the letter by the AAMC be
printed in the Record.

There being no objection, the letter was ordered to be printed in the
Record, as follows:

ei SS a ONS SO ci hate ni ea nO Sn” hs A li, LS: a

Measure Debated by FRIST (R-TN) and HARKIN (D-IA) -+ §. 830
Food and Drug Administration Modernization and Accountability Act of
1997 [CR page $-9761, 65 lines] ‘ .

Attributed to FRIST (R-TN)

Mr. FRIST. Mr. President, raising the Office of Alternative Medicine to a
center at NIH greatly increases its statutory authority. Has the field of
alternative medicine demonstrated that track record to date? Again, let's
review these issues in the committee process. The Office of Alternative
Medicine teday clearly does not have the organizational structure or the
necessary budget to support this proposal--creating a national center for
complementary. and alternative medicine would require setting up a whole new
administrative structure and a whole new research infrastructure to support
this activity.

Are we ready for that today? Possibly.

let's ask the scientists around the country. Let's have. alternative

medicine researchers come forward and testify. Let's ask the National
Institutes of Health. Before we go out and create another center, which again
is a new entity, we need to look at the proposal about its administration,
and about how it will be paid for.
Again, the watchwords today are. “consolidation and coordination,” not
proliferation.

Mr. President, I would like to reserve the remaining minute of my time.
The PRESIDING OFFICER. Who yields time?

Mr. HARKIN. Mr. President, I have a couple of minutes.

The PRESIDING OFFICER. The Senator from Iowa has 2 minutes and 45 seconds.

_ Mr. HARKIN. Mr. President, I will respond to my friend: from Tennessee who
made the argument. He said it would create a huge center at NIH. I am SOrry.
The Office of Alternative Medicine has 14 employees, the last count I had,
and its budget next year is $13 million out of $13 billion at NIH. That is
one-tenth of 1 percent. Huge? I beg to differ.

There are only two changes under this amendment. It provides that it could
make grants, that it could do its own grants, and could have peer review.
That is the only difference. We are not creating anything new and huge. It is
up to the Congress to decide later on if they want to expand it or not. I am
just changing its status.

Also, Mr. President, I want to say that if it were not for this point of
‘order this amendment would pass. The cosponsors are Senators Hatch, Daschle,
Craig, Mikulski,. Lugar, Specter, Grassley, Durbin, Wellstone, Moseley~Braun,
and a number of others. I am not going to read them all.

 

This amendment would pass, if the point of order were not raised.

The Senator says it should go through the committee structure, that we have
not had hearings, and stuff. I say in all friendship--and he is a great
friend of mine, the Senator from Tennessee--that just a couple of weeks ago
the Senator voted on the Gorton amendment that cut out title I--vocational
education, safe and drug-free schools, education technology, bilingual
education--knocked. it all out. And, yet, we never had one hearing on it. It
never went through our committee, of which the Senator and I both sit. We
never had any hearings on that. Yet the Senator from Tennessee says fine. He
stepped up and voted to abolish all of those without going" through the
‘hearing process.

But I would say to my friend from Tennessee, you want more testimony. Look
at the Record. Our subcommittee on both the appropriations side and on the
authorizing side have had hearing after hearing after hearing on this. We
have had all kinds of testimony come in.

But the most compelling testimony, Mr. President, for this amendment is

that more and more Americans are using alternative practices in medicines
than they are using with mainstream doctors. They are spending billions of
dollars a year. At last count it was over $13 billion in 1 year.

It is up to us to make sure that we do the adequate scientific research to
find out what alternative medicines are working and what are not.

. That is why this center is needed. It may not be germane to this bill. Bur

i will tell you. It is needed. It is drastically needed today--not next year
Or 2 years or 3 years from now. We have had enough testimony basically from
the American people. :

Mr. President, I ask unanimous consent to have printed in the Record a
letter from a number of organizations supporting the amendment.

There being no objection, the material was ordered to be printed in the
Record, as follows: