[Congressional Record (Bound Edition), Volume 147 (2001), Part 14]
[Senate]
[Pages 20333-20335]
[From the U.S. Government Publishing Office, www.gpo.gov]



         PHARMACEUTICAL PRODUCTS, BIOTERRORISM AND OUR CHILDREN

  Mr. DODD. Madam President, I have two subject matters I want to 
address. I will take the first 10 minutes or so with my colleague from 
Ohio to talk about the issue of children and bioterrorism, a matter I 
shared for many years working with the Senator from Ohio particularly 
dealing with pharmaceutical products and testing for pediatric cases, 
children. I want to take a few minutes to talk about some thoughts we 
share together about the subject matter.
  The second subject matter is about the recent, very positive news 
today coming out of Northern Ireland. In the midst of a lot of bad 
news, we have heard the news today out of Northern Ireland that a 
decommissioning process has begun and is underway as I speak, and that 
finally, the real opportunity for lasting peace in Northern Ireland is 
at hand. I am sure my colleague from Massachusetts, Senator Kennedy, 
who spent has worked tirelessly over many years to reach this day, will 
shortly have some comments and thoughts he would like to express on 
this subject matter as well.
  Let me express, on this first subject--and I see my colleague from 
Ohio--and talk about the issue of bioterrorism and children. We know 
there is a lot of work going on right now in trying to put something 
together.
  Last week, as some of our colleagues may know, Senator DeWine and I 
were able to pass unanimously in this body--by the way, we thank all of 
our colleagues for their support. Certainly, the chairman of the 
committee, Senator Kennedy, deserves a great deal of credit for working 
out a package for which we were able to garner the unanimous support of 
our colleagues to pass the Best Pharmaceuticals for Children Act, which 
is designed, as I think many of our colleagues know, to induce the 
industry to develop products specifically designed for children.
  Less than 20 percent of all pharmaceutical products on the shelves 
today are for children. Senator DeWine and I thought we ought to fix 
that. We, in 1997, passed a 3-year bill as a trial more than anything 
else. We had no idea whether or not it would work, but by providing a 
very limited 6-month period of exclusivity, we hoped we might induce 
the industry to do a lot more in this area.
  In the previous 7 years before 1997, there had been 11 clinical 
trials and two new products on the shelves of America for children. In 
the 36 months since we passed that bill in 1997, there were 400 
clinical trials and 40 new products on the shelves. As a result of that 
tremendous, beyond-our-wildest-imagination result, the other day, we 
were able, with the full support of this body, to pass a 5-year bill 
that will extend that very concept, with some additional provisions in 
it.
  Why do we mention that particularly? It is because we believe today, 
in this era of bioterrorism we are now very painfully aware of, that we 
want to make sure children are going to get properly tested, that 
products will be developed for children that will be especially 
vulnerable to release of chemical or biological toxins. So we outlined 
some provisions. That is first of all.
  We want to see legislation that will certainly take into account 
children's needs. We identify antibiotics or vaccines to prevent or 
treat illnesses related to bioterrorism. We adults certainly need to 
know how children will be affected as well, particularly during the 
critical growth periods for children and the development that occurs 
then that could lead to detrimental effects later in life. So we must 
have proper medications to prevent those risks.
  Secondly, we want to make sure the public health community will have 
emergency response personnel, doctors, and nurses who are properly 
trained to address the special needs of children.
  Thirdly, we think our children's mental health is as important as 
their physical health. There are a lot of issues we cannot even begin 
to calculate yet. Certainly, everyone in this Chamber can speak about 
the great fear many in our Nation are experiencing as a result of the 
recent bioterrorism attacks.
  Just imagine the fear our children are experiencing as a result of 
those same acts. We need to do everything in our means to address those 
particular anxieties.
  Fourthly, we need to make sure all places where children gather, from 
schools, child care centers, Head Start, and the like, are going to be 
prepared to deal with these emergency situations. The old way would 
have been for them to be prepared for a fire, but today, as we know 
only too well, emergency situations require a new response.
  In times of bioterrorism, the children may not need to just exit the 
building and stand on the sidewalk. We need to plan to potentially 
address a far more grave crisis, as we have painfully learned in the 
Congress of the United States in the last several days.
  We know people are working on this. We know the Senator from 
Massachusetts is working on it. The Senator from Ohio and I have some 
very strong feelings about children and their need to be protected in 
this area, and we wanted to take a few minutes today to share those 
thoughts with our colleagues.
  I yield to my friend from Ohio for whatever time he may need to 
respond to make some comments.
  Mr. DeWINE. I thank my colleague and congratulate him for the great 
job he has done during his career in the Senate as an advocate for 
children. The bill he and I worked on several years ago, I think it is 
safe to say, we anticipated would do good things, but neither one of us 
had a full appreciation of what it would do until we saw several years 
later the advances and the help it has given to children.

[[Page 20334]]

  We hope, by the bill we were able to pass last week unanimously in 
this body, we will continue and actually expand that work. The whole 
idea that when new drugs come on the market they would be appropriately 
labeled for children so pediatricians and parents understand and will 
know exactly, based on scientific data, what the best and proper dosage 
of that drug is. So I thank him for that work.
  He and I have also been working in the last few days on the 
bioterrorism bill. Many people are involved in putting this legislation 
together. We are going to be drafting and ultimately debating this 
legislation to protect our Nation against chemical and biological 
terrorism. Senator Frist and Senator Kennedy are working on that 
bioterrorism bill. Senator Dodd and I are working to help them on it.
  Several weeks ago, Senator Clinton introduced a bill that would 
address some of these issues. This is going to be a real bipartisan 
bill.
  As we develop this legislation, it is absolutely essential we 
remember our children. It is critical that any measure we develop 
addresses the unique risk children face against the threat of chemical 
and biological terrorism. Children are not just small adults. My wife 
Fran and I, with our eight children, grandparents of six, we are well 
aware of that. We can't treat children the same way we treat adults.
  So, again, as we consider steps to protect adults against 
bioterrorism, it is really absolutely essential that any measures we 
employ also protect our children.
  The sad fact is that currently little scientific data are available 
about how the chemicals and microbes that terrorists might use, from 
anthrax to sarin gas, could affect children. It is not a leap in logic, 
however, to suggest that children, because of their size, their 
developing immune system, and higher respiratory rates, are at a very 
high risk.
  Our Nation today is not fully prepared to treat the specific needs of 
children in the event of a large-scale chemical or bioterrorist attack. 
That is the sad truth.
  Health care professionals, childcare providers, educators, and 
parents lack basic information about how to identify and treat 
biological attacks. Furthermore, we lack research on antidotes and 
antibiotics, and their effects on children. We need more information on 
the proper drug dosages for children, and we need to learn if certain 
drugs can or even should be administered to children at all.
  My point is very simple. Any legislation that we consider to address 
the chemical and biological terrorism must, absolutely must at a 
minimum contain provisions to protect the needs of our children. In 
doing so, I believe there are four primary areas that must be 
addressed.
  First, we need to fund more drug research for children. Our Best 
Pharmaceuticals For Children bill is a step in making sure children are 
protected. We need to continue to ensure that drugs are tested and used 
appropriately for children.
  Basically we need to do two things. One is to spend more money on 
research for children, and we need to put the resources behind 
developing the protocols and the testing so once the drugs are 
developed we know how they can be best used for children.
  Second, we need to train health care workers to recognize and treat 
symptoms of chemical and biological attacks. Pediatricians must be 
included in disaster planning and such plans should take into account 
the need for special equipment and medications for children. Parents 
and emergency response personnel also should be given information on 
the care and treatment of children in the event of an attack.
  Third, we need to provide adequate mental health services for 
children to address the very real psychological effects of terrorism. 
Children are scared just as adults are. We have to focus on how 
children are perceiving the world around them. We have to listen to 
them. We have to hear their concerns.
  Fourth, we need to educate childcare providers, teachers, schools, 
daycare providers, childcare facilities--anyone who takes care of 
children. They all need to have information available so they are 
prepared to act in the case of a bioterrorist attack.
  Ultimately, all the measures we debate to fight against terrorism are 
about the future, about making our world safe, stable, and secure. This 
is all about the future. Children, of course, are our future.
  When I think about that I am often reminded of something very 
powerful that the great American President Abraham Lincoln once said:

       A child is a person who is going to carry on what you have 
     started. He is going to sit where you are sitting and when 
     you are gone attend to those things which you think are 
     important. He will assume control of your cities, states, and 
     nations. He is going to move in and take over your churches, 
     your schools, your universities and corporations. The fate of 
     humanity is in his hands.

  Lincoln's words are as true today as they were more than a century 
and a half ago. There is no question that we have an obligation to 
protect our children to make sure they are safe now so they can grow 
into healthy, happy adults. So I urge my colleagues to remember that 
and to support antiterrorist efforts that will protect our children.
  I thank my colleague for his kind comments. I, again, congratulate 
him on the birth of his child. We talked about that a little last week. 
I know what a wonderful occasion that is, what a great joy. I had the 
opportunity to see my colleague come into the Senate office building, 
probably for the first time, with his baby and see what a happy time 
that was. I thank him again for his deep and longstanding commitment to 
the children of this country.
  Mr. DODD. Madam President, I thank my colleague from Ohio. As I said 
before, he not only brings an intellectual commitment to this issue 
but, with eight children and six grandchildren, he is a wellspring of 
good practical advice as well. If you have a bill about children and 
you want to know whether or not it is practically going to work, Mike 
DeWine is the fellow you want to talk to, given his family.
  I thank him and point out, as he has said so eloquently here, that we 
have learned a lot in the last several days and weeks. The thing we 
have learned the most I guess is how little we know and how ill-
prepared we are in many ways and how vulnerable we are. People take 
advantage of our freedoms to use those freedoms against us in many 
ways. The best answer to that is to not give up these freedoms but be 
better prepared to face the challenges. That is what Senator DeWine 
advocated in his outline of four or five points that are to be included 
in any bill on bioterrorism where children are concerned.
  Senator Kennedy graciously has provided some time for us to have some 
hearings. It may not be possible this Friday. We had hoped to this 
Friday, but a couple of key witnesses we wanted to have testify may not 
be able to appear because of the demands that are being placed on them 
dealing with the present situation here in the Halls of Congress. But 
we may postpone it a week or so.
  We want to look at this issue in a broad way. I have always thought 
some of the most important functions we engage in are not only 
legislating but providing a forum where people can be heard in order to 
educate people. So we would like to craft as well a comprehensive bill 
as we can to deal with children. We may not get it all done in a 
bioterrorism bill. We may look further than that in the coming months, 
as to how best prepare America--families, parents, schools, childcare 
centers, others, as the Senator pointed out--how to deal with these 
situations, how to be well educated in their own response. The 
Subcommittee on Children and Families, which I serve now as chairman 
and on which I worked very closely with my colleague from Ohio on a 
number of bills in the past, will be holding a number of hearings on 
children and the effects of recent events in New York and Washington, 
the savage attacks on September 11 and then, of course, the most recent 
attacks here in Washington, Florida, New York, New Jersey, and 
elsewhere with anthrax. It is just an indication of the kinds of 
exposures to which we are all vulnerable.

[[Page 20335]]

  We have a lot of work to do here but we welcome the challenge. I 
can't tell you how much I look forward to working with my colleague 
from Ohio and others. The Senator from Ohio properly pointed out there 
are a lot of our colleagues who are interested in this subject matter. 
Certainly Senator Kennedy is, Senator Frist has done a lot of work 
here, our colleague from New York, Senator Clinton, has a deep interest 
in the subject matter and has made various proposals. We hope to be 
able to marshal all of this together and come out with the best ideas 
we can to deal with the immediate problems, and then recognize this 
must be an important part of our agenda in the coming months.
  It is regretful to say that, but the world has changed. You can 
pretend it didn't happen, pretend it doesn't exist and leave yourself 
vulnerable to further attacks. Or you can address it. I think what the 
Senator from Ohio and I are suggesting this afternoon is that we 
address these problems.
  I thank my colleague from Ohio for his comments and kind words.
  Mr. DeWINE. I thank my colleague.

                          ____________________