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September 11, 2001 : Attack on America
Congressional Record Senate Pharmaceutical Products, Bioterrorism and Our Children; October 23, 2001


PHARMACEUTICAL PRODUCTS, BIOTERRORISM AND OUR CHILDREN -- (Senate - October 23, 2001)

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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.

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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.

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

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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.

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.

END



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