Human Papilloma Virus

Floor Speech

HUMAN PAPILLOMA VIRUS

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Mr. GINGREY. Mr. Speaker, this looks like Georgia night in the great Chamber of the House of Representatives. My colleague, Representative Price, just talked about one of the most important debates that we have had in this body in a long time and will have in regard to the situation in Iraq and the Commander in Chief and the constitutional right for the Commander in Chief to make the decisions along with the combatant commanders.

These issues are hugely important. Things like the energy crisis that we faced 25 years ago, and we are facing again today, are hugely important issues. In fact, former Vice President Gore will be before the Science and Energy and Commerce Committees on Thursday talking about global warming and what we think we ought to do in regard to not only solving the energy crisis, but to keep from polluting the atmosphere. Hugely important issue.

Trying to solve the crisis that is looming in regard to the entitlement spending which is, that along with the interest on the debt, is probably approaching 65 percent of what we spend each year in a $2.7 trillion budget, hugely important issue.

Then, Mr. Speaker, every now and then along comes something that maybe does not get at first notice very much. There is not a lot of press. It is not one of the marquee issues of the day, but what I am speaking to my colleagues about tonight is also hugely important, and it, thank goodness, is beginning to get the attention that it deserves.

That is an issue that I, as a physician and OB/GYN specialist in particular, physician Member of this body, feel very, very strongly about. What I am referring to is the recent decision by one of the Governors of our 50 States to mandate that young girls in the public school system of that particular State would be required to receive a new vaccine, which I will describe in detail in just a minute.

They would be required before they could enter the sixth grade, the sixth grade, we all know sixth, seventh and eighth, and in some cases, considered the middle school years. So coming out of elementary or what I used to call grammar school, where there are many of these young girls, including my precious granddaughters, are still thinking about watching Little House on the Prairie as an example or playing with their dolls, would be required, just like they would be required to have their shots up to date in regard to measles and mumps and rubella and chickenpox, these highly contagious, infectious diseases that can be acquired just on casual contact; if you sneeze in the vicinity of a classmate, the disease is spread. This new vaccine, though, is not against one of these highly contagious communicable diseases, no, Mr. Speaker.

This vaccine, called Gardisil, is a vaccine against cervical cancer-causing viruses, referred to as human papilloma virus, or HPV. There are probably 100 strains of that virus in existence that have been identified, but four of them, virus number 6, number 11 and particularly number 16 and number 18, have been associated with the dreaded disease of cervical cancer about 70 percent of the time. About 70 percent of the cases that occur, the 9,000 new cases that occur in this country every year, are associated with that HPV virus. So there is certainly a suggestion, a strong suggestion, of cause and effect.

One of our great pharmaceutical companies in this country developed a vaccine that was approved a year ago, June of 2006, to prevent the contraction of this HPV virus, and it is a great vaccine. The studies, the phase III trials, while there, Mr. Speaker, may be some minor side effects, the safety seems to be there. The recommendation, of course, is that sexually active young women between the ages of, well, actually 9 and 16, I would hasten to add that there are not too many 9-year-olds that are sexually active, but the vaccine is approved for those in that age group.

It is thought that a series of three vaccines, given a month or two apart, at the cost of $360 just for the vaccine, probably up to $500 once you add the cost of going to a physician, going to a gynecologist and having these vaccines administered, the cost of an office visit, the administration of the vaccine, probably a $500 charge, but a good investment in this humble Member, physician Member, former gynecologist, in his opinion, probably a good choice for a young woman even at the age of 14 or 15, if she is sexually active or going to be sexually active, or maybe even a little bit younger if her parents are concerned about that possibility.

Then I think the vaccination that has been developed by this pharmaceutical company and the vaccine referred to earlier, Gardisil, I would highly recommend, and if I was still practicing medicine, Mr. Speaker, and a mom brought her daughter in and asked me about that and said that she heard about it and wondered if I would recommend it, I would absolutely recommend it.

But what was done in the last month or so, and this Member just happened to notice, and that is why I say this maybe seems like a small thing, but what it does is the mandate was issued that every single girl in that State at age 11, before going from elementary school, grammar school, to middle school, would have to have that vaccine, or she would not be able to continue in that public school system.

Mr. Speaker, that is just flat wrong, and my bill that I introduced the very next day in this body, H.R. 1153, the title of that bill is the Parental Right to Decide Protection Act, because this is all about the rights of a parent to decide what is best for their child. There is no State interest in this because, as I point out, you do not contract human papilloma virus by casual contact. No, it is by sexual activity, and to force every single 11-year-old child in this country to get that vaccination or they cannot go to the public school system, even though they have paid their property taxes, they live in that school district, they have been in that school district, they have supported that school district, and their parents teach their children, maybe they believe firmly in abstinence-based sexual education, but they have that right to decide. The State does not have that right.

That is why I say to my colleagues tonight that this is a hugely important issue. Cancer is a dreaded disease. We all probably would choose any other way to die than from a long, protracted case of any kind of cancer. Cervical cancer worldwide is probably the second leading cause of cancer death in women. That is not true in the United States. It may be the ninth or tenth or eleventh but it is too many. There are probably 9,700 new cases of cervical cancer in this country every year, and of those, approximately 3,700 die, and that is too many. We need to do everything that we can to prevent cervical cancer, and that is why I say the vaccine is a good thing.

That is why I say that I, as a compassionate physician Member of this body, would recommend that vaccine to someone who has either told their parents that their daughter and her boyfriend are sexually active or they plan to be sexually active, and that could be

14 years of age. I know we all would hope that it would not be, but our daughter or granddaughter, but it could, and in those cases the recommendation to voluntarily take this opportunity to get that immunization on board really before they become sexually active, certainly before they become sexually active with multiple partners, is a good thing, but it is not a good thing to mandate it and to require it.

We will talk about this throughout the hour, and I am very, very pleased to welcome one of my colleagues, a new Member, a very bright Member. He does not seem like a new Member because he is doing such a great job in these first 3 months of the 110th Congress. At this point I would like to yield to my good friend Mr. Jordan for his comments.

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Mr. GINGREY. I appreciate the comments of the gentleman from Ohio, and this point about opt in-opt out, on most of the bills that have been introduced, probably, in maybe 23 or 24 States, not a Governor issued a mandate, but where bills were actually introduced. The opt-out provision actually requires one of two things, either a doctor's excuse or the parent to sign that they want their child to not take the vaccines, but they have to have it notarized.

Just think about the burden that really puts on people to try to find a notary. I mean, it's just not that easy to do, and it's certainly not easy to get a doctor to write an opt-out provision.

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Mr. GINGREY. I thank my friend, the gentleman from Ohio, for being with me tonight as long as he can stay. I appreciate his input, his comments. He is right on target.

Statistics suggest, and this is actually from the center of the CDC in Atlanta, my home, the Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with HPV each year. Over half, now listen to this, my colleagues, over half of all sexually active men and women become infected at some time in their lives, over half of all sexually active men and women become infected at some time in their lives with the HPV virus.

Now, if you do the math on that, and I think I am correct if my Georgia Tech math serves me well, that means that about 0.2 percent, 0.2, not 2 percent, but 0.2 percent of women who are actually infected with HPV virus, 16 or 18, the virus that this vaccine would prevent, even if they contract the virus, only 0.2 percent.

Well, I said at the outset of the discussion that accounts to, in this country about 9,700 new cases of cervical cancer each year and over 3,000 deaths. Even though it's a small, small number, it has significance, clearly. But you have to ask yourself if that would warrant vaccinating mandatorily every little 11-year-old girl in every public school system in all 50 States of this country.

I don't have the number, how many little girls that would be; but I will tell you one thing, it's far more than this number. Then there are some other things that we can discuss in regard to risk and adverse reactions, even though the FDA, and I don't disagree with the decision, the trials that show this vaccine is safe, but yet it has only been on the market for less than a year. All of a sudden, the big experimental model is going to be my granddaughters and your daughters all across this country. I think that is absolute insanity.

At this time, I want to yield to my good friend from New Jersey, my classmate, Representative Scott Garrett, for his comments.

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Mr. GINGREY. I really appreciate my friend from New Jersey. As we all know, every Member in this body knows, he is a strong, strong fiscal conservative. He pointed out the fact that we have very limited dollars. Every day, each one of us, Representative Jordan, his constituents come up here from Ohio, and Representative Garrett's constituents from New Jersey, mine from Georgia, and each one of them has a request. Many of them are health-care related.

Today I was visited by a mom who has two autistic children. Maybe my colleagues had constituents advocating on behalf of more funding for autism, and it goes on and on and on. It is our job, with limited dollars, to try to decide how to apply them for the greater good.

I really appreciate the gentleman's comments in regard to putting the money where it's going to be most effective and not to waste it, not to waste those precious dollars. As he pointed out, you can only spend that dollar once.

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Mr. GINGREY. I thank the gentleman from Ohio for being with us tonight. I mentioned at the outset about the statistics with regard to cervical cancer worldwide being the second leading cause of cancer death in women, but maybe 9th or 10th in this country, and the difference is attributed to the fact that in this country, since the mid-1940s with the discovery of the pap smear, the value of the pap smear to screen for cervical cancer was discovered. Annual checkups were recommended for sexually active, certainly for sexually active adult women, and, again, that could start at age 14 in many instances. In some instances, it may be when a young girl is going off to college, or maybe on occasion it is not till someone is 22 or 23 years old.

But at that point in her life, the most important way to prevent cervical cancer or to be able to have early detection, when it can be cured, is by having that physical examination done on a timely basis.

For the most part, the recommendation is a yearly exam. And I think most women in this country get that examination on an annual or maybe every 2-year basis if they have gone several years with normal Pap smears. And it is very simple, almost painless, not something that they would rush to have done, but women know the importance of this for their protection.

Mr. Speaker, I have some concerns that unless we do a great job of educating the public in regard to this vaccine, that women might get the idea that, first of all, the vaccine protects them against sexually transmitted diseases. And it does protect them against HPV virus, that virus that causes genital warts in the 0.2 percent of cases that can actually lead to cervical cancer, but it offers no protection against things like herpes and syphilis and HIV/AIDS. And I could go on and on and on, Mr. Speaker. I don't want to do that and get overly descriptive. But it only protects against that one sexually transmitted disease that is associated with cervical cancer.

I want to give my colleague from New Jersey an opportunity in the time left to weigh in a bit.

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Mr. GINGREY. I thank the gentleman from New Jersey.

As I was pointing out in regard to this annual checkup, it is not just for the Pap smear and for screening for cervical cancer, but also for a complete wellness examination in women to detect very early breast cancer, a small lump that maybe the patient cannot detect or that is not picked up on a mammogram. But the opportunity is so invaluable to screen for not only cervical cancer, but for colon cancer and breast cancer.

So the bottom line, Mr. Speaker, there is nothing more important than that periodic checkup for adult women to have every 1 or 2 years to make sure that if they do come in contact with something like HPV or any other sexually transmitted disease, you are going to be able to treat that and treat it successfully.

Cervical cancer is not something that a person is exposed to or the causative agent like human papilloma virus, it is not an exposure 1 month and cervical cancer the next month or 6 months later or 1 year later, or maybe in many instances not even 5 years later. It goes through, thank goodness, a very slow progression, and there is great opportunity to treat at various stages and to treat successfully. But clearly, the earliest detection when there is just a slight abnormality is the best opportunity to treat.

And, of course, with this introduction of this vaccine, which I highly recommend, but not on a mandatory basis and not be forced upon our 11-year-old, as I pointed out, daughters and granddaughters, not my granddaughters, this is wrong. It is the government interfering between the doctor, the parents, and the patient. And it seems to me that it is such common sense that when I introduced this bill; and I want to make sure, Mr. Speaker, that all of my colleagues on both sides of the aisle, and I am soliciting cosponsors, and that list is growing every day.

I want my colleagues to understand that what this bill does is simply state this: If you force your youngsters, your 11-year-olds in whatever State we might be talking about, maybe my own State of Georgia, hopefully they wouldn't do that, but if legislation is passed, and the Governor approves of it, then my bill says the Federal Government will not participate in the cost of those vaccines that are forced on our young children either through the Medicaid program or the SCHIP program, the childhood vaccination program, the Federal program.

All these are wonderful programs, these safety net programs. I am a very strong advocate of that, of continuing things like SCHIP, to even strengthen it. And, parenthetically, Mr. Speaker, my State of Georgia with their Peach Care program, that is what SCHIP is referred to in Georgia, they have done such a wonderful job of seeking out those children that don't have insurance and covering them, and I commend my colleagues in the Georgia General Assembly, I commend my Governor, Governor Sonny Perdue, for doing such a great job. But I think they would agree with me and they would agree with my friend from New Jersey and my friend from Ohio, Mr. Garrett, Mr. Jordan, that it is inappropriate expenditure of dollars to take a shotgun approach and force children who have a right to a public education, indeed they are paying for it through their property taxes in most States in this country, and then to say to them you can't enroll in the fifth or sixth grade in middle school because you haven't had this vaccine. It is totally inappropriate. And that is not just this Member's opinion, it is the opinion of all those cosponsors who have signed on to H.R. 1153.

Mr. Speaker, I have got a few charts that I wanted to show. This first one, the American College of Pediatricians and the Association of American Physicians and Surgeons are both opposed to any legislation which would require HPV vaccination for school attendance. We have already talked about the vaccine being approved last June and the studies that were done, and it is approved for females age 9 to 26.

But what they don't know yet, and I have talked to the company that manufactured Gardasil, they say that

they really don't know how long the vaccine will last and how much immunity will be given. They think about 5 years, but they are not sure. Maybe it will last longer. Maybe when they do blood studies 5 years later, they will find that the antibody level against this type 16 and 18 HPV virus is high enough that the person doesn't need a booster. But like tetanus shots, of course we know that very typically, the same thing with hepatitis, sometimes these vaccines, the immunity will subside, and the patient is once again at risk, and they will have to get another shot.

So if the vaccine gives immunity for 5 years, and you give it to every single 11-year-old, I would say 99.99 percent of whom are not sexually active, and you spend $500 either through their own insurance program or out of Mom and Dad's pocket or subsidized through the Federal Government, Medicare, Medicaid; you give them that shot and it lasts 5 years, and let's just assume it wears off by the time they are 16, just about the time that they are falling in love and become sexually active with their boyfriend, and that is the very time that they need the protection, and the vaccine has worn off, and we have no guidance. At this point we have no guidance.

So, Mr. Speaker, it is clearly the wrong thing to do, and my bill would say that in any situation where this is a voluntary program, an opt-in program, not an opt-out, we don't make parents jump through hoops and go get a notarized signature, or take a half day off work and go to their doctor and maybe have to have paid for a doctor appointment just so they can get a letter signed so their child doesn't have to get this vaccine. That is insanity.

We need to do a good job. We physicians, those of my colleagues who are still practicing, especially my good OB/GYN friends across this country and primary care doctors everywhere, pediatricians need to talk to their parents, talk to their patients and explain that this great vaccine is available, and it has a potential for great good. And I am sure that many, many doses of those vaccines will be sold.

And I hear my colleagues in this body many times bashing the pharmaceutical companies and Big Pharma, and I heard that so much as we were passing the great Medicare prescription drug part D program for our needy seniors back in November of 2003, really beat up on the pharmaceutical industry. But this is a good company, and this should be a profitable product for them. And when they first came out with the vaccine, Mr. Speaker, it was their recommendation, and they worked with State legislators, particularly female State legislators, across the country and said maybe this would be a good idea to have it mandatory in the schools.

But to their credit, after this Governor made it mandatory, not by legislation, but just by rules and regulations in his decision, there was so much public outcry against that that the company now understands that that is not the right way to go, and that is to their great credit. They understand that they have got a great product, but it is not something that should be mandatory. It should be available. It should be available, though, for those who need it most.

Mr. Speaker, I am a real strong advocate for a public education. Now, I have a background of going to a Catholic school when I was growing up, but I also have a background of being on a school board in the city of Marietta, Georgia, in Cobb County, my first venture into public service, and I love that public school system. And all my children, adults now, all four, and thank God I am soon to be the father of my seventh grandchild by those four children, went to that public school system, and we loved it. We had friends that either home-schooled their children or went to private school for various and sundry reasons, and I don't argue with that at all. In fact, given the same circumstances, I would maybe have made the same choices. But I want to see our public schools in this country, in my State of Georgia, in every State, I want to see them thrive and do well. And I firmly believe in the principles of No Child Left Behind, that each and every youngster, no matter where they started in life, that they have that equal opportunity at the brass ring in our public system schools across this country.

But when you start doing things like this, and that is why at the start of the hour, when I said, you know, this might not be a marquis issue like what is going on in the Middle East or global warming or the economy, this is hugely important, because if you force this, if you mandate this in the public school system, you are going to see, you talk about a flight without vouchers to home schooling and to private schooling, and we don't want to see that. I don't want to see that. I want what is best for the youngsters. And I think that we need to keep a hands-off in regard to this.

I have got a few letters here, Mr. Speaker, that I could share. I have got one from a Phyllis Schlafly with the Eagle Forum who is supporting us on this issue.

I have a letter here from the Concerned Women of America. I will just read the first paragraph. And this is what they say: ``Dear friends, CWA, Concerned Women for America, gives kudos to Representative PHIL GINGREY, Republican from Georgia, a former obstetrician gynecologist, on a bill that he plans to introduce. Congressman Gingrey's bill will prohibit Federal funds from being used to implement a mandatory, let me emphasize, a mandatory vaccine program for human papilloma virus, a sexually transmitted disease and a cause of cervical cancer. CWA urges you to call your Member of Congress and ask them not only to cosponsor this bill, but to take whatever action they can to pass it.''

I appreciate that, and it is not for kudos or thanks that I am up here tonight. Mr. Speaker, as we do these Special Orders on both sides of the aisle, people do this because they have a commitment to a cause. And I have a commitment to a cause, and that is the cause of our young people that we make sure that we don't take away the parental right to decide. That is sacrosanct in my mind, and that is why I am here tonight spending this time with my colleagues to try to urge you to sign on to H.R. 1153, and let's do this right.

Once again, as I move to closing, Mr. Speaker, I want to make sure that everybody listening in this Chamber and anybody that can hear my voice far and near understands that this bill simply says, if you force it upon our public school children, whatever State we are referring to, then we are not going to pay for that for those children who otherwise can't afford it. But absolutely, if it is appropriately done, and it is a voluntary program, an opt-in program, and I think parents are smart enough, and certainly young girls, when they get to high school, are smart enough to know that if this is available, they are going to take advantage of it; and to understand that if they don't have insurance, and they can't afford it, that we have these programs, these Federal-State programs like Medicaid and like the SCHIP program, and the Federal childhood vaccination program, so that this opportunity will not be denied to those who need it, as Representative Garrett pointed out, but we won't be wasting money on those who don't need it and don't want it.

With that, Mr. Speaker, I will close. And I want to thank my colleagues. I want to thank you for your attention. I want to thank the gentleman from Ohio, our new Member, Mr. Jordan, and I want to thank my classmate, Member SCOTT GARRETT from New Jersey, for being with us tonight.

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