2

1 "(r) The introduction or delivery for introduction into 2 interstate commerce the drug diethylstilbestrol (DES) for

3 use as a postcoital contraceptive for a one-year period begin4 ning on the date of the enactment of this subsection".

Senator KENNEDY. Senator Schweiker?

Senator SCHWEIKER. Thank you very much, Mr. Chairman.

I think the hearings today have great significance, not only because of the tragic cases which will be described here this morning but because it points up the question of which agency of the Government is responsible in situations like this. It occurs to me that this applies not only to this drug.

I hope that this morning's hearing will shed light not only on the responsibility that needs to be pinpointed in the Executive, but also the role Congress itself must exercise in this area.

I think that is the significance of the hearing today.

Thank you.

Senator KENNEDY. Thank you very much.

Carrying Senator Schweiker's point even further, I am sure, as we will hear during the course of the morning, we will hear that the drug companies may very well produce a drug that meets certain standards of the Food and Drug Administration, but once they do, how can we expect that they are going to bear a responsibility on the question of whether it is being used appropriately.

The Food and Drug Administration may approve a particular drug for certain use and, yet, how can they be assured that the drug is going to be used just for that particular purpose and not be used for other purposes by some doctors?

We have heard the representatives of the American Medical Association say that they do not want to be interfered with in how a particular drug would be used. And then we find it is the consumer, the patient, so to speak, that is left holding the bag.

These are some of the viewpoints that are going to be tested this morning.

It is quite clear that in this particular instance it has had tragic implications. I want to make sure that the responsibility and accountability is insisted upon, and we are looking forward to this hearing. We will hear this morning Mrs. Mallov, Mrs. Green, and Mrs. Luder. We are interested in your stories. We know that this is a difficult experience-I know it is just from personal experience-to be talking about particular health difficulties.

But we want you to know how much we appreciate your presence here and how much we appreciate your sharing with us your own knowledge and understanding and experience of this particular drug. Mrs. Malloy, would you be kind enough to start off?

STATEMENT OF MRS. JOHN MALLOY, SAN DIEGO, CALIF., ACCOMPANIED BY MRS. ALBERT GREEN, GLENCOVE, LONG ISLAND, N.Y., AND MRS. JANICE LUDER, LOS ANGELES, CALIF., A PANEL

Mrs. MALLOY. Yes, sir, Senator.

Senator KENNEDY. Tell us very briefly just about yourself for the moment and tell us how you came in contact with DES.

Mrs. MALLOY. My first experience with DES was back in 1955 when I was threatened to lose the baby, the doctor gave me a little white pill to take. This was a miracle that was going to save my child, and I lost that baby in 6 months.

I became pregnant about 3 months later and again started spotting. And about the third month, the doctor gave me a little white pill called diethylstilbestrol, and I took that during the course of my pregnancy. In December 1955, Christmas Day, I had a baby girl.

When she was 14, I was reading the morning paper, and the morning paper had an article written by Dr. Herbst, describing the dangers of DES, and stating that several daughters of mothers who were taking DES had vaginal cancer.

Of course, I became alarmed, and I called my doctor immediately and brought my two daughters-I am sorry-first I had taken DES in 1949 with another daughter. I took the two daughters to the doctor, and during the course of examination, Marilyn was found to have cancer of the vagina.

Three weeks later, she had vaginal surgery in New York City. She was 4 weeks in the hospital. The doctors told me they had gotten all of it, there was no problem, everything was taken care of, the cancer had rarely ever spread beyond the female organs.

And so, reassured, we went back to Virginia. And then, a year later, she had cancer of the lung, and she had three tumors on her trachea and her bronchial tubes. And the doctors operated and removed the lung. They removed the tumors from the trachea and the bronchial tubes.

About 4 months later, she started having severe head pains. The cancer had spread into her head. She had whole head radiation, and her hip started to hurt, and she had hip radiation, and from hip radiation she went on to the arms and legs and, eventually, she went blind and died 21/2 years after we had discovered the cancer.

Our other daughter, our middle daughter Patty, who is now 24, is under constant care. She is being watched every 3 months by the doctors because she had a condition known as adenosis. I am not sure of the medical description of adenosis but it is an abnormal condition in her vaginal tract. And she does have to be watched very carefully because of the DES I took during pregnancy.

Senator KENNEDY. What kind of strain has this placed on you and your family during this period?

Mrs. MALLOY. It is a little hard to describe the strain, Senator.

I myself went into a fairly deep depression after her first surgery. I got her back on her feet and, for no reason, no apparent reason, I went into a depression. I recovered, fortunately, without medical help, and I went on myself and realized what was happening and fought it. We are under constant pressure. It is a horrible, terrible thing, to

watch the child suffer and, eventually, when she dies, you think that this is a blessing, this is far easier to accept than the actual suffering. Senator KENNEDY. Did you know at the time you took that drug it was generally recognized as to being an important drug in terms of miscarriages?

Mrs. MALLOY. That was the impression I had.

Senator KENNEDY. And it has been in recent times that these studies that you have mentioned, that had really detected in the daughters of women who had taken the drug, cancer of the cervix or vaginal cancer. Now, it has been approved for a very limited use, but I think we will hear testimony this morning which will indicate it is much more broadly and widely used than what it has really been permitted for, the types of emergency of incest and rape.

What would you say to the young women of the country who are using it indiscriminately?

Mrs. MALLOY. Stay away from it, as far away as you can get.

Our middle daughter, just graduated from the University of Georgia, and even at the University of Georgia, it was handed out indiscriminately. This is, I think, the danger with a drug like this. It is supposed to be for emergency cases only. But, is it?

This concerns me. I am also concerned deeply about its use in cattle. I am going to give up eating beef before I

Senator KENNEDY. Well, we will come to this, but I suppose one of the important messages I hear from you this morning is that to the mothers who have taken this DES and do have daughters, the importance of followup procedure. That is, I think, an extremely important message that hopefully will go out from this hearing to the thousands and tens of thousands of people, even millions of people who may have taken this particular drug, that the importance of followup is something which is extremely essential.

Mrs. Green.

Mrs. GREEN. My case, I think, was a little different.

I had a son in 1948, and 2 years later decided we would like another child. No problem with the son. My period was very regular.

One month I was a little late, you know, and when my period came it was very heavy, and he said I think we ought to give you diethylstilbestrol, I think you have had a spontaneous abortion.

We went to the hospital. I never had a D. & C. I never had any other problems. And I started to take diethylstilbestrol. I am making a point of that because I feel it was given out that easily. This must have been 1950.

My daughter was born on February 9, 1951, and she was fine until she was 15. She hemorrhaged one day. I lived in a small town in New York called Glen Cove. And the doctors told me she had a very rare form of cancer. This was in 1966.

In my hometown, no one had ever treated it, no one had ever seen it, and they recommended a doctor in New York City which is about 25 miles away. The doctor who treated my daughter and was wonderful to her was treating one other case from California.

She was fine for awhile, and then the cancer spread. She died when she was 18, in March 1969.

About 2 years later, I guess, I received a call from Dr. Herbst, I think it was, asking about Susan, and telling me there was some con

nection between diethylstilbestrol, DES, and my daughter's vaginal

cancer.

I could not believe that something with any inherent danger would be given out as indiscriminately as that drug was given out in the 1950's.

The other thing that bothers me is that many friends contacted me when this became publicly known, and said they had taken it, what do I suggest they do, and I suggested the alternative you mentioned, they take their daughters and have them checked immediately.

And many of them were told by gynecologists, oh, do not worry. Your chances of your daughter contacting cancer-well, you can get hit by an automobile faster.

You know, that was another thing that bothered me, the attitude of some of the doctors in the field.

You know, if you take statistics, it is very meaningless unless that statistic is one of your own children.

I am acting dean of a school of education with many, many young women. We have about 1,200 majors in education, most of which are young women. I know that they do not use the pill, the morning after pill in just extreme cases. I know that it is used indiscriminately. Senator KENNEDY. That is today?

Mrs. GREEN. Yes.

Senator KENNEDY. In 1975.

Would you be distressed or disturbed, given your own kind of understanding or awareness of personal experience, to find out that it is being widely used in many different situations in women's colleges and broadly distributed in many different parts of the country?

We are going to hear direct testimony to that effect this morning. Mrs. GREEN. No; I am not surprised. I think it seems to me that before you would try any pill, there would be certainly a great deal of research with control groups, or longitudinal studies, or something, before you would give it out to the public.

I think that the drug companies have a responsibility when something comes out, realizing it may not be used for exactly the reason they are stating on the bottle of the pill and, in this case, where the pill has been proved to cause cancer, just do not feel that any condition is worth taking that kind of risk that you would prescribe this kind of pill.

I know it is being used, as I said before.

Senator KENNEDY. I think, in both your cases, that Dr. Herbst deserves great credit. He has been the real leader in research in this area, and I think to a great extent the fact that this particular problem has been flagged as significant as it has is to his credit.

Ms. Luder.

Ms. LUDER. First of all, I would like to say that my story is not going to be about any of my children that took the drug simply because I will never be able to have any children. It is the fact that my mother took the drug.

I first found out last summer. I went to a gynecologist for what I supposed was a routine exam. At that time he told me that he had found what he described as an irritation, and he made another appointment, and asked me to come back. So I did.

At that time I did not think too much about it. I was not really worried. I went back the second time, and they did a biopsy, and this time he told me that he thought I had adenosis, which as Mrs. Malloy said was some kind of irritation in the vagina.

He also mentioned, for the first time, on this visit that he would like me to go home and ask my mother if she had ever taken a drug called diethylstilbestrol.

I said all right. I went home, and I asked my mother, and her first reaction was that she was very positive that she had never taken any such drug. She claimed that during her pregnancy she had never taken anything more than a common vitamin.

So naturally she was alarmed thinking that perhaps she had taken the drug, so she called right away, and the doctors told her, no, she had not.

So I called my gynecologist on the phone and said my mother had found out she had not taken the drug. He did not say too much about it. He said, all right. He said I would still like to see you again. In the meantime the doctor called back and said they had found the records, and she had taken the drug after all.

So I would like to say here that there might be a chance that perhaps records are lost over a period of time, and certain women who do not think they have taken the drug should have their daughters go in for a test anyway, because the pap test is very important.

I went back, and he sent me to a hospital clinic to be examined by another doctor, who was a specialist in the field at this time, and he took another biopsy, and called me on the phone 2 days later, and confirmed the fact that as he put it, there was a tumor.

He did not like to use the word cancer, I guess too many people cannot handle that.

My husband was overseas at the time. The Red Cross brought him home, and together, 2 days later, we went down to the medical center and at that time my doctor told me I definitely did have cancer.

I was operated on last August. The repercussions of this operation are still strong in my life. It has only been 5 or 6 months since the operation. I think the most tragic thing in my life, assuming that I will live a long, full life, there is always that chance that the cancer will appear again, that it has rendered me sterile.

Family life is very important to me. It is the mental thing I am still trying to adjust to as a woman.

I have talked to many other women since then who have had hysterectomies, and I think it is common knowledge that you go through a transition period where you feel like you are not a woman, and this type of thing.

And added to this is the constant fear hanging over your head— the suspicion that the cancer will crop up again.

Not only has it affected me, naturally it has affected my family, but specifically my mother. Sometimes I can just cry when I see her. She feels very guilty.

Senator KENNEDY. There could be no reason that I could possibly imagine why your mother should feel in any way a sense of anything but a tremendous admiration for you, and for your bravery.

Ms. LUDER. That is true. She was a woman who was in danger of losing her child. Naturally you put your trust in your doctor, that is