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Also, our research has resulted in improving the oral contraceptives that are now available. It was shown some time ago that oral contraceptives can produce embolism in women, and that this is dose related. The risk of thromboembolism depends on how much estrogen is in the pill. As a result, pills now contain less estrogen and fewer women in this country and abroad suffer from embolism associated with the use of the pill.

Senator Bayh. How do you handle this research? Is it done inhouse? Do you have project grants?

Dr. CORFMAN. The Center for Population Research for which I am responsible has grants and contracts all over the country and in some foreign countries. Our Institute also has an in-house program which is related.

Senator BayH. Is your area similar to those other areas such as cancer and heart and others, where there are a number of research projects that have been proposed but do not have the funds for it?

Dr. Corfman. Yes; we have that problem.
Senator Bayh. With what projects?

Dr. CORFMAN. For the last several years we have had a significant number of approved, good projects that we are unable to fund. We are not alone, of course, in this problem.

Senator Bayh. How far along are you in the approach to this problem, from the male standpoint?

Dr. CORFMAN. Because little work has been done on male reproduction, we have a lot of fundamental research to do but we have made some progress in the last 5 or 6 years. And, as I mentioned, some new drugs are now in clinical trials. The time required for something like this is 7 to 10 years.

Senator BAYH. Is there anyting that we can do together to make that 5 years instead of 10 years?

Dr. ČORFMAN. We can shorten the time by increasing the number of people doing the work and the funds available to them. There are certain questions in science, however, that we cannot speed up. There are some projects that require a fixed period of time to bring to completion.

Senator BAYH. With what we now have available, does it appear that the side effects of the use of the substance--pill or whatever it may be on men—the side effects on men would present the same kind of a problem as certain approaches with women?

Dr. CORFMAN. That may be an important problem. Some of our work on contraceptives for men is based on the use of steroids which are somewhat similar to the steroids in oral contraceptives used by women. It's possible that we may have some of the same problems with men that we have had with oral contraceptives for women.

Senator Bayh. It is fair to say that you as a scientist, a researcher, a doctor, would not want to say that that necessarily is the only answer. But what you said already, you admitted that we have not done nearly as much to approach the problem in that respect as we have in the female.

You know, I have a moment of confession here. One of the unfortunate tendencies is to urge you in advance that those of us who are nonresearch oriented sit over on this side of the table and say, OK, we want X results. How much money does it take? How long will it take to get the answers? It is like two plus two equals four. But in your area we have so many unanswered questions; so many questions that have not even been asked.

Nevertheless, recognizing that, we may never really move forward unless we demand more of ourselves. I wish that you would go back and sharpen your pencil and give me, as quickly as you can, an amount planned for increasing our intensity and concern in this area.

Dr. CORFMAN. I shall certainly do this.

Senator Bayh. I understand that there may be some people to whom you are responsible, or those to whom they are responsible, who would frown on this. But I would think that if you had a direct request from a member of the legislative branch, in the spirit of harmony and peace that should exist between the legislative and executive branches, that you would not have the reluctance you might otherwise have to dig in and get that information.

Dr. CORFMAN. I assure you that we have such a plan.

Senator BayH. Would you look at it again from the perspective that it is an issue which is as emotional as any I have come in contact with in 20 years of public life. It seems to me we need to search for ways in which we can direct our energies to things that have a positive effect on building this society, and put aside some of those things that divide us.

If we could come up with an answer to this question that would be acceptable to most of those in both camps, we are never going to lose everybody. But I think we would have made a significant step toward creating a better climate to solve a different problem.

This is a very deep, emotional, moral, and in many cases a religious conviction. The intensity is equally strong on both sides of this issue. So I would urge you to look at it under a magnifying glass because the problem is more tense now than it may have been when you first put that plan together.

Dr. Douglas, let me ask you one more question.

We are talking about brain wave activity. Could you tell us a little bit more about what we know now or what we could expect to know about brain wave activity in fetuses? At what time in the period of pregnancy are these evident? Can we equate the intensity of the change of these waves to the development of certain life-giving or providing or sustaining functions? Dr. Douglas. I am not an expert in this area. I can tell you

what I know about it.

Studies have been done on the development of the brain during the pregnancy which illustrate the fact that the brain goes through a very complicated developmental process. It is characterized in terms of electrical activity or brain waves by the fact that the patterns in general move from a pattern of great simplicity into an area of greater complexity, as you would expect, when the brain develops.

The interesting thing that I mentioned earlier was the fact that there seems to be an identical period of time, rather sharply defined, between 28 and 32 weeks in which some very substantial changes take place in the adult pattern.

Senator BAYH. 28 and 32 weeks?

Dr. Douglas. This is what is stated. I am not an expert in this. I only repeat what I have read quite recently. But it is a very interesting concept to me because of the fact that the ability to salvage premature infants depends so very heavily on the degree of development that has already taken place. The life support systems that were utilized in intensive care units for newborns are almost invariably designed to support and repair or replace these immature, still very primitively developed organ systems. Certainly one of the most necessary ones is the central nervous system. If we are able to identify a definite point in pregnancy-a time when a more mature form of activity is going on in the baby's brain-I think this is a great step forward in trying to approach this issue in a rational way.

I do not believe that this is anything like a completed area of investigation, Mr. Chairman. I think that it is very exciting to me that steps are being made forward in this context.

Senator BAYH. Dr. Douglas, let me go back and just quickly hit those four classifications that you used in your opening statement. If Dr. Corfman has any contrary thoughts or wants to substantiate yours, please feel free to do so. I just want to get an idea about where we are now as far as the degree of reliability, with the evidence, realizing there are exceptions.

In the combination pills, I do not see anything in your statement that suggests what the percentage of results is; what degree of certainty there is in the use of that kind of contraceptive.

Dr. Douglas. By that, you mean the effectiveness?
Senator Bayh. Yes.

Dr. Douglas. As to the combination pills, I am under the impression-certainly it has been our experience—approach 100 percent if utilized as prescribed. The failures that we have seen--and I speak now simply for Bellevue Hospital, and for our family planning clinicthese failures have been, without exception have been failures in the administration or schedule. We have not seen a pregnancy with the combination pills where we could be sure that the pills were taken as prescribed, in a proper way.

It is stated by those who manufacture pills and conducted large scale studies that, I believe, that there is a likelihood of a successful ovulation of about 1 in 1,000 in the first month of use. Thereafter, for all intents and purposes, the suppression of ovulation is complete. This applies to combination pills in which the dosage of the progestin and the estrogen is adequate. Pills are now appearing on the market, and not only has the estrogen been reduced for reasons that Dr. Corfman mentioned for safety--but the dosage of progestin has also been reduced. And when you reduce the dosage of progestin you reach a point at which ovulation can occur. Some of these compounds have been accompanied, even though they are combinations, by a very definite pregnancy rate. It is low, but it is there.

Senator Bayh. Is that the estrogen that causes the embolism?

Dr. Douglas. That is believed to be so. The question of causation of that disease is a little bit difficult, because estrogen affects not only components of the blood coagulation system, but can also affect blood vessel walls. The progestin, as far as I am aware, operate mainly in relation to the walls of the blood vessels.

Senator Bayh. What about the sequential pills, as far as reliability? Dr. Douglas. These are considerably less reliable for all intents and purposes. They can be compared to just simply taking estrogen alone. And I think that per 100 woman years of use that two or three would become pregnant. This has been described in the circulars and so on-people take sequential pills because there are fewer side effects, but they accept a very definite pregnancy rate in relation that use.

Senator Bayh. Three per hundred?
Dr. Douglas. I can obtain accurate figures.
Senator Bayh. Per year?
Dr. Douglas. Per 100 women utilizing this method, per year.
Senator BAYH. At the end of the year, with your statistics, you start

Bayh all over again?

Dr. Douglas. This is the general statistical method whereby we compare the effectiveness of intrauterine devices and pills and all methods-rhythm.

Senator Bảyh. Do you concur, Dr. Corfman, with that?
Dr. CORFMAN. I certainly do.

The minipills, which is the last class, are even less effective than the sequentials. The combination pills are the most effective, and the minipills the least.

Senator Bayh. What is the percentage on the minipills?

Dr. CORFMAN. The risk of pregnancy is 4 or 5 percent a year; more than the IUD, which has a risk of 2 or 3 percent per year.

Senator Bayh. The IUD has as high as 2 or 3 percent?
Senator Bayh. Four or five for the minipill.

As I recall in asking about the IUD, your assessment was about 2 million women in the United States are using that approach.

Dr. CORFMAN. I shall give you more recent data for the record.

Senator Bayh. How about the minipills? Do we have any assessment?

Perhaps it would be better, unless you could give us a general

Dr. CORFMAN. We shall provide you a table showing our best estimates on the current use of contraceptives in the United States.



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Source: Preliminary estimates from the national survey of family growth, National Center for Health Statistics, V.S. Public Health Service.

Senator Bays. If you were to take-would you know how many are using the postcoital pill?

Dr CORFMAN. No; we have no good data on that but the use is quite small.

We need to know about contraceptive use so we have done these surveys every 5 years. The only way to find out for certain about this, is to ask people.

Senator BAYH. That may be the best way to find out; I do not know if that is the only way to find out in an area as sensitive as this.

Dr. CORFMAN. Industry can tell us what they are making, but they do not know how many pills are actually sold. Pharmacists will tell us how many may be sold, but not how many couples actually use them. That is the rationale for our recurrent surveys.

Senator Bays. The institution preserves us from à method that may give us more accurate information.

If you could provide us that information of use—and more significantly, if you could provide us with an overall program of increased concern and response to this problem, how long would you take to get that kind of a program up here to us?

Dr. CORFMAN. The table of current use?
Senator Bayn. I mean the program, a plan.

Dr. CORFMAN. Such a plan is ready. The table on current use will be provided.

Senator Bayh. Will the plan come to us directly, or does it get forwarded through the normal channels? The only reason I am concerned about this, Doctor, is we are now beginning to look at the HEW 1976 fiscal year budget. And if you can make a convincing case, I am prepared to do battle to get some more money in there so that we can do what we should have been doing 10 or 15 years ago in this area.

Can you send that directly to me, or could I have my chief counsel come down and pick it up?

Dr. CORFMAN. We shall work out whatever seems appropriate.
Senator Bayh. For you or for me?
Dr. CORFMAN. For both of us.

Senator Bayh. I do not want to play games; I do not want you to get in hot water. I want the information. I do not want to have to scream three times to a guy sitting down there, that if you put another $100 million in contraceptives, this is going to increase the inflation rate. Every time I talk to those people about getting more money for cancer research, mental health research, drug addiction research, alcoholism research, I get this business: you cannot do that, Senator, because we are confronted with more inflation. That is a fact. I get this inflation stand, and then Mr. Miller, sitting over here on the right says, Senator, the administration is more concerned with the inflation.

Well, I have come in contact with a lot of people who are concerned about pregnancies and abortion and cancer and alcoholism and all these other things. I realize there are limits. It seems to me the limit in this area is the matter of life itself, to be what we are capable of in adjusting our system of research, with our scientists and our researchers. The impact of inflation is miniscule compared to the way we are spending money in large chunks other places.

You can suggest we ought to have another billion dollars for a B-1 bomber or something and that is not going to be inflationary. But to deal with the problems of preventing pregnancy and those dealing with



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