Mr. DLOUHY. Essentially or exactly the same language. Senator BUMPERS. Has Lederle experienced any lawsuits which were brought as a result of live virus polio vaccines?

Mr. DLOUHY. Yes; we have.

Senator BUMPERS. How many?

Mr. DLOUHY. I do not know the number offhand. It is a couple a year, something in that order. It is a very small number.

Senator BUMPERS. Can you tell me how much these lawsuits which were filed as a result of polio vaccines have actually cost Lederle? Mr. DLOUHY. I am not really sure I can answer that question. Many of these cases were settled out of court, and I am not really sure it would be appropriate to discuss these.

They can be substantial.

Senator BUMPERS. Has your company ever considered the cost of the paperwork, and man-hours involved in such a consent, as opposed to what your actual losses have been?

Mr. DLOUHY. No; we really have not looked at it that way.

We have looked at it from our potential losses, and most specifically, we believe we have to comply with the law regardless of the cost.

Senator BUMPERS. Were you here when Dr. Ginsburg answered my question about the number of polio cases that have been caused by the administration of the vaccine?

Mr. DLOUHY. Yes, I was.

Senator BUMPERS. He said that last year there were four cases of polio in this country, and only one of those cases was directly related to receiving the vaccine, the other three cases were contacted by coming in contact with people who had been immunized.

First of all, have you ever had to defend a lawsuit from somebody who got polio, as a result of their contact with somebody who had been immunized?

Mr. DLOUHY. Yes, we did.

Senator BUMPERS. How much of the vaccine which was used in 1975 did Lederle manufacture?

Mr. DLOUHY. In 1974, the total dosage was about 26 million, and Lederle sold about 15 million.

Senator BUMPERS. Fifteen of the twenty-six million?

Mr. DLOUHY. Right; in round numbers.

Senator BUMPERS. Do you know how many doses there are on hand right now?

Mr. DLOUHY. We know our inventory; yes.

Senator BUMPERS. What is your inventory?

Mr. DLOUHY. In various stages of manufacture, it is some 35 million doses, and 2.7 million doses are ready for shipment at any moment. Senator BUMPERS. Of this new contract, how many doses were you to manufacture?

Mr. DLOUHY. A maximum of 7 million doses over a 1-year period. I believe that is the number.

Senator BUMPERS. Who else is manufacturing vaccine right now? Mr. DLOUHY. I believe that is the number; yes.

Right now in the United States, nobody in the United States is manufacturing, but Pfizer is still on the market in the United States, based on imported material, so we are still competing with them.

Senator BUMPERS. Pfizer is not making vaccine now, are they? Mr. DLOUHY. I learned yesterday they stopped making in July of this year.

Senator BUMPERS. As far as you know, the 7 million you will be required to manufacture in this contract is all that is present to be manufactured in this country?

Mr. DLOUHY. No.

Senator BUMPERS. I am advised by staff that there are also private and State contracts?

Mr. DLOUHY. That is correct.

Senator BUMPERS. Do you have statistics on how many doses are presently scheduled to be manufactured under all contracts?

Mr. DLOUHY. I do not have it offhand, but let us assume that the requirements in the coming year would be the same as last year, some 25 million doses, and we can supply that in the coming year.

We have increased some of our production to meet this demand. Senator BUMPERS. One final question, does Lederle now require informed consent agreement with its vaccine?

Mr. DLOUHY. Sales made to the public, public health agencies; yes. Senator BUMPERS. How about doctors?

Mr. DLOUHY. No; not to doctors.

Senator BUMPERS. Why do you make that distinction between doctors and say the county health department in Franklin County, Ark.

Mr. DLOUHY. Our total approach with this has been to comply with the law, as it came out in the Reyes case, and the judge in that case made a clear distinction between administration of the vaccine by a physician, a distinction, in other words between individual administration versus a public health program.

Senator BUMPERS. Was that a case involving polio vaccine?

Mr. DLOUHY. That was a case involving polio vaccine, yes, and he made a very clear distinction, and this is really the only thing, the whole purpose with our approach to this question is to comply with that decision which went to the Supreme Court.

Senator BUMPERS. Do you feel that that Supreme Court decision was in error?

Mr. DLOUHY. I would not like to comment on that.

Senator BUMPERS. I for the life of me cannot understand why it makes any difference who gives it. When you are taking an oral dose of polio vaccine.

We gave millions and millions of doses in churches and high schools all over this country when we went into the mass immunization program back in the early 1960's. I simply cannot understand why we have this redtape, and 30 million children suffering in this country, when all you have to do is put a drop of polio vaccine in a cup and drink it.

Mr. DLOUHY. Fine, but I have to come back to the judge's ruling. Senator KENNEDY. Just in conclusion, you have to assume the CDC will, we will hear from them in a minute, they obviously know the Reyes case, you had direct conversations about this problem a year ago, and you made the application in June.

The shortage, it started to exist in August, in September, when the negotiations started to take place.

It was worked out in a period of a week?

Mr. DLOUHY. That is correct.

Senator KENNEDY. Now, the issue that was being raised by your company, we have been into this question, to understand it both in terms of my understanding it, and I think for the rest of us as well, the liability you are talking about here deals with the unavoidable, an unsafe dissemination of the vaccine.

It will be unavoidably unsafe in certain circumstances. That is the language. That seems to be an imminently fair and valid and legitimate concern for the companies.

Mr. DLOUHY. We think so, yes.

Senator KENNEDY. One that has been around a bit with the companies, and some of the other questions of liabilities, but this seems to be imminently fair, and just again, we will hear why the holdup on it, but the interesting part of it again, should not be necessarily noteworthy, but I would like to point out anyway, was that your decision came down on the side of informed consent, of which this committee has been extremely interested in regard to the protection of the human subjects, as we follow these issues in terms of sterilization, all of these other kinds of issues, DES, we have been very, very interested and concerned, and your company came down strongly on the side of that particular issue, and then the third point I make, is at the time it actually came into the question of negotiations, these difficulties were worked out in the matter of just a few days, which I think again is a reflection of the willingness of the company to deal effectively with this problem to meet a need.

I appreciate this, because in the other exchange with Dr. Sencer, and in the course of those exchanges, I do not feel myself that I understood the particular issue we talked about here properly, and I think to any reading of that particular exchange, I think could be interpreted as a disservice to the companies that we are dealing with there, and I want this record to reflect that and show it.

I do not feel quite frankly in reviewing the exchange with the CDC, that it was a fair representation on their part, and we will explore that later on, we will have a chance to do that, it may lead to what the nature of the problem was.

That is not for you to comment on, but I would think in these terms of implications, although your company was not mentioned, you probably got some of the rap, at least from me, and I just want the record to show that I was mistaken.

Senator BUMPERS. Mr. Chairman, do you know how many doses were given by clinics and clinicians as opposed to private physicians? Mr. DLOUHY. In 1975, the private sector was 9.8 million doses, and the public sector was 15 million doses, so the public sector is larger than the private sector.

Senator KENNEDY. We hope that you will feel free to keep us informed as well.

We have oversight responsibility obviously, and we welcome leaving the communications being open, and so we hope you feel free to keep in contact with us.

Mr. DLOUHY. Thank you.

Senator KENNEDY. Our final panel of witnesses today is made up of James F. Dickson III, M.D., Deputy Assistant Secretary for Health of the Department of Health, Education, and Welfare.

Dr. Dickson is accompanied by Mr. Gene R. Haislip, Deputy Assistant Secretary for Health Legislation of the Department of Health, Education, and Welfare;

David J. Sencer, M.D., Director, Center for Disease Control;

Alexander M. Schmidt, M.D., Commissioner, Food and Drug Administration;

John R. Seal, M.D., Deputy Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; and

Harry M. Meyer, Jr., M.D., Director, Bureau of Biologics, Food and Drug Administration.

Dr. Dickson, you may lead off.

STATEMENT OF JAMES F. DICKSON III, M.D., DEPUTY ASSISTANT SECRETARY FOR HEALTH, DEPARTMENT OF HEALTH, EDUCATION AND WELFARE

Dr. DICKSON. Thank you, Mr. Chairman.

I do have a formal statement which, with your permission, I would like to submit for the record, and make a few opening remarks.

Senator KENNEDY. Without objection, it will be made a part of the record and inserted at the conclusion of your testimony.

Dr. DICKSON. There has been a good deal of discussion in recent months about influenza problems. However, there are other immunization problems that we do have to deal with, particularly the immediate problems of the availability of vaccines, other than the flu vaccine. As we discussed with you in August, we had difficulty in entering into a contract with the vaccine manufacturers to provide vaccines for rubella and polio.

At this time, in summary, I would like to report that these problems are well in the process of being overcome, due in part to the interest aroused by your earlier hearings on this topic.

I would like also to note, with respect to this area, that preventive medicine does recognize it does not operate in a vacuum, that the people must be informed about the risk of not taking action with respect to preventing disease. I believe that the American public is sufficiently motivated and informed to be able to make meaningful choices if the risks and benefits are made clear to them.

Finally, I would like to say that we are actively looking into the future in this area in terms of long-range solution to preventive medicine, and to the long-range development of immunization policy in the United States. In the near future, and to this end, the Public Health Service will convene a national conference that will concern itself with the matter of policy development, priority studies, and the guidance of implementation with respect to our overall national immunization efforts as it exists now, and as it should exist in the future. We intend that in this conference there will be full participation from all sides-from the public and the private sector. We do welcome this hearing, and we will be glad to keep you informed of the ongoing planning for this conference.

I do believe that over the next 6 months it will be possible to come to a public position, and to assure that the American public has an adequate opportunity to receive the most effective immunization agents available, and also to receive them in an environment that

will adequately protect them against any inadvertent effects from these vaccines.

Mr. Chairman, at this point, and with your permission, I would like to ask Dr. Sencer, Director of the Center for Disease Control, if he would like to make some brief comments on the general availability of vaccines, other than the flu vaccine this fall.

Senator KENNEDY. All right.

We would like to hear from Dr. Sencer.

Have you a copy of a prepared statement, Dr. Sencer?

Dr. SENCER. We have the prepared statement of the Department. Senator KENNEDY. Yes. All right.

Dr. SENCER. Thank you.

Senator KENNEDY. Before we hear from Dr. Sencer-and I do want to get into these other issues-but I do not really feel that a conference is sufficient to deal with the kind of problems we have here, the problems we are really concerned with and talking about and which are raised in this issue here.

I think a conference can be useful under certain circumstances, but I think all of us who attend them do obtain some degree of information or knowledge; but due to the kind of indepth work that I think needs to be done, as I outlined in my opening statement, I think it needs a commission.

I think there needs to be a good hard look taken at these public policies and scientific questions.

I think we need to have that reported back to this committee prior to the time the next round of contracts goes on behind the scenes, so that we can exercise proper responsibility.

We are really going to insist on this. I hope we can get HEW to work with us, to cooperate, so we can get to the appointment of such a commission, and I hope we can get the Office of Technology Assessment to go into it.

I think it is much better to get this worked out, but in any event, I do not want to dwell on that, although I want to make the record very clear as to what my views are on it, and we will work on it and come back to you again.

Dr. SENCER. Mr. Chairman, to that point, our intent is not merely to have a conference, but to use this as a beginning point, much as today's hearings are, to enter into a full and open discussion of immunization policy in this country, and we hope to have a substantial report available by mid-March. We would propose incorporating into that the requirements of Congress that we do a study on indemnification, or damages resulting from the immunization programs. This would not necessarily be done as an internal HEW program, but to incorporate it as best we can from the outside. I think we are in substantial agreement on the proposal.

I would like to make a few comments on the general subject; we have been concerned, not about informed consent, but about how informed consent is given.

We have been working with industry and public health practitioners trying to find a method in which this could be done, and protect not only the rights of the individual, but also protect them if something were to inadvertently happen. Early in this calendar year we made proposals for action to be taken.