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had for improvement in management of the program and in the way FDA goes about its business, and the action the FDA takes on these recommendations, such as the accumulation and analysis of consumer complaints, so that it could direct its resources to the areas of greatest need, and its improvement of the inventory of the establishments which it has to regulate, which it did not have a good fix on. A lot of these other things are going to impact on what is the proper level of resources to carry out that mission.

But certainly in today's ball game, I think it is quite clear they do not have adequate resources—210 inspectors to inspect some 232,000 food plants in the country is not sufficient to do the kind of job we are sure Congress wants to be done.


Senator PERCY. A matter of special concern to the subcommittee is the relationship between S. 1177, to create a consumer protection agency to represent the interests of consumers in proceedings before Federal agencies and courts, and S. 3419 which we are considering today.

Do you see any conflict between them?

Mr. AHART. Certainly, on the face there is an overlap, Mr. Chairman. The Commerce Committee in its report made clear its intent, that it expected the consumer safety agency, if the consumer protection agency was created, to seek the representation from that agency rather than go directly on its own and seek the representation.

So even though there is apparent overlap of authority, there is congressional intent stated that this overlap be minimized through reliance by the consumer safety agency on the consumer protection agency in this particular area.


Senator Percy. Finally, Mr. Carlucci's statement, which you have heard, opposed section 112 involving direct submission of annual reports to the Congress on the grounds it would interfere with the President's authority to manage the executive branch. Do you agree?

Mr. AHART. I am a little bit puzzled, personally, as to the real thrust of Mr. Carlucci's statement. As I understand the provision as it relates to his concern-section 112—there would be a requirement for an annual report by the Administrator to the Congress and the President, I think 120 days after the opening of each session of the Congress, which, in the budgetary vein, would merely ask for the history of the budget consideration during the previous 3 fiscal years. As I would read it, it would mean that if they were submitting it this May, they would carry through to fiscal year 1971, giving the judgment of the Commissioners as to what they needed, the judgment of the Administrator as to what he needed, the judgment made by the President, and then the final judgment made by the Congress.

Now, as I interpret Budget Circular A-10, which sets out the restrictions on the provision of this information to the Congress, it would allow the same kind of information to be furnished to the Con

gress on the request of any appropriations committee or any Member, even for the current budget year, so long as it is requested.

I am a little bit puzzled as to why there is objection to historical information which would come up after the fact, after the budget has been considered, so that it would lay out the trends. I think this would be useful to Congress, this visibility, as I indicated in my state. ment. It would lay out the trends as to what various levels in the hierarchy had been asking, what their judgments had been. So that would be laid before the Congress and I would think it would be useful to them in relation to the current budget and also useful to the public.

WHAT SHOULD BE THE ROLE OF OMB? Senator PERCY. In your judgment, what should be the role of OMB, if any, in reviewing the legislative recommendations of the consumer safety agency in its own area of expertise ?

Mr. AHART. Well, certainly, as Mr. Carlucci pointed out, I think there is a responsibility for them to review legislative proposals on behalf of the President and make sure there is nothing done, at least that they don't know about, that may be inconsistent with the President's overall program.

At the same time I do not see any particular objection, irrespective of what the judgment may be by OMB, to having the agencies make legislative suggestions to the Congress directly. Certainly in this area the Administrator should have a lot of expertise, the staff will have a lot of expertise, and they should be able to reach some pretty good judgments on what needs to be done to improve their legislative authority to carry out the mission Congress wants them to carry out.


Senator Percy. On behalf of Senator Ribicoff, what problems are there with placement in EPA of the regulation of pesticides used for household purposes? What recommendations do you have to solve these problems?

Mr. Ahart. I am not sure I understand the intent of that question, Mr. Chairman. Would you repeat it?

Senator PERCY. The question is: What problems are there with the placement in EPA of regulation of pesticides used for household purposes?

Mr. AHART. As I noted in my statement, what we suggested was possibly the inclusion of household pesticides within the definition of consumer product. Our concern here is that the pesticides used around the house are probably not too high on the priorities list of an agency whose principal mission is the protection of the environment.

These are used in fairly small quantities. They are used where children can reach them, and so on, and there is probably a need to look at them from the standpoint of the safety of the consumer as well as, and properly so, EPA's function of looking at thern principally in the context of protection of the environment.

Senator PERCY. I have no further questions. If you or any of your colleagues have any other comments of a general nature that you would care to make, we would be happy to have them.

If not, we very much appreciate your being here. Would you express my personal appreciation to Mr. Staats for the high quality testimony.

Mr. Ahart. I certainly will. Thank you very much.

Senator PERCY. Our final witness in these hearings is Dr. Peter Isacson. Dr. Isacson is associate professor of social and preventive medicine; project director of the Vaccine Evaluation Unit, State C'niversity of New York at Buffalo, N.Y.

Dr. Isacson, we welcome you this morning. Would you care to summarize your testimony and just speak from it? You have such a profound knowledge of this field.

If you would like to summarize it, we would be happy to have that summary, then followed by the full text of your statement, which would be put into the record.


Dr. IsAcson. Thank you very much. I am delighted to be here. I am speaking because my field has been the field of laboratory evaluation of vaccines and I have a natural concern of the appropriateness of the Division of Biologic Standards. The points I would have to make primarily are two, that the DBS does not adequately serve its regulatory function, both in respect to removing possible dangerous or infective vaccines and, secondly, for really setting up a systematic investigation of their possible long-term harmful effects.

And second, that there has been a possible conflict of interest situation developed because of the organizational structure in the Division of Biologic Standards and this may have impeded the development of really a much more useful, I believe, and more valuable Rubella vaccine.

Now, the failure to act has been well documented by the General Accounting Office and they have already provided a list of vaccines. I will not go in, then, to the details of what is in the testimony on the two vaccines I would add to this. However, my point in raising them is that I think it is pertinent to the committee to consider the reasons why they failed to act, and I think in both cases what has evolved is, first of all, that the vaccines were more or less being withdrawn from that market, anyway. They did not feel they had that.

Second, I think the DBS has had a tendency to downplay any open public discussion of the possible harmful effects of vaccines. This is on quite reasonable grounds, really, that the public might become alarmed, may not understand the scientific intricacies involved, may begin to doubt the value of other vaccines of proven efficacy, and therefore the fundamental job of preventing disease would be made harder.


This is a valid argument. The decisions DBS have to make are certainly not easy ones. I am not, nor do I know, of any one questioning their basic motivation in any of this, but I have something of an objection to this line of reasoning.

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For one thing, facts do tend to become known, and this committee, itself, testifies to. Public dismay over what appears to be a slow, lengthy regulatory effort, can be really highly disastrous to vaccines in the long run. Conversely, if there is initial open and full public arguments, the public may be worried for a while, it is true, but if they are presented with a picture of decisive regulatory action, an agency working to their benefit, I think in the long run this would help public acceptance of vaccines.

In the other point I have may be rather central to a lot of argument, and particularly coming into play in this organization, is this whole argument about whether or not they should make discussion open and available and possibly frighten people, which is not really a scientitic argument.

It is not one DBS scientist or any other scientists for that matter are necessarily qualified to say anything about by their training or experience, and yet they do. This is taken upon themselves.

It is an instance, I think, of what might be scientific eliteism at work and I think this ought to be straightened out.


I would like to say just a few words of detail about the possible conflict of interest. Dr. Hayflick, in previous testimony to this committee, has gone through this. I summarize it only in brief detail. There have been several groups of scientists working toward and developing strains of rubella virus that would be candidate strains for vaccine groups. One of these groups was DBS scientists, and since the Division of Biologic Standards is the agency that will eventually license the vaccines, therein is the obvious conflict of interest. And, of course, we are not talking here about a financial conflict of interest, but scientists are made in prestige and respect of their peers and how widely known their name is. These are all features that would accrue to someone whose vaccine strain is used in an important and widely distributed vaccine.

But I would like to very quickly add the two scientists involved, Dr. Harry Meyer and Dr. Paul Parkman seemed to enjoy a remarkably high international reputation, both as scientists and persons of integrity and honesty.

The question is not one of personalities; it is really the situation that was created there.

Now, there is also, of course, an institutional bias. I refer to the DBS strain of vaccine virus as other people do, so that credit is re. flected on DBS for the development of this vaccine which they subsequently licensed.

Now, as a matter of fact, the first two vaccines used did use the DBS strain of vaccine virus. Subsequently a third, which was used in Belgium, was licensed.


Now, the important scientific points about rubella are these :

It is a peculiar situation from a public health standpoint. Rubella is a harmless disease in young children. That is not why we are developing the vaccine. It is for all practical purposes nothing to

worry about. What we worry about, of course, is the fact if a woman in the early stages of pregnancy develops rubella, then there is a high likelihood the child will be born dead, with malformation, blindness, deafness, heart defects. So that people at risk are woman of childbearing age. These are the ones we need to immunize the most, protect.

The vaccines under consideration either licensed or not licensed, are all live virus vaccines. That means the virus will grow in the body after it is innoculated. The vaccine virus itself could damage the fetus of a pregnant woman. So you would never give it to a woman who is pregnant.

Now, it is most dangerous in the early months of pregnancy. The woman does not know she is pregnant for several months. For all practical purposes, you have to extend this restriction to all women of childbearing age, which in this country now starts, they tell me, at age 11.

So you see the very old situation that is created. How do we face this! Most public health authorities then want to protect these women indirectly. They feel if enough other people can be immunized, school children in particular, you can break a chain of transmission.

The woman would effectively not be exposed to rubella virus. So the best vaccine is the one most effective in breaking this chain of transmission.

Now, a vaccine could do two things. It can first prevent the person from getting the disease, but this is separate from its ability to prevent that person from transmitting the virus.

Unfortunately, the DBS strains that are now licensed have been subject to a great deal of scrutiny and it does appear that although they are highly effective in preventing rubella as a disease in the recipient, they are not as good as we had hoped in preventing that person from transmitting the disease.


For example, a child who has the DBS strain of vaccine, who has been immunized sometime in the past, may then later be exposed to German measles. He will not get sick, he will not develop rubella, but he is capable of bringing the virus home, which will multiply in his nose and throat, to his pregnant mother.

We have not accomplished our aim that way. This is real tough. The DBS strains have some ability to cut down virus secretion, but it is very likely the strains of transmission will not be broken.

The reason for this backrun is there is a vaccine called RA 27/3, developed by Stanley Plotkin and coworkers at the Eistar Institute, which has the enormous advantage of first inducing a high level of protection, and second, preventing this transmission of infection. It induces a lot of antibiotics right in the nose and throat and when these children are subsequently challenged with rubella virus, either naturally or otherwise, they tend to resist this reinfection. This vaccine is potentially highly capable of breaking the chain of transmission so important in the field of rubella.

This vir rine has madrheen licensed, since a possible conflict of int


what gives us pause.


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