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be a much stronger reliance on interagency agreements. FDA and DBS have an interagency agreement on efficacy. I believe we should have interagency agreements between institutes generating scientific information on foods and drugs, and products for that matter, which will cause that information to move directly from the institute when it is generated into the decisionmaking process of the regulatory agency. This, I think, will be more likely to happen if the agency is outside HEW than inside. As it has been inside, the only way we can accomplish these kinds of relationship is by creating a high priority by putting a spotlight on a crisis area. Then, the Secretary will begin to try to bring together some of the functions.

Senator Percy. Thank you very much, indeed. I turn the chair back to the chairman.

Senator Harris. You heard my question a while ago to Mr. Elkind about the standing with the Congress insofar as appropriations are concerned for an independent agency as compared to say, being within HEW.

Would you care to comment on that?

Mr. TURNER. I think that is clearly a record that the independent agencies have not gotten large budgets from Congress, but I think that that is a result rather than a cause of their problems. I think it is a result of their inherent weakness as agencies. I believe the money will follow the function, and when you are establishing a safety function, and you do have the strong base of the 60-and-some years of the food and drug law development in the courts and in Congress and by the agency, it will be not only possible but highly likely that the funds needed will come forward.

As it is now, the levels of budgetary request you have to go through are very many, and each of those levels believes it must have a policy input into that budget. That is what we are trying to cut through.

Senator Harris. I agree with that. I think you are absolutely right.
That is, I think, the question this committee ought to consider.
Let me ask you a separate question, not related to that.

REGULATORY BODIES

The things that worries me about regulatory bodies generally, as it probably does you, at the national level as well as around the States, you look at these regulatory bodies, and almost as fast as we can create them they become controlled by those who are supposed to be regulated. That is true at the Federal level, I know. This bill has a division in it about mandamus suits, and so forth. Will that give us some insurance against the control of the agency by those it is supposed to regulate, and are there other safeguards that you can point to or suggest?

Mr. TURNER. Well, I think that definitely it will give some assurance but that the basic problem you are alluding to, the problem of regulatory agencies being captured by those they regulate, has a couple of clauses which will help avoid capture by industry and are used in the argument for this bill.

First of all, when the ICC, for example, was created, or the FDA was created originally, they were created with the support and the development of the industries involved; that is, the development did not take place until after they had received the endorsement of the industries that were going to be regulated by them. This is a crucial step in the history of the regulatory agencies. It also seems to me it is a crucial reason why they have been weak agencies and have not been trying to get the funding they were needing. They were captured before they came into existence.

PEOPLE MUST BE INVOLVED

In addition, I think it is very important for the American public to act on something it already knows and that is that Government is not a substitute for themselves acting for their own rights. Much too often, we think that creating a Government agency will then solve all of our problems and we can go away and everything is taken care of. By historical examination and current observation, this is clearly untrue. People must be involved. If they learn they must be involved, then, Government will not be looked upon as failing when it does not score touchdowns for the public.

Government is supposed to be the referee. It is not supposed to be the guys playing on one side. Government is not consumers; Government is not industry. The consumer movement's major and most effective argument against Government up until now has been its tendency to play on the industry team. What we are now arguing is not that Government should play on the consumer team, we are arguing the consumer team ought to get in there and do its lawsuits, have its advocacy agencies, develop organizing principles to bring itself to bear in the economy, and the Government ought to be strictly a referee agency which basically makes sure the minimum rules established are enforced, make sure there is no tripping, no unnecessary roughness, and so forth.

But above and beyond that, the quality of the society must depend upon the interaction between the people acting as consumers in the marketplace and the people acting as sellers in the marketplace and that interaction referred by the Government will be the greatest insurance against having the agency captured by industry.

Without that concern by the public, I think we are going to have a hard time.

Senator HARRIS. You have been very helpful, and also very patient. Thank you very much.

Mr. TURNER. Thank you very much. I always appreciate listening to Mr. Elkind. He has fantastic information on the subject.

Senator Harris. Thank you, Mr. Turner. I want to call now on Dr. Leonard Havflick.

Dr. Hayflick is a professor at the Stanford University School of Medicine.

Dr. Hayflick, we are pleased you are here and pleased to hear from you at this time.

TESTIMONY OF DR. LEONARD HAYFLICK, PROFESSOR, STANFORD

UNIVERSITY SCHOOL OF MEDICINE, STANFORD, CALIF.

Dr. HAYFLICK. Thank you, Senator Harris. I am pleased your committee thought to invite me here. The thrust of my remarks, which have been submitted as a formal document, will be abstracted at this point.

Senator HARRIS. As we have done earlier, without objection, we will print the entire statement in the record.

(See exhibit 4, p. 119.)
Dr. HAYFLICK. Thank you.

My remarks are really based on 10 years of experience in dealing with the policies and some of the people at the Division of Biologies Standards, which we refer to here as DBS.

It will be my purpose to make three salient points from which I intend to draw five conclusions.

The points to be made are the following:

1. That DBS has been inordinately slow to respond to new research developments which lead to the improvement in the safety, purity, and efficacy of virus vaccine products for which it is responsible.

2. That DES's activities in the area of biomedical research raise serious questions of conflicts of interest arising between DBS and non-DBS scientists which can work to the disadvantage of the public.

3. That DBS's policies or lack of policies have worked to the detriment of their constituencies.

SLOW RESPONSES

Although there are several examples of slow responses by DBS to new research developments, I will confine my substantiation of this charge to the arena of human virus vaccine substrates where

my

firsthand experiences extend over the last decade.

The production of human virus vaccines has historically depended upon advancements in the field of tissue or cell culture. Virus vaccines consist of viruses in either a killed or weakened state. Thus, in order to produce vaccines, it is necessary to produce large amounts of virus particles. These can only be produced in living cells, either from animals or from man. It is extremely important that the cells in which the virus grows are free from contamination. If the cells contain disease-producing microbial contaminants, vaccine viruses could spread an unwanted disease. The cells of some animals in which vaccine viruses are produced have been shown to contain contaminants which have caused cancer in laboratory animals and human tissue cultures and have caused human fatalities.

HUMAN CELL CULTURES

In 1961, my associates and I isolated human cell cultures in which vaccine viruses could be produced. We believe that these cells were safer than animal cells in which vaccines were then being produced. Yet, for more than 10 years, DBS failed to encourage manufacturers to work on licensing a single vaccine produced in these cells, and continued to license vaccines produced in the animal cell cultures known to be subject to contamination.

POTENTIAL ADVANTAGES

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The potential advantages of growing virus vaccines in a secondary or serially propagated cell population, such as I have just described, are embodied in two words: "safety" and "standardization."

Serially cultured normal cells such as those developed by us from human tissue some 10 years ago have the following advantages over primary cell cultures:

1. These cells can be frozen in liquid nitrogen freezers for apparently unlimited periods of time, reconstituted at will and exhaustively tested by dozens of laboratories prior to their use as vaccine virus substrates. This cannot be done with primary cells.

2. Enough vaccine can be produced from the cells of a single tissue derived from a single donor to immunize hundreds of millions of people. This is the ultimate in cell standardization and cannot be realized with primary cell cultures, each of which comes from a different animal with different characteristics.

3. Unlike monkey cells, the human diploid cell strain WI-38 tested in hundreds of laboratories throughout the world has never been found to contain an indigenous contaminating micro-organism.

4. The same exhaustively tested cell population can be used by several different vaccine manufacturers unlike the thousands of unstandardized primary cell populations now required.

5. A significant diminution in the annual slaughter of monkeys for their kidneys used in polio vaccine manufacture can be effected. Some of these species are threatened with extinction and their handling has killed 25 workers worldwide from at least two exotic virus diseases.

WI-38

The primary cell populations in current use for vaccine production in this country are derived from dog, chicken, duck, rabbit, and monkey tissues. Since DBS requires that the cultures derived from these animals be primary cultures, you can see why it is necessary to kill tens of thousands of these animals annually to provide a variety of cell substrates for virus vaccine manufacture.

In 1961, we reported that serially cultivated human cells derived from the lungs of an aborted fetus remained absolutely normal in all respects for a period of 50 serial subcultivations and then these cells died. We also showed that these cells could be frozen in liquid nitrogen and stored indefinitely. Finally, we showed that these normal human diploid cells, as they are called, were absolutely “clean” in the sense that no contaminating foreign viruses or micro-organisms could be found in them. As a result of our confidence in one strain of these cells called WI-38 and their clear superiority to existing primary monkey kidney cell substrates, we produced a polio virus vaccine in them and proved the efficacy of this vaccine in man in 1962.

POLIO VACCINES

From the time that polio vaccines were first licensed in this country by DBS in the late 1950's and until last month, such vaccines were grown in primary cultures of monkey kidney cells.

Each monkey is a universe unto itself and may carry harmful viruses in its cells, unlike WI-38. Therefore, the thousands of different kidneys going into polio vaccine production provides the ultimate in an unstandardized heterogenous tissue medium. The scope of this problem can be appreciated if one realizes that each lot of vaccine may require the sacrifice of several hundred monkeys whose kidneys are a veritable storehouse for the most dangerous kinds of contaminating viruses. In fact, monkey kidney is in this sense the "dirtiest” organ known.

SV 40

In 1961, a virus indigenous to monkey kidney cells and known as SV 40 was found as a live contaminant in the Salk polio vaccine and an adenovirus vaccine administered to over a million people in the country. This virus, SV 40, produces tumors in rodents and can convert cultured normal human cells to cells with cancerlike properties. Despite this discovery in 1961, and despite what several scientists believe to be inadequate tests sanctioned by DBS to detect this agent, monkey kidney has been continued for 10 years to be used for the production of polio vaccine.

Perhaps the risk of continuing to license vaccines produced in monkey cells would have been worth taking if no other substrate was available for the production of polio virus vaccine. But as indicated previously, the observation that normal human cells like WI-38 were a reasonable alternative was made in 1961–62. Yet, for reasons best known to DBS, they dug in their heels and for the next decade refused to offer any encouragement for the use of these cells in this country until foreign countries began switching over to the use of WI-38. This intractable position was maintained even though the military in this country-which does not come under DBS authority-sanctioned the use of a very effective adenovirus-a cold-like disease-vaccine for use since 1966. Adenovirus vaccines were, prior to 1966, made in monkey kidney cells, but for reasons already cited, the military made the change from monkey kidney cells to normal human WI-38 cells a full 6 years before DBS.

ADENOVIRUS VACCINE As further evidence of the pace with which DBS reacts, the adenovirus vaccine used successfully in the military since 1966 was submitted to DBS for licensing for civilian use about that time and to this day a license has not been forthcoming. In the intervening years, the manufacturer has been asked to comply with a series of additional requirements that apparently the military has not seen fit to demand.

In addition to SV 40, primary monkey kidney cells are known to harbor at least 20 other kinds of contaminating viruses.

Vaccines produced in the human diploid cell strain WI-38, have been licensed by several countries since 1967. Yugoslavia was the first, followed by France, the United Kingdom, and the U.S.S.R.

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