Mr. BROYHILL. Where would you anticipate that most of that premium dollar will go, to pay for what expense? That is not a profit. Since you indicated that you were having difficulty with companies signing up to take a share of the risk, I assume that a large proportion of that $8 million-plus premium is going to go to some expense.

Mr. HARDER. The expense side of this insurance undertaking, what we would call the expense side, not loss or loss expense, this is the nonloss or indemnity expense side, is very modest.

The biggest single piece would be State premium taxes, U.S. State premium taxes. That would be about 3 percent on this category, 21⁄2 to 3 percent of the premium.

The brokerage commission has been reduced to a level that you do not see in ordinary commercial relationships between underwriters, manufacturers, and insurers.

So that you would have to allocate a very high percentage of that total premium to the risk of indemnity and defense loss, paying on behalf of manufacturers both the cost of defending them and indemnity to the Federal Government who in that circumstance would be successful in suing them in a Federal court under the contract and at law for negligence arising out of the swine flu vaccine program.

In other words, I was afraid you were going to ask now about profit, supposing no loss occurs.

Mr. BROYHILL. Are you anticipating most of that is going to pay for loss?

Mr. HARDER. It is very difficult to divide that. We would assume that if a loss occurs defense will be very expensive.

Mr. ROGERS. I think they are saying you are paying for their assuming some of the risk.

Mr. HARDER. We have not tried to divide in this case. We have no experience on which to divide the probability of loss between indemnity and defense cost.

Mr. ROGERS. Is this a straight premium?

Mr. HARDER. It is a straight, flat, not retrospectively rated.

Mr. ROGERS. So if there are very few claims this will be a good deal for you. If there are many claims it may not be.

Mr. HARDER. It may not be. On the other hand, the insurance underwriter's profit can only be determined when you add this exposure to his other undertakings and draw a bottom line at the end of the year. Any one transaction you cannot cost the way you do a manufacturer.

Mr. ROGERS. I think we have the picture very clearly.

You have now entered into the necessary agreements with the companies as I understand it.

Mr. HARDER. Yes, sir. At this point it is largely verbal.

Mr. ROGERS. I would like you to put on the record what you are hearing about insurance coverage for health departments, hospitals, volunteers, employers allowing use of their facilities, and so forth.

We will have to recess for another 5 minutes, I am sorry. We have one more witness after you. So, if we could discuss this briefly as soon as we come back, we will let you go.

The committee stands in recess for 5 minutes.

[Brief recess.]

Mr. ROGERS. The subcommittee will come to order, please.

If you could just give us a brief comment if you have heard anything with respect to insurance for other participants in the program.

Mr. HARDER. I have not. I just read the letter Mr. Hyde had received from the hospital association. It would be in every interest of the underwriting insurance community to not encourage charges of any sort for administration of the swine flu program.

The various insurance associations, I am sure, will do their best to make it clear and will directly contact the insurance companies involved in the hospitals particularly. I have not had any conversations in the business to know that the insurer would not charge. We would not want to stimulate that by any kind of premium processes or underwriting process.

Mr. ROGERS. Thank you very much.

Our last witness is Marica Greenberger.
We welcome you to the committee.

Susan Marks, we welcome you also to the committee.

Your statement will be made a part of the record [see p. 342] and if you could just summarize for us your main points it would be helpful to the committee because I think we are going to have another vote

very soon.

STATEMENT OF MARCIA GREENBERGER, ATTORNEY, AND SUSAN MARKS, LAW STUDENT INTERN, WOMEN'S RIGHTS PROJECT, CENTER FOR LAW AND SOCIAL POLICY

Ms. GREENBERGER. Yes, sir.

The subject of our statement today is the consent forms which have been proposed to be used in the flu vaccination program. We are concerned that these forms are not adequate and that as a result the informed consent will not be secured from individuals before they are given the vaccination.

We are concerned, first of all, that if informed consent is not secured, there is obviously a volation of the act as well as public policy.

In addition, the Federal Government, because of the insurance provisions found in the act, will be subjecting itself to large possible liabilities for the failure to secure informed consent and a possible drain on public funds that could otherwise be avoided if proper forms and proper procedures were established at the outset.

I would like to go through, if possible, the basic concerns that we have with the form.

Mr. ROGERS. If you could just point it up quickly for me that would be helpful.

Ms. GREENBERGER. Yes, I will.

First, as I am sure you are aware, the original form which was established

Mr. ROGERS. Now, this has been amended.

Ms. GREENBERGER. Yes.

Mr. ROGERS. What other changes do we need to make?

Ms. GREENBERGER. The first form was amended at the suggestion of the National Commission for the Protection of Human Subjects. There was a second introductory statement that was intended to reflect the concerns of the National Commission.

The Commission met this weekend and reviewed the second statement. As I understand it from our telephone call this morning with the staff of the Commission, they still have concerns along the lines of the concerns we express in our testimony about the possible inadequacy of the revision and the fact that these revisions may not take their concerns sufficiently into account or correct them.

One major concern is the advice being given to pregnant women about whether they should consent to take the vaccination. Mr. ROGERS. What is your feeling?

Ms. GREENBERGER. Our feeling is certainly not to give a judgment. of whether they should or should not but merely to reflect the adequate statement of scientific knowledge that there are no studies about the risks and benefits of taking this swine flu vaccine for pregnant women.

The contrary impression is clearly given in the form. There is a blanket statement that it is safe to be taken during pregnancy which will still be given to women before they consent to take the vaccine. There is an introductory statement which has a quote from an advisory committee apparently intended to modify the blanket statement that it is safe to be taken during pregnancy. However, the introductory statement is useful only if women reading it had a scientific background and understood the very technical language which is used in the introduction, such as the term "contradictions."

It is our firm belief, and I think Mr. Waxman had read the statement earlier in the hearing, that the statement in the introduction is not worded in a way that most individuals would understand. It is very confusing, it uses scientific language. Women who read it will then turn to the next page and see a clear, simple, lay term statement that the vaccine is safe to be taken during pregnancy.

We think, therefore, the forms have been made worse and more confusing rather than better with regard to pregnant women.

There were other concerns as well. One of the concerns of the National Commission for the Protection of Human Subjects which we share is that the form that the individual is asked to sign is termed a "registration form," not a consent form.

The clear impression that people will receive is that they are registering, not that they are being asked to give their consent. That has not been changed. There is language now which says that you are going to be asked to give your consent but it is not set out in a fashion that would catch the eye. The type, the clear big type, is "registration form," and that has not been changed.

To return to the issue of information concerning pregnancy, the improper statement which will still be given to pregnant women concerning safety during pregnancy is especially troubling because of the fact that the Government is at this very minute giving out information which continues to be misleading.

We attended a consumer representative meeting with the Food and Drug Administration last week on September 8 and requested that the swine flu program be placed on the agenda. It was on the agenda. For the information of the national consumer representatives present, an FDA consumer memo was circulated and is attached as exhibit C to my testimony.

It is a list of questions and answers concerning swine flu and the vaccination. There is a question on the second page, "Is it safe for pregnant women to get the vaccine?" The answer on the form says, "Yes, flu vaccine can be taken safely during pregnancy." That is obviously not a correct and full forthcoming statement of what is truly known about the safety of swine flu vaccine during pregnancy. Wa asked whether a new form was being prepared and there was not a clear-cut answer whether a new form would be prepared. We then asked whether as of that time the FDA would agree to stop sending out the misleading memo and they refused to commit themselves to stop sending out the misleading memo.

As a result we have a situation where the Federal Government is sending out misleading information especially for pregnant women. Not only their own health but the unborn child's health is at stake and we have a consent form which in effect underscored the misleading information that is being sent out to the population. We have serious concerns about this. We would hope that there could be a simple, concise, straightforward consent form which indicates the proper information for people faced with the issue of whether to receive the vaccine.

I might add one further note. When that confusing statement in the introduction to the consent form was read earlier, I think it was Dr. Cooper who stated, well, what they intend to say is the women should ask their physicians. We would think that was a very important bit of information. That is just the sort of information that should be in a consent form and pregnant women should be told to ask their physicians first. That would be a crucial bit of information we would ask be added.

[Ms. Greenberger's prepared statement and exhibits follow:]

STATEMENT OF MARCIA GREENBERGER, ATTORNEY, AND SUSAN MARKS, LAW STUDENT INTERN, WOMEN'S RIGHTS PROJECT, CENTER FOR LAW AND SOCIAL POLICY

I am an attorney with the Women's Rights Project of the Center for Law and Social Policy, a public interest law firm located in Washington, D.C. Ms. Marks is a law student intern with the Women's Rights Project. Our Project is concerned with a wide range of issues affecting women, but has a particular focus on women's health needs.

We appreciate the opportunity to appear before you today to discuss the consent procedures to be used in the Swine Flu Vaccine Program.

STATUTORY REQUIREMENT OF INFORMED CONSENT

Section 2(j) (1) (F) of the National Swine Flu Immunization Program of 1976, Pub. Law 94-380 (August 12, 1976) ("the Act"), requires that a written informed consent form and procedures be developed and implemented to assure that the risks and benefits from the swine flu vaccine be fully explained to each individual to whom the vaccine is administered.

The Act properly recognizes the right of every individual to be fully informed before agreeing to the vaccine, and the obligation of the government to provide such information. We are concerned, however, that the government is not meeting its responsibilities as clearly set forth in the Act.

THE CONSENT FORMS DEVELOPED ΤΟ DATE ARE

1. The Original Forms

SERIOUSLY INADEQUATE

The government developed forms, dated July 15, 1976, apparently intended to serve as the consent forms required by the Act. The forms are attached hereto as Exhibit A. These forms, one for the monovalent vaccine and one for the bivalent vaccine, not only fail to fully explain the risks and benefits of the vaccine as required by the Act, but are actually affirmatively misleading in the information they do present.

First, the form states: "In contrast with some other vaccines, flu vaccine can be taken safely during pregnancy." There can be no question that this statement is not supported by the present available scientific knowledge.

There have been no tests to determine the safety of the swine flu vaccine either for the pregnant woman or her unborn fetus. Further, there have been no studies of the long-term effect of any vaccine on the children, and no conclusive studies on the effect on the fetus. Finally, there have been no studies on the effect of any vaccine on subsequent fertility of the woman.1

In the face of this absence of knowledge, it is hardly correct to boldly assert, as does the government's form, that the flu vaccine can be taken safely during pregnancy.

There are other serious problems with the form as well. It gives no information concerning the likelihood of a swine flu epidemic. It gives no explanation of who should take the monovalent or bivalent vaccine. It gives no information concerning the recovery rights against the government if injured by the vaccine. And, the form fails to give the impression that it is in fact an informed consent form. The section to be signed by the vaccine recipient is termed a "Registration Form," not a consent form. Vaccine recipients could easily believe that they are not giving informed consent by signing the form.

2. The Additional Statement

After review of this form by the National Commission for the Protection of Human Subjects of Biomedical and Behaviorial Research, as required by the Act, several of these flaws in the government's form were outlined. The government's response to the Commission's suggestions was to supplement the form with an additional one page statement, attached hereto as Exhibit B.

This statement explains that it is possible that there could be an epidemic this winter though "no one can say for sure." It briefly explains who should get the bivalent vaccine. It gives information concerning the filing of claims against the government.

It also addresses the issue of vaccination during pregnancy and quotes the Advisory Committee's statement that:

There are no data specifically to contraindicate vaccination with the available killed virus vaccine in pregnancy. Women who are pregnant should be considered as having essentially the same balance of benefits and risks regarding infiuenza vaccination and influenza as the general population.

There are obvious problems with the adequacy of this statement on the vaccine during pregnancy. First, it is certainly not written in lay terms, using language easily understood by the general public. Second, it gives no information whatsoever concerning risks to the fetus. And third, it does not explain the crucial fact that the lack of data specifically contraindicating vaccination during pregnancy is due to the lack of any studies which show either the indications or contraindications during pregnancy.

However, not only is the substance of this additional statement troublesome with regard to pregnancy, but the placement of the information in a second page raises serious problems as well. Because information appears on two separate pages, it is difficult for the vaccine recipient to follow or to synthesize. In addition, nowhere does the signature page, termed the "Registration Form," indicate that the information in the supplemental page should also be read. Finally, there is no deletion of the incorrect statement that the swine flu vaccine is safe to be taken during pregnancy.

As a result, women will be given a technical and confusing statement concerning the absence of data showing contraindications to be followed by the clear statement in lay terms that the vaccine is safe when taken during pregnancy. In short, in no meaningful way has the misleading statement in the first sheet concerning pregnancy been corrected.

OTHER INFORMATION BEING SENT OUT BY GOVERNMENT IS MISLEADING

Compounding the problem of the inadequate consent form is the fact that the government has and continues to send misleading information to the public. For example, the Food and Drug Administration ("FDA") has prepared a Consumer Memo on the Swine Flu Vaccine, attached hereto as Exhibit C. This Memo was distributed just a few days ago, on Wednesday, September 8, 1976, to

In contrast, it is known that high fever in pregnant women can cause damage to the fetus.