ASTHO Recommendation

18. HEW should develop a mechanism for involving national, State, and local medical societies in medical policymaking at an earlier stage.

19. The role of private medicine in such a program should be enhanced and encouraged.

Department Comment

The Department concurs. No national immunization program can succeed without the active participation of private medicine. Unfortunately, the cooperation and participation of private medicine in the swine flu program of 1976 was generally less than expected.

With respect to the decisions made during the swine flu program, national medical groups were represented on the Advisory Committee on Immunization Practices and through participation in national meetings held at the White House on March 24, 1976, and at the CDC on April 2, 1976. On a continuing basis the CDC attempts to involve medical societies through the Advisory Committee on Immunization Practices and other Departmental advisory committees. In addition, the general issue of the involvement of all elements of the health care delivery system in the decision-making process is being studied both retrospectively, with respect to the swine flu program, and prospectively, with respect to future immunization programs.

Mr. ROGERS. The committee will have to stand in recess for 10 minutes. I know that there are some of you who have to catch planes, and I apologize, but we are running behind schedule. We will try to get to you as soon as possible.

The committee stands in recess for 10 minutes.

[Brief recess.]

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

We will now have the testimony from the official health agencies, Dr. Douglas S. Lloyd, Connecticut Department of Health on behalf of the Association of State and Territorial Health Officials; Dr. William Elsea, Health Officer and Director of the Fulton County, Ga., Department of Health, on behalf of the National Association of County Health Officials; and Dr. Richard M. Biery, Director of Health, Kansas City, Mo., Director of Health, Kansas City, Mo., Department of Health, on behalf of the U.S. Conference of City Health Officers.

All of you are welcome. Your statements will be made part of the record, and at this point, we will hear from Dr. Lloyd.

STATEMENT OF DOUGLAS S. LLOYD, M.D., ON BEHALF OF THE ASSOCIATION OF STATE AND TERRITORIAL HEALTH OFFICIALS (ASTHO)

Dr. Lloyd. Thank you, Mr. Chairman.

My name is Dr. Douglas Seward Lloyd. I am Commissioner of Health for the State of Connecticut. I appear before you today representing the Association of State and Territorial Health Officers (ASTHO) to give testimony concerning the 1976-77 A/New Jersey-A/Victoria national influenza immunization programPublic Law 94-380.

The information contained herein represents the combined response of the State and Territorial Health Officers who participated in a nationwide survey conducted by ASTHO at the conclusion of the swine influenza program

ASTHO members were asked to characterize the way in which the decision to immunize the nation's population against the A/ New Jersey/76 virus was made. The vast majority felt that the decision was correct, given the facts available at the time, and not politically motivated. It was a mistake, however, to have the program announced by the President, as such endorsement prevented any later attempt to modify the program, and it cast a political overtone on the decision.

A major weakness of the decisionmaking process was the lack of input from State and local health departments. Opposition to the decision to launch the program should have been presented forthrightly at the time the decision was announced. The apparent HEW philosophy to "move forward at all costs," rather than to modify the program as problems developed, was another major weakness.

Of communication between the Center for Disease Control (CDC) and the States, the State and territorial health officials felt that all too often the press received information before the health officials I can relate a personal example of this particular situation, Mr. Chairman. When the conference call to halt the program was to come from CDC, local television camera crews had already been alerted through their news wires and were in my office filming me answering the phone. Their abilities with communications far exceeded the Federal capability to relay information concerning health expeditiously.

It was quickly found that conference calls cannot be used as a forum for discussion. It was often difficult, if not impossible, to find an appropriate person at CDC to answer questions when the pres

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sure for those answer were upon State and local officials and the data on which to base the answer were in Federal hands. Communication did improve as the program progressed, but never reached satisfactory levels.

On the issue of funding of the program, the answers were almost unanimous. There was a definite drain on State and local resources to administer and implement the program, so that other public health programs suffered from diversion of staff to the influenza program. In some States, there was no possibility to obtain additional State or local funds, since appropriating legislative bodies were not in session.

A cost analysis of Connecticut's program clearly demonstrated that municipal governments had to bear the brunt of the costs of the program. At 50 cents per dose for the vaccine and 13 cents per dose for its delivery, the Federal expenditure per inoculation was 63 cents. The Connecticut State Health Department added another 11 cents per dose. This brought the total expenditure by the Federal and State Governments to 74 cents per dose. On the average, a town in Connecticut which immunized 30,000 people spent an additional 73 cents per vaccination. There were no extra State or Federal moneys available to offset these costs to the towns.

Public information and public awareness efforts can be characterized as too little, too late and reactive after the fact rather than anticipatory. The national public information effort through the mass media was inadequate and did not really educate the public. Materials provided by CDC for local use were received too late to be of much value. Although the quality of materials was generally good, some were too technical for the general public. Professional education was almost totally lacking, but an interesting finding was that the public can appreciate basic data on relative risks. When ASTHO members were asked to comment on vaccines and supplies, the following answers were recorded: The Vaccine supply was adequate, only because the program was curtailed. The greatest problem encountered in implementation of the program was the late, delayed and fluctuating delivery of vaccines, which resulted in cancellation of clinics and strained credibility with the public and volunteers.

National campaigns should be as simple as possible; the complexity of immunization schedules and the use of four vaccines unnecessarily complicated the program. Jet injector guns were of inferior quality; the breakdown rate exceeded previous experience.

Perhaps the most controversial issue of the program centered about the informed consent procedures. The most typical problems voiced by respondents were as follows:

Frequent changes in the form added to the confusion surrounding the program and wasted large amounts of paper and money. No provisions were made for handling informed consent forms from those who do not have a written language, such as Indians, or speak a less common foreign language, the foreign translation of the form was generally poor.

Problems in form distribution were similar to those with vaccine distribution. Forms were designed by lawyers to fulfill liability problems and, accordingly, did not serve as a tool to inform or educate the vaccine recipients.

The form was too long and was not read or understood.

A major oversight in the planning and funding of this immunization program was the failure to provide for orderly recordkeeping systems. If we are to carry out public health service programs on a mass scale we must keep retrievable individual records of those served just as would be expected in routine medical delivery.

Because of CDC's inability to fund computerized data systems, Connecticut now has 1,700 lineal feet of 3 by 5 catalog cards which are yet to be alphabetized by hand. The result is difficulty in tracing consent records on individuals who have sued the Federal Government for vaccine reactions, and inability to conduct evaluations of these data which could expand our knowledge of flu vaccine.

Opinions of ASTHO members varied considerable when the question of relationships with private medicine was posed, but several points were universal. The program fared better in those locations where the relationship with private medicine was good. Like State and local health departments, private medicine in general was not included in the decisionmaking process. Private medicine never really understood the program or the rationale behind it. There was little discussion of the medical issues in the medical journals. Lack of a position on the program by the American Medical Association, we felt, also detracted from the support of the program by private medicine. Problems with vaccine distribution and the lack of availability of vaccine through normal commercial channels particularly irritated the private medical community.

All but one respondent felt that Federal public health advisers and Epidemic Intelligence Service Officers employed by CDC and assigned to the States were invaluable in the planning, coordination, and implementation of the program.

Medical complications were the issue that led to the final demise of the program. Health professionals were extremely critical in this area. The general feeling was that more advance warning on the possibility of coincidental mortality was needed. The media were at times overly negative in reporting deaths and complications because they had not been previously desensitized. CDC handled the Guillian-Barre Syndrome issue well. However, unfortunately, knowledge that this syndrome may follow other immunizations may detract from future immunization programs. CDC could have provided more information to the States regarding the complications and deaths.

Finally, on the question of the clinical trails of the vaccine, the information was thought by some to be misleading and overly optimistic. Data provided to the States did not entirely support the recommendations. Most, however, felt the data were adequate but were not shared sufficiently early.

The recommendations were:

One: State health departments should have input at two levels, that is, policy decisions and implementation decisions, in any future program.

Two: There should be a rational, detailed discussion of the medical facts bearing on the decisions in the medical press.

Three: There should be a clearly delineated focal point within HEW for such a program, rather than a variety of leaders.

Four: Immunization programs should be aimed at high-risk groups, not at the total population of the country.

Five: All State health departments should have teletype or reactive computer terminal capability in order to receive rapid communication from CDC.

Six: More teletype and postal communications should emanate from CDC; all telephonic communications should be followed by written confirmation.

Seven: CDC should develop a mechanism to obtain input from State and local health departments.

Eight: If CDC is going to use its regional offices to transmit or handle requests for information, such offices need to be better informed.

Nine: When considerable amounts of State and local resources will be required for such a program, the program should not be hailed as a Federal program.

Ten: An estimate of State and local costs should be considered in the initial decisionmaking process.

Eleven: Funds should be made available for State and local public information efforts, since these were generally more effective than the Federal efforts.

Twelve: The public should be provided at the start of a program with information on potential side effects.

Thirteen: More realistic dates for vaccine delivery should be given with recognition that delays will occur.

Fourteen: Normal distribution channels should be used for vaccine, with availability through commercial outlets, where possible. Fifteen: Immunization schedules should be kept simple.

Sixteen: HEW should develop a national policy on informed consent with substantial planning around the issue of informed consent before the next program requires immediate action.

Seventeen: Input on form preparation should be obtained from public health professionals and lay persons.

Eighteen: HEW should develop a mechanism for involving national, State, and local medical societies in medical policymaking at an earlier stage.

Nineteen: The role of private medicine in such a program should be enhanced and encouraged.

Twenty: More publication of clinical trials data is needed in medical journals.

Almost all of these criticisms and recommendations bear on CDC's handling of this program. This is inevitable, given CDC's key role in coordinating the program and communicating with the States. The State health officers do not mean to impugn CDC. On the contrary, the Center is held in high regard as an indispensable source of aid and expertise in preventive medicine, especially in communicable disease control. It is, in fact, the Federal agency most adept at providing public health services, working through State and local health departments. Our hope is that through CDC the Federal capability to pursue all sorts of preventive medical programs on a mass scale may be refined and expanded.

If one were asked to make an overall assessment or draw conclusions from the multitude of responses from the health department heads throughout the country, the following would be the product: