Statement of Samuel L. Katz, MD
Professor Emeritus, Department of Pediatrics
Duke University Medical Center

Representing The Infectious Diseases Society of America, The Pediatric Infectious Diseases Society, And the American Academy of Pediatrics

Good morning.

My name is Dr. Samuel Katz. I've been asked to talk to you this morning to represent the perspective of the American Academy of Pediatrics, the Infectious

Diseases Society of America, and the Pediatric Infectious Diseases Society. The American Academy of Pediatrics represents over 55,000 pediatricians in the United States and the Infectious Diseases Society and the Pediatric Infectious Diseases Societies are the professional societies of infectious diseases researchers, clinicians and public health professionals in the United States. These two societies have a combined membership of over 6,000 infectious disease specialists. I've also been asked to speak with you this morning since I was the Chair of the Advisory Committee on Immunization Practices (ACIP) for eight years. Indeed, I was the Chair in 1991 at the time that the Committee recommended to the Director of the CDC and the Assistant Secretary for Health that hepatitis B vaccine be added to the childhood immunization schedule to reduce the morbidity and mortality of hepatitis B infection, a serious infection that could be safely and effectively prevented with this vaccine. In addition, I was asked to speak with you this morning because I have been personally involved as a practicing pediatrician and in immunization research, development and policy for over 40 years. I am also a father and a grandfather whose eight grandchildren (ages 2 months to 4 years) have all received the hepatitis B vaccine. I fully recognize, as does this Committee, that the deliberations and recommendations that come from Committees like this, as well as those on which I have served, are not merely interesting discussions but will eventually affect every child in the United States — including my own. We all keep pictures of these youngsters in our mind's eye every day as we make our decisions and recommendations, and as we monitor the impact that these decisions have.

During this time, I have had the honor and good fortune to serve this country, in regard to immunization issues, in a number of ways. I have served on a number of committees that study, review, and formulate vaccine research and immunization recommendations. These committees have been convened by the Institute of Medicine (IOM), the National Academy of Sciences (NAS), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the World Health Organization (WHO). In addition, I am currently a member of the Advisory Committee on Childhood Vaccines. This committee brings together people with a wide range of backgrounds, from parents to immunization scientists, to assure that the vaccines we provide for our children continue to be as safe and effective as possible. In the rare instances where children are injured by vaccines, this Committee assures that they and their families are appropriately compensated.

I am also the co-chair, along with Dr. Louis Sullivan, of a special project of the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society. Dr. Sullivan, as you may know, is the president of Morehouse School of Medicine and a former Secretary of the Department of Health and Human Services. This project — the Vaccine Initiative — was undertaken to help effectively address the types of questions that your committee is asking today. Those of us working to protect our children's health recognize the need to ensure that parents and health care providers are able to make fully-informed decisions regarding vaccines. We want parents and providers to have the best information that modern science has to offer. If emotion plays a disproportionate role in making decisions about the use of a vaccine, those decisions are less than fully informed. Yes, vaccines and "shots" can cause minor reactions — and in extremely rare cases, serious reactions. However, it is important to remember, that in the vast, vast majority of cases, vaccines bring considerable health benefits.

As a parent, grandparent, and physician, I feel great sympathy for the people who testified on the first panel. I wish we could find the true causes for serious, complicated, and often vexing medical conditions such as multiple sclerosis and autism. But the fact is, there are no scientifically sound studies that demonstrate current immunization recommendations are a cause of autism, diabetes, asthma, inflammatory bowel diseases, SIDS, multiple sclerosis, or any number of acute or chronic illnesses. If a vaccine were shown to be a cause of such medical conditions, you can rest assured that we, as the physicians who care for the nation's infants and children, would be the first to raise the questions. Rather, as a pediatrician who has been seeing patients since 1955, I can tell you that vaccines are among our most effective medical tools. Were it not for the widespread use of vaccines in this country, we would have a far greater number of infant and childhood deaths. We would also have many, many children suffering from the painful, chronic, and often crippling effects of infections caused by meningitis, polio, diphtheria, measles, pertussis, and congenital rubella.

In speaking on behalf of the pediatricians of this country, they asked that I remind you that their principal and guiding interest is to guarantee the health and well-being of the children for whom they have the privilege of caring. It is our mission to ensure that scientifically accurate, unbiased information goes into important decisions that protect the health of our children and our communities. With that, I would also like to mention that I have included a letter to the Committee from Dr. Joel Alpert, President of the American Academy of Pediatrics, as part of my written testimony.

Hepatitis B infection is often a silent infection that emerges years later in the form of chronic liver disease, cirrhosis and cancer. As the World Health Organization has noted in a letter to the Committee, the hepatitis B vaccine, given to hundreds of millions of people in 100 countries around the world, has been more than 90% effective in preventing acute and chronic disease. In a study published in the New England Journal of Medicine in 1997, the use of this vaccine in Taiwan was shown to be responsible for a remarkable downward trend in liver cancer. Hepatitis B vaccine is truly our first anti-cancer vaccine. It is also important that you are aware of another study in the New England Journal of Medicine that was published in March of this year. This study documented an increase in liver cancer in the United States, especially in communities of color, largely attributed to hepatitis B and hepatitis C virus infections. This highlights the importance of using hepatitis B vaccine to protect the next generation. Finally, it is critical to recognize that hepatitis B infection is not simply a "lifestyle" infection. In fact, in at least one-third of people infected with this virus, the source of infection is completely unknown! As you have heard this morning there are many people with hepatitis B, including parents of children with hepatitis B, who would give anything to wind the clock back so they could have taken advantage of the protection this vaccine offers.

Making recommendations: ACIP, AAP, AAFP, and others

The Advisory Committee on Immunization Practices (ACIP) is an Advisory Committee assembled to provide expert advice. Its voting members, appointed by the Secretary of the Department of Health and Human Services, are physicians, researchers and other experts in immunization selected for their expertise in a wide array of fields relevant to the evaluation of immunologic, clinical, and epidemiologic data, including vaccine clinical trials. For the most part, these experts come from academia and from State and local health departments. Their advice and recommendations are considered by the Director of the CDC who has final discretion to accept or reject recommendations.

Further, the ACIP is not the sole group of experts that reviews immunization data and formulates immunization recommendations. Depending on the vaccine in question and the population for which it is intended, other groups including the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians, have a similar, yet independent process. Each organization selects expert panels to review and make independent recommendations. In addition to the AAP, many of those groups are represented here today. Even though there wasn't time for you to hear from them during today's hearings, I urge you to talk with them after the hearing.

In addition, when relevant, as with the case of hepatitis B vaccine, many other groups, such as the National Multiple Sclerosis Society and the International Federation of Multiple Sclerosis Societies undertake an independent review of the data to provide their constituents with the best information that will affect their health. I can think of no group who would like to find a cause for multiple sclerosis more than the National MS Society. It is therefore noteworthy that their Scientific Advisory Board has reviewed the hypothesis of a causal association between hepatitis B vaccine and multiple sclerosis and has rejected it. The cause of multiple sclerosis remains unknown.

The ACIP process

The ACIP does not make hasty decisions. The Committee's review of information about hepatitis B vaccine demonstrates this quite clearly. Since the early 1980s, the ACIP has been considering and routinely evaluating appropriate recommendations for the use of hepatitis B vaccine. The Committee asked the CDC's Hepatitis Branch to prepare a draft update statement on hepatitis B vaccine. This statement addressed the issues of: 1) the overall trends of use of hepatitis B vaccine to date; 2) the evidence of safety and effectiveness of the recombinant DNA vaccine; 3) the need for booster doses; 4) indications for testing for antibody status after vaccination; 5) safety of new and old vaccines; and, 6) a strategy for perinatal testing. Over the next several meetings, each of these issues was discussed in order to advise the Director of CDC on these issues. Beginning in October of 1990 the Committee began to discuss strategies toward improved hepatitis B virus control. The early discussion focused around the prevention of perinatal transmission and universal immunization for infants in high risk populations (e.g., Alaska, Native American communities). In February 1991, the Committee voted 8-0 in favor of including hepatitis B vaccine as part of the current immunization program. Following the review of the draft ACIP statement in June 1991 the committee voted, again unanimously, for universal infant immunization and the immunization of adolescents "until the impact of universal immunization is felt."

It is worth highlighting that all recommendations resulted from an exhaustive and comprehensive expert review of the available information. There are no voting members of the Committee from any Government agency and no voting members from any vaccine manufacturer. Committee members with any perceived conflict of interest (e.g., the principal investigator or participant in a vaccine trial supported by a vaccine manufacturer) are prohibited from casting a vote on any question involving a vaccine manufactured by a company with which they have such a relationship.

Informed decision-making, parental choice, individual health and community health.

While the ACIP provides recommendations to the CDC Director, decisions about the health of the citizens of the United States are made at the State level and not enacted "nationally." Each state's legislature and governor, along with its respective public health advisory groups must reach its own conclusions about whether to adopt and how to implement each recommendation. It is quite appropriate that these decisions are made in each state by those best situated to judge what is best for their community.

As I mentioned before, the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society have embarked on a special project that is designed to address concerns that patients are discussing with their doctors about immunizations. As a necessary first step, we have gone out to listen to what parents think about when it comes to their children's immunizations. We currently have a national survey in the field of parents of young children. With results expected shortly, I would like to share with you this morning what we have learned from focus groups of parents that we have conducted across the country over the past three months on this issue. Not surprisingly, the vast majority of parents agreed that they should be allowed to make choices about the decision to immunize their children. However, when asked if they would want to send their children to schools where all parents had that same choice, their near-universal response was one of concern about the health and safety of that school. Some parents worried that in such settings diseases might circulate that could possibly overwhelm the protection provided by immunization. In fact, several parents recognized that immunization is just one of many things that we do as a society to assure the health and safety of our children, our neighbors and our communities. How would we feel about the safety of our roads if stopping at a stop sign were optional?

We all recognize the role and value that the introduction of informed consent has had on medical research and on medical practice. In every field of medicine this has been a central point of discussion with patients and parents about benefits and risks of medical interventions and procedures. However, the concept of informed consent has limitations when it comes to preventing epidemics in our communities. In the late 1960s and early 1970s, despite the availability of a safe and effective measles vaccine, we continued to experience regular epidemics of measles. These outbreaks led to school closings and other disruptions in the normal functioning of communities. One of the reasons that these outbreaks occurred was individual discretion in the use of the vaccine. Left to individual choice we were only able to achieve utilization rates of 60-70% in most communities. For measles, a 60-70% coverage rate will not provide sufficient "community immunity" to dampen an outbreak.

Fortunately, an effective public health tool exists for increasing the coverage rate to a level that virtually eliminates epidemics. That tool is universal vaccine use among infants and children to ensure that they are protected. I can assure you, based on experience in communities in the United States as well as the experiences reported from other countries, that unless we continue to achieve high levels of immunization coverage, terrible diseases will return — some in epidemic form and some, like hepatitis B, that won't fully emerge until after infection, in the form of chronic liver disease, cirrhosis and liver cancer. If that occurs I can also assure you that many people will suffer unnecessarily and die prematurely from these diseases. This has been seen in other countries when immunization programs were halted. Frankly, we would all like to avoid being invited to a future Congressional subcommittee hearing to explain why we failed to rely on the best that science had to offer and act appropriately.

Conclusion

Let me offer a few concluding remarks to help you put all that you hear today into proper perspective. As noted in some of the fliers about this hearing and the events surrounding it, some are calling for a "full investigation." If, as an outcome of these hearings, this is what you decide, let me suggest what you are likely to find.

First, vaccine safety is not a "new issue." Even before this hearing was called, the federal government, state governments, academic institutions, and vaccine manufacturers had been and continue to be involved in a wide range of programs and activities designed specifically to ensure that the vaccines that we provide to children, adolescents and adults are held to the highest standards of safety and efficacy. You will find that there exists a robust system of checks and balances that monitors the safety and efficacy of our vaccines. These efforts are designed to assure that our recommendations about immunization practices and procedures reflect the best available science.

Second, you will find that the immunization community — the public and private sector and academia — has been alert and responsive to vaccine safety needs. For example, when we recognized the need to improve the safety of the whole cell pertussis vaccine, we focused our collective efforts to thoroughly investigate, and then license, an acellular pertussis vaccine. The new vaccine, which has largely replaced the earlier generation whole cell pertussis vaccine, has resulted in a significant decrease in actual, as well as reported, adverse events. A similar result has happened with polio vaccine with the adoption of new recommendations that move away from the live virus oral polio vaccine in an effort to further reduce the occurrence of vaccine-associated paralytic poliomyelitis. These two examples illustrate the responsiveness of the entire immunization community when it comes to vaccine safety.

You will find that the Department of Health and Human Services recently published the report of the Congressionally-mandated Task Force on Safer Childhood Vaccines. This report, presented to a number of advisory committees and available on the Web, describes the vast network of current vaccine safety activities. These activities ranging from basic science, through clinical trials, to licensure and use, result in the superb quality of the U.S. immunization program. The report also made recommendations to further strengthen this program.

You will find that the National Vaccine Advisory Committee and the ACCV, committees with broad representation — including the voices and views of consumers — has had a long-standing subcommittee on Vaccine Safety. Your investigation will also find that these and many other questions have been brought before independent committees of the Institute of Medicine for their review. There have been many IOM vaccine safety studies, meetings, and workshops. Two important reports from the IOM have reviewed the existing safety data on childhood vaccines. While each report has pointed to the need for ongoing research, they both have concluded, from all types of evidence, that serious adverse events are extremely rare. As I have already mentioned, there were no substantive data to support the linkage of vaccines to a variety of chronic medical or autoimmune conditions.

Third, there is absolutely no need to set aside special funds for independent vaccine safety research. There is already a structure in place for the scientific investigation of vaccine safety research questions. As you must know the National Institutes of Health, the premier biomedical research organization in the world, is already charged with that mission. Congress relies on NIH to set the standards necessary to assure that tax-payer dollars go to those scientists and organizations who know how to pose research questions and have the ability to address them. If your Committee concludes that our existing well-established and highly-regarded processes and structures of scientific peer-review are not the most effective for addressing vaccine safety science, you will be embarking on a slippery slope. I see at least three serious problems with such a consideration.

First, you will need to create a new system and infrastructure to allocate these special funds. How will you assure taxpayers that your new system is an effective and cost-efficient use of tax dollars? Who will establish the scientific criteria and guidelines for evaluating proposals? You should realize that those who seek these special funds are likely to be those whose research proposals were unsuccessful in meeting the criteria of current NIH study sections.

Second, any researchers who receive these special funds will, by virtue of accepting the funding, become government-sponsored researchers, therefore raising the question of what is an "independent researcher?"

Third, you will ultimately end up with more government, not less.

In closing, I welcome the opportunity to speak with you today and am glad to see that you too are concerned about the safety of our vaccines. As a result of these discussions, I hope that you will become convinced, as I have over my many years in this field, that the vaccines that we give to our children and grandchildren are carefully scrutinized at every step in the process — from development to production to use in the population. This system, the best in the world, assures that our vaccines are held to the highest safety standards, and are effectively preventing serious, often life-threatening infections.