Testimony Of Samuel L. Katz, Md,
Professor Emeritus, Department Of Pediatrics
Duke University Medical Center
Representing The American Academy Of Pediatrics And Infectious Disease Society Of America
Good afternoon, Mr. Chairman. I am Dr. Samuel L. Katz, a pediatrician from Duke University in Durham, North Carolina. I am a professor emeritus of pediatrics and have been involved in immunization research and development, patient care, teaching and policy for over 40 years.
During this time, I have served on a number of national and international committees that study, review, and formulate vaccine research and immunization recommendations. These include 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), the National Vaccine Advisory Committee (NVAC), the Advisory Commission on Childhood Vaccines (ACCV), the National Institutes of Health (NIH) and the World Health Organization (WHO).
I am also a father and grandfather whose eight grandchildren (ages 5 months to 4 years) have all received their recommended childhood immunizations. I fully recognize, as does this Committee, that the deliberations and recommendations that come from Committees such as this, as well as those on which I have served, are not merely interesting discussions but will eventually affect every child and grandchild in the United States including my own. We all keep pictures of these children in our mind's eye every day as we care for our children, as we make our decisions and recommendations, and as we monitor the impact that these decisions have on our communities.
Today, I am here representing the American Academy of Pediatrics and the Infectious Diseases Society of America. The American Academy of Pediatrics represents over 55,000 pediatricians. Its mission and guiding interest is to guarantee the health and wellbeing of the infants, children and adolescents for whom pediatricians have the privilege of caring.
The Infectious Diseases Society of America (IDSA) is the professional society of infectious disease researchers, clinicians, teachers and public health professionals with a membership of over 5000 infectious disease specialists.
Immunization is the single intervention that has most dramatically reduced childhood morbidity and mortality. In our lifetime it has led to longer, healthier and happier lives. No longer do parents live in fear that their children will develop life-threatening paralysis from polio when they are at a swimming pool or the movie theater in the summer. No longer is a child with a fever in a day care center the harbinger of an outbreak of fatal bacterial meningitis with the well- documented chronic debilitating effects of seizures, deafness and mental retardation in up to one-third of the survivors. No longer are respirators standing by as a child, suffocating with the glue-like secretions of whooping cough, is brought to the emergency room late at night with his or her anxious parents trembling in a comer of the waiting room. We have entered a new era thanks to the development and widespread use of modem vaccines. Immunizations have reduced by more than 95 to 99 percent the vaccine- preventable infectious diseases in this country although the causative agents (except for smallpox) persist in epidemic or endemic burdens elsewhere in the world.
Limits of Effectiveness and Safety
We also know that despite all that vaccines have done to improve the health of individuals and communities in the United States and around the world, they are not perfect. However, the benefits of immunizations far outweigh any possible risks.
Our current level of protection is remarkable. It is a function of two things: the performance of the vaccines and their use broadly in the population, the latter largely a function of the increasing importance that most parents and all clinicians place on protecting children from diseases that are easily prevented with vaccines.
We know too well that the level of protection that we have now established in our children and our communities is a fragile one that depends on what we refer to as community or "herd" immunity. From the standpoint of effectiveness, modem childhood vaccines are approximately 90 - 95% effective. What that means is that for every 20 children who are vaccinated one or two may not develop a sufficient immune response. It cannot be assured that these children will be protected from the virus or bacteria should they encounter it at school, at a playground, at a shopping mall, or at their church day care. However, if sufficient numbers of children in a community are immunized, the vaccinated ones protect the unprotected by effectively stopping the chain of transmission in its tracks and drastically lowering the probability that the susceptible child will encounter the bacteria or virus.
As long as the great majority of children receive their vaccines, we will be able to maintain our current level of disease control. However, should the level of community protection drop to the point where the viruses and bacteria travel unimpeded from person to-person, from school-to-school, and from community-to-community, we instantly return to a past era when epidemics were an accepted part of life. We experienced that just a decade ago (1989-91) with the resurgence of measles. There were 55,622 reported cases mainly in children less than 5 years of age, more than 11,000 hospitalizations and 125 deaths.
Because of the quality of our vaccines and our diligence in carrying out immunization policies, the US is the envy of the world with regard to the control of childhood infectious diseases. I have included a table from a recent edition of the CDC's MMWR that shows the power of vaccines and demonstrates quite clearly the full impact of vaccines today, compared with the prevaccination era. (MMWR, April 2, 1999).
Balancing Public Health and Safety with Personal Freedom of Choice
Personal freedom of choice must be examined in perspective. As framed in this hearing, on one side of the equation is "insuring a person's freedom" to make decisions while the other is "public health and safety." In this context, personal freedom of choice implies the decision of parents choosing not to immunize their children. Given such a "choice" we must acknowledge that this increases the potential for harm to other children who, fora variety of reasons, are either not able to be vaccinated (they may be too young or too ill) or who were vaccinated but in whom-the vaccine did not provide the expected protection. A recent article in the Journal of the American Medical Association (copy attached) found that, on average, those who chose to exempt from immunizations ran a 35 fold greater risk of contracting measles compared to those who had been immunized. This important paper also demonstrates that disease that occurs more commonly in the exemptors has the ability to initiate and propagate an outbreak in the community at large.
Compulsory vaccination laws in the United States have repeatedly been upheld as a reasonable exercise of the state's compelling interest even in the absence of an epidemic or even a single case. As the U.S. Supreme Court held in 1905 in the case Jacobson vs. Massachusetts:
"...in every well-ordered society charged with the duty of conserving the safety of its members the rights of the individuals in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations as the safety of the general public may demand, ..the liberty secured by the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good .... (Liberty) is only freedom from restraint under conditions essential to the equal enjoyment of the same right by others."
Understanding and Communicating Risk
Mr. Chairman, we did not get where we are today by accident. 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. Left to individual choice we were only able to achieve utilization rates of 60 - 70% in most communities. A 60 -70% coverage rate for measles did not and will not provide sufficient "community immunity" to dampen an outbreak. States without school immunizations requirements had incidence rates for measles significantly higher than states with these requirements. Recognizing these data other states, not the federal government, quickly adopted similar requirements. These requirements are supported by the American Academy of Pediatrics. The results are striking. Before we had a measles vaccine an estimated one-half million cases of measles was reported each year. Last year there were 89 cases of measles in the United States with no measles associated deaths. Most counties in the U.S. were free of measles. However, we have learned that nearly all of the cases of measles that did occur in the U.S. were imported from other countries. This would not have been possible without the "school exclusion" statutes that now exist in every state. While we hear dramatic stories of exotic diseases that are just a plane ride away, the importation of vaccine preventable diseases into a susceptible population is much more frightening. Should we allow our community immunity to wane, we will negate all the progress we have made and allow our communities to be at risk from threats that are easily prevented.
As a parent, grandparent, and physician, I feel great sympathy for those unfortunate few who are harmed as a consequence of immunization. Though we recognize these reactions are rare, virtually every time a pediatrician or clinician advises a patient on the benefits to be derived from vaccines in preventing disease in individuals and in the community and about the risks of those vaccines, he or she acknowledges that there is a very remote chance of an adverse reaction to the vaccine. We know all too well that these rare events are not statistics but are real people our patients. We also know that our patients, if not protected by immunizations, could easily contract a severe, possibly life-threatening disease that could threaten their well-being and prospects for a healthy future.
While we take risks every day in everything that we do, when it comes to immunization, we also know our vaccines are one of the safest forms of medicine ever developed. Few would argue that vaccines must be held to the highest standards of safety, barring none.
Immunization is not like most other aspects of medical practice as it has a clear community benefit in addition to its benefit to the individual patients. An individual's "freedom" to ignore a stop sign while driving, pollute the environment, or spread disease does not ultimately serve the good of freedom.
Vaccine Adverse Events Reporting System
Ongoing vaccine safety efforts and continuous monitoring of potential adverse events from vaccinations are crucial to our nation's childhood immunization program so that we can make our safe vaccines even safer.
The Vaccine Adverse Events Reporting System (VAERS) was established by the Department of Health and Human Services in 1990 to receive and compile all reports of adverse reactions that may be associated with vaccines. Operated by both the Food and Drug Administration and the Centers for Disease Control and Prevention, reports to VAERS may be made by anyone, including private physicians, state/local public health clinics, other health care professionals, vaccine manufacturers, vaccine recipients, parents or legal guardians. This system collects data about all possible vaccine adverse events and although it is not known how many reactions may go unreported, research has shown that the more serious events are likely to be accounted for. However, the strength of VAERS as a "passive surveillance" system that collects and accepts any and all reports is also its potential weakness since it cannot take into account those serious health problems that may happen around the time of vaccinations coincidental events that are not related to vaccines. Children regularly experience conditions such as fevers and seizures regardless of when they are vaccinated.
Temporal Versus Causal Associations
The Academy and IDSA have monitored concerns about hepatitis B virus vaccine including some reports that a variety of illnesses have been caused by the hepatitis B virus vaccine. The scientific evidence does not support hypotheses that hepatitis B virus vaccines may have caused Sudden Infant Death Syndrome (SIDS), multiple sclerosis, autism or other demyelinating disorders. Although it is easy to understand how a family can believe that a vaccine caused the sudden, unexpected death of a child, the evidence is to the contrary. In fact, the progressive decline in the incidence of SIDS occurred during the introduction of routine hepatitis B virus vaccination for infants and there is no reason to hypothesize that this vaccine increases the risk of SIDS. Additional studies in individual states including Alaska and Hawaii where universal hepatitis B virus vaccination was first introduced in the mid 1980% indicated no increased risk of any serious medical conditions in infants who have received hepatitis B vaccination at birth. Thus the available scientific evidence indicates that there is no relationship between these unfortunate events and the hepatitis B virus vaccination.
We all want explanations for events that come unexpectedly and have no specific identifiable cause. Intense research has been conducted for many years into the cause of SIDS and we are making further advances in our understanding of it. While we sympathize with the parents of children who have died from SIDS, we should not assume that the vaccine necessarily causes events that occur in the hours, days or weeks following vaccination.
Whenever vaccines are administered, there is always the risk that coincidental illnesses, those that are known to occur at various ages, will occur and may be falsely attributed to the vaccine. During the late 1970% and early 1980% there was great concern about the possibility of SIDS being caused by pertussis-containing vaccines. It took several years and multiple carefully conducted studies to disprove this hypothesis. Although there are some cases of SIDS that occurred within two days after the DTP vaccination, the risk of SIDS in vaccinated children is lower than the risk for children who have not received the vaccine. The scientific evidence convincingly demonstrates that the DTP vaccination does not cause SIDS.
The National Vaccine Injury Compensation Program
Mr. Chairman, in the late 1970's until the mid-1980's this country faced a crisis in the availability of vaccines, brought about largely by an increase in litigation. In the 1970's, courts imposed liability on manufacturers of vaccines for failure to warn of side effects even when a vaccine was provided through clinics in a public program. In the early 1980's, allegations of injury from the pertussis component of the DTP vaccine led to the filing of approximately 300 lawsuits against this country's DTP manufacturers. In 1984, one of the three DTP producers stopped producing the vaccine and the others reported increasing difficulty in obtaining insurance and seriously considered withdrawing their DTP vaccines from the marketplace. Shortages of the vaccine occurred in several areas of the country and prices escalated dramatically.
Under the leadership of this Committee's Ranking Minority Member, Representative Waxman, Congress, with broad bipartisan support, enacted the National Childhood Vaccine Injury Compensation Act of 1986, which established a no-fault system of compensation for injuries or deaths reasonably associated with the administration of childhood vaccines. Unique under United States law, the compensation system is supported by a surcharge on each vaccine covered under the no-fault program.
Special Masters within the United States Court of Federal Claims administer it. A statutory Vaccine Injury Table (Table) which may be amended by administrative rule lists the compensable conditions covered on a per-vaccine basis and the time period after administration of the vaccine that the condition must have occurred in order for compensation to be available. If a person sustained the injury or other condition (or died) under circumstances that "fit" the Table, causation is established and compensation is awarded unless there is a preponderance of the evidence that the condition for which compensation is sought was caused by factors unrelated to the administration of the vaccine. This simplified showing is of enormous benefit to claimants because it requires much less proof than is necessary to succeed in a traditional court case. Opportunity is also provided for compensation for conditions "outside" the Table. In these instances, the claimant must demonstrate that the vaccine caused the injury, rather than rely on the Table to establish causation.
The law provides for the addition of new vaccines to the Vaccine Injury Table upon the occurrence of two events. First, the CDC must recommend to the Secretary of Health and Human Services that the vaccine be routinely administered to children. Second, Congress must enact an excise tax, or surcharge, on the vaccine, to support the compensation system. Once a new vaccine is included in the Table, all vaccine-related injuries (or deaths) that occurred 8 years or less prior to the vaccine's inclusion are covered under the compensation system.
Initially, the no-fault compensation program covered three childhood vaccines: polio, DTP and measles, mumps and rubella. Four vaccines, including the hepatitis B vaccine and the rotavirus vaccine, have been added. To date, over 100 petitions seeking compensation for injuries allegedly resulting from the administration of the hepatitis B vaccine have been filed. The rotavirus vaccine was added to the Vaccine Injury Table effective July 27, 1999.
There can be no doubt that the vaccine injury compensation program is an enormous success for the protection of our children. First, the DTP vaccine remained available to pediatricians and health clinics in the 1980s and this country avoided epidemics of pertussis (whooping cough) that have occurred in other developed nations. After a period of regression, in which several vaccine manufacturers abandoned the marketplace, new childhood vaccines have become available; this has had a direct benefit on the health of children in this country. For example, infants now receive a vaccine to prevent Hemophilus influenza type b (Hib) meningitis, one of the leading causes of death and mental retardation. Prior to the licensing of the first Hib vaccine in 1985 approximately 20,000 cases of Hib invasive disease occurred annually in children less then 5-years of age. Today, through the use of the Hib conjugate vaccine (licensed in 1987) this disease is virtually gone but will reappear if we do continue to be vigilant in vaccinating our children against this disease.
Many children have been fairly compensated under the no-fault law for injuries attributable to vaccines. To date 1,400 claims have resulted in compensation of over $1billion. Awards have ranged from only a few thousand dollars to $8 million. A little over 500 cases remain under review. While there can be legitimate criticism of a process that is much more complicated than its proponents expected, and while there will always be disagreement over the scientific basis for inclusion or exclusion of conditions under the Table, there can be little doubt that the law has protected the public health, stimulated vaccine research and production and provided reasonable compensation to hundreds of children.
Professional and Public Information
Physicians must and do regularly update their knowledge about specific vaccines and their use because information about the safety and efficacy of vaccines and recommendations relative to their administration continue to develop after a vaccine is licensed. Physicians as well as other health care professionals rely on the American Academy of Pediatrics' Red Book: Report of the Committee on Infectious Diseases, a definitive resource for the control of infectious diseases in children. In addition to the Red Book, statements developed by the American Academy of Pediatrics' Committee on Infectious Diseases and approved by the Academy are published in Pediatrics the Academy's peer-reviewed journal. The Morbidity and Mortality Weekly Report (MMWR) of the CDC contains current vaccine Advisory Committee on Immunization Practices (ACIP) recommendations and product specific official package inserts provide physicians with additional information. Moreover, we know that families are more likely to have their child immunized if they understand the comparative benefits and risks of immunizations and the consequences of diseases they prevent. To ensure that parents and other caregivers take advantage of the benefit of immunizations, particularly for preschool children, the American Academy of Pediatrics recommends that public education efforts on the importance of immunizations continue. To that end the American Academy of Pediatrics provides a variety of easy to read patient education materials such as the recently published brochure Immunizations.' What you Need to Know. This informative brochure covers the reasons why immunizations are so important, as well as the common misconceptions, success rates, and risks.
Mr. Chairman, 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 will 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. 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.
In addition, Mr. Chairman, there can be no doubt that the immunization community the public and private sectors 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 cellpertussis 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 the rare cases of vaccine-associated paralytic poliomyelitis. These two examples illustrate the responsiveness of the entire immunization community when it comes to vaccine safety.
Perhaps more timely, in the past several weeks, two "vaccine safety" issues have emerged involving the aggregate exposure to mercury from a preservative known as thimerosal, and concerns, still unproven, that a new vaccine against rotavirus diarrhea could be causing a bowel problem in some children.
The identification of these potential safety issues, their rapid review and the broad dissemination of interim guidelines to all immunization programs and practitioners, is yet another example that we have an early warning system in place that has the ability to detect and rapidly respond to new information. Of course, like any alarm system, the ideal is to assure that it does not misfire and works efficiently and effectively when it should. We must pay attention to this system to assure that it performs to the best of its ability. We need to do all that we can to assure that when a question of vaccine safety or effectiveness arises we have the capacity to find the answer and act accordingly in the public's interest.
In closing, I welcome the opportunity to speak with you today and I am gratified that members of this Committee 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, continues to improve as science expands with the clear goal that our vaccines are held to the highest safety standards, and are effectively preventing serious, often life-threatening infections.
Mr. Chairman, I appreciate this opportunity to present this statement will be pleased to answer any questions that you may have.