The people vs. VAPP: parents can make a difference.
At the doctor's office, parents hold their children and suffer right along with them through the normal battery of vaccinations, consoled by the thought that they are ultimately protecting them from unnecessary illness. The availability and potency of OPV in the form of drops replaced the IPV type, sparing children a moment of pain from an injection.
"We all go through this guilt, feeling like, `What have I done? I held my child while the doctor gave him polio.' As an organization, we recognize that our mission is to move toward an all-IPV schedule so that we can completely remove any risk of VAPP. (Currently, the CDC recommends the sequential vaccine schedule, but also allows doctors and parents to chose an all-OPV or all-IPV schedule.) It is too late for our children, but we can save others from having to go through the same thing. For ourselves, we parents have benefited from networking and supporting each other, and learning to give up the guilt," says Mr. Salamone acknowledging the role that IPAV has played.
In the group's "Family Meeting," held last March in Washington, D.C., families and individuals dealing with the effects of VAPP gathered together to empower and educate themselves, the medical community, and the public. "This is the first time these families have gathered. They evaluated what has been accomplished and what still needs to be done. Since more physic, tans have been using the `mixed' vaccine schedule recommended by the CDC, there has been a study which indicates that acceptance of the new recommendations among healthcare professionals has increased," states Mr. Salamone. In its statement recommending the new vaccine schedule in September, 1996, the CDC estimated that the occurrence of VAPP would decrease by 50 to 75 percent after it was put into practice. While the mixed schedule is beneficial for most children, parents are advised by the CDC to discuss all vaccination options thoroughly with their child's physician, as an all-IPV or all-OPV schedule may be necessary (and is also acceptable), depending upon the case.
"Our group has accomplished a great deal. This was not done single-handedly, however; but with the CDC in the spirit cooperation." But IPAV's fight is not over. Cases of VAPP continue to occur in which parents were not informed of their choice of vaccine schedules. In their continuing function as a watch dog organization, IPAV has filed a citizen's petition with the Food and Drug Administration's (FDA) Advisory Committee on Vaccines and Related Biological Products asking that a "black box" warning label be printed on the OPV packaging.
"The propose of the boxed warning," explains Mr. Salamone, "is to remind doctors who see the OPV bottle to discuss with parents the risks that can be associated, albeit small, with this vaccine so that together, they may make an informed choice." IPAV is conducting a letter-writing campaign to the FDA and Congress. Members of the group appeared before the FDA Committee in May to give testimony. The Committee, made up of physicians, scientists, and citizens, is charged with hearing arguments and will then be making a recommendation to the FDA.
"...People who have lives"
Katherine Edwards, M.D. is professor of pediatrics at Vanderbilt University, Nashville, Tennessee, and is a member of the FDA Committee. "We all share the concern about each case of VAPP. The IPAV parents' appearance before the committee was very important in putting a voice and a face on this problem. They made an impact on the deliberations. I've learned from them and so has the Committee." Referring to the statistically small number of VAPP cases, (approximately eight to ten) which are reported each year, Dr. Edwards comments, "Those individuals who contract VAPP each year are people who have lives." In drawing the Committee's attention to cases that are still occurring where the parents were not informed of their choice, IPAV has provoked praise as well as action. Dr. Edwards says, "IPAV has accomplished so much, even though they may feel frustrated at the moment. The change is coming."
Dr. Edwards voiced an opinion shared by most of the Committee when she found the use of a warning label to be insufficient. "I do not think that the `black box' warning label is the way to go. Most doctors don't read them, they get their information from other sources. A package insert or a label is not the way, telling the stories of those parents is. The best way to change behavior is to educate. Both physicians and parents must know the risks and benefits so physicians may deliver the safest vaccine available for the child."
She envisions including various topics relating to VAPP, as well as having IPAV members relate their experiences, circulate their informational literature and parents' fact sheet in educational forums and lectures, like those given by medical professional organizations such as the American Academy of Pediatrics (AAP).
John Livingood, M.D. is the director of Epidemiology and Surveillance at the National Immunization Program of the CDC and a member of the FDA Committee. "Use of IPV has gone up," Dr. Livingood reports, noting that between 60 and 75 percent of pediatricians have responded to the new recommendation. He says the Committee wants to increase that number. "The difficult task is still before us, but it must be done. The vaccine information and recommended schedule of sequential vaccines are clearly stated in the literature of provider groups, such as the AAP, American Academy of Family Physicians (AAFP), and the National Medical Association. We are very interested in working with them to make sure physicians get the latest information in immunization delivery and that parents get to read about the risks of all three first."
"The parents' efforts played an important role in pointing out the lack of physician education and clearly we must do more to educate doctors to the risk of VAPP and to involving parents about vaccine choices," says Neal Halsey, M.D., the chairperson of the AAP Committee on Infectious Diseases and professor of international health and pediatrics at Johns Hopkins University, who was also present for the testimony that was given before the FDA Committee. Echoing Dr. Edward's position, Dr. Halsey states, "It is the AAP's position that parents should participate in that decision. The AAP needs to do more to make sure that physicians are informed and that is our responsibility."
Dr. Halsey also points out that immune deficiency is a concern when vaccinating a child against polio and parents should be vigilant about asking their doctors questions. Calling on parents to have a continuing dialogue with their child's physician, Dr. Halsey observes that parents who have a family history of primary immune deficiency (or know that someone with immune deficiency will be in close contact) should tell their doctor and ask about what considerations need to be made as to which polio vaccine their child should get.
The CDC-recommended sequential schedule calls for the initial dose of OPV to be given at 12-18 months of age to allow physicians enough time to diagnose immune deficiency in a child. Based on members experiences and findings reported to the CDC that people with immune deficiencies are among those at greater risk of contracting VAPP, IPAV formed a partnership with Immune Deficiency Foundation (IDF) in order to share and use information concerning both diseases effectively. According to Mr. Salamone, "The only way for parents to completely avoid the risk of VAPP would be to opt for the all-IPV schedule as recommended by the CDC and the AAP."
Looking toward the future
IPAV maintains that getting an all-IPV schedule adopted by the CDC is one of their goals. Dr. Halsey notes that, "If the global effort to eradicate polio succeeds, then vaccination with the OPV can be stopped. Meanwhile, people in this country must know that they have a choice of vaccines. The AAP appreciates that IPAV is a group which does not want to end vaccinations until polio is eradicated. It is important to be immunized against polio. The worst thing is that people not get the vaccines."
Mr. Salamone is optimistic that even if the FDA Committee does not recommend the warning label, that it will act on educational programs. Through this and their own efforts, IPAV hopes to continue to keep the spotlight focused on VAPP and inform the public of the risk. IPAV also stands as one example to let parents know that they can affect change when they work together with healthcare professionals and our government system. In the case against VAPP, IPAV has made tremendous progress so far, but until the risk of polio in any form is wiped out completely, the prosecution will not rest.
RELATED ARTICLE: PEOPLE--NOT STATISTICS
Tim and Michelle Ceballoses are parents in the process of emerging from a state of shock. Their only child, Ciara, has quadriplegia as a result of VAPP. Ciara was given the OPV at two months of age in November 1997, almost a year after the CDC recommendations was published. Though she does not have an immune deficiency, she contracted VAPP three weeks after receiving the vaccine. Today, Ciara wears a brace, from under her arms to her pelvis, to prevent scoliosis, since she is non-weight bearing. Her parents rarely leave Ciara in the care of anyone else or bring her to public places because respiratory hardship, due to her quadriplegia, could be exacerbated if she catches so much as a cold. As part of their journey to come to terms with the enormity of their situation, the couple attended the IPAV Family Meeting. "It gave us insight and enabled us to deal with the emotions," says Mr. Ceballos. "Meeting other parents who have gone through this has helped put into perspective."
Mrs. Ceballos tries to keep the pain and anger out of her voice as she recalls how she was given outdated literature above OPV after the vaccine was administered to her daughter. The current information was approved by the CDC in June 1996 and published in January 1997. It notes change in the routine polio vaccine schedule and also lists the risks and benefits of both the IPV and OPV schedules. The Ceballoses, in dealing with their own grief, are now adamant that steps be taken so others may avoid the same hardship. "Parents need more information. They should know that there is a choice," says Mrs. Ceballos.
The couple traveled back to Washington, D.C. in May to urge the FDA to require a "black box" warning on the oral-live vaccine that would remind physicians to tell parents about the risk. When the couple appeared before the FDA Advisory Committee, they gave their heartfelt testimony. Mrs. Ceballos declares, "The risk may be small statistically, but it is not small to us or the next family. We begged them to prevent this from happening to other families. They can't delay--this affects people's lives."
Gordon Pierson developed polio after he was given the OPV at the age of two months. Now six-years old, Gordon remains paralyzed (except for limited head and toe movement), ventilator dependent, and requires round-the-clock nursing care. Gordon's parents, Randy and Susan, are straightforward about the situation. Mr. Pierson described the family's coping methods, "We survive moment to moment."
At the conference, the Piersons, of Jackson, Tennessee, were inspired by meeting families like their own. "This was our first experience to meet other parents. We ourselves gain great satisfaction from giving encouragement to other families," explains Mrs. Pierson. The Piersons have a strong support system in their family, their church, and in each other. As Mrs. Pierson puts it, "Faith in the goodness of God has gotten us through."
The Piersons are connected that Gordon not be expressed to infection so he receives home therapy, including physical, occupational and speech therapy. He can communicate using his eyes and is currently learning to use augmentative communication computer software. Gordon's siblings, Erin, ten, Lindsay, eight, Thomas, two, and Claire, seven months, have no problem understanding him. "They are used to seeing him and being with him. They know by his eyes whether he is happy or sad or if he wants something," according to Mrs. Pierson. "They never remember him being any other way, so they accept him and love him for who he is."
To other parents of children with disabilities, Mrs. Pierson imparts her philosophy, "I would encourage them to focus on what their child can do and all the positive things there are to consider." The Piersons went before the CDC with other IPAV families to testify in favor of giving children the inactive polio vaccine instead of the oral vaccine. "Parents may need to be involved in the education process and take a proactive stand," states Mrs. Pierson.
"In raising David, we always contend that the glass is half full, instead of half empty," says David's father John Salamone. David contracted VAPP when he was five-months old and remained undiagnosed for two years, when it was also found that he had Brutons agammaglobulinemia, a rare genetic disorder, which causes immune deficiency. David now uses a brace on his right leg, which still bears the effects of the paralysis. "We count our blessings every day. David tries everything. He is at the age now where he starts to ask questions: why can't he do everything that the other kids do? But he has a good degree of acceptance and always has a smile on his face. He gets satisfaction out of knowing that he made a difference by helping to make sure that other kids don't have to experience what he is going through."
As for his daughter, Elizabeth, according Mr. Salamone, "she is a typical teenager, 13 going on 30." But he and his wife, Kathy, worry that David's disability has left its mark on her as well. "People forget the tremendous challenge for the sibling of a child with a disability because everyone is concerned about the special child. That weighs on kids. It impacts their self esteem, which is always a problem with teens. Having to contend with a sibling's disability makes it much tougher. My wife and I try to make a conscious effort not to make her feel slighted, but David's medical needs are always on our minds."
Paul Raymond Sigloch
"I never dreamed he would ever leave the hospital," recalls Susan Sigloch as she remembers when her son, Paul Raymond, contracted polio from his last dose of the OPV booster at 18-months old. The disease caused paralysis from his neck down and then subsides. Paul Sigloch, the boy's father continues, "We felt helpless when it first happened." The ordeal was made even more difficult when, at first, no diagnosis was found. Mrs. Sigloch points out that most health care professionals do not recognize a case of polio today because it is so rare. She credits John Salamone's article (August 1996), detailing his son's case of VAPP, for helping doctors find Paul Raymond's diagnosis.
Though Paul Raymond regained strength in most of his body through intensive therapy, he still has weakness in the legs and right shoulder. He was also found to have Brutons agammaglobulinemia, a rare genetic disorder which had made him susceptible to the polio that is in the oral vaccine. Brutons has left him with immune deficiency and susceptible to have polio again. He must also receive gammaglobulin shots every four weeks for the rest of his life.
Getting on with life
As is common in families with children who have VAPP, the parents blamed themselves. "I found out that I am a carrier of the immune deficiency, so I felt responsible," says Mrs. Sigloch. "I blamed myself, adds Mr. Sigloch, "I held him while he got the vaccine." Meeting with the other VAPP families, however, gave the Siglochs, of Waterford, New Jersey, the chance to meet other parents and individuals with the disease--and to understand that they should not feel guilty. "We learned a great deal, both from the conference and form other parents. It was conforting to meet them," Mrs. Sigloch explains. "You learn you're not alone, you're got more hope and it makes things a lot easier," adds Mr. Sigloch. "We also wanted Paul Raymond to see David Salamone, since their cases are so similar. We want him to know that there are other kids out there who have polio and can relate to what he's been through."
Though Paul Raymond uses braces on his legs, his father describes him as an active little boy. "He doesn't let it slow him down. He's a blur! We have always tried to be as normal as possible about his braces. He doesn't make a big deal out of them and explains to people who ask, `I got sick and I need them to help me walk.'" Mr. Sigloch describes the family's efforts in helping the boy battle back from the disease, "We played normal games like we always did. We went to the playground, gave a little boost and made him do the rest. We pushed him, but he deserves all the credit. He still improves each day." The couple also credit their younger son, 20-month-old Connor, with keeping his big brother on his toes and expect their new son, Ryan Joseph, born in July to do the same. Now that the Siglochs know what caused Paul Raymond's disease, the two younger boys will be receiving only the inactive polio vaccine so as not to risk getting the disease or contaminating Paul Raymond.
The Siglochs have also educated everyone they know, as well as any who ask about their son's disability to the reality of VAPP and its contamination risk. "Everyone is under the misconception that polio is eradicated," says Mrs. Sigloch. "Getting the message out is the biggest thing. Our pediatrician's office want us to teach them anything we learn about Brutons and VAPP because they are not familiar with either and we are handling both. When you know someone who has come down with it, it is no longer a case of that `one in a million,' it becomes `the kid on my block.'"
IPV: Inactive polio vaccine. Administered in the form of an injection.
OPV: Oral-live polio vaccine. Administered in the form of drops taken by mouth.
Learning the hard way
Parents like John Salamone, and the others who comprise IPAV, found that a dose of OPV can have life-altering ramifications--causing the disease it is meant to prevent. Not only can the OPV cause the disease in vaccine recipients, but recipients may act as carriers, transmitting the virus to anyone in close contact with them. This is possible since the virus exists in the recipient's system, especially in the stool, for several weeks after vaccination. The presents also found out that if they had been told of the risk, they could have opted instead for the inactive vaccine for their child, which cannot cause polio.
RELATED ARTICLE: Resources
For more information about polio vaccines, immune deficiency, or VAPP contact the following organizations:
American Academy of Pediatrics-AAP 141 Northwest Point Blvd. Elk Grove, IL 60007 (847) 228-5005 fax: (847) 228-5097 Web site: http://www.aap.org
Immune Deficiency Foundation-IDF 25 W. Chesapeake Ave., Ste. 206 Towson, MD 21204 (800) 296-6647 fax: (410) 321-9165
Informed Parents Against VAPP-IPAV PO Box 53212 Washington, DC 20009 (888) 363-8277 Web site: http://www.ipav.org
Centers for Disease Control and Prevention-CDC National Immunization Program (800) 232-7468 (English) (800) 232-0233 (Spanish) Web site: http://www.cdc.gov/nip