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Smallpox vaccination and adverse reactions/An 8-year-old with encopresis: A dramatic turnaround/Can small practices afford to give vaccines?/On the matter of "partial birth abortions"/Getting out those beads
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A statement about flu vaccine in the June 2003 Updates should have read "Vaccination of children 6 months and older who have certain medical conditions is strongly recommended" (not "children younger than 6 months").
"Smallpox: Preparing for an old (but no longer familiar) threat" (May 2003) selectively presents data in a manner that might mislead readers. The data presented in Table 3 of the article are taken from the two 1968 studies on smallpox vaccine adverse event rates in the United States. The adverse reaction rate among secondary vaccinees is much lower than among first-time vaccinees, and is also much lower among those 20 years and older. Why were those data not presented? It certainly is more relevant for pediatric health-care providers who are deciding whether to be vaccinated.
The article cites a recent report that found that 36% of vaccinees were sufficiently ill to miss school, work, or recreational activities or to have trouble sleeping.1 The CDC Web site on smallpox does warn that one out of three vaccinees may be sufficiently ill to miss school or work. However, recent data on more than 36,000 civilian vaccinees and more than 430,000 military vaccinees do not bear this out.
The CDC data show that, among the 36,217 health-care and public health volunteers (who are mostly secondary vaccinees) immunized between January 24 and May 9 of this year, 488 nonserious adverse events (including self-limited responses such as fatigue, headache, and pruritus) were reported after vaccination.2 The number of cases of selected adverse events associated with vaccination (more serious events such as myopericarditis and inadvertent autoinoculation) was 43: 30 suspected, six probable, seven confirmed.2
Among the more than 430,000 military personnel (mostly primary vaccinees who are at higher risk of adverse reaction) immunized through May 28, 2003, the sick leave rate was 3%.3 Of that 3%, average sick time was 1.5 days. There were 48 cases of autoinoculation (none severe) and 36 cases of generalized vaccinia (all mild) but no severe reactions (e.g., eczema vaccinatum, progressive vaccinia) after vaccination.3
Among both civilian and military groups vaccinated, all adverse reactions combined amount to much less than the 36% rate reported in the Contemporary Pediatrics article.
1. Frey SE, Couch RB, Tacket CO, et al: Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med 2002;346:1265
2. Centers for Disease Control and Prevention: Update: Adverse events following civilian smallpox vaccinationUnited States, 2003. MMWR 2003;52:475
3. Grabenstein JD, Winkenwerder Jr W: US military smallpox vaccination program experience. JAMA 2003; 289:3278
Author reply: Perhaps Dr. Miller interpreted the intent of my article as presenting some side of the various debates concerning smallpox vaccination. That was not my intention. It was merely to provide data about smallpox and smallpox vaccine and to mention the areas of debate, as these things have been in the news quite a bit lately.
The data on primary vaccination were presented because this article was primarily about children, all of whom would be first-time vaccinees. In fact, the majority of the United States population has never been vaccinated. No one disputes that severe adverse reactions are much less common in re-vaccinees.
The data cited by Dr. Miller on selected adverse events associated with smallpox vaccination among civilians (from the CDC's Morbidity and Mortality Weekly Report) show a "snapshot" of the evolving data on outcome from the current smallpox immunization effort. These are preliminary data, and it is not known how many of the reported adverse events will be confirmed. It is interesting that the calculated rate of suspected adverse events would be 828 for every one million, which is similar to older data on adverse events. As with any study, however, it is the finished product, reviewed and published in a peer-reviewed journal, that has the data we should quote.
There are many differences between the civilian and military populations now being vaccinated and the populations studied in the past. First, the current vaccination program includes ambitious pre-screening that ensures vaccinees' lack of contraindications and their understanding of how to care for the vaccine-induced skin lesion. In the past, screening was less detailed. In a mass vaccination program, such ambitious screening would be difficult to carry out. Second, the relatively low rate of absenteeism is typical of the military, whose members are strongly averse to taking sick leave. Among vaccinees with whom I am familiar, many took a small amount of time off because of mild or moderate malaise that could have been ignored if truly necessary. It will be interesting to compare the civilian data with the military data when the former become available.
Here is some follow-up on my patient who was featured in the June 2003 Behavior: Ask the Experts ("Intractable toilet problemthree approaches"). Shortly after we received the advice from the Contemporary Pediatrics behavior experts (I sent a copy of their comments directly to the child's mother, who has always been very adherent to doctors' advice), the family took the boy to a child psychologist who works with the pediatric gastroenterologist at a tertiary care center. The psychologist recommended: regular (not prn) daily doses of Miralax to soften his stools; a reward system; continuing to make the child take care of soiled clothes; and discontinuing diapers.
Nothing happened for about two weeks and then, for no apparent reason, the boy tried going on the toiletwith success! He has been going on the toilet since then. He even tells his mother, "You're right, Mom! This [going in the toilet] IS a lot easier!" I asked his mother if the psychologist had said or done anything different than what was tried before and she could not identify any new ideas or significant changes. I guess all's well that ends well!
The mother is very appreciative to the expertsDrs. Schmitt, Blum, and Greenfor their help, as am I.
The rising cost of vaccines has become a real issue for many pediatricians. We usually have to pay for them within 90 days of receipt, store them, administer them, and then wait no telling how long to receive reimbursement. My five-person practice doesn't have pockets as deep as some large groups, so our cash flow takes a hit. Furthermore, although companies continue to raise the cost of vaccines (notably, the conjugate pneumococcal vaccine, Prevnar), we are not getting paid more for the vaccine. In the old days, we could pass along cost increases to the consumer; we can't do this today because of constraints by third-party payers.
I fear that small pediatric groups will eventually be driven out of the vaccine business.
In Eye on Washington (Updates), May 2003, you report on the "ban on intact dilation and extraction (called partial birth abortion by abortion opponents), passed last month by the Senate and awaiting action in the House."
This account has it exactly backward. The partial birth abortion procedure is distinct from dilation and extraction. In fact, it is significantly more dangerous for the mother than other D&X procedures. The American Medical Association has testified to Congress that there is no known medical indication for the partial birth abortion procedure. Abortion proponents have tried to rename this procedure as "intact dilation and extraction" to make it sound like the more medically accepted procedure.
Shame on you for propagating such blatantly political inaccuracies!
Editors' reply: The bill referred to in the Eye on Washington item is called "The Partial Birth Abortion Ban Act." It does not use the term "intact dilation and extraction." However, both the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists (ACOG) agree that "partial birth abortion" is a non-medical term that refers to a particular abortion procedure known as intact dilatation and extraction. In its statement on "so-called 'partial birth abortion' laws," ACOG writes: "'Partial birth abortion'" is a non-medical term apparently referring to a particular abortion procedure known as intact dilatation and extraction (intact D&X, or D&X), a rare variant of a more common midterm abortion procedure known as dilatation and evacuation (D&E)."
The AMA, in its statement on late-term pregnancy termination techniques, says that, "According to the scientific literature, there does not appear to be any identified situation in which intact D&X is the only appropriate procedure to induce abortion . . . The AMA recommends that the procedure not be used unless alternative procedures pose materially greater risk to the woman. The physician must, however, retain the discretion to make that judgment . . ."
We often have "bead accidents" during Mardi Gras here, so I would like to offer another suggestion, born of experience, for removing beads from ears (Readers' Forum, June 2003; Clinical Tip, April 2003): Place a drop of viscous lidocaine in the ear canal and apply suction with a piece of tubing on a syringe. This has worked twice for me with smooth round beads.