Date: Fri, 24 Jan 1997 21:32:09 +0000 Subject: Pertussis Vaccine Article Reply-To: "Lon Morgan, DC" Dr. Dwyer recently posted a research paper on the topic of pertussis immunization and invited commentary. Dr. Dwyer is to be commended for his research efforts. In this spirit of information exchange I would like to offer some observations, realizing therein that final answers may be elusive. Dr. Dwyer performed a medline review of some 300 references, extending back to the 1950's, produced a final list of perhaps 70 references, listed at the end of the paper. Of these about 17 were written in the 1990's, the rest extended into prior decades. As a suggestion: as more knowledge has been gained, larger, better and more accurate studies have been performed. From a scientific perspective, we come closer to an accurate understanding of a scientific issue if the latest and best data is used. This holds true whether we discuss computers, aircraft design or immunization. A medline scan I ran revealed some 188 pertussis vaccine related studies conducted just since 1994 - almost none of these were included in Dr. Dwyer's paper. I would suggest to Dr. Dwyer putting more emphasis on recent studies (1990's), and eliminating those references not coming from peer-reviewed professional journals. The value of references in a professional paper are useful only when they are directly tied by reference number to the point being made. I suggest Dr. Dwyer consider doing this. It is nearly impossible for a reader to determine which reference is being used for which discussion item, and to confirm the accuracy of the author's interpretation and use of the material. Dr. Dwyer commented: >James Cherry, MD, MSc, is an articulate and enthusiastic advocate >for pertussis vaccination . . .Dr. Cherry's critics, however, have >been quick to point out the substantial financial benefits he >receives from the pharmaceutical industry. I suggest that a professional paper is not a proper place to cast aspersions on a researcher unless solid, specific, verifiable evidence is presented. Where funding comes from, in what amounts, and under what conditions, is knowledge a reader should have. Given that information, a reader can draw his own conclusions about whether funding influenced the outcome. It also needs to be remembered that 'critics' can have their own biases and agendas - particularly if they depend for their livelihood on the sale of anti-vaccine literature. Dr. Dwyer concluded: >The whole-cell pertussis vaccine is an example of a medical >intervention which was used for decades despite fairly strong >evidence suggesting that it did more harm than good I am not satisfied that the evidence Dr. Dwyer presented in this paper supports this conclusion. Quite to the contrary, the larger, better studies conducted in recent years have consistently demonstrated both the relative efficacy and effectiveness of pertussis vaccine, although the acellular product appears to be a superior product. A few examples: A large study of over 38,000 Tennessee children examined for seizures and concluded: "There was no evidence that in the 0-3 days following DTP immunization the risk of afebrile seizures or acute symptomatic seizures was increased. No child who was previously normal without a prior history of seizures had a seizure in the 0 - 3 days following immunization that marked the onset of either epilepsy of other neurological abnormality."(1) Hodder, et.al., noted: "Although epidemiological studies appear to have largely, if not completely, absolved pertussis vaccine of responsibility for inducing death or permanent neurologic disability, a less reactive vaccin e is highly desirable, not only to promote acceptance of a full course of immunization for the world's children but also for simple humanitarian reasons."(2) Gale did a statewide surveilance of DTP immunization in 218,000 children up to 24 months of age in Washington and Oregon with case children matched against control children. This was the largest suc h study ever conducted in the United States. Their conclusions: "This study did not find any statistically significant increased risk of onset of serious acute neurological illness in the 7 days after DTP vaccine exposure for young children."(3) In a review of the literature Rabinovich noted: ". . well-conducted studies fail to show a causal association between pertussis vaccination and sudden infant death syndrome"(4) Is pertussis a serious, present problem? Wortis noted: "During 1992 and 1993, 23 deaths attributed to pertussis were reported to the Centers for Disease Control and Prevention. Cultures for Bordetella pertussis were positive in 18 (90%) of the 20 cases in which it was performed. Twenty (87%) of the 23 children who died were younger than 1 year of age, and 18 (78%) of the children had received no doses of pertussis vaccine. Pneumonia was a complicat ion in all but 1 (96%) of the cases. Seizures occurred in 4 cases (17%), and acute encephalopathy occurred in 3 cases(13%). CONCLUSIONS. Pertussis continues to cause serious illness and death in the United States, particularly among infants who are not vaccinated."(5) Is the new acellular vaccine more desirable? Certainly. Despite the fact that the better, more recent studies demonstrate that the whole-cell preparation did not cause anywhere near the neurological damage earlier feared, its potential irritative effects (swelling, redness, fever, etc) reduced its desirability. Zimmerman noted: "Vaccination has dramatically reduced the number of annual cases of pertussis, diphtheria, measles and congenital rubella syndrome. Although side effects of immunizations can occur, serious adverse e vents are rare for all vaccines commonly used in the United States. Infantile spasms and sudden infant death syndrome are not associated with childhood vaccines. Compared with whole-cell pertussis vaccine, acellular pertussis vaccines are significantly less likely to produce moderate reactions such as fever, fussiness, pain, drowsiness, anorexia and local redness or swelling."(6) One other item might be worthy of discussion: The Vaccine Injury Compensation Trust Fund. This program was established in Oct. 1988 to bring stability to a problem that threatened vaccine supply. Based on incomplete data, and erroneous interpretations of data, lawyers were having a field day suing for alleged vaccine injury. Their ads appeared on billboards and in the yellow pages. The Trust Fund made it easier and faster for injured children to obtain compensation, and brought a measure of accountability to frivolous suits. The result: despite an ever growing population and an ever increasing number of immunizations given, an awareness of the data from the latest studies has resulted in dramatic drops in the number of annual petitions from an inflated high of 3,246 in 1990, to only 84 filed in FY 1996. Presently, only about 6 petitions claiming vaccine injury per month are being filed. The number of petitions filed is dropping every year. In the NVIC program, a variable vaccine tax of up to $4.50 was added to the cost of each dose administered. The Secretary of HHS has now proposed to Congress that this tax be greatly reduced. The reason: far too much money is being collected - far more than is needed to fund the program. It has been recommended that the tax be reduced to a flat 51 cents per dose. This rate will no longer be variable by vaccine - there was insufficient evidence that any one vaccine necessarily caused significantly more damage than another.(7) Dr. Dwyer asked: >. . .why did the alternative health community in general, and > the chiropractic community in particular, resort to hyperbole > (regarding immunization)? Dr. Dwyer has asked an excellent question. So often chiropractic's expressions on this topic have been the result, not of reasoned connection with scientific based reality, but of exaggerated and fictitious histrionics. This has destroyed much credibility and greatly reduced influence we might otherwise have had. The issue is not one of whether a prudent and cautious approach should be taken toward immunization, or any health care intervention, but whether our attitude is based on a rational and measured review of the latest and best in current knowledge. REFERENCES: 1) "Risk of Seizures and Encephalopathy After Immunization With the Diptheria-Tetanus-Pertussis Vaccine" JAMA, March 23/30,1990 Vol 263, No 12 2) "Epidemiology of pertussis and reactions to pertussis vaccine" Epidemiologic Reviews, 14:243-67, 1992. 3) "Risk of Serious Acute Neurological Illness After Immunization With Diptheria-Tetanus-Pertussis Vaccine" JAMA, Jan. 5, 1994 Vol 271, No 1 4) "Pertussis Vaccines - A progress report" JAMA, Jan 5, 1994 Vol 271, No. 1 p. 68. 5) "Pertussis deaths: report of 23 cases in the United States, 1992 and 1993." Pediatrics 1996 May Wortis N Supplement: 5 Vol 5 607-12 6) "An update on vaccine safety." Zimmerman RK, Kimmel SR, Trauth JM, Am Fam Physician 54: 1, 185-93, Jul, 1996. 7) http://www.hrsa.dhhs.gov/bhpr/vicp/new.htm Lon Morgan, DC lmorgan@primenet.com "The role of science is not to provide everlasting truth; but rather, to provide a modest obstacle to everlasting error." -Anon- ************************************** Date: Fri, 24 Jan 1997 22:27:24 +0000 Subject: Additional Pertussis information Reply-To: "Lon Morgan, DC" Recent studies on the experience of countries who discontinued pertussis immunization. ================= Baron S, Begue P, Grimprel E [Epidemiology of pertussis in industrialized countries]. [French] Sante 1994 May-Jun;4(3):195-200 " ...In some countries such as Japan, UK and Italy, concerns about the occurrence of severe adverse events following pertussis vaccination in the 70's led to a reduced acceptance and thus, to a significant decrease in immunization coverage. In Sweden, the protective efficacy of pertussis vaccine was questioned and vaccination was discontinued in 1979. In all these countries, severe epidemics of pertussis were observed in the following years, and immunization was then reinforced in some (UK). In Japan, considerable efforts were made to develop new and safer pertussis acellular vaccines which have replaced the whole-cell vaccine since 1981." Romanus V, Jonsell R, Bergquist SO Pertussis in Sweden after the cessation of general immunization in 1979. Pediatric Infectious Disease Journal 1987 Apr;6(4):364-71 Immunization against pertussis was introduced in Sweden in the 1950s and discontinued in 1979. This was followed by a low endemic level of pertussis for 3 years. Thereafter the incidence gradually increased and there were two outbreaks in 1983 and in 1985. In the period 1980 to 1985 pertussis was confirmed by culture or serology in 36,729 patients of which 11% were younger than 12 months of age and 69% were ages 1 to 6 years. An estimate of the total frequency of pertussis in preschool children was made from reports from a sample of the child health centers. The annual incidence rate per 100,000 population ages 0 to 6 years increased from the 700 cases in 1981 to 3200 in 1985. The ratio of total cases to those reported from the laboratories was 3:1 in 1981 and 2:1 in 1985. The cumulative incidence rate by the average age of 4 years was estimated at 16% of the unimmunized cohort born in 1980 compared with 5% of the immunized cohort born in 1978. The seriousness of pertussis was evaluated by studying the 2282 pertussis patients hospitalized from 1981 to the end of 1983. Forty-eight percent were infants younger than 12 months of age. Neurologic complications were noted in 4% and pneumonia in 14% of the hospitalized patients. Eleven children received assisted ventilation. Fatal outcomes were reported in 3 children (0.1%), 2 of whom had severe congenital disabilities. Lon Morgan, DC lmorgan@primenet.com