|Vaccination Debate: Do Vaccines Cause Cot Deaths?|
Below is a series of articles regarding the vaccination link to sudden infant death syndrome (SIDS). The first article is by Harris L. Coulter, PhD, where he criticises two official studies that purport to refute the vaccination/SIDS link. Following this is a two-part debate between Coulter and Lon Morgan, DC.
Harris L. Coulter:
Two studies by teams of epidemiologists headed by Marie R. Griffin represent perhaps the absolute worst I have encountered in many years of reading this literature (Marie R. Griffin, Wayne A. Ray, John R. Livengood, and William Schaffner, "Risk of Sudden Infant Death Syndrome after Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." NEJM 319:10 [Sept. 8, 1988], 618-622. Marie R. Griffin, Wayne A. Ray, Edward A. Mortimer, Gerald M. Fenichel, and William Schaffner, "Risk of Seizures and Encephalopathy After Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." JAMA 263:12 [March 23/30, 1990], 1641-1645). For those who are still interested I will attempt to show the reasons for my conclusion.
The first article, on "sudden infant death," was presumably written to refute the conclusion reached earlier by Alexander Walker et al.: "we found the SIDS mortality rate in the period zero to three days following DTP to be 7.3 times that in the period beginning 30 days after immunization...only a small proportion of SIDS cases in infants with birthweights greater than 2500 grams could be associated with DTP" ("Diphtheria-Tetanus-Pertussis Immunization and Sudden Infant Death Syndrome." American Journal of Public Health 77:8 , 945-951).
So Walker et al. did find that the DPT shot was apparently causing "sudden infant death." And these deaths were not associated with just the first DPT shot, but with each succeeding shot.
Griffin et al. set out to refute this conclusion - not, indeed, by visiting these children and their parents but, in the new style, by leafing through computerized immunization records for children born between 1974 and 1984 in the state of Tennessee, "augmented through linkage of records with state vital statistics and Medicaid files."
The major problem with an epidemiologic study is always that of ensuring that the sample picked is representative of the larger group. It is logistically difficult to include all children, despite the availability of computerized records. Therefore, how the sample is selected is of paramount importance.
Griffin et al. found that, out of 280,000 children born in four Tennessee cities between 1974 and 1984, 180,000 had records in Public Health clinics.
Oddly enough, for over 41,000 of these 180,000 children no immunizations had ever been recorded. But instead of looking into SIDS incidence in this sizable group, Griffin et al. simply excluded them from the study.
Another 3000 children were excluded because their immunization records were confused.
This left 130,000 children in the cohort. And it is legitimate to ask if these 130,000 were truly representative of the 180,000 with public health service records. And, even more to the point, are they representative of the 280,000 children born in these same cities who did not have Public health clinic records?
Next they found that 204 children had died during days 29 to 365 of life. But they excluded 95 of the 204 because "a cause of death was listed [on the death certificate] that was clearly not SIDS." But what were these causes that were clearly not SIDS? Griffin et al. do not vouchsafe us that information, even though causes of death on death certificates are not necessarily reliable. At the very least, the chronological relationship between these deaths and a preceding vaccination should have been provided. Two of the 95 deaths had actually been coded SIDS by the attending physicians, but Griffin et al. knew better and changed the diagnoses: one baby had pneumonia (as if there is no connection between pneumonia and a vaccine reaction), while the other had heart disease (as if babies with congenital heart disease are never vaccinated).
By this time the SIDS sample has been so restricted as to be entirely unrepresentative of anything, and we are not surprised to find that Griffin et al. found the incidence of SIDS to be identical with the expected background incidence ("marginal rate of SIDS for that age group," as it is called).
As we might expect, no published references are given in support of the concept of "marginal rate of SIDS for that age group."
Griffin et al. dismiss the results of the Alexander Walker study above (7.3 times as many SIDS deaths in the first 3 days after vaccination as 30+ days after vaccination) as follows: "Since the first DTP immunization is usually given near the age when the incidence of SIDS peaks, the results of such case-series analyses are biased toward finding an apparent association between SIDS and DTP immunization." But Walker had found that SIDS was clustered not only around the first DPT shot, but around each succeeding shot. So Griffin et al. are hypothesizing that the background incidence of SIDS "peaks" every two months (!!).
It is amazing that such a study could be accepted by a reputable scientific journal. The reason was doubtless that the study was funded by the CDC and the FDA, and that two of the coauthors (Griffin and Ray) were at the time "Burroughs Wellcome Scholars in pharmacoepidemiology" (whatever that is). Burroughs-Wellcome is, of course, a major producer of the pertussis vaccine. Have these people never heard of conflict of interest?
The second article by this same group of authors is equally typical of the kind of epidemiologic research conducted by those who work with government funding. Marie Griffin et al., "Risk of Seizures and Encephalopathy after Immunization with the Diphtheria-Tetanus-Pertussis Vaccine" is a retrospective analysis of 38,171 Tennessee children enrolled in Medicaid who received DPT immunizations during the first 3 years of life.
These constituted 29% of all children immunized in the public sector and 12% of all children born in the area during the study years, so the problem of "representativeness" of the sample is just as significant here as in the earlier study.
The "event" monitored was the "first nonneonatal seizure or episode of encephalopathy that resulted in a Medicaid reimbursement for a medical encounter, between the first DPT immunization" and the child's attainment of 36 months of age.
Griffin et al. found that 1187 study children had a potential "outcome of interest," meaning a seizure, but hold on, we can't just throw all these cases into the hopper, as it might lead us to the wrong (right!) conclusion. So Griffin et al. started whittling down the sample.
Records were "unavailable" for 359 (30%!!), and they were excluded! Just like that! And even though half of these, in the authors' estimation, would have met their criteria for inclusion! How about some good old shoe-leather epidemiology? Sorry, that's not how we do things these days.
Of the remaining 828 children 470 more (43%!!) were excluded as not meeting the "case definition." Ultimately, only 358 of the children remained in the study - 30% of the initial number!!
The 470 excluded cases consisted of: 34 seizures in the first 30 days of life ("neonatal"), 150 cases of chronic preexisting neurological abnormality without seizures, 18 "spells" "that were not clearly seizures," 82 diagnoses of "failure to thrive," 121 other nonneurological events, and 65 miscoded records. There is no way in the world that Griffin et al. could reliably conclude that these cases were unrelated to vaccination merely by examining Medicaid records and without interviewing the families. We must take these exclusions on faith, and such faith or confidence in the conclusions reached by government-funded epidemiologic surveys of vaccine damage is today in pretty short supply.
Griffin et al. conclude: "no child had the onset of encephalopathy, epilepsy, or other serious neurological disease in the first week following DPT immunization." But this is entirely disingenuous, since the "event" of interest has been defined as a neurological illness resulting in a medical encounter. The parents would have had to take the child rather quickly to the "medical encounter" to qualify under the terms of this study. If a parent left the baby in peace for a few days, just to see what was happening, or if the parents just did not notice a seizure in the baby (seizures are not very evident in small babies), this would not qualify as an "event" worth reporting.
Furthermore, the authors seem to assume that a seizure must occur within three days after vaccination to qualify as vaccination-related. There is no evidence for this anywhere in the vaccination literature. But it allows them to ignore a few unpleasant, and even potentially disastrous, outcomes, viz.: "Four children who were previously normal and had no prior seizures developed some neurological or developmental abnormality following the index seizure. In only one was the index event a febrile seizure, and this occurred more than 30 days following immunization. The other 3 occurred after acute symptomatic seizures. An additional 11 children who were previously normal developed epilepsy. One of these children had an initial afebrile seizure in the 8-14 days following immunization; the initial seizures for the other 10 were all in the period 30 or more days after immunization." Or: "Two children were hospitalized with encephalopathy between their first DTP immunization and 36 months of age. The 2 children with encephalopathy both had their onset of illness more than 2 weeks following DPT immunization, and neither had permanent sequelae. These 2 children will not be considered further." (??) Or, "There were six febrile seizures in the 0-3 days following immunization... Other events in the 0- to 3-day interval following DTP immunization included one afebrile seizure, zero symptomatic seizures, and six potential seizures, with no evidence for an increased rate of occurrence compared with the control period of 30 or more days following DPT immunization."
Amazingly, the authors think that seizures or other neurological events occurring more than 30 days after a vaccination are unrelated to the vaccination and part of the "background incidence." Hence the period commencing 30 days after vaccination is apparently used as a "control period," allowing the authors to conclude that the incidence of afebrile seizures in the 3 days following vaccination was no greater than in the "control period."
They do find, however, that the incidence of febrile seizures (generally thought to be less serious than the afebrile ones) is 50% higher in the period 0-3 days after vaccination than in the period 30+ days following vaccination.
The inherent difficulty of making sense of this article is due in part to the authors' tendency to contradict themselves from one paragraph to the next. For instance, after stating that afebrile seizures are 50% more common in the period 0-3 days post vaccination, they then say: "Indeed, there was no significant increase in febrile, afebrile, or acute symptomatic seizures in the early post-immunization period, compared with the control period of 30 or more days following DTP immunization."
In sum, this article eliminates 70% of the cases which initially presented, without giving any justification for such elimination. The authors then excuse the neurologic illnesses and disabilities which occurred on the ground that they are part of a background incidence (whose existence and magnitude in an unvaccinated population has never been demonstrated). And this article appeared in the "peer-reviewed" Journal of the American Medical Association!
These kinds of articles bring the Public Health Service, the CDC, the FDA, the "peer-reviewed" journals, and the rest of the medical-industrial-government complex into disrepute. Physicians can swallow this garbage if they want, since they make their living from it, but parents who expect at least elementary honesty from those who call themselves "scientists," and whose children are being maimed and crippled by the very vaccines which are proclaimed innocuous by authors such as Griffin et al. are already taking steps to put this invalid out of its misery.
The relations between the public and the vaccine establishment are surely going to get a lot worse before they start getting any better.
(Harris L. Coulter, PhD, June 11, 1996, firstname.lastname@example.org)
Lon Morgan's response to Harris Coulter - Part I:
1) A recent posting by Harris Coulter reviewed his assertion of a connection between DPT immunization and SIDS. He attacked studies by Griffen, et.al., published in JAMA and NEJM, which severely challenged this assertion.
2) Coulter's primary basis for his claim of a DPT/SIDS association is a study done by Walker in the August, 1987 AJPH. (1) Coulter systematically clings to this one, nearly 10 year old study, and purposefully ignores numerous studies done since then that seriously challenge his conclusions.
3) Since Coulter has made the 1987 study by Walker his 'end-all, be-all' for an alleged DPT/SIDS connection, a systematic examination of this study to examine the legitimacy of Coulter's position is in order.
5) Coulter's claim:
6) REALITY CHECK:
7) What does this mean? The study itself noted:
8) This phenomenon was further observed in another English study wherein the risk of SIDS was 2.4 times GREATER in NON-IMMUNIZED children. (2)
9) It was further noted that SIDS rates in the UK did NOT rise or fall when pertussis vaccination was discontinued. (3)
10) SUMMARY: The AJPH study that Coulter is so fond of lends basically NO support to his theories. It states quite clearly that "...only a small proportion of SIDS cases...could be associated with DTP," and that "The relatively small number of SIDS cases in the present study also admits the possibility of substantial random error."
11) Coulter's claim:
12) REALITY CHECK:
13) Is he merely incompetent, or jealous that the scientific community ignores him? An examination of his background reveals ZERO training in the health sciences, and ZERO research experience. Yet he presumes to stand in high judgement of all the world's science! Incredible!
14) Part II of our review will examine why Coulter is so upset with the pertussis studies done by Griffin.
(Lon Morgan DC, July 15, 1996, email@example.com)
1. Diptheria-Tetanus-Pertussis Immunization and Sudden Infant Death Syndrome, Walker, AJPH, August, 1987, Vol. 77, No. 8.
2. Possible temporal association..., Ped. Infect Dis, 1983; 2:7-11.
3. Effect of low pertussis vaccination uptake on a large community. BMJ, 1981;282:23-26.
Harris L. Coulter responds:
I have made several contributions lately to VIA criticizing various government-funded and industry-funded epidemiologic studies of vaccine damage. The point I have been making is that the raw data are carelessly and inadequately gathered, the conclusions are not supported by the data, and, often enough, the articles are so slanted in favor of the government/industry position as to verge on the fraudulent.
Now we have a response by Lon Morgan, DC, which ignores my criticisms and quotes, or misquotes, an article back at me as if I had never written the critique in the first place.
I am happy to engage in controversy. We all need more light on these issues, and the sparks of controversy often cast that sort of light, but I am not willing just to waste my time (and the readers' time as well). Responding to Dr. Morgan's supposed critique of my articles comes close to being a simple waste of time, but I will try to show what I mean, going through Dr. Morgan's contribution paragraph by paragraph.
This following should be read and compared with my initial contribution(s).
1) Marie Griffin's name is misspelled.
2) I do not "systematically cling" to the Walker study. It was the fifth article cited by me, four of which supported a vaccine-SIDS connection.
3) Again, it is not my "end-all, be-all" (for the reasons given above in 2).
4) Dr. Morgan accepts the raw data on SIDS. I do not: very many deaths were excluded from the survey without the reader being told the reason. It is a matter of common knowledge that only 10% of vaccine reactions are reported by physicians. And it is ludicrous to think that the authors of the study could get a true picture of SIDS by scrutinizing death certificates, hospital discharge data, and pharmacy use. The article does not state that the families of the babies concerned were interviewed. But even with these defects and exclusions, the SIDS incidence after vaccination was uncomfortably high, as the authors admit.
5) "We found the SIDS mortality in the period zero to three days following DPT to be 7.3 times that in the period beginning 30 days after immunization" is not "Coulter's claim," but is taken from the article Abstract. "So Walker et al. did find that the DPT shot was apparently causing 'sudden infant death'" was my paraphrase of the article Abstract.
6) I did not "conveniently" and "deliberately" omit mention of SIDS mortality in non-immunized infants. I have never held that all SIDS is from vaccinations. In DPT: A Shot in the Dark Barbara Loe Fisher and I estimated that 13% of all SIDS cases were from vaccination. So the fact that six unvaccinated babies in a population of 26,500 apparently died of SIDS is of no significance at all. What the study was measuring was the time interval between vaccination and SIDS.
7) This is pure hypothesis, of the sort with which we are too lamentably familiar in SIDS epidemiologic studies. The authors themselves state "might" and "could," and Dr. Morgan elevates these suppositions to the level of fact.
8) This paragraph is unintelligible. Dr. Morgan seems to be discussing an English study, but his reference is to a study conducted in Los Angeles, California. The article ("Possible Temporal Association, etc.), however, does state: "Both the efficacy and safety of pertussis vaccine have been questioned recently, particularly in the United Kingdom."
9) This 1981 British study is too old and too obscure to be cited as a reference for anything. And it is inappropriate to try to disprove my conclusions by citing references which suffer from the same defects as those being criticized.
10) Walker et al. mention the "possibility of substantial random error," and Dr. Morgan elevates this second supposition to the level of fact. Of course, the random error could just as well operate in the opposite sense, i.e., reinforcing the authors' conclusion about a connection between vaccination and SIDS, a point which Dr. Morgan may not fully appreciate. The conclusion of Walker et all. That "a small proportion of SIDS cases...could be associated with DPT" is the important element in this article, and to state that it "lends basically no support" to my position is just silly.
11) I stand by this conclusion.
12) I only wish I made as much money "peddling anti-vaccine literature" as the average CDC/PHS operative does peddling vaccines. But it does help keep me independent of government- or pharmaceutical-industry-handouts ("grants," "funding," etc.) and enables me to tell the truth as I see it rather than have to support an official line.
13) I have never claimed to be anything but a historian and writer. But a cat can look at a queen and a historian can look at scientific data. I wouldn't want to be associated with the kind of "research" which Dr. Morgan seems to admire so much. Furthermore, the scientific community has not been ignoring me at all. DPT: A Shot in the Dark sparked passage of the "National Childhood Vaccine Injury Act" of 1986 together with three studies of vaccine damage by the National Academy of Sciences Institute of Medicine, all of which make specific mention of this book. My second book, Vaccination, Social Violence, and Criminality (North Atlantic Books, 1990) has also had its share of attention, both official and professional. Someone out there may be "jealous," but it isn't me.
14) I will take up Part II of Dr. Morgan's review in my next communication.
(Harris L. Coulter, PhD, July 22, 1996, firstname.lastname@example.org)
Lon Morgan's response to Harris Coulter - Part II:
In a recent posting Harris Coulter attacked studies done by Marie Griffin, M.D., et.al., which examined for any connection between DPT immunization and SIDS or seizures. These studies were published in NEJM and JAMA. (1)(2). For the sake of brevity, I'll confine my comments to Coulter's handling of the JAMA study, although it would be similar in both cases.
1) Coulter claims the purpose of the Griffin study is to 'refute' a prior study by Walker. (3) Coulter has ZERO evidence to support this claim. As demonstrated in a prior post (7/15/97) on this topic, despite Coulter's attempts at distortion, the Walker study is highly supportive of DPT immunization.
2) Coulter claims the cohort sample of 29% of children immunized in the public sector and 12% born in the area has a problem with "representativeness." This is incredible. National election polls can predict outcomes very accurately with only a fraction of one percent of the population polled. And Coulter thinks 29% of a population is not representative enough?!
3) Coulter makes the claim that: "the authors seem to assume that
a seizure must occur with three days after vaccination to qualify as vaccination-related."
Coulter's confusion and befuddlement is pathetic. All Coulter had to do
was read the seizure classification used in the study, which was similar
to that of Hauser and Kurland, and which clearly stated the seizure types
that were examined:
4) Is that too difficult for anyone to understand? Apparently it was for Coulter. One could go on at length, but his wearisome pattern of distortion and misrepresentation remains the same.
5) Since it is obvious that nothing honest or candid regarding this
study will be forthcoming from the Coulter camp, a summary follows:
6) So why is Coulter so upset with this study? Probably because it, like a steadily increasing number of other DPT studies, blows holes a mile wide right through the middle of his insipid theories.
7) EXAMPLES OF OTHER DPT STUDIES:
8) Many more studies from all over the world could be cited - all with a similar finding: The risk of serious neurological problems, or SIDS, from DPT immunization is infintisimal. But Coulter considers these studies to be all part of a worldwide "medical-industrial-government" conspiracy.
9) So why does Coulter continue with his paranoid charade? He has obviously
staked his reputation, such as it is, on the outcome. He further derives
a substantial portion of his personal income peddling anti-vaccination
10) All this from "the premier medical historian of our time."
(Lon Morgan DC, July 16, 1996, email@example.com)
1. "Risk of Sudden Infant Death Syndrome after Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." NEJM 319:10 [Sept. 8, 1988], 618-622.
2. "Risk of Seizures and Encephalopathy After Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." JAMA 263:12 [March 23/30, 1990], 1641-1645).
3. "Diptheria-Tetanus-Pertussis Immunization and Sudden Infant Death Syndrome." AMJH 77:8, 1987, 945-951.
4. "Neurologic events following diptheria-tetanus-pertussis immunization." Pediatrics. 1988;81:345-349.
5. "Relationship of pertussis immunization to the onset of neurologic disorders." J. Pediatrics. 1988;113:801-805.
6. "Pertussis immunization and serious acute neurological illness in children. BMJ. 1981;282:1595-1599.
Harris L. Coulter's response:
I have written several articles lately criticizing various government-funded and industry-funded epidemiologic studies of vaccine damage. The point I have been making is that the raw data are carelessly and inadequately gathered, the conclusions are not supported by the data, and, often enough, the articles are so slanted in favor of the government/industry position as to verge on the fraudulent.
Now we have another response by Lon Morgan, DC, which commits the same errors as his earlier one, indeed, the very errors I have been criticizing. I will respond in the same way as I did to his earlier critique, going through Dr. Morgan's contribution paragraph by paragraph.
1) I did not claim that the purpose of this study was to "refute" the prior study by Walker. I made that claim for the other Griffin study, the one published in NEJM (ref. 1 below), because Griffin et al. referred to it specifically in paragraph l of that article. Does Dr. Morgan know which article he is critiquing? In any case, the Walker study (ref. 3 below) does find a connection between SIDS and DPT immunization (Dr. Morgan is getting off to a shaky start!).
2) I was concerned about the representativeness of the study population and, even more, by the small size and representativeness of the case group: 358 out of a population of 38,171 children immunized, or less than 1 in 100.
3) and 4) Dr. Morgan is simply confused here. My point is that Griffin et al. seem to consider seizures occurring more than 3 days after a vaccination is not vaccine-related but, as it were, part of a (never demonstrated) "background incidence" of seizures
5) and 6) Dr. Morgan quotes against me the conclusions of the very study I have criticized as methodologically defective. A little elementary logic is called for: before he can cite the article in his favor, he must deal with my criticism of it.
7) Again, he quotes studies whose methodology I have criticized. Dr. Morgan does not seem to understand that criticism of a study's methodology cannot be refuted by citing the conclusions of the same study.
To be specific: the Walker study he mentions (ref. 4), while suffering from all the methodological defects I have mentioned, does, even so, note one very disturbing case: "The single seizure that occurred within three days of a DPT was in an 11-month old white girl who suffered a 2 ½ hour generalized tonic-clonic seizure on the evening of her third DPT-oral poliovirus vaccination. Her temperature during the seizure was 39 degrees C. (102.2 degrees F.). Results of CSF studies were normal. There was a transient left hemiparesis and right sixth-nerve paresis. She was treated with phenobarbitol. At 6 years of age, while still taking phenobarbitol, she was experiencing rare focal left-sided seizures in the absence of fever and continued to have abnormal EEG tracings." So Dr. Morgan's "NO cases of unexplained encephalopathy or seizure disorders" seems to be a transparent lie. This girl will suffer from afebrile seizures for the rest of her life.
Dr. Morgan's depiction of the conclusions of the Danish study (ref. 5) is also erratic and incorrect. When the age of vaccination was changed, there was a concomitant change in the pattern of central nervous system infections, febrile convulsions (sometimes associated with long-term seizures), and central nervous system illnesses generally. My critique of that study may be found at: www.healthy.net/clinic/familyhealthcenter/children/vaccination.
His reference to the National Childhood Encephalopathy Study is also tendentious (ref. 6). The contribution made by this study and its followups has been to demonstrate that vaccinations do cause acute reactions and long-term neurologic sequelae. The authors suggested a low figure of 1:100,000 for the incidence of these conditions, but does anyone really believe that figure? Maybe Dr. Morgan does, but everyone else knows the figure is going to go up. My own estimate is 1:5-1:10.
8) I don't think I have ever used the word "conspiracy" in any of my writings. However, being a political scientist and historian by training, I know that social and professional groups usually work together to pursue common goals and to benefit themselves at the expense of society as a whole. This is what is happening in medicine today.In a society which expends $1 trillion every year on what are mistakenly called "health services," those who control these expenditures do so in such a way as to benefit themselves first and foremost. Pediatricians make about half their income from giving shots; hence they will defend shots to their dying day (may it come soon!) and are simply uninterested in data showing vaccinations to be dangerous. If this were a "conspiracy" against the public health, meaning that pediatricians gave vaccines deliberately in full awareness of their riskiness, they would not be vaccinating their own children.
9) I do a lot of other things besides criticizing vaccinations. And Dr. Morgan, with his usual silliness, doesn't even understand the concept of conflict of interest. If Barbara Fisher went on the Oprah Winfrey show to promote sales of DPT: A Shot in the Dark, would she be in "conflict of interest?" As I stated earlier, trying to answer Dr. Morgan is just a waste of time.
10) That honorific was bestowed upon me by The American Chiropractor, in part because of my admiration for the science and art of chiropractic (see my Divided Legacy, Vol. IV, Chapter VIII). Perhaps Dr. Morgan doesn't read the chiropractic literature any more.
In conclusion, let me note that Dr. Morgan uses the common, although not admirable, technique of misquoting the specialized literature on the assumption that no one will check up on him. But I check up on everyone and everything.
To me these vaccination issues are too important to proceed in this way. Each statistic is a human life which has been ruined, and the life of the statistic's family is usually ruined into the bargain.
These and other articles need to be critiqued on the Internet, since the medical profession doesn't do the job, and the critiques need to be critiqued as well. I have tried to start the ball rolling, and I hope that future contributions will be of higher quality than those of Dr. Morgan.
(Harris L. Coulter, PhD, July 22, 1996, firstname.lastname@example.org)