There Goes That Argument! by F. Edward Yazbak, MD, FAAP

For years Andrew Wakefield has been vilified and persecuted for publishing an article in Lancet on February 28, 1998.

Since then, he has been accused of inventing a gastro-intestinal illness and endangering the world because he reported that some of the 12 parents in that UK study had stated that their children’s autistic and gastro-intestinal symptoms had started soon after they had received an MMR vaccination.

It is safe to propose that prior to 1998, parents (and pediatricians) in Utah, Minnesota. North Carolina and elsewhere in the United States had not heard of Dr. Wakefield and had no idea that autistic regression sometimes followed MMR vaccination.   

I have been interested in VAERS, the Vaccine Adverse Event Reporting System since it was launched and have acquired some expertise in understanding and evaluating individual reports. 

It was with some surprise that I recently discovered that there had been 15 reports filed with VAERS prior to December 31, 1997 by parents stating that their children had developed autistic symptoms after receiving MMR vaccines in the United States.  

There seems to be general agreement about the following two statements:

1: A report to VAERS does not necessarily imply causation
2. Only a small percentage of vaccine adverse events are ever reported to VAERS

I excluded one of the 15 VAERS reports in question because I felt it was unreliable.   

Demographic data from the remaining 14 reports are listed in the following table.

R E F	Report	State	S E X	Age	Date Vaccine	Date Symptoms	Date Reported
1	42498	CA	M	1yr	2/21/90	2/21/90	5/29/92
2	66998	PA	M	4.5y	9/1/94		9/29/94
3	75900	WA	M	15m	11/18/92	11/19/93	7/11/95
4	80851	UT	F	16m	2/28/92		1/11/96
5	86243	MN	M	15m	1/26/94	2/5/94	5/7/96
6	88924	FL	F	1yr	8/1/94	8/3/94	8/5/96
7	90090	CT	M	2.9y	11/30/94	12/1/94	9/17/96
8	94657	MN	M	15m	10/11/94	10/11/94	1/30/97
9	101800	TX	M	15m	2/23/95	3/5/95	8/18/97
10	77558		M	4y	3/4/92		9/11/95
11	102477	NY	M	15m	10/18/90	10/18/90	8/12/97
12	102670	NC	M	4.5y	5/9/96	5/9/96	9/23/97
13	102948	TX	M	15m	2/23/95	3/4/95	10/2/97
14	103158	NJ	M	15m	11/14/95	11/18/95	10/4/97

Comments

-Children 15-23 months are sometimes listed as 1 year.

-Date of symptoms is the date symptoms and not autistic symptoms, appeared

-Reports related to the first dose of the vaccine were usually filed 2 to 3 years after vaccination, a reasonable period for the symptoms to appear and for the diagnosis to be formulated. Case 11 was filed seven years after vaccination.

-Reports about 4-year-old children appear to have been filed more promptly. Case 2 for example was filed with VAERS within a month of vaccination. It could represent a situation referred to as Challenge/De-Challenge/Re-Challenge where the child had reacted to his initial dose, improved somewhat, then promptly crashed after the booster dose. Unfortunately the report is very sketchy and the Lot number is not listed for further analysis.

-Case 1 was about a California toddler who was vaccinated and apparently had fever and or symptoms of encephalopathy the same day. The dose of MMR Vaccine he received was from Lot 2018R. Another California toddler (Report 26127) a girl, who received a dose of vaccine from the same lot just one week later, developed severe Thrombocytopenic Purpura within 28 days of vaccination. Her platelet count dropped to 4000/ mm3. The normal platelet count for that age is 150,000-450,000 platelets per mm3. According to the MMR®II product insert, thrombocytopenia is an adverse reaction to the vaccine. [http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf]  

On March 24, 1997, a full seven years later, the National Vaccine Injury Compensation Program (VICP) added thrombocytopenia to the “Vaccine Injury Table”.
[http://library.findlaw.com/1997/Aug/13/127439.html]
 

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The “Symptoms” and “Write-ups” below are exactly as they appear on the VAERS reports.

1. Report 42498 - http://tinyurl.com/4o24gao 

Symptoms: Autism, Encephalopathy, Hyperacusis, Immunoglobulins decreased, Immunoglobulins increased, Mental retardation severity unspecified, Personality disorder, Speech disorder

Write-up: Pt recvd MMR vax & exp fever, austistic behaviors, encephalatic condition, began to tune out; sound sensitivity, hand-flapping, wheel-spinning; nightime sweats, appetite inc;

2. Report 66998 - http://tinyurl.com/4dnadyk

Symptoms: Autism, Laboratory test abnormal

Write-up: pt recvd vax & was dx w/ autism;

 3. Report 75900 - http://tinyurl.com/4jgl5e5

Symptoms: Autism, Hypersensitivity, Mental retardation severity unspecified, Speech disorder, Thinking abnormal

Write-up: pt recv vax 18NOV92 & the same day exp allergies, learning difficulties & stopped talking; no further info provided

4. Report 8085 - http://tinyurl.com/4bnroyq

Symptoms: Autism, Otitis media

Write-up: pt recvd vax; became autistic p/ vax; repeated ear infection;

5. Report 86243 - http://tinyurl.com/4mgqmdd

Symptoms: Agitation, Aphasia, Autism, Convulsion, Gaze palsy, Personality disorder, Pyrexia, Speech disorder

Write-up: pt was fussy & w/fever noc a/& all day that noc about 10PM;pt became very hot & given APAP 5min later;911 called took pt to hosp dx autism;behavior changed, (sz disorder), loss eye contact

6. Report 88924 - http://tinyurl.com/4vb82j9

Symptoms: Agitation, Autism, Immune system disorder, Immunoglobulins decreased, Mental retardation severity unspecified, Pyrexia, Rash maculo-papular

Write-up: low fever, much discomfort, pt laid in bed & cried & moaned, 3-4 days p/vax rash travelled over pt body & lasted @ least 1 wk;w/in 6 wk of vax pt was observed as losing prev gained language & social skills;dx autistic;

7. Report 90090 - http://tinyurl.com/4ck8bsy

Symptoms: Autism, Hypotonia, Infection, Mental retardation severity unspecified, Personality disorder

Write-up: loss of words, loss of eye contact, inc toe walking, hand flapping;inappropriate laughing, temper tantrums biting of clothing, repetition of words-no meaning;tx vitamin B-minerals;dx autism M.S.D.D.;

8. Report 94657 - http://tinyurl.com/4v3jglm

Symptoms: Autism, Delirium, Depersonalisation, Dermatitis exfoliative, Mental retardation severity unspecified, Pyrexia, Rash maculo-papular, Speech disorder

Write-up: high fever for 3-4 days then rash for 5 days;then high fever for 2 days;blotchy rash-hands peeled;pt stopped talking p/vax;lost eye contact;devel autistic traits;tx mom called ER given Ibuprofen;

9. Report 101800 - http://tinyurl.com/4cu4zhv

Symptoms: Autism, Drug ineffective, Febrile convulsion, Hypotonia, Infection, Pyrexia, Rash, Speech disorder

Write-up: pt recv vax 23FEB95 & pt exp short feb sz w/t105;5MAR97 pt taken to ER & hosp;rash initially thought to be chicken pox dx as roseola the following day;mom reported child devel autism p/vax;pt stopped all devel & lost little bit of speech ha

10. Report 77558 - http://tinyurl.com/46f3enj

Symptoms: Autism, Deafness, Neuropathy

Write-up: pt recv vax;few months later was dx as being autistic; a dx of bilateral severe nerve deafness was also made; pt had previously been nl;autism & nerve deafness persisted; addtl info not expected;

11. Report 102477 - http://tinyurl.com/4sjs9n5

Symptoms: Autism, Gait disturbance, Hyperacusis, Mental retardation severity unspecified, Pyrexia, Speech disorder, Stupor, Visual disturbance

Write-up: fever-dec level of consciousness;dec ability to focus;loss ability to speak;autism;

12. Report 102670 - http://tinyurl.com/4plyf4e

Symptoms: Autism, Hyperhidrosis, Immunoglobulins increased, Lymphadenopathy, Personality disorder, Pyrexia, Speech disorder, Urticaria

Write-up: pt recv vax 9MAY96 & same day pt devel high fever, noc sweats, dehydration, large swelling of all lymph glands, strange behavior & was talking to himself;11MAY96 all sx cont;hive-like swelling of the glands;made grunting sounds;dx autism

13. Report 102948 - http://tinyurl.com/4h44u9g

Symptoms: Autism, Febrile convulsion, Gastrointestinal disorder, Infection, Mental retardation severity unspecified, Pyrexia, Rash, Speech disorder, Vomiting

Write-up: 9 days post vax pt rushed to hosp w/t105, vomiting, febrile sz, faint rash on trunk of body-became autistic-measles titer of 116;lost speech;

14. Report 103158 - http://tinyurl.com/4umjez9

Symptoms: Autism, Deafness, Personality disorder, Stupor

Write-up: p/15mo shot pt became autistic;1 starring spell noted a few days p/vax;pt seemed deaf & in own world;reported info to MD & eval started;

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As of February 28, 1997, exactly a year before Dr. Wakefield published his study of 12 in the Lancet, 5,123 petitions for compensation had been filed with the National Vaccine Injury Compensation Program (VICP). Of these, 73% were related to DTP vaccination. The second largest group (14%) included petitions about adverse events related to the MMR vaccine or its components. [http://library.findlaw.com/1997/Aug/13/127439.html]

A number of those were related to autism and autistic spectrum disorders (ASD).  

[http://www.hrsa.gov/vaccinecompensation/statistics_report.htm]

In a detailed 1998 review of measles vaccine-related encephalopathy, researchers and statisticians from the National Vaccine Injury Compensation Program and the Office of the General Counsel, United States Department of Health and Human Services did not once mention autism or ASD by name although they repeatedly discussed developmental regression.

[“Acute Encephalopathy Followed by Permanent Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program” by Weibel, Caserta, Benor and Evans. Pediatrics 1998;101;383-387]

According to Weibel et al.:

    •    From 1970 to 1993, forty eight (48) children met the inclusion criteria of an acute encephalopathy 2 to 15 days after receiving measles vaccine, alone or in combination (MR or MMR)
    •    Eight children died and “the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders” (permanent brain impairment)
    •    The patients ranged in age from 10 months to 49 months, with a median age of 15 months and a mean age of 17.5 months.
    •    The onset of neurologic signs or symptoms occurred with a nonrandom, statistically significant distribution on days 8 and 9 following vaccination.

The authors concluded that “This clustering suggests that a causal relationship between  measles vaccine and encephalopathy may exist as a rare complication of measles immunization.” 

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 Conclusions

On February 28, 1998, thirteen years ago today, Dr. Andrew Wakefield and others published an article in Lancet.

Although Dr. Wakefield never once said that MMR vaccination caused autism, his life has been ruined and his license to practice medicine has been revoked because he dared suggest that research was needed to look at all the possible causes of autistic regression.

It is now clear that before they ever heard of Dr. Wakefield, some US parents had also suspected that their children’s autism and encephalopathy were at least chronologically related to their MMR vaccination.

Fourteen of those parents reported their children’s reactions to the Vaccine Adverse Event Reporting system between May 28, 1992 and October 4, 1997.

Others filed petitions with the National Vaccine Injury Compensation Program.

It is time to stop attacking the messenger.

It is also time to honestly investigate all the possible causes, without exception, of the terrible calamity that has decimated a generation.   

 

F. Edward Yazbak MD
Falmouth, Massachusetts 02540

February 28, 2011