An Unconvincing Finnish Study

F. E. Yazbak, MD, F.A.A.P.; K. Yazbak, B.A., M.A.

Amazingly, MMR manufacturer Merck has sponsored yet another safety study from Finland.  This latest work by Patja, Peltola and Associates, which was published in the December issue of the Journal of Pediatric Infectious Diseases will surely be used by Governments to rule out an MMR-autism connection.

It should not.

The study, which lasted 14 years, ended in 1996, before parents and physicians had ever heard of an MMR-autism connection. The study never looked at autism and H. Peltola publicly stated that the research was not designed to pick up cases of autism.

Actually, the authors could not have found any cases of autism, even if they tried, because of the study inclusion criteria.

The study, a passive surveillance, only included information reported by health providers to the study’s central office. This method, somewhat similar to the United States’ VAERS reporting, is notorious for its representation of only a tiny proportion of actual cases (perhaps 10%).

In fact, a 1995 study, by members of the UK Public Health Laboratory Service which was published in the Lancet, stressed that passive surveillance is not successful and that active surveillance of adverse events associated with MMR and DPT is imperative.

Patja and Associates state that reports were more frequent at the beginning of the study and then decreased in number.  They also indicate that cases listed were reported shortly after MMR administration and followed as long as possible.  This approach is obviously inappropriate for chronic conditions such as autism, which characteristically have an insidious onset.  The cases which only started to exhibit speech regression, developmental stagnation, and behavioural deterioration, after a longer period were never reported and investigated nor followed-up.  In fact, even if the inclusion criteria were broader, the whole group of children with autism would still have been missed because from 1982 to 1996, absolutely NO ONE suspected that Autism was linked to a vaccine.

One should question if even the acute cases were reliably reported.  The authors intimate under "Results," in the beginning of the article, that after reviewing the cases of 1.8 million individuals who received some 3 million doses of MMR, there were only 173 "potentially serious reactions claimed to have been caused by MMR vaccination."  The authors then mention that, of the 77 neurological, 73 allergic, 22 miscellaneous reactions and one death reported, some 45% were probably caused or contributed by some other factor.

On the third page, the authors mention that only 437 patients were reported to have a vaccine-associated untoward event, of which 169 (almost half of whom were hospitalised) were considered "potentially serious."  Under these results, the authors mention that “the majority of the reports concerned innocuous symptoms and signs not fulfilling the above mentioned criteria and were excluded from further analysis” (Table 1).  Idiopathic Thrombocytopenic Purpura was also excluded "because it has been analysed previously."  This is most unusual and particularly unacceptable in view of the fact that ITP is listed as the third complication under adverse reactions to MMR in the American Academy of Pediatrics Red Book 2000 (p.392).  The review of Patja’s Table 1 (minor and self-limited adverse events) can put the whole study into perspective.  Patja reports there were 277 cases with fever, 162 cases with rash, 85 cases with lymphadenopathy and 24 cases with joint pain.  The Red Book lists the incidence of fever of 39.4oC (103oF) or higher at 5 to 15%.  The 277 febrile cases listed by Patja would represent 63% of the selected 437 cases (way too high) or 0.01% of the total number of vaccinees (way too low).  Similarly, if one looks at the 5% incidence of rashes after vaccination listed in the Red Book one would expect 22 cases out of 436 in Patja’s group to have a rash and not 162.  Similar discrepancies are also easily demonstrated in the incidence of lymph nodes enlargement and joint pain, two frequently noted symptoms.

One has difficulty sorting out the significance of what the authors are really reporting.  When it came to serious reactions in the limited group selected, the authors acted like defence lawyers trying to exonerate their clients rather than scientists investigating side effects.

The only death in the study was described as follows:  "A previously healthy 13-month old boy died during sleep 8 days after MMR vaccination.  The parents had noticed transient flaccidity and faintness a few hours preceding the death, but the symptoms had subsided immediately and the boy was entirely healthy when put to bed.  Forensic autopsy disclosed the cause of death as aspiration of vomit caused by acute gastritis.  His older sister also had a history of flaccid attacks unrelated to vaccinations."  This statement suggests that healthy (mentioned twice) 13-months old children are routinely put to bed and expire in their sleep of aspiration pneumonia secondary to acute gastritis.  The authors even mention the sister’s "flaccid attacks," whatever those are, to intimate some familial tendency to disaster but are careful not to say that 22 patients or 5% of all cases with adverse events had nausea and vomiting and that in 5 cases (1%) vomiting was the main event.  The same tone is noted in the less serious cases.

For example, when mentioning orchitis, which is inflammation, swelling and pain of a testicle, the authors say that in four 17- to 18-months old boys, orchitis was “suspected” 5 to 9 days post vaccination.  Orchitis is a known complication of the mumps vaccine component of the MMR.  A firm diagnosis of orchitis should be obvious and easy to make.  Certainly the boys and their parents knew.

Similarly, after reporting that two children were diagnosed with diabetes, one two weeks and the other 80 days after vaccination, the authors ruled out any association with the vaccine by mentioning the high incidence of Diabetes Mellitus in Finland.  They actually deemed a causal relationship unlikely because of a hard to believe personal communication, which they quoted, and which listed the incidence of Diabetes Mellitus in the general population as 10 times higher than that found in this series.

Most disturbing of all is the fact that immediately following the discussion of the diabetic events and in the same paragraph, the authors added the following, totally unrelated statement, "No cases of ulcerative colitis, Crohn’s disease or any other chronic disorder affecting the gastrointestinal tract were reported."

This statement denying the presence of certain findings does not belong at the end of the third paragraph on diabetes and after two paragraphs on pneumonia and orchitis under the heading "Miscellaneous Complaints."  This statement on Gastro-intestinal disorders was clearly added on and intentionally aimed at neutralising Dr. Andrew Wakefield’s upcoming revelations.

If anyone ever doubted that the publication of this paper was a pre-emptive coup, this alone should remove all doubts.
Patja and her associates report that the incidence of serious adverse events with possible or indeterminate causal relation with MMR vaccination is 5.3 per 100,000 vaccinees and 3.2 per 100,000 vaccine doses.  One wonders if there is a sinister ulterior motive in publishing a study with such “reassuring” findings, and sponsored by the vaccine manufacturer, which had been   withheld for FIVE years … but is released just before the anticipated Wakefield Report.

The authors owe everyone an explanation.  In the meantime, the good people of Finland urgently need independent and responsible research to answer the following questions:

Ø    Why does Finland have the highest incidence of Diabetes Mellitus worldwide?

Ø    Why is a higher incidence of autism being noticed in Finland (and in the western world) lately?

Ø    Why is there such a high incidence of Irritable Bowel Disorders in Finland?

Ø    Why is Schizophrenia more prevalent in Finland than in most other western countries (Torrey 1987,
        Lehtinen 1990, Hovatta 1997)?

Ø    And why an “Explosive School-based Measles Outbreak” occurred in a country such as Finland with a
        near perfect vaccination record as reported by Dr. Patja’s group?

Reference

Mikko Paunio, Heikki Peltola, Martti Valle, Irja Davidkin, Martti Virtanen, and Olli P. Heinonen (University of Helsinki, Helsinki, Finland) Am J Epidemiol 1998;148:1103-10

Conclusion

This latest study offers no new insight into the very important debate about MMR vaccination and potential side effects. As ever, it is imperative that Governments commission serious, scientific and independent research.

The preceding statements may not represent the views of organisations to which we belong.

TL Autism Research

Falmouth, Massachusetts

January 19, 2001