“Study protocol was not followed” means they committed FRAUD!
In a compliant on October 14, 2014 to CDC Dr. Brian Hooker and Dr. Wakefield wrote:
We write to report apparent research misconduct by senior investigators
within the National Immunization Program (NIP), Battelle Memorial
Institute at the Centers for Public Health Evaluation (CPHE), and the
National Center on Birth Defects and Developmental Disabilities (NCBDDD),
and to request an immediate investigation.
The Analysis Plan dated September 5, 2001 [Exhibit 2] set forth the
objective of the research reported in the above-titled article, to compare
ages at first MMR vaccination between children with autism and children
who did not have autism, and to test the hypothesis that age of first MMR
vaccination is associated with autism risk.
The research team, headed by Dr. Frank DeStefano, MD., (NIP) including
Dr. William Thompson Ph.D., (NIP) Dr. Marshalyn Yeargin-Allsopp, MD
(NCBDDD), Dr. Tanya Karapurkar Bashin (CPHE), and Dr. Coleen Boyle,
Ph.D., (NCBDDD) (collectively referred to by Dr. Thompson as “The Group”)
found statistically significant associations between the age of first MMR
and autism in (a) the entire autism cohort, (b) African-American children, 2
and (c) children with ‘isolated’ autism, a subset defined by The Group as
those with autism and without comorbid developmental disabilities.
However valid results pertaining to the latter groups (b) and (c), crucial to
resolving the debate over MMR and autism causality, obtained according to
the Analysis Plan, were omitted from The Paper. The concealed results
rendered The Paper’s conclusion false and misleading: “we found that,
overall, the age at time of first MMR administration was similar among case
and control children.” [Exhibit 1, page 265]
This false and misleading report contributed to the CDC’s conclusion that
MMR vaccine did and does not cause autism, to rejection of a causal
association by the Institute of Medicine (IOM), and to denial of
compensation mandated by Congress in the National Vaccine Injury
Compensation Program (NVICP).
This misconduct was recently made public by Dr. William Thompson Ph.D.,
one of the authors of the Paper, an epidemiologist and statistician, and
presently a Senior Scientist at the CDC. He issued a statement [Exhibit 3]
on August 27, 2004, where he explained in part:
I regret that my coauthors and I omitted statistically
significant information in our 2004 article published in the
journal Pediatrics. The omitted data suggested that African
American males who received the MMR vaccine before age 36
months were at increased risk for autism. Decisions were
made regarding which findings to report after the data were
collected, and I believe that the final study protocol was not
Dr. Thompson brought the misconduct to the attention of Dr. Julie
Gerberding, the CDC Director at the material time, despite which the
misconduct was allowed to continue and continues to this day.