New IOM Report on Vaccine Adverse Effects Shows Alarming Lack of Good Science SafeMinds Notes: Parents Should Still be Concerned
Safeminds.org Washington DC. The Institute of Medicine's Panel on Adverse Effects of Vaccines issued a report today on the evidence and causality of vaccine harms. Despite a glowing press release, the report does little to allay public concerns over adverse effects of vaccines and suggests that we urgently need more science on vaccine adverse effects.
The IOM report took two years to produce, mostly behind closed doors, and was paid for by the Department of Health and Human Services, the government agency which is also a defendant against the vaccine-injured in the government's vaccine court.
Due to a narrow set of objectives defined for the IOM by the government, the report only looked at a small set of published research studies linking just two vaccines to developmental disorders such as autism. Only four epidemiological studies were considered of sufficient quality to evaluate the MMR vaccine in relation to autism and no studies were deemed of sufficient quality for the DtaP vaccine and autism analysis. The committee did not attempt to evaluate six other vaccines for autism causation, the safety of the cumulative vaccine schedule and health outcomes like autism, or the safety of vaccine ingredients like mercury and aluminum in the context of chemical exposures from other sources like air pollution or consumer products.
The report considered 158 potential adverse outcomes from vaccines. Of these, 135 or 85% were found to have inadequate research to accept or reject a causal association. Of the 23 outcomes where the research was deemed adequate, 18 or 78% were found supportive of harm. Vaccines were cleared of safety concerns for just five of the outcomes considered. "These statistics are hardly reassuring to parents who are now asked to give their young children over 32 vaccinations," noted Sallie Bernard, President of SafeMinds.
The report found likely causality of immune dysfunction, seizures and encephalopathy from some vaccines. These conditions are often found in individuals with autism. "It is plausible that a subset of children became autistic because of these adverse events from their vaccines. There are many cases of autism compensated by the vaccine court after having one of these conditions," noted Lyn Redwood, RN, Director of SafeMinds. Details of a recent review are available HERE: A SafeMinds review (HERE) of the epidemiological studies on MMR and thimerosal and autism is available:
That 85% of even a small subset of health outcomes has inadequate science speaks of the critical need for more research on vaccine safety. SafeMinds calls on Congress and the Administration to institute a rigorous science program on vaccine safety. This program would include the establishment of an independent Vaccine Safety Agency (similar to the National Transportation Safety Board), the launch of a study comparing health outcomes between vaccinated and unvaccinated children, the inclusion of vaccines as an exposure variable in the National Children's Study and mandatory reporting by physicians to the Vaccine Adverse Event Reporting System.
The Coalition for SafeMinds is a 501C-3 organization dedicated to restoring health and protecting future generations by eradicating the devastation of neurological disorders induced by mercury and man-made toxicants.
Carol, Polish children used to be exempted but this is not the case anymore. With strong focus on vaccination rates our vaccine-pushers started a campaign to vaccinate also children with neurological problems. Right now our vaccine-pushers do just copy & past from US AICP and adjust only for financial reasons.
No one knows the numbers of autistic children in Poland. Many parents with autistic children don't even use public health sector as it is not very helpful.
Posted by: Marc | August 29, 2011 at 05:07 PM
So Polish children who exhibit autism, developmental delays or other health problems are exempt from further vaccinations? Interesting.
What's your estimation of autism in Poland? Is it increasing? Decreasing?
Posted by: Carol | August 29, 2011 at 10:25 AM
@Carol, your translation is correct. And correct, those non-vaccinated got everything else but not M or MMR. As we know the abstract is read by many who would not bother to do the translation. That is the biggest lie from 2009 : "The study provides strong evidence against association of autism with both MMR and a single measles individual vaccine."
Posted by: Marc | August 29, 2011 at 06:01 AM
And Carol - the Cedillo's did think that it was a prior DPT shot that set their child up for it's reaction to the MMR.
Posted by: Benedetta | August 28, 2011 at 08:49 PM
In the original Polish version of Mrozek-Budzyn et al., the authors explain the supposed protective effect of M or MMR vaccination this way (translation provided by Google and me, so be kind):
"Our results would seem to provide a basis to believe that [M or MMR] vaccination is highly protective against autism, but the results cannot be interpreted in that way. This [supposed protective] effect is no doubt due to the fact that children with prior health conditions were not vaccinated for measles. In our study, autism was the earliest appearing (?) serious disease. Disorders and developmental delays caused by perinatal problems and problems in infancy may have exempted children from measles vaccination."
Something like that. I'd be curious to know if a paragraph similar to this exists in the later [ghostwritten?] version of Mrozek-Budzyn.
It appears that when the authors say "non-vaccinated," all they mean is the kids didn't get vaccinated for measles. So the poor kids who already had autism didn't get M or MMR.
In 2006, Polish children were getting BCG and Hep B at birth. At 2 months, Hep B and DTP (not DTAP). At 3-4 months, DTP and IPV. At 5 months, another DTP and IPV. (Can I be reading this right?) At 6-7 months, another Hep B. At 13-14 months, mumps, measles and rubella. At 16-18 months, more DTP and IPV. Then they get a few years to recover.
Posted by: Carol | August 28, 2011 at 04:35 PM
indeed there are many issues with the paper in 2009 and 2010:
1. the abstract in English from 2009 paper says:
"The study provides strong evidence against association of autism with both MMR and a single measles individual vaccine."
This statement indicates that this was a study against children non-vaccinated with M or MMR. Technically this is correct but in the text itself it is noted that those non-vaccinated children were exempted due to their developmental delays and disorders!
„Jednak część dzieci charakteryzowała się pewnymi obciążeniami z okresu okołoporodowego oraz wieku niemowlęcego, które mogły być odpowiedzialne za pojawienie się zaburzeń i opóźnień rozwojowych już w pierwszym roku życia, co mogło być powodem zwolnienia dzieci z grupy przypadków ze szczepienia przeciw odrze.”
2. In the 2010 paper all analyses against the non-vaccinated children were at once "statistically not significant"
3. in the paper 2009 in table III you will find details about the age at which children got M or MMR, 34 cases got MMR before 18th month, 35 got MMR before 24th month, 37 got MMR before 36th month. This means that small percentage of this very small group of cases was vaccinated at the typical age of 13th - 14th month.There is no analysis of age of vaccination/onset of autism
4. Main author is director of goverment agency chasing parents who delay or refuse to vaccinate and up to short time ago making pressure and putting financial fines on such parents. She disribes herself as "great supporter of vacciantion"
5. FYI: Our "mandatory" schedule (until now!) consists of 3 x 25mcg EtHg (HepB) and 3 x 25mcg EtHg (DTP) until age end of 7th month
Posted by: Marc | August 28, 2011 at 04:17 PM
Thanks, Marc. I could tell that the English language abstract in Przegl Epidemiol was not a translation of the Polish so I put the Polish through Google Translate:
"In Poland, despite high vaccination rates MMR, testifying to their good acceptance there are still doubts about their safety, and especially the potential link with autism. Although many publications niepotwierdzających such a relationship, some doubts in many people remain, especially that from time to time may be exacerbated antyszczepionkowych by representatives of movements. The pediatric population in the Malopolska province, characterized in recent years a great diversity in terms of vaccination against measles, mumps and rubella was a good group to undertake research on this issue. In a clinicopathologic study - a control group of test children were diagnosed with childhood autism or atypical. The control group was chosen so to every child from the group cases corresponded two children of the same sex, same age and of primary care in the same clinic every child with autism. Studies have confirmed no relationship between vaccination vaccine MMR and the incidence of autism in children."
Putting the whole article through Google Translate gives a good idea of the lay of the land. As you pointed out, there is no mention of mumps vaccination.
Posted by: Carol | August 28, 2011 at 08:15 AM
Yes, the amount of distrust of governmental agencies is quite alarming. It's so bad that I have seen people claim that having no governmental agencies is better than having the current ones. I think a lot of changes are needed.
Posted by: Heidi N | August 26, 2011 at 07:07 PM
The study Budzyn-Mrozek et al (2010) has following major flaws:
- in the period considered by authors that is 1992 - 2005 (children 2-15 years old, study took place 2006 - 2007) the ratio of children vaccinated with single:MMR was 3:1 (or even 4:1)
- the MMR uptake reached 50% in 2004 as it became part of the obligatory vaccination schedule (right after the attempt to mandate MMR with URABE AM9 which was rejected by parents and medical community), here earlier study with Fig. 1 showing the uptake of MMR in that part of Poland http://www.pzh.gov.pl/oldpage/przeglad_epimed/62-3/623_27.pdf
- in the years considered by authors there was official recommendation to get single mumps vaccine after 13th month of life, whereas obligatory measles vaccine was scheduled for 13-14 month, study does not tell anything whether in any of the children combination of both injections took place or not
The first publication from Prezgl Epidemiol in Polish in 2009 had another focus and did not consider timing of autism onset. Here the paper in Polish: http://www.pzh.gov.pl/oldpage/przeglad_epimed/63-1/631_20.pdf
I am schocked that this paper (2010) comparing single vs MMR is considered as evidence that MMR does not cause autism.
Moreover in this IMO Report there is another Polish paper considered with regards to DTP and DTaP http://www.ncbi.nlm.nih.gov/pubmed/19108523. This one is based on so-called obligatory monitoring system of AEs. This is a joke. Most of our doctors are still not aware of any vaccine side effects and even if they are they dont report as they are obliged to(only doctors can report).
I hope it helped.
Posted by: Marc | August 26, 2011 at 05:53 PM
If nothing else .. this latest IOM report provides clear.. convincing evidence .. that existing federal public health agencies (IOM, FDA, CDC, HHS, etc) cannot be trusted to conduct an independent .. scientific study of "vaccinated vs. unvaccinated" populations .. to ascertain .. once and for all .. if BOTH populations have suffered the same dramatic, inexplicable increase in chronic autoimmune disorders that were far less common in all previous .. less vaccinated generations.
This critical study is long overdue .. and .. over decades .. existing public health agencies have given us every reason to believe their only interest is to protect the "status quo".
So, we should begin identifying those we trust to do it.
The same distrust has been earned by the Vaccine Adverse Event Reporting System (VAERS) .. who has long ignored widespread reports that doctors and pediatricians routinely refuse to "voluntarily" comply as requested.
After all .. what trust should we have in VAERS if they don't care if the vast majority of doctors and pediatricians don't comply with their "request" to report adverse reactions .. even if the doctor and pediatrician are not sure whether the vaccine caused the adverse event?
Let's begin by demanding VAERS define a suspected vaccine injury .. so everyone .. doctors, pediatricians and parents .. know what should be considered an adverse event?
Does anyone know the answer to that?
Posted by: Bob Moffitt | August 26, 2011 at 05:19 PM
The report is another good example of scientists finding what they're looking for.
Posted by: Frank | August 26, 2011 at 03:22 PM
Mrozek-Budzyn was originally published in Prezgl Epidemiol in Polish in 2009. Here's the English language abstract for it:
"The matched case-control study has been undertook to investigate whether measles, mumps, and rubella (MMR) vaccine may be casually associated with autism in children. Cases were children to 14-year old with diagnosis of core autism or atypical autism. Controls were matched on age, sex and general practice. The 96 cases and 192 controls were included. The study provides strong evidence against association of autism with both MMR and a single measles individual vaccine. Additionally children vaccinated with MMR, regardless of age of vaccination (to 18th, 24th and 36th month of life), had risk equal half of that of single measles vaccinated (for vaccinated to 18th month OR=0.41 95%PU: 0.20-0.85). Our findings confirm that MMR vaccination is not associated with an increased risk of autism in children."
By the time the article got published in Pediatric Infectious Disease Journal, the English of the abstract had been cleaned up (mostly) and the numbers cited were somewhat different.
It might be interesting to compare the two articles, especially since the study indicates that MMR vaccination protects against autism. A lot. Someone read Polish out there?
Posted by: Carol | August 26, 2011 at 01:09 PM
Most of the media outlets seem to be confused. This IOM report is not "good science," because it's not science at all. It's not a study; it's an analysis of prior studies, and as Anne points out (in the Seattle Times quotation), there is a paucity of data:
"But in the vast majority of cases – 135 out of 158 examined – the committee couldn’t reach any conclusions about connections between vaccines and serious health conditions, saying there was insufficient evidence."
So in the end, for most of the questions, we don't know the answer. You'd think the next step would be to commission a comparative health outcome study of vaccinated and unvaccinated populations, as SafeMinds rightly calls for. Choosing not to commission such a study means that the IOM really doesn't want to know.
Posted by: Theresa O | August 26, 2011 at 12:40 PM
Another bogus study to defend the profitable vaccine industry.
The study may as well say vaccines are safe because we said so.
Meanwhile where is the urgency to find the cause of the autism epidemic effecting millions of families?
Posted by: Rich | August 26, 2011 at 11:55 AM
..."This program would include the establishment of an independent Vaccine Safety Agency (similar to the National Transportation Safety Board), the launch of a study comparing health outcomes between vaccinated and unvaccinated children...."
This would be a great idea.
If the AAP is given "weekends off" for vaccinating children, nearly 114 children "crash into the world of Autism" each weekday.
As always, the vax/ unvax study is critical. It has not been done because the IOM, NIH, IACC, AAP & CDC knows exactly what the hell they will find.
Posted by: cmo | August 26, 2011 at 11:01 AM
While the NY Times, the Wall Street Journal and the other major news outlets are telling us once again that more evidence debunks a link between vaccines and autism or other serious side effects, the Seattle Times is presenting a totally different story.
"But in the vast majority of cases – 135 out of 158 examined – the committee couldn’t reach any conclusions about connections between vaccines and serious health conditions, saying there was insufficient evidence.
"For example, the committee said it did not try to determine how often such serious vaccine-caused adverse events occur. . . .
"But in the briefing, Clayton and other committee members could not put a number on 'rare.'
"Without numbers, it’s impossible to compare the risk of an adverse event to the risk that an unvaccinated child might get seriously ill from a disease.
"The committee also said it was not asked to answer the question 'Are vaccines safe?' Nor did it have data to address the concern by many parents about multiple vaccines given at one time."
So why are so many big media sites telling us this report is good science?
Posted by: Anne McElroy Dachel | August 26, 2011 at 10:24 AM
After reading the report brief I can only echo what The Bard said many many years ago; "Much To Do About Nothing".
Posted by: Harry H. | August 26, 2011 at 09:55 AM
"independent Vaccine Safety Agency (similar to the National Transportation Safety Board)"
Sounds like a great idea.
There have been so many great ideas in the last century trying to curb this insanity - and pharmaceutical/special interest have invaded into evey idea ruining every good idea and saftey net that is suppose to protect the public.
After all there already exist :
The Institute of Medicine's Panel on Adverse Effects of Vaccines.
Oh, and let us not forget VAERS. That works really well too doesn't it.
See how well that has worked for all of us.
Posted by: Benedetta | August 26, 2011 at 08:33 AM
Immune Dysfunction, Seizures, Encephalopathy....that IS Autism!
Posted by: Shelly Sulkoske | August 26, 2011 at 07:41 AM