The dangers of the DPT and MMR vaccines are well known to anyone who examines the 'non-official' evidence that is coming regularly from parents whose children have been damaged by both these vaccinations, and others. Those who have not looked into this are entirely reliant on official Department of Health, NHS, and GP denials, and the mainstream media's passive and unquestioning acceptance of these denials.
Regular readers of this blog will be aware that I have recently published 3 blogs in relation to the dangers of the DPT and the MMR vaccines, routinely given to our young children.
The third blog was an 'open' letter to Jeremy Hunt, Secretary of State at the Department of Health, asking him to confirm the 'side-effects', 'adverse reactions', or DIEs, contained within these package inesrts.
There has now been a response from the Department of Health to my letter. I have copied the Department of Health's response letter below, so that if anyone wants to plough through it can do so. However, for those people who don't want to do so this is my précis of what they seem to be saying.
Here is the DoH letter...
"The two documents you refer to are the product inserts in Infanrix vaccine and MMRII vaccine in the United States. Whilst the Department is unable to comment on the US manufacturers' rationale for including these events you describe in these inserts, it should be noted that both documents state that such events may be listed without regard to causality. It is therefore possible that some events listed in the US product inserts were coincidental with vaccination.
In the UK and Europe, possible side effects of medicines and vaccines are listed in the Summary of Product Characteristics (SPC) for healthcare professionals and the Patient Information Leaflet (PIL) for patients. These will differ in some ways to the US product inserts. Although Infanrix and MMRII are no longer marketed in the UK, the UK SPC and PIL for the similar products, Infanrix IPV and MMRVaxPro, can be viewed on the electronic medicines compendium website at http://www.medicine.org.uk/emc/.
Although in the past some adverse events were included in many EU SPC and PILs on the basis of spontaneous reporting and without established causality, current practice is that events should not be listed as a possible side effect in the SPC or PIL unless there is reasonable suspicion or evidence of a possible causal association. When a new signal of a possible side effect emerges, the Medicines and Healthcare Products Regulatory Agency (MHRA), which has responsibility for safety of medicines and vaccines in the UK, together with other European regulators, takes steps to review all available evidence to assess a causal association and to quantify the risk. Regulatory action may then be taken to ensure prescribers and patients are aware of the possible risks via the product information and other relevant communication.
The UK product information for Infanrix IPV (and other DPT vaccines_ does not list Sudden Infant Death Syndrome (SIDS) as a possible side effect. There is reference to DIDS within the SPC but only to state that a family history of SIDS should not preclude vaccination. The association between infant immunisation and SIDS has been extensively studied through epidemiological research. These studies have found no evidence of a causal association and are published in the medical literature.
Similarly, Guillain-Barre syndrome (GBS) is not listed as a possible side effect in the Infanrix IPV and there is no robust evidence to support this association. Researchers in the US have recently published a study which found no evidence of an increased risk of GBS following vaccinations of any kind (including DPT and MMR vaccines). Although GBS is listed as a possible side effect in the MMRVaxPro SPC, this is an historical inclusion in MMR vaccines SPCs based on temporally-associated case reporting, and there is no robust evidence of a causal association.
Encephalitis, if causally associated with MMR vaccine, has been reported at a frequency below one per 10 million doses. Any risk of encephalitis following administration of the vaccine is far below the risk of encephalitis cause by natural diseases (measles: 1 in 1000 to 2000 cases; mumps: 2-4 in 1000 cases; rubella: approximately 1 in 6000 cases). The balance of risks and benefits of MMR vaccine are clearly favourable.
Of course, as with any medicine, vaccines can cause side effects in some people and potential risks must be balance against the expected benefits in preventing serious disease. However, serious side effects are very rare. It is important that healthcare professionals discuss potential risks and benefts with vaccines or their parents/carers, and the PIL should be made available to parents/those being vaccinated when they receive the vaccine. The PIL is a useful basis for this discussion.
Regular readers of this blog will be aware that I have recently published 3 blogs in relation to the dangers of the DPT and the MMR vaccines, routinely given to our young children.
- The DPT Vaccine. Do doctors really know it is dangerous? And if so why are they not telling us?
- The MMR Vaccine: Our GPs, the NHS, and Big Pharma know it is dangerous.
- Open Letter to Jeremy Hunt, Health Secretary regarding the information on these vaccines
The third blog was an 'open' letter to Jeremy Hunt, Secretary of State at the Department of Health, asking him to confirm the 'side-effects', 'adverse reactions', or DIEs, contained within these package inesrts.
There has now been a response from the Department of Health to my letter. I have copied the Department of Health's response letter below, so that if anyone wants to plough through it can do so. However, for those people who don't want to do so this is my précis of what they seem to be saying.
- The package inserts relate to vaccines used in USA, and not in the UK and Europe. There is no explanation about just how different these vaccines are, but the insinuation appears to be is that the US vaccines are not safe (although they do not comment on this) but that 'our' vaccines are safe!
- And, as the US vaccines are no longer used here, this is not a problem for us.
- In the USA, such adverse reactions 'may be listed without regard to causality' so that 'it is possible that some events listed in the US product inserts were just a coincidence', that is, the vaccination and the adverse reaction may have come together, but this was just coincidental! The two events are quite separate. The child may have been healthy prior to the vaccination, and damaged (or even dead) after the vaccination, but without proof of causality we must not assume that the vaccine caused the damage!
- In Britain, we are told, 'current practice is that events should not be listed as a possible side-effect ... unless there is reasonable suspicion or evidence of a possible causal association'. In other words 'spontaeous reporting' (which I assume means a parent reporting that their child has been damaged, and there is a connection) is not good enough. This kind of evidence is considered to be 'anecdotal', and not 'scientific'. Parents making such claims are not to be believed, per se. If there is suspicion that there is a connection between a vaccine and child damage, there is no need for action until such time that a causal link has been found.
- Only when such a 'causal relationship' is found will the MHRA investigate into the situation. Of course, it is well to realise that the Department of Health, and the MHRA, has no money to research these 'causal links' independently, so usually it is the manufacturer who is asked to fund the research, and be good enough to let us all know.
- The main part of the letter gets complicated, with talk of 'SPCs' (Summary of Product Characteristics) and 'PILs' (Patient Information Leaflets), and what is, and (more accurately) what is not put in them. What seems clear from this description is that drugs and vaccines are put on to the market, they are given to us, and there are a variety of hurdles to negotiate before any 'adverse reaction' reports are even considered, leave along added to SPCs and PILs.
- Then comes the statistics about some of the diseases I highlighted in my letter. And, as you can see, there is just nothing to worry about!
- Finally comes the 'all drugs and vaccines have side-effects' argument, and the ultimate 'no gain without pain' argument, which for homeopaths, of course, is alway met with much laughter!
Here is the DoH letter...
"The two documents you refer to are the product inserts in Infanrix vaccine and MMRII vaccine in the United States. Whilst the Department is unable to comment on the US manufacturers' rationale for including these events you describe in these inserts, it should be noted that both documents state that such events may be listed without regard to causality. It is therefore possible that some events listed in the US product inserts were coincidental with vaccination.
In the UK and Europe, possible side effects of medicines and vaccines are listed in the Summary of Product Characteristics (SPC) for healthcare professionals and the Patient Information Leaflet (PIL) for patients. These will differ in some ways to the US product inserts. Although Infanrix and MMRII are no longer marketed in the UK, the UK SPC and PIL for the similar products, Infanrix IPV and MMRVaxPro, can be viewed on the electronic medicines compendium website at http://www.medicine.org.uk/emc/.
Although in the past some adverse events were included in many EU SPC and PILs on the basis of spontaneous reporting and without established causality, current practice is that events should not be listed as a possible side effect in the SPC or PIL unless there is reasonable suspicion or evidence of a possible causal association. When a new signal of a possible side effect emerges, the Medicines and Healthcare Products Regulatory Agency (MHRA), which has responsibility for safety of medicines and vaccines in the UK, together with other European regulators, takes steps to review all available evidence to assess a causal association and to quantify the risk. Regulatory action may then be taken to ensure prescribers and patients are aware of the possible risks via the product information and other relevant communication.
The UK product information for Infanrix IPV (and other DPT vaccines_ does not list Sudden Infant Death Syndrome (SIDS) as a possible side effect. There is reference to DIDS within the SPC but only to state that a family history of SIDS should not preclude vaccination. The association between infant immunisation and SIDS has been extensively studied through epidemiological research. These studies have found no evidence of a causal association and are published in the medical literature.
Similarly, Guillain-Barre syndrome (GBS) is not listed as a possible side effect in the Infanrix IPV and there is no robust evidence to support this association. Researchers in the US have recently published a study which found no evidence of an increased risk of GBS following vaccinations of any kind (including DPT and MMR vaccines). Although GBS is listed as a possible side effect in the MMRVaxPro SPC, this is an historical inclusion in MMR vaccines SPCs based on temporally-associated case reporting, and there is no robust evidence of a causal association.
Encephalitis, if causally associated with MMR vaccine, has been reported at a frequency below one per 10 million doses. Any risk of encephalitis following administration of the vaccine is far below the risk of encephalitis cause by natural diseases (measles: 1 in 1000 to 2000 cases; mumps: 2-4 in 1000 cases; rubella: approximately 1 in 6000 cases). The balance of risks and benefits of MMR vaccine are clearly favourable.
Of course, as with any medicine, vaccines can cause side effects in some people and potential risks must be balance against the expected benefits in preventing serious disease. However, serious side effects are very rare. It is important that healthcare professionals discuss potential risks and benefts with vaccines or their parents/carers, and the PIL should be made available to parents/those being vaccinated when they receive the vaccine. The PIL is a useful basis for this discussion.
SD, Ministerial Correspondence and Public Enquiries
