This year alone has seen India suspend the Measles vaccine, the Cervical cancer vaccine and the HIB vaccine; Australia, the Flu vaccine; Sweden, the Swine Flu vaccine along with Finland; and the USA, Switzerland and Jordan, the Rotavirus vaccine. What is going on? Last year the world faced a ‘so called’ pandemic of Swine flu, this year however, we are faced with an even worse pandemic of vaccine suspensions.
Can the companies manufacturing these vaccines be trusted or are they more interested in profit than protecting our health?[adrotate banner=”9″]With four of the countries suspending vaccines that the giant, GlaxoSmithKline, has developed, it seems that the company GSK cannot seem to get its vaccines right at all this year. The first vaccine to present problems for GSK was the Rotarix vaccine. This vaccine is supposed to protect us from the rotavirus, a virus that causes severe diarrhoea and sickness, particularly in very young children. Rotarix was suspended in the USA by the FDA, together with Switzerland and Jordan because it was found to be contaminated with benign pig virus, Age of Autism said at the time:-
“Fortunately for patient safety, AP Medical News reported “A group of scientists testing a new way to detect viruses in a variety of products stumbled onto fragments of genetic material â€” broken pieces of DNA â€” from what’s called porcine circovirus-1 in Rotarix and alerted Glaxo, which confirmed the findings and in turn alerted FDA, Hamburg said.
The report stressed that the suspension of use has been recommended despite no evidence of harm.”
Eventually the vaccine was returned to the market after extensive testing proved that the vaccine was thought to be safe and that these viruses could not harm the public. The FDA put out this press release in June of this year:-
“Update on Rotavirus Vaccines
In March 2010, FDA became aware of the presence PCV1 in Rotarix and DNA from PCV1 and PCV2 in RotaTeq. These viruses are not known to cause any infection or illness in people. Based on a careful review of a variety of scientific information, FDA has determined it is appropriate for clinicians and public health professionals in the United States to use these vaccines. All available evidence supports the safety and effectiveness of Rotarix and RotaTeq, which have been extensively studied, both before and after approval.”
With these problems still not yet resolved GlaxoSmithKline next hit problems with their H1N1 vaccine, the vaccine to protect the public from Swine flu. Glaxo’s vaccine Pandemrix was reported to be causing the sleep disorder narcolepsy in some patients. The Daily Telegraph reported that so far there have been 27 reports of suspected narcolepsy in people across Europe. They said:-
“Finland suspended its national vaccination programme on Tuesday after eight suspected cases of narcolepsy following administration of the jab. A further ten cases have been reported in Sweden, six in France, and one each in Germany and Norway.”
Things are really not going too well for GlaxoSmithKline who says in its GlaxoSmithKline Briefings – Working Together for the Health of Mothers and Children paper:-
“For decades, GSK has produced safe and effective products to help reduce the burden of disease and improve the lives of children and mothers. With our partners, we are constantly challenging our business model to find new ways of researching and delivering our products in order to provide sustainable solutions that reduce mortality in mothers and children and break the cycle of decline from illness. Better health leads to better economic development.”
Personally I am not convinced.
Another GSK vaccine with a difficult history of side effects and one which has constantly appeared in the UK media especially last year, is Cervarix, the vaccine to protect young women against cervical cancer. The side effects of this vaccine have been so bad that they were discussed by MPs in the Houses of Parliament in the House of Commons. I wrote an article in September 2009 So is it ALL in parents heads or is it in THE syringe? Cervarix danger by vaccination when the vaccine was approved by the FDA. In it, I wrote the following-
“This will have been recommended because of what is written in the CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant Vaccines and Related Biological Products Advisory Committee (VRBPAC) Briefing Document September 9, 2009 which I was lucky enough to receive a link to a copy through one of my colleagues from ICAP-International Coalition of Advocates for the People, from the Netherlands. Once again it seems that women and children are just ‘lab rats’ for GSK to test on. It says in section 6
Given the natural history of HPV disease, reduction in cervical cancer due to vaccination will take years and even decades. GSK has developed a model using a standardized approach (details of methodology are currently undergoing independent review by the Centers for Disease Control and Prevention [CDC]) in order to estimate how Cervarix may impact future cervical cancer incidence and related deaths in U.S. girls and women.”
Further down in original studies it is interesting to note :- (SAE = Serious Adverse Event)
“Of the 43 subjects who withdrew due to SAEs, study discontinuation resulted from a fatal event in 28 subjects (11 subjects in HPV group and 17 subjects in pooled controls; one subject in HAV720 group withdrew because of the death of her child due to congenital heart disease). See Section 7.3.5 for further details of all fatal events reported all clinical studies in which Cervarix has been administered. The other 15 subjects withdrew due to non-fatal SAEs, none of which were considered as causally related to vaccination by the study investigator”
“The most common individual SAEs reported during the vaccination period were:
– Spontaneous pregnancy loss (including incomplete and complete spontaneous loss and missed abortion) with 59 subjects (1.87 per 1000 subjects) in HPV group and 51 subjects (2.15 per 1000 subjects) in the control group,
– Appendicitis with 25 subjects (0.79 per 1000 subjects) in the HPV group and 27 subjects (1.14 per 1000 subjects) in the control group,
– Dengue fever with 10 subjects (0.32 per 1000 subjects) in the HPV group and 10 (0.42 per 1000 subjects) in the control group,”
I found the most worryingly results were deaths although these were played down.
In the analysis of all clinical studies in which Cervarix has been administered (up to the data lock-point of August 31, 2008), 37 subjects were reported with a fatal outcome:20 subjects of 31,472 subjects (0.64 per 1000 subjects) in the HPV group and 17 subjects of 23,700 subjects (0.72 per 1000 subjects) in the control group. The median interval between the date of last vaccination and the date of death was 1.5 years (range 30 days to 3.3 years). Of note, the mean duration of follow-up was 2.2 years in HPV group and 2.5 years in the control group.
A summary of the number of deaths by group classified by its underlying cause is presented in Table 34. All the fatalities in vaccinated subjects occurred more than 1 month after the last study vaccine administration, with a median interval between the date of last vaccination and the date of death of 1.5 years (range 30 days to 3.3 years). Road traffic accidents (10 cases) and suicides (7 cases) were the most common underlying causes of death.
In the group that received Cervarix, the following case fatalities were reported:
Road traffic accidents (5 cases): with intervals ranging from 386 to 124 days from last vaccination to death,
Homicide (2 cases): with intervals of 217 days and 826 days from last vaccination to death,
Suicide (2 cases, one case reported as gun shot wound possibly related to suicide) with 148 and 686 days from last vaccination to death,
Neoplasms: gestational trophoblastic neoplasia (onset 151 days after last dose), ovarian cancer (onset 1,127 days after last dose) and cervical cancer (46 year old in Study HPV-015 with normal cytology at enrollment but HPV-18 DNA positive, developed metastatic cervical cancer 205 days after last dose; study population of HPV-015 mainly consists of healthy women but includes also a subset of women with previous history of HPV infection),
Autoimmune diseases (3 cases): systemic lupus erythematosus (SLE) with Candida sepsis (SLE pre-existing with renal complications 6 months after first dose leading to sepsis and eventually death 21 months after the first and only dose), inflammatory bowel disease (IBD) with pyoderma gangrenosum (IBD diagnosed 2 months after third dose with multiple complications and eventually a pyoderma gangrenosum with a fatal outcome 22 months after last dose) and CrohnÂ´s disease with toxic megacolon and septic shock (CrohnÂ´s disease diagnosed 16 months after second dose, complicated with toxic megacolon and septic shock with fatal outcome 17 months after the second and last dose),
Infectious diseases (3 cases): septicemia (onset 758 days after last dose), bacterial septicemia (onset 770 days after last dose) and acquired immune deficiency syndrome (onset 254 days after last dose),
Cardiovascular disorders (2 cases): vascular thromboembolism (onset 1167 days after last dose) and acute myocardial infarction (onset 485 days after last dose).
In the pooled controls group, the following case fatalities were reported:
Road traffic accidents (5 cases): with intervals ranging from 30 days to 862 days from last vaccination to death
Homicide: death 961 days after last dose
Suicide (5 cases): with 49 days to 817 days from last vaccination to death,
Neoplasms (2 cases): osteosarcoma (onset 165 days after last dose) and colon adenocarcinoma (onset 112 days after last dose)
Autoimmune diseases: insulin-dependent diabetes mellitus with diabetic ketoacidosis
(onset 154 days after last dose)
Infectious disease: septicemia (onset 650 days after last dose)
Unknown cause of death (2 cases): sudden death 67 days after last dose in a subject with medical history of valvulopathy and hepatopathy prior to vaccination and one case for which study staff read in a newspaper that the subject was found dead; as an autopsy report cannot be released until all forensic analyses are completed, insufficient documentation for a complete assessment of the diagnosis and the cause of death is available.
No safety signal has been identified based on medical review of these 37 individual case fatalities.”
Two ICAP members, Freda Birrell of Scotland, Grace Filby of England have this week written letters and compiled documents all of which have been presented to both the Scottish and UK Government.
These documents have looked at in particular 10 girls who have been in the UK press recently because they have had an adverse reaction to Cervarix.
Carley Steele Stockport – Manchester
Rebecca Ramagge – Surrey
Paige Brennan – West Midlands
Ashleigh Cave – Liverpool
Hattie Vickery – Devon
Lauren Smith – Surrey,
Sarah Chandler – Surrey,
Leah Mann – Nottinghamshire
Debbie Jones ‘daughter’ – Orkney
Stacey Jones – West Midlands whose story is not released as yet.
Another 2000 reports of adverse reactions have been received in the UK as reported on MHRA website.”
There has only been one suspension of Cervarix so far, after a death occurred in the UK but it later emerged that the child was already ill and the death was not found to be due to the vaccine.
As problems mount for GSK we have to ask ourselves just how safe are the vaccines and medications that this company is producing. GSK not only faces huge problems with its vaccines but it is also facing problems with its medications. Seroxat (Paxil) an antidepressant has been reported to have severe side effects for many years. The website Seroxat Sufferers Stand up and be Countedvisitors have been writing at length about this medication and reports that GSK goes to a lot of trouble to cover up the side effects that Seroxat/Paxil causes. Bob Fiddaman who runs the site reported that –
“Later this year…or early next year, GlaxoSmithKline will be in the High Court in London, UK, defending a group action brought against them that claims that consumers had difficulty withdrawing from their product, Seroxat [known as Paxil in the US]”
As if things were not bad enough for GSK, today, reports flood in about another GSK disaster area, a drug called Avandia. Avandia is a drug for diabetes and has been reported to be causing heart problems in some patients. Avandia has been suspended in Saudi Arabia along with the FDA in the USA partially suspending trials and India suspending trials.
Can we really trust this company or any other company manufacturing drugs and vaccines with our health? Only time will tell.