THE Leading Researcher Has Called Gardasil A "Public Health Experiment" And Warns Of Serious Adverse Events.
By Jennifer Hough
Monday, August 30, 2010
“THE Leading Researcher In The Development Of The Cervical Cancer Vaccine, Gardasil, Has Called It A "Public Health Experiment" And Has Warned That Parents Must Be Made Aware Of The Serious Adverse Events Associated With Its Use.”
The vaccination programme is set to be rolled out here next month, targeting first- and second-year secondary school students.
However, Dr Diane Harper, who carried out safety studies to get Gardasil approved, warned of "serious adverse events including death" associated with it.
It has already begun on a trial basis, with 1,300 vaccines given in May, and 1,000 vaccines given in July.
The HSE said the vaccine has been shown to be very safe, with 60 million doses already given worldwide.
However, concerns are mounting with in excess of 18,000 adverse reactions recorded in the US, including 75 deaths. Adverse reactions have also been recorded in New Zealand, Canada and Australia.
A US federal report in 2009 found the vaccine had a 400% higher rate of adverse reactions than another comparable vaccine, the Menactra anti-meningitis shot.
The Irish Medicines Board (IMB) said it had received 10 reports of suspected adverse reactions associated with Gardasil.
One was received following the start of the HSE HPV school vaccination programme in May.
Apart from the small risk of being adversely effected, research shows the vaccine only lasts for five years.
In an unpublished report on research carried out by many clinicians, seen by the Irish Examiner, Dr Harper claims there is no data showing it remains effective beyond this.
The paper maintains any risk of permanent disability or death, no matter how rare, must be addressed as women have the choice of a lifetime of cervical screening without vaccination which accomplishes superior cervical cancer prevention.
"If the vaccine does not last at least 15 years, and if vaccination starts at 11 or 12, then women will not be protected long enough to prevent infection.
"We’ve put them at harm from side effects, small but real, for no benefit. This makes Gardasil very expensive with very limited, if any, clinical benefit," said Dr Harper.
A spokesperson for drug company Merck, which makes the vaccine, said the observation of an event after vaccination, including disease and death, does not mean that vaccination has caused this event or increased the risk, but just that the event occurred after vaccination.
"No investigation has currently led authorities into questioning the good safety profile of Gardasil or into modifying their vaccination recommendations."
However, Dr Diane Harper, who carried out safety studies to get Gardasil approved, warned of "serious adverse events including death" associated with it.
It has already begun on a trial basis, with 1,300 vaccines given in May, and 1,000 vaccines given in July.
The HSE said the vaccine has been shown to be very safe, with 60 million doses already given worldwide.
However, concerns are mounting with in excess of 18,000 adverse reactions recorded in the US, including 75 deaths. Adverse reactions have also been recorded in New Zealand, Canada and Australia.
A US federal report in 2009 found the vaccine had a 400% higher rate of adverse reactions than another comparable vaccine, the Menactra anti-meningitis shot.
The Irish Medicines Board (IMB) said it had received 10 reports of suspected adverse reactions associated with Gardasil.
One was received following the start of the HSE HPV school vaccination programme in May.
Apart from the small risk of being adversely effected, research shows the vaccine only lasts for five years.
In an unpublished report on research carried out by many clinicians, seen by the Irish Examiner, Dr Harper claims there is no data showing it remains effective beyond this.
The paper maintains any risk of permanent disability or death, no matter how rare, must be addressed as women have the choice of a lifetime of cervical screening without vaccination which accomplishes superior cervical cancer prevention.
"If the vaccine does not last at least 15 years, and if vaccination starts at 11 or 12, then women will not be protected long enough to prevent infection.
"We’ve put them at harm from side effects, small but real, for no benefit. This makes Gardasil very expensive with very limited, if any, clinical benefit," said Dr Harper.
A spokesperson for drug company Merck, which makes the vaccine, said the observation of an event after vaccination, including disease and death, does not mean that vaccination has caused this event or increased the risk, but just that the event occurred after vaccination.
"No investigation has currently led authorities into questioning the good safety profile of Gardasil or into modifying their vaccination recommendations."
This story appeared in the printed version of the Irish Examiner Monday, August 30, 2010
By Jennifer Hough
Monday, August 30, 2010
They are from Florida and Wisconsin, Texas and Tennessee, New Mexico, New Zealand and Australia.
There’s Savanna from Ohio, Kahlia from New Zealand, and Kristyn from Washington State. They are just a handful of the girls whose pretty smiling faces peer back from the website Sanevax.org.
What binds them together? Suspected serious adverse reactions to cervical cancer vaccine Gardasil, and the fact that they were all perfectly healthy prior to receiving the vaccine.
Savanna was 12 when she got the vaccine. Since then her list of symptoms has included vision problems, twitching, numbness, memory loss, trouble concentrating, confusion, brain fog (can’t find the right words), trouble breathing, sleep paralysis (can’t move upon first waking) and hair loss.
Her mother spends almost every waking moment trying to warn people. Her mission is to make sure no one else has to watch their child go through the traumatic, life-changing events her daughter has experienced.
And there’s Kristyn Allen. On March 2009, the day after her 16th birthday, she received her second Gardasil injection. Shortly after, she started complaining about odd symptoms and eventually ended up in the emergency room. She was having severe pain in both legs, tingling sensations in both legs and one arm, and terrible weakness. Multiple blood tests and a CT scan could uncover no reason for the symptoms.
Her list of symptoms now includes back pain from her neck to her feet, terrible pressure in her head, involuntary muscle spasms, nausea, diarrhoea, weight loss, severe fatigue, chest pains, rib pain, rapid heart beat, dizziness, vision problems, difficulty breathing, brain fog and hair loss.
There’s also 17-year-old Kahlia, who says her family have suggested Gardasil as a cause for her illnesses to the doctors. "They will not say it is 100% the cause, because they cannot prove it. On the other hand, they can’t say it’s not 100% the cause, because they cannot prove that either."
Jessica Ericzon was one of the first recorded Gardasil-associated fatalities. Until receiving her third injection of HPV vaccine, Jessica was healthy, happy, active, never smoked or took drugs. On February 20, 2008, less than 48 hours after her last Gardasil shot, her parents found her dead on the bathroom floor. She was only 17. According to her coroner, the death was unexplainable.
There’s Savanna from Ohio, Kahlia from New Zealand, and Kristyn from Washington State. They are just a handful of the girls whose pretty smiling faces peer back from the website Sanevax.org.
What binds them together? Suspected serious adverse reactions to cervical cancer vaccine Gardasil, and the fact that they were all perfectly healthy prior to receiving the vaccine.
Savanna was 12 when she got the vaccine. Since then her list of symptoms has included vision problems, twitching, numbness, memory loss, trouble concentrating, confusion, brain fog (can’t find the right words), trouble breathing, sleep paralysis (can’t move upon first waking) and hair loss.
Her mother spends almost every waking moment trying to warn people. Her mission is to make sure no one else has to watch their child go through the traumatic, life-changing events her daughter has experienced.
And there’s Kristyn Allen. On March 2009, the day after her 16th birthday, she received her second Gardasil injection. Shortly after, she started complaining about odd symptoms and eventually ended up in the emergency room. She was having severe pain in both legs, tingling sensations in both legs and one arm, and terrible weakness. Multiple blood tests and a CT scan could uncover no reason for the symptoms.
Her list of symptoms now includes back pain from her neck to her feet, terrible pressure in her head, involuntary muscle spasms, nausea, diarrhoea, weight loss, severe fatigue, chest pains, rib pain, rapid heart beat, dizziness, vision problems, difficulty breathing, brain fog and hair loss.
There’s also 17-year-old Kahlia, who says her family have suggested Gardasil as a cause for her illnesses to the doctors. "They will not say it is 100% the cause, because they cannot prove it. On the other hand, they can’t say it’s not 100% the cause, because they cannot prove that either."
Jessica Ericzon was one of the first recorded Gardasil-associated fatalities. Until receiving her third injection of HPV vaccine, Jessica was healthy, happy, active, never smoked or took drugs. On February 20, 2008, less than 48 hours after her last Gardasil shot, her parents found her dead on the bathroom floor. She was only 17. According to her coroner, the death was unexplainable.
Speaking to the Irish Examiner, Scottish political activist and Sanevax.org co-founder Freda Birrell said it was imperative people were aware of the risks, even if there were not being taken seriously by politicians and the drug company.
Birrell told the Irish Examiner that politicians here were "closing their ears" to the other side of the story in relation to the vaccine. Ms Birrell, who has written to Minister for Health Mary Harney, said if there are no serious adverse reactions associated with the vaccine’s use in Ireland, it will be the only country in which it has not happened.
In March, Birell, who is working for a formal investigation, along with five other campaigners, addressed the US Food and Drug Authority (FDA). During the teleconference with several FDA officials, the women presented documents, charts and discussed details of the cases they have collected from various countries in hopes of convincing the agency to take a tougher look at the Merck product.
However, the FDA remains satisfied these events are rare, coincidental and probably not related to HPV vaccines. It insists underlying conditions must have caused the reactions.
More worryingly, no one in this country seems to be aware of the possible side affects of Gardasil, and no one is warning parents of the possible dangers so they can make an informed decision on the issue.
For those who might be sceptical about the claims of the "Gardasil girls" and campaigners like Birrell, it is worth looking at an extraordinary turn of events in India this year.
In April, the Indian Council of Medical Research (ICMR) ordered the nation’s Health Ministry immediately to suspend a cervical cancer vaccination programme after reports of four deaths and 120 complications in girls receiving Merck’s Gardasil. The move came after concerned NGOs and activists submitted a memo to the health minister claiming: "It is beyond doubt the worst case of human rights violation, where young healthy girls have to die for being part of a state-endorsed experiment, initiated by a profit-making private company."
All of those given the vaccine were from poverty-stricken regions. The girls complained of stomach disorders, epilepsy, headaches and early menstrual cycles. But, while administration of the vaccine has been suspended "as a precautionary measure", the ICMR insist the girls died of extraneous reasons, not due to the vaccine.
Dr Diane Harper, who carried out safety and effectiveness studies to get Gardasil approved, and has been a paid speaker and consultant to Merck, wrote about the incident in a Discovery Medicine article. "The most disquieting objection to the programme, voiced by over 70 civil society groups, public health organisations, medical professionals, human rights organisations, women’s groups and others, was the lack of information provided to the public so that each participant could be afforded the opportunity for informed decision making about their cervical cancer protection."
This desire for information is not limited to India. With the vaccine set to be rolled out fully in Irish schools next month, Dr Harper’s article, which reviews the current information on cervical cancer prevention, is surely a must read for the Department of Health, the HSE, parents and schools. There are very real concerns and taking the word of the drug company who made, tested and marketed the product is not good enough.
No one can prove why all these young girls are getting sick and worse dying, but they and their families, and sometimes their doctors, believe it could be because of the vaccine.
Birrell maintains the denial will go on because of the power big-pharmaceutical companies have.
"The simple truth is we don’t want there to be any Irish stories telling of more young girls being harmed by Gardasil," she said. "How many more deaths and how many more serious illnesses will they ignore before they ask for an investigation? These young lives are precious and should be protected, not ignored."
Ms Birrell says the women have requested a second meeting with the FDA, which she says, treats them "with respect". She maintains that along with the reported adverse reactions, there must be a raft which are going un-reported. "As we told the FDA, it is not normal for young healthy teenagers to get sick or just drop dead. If there are no serious adverse reactions associated with the vaccine in Ireland, it will be the only country without any side effects."
Indeed, it is estimated VAERS reports only make up a small percentage of actual bad reactions.
Here a HIQA report, much misquoted as it has been, clearly states: "Vaccination against HPV infection does not get rid of the need for routine cervical cancer screening, as the vaccines only target the two HPV types that cause seven out of ten cases of cervical cancer.
"Also, the vaccines may not be 100% effective, their long-term efficacy has not yet been established in clinical trials longer than five years, and the vaccines are not effective in women already infected with those specific types of HPV."
According to Dr Harper, 11 to 12 year olds are not promised protection until they leave the age range for highest acquisition of high risk HPV infections, which is 36. So, even if there was a chance it would last 15 years – which is highly unlikely – girls vaccinated at 12 still would not be fully protected. As things stand, there is no evidence showing it remains effective beyond five years.
"This makes Gardasil very expensive with very limited, if any, clinical benefit," Dr Harper said.
Indeed, such is the mis-information around the marketing of these vaccines (there is another Cervarix which Britain opted for) there are fears women will believe they are fully protected from cervical cancer by getting it, and so will not continue with essential screenings.
Officially, Gardasil is deemed to be safe by all the regulatory bodies. The current post-marketing commitment between Merck and the FDA is to recognise a rate of serious adverse events that exceed two in 10,000 women in a cohort of 44,000 women who have received all three doses of Gardasil. This means any serious reactions which do not satisfy this clause will not be acted upon – even if they are as severe as death.
In her yet unpublished survey assessing all published research relating to the safety of the vaccine, Dr Harper stresses that independent scientists and clinicians reports of bad reactions are a valid source of information, and are of great value for safety issues.
What the end result of what Dr Harper calls a "public health experiment" will be no one knows. But one thing is clear, the HPV vaccine is unnecessary as it does not prevent cervical cancer.
Birrell told the Irish Examiner that politicians here were "closing their ears" to the other side of the story in relation to the vaccine. Ms Birrell, who has written to Minister for Health Mary Harney, said if there are no serious adverse reactions associated with the vaccine’s use in Ireland, it will be the only country in which it has not happened.
In March, Birell, who is working for a formal investigation, along with five other campaigners, addressed the US Food and Drug Authority (FDA). During the teleconference with several FDA officials, the women presented documents, charts and discussed details of the cases they have collected from various countries in hopes of convincing the agency to take a tougher look at the Merck product.
However, the FDA remains satisfied these events are rare, coincidental and probably not related to HPV vaccines. It insists underlying conditions must have caused the reactions.
More worryingly, no one in this country seems to be aware of the possible side affects of Gardasil, and no one is warning parents of the possible dangers so they can make an informed decision on the issue.
For those who might be sceptical about the claims of the "Gardasil girls" and campaigners like Birrell, it is worth looking at an extraordinary turn of events in India this year.
In April, the Indian Council of Medical Research (ICMR) ordered the nation’s Health Ministry immediately to suspend a cervical cancer vaccination programme after reports of four deaths and 120 complications in girls receiving Merck’s Gardasil. The move came after concerned NGOs and activists submitted a memo to the health minister claiming: "It is beyond doubt the worst case of human rights violation, where young healthy girls have to die for being part of a state-endorsed experiment, initiated by a profit-making private company."
All of those given the vaccine were from poverty-stricken regions. The girls complained of stomach disorders, epilepsy, headaches and early menstrual cycles. But, while administration of the vaccine has been suspended "as a precautionary measure", the ICMR insist the girls died of extraneous reasons, not due to the vaccine.
Dr Diane Harper, who carried out safety and effectiveness studies to get Gardasil approved, and has been a paid speaker and consultant to Merck, wrote about the incident in a Discovery Medicine article. "The most disquieting objection to the programme, voiced by over 70 civil society groups, public health organisations, medical professionals, human rights organisations, women’s groups and others, was the lack of information provided to the public so that each participant could be afforded the opportunity for informed decision making about their cervical cancer protection."
This desire for information is not limited to India. With the vaccine set to be rolled out fully in Irish schools next month, Dr Harper’s article, which reviews the current information on cervical cancer prevention, is surely a must read for the Department of Health, the HSE, parents and schools. There are very real concerns and taking the word of the drug company who made, tested and marketed the product is not good enough.
No one can prove why all these young girls are getting sick and worse dying, but they and their families, and sometimes their doctors, believe it could be because of the vaccine.
Birrell maintains the denial will go on because of the power big-pharmaceutical companies have.
"The simple truth is we don’t want there to be any Irish stories telling of more young girls being harmed by Gardasil," she said. "How many more deaths and how many more serious illnesses will they ignore before they ask for an investigation? These young lives are precious and should be protected, not ignored."
Ms Birrell says the women have requested a second meeting with the FDA, which she says, treats them "with respect". She maintains that along with the reported adverse reactions, there must be a raft which are going un-reported. "As we told the FDA, it is not normal for young healthy teenagers to get sick or just drop dead. If there are no serious adverse reactions associated with the vaccine in Ireland, it will be the only country without any side effects."
Indeed, it is estimated VAERS reports only make up a small percentage of actual bad reactions.
Here a HIQA report, much misquoted as it has been, clearly states: "Vaccination against HPV infection does not get rid of the need for routine cervical cancer screening, as the vaccines only target the two HPV types that cause seven out of ten cases of cervical cancer.
"Also, the vaccines may not be 100% effective, their long-term efficacy has not yet been established in clinical trials longer than five years, and the vaccines are not effective in women already infected with those specific types of HPV."
According to Dr Harper, 11 to 12 year olds are not promised protection until they leave the age range for highest acquisition of high risk HPV infections, which is 36. So, even if there was a chance it would last 15 years – which is highly unlikely – girls vaccinated at 12 still would not be fully protected. As things stand, there is no evidence showing it remains effective beyond five years.
"This makes Gardasil very expensive with very limited, if any, clinical benefit," Dr Harper said.
Indeed, such is the mis-information around the marketing of these vaccines (there is another Cervarix which Britain opted for) there are fears women will believe they are fully protected from cervical cancer by getting it, and so will not continue with essential screenings.
Officially, Gardasil is deemed to be safe by all the regulatory bodies. The current post-marketing commitment between Merck and the FDA is to recognise a rate of serious adverse events that exceed two in 10,000 women in a cohort of 44,000 women who have received all three doses of Gardasil. This means any serious reactions which do not satisfy this clause will not be acted upon – even if they are as severe as death.
In her yet unpublished survey assessing all published research relating to the safety of the vaccine, Dr Harper stresses that independent scientists and clinicians reports of bad reactions are a valid source of information, and are of great value for safety issues.
What the end result of what Dr Harper calls a "public health experiment" will be no one knows. But one thing is clear, the HPV vaccine is unnecessary as it does not prevent cervical cancer.
This story appeared in the printed version of the Irish Examiner Monday, August 30, 2010
See Also:
Irish Mothers Unite to Stop the Assault on Their Children “Lock up your Daughters - Suspected Serial Killer Due for Release - It's Called Gardasil”
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