This is a Guest post from Marcella Piper-Terry
It's Flu Season! Let the Fear-Mongering Begin!
by Marcella Piper-Terry on Saturday, 09 October 2010 at 14:39
Yesterday morning a pediatrician left a comment on my critique of the MMR study, asking pointedly why I chose to critique such a small study. The doctor stated that the study in question was the smallest one he's ever seen. He asserted that there are many more vaccine studies, "some with over a million subjects." He wanted to know why I don't critique them. I asked him to please provide the links because I have not been able to find any such studies. The fact is, it is standard operating procedure for the vaccine makers to conduct studies with very small sample sizes and to then make sweeping declarations of the safety of their products. This is particularly true for the flu vaccine.
NOTE: Here is a link to the critique of the MMR study mentioned above:
http://www.facebook.com/#!/album.php?aid=69858&id=1468367643&comments&po=1
Last week I walked into the local CVS pharmacy and asked for the package insert for the flu vaccine they will be using this Saturday at their "vaccine clinic." The girl behind the pharmacy counter didn't know what I was talking about. So I asked if they have the vials on hand. She said yes. I asked to see the box. She retrieved it from the refrigerator. I wrote down the name - "Fluvirin" and noted that it is the multi-dose variety.
Here is the manufacturer's insert:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123694.pdf
Each .5 ml dose contains 25 mcg. of thimerosal (ethyl mercury), which means if your child gets two doses, he or she will be getting 50 mcg. of thimerosal.
If you ask your doctor if this is safe, you will most likely be told "Yes." If you ask if the research has been done to prove safety of this particular vaccine, you will most likely be told "yes." I suggest you don't stop there.
On page 10 of the package insert (link above), you will find the information about the clinical studies in the pediatric population. Here it is:
_________________________________________________
In 1987 a clinical study was carried out in 38 ‘at risk’ children aged between 4 and 12 years (17 females and 21 males). To record the safety of FLUVIRIN, participants recorded their symptoms on a diary card during the three days after vaccination and noted any further symptoms they thought were attributable to the vaccine. The only reactions recorded were tenderness at the site of vaccination in 21% of the participants on day 1, which was still present in 16% on day 2 and 5% on day 3. In one child, the tenderness was also accompanied by redness at the site of injection for two days. The reactions were not age-dependent and there was no bias towards the younger children.
Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6 - 47 months). Of these, 285 healthy subjects plus 41 ‘at risk’ subjects received FLUVIRN. No serious adverse events were reported.
FLUVIRIN should only be used for the immunization of persons aged 4 years and over. _____________________________________________________________
That's it. The 2010-2011 Fluvirin Vaccine has been deemed safe to administer to ALL U.S. children 4 years and older, and this decision is based on studies of 38 children that were done in 1987, and 326 children studied between 1995 and 2004.
That's not a lot of kids to base the decision that the vaccine is safe for ALL children.
What's even more troubling is that this year's vaccine contains two strains of seasonal flu (A & B) AND it also contains H1N1.
H1N1 did not resurface until 2009. The vaccines that were studied in 1987, 1995, and 2004 did not contain H1N1.
This flu vaccine has NEVER been studied in children. But it has been deemed "Safe for all U.S. children aged 4 years and above."
Yesterday morning I contacted the USI Student Health Clinic to find out what flu vaccine they are giving and to what groups. I spoke with a nurse who told me they are using Fluzone multi-dose vials and they are giving it to "all ages" including pregnant women. The nurse added, "We gave it to them last year."
Here is the package insert for Fluzone:
Clinical Trial Experience in Pediatric Subjects
https://www.vaccineshoppe.com/image.cfm?doc_id=11964&image_type=product_pdf
Page 1: "Safety and effectiveness of Fluzone have not been established in pregnant women, nursing mothers, or children <6 months of age."
Page 3: "6.1. Clinical Trial Experience - Fluzone - Pediatric Studies: The 2003-2004 formulation of Fluzone was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were simliar to the proportions in adults."
This vaccine, which contains mercury, is being recommended for ALL children 6 months and older. It has been deemed "safe" on the basis of clinical trials that included a total of 31 children between the ages of 6-36 months.
THe formulation that was studied in 2003-2004 is different from the formulation this year, so this year's flu vaccine has not been studied AT ALL for its effect in infants and young children.
Page 4: "8. Use in specific populations - 8.1 pregnancy: Pregnancy Category C.: Animal reproduction studies have not been conducted with Fluzone. It is also not known whether Fluzone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone should be given to a pregnant woman only if clearly needed."
WHY WOULD ANYONE ASSUME IT IS OKAY TO GIVE THIS VACCINE TO PREGNANT WOMEN? WHY WOULD PREGNANT WOMEN BE LINING UP TO RECEIVE IT? WHY WOULD PARENTS OF INFANTS AND YOUNG CHILDREN BE LINING UP TO HAVE THEIR KIDS VACCINATED WITH SOMETHING THAT CONTAINS MERCURY AND WHICH HAS NOT BEEN TESTED FOR SAFETY?
People are afraid of the flu. They are afraid because the CDC tells them to be afraid.
This is the lnk to the CDC's own report of the 2009-2010 flu season:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5929a2.htm
On pg. 3: "A dramatic increase in hospitalizations in the younger age groups was indicative of the influenza pandemic's impact on children." If you look at the numbers and do the math, the "dramatic increase" in children 4 and under was 83 hospitalizations per 100,000 as compared with 34/100,000 (avg. from the previous 3 flu seasons).
The "dramatic increase" in hospitalizations in kids 4 yrs and under amounts to 6.83 kids per month in a city of 100,000 people, as compared to between 2.62-4.25 kids per month in the same city during each of the previous 3 flu seasons.
Breaking it down by week... during last years "pandemic" flu season, in a city of 100,000 people there was an average of 1.63 hospitalizations for flu (confirmed by laboratory analysis) in children four years and younger.
In the previous three flu seasons, in the same city of 100,000 people, hospitalizations for kids 4 and under were between .63 and 1.01 kids per week.
So, according to the CDC's own document, the "dramatic increase" on the pediatric population (kids four and under, in this case), as measured by hospitalizations for laboratory confirmed flu, amounted to less than one child per week in cities of 100,000 people.
Who is "fear-mongering" now?
Scaring the public with terminology like "dramatic increase" in order to sell more vaccines to pregnant women and parents of infants and toddlers when the vaccines have not been tested for safety in these groups is unethical and unconscionable.
NOTE: Here is a link to the critique of the MMR study mentioned above:
http://www.facebook.com/#!/album.php?aid=69858&id=1468367643&comments&po=1
Last week I walked into the local CVS pharmacy and asked for the package insert for the flu vaccine they will be using this Saturday at their "vaccine clinic." The girl behind the pharmacy counter didn't know what I was talking about. So I asked if they have the vials on hand. She said yes. I asked to see the box. She retrieved it from the refrigerator. I wrote down the name - "Fluvirin" and noted that it is the multi-dose variety.
Here is the manufacturer's insert:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123694.pdf
Each .5 ml dose contains 25 mcg. of thimerosal (ethyl mercury), which means if your child gets two doses, he or she will be getting 50 mcg. of thimerosal.
If you ask your doctor if this is safe, you will most likely be told "Yes." If you ask if the research has been done to prove safety of this particular vaccine, you will most likely be told "yes." I suggest you don't stop there.
On page 10 of the package insert (link above), you will find the information about the clinical studies in the pediatric population. Here it is:
_________________________________________________
In 1987 a clinical study was carried out in 38 ‘at risk’ children aged between 4 and 12 years (17 females and 21 males). To record the safety of FLUVIRIN, participants recorded their symptoms on a diary card during the three days after vaccination and noted any further symptoms they thought were attributable to the vaccine. The only reactions recorded were tenderness at the site of vaccination in 21% of the participants on day 1, which was still present in 16% on day 2 and 5% on day 3. In one child, the tenderness was also accompanied by redness at the site of injection for two days. The reactions were not age-dependent and there was no bias towards the younger children.
Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6 - 47 months). Of these, 285 healthy subjects plus 41 ‘at risk’ subjects received FLUVIRN. No serious adverse events were reported.
FLUVIRIN should only be used for the immunization of persons aged 4 years and over. _____________________________________________________________
That's it. The 2010-2011 Fluvirin Vaccine has been deemed safe to administer to ALL U.S. children 4 years and older, and this decision is based on studies of 38 children that were done in 1987, and 326 children studied between 1995 and 2004.
That's not a lot of kids to base the decision that the vaccine is safe for ALL children.
What's even more troubling is that this year's vaccine contains two strains of seasonal flu (A & B) AND it also contains H1N1.
H1N1 did not resurface until 2009. The vaccines that were studied in 1987, 1995, and 2004 did not contain H1N1.
This flu vaccine has NEVER been studied in children. But it has been deemed "Safe for all U.S. children aged 4 years and above."
Yesterday morning I contacted the USI Student Health Clinic to find out what flu vaccine they are giving and to what groups. I spoke with a nurse who told me they are using Fluzone multi-dose vials and they are giving it to "all ages" including pregnant women. The nurse added, "We gave it to them last year."
Here is the package insert for Fluzone:
Clinical Trial Experience in Pediatric Subjects
https://www.vaccineshoppe.com/image.cfm?doc_id=11964&image_type=product_pdf
Page 1: "Safety and effectiveness of Fluzone have not been established in pregnant women, nursing mothers, or children <6 months of age."
Page 3: "6.1. Clinical Trial Experience - Fluzone - Pediatric Studies: The 2003-2004 formulation of Fluzone was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were simliar to the proportions in adults."
This vaccine, which contains mercury, is being recommended for ALL children 6 months and older. It has been deemed "safe" on the basis of clinical trials that included a total of 31 children between the ages of 6-36 months.
THe formulation that was studied in 2003-2004 is different from the formulation this year, so this year's flu vaccine has not been studied AT ALL for its effect in infants and young children.
Page 4: "8. Use in specific populations - 8.1 pregnancy: Pregnancy Category C.: Animal reproduction studies have not been conducted with Fluzone. It is also not known whether Fluzone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone should be given to a pregnant woman only if clearly needed."
WHY WOULD ANYONE ASSUME IT IS OKAY TO GIVE THIS VACCINE TO PREGNANT WOMEN? WHY WOULD PREGNANT WOMEN BE LINING UP TO RECEIVE IT? WHY WOULD PARENTS OF INFANTS AND YOUNG CHILDREN BE LINING UP TO HAVE THEIR KIDS VACCINATED WITH SOMETHING THAT CONTAINS MERCURY AND WHICH HAS NOT BEEN TESTED FOR SAFETY?
People are afraid of the flu. They are afraid because the CDC tells them to be afraid.
This is the lnk to the CDC's own report of the 2009-2010 flu season:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5929a2.htm
On pg. 3: "A dramatic increase in hospitalizations in the younger age groups was indicative of the influenza pandemic's impact on children." If you look at the numbers and do the math, the "dramatic increase" in children 4 and under was 83 hospitalizations per 100,000 as compared with 34/100,000 (avg. from the previous 3 flu seasons).
The "dramatic increase" in hospitalizations in kids 4 yrs and under amounts to 6.83 kids per month in a city of 100,000 people, as compared to between 2.62-4.25 kids per month in the same city during each of the previous 3 flu seasons.
Breaking it down by week... during last years "pandemic" flu season, in a city of 100,000 people there was an average of 1.63 hospitalizations for flu (confirmed by laboratory analysis) in children four years and younger.
In the previous three flu seasons, in the same city of 100,000 people, hospitalizations for kids 4 and under were between .63 and 1.01 kids per week.
So, according to the CDC's own document, the "dramatic increase" on the pediatric population (kids four and under, in this case), as measured by hospitalizations for laboratory confirmed flu, amounted to less than one child per week in cities of 100,000 people.
Who is "fear-mongering" now?
Scaring the public with terminology like "dramatic increase" in order to sell more vaccines to pregnant women and parents of infants and toddlers when the vaccines have not been tested for safety in these groups is unethical and unconscionable.
