http://www.whale.to/v/prevnar2.html
PREVNAR
A
Critical Review of a New Childhood Vaccine
©
Michael Horwin, MA
September
19, 2000
Summary:
Part
I:
Potential
Conflicts of Interest in Testing, Promotion & Approval
Drs. Black & Shinefield: Wyeth Lederle Paid for Prevnar Studies
Drs. Black and Shinefield of Kaiser Permanente undertook the primary studies
cited regarding Prevnar. Wyeth Lederle, the vaccine’s manufacturer, paid for
these studies.
These doctors have also presented Prevnar at various conferences throughout
the world. Wyeth Lederle subsidized these conferences.
Drs. Stephen I. Pelton & Kathryn Edwards: Wyeth Lederle Pays to
Reassure Parents
Wyeth Lederle also pays for an Internet forum (pneumo.com) where these
doctors answer Prevnar-related questions from concerned parents. Several of
their answers are inconsistent with relevant information reported from other
medical sources.
Dr. Kathyrn Edwards: Wyeth Lederle Pays to Reassure Doctors about Prevnar
The Internet forum subsidized by Wyeth Lederle (pneumo.com) also addresses
Prevnar related questions presented by pediatricians and other clinicians.
Several of the answers by Dr. Edwards demonstrate inconsistent information.
Wyeth Lederle had paid Dr. Edwards $255,023 per year from 1996 to 1998 for the
study of pneumococcal vaccines (i.e. Prevnar). Edwards is also one of fifteen
full-time members of FDA’s Vaccines and Related Biological Products Advisory
Committee, the committee that advises the FDA on the licensing of new vaccines.
Dr. Margaret B. Rennels: The Wyeth Lederle-Prevnar-RotaShield Connection
Rennels was instrumental in getting RotaShield to market and is now involved
in Prevnar. Her university receives a total of over $2.5 million from various
drug and vaccine companies including Wyeth Lederle, Prevnar’s manufacturer. She
is also one of the twelve members of the Committee on Infectious Diseases, the
committee that makes vaccine recommendations as part of the American Academy of
Pediatrics.36
Dr. Jerome Klein: Wyeth Lederle and the National Vaccine Advisory
Committee
This doctor has been employed by the major vaccine manufacturers to testify
against vaccine injured children. He is also chief editor of pneumo.com the
website paid for by Wyeth Lederle to sponsor Prevnar. Furthermore, Klein holds
a position on the National Vaccine Advisory Committee, the committee that
recommends products for universal vaccination.
Part
II:
Efficacy
of Prevnar and other Vaccines Combined with Prevnar
The efficacy of Prevnar appears to be very limited - 7% fewer new
earaches, and 0.1% fewer instances of invasive pneumococcal disease
(compared to an experimental vaccine used as a control).
The studies done on Prevnar suggest that it may interfere with the efficacy
of two other vaccines (pertussis and IPV) and could interfere with two more
vaccines (MMR and Varicella).
Part
III:
Safety
of Prevnar
According to the American Academy of Pediatrics, Prevnar may prove to be
among the most reactogenic of vaccines.
Danger of Inappropriate Injection
The vaccine insert repeatedly warns the clinician to keep the injection away
from a child’s blood vessels. Doctors and nurses are attentive to this, but
parents should be aware that there is always a danger if the vaccine is wrongly
administered.
The manufacturer states that injecting a child with Prevnar who is under six
weeks may not be safe, but that it is warranted to inject a six-week old. This
does not provide the practitioner with a reasonable cushion.
Reviews the emergency room visits, seizures and SIDS associated with
administration of Prevnar as discussed in the package insert.
Possible Allergic Reactions
Pediatricians are warned to be ready for possible allergic or anaphylactic
reactions from administration of the vaccine.
Prevnar contains aluminum and according to the manufacturer there have been
no carcinogenic, mutagenic or fertility studies done on the vaccine.
Relationship with Chronic Diseases
No long-term studies have been completed. One researcher sees a causal link
to diabetes.
Prevnar is directed for administration to immune-suppressed children, a
practice that apparently has not been studied for either safety or efficacy,
Part IV:
The
Bottom Line $
At $242 per child, Prevnar is expected to deliver sales of between $300-$500
million per year for its manufacturer.
Conclusion
The safety and efficacy evaluations, and federal approval of Prevnar is
laden with ethical questions. Many of the doctors directly involved in the
testing and approval process appear to have significant conflicts of interest.
The efficacy of the vaccine is questionable and safety testing has been
terribly inadequate. There are no long-term studies (i.e. more than 5 years) of
the chronic, debilitating and life threatening diseases that this vaccine may
cause. The fact that the vaccine is bio-engineered by combining various types
and portions of bacteria should require it to undergo considerable scrutiny.
Assuming the vaccine has any efficacy at all, the need for universal
vaccination needs to be reexamined in light of the small number of children who
might be at risk from serious complications from pneumococcal disease.
Introduction
On February 17, 2000, the FDA approved a new childhood vaccine called
Prevnar. Prevnar is manufactured by Wyeth Lederle Vaccines. Wyeth Lederle is a
business unit of Wyeth-Ayerst Laboratories, which is a division of American
Home Products the same company that manufactured RotaShield, the vaccine that
was recalled after it caused injury and death to some children. Prevnar is
marketed to prevent pneumococcal infections that can cause earaches,
meningitis, blood poisoning and pneumonia. The American Academy of Pediatrics
Committee on Infectious Diseases has recommended universal vaccination. All
children should now receive four doses at 2, 4, 6, and 12-15 months of age.1
For an 18-month old child, this brings the total number of vaccinations he or
she receives to twenty.
Does
Your Child Need Prevnar?
According to studies quoted by Prevnar’s manufacturer if your child is over
two years old, he or she has about a 1 in 5,000 chance of being diagnosed with
a pneumococcal disease. 47 If your child is under two, the number is
reported to increase to 7.5 in 5,000.47 How dangerous is this
disease? Apparently it can be life threatening in a very small number of
children. For example, according to the manufacturer, Pneumococcal meningitis
in childhood has been "associated with" a mortality rate of
approximately 1 in 178,571 children.47 Is it reasonable to expect
that your child could be one of these victims?
According to the 1994 Red Book Report of the Committee on Infectious
Diseases published by the American Academy of Pediatrics, children who are at
risk of pneumococcal infections are those with specific predisposing factors.
The Redbook states:
"(Pneumococcal
Infections) are more likely to occur when predisposing conditions exist,
including immunoglobulin deficiency, Hodgkin’s disease, congenital or acquired
immunodeficiency (including HIV), nephrotic syndrome, some viral upper
respiratory tract infections, splenic dysfunction, splenectomy and organ
transplantation."46
Most healthy children do not have these risk factors.
Part
I:
Potential
Conflicts of Interest in Testing, Promotion & Approval
Six
Key Supporters of Prevnar
Six of the most outspoken supporters of the use of Prevnar for universal
vaccination are:
What inspires these doctors to do studies on Prevnar or to get on an
airplane and travel thousands of miles to present Prevnar to other physicians?
What motivates them to spend hours addressing the concerns of fearful parents
and cautious pediatricians?
Drs.
Black & Shinefield: Wyeth-Lederle Paid for Prevnar Studies
Drs. Shinefield and Black of Kaiser Permanente undertook most of the studies
on Prevnar which proved its efficacy and safety.2 According to Dr.
Black, "This vaccine is urgently needed...It is great news for parents and
physicians."3 Dr. Shinefield is equally enthusiastic. He
states, "It’s a remarkable vaccine that will have a dramatic effect."4
How do we know the vaccine is safe and effective? The manufacturer, Wyeth
Lederle Vaccines points to the studies of Drs. Black and Shinefield to vouch
for the vaccine’s safety and efficacy. A Wyeth press release states:
"Results and data
released last September and updated this May from a major clinical trial
conducted by Kaiser Permanente…suggested that the vaccine is effective against
invasive pneumococcal disease caused by seven serotypes (strains) of the
bacteria most prevalent among children in the U.S."5
Who paid for these studies? According to the Harvard Medical School Office
of Public Affairs, the "study was supported by a grant from Wyeth Lederle
Vaccines & Pediatrics."6 This was confirmed by the
Associated Press, which reported that Wyeth-Lederle Laboratories "paid for
the testing."4
In fact, the financial ties between Wyeth Lederle Vaccines and Drs. Black
and Shinefield are so close that the two doctors appeared in a glossy photo in
the 1997 Annual Report of American Home Products (Wyeth’s parent company).8
In the photo you see the two grinning physicians dressed in white lab coats
while a group of children play in the background.
(See http://www.ahp.com/annrpt97/sreport3.htm
).
Drs.
Black & Shinefield: Wyeth Lederle Paid for Conferences
Drs. Black and Shinefield also have gone globe trotting to present the
wonders of Prevnar to other doctors throughout the world. This list of
conferences where they presented information about Prevnar includes:
The one in Washington DC seemed particularly entertaining because it was
held at the Smithsonian. According to the event’s brochure:
"The entire first floor
of the Smithsonian National Museum of American History will be open to
symposium attendees and their guests during the evening… Visitors of all ages
can experience the thrill of DNA fingerprinting or measuring the radioactivity
of common objects in the hands-on science center." 10
And who paid for the cost of all these conferences so that the doctors in
attendance could learn about Prevnar, and their families could measure the
radioactivity of common objects?
Would Drs. Black & Shinefield be influenced because their studies and
efforts were paid for by Wyeth-Lederle? Would their professional judgement be
swayed because the vaccine’s manufacturer paid for the conventions they
attended? Do you want the efficacy and safety of products that will be injected
into your children determined by people who are receiving money from the
corporation manufacturing that product?
Drs.
Stephen I. Pelton & Kathyrn Edwards:
Wyeth
Lederle Pays to Reassure Parents
Two other supporters of Prevnar are Dr. Stephen I. Pelton and Dr. Kathyrn
Edwards. Both spend time answering questions about Prevnar from concerned
parents and pediatricians. Below are a few examples:
In this instance, Dr. Pelton assures the concerned mother of a 6-month old
who experienced adverse reactions to Prevnar. On May 4, 2000 she wrote:
"My 6 month old
received the Prevnar vaccine two days ago. Her temperature went to 102.6 and
she vomited that evening. The fever dropped to 100 yesterday. The injection
site is very inflammed - it looks like a burn almost. It has a large knot under
it that is not only just beneath the injection site, but it extends from the
site like a finger. Is this reaction normal?"17
On May 24, 2000, Pelton replied:
"The most common side
effect is local reactions. The one that you are describing sounds somewhat
greater than average but is within the spectrum of what we see."17
On May 7, 2000, another mother advised Dr. Pelton of the unfortunate
experience of her young son after getting Prevnar. She wrote:
My 10-month old son received
prevnar four days ago. Since then he has been vomiting and developed a rash on
his body. I will not let him receive the vaccine again."17
This time, it only took three days for Dr. Pelton to write back. On May 10,
2000 he replied:
"…Rash occurs in about
1% of recipients, vomiting in almost 10% however this was seen to be equal in
children who received other vaccines without Prevnar."17
On May 15, 2000, another mom wrote about what happened to her 12-month old
daughter after receiving Prevnar and other vaccines in combination. She wrote:
"My 12-month-old
daughter just received HiB, DTP, Chickenpox and Prevnar vaccines on 5/1/00. The
morning of 5/13, she vomited for 3 hours and had diarrhea. After a visit to the
Dr., he had her admitted to the hospital…After a chest x-ray, they were able to
see that it was pneumonia in her lower right lobe of her lung…I feel 99.9%
confident that this was caused by the combination of vaccines that she
received."17
On May 22, 2000, Dr. Pelton responded:
"…Most febrile
reactions to vaccine occur within 48 hours of administration. An event 2 weeks
later is unlikely to be due to the vaccine itself."17
But his response fails to mention the admission by vaccine manufacturers
that pneumonia can be a side effect of getting the Hib and DTP vaccines
together.37
On July 24, 2000, Tmjh wrote:
"I’m concerned about
data linking prevnar to the onset of juvenile diabetes. Could you
comment?"17
On July 25, 2000 Dr. Pelton responded:
"The best reference
that I am aware of denies any linkage between the two." 17
This response appears to ignore at least one study completed at the
University of Washington which stated, "Aged 65 years or older and having cardiovascular
disease or diabetes mellitus were specific indications significantly correlated
with receipt of influenza and pneumococcal vaccine." 38
Prevnar is a pneumococcal vaccine and this study therefore suggests that late
onset of diabetes may possibly be associated with the vaccine. In addition, Dr.
J. Bart Classen told the FDA that Prevnar "may be seven times as toxic as
the hemophilus vaccine, possibly causing an estimated 400 to 700 children to
develop insulin dependent diabetes per 100,000 children immunized. These cases
of diabetes may not occur until 3.5 to 10 years following immunization."49
A mother named Anne wrote on August 23, 2000:
"Parents magazine had a
Prevnar ad, which stated ‘Prevnar has not been evaluated for any carcinogenic
or mutagenic potential, or impairment of fertility.’ Can you give me a layman’s
explanation…should I be worried...?" 17
Dr. Kathyrn Edwards responded on September 5, 2000:
"The vaccine has been
studied in animals and found not to be associated with cancer or infertility."
17
This is an interesting response because we have been unable to find a single
published report that relates to any carcinogenic or mutagenic studies on
Prevnar. In fact, the manufacturer’s insert also fails to cite such a document.
We challenge Dr. Edwards to produce such a peer-reviewed study.
A mom named Susan wrote on September 6, 2000:
"(I read) some
disturbing comments from parents whose children have already received the
vaccine. They said it has terrible side effects, such as poor appetite,
difficulty breathing, sleeping problems, and can cause juvenile diabetes…of
course this has me worried." 17
Dr. Kathryn Edwards responded on September 12, 2000:
"The vaccine was
administered to nearly 20,000 children prior to licensure and the side effects
seen in these children were carefully evaluated and not shown to increase the
rate of diabetes, respiratory problems, or weight loss." 17
As we have already seen the diabetes question is not resolved. In addition,
as far as respiratory problems are concerned, it appears that Prevnar can
cause or contribute to such a diagnosis. According to the manufacturer’s
insert: croup, pneumonia, asthma, bronchiolitis, and wheezing were associated
with the administration of Prevnar.32
The forum where all of these questions are asked and answered is titled
"Pneumo.com." The entire venue is paid for by Wyeth-Lederle Vaccines,
the manufacturer of Prevnar. (The site is "supported by an unrestricted
educational grant from Wyeth-Lederle Vaccines.") In fact, both Edwards and
Pelton are listed as "National Editors" on the site.18
Could Wyeth’s sponsorship of this forum have anything to do with these doctors’
answers?
Dr.
Kathyrn Edwards:
Wyeth
Lederle Pays to Reassure Doctors about Prevnar
Dr. Edwards is not only busy assuring worrisome parents about Prevnar, but
finds the time to reassure concerned pediatricians too. Here are some examples:
On April 1, 2000, Dr. Hemendra Parikh asked Dr. Edwards about the safety of
injecting Prevnar and Comvax simultaneously (Comvax = haemophilus influenzae
type b and hepatitis B together). He wrote:
"Has there been any
study to show the impact of the simultaneous vaccination with the pneumococcal
vaccine and other recommended childhood vaccines? Especially the simultaneous
vaccination with prevnar and comvax?"19
On April 5, 2000 Edwards responded that while there are no studies on this
question, it should be ok anyway:
"…To my knowledge, no
studies of the pneumococcal conjugates administered with Comvax are ongoing but
there is not current information to suggest that it would be a problem."19
On April 6, 2000, Dr. Mark McGwire asked:
"Any interactions
between anabolic steroids, nutritional supplements and prevnar?"19
Edwards considered this to be a funny question. She thought that it was
rather impossible that a parent could give a child a vitamin supplement. On
April 10, 2000, she replied:
"I’m glad you have a
sense of humor. Fortunately infants and young children receiving the
pneumococcal conjugate do not use these supplements and steroids."19
Is it ethical that this forum is also paid for by Wyeth Lederle, Prevnar’s
manufacturer? (The site is "Supported by an unrestricted educational grant
from Wyeth-Lederle Vaccines.") Was there a conflict of interest when
Edwards accompanied Drs. Black and Shinefield to Boston on May 12-16, 2000, to
speak about "the development and performance of conjugate pneumoccocal
vaccines (i.e. Prevnar),"20 even though the conference was
"supported in part by an educational grant from Wyeth-Lederle Vaccine and
Merck Vaccine Division?"20 Is it ethical that Wyeth Lederle
paid Dr. Edwards $255,023 per year from 1996 to 1998 for the study of
pneumococcal vaccines48 (i.e. Prevnar) and now Edwards is addressing
questions from pediatricians and parents about the product? Is it a conflict of
interest that Edwards is one of fifteen full-time members of FDA’s Vaccines and
Related Biological Products Advisory Committee, the committee that advises the
FDA on the licensing of new vaccines?
Dr.
Margaret B. Rennels:
The
Wyeth Lederle-Prevnar-RotaShield Connection
Dr. Margaret B. Rennels has also done a study that proved the safety and
efficacy of Prevnar.21 Speaking about the importance of her findings
she said that there is "an urgent need for pneumococcal vaccines that are
effective in infants."45 Dr. Rennels should know because she
has a lot of experience with vaccines especially the rotavirus vaccine.
According to her bio (which has a nice picture of her - see: http://medschool.umaryland.edu/CVD/FACULTY.HTM):
"Dr. Rennels has been
involved in Phase 1 through 4 evaluations of new and improved vaccines for
children over the last 15 years. She participated in virtually all phases of
the testing of the recently licensed rotavirus vaccine and was the lead author
on the report of the pivotal U.S. efficacy study. More recently, she has led
the U.S. safety and immunogenicity study of the heptavalent conjugate
pneumococcal vaccine (i.e. Prevnar)…Currently, she is the principle
investigator of a large study of the safety of rotavirus vaccine in premature
infants." 22
She certainly is the rotavirus expert. Her journal letters and articles have
titles like "Rotavirus vaccine comes of age."23 And when
there was the possibility that RotaShield (the brand name for the rotavirus
vaccine) could cause intussusception (collapsing of the intestines that can
lead to death) she wrote an article entitled "Lack of an apparent
association between intussusception and wild or vaccine rotavirus
infection."24 Although Dr. Rennels was part of the US Rhesus
Rotavirus Vaccine Study Group subsidized by Wyeth-Ayerst research (the
manufacturer of RotaShield)25 her financial ties with the
manufacturer would never interfere with her judgement. Nor would it interfere
with her work as one of the twelve members of the Committee on Infectious
Diseases, the committee that makes vaccine recommendations as part of the
American Academy of Pediatrics.36
Because of the increasing numbers of intussusception injuries related with
the vaccine, Wyeth Lederle Vaccines suspended further distribution and
administration of RotaShield on July 16, 1999 and withdrew it from the market
on October 15, 1999.26 This was very remarkable because Rennels had
found a "lack of an apparent association" only one year before.24
Now, Dr. Rennels is busy demonstrating the "safety" of Prevnar.
The major vaccine and drug manufacturers (including Wyeth) have donated a total
of over $2.5 million to the University of Maryland School of Medicine where Dr.
Rennels works.27 Is this ethical?
Dr.
Jerome Klein:
Wyeth
Lederle and the National Vaccine Advisory Committee
Our last doctor is named Jerome Klein. He has enthusiastically called
Prevnar "a big win for kids."28 Dr. Klein has done his
best to protect the financial sanctity of vaccine manufacturers from parents
whose children have been injured or killed by a vaccine. He has been hired by
the major drug companies to testify in legal cases on behalf of vaccine
manufacturers and against vaccine-injured children. Here’s one example as
summarized from the legal literature:
On August 22, 1984 a healthy
nine-month old baby named Sean Leary was administered his third DTP vaccine.
Sean immediately began vomiting. The next day, he stopped eating. He stayed
alert but was no longer active. That night he cried out every 15 to 30 minutes.
The pediatrician immediately noted the "obvious circulation
collapse." There at the pediatrician’s office, "Sean’s eyes rolled
back in his head and he stopped breathing." He was rushed to an emergency
room. Resuscitative efforts failed and Sean was pronounced dead at 1:44 p.m.
Dr. Jerome Klein testified that the relationship between vaccination and Sean’s
death was "merely coincidental."29
Dr. Klein is also a member of the National Vaccine Advisory Committee. This
committee makes recommendations to the assistant Secretary of Health concerning
vaccine safety and efficacy. He is also the chief editor of
"Pneumo.com" the pro-Prevnar website that is "Supported by an
unrestricted educational grant from Wyeth-Lederle Vaccines."30
Would Dr. Klein’s financial ties to Wyeth-Lederle vaccines and other drug
companies influence his pro-Prevnar stance or his actions as a member of National
Vaccine Advisory Committee, the committee that recommends vaccines to our
nation’s government? Are you comfortable trusting your child’s health to
individuals like Klein who have long-standing relationships with the
multi-national corporations that manufacture the vaccines?
Part
II:
Efficacy
of Prevnar and other Vaccines Combined with Prevnar
The Efficacy of Prevnar
How good is Prevnar? According to the study paid for by Wyeth Lederle and
generated by Drs. Black and Shinefield:
"The study showed that
children in the vaccine group fared better than those in the comparison group
in other ways. In the primary analysis of all acute otitis media episodes (i.e.
earaches), children receiving the investigational 7-valent pnemococcal vaccine
(i.e. Prevnar) had 7 percent fewer new episodes."31
Seven percent few episodes of earaches! Do you find that impressive? Keep in
mind that there are at least five other pediatric vaccines that can cause
earaches, ear infections or ear-related injury. It appears that we now have
Prevnar, a vaccine designed to prevent adverse effects that can be caused by
other vaccines.33
What about preventing invasive pneumococcal disease? According to data from
the manufacturer’s insert, after one dose of the vaccine .016% of the
recipients (3 out of 18,906) were diagnosed with invasive pneumococcal disease.39
But, .14% of controls (27 out of 18,910 children who were administered a
different experimental vaccine) got invasive pneumococcal disease. 39
This means that based on this data (relative to the control), Prevnar decreases
a child’s chance of getting invasive pneumococcal disease by about 0.1%!
Prevnar
Interferes with Other Childhood Vaccines
When Prevnar is injected along with the other childhood vaccines, does it
interfere with the promised efficacy of the other vaccines? Incredibly, the
manufacturer states that in some cases it does and in other cases they just do
not know. Under "Simultaneous Administration with Other Vaccines,"
the package insert states:
In other words, Prevnar can interfere with the "effectiveness" of
the pertussis vaccines but they really don’t know a great deal about the
implications of this. The manufacturer’s insert also states:
This admission is astounding. The manufacturer is stating that they do not
know what Prevnar does to the efficacy of either the MMR or Varicella
(chickenpox) vaccines. The insert continues:
Here they admit that Prevnar actually interferes with the inactivated polio
vaccine.
Apparently, Prevnar interferes with at least two other vaccines (Pertussis
and IPV) and may interfere with two more (MMR and Varicella). This information
also appears to be contrary to what some parents are being told regarding how
Prevnar acts in combination with other vaccines.
On April 26, 2000, a nurse revealed her concerns about the safety of
Prevnar. She wrote:
"As an RN I have only
administered the vaccine to the elderly population, now I was informed that the
pediatrician dose for pneumococcal has been released and advised. I’m not sure
the medication is safe…my child is 9 weeks old, how safe and effective will
this drug be to a newborn, who is born healthy? Were there any serious side
effects? Is it safe to administer with his routine vaccines? I’m not
comfortable with the administration of 4 vaccines at once."19
Dr. Edwards reassured the nurse that comparable antibody responses are
generated. A statement that is inconsistent with admissions from the
manufacture. On May 1, 2000 she wrote back:
"…It is safe to
administer with other vaccines…The administration of four vaccines at once has
been shown to generate comparable antibody responses…"19
Statistically
Valid Studies?
How thorough were the studies? According to the Wyeth-Lederle, for the study
concerning DPT and Hib efficacy with Prevnar, the number of infants
reviewed (who were given Prevnar) was a total of 214. 32 For toddlers
the total number was 47 children.32 For reviewing the efficacy of
Hep B with Prevnar the number of infants studied (who were given Prevnar) was
156. 32 For toddlers the total number was zero. 32
Over seven million infants and toddlers are scheduled to receive this
vaccine. The numbers of children tested (214, 47, 156, and 0) do not appear to
be statistically valid in comparison to the seven million. Therefore, it is
possible that no one really knows what Prevnar will or won’t do in combination
with the other childhood vaccines.
Is
this Rational?
The vaccine establishment is militant; requiring that every child in America
receive every vaccine they decide is necessary. With Prevnar we now have a
vaccine that admittedly interferes with the efficacy of other vaccines. Yet,
Prevnar was still approved for universal vaccination. How is that possible? The
message appears to be that it does not matter. Perhaps what matters most is
that millions of units of the vaccine are sold.
Part
III:
Safety
of Prevnar
The
Safety of Prevnar
Prevnar is a bio-engineered product. It is created by combining the
protein-polysaccharides from seven strains of dangerous Streptococcus
pneumoniae bacteria with diphtheria toxin (Corynebacterium diphtheriae)
grown in casamino acids and yeast extract and purified with ammonium sulfate.32
Such a creation has never before existed on this earth and the human race has
never before in its entire history been exposed to such a product.
According to the American Academy of Pediatrics:
"Available data suggest
that PCV7 (i.e. Prevnar) may prove to be among the most reactogenic (e.g.,
local reactions and incidence of fever) vaccine of those currently used,
including the DTaP and Haemophilus conjugate vaccines."36
In fact, the manufacturer’s insert describes reactions as the following:
Redness
& Tenderness
For one small group of children 20.8 out of 24 (87%) had erythema (redness
of skin produced by congestion of capillaries) and 4.2 out of 24 (17.5%) had
"tenderness that interfered with limb movement."40
Danger
of Inappropriate Injection
Physicians and nurses know that there is a danger of an anaphylactic
reaction if a vaccine is accidentally injected directly into a child’s
bloodstream. Prevnar appears to be no exception. Under "Precautions,"
the package insert states:
"Prevnar SHOULD UNDER NO
CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY. The safety and immunogenicity for
other routes of administration (e.g. subcutaneous) have not been
evaluated."32
Under "General," the insert repeats this warning and states:
"Special care should be
taken to prevent injection into or near a blood vessel or nerve." 32
And again under "Dosage and Administration" the warning is stated
a third time:
"For intramuscular
injection only. Do not inject intravenously…After insertion of the needle…wait
to see if any blood appears in the syringe…If blood appears, withdraw the
needle and prepare for a new injection at another site." 32
Most clinicians are very careful and very competent in avoiding this danger.
But how reasonable is to expect that a pediatrician can always avoid injecting
the product "near a blood vessel" when an infant’s or toddler’s blood
vessels can be very small and the child may be squirming and moving. No
vaccination is without risk.
The
Six-Week Threshold is a Very Fine Line
The manufacturer’s safety threshold is so narrow that it could be deemed
medically irresponsible. For example, according to the insert, "The safety
and effectiveness of Prevnar in children below the age of 6 weeks have not been
established." 32 However, the insert goes on to state that
"(Prevnar) can be given as young as 6 weeks of age." 32
This appears to suggest that one second before a child is 6 weeks old the
vaccine is unsafe but one second later everything changes and now it is safe.
There appears to be no responsible safety cushion built into this language.
ER
Visits, Seizures and SIDS Associated with Prevnar
In respect to dangerous reactions, the insert describes the following:
"Of the 17,066 subjects who received at least one dose of Prevnar…there
were 162 visits to the emergency room within 3 days of a dose…"32
Obviously some of these visits have nothing to do with the vaccine (i.e.
ingrown toenail) but others may be associated (i.e. pneumonia). In addition,
"seizures were reported in 8 Prevnar recipients" within three days of
vaccination.32 Furthermore, the insert tells us that, "Twelve
deaths (5 SIDS and 7 with clear alternative cause) occurred among subjects
receiving Prevnar." 32 This number was less than the "21
deaths (8 SIDS, 12 with clear alternative cause and one SIDS-like death in an
older child)" that occurred in the control group. However, both groups
(Prevnar and control) received some form of experimental vaccine. Therefore,
all we know is that 33 children are dead and at least 13 died of SIDS. How do
these numbers compare to unvaccinated children? Has there ever been a study to
determine this? What about visits to the ER or seizures after 3 days, such as
on day 4 or 5 or 6 or 7, etc.? It appears that no study was completed.
Possible
Allergic Reactions
The insert warns doctors that they should have epinephrine (i.e. adrenaline)
"ready and (available)" in case the child has an allergic reaction
after vaccination with Prevnar. 32
Unknown
Toxicity and Carcinogenicity
Each .5 ml dose of the vaccine includes .125 mg of aluminum.32 Aluminum
is considered neurotoxic to humans. Ironically, the American Academy of
Pediatrics admits that:
"Aluminum is now being
implicated as interfering with a variety of cellular and metabolic processes in
the nervous system and in other tissues."41
In addition, as we have already discussed, the manufacturer has admitted
that:
"Prevnar has not been
evaluated for any carcinogenic or mutagenic potential, or impairment of
fertility."32
Our children are the guinea pigs and we will see what happens in a few
years. In fact, cancer is now the leading cause of death by disease for
children under fifteen years old42 and there is a growing
information to suggest potential vaccine-cancer links with other vaccines
already administered to children.43
Relationship
with Chronic Diseases
What do we know about Prevnar’s role in causing debilitating and
life-threatening chronic diseases? Not very much. There have been no long-term studies
done (i.e. more than five years). In addition, it is unclear whether the
manufacturer has even looked at Prevnar’s relationship with the growing list of
autoimmune diseases diagnosed in children.
Can Prevnar cause diabetes? As discussed above, at least one researcher
believes it can.49 Will it cause other diseases? Unfortunately the
answer will probably come from the 7 million children targeted to receive the
vaccine. Our children are the guinea pigs.
Prevnar
is Administered to Immune-Suppressed Children
Prevnar is being administered to immune-suppressed children:
On July 24, 2000, Dr. M. Sadof wrote:
"If you have a patient
who is immunocompromised and 24 months old, which vaccine do you use…?19
Dr. Pelton responded on July 26, 2000,
"The current concept
for patients like this is to give the prevnar vaccine…"19
Dr. L Eger wrote on August 18, 2000:
"There is a general
recommendation to vaccinate immunocompromised children with Prevnar."
19
Dr. Kathryn Edwards responded on August 23, 2000:
"Since the vaccines do
not contain live bacterial components they pose no threat to the patient."
19
Apart from the fact that an immune-suppressed child may not be able to
elicit an appropriate immune response to the vaccine, the more important
question is - how safe is this practice? The answer appears to be that nobody
knows because according to the manufacturer’s insert there have been no
appropriate studies regarding the administration of Prevnar to
immune-suppressed children. Once again, our children are the guinea pigs.
Part
IV:
The
Bottom Line $
The
Bottom Line Why Prevnar Will be Injected Into Your Healthy Child
Four doses of Prevnar (the amount for each child starting at two months old)
costs $232.44 In this country alone, approximately seven million
children under two-years of age are targeted to receive the vaccine.34
According to pharmaceutical industry-financial analysts interviewed by the news
agency Reuters, Prevnar is expected to deliver sales of $300 to $500
million a year for its manufacturer Wyeth Lederle Vaccines.35
Figures like these are relatively typical. The following information comes from
two annual reports:
We have attempted to obtain additional financial data on specific vaccines,
but the manufacturers refuse to release this information to the public.
Conclusion
The evaluation of safety and efficacy and federal approval of Prevnar is
laden with ethical questions. Many of the doctors directly involved in the testing
and approval process appear to have significant conflicts of interest. The
efficacy of the vaccine is questionable and safety testing has been terribly
inadequate. There are no long-term studies (i.e. more than 5 years) of the
chronic, debilitating and life threatening diseases that this vaccine may
cause. The fact that the vaccine is bio-engineered by combining various types
and portions of bacteria should require it to undergo considerable scrutiny.
Assuming the vaccine has any efficacy at all, the need for universal
vaccination needs to be reexamined in light of the small number of children who
might be at risk from serious complications from pneumococcal disease.
Recommendations:
An
Important Final Note:
Nothing in this report should be construed as medical advice.
However, as a parent or guardian, you are entitled to make informed
decisions regarding what medical interventions (i.e. vaccines) are administered
to your child. There are a number of exemptions available (i.e. religious,
medical) if you decide not to vaccinate. For more information about using an
exemption or about Prevnar or other childhood vaccination we encourage you to
read, research and ask questions. For example, read the manufacturer’s inserts
for all vaccines before your child is vaccinated. The inserts list
adverse reactions, precautions and warnings. All the inserts are printed in a
book called Physician’s Desk Reference that is available at most large
bookstores. In addition, there are a number of reputable organizations that can
provide additional information on childhood vaccination. These organizations
include: the National Vaccine Information Center (NVIC) http://www.909shot.com; Informed Parents
Home Page http://www.unc.edu/~aphillip/www/vaccine/informed.htm;
Vaccination Information & Awareness http://www.access1.net/via;
PROVE http://vaccineinfo.net/; Australian
Vaccination Network http://www.avn.org.au/;
P.A.V.E . http://www.vaccines.bizland.com/;
Eagle Foundation http://www.eaglefoundation.org;
and many others.
For more information about the conflicts of interest responsible for
determining what gets injected into your child see the August 21, 2000 Staff
Report from the U.S. House of Representatives Committee on Government Reform
entitled "Staff Report on Conflicts of Interest in Vaccine Policy
Making" at http://www.house.gov/reform/.
Citations:
(1) Policy Statement: Recommendations for the Prevention of Pneumococcal
Infections, Including the Use of Pneumococcal Conjugate Vaccine (Prevnar),
Pneumococcal Polysaccharide Vaccine, and Antibiotic Prophylaxis (RE9960);
American Academy of Pediatrics, Volume 106, Number 02, August 2000, pp.
362-366. (last visited on 9/14/2000) http://www.aap.org/policy/re9960.html
(2) See for example:
(3) Kaiser Permanente News Release: Investigational vaccine is first to show
effectiveness against childhood ear infections; May 4, 1999 (last visited
5/20/2000) http://www.kaiserpermanente.org/newsroom/releases/vaccine1.html
(4) Associated Press: New vaccine reduces risk of severe pneumonia in
children; October 1, 1999 (last visited 5/20/2000) http://www.idahonews.com/10011999/health_a/386.htm
(5) American Home Products News & Announcements: American Home Products
Corporation’s Pneumococcal Conjugate Vaccine for Children Receives Priority
Review status from FDA, July 21, 1999, (last visited 9/14/2000) http://www.ahp.com/releases/wa_072199b.htm
http://isid.organize-it.com/9th_congress/sat_symposia.html
(17) Pneumo.com Online Forum (last visited 9/13/2000) http://www.pneumo.com/msgboard/messages/parent-messages.html
(18) Pneumo.com "Ask an Expert" (last visited on 9/14/2000) http://pneumo.com/contact/contact2.html
(19) Pneumo.com Online Forum (last visited 9/13/2000) http://pneumo.com/home.html
(click on: "Online Forum for Physicians")
(21) Rennels MB, Edwards KM, Keyserling HL, Reisinger KS, Hogerman DA,
Madore DV, Chang I, Paradiso PR, Malinoski FJ, Kimura A, Safety and
immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in
United States infants. Pediatrics 1998 Apr;101(4 Pt 1):604-11
(22) Univesrity of Maryland School of Medicine Faculty (last visited on
9/14/2000) http://medschool.umaryland.edu/CVD/FACULTY.HTM
(23) Rennels MB, Rotavirus vaccine comes of age, J Pediatr 1997
Oct;131(4):512-3
(24) Rennels MB, et al. Lack of an apparent association between
intussusception and wild or vaccine rotavirus infection, Pediatr Infect Dis J
1998 Oct;17(10):924-5
(25) Markwick AJ, Rennels MB, Zito ET, Wade MS, Mack ME, Oral tetravalent
rotavirus vaccine can be successfully coadministered with oral poliovirus
vaccine and a combined diphtheria, tetanus, pertussis and Haemophilus
influenzae type b vaccine. US Rhesus Rotavirus Vaccine Study Group. Pediatr
Infect Dis J 1998 Oct;17(10):913-8
(26) American Home Products News & Announcements "Wyeth Lederle
Vaccines Voluntarily Withdraws from the Market its Rotavirus Vaccine"
(last visited on 6/17/2000) Rotashield"http://www.ahp.com/releases/ahp_101599.htm
"
(27) See: University of Maryland School of Medicine Donors and Medical
System Donors: (last visited 9/14/2000 - Under "Contributions" click
on "Medical System" and "School of Medicine")
http://www.umm.edu/annualreport/9798ar/site/main.htm
Examples include: Warner-Lambert Company - 1,000,000-4,999,999; Parke-Davis
- $500,000-$999,999; Hoffman LaRouche, Inc. - $250,000-$499,999; Merck &
Company - $250,000-$499,999; Bristol-Myers Squibb - $250,000-$499,999;
SmithKline-Beecham $100,00-$249,999; Abbott Laboratories - $10,000-$49,999;
Pfizer Inc. - $10,000-$49,999; Wyeth-Ayerst Laboratories $10,000-$49,999 to Medical
System and $10,000-$49,999 to Medical School; American Cyanamid -
$1,000-$9,999, etc.
(28) Klein JO, The pneumococcal conjugate vaccine arrives: a big win for
kids, Pediatr Infect Dis J, 2000 Mar, 19(3) 181-2
(29) Leary v. Secretary of the Department of Health and Human Services,
1994 WL 43395 (Fed.Cl.)
(30) Default Pneumo.com content frame http://pneumo.com/home.html
(see top of page)
(31) Kaiser Permanente News Release: Investigational vaccine is first to
show effectiveness against childhood ear infections; May 4, 1999 (last visited
5/20/2000) http://www.kaiserpermanente.org/newsroom/releases/vaccine1.html
(32) Pneumoccocal 7-valent Conjugate Vaccine (Diphtheria CRM197
Protein) Package Insert (last visited on 9/13/2000)
http://www.pneumo.com/vaccine/PI.html
(33)See: Parotitis from Biavax: Rubella & Mumps (Merk) 51st
Edition of Physicians Desk Reference, Medical Economics Company p.1653-1654,
1997; Tinnitus and earache from Engerix - B: Hep B (Smith Kline) 51st
Edition of Physicians Desk Reference, Medical Economics Company p. 2656 - 2658,
1997; Parotitis and otitis media from MMR (Merck) 51st Edition of
Physicians Desk Reference, Medical Economics Company p. 1730 -1732, 1997;
otitis media from Tetramune (DTP and Hib) (Lederle) 51st Edition of
Physicians Desk Reference, Medical Economics Company p. 1449 - 1452, 1997;
otitis from Varivax (Merck) 51st Edition of Physicians Desk
Reference, Medical Economics Company p. 1807 - 1810, 1997.
(34) Health News Daily, Volume 12, Issue 32, Friday February 18, 2000
(35) ABC News: Pneumococcus Vaccine Approved as reported in Reuters
February 17, 2000
(36) Technical Report: Prevention of Pneumococcal Infections, Including the
Use of Pneumococcal Conjugate and Polysaccharide Vaccines and Antibiotic
Prophylaxis (RE9960)
American Academy of Pediatrics, Gary D. Overturf, MD, and the Committee on
Infectious Diseases (last visited on 9/14/2000)
http://www.aap.org/policy/re9960t.html
(37) See: Tetramune (DTP and Hib) (Lederle) 51st Edition of
Physicians Desk Reference, Medical Economics Company p. 1449 - 1452.
(38) Buchwald D, et al. Influenza and pneumococcal vaccination among Native
American elders in a primary care practice. Arch Intern Med 2000 May
22;160(10):1443-8.
(39) Pneumoccocal 7-valent Conjugate Vaccine (Diphtheria CRM197
Protein) Package Insert See: http://www.pneumo.com/vaccine/PI.html
Note: The calculation presented results from dividing all invasive pneumococcal
serotypes that the children were afflicted with in the "intent to
treat" figures (children who received at least one dose of the vaccine) by
the number of children and comparing the percentages for Prevnar and the
control. This data is derived from the text and figures in Table 1 of the
package insert. The studies conducted by Drs. Black and Shinefield claim an efficacy
rate of over 90%. But this is computed using relative percentages, not absolute
numbers. For example, in the article entitled Efficacy, safety and
immunogenicity of heptavalent pneumococcal conjugate vaccine in Children.
Northern California Kaiser Permanent Vaccine Study Group (Pediatr Infect
Dis J 2000 Mar;19(3); 187-95), Black, Shinefield et al claim an efficacy of
Prevnar of over 97%. There were 40 cases of pneumococcal disease (39 in control
group and 1 in Prevnar group). Therefore the control group accounted for 97.5%
of the children with pneumococcal disease (39/40 = 97.5%). Compared to the
control group, Prevnar was 97.5% effective. But these are relative percentages
and present a confusing message regarding absolute efficacy and value of the
vaccine. For example, imagine your child had a .0000000000000000001 chance of
getting a disease (18 zeros). And the vaccine reduced this rate to
.000000000000000000001 (20 zeros). Based on Black and Shinefield’s approach
(relative percentage) this hypothetical vaccine is actually 99.9% effective.
But, as a parent I would be most interested in the absolute value of the
vaccine. "Tell me my child’s risk of getting the disease if I don’t
vaccinate. Tell me my child’s risk of getting the disease if I do vaccinate."
According to Lederle’s data from the package insert, if you don’t vaccinate
with Prevnar the risk is approximately 20 in 100,000 (0.020%) for all persons,
and 150 in 100,000 (0.15%) for children under two. If you do vaccinate with
Prevnar, the risk decreases to 3 out of 18,906 (.016). If you vaccinate with
the control vaccine, the risk is 27 out of 18,910 (0.14%). By looking at this
comparison, Prevnar provides an absolute value of 0.13% (0.15 - 0.016 = 0.13%)
compared to no vaccination, and 0.12% ( 0.14 - 0.016 = 0.12) compared to the
control. (In fact, the data may already be skewed in favor of Prevnar because
the Prevnar and control figures were for various ages of children but the
comparison without the vaccine is being made to infants. This inflates the
comparative efficacy of Prevnar because infants have a higher rate of
pneumococcal disease compared with older children.)
(40) Study number 118-12 - Percentage of Subjects Reporting Local Reactions
Within 3 Days of Immunization in Infants and Children from 7 Months through 9
Years of Age, Cited in Prevnar’s insert http://www.pneumo.com/vaccine/PI.html
as "Data on File at Lederle Laboratories."
(41) Aluminum Toxicity in Infants and Children (RE9607), Pediatrics Volume
97, Number 3 March, 1996, pp. 413-416. (last visited on 9/14/2000): http://www.aap.org/policy/01263.html
(42) USPHS. 1991. Vital Statistics of the United States, 1988, Volume II:
Mortality. National Center for Health Statistics, U.S. Public Health Service,
Washington, DC.
(43) http://ouralexander.org/BurtonDan2velec.doc
(44) Abramowicz, Mark. A pneumococcal conjugate vaccine for infants and
children, Medical letter on Drugs & Therapeutics, May 20, 2000
(45) Doctor’s Guide to Medical & Other News, Experimental Vaccine Shows
Promise Against Pneumococcal Disease in Kids, April 7, 1998 (last visited on
5/28/2000) http://www.plsgroup.com/dg/6B37A.htm
(46) 1994 red Book Report of the Committee on Infectious Diseases, 23rd
Edition published by the American Academy of Pediatrics, 1994, p. 371.
(47) According to the manufacturer’s insert, there are an estimated 10 to 30
cases per 100,000 children less than or equal to two years old. Taking the mean
of 20 cases per 100,000 = 1 case in 5,000. If your child is under two, the
number is 140 to 160 cases per 100,000. The mean of 150 cases per 100,000 is
equivalent to 7.5 cases in 5,000. The manufacturer states that "The annual
incidence of pneumococcal meningitis in children between 1 to 23 months of age
is approximately 7 cases per 100,000 persons" and that this disease
"has been associated with 8% mortality." Seven cases per 100,000 is
equivalent to 70/1,000,000. 8% of 70 = 5.6. 5.6/1,000,000 = 178,571. Source of
data: Pneumoccocal 7-valent Conjugate Vaccine (Diphtheria CRM197
Protein) Package Insert (last visited on 9/13/2000) http://www.pneumo.com/vaccine/PI.html
(48) Conflicts of Interest in Vaccine Policy Making, Majority Staff Report,
Committee on Government reform, U.S. House of Representatives, August 21, 2000,
p. 17.
(49) New `Tuskegee-Like Experiment' Planned with Pneumococcal Pneumonia
Vaccine, Reported by Classen Immunotherapies (last visited on 9/18/2000) http://vaccines.net/pneumoco.htm
(50) SmithKline Beecham 1999 Annual Report, Principal Products p. 38.
(51) Merck 1999 Annual Report, Financial Section, p. 31
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.