A
Critical Review of a New Childhood Vaccine
© Michael Horwin, MA
[email protected]
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.
Drs.
Black & Shinefield: Wyeth Lederle Paid for Conferences
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
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).
Prevnar
Interferes With Other Childhood Vaccines
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).
Statistically
Unconvincing Studies
The
studies of efficacy of other vaccines in combination with Prevnar used numbers of children (n =
214, 47, 156, 0) that are statistically questionable in respect to the seven million children
targeted to receive Prevnar.
Part
III:
Safety
of Prevnar
The
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
Six-Week Threshold is a Very Fine Line
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.
ER
Visits, Seizures and SIDS Associated with Prevnar
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.
Unknown
Toxicity and Carcinogenicity
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 Administered to Immune-Suppressed Children
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 $
The
Bottom Line Why Prevnar Will be Injected Into Your Healthy Child
At $242 per child, Prevnar is expected to deliver
sales of between $300-$500 million per year for its manufacturer.
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.
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:
1.
Dr. Steven Black of Kaiser Permanente
2.
Dr. Henry Shinefield also of Kaiser Permanente
3.
Dr. Stephen I. Pelton of Boston Medical Center
4.
Dr. Jerome Klein also of Boston Medical Center
5.
Dr. Margaret B. Rennels of the University of Maryland Medical Center
6.
Dr. Kathryn M. Edwards of Vanderbilt University School of Medicine.
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:
§
Washington DC (Friday October 8, 1999)10
§
Buenos Aires (April 10-13, 2000)11
§
Boston (May 15, 2000)12
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?
§
The conference at the Smithsonian in Washington DC was "supported by an unrestricted
educational grant from Wyeth Lederle vaccines."13
§
The one in Buenos Aires was "sponsored by Wyeth Lederle vaccines."14
§
The one in Boston was "supported in part by an educational grant from Wyeth-Lederle
Vaccine and Merck Vaccine Division."15
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:
·
"Although some inconsistent differences in response to pertussis antigens were observed,
the clinical relevance is unknown." 32
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:
·
"MMR and Varicella immunogenicity data from controlled clinical trials with concurrent
administration of Prevnar are not available." 32
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:
·
"The response to two doses of IPV given concomitantly with Prevnar.(was) lower for
(poliovirus) Type 1." 32
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:
|
|
Type
of Vaccine
|
Manufacturer
|
Annual
Sales $
|
Hepatitis
Vaccines
|
Smithkline
Beecham
|
$278
million50
|
"Vaccines/
Biologics"
|
Merck
|
$860
million51
|
|
|
We have attempted to obtain additional financial data
on specific vaccines, but the manufacturers refuse to release this information to the public.
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:
·
All the safety and efficacy data related to Prevnar should be reevaluated by independent
doctors and scientists who have no financial ties to the manufacturer.
·
The need for universal vaccination with Prevnar should also be reevaluated by independent
doctors and scientists who have no financial ties to the manufacturer.
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.nvic.org;
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/.
(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:
·
Shinefield HR, Black S, Efficacy of pneumococcal conjugate vaccines in large scale field
trials. Pediatr Infect Dis J 2000
Apr;19(4):394-7
·
Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, Elvin L, Ensor KM, Hackell J,
Siber G, Malinoski F, Madore D, Chang I, Kohberger R, Watson W, Austrian R, Edwards K, Efficacy,
safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern
California Kaiser Permanente Vaccine Study Center Group. Pediatr
Infect Dis J 2000 Mar;19(3):187-95
·
Lieu TA, Ray GT, Black SB, Butler JC, Klein JO, Breiman RF, Miller MA, Shinefield HR,
Projected cost-effectiveness of pneumococcal conjugate vaccination of healthy infants and young
children. JAMA 2000 Mar 15;283(11):1460-8
·
Shinefield HR, Black S, Ray P, Chang I, Lewis N, Fireman B, Hackell J, Paradiso PR, Siber
G, Kohberger R, Madore DV, Malinowski FJ, Kimura A, Le C, Landaw I, Aguilar J, Hansen J, Safety
and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr
Infect Dis J 1999 Sep;18(9):757-63
(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
(6)
Harvard Medical School Office of Public
Affairs News release, Researchers Find Use of Pneumococcal Conjugate Vaccine for Children Could
Reduce Disease-Related Costs, March 14, 2000 (last visited 5/27/2000) http://www.hms.harvard.edu/news/releases/0300lieu.html
(7)
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
(8)
American Home Products: 1997 Annual Report (last visited 9/2/2000) http://www.ahp.com/annrpt97/sreport3.htm
(9)
(deleted from text) http://www.mailbase.ac.uk/lists-p-t/public-health/1999-09/0003.html
(10)
MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course
(last visited on 5/26/2000) http://www.mededregister.com/vaccine.html
(11)
9th International Congress on
Infectious Diseases, April 10-13, 2000, Buenos Aires, Argentina (last visited on 5/26/2000)
http://isid.organize-it.com/9th_congress/sat_symposia.html
(12)
Pediatric Academic Societies & American
Academy of Pediatrics Joint Meeting - Haynes Convention Ctr. May 16, 2000 (last visited on 5/27/2000)
http://www.aps-spr.org/Meetings/2000/Monday.htm
(13)
MedRegister.Com: Preventing Pediatric Diseases - A Continuing Medical Education Course
(last visited on 5/26/2000) http://www.mededregister.com/vaccine.html
(14)
9th
International Congress on Infectious Diseases, April 10-13, 2000, Buenos Aires, Argentina (last
visited on 5/26/2000)
http://isid.organize-it.com/9th_congress/sat_symposia.html
(15)
Pediatric Academic Societies & American Academy of Pediatrics Joint Meeting - Haynes
Convention Ctr. May 16, 2000 (last visited 5/27/2000)
http://www.aps-spr.org/Meetings/2000/Monday.htm
(16) MedRegister.Com:
Preventing Pediatric Diseases - A Continuing Medical Education Course (last visited on 5/26/2000)
http://www.mededregister.com/vaccine.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")
(20) Pediatric
Academic Societies & American Academy of Pediatrics Joint Meeting - Haynes Convention Ctr. May
16, 2000 (last visited 5/27/2000)
http://www.aps-spr.org/Meetings/2000/Monday.htm
(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