http://www.nccn.net/~wwithin/prevnar.htm
Any
information obtained here is not to be construed as medical or legal advice.
The decision to vaccinate and how you implement that decision is yours and
yours alone.
PREVNAR
A Critical Review
of a New Childhood Vaccine
© Michael Horwin,
MA
mhbiomed@aol.com
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.
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:
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?
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.