Prevnar Vaccine

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Dr. Erdem Cantekin on Pneumococcal Vaccine - Prevnar

History of American Home Products/Wyeth-Ayerst/Lederle
Many recalled products, fines by the FDA, and on and on

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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?

Continued - Part 2 of 2