Cynthia A. Janak
HPV reports to FDA - - oversight, errors and/or omission. That is the question.
By Cynthia A. Janak
In my article dated September 16th, 2011, I referenced an FDA document. "Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18. Dated September 11, 2008"
A very astute individual brought to my attention an interesting fact. On page 139 it states under the reviewer's comments that "New Medical Conditions in HPV-018 (Gardasil compared to true saline placebo). What I did was review the whole 187 page document. This is what I found.
Page 5 makes the same assertion — safety data for study HPV-018 out to Month 30, the saline placebo controlled study. Again on page 13 — Month 24 for study HPV-018 (safety and immunogenicity profile) in pre-adolescent girls and boys as compared to a true saline placebo. Page 135 — received alum control or saline placebo. Even in the header of table 80 it states Saline Placebo. Is this an error or just oversight?
Page 78 reports of a death from their so called saline placebo participant. In the 24 Month safety follow-up report for study HPV-018 (safety and immunogenicity study of boys and girls 9-15 years of age), submitted in 125126/ -(b)(4)-, there was the following death in the saline control group: AN 71910 [MEDULLUBLASTOMA]: an 11-year-old Hispanic male,
It goes on to say these interesting facts. He had a history of sulfonamide allergy, headache, obesity, hypercholesterolemia, hypercorticoidism, hyperinsulinism, gastroesophageal reflux, and ventricular drainage (extra cranial ventricular shunt replacement).
Approximately 165 days post Dose 2 the subject suffered from what was believed to be a "cerebral tumor with cervical spine metastasis," however this diagnosis was changed 290 days post Dose 2 to medulloblastoma. The investigator determined that the death was not related to the vaccine or any procedure performed within the study.
I want to address this sulfonamide allergy — The most common "sulfur allergy" is that to a sulfonamide drug. Canterbury District Health Board. The interesting point that was made is this: However, rashes associated with morphine are not usually allergic in nature but due to the drug itself causing histamine release as part of its pharmacological activity. (I will come back to this further in the article.)
What makes the insertion of Saline Placebo important? This is why. In the initial report for approval of Gardasil, Clinical Review of Biologics License Application for Human Papillomavirus, 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae), (STN 125126 GARDASIL), manufactured by Merck, Inc., June 8, 2006, which is 464 pages, states on page 2 the ingredients of the vaccine. One of the ingredients in the carrier solution is — 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant). The carrier solution is all the ingredients except for the HPV-VLP's (virus-like particles)
According to the Canterbury DHB this child was already predisposed to a reaction from the so called placebo. Now you add L-Histidine which is the precursor of Histamine and it is known that the immune stimulation of IgE in a person with allergies has the potential to cause elevated levels of histamine to be released from the histamine receptors in the body. This can cause excessive inflammation.
It is my belief that this young boy should not have been allowed to participate. This young boy had a history of medical issues. Was this just oversight? If so by whom?
Why is this important for the comparison between the two reports?
In the original report it shows conflicts as to what is in the HPV-018 study group placebo. One page 45 at the end of table 24 it says saline was used in the placebo. But, and this is the goody, but on page 50 the last item in table 26 it shows the composition of the placebo. Here is what it has: Placebo, PV501 VAI028P005, 225 mcg aluminum adjuvant/0.5 mL.
Continuing on with this we come to page 300 Table 210. This is what it shows.
TABLE 210
Protocol 018: Vaccine Products Used
I hope you remember what I said about the carrier solution. Here again it is mentioned for Protocol 018 (HPV-018).
Let's go on for another possible error. Check out table 212 on page 304.
TABLE 212
Protocol 018: Subject Disposition by Vaccination Group
Now for some reason on page 304 thru 306 we no longer have aluminum (AAHS) in the placebo. The same stands true for table 216. This goes all the way through pretty much to the end of the document. I wonder how many different people than the original writer was doing this report and forgot what was in the placebo. I don't think we will ever know. I feel these people who ever they are resented false information to the FDA and should be held accountable for the error/omission/oversight of this report.
So I feel that it is safe to say that the placebo is not and was never a saline only placebo but probably did include the AAHS (amorphous aluminum hydroxyphosphate sulfate) which had the potential to cause issues with the boy that passed because of his sulfate allergy. We will never know what his condition was prior to the study.
Because of all this I had to check to see what the physicians receive with the product.
It has been a while since I checked out the Physicians Package Insert and I know additions have been made so I wanted to see if sulfur or sulfate allergies are mentioned. This is what is listed: 4. Contraindications: Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. [See Description (11).]
No mention of sulfur or sulfate allergies. Why is this omitted? I would assume that because sulfate is a component of the adjuvant that physicians with patients with sulfur allergies should be notified.
As I continue to review the Physicians Package Insert on page 6, table 5 it states AAHS (amorphous aluminum hydroxyphosphate sulfate) control or Saline Placebo. I am going to surmise that they are referring to the now infamous HPV-018 study group. Since I have proven in the original report that this was an alum carrier solution, is this an error or oversight?
Questions, questions, questions, just so many questions with this comparison of the documents that the FDA has on their site.
With all the variances either by omission, error, or oversight it would be in the best interests of all parties concerned for all of the documentation be turned over to an independent party to review and write a report that will have all the facts straight. This is a hodge podge of blunders that should never get past the eyes of the reviewers in the FDA. Due to the errors/omission/oversight in regards to these two documents both HPV vaccines need to be temporary suspended until the final report is made.
Since all the challenges are flying around I am going to challenge the FDA to handle this and present the public with an answer as to why this happened and why was it allowed? Was it just errors, omission or oversight and who is responsible?
One more question. Is this typical of all the reports presented with any and all vaccines or medications reviewed?
I want to thank the FDA for all the documents that they keep on the website in an effort at transparency. I would also like to see an independent panel with no affiliations to assist in the approval process for vaccines and medications.
Interests: I am a board member of the Truth About Gardasil and have no other affiliations with any other group.
© Cynthia A. Janak
September 19, 2011
In my article dated September 16th, 2011, I referenced an FDA document. "Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18. Dated September 11, 2008"
A very astute individual brought to my attention an interesting fact. On page 139 it states under the reviewer's comments that "New Medical Conditions in HPV-018 (Gardasil compared to true saline placebo). What I did was review the whole 187 page document. This is what I found.
Page 5 makes the same assertion — safety data for study HPV-018 out to Month 30, the saline placebo controlled study. Again on page 13 — Month 24 for study HPV-018 (safety and immunogenicity profile) in pre-adolescent girls and boys as compared to a true saline placebo. Page 135 — received alum control or saline placebo. Even in the header of table 80 it states Saline Placebo. Is this an error or just oversight?
Page 78 reports of a death from their so called saline placebo participant. In the 24 Month safety follow-up report for study HPV-018 (safety and immunogenicity study of boys and girls 9-15 years of age), submitted in 125126/ -(b)(4)-, there was the following death in the saline control group: AN 71910 [MEDULLUBLASTOMA]: an 11-year-old Hispanic male,
It goes on to say these interesting facts. He had a history of sulfonamide allergy, headache, obesity, hypercholesterolemia, hypercorticoidism, hyperinsulinism, gastroesophageal reflux, and ventricular drainage (extra cranial ventricular shunt replacement).
Approximately 165 days post Dose 2 the subject suffered from what was believed to be a "cerebral tumor with cervical spine metastasis," however this diagnosis was changed 290 days post Dose 2 to medulloblastoma. The investigator determined that the death was not related to the vaccine or any procedure performed within the study.
I want to address this sulfonamide allergy — The most common "sulfur allergy" is that to a sulfonamide drug. Canterbury District Health Board. The interesting point that was made is this: However, rashes associated with morphine are not usually allergic in nature but due to the drug itself causing histamine release as part of its pharmacological activity. (I will come back to this further in the article.)
What makes the insertion of Saline Placebo important? This is why. In the initial report for approval of Gardasil, Clinical Review of Biologics License Application for Human Papillomavirus, 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae), (STN 125126 GARDASIL), manufactured by Merck, Inc., June 8, 2006, which is 464 pages, states on page 2 the ingredients of the vaccine. One of the ingredients in the carrier solution is — 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant). The carrier solution is all the ingredients except for the HPV-VLP's (virus-like particles)
According to the Canterbury DHB this child was already predisposed to a reaction from the so called placebo. Now you add L-Histidine which is the precursor of Histamine and it is known that the immune stimulation of IgE in a person with allergies has the potential to cause elevated levels of histamine to be released from the histamine receptors in the body. This can cause excessive inflammation.
It is my belief that this young boy should not have been allowed to participate. This young boy had a history of medical issues. Was this just oversight? If so by whom?
Why is this important for the comparison between the two reports?
In the original report it shows conflicts as to what is in the HPV-018 study group placebo. One page 45 at the end of table 24 it says saline was used in the placebo. But, and this is the goody, but on page 50 the last item in table 26 it shows the composition of the placebo. Here is what it has: Placebo, PV501 VAI028P005, 225 mcg aluminum adjuvant/0.5 mL.
Continuing on with this we come to page 300 Table 210. This is what it shows.
TABLE 210
Protocol 018: Vaccine Products Used
I hope you remember what I said about the carrier solution. Here again it is mentioned for Protocol 018 (HPV-018).
Let's go on for another possible error. Check out table 212 on page 304.
TABLE 212
Protocol 018: Subject Disposition by Vaccination Group
Now for some reason on page 304 thru 306 we no longer have aluminum (AAHS) in the placebo. The same stands true for table 216. This goes all the way through pretty much to the end of the document. I wonder how many different people than the original writer was doing this report and forgot what was in the placebo. I don't think we will ever know. I feel these people who ever they are resented false information to the FDA and should be held accountable for the error/omission/oversight of this report.
So I feel that it is safe to say that the placebo is not and was never a saline only placebo but probably did include the AAHS (amorphous aluminum hydroxyphosphate sulfate) which had the potential to cause issues with the boy that passed because of his sulfate allergy. We will never know what his condition was prior to the study.
Because of all this I had to check to see what the physicians receive with the product.
It has been a while since I checked out the Physicians Package Insert and I know additions have been made so I wanted to see if sulfur or sulfate allergies are mentioned. This is what is listed: 4. Contraindications: Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. [See Description (11).]
No mention of sulfur or sulfate allergies. Why is this omitted? I would assume that because sulfate is a component of the adjuvant that physicians with patients with sulfur allergies should be notified.
As I continue to review the Physicians Package Insert on page 6, table 5 it states AAHS (amorphous aluminum hydroxyphosphate sulfate) control or Saline Placebo. I am going to surmise that they are referring to the now infamous HPV-018 study group. Since I have proven in the original report that this was an alum carrier solution, is this an error or oversight?
Questions, questions, questions, just so many questions with this comparison of the documents that the FDA has on their site.
With all the variances either by omission, error, or oversight it would be in the best interests of all parties concerned for all of the documentation be turned over to an independent party to review and write a report that will have all the facts straight. This is a hodge podge of blunders that should never get past the eyes of the reviewers in the FDA. Due to the errors/omission/oversight in regards to these two documents both HPV vaccines need to be temporary suspended until the final report is made.
Since all the challenges are flying around I am going to challenge the FDA to handle this and present the public with an answer as to why this happened and why was it allowed? Was it just errors, omission or oversight and who is responsible?
One more question. Is this typical of all the reports presented with any and all vaccines or medications reviewed?
I want to thank the FDA for all the documents that they keep on the website in an effort at transparency. I would also like to see an independent panel with no affiliations to assist in the approval process for vaccines and medications.
Interests: I am a board member of the Truth About Gardasil and have no other affiliations with any other group.
© Cynthia A. Janak
The views expressed by RenewAmerica columnists are their own and do not necessarily reflect the position of RenewAmerica or its affiliates.
(See RenewAmerica's publishing standards.)
