Surrogate Endpoints Used in Development of Gardasil Vaccine; CBCD Scientist Interviewed Regarding Criticism of FDA's Approval of Drug

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CBCD scientists voice criticism of science behind FDA approval of Gardasil during radio interview.

The CBCD has posted a radio interview with Dr. Hanan Polansky on the Holy Hormones radio program to its website regarding the HPV vaccine, Gardasil.

In agreement with the views expressed by Dr. Polansky during the interview, the Center for the Biology of Chronic Disease (CBCD) joins other scientists in warning the public: The FDA counted on guesswork in approving Gardasil, the HPV vaccine.

During clinical trials, Merck’s scientists decided to use a “surrogate end point” instead of measuring the effect of the HPV vaccine directly on the development of cancer. Why? And, what does “surrogate end point” mean?

As for why, it takes 20 – 40 years from infection of the HPV virus to the onset of cervical cancer. Merck scientists couldn’t wait that long. Merck’s studies stopped after just 5 years. So, what did they do instead? They used “surrogate endpoints.”

What is a “surrogate endpoint?” It is something that scientists can observe today that they hope will predict cancer 20 – 40 years from now. However, all surrogate points involve hope and guesswork.

Thus, the FDA relied on incomplete evidence, hope, and guesswork when it approved Gardasil, and simply took a giant risk…with the public’s health.

“Above all, health policy must be driven by science.” – Lawrence O. Gostin, JD [2] According to a study published in the Journal of American Medical Association (JAMA), the science does not back up current health policy that encourages or mandates HPV vaccination. [3] The Center for the Biology of Chronic Disease (CBCD)’s research concurs.

Lucija Tomljenovic and Christopher Shaw of the University of British Columbia’s Neural Dynamics Research Group wrote in an article in JAMA that, “clinical trial evidence has not demonstrated that HPV vaccines can actually prevent invasive cervical cancer, let alone cervical cancer deaths.” [4]

“Because HPV vaccines were specifically developed to protect against cervical cancer, we conclude that in the absence of long term data, their true benefits remain speculative.” - Lucija Tomljenovic and Christopher Shaw

Moreover, Lucija Tomljenovic and Christopher Shaw wrote: “There are still unresolved concerns regarding HPV vaccine safety. HPV vaccines can cause serious adverse events, including death and long-term disabling autoimmune conditions.” [3] [4] In addition, last year, in response to a Freedom of Information Act request by Judicial Watch, the FDA reported 26 new deaths and many more severe reactions — including seizures, blindness and paralysis — in patients receiving Gardasil injections between Sept. 2010 and Sept. 2011. [5]

With the above information in mind, the CBCD agrees with Gostin who wrote further, “Political leaders [as well as the medical profession] have a moral responsibility to ensure their political advocacy is well informed and does not cause future harm to America’s youth.” [1]

The CBCD would like to propose a method to replace or at least augment “surrogate endpoints.” This method includes a better understanding of the biological mechanism underlying disease. In simple terms, it is answering the following question, "What is the biological mechanism that leads from being infected with the dormant HPV virus to cancer?"

When science has the answer to this question, all it needs is to develop a treatment that interrupts this mechanism. Some scientists are already familiar with this mechanism. It is called Microcompetition. This mechanism was discovered by Dr. Hanan Polansky and published in his highly acclaimed "Purple" book, entitled Microcompetition with Foreign DNA and the Origin of Chronic Disease. In his book, he also explains how dormant viruses can cause other major diseases.

"Not only does the book present a strong theory to unify the cause of many diverse disease states, the book itself represents an aspect lacking in the field of medical science, an attempt to unify observations into coherent theories." - Q. Ping Dou, PhD - Co-Leader, Prevention Program, Barbara Ann Karmanos Cancer Institute, and Professor, Department of Pathology, School of Medicine, Wayne State University

The book has been read by more than 5,000 scientists around the world, and has been reviewed in more than 20 leading scientific journals such as the Archives of Virology and the European Journal of Cancer.

The CBCD encourages biologists, virologists, geneticists, scientists and the public to obtain a copy of Dr. Hanan Polansky's book and read it. The book is available as a free download from the CBCD website. (http://www.cbcd.net)

The CBCD endorses Dr. Polansky’s theory, and invites the media, scientists, and the general public to contact us on this issue.

For more information on the Center for the Biology of Chronic Disease, or to schedule an interview with Dr. Polansky, please visit http://www.cbcd.net or call 585-250-9999.

References:

[1] Rothman SM and Rothman DJ, Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism, JAMA 2009, 302(7); 781-786.

[2] Gostin LO. Mandatory HPV vaccination and political debate. JAMA. 2011; 306(15):1699-1700.

[3] Tomljenovic L, Shaw AE. Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds? Ann Med. doi:10.3109/07853890
.2011.645353

[4] Harper DM, Williams KB. Prophylactic HPV vaccines: current knowledge of impact on gynecologic premalignancies. Discov Med. 2010;10(50):7-17.

[5] http://www.judicialwatch.org/press-room/press-releases/judicial-watch-uncovers-fda-gardasil-records-detailing-26-new-reported-deaths/

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The Center for the Biology of Chronic Disease (CBCD, http://www.cbcd.net) is a research center recognized by the IRS as a 501(c)(3) non-for-profit organization. The mission of the CBCD is to advance the research on the biology of chronic diseases, and to accelerate the discovery of treatments for these diseases.

The CBCD published the “Purple” book entitled “Microcompetition with Foreign DNA and the Origin of Chronic Disease” written by Dr. Hanan Polansky. The book presents Dr. Polansky’s highly acclaimed scientific theory on the relationship between the DNA of latent (chronic) viruses and the onset of chronic diseases. Dr. Polansky’s book is available as a free download from the CBCD website.

We invite biologists, virologists, and scientists everywhere to download Dr. Polansky's book here: http://cbcd.net/.

The radio interview with Dr. Polansky can be accessed through the CBCD.net website as well as:
http://dl.dropbox.com/u/41576890/02.06.12%20HHH%20Polansky%20Interview%20.mp3

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John S. Boyd, PhD
Center for the Biology of Chronic Disease
(585) 250-9999
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