Wednesday, July 18, 2012

New Study: HPV Vaccine and Evidence of Herd Immunity or Type Replacement?

By Norma Erickson, President

(This is a rebuttal to one of the poorly done industry sponsored 'studies' that has been all over the Press this week, even though it is not scheduled for publication until August. Seems industry sponsored papers do not need to follow the same rules as other scientists and medical professionals do when submitting papers for publication. Emphasis added Freda Birrell via Ed. )

Medical professionals rely on studies published in medical journals to keep abreast of new developments in their field. What happens when published studies raise more questions than answers? Where does that leave trusting medical consumers?

On July 12, 2012, Australia became the first country in the world to formally offer taxpayer sponsored HPV vaccines to their young men. HPV vaccines have been advertised as ‘cervical cancer’ vaccines. Boys obviously do not have a cervix, so how do you ‘sell’ males on the idea of a three shot series of the most expensive vaccine on the market?

Miracle of miracles – almost immediately press reports begin to come in from around the world about a new study that supposedly demonstrates evidence of HPV vaccinations providing protection to the unvaccinated population. What an outstanding way to convince boys it is their duty to protect those around them.

Unfortunately, none of the articles reporting this ‘miraculous’ development provide a link to the actual study so a person can check for themselves. So much for responsible journalism!

“Vaccine-Type Human Papillomavirus and Evidence of Herd Protection After Vaccine Introduction,” by Jessica A. Kahn, MD, MPH, et al., was accepted for publication in April 2012 by the medical journal Pediatrics, but will not be formally published until August.1

Historically, academic ‘experts’ paid directly or indirectly by the industry have cherry-picked populations with a high prevalence rate of HPV infections or cervical cancer to generate a set of data. They extrapolate the ‘scientific’ data obtained from irrelevant populations to promote a vaccine with questionable value or an analytically inaccurate HPV test for use in the general population.

In 2001, a group of employees of the National Cancer Institute, a major patent holder and financial beneficiary of HPV vaccines, did just that when they used a population with an extremely high cervical cancer rate in a subpopulation of Costa Rica during development of the HPV ‘cancer’ vaccine and an HPV test for cervical cancer screening.2

Then they helped expedite approval of HPV vaccines and an inaccurate HPV test through the Food and Drug Administration to be used in populations with little threat of cervical cancer progression.

In their most recent study, Jessica A. Kahn and her coauthors have done the same thing by using a cherry-picked subset of African American women with an extremely high rate (68.3%) of HPV infection for a statistical analysis to justify wide spread implementation of the HPV vaccination policy through so called “herd protection.”

The authors conveniently ignore the fact that most American women under the care of gynecologists in private practice have a less than 10% HPV infection rate even when the most sensitive nested PCR amplification is used for detection. They also ignore the fact that African American women usually carry different strains of HPV viruses than women from other ethnic backgrounds.3

It is well known that test results obtained in a population with high disease prevalence rates cannot be extrapolated to a population with a low prevalence of the disease. These authors knowingly misapply their statistical data to support this “herd protection” hypothesis as if HPV infection had become a contagious disease like influenza in the classrooms of all high schools throughout the world.

It is unfortunate that their opinion, supported by public funding, is published in the official journal of the American Academy of Pediatrics as a continued medical education material to influence the practice of the pediatricians, policy-makers and health authorities.    
This is particularly true when a careful reading of Khan et al.’s article reveals the following points:

1.      1. Vaccine-type HPV infections reportedly decreased by 21.9% in vaccinated participants; but vaccine-type HPV infections also showed a decrease of 14.8% in the unvaccinated group when compared to the data from 2006-07. These changes are especially remarkable given that many participants were sexually experienced, presumably exposed to HPV, and only 1 HPV vaccine dose was required to be considered “vaccinated” in this analysis.

2 . The authors should know there are 3 subtypes of HPV-18, namely the European, the Asian-American and the African subtypes.4 In the U.S., 91% of the HPV-18 isolates from white women are reported to be of the European and Asian-American variants, and 64% of the HPV-18 isolates from African American women belong to the African variants.5 The production of the Gardasil® HPV-18 VLPs uses the HPV L1 gene from the SW756 cell line6 which carries an African subtype of HPV-18.4 Therefore, any “herd protection,” even if conveyed to a subset of African American women by Gardasil® vaccination, cannot be automatically extrapolated to other races or ethnicities.

3. Why do the authors of the study consider one shot of Gardasil® to give the participants vaccinated status when the recommended dose is a series of three injections? If one shot is enough, is three to many?

4 .The study utilized the Roche Linear Array for HPV typing. According to World Health Organization documentation, only 8 of 17 datasets in a worldwide survey using the Roche Linear Array assay reported a 100% proficiency result in HPV genotyping.7 (table 2) In 7 of the 17 testing sets, false positive HPV types were detected by the Roche Linear Array assay.7 (table 3) This information brings the entire study into question.

5. The authors of the study state, “the overall HPV prevalence increased "modestly" between the two studies.” How can this happen if the vaccine provides herd immunity?

Consider the following data taken from the soon to be published article regarding this ‘modest’ overall increase in HPV infections. This chart is a representation of HPV prevalence changes discovered when the post-vaccination surveillance group of 2009-10 was compared to the pre-vaccination surveillance data from 2006-07:


Any Type   8.5% increase      9.0% increase     1.8% increase

High Risk Type   1.1% increase       5.2% increase      7.5% reduction

Vaccine Type (16/18/11/6)    18.3% reduction  21.9% reduction  14.8% reduction

High Risk Vaccine Type        14.2% reduction  17.8% reduction  12.0% reduction

Non-Vaccine Type        14.0% increase    15.2% increase    7.6% increase

Non-Vaccine High Risk Type         7.6% increase      13.6% increase          2.7% reduction

Why was there no statistically significant change in HPV infection rates among the unvaccinated participants? Does this mean that other types of HPV are taking over the role of the vaccine-suppressed HPV types in the vaccinated? If so, will the other types become more dangerous than the suppressed ones?

Does this mean the manufacturer targeted the wrong types of HPV for this population? Or, does it simply mean the vaccine doesn’t work?

Does this article provide evidence of herd immunity or potentially dangerous HPV mutation/type replacement?

Is this simply another example of the quality one can expect from industry sponsored ‘scientific studies’ destined to be blindly accepted and widely quoted to influence worldwide health policies?

This study raised far more questions than it answered. Medical consumers deserve better.


1.      Kahn JA, Brown DR, Ding L, Widdice LE, Shew ML, Glynn S, Bernstein DI. Vaccine-Type Human Papillomavirus and Evidence of Herd Protection After Vaccine Introduction. Pediatrics. 2012 Jul 9. [Epub ahead of print]

2.    HPV co-factors related to the development of cervical cancer: results from a population-based study in Costa Rica. Hildesheim A, Herrero R, Castle PE, Wacholder S, Bratti MC, Sherman ME, Lorincz AT, Burk RD, Morales J, Rodriguez AC, Helgesen K, Alfaro M, Hutchinson M, Balmaceda I, Greenberg M, Schiffman M. Br J Cancer. 2001 May 4;84(9):1219-26.PMID: 11336474 [PubMed - indexed for MEDLINE] Free PMC Article Free textRelated citations

3.    Dunne EF, Unger ER, Sternberg M, McQuillan G, Swan DC, Patel SS, et al. Prevalence of HPV infection among females in the United States. JAMA 2007; 297: 813-9.

4.    Lurchachaiwong W, Junyangdikul P, Termrungruanglert W, Payungporn S, Sampatanukul P, Tresukosol D, Niruthisard S, Trivijitsilp P, Karalak A, Swangvaree S, Poovorawan Y.: Whole-genome sequence analysis of human papillomavirus type 18 from infected Thai women. Intervirology 2010, 53:161-166

FDA Lawyers Getting Heat Over Agency Spying on Scientists, Doctors

  (Senator Charles E. Grassley, an Iowa Republican whose former staff member’s e-mails were cataloged in the surveillance database, said that “the F.D.A. is discouraging whistle-blowers.” He added that agency officials “have absolutely no business reading the private e-mails of their employees. They think they can be the Gestapo and do anything they want.”)

The Food and Drug Administration's top lawyers are under fire from Congress for apparently explicitly authorizing, in writing, a program to conduct surveillance on agency scientists who expressed safety concerns about medical products.

In a growing controversy on Capitol Hill, Sen. Chuck Grassley (R-Iowa) said in a letter Monday that his office received information that an FDA official asked the agency's general counsel's office to look into a program about monitoring email of employees, including emails sent to Grassley's and other congressional offices.

Grassley demanded that the FDA immediately provide him with the name of the official and the memo drafted by the general counsel, in a letter that not only takes the agency to task for the "massive spying campaign" but reminds the agency that interfering with a congressional inquiry is against the law. Grassley also wants the author of the memo available for an interview with his staff investigators.

"It is evident from the documents I have obtained that FDA did in fact target communications with Congress for monitoring and then took adverse personnel actions against FDA whistleblowers who were communicating with Congress," Grassley said. "FDA's misconduct cannot be ignored."

Grassley said he will be handing over these documents to the Department of Justice for further investigation into any wrongdoing, including possible violations of whistleblower protection statutes and the Stored Communications Act. He will also turn them over to the Office of Special Counsel and the Department of Health and Human Services Office of Inspector General.

Six FDA scientists and doctors filed a lawsuit against the FDA in U.S. District Court in Washington in January accusing the agency of surveillance over two years as the plaintiffs accessed their personal Gmail accounts from government computers, the Washington Post reported at the time their suit was filed.

The lawsuit alleges that information from those emails eventually contributed to the harassment or dismissal of all six of the FDA employees, the Post reported. All had worked in an office responsible for reviewing devices for cancer screening and other purposes.

Grassley wrote a letter asking questions about the program in January. He says now that the agency for the past six months has refused to provide any meaningful information in reply to the January letter, saying only that it was being worked on and that there was a 'good story' to tell regarding the spying on employees.

"It is simply not credible that FDA went to such great lengths over the course of two years to monitor employees personal email accounts, then spent six months crafting a reply to my questions about it, and yet still cannot identify who authorized the spying," Grassley's letter states.

The agency did not provide a document that detailed the program in a response to Grassley last week. But, Grassley calls it "even more astonishing" that the document was apparently posted inadvertently on a public internet site.

The New York Times found that document, along with about 80,000 pages of previously undisclosed and confidential communications the program captured between whistleblowers, their attorneys, Congress, and the OSC.

The surveillance operation moved to quell what one memorandum called the "collaboration" of the FDA's opponents, and identified 21 agency employees, congressional officials, outside medical researchers and journalists thought to be working together to put out negative and "defamatory" information about the agency, the story found.

An FDA spokesperson did not immediately return a call for comment.

(“The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction,” the group continues. “The FDA is expanding its reach even to commerce within the state …. in order to protect drug company profits.”)

Taking the collectivist logic of prohibition and food regulation to its logical conclusion, the Food and Drug Administration (FDA) claims that adult stem cells are drugs, and that stem cell therapy affects interstate commerce in FDA-approved drugs. In principle, this means that an individual’s body, for regulatory purposes, should be considered federal property.

Last August, the FDA filed a motion for summary judgment in a federal court battle with Regenerative Sciences, LLC, a Colorado health clinic offering a non-surgical treatment for people suffering from joint pain. The procedure uses samples of bone marrow or synovial fluid extracted from the client, from which adult stem cells – undifferentiated, highly adaptable cells – are cultured. The cells, along with a medium composed of various nutrients, are then injected into ailing joints to repair damaged tissue. Many mainstream health care professionals and professional athletes have come to regard this approach as a safe, minimally invasive alternative to surgery.

As the Alliance for Natural Health points out, the FDA’s central claim in the motion for summary judgment is that an individual’s stem cells “are drugs and therefore fall within their jurisdiction.” In addition, the agency claims that use of any product shipped across state lines (such as plastic syringes or laboratory flasks) by the clinic, or the involvement of customers from outside the state of Colorado, implicates the procedure in “interstate commerce.”

Most remarkably, the FDA “just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs,” points out the Alliance for Natural Health. “No more beating around the bush…. This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.”

“The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction,” the group continues. “The FDA is expanding its reach even to commerce within the state …. in order to protect drug company profits.”

The FDA has never been diffident in making novel jurisdictional claims, and for decades its institutional default setting has been “overkill.” Two decades ago, under the reign of uber-zealot David Kessler – a humorless bureaucratic scold who combined priggish, pharisaical self-righteousness with the executive disposition of a Soviet-era secret police chief – the FDA dispatched armed raiding parties to terrorize grocery stores, chiropractors, nutritionists, and others who were demonized as threats to “public safety.”

In 1991, an FDA strike team invaded a Florida orange juice producer, destroying 24,000 half-gallon containers of Citrus Hill “fresh choice” juice because Kessler and his fellow commissars regarded the label to be misleading. The following year, the FDA conducted a guns-drawn raid on a medical clinic in Tahoma, Washington because the presiding physician emphasized a nutrition-centered approach to some forms of conventional medical treatment.

Two years ago, the FDA dispatched a threatening letter to Michael J. Mendes, CEO of the Diamond Foods company, warning him that advertisements describing the long-documented health benefits of walnuts meant that they would be regulated as drugs:

“The Food and Drug Administration (FDA) has reviewed the label for your `Diamond of California Shelled Walnuts’ products…. Based on our review, we have concluded that your walnut products are in violation of the Federal Food, Drug, and Cosmetic Act…. Based on claims made on your firm’s website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.”

The FDA has also made itself notorious for its escalating jihad against the sale and consumption of raw milk – a campaign involving SWAT raids against Amish dairy farmers in Pennsylvania and rural dairy farmers in Wisconsin, as well as the use of undercover informants and provocateurs deployed against food clubs across the country.

All of this is an outgrowth of the collectivist assumption that the government has the authority to regulate what individuals choose to consume, which means that each individual’s body is in some sense State property – right down to our stem cells.

No comments: