All New Zealand samples contaminated.

A few days ago, an American organisation put on their website a copy of a letter sent to the FDA, in which they stated that thirteen samples of Gardasil from Poland, France, Spain, USA, New Zealand and Australia, made in four different Merck factories (USA, Holland, France and CSL Australia) had been tested, and found to contain genetically engineered dna fragments which the purification process failed to remove.  Yesterday, a more detailed press release was put onto SANE-Vax's site, which showed samples contaminated with HPV DNA 11 and 18.  The New Zealand results can be seen here.

One of the genetically engineered particles found is said to be  a genetically engineered syntheticaly constructed gene designed to instruct the yeast or baculovirus cells, to make the HPV-11 outer capsid protein (virus-like particles) for the Gardasil vaccine.  

This is the Pubmed site for GenBank Locus SCU55993, which is the picture below, of ONE of the alleged contaminants:




Wavy lines mean nothing to me, and probably nothing to you.  

SANE-vax's letter doesn't specifically say what the other contaminants are, but say that the rest of their proof is available for review provided that FDA provides " appropriate safeguards ... to protect the proprietary processes and information utilized by our laboratory to test the samples."

To me, no platitudes and fob-offs on this issue are acceptable.

The first question that comes to mind is,

"Is  this  a  big  deal?"

This isn't a quality issue in one factory.

The problem, according to the testing done by SANE-vax shows;

A global manufacturing fault.

 

A global manufacturing issue relating to vaccine design, process and purity - IS - a big deal.

The next question is:

Are  the  "genetically  altered  HPV  DNA  fragments"  a  big  deal?

 Read Full Blog

Infectious Disease News Alerts have dropped into my inbox now, for nearly a decade.  This organisation is run by a company called "SLACK Incorporated, and "strives to be the global, definitive information source for ID professionals by delivering timely, accurate, authoritative and balanced reports on clinical issues, socioeconomic topics and industry developments, as well as presenting clinically relevant information on medical therapies for the benefit of the patient."  Of course, that's followed by the usual disclaimer saying words to the effect of "believe us at your peril".

There is this caveat here: "All staff-written news reports are sent to quoted sources for verification of medial accuracy. Quotes and other information in staff-written news reports are verified for accuracy with sources prior to publication. Excluded from this policy are InfectiousDiseaseNews.com website-first articles, which are not sent to sources to facilitate the rapid dissemination of this news."

Just before that, is stated, "All articles posted on InfectiousDiseaseNews.com are reviewed by the Chief Medical Editor and Executive Editor, who are solely responsble for deciding upon their acceptance, rejection, or need for revision, based upon their appropriateness to the mission of the publication."

So while two people must review all articles, the buck stops with Chief Editor, Dr Paul A Volberding,  Go hunting for his particulars and you see this.  And given that,"Dr. Volberding serves as scientific advisor to Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Ortho Biotech, Pfizer/Agouron, Shire, and Schering; and on the speakers bureau for Gilead, GlaxoSmithKline, Ortho Biotech, and Schering." ....  you would think he would understand the term "accuracy", right?

Apparently not, because this week InfectiousDiseaseNews Alerts posted an article, which is solely his responsibility, which heralded the news that HPV Vaccines  prevent anal cancer in women (pdf of news item, since I'd be surprised if it's not pulled.) The article states:

There were 27 diagnosed HPV 16-related anal cancers in the vaccine group vs. 85 diagnoses in the control group, for a vaccine efficacy of 68.2% (95% CI, 51.4-79.7). For cervical cancer, researchers observed 28 diagnoses in the vaccine group compared with 116 in the control group. Vaccine efficacy against cervical HPV 16 was 75.8% (95% CI, 63.8-84.2).

For HPV 18, there were 20 diagnosed anal cancers in the vaccine group compared with 45 in the control group. Vaccine efficacy was 55.5% (95% CI, 25.2-74.2). Thirteen vaccinated patients were diagnosed with cervical cancer vs. 61 in the control group. Vaccination efficacy against cervical HPV 18 infection was 78.6% (95% CI, 62-88.7).

So let's check this out shall we?  Kreimer's article, starts with this statement: "Anal cancer remains rare (Incidence of about 1.5 per 100,000 women yearly)." 

So two people should have read Kreimer's article, ...  the first sentence raises the first red flag.  Given that Kreimer's study included just over 4,000 women, if according the Kreimer there are 1.5 anal cancers in 100,000 women per year, how many would you expect in 4,000? 

Read further and you find that this study was about INFECTIONS, not actual CANCERS.  Read the article very carefully and you will see many reasons why Kreimer's article really doesn't deserve a news item in Infectious Diseases News at all, but having ascribed virtues to the vaccine, which the study did not...., Dr Volberding needs a disciplinary reminder.  With his CV, he should know better.  And talking about his CV, note that (coincidentally) Volberding approved an untrue article about a vaccine, made by a company whose payroll he is on.  Hmmm........  Read Full Blog

Further to yesterday’s blog, the latest Lancet once again, misses the point. Something inevitable with Mr Fog-Optics in his Ivory Tower. In his latest contribution to the debate, called The Vaccine Paradox,  a two pronged attack-approach is taken. First, those who dare criticise or question vaccines are vilified by implication. Second, Bill Gates’ Foundation is fingered for silence about what Horton considers is really important.

In order to define what is "important", Horton quotes the “2010 Global Strategy for Women’s and Children’s Health”, saying;

“Ban Ki-moon’s 2010 Global Strategy for Women’s and Children’s Health sets out a comprehensive approach to reaching Millennium Development Goals (MDGs) 4 and 5 for the world’s poorest countries. The strategy is broad, inclusive, and ambitious.”

Have a read of the 2010 Global Strategy. Frankly, it’s not broad enough - and certainly doesn’t include the really important political and social needs for a stable, healthy society.

But Horton goes further. He says;

“While civil-society movements demand access to new interventions—from antiretrovirals to emergency obstetric care—there is not the same fervour about access to vaccines. The notion, expressed elsewhere in global health, of the right to the highest attainable standard of health is rarely expressed in the field of vaccines. For these attitudes to change, the vaccine community, together with its partners, has an opportunity to rewrite the terms of engagement between vaccines (as part of a larger package of services) and communities threatened with vaccine-preventable diseases. While the past has much to teach us, it is the future of vaccines that must command our priority today.”

This has to be the biggest load of blinded drivel I’ve ever seen written on paper, but it’s what you expect from medical journals whose editors walk in lockstep with, and who are joined at the hip to vaccine manufacturers. Vaccine manufacturers can never “get enough”. It’s not enough, that vaccines are rammed down all parents “throats” from the moment a doctor opens his mouth. It's not enough that families in Africa have no choice about vaccines, and they are administered pretty much at gun point.  Read Full Blog

Perhaps this Australian documentary should have been labelled...

Totally missing the point. Or .. A bunch of Lies.  Take your pick.

The Australian 60 Minutes journalist who had the responsibility for doing the research for this programme, is professionally incompetent.

You will not understand this blog unless you take the time to download all the full text medical articles, tables, graphs etc in this blog, and study for yourself what a 60 minutes journalist refused to look at.  Or .... chose not to.

The increase in pertussis has nothing to do with the unvaccinated at all.  It's all happening because doctors in Australia have finally woken up to the fact that pertussis can happen in vaccinated people and are testing for it.

The reason all the old studies over-estimated pertussis vaccine efficacy was, as Cherry said in a 1998 medical article, that doctors believe that vaccinated people never got pertussis, so they never diagnosed it.  SIMPLE.  Pertussis after a vaccine was coincidence and something else.   According to Dempsey 2009, that situation still exists in USA today. 

As to the Australian whole cell whooping cough vaccine, it was implemented solely on the basis of trust, because as CDI admitted in 1994, there were NEVER any efficacy tests done on it, and there were no "serological correlates" or tests to prove immunity, for them to use as a basis of discussion anyway. 

Wonder what the Australian public would have said back then, if some doc had said, "We don't know if this works, because we don't know how to test for immunity to pertussis, but we assume this bright idea is a good one."

The Australian CDI went one further in 1997, and admitted that they ALSO... didn't collect data on the vaccination status of whooping cough cases either.  Read Full Blog

A few days ago, I talked about GSK smacking the UK Minister of Health's hand, and how GSK been done out of lots of money by the UK Government wanting out of the Swine Flu vaccine contract. Worse news has arrived. GSK, according to the UK telegraph only made £698 million pounds from the Swine Flu vaccine that no-one wanted, which sits in the cupboard while people try to get rid of the white elephant. Okay, I whine, after all the headline said, "GlaxoSmithKline profits climb on health sales of swine flu vaccine." Read Full Blog

Here's how the story goes. In 2005 Glaxo Smith Kline, amongst other vaccine firms, threatened the UK Government, saying - "You've got to increase the use of ordinary annual flu vaccine in UK, or if a pandemic comes, we won't supply pandemic vaccine!  So there."  Fast forward to 2010. The UK Government wanted to back out on the 2009 H1N1 vaccine contract, but GSK refused.  And I bet they reminded them of that wee discussion in 2005. "Not gonna let you cancel", says GSK. "We'll downgrade your order of H1N1 vaccine from 130 million doses down to 34.8 million doses, but here's the deal:" Read Full Blog