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Hilary's Desk

The limitations of Gardasil safety trials

Hilary Butler - Monday, January 18, 2010

We've all heard how wonderfully safe Gardasil is. The many trials that were done, and blended into one. The literature brims with glowing recommendations, with only a few inconsiderate pesky naysayers getting in the way of the the vaccine publicity machine.

When the vaccine was first licensed it took me MONTHS to read the first major Gardasil FDA 060806.pdf, as well as locate the others. Now, you can find an ark full of those documents here. And after you've read everything, you will still have to go and search for some more on Pubmed.

My concerns about vaccine safety trials, go way further than just Gardasil. To see what I mean, you have to go to www.clinicaltrials.gov and using the search engine, bring up a baby / children / adolescent vaccine trial. Any trials, of any vaccine now in the schedule. Or new ones if you like. Try the swine flu studies if you want a headache.

For a vaccine already in the baby schedule, write down the particular vaccine, and then look up all the phase trials done with that vaccine, through to FDA approval. Check which babies are included; which are excluded; which countries the studies are done in; who does the studies, and where possible, find the final fulltext published study in a medical database.

The whole process is well worth going through. Before discussing some of my concerns, let's look at a few fundamentals, using Gardasil as an example:

  • The medical profession knows that different races have different genes.
  • Different genes can predispose to different illnesses, and different reactions to drugs and vaccines.
  • Environmental influences and nutrition has a huge impact on whether or not a person gets a disease or a cancer, because these factors can change genes.
  • Different races respond to different drugs in completely different ways and often require completely different dosages. What is a massive overdose for one race, might do nothing in another.
  • Whether a vaccine or a drug "works", or "reacts" inside a person, depends on their genes and any epigenetic alterations of those genes. Which isn't a message drug companies want to hear, because if you admit that drugs and vaccines might only be suitable for certain people, you can't blanket cover a whole population and expect them all to accept your product:

"The concept of targeted drugs has obvious benefits for patients. But it has economic implications too. ..... a test determining who the drug works for would save money for hospitals and drug agencies like Pharmac. The drug companies might not be so happy. Seeing as much as 20 per cent shaved off their sales is not something they're likely to take lying down."

Any acknowledgement of individual (gene) susceptibility to vaccine reactions, or disease susceptibility and complications, is ignored in vaccine studies, and certainly isn't talked about once a vaccine is licensed.

We're all cloned ticky tacky little "boxes". Knowing who could be "different" and why, complicates things.

"Shoot'em-all-up", is nice and simple. It means that the doctor can implement a one size fits all programme like a good drug delivery technician. They don't have to think. It also means you don't have to explain to the susceptible, why they are susceptible and their next door neighbour isn't. That could be racist, or even, class-ist.

There is no specific pattern of vaccine reactions, because we are not clones, eating the same food, doing the same things, thinking the same things, and exposed to the same genetic influences. Reactions in people to the same drugs, will vary greatly. Given that we do have arms, legs, a body and a head, with an immune system with similar inate immune mechanisms, a few symptoms may be common to many, like fevers, sore arms, etc. But when it comes to other reactions, THEY will be determined by the specific uniqueness of that person alone, so the reactions will vary considerably.

However, vaccine studies mandate that there has to be a similar pattern of reactions for that one vaccine, for those reactions to be caused by that vaccine. And because there is no nice tidy simple box to put all reactions in, and because your reaction might not fit in their narrow box, .... it wasn't caused by the vaccine.

Yet we know the epigenetic concept of genes changing everything, is applicable to vaccines, because there is a vaccine "science" called vaccinomics, which show that people who have vaccine reactions have different genes from those who don't, and people who don't develop antibodies from vaccines, often won't develop antibodies to the same disease (corresponding to the vaccine).

People are usually "excluded" from vaccine trials, if their 'medical history' indicates that they might mess up a study. Often, more than 50% of the original trial applicants can be stood down. The researchers hope that by eliminating visible or known health problems, they will eliminate really "bad" genes. Anything that happens to someone in a vaccine trial, will then have to conform to a pattern, and will be determined by the researcher's "value judgement", as to whether or not it would have happened anyway.

If you look at the 060806 Gardasil pdf, in the 1,179 school age children aged 9 - 15 years, there were five serious reactions in the vaccine group ( which is one per three hundred vaccine recipients) and none in the placebo group ( page 317, table 231). Presumably, the researchers considered these serious side effects coincidental, since this is never told to New Zealand children about to have the vaccine.

Children's genes are affected by their mothers' diet during pregnancy, their birth circumstances, whether they were breastfed, whether they were fed on white bread, junk food and soft drinks. Their genes are affected by toxins / sprays in the environment by a process known as epigenetics. Children's genes are affected by stress, bad family dynamics - a whole raft of unquantifiable confounders. The genes of children shifting from childhood through to puberty, are vulnerable, because of hormonal changes being orchestrated. Scientists know that adolescents at this stage are particularly vulnerable to the effects of drugs. But adolescents are "immune" to any side effects from vaccines!

Merck did lots of safety studies in lots of different places, with many different races, and ages, all with different gene types, and all with different epigenetic effects, all subject to the influences Patrick Gladding talks about here too. They put all these different groups of different cohorts, at different times, stirred them up, applied their computer generated mathematical models, and said, "Here you are, New Zealand. Our linear maths, shows that Gardasil is safe for every single non-linear, genetically different child in your country. Even the ones we excluded from our studies!"

This is "evidence based medicine"; the stamp of authority representing scientific validity - yet - how is it, that Adverse Drug reactions have become a major cause of illness and death in the supposedly safe, effective "scientific" developed world?

Where are the majority of deaths from cervical cancer occuring?

Places like Africa. Why?

Because malnutrition, war, dislocation, lack of primary health care, screening and HPV lesion diagnosis means that women living in under-developed countries are effectively on their own.

These women contract cancer in greater numbers than New Zealanders would, and can die a much higher numbers because their malnourished immune systems can't fight off HP viruses as well, and because they would never have seen a pap smear, let alone a "leep".

Question: Will Merck's massive pile of safety trial documents, in the FDA repository, ALSO be considered applicable to African women as well?

 

 

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