Study finds no evidence that Gardasil vaccine caused health problems

[Gez_Blair]

And a very good blog explaining the background on "anti-vaxxers and their dangerous nonsense":

slate.com/blogs/bad_astrono...

[johnsmith]

I am not anti-vaxer. However, I have a great mistrust of a lot of medical reports which claim a vaccine is safe and quote all sorts of reasons why the suspicion that a vaccine caused a problem was due to other reasons.

Vaccines are made in batches. The vaccine that is administered can be from a totally different batch than the so called safe vaccine that had been trialled. There is something called stress overload. What is needed and is never done is the question being asked. Is the person okay to receive the vaccine at this moment in time? Are there any reasons why they should not?

A person near their stress breakdown limit receiving a vaccine may be pushed over their stress breakdown point with the result that everything collapses and the person is injured. The vaccine is absolved of blame because it was successful in hundreds of other cases. The important point of the vaccine pushing a person's state above their stress breakdown point is never looked at, considered or looked at to see if such an event has happened.

Questions need to be asked and not covered up because it is convenient.

[Zeno in reply to johnsmith]

That's why all manufacturers have to comply with Good Manufacturing Practice (GMP). This gives the necessary controls on manufacturing processes and quality control to ensure they produce what they say they produce. Manufacturers are inspected regularly by the MHRA and cannot produce medicines without a licence.

I have no idea what 'stress breakdown limit' you're referring to.

[johnsmith in reply to Zeno]

Thanks for the reply.

Most people do not know what stress breakdown limit is. It is often never considered by medical consultants or psychiatrists.

All engineering systems have a limit to the stress that they can take. Go above this stress point and the engineering system breaks down. The human body is an engineering system. At anyone time it can be experiencing various stresses. Some stresses may be high some stresses may be low. A vaccine is a stressor. It is often a low stressor. However, if the body as an engineering system is in a high state of stress and this stress is close to the stress limit of the body's engineering system then the vaccine could be enough to push the stress of the engineering system above the stress point at which the body breaks down.

A long time ago I was a quality and reliability engineer. Quality control is not the same as reliability control. Quality control does not mean that all of a product is good. It means that the majority of a product meets various specifications. A small percentage will always fall outside these specifications. Most of the time the very small number of items that fall outside the specifications are not noticeable. Sometimes some poor human catches it and is left damaged by the product outside specifications. Because the amount of this faulty product is very small it is very difficult if not impossible to trace a fault back to the manufacturer.

Reliability is a different issue which very few people every consider. What is the reliability of the vaccine's behaviour. I have never seen this discussed. Have the manufacturer ever looked at it. Have the medicine regulator ever looked at it?

Quality and reliability statistics can be quite complex. It is easy to falsify what the statistics say to make things appear okay when they are not.

A scam that is sometimes pulled by manufacturers is to take a bad quality batch and mix it in with a several good quality batches. Statistics would say that they are good quality batches despite the fact that they have a bad quality batch deliberately mixed in with them.

A bad quality batch if destroyed loses the manufacturer money. Thus to mix the bad quality batch with good batches does not lose the manufacture money. It is a practice that is impossible to pick up unless the regulators are looking for it. To look for it is time consuming and expensive and as a result will not be looked for.

Hope this has been useful.

[Zeno in reply to johnsmith]

Sorry, no.

[johnsmith in reply to Zeno]

How can I make my comment useful?

[Zeno in reply to johnsmith]

Instead of speculating on what *might* happen, evidence that it has or does.

[johnsmith in reply to Zeno]

This works both ways. You are only party to the data the regulators say you should have. Data that the regulator or manufacturers decide you should not have can modify what you believe in.

“Cracked” ISBN: 9781848315563 a book written by James Davies Senior Lecturer Social Anthropology and Psychotherapy at The University of Roehampton (London UK) details some of the misleading and dishonest research results that have been presented in Professional Journals and conferences.

“Bad Pharma” ISBN 978-0-00-735074-2 a book written by Ben Goldacre in 2012 details how drug companies mislead doctors and harm patients.

In the 6th September 2014 New Scientist there was an article which referred to Diederik Stapel who in 2011 admitted to inventing the data in dozens of psychology research papers.. The New Scientist referred to 24 of Stapel's papers which are known to be fraudulent. The New Scientist in previous editions has referred to Fraudulent results in Scientific papers by other Authors.

Power and Dependence: Social Audit on the Safety of Medicines by Charles Medawar

A number of cancer trials have been found not to be repeatable. An estimate on pyschology trials have found a third a not repeatable.

There have been Phd theses on problems with data in the NHS. There is a famous paper on PLOS which discuses the issue that medical trial results before 2005 are questionable.

I could go and give a long list. This will take up a lot of my time which I have not got.

You can search in Lancet and the British Medical Journal, Science, Nature, American Scientist and Scientific American concerning this serious issue of problematic trial data results.

It is a bit more difficult to present data on vaccines because vaccine data is not easy to get hold of.

I have met people whose sons and daughters have been damaged by vaccines. I know of the impossible odds they had to face to get help.

I have given you the areas that need looking at. You can carry out your own investigation and this will take a lot of time or you can leave it alone.

[Zeno in reply to johnsmith]

Yes, there is good evidence some pharmaceutical companies have distorted and misled. However, your accusation was specific to particular medicines and this particular topic is about one.

It was you who made these specific accusations so the onus is on you to substantiate them.

[johnsmith in reply to Zeno]

I cannot substantiate. This is because the data is not available to me. I do not have time to try and obtain it. A lot of company data is classed as confidential and requires things like court orders to get it.

I have given reasons why data that proposes something is good is not totally trustworthy and should not be blindly trusted.

Absence of evidence does not mean that a problem does not exist.

[Zeno in reply to johnsmith]

No one is blindly trusting. However, hand waving accusations that are not substantiated don't help move the argument forward

To get back to what the OP was actually about: what do you think of the study that found no evidence that Gardasil vaccine caused health problems?

[johnsmith in reply to Zeno]

It is a very limited study that does not address the issue.

How can I determine that this person who I want to give the vaccine to is okay to receive the vaccine?

A vaccine which has a probability of 0.05% of injuring someone is deemed to be perfectly safe. And an expert can be found to say "the study has found no evidence that Gardasil vaccine caused health problems?"

[Zeno in reply to johnsmith]

What are the limitations?

[johnsmith in reply to Zeno]

At this point to run though the statistics will take me too long and is pointless.

The only question that needs addressing is: "How can I determine that this person who I want to give the vaccine to is okay to receive the vaccine?"

A population of people will respond to the vaccine at differing levels of response. A very very small percentage will have a bad effect for various reasons. We want to detect those people and not give them the vaccine.

There is a need to do the work to detect those people. To only do work to justify the safety of the vaccine is frankly unethical.

[Psy80195 in reply to johnsmith]

Hi John Smith

I take your point that absence of evidence isn’t evidence of absence, but it seems to me that you are speculating that the absence of published evidence is concealing something you have no evidence for. I’m also not sure how you know that those many people you know, can be certain that their children’s problems are caused by vaccines. It seems to me that you have suspicions/beleifs, and are elevating anecdotes, personal hypotheses based on engineering analogies, and the known problems of medical science into an accumulative argument that, for you, is so logical, it is as good as evidence.

I also note that you seem unimpressed by this study. It is my experience that very weak studies are often to sufficient to prop up personal beliefs – anecdotes even – but no study is ever quite good enough to challenge them. I wonder if that’s going on a bit here?

Thanks for your time.

[johnsmith in reply to Psy80195]

You say: "It is my experience that very weak studies are often to sufficient to prop up personal beliefs – anecdotes even – but no study is ever quite good enough to challenge them. I wonder if that’s going on a bit here?"

Thanks for reminding me about this problem. It is something I have to bear in mind. It is something one has to apply to all thinking. I have thought about it.

Many studies only concentrate on a particular aspect to prove or disprove a particular aspect. In this respect the study looks fine and appears to carry out the task. However, we can write a study like that as: y = f(x). Nice easy straight forward we have proved or disproved something.

Reality is: y = f(a, b, c, d, x, y, z). In the study a, b, c, d, y and z have never been looked at or considered or not reported. You have a wrong answer from the study.

[Psy80195 in reply to johnsmith]

Thanks John Smith. I agree, there is no perfect study, and we should be mindful about generalising beyond the data. I'm not sure anyone is saying that this study answers all your questions/concerns, but it seems you are suggesting it is too flawed to answer any questions/concerns (before even applying yourself to the data). Good luck with your enquiries.

[old_dragon]

I'm also not anti-vaccines. I totally agree that on a population level they are definitely beneficial. I do however "believe" (ie an evidence free statement) that nothing can ever be 100% safe and that some individuals will be harmed. But, given the proven benefits, I'd recommend vaccination.