By Ellen Bown, Contributing Author from the UK
This area should be looked at in some considerable detail. The legal definition of informed consent is quite clear; a patient must be given full, unbiased details of all the risks that can occur from a vaccine, the benefits of the vaccine and details of any alternatives. This definition is widely available on many websites and for the purpose of this report I do not feel the need to validate it by referencing any one specific site. It is clear that the onus is on the medical professional to provide the information. However, straight away we then find a contradiction. The Department of Health state on their website that “In order to make a decision, you and your child need to be provided with information about the treatment being offered.
If you feel you haven’t understood or don’t have enough information, you should always ask questions. For example:
• What sort of things will the treatment involve?
• What benefits do they hope will result?
• How good are the chances of getting such benefits?
• Are there any alternatives?
• What are the risks, if any?
• If there are risks, are they minor or serious?
• What may happen if your child doesn’t have treatment? “1
The paradox is that this list of questions is all the information that the patient must be given as part of the informed consent process. Without it, the medical professional has not provided adequate information to allow the patient to make an informed decision.
The British Medical Association (BMA) writes:
“Seeking consent is a process, not a single event. Providing information (as discussed below) is part of that process. Information should include advice about likely risks and benefits and be provided in a way the recipient can understand. Doctors should also respond to questions honestly and as fully as the individual requires. Consent should only be sought after the patient (or patient’s parent) has had an opportunity to consider the information and come to a decision.”
They also state:
“Parents have a right to receive unbiased information so that they can make an informed choice with regard to the vaccination of their children” they go on to say “Healthcare professionals have a duty to ensure that up-to-date, accurate and evidence-based information is available to parents. In this way, each family can make an informed assessment of the relative risks known to be associated with the various options, including the risks arising from doing nothing. Parents need medical information, which is objective, balanced and politics-free.”2
Nothing that I have read in my research has shown that this issue is free from politics.
Considering the issue of informed consent, you must begin at the top and work down; the “top” being the Department of Health. On the 2nd May 2008 Professor Salisbury sent a letter to the PCT immunisation coordinators, SHA immunisation leads & HPU immunisation leads outlining the role out of the new HPV vaccination. The letter covers; The immunisation programme, funding and service arrangements, delivery of the routine programme, HPV vaccines and the supply and management of vaccine stocks, communications, consent, monitoring vaccine uptake, data management and monthly and annual datasets.
What is interesting about this letter is that at no point does he mention adverse reactions, he does however make reference to two websites where further information can be obtained. Should his colleagues have the time to search these websites they will find that the first website mentioned www.immunisation.nhs.uk/hpv provides no pertinent information pertaining to any side effects of this vaccination. The second website www.dh.gov.uk/greenbook mentions only the most common reaction to Cervarix and by passes the issue of serious side effects by a blanket covering with recommendations that any reactions should be reported.
If the Department of Health does not disclose all details in an unbiased way to the relevant health care professionals, how can they know the true facts and how can this information be disseminated accurately to patients?
If Doctors do not know of the existence of serious adverse reactions how can they answer any question from a patient in an informed way? I put the question to my own Doctor recently asking if he had done any independent research with regards to this vaccination and sadly he told me that he had relied on the information that the government had sent him. A response I suspect that would be similar to every GP in the country.
The same letter from the Department of Health dated 2nd May 2008 states:
“JCVI has recommended that the implementation of the HPV immunisation programme would be most efficiently delivered through schools”
This appears to be exactly what all Primary care trusts (PCT’s) have done. Each girl comes home from school with a leaflet and a consent form. The leaflets quite simply do not disclose all the details needed to make an informed decision; they do not give a list of all reactions or indeed the alternatives to this vaccination. I obtained a leaflet from a local GP practice: leaflet number 301778. On the front page there is a picture of a mobile phone with the text message saying “Had my cervical cancer jab 2day, no probs”
This quite clearly contravenes section 5, part 86 of the medicines act 1968 which states under “leaflets”
“(3) Without prejudice to the preceding provisions of this section, no person shall, in the course of a business carried on by him, supply with a medicinal product of any description, or have in his possession for the purpose of so supplying, a leaflet which—
(A) Falsely describes the product, or
(B) is likely to mislead as to the nature or quality of the product or as to the uses or effects of medicinal products of that description.”
The vaccination is not a cervical cancer vaccination but a vaccination for HPV and has therefore been falsely described.
The leaflet goes on to say “beating cervical cancer” at the bottom of the front cover. This is also misleading because (as mentioned earlier) it does not beat cervical cancer. In fact, according to the manufacturers it actually may increase your chance of getting it if you have already been exposed to the virus.
In addition we will not know for at least thirty years if it has any impact on cervical cancer at all. Therefore claims made at this stage that cannot be substantiated. The leaflet does not list any of the serious side effects, the only mention it gives them is “More serious side effects are extremely rare and the nurse knows how to deal with them” By suggesting that a school nurse is capable of dealing with serious side effects it gives the impression that even the serious ones are nothing to worry about and this is not the case.
The leaflet does refer you to a website for further details on side effects, but not every parent can read and many parents have neither a computer at home nor the money to access the internet. In this position would you bother to do any further research when the leaflet quite clearly implies that there are no problems associated with this drug?
Furthermore under the Medicines Act, section five, part 91 anyone contravening part 86 are guilty of an offence and liable to a fine or a prison sentence. The case of Cunningham v Charles Pfizer (532 P.2d 1377) 19743 seems to reflect the issues surrounding the HPV controversy very well and should be read.
The Patient information leaflet (PIL) is the only leaflet that gives a more detailed disclosure of the side effects of this vaccine. It still does not allow parents to give fully informed consent as it does not give details of any alternatives and in places is misleading.
But, it does go part the way to resolving the issue of consent. However, it is only provided in the box that the actual vaccine comes in. Because of this it cannot be legally separated from the vaccine. It should be given by the medical professional to the patient at the time of vaccination and the patient should be given time to read it in full. This causes several problems, especially where the vaccination is given at school;
- None of the school children I know, including my own daughter, have ever been given a PIL. Even for other types of vaccinations.
- Even if children are given this leaflet, are they given the time to read it, digest it and understand the implications? (I can’t imagine the school nurse waiting even half an hour for each child to read the leaflet before the vaccination can be done, when they have a queue of children to vaccinate. It would be both time consuming and expensive)
- Parents, in most cases, know nothing about this leaflet, are never referred to it and do not ever see it; even when signing the consent form.
Most people are unaware this document can be downloaded from the internet.
It should be noted that under “Gillicks Law” a child can refuse vaccination or indeed choose to have the vaccination against their parents’ wishes. “In such situations it has to be considered whether a child is able to provide valid consent – what is known as ‘Gillick competent’. This phrase originates from the case of Gillick v West Norfolk and Wisbech Area Health Authority, a 1985 House of Lords case.
It was ruled that patients under the age of 16 could consent to treatment; that the parental right to determine treatment ends when the child has sufficient capacity to understand what is fully proposed. To assess whether a child is ‘Gillick competent,’ it must be decided whether the child has the maturity and intelligence to fully understand the nature of the treatment, the options, the risks involved and the benefits.”4
Of course this is laughable when full information is not even disclosed to adults.