On Saturday 26th September a trial began involving 1,000 children to test two swine flu vaccines before the launch of a UK vaccination. The information is limited but the trial will allow the experts to observe immune reactions and any side effects which may occur.
The children participating in this trial are aged between six months and 12 years from Oxford, Southampton, London, Bristol and Devon. Participation in the trial is voluntary and consenting parents were be briefed on the risks. The children are given two doses of the vaccine three weeks apart, then a blood test three weeks after that.
The aim of the trial is to find out if one of the vaccines is better than the other in terms of immune reactions. They also want to ensure that the side effects are minimal before launching the UK vaccination programme.
One of the main problems the study seems to be having is recruiting enough children under the age of three, getting older children didn’t seem to be a problem just the younger ones, Doctor Saul Faust suggests that the younger children don’t usually respond to vaccines as well as adults and older children but says that they need to find out how the younger children respond before the vaccine becomes available to the UK. This could be because the younger children are deemed to be one of the high risk groups because young children, especially those that are under five, do seem to be at risk of serious illness. Also flu epidemics and pandemics are spread very efficiently by children.
The Department of Health has said that they will have enough vaccine for half of the population by the end of the year and that the high risk groups which are medical staff, the elderly and the very young will be immunised first.
There are claims that over half of the children taking Tamiflu to cure swine flu suffered side effects such as nausea, insomnia and nightmares. The statistics show that 1 in 5 children had a neuropsychiatric side effect, such as poor concentration, inability to think clearly, problems sleeping, and feeling dazed or confused. The research that was carried out was flawed as there was no control group therefore it is impossible to say whether the symptoms were a result of the drug or the virus; however, there were no serious long term side
Participants for the study were selected differently in the three schools. In two schools (one primary and one secondary school) the researchers selected all the classes who were offered prophylaxis, (age 4-11 years in the primary school), and all of one year group in the secondary school (age 13-14 years). In the other secondary school, the questionnaire was offered only to pupils in four of the classes in the year group (age range 11-13 years). This is a flawed sample as there is no fixed criteria for selecting the participants for the research.
Here are a few of the questions that were asked to the sample:
- Whether children who had been offered Tamiflu had taken it?
- How long they took it for?
- Were they taking any other medication with Tamiflu?
- Were there symptoms after taking Tamiflu (including specific gastrointestinal and neuropsychiatric symptoms)?
Out of 256 schoolchildren, 103 replied which is 40% of the participants. The number of responses from the secondary school were higher than those from the primary school. The results show that only 48% of the primary schoolchildren in comparison to the 76%of the secondary schoolchildren. The most common side effects were nausea and vomiting, followed by mild neuropsychiatric effects such as difficulty sleeping, nightmares and poor concentration.
It is worth pointing out that Tamiflu has not been withdrawn and is still used to treat swine flu. All drugs come with side effects and not everybody experiences them, thus suggesting that Tamiflu is no different to any other medicine.
A study in London gave 200 children pedometers to see how far they walked or ran. The researchers only realised that some of the children were cheating when they were surprised by the activity level of some of the obese children, it was then that they discovered that they had been attached to dog collars.
The researchers claim that it is not uncommon for participants to manipulate the findings. In psychology this is known as social desirability bias, in other words the participants want to been seen in a positive light so they think that if they can make the results higher that the researchers will be pleased with them.
This is a classic example of one of the biggest flaws in research if the participant is aware of the experiment, thus raising the question how accurate is any medical research?