Friday, October 16, 2009

And so the parental decision making begins....

I can't believe that Ethelred is barely 20cm long and only halfway cooked, and already we're facing a "Big Decison" regarding his/her health.

For anyone who has been living on Mars since the early summer, I'm talking about swine flu, the H1N1 virus. And oh, what a Pandora's box has been opened this week! As of next Monday, the UK H1N1 vaccination programme begins, starting in hospitals with frontline healthcare staff and immuno-compromised patients, and then moving out into GP land and "high risk" patients on the 26th October. As a pregnant woman in the 2nd trimester, I fall firmly within the latter category - in pregnancy, the immune system is naturally suppressed, so pregnant women are more likely to catch swine flu, and if they do catch it, much more likely to develop complications such as pneumonia and breathing difficulties.

6% of the patients who have been hospitalised with swine flu have been pregnant women, and just this week two otherwise healthy pregnant young women (aged 17 and 21) have died in Britain. In fact, of the 106 confirmed deaths from swine flu in the UK, a total of six have been in pregnant women.

Nicola Sturgeon, Scotland's Health Secretary, and Sir Liam Donaldson, England's Chief Medical Officer, have both urged all pregnant women to get vaccinated - in Sir Donaldson's words, "I do not want to see pregnant women dying of a preventable disease, that's the bottom line."

And yet.....the pregnancy forums are abuzz with women vehemently proclaiming that there's no way they would risk their babies' lives with any kind of flu jab. They believe that this has been "rushed through", while an alarmingly large number of them claim to have had friends with swine flu who were absolutely fine. Non-pregnant friends, I should point out....

How could it be that the message isn't getting through?

Well....the National Health Service has opted to choose GSK's Pandemrix vaccine for their mass rollout of the H1N1 vaccination programme, rather than the less controversial Celvepan, produced by Baxter (in fact the reason Pandemrix has been chosen is because the alternative requires two doses over the space of three weeks - which leaves us unprotected for those three weeks between GP visits). And herein lies the problem.

Sky News, in their infinite wisdom, decided to start the usual vaccine scare mongering with a vengeance, confidently proclaiming that "Pandemrix, which makes up the bulk of the NHS supply, contains a chemical never tested on mums-to-be". And another killer headline: "Pregnant women in Britain are to get a form of swine flu vaccine that is not recommended by the World Health Organisation (WHO)".

This "chemical" that Sky News talks about is an adjuvant - a chemical (often aluminum or oil-based) that can be added to vaccines to reduce the amount of active ingredient (antigen) needed per dose of vaccine by “turbo-charging” the immune system response in the patient. This can maximise the supply, providing six times as many doses from the same quantity of antigen - whereas there are genuine concerns that the yield of Celvepan is not nearly high enough to meet demand, and so supplies will be unreliable and finite.

Professor David Salisbury, the Department of Health's director of vaccines, certainly doesn't have any doubts about vaccinating pregnant women with Pandemrix, and today the World Health Organisation stated that "Inactivated non-adjuvanted vaccines similar to most seasonal influenza vaccines are considered the preferred option given the extensive safety data on their use in pregnant women. However, if such a product is not available pregnant women should be vaccinated with another pandemic influenza vaccine available at that time, for example an adjuvanted inactivated influenza vaccine or a live attenuated influenza vaccine" - effectively backing the use of Pandemrix.

And yet despite all the facts surrounding the benefits of the vaccine programme, the backing of our most senior health professionals and the undisputed fact that pregnant women are at increased risk for severe disease, potentially resulting in spontaneous abortion and/or death, especially during the second or third trimesters of pregnancy, STILL most of the women on the pregnancy forums are unswayed. This morning there were well over 50 posts against the vaccine, and not a single one for.

So, I thought it might be time to inject a little reason - excuse the pun!

Here is my own response - I'm expecting the "you evil woman who doesn't care about your poor vulnerable baby" lynch mob to be banging down the front door any minute now:

"Well, I guess I'm going to put the cat among the pigeons here, but I am planning on having the vaccine!

I've grown up with medics (Dad's a Dr, Mum's a nurse & former midwife and my brother's a med student), and I work in clinical trials (including H1N1 and influenza vaccine trials), so I may be a little biased, but I'm very pro-vaccines.

(I saw someone referencing that poor girl who died after getting the cervical cancer jab, and that worries me - the worst example of media hype causing panic and misinformation....)

But I do know that pregnant women are more than 4 times more likely to develop serious (i.e. life-threatening) complications as a result of catching the swine flu. So even if you have had flu before, or your friends have had swine flu and were "fine", you have to remember that we might not be so lucky with our compromised immune systems (thanks, baby mine!).

Yes, the flu doesn't harm our unborn babies, but having a dead mother absolutely does hurt our little ones!

Anyway, although this particular vaccine hasn't been around for years, and it might appear that they have been "rushed through", they will still have been through rigorous testing in the usual huge sample sizes of thousands of subjects, and animal trials before then (Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development). Vaccine trials are always very fast to recruit patients, because they involve healthy volunteers - i.e. you don't need to wait for someone to be sick before you can enrol them in the trial. So all the GPs that were involved in the trials could just ask every single patient that walked through their door each day whether they were interested in receiving the investigational vaccine. It only takes a couple of weeks before you have enough patients enrolled to prove that the drug is safe and effective.

Unfortunately you are not ethically allowed to include pregnant or lactating women in clinical trials, so no new drug that is released will ever have been proven in pregnant women.

I know it's a great unknown as a result, and we don't know what the long term effects are, but I would rather take the risk with the vaccine, rather than face the known fact that several otherwise healthy pregnant women are now dead.

Sorry this has turned into a bit of an essay, but I have also been giving this a lot of thought in the last couple of days. It's unfortunate that the NHS chose Pandemrix, which makes our decision a lot harder - but the flu vaccine has been around for ages, this is just a different (albeit much more virulent) strain of flu. So we know the technology behind the vaccine is safe, and in actual fact, the WHO have now backed Pandemrix.

Anyway, I know it's a very personal decision - and I'm in no way trying to knock anyone who has decided against the vaccine, because I know it's taken me a lot of thought to get to this decision myself! - but I just thought that it might be good to see the other side of the argument....

Here's to our happy, healthy babies and mums, regardless of our choices!

The Pregnant Pepper 19+5 Smile"

Bring on the hate mail!