Government order a review of controversial medical treatments
22 February, 2018
A review of three major public health scandals has been ordered by the Prime Minister following an outcry over failings to address public concern about the effects of the treatments.
The use of vaginal mesh implants surgery, the hormonal pregnancy test drug Primodos, and the epilepsy medication sodium valproate will be investigated, led by former health minister, Baroness Cumberlege.
The review will look into whether wider enquiries into their alleged failings are needed, but what exactly are the campaigners' concerns?
The drug sodium valproate is used in the treatment of epilepsy, bipolar disorder and migraines, but since its introduction in the 1970s, around 20,000 babies in the UK have been born with disabilities. Campaigners say the possible dangerous effects of the drug were not made sufficiently clear to pregnant patients.
A current European review is looking at whether there are strong enough warnings about the risk to unborn babies through pregnant mothers using the drug.
Exposure to valproate medicines such as this in the womb leads to a 10% chance of the baby developing physical abnormalities, and a four in ten chance that they will have cognitive problems such as autism or learning difficulties.
Scientific papers suggested as early as the 1980s that valproate medicines were a danger to developing babies, with more information coming to light in the 1990s. But it wasn’t until 2005 that patient information leaflets included warnings about possible development in children, and only last year were warnings added to the pill packets themselves.
Doctors are instructed not to prescribe the drug to pregnant women, and patient leaflets have more recently been updated to say that it should not be used whilst pregnant unless there is no other alternative, or the risks have been thoroughly discussed.
While the medicines regulator claims warnings are updated as more information became available, the women whose babies were affected claim that no one warned them about the extent of the danger.
Legal action is also being pursued in France against the drug manufacturer Sanofi, and the government have set aside €10 million as compensation for the families who have been affected.
The second medical failing that the review will investigate is the use of vaginal mesh. This is a topic that has had a lot of news coverage in recent months, and something First4Lawyers have been following, in particular the importance of a review.
Vaginal mesh is used to treat incontinence and pelvic organ prolapse following childbirth, but the mesh can protrude and cut into the vagina, meaning that many women experience severe pain and/or discomfort from the mesh. This has left some sufferers unable to work, have sex or even walk.
As the controversy has grown, so has the number of women bringing negligence cases against the NHS, and this latest review will look at how many women in England have been affected as a result of these implants.
The review will also investigate the hormonal pregnancy test Primodos. This drug, originating from Germany, was used by women in the 1950s to 1970s in the UK, and triggered menstruation where there was no pregnancy. It was no longer used from 1975 and was removed from the market in 1978 under the guise of ‘commercial reasons’ but it has been claimed by a number of the 1.5 million women who used it during early stages of pregnancy that it was responsible for causing birth defects such as missing limbs, brain damage and miscarriage.
There is some disagreement about the effects of Primodos. An enquiry led by the UK government said that the evidence did not support a ‘causal link’. Yet a new study by Dr Neil Vargesson from the Institute of Medical Sciences at Aberdeen University has found that the drug has the ‘potential to damage embryos in the womb.’
The test was carried out on zebra fish embryos, as they can replicate the reaction of human embryos (for example, with thalidomide, a drug known to shorten limbs, they developed shorter fins). This research found that Primodos caused a range of deformities across the entire body of the fish, such as eye defects and shortened tails, spines and fins. It also found that the effects can vary in severity depending on what stage of the pregnancy the test is taken.
Theresa May has said that the inquiry will not repeat work that has been done previously, i.e. they will not re-examine the inquiry into Primodos, despite the fact that the government has been widely criticised for failing to include Dr Vargesson’s research or waiting for it to be published. Instead they used studies on Primodos which were conducted decades ago using outdated methodology.
First4Lawyers welcome this long overdue review into a number of serious medical failings that are causing enormous concerns to the public. We have campaigned for further investigation into vaginal mesh injuries and we look forward to seeing this being carried out, alongside the very important research into the life-changing effects of Primodos and sodium valproate on babies.
Our worry is that if the government are unwilling to go over old ground, then the very valid findings of Dr Vargesson will once again be discounted, and families will be denied the justice they have long since campaigned for.
We hope that the review will consider this and conduct a thorough review into all the available evidence.