The Hughes Report: Options for redress released by the Patient Safety Commissioner
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Many patients have been fighting for years for compensation after birth defects and developmental disorders were caused by the epilepsy drug Valproate; pain and tissue erosions caused by synthetic mesh used in incontinence operations or the reproductive and fetal developmental problems caused by Primodos. Dr Henrietta Hughes, the Patient Safety Commissioner (PSC), has released her recommendations for compensation for Valproate and mesh victims: £100k for Valproate, £20k for mesh and zero for Primodos!
Whilst proposed compensation payments are a start, the amounts are insufficient for people whose lives have been ruined; recommended mesh payments are less than an average year’s salary despite years of lost employment for many. And why has the hormone pregnancy test, Primodos, been forgotten again?
It is also shocking that the government is putting their hands in their (our) pockets for payments, rather than making the pharmaceutical industry pay. The industry will not improve safety until there is a financial benefit for them to do so – there is no incentive if governments keep paying for their mistakes.
If there is sufficient evidence to justify government funds to compensate victims, why isn’t there sufficient evidence to demand this compensation comes from the manufacturers?
Why is the PSC’s remit so narrow, on one medicine and one medical device? What about the dozens of other medicines and devices that have caused harm over the past few decades?
How can systemic failures be identified if only looking at a fraction of the medicines and devices that have caused harm?
The tunnel vision on only 2 products helps drive the divide and rule, which encourages those harmed by medicines to work in silos, focused on their own legal battles and compensation claims, rather than working together in a single coordinated effort.
The elephant in the room however is why neither the report nor the media coverage address the regulatory failures that allowed Mesh and Valproate to harm for so long?
Whilst redress is important, what is critical is how we prevent future scandals from other medicines?
Looking back to Dr Henrietta Hughes 100 day report published a year ago, her proposed strategy to prevent future harm is Priority 1 “Culture change”. Whilst good in intent, culture change is difficult to measure and even more difficult to implement. Anyone with experience trying to change culture in even a small company will know the challenge, how do you achieve that across the diverse range of medical services providers in the UK?
Emma Muphy’s statement ‘I got fobbed off. I was told I was reading into things’ reflects how many have been treated. My own mum was told for many years there was no link between the HRT and breast cancer that killed her, was told off for “internet research” and was told the symptoms of her brain tumour had psychological rather than physical causes. The culture of playing down harm is systemic.
Nearly all of the victims I speak to tell the same story with different words: changing this culture could take decades, the PSC only has 3 years.
Dr Henrietta Huges clearly listens to patients and has done a great job to outline the harm to patients in their own words, share their requested outcomes and she makes some great recommendations for improvements, for example:
- mandatory Yellow Card reporting,
- having a named patient voice on all boards and
- working with policy teams to improve conflict of interest declarations.
But a year on we see little progress on these actions – does the PSC have the teeth to implement these ideas?
Given systemic failure of MHRA that was identified in The Cumberlege report, First Do No Harm (FDNH) that resulted in the PSC role, why isn’t “regulatory reform” Priority 1?
Surely it’s simpler to reform a single regulator, than change the culture across the entire health service?
If the PSC won’t call for regulatory reform, then we have no choice but to demand this ourselves.
Please sign my petition demanding the reform of MHRA.
Thank you to guest author: Alex Hicks @hicksyalex
