On 27 February, the Daily Mail reported that a major review would be made into three health scandals – Primodos, sodium valproate and transvaginal mesh.
You must welcome a government review into the scandals surrounding these products; all of have been linked with horrendous side effects in large numbers of people. Primodos was withdrawn from use and in France, the government is actually compensating victims of sodium valproate whilst here the NHS now acknowledges mesh should not be used in many cases. And yet all of these products went through our licensing system with no recall.
It can only be a start though. Our regulatory system of drugs and devices is simply not fit for purpose. In 2004 Vioxx was withdrawn by its makers for its link with a hugely increased risk of heart attack and stroke and yet it remained approved. DePuy removed its ASR metal on metal hip prosthesis from the market in 2010 four years after the MHRA was convening secret meetings to consider the risks of metal poisoning and serious damage with implants. PIP went on producing implants with non-medical grade silicone for ten years whilst fielding a long dull series of letters from the MHRA querying its safety but not warning the public.
I hope Baroness Cumberlege will find from her review that the appalling stories of ineffective regulation along with the acknowledgement that Brexit will mean the government will have to change its current regulatory process, mean that nothing less than a full and open pubic inquiry is needed as soon as possible. Only in this way can the public expect to regain confidence in the regulation of drugs and devices for patient safety.
My firm and I have experience of defective and withdrawn products stretching back into the 1980s and the various reviews, select committee inquiries and safety reviews during that time. I will be offering any help that I can provide to the Baroness so that our clients can feel this is an effective review and not a public relations exercise by a health minister constantly under pressure.
