• Primodos families still not being compensated after evidence presented
• Average time withdrawn medicines on market was 11 years
• Primodos, sodium valproate and pelvic mesh caused “avoidable harm”
How distressing it must be for the women and families harmed by Primodos that they are still having to fight nearly five decades on. Their road to justice has been long and cruel, and it is shameful that we (MPs) find it necessary to debate this again. The independent medicines and medical devices safety review, ‘First Do No Harm’, found that Primodos, sodium valproate and pelvic mesh had all caused “avoidable harm”. In 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) listed 27 medicines that had been withdrawn on safety grounds. The average time they were on the market was 11 years.
In 2020, Dame June Raine, the Chief Executive Officer of the MHRA, stated that her agency had transformed itself from watchdog to enabler. However, it appears that not much has changed since the Health Committee inquiry in 2004. In a recent meeting of the APPG on pandemic response and recovery, Professor Carl Heneghan and solicitor Peter Todd raised concerns about the MHRA’s handling of safety concerns and the Government’s vaccine damage payment scheme.
Three years on from Baroness Cumberlege’s landmark review, the Government has not fully implemented its recommendations. In particular, we are still waiting for redress schemes to be set up to meet the costs of additional care and support for those who were harmed by Primodos, sodium valproate and pelvic mesh.
Esther McVey, a former Government Minister, is a Conservative MP and Co-Chair of the All-Party Parliamentary Group Pandemic Response and Recovery. Jacob Rees-Mogg also contributed to the debate, wondering why even where scandals occurred decades ago, the present Government so often seems reluctant to face up to the errors and implement the recommended measures.
The case of Primodos is not an isolated case, and there have been many examples of our regulatory bodies failing to keep patients safe from new medicines and medical devices. The Health Committee inquiry in 2004 noted the “closeness that has developed between regulators and companies” and the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust. The ‘First Do No Harm’ review in 2020 showed that patients had been let down, and it called for significant reforms of the MHRA, due to its mishandling of safety concerns. Professor Carl Heneghan and solicitor Peter Todd raised concerns about the MHRA’s handling of safety concerns and the Government’s vaccine damage payment scheme.
It is clear that the Government has not fully implemented the recommendations of Baroness Cumberlege’s landmark review, and we are still waiting for redress schemes to be set up to meet the costs of additional care and support for those who were harmed by Primodos, sodium valproate and pelvic mesh. The Government must act now to protect patients from harm and to look after those who have already been harmed.
How distressing it must be for the women and families harmed by Primodos that they are still having to fight nearly five decades on. Their road to justice has been long and cruel, and it is shameful that we (MPs) find it necessary to debate this again. How can it be that the Primodos families are still not being properly supported and compensated after all the evidence that has been presented?
Sadly, Primodos is not an isolated case, and we have seen many examples over the years of our regulatory bodies failing to keep patients safe from new medicines and medical devices. In 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) listed 27 medicines that had been withdrawn on safety grounds. The average time they were on the market was 11 years. I wonder how many times we will allow history to repeat itself. There have been reports and reviews calling for reform, and back in 2004 the Health Committee undertook an inquiry into the influence of the pharmaceutical industry. It noted, of drug companies, the “closeness that has developed between regulators and companies”, which had “deprived the industry of rigorous quality control and audit”.
It also highlighted “the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust”.
In 2020, Dame June Raine, the Chief Executive Officer of the MHRA, stated that her agency had transformed itself from watchdog to enabler, so I ask: has anything improved in the intervening 20 years since the Health Committee inquiry? I fear not, and I think the time has come for another inquiry of similar scope and depth, only with more robust outcomes. That is what we want — robust outcomes.
In 2020, the independent medicines and medical devices safety review, ‘First Do No Harm‘, found that Primodos, sodium valproate and pelvic mesh had all caused “avoidable harm”. The review showed that patients had been let down, and it called for significant reforms of the MHRA, due to its mishandling of safety concerns. The review was clear that there is “gross under-reporting” of suspected adverse reactions and that “systems are both too complex and too diffuse to allow early signal detection”.
That theme keeps coming up, and in a recent meeting of the APPG on pandemic response and recovery we heard from Professor Carl Heneghan, who described widespread problems with the reporting of adverse drugs and device reactions, which continue to be a major cause of hospital admissions. As many as 98 out of 100 adverse drug reactions go unreported.
The APPG, of which I am a Co-Chair, was told that the MHRA is running a system that is too slow to act and is beset by conflicts. Failure to act now will only lead to more harm. We also heard from the solicitor Peter Todd who was acting for 43 individuals who suffered blood clots as a result of the AstraZeneca vaccination. He described how the Government’s vaccine damage payment scheme is operating poorly and failing to help those who have been injured. Not only is the current system unable to protect patients from harm, but it is failing to look after those who have already been harmed.
Three years on from Baroness Cumberlege’s landmark review, the Government has not fully implemented its recommendations. In particular, we are still waiting for redress schemes to be set up to meet the costs of additional care and support for those who were harmed by Primodos, sodium valproate and pelvic mesh. Why has that not been done?
Esther McVey, a former Government Minister, is a Conservative MP and Co-Chair of the All-Party Parliamentary Group Pandemic Response and Recovery. This is an edited transcript of her speech in the House of Commons debate on Hormone Pregnancy Tests.
Stop Press: Jacob Rees-Mogg also contributed to the debate, wondering why even where scandals occurred decades ago, the present Government so often seems reluctant to face up to the errors and implement the recommended measures.
The case before us seems so remarkably straightforward that it is impossible to see why there is such a stick-in-the-mud attitude from the Government, though perhaps less so from the pharmaceutical companies, because they know that they are culpable and, ultimately, deserve a financial liability. Why can I be so confident of that link? There seems to be one very striking fact, which was revealed by Jason Farrell in the important work he did for Sky News: the drug was used in South Korea and Germany as an abortifacient. It was used to procure abortions. What is a drug that will do that doing to a baby? It is causing harm. That is so straightforward. We have heard already that Primodos contained 40 times the amount of hormone in a contraceptive pill. It also contained 13 times the amount of the morning-after pill. It is so clear and self-evident that harm has been caused, and therefore responsibility must be laid at someone’s door. We know from today’s debate where those doors are.
I have great sympathy for the Minister who is to respond, because there is an extraordinary, peculiar tendency of Government — one I do not understand as a Back Bencher and did not understand in Government — to cover up the mistakes of long-since-passed Administrations. We have seen it with Hillsborough, the infected blood scandal and even with thalidomide. There is no doubt an almost endless list. I do not understand it — it is not the current Administration at fault. They have done nothing wrong; some were not even born — the Prime Minister was not — when the scandal started. Yet again and again, Governments and the bureaucracy will not open up, allow the real truth to come out and follow the evidence that was so brilliantly and clearly put by Baroness Cumberlege in her report.
