UK Medical Regulator Receives A Rare Battering In The Commons

The time has come for "robust changes"

Last week, Conservative MP for Tatton, Esther McVey, spoke on the Medicines and Health Regulatory Agency’s (MHRA) negligence overseeing the administration of Primodos.

For those unacquainted with Primodos, it is a hormone-based pregnancy test used in the 1960s and 1970s, consisting of two pills. The pills induced menstruation in women who were not pregnant. The presence or absence of menstrual bleeding was then used to determine whether the user was pregnant.

Warnings about the drug were issued in 1975 and 1977, yet the product was not removed from the market until 1978.

In July 2020, Baroness Cumberlege published an independent report on Primodos, which confirmed the link between Primodos and severe birth defects. Some involved heart murmurs and feet deformities.

Later that month, Matt Hancock, then Health Secretary, formally apologised on behalf of “the NHS and the entire health service” for the devastating outcomes faced, telling families their “voices had now been heard”.

Here is what McVey said on MHRA and Primodos:

I, too, thank the hon. Member for Bolton South East (Yasmin Qureshi) for bringing this debate to the House. Listening to all the powerful speeches really makes me proud of the Chamber. This is the Chamber at its best, with the powerful speeches of my right hon. Friend the Member for Maidenhead (Mrs May) and the right hon. Member for Kingston and Surbiton (Ed Davey).

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 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 In 2013, the Medicines and Healthcare products Regulatory Agency listed 27 medicines that had been withdrawn on safety grounds.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 have 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?

This is a bleak and worrying situation, so I will try to end on a more positive note by commending the important work of the hon. Member for Bolton South East as chair of the APPG on hormone pregnancy tests. My final tribute must go to Marie Lyon, whose tireless campaigning on Primodos over the decades has been inspirational. She deserves the full support and respect of this House, and I hope she and others harmed by this drug can finally get justice.

When McVey references the “closeness that has developed between regulators and companies”, she is being polite. Investigative journalist Maryanne Demasi found that up to 86% of MHRA’s budget derives solely from drug companies - that is Epstein, JP Morgan kind of closeness.

(Note the percentage of the TGA... *shriek*)

What McVey relays about the UK’s Vaccine Damage Payment System (VDPS) is more on point. Sir Christopher Chope, MP for Christchurch in Dorset, discovered as of 23 February 2023, the number of applications related to Covid vaccines was 3,887. Of these, there are 48 awarded claims (1.23%), 890 rejected claims (22.90%), 849 of which were medical rejections and 41 were invalid applications. A staggering 1,612 applications have remained unresolved for more than six months (41.47%).

It might also be worth noting the obvious reality that the advertising campaign for vaccine damage compensation has not even come close to that of the vaccines. Couple that with the claim of 98 out of 100 adverse drug reactions go unreported and you have a brutal picture.

In any case, this parliamentary session constituted a rare moment of unity across the house. Many MPs were unequivocal in their condemnation of Primodos, particularly that of Liberal Democrat Ed Davey. Per his own words:

All these examples add up to show that a lot of powerful people are trying to stop justice being done in this country and around the world, so I am so pleased to see cross-party support here today, in a very powerful way, to make sure that is put right.

If Ed Davey, who considered paying young people to get the Covid vaccine, can realise a world in which powerful people attempt to stop justice for Primodos, why can he not do the same for the Covid vaccines? And more importantly, will vaccine victims have to wait over 60 years for recognition like Primodos victims?

In my humble opinion, they’re using the same tactic with the Covid Inquiry. Delay, delay, delay until emotion dissipates. Perhaps then, to Covid vaccine victims, they may say, your “voices have been heard”... for what good that does.

You can watch McVey’s speech here.