First Do No Harm

The report of the Independent Medicines and Medical Devices Safety Review

On the 8th of July The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege published its long awaited report. Titled “First Do No Harm” it comes after a two-year review of patients in relation to Primodos [1], sodium valproate [2] and pelvic mesh implants [3]. Hernia mesh was not included in the review.
The review was announced in the House of Commons on 21st February 2018 by Jeremy Hunt the then secretary of State for Health and Social Care. Its purpose was to examine how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future.
The review team interviewed hundreds of people whose lives had been affected and also received written evidence. The team also took evidence from those in the healthcare system including regulators, professional bodies, manufacturers and policy makers.
Baroness Cumberlege said:

“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of the suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.”

The Review’s major recommendations:

That the government immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh
That a Patient Safety Commissioner is appointed to hold the system to account, monitor trends and demand action
That separate schemes should be set up for Hormone Pregnancy Test, valproate and pelvic mesh to meet the cost of providing additional care and support for those who have experienced avoidable harm and are eligible to claim
That a Redress Agency for those harmed by medicines and medical devices in future should be established. This will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systematic failings, rather than blaming individuals
That there should be established two types of specialist centres, located regionally for mesh and separately for those affected by medication taken during pregnancy
That the regulator of medicines and medical devices the MHRA needs to put patients at the heart of its activity and to overhaul adverse event reporting and medical device regulation
That a central database should be created by collecting key details including the patient, the implanted device and the surgeon
That the register of the General Medical Council should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctor’s clinical interests and specialisms
That the Government should immediately set up a task force to implement the Review’s recommendations.

Comment

This is a bold and far reaching report which must be hugely welcomed by those who have campaigned tirelessly for years. The report has identified critical failings in the system which has led to unnecessary patient harm and suffering for many years. Having commissioned this important work the government must not ignore the recommendations influenced by those resistant to change. It is also hoped that it will be embraced by the Scottish Government to protect Scottish patients. This must be essential reading for all countries around the world interested in protecting patients from harm.

Baroness Cumberlege recognised that in the UK:

“There is an institutional and professional resistance to changing practice even in the face of mounting safety concerns”.
“Mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of overall effective accountability”
Baroness Cumberlege found the system to be “disjointed, siloed, unresponsive and defensive”.
There was a failure to listen to patients and recognise that “the patients are its raison d’etre”.

The first step in making progress is recognising that we have a system which is deficient and does not protect patients. The next step is to act proactively to achieve change to ensure as far as possible that the scandals of recent years are not repeated.
Sadly the review did not include Essure, Roaccutane, PIP breast implants, cervical cancer vaccination, in utero exposure to hormones and valproate use in children. Hopefully there can be consideration of other areas where patients have been harmed at some point in the future and similar schemes introduced.
It is important that new treatments are offered to patients and there must be room for innovation and development. Developments in medicine have undoubtedly saved lives and innovation and research must not be curtailed or restricted unnecessarily and without cause. However, patient safety must be the paramount consideration for all.
The question is how to protect patients but promote development and it seems clear that the appointment of an independent Patient Safety Commissioner must be a step in the right direction. If there is to be any improvement that person must stand outwith the system and be independent of any influence.
Baroness Cumberlege said “This person would be the golden thread, tying the disjointed system together in the interests of those who matter most”.
The system whereby hospitals have conducted their own independent reviews of adverse events has failed patients consistently over the years. The voice of the patient is often silent in such investigations where they should be at the centre of the investigation and have full access to all information obtained. As was recognised in the report patients often know when something has gone wrong and their voices have been ignored. She said “Their experience must no longer be considered anecdotal and weighted least in the hierarchy of evidence-based medicine”.
Patient’s told Baroness Cumberlege stories familiar to many claimant lawyers. They complained of lack of information to enable them to make informed choices, the struggle to be heard and believed, the sense of abandonment and loss of confidence in the medical profession which can have a profound effect on the ability to have future treatment. There were complaints of inaccurate or altered patient records another theme regularly heard by lawyers who act for claimants. She recognised that many patients had lost their health their jobs, their families and their futures.
Where new treatments, drugs or products are being introduced this must be done safely. Any regulation must be impartial and fair to all. It is also important that there is independent continued surveillance and reporting of adverse consequences on a national scale to pick up as early as possible any adverse consequences not anticipated or identified. Adverse consequences can be reported with patient details redacted if necessary. Baroness Cumberlege states “In our view openness and transparency should be a statutory requirement for adverse event reporting in the UK”.
There has been a longstanding problem in the UK bringing litigation against manufacturers who have enormous financial resources. This report recognises that steps must be taken to ensure that where there is a new medical device or development this must be carefully and independently scrutinised to prevent harm occurring.
The report recognises that the MHRA has no involvement in the pre-market phase of medical device development and states that it should develop a proactive regulatory role for devices which must be as least as stringent as the new EU Medical Devices Regulations. There should be a register of all approved devices. Manufacturers should be required to apply to the MHRA before marketing their device. Marketing approval for devices should be a staged process and there will be power to remove a device from the Register.
Baroness Cumberlege has also recognised that some doctors may have financial and other links with pharmaceutical companies and that at present there is no register of clinicians’ financial and non-financial interests. She has advocated that such a register is set up. Patients should be able to access information on whether their clinician has a financial interest with a pharmaceutical company. There should be no inducements to initiate new treatments.
In Montgomery v Lanarkshire Health Board the Supreme Court recognised that patients were no longer passive recipients of medical care and that they must be involved in decisions about their own health care. To do so they require to have information to enable them to exercise an informed choice. Patients must be a central part of any new system introduced and should have access to information on adverse events identified with any new product/drug to enable them to make informed decisions on their healthcare. It is clear that regulation cannot be left in the hands of manufacturers or Health Boards to determine the safety of a product or to regulate the occurrence of adverse consequences.
The report is titled “First Do No Harm” but as Baroness Cumberlege says in the report the next step is “Do Some Good”.

Read more in Marion Scott’s fantastic article in the Sunday Post.

[1] This test was withdrawn from the market in the 1970’s and was thought to be associated with birth defects and miscarriages
[2] This is an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy
[3] Used in the surgical repair if pelvic organ prolapse and to manage stress urinary incontinence