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Month: June 2023

Healthy Mum, Healthy Baby, Healthy Future – a year on, what progress has been made?

“We cannot allow another 40 years to pass by with no new medicines for pregnant women” – Professor Katie Morris reflects on BHP’s Pregnancy Policy Commission and its work since the publication of the Healthy Mum, Healthy Baby, Healthy Future report in 2022. 

Most pregnant women will have a healthy pregnancy and give birth to healthy babies. An increasing number of women, however, will either have one or more health conditions before they become pregnant which require on-going treatment, or they may develop complications of pregnancy which require treatment.

The care of these women is severely hampered by a lack of suitable medicines, that we definitively know to be safe and effective for use in pregnancy or during breastfeeding. As a consequence, women and babies worldwide continue to become sick and die during or immediately after pregnancy. Despite this, over the last 40 years, only two new medicines have been approved for use in pregnancy.

Birmingham Health Partners‘ 2021 report, ‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ highlighted the absence of research and information on the safety of medicines in pregnancy. It also drew attention to the urgent health needs of this neglected group both nationally and internationally, and the potential for saving and improving millions of lives globally.

As a direct response to this report the University of Birmingham and Birmingham Health Partners convened a Policy Commission focussing on the UK, canvassing knowledge and opinions from key parties including patient groups, the pharmaceutical industry, scientists, clinicians, NHS leaders, regulators and insurers. It aimed to explore the scale of the problems that are preventing the evaluation and development of safe medicines for use in pregnancy and collected recommendations for how these could be overcome.

The Commission report was published in May 2022 and entitled “Healthy Mum, Healthy Baby, Healthy Future.” It made a series of eight recommendations related to advocacy, widening participation of pregnant women in clinical trials, updating information on existing medicines, de-risking the insurance process for clinical trials, incentivising industry to develop pregnancy specific medicines, establishing a UK-wide network of research centres, improving the use of routine data, and appointing a UK steering committee to deliver these recommendations.

Over the last year, members of the Commission have been working to develop the steering group and engage with industry and insurance companies to drive forward these recommendations. There are challenges in driving this agenda forwards which can be broadly described as a de-prioritisation of women’s health, and particularly pregnancy, by industry and in the delivery of clinical trials related to workforce and capacity.

Without combined efforts from all stakeholders; public, scientific, clinical, industry, regulatory and governmental sectors, we will not see any progress. The first step will be through co-ordinated efforts via the recently formed steering committee and renewed approaches for engagement with industry and insurance providers.

We cannot allow another 40 years to pass by with no new medicines for pregnant women.

Together these stakeholders must advocate for change, respond to research and funding issues, and, where necessary, work to change official guidance or law to enable progress in this much neglected area.

The UK is well placed to become a global pioneer of maternal health research innovation. We have the health infrastructure of our NHS, with its birth-to-death records. Our medicines regulator is able to fast-track drug development and make changes to streamline the process, as well as working globally with Europe, the US and other regions. We are already a global hub for insurance – and we can support and build on this to add to our potential in becoming a leader in clinical studies for medicines in pregnancy.

There is an urgent need for action to address the underserved area of medicines use in pregnancy. Without it, women and babies will continue to die when they could be saved. They will continue to experience long-term health effects, disability and distress, which might be avoided. It is no longer ethical to deny pregnant women and their unborn babies access to safe, modern medicines that the rest of the population enjoys.

Birmingham’s world-leading cancer trials unit gets £10m boost

A new £10m grant from Cancer Research UK will ensure that adults and children with cancer continue to benefit from world-class clinical trials led by the University of Birmingham.

The news has been hailed as a ‘major boost for patients’ by both clinicians and cancer survivors.

The Cancer Research UK Clinical Trials Unit (CRCTU) at BHP founder-member the University of Birmingham has already achieved significant progress in the treatment of cancer in the UK and internationally, including establishing new standards of treatment for the rare bone and soft tissue cancer, Ewing Sarcoma.

Scientists at the centre have also transformed the management of some types of prostate cancer and introduced treatment innovations for patients with blood cancers.

The new grant will allow researchers working on more than 100 national and international trials to continue developing safe and effective treatments as well as new tests for cancer over the next five years.

Professor Pamela Kearns, Director of the University of Birmingham-based CRCTU unit and children’s cancer expert, said:

“The renewal of funding for cancer trials in Birmingham is a major boost for our research here and we are delighted to continue working with research teams and patients to find new solutions in cancer care. Our clinical research enables us to translate discoveries from the lab and accelerate the improvement of cancer treatments, giving more patients the best chance of beating their disease.

“As a paediatric oncologist, I am particularly pleased this funding will allow our unique Children’s Cancer Trials Unit at Birmingham to continue to design and run clinical trials to improve the care of children with cancer.

“For example, with support from Cancer Research UK, we are leading International trials for children and young people with difficult to treat cancers like FaR-RMS; a trial testing innovative new treatments for rhabdomyosarcoma and the BEACON 2 trial, testing a range of new combinations of therapies for children and young people with a type of childhood cancer called neuroblastoma, at a stage where they have failed to respond well to standard treatments.”

The Birmingham CRCTU will combine strengths in innovative clinical trial methods with outstanding scientific and clinical expertise nationally and internationally to deliver new clinical trials, across all age groups over the next five years. The CRCTU will work alongside the Birmingham Experimental Cancer Medicine Centre, which is also funded by Cancer Research UK and the National Institute for Health and Care Research on trials to tackle more complex types of cancer and for cancers of unmet need.

Professor David Adams, Head of the College of Medical and Dental Sciences and Pro-Vice-Chancellor at the University of Birmingham said:

“The CRCTU is a jewel in the crown of our research portfolio across the University and I am delighted that with this latest funding we will continue to conduct internationally leading research to find better treatments and tests for cancer.

“Together with the ongoing funding for our Experimental Cancer Medicines Centre, the University is ideally placed to continue advances in cancer research which has a hugely significant role in society today. With unprecedented challenges for our NHS and after the effect that the pandemic has had on waiting lists and access to care, we need more than ever to have quick, effective and safe care for cancer.”

The team coordinates ground-breaking clinical trials across the UK and internationally, as well as regionally through Birmingham Health Partners (BHP) – a strategic alliance between seven higher education and health institutions including the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Birmingham Women’s and Children’s NHS Foundation Trust.

Improving outcomes – Francesca’s story

Cancer survivor Francesca Williams was one of 640 patients across Europe to benefit from a trial led by the Birmingham centre that has significantly improved outcomes for children and adults with Ewing Sarcoma.

Diagnosed with a tumour in her rib bone just weeks after her 27th birthday in July 2017, Francesca had 15 sessions of chemotherapy and five weeks of radiotherapy back-to-back over ten months. This was followed by major surgery at Heartlands Hospital in April 2018 to remove the remainder of her tumour and rebuild her chest wall using muscle from her back.

Despite going through medically induced menopause and having no time to store any eggs for fertility treatment, Francesca is expecting her first baby in July.

“I feel so lucky to have been part of the trial,” said Francesca, a 32-year-old English teacher who now lives in Austria.

“The worst thing for me was thinking I wouldn’t be able to have children so to find out I was pregnant last year was incredible. I’m really excited about becoming a mum.”

The European-wide trial EE2012, run by the University of Birmingham’s Cancer Research Clinical Trials Unit, tested the standard chemotherapy treatment plan against a new experimental treatment plan in children and adult patients from ten European countries.

The trial – a shorter treatment than the previous standard – found that six per cent more patients were cancer-free after three years, with fewer toxic side-effects. Results were so conclusive that the trial finished early in 2019 and the new treatment adopted as standard across Europe.

“I was very dubious about the trial to begin with but I’m so glad my dad persuaded me to go for it,” said Francesca. “I had no sickness from the chemotherapy so it’s great to hear that the treatment is now being offered as standard. That’s why I feel so passionately about supporting research. Without improvements like this I wouldn’t be here now.

“It’s such a deadly cancer and it is so aggressive, there isn’t the biggest window of opportunity for treatment. It affects a lot of young adults and children who can lose limbs if it’s found in an arm or a leg, but treatment can be successful if it’s caught early enough.”