Force pharma companies to provide drugs for rare cancer trials, UK govt told
MHRA 'should regulate' the release of drugs for clinical trials for innovative cancer treatments | Medical experts lambast big pharma’s unacceptable lack of involvement in Glioblastoma campaign | Forcing companies will ‘undermine public trust’ says pharma body.
The UK Parliament has been told to force pharmaceutical companies to release drugs for clinical trials for new cure cancer treatments, sparking debate from medical experts.
Members of Parliament (MPs) discussed the extent to which innovation can improve outcomes for some of the least survivable cancers, including pancreatic, brain, and some respiratory cancers, during a Health and Social Care Committee meeting.
But an association that represents pharma companies and a company that has participated in trials hit back by arguing forcing companies to release drugs risks undermining public trust in medicines as trials can go wrong.
The discussion, held January 9, explored existing health inequalities and innovations with the capability of improving poor rates in early diagnosis.
Paul Mulholland, a medical oncology consultant from the University College Hospital, the National Hospital for Neurology and Neurosurgery, and Mount Vernon Cancer Centre, said one of the main blocks on improving patient outcomes is access to drugs for clinical trials.
“The pharmaceutical industry may not want to do those trials, it may not be part of their portfolio, but we need to be doing trials for patients,” said Mulholland, responding to a question from Paul Bristow MP.
“Although the drugs belong to those companies, they have an obligation to supply them, but there is no legal obligation for them to give us drug supply,” said Mulholland.
Pharma’s lack of Glioblastoma help ‘unacceptable’
The committee heard how Dame Siobhain McDonagh, the Labour MP for Mitcham and Morden and initiator of the Glioblastoma Campaign, had reached out to the big pharmaceutical companies and asked them for drug supply, however, they declined.
The Glioblastoma Campaign, initiated by Baroness Margaret McDonagh and her sister Siobhain, aims to address the inadequacies in the treatment of the brain tumour condition within the NHS.
The campaign advocates for improved research, training, and resources for glioblastoma patients, emphasising the urgent need for advancements in clinical trials and treatments.
Mulholland described the decision by pharma companies to not help in the campaign as “unacceptable” as it is “very little” for them to give a drug supply for a clinical trial.
“We can do the trials, but we need their drugs,” he added.
This change would require regulatory change with the Medicines and Healthcare products Regulatory Agency—which is an executive agency of the Department of Health and Social Care in the UK responsible for ensuring that medicines and medical devices work and are acceptably safe.
ABPI: ‘Pharma already provides medicines for external trials’
Tas Gohir, senior IP and commercial research manager at Guy’s and St Thomas’ NHS Foundation trust, found it “disappointing” to hear that pharma companies have not yet agreed to provide the relevant drugs for undertaking clinical trials, in relation to cancers where markets are relatively small.
He believes there is an opportunity in this situation for drug companies to enhance their overall reputation within the medical community and public by providing materials for trials.
“Such reputation gains are very likely to provide financial benefits elsewhere across their business and are also a means of demonstrating corporate social responsibility, something which is increasingly important to all stakeholders,” he added.
Amit Aggarwal, executive director of medical affairs at The Association of the British Pharmaceutical Industry (ABPI) said: “Pharmaceutical companies exist to find, develop, and deliver effective treatments for patients and they do already provide medicines for external clinical trials for new uses.”
He explained that voluntary partnerships allow companies and outside researchers to share important information about the science of medicines based on experience—something that could be lost under a regulated scheme.
“Forcing companies to release their products for every request risks undermining public trust in medicines if for example, a medicine doesn’t work for a new use, or worse, something goes wrong in a clinical trial the originator company had no involvement with,” added Aggarwal.
Additionally, in order for a trial to receive regulatory approval, an assessment of the likelihood of the trial working and the study meeting the ethical standards is needed, according to Aggarwal.
According to Kelly Warrington, precision medicine and genomics lead at Roche, traditional clinical trials in rare cancers have historically been challenging due to the often small number of patients.
However, advances in how trials are conducted have led to more innovative ways “to include patients with rare or difficult to treat cancers, ensuring they are not left behind,” she said.
Pharmaceutical market failure
Within the oral evidence session, James Morris MP suggested that the UK might be experiencing “market failure” in the pharmaceutical industry with regards to clinical trials and asked Mulholland how this can be addressed.
Mulholland acknowledged the positive collaboration and efforts the NHS and drug companies have undergone in regards to the NHS wanting to conduct trials for drug companies for common types of cancers, however, raised concerns about neglected cancers such as brain cancer, pancreatic cancer, and mesothelioma.
To address this, investigator-initiated studies are proposed where universities, hospitals and the NHS conduct trials with drug company support—these rely on donated drugs, as purchasing them at high costs is not feasible.
The drugs are commercially available, however, they are not indicated for that particular tumour type and are not being repurposed, according to Mulholland.
Gohir put forth his prediction that future trends in genomics indicate that many treatments are likely to become more personalised to smaller patient groups, rather than the deployment of a single drug entity for all patients with certain clinical conditions.
“The traditional pharma business model of reliance on blockbuster drugs may need to be reconsidered, in order to account for the increasing number of smaller niche personalised markets driven by genomics,” he said.
This would suggest that going forward, pharma companies would need to adjust their approach to opportunities—some restructuring of operations is probably needed, according to Gohir.
Ongoing research efforts
ABPI highlighted current ongoing research to test cancer medicines for new uses by companies doing it themselves, and external researchers doing it with the support of companies.
Examples include; the Determine trial for rare cancers where Roche has provided seven of their targeted therapies to be evaluated in the first instance; Phase 0 clinical trial; Phase II clinical trial; Phase II clinical trial; Phase II/III clinical trial; Phase III clinical trial ( further information); and Phase III clinical trial.
Roche claimed to focus on potential treatments and gaining a better understanding of the factors driving the cancers so oncologists can identify the right treatment for the patient.
Additionally, Roche ran its own studies to understand how newly developed treatments could potentially improve the lives of patients with rare and difficult to treat cancers.
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