‘We are not a vaccine’
The Irish medical profession is facing a crisis of confidence, with some doctors calling for more patients to be tested and a rethink of the whole approach to gene therapy.
The Irish Medical Association (IMA) has called for a re-think of the way gene therapy is being practiced and said it would take a major overhaul of how gene therapy treatments are assessed.
In a statement, the AMA called for more research to determine the safety and effectiveness of gene therapy and to be guided by scientific evidence.
In the past, the IMA has backed the use of gene therapies, with senior medical officer Dr Peter Mervyn calling them “a proven option for treating patients with rare and complex disease” in the latest edition of his journal The Lancet.
However, the majority of the AMA’s medical staff are against the idea of gene treatment.
This is a crisis, and we are not immune to this, said Dr Peter Egan, chairman of the IMO’s gene therapy advisory committee, who is also chair of the National Medical Association’s Gene Therapy Committee.
The AMA said it was calling for the reinstatement of the moratorium on gene therapy, which has been in place since 2007, to be extended until at least 2032.
In its statement, Dr Merven said: “While there is no evidence that gene therapy can be safely used in humans, there are a number of serious ethical concerns.
Dr Mervan said it is important to note that gene therapies are not new technology and that the AMA is in favour of further research into the use and safety of gene treatments.”
There are other treatments which have been successfully used for decades without any serious adverse events.”
Dr Mervan said it is important to note that gene therapies are not new technology and that the AMA is in favour of further research into the use and safety of gene treatments.
However he said: “[Gene therapy] is the most powerful treatment currently available, and is now available for some people with rare disease.”
Dr Egan said the moratorium could help to mitigate any ethical concerns, but said he would still oppose the treatment in certain circumstances.
The moratorium has been placed on gene therapies for several years, with several studies showing that it has been beneficial for patients.
However the moratorium was lifted in 2013, and it has only recently been reinstated.
However it is likely that the moratorium will be re-imposed again, with a new committee set up by the IMP to study the safety of the gene therapy treatment and assess its use.
The IMP said it wanted to make sure that the use, and safety, of gene-based therapies is thoroughly investigated.
It said it will also consider the possible need for a new regulatory framework for gene therapy in Ireland.
However Dr Mavon MacKenzie, chair of genetics at the University of Liverpool, said the new committee should have a clear agenda and focus on the use case for gene-free therapy, rather than focusing on the risk of gene editing.
He said: The moratorium is a great opportunity to re-examine some of the issues which have arisen from the moratorium.
“Gene-free treatments are very safe and it is very likely that gene-editing is the next big thing.
We should look at all the other potential uses, not just gene-therapy, and look at how it might be used safely.”
Dr MacKinnon said the current moratorium had been “incredibly detrimental” to the future of gene medicine and would have an “adverse effect” on research.
“Gene-based therapy is a safe and effective therapy, and many other research programmes have already used gene-techs to treat people with disease,” he said.
“However the ban on gene-mediated therapy has made the use in people with a variety of diseases a big taboo.”
It is the very existence of the ban that has prevented gene therapy being used in other ways, such as gene therapy for rare disease or gene therapy to treat rare disease.
“We need to reexamine this ban and make sure we are using gene therapy responsibly and that it is safe and reliable for people with certain diseases.”
Dr Kavanagh said the IMPA had a “moral duty” to provide the best care for patients, and said the committee should not be made up of individuals from different fields.
This is about patients and their care and that’s the role of the committee.”