Experimental drugs may become available to patients

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A bill proposed by Lord Saatchi has received backing from doctors and the Government and could result in dying patients obtaining access to untested medications.

The health secretary, Jeremy Hunt, has thrown the weight of his department behind the Medical Innovation Bill which will make it simpler for doctors to test new treatments on patients without the fear of possibly being sued.

The Bill has caused division in the medical profession, but has received tentative support from a leading cancer charity and the General Medical Council.

Lord Saatchi, an advertising magnate, proposed the legislation after starting a campaign after his wife, Josephine Hart, died from ovarian cancer. He said the principle related to testing new drugs on desperately ill patients was already in effect in the case of Ebola victims in Africa.

He said that by dealing with the deadly Ebola epidemic, the World Health Organisation has made the decision that moving from standard evidence-based treatment is essential and justified. He said they have set ethical guidelines for using new interventions and therapies, which are identical to those set out in the Medical Innovation Bill.

Supporters of the Bill, which could become law by March if peers and MPs agree, will give victims of rare cancers the opportunity to volunteer for treatment with untested drugs.

The elimination of years of clinical trials will reduce the cost of the medication and this could result in pharmaceutical companies becoming more willing to fund experimental drugs which will only be beneficial to a small number of people suffering from rare diseases.

The Bill is up for debate in the House of Lords this Friday and will be considered in the House of Commons during December. According to its supporters, the Bill has a 75% chance of becoming law.

The Government offered its support of the Bill after new safeguards were agreed with the medical director of NHS England, Sir Bruce Keogh. The amended Bill now stipulates the requirement of at least one other specialist before untested medications are tried on patients.

Presently, doctors routinely seek an opinion from their colleagues in hospital in what is termed the ‘Bolam test’. The amendment to the Medical Innovation Bill will require them to seek consent from other specialists within the particular field. This will prevent ‘dominant personalities’ within a hospital, sometimes a senior consultant, to get their own way and act against the best interests of the patient.

A spokesman from the Department of Health said that innovation is important for modernising the NHS and it is vital to find new cures and improve treatments, hence work on the Medical Innovation Bill will be ongoing. The spokesman said that they are pleased that Lord Saatchi tabled amendments to the Bill to ensure staff and patient safety.

The new amendments have resulted in the General Medical Council, which was opposed to any changes during April, to offer its tentative support for the changes.

The council’s chairman, Professor Sir Peter Rubin, said medicine is a risky business and there are many people who are alive today because doctors were willing to deal with uncertainty, innovate, and take reasonable risks which are shared with, understood and consented to by the patient in line with adequate medical practice.

He said they welcome the amendments to the Bill and are keen to review the final version.

Cancer Research UK has offered support for the changes in the Bill. The director of policy and information at the charity, Sarah Woolnough, said they must ensure that the Bill contains suitable safeguards for the protection of patients.

In spite of these changes, there are still doctors with concerns. Michael Baum, Professor Emeritus of Surgery at University College London, said they have never encountered obstruction or interference due to fear of legal action.

He said there are many obstacles to progress, but a change to the law by using this Bill will not improve cancer therapy innovation. However, as a result of unintended consequences, it might endanger patients through uncontrolled experimentation.

Image Credit: e-Magine Art

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