Monday, 17 February 2014

The Saatchi Bill: liberating doctors to innovate

Lord Saatchi
Maurice Saatchi
The Medical Innovation Bill - otherwise known as the Saatchi Bill - is designed to enable doctors to innovate new treatments and cures for cancer and other diseases.

I wrote about it last year and my reasons for supporting it, and if your life has been touched by cancer in any way please read on.

Since the death of his wife, Josephine Hart, to ovarian cancer, Lord Maurice Saatchi has campaigned to change the law so that, with consent, doctors can treat patients dying of cancer and other diseases with new and innovative treatments, instead of having to stick to failed standard procedures, as the law currently requires. The Government is asking patients what they think, and you can get involved 

Imagine this situation. Not a pleasant one, granted,  but one that is all too common.

You have been diagnosed with high grade pre-cancerous cervical cancer. Previous surgeries to remove the cancerous cells have not been successful and your doctor says the only option is a hysterectomy. But you still want to be able to have children so you ask if there is any possible alternatives.

The doctor tells you there is a drug, Lopinvir, that has proved successful with a 90% success rate in trials in Kenya. It is a small gel capsule, inserted like a pessary, and has no adverse effects and doesn't compromise fertility. The doctor says you can try it out for 4 weeks (which is called a 'window trial') while you wait for surgery, if it's successful you won't need the operation and if it doesn't work you've lost nothing.

What would you do? Would you choose to try the new treatment? I know I would, and I imagine most other women would too.

Dr Lynne Hampson and Dr Ian Hampson
Dr Lynne Hampson and Dr Ian Hampson, 
But as the law stands now, the doctor would stand the risk of being struck off, or sued,  for offering the new treatment.

That is what the Saatchi Bill wants to change.

A few days ago I was part of a group of bloggers invited to visit Dr Ian Hampson (a reader in viral oncology) at his labs at Manchester University. He is also head of the University of Manchester Gynaecological Oncology lab, based at St Mary’s Hospital and he and his wife Dr Lynne Hampson (Non Clinical Lecturer in Gynaecological Oncology) and his team are committed to finding a cure for cervical cancer.

Infection with high-risk forms of the human papilloma virus (HPV) is the main cause of cervical cancer and it was whilst doing exploratory work on HPV that Ian started to look at Lopinivir, an approved HIV drug, as he had a hunch that the drug might work on early stage cervical disease. Taking an already approved drug and applying it elsewhere - that’s innovation.

Ian decided to trial the drug as a treatment for cervical cancer but couldn't afford to do the trials in the UK so he chose to carry them out in Kenya, partly because cervical cancer is the main cancer killer of women in Sub Saharan Africa. However, the standards in Kenya are exactly the same as in the UK – that is to say, the trial was run on UK lines and the women were supported to UK standards.

He had to beg and borrow equipment and money in order to make the trial work.  His work was funded by various cancer charities and philanthropists, and Hologic donated £250,000's worth of equipment. Interestingly, none of the trial was funded by the NHS.

The results of the trial were staggering. Out of 23 women who had tested for high grade HPV only 2 women still had it at the end of the 4 week trial, and Dr Hampson believes the unsuccessful ones just needed more treatments.

The Lopinvir soft gel capsule
The Lopinvir soft gel capsule

The trial in Kenya was a Phase 1 trial, which is designed to test the safety of the treatment. And there were no side affects (other than some women noted their pants were slightly stained from the colouring on the soft gel capsules).

This means that Ian’s treatment can be used again and again – with absolutely no risk of infertility – even if abnormal cells do reappear.

Phase 1 trials are there to test the safety of the treatment. Phases 2 and 3 are to test whether it is effective, although in this case Ian's trial has already shown it to be highly effective. It is too soon to say if Ian’s treatment will be a complete alternative to surgery, and it will still need to go through a Phase 3 trial which can take up to 12 years and millions of pounds before it can be used, but if the Saatchi Bill becomes law it would enable a patient to use the treatment now in a so-called 'window trial'.

We want cures. And we want better treatments. We want doctors to listen to patients and to respond to us, and here's how you can help.

The overwhelming public response to the Saatchi Bill has directly resulted in the Government agreeing to hold a public consultation. The Health Secretary, Jeremy Hunt, released a statement in November to say that the Government is supportive of the Bill but it will become law ONLY if we, the public, demand it.

Ultimately you need to respond to the consultation. Tell the Government what you think.  It is really important that everybody has their say on this matter.  After all – it’s our NHS.

If you believe medical innovation is the way forward, please respond to the consultation via the widget below. You can also follow the conversation on twitter with the hashtag #SaatchiBill @SaatchiBill and on FacebookThank you.