Health - Clinical trials: to sink or swim?
Volunteering to help test an experimental medication is a daunting decision: a possibly painful journey to nowhere versus the chance of extra life. Jane Feinmann talks to a few brave souls who took the plunge. Illustration by James Fryer
When Christine Taylor was invited to participate in a clinical trial testing a controversial new drug for multiple sclerosis in 2003, she didn’t hesitate. “I was 48, already losing the ability to walk and staring at a life of increasingly severe disability. I was ready to try anything,” says the 54-year-old west London practice nurse.
Testing this radical new treatment, known as monoclonal antibody therapy, is about as experimental as a drug trial can be. MS is a chronic inflammatory disease which causes the immune system to begin to turn on itself; the drug works by “re-booting” the immune system to get rid of the elements responsible for this abnormal reaction.
Dr Alasdair Coles, a Cambridge neurologist and trial leader who has been working on the drug, alemtuzumab, since 1991, explains: “We give two annual cycles of the drug intravenously to kill off the immune system cells. It leaves the patient with the immune system of a newborn baby, except that we leave just enough stem cells behind to fight off infections during the treatment and then build a new, glitch-free immune system.”
While the scientists knew it should work, the trial – with 280 recently diagnosed MS sufferers – was the first opportunity to try it out on a mass scale. As it turned out, it was a good call. The new drug still does not have a full licence as further trials have to be completed; but the results of the trial that Christine joined (reported in April 2008 and already in the clinical history books), have established this promising drug as one of the most significant breakthroughs of modern science.
After three years, participants in the trial had a 74 per cent reduction in the risk of suffering a relapse, effectively stabilising the disease, for which until recently doctors could do little or nothing. For some, the impact of taking the drug has been far greater.
Tony Johnstone, a professional golfer of 53, said that before the trial, he couldn’t hit his foot with a golf club because of MS. Now, after two “difficult” years on the trial, he’s able to win cups again.
Christine’s recovery has not been so dramatic, but she is walking again and feels that the threat of being compelled to use a wheelchair has receded. “I haven’t gone back to work yet but nor have I given back the key to the practice,” she says.
It’s probably the promise that such “miracles” might happen that attracts hundreds of thousands of people, many of whom have a serious illness, to take part in what is inevitably a risky arrangement with an uncertain outcome. Over the 12 months to April 2009, more than 300,000 NHS patients participated in studies supported by the National Institute for Healthcare Research (NIHR), the biggest research funding agency in England and Wales. And there are plenty more to come, with 1,900 NIHR trials currently open to recruitment and a further 360 in the process of being set up. And that’s just a fraction of the total number of the trials in the UK.
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