In the weeks leading up to the trial, which I had signed up for a few months back, I had been constantly forewarned about the possibility of losing my leg or growing an extra limb. These worries expressed friends and family are well meaning but they are reminiscent of a bygone era. Medical trials, since the 2006 disaster at Northwick Park hospital, where volunteers suffered severe long-term effects, ranging from extreme swelling to permanent brain damage. It shook the medical world and damaged public perception of a process so crucial to modern healthcare – to the surprise of the pharmaceutical companies involved, applications remained consistently high, but the public remain wary.
As with all medical trials, a certain level risk is always involved and that must be considered before you embark on a trial. You will be briefed on the potential side effects before and on the day of the first dosing, and with doctors on call around the clock, safety is paramount. Everybody is aware of their responsibilities towards yourself, the ‘trialer’ and should you have any questions, they will be answered by the nurses. If you do happen to lose your nerve, figuratively, not physically for all intents and purposes, you can leave at any moment during the study, even before dosing – therefore the study has reserves.
Gazing across the ward I see 7 other beds, all men aged 18 to 40, and this is a common sight, but trials can become available for anyone, no matter the age bracket.
Our uniting desire? Money, clinical trials in the UK can pay thousands depending on the length and phase of the trial with the first phase usually regarded as they highest paying studies; this is because they are usually the first to involve humans. Ending with phase 3, this is where large scale testing begins, usually to gather final information before being released onto your local pharmacies shelf.
All studies and their medicines must be approved by the MHRA, the UK’s primary body for regulating and overseeing clinical trials. Through their oversight, 22 new recommendations were made to improve the conditions and effectiveness of stage 1 clinical trials – this was huge wake up call.
It certainly feels as though everything is under control and I am regularly checked throughout the day, you could argue it is a detox camp, like one of those Kate Moss attended in Turkey, only less glamorous. I feel healthier, less stressed and eating far better than the day I arrived. One of the first lines you read in the volunteer pamphlet is that there is “no perceived benefit” from the study medicine. They forgot to mention the immense benefits that come from a consistent diet and a regular water intake, so often we forget these basic needs during the day and wonder why we feel so lethargic, but the boost has been phenomenal.
Clinical trials despite their bad press, continue to number into the thousands and amidst the pandemic; campaigns to recruit have been overwhelmingly successful, 100,000 people applied to take part in NHS vaccine research, and this has since revitalised interest in medical studies. As public relations go, we are a world away from the tragic consequences suffered by those 15 years ago and that signals a huge sigh of relief for an industry historically treated like marmite.
Understandably for the naysayers, it is less about the safety of the trial and more about the oligopoly they hold, arguably restricting innovation through holding government patents, meaning they could hold a cure without a financial need to sell it yet. Cash flow is king for big-pharma and without a cash cow cure, they are prized to implode, the stock charts do not lie when it comes to the unpredictability of the market. Investors can become incredibly flighty when best laid plans fall flat.
Just as TeGenero went bankrupt in 2006 after the disaster, big-pharma must not take volunteer enthusiasm as sure-fire sign of trust – trials must stay safe and continue to develop a strong safety net for volunteers. Corporate social responsibility, as shallow as it sounds, must be more transparent than ever post pandemic, as global services have shut down and governments prove unreliable, vaccines have come out on top, and those making them take all the praise. Pharmaceuticals however, must, curb their enthusiasm and make sure study safety is not left behind in pursuit of ever wilder success.
The irony is that as volunteers, we come for money too and those may scoff at our seemingly desperate cash grab but without willing volunteers, modern medicine would be far from possible, if anybody should take the credit for our vaccine success, ‘trialers’ must surely have a slice of the cake.
Harry Allen 