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Artwork by Mark Fisher Volunteering for clinical research trials can be a rewarding experience, not least, financially — or so the research companies would have us believe. To offer oneself as a guinea pig for the future benefit of others is undoubtedly a selfless act, but under what safeguards are these studies conducted?
With the announcement in September that an NHS communications manager, Ruth Atkins, had volunteered to be injected with an Ebola vaccine containing genetic material from the Zaire strain of the virus, the media were champing at the bit with speculation and doom mongering.
Such fears, of course, are not without Cels birmingham essay bank. From the horrors of Nazi doctors conducting experiments on concentration camp victims during World War II, to the Thalidomide scandal of the late s, clinical research communities have faced serious PR problems when it comes to allaying our concerns about the work they do in the name of progress.
But that plays into the hands of the detractors somewhat, since many thousands of clinical research studies are conducted every year, without incident, without side effects and without hitting the headlines.
And whereas all drugs testing comes under the banner of clinical research, not all clinical research studies concern drugs testing. A clinical trial is defined as either a biological or behavioural research study on human test subjects, designed to answer specific questions regarding anything from the effects of a new vaccine or drug, to effective treatment models for biological or behavioural disorders, to the requirements of certain health conditions, or for testing new devices and healthcare products intended for the open market.
For the majority of those who volunteer for such studies, the experience has only ever been positive. Former social care support worker Neal, 52, started volunteering with Intertek, a testing and certification company for the chemicals and textile industries, after a friend, already a volunteer, recommended it.
As a single parent, my reasons for signing up were mostly financial, but I was also curious about the work they were doing.
I ended up testing a new deodorant. It would depend what it was for. Last year, I took part in a sun burn study for Manchester University that involved taking several biopsies from my buttocks. Clinical trials on humans constitute only a small part of the extensive research that goes into developing a potential new treatment, drug or product.
With the occasional exception, where it is deemed expedient to fast-track a study the proposed Ebola vaccine being a case in pointany proposed trial must undergo several years of rigorous laboratory research before it is approved by regulatory bodies and reaches Phase 1, the stage where human test subjects are involved.
Subjects Sharon and Danny, a married couple in their 40s, first started volunteering four years ago after a recruitment leaflet dropped through the letterbox.
A private tutor and a sound engineer respectively, they have taken part in numerous skin, hair and dental studies. Six male volunteers were contracted by the US drugs testing company Parexel to test a new anti-cancer drug known as TGN Within minutes of being injected, the men began vomiting, their heads puffed up to twice their size and some began slipping in and out of comas as they showed signs of multiple organ failure.
Thankfully, all the volunteers recovered, although one was reported to have had his toes amputated, but the incident raised serious concerns about trial procedures and medical ethics in general. In his Sunday Times bestseller Bad Pharma How medicine is broken and how we can fix it Doctor Ben Goldacre sees the events at Northwick Park as symptomatic of a wider, systemic problem with research studies, where interested parties such as pharmaceutical companies can exert, quite legally, undue influence on the results of clinical research.
Unsurprisingly, these trials tend to produce results that favour the manufacturer.
Not everyone has a horror story to tell when it comes to drugs testing. Maggie was a barmaid in her early 20s when she took part in residential drugs trials with Medeval, later known as Icon Development Solutions: All said it was easy money, nothing to it, perfectly safe, etc.
I had been broken into twice and was just desperate to move. I just wanted to make some money to put a deposit down on a flat.
I did two trials, both for drugs already in use, which I considered to be less scary. One involved being woken up every morning with a shot of vodka. I have a history of depression, which would automatically exclude me from most studies.
That and the fact my mum, who was a nurse at the time, was horrified when she heard what I was doing. Looking back, I think she was maybe right to be concerned. She was much more aware than I was that things can go wrong.
Atkins, a former nurse in the NHS, was reported as saying: According to the World Health Organisation, the strain has a mortality rate of up to 90 percent, and it is for this reason that the new study, which will involve up to 60 volunteers, has been backed by the Medical Research Council and the UK Department for International Development.
Leading the study, Professor Adrian Hill of the Jenner Institute stressed that all the volunteers were safe, stating: The tragic events in Africa demand an urgent response. And how else will we find the cure for cancer? However, the regulations and codes of conduct under which studies are carried out need to be of a universally accepted standard set in international law, and not be dictated by the financial considerations of multinational pharmaceutical companies, private health bodies or cash-strapped governments.
As for volunteering, it remains with the individual to decide what they are willing to participate in and to fully verse themselves on the potential risks. A brief history of clinical research The First Clinical Trial The first proper clinical research trial comes in the wake of the disease scurvy and its catastrophic effects on the welfare of sailors on long distance voyages.
Physician James Lind conducts the trial on infected sailors and establishes beyond doubt that scurvy is caused by vitamin C deficiency, arguably saving many thousands of lives in the process. The Nuremburg Code At the end of the Second World War, numerous Nazi doctors who had performed human experiments are tried at the war crimes tribunal in Nuremburg.3 This is a huge collec tion of modern En glish that was initi ated by the Universi ty of Birmingham.
It is regularly updated and, to date, consists of million words. the birmingham journal, n o v e m b e r 5* 4. 15 news of the week. FOREIGN AND COLONIAL. ROMANCE IN CANADA A Miss Strange, niece of llie late member of Parliament of that name in the Upper Ca- nada Legislature, was engaged to be married to a Mr.
Du- . ashio-midori.com is a platform for academics to share research papers. At its height International Times was printing 44, copies and each copy was often read by four or five people. Oz, in the 60s, was selling about 30, and a great deal more during the obscenity trial of Search the history of over billion web pages on the Internet.
This is a complete Journal issue.