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licensed. TGN1412 was a monoclonal antibody which is capable of boosting the action of killer immune cells (T lymphocytes, T cell) to help fight against cancer cells, rheumatoid, arthritis and leukaemia. By combining with T- cells they release cytokines which undergo cell proliferation. Monoclonal antibodies are laboratory produced substances that can locate and bind to specific molecules a protein involved in causing the and damage of .This inflammatory drug then tries to help the immune system fight cancer cells. Antibodies are made when you are exposed to a virus, your body will produce antibodies to help rid your system of the infection. These two antibodies are different as a monoclonal antibody is a drug which is a protein which helps inflammation however an antibody is made by your immune system to help kill any antigens that have entered your body.
During the drug trial at Northwick Park there were many conspiracies theories of the reason behind this catastrophic incident. Several web links and quotes say the dose was to be given within a 2 hour period but instead given during 2-6 minutes. This small misjudgment could have been the difference in a successful trial and a cure for all the antigens its fighting with, but we have to remember drug trials happen all the time this event could have been a one off which has to be forgotten quickly if more drug trials are to go ahead. Despite how serious events were in Northwick Park and how much damage TGN1412 cause to the volunteers “the 6 suffered multiple organ failure. The possible reason for organ failure could be the way the drug reacted inside the body. As I said earlier TGN 1412 was designed to target a subtype of immune cell, regulatory t-cells (they prevent the body attacking itself). Instead TGN 1412superactivatedthe immune system and volunteers suffered multiple organ failure. Instead of switching as the regulators, activator switched on and super-immune systems sending WBC called t cells rampaging through the body destroying its own tissue (new scientist). As Paraxel research unit said “subjects experienced cytokine release syndrome” and two were said to be critically ill, the drug trial was stopped as soon as the men fell ill”.()
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TGN 1412
The effects of TGN 1412 were ferocious and never seen before during my lifetime, which I hope to never see again. However to succeed in successful drugs which are kind to humans all have effects and TGN 1412 had many. TGN 1412 was made to specially bind to receptors in human t-cells so by using the drug on animals it didn’t bind the equivalent to another species which is why 9/10 drugs that pass animal testing fail in human trials. The drug trial for many reasons was stopped: This was due to severe vomiting, swelling of body which was what Nav modi ‘elephant man’ was suffering with as well as mental trauma and severe headaches which was common between the 6 volunteers and some symptoms of:
Severe aching of body
Coma longest case lasting two and half weeks
Mummification of body parts
Weakened immune system
Despite this tegenero and paraxel will learn from these unfortunate events as they successfully conducted drug testing process but as it wasn’t tested on human cells they failed to achieve of what could be a huge success. (Teachers note & www.bbc.com/news)
This was 1 of many effects the drug had after it was taken. Rock fingers.
Research from findings
Clinical trials tend to be set by the NHS hospitals by charitable or academic institutions as well as special companies, who carry out the trials on behalf of pharmaceutical companies. Although this event was catastrophic it was a one off, we all need to remember that drug trials happen all the time and most do become successful although there are drawbacks but despite that the drug could still be success and a licensed drug in years to come. Even though this incident happened, drug trials are very safe “this is an absolute exceptional occurrence I cannot remember anything comparable”, Professor Richard Ley. ()
The drug TGN1412 had been shown to be a possible treatment for serious disease with evidence provided by Aisling Burnand “250 million patients worldwide have benefited from approved biotech medicines of these 17 are monoclonal antibodies, helping patients across a variety of indication including cancer, rheumatoid, arthritis and transplant rejection”. ()
Had clinical trials not happen scientists and doctors couldn’t develop many new drugs,
without human drug trials we would never have known whether drugs that are monoclonal antibodies or general drugs are safe for humans. Newly developed drugs have helped cure many diseases without such controversial incidents like the one at Northwick Park hospital. Volunteers also benefit from it as they of course do get paid and will help possibly make a cure for a disease they could one day suffer from also the drug
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had good potential in helping to cure arthritis, cancer leukemia and rheumatoid to see whether or not TGN1412 was suitable for humans which will be unanswered until
another drug trial. Volunteers who take part in a drug trial are always told about the possible risks but drug trials take place for the good of wider population so people need to understand without drug trials it will be nearly impossible to stop deaths which could have prevented so scientists have to translate the theory into humans to get a better understanding of the point of drug trials and to be aware events that occurred in
Northwick Park is very rare. I have used limited and certain references so this argument could be fair and accurate which was to achieve the right answer in this widely disputed matter.
Conclusion
To summaries, clinical trials are the testing of drugs to see whether they are successful or not I feel despite unpredictable effects they could possibly because they should still go ahead as there’s as much chance of being successful and unsuccessful. Also I believe the work on monoclonal antibodies should and must continue as TGN 1412 can be a lot more successful and maybe a drug one day for humans to use. Furthermore there will always be complications to every drug trial that takes place but as Aisling burnand said a successful trial can “help people across a variety of indications”. I am strongly for clinical trials as they help promote the discovery of new medicines and breakthroughs in science as they can potentially save lives. However there needs to be a safer way to conduct trials to ensure events like Northwick Park do not occur again possibly a depth study into testing on human cells or cells which have been affected and could be killed by the drug; the should be guaranteed more safer and know the specificity of the drug and whether or not humans trials should go ahead if the drug is effecting two different systems of a species. Also MHRA needs to review their drug testing policy because monoclonal antibodies are biological molecules and have different effects than other chemical drugs. There is a need to have clear testing criteria for monoclonal antibodies. I have come to this conclusion on the grounds of evidence I was produced with and that I used from websites and still am strongly FOR drug trials.
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Definitions
Placebo: a substance having no pharmacological effect but given merely to satisfy a patient who suppose it to be a medicine.
Clinical trail: scientific evaluation of a new treatment that has shown benefit in animal or laboratory studies, but that has not yet been proven superior to existing therapies for people.
Monoclonal antibodies: capable of boosting the action of killer immune cells (T cell) to help them fight cancer cells which they can’t normally do.
MRHA: medicines and healthcare products regulatory agency.
In vitro: made to occur in a laboratory vessel or other controlled experimental environment rather than within a living organism or natural setting.
Pre-clinical: the period in medical or dental education preceding the clinical study of medicine or dentistry <the preclinical years>; specifically: of or relating to the early period of prescribed medical or dental study devoted to the basic sciences
Cytokines: Any of several regulatory proteins, such as the interleukins and lymphokines, that are released by cells of the immune system and act as intercellular mediators in the generation of an immune response.
Proliferation: the growth or production of cells by multiplication of parts.
Lymphocytes: Any of the nearly colorless cells found in the blood, lymph, and lymphoid tissues, constituting approximately 25 percent of white blood cells and including B cells, which function in humeral immunity, and T cells, which function in cellular immunity.
Antigen: Immunology. Any substance that can stimulate the production of antibodies and combine specifically with them.
Pharmaceutical: pertaining to pharmacy or pharmacists.
Bibliography
http://www.thesun.co.uk/article/0, 2-2006140654.
http://news.bbc.co.uk/1/hi/health/4808090.stm
Teachers note & www.bbc.com/news
