In March 2006 six healthy men, all under the age of 40, signed up as volunteers in a drug trial that was being conducted at a research unit based at Northwick Park Hospital in northwest London. The drug being tested was TGN1412, an anti-inflammatory drug designed to treat conditions such as leukaemia, rheumatoid arthritis and multiple sclerosis. Manufactured by TeGenero, a German pharmaceutical company, the experimental drug was supposed to work by subtly ‘re-tuning’ the body’s immune system. Following extensive testing in laboratories and on animals, the trial marked the first phase of the three-stage human testing process – the purpose of which was to check for side-effects rather than to see if the drug worked.
Within hours of the drug being administered all six volunteers suffered catastrophic organ failure, accompanied by sharp falls in blood pressure, swellings and excruciating pain. Seriously ill, they were admitted to the hospital’s intensive care unit. Here they made a gradual recovery and most were discharged after a few weeks, although one man remained in hospital for four months and had to have fingers and toes amputated after contracting septicemia. The victims’ puffy and bloated appearance, caused by the steroids with which they were treated, led to them being dubbed ‘elephant men’, a phrase that promptly resonated around the world’s media.
Parexel, the US-based clinical research organization that was administering the trial, has never admitted any liability or apologized to the victims, who have launched a multi-million pound damages claim against the company. The MHRA, the UK regulatory authority responsible, found no initial evidence of errors or irregularities, but was itself criticized for having approved the trial in the first place and did subsequently conclude that Parexel had given insufficient information to the volunteers and had not followed proper procedures.
When: March 2006
Where: Northwick Park Hospital, London, UK
Death toll: None. However, but for the prompt and effective response of hospital staff all six volunteers would almost certainly have died.
You should know: The long-term effects of the trial on the volunteers remain unknown. One man has since had a cancer diagnosis (which may or may not be connected) while another believes that his auto-immune system has been permanently damaged. Ironically, the drug has probably left the six at greater risk of contracting the very diseases it was designed to help cure.