Parexel - TGN 1412: TV show revelations leaked to press

The victims of the catastrophic TGN 1412 'Elephant Man' clinical trial were given the test drug at a 'reckless' rate, according to experts.

The drug, designed to fight leukaemia, rheumatoid arthritis and multiple sclerosis, was injected 15 times more quickly than when given to monkeys in animal studies, confidential documents have revealed.

Leading scientists believe this 'reckless' mistake could explain the horrendous reaction to the drug which left volunteers fighting for their lives.

The six young men - all fit and healthy before signing up for the March trial at Northwick Park Hospital in North-West London - suffered a host of side-effects, including pain, vomiting and organ failure.

Bar manager Mohamed 'Nino' Abdelhady, 28, was described as 'the Elephant Man' by his partner Myfanwy Marshall after his head swelled up.

Trainee plumber Ryan Wilson, 20, suffered heart, kidney and liver failure, pneumonia and blood poisoning and was in a coma for three weeks.

While in the coma, he suffered a frostbite-like reaction and has since lost parts of his fingers and had his toes amputated.

The volunteers, who are launching a multimillion pound damages claim against Parexel, the private research firm that ran the trial, face the risk of contracting cancer and other chronic and incurable diseases such as multiple sclerosis.

TeGenero, the company who were developing TGN1412, have already gone into liquidation.

The UK TV programme "Dispatches: The Drug Trial That Went Wrong" will be on Channel 4 this Thursday at 9pm.

Daily Mail

The Sunday Times has more detail.

TGN1412 - "informed consent"?

Back stories here.

New research presented today shows that the information given to the volunteers of the disastrous Northwick Park “Elephant Man” trial would not have passed a ‘readability’ test. The research, presented at the international meeting of the Drug Information Association today, highlights an immediate need for all information provided to volunteers in clinical trials to be ‘User Tested’ before future trial protocols can be approved.

The University of Leeds commissioned Luto Research (Leeds University Testing Organisation) to undertake the User Testing component of the presented research, which highlighted that members of the public took up to an hour to find all of the answers to questions about key facts in the volunteer information provided – and with six of the 21 questions, at least 20 per cent of participants did not understand the key facts at all. The volunteers involved in the Elephant Man trial reported to the media, after their trial ordeal, that they were only given approximately 10 minutes to review their consent forms and the drug information sheet before entering into the clinical trial. User Testing, is a form of “readability” testing and is currently applied to patient information leaflets inside medicine packs to ensure that they are clearly written and can be understood by the target audience and it is required by EU law. However, this law does not currently extend to participant information provided to people about medicines within clinical trials, which could be licensed or unlicensed.

“In light of this new research, common sense would dictate that if there is current EU legislation around the need for User Testing information provided to patients about established medicines, the same standards should be applied for information given to patients about un-licensed, and as yet un-proven, medicines, where the volunteer is at a higher degree of risk. In the meantime I have written to Research Ethics Committees asking them if they will take steps to include the User Testing of information intended for trial volunteers before they approve any clinical trial protocols. The UK could take a lead in Europe in this initiative – in the way that the Medicines and Healthcare products Regulatory Agency (MHRA) did to ensure a thorough and consistent approach to User-Testing licensed medicines”, commented Professor DK Theo Raynor, Professor of Pharmacy Practice, University of Leeds.

Source

Elephant Man - Sesame Street

Enjoy!

Parexel - clinical trials, ain't they a bitch!?

TWO volunteers are in hospital after taking experimental drugs being tested by the company which ran the disastrous "Elephant Man" drug trials two years ago.

The controversial US giant Parexel has been recruiting “guinea-pigs” to test a potentially dangerous new drug designed to help people overcome addictions.

Two have been taken to hospital suffering from potentially deadly conditions after taking nalmefene.

More at The Sunday Express

PAREXEL - file in the "irony drawer"

PAREXEL, the company who ran the TGN1412 "elephant man" clinical trial, has been named the "Best Contract Research Organization (CRO)" by Scrip World Pharmaceutical News. The award was presented to PAREXEL at the fourth annual Scrip Awards ceremony held on December 10, 2008 in London, England. The Scrip Awards are designed to celebrate innovation and a continued commitment to improving healthcare worldwide.