The Elephant Man Horror Threatens Human Drug Trials; EXPERTS ADMIT THEY ARE BAFFLED BY CASE WHICH LEFT SIX FIGHTING FOR LIFE

Daily Mail (London), April 6, 2006 | Go to article overview

The Elephant Man Horror Threatens Human Drug Trials; EXPERTS ADMIT THEY ARE BAFFLED BY CASE WHICH LEFT SIX FIGHTING FOR LIFE


Byline: JENNY HOPE;MICHAEL SEAMARK

HUMAN drug trials were under threat last night after a Government safety watchdog admitted it was baffled by the 'Elephant Man' case.

Emergency measures have been introduced after an urgent investigation failed to discover why six volunteers injected with TGN 1412 were left clinging to life.

Foul play and human error have been ruled out. There was no apparent contamination of the drug or mistakes in last month's trial at the privately-run Parexel research unit in a London hospital.

Yet, despite a dose 500 times lower than that given to monkeys, when injected for the first time into human guinea pigs it provoked an 'unpredicted' reaction.

The Medicines and Healthcare Products Regulatory Agency report into the ill-fated trial of the drug - developed by German company TeGenero - concluded that the most likely cause of the adverse reaction was an 'unpredicted biological action of the drug in humans'.

An expert group has now been formed to examine the issue and will report to Health Secretary Patricia Hewitt in the next three months.

Meanwhile, the MHRA will seek expert advice before authorising any more firstinman trials of drugs such as TGN 1412.

But Ann Alexander, the solicitor representing the two most seriously affected victims, condemned the MHRA report as 'totally inadequate.' She called for an independent inquiry into the conduct of the trial on the drug designed to treat leukaemia, rheumatoid arthritis and multiple sclerosis.

She plans to make her concerns about the MHRA known to the Health Secretary and the Commons Health Select Committee and complained of too much secrecy surrounding pre-clinical testing.

She said: 'How long did it last, what animals were involved, what were the effects, and had these trials been completed? My clients and the general public are entitled to answers to these questions.'

Martyn Day, the solicitor representing the four other men, said he had serious concerns that the MHRA was 'regulating itself' after authorising the trial.

The fact that TGN 1412 was a 'novel' drug had not been explained to them, he said. 'If it had been explained that it was so new, then there's not the slightest chance that one of them would have gone through with the test. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

The Elephant Man Horror Threatens Human Drug Trials; EXPERTS ADMIT THEY ARE BAFFLED BY CASE WHICH LEFT SIX FIGHTING FOR LIFE
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.