3.16.2006

From the Irony Department

German pharmaceutical company TeGenero AG conducted a clinical trial in England for their new drug, TGN1412, an anti-inflammatory drug intended to treat rheumatoid arthritis, leukemia and multiple sclerosis.

Unfortunately for six men involved, the anti-inflammatory drug caused severe fevers and the swelling of their faces and internal organs landing them all in the hospital. Two men are currently on life support in critical condition; the remaining four are reportedly improving, but still listed in serious condition.

One of the clinical participants who received the placebo described the situation like this:

Raste Khan, 23, said he was terrified as the six men, all previously healthy, "went down like dominoes" screaming that their heads felt like they were going to explode as the anti-inflammatory drug, never before tested on humans, began to have a devastating effect.

Mr Khan, one of two participants given a placebo in the clinical trial, told The Sun: "First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode. It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and I didn't know why."

One volunteer’s girlfriend described the swelling as resembling the Elephant Man. Her 28-year-old boyfriend’s doctors told her, "He needs a miracle; those were their words, he needs a miracle."

TeGenero AG and Parexel, the firm administering the clinical trial, are both shocked over the outcome of the trials, which were successful in animal testing, and several British scientists have expressed concern that the publicity might deter volunteers from joining human clinical trials in the future. No shit!

annamaria at 9:34 AM

4 spoke

4 Comments

at Thursday, March 16, 2006 5:18:00 PM Blogger Kurt said...

HHHHHHHHEEEEEEEEEYYYYYYYYYY!
don't tell your slacker temp the bad part and let her know it might be way to make alot of extra money...

 
at Thursday, March 16, 2006 5:31:00 PM Blogger annamaria said...

Kurt! You're brilliant! And when she finally comes back to work (yep, that's four days this week she's been gone), I'll make that suggestion.

 
at Thursday, April 06, 2006 4:53:00 AM Anonymous BOB FIDDAMAN said...

MHRA - In whose Interests?

The recent TeGenero drug trial debacle was an accident waiting to happen. As long as the Pharmaceutical Industry continues to suppress clinical trial data the MHRA (Medicines and Healthcare products Regulatory Agency) will walk blindly and feed the British public false information.

News this week that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA regarding the top selling anti-depressant drug Seroxat will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe.

The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest?

For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public.

A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel?

The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of ‘delivering jobs for the boys.’



Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group)

Birmingham, UK

 
at Saturday, July 08, 2006 2:18:00 PM Anonymous Anonymous said...

Exactly - if laying blame, the MHRA (the totally corrupt, 100% industry
funded UK drug regulatory body) is high on the list.

 

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