drug trial has gone wrong

The most worrying part of this is that it gives ammunition to the anti-vivisectionists.

They will try and claim now that animal experimentation is unjustified because reactions like this can't be picked up before human experimentation.

Listening to the news on the radio this morning, there was conjecture that this was an idiosyncratic reaction - but I don't see how that is possible - it's certainly highly unlikely given that all 6 people administered the API were affected together.

Here is the MHRA press release regarding the suspension of the clinical trial authorisation:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023396&ssTargetNodeId=389

Reply 2

Xenon

I heard the some people say that perhaps the reactions should have been expected given the mode of action of the drugs or something (don't know anything about it myself though).

Reply 3

Kingspharm

Well all that's been said is that they were 'anti-inflammatory' drugs.

Given that their proposed indication is leukaemia or rheumatoid arthritis then I suspect this is a DMARD or monoclonal antibody type drug.

If it's a mAb then these reactions are not altogether surprising - possibly a difference between human physiology and whichever animal model the drug was previously tested in. I would be concerned that these people have suffered permanent genetic damage - and I personally don't rate their chances of recovery.

Reply 4

Xenon

Any improvement on the two who were still critically ill?

nope, not yet.

I found the statement on the drug company's website that describes the nature of the drug as 'an immunomodulatory humanized agonistic anti-CD28 monoclonal antibody'.

http://www.tegenero.com/news/statement_re_tgn1412/index.php

There's also a story on Sky News about a guy who attended the trial but pulled out as he was concerned about the safety of the drug:

http://www.sky.com/skynews/article/0,,30000-13514092,00.html

Reply 7

HannahD

The participants seem to be quite young and one was a student. I was quite alarmed by the statement made by the patient given the placebo:

"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."

But then again, it was reported by the Sun who may have re-worded it for sensational reporting.

Definitely scares other people off trials that are quite safe.

Reply 8

Blates as

According to my tutor, who was one of the people interviewed on sky news (he's still bragging about it!!) the participants in the study should be ok in the long term. The reason they swelled up so much was because they had large amounts of saline infused into their blood streams to try and increase their blood pressures. The anti-cd28 action caused a release of inflammatory mediators and caused the blood vessels to become "leaky", hence the huge drop in blood pressure.

If their BPs are kept high enough to limit/prevent organ damage then the rest of the problems should sort themselves out...

drug trial has gone wrong

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