Drug trial man 'may lose fingers'

[joeunderdog]

Mr Wilson was among the volunteers to have been given the TGN1412, created by German pharmaceutical company TeGenero, by medical research company Parexel.

snip
He suffered heart, liver and kidney failure, pneumonia, septicaemia, and was ventilated on 99% oxygen. Doctors then tried to save him from dry gangrene.


snip
"When I woke up in intensive care after almost three weeks unconscious, I only realised how serious my injuries were when I saw my hands and feet were black," he said.

Snip
It (TaGenero) found there were no obvious errors in the testing procedure but said in future first-in-man trials of similar drugs would not be authorised without expert advice.

http://news.bbc.co.uk/2/hi/health/4914546.stm


Anyone wanna guess how many of these stories never get press in the US? This drug is probably distributed over here under a different name.

[Stuckinthebush]

1. Drug trials

...are very closely watched here in the US. I don't know about how it goes in other countries, but our IRBs and the Office of Human Research Protection (OHRP) are very aware of risks v. benefits.

[Warpy]

2. No, actually it isn't

The reason this is getting extensive press is because it is extremely rare. The test subjects had tolerated the drug once before, so the best guess is that the first dose "switched on" the immune system and the second dose provoked an extreme reaction.

I've seen some weird reactions to study drugs. They're generally not life threatening so they don't make the news. Anyone who signs up for clinical trials is a true hero, IMO, whether or not it's a last ditch effort for them after standard treatment has failed.

I'm grateful to all of them.

[muriel_volestrangler]

6. I don't think they had the drug before

(see the interim report from the regulatory agency), but the drug is a monoclonal antibody designed to activate the immune system. One of the questions still not answered, as far as I know, is why they gave it to six people in a short space of time, rather than observing just one at first (well, I suppose 'money' is the answer, but I don't think it's a good enough one).

Consider the simple issue of timing. It is now clear the doses of TGN1412 used in the trial were given with extraordinary rapidity, with an interval of only minutes separating each patient's injection. Normally, doses would be interspersed with waits of hours to give researchers time to study volunteers for side-effects. Indeed, sometimes doses are given at intervals of days, even weeks, as Dr Kate Law, of Cancer Research UK, said.

'We usually give one person a small dose. Then weeks later we give another volunteer an equally small dose,' she said. That precaution was clearly not enforced last week.
...
The drug targets a site called CD28 which lies on the surfaces of white blood cells called T-cells, key components of the body's immune system. In effect, the drug latches on to the T-cell and initiates a chemical reaction that should fire the body's immune system into action. Thus it was hoped TGN1412 could be used to treat a disease called B-cell chronic lymphatic leukaemia (B-CLL), and also auto-immune diseases which include rheumatoid arthritis and multiple sclerosis.

'The aim would be to kick the body's defences into a highly active state so that they could mount a more effective attack on the proliferating B-cells that were causing a patient's leukaemia,' said Dr David Chiswell, a monoclonal expert and former chairman of the BioIndustry Forum.

http://observer.guardian.co.uk/focus/story/0,,1734386,00.html

[LisaL]

7. They haven't been given the drug before.

As far as I know.

[scordem]

3. This poor guy.

I wonder how the others are really doing? This is truly the most gawdawful thing I've ever heard of. They need to support this guy thoroughly, and retrain him if he can work and wants to, for the rest of his life.

[LisaL]

8. I think the others are doing better than him.

It's just a horrible for him.

[MannyGoldstein]

4. Never, Never, Never

I used to work in this field:

1. I would never be a subject in a clinical trial. Drug companies are doing their best to get to market and make a buck quickly, rather than to ensure your health.

2. The docs doing clinical trials are paid staggering sums of money for their participation - it's part of how drug companies "encourage" docs to be friendly towards them. If you agree to be a guinea pig, then you also deserve a princely sum - after all, your life is at risk.

3. As far as I've seen, American trials are safer than European trials. I've seen things done in Europe that are truly ghastly - utter, blatent, and reckless disregard for human life that I've not seen here.

[DrDebug]

9. It was a phase I, so he was paid and probably a lot

It wasn't a Phase II or III, but he was one of the first humans to get the drug and he already signed away all his rights prior to starting the trial.

Phase I is even worse, because the medical staff is hired by the drug company, but he knew what he was getting into.

He was paid £150 / day * 15 days = £2,250 for his participation in the trial ( http://www.timesonline.co.uk/article/0,,8122-2087471,00.html )

And this the way they sell their guinea program:

You may be helping friends and family by being involved in the development of a new medicine or helping to improve an existing one.

You’ll receive a thorough medical check up – FREE!

You’ll be paid for your time and inconvenience.

Free food for the duration of your stay – and NO shopping or washing up!

You'll have plenty of free time to read or study, or just relax - with digital TV, pool table, videogames, DVD player, and now FREE Internet access!

You can even just catch up on some sleep!

http://www.drugtrial.co.uk/for_you/default.ihtml?step=4&pid=3

And if you are unfortunate the sleep will be long. Note that they don't mention the waiver where all your rights are signed away in case something goes wrong

[Telly Savalas]

11. So we get rid of clinical trials and just take drugs like this

straight to the market?

While many companies cut corners with ethics to fatten their profit, it's hard to see how this is the case here. Consumers are apt to notice a little detail like the fact that half of patients who take this drug have seizures almost immediately. The companies involved stood little to gain since the product was unmarketable, and had much to lose since they've damaged their reputations.

Vioxx was a case of a pharmaceutical company trying to make a buck on a potentially dangerous product. This incident is just a case of people fucking up.

[pansypoo53219]

5. i was a former guinee pig

and wound up with the placibo, which turned out was the best option for that study. whoo hoo!

but the study seemed quite safe to me.

[bleedingheart]

10. I can just see the commercial for this drug now..."may suffer from dry

mouth, or loss of fingers.."

I feel bad for the guy ...I find that volunteering to be a guinea pig very scary...