Drug Trial - Fiasco?

[jayuk]

Has anyone been following this drug trial mishap that has occured over the past week?

I was reading an article today, and jeeez! once the drug was administered the reactions and what kicked off must have been some seriously scary stuff!!.....

I think this has Compensation written all over it!....but still extremely worrying!!

http://www.in-pharmatechnologist.com/ne ... on-phase-i

J

[GarethB]

I know of drug comapnaies that have promised the earth with new wonder drugs that have failed to deliver and it has nearly bankrupted the company.

The two involved are not what you may call major pharma's so regardless of compensation claims they are fighting for their own survival.

I know many of the large companies have thier lawyers and compliance people keeping a close eye on what is happening. Incidents like this will mean tougher restrictions on the pharma companies. Of course by the time all the evidence is in and changes implemented the general public and media would have forgotten about it.

History within the industry shows that some good will come from it in that monitoring and regulation will be a lot tougher and further safeguards will be put in place once we learn what went wrong.

[jayuk]

Gareth

Agreed, but with the additional red tape it does make me wonder whether we have now delayed the advancement of medicine?.....whilst I agree that this should NEVER have happened, and I think there are some fundamental questions that need to be asked and answered; I really dont think that the developer of the drug had the experience and knowledge of how to approach the testing phase (although I do understand the testing was given to another contracted company)

But as with all events, there are some tough questions that do get asked; such as Should the people that agreed to the trial and signed away there right;be entitled to any compensation!...and its when we get to these questions that things get a little tough!

J

[Val G]

If there has been any negligence in these trials it obviously needs to be adressed, but this is a risky business these people are in and there are always going to be a minority of unforseen reactions. I agree that this incident will have a detrimental effect on development of drugs in the future and many people many suffer the consequences.
I regard myself to be an extremely conscientious professional, I work in a Biochemistry lab. In this compensation culture we live in, I work in the dread that I may put out a result that is incorrect and may have a negative effect on someone, despite all precautions. I feel it will not be the thousands of useful test results I produce a year, it will be the one erroneous one. It is all scientific experimental work, not Magic!
I wouldn't encourage my children to go into medicine or similar, I have colleagues that feel the same, because you are putting your neck on the line in your desire to help people, the responsibility is huge. Thankfully there are people willing to take this responsibility but we must remember thay are only human and should not be blamed if errors are made, this is not always negligence.

[Sweet]

Yes i have been following this closely. multi organ failure is life thretening and i really feel for the relatives concerned. To the people involved they saw this as a quick way to make some money but sadly it has all gone wrong. However drugs are tested every day with no bad events so i do hope that this doesn't stop because of this. If people didn't test drugs we would fall short on new medicines being used in the future.

I am not too sure about compensation and am hoping that the relatives are not thinking this at present. Right now the patients need to be well, the last i heard two are reponding to treatment. I know the one who was given a dummy drug stated that the risks weren't given but you are hardly going to take a drug are you if they printed that there was a risk that you would die! So as with most things compensation is a major battle ground and i wouldn't be thinking about it right now. Strangely enough as emotional stress ranks higher than death in negligence claims i suppose the relatives have a higher chance of getting more money. But i would feel sad if the only thing that came out of this was a claim for compensation, there is much more to life than money.

Sweet X x X

[jayuk]

Sweet

I do agree with you, however from what I read this morning, the trial patients have already engaged with Lawyers to launch a case?!?!..So I would be very surprised if some form of compensation was not given......

J

[Sweet]

Hhmm ok, so are they are out of the woods now and getting better? Am not following the news much lately as the tv can be so dam annoying when you can't see it!!

[jayuk]

Sweet

I am led to beleive 4 of the patients are now awake and concious , however one is still in Coma and may not actually come round for upto a year (how they can determine this I dont know)

J

[Andrew MacLean]

I have been following the story with interest.

I am not sure that it is fair to say that there has been a fiasco. An enquiry will determine that.

What is clear is that human trials are a necessary pre-requisite of a medicine being licensed for use. the purpose of these trials is to find out if there are contra-indications that would make the substance un-usable.

I'd say that these trials had succeeded in identifying contra-indications.

There are questions around the way the trials were set up; was there informed consent, was the substance preoperly administered, were there any contaminants present ... and so forth. These questions will doubtless be addressed in the enquiry.

In the meantime there is a human tragedy unfolding. I hve no doubt that from all sorts of points of view this story has a long way to go.

Andrew

[Sweet]

Hopefully the forthcoming investigations will be able to identify what went wrong. Am just hoping that they all make a full recovery.

Sweet X x X