Drug Trial (Again!).

[flip-flop]

I didn't think it would take long, and I'm not disappointed.......the compensationwallahs have started circling already.

Now, on the assumption there is NO negligence involved here and as these people were paid and without doubt signed a liability waiver, should they be compensated?

I have had a number of injuries over the years on the Rugby field, but from my O Level Law days I seem to recall this is classed as consent (volenti non fit injuria or some other latin cobblers if memory serves): wouldn't the drug tests also fall into this category?

[jake-the-peg]

I think you hit the nail on the head when you say on the assumption that NO negligence was involved.

That might seem a big assumption given the violence of their reaction and the speed of it but hey I'm not a reseach biochemist.

I would imagine that any compensation claim would have to be based around an accusation of negligence.

[WaldoMcFroog]

Agree with everything Mr Peg says. These people are bound to have pretty tight contracts in the first place, and I doubt there's much chance that they will get anything unless negligence is proved.

I note in the papers this morning that one of the (the only?) bodies that represents drug testers has implied that administering all six injections simultaneously was not the brightest idea - and given that the adverse reaction began roughly five minutes afterwards, you can see why. So perhaps there is a case for negligence.

As was pointed out by people who have worked in the field on the other thread, this is a very unusual occurance and we shouldn't assume that one extreme example is indicative of, dare I say it, 'Drugs Testing Gone Mad'.

Take from that any subtext you wish...

[morg_monster]

They will be compensated without having to prove negligence. When they agreed to participate, a clause in the consent form will have said that the company can compensate them without necessarily having to accept liability for negligence. Of course, if negligence is proved, then they'll probably get even more compensation, but if it just turns out to be a random event they will still get money. The company will have huge insurance and this is what it is for. This is standard in these kind of trials.

[nikita**]

THe clinical trials did not follow the correct procedures. Negligence IS involved. Possible death and not just side effects are at issue. Apparently the drug involved went through animal testing first. Just shows how our bodies work sooo differently to animals in many ways.

:- ( People who 'have nothing to lose' are exploited.

(The Constant Gardener shows some insight into how the multi-million dollar drug industry work in a very corrupt way.)

[morg_monster]

How do you know it was negligence, nikita? do you have inside information? because at the moment there is no news to this effect. So far the inquiry hasn't reported what happened.

If it turns out to be a completely random effect that could not have been predicted, if no errors were made during the pre-clinical lab and animal testing of the drug, and no errors made during administration of the drug to the men, if all the professionals involved treated the patients to the letter of the law and to the best of their abilities, then it is not negligence. If something went wrong, if someone made a mistake, if someone ignored protocol or skipped testing steps, then it is negligence.

It isn't negligence purely because something terrible happened. Its great to have someone to blame for things but just occasionally there is truly no-one to blame. Lets wait til all the facts are in before we start accusing people.

By the way, the Constant Gardener is fiction. Of course there are pharma companies who have acted very dubiously in the past - but do your own research on it, don't just rely on a film for your information! Not all pharmaceutical companies are corrupt! Think of all the good they do as well.

[nikita**]

Constant Gardener is based on a true story. A large number of companies are corrupt. You must live in the dark ages. Pharmaceutical Drug Racket: International bribery and corruption, fraud in the testing of drugs, criminal negligence in the unsafe manufacture of drugs - the pharmaceutical industry has a worse record of law-breaking than any other industry and that is a fact whether you like it or not.

The latest news so far today: That they DID not follow the correct procedures and looking into it.

I feel sorry for the men. It amazes me how cold people are.What is human life worth to you? not much? expendible? Maybe you should give it a go.

[Oneeyedvic]

"Constant Gardener is based on a true story" - well actually the film is based on a 'novel' by 'fiction' author John Le Carre.

[nikita**]

Oneeyedic - you keep following me on this site.

Here is an example of another: "The truth has finally come out about Vioxx: insider emails published by the Wall Street Journal reveal that Merck, the maker of Vioxx, was fully aware of the health risks of its COX-2 inhibitor anti-inflammatory drug as early as March, 2000. As is apparent from the published emails, there was a concerted effort to bury the negative evidence and even distort the drug trials by excluding heart patients from the Vioxx studies so that, "...the rate of cardiovascular problems for Vioxx patients would not be evident."

Why do you stand by corruption?

[nikita**]

"Scientists are accepting large sums of money from drug companies to put their names to articles endorsing new medicines that they have not written - a growing practice that some fear is putting scientific integrity in jeopardy."

" Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed....".

British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children's Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities......"

"Vast numbers of dead, the compromising of key elements within the medical community and its regulatory structures, the blind pursuit of billions of dollars in corporate profits -- all have surfaced in a detonating pharmaceutical industry scandal of global dimension" By Ritt Goldstein.

But we are just 'little' people to the companies who 'play god'.

[morg_monster]

nikita - i said i know the the pharma industry has "acted very dubiously", and I know at the end of the constant gardener there was a comment from John le Carre saying something like 'this isn't directly based on true events but my research into the industry leads me to believe that the story depicted in this film is actually rather tame'.
All I was actually saying is that your argument sounds better if you are able to refer to actual events rather than just saying 'go see this film'. I'm by no means denying that these events have actually happened - I know they have - but John LeCarre says himself that the story in the constant gardener is not based on true events, even if worse things have happened.
How dare you say I am cold, and do not value human life. You don't even know me. I feel awful for these men! I can't imagine what it would be like if it was someone I was close to. For goodness sake! I did not see that they have reported incorrect procedures had been followed, my news source obviously isn't as up to date as yours. All I said was - lets not jump to conclusions in this particular case. There is no need for a personal attack.

[morg_monster]

The problem is, aside from corruption and unethical practices in the pharma industry, we'd all love to get rid of animal testing and manufacture perfect, side effect-free drugs. But the fact is, when trying to ease diseases like cancer, rheumatism etc, to have a strong enough effect on the human body to cure or ease these diseases, the drugs are bound to have bad side effects. At the moment, I really think that the systems in place are the best available options at the current time for developing drugs. We can't stop testing potentially life saving drugs just because of this one terrible event, although procedures of course will have to be reviewed. I have seen family members die from cancer and cystic fibrosis and am so thankful for the drugs they took which prolonged their life and improved their quality of life. I also am thankful for the men who initially were brave enough to test those drugs way back when.

[morg_monster]

sorry we cross posted nikita - now your argument sounds much better!

I'm just not sure that corruption is directly involved in this particular incident - surely corruption would be if we had never heard about this event, if the families had been quietly paid off and they carried on testing the drug. That sounds like what might have happened in other events - at least some of this is out in the open.

this kind of thing would happen far more frequently if we didn't test on animals - its not perfect by any means but its better than any other option we've got at the moment, surely.

[nikita**]

"STOCKHOLM, Oct 4 (IPS) - Vast numbers of dead, the compromising of key elements within the medical community and its regulatory structures, the blind pursuit of billions of dollars in corporate profits -- all have surfaced in a detonating pharmaceutical industry scandal of global dimension.

The suicide deaths of numerous young people, despite the existence of information that could have precluded them, sparked the revelations. But a far broader, systemic and devastating problem has emerged regarding the full spectrum of newer prescription medications.

Drug Industry Scandal a 'Crisis'
Ritt Goldstein

[nikita**]

"SSKRP ATTORNEYS IN THE NEWS


By Mary Papenfuss
Dec. 9, 2002A growing number of medical researchers have a financial stake in the experimental drugs they administer. The resulting conflict of interest can be decidedly unhealthy for their patients.

Five years ago, terminal cancer patients were given hope that a longer life -- possibly even a cure for the disease -- could be within reach. Researchers at several hospitals, including the M.D. Anderson Cancer Center at the University of Texas in Houston, were conducting trials on what was being regarded as something of a cancer wonder drug -- an agent that appeared to successfully block a growth factor that turns cells malignant. Abdominal tumors nearly disappeared in a 28-year-old Miami woman taking the drug.


But this year the Miami woman died, months after the federal Food and Drug Administration rejected the application for the drug's approval, saying some clinical tests designed by the manufacturer had flaws that failed to prove the drug's effectiveness. "

[nikita**]

No, I don't believe it . What,corruption, the bio med companies? Never.

[nikita**]

"The integrity of clinical trials has come under increasing scrutiny since a series of safety measure meltdowns and deaths during research trials at some of the top medical institutions in the country. Among the factors in at least some of those tragedies is the link between research and corporate funding."

[nikita**]

"Nonee Walsh: John Le Carre could have written this story. There are millions of dollars at stake, attempts to suppress information about potential dangers of drugs, double dealing, children being taken off medicine, anonymous hate mail, culprits identified by DNA and plenty of court action.

But it�s really about the supposedly mundane issue of drug trial ethics and academic freedom. Though there was nothing mundane about the consequences for Canadian blood disease specialist, Dr Nancy Olivieri when she identified a potential medical risk in a drug trial."

[nikita**]

"Norman Swan: Nonee Walsh with that remarkable story, which clearly isn�t over yet. And the issue of independence in drug trials is alive and well in Australia. And it�s hard to get people to talk about it because they don�t want to jeopardise their future grants."

[nikita**]

I am not anti-clinical trials but unfortunately there is an ethical side to all of this.

[nikita**]

Asia Times reports: "India increasingly emerges as a preferred destination for outsourcing clinical trials - testing of new drugs on humans - the country may also be heading toward providing the greatest source of human guinea pigs for the global drug industry."

"Africans should not be silent about unethical trials
Vaccine trials centre in Africa
24 June 2005
Source: African Journal of Neurological Sciences

African scientists should not be silent when unethical trials are conducted in their countries, says .....
A quarter of all clinical trials are now done in the developing world, but often the research lacks a rigorous ethical framework. "