A drug company was doing trials on humans and unexpectedly the drugs had a dreadful effect, all six who were given the drug ended up in intensive care, two are in a critical condition, the other four are seriously ill. Two were given placebos and are fine.

As it is an American drug company one hopes they will be generous in compensation payment although I assume the men will have had to sign some form of risk acceptance agreement prior to the testting, but that is only my guess, not a fact.

BBC News website

This article talks about the lack of compensation payments - not looking good.

BBC News

This isnt an American drug company, it is an American owned contract research organisation who carry out trials for different drug companies worldwide in all Phases of drug discovery.

The drug supplier is a small German biotech drug discovery company. They will have found the antibody and probably (as they will not have their own manufacturing facility for upscaling enough product for a trial) have had the entity made at another outsourced manufacturer. Not an unusual occurence even with larger biological drug pharma companies.

Phase I trial approval is only given after extensive applications to the country involved Regulatory authority (MHRA in the UK, FDA in the US, etc) and then once they have this approval, it has to go before a local ethics committee for the clinic or hospital involved in the trial. Ethics committee's solely have the interests of patients as their main driver and will often refuse permission for a trial to be carried out.

I have been involved in several Phase I trials for my company and please be assured that the most stringent of conditions are applied.

We have never used Parexel, but there are many companies out there who are well regulated, audited by regulatory authorities, and carry out their work with the highest integrity.

I would not like to hazard a guess at what has happened here, but possibly contamination of the drug antibody during manufacturing or preparation stage. The dosing for first patients would have been extremely low, and much lower than any doses they had tested in pre clinical animal studies.

Patients taking part in a Phase I trial are not all students, and should have been given excellent information before they gave their informed consent. I think that some are so keen on the financial reward of expenses, that they may not read the information they are given carefully enough.

Testing of this investigational drug should have taken place at all stages of its preparation and lets hope that the findings are quickly resolved.

Although this particular drug will now be banned, there are many similar biologics in testing and this will certainly make waves across the industry. Quite rightly so.

On the news this morning I heard that one of the men could be in a coma for a year.

The lastest in this story is that one of the men concerned is testing positive for some abnormal cells in his blood, an early indication that he could be going to get cancer. It is not known if the drug was the cause. I guess that unless the others also get cancer then it will just be a coincidence.

BBC News

This story follows on from this one which says that four of them have been given an interim payment provided they do not sue the company.

I have always felt that people who agree to participate in drug testing trials are agreeing to be used as human guinea pigs, including exposing themselves to any possible risks and side-effects. That's part of what drug testing is all about.
Whether the drug manufacturer should, or will, compensate a person for any deleterious side-effects is something that should be noted in the contract or release form the person signs prior to participating in the trials. People should never sign anything of that sort without first making sure that they fully understand it.

Apart from some sort of negligence on the part of the drug manufacturer, or some failure to disclose information, I'm not sure I would hold the drug manufacturer legally responsible for any side-effects which might occur doing testing trials. However, if something horrific, and totally unexpected, occurs, the drug manufacturer should feel some moral obligation to offer compensation.

Not only should people be cautious about participating in drug trials, they should also be cautious and informed about the medications their doctor routinely prescribes, or medications which they request from their doctor. Thanks to a barrage of TV advertising by drug manufacturers in the U.S., we now have people directly requesting specific medications from their physicians, and some of these can have quite harmful side-effects (hastily listed at the end of the commercials).
For instance, I note that the drug in the UK was an anti-inflammatory agent. At least several times a week here I see a commercial for a drug to relieve rheumatoid arthritis (I can't remember the name of the drug). The commercial emphasizes how much better one's life will be if you take this drug. Then, at the end, a voice rapidly says that serious rare side effects, including fatal infections and lymphoma, can occur with this drug. Hell, I'd rather suffer with rheumatoid arthritis than risk those side-effects. But other people might be willing to either ignore the warning, or take the risk. If they then develop lymphoma, or a fatal infection, should the drug manufacturer have to compensate them or their estate? Personally, I think not.

If you look up information on anti-inflammatory agents, similar to those used in the UK study, I think you will find very serious side-effects noted--for drugs already on the market. Drugs of this type can carry serious risks, and the benefits must clearly outweigh the potential risks for people who take these drugs. People should either inform themselves about potential side-effects, or ask their physician or pharmacist about them, before they take any drug, for any medical condition.

Sometimes things go terribly wrong during a drug trial, as was the case with the study in the UK. If these effects could not have been reasonably anticipated, and no negligence was involved, and trial subjects were duly informed of all possible known risks, then I'm not sure the drug manufacturer is legally responsible for damages. But, morally, as a gesture of good will, and to insure that people might be willing to participate in future trials, they should try to offer some compensation.

People must always understand what they are getting into when they volunteer for a drug trial. If they can't understand it, they should ask their own doctor or a lawyer for some advice and guidance. Obviously, one purpose of the drug trials is to ferret out side effects of these drugs. People should clearly understand that before they agree to participate.

It is very tragic when something so devastating occurs. No one wants to see something like this happen. The question is, why did it occur in this case?

Presumably, by falling victim to serious side effects, they've saved the drug company from potentially massive future compensation claims. It would be nice to think the company might recognise this, and award suitable compensation. Considering some of the court awarded compensation payments for relatively minor injuries and inconveniences, it should not be too difficult for these volunteers to make a successful compensation claim - though that would be 'justice', not 'law' so maybe not!

Hey I just noticed this my 1066th forum post - 'Remember the Battle of Hastings'!

aramis--They haven't spared the drug manufacturer from future claims. Obviously, with side effects like this, this drug will never reach the market. And, unfortunately, that's one purpose of the drug trials, to see what, if any, side-effects occur. Future, after-market, claims of harm are not that troublesome for the drug manufacturer if they could not have been anticipated from the trials, and if the drug manufacturer continues to disclose all side-effects reported once the drug is in use. At some point the consumer (and the physician) becomes responsible for knowing all disclosed risks.

I think that until an investigation occurs, to figure out why this happened, it is too premature to ascribe any blame of negligence to the drug manufacturer. This might simply have to do with this particular drug's effect in humans.
So far, that seems to be the case:

web page

Money is really no "compensation" if one's health and one's life are destroyed. But it might be of assistance to the families of these volunteers, and the drug manufacturer is aware of the need to protect their reputation and maintain good will with the public.

Doesn't make pleasant reading.