Seriously ill volunteers after clinical trial treatment

[Rolfe]

Rolfe, I could be wrong, but everything I've read indicates that these sorts (type I) of trials are often done on the very ill, i.e. an cancer drug might be given to someone with advanced cancer who has exhausted most treatment options. The original link led me to this which confirms this.

Christine, since every single report of this incident has referred to these men as young and (previously) healthy, I don't know why you're pushing this one. This article for example.

Healthy volunteers are used to test the safety of the drug in "phase one" of the trial before further tests with people who have the condition to determine whether the drugs work.

There's no question that these were healthy volunteers.

This article mentions that this phase of trialling is sometimes done on people with a medical condition, but usually it isn't.

This student, who helped recruit one of the victims, and was himself scheduled to take part in a later round of the testing schedule, is obviously healthy.

This guy, who is perfectly healthy, says he makes about £13,000 a year doing drug trials, one every 3-4 months.

The guy who was in the placebo control group, interviewed on TV several times last night, was obviously young and healthy.

Discussing the chances of the sick men, a spokesman for the MHRA said on TV last night that the fact they were young and healthy was a big factor in giving them the best possible chance.

Sorry to belabour the point, but there's no question at all that the men involved were young and healthy, and that this is the usual situation for trials of this type. Misinformation really isn't helpful.

Rolfe.

PS. Apparently the drug involved had been tested without incident on monkeys (and rabbits).

 

[Abooga]

Well, I almost took part in a clinical trial, a few years ago, in Manchester. I couldn´t do it because I didn´t get some paper from my doctor in time, so I missed the chance to get some easy money taking large doses of Vitamin C. Pretty inocuous, I thought. Well, about a year later I read about some study that linked a higher risk of cancer to overdoses of vitamin C... hummmm...
My girlfriend took part in one of these trials, taking antihistamines (hay fever remedies) for about a month. The study finished and she was never called back to check for long (or even mid) term effects. Strangely enough, she developed hay fever the year (spring) after she did the trials! But that´s never going to show up in the results of the clinical trials, is it? This (and the case of a friend of mine taking some sort of antidepressants) left me with a very suspicious feeling toward clinical trials and the way they are carried out. See, I´m a skeptic when it comes to modern medicine too, because of those experiences, mainly. This site is great in debunking charlatanism and false practices, but gives an image of "how great is modern science and medicine", and in my opinion we should be very careful about them too. Science calls for extensive tests and trials to establish the validity and innocuity of (in this case) medicines, but that´s expensive. Pharmaceutical companies need these trials to be as cheap as possible. So there is a certain clash of interests here, don´t you think?
I see there are some proffesionals of medicine in this forum. What are your thoughts about this? How can we trust medicines to be safe?

 

[Capsid]

The regulations for conducting clinical trials are very stringent. Although there are no guarantees for medicine safety, the risks are minimised through the licensing process so that they are outweighed by the benefit.

 

[ChristineR]

There's no question that these men were healthy.

 

[Abooga]

CAPSID wrote: "The regulations for conducting clinical trials are very stringent. Although there are no guarantees for medicine safety, the risks are minimised through the licensing process so that they are outweighed by the benefit"

Oh well, if that´s the case then everything´s allright. How stupid of me to doubt !

 

[geni]

Computational toxicology is a pipedream right now, and it will be for the forseeable future.

Modelling Absorption, Distribution, Metabolism and Excretion (so-called ADME), is hardly any better. There's just not enough data.

I was more think of looking for molecules that were the right shape for bonding to the target receptor.

 

[JamesM]

I was more think of looking for molecules that were the right shape for bonding to the target receptor.

I agree that that can be done with a higher accuracy - hardly stellar performance, but probably better than random selection of molecules. It can't be used for ADME/Tox prediction, though, except perhaps in some limited way with X-ray structures for cytochromes P450.

 

[Camillus]

I have recent personal experience with the German drug testing firm Parexel that put these people in the hospital.

Parexel is a US company based in Massachusetts.

The company who developed the drug at the centre of the problem, Tegenero, are German.

 

[Rolfe]

I think it's important to bear in mind what is and what isn't a clinical trial. This wasn't, it was a pre-clinical trial. Looking at the pharmacokinetics and for minor side effects and so on, just to see how the drug is handled by and tolerated by the human body. Nothing to do with efficacy.

Only later would it move on to the actual clinical trial, using patients suffering from the disease it's meant to treat, to see whether it actually performs. A lot of people have been calling this a "clinical trial", but strictly speaking, it wasn't.

Rolfe.

 

[Abooga]

Did anyone notice my question? Is it irrelevant? why?
I said:

"Science calls for extensive tests and trials to establish the validity and innocuity of (in this case) medicines, but that´s expensive. Pharmaceutical companies need these trials to be as cheap as possible. So there is a certain clash of interests here, don´t you think?
I see there are some proffesionals of medicine in this forum. What are your thoughts about this? How can we trust medicines to be safe?"


And nobody seems to give a ◊◊◊◊ about it...
Well, it just surprises me. I expected a higher level of skepticism in this forum...

 

[Asolepius]

Rolfe, I could be wrong, but everything I've read indicates that these sorts (type I) of trials are often done on the very ill, i.e. an cancer drug might be given to someone with advanced cancer who has exhausted most treatment options. The original link led me to this which confirms this.

Oncology trials are an exception. This is because most orthodox cytotoxic drugs are so toxic that it's unethical to give them to healthy volunteers. This is a phase I clinical trial. Even though the word clinical implies patients, it's the word used by everyone to mean studies in humans, including healthy ones. It is most likely a single ascending dose study, with each of 6 subjects getting a different dose and 2 getting placebo. Randomised and double blind usually. Biologic drugs like this one are not cytotoxics so volunteer studies are usual in phase I.

I read that studies in monkeys were done (BBC News). I work in phase I currently and I think a dosing error is unlikely. Dosing is checked by 2 people usually, and I normally attend to observe the first dosing day. Not much point in speculating further without hard info.

 

[Rolfe]

Abooga, the reason nobody's discussing your paranoid fantasies is that most people know enough about the real situation to find such discussion pointless. The one thing that scares pharmaceutical companies witless is an incident of this nature. I'm sure you can understand why.

Rolfe.

 

[Asolepius]

Did anyone notice my question? Is it irrelevant? why?
I said:

"Science calls for extensive tests and trials to establish the validity and innocuity of (in this case) medicines, but that´s expensive. Pharmaceutical companies need these trials to be as cheap as possible. So there is a certain clash of interests here, don´t you think?
I see there are some proffesionals of medicine in this forum. What are your thoughts about this? How can we trust medicines to be safe?"


And nobody seems to give a ◊◊◊◊ about it...
Well, it just surprises me. I expected a higher level of skepticism in this forum...

I have only just dived into this thread, so apologies for not replying sooner. Firstly, I hate the word `safe'. Nothing is safe. All you can have is an acceptably low risk. Anyone who thinks medicines can be without risk is in cloud cuckoo land.

WRT costs of trials, no the companies don't want trials to be as cheap as possible. They want them right and on time. The damage of lateness commercially is vastly more than the saving by choosing the cheapest option. I work in phase I right now, have been in the industry for over 30 years, and know this at first hand. Drug development takes up to 10 years, and you only get 20 years patent life so lateness costs money. You can trust medicines to have been tested to the limit of what's humanly possible, by and large. Unless you have seen it happen, you would not believe the effort that goes into collecting and processing drug safety data by the companies. It's a process that doesn't stop until the drug comes off the market, usually via retirement. Drugs are no different commercially from any other industry (other than being very high risk). Cars kill people as well, so if there's any clash of interests it applies to them also.

 

[Abooga]

Thanks a lot Asolepius for your reply, that´s what I was looking for. I don´t think, as Rolfe says: "most people know enough about the real situation to find such discussion pointless". The general public doesn´t know much about drugs testing. Paranoid fantasies? What are you saying, Rolfe? That one should never question the holy methods of modern science? "Let the scientists to it, they know best"?
I seem to recall that many scientists question the validity of some antidepressants. There was a case a few years ago that made it to the newspapers about some anti-anxiety pills that caused a lot of discomfort and dependency on the users. And those pills had passed the tests...
I mean, I´m the first one to use modern western medicine (thank f*ck for antibiotics) but.. what if you are one of those unlucky anxiety sufferers I mentioned? A friend of mine was one of them and he had a bad time coming off that drug.
And, Asolepius, I understand it is in the interests of pharm. companies to produce good drugs. But their first and foremost "raison d´etre" is making money. And, well, since I´m not one a "neoliberal" this will always make me a bit unconfortable.
Do I make myself clear? English is not my first language, pardon me if I write a bit odd.

 

[Hellbound]

Another point to Abooga:

These trials you were a part of are the initial, short-term trials. They aren't looking for long term effects. That comes later with the stage 3 trials and the continuing post-approval re-examinations that are required by law.

The reason you didn't get a response is because you could have answered your own question with 5 minutes on Google, or even by reading the articles that have been linked in this thread.

Most of us don't mind leading a horse to water, but we aren't going to hold it's head up and funnel water down it's throat. If you can't take 15 minutes to find out how drug trials are actually conducted, you're the last person to be giving anyone lessons about being skeptical.

 

[Abooga]

I know, I´m always suspecting big conspiracies around me. But there are so many krazy conspiracy theories, that SOME OF THEM MUST BE TRUE! Don´t you think?
Yes, you have a point there, huntsman, but it might take more than 5 minutes for a properly satisfying answer. And I got answers in this forum real quick, from proffesionals, first hand and charged with delicious superciliousness!
It´s more fun this way, but pardon me if my intrusion made you waste some of your precious time. I´ll shut it now.

 

[Rolfe]

Funny thing is, we all need money to eat and pay the bills and so on. Does that mean that we're all doing the most sketchy job possible with no thought for the consequences? Does being paid bypass all instincts of social responsibility and professionalism and sheer pride in the job? Do only charities try to do a good job? Wow, I'd better find a motor mechanic who doesn't work for money, because if he's working for money, then how can I trust him to make my car as safe as possible?

Everybody has to make money, otherwise they'll go out of business. To leap from that to the assumption this means that there is no conscience, no thought for safety, and no desire to act professionally and responsibly, is a very big assumption.

Abooga, I'm beginning to assume that you must be one of those people who puts as little as possible into their job, and doesn't care if it's done well or not, because it's only about the money, isn't it?

Please don't assume that everybody else is like that.

Rolfe.

 

[Abooga]

"you must be one of those people who puts as little as possible into their job, and doesn't care if it's done well or not, because it's only about the money, isn't it?"
Well, to some degree, yes, since I should be doing work right now, but it´s friday and I can´t be arsed.

Now seriously, I don´t trust the "conscience" of big corporations. And I don´t trust the conscience of many people either. I know a bit about the inner workings of local politics and, ... man, there are some real bastards out there who really think only for themselves and how to do the greatest evil possible to those they don´t like!.
I don´t want to get in a political debate but this reminds me of those "newliberalism" versus "commie" kind of debates, and I guess that for american standards I´d be a bit of a commie, I don´t trust economical forces produce a good equilibrium that will protect the weakest members of society... yawn... old topic, forget it... maybe some other time.

I think you get my point.

 

[Asolepius]

And, Asolepius, I understand it is in the interests of pharm. companies to produce good drugs. But their first and foremost "raison d´etre" is making money. And, well, since I´m not one a "neoliberal" this will always make me a bit unconfortable.

So the market economy clashes with making good drugs does it? How many major drugs ever came out of the communist bloc? Go on, name one.

 

[Elaedith]

Paranoid fantasies? What are you saying, Rolfe? That one should never question the holy methods of modern science? "Let the scientists to it, they know best"?

That statement seems odd. If it were true that companies wanted to cut costs by avoiding testing it wouldn't be the fault of science. In fact any problems caused by inadequate testing would reflect the lack of scientific methods, not the use of them.