| Product: |
Clinical trials |
| Date: |
28/12/01 (146 review reads) |
| Rating: |
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Advantages: New treatments available, Betters the best!
Disadvantages: Time taken to do them., Paperwork for poor doctors.
Right, time to get back into "work" mode, stop writing ops on all my rather excellent Christmas presents, and add my views on this controversial issue.
Trialling new drugs, to me, includes pre-release human testing. I've had personal experience of this, as an impoverished student, when I attended Glaxo (now merged with Smithkline Beecham) on 6 consecutive weekends and got paid £600 to stay overnight having blood tests, urine tests, eating certain foods and drinking either the new drug or a placebo.
Actually, it has concerned me a little. Apparently, the drug in question was a cholesterol-lowering one, which means the liver is the most likely affected organ... and since then, my alcohol tolerance has dropped considerably (although that could be to do with me not being a student any more..)
Anyway, back to the point. So, the drug has been tested in a lab, tested on animals (more than likely, but this isn't the time or the place for a debate on that), tested on people. Then it is released. And that, usually, is where trialling comes in.
The way I see it, clinical trials take place all the time. As a GP, I see drug reps several times a week, and they all try to persuade me that their drug for condition X is better than their competitors. So what do I do? Do I ignore it? Or do I swap everyone across? Or do I try a few of my patients on the new brand, see how they get on, and draw my own conclusions? Correct me if I'm wrong, but wouldn't that seem the sensible option?
The big, official drug trials are a different matter. As the frontline, us poor GPs are told what to do - we have no input into who gets what and why. All we do is figure out who is eligible for the trial, and OFFER them the chance to be in it. No-one is ever put in a big trial without express consent. Not any more. It's too risky.
Back in the good old days, I agree, people were trialled on a regular basis with placebos. But al
l trials have to be passed by the Ethics Committee, and if there is already a recognised treatment for something, it is unethical to withhold treatment. So most of the big trials going on at the moment are either "adding" something to existing treatment, or giving 2 groups 2 different treatments - the "gold standard" traditional one, and the "trial" new one. I can't think of a trial being performed in our practice currently where patients are being given sugar tablets.
The Ethics Committee is actually fairly strict about this sort of thing, and, with all the advances in medicine, many conditions do have a "cure" or recognised treatment.
It's a different matter, of course, for conditions with no known treatment. As a personal example, I present my mum...
Mum has malignant melanoma. It was excised, but it had spread to the pancreas. The pancreas was taken out, and at the moment, she is in remission. But with melanoma, there is no "cure". No radiotherapy, no chemotherapy. Nothing. So she's attending St George's Hospital in London (my old university), being given a trial of either nothing, or (believe it or not) inactivated tuberculosis! This will be a long trial, but basically the participants have nothing to lose. It's nothing, or try this! So, in that situation, I'd give it a try - and I guess many of you would as well.
So, my point?
I'm very concerned, particularly within the current media hype of "evil medicine", that public perception of doctors is not very good. When we qualify, we pledge under the Hippocratic Oath to do no harm. No trial is performed secretly, no trial withholds an effective treatment if one is available, and no trial is performed unless necessary.
Many trials have actually been cancelled half-way through, because it has become rapidly obvious that the new treatment is so much better, it would be unethical to con
tinue trialling it.
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Last comments:
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- 16/01/02 That was very interesting reading. At the end of the day I suppose they have to tried on humans at some point.I think the "guinea pigs" should be made very aware of any possible repercussions. Then it's up to them whether or not to go ahead. Great op.Kim |
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- 29/12/01 I remember back in the 1970's signing up for some clinical trial or other to test some new drug for cholesterol manufactured by some Swiss company.
At the time, I was a "practicing" alcoholic, and the money was very attractive.
But no checks were carried out on my medical background, and I was accepted into the trial without question. I took place in a residential clinic, and most of the "trialists" were either alcy's like myself, or junkies.
Some might argue that the company were testing the drug out on "lesser" human beings, but I've thought a lot about this since, and it does strike me as highly unethical on the part of the medical authorities. Maybe things are done differently now; I certainly hope so!
Also, I agree very much with nikkisly. I ALWAYS question doctors as to what exactly they are prescribing for me, and wont take it until I understand fully the answer they give me.
But I do agree with trials, otherwise medicine would never make any advances.
A good read. Thanks.
Ken |
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- 29/12/01 I think a lot of the problem lies at the hands of the media. People are much 'better educated' nowadays, having read their newspapers and watched TV documentaries that focus largely on the cases where things do go wrong, thus not presenting a balanced viewpoint. Some of the psychological experiments performed in the 1960's (eg Milgram) would never be allowed now because of ethical concerns.
Hope things go well for your Mum. (A friend of mine had the same condition and my husband actually asked her with great concern how her "malignant meglomania" was.) |
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