Clinical trials

Actually, it’s part of normal proceedings for trials – I might not agree with it but that’s how it is. Fluvoxamine is an SSRI for depression and alosetron is for irritable bowel disease. I don’t know much about these two drugs or if there is a huge need to test it taken in conjunction with one another. In a nutshell:

Phase I is tested on healthy human beings. Traditionally, women of childbearing age are not included, but for depression it’s the major patient population, so maybe that’s why. Or maybe the regulations have changed. If there are no overwhelming adverse events, the trial proceeds to Phase II, which tests a group of people suffering from depression/IBD. If it is effective, and there are no unexpected side effects, Phase III then tests patients in two arms (drug vs. placebo) using a (randomized) controlled trial protocol, where people with depression/IBD are either given both drugs or just fluvoxamine with a placebo instead of alosetron.

Phase IV is actually when the drug goes onto the market and they sell it to you … it’s usually pretty safe by then. By definition that’s Phase IV, it doesn’t mean the drug is unsafe, so don’t freak out! Then again, there are drugs which have been withdrawn because the trials don’t test sufficient numbers of people before going onto the market and things happen.

But before taking a new drug it’s always good to look at the trials if you know how to find/evaluate it. The thing is most drugs are sponsored by drug companies so the results may be biased.

I’d say that Bev was asked to participate in a Phase I trial which is the riskiest. Don’t recommend it. I wouldn’t take any drugs I don’t need, paid or unpaid.

Danae.

Clinical trials

Actually, it’s part of normal proceedings for trials – I might not agree with it but that’s how it is. Fluvoxamine is an SSRI for depression and alosetron is for irritable bowel disease. I don’t know much about these two drugs or if there is a huge need to test it taken in conjunction with one another. In a nutshell:

Phase I is tested on healthy human beings. Traditionally, women of childbearing age are not included, but for depression it’s the major patient population, so maybe that’s why. Or maybe the regulations have changed. If there are no overwhelming adverse events, the trial proceeds to Phase II, which tests a group of people suffering from depression/IBD. If it is effective, and there are no unexpected side effects, Phase III then tests patients in two arms (drug vs. placebo) using a (randomized) controlled trial protocol, where people with depression/IBD are either given both drugs or just fluvoxamine with a placebo instead of alosetron.

Phase IV is actually when the drug goes onto the market and they sell it to you … it’s usually pretty safe by then. By definition that’s Phase IV, it doesn’t mean the drug is unsafe, so don’t freak out! Then again, there are drugs which have been withdrawn because the trials don’t test sufficient numbers of people before going onto the market and things happen.

But before taking a new drug it’s always good to look at the trials if you know how to find/evaluate it. The thing is most drugs are sponsored by drug companies so the results may be biased.

I’d say that Bev was asked to participate in a Phase I trial which is the riskiest. Don’t recommend it. I wouldn’t take any drugs I don’t need, paid or unpaid.

Danae.

Yikes

I think I’d rather be depressed than have those “discomforts!” Hee hee!