Clinical trials are mandated for each and every drug that hits the US market. These drugs undergo a great deal of testing. First, they undergo the theoretical part (why would this drug work?), then they undergo two separate animal trials (does the drug do what it's supposed to?), and only then can they be upgraded to human trials, and only after an extensive ethical review (since they are testing on human subjects).
Phase 0 of these trials deals are used to see if the drug functions the same way in humans as it did in the pre-clinical trials. Phase 1 is done on healthy subjects primarily, though oncology and HIV trials use sick subjects as well, and are used to determine the safety of the drug. Phase 2 determines the efficacy of the drug (how well it works). Phase 3 is a much broader trial, run in various locations on various groups of people. Finally, phase 4 is post-production tests, to ensure the continued safety of the drug.
What's left unsaid about the bulk of these trials is that they often leave out whole groups of people. Why is this a problem? Well, when the drug goes to market, it often won't be given to certain people because it isn't proven to work in them, or the drug may come back with a wide variety of dangerous side effects because the interactions of the drug are different in different populations.
For instance, pregnant women are not included in these clinical trials. Why? Well, the drugs could be dangerous both for her and the baby growing inside her... it is unknown whether the drug would cause birth defects or not. The downside to this is, of course, that there are simply not drugs proven safe and effective for the diseases these women (who amount to approximately 500,000 per year) encounter while pregnant.
Similarly, there is much debate about including newborns in clinical trials, despite the fact that they too deserve evidence-based medicine for treatment. The idea of informed consent is also one that pops up frequently in clinical trials, such as these complaints about oncology (cancer) trials.
All in all, there are a multitude of ethical issues surrounding clinical trials. Below are just a few.
- Should we have human testing?
I think we can all agree 'yes' on this one, if only because without human testing, everyone puts their lives at risks when taking any sort of medication---as a side note, no dietary supplement is required to undergo this sort of safety and efficacy testing; the FDA expects the companies to do their own quality assurance testing, but it does not need to be submitted to the FDA, nor to the consumer.
- At which point can we start human testing?
This one blurs the line a little. If you're against animal testing (and there are many reasons to be against it), when should we start testing it in humans? If you're not against animal testing, at which point can we determine it's safe enough for humans to use the drug? Drugs go through an extensive screening process before they even make it to these clinical trials. For instance, some cancer drugs may spend 6 years in development before they even enter Phase 0 of the clinical trials. Since cancer drugs need long periods of time to determine efficacy, it could be decades before a cancer drug actually makes it out onto the market. I'm not sure I know the answer to this one.
- Who is eligible for clinical trials, and should they pay for the treatment?
Many insurance companies won't cover experimental treatments, that is, those that would be in clinical trials. So, is it right for these people to have to pay for their treatment? Should pregnant women and newborns, as well as the multitudes of sick people be eligible for these clinical trials in the first place? Because each of these requires treatment, it is important for them to be considered for clinical trials. After all, we are moving towards more evidence-based medicine... why should women and children (and in some cases minorities) be subjected to medications that haven't been tested for safety with their unique makeups? They shouldn't.
Thoughts? Opinions?
Read other parts of this series at the links provided: Placebo Pills, Drugs and Transplants, Medical Confidentiality, Culture and Religion, and Quality of Life.
alopathic medicine is a curse on our lives. our corrupt capitalist society adds to the evil by keeping the sick ill so that he has to buy the medication again, after consulting with the doctor again.
in our future society, we will heavily depend on herbal medicine, and organ transplants grown by using stem cells (obtained not from babies, but from other ethical ways that we will soon develop).
therefore, no ethics involved.
I would love to depend upon herbal medicine. It's a bit hard to find something to help with my asthma, however. Same with allergies. When you're allergic to nature, it can be difficult to depend upon nature to help.
And that's comin' at ya' from yer local redneck hippie.
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Ooh, ooh, pick me, pick me!!!
Many pharmaceutical drugs are more potent forms of herbal medicine. Aspirin, for instance, is a concentrated form of salicylic acid, found in willow bark. Some traditional medications are rather deadly. For instance, shosaikoto, a Japanese liver treatment, has proven deadly. The prevention of smallpox used to be to grind up the scabs and make a person ingest them. This would often cause the person to die, rather than build up a resistance. And yet, our vaccines today are remarkably effective. Just because it's natural, doesn't mean it's safe.
Furthermore, modern medicine has brought with it a myriad of beneficial treatments. Insulin, for instance, can now be mass produced with a vat of bacteria, something that was previously impossible. And this insulin is identical to human insulin.
But we still run into the same problem. Herbal medicines can be just as dangerous as modern medicines. They should be tested for efficacy and safety just like the drugs we use today. I don't see why we should use something that we don't know works (vitamin C to ward off a cold doesn't work, by the way), and so even if we moved back to completely herbal medicines, we will still face the same dilemmas as I have mentioned in this post, if we wish to be sure our medicine will work.
~C
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While the Vitamin C thing may be true, and for all intents and purposes, it is, it must also be seen in another light.
Taking Vitamin C during/before a cold can actually cause less severe/shorter colds. This may just be because people believe the Vitamin is working, but who cares if it works? (http://www.quackwatch.org/01QuackeryRelatedTopics/DSH/colds.html)
However, according to the same site, it isn't necessary to take more than 250 mg/day to shorten the duration / decrease the severity of a cold.
-acertainsaint-
It's a supercharged placebo effect. The Vitamin C isn't actually doing anything.
~C
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Prove it - those scientists only speculated that was why people got less sick/didn't get sick for as long. There is still no definitive proof one way or the other - the general consensus, however, is that you're right.
-acertainsaint-
Well, Nick, WebMD says that Vitamin C only reduces the length of a cold by 8% in adults and 14% in children. That's not a drastic reduction... it essentially means one day less per year for the average adult, and 4 days less per year for the average child.
Mayo Clinic, another really good resource, says something similar, though it mentions that Vitamin C does help a certain population... namely elite athletes and military personel. This is the study Mayo references. Based on this study, I might suggest that the vitamin C only minimizes the symptoms of the cold (since the actual sickness part is just your body trying to kill off the virus), but I'm no expert in immunology, so I may be totally off the mark as well. Finally, this study demonstrates that the results are not incredibly consistent, and that the idea needs some more precise research.
So, maybe I'm wrong. Maybe the vitamin C is doing something. And if my above hypothesis is correct, what it might be doing might not be an entirely good thing.
~C
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I never said that you were wrong - only that you couldn't prove, one way or the other, that Vitamin C isn't a good thing when you're trying to ward off a cold. :-P More study is needed since with this kind of study, we're forced to work with nothing but averages. The average length of a cold. The average severity of a cold. The average number of colds in a year.
-acertainsaint-
WTF to the smiley.
-acertainsaint-
I do believe a playful text smiley has been transmogrified. :-))
And that's comin' at ya' from yer local redneck hippie.
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Ooh, ooh, pick me, pick me!!!