anyone been a subject in a clinical trial?

[Jenks]

Re: anyone been a subject in a clinical trial?

sperm donation > plasma donation - imo

did you ever go to the plasma donation joint on campus @ mizzou toasty?

[KinKyJ]

Re: anyone been a subject in a clinical trial?

Maybe some side effects can get you a job in Hollywood Anonin:

[YOUTUBE]http://www.youtube.com/watch?v=ACNnLNxEYXI[/YOUTUBE]

[toasty]

Re: anyone been a subject in a clinical trial?

did you ever go to the plasma donation joint on campus @ mizzou toasty?

I remember looking into it at one point, but I spoke with someone who did it, and it sounded really unpleasant. I guess it's pretty uncomfortable when they run the blood back into you?

I dunno. I'm not a needle guy anyway, so when I heard it was anything other than gumdrops and lollipops, that pretty much ended it for me.

[threehills]

Re: anyone been a subject in a clinical trial?

Serious question because this is something I considered when I was younger. Would you find it weird to know that you could be unknowingly standing next to your kid on the street? I had this vision of me walking down the street and thinking, "Hey, that little dude kinda looks like me." What do you do if the kid decides one day he wants to know who is biological father is and manages to track you down? Man would that be weird.

No, that would not bother me. They cannot track me down, if they do, I will then be insanely rich from the lawsuit I will file. The U.S. has different laws than the Great Britian where they may be able to track you down. The company I "sell" to, therefore does not business with anyone based in the UK.

So what if he does track me down? I don't want children myself, but would be happy to sit down with someone with my genes and talk to them. So long as they don't want a father figure.

My wife and I have both talked it over at length, and we're okay with doing it. She is looking to sell her eggs. Like I said, we don't want kids, but loads of people out there desperately want them but can't have them without help from someone like us.

[minneec]

Re: anyone been a subject in a clinical trial?

There is a place called Covance in my hometown which performs clinical trials... They have television and billboard ad campaigns which I feel are intentionally misleading to people unfamiliar with the potential side effects of these experimental drugs, particularly preying upon the economically disadvantaged. You probably won't see anybody in there who doesn't need the money.

The billboards simply say "Most summer jobs aren't this rewarding" in a handwritten font as if someone who did this is recommending it to you... I would like to climb up with a spraycan and write "most jobs don't have side effects either" underneath it.

Additionally, these trials allow pharmaceutical manufacturers like Merck to claim that unsafe products like Vioxx and potentially unsafe ones like Gardasil are clinically tested and proven safe, before sufficient observations have been made in the long run. Then in the ads for the products you have this twilight zone dichotomy of a soothing voice listing off dreadful symptoms and potential reactions that people have experienced.

As a historical footnote, the companies that once made up IG Farben (Bayer, BASF, and other German subsidiaries) are known to have tested and developed pharmaceutical products by experimenting on concentration camp detainees. Today nobody would stand for that, but they haven't ethically evolved much, because the poor are prisoners too in a way, and the few grand they can offer you is a tiny pittance compared to the billions in profit that can be reaped from these drugs.

As long as you understand the risks, your body is your own to use as you see fit. Personally, I wouldn't go near the place without a bulldozer.

much as i would love to say you have a point in thinking pharma is bad, you have to understand the state of modern medicine. in the half a century since discovery of penicillin and the hundred years since asceptic cleanliness, there hasn't been that much advancement on the treatment side of things. we can still basically only kill bacteria, most of the time. there's lots of stuff out there for fungus, some for viruses, some that are receptor specific to tone down the body's reaction to stuff, but say if you got mono for example, there's nothing that medicine can do except to recommend that you stay at home for three months, rest, eat well and stay away from alcohol for a bit. yes pharmaceuticals are in the business of making money off modern innovations in science, but for the common good. after 10 years, the patent on the drug expires and generics can be made of the drug and sold cheaper, and thus be available to more people. NSAIDs being a great example, and Vioxx being one of them. Think of all the headaches you held at bay with aspirin and ibuprofen. Yes there are side effects, but you as the consumer should be aware of them. NSAIDs do cause gastric ulcers, if dehydrated could hurt your kidneys, do have negative cardiovascular effects. And it's sad that things occurred the way they did with Vioxx. They knew about the side effects, but thought the benefits outweighed the costs. But there are rigorous FDA regulations each drug that tries to go to market has to go through. Each drug that actually makes it takes billions of dollars in research (from the test tube to clinical trials, a process that takes years, like decades) before it makes any profit for the company. So from the standpoint of business, of course pharma want the drug to sell and will downplay the bad points. But without this system, there won't be any innovation in medical treatment. I'm in vet school and animals definitely get the shaft when it comes to pharma love. Most of the drugs we use are years behind modern human medicine and we have to base a lot of the knowledge on human trials, because though loved by their owner, they just don't bring in as much revenue for these companies. But because there still is such a system in place, we can get access to better drugs than just penicillin G (which if you ever had to give it don't give intravenously!) and at least give the animals a fighting chance in their diseases.
as for the economically challenged bit, when i was at cornell med in connection with MSK, lots of better off people agreed to trials, and not because they needed money. they were hoping for a cure. so maybe pharma is preying on desperation....
sorry for the novel. I just had to put in my two cents.

[WaveSculptor]

Re: anyone been a subject in a clinical trial?

No, I appreciate it. I certainly respect the contributions that pharmaceutical medicine has made, and the relief it has brought people (though I personally haven't taken so much as a headache pill in over 15 years, and owe my excellent health to a conscientious diet and active lifestyle). The aggression of their marketing and legal practices however, continues to astound me and at times even appears to coincide with eugenic ideology. For example, in 1997 (old news, I know) a coalition of 38 multinational pharmaceutical companies, lead by GSK and BMS among others, filed suit to delay the implementation of the South African Medicines Act, which was intended to make generic HIV drugs accessible to millions of infected African men, women and children.

"Since the suit was filed in 1997, blocking its implementation, 400,000 South Africans have died of AIDS [as of 2001]. If implemented, the Medicines Act would allow South Africa to dramatically increase access to affordable medications, including life-extending HIV medications, acquired as low-cost quality generic drugs, and/or through mechanisms of parallel importation and compulsory licensing."

[taken from http://www.commondreams.org/news2001/0301-09.htm]

"'These companies have the audacity to sue Nelson Mandela and the government of South Africa for attempting to extend affordable medication to millions of people who otherwise face a death sentence,' said ACT UP's Shahiid Robinson.
...
In May 2000, with a huge amount of publicity, pharmaceutical companies including GSK announced that they would provide AIDS drugs at deep discounts to African nations. However, these plans amount to treatment for only about 2,500 of the 36 million people now living with AIDS.
...
Activists note that worldwide people with AIDS are dying at a rate of one million every four months."

Of course, I can't make the generalization that this applies to the pharmaceutical industry in general, but it would certainly be nice to see the driving ideology behind this sort of bureaucratic genocide vanquished. A ways off topic, I know, but I cite this to illustrate that the so-called 'profit vs. public service dilemma' has long been decided.

You are definitely more accurate in saying that they prey off of desperation, and I should be careful to include in my consideration that group which is seeking cures to their ailments or to help others find one rather than pursuing financial compensation, though I still suspect a drastic imbalance overall, unlike the ads where people always say "For me, it's a little bit of both."

As far as incentive goes, good people have always been naturally inclined to provide comfort & healing to the wounded and sick. Although lucrative financial incentive certainly spurs research onward, as you said there really haven't been any major developments in recent history (though I hear that exotic venom derivatives are being considered for experimental cancer treatments), and I find the socio-economic landscape of today's medical industrial complex to be rather bleak. If you wish to direct me to some resources that might broaden my perspective on pharmaceutical research and the FDA approval process, I would certainly jump at the opportunity.

[toasty]

Re: anyone been a subject in a clinical trial?

No, that would not bother me. They cannot track me down, if they do, I will then be insanely rich from the lawsuit I will file. The U.S. has different laws than the Great Britian where they may be able to track you down. The company I "sell" to, therefore does not business with anyone based in the UK.

So what if he does track me down? I don't want children myself, but would be happy to sit down with someone with my genes and talk to them. So long as they don't want a father figure.

My wife and I have both talked it over at length, and we're okay with doing it. She is looking to sell her eggs. Like I said, we don't want kids, but loads of people out there desperately want them but can't have them without help from someone like us.

The bold part would be my biggest concern.

As to the rest of it, good for you and your wife. That's an admirable outlook to take, you're definitely helping some people out...

[MJ]

Re: anyone been a subject in a clinical trial?

alright people, i went into the clinic today and read over the paperwork, it said a less common side effect from the drug is growing breasts, wtf?!?!, after that i told them i'd have to go home and think about it, i'm not sure i want to grow through with it if i may grow breasts, thats a bit to wild for me.

You just had two guys rolling around with tears in their eyes when they read that.

[Miroslav]

Re: anyone been a subject in a clinical trial?

alright people, i went into the clinic today and read over the paperwork, it said a less common side effect from the drug is growing breasts, wtf?!?!, after that i told them i'd have to go home and think about it, i'm not sure i want to grow through with it if i may grow breasts, thats a bit to wild for me.

I don't think you want to do this...especially for 3 grand..

[anonin]

Re: anyone been a subject in a clinical trial?

*update*

most def. NOT doing it, the second drug they are testing is only in phase 2 of FDA approval, i basically told the lady "phase 3 or stfu", no way i'm fucking around with some phase 2 bullshit thats gonna make me grow breasts. AND the study is for a drugs by glaxosmithkline and last time i checked they wern't even that sweet, so in conclusion,

a) don't participate in clinical trials that test how drugs interact with other drugs and side effects like 'yo, you might grow breasts' are listed
b) don't fuck with clinical trials that have drugs in early ass stages like phase 2
c) don't participate in clinical trials with only the $ on your mind, fact is big drug companies are dodgy as fuck and your health is more important than $.

[KinKyJ]

Re: anyone been a subject in a clinical trial?

pussy

[threehills]

Re: anyone been a subject in a clinical trial?

a) don't participate in clinical trials that test how drugs interact with other drugs and side effects like 'yo, you might grow breasts' are listed
b) don't fuck with clinical trials that have drugs in early ass stages like phase 2

but DO takes those hits of E that some random dude mixed up his basement.

[WaveSculptor]

Re: anyone been a subject in a clinical trial?

Glad you looked into it before signing off.

[MJ]

Re: anyone been a subject in a clinical trial?

*update*

most def. NOT doing it, the second drug they are testing is only in phase 2 of FDA approval, i basically told the lady "phase 3 or stfu", no way i'm fucking around with some phase 2 bullshit thats gonna make me grow breasts. AND the study is for a drugs by glaxosmithkline and last time i checked they wern't even that sweet, so in conclusion,

a) don't participate in clinical trials that test how drugs interact with other drugs and side effects like 'yo, you might grow breasts' are listed
b) don't fuck with clinical trials that have drugs in early ass stages like phase 2
c) don't participate in clinical trials with only the $ on your mind, fact is big drug companies are dodgy as fuck and your health is more important than $.

And I'm wondering why it took you so long to figure all this out. Fuck that being a guinea pig shit, I'd rather have no money at all!

[minneec]

Re: anyone been a subject in a clinical trial?

If you wish to direct me to some resources that might broaden my perspective on pharmaceutical research and the FDA approval process, I would certainly jump at the opportunity.

sorry it took so long to get back to you. clinics...
anyway, my pharmacist friend said this about the approval process
Drug approval is a lengthy and expensive process, split into several steps.
1) Pre-clinical research: manufacturer develops and screens molecules for biologic activity, and conducts in vitro and animal testing
2) Manufacturer applies for FDA approval of an IND (investigational new drug). FDA approval of IND is required in order for human testing to begin.
3) Clinical trials: during 3 phases of human testing, the manufacturer determines the safety and efficacy of the drug.
4) Manufacturere applies for FDA approval of an NDA (new drug application). No drug may be marketed in the US without an NDA. The reason the FDA requires this is to ensure the safety and efficacy of the US drug market. The FDA may reject the NDA if it determines the drug is not safe or effective.
5) Once FDA approves the NDA, the manufacturer conducts Phase 4 trials. The manufacturer collects and reports long term safety data to the FDA, since a lot of adverse events do not show up until after several years in humans.

1) http://www.fda.gov/cder/handbook/develop.htm

2) http://www.fda.gov/cder/regulatory/applications/apps-sitemap.htm

The whole process may take at least 10 years and is very expensive. Also, I've heard that for every drug that makes it to market, at least 1000-10,000 drugs do not make it through the testing process.
hope this helps