JustErin said:

I guess I just need to do more research and talk to them and make up my mind. I'm wary, but it's tempting nonetheless...

Mach said:

I would need to know which study she was talking about and read the consent form.
If I was over weight and it seemed relatively safe, I would do it.
If it is the same study that we were getting ready to do before I moved, I would tell her to go for it.
The dr that I worked with did a lot of research about it and wanted to do the study herself but if you work in clinical research, you cannot participate in a trail.
So, if I had all of the info and if I was over weight, I would seriously consider it.

CarrieMpls said:

With most studies there are placebo's involved. The placebo effect works 30% of the time.
You have to feel right about it before you do it. If you get the consent form and read it and have questions, they will answer them for you before you start.

shanti0608 said:

I do agree it seems well regulated and you get monitored by drs all the way with blood work and screenings, etc.

I don't have a regular doctor I see to really get a "second" opinion, but I believe I have a strong sense of self when it comes to my health. If anything felt "off", I'd know when to quit.

CarrieMpls said:

You can discontinue at any time but they will need to do a final visit on you to collect data and make sure that you are alright when you stop taking the meds.

CarrieMpls said:

Well proceed with caution. I am VERY sensitive to drugs and don't take cold medicine for the fact that I feel like I mainlined an 8 ball after drinking Theraflu Nyquil keeps me awake instead of putting me to sleep.

When I had my surgery for my appendix, the nurse came in with a giant syringe and when I saw it I asked her what it was. She told me it was demerol and that it would knock me right out. She said it would put an elephant to sleep. I told her not to give me the whole thing and only to give me half. Mind you, I hadn't eaten in 4 days at this point (5 days total before I ate again) and I dropped down to 106 pounds. At 118 I was already way way WAY sensitive to drugs and in this state and 12 pounds lost, for sure I would be even more sensitive.

So she gave me half the shot like I asked for and left. About 30 seconds later I am buzzing for the nurse and she asks what was happening and I asked if she could PLEASE come sit with me for a few minutes as I wasn't feeling too good. So she came and asked what was wrong and I told her I was really dizzy and felt like I was going to pass out. So she took my blood pressure and my pulse. Before she gave me the shot, my resting heartrate was 63 beats per minute. When she took my pulse after giving me the shot, it was 160 beats per minute That was supposed to sedate me and instead it had the total opposite effect.

If you are like this, BE CAREFUL!

....
[Edited 1/19/08 12:29pm]

SupaFunkyOrgangrinderSexy said:

Pretty much, and the possibility of a stroke. Sounds like Phen-Fen, or whatever that shit was.

That sounds dangerous. I'd rather be chubby.

I like the idea of a free dietician /nutritionist. And the placebo. But not the actual pill.

horatio said:

Then why not just fake taking any pill and just use the advice?

JustErin said:

good point

CarrieMpls said:

Phen/fen had passed clinical trials, and been on the market as a prescription drug, when it was discovered it caused primary pulmonary hypertension and valvular disease.
I know people who took it and lost weight. It was removed, and the company settled alot of lawsuits.
During the clinical trials, the drug clearly worked for weight loss. Unfortunately, the cardiac problems got missed.

"bad gateway" so I re-posted.....
[Edited 12/11/07 15:32pm]

SupaFunkyOrgangrinderSexy said:

I thought that was a lame sucky Kevin Bacon movie....

wrong thread....
[Edited 12/11/07 16:14pm]

I participated in one of those once (case studies) tried out several different types of medicines. It was an interesting experience but it turned out to be ineffective in my case. But I'd do it again in a heartbeat, got some tiptop medical care during it so I guess it all balanced out.

In the course of my daily job, I study news stories about pharmaceutical companies and products. You would be floored by the number of drugs on the market that have horrible side effects.

Many have effects on the heart. Many have psychological effects.

They really aren't worth it. $450, IMO, wouldn't be worth the risks, either.

$450 for six months isn't great. i wouldn't do it.

Anxiety said:

Honestly. without risking life and limb, you could save that much in that time period.

If it was me, I don't think I would do it. That kind of thing scares me.

i agree don't do it girl. you might catch an epsoide

DO NOT DO THIS SHIT, Carrie $450 will be gone like THAT. You have no idea what this will do to your body & what kind of longterm negative effects it can have. DO NOT, DO NOT, DO NOT

Please, man If you're willing to risk your BODY for a mere $450, then dammit push it to the wall & test your body @ the gym w/ some truly intense training for a few months (if weight loss is the goal), otherwise scrimp & save the $450. It's just not worth it if you have some adverse reaction


.
[Edited 12/12/07 12:50pm]

http://www.newstarget.com/022135.html

NewsTarget.com printable article
Originally published October 18 2007
Clinical Drug Trials: FDA Fails to Monitor Safety and Integrity
by Herb Newborg

(NewsTarget) A new report issued on September 28th, 2007 by Department of Health and Human Services Office of Inspector General found that federal health officials don't even know how many clinical trials are being conducted in the US. The report said the FDA has 200 inspectors (some part time employees) to police an estimated 350,000 testing sites.

It estimated that only 1 percent of all clinical trials were audited between 2000 and 2005. During the period between 2000 and 2005 - of the estimated 350,000 trial sites the FDA was believed to have inspected just 2,855.

The report also found there was a lack of follow ups on sites which had been issued a warning letter after being classified as 'official action indicated' (OAI) for violations of regulatory significance.

The FDA must re-inspect sites that have been sent a warning letter to ensure there are no repeat violations, but according to FDA data, which was noted to be inadequate by the report, the agency only conducted three follow-ups for every 100 inspections that were classified as OAI or voluntary action indicated (VAI).

Other statistics showed that of the 348 OAIs classified by the FDA only 26 were disqualified from further clinical trials and only two had their data disqualified. Seventy percent received a warning letter, relying heavily on voluntary compliance to correct regulatory violations.

Many OAI recommendations were also downgraded to a classification where violations did not have to be formally addressed.

The FDA also was faulted for failing to make sure that any problems found are properly addressed.

The FDA oversees the safety of trials by companies seeking approval to sell drugs or devices. There is no federal oversight for private, noncommercial trials. The inspector general's report calls for the creation of a comprehensive database of all clinical trials, a federal registry of clinical trial inspectors and increased legal oversight.

Equally as important as the integrity of the research data is the safety of the human subjects participating in these clinical trials.

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

Animal research centers have to: register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, according to Mr. Caplan.

Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been.

Don't do it Carrie. You're not that desperate for cash surely.

Last one, I promise Carriebaby. http://www.newstarget.com/020061.html

NewsTarget.com printable article
Originally published August 21 2006
Warning Over Unfair Terms for Patients in Clinical Trials (press release)
by NewsTarget

Patients who volunteer to take part in clinical trials are currently being left without adequate legal protection in the event of injury, warns a senior doctor in this week’s BMJ.

Professor Desmond Laurence argues that when patients are invited to enter clinical trials, they are at present being induced to believe that the trial sponsor will have a legal obligation to compensate them in case of injury, when in fact that is not true.

Patients who volunteer for clinical trials enter a consumer contract with the trial sponsor. Consumer law requires such contracts to be expressed in plain language.

But Professor Laurence argues that the words used in clinical trial contract documents concerning injuries to patients are not plain language and do not therefore meet the legal requirement of fairness and openness under consumer law.

“If the law were to be observed, patients would be told frankly, in words lay people could readily understand, that they might be seriously injured but with merely discretionary compensation,” he says. “The trial sponsor of course may always pay ex gratia compensation, if it cares to,” he adds. “But if it does not, then the cost of compensation for non-negligent harm falls upon the injured patients themselves.”

He calls on the Department of Health to obey the law. “If patients were told the truth, any resultant shortage of volunteers could well lead to the introduction of more humane compensation arrangements for injured patients,” he says. “If it simply will not, then the Office of Fair Trading should now enforce the law.”

You should never participate in a clinical study for cash. I am sure Carrie knows that and was not doing it just for the money.