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July 7, 2008 7:00 PM   Subscribe

I'm considering participating in a Pfizer clinical trial for a new medication. The trial is in Phase 2 to determine dosage levels of a medicine to treat nonrestorative sleep issues.

The consent form does state that Pfizer will cover medical costs for any illness or injury resulting from the trial. It does not state that I can't sue Pfizer if anything goes wrong, but it would surprise me if I were allowed to do that. Has anyone participated in something like this and regretted it?
posted by Nathanial Hörnblowér to Health & Fitness (6 answers total)
Have you asked them if they will cover the medical costs for any illness or injury resulting from the trial? If you have to sue them, you've already lost. It should be covered as part of the disclosed protocol.
posted by alms at 7:08 PM on July 7, 2008

This is probably the wrong way to be looking at this, unless your primary objective is to take a medicine that makes you sick in order to sue for monetary gain. And that's a wrong-headed objective.

You pretty much can't sign away your right to sue. Even if you agree to binding arbitration a good lawyer can usually figure an angle where the circumstances warrant consideration from the court. Pfizer doesn't want to scare you off; to the contrary, you're in a Phase 2 trial that is designed to learn about safety and efficacy and so they want your participation and they're promising that if the medicine isn't safe and harms you that they'll pick up the tab of whatever it takes to make you right.

That's not a guarantee that you won't be harmed and it's not a promise that you can be fixed if you are harmed, but it's as good as Pfizer can offer - really the best possible thing they can promise to deliver - and that's why they're promising it to you.

Has anyone participated in something like this and regretted it?

Sure. People die in clinical trials all the time.
posted by ikkyu2 at 7:29 PM on July 7, 2008 [1 favorite]

It's already been in first-in-man trials - so it didn't kill (too many) rats and monkeys and humans. At this stage, the worst that will happen, usually, is that the API is ineffective. A dose-ranging study will usually provide participants with at worst a dose too low to be effective and at best a dose too high to be marketable, although that high dose may be effective.

I don't see much downside to participating; the first-in-man trials are the killers. Now that it has been established as reasonably safe, the only real question is efficacy. At worst, you will have a great drug that really helps you and isn't approved by FDA (and therefore is unavailable). Sadly, this happens all too often; it is extremely sad when kids with fatal diseases are deprived of compounds that could save their lives but aren't approved by FDA due to statistical reasons. Yes, I understand and teach statistics, but I find it bothersome nonetheless.

It sounds like a compound that crosses the blood-brain barrier - is psychoactive, in other words - and I would be wary and careful and ask many questions about the Ph I trials and the side effects reported therein. This information should be available to you. Good luck.
posted by Punctual at 7:50 PM on July 7, 2008

You have to have the right attitude here: you are taking a significant risk in order to try to improve the human condition. You are taking a risk in order to help develop a drug that can help people who are sick. You are taking that risk because someone has to do it. If no one does, no new drugs will appear and the people who need those drugs will continue to suffer.

If you're not willing to accept that risk, you shouldn't participate in the program. Let someone else be a hero.

They have reduced the risk as much as they can, but the risk is not zero. This clinical trial is part of the process of making sure the drug is safe for everyone else, and the reason it's still in clinical trial is that the safety (and efficacy) hasn't been fully established yet to the satisfaction of the FDA.
posted by Class Goat at 8:15 PM on July 7, 2008

Even if you agree to binding arbitration a good lawyer can usually figure an angle where the circumstances warrant consideration from the court.

This is an irresponsible assertion. You're basically advising people to agree to binding arbitration on the assumption that a "good lawyer" will "usually" be able to get them out of it.

That's wrong, and really, really stupid.

Have you ever sat in court and watched a judge essentially laugh someone out of the courtroom when they tried to get out of the binding arbitration that they agreed to in writing? I have.
posted by jayder at 8:17 PM on July 7, 2008 [1 favorite]

Response by poster: Just to clarify, I'm not looking to participate in the trial simply so I can sue Pfizer if something goes wrong. I'm interested in free treatment for an issue that I would not be able to afford to address otherwise, and regardless of whether the trial drug works, my doctor can continue to treat me after the trial based on the data gathered during the trial. And of course I'd be happy to participate in something that will help others down the road. I probably would not be as willing to participate if it was in Phase 1, but it being in Phase 2 seems acceptable to me. I understand that there are risks involved, as there are even with some FDA-approved drug. I'm just curious if any other MeFites have done something like this and what their experiences have been.
posted by Nathanial Hörnblowér at 6:48 AM on July 8, 2008

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