(Clinical trials) Do you want to be a guinea pig?

[Guest guest]

Do you want to be a guinea pig?

By Cohen

CNN Medical Correspondent

http://www.cnn.com/2008/HEALTH/06/26/ep.clinical.trials/index.html

ATLANTA, Georgia (CNN) -- They want to pay me for the use of my body.

No, I'm not vain, nor is anyone trying to push me into prostitution.

They want me (and you) to be subjects in medical studies.

A poster in my internist's waiting room asks whether I'd be

interested in participating in a cholesterol study. In my

gynecologist's waiting room, another poster tries to recruit ladies

for studies on prenatal vitamins and on vulvar vestibulitis (you

don't want to know). On my way home from work, I hear radio ads that

go something like this: " Depressed? Come join our study of a new

medication. "

" The more people sign up for clinical trials, the better we're all

going to be, " says Burns, a trial participant.

" The industry has been advertising like crazy, " says Diane ,

president of the Center for Information and Study on Clinical

Research Participation. " It's been a real problem getting people to

volunteer for clinical trials, so there's advertising on billboards,

on radio, TV and print. "

You don't have to be sick to join a study. Often, researchers are

looking for healthy people.

There are advantages to joining. You can make money, sometimes

hundreds of dollars or more. To a certain extent, you're getting free

medical care. If you're sick, you get the chance to try a treatment

so new, you can't get it from your doctor. You're also helping your

fellow human beings by being a part of medical research.

But before you sign up, here are a few key questions to ask.

1. What are the side effects of the medicine or procedure being

studied?

Ask about side effects of the experimental treatment compared with

the side effects of your current treatment, advises the National

Institutes of Health. What should you expect? Could it make you sick?

Could it have long-term effects? Will the doctors in the study follow

up with you long-term?

2. Who's making money off me, and will that influence how they treat

me?

The doctors running the study might stand to make money if the

experimental treatment works, and there are concerns that could

influence what they do with you. The nightmare scenario is that

they'll enroll you in the study even when the new treatment could

harm you or that they'll keep the study going even though the new

treatment is clearly causing dangerous side effects.

Alta Charo, a bioethicist at the University of Wisconsin, suggests

that you find out whether the recruiters, doctors and nurses involved

in the study are " likely to be influenced in their judgments by money

or professional connections to the study sponsor. "

3. Will it cost me money to be in this study?

Even if they're paying you a stipend, there might be hidden costs.

Art Caplan, a bioethicist at the University of Pennsylvania, says to

ask very specific questions: If you need to hire a baby sitter while

you go to required appointments, who pays? Will the study sponsor pay

for lost wages if the treatment makes you sick and you miss work?

4. What happened to other people who had this experimental treatment?

" Ask about the trials that came before the one you're going to do, "

advised Burns, who has Parkinson's disease and has participated

in several clinical trials. " If it's a phase three study, ask what

happened to the people in phases one and two. If it's a phase one

study, ask what happened in the animal studies. "

The National Institutes of Health has more information about phases

of studies and how clinical trials are conducted.

5. If the experimental treatment helps me, can I keep getting it

after the study ends?

Don't assume you can keep taking the treatment after the study ends;

you might not be able to. Ask about this in advance.

When it comes to studies, this is the bottom line: The purpose of the

study is to investigate a new treatment, not to take care of you as a

patient. As Charo puts it, " In a study, while you are important and

the professionals will look out for you, their primary interest is in

getting data. You come second. "

This means you have to know your rights. The NIH has a bill of rights

for study participants. Show Us the Cure, a group Burns is involved

with, has a bill of rights for Parkinson's patients, but it applies

to others as well.

If you're going to join a study, be prepared for disappointment.

Maybe the new treatment will work, but maybe it won't. Burns spent

two years taking a Parkinson's drug that turned out to be a failure'

the patients on the placebo did better than the patients on the drug.

" It was very disappointing. It was devastating, " she said. " But the

more people sign up for clinical trials, the better we're all going

to be. I'm always looking for another trial to join. I would gladly

sign up, but I would do my homework first. "