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Trial(s) and Error: PWC Offers
Participating in Drug Tests
By Michelle Lapuk
It was more than 10 years ago, but
I still remember that
autumn day well. A friend called to tell me that she had heard about a drug
trial taking place at the National Institutes of Health (NIH) in Bethesda
I lived in
and had very little
money, but my friend insisted that I call anyway. To my amazement, NIH offered
to pay for all my travel and food needs ó and to provide the drug free of
charge. I was enthusiastic, excited, a bit intimidated and unsure of what to
expect from my first CFIDS
That trial was for an anti-viral drug
called Acyclovir. Then came hydrocortisone, Inter-leukin 6, Florinef, Ampligen
and a host of other trials. Over the past decade, Iíve become a regular
participant in trials for
treatments. In fact, you could call me a drug trial junkie. In writing this
article I hope to share some of my expertise with others who are looking to take
part in clinical drug testing.
The question I
get asked most often
is where I find all these studies. I have seen advertisements on television and
newspaper articles. I also search the Internet. Drug companies also have Web
sites looking for volunteers. Two of the most helpful sites are
(Editorís note: The CFIDS
Chronicle occasionally posts calls for test subjects in the Bulletin Board
section. A list of current drug trials also is available on the
Associationís Web site, www.cfids.org.)
Itís important to understand that all
trials are not alike. Some of them are an attempt to get an experimental drug on
the market, some are trying to prove a certain drug can be used for a particular
condition and some are looking at dosing changes.
The people who run trials also have
different agendas. Some trials are run by drug companies who just want their
drug on the market. Some physicians run clinical centers and do studies strictly
for the money. Some doctors have a genuine interest in
You need to ask a lot of questions
out if a trial fits your needs. Before entering any drug trial, you should
receive a consent form. This form should list all possible drug side effects and
possible interactions. Read it very carefully. Show it to your primary care
physician, and ask for advice.
This is especially important when the
is truly experimental. If a drug does not have FDA approval, the government has
not officially deemed this drug safe. If the consent form indicates that monkeys
had heart trouble in previous studies, ask how the monkey heart trouble could
translate to human heart problems. Your question may seem silly, but if it eases
your mind then it is worthwhile.
By the way, donít assume that a doctor
running your trial now becomes your primary care physician. Thatís not the case.
You will continue to use your regular doctor for all issues not directly related
to the drug trial.
Many of the trials I have participated
used a double-blind placebo format. To someone not familiar with research
jargon, this all sounds like gibberish. But itís not that complicated. A placebo
is an inert or innocuous substance used in a controlled experiment to test the
efficacy of a drug. A placebo may be a sugar pill or a saline drip or anything
that the drug company feels will not have an actual effect on the patient. Some
patients get the real drug, while others get the fake, look-alike placebo.
The problem with
CFIDS and placebos is that many patients have
so many sensitivities. In some cases a placebo may not actually be one. For
example, if saline is used as the placebo, and saline may help with orthostatic
intolerance, then the study is flawed to begin with.
Double blind means that neither the
nor the patient knows what is being administered. I prefer double-blind studies
because when the doctor knows what they are administering it is very hard to be
You must always consider your level
commitment before starting a drug trial. In many cases you may have to give up
more time than you initially expect. It is not as simple as swallowing a pill
and going home. There may be screening questionnaires, depression evaluations,
blood work, daily activity logs and an array of various forms to fill out. I
urge you to tell the truth. I have seen many patients so desperate for help,
that they are not honest on the forms. You may be disqualified, but in the end
it probably is for the best. I once got kicked out of a
CFIDS study halfway through because they found
out I also have a thyroid condition. I should have told them up
Only one in 20 people who start trials
actually finish them. When you change your mind and drop out, it only hurts
those who stay in. It is unfair and slows down the study. It is one thing to
drop out because of side effects; it is another to drop out because of lack of
commitment. These studies are slow enough. By the time it is unblinded and
published it can take years.
One thing I like about studies is that
many cases everything is paid for. You may or may not be paid to participate,
but you should be receiving the drug for free. You also may be paid for air or
car travel costs. Be extremely cautious of any study where they ask you for
I am also on Social Security Disability.
am not sure if it helps, but I always let them know that I am participating in
various studies. It shows a continued desire to try to get well.
All in all I really enjoy participating
drug trials. I feel that in a small way I am helping my own fate. I do
acknowledge that drug trials are not for everyone. Thatís a decision youíll have
to make on your own.
is a former ABC
television reporter. She is currently co-president of the Connecticut
CFIDS/FM Association, Inc.
Michelle lives in Bloomfield, Conn.
drawbacks before starting trials
Clinical drug trials are essential
CFIDS research. But be aware of these potential
drawbacks before participating:
- You may need to go off all other
medication ó even those not related to
- Some drugs cause an initial worsening of
CFIDS symptoms. You may need extra help from
caregivers at first.
- The drug may not be available for use
after the trial. Even if it is available, you may have to pay for