Clinical Trial's
End Ends Woman's Hope Of Pain-Free Life
Doctors Say Clinical Trials For Research, Not Therapy
POSTED: 4:31 pm EDT August 16, 2005
UPDATED: 3:20 pm EDT August 17, 2005
BOSTON – When people lend their bodies to science to help
test drugs for safety and effectiveness, they take risks including
potential
dangerous side effects. But what happens if a drug works and is then
taken away?
NewsCenter 5's Liz Brunner reported that a Framingham, Mass., woman
said the experimental drug she was on gave her back hope,
but that hope was gone when the trial ended and the drug company
stopped supplying the medication.
Getting around is a daily challenge for Valerie Daniell.
"It's like I'm on fire all the time. It's like my skin is just
tingling," she said.
A fall out of bed five years ago left Daniell completely paralyzed.
"(Doctors) said I would never walk again for sure," Daniell said.
Daniell was determined to prove them wrong. She worked hard and managed
to restore some of her mobility. But even though she
was walking, the pain made each day almost unbearable.
Then her doctor recommended she take part in a trial at Spaulding
Rehabilitation Center for a new drug being developed by Sanofi-
Aventis called HP-184.
"I was standing strong, I was actually starting to do stairs.
Everything was kicking in. It was just incredible. I could feel this
inner
strength happening," she said.
But the drug trial was only six months long, and within weeks of
stopping the drug, Daniell's pain returned.
"Devastating. Devastating," Daniell said.
Daniell signed a consent form limiting the trial to six months, and
admitted she was unprepared for the emotional upheaval when the
trial ended.
Boston University bioethicist Michael Grodin said many clinical trial
participants don't fully understand that trials are not meant for
therapy, but for research.
"Research is research because we don't know if drugs are safe and
effective, and that they're going to help people as opposed to hurt
them," said Grodin.
Earlier this year, patients participating in a Parkinson's disease
trial sued drug maker Amgen when the company halted the trial for
safety reasons. Two courts ruled against the patients.
"People need to realize and appreciate that when they enter a research
trial, they're entering it for altruistic reasons, not to benefit
themselves," Grodin said.
Daniell asked the drug maker to allow her to continue taking it, but so
far, has not received a response.
"To be able to continue on it while they are doing more of the trials
instead of cutting you off – absolutely cold. It just seems
so
heartless to do that," Daniell said.
The Food and Drug Administration said a drug maker can make exceptions
and continue experimental drugs in some patients with
exceptional circumstances, but the company would need to also accept
the liability for doing so.
Daniell said she has applied to take part in Phase 3 of the drug trial,
but said she's not getting her hopes up.
