[Mb-civic] VOLUNTEERING CAN BE DANGEROUS

[IHHS at aol.com]

REMEMBER HOW IF YOU NEEDED A LITTLE EXTRA CASH YOU COULD VOLUNTEER FOR A  
STUDY IN COLLEGE.  WITH BIG PHARMA IT MAY BE A LITTLE MORE DANGEROUS IN  THEIR 
'RUSH' TO MARKET THESE DAYS.    WARN THOSE YOU CARE  ABOUT!


_http://abcnews.go.com/GMA/story?id=1273115_ 
(http://abcnews.go.com/GMA/story?id=1273115) 
ABCNews

How  Safe Are Drug Trials for Participants?
Bloomberg News Investigates  Conditions for Human Guinea Pigs

Nov. 2, 2005 - - Nearly 4 million  Americans each year become human guinea 
pigs when they volunteer to be subjects  in drug trials. Universities used to 
handle most of these trials, but now  they're mostly done by private, 
profit-driven testing centers. Every year, human  testers get sick or dieduring these 
drug trials, but no one knows how many  because nobody tracks that number, 
explains GMA consumer correspondent Elisabeth  Leamy.

Gary Polsgrove, an ex-Marine, was one of those who died. He was  enrolled in 
a trial of a generic schizophrenia drug at the Fabre Research Clinic  in 
Houston.

"I think, you know, he was truly mistreated," said Nancy  Gatlin, Polsgrove's 
older sister.

Polsgrove was homeless and unemployed  when he enrolled in the study, but was 
physically healthy. He signed up to get a  bed and some cash. He was kept on 
the drug even after he developed adverse  reactions, and died of heart 
swelling after 23 days in the clinic.

IVAX,  the company that sponsored the drug trial in which Polsgrove died, 
points out  the Food and Drug Administration took no action against it.

"The consent  form . disclosed the cardiovascular risk," the company said in 
a statement.  "IVAX believes we have fully complied with all applicable rules 
and  regulations."

Almost three years after Polsgrove died, the FDA sent the  Fabre clinic a 
letter accusing it of violating the rules to conduct proper drug  trials.
Clinic owner Dr. Louis Fabre denied wrongdoing but shut down the  clinic in 
April. Fabre did not respond to ABC's request for comment.

The  FDA says the drug trial system is safe.

"We believe the system is safe .  human subject experiments always carry a 
small degree of risk," said a spokesman  for the FDA.

But Arthur Caplan, director of the University of  Pennsylvania's Center for 
Bioethics, believes drug trials are filled with  conflicts of interest.

"The ethics of clinical research has become grim,"  Caplan said. "I'm
actually frightened about it."

Bloomberg News  reports that pharmaceutical companies most often hire private 
clinics or doctors  to do their trials. The drug companies also pay private 
independent review  boards to monitor the studies.

"If you think about it, how can you trust  someone to look out for your best 
interests if the person who's paying them is  the sponsor of the study?" 
Caplan said.

Suggested reforms to the system  include giving clear explanations to
volunteers of exactly what the risks  are, as well as a public national
registry of drug trials with the results  and the participants.
____________________________________
 
Human injury, death found in drug industry  testing

[published on Sun, Nov 6, 2005]

By DAVID EVANS  davidevansbloomberg.net
MICHAEL SMITH
and LIZ WILLEN
Bloomberg  News

editor responsible for story
Jonathan Neumann   jneumann2bloomberg.net

_http://www.nwherald.com/BusinessSection/317524790534182.php_ 
(http://www.nwherald.com/BusinessSection/317524790534182.php) 

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