Drug company that put 2 men in Coma testing drugs in India
- From: J <analyse@invalid>
- Date: Wed, 22 Mar 2006 04:28:33 -0500
visualseeplus wrote:
World News: Boston's Parexel to tap India's potential in clinical
research
29-April-2004
New York, Boston-based Parexel International Corp., a $615 million
biopharmaceutical outsourcing company, said Thursday it has entered
into a tie-up with Synchron Research Services of Ahmedabad to tap
India's emerging potential in the area of clinical research
outsourcing.
Under the alliance, Nasdaq-listed Parexel will leverage Synchron's
capabilities to benefit biopharmaceutical clients with expanded
geographic coverage and patient recruitment capabilities in India, the
company said in a statement.
The alliance also provides Synchron's customers with access to the
clinical trial expertise, advanced technologies, and project
management skills of the Parexel, whose operations spread across 37
countries.
"The collaboration with Synchron expands our global clinical research
services into regions that should help expedite the drug development
process for our clients," said Parexel chairman and chief executive
Josef H. von Rickenbach.
"Our alliance with an established company headquartered in India
underscores Parexel's commitment to providing clients with
comprehensive drug development services in emerging markets."
Commenting on the alliance, Shivprakash, chief executive officer of
Synchron Research, said the company will now be able to offer clients
an extensive portfolio of clinical development solutions
--------------------
Two Men Remain in Coma After Drug Trial
http://news.yahoo.com/s/ap/20060321/ap_on_he_me/britain_drug_trial_2
By TARIQ PANJA, Associated Press Writer Tue Mar 21, 9:20 AM ET
LONDON - They were chosen because they were fit and healthy, but minutes
after being injected with a test drug designed to combat leukemia and
other diseases, the men went into convulsions as their internal organs
began to fail.
Two men were still in a coma Tuesday and four others were seriously ill
but improving after participating in the trial last week. The drug sent
the men into vomiting fits; they removed their shirts in panic as their
bodies seized up with pain.
Fresh questions are being asked about the safety of clinical trials and
whether the tests draw vulnerable people with promises of pay. Parexel,
one of the makers of the drug, paid eight men 2,330 pounds (US$4,092) each
to participate, said Raste Khan, 23, one of two patients who had been
given a placebo.
He described the gruesome scene in the hospital ward.
"It felt like we stepped into some sort of horror film," Khan told The
Associated Press. "The three other men in my ward started vomiting, then
they began to fall in and out of consciousness. The person on my left was
begging doctors to help him. I was really scared and was just waiting for
it to start happening to me."
After taking the drug the men lapsed into comas as their organs failed,
forcing doctors to put them on organ support machines, said Dr. Ganesh
Suntharalingam, who was treating the men at Northwick Park hospital in
London.
The Medicines and Healthcare products Regulatory Agency ? which authorized
the trial ? said there was nothing unusual about the results of laboratory
and animal tests on the drug or the methodology for the human trials
provided by Waltham, Massachusetts-based Parexel and the other maker,
TeGenero AG of Wuerzburg, Germany.
TeGenero's chief scientific officer, Thomas Hanke, said the drug TGN1412 ?
designed for the treatment of autoimmune and inflammatory diseases and
leukemia ? had been tested on rabbits and monkeys with no "drug-related
adverse events."
MHRA spokeswoman Sara Coakley said the reaction of the six study
participants was "completely unheard of."
"There could have been a manufacturing problem, some form of
contamination, a problem with the drug's administration, or ... it could
be that (defects with the drug) just didn't show up in preclinical data
from the tests on primates," she said. "It will be weeks before we find
out exactly what happened."
Some experts, however, said the six men should not have received doses
within such a short period.
"The idea you give six people an injection at the same time is unusual,"
said Kate Law, head of clinical trials for Cancer Research U.K. ?
Britain's largest cancer charity. "In any of our tests we never test drugs
on the volunteers all at the same time."
David Glover, former chief medical officer at biotech company Cambridge
Antibody Technology, said testing antibody drugs like TGN1412 must go on
despite the tragedy. He cited drugs like Herceptin, which has made a big
impact on the treatment of breast cancer.
"We need to understand the issues we face and look at creative solutions,"
said Glover.
Most phase one trials ? in which the drug is tested on humans for the
first time ? are conducted in industrialized nations. In Britain, the MHRA
authorizes around 350 such tests per year.
Complicated health regulations and the need for sophisticated
infrastructure usually prevent such trials from being conducted in
developing nations. Phase two and three trials, in which the drug is
tested on patients in need of treatment, can take place in poor countries.
The procedure for selecting healthy volunteers for phase one trials has
also caused controversy in Britain in the aftermath of the men's
hospitalization.
Parexel recruited the eight men for what should have been a two week
trial, said Khan. They were to stay for three nights, and then attend 11
follow up days.
"It worries me that you could earn a living from being a participant,"
said Ray Noble a medical ethicist at University College London. "It might
blind people to the obvious potential pitfalls of participating in too
many trials."
Others say that without offering financial inducements it would be
extremely difficult to get subjects for the essential phase one tests.
"It's a fine line. How do we attract people to do something for which
there is not much reward?" said Derbyshire.
.
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