Business/Financial Desk
| May 6, 2003, Tuesday Drug's
Approval Hints at Flexibility In F.D.A.
Process
By ANDREW POLLACK (NYT) 1601 words
Late Edition - Final , Section C ,
Page 1 , Column 5
ABSTRACT
- Food and Drug Administration approves
AstraZeneca's drug Iressa for treating
people with lung cancer who have run out of
other options; drug is first of new class of
therapies that can attack tumors while
avoiding some of usual side effects of
chemotherapy; drug does not work for vast
majority of patients and is associated with
potentially fatal side effect, type of
pneumonia; FDA's decision that benefits of
drug outweigh risk is seen by some patient
advocates and by analysts as new sign of
flexiblity on part of FDA in viewing drugs
for life-threatening diseases; some advocacy
groups have criticized FDA, saying it has
demanded too heavy burden of proof for
drugs, even when patient will die anyway;
Frank Burroughs, president of Abigail
Alliance for Better Access to Developmental
Drugs, praises FDA Comr Mark B McClellan for
speeding up drug reviews; FDA officials say
there is no new leniency; La Jolla
Pharmaceutical says it will submit
application for approval of its drug Riquent
for treating lupus even though main clinical
trial of drug did not meet its goal; Corixa
Corp says FDA has delayed decision for three
months on Bexxar, its drug for non-Hodgkin's
lymphoma, but company's comments suggest it
is likely to win approval; chart; photo (M)
The Food and Drug Administration yesterday
approved a drug for treating people with
lung cancer who have run out of other
options.
The drug, AstraZeneca's Iressa, is the
first of a new class of therapies that can
attack tumors while avoiding some of the
usual side effects of chemotherapy like
anemia, increased risk of infections, nausea
and hair loss. In studies, it has been shown
to drastically shrink tumors, but only in a
small percentage of patients.
PURCHASING
FROM NYTIMES.COM IS QUICK AND
SECURE.
To read the complete article,
simply click on one of the BUY
NOW buttons below.
You can buy
this single article or, for even
greater value, you can purchase
this article as part of a
multi-pack. You'll then have the
opportunity to buy additional
articles now or in the future at
significant savings!
Purchase
Single Article -- $2.95
Purchase as part of Article
4-Pack -- $7.95 ($1.99/article - a 33%
savings!)
Pack expires after 1 month
Purchase as part of Article
10-Pack -- $15.95 ($1.60/ article - a 46%
savings!)
Pack expires after 3 months
Purchase as part of Article
25-Pack -- $25.95 ($1.05/ article - a 65%
savings!)
Pack expires after 6 months
How multi-packs work: A
multi-pack is an archive package that saves
you money by allowing you to pre-purchase a
set number of articles in bulk at a reduced
price. You can then debit from your
multi-pack and quickly access articles from
the archive at your convenience over the
lifetime of the multi-pack.
Once you purchase an
article, you may view it as often as you
like over the next 90 days. Archive articles
do not include photos, charts or graphics
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"