ju s t out ▼ ju n s 18. 1 0 0 5 ▼ 11
Thousands blocked
from 3TC
What could be the most promising HIV drug ever has limited
distribution and is waiting for FDA approval
▼
by Rex Wockner
he Glaxo pharmaceutical company
has stopped offering the most promis
ing anti-HIV drug ever to tens of
thousands of seriously ill people with
AIDS, saying it just can’t make enough
to meet demand.
The drug, 3TC, which could be only months
away from approval by the Food and Drug Ad
ministration, has been shown in trial studies to
substantially increase CD4 immune system cells,
to reduce HIV levels in blood cells by 99 percent,
and to reduce levels of HIV in the bloodstream by
91 percent.
These effects, which have been shown to per
sist for at least one year (there have been no longer
studies), occur only when 3TC is used in combi
nation with AZT. Researchers theorize that when
HIV mutates around AZT in an individual, the
virus is then susceptible to 3TC, and that when it
then mutates around 3TC, it mutates in a specific
direction that once again makes it susceptible to
AZT.
The respected Bulletin o f Experimental Treat
ments fo r AIDS says of the 3TC/AZT combina
tion: “[It] produces the most pronounced and
prolonged effect of any anti-HIV regimen yet
studied in suppressing HIV replication and in
creasing CD4 counts. [It is] a remarkable combi
nation.”
While awaiting completion of trial studies,
Glaxo had been providing 3TC free to most people
with AIDS who wanted to try the drug. But that
stopped this spring, when the company announced
that demand had begun to exceed supply.
Now, people with AIDS who want the drug
have to prove that their CD4 cells have averaged
less than 100 (approximately 1,000 is normal) on
two separate tests and that they are unresponsive
T
to or unable to tolerate the four approved anti-
HIV drugs (AZT, ddl, ddC, d4T). They are then
put on a waiting list— the wait is presently about
35 days. No more than 350 new patients per week
are allowed tojoin the 24,000 already taking 3TC.
While Glaxo claims a shortage of 3TC, the
Glaxo 3TC patient hotline tells callers that when
the FDA approves
the drug for sale in
“early
1996,”
there w ill be
plenty for every
one. A ctivists
wonder if Glaxo
would rather sell
3TC in 1996 than
give it away in
1995.
Glaxojustpaid
$15 billion to buy
A ZT m an u fac
turer W ellcom e
PLC. Glaxo’spur-
chase
of
Wellcome was the
s e c o n d -la rg e s t
business merger
ever and created
the world’s largest pharmaceutical company, to
be called Glaxo Wellcome.
“I’d like to get 3TC but I can’t,” says Peter
Staley, founder of New York’s Treatment Action
Group.
“The size of the company leaves one a little
skeptical,” he continued. “It’s the largest pharma
ceutical company in the world. [But] Glaxo has
been incredibly frank and open about their sched
ule of moving from laboratory production to
factory production. Their explanation is largely
that to move to larger quantities they have to do a
factory shutdown of one month. When they real
ized they were going to have to do this shutdown,
they say they made strong efforts to find a third-
party manufacturer to pick up the supply shortage
and nobody was able to gear up faster than Glaxo
itself will be able to.
“I have my doubts about how far and wide they
looked for that third party. There is some idle
factory out there somewhere that could have
geared up a much quicker turnaround, and Glaxo
wasn’t willing to pay for it,” Staley says.
Glaxo’s supervisor of media relations, Ramona
Jones, explained the company’s rationing of 3TC
this way: “This is a supply issue.... We were
trying to anticipate what the demand would be
when we were developing supplies, and in just
four months we went from enrolling about 550
patients a month to enrolling more than 4,000 a
month. So we had to make some decisions, and
what we realized by looking at the numbers was
that we would be able to supply more patients if
we paced the enrollment. Otherwise, we would
have had to cut off enrollment completely with
the facilities that we’ve got now.... We are work
ing on the factory that makes that drug to change
the equipment to handle the demand, which we
were really surprised about, but the [trial study]
results were surprising and encouraging.”
Glaxo’s 3TC media spokesperson, Jennifer
McMillan, added: “When we began to build up a
facility to produce 3TC, we did that without any
data showing the AZT/3TC combination worked.
Once we started to get data in, in late 1994, we
started to figure out how many supplies we would
need and we did a lot to envision the biggest
Expanded Access program we could. [“Expanded
Access” is an FDA classification that allows
seriously ill patients to access unapproved drugs. ]
It was difficult to predict, but we predicted a
program slightly bigger than the ddl Expanded
Access program had been. We were expecting
500 or so patients a week, but during March of this
year it was up to 1,000, so it was something no one
in the community expected.... When we started to
get those kinds of numbers, we were faced with
how do we gear up. We looked at all kinds of
alternatives, including contracting out manufac
turing stages and utilizing other plants, and every
other option we looked at was no faster than
shutting down the plant this summer and upgrad
ing it and having it come on-line this fall. [When
it comes on-line], we will open up the program
either by raising the CD4 count [for enrollees] or
increasing the number of patients we enroll per
week.”
McMillan noted that Glaxo at first planned to
address the shortage by simply limiting access to
3TC to 350 new patients per week but—after
consultations with AIDS activists—decided to
also lower the required CD4 cell count from 300
to 100 “so that the people who could least afford
to wait could get 3TC sooner. The best way to do
that, the activists told us, was looking at the T-
cells [CD4 cells],” McMillan said.
In the meantime, as Glaxo remodels its fac
tory, thousands of people with AIDS who have a
few more than 100 CD4 cells and no longer
respond to AZT, ddl, ddC or d4T, or had to stop
taking them because of side effects (the most
common being peripheral neuropathy, a type of
serious nervedamage), are waiting for theirchance
to obtain the most exciting anti-HIV drug ever—
waiting and, more often than not, watching their
CD4 counts drop by the month.
“When I last had my blood drawn,” said one
person with AIDS who has 134 CD4 cells and
peripheral neuropathy, “I told the nurse about the
mess with 3TC access and asked her if there was
some way she could make me have less than 100
T-cells. She said, ‘I’ll shake the vial of blood
really, really hard before I send it to the lab.’ ”
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