"For years, scientists have been aware of the effectiveness
of placebo in treating a surprisingly wide range of
conditions," said Dr. Jonathan Bergen of the FDA's Center for
Drug Evaluation and Research. "It was time to provide doctors
with this often highly effective option."

In its most common form, placebo is a white, crystalline
substance of a sandy consistency, obtained from the
evaporated juice of the Saccharum officinarum plant. The FDA
has approved placebo in doses ranging from 1 to 40,000
milligrams.

The long-awaited approval will allow pharmaceutical companies
to market placebo in pill and liquid form. Eleven major drug
companies have developed placebo tablets, the first of which,
AstraZeneca's Sucrosa, hits shelves Sept. 24.

"We couldn't be more thrilled to finally get this wonder drug
out of the labs and into consumers' medicine cabinets," said
Tami Erickson, a spokeswoman for AstraZeneca. "Studies show
placebo to be effective in the treatment of many ailments and
disorders, ranging from lower-back pain to erectile
dysfunction to nausea."

Pain-sufferers like Margerite Kohler, who participated in a
Sucrosa study in March, welcomed the FDA's approval.

"For years, I battled with strange headaches that surfaced
during times of stress," Kohler said. "Doctors repeatedly
turned me away empty-handed, or suggested that I try an over-
the-counter pain reliever-as if that would be strong enough.
Finally, I heard about Sucrosa. They said, 'This will work,'
and it worked. The headaches are gone." Researchers diagnosed
Kohler with Random Occasional Nonspecific Pain and Discomfort
Disorder (RONPDD), a minor but surprisingly pervasive medical
condition that strikes otherwise healthy adults.

RONPDD is only one of many disorders for which placebo has
proven effective, Bergen said.

"Placebo has been successful in the treatment of everything
from lower-back pain to erectile dysfunction to nausea,"
Bergen said. "That's the beauty, and the mystery, of placebo.
It's all-purpose. Think of it like aspirin, but without any
of the analgesic properties."

The FDA is expected to approve the drug for a wide range of
mood disorders later this year. According to Bergen, initial
research has shown placebo to be effective in the treatment
of bipolar disorder, depression, dysthymia, panic disorder,
post traumatic stress disorder, seasonal affective disorder,
and stress.

As industry analysts predict the drug's sales will top $25
billion in the first year, the approval of placebo is
expected to unleash one of the pharmaceutical industry's
biggest marketing battles to date.

GlaxoSmithKline expects to have two versions of placebo on
the shelves in late December. One, a 40-milligram pill called
Appeasor, will be marketed to patients 55 and over, while the
other, Inertra, designed for middle-aged women, is a liquid
that comes in a 355-milliliter can, and is cola-flavored. Eli
Lilly plans a $3 million marketing campaign for its 400-
milligram tablet, Pacifex.

"All placebos are not the same," Eli Lilly spokesman Giles
French said. "Pacifex is the only placebo that's green and
shaped like a triangle. Pacifex: A doctor gave it to you."
Despite such ringing endorsements, some members of the
medical community have spoken out against placebo's approval,
saying that the drug's wide range of side effects is a cause
for concern.

"Yes, placebo has benefits, but studies link it to a hundred
different side effects, from lower-back pain to erectile
dysfunction to nausea," drug researcher Patrick Wheeler
said. "Placebo wreaked havoc all over the body, with no rhyme
or reason. Basically, whichever side effects were included on
the questionnaire, we found in research subjects."

Added Wheeler: "We must not introduce placebo to the public
until we pinpoint exactly how and why it works. The drug
never should have advanced beyond the stage of animal
testing, which, for some reason, was totally ineffective in
determining its effectiveness." In spite of the confusing
data, drug makers say placebo is safe.

"The only side effect consistent in all test subjects was a
negligible one-an almost imperceptible elevation in blood-
glucose levels," French said. "It's unfair to the American
people to withhold a drug so many of them desperately think
they need."