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WASHINGTON, DC—After more than four decades of testing in tandem
with other drugs, placebo gained approval for prescription use from the Food
and Drug Administration Monday.
“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
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.
"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,
“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.”
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