“Assumption number one was that if a trial were
managed correctly, a medication would perform as well
or badly in a Phoenix hospital as in a Bangalore clinic.
Potter discovered, however, that geographic location
alone could determine whether a drug bested placebo
or crossed the futility boundary. By the late '90s,
for example, the classic antianxiety drug diazepam (also
known as Valium) was still beating placebo in France
and Belgium. But when the drug was tested in the US,
it was likely to fail. Conversely, Prozac performed
better in America than it did in western Europe and
South Africa. It was an unsettling prospect: FDA approval
could hinge on where the company chose to conduct a
trial.
“Mistaken assumption number two was that the
standard tests used to gauge volunteers' improvement
in trials yielded consistent results. Potter and his
colleagues discovered that ratings by trial observers
varied significantly from one testing site to another.
It was like finding out that the judges in a tight race
each had a different idea about the placement of the
finish line.”
—
“Now, after 15 years of experimentation, he has
succeeded in mapping many of the biochemical reactions
responsible for the placebo effect, uncovering a broad
repertoire of self-healing responses. Placebo-activated
opioids, for example, not only relieve pain; they also
modulate heart rate and respiration. The neurotransmitter
dopamine, when released by placebo treatment, helps
improve motor function in Parkinson's patients. Mechanisms
like these can elevate mood, sharpen cognitive ability,
alleviate digestive disorders, relieve insomnia, and
limit the secretion of stress-related hormones like
insulin and cortisol.”
—
“ ...the nocebo effect. For example, men taking
a commonly prescribed prostate drug who were informed
that the medication may cause sexual dysfunction were
twice as likely to become impotent.”
—
“In a study last year, Harvard Medical School
researcher Ted Kaptchuk devised a clever strategy for
testing his volunteers' response to varying levels of
therapeutic ritual. The study focused on irritable bowel
syndrome, a painful disorder that costs more than $40
billion a year worldwide to treat. First the volunteers
were placed randomly in one of three groups. One group
was simply put on a waiting list; researchers know that
some patients get better just because they sign up for
a trial. Another group received placebo treatment from
a clinician who declined to engage in small talk. Volunteers
in the third group got the same sham treatment from
a clinician who asked them questions about symptoms,
outlined the causes of IBS, and displayed optimism about
their condition.
“Not surprisingly, the health of those in the
third group improved most. In fact, just by participating
in the trial, volunteers in this high-interaction group
got as much relief as did people taking the two leading
prescription drugs for IBS. And the benefits of their
bogus treatment persisted for weeks afterward, contrary
to the belief—widespread in the pharmaceutical
industry—that the placebo response is short-lived.”