The Declaration of Independence affirms our right to the pursuit
ofhappiness, but the Founding Fathers did not anticipate that
laboratory-de-signed drugs such as Prozac would become the preferred path
for so many. Prozac has become the most widely prescribed psychiatric
drug in America.
Does it really improve depression? Long a skeptic about claims for
new psychiatric wonder drugs, I decided to undertake a comprehensive
analysis of the drug and its effects. Making extensive use of the Freedom
of Information Act to obtain FDA documents pertaining to the approval of
Prozac, what I found was more dismaying than my initial skepticism
suggested. The full results are published in a new book, Talking Back to
Prozac (St. Martin's) I co-wrote with Ginger Breggin.
Contrary to widespread public belief, the FDA does not conduct any
of the studies used for drug approval; they are financed, constructed,
and supervised by drug companies using doctors they hire. While it may
take a decade for a drug to get through the FDA bureaucracy, the actual
controlled scientific studies last--as in the case of Prozac--just four
to six weeks. Anecdotal material is collected on longer-term patients,
but for Prozac, only 63 patients were followed for more than two years
before the drug's approval.
For starters, seriously suicidal patients and hospitalized patients
were excluded. Of the included patients, many were allowed to take
sedatives and minor tranquilizers to overcome Prozac's stimulant-like
side effects, vastly compromising data interpretation.
After weeding out the most badly flawed studies, the FDA found only
four that were adequate enough to consider. One of these showed that
Prozac was no better than placebo. Three others supposedly showed Prozac
to be somewhat superior to the sugar pill, but not as good as older
antidepressants. However, due to adverse drug effects and lack of drug
effectiveness, the dropout rates in most of these studies was very
high.
While the gross number of patients receiving Prozac in all the
trials was more than 5,000, the actual number finishing the trials used
for approval was very small. When I counted the actual number of patients
who completed the four- to six-week trials used for the approval of
Prozac, it turned out to be a grand total of 286. It bears
restating--only 286 patients finished the four- to six-week trials used
to determine Prozac's efficacy.
Because of the high dropout rates and because Prozac was often no
better than place-bo in many trials, many statistical maneuvers were
required to make the studies look positive. In one of the key studies,
involving six different sites around the country, results at five sites
showed Prozac to have no benefit. One site--representing 25 percent of
the patients who finished the trials--was discarded. Then the data from
the remaining sites were pooled. This is such a scientifically
unacceptable practice that the FDA prohibits drug companies from doing it
in the studies used to support advertising claims. Yet the FDA allowed it
in this case. Otherwise Prozac could not have been approved.
If Prozac was largely ineffective in the FDA studies, how and why
has it become so popular? Controlled studies routinely show that placebo
is highly effective in relieving depression. When a drug becomes a social
fad, placebo can gain miraculous powers.
There is, however, another, more disquieting reason for Prozac's
popularity. The FDA's own analysis--expunged from its published
conclusions--originally determined that Prozac is a stimulant-like drug.
Nearly all of Prozac's clearly established effects are indistinguishable
from those of classic stimulants such as the amphetamines and cocaine:
activation or energizing, nervousness, anxiety, agitation, insomnia,
nightmares, sweating, anorexia, weight loss, and in the extreme,
hypomania and mania. There is also evidence that Prozac can produce
behavioral abnormalities consistent with stimulants including paranoia
and violence, and crashing, with depression and suicidality.
Americans have always loved stimulants. During the 1960s,
amphetamines were prescribed in even greater numbers than Prozac, and
they were touted for the same disorders, including depression and
fatigue. Cosmetic psychopharmacology, presented as a unique Prozac
phenomenon, has a long history in association with stimulants. Sigmund
Freud, as he became hooked on cocaine, wrote glowingly about how it
transformed his personality entirely for the better without any negative
side effects.
Prozac's seemingly good effects are probably based on a combination
of placebo and stimulation, with no specific "antidepressant" effect.
Being artifically jazzed up can be tempting for meeting the demands of
our high-stress, high-production lifestyles.
Many people do not feel high or euphoric on Prozac, but react with
a narrowing of their emotional spectrum. They lose touch with themselves
and others, and may perceive this as a kind of relief. Commonly,
Prozac--like other stimulants--acts as an "anti-empathy" agent. It
disconnects a person from the rest of the world and from his or her own
real-life issues.
Sometimes it dulls the perception of emotional despair. Other times
it produces an artificial euphoria that can progress toward mania. At
best, people who use Prozac may become "better adjusted" to circumstances
that do not truly meet their needs or fulfill their ideals. Worse, an
individual can develop drug-induced apathy or euphoria.
Tags:
anecdotal material,
data interpretation,
declaration of independence,
depression,
drug approval,
drug effects,
drug trial,
effectiveness,
fda documents,
freedom of information,
freedom of information act,
ginger breggin,
initial skepticism,
minor tranquilizers,
placebo,
preferred path,
prozac,
psychiatric drug,
public belief,
sugar pill,
suicidal patients,
term patients,
weeding,
wonder drugs
