Freedom of Information Act Document Reveals Antidepressant Drugs Are Less Effective Than Placebos
Freedom of Information Act Document Reveals
Antidepressant Drugs Are Less Effective Than Placebos
by Monty Henry on Monday, October 30, 2012 at 10:16am
Janis Schonfeld recalls the events that started her on her
recovery from 30 years of depression with snapshot clarity: the newspaper ad
she saw in 1997 seeking subjects for an antidepressant study; the chair she was
sitting in when she called UCLA's Neuropsychiatric Institute; the window she
was looking out of when she first spoke with Michelle Abrams, the research
nurse who shepherded her through the trial. She remembers being both nervous
and hopeful when she arrived at the institute, and a little uncomfortable when
a technician put gel on her head, attached a nylon cap shot through with
electrodes, and recorded her brain activity for 45 minutes. But most of all she
remembers getting the bottle of her new pills in a brown paper bag from the
hospital pharmacy. "I was so excited," she told me. "I couldn't
wait to get started on them."
Within a couple of weeks, Schonfeld, then a 46-year-old
interior designer, got quickly and dramatically better, able once again to care
for herself and her husband and daughter, no longer so convinced of her own
worthlessness that she'd consider killing herself. For the next two months, she
came back weekly for more interviews and tests and EEGs. And by the end of the
study, Schonfeld seemed to be yet another person who owed a nearly miraculous
recovery to the new generation of antidepressants -- in this case, venlafaxine,
better known as Effexor.
But during her final visit to the institute, one of the
doctors directing the research sat her down to deliver some disturbing news.
"He told me I hadn't been taking a medicine at all. I'd been on a placebo.
I was totally shocked." So was nurse Abrams. Both women knew that half the
test subjects were getting placebos and that Schonfeld might be among them. But
not only was she feeling better -- she'd even experienced nausea, a side effect
commonly associated with Effexor, so they had each assumed that she was in the
drug group. Schonfeld was so certain of this that at first she didn't believe
the doctor. "I said to him, 'Are you sure? Check those records
again.'" But there was no doubt. The brown bag contained nothing but sugar
pills. Which didn't mean, he was quick to add, that she was making anything up,
but only that her improvement couldn't possibly be due to the pharmacological
effects of the pills.
Schonfeld's experience is hardly unique, although you
wouldn't know it from the ubiquitous advertisements for antidepressants -- nor,
if you were a doctor, would you know just how common it is from reading the
medical journals. Psychiatrists and other mental-health professionals (I am a
practicing therapist) know that any given antidepressant has only about a 50
percent chance of working with any given person. But what most people --
patients and clinicians alike -- don't know is that in more than half of the 47
trials used by the Food and Drug Administration to approve the six leading
antidepressants on the market, the drugs failed to outperform sugar pills, and
in the trials that were successful, the advantage of drugs over placebo was
slight. As it would hardly help drug sales, pharmaceutical companies don't
publish unsuccessful trials, so University of Connecticut psychology professor
Irving Kirsch and his co-authors used the Freedom of Information Act to extract
the data from the FDA.
What they found has led them, and other researchers
who've investigated antidepressants' relatively poor showing against placebos,
to conclude that millions of people may be spending billions of dollars on
medicines that owe their popularity as much to clever marketing as to
chemistry, and suffering serious side effects -- not to mention becoming
dependent on drugs for healing they might be able to do without them -- in the
bargain.
But many doctors remain convinced that antidepressants do
work, that the flaw lies not in the capsules themselves but in the studies used
to evaluate them. Clinical trials can consume half a drug's patent life. And so
pressure to bring the medicine to market leads researchers to adopt strategies
-- such as recruiting people whose depression is too mild to yield powerful
results -- better suited to clearing regulatory hurdles than generating useful
scientific knowledge. That, and not the power of suggestion, is why
antidepressants barely outperform placebos, these scientists say.
While some of this debate breaks down along familiar lines
-- psychologists resisting the tendency to reduce all mental suffering to
biology versus psychiatrists more comfortable with matter than spirit -- no one
disputes that the statistics about antidepressant efficacy are dismal, and that
they do little to clarify the question of whether people who get better on
antidepressants do so because they are taking Prozac or Zoloft or because they
are taking a pill -- any pill.
BEFORE SCIENCE TOOK OVER the healing arts and focused
physicians' attention on biological causes of disease, mystics and alchemists
and flimflam artists alike offered potions and powders to the ailing. Some of
these remedies were bizarre, like usnea -- the moss from the skull of a hanged
man, used to treat nervous illness -- and others merely fanciful, like powdered
unicorn horn. Some were truly dangerous, like calomel, a mercury-based laxative
that may have hastened George Washington's death from the cold he famously
caught while riding on a rainy night. Some -- notably cinchona bark, the source
of quinine -- turned out to have actual healing powers, but there were so few
of these that in 1860 Oliver Wendell Holmes, the doctor who fathered a Supreme
Court justice, wrote, "If the whole materia medica could be sunk to the
bottom of the sea, it would be all the better for mankind and all the worse for
the fishes."
But Holmes was not entirely correct. Despite their lack of
specific healing properties, many ancient medicines worked -- or at least
people often got better after taking them, as they still do. Most illnesses remit
as part of their natural course, but the placebo effect occurs far too
frequently to be mere coincidence. No one really understands why, but doing
something for an illness -- especially if that something involves a pill -- is
usually better than doing nothing at all.
There's no money to be made in sugar pills, so drug
companies, which fund much of the drug research in the United States, have not
looked very hard into this question. But placebos do figure prominently in
their studies -- as a stalking-horse for the potential new medications. Because
any drug may well be acting as a placebo, it is not a sufficient test simply to
give a new compound to sick people to see if they get better. To rule out the
possibility that patients are recovering because of faith or a good sales
pitch, and to ensure that the drug works by virtue of its biochemical
properties, the FDA has, since the late 1970s, required that all drugs be
tested against placebos. Typically, between 35 and 45 percent of people given
placebos improve. If a candidate drug outperforms a placebo in two independent
studies, and if it does so without untoward side effects, the FDA will approve
it for use.
The FDA does not consider, however, the relative advantage
that new drugs show over placebo. So long as the difference is statistically
significant -- meaning that the results are not merely random -- a drug can be
advertised as "safe and effective" whether clinical trials proved it
to be 5 percent or 50 percent or 500 percent more effective than an inert pill.
In the case of the Prozac generation of antidepressants, marketing efforts have
paid off wildly. Some 92 million prescriptions were written for the top six
antidepressants in 2002, a ubiquity that has, far more than any research,
helped to bolster the theory that depression is the result of a biochemical
imbalance that the drugs cure -- a theory that has not been proved, despite
more than 40 years of trying.
But critics, psychologists and psychiatrists alike, have
been suspicious of the drugs since they were introduced, and it turns out they
have some striking data on their side. "In the early '90s, many of our
psychiatric colleagues felt that patients did not do as wonderfully as all
these reports of 'magic pills' would suggest," recalled psychologist Roger
Greenberg, a professor at the State University of New York's Upstate Medical University.
"So we went back to the literature." Greenberg [no relation to the
author] and his team analyzed all the data from Prozac's clinical trials that
had been published. They determined that the new drug showed negligible
advantage over earlier antidepressants and that two-thirds of the patients
would do as well or better with placebos.
Greenberg started with material hidden in the plain light of
professional journals, but a bit of detective work by Irving Kirsch and his
research team has turned up even more disturbing evidence about the low rates
of antidepressant effectiveness. Kirsch is a soft-spoken and slight man who has
spent more than 30 years studying the placebo effect. He has a native suspicion
of biological explanations of depression and sees in the placebo effect the
potential for self-healing without resorting to expensive and possibly
dangerous drugs. While many researchers duplicated and refined Greenberg's
initial findings, Kirsch knew that there was a body of results that no one was
looking at. Manufacturers don't have to publish all their data in journals, but
they do have to report every trial to the FDA. "This was all so
controversial," he told me. "And the defenders claimed that our data
didn't tell the whole story. So we figured, why not use the Freedom of
Information Act to investigate?"
Kirsch requested the complete files on the six most widely
prescribed antidepressants approved between 1987 and 1999: Prozac, Zoloft,
Paxil, Effexor, Serzone, and Celexa -- drugs that together had $8.3 billion in
worldwide sales in 2002. Within a month, he had an even less drug-friendly
story than the one told in the journals. In "The Emperor's New Drugs,"
published in the July 2002 issue of the American Psychological Association's
Prevention & Treatment, Kirsch's team presented their findings: Of the 47
trials conducted for the six drugs, only 20 of them showed any measurable
advantage of drugs over placebos, a much lower number than turns up in
published research. This was not entirely unexpected -- "publication
bias" has long been known to be a problem in assessing the effectiveness
of drugs -- and Kirsch is quick to point out that even these meager numbers
"leave no doubt that there is a difference between drug and placebo. But I
was surprised at how small the difference was in clinical terms. The studies
all used the same measure" -- the Hamilton Depression Rating Scale, the
nearly universal way clinicians assess a patient's level of depression --
"so it was easy to see how much clinical improvement there really
was." And there really wasn't much at all: The average patient on drugs
improved by about 10 points on the 52-point Hamilton, while a placebo patient
improved by a little more than eight. "A two-point difference on the
Hamilton -- it's just clinically meaningless. Trivial," Kirsch says.
"You can get that from having an improvement in sleep patterns, and if one
of the side effects of the drugs is to induce drowsiness, the whole difference
could be right there." (Indeed, critics say the Hamilton is skewed toward
physical symptoms of depression, those most likely to be affected by
medication.)
Kirsch received copies of memos indicating that regulators
had, in at least one case, raised questions about clinical significance. In
1998, Paul Leber, then director of the FDA's Division of Neuropharmacological
Drug Products, wrote of Celexa, "There is clear evidence from more than
one adequate and well-controlled clinical investigation that [Celexa] exerts an
antidepressant effect. The size of that effect, and more importantly, the
clinical value of that effect is not something that can be validly measured, at
least not in the kind of experiments conducted." A deputy agreed: "It
is difficult to judge the clinical significance of this difference," he
wrote, but added that this shouldn't be an impediment for bringing Celexa to
market because "similar findings for...other recently approved antidepressants
have been considered sufficient."
Kirsch argues that by the FDA's own logic, it's not even
clear if the drugs' small advantage is truly pharmacological. In trials, every
drug response is assumed to be partially a placebo response, and the drug
effect is only the additional benefit -- in the case of the antidepressant
studies, less than two points out of ten, or 20 percent of the overall
improvement. This means, he said, that "80 percent of the drug effect is
the placebo effect." And even the remaining 20 percent could be due to placebo
effects enhanced by the drugs' side effects, amplified by the way the trials
are conducted. "A person is brought into a clinical trial and told, 'You
may be getting placebo or drug. The real drug has the following side effects.'
Put yourself in this position. You're certainly curious about what you're
getting. And you want to get better. You notice that your mouth is getting dry,
which is one of the side effects they told you about, and that leads you to
conclude that you've been assigned to the drug condition. Presumably, a placebo
works by affecting a person's expectancy about what is going to happen. If you
know you've been assigned to the drug condition, you may have a stronger
placebo effect because you're now more convinced that you're getting something
that's going to help you." Greenberg's research shows that both patients
and raters in clinical trials often "break the blind" by guessing
which condition they have been assigned and that the most powerful drug effects
are reported when this occurs. The guesses don't even have to be accurate.
Janis Schonfeld experienced side effects on placebo, and this was part of what
led her (and nurse Abrams, who was scoring the Hamilton) to assume she was on
drugs. According to Kirsch's theory, Schonfeld's strong response (and Abrams'
rating of her progress) may have come about because they thought -- due to
symptoms caused by the power of suggestion -- that she was on the drug.
Kirsch thinks it is possible to test his theory, but only
with a radical redesign of the method used to validate drugs. Instead of two
groups, a study would have four. Researchers would tell two groups of patients
they were getting placebo and the other two that they were being given the
drugs. But only half the patients would be told the truth. And the placebo
would be a nonpsychoactive substance designed to mimic at least some of the
side effects of the real drug. This way researchers could look directly at the
role of suggestion in response to both placebo and drug. It is, however,
currently considered unethical to deceive patients in this fashion.
But there is plenty of indirect evidence for Kirsch's
position, including a peculiar recent finding: Both placebo response and drug
response for antidepressants have steadily increased over time, so much so that
the best predictor of whether research shows positive results is the year the
study was published. This result has yet to be explained, but Kirsch thinks it
indicates the way the wide- spread publicity about antidepressants shapes
patients' expectations. "It suggests that over time the drugs have gotten
more potent for reasons other than chemistry. I would suspect that it's because
of increased marketing." Kirsch explains the way that marketing can
capitalize on a central mechanism of depression: "The hopelessness of
depression is the expectancy that a terrible state of affairs is not going to
get better. Now you give somebody a treatment that's been touted as the cure
for the worst thing in their lives. What that does is to instill a hope, which
is the opposite of depression." Kirsch's theory leads to an unsettling
conclusion: Drug companies may have marketed their antidepressants beyond what
statistics justify, but the barrage of advertising may also have inadvertently
amplified the placebo effect and thus increased the effectiveness of the drugs
they are selling.
WHEN I FILL OUT A treatment report explaining to an
insurance company why they ought to pay for someone's therapy, I am asked for a
diagnosis. If the patient is depressed and not on antidepressants, I often must
explain why not. Were it not for these bureaucratic demands -- and for all the
miracle-drug testimony found in advertising and casual talk -- the FDA
statistics would hardly be surprising or disturbing, because, like many clinicians,
I have come to see that the effects of Prozac and its cousins are just about as
pallid as those numbers would predict: The drugs are not panaceas, not solid
evidence that depression is a chemical imbalance, but have proved to be
moderately useful for some people (and moderately harmful to others). No
scientist doubts the existence of the disconnect between the data and the way
antidepressants are perceived and used, but Kirsch's theory about it is far
from the industry standard. Indeed, some simply dismiss it out of hand -- like
Donald Klein, a renowned psychiatry professor at Columbia University's New York
State Psychiatric Institute, who thinks that Kirsch's work is so biased against
antidepressants that, though asked, he declined to be among the respondents to
"The Emperor's New Drugs" -- "for the same reason," he told
me, "that I don't argue with creationists."
Klein, who has conducted antidepressant trials for
pharmaceutical companies, acknowledges that the data can leave the impression
that the drugs don't work very well. But he is among those who think this says
more about the trials than the drugs. According to Klein, the FDA standard --
two successful trials without untoward side effects -- won't elicit a full body
of knowledge about new drugs, and may even limit what the tests can tell us. "The
job of the pharmaceutical company is to get FDA approval," he says.
"So you want to go in with a dose which is effective but doesn't create
side effects. It's a real problem. Drugs are not being tested for their optimum
efficacy." Nor, given this strategy, are they tested for their maximum
side effects -- which may be why reports of agitation and suicidal impulses in
excess of what the trials found have dogged the Prozac generation of antidepressants
since they were introduced.
Clinical trials can become a game for drug companies to win
rather than a venue for generating scientific knowledge. And it's a game that
establishes perverse incentives, in part because drugs' limited patent lives --
usually 20 years -- begin before clinical trials, which can take a decade,
start. "We're talking real money here," says Klein, noting it takes
between $300 to $500 million to develop a new drug. Klein told me that within
the industry the clinical trial period is thought to cost "a million
dollars a day. That adds some pressure for finishing trials fast."
Despite the bottom-line approach, "there are lots and
lots of compounds that get evaluated and never approved," notes Lawrence
Price, a psychiatrist who directs research at Brown University's Butler
Hospital. A more nuanced criterion for a successful trial is possible, but,
says Price, "it would just take forever. It's not that there aren't
important questions, but you would get so bogged down in trying to nail down
the details that you would just never make any progress with newer
compounds."
You also might not make any progress if you waited around
for severely depressed people to test drugs on. "The problem with
antidepressant studies," according to Klein, "is that anything that
can be confused with ordinary unhappiness gets in" -- which means that
subjects in clinical trials are insufficiently depressed, too close to normal
to show dramatic improvement. Price, who has conducted clinical trials of
antidepressants for 25 years, points out that recruitment techniques like the
one that attracted Janis Schonfeld to UCLA can lead to a skewed sample.
"If you go out and advertise in the newspaper for depressed people,"
says Price, "you are going to get less ill people than if you are taking
people who are brought in via the emergency room."
Relatively high-functioning, moderately depressed people,
those most likely to enroll in and finish a trial, are, as it happens, more
likely to register a high placebo response. There are no biochemical markers of
depression, no blood test or X-ray that confirms its presence, so it can be
judged only by its appearance -- which means, in trials, by the Hamilton, a
test of subjective states scored by clinicians whose employers are paid up to
$10,000 for each patient who completes a study. "If the investigator has
directed his/her research assistant to rate liberally on the Hamilton,"
says Price, "then you are going to have more people meeting the entry
criterion," typically, at least 17 points -- the line dividing mildly and
moderately depressed. (One of Price's colleagues estimates that Hamilton scores
are inflated by up to five points for clinical trials.)
The drug companies, of course, want more than speedy trials.
They want successful ones. "Placebo is a killer for them," Price
explains, "because if they spend $40 million on a trial and get a placebo
response rate of 50 percent, then they've just wasted that $40 million. There's
a huge interest in trying to address the high placebo response rate in
depression. How can it be lowered? How can you identify the sample of people in
whom these compounds are really going to work?"
The study in which Janis Schonfeld enrolled may provide some
answers to these questions -- although somewhat inadvertently. Hoping to
eliminate the trial-and-error method used to match patients with
antidepressants, the UCLA doctors were using electroencephalograms to determine
if there was some neurochemical difference between the brains of people who
respond to Effexor and those who respond to Prozac. The researchers found the
differences they were looking for, but they also got a surprise. The EEGs of
placebo responders were different from those of the drug responders, and
similar to each other, a phenomenon that had never before been observed and
that may be the first step to identifying the neurochemistry of the placebo
response. This was welcome news to the drug companies, who'd like nothing more
than to eliminate placebo responders from their studies.
Take away the people most likely to show a strong placebo
effect, include the people most likely to respond to a drug, and the statistics
become more favorable for the manufacturers and provide less ammunition for
critics like Greenberg and Kirsch. Psychologist David Antonuccio, a professor
at the University of Nevada, claims that the deck is already stacked. In
addition to publication bias, inflated Hamilton scores, and broken blinds, he
points to the placebo washout period that starts every clinical trial: All patients
are given a week of placebo treatment, and the strongest responders are
eliminated from the study. The idea, of course, is to get a more accurate
estimate of the true drug effect, but "if you put everybody on an
antidepressant and washed out everyone who responds, people would say, 'That's
a very biased strategy against the drugs.' Well, I believe we have a strategy
here that's biased against the placebo condition."
AFTER JANIS SCHONFELD was debriefed, she was given her
reward for participating in the study: a one-year supply of Effexor. She didn't
consider not taking the drug. "They told me that I'd gotten a good start,
that if I'd done well on placebo, I'd probably do better on the drug." And
so she did. "After about a week or maybe two weeks it was like a fog was
lifted from my eyes. I realized I had spent much of the last 20 years in that
fog." Schonfeld took Effexor for two and a half years and then "one
day I just thought, 'You know, I don't think I need this medication anymore.' I
spent three weeks weaning off of it. That was about a year and a half ago, and
I haven't really felt that I needed it since." She emphatically rules out
the possibility that her improvement was a result of placebo effects, amplified
or otherwise.
To Kirsch, Schonfeld's is a case of lost opportunity.
"Why not say to her, 'You did this'? People respond the way they were
expecting to respond, so why not work on that expectation? Why not teach her
the strategies that she can use to make herself feel better?" Antonuccio
says, "Placebo is a valid intervention in and of itself," adding that
people like Schonfeld have ample contact with trained staff during trials,
which may itself be what accounts for the high placebo rates. "It's
possible that psychological treatments are mostly placebo as well," he
says -- not, as he is quick to add, that there's any- thing wrong with that.
"We just ought not to see the placebo effect as some sort of inferior
response or condition."
But even though, as Kirsch notes, "more placebos have
been administered to research participants than any single experimental
drug," they remain poorly understood and used, for the most part, only
inadvertently and haphazardly. The discovery of biological underpinnings of the
placebo effect may change this, as drug researchers grasp the potential of
turning yet another neurochemical pathway into a pharmaceutical market by
developing a placebo drug. Bizarre as this sounds, it may be the only incentive
that will lead a profit-driven health care industry toward an understanding of
humanity's oldest means of healing.
Additional Reading:
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- Pharmaceuticals Found In Our Drinking Water!
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*
If you are near or beyond your credit limit or simply want to avoid
high interest credit card fees, our e-layaway is the smart choice for
you.
Flexible Payment Schedules:
*
Similar to traditional layaway, e-layaway lets you make regular payments
towards merchandise, with delivery upon payment in full. Payments are
automatically deducted from your bank account or made in cash using
MoneyGram® ExpressPayment®
A Tool for Planning Ahead:
*
Our e-layaway makes it easy for smart shoppers like you to plan ahead
and buy items such as bug detectors, nanny cameras, audio bugs, gps
trackers, and more!
No Hidden Charges or Mounting Interest:
Our
e-layaway makes shopping painless by eliminating hidden charges and
monthly interest fees. Our customers pay a flat transaction fee on the
initial purchase price.
NO RISK:
* You have the right to cancel any purchase and will receive a refund less a cancellation fee. See website for details.
Security and Identity Protection:
DPL-Surveillance-Equipment
has partnered with trusted experts like McAfee and IDology to ensure
the security and integrity of every transaction. Identity verification
measures are integrated into our e-layaway system to prevent fraudulent
purchases.
Note: Simply Choose e-Lay-Away as a "Payment Option" in The Shopping Cart
DPL-Surveillance-Equipment.com
is a world leader in providing surveillance and security products and
services to Government, Law Enforcement, Private Investigators, small
and large companies worldwide. We have one of the largest varieties of
state-of-the-art surveillance and counter-surveillance equipment
including Personal Protection
and Bug Detection Products.
Buy, rent or lease the same
state-of-the-art surveillance and security equipment Detectives, PI's,
the CIA and FBI use. Take back control!
DPL-Surveillance-Equipment.com
Phone: (1888) 344-3742 Toll Free USA
Local: (818) 344-3742
Fax (775) 249-9320
Monty@DPL-Surveillance-Equipment.com
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Phone: (1888) 344-3742 Toll Free USA
Local: (818) 344-3742
Fax (775) 249-9320
Monty@DPL-Surveillance-Equipment.com
Google+ and Gmail
DPLSURVE
DPLSURVE
MSN
Monty@DPL-Surveillance-Equipment.com
AOL Instant Messenger
DPLSURVE32
Skype
Montyl32
Yahoo Instant Messenger
Montyi32
Alternate Email Address
montyi32@yahoo.com
Join my Yahoo Group!
My RSS Feed
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