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Uffe Ravnskov
I assume that all of you know Petr Skrabanek, a brilliant mind and one of
the first cholesterol sceptics. Unfortunately he died all too early in the
midst of his career as an outspoken medical philosopher and scientist.
James
McCormick, the president of The Skrabanek Foundation and a member of
THINCS has informed me that Petr's books, "Follies and Fallacies",
"The Death of Humane Medicine" and "False Premises, False
Promises" are now available from Dr. Maurice Gueret mgueret@iol.ie
. Each priced at £25, £23 and £23, respectively. Cheques to be made
payable to The Skrabanek Foundation.
I
can recommend all Petr's books warmly. The first one, which he wrote
together with James, should become standard reading for all medical
students. I am confident that if it had been, much of the lousy science
that we so disrespectfully have compared with various forms of animal
spillings would never have come into print.
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Dag Viljen Poleszynski
I
have read Skrabanek's and McCormick's "Follies and fallacies in
medicine" and am not that impressed. The chapter on placebo effects
completely ignores the very methodical and careful criticism raised
against this concept by Gunver Sophia Kienle in "Der sogenannte
Placeboeffekt" (Schattauer NY 1995), which she demonstrates does not
exist anywhere in the literature surveyed. Furthermore, his chapter on
"Alternative medicine" picks some of the least interesting
alternatives and concludes that the whole field is full of humbug:
"The claims of systems of alternative medicine all have two things in
common. They have no detectable or coherent raison d'être other than the
enthusiasm of their advocates and, almost withouth exception, they claim
to cure or alleviate a very large number of ill-defined and quite
disparate ills."
Another
statement is: "Many people are convinced of the benefit which they
derive from the daily addition of vitamins or other substances to their
already adequate diets" (p. 10). No data are offered to show what
this means, nor to refute the proven benefits of many nutritional
supplements (like folic acid, B6 and B12). Such statements should speak
for themselves as an indication of their objectivity and approach to
science.
Aside
from his sarcastic tone and non-scientific jargon, the book contains many
good points concerning conventional medicine.
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Uffe
Ravnskov
Your criticism of Follies and Fallacies is unfair. On page 113 you can
read: Regrettably, not all doctors practice rational medicine (certainly
not; my comment), and conversely, not all healers are quacks."
What
Petr and James wrote about was the myriad of unscientific alternative
healing principles such as homeopathy, Bach´s flower therapy, Christian
Science, iridology and much more, all of which "does not derive from
any coherent or established body of evidence, and...is not subjected to
rigorous assessment to establish its value"(Quotations from FAF).
The
non-existence of the placebo effect was unknown to me and is in
conflict with my 40 years experience of clinical medicine. Please explain.
Besides,
the paper you cite was published 1995 whereas Follies And Fallacies was
published 1989. By the same reason the authors could not know any
possible effects of folic acid, B6 and B12 besides those that are seen in
vitamin-deficient patients
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Dag Viljen Poleszynski
I disagree that criticism of Skrabanek & McCormick is unfair. Nobody
is beyond criticism. That doesn't mean that they don't have some good
points. However, I'm not very impressed with Skrabanek's evaluation of
alternatives nor with his sarcasms. If he and his partner were a bit more
openminded, they would have known a lot about vitamin therapy in 1989 - 20
years after McCully suggested that the three B vitamins could cure
homocysteinurina, more than 30 years after Hoffer's first niacin studies
with schizophrenics and about 40 years after the first successfull
treatments with megavitamins. The effects of many vitamins were well
known by then, although not recognized by orthodox doctors. There are
hundreds of alternative therapies, several of which actually work, but S
& McC apparently could not find any that had any merit! The
effectiveness of vitamin C has nothing to do with the "faith of the
therapist", as the authors perhaps would imply - most very effective
therapies work by themselves without the necessity of believing in them.
One prime example is cutting out wheat and other gluten-containing
products by a celiac patient - faith doesn't matter in the improvements
which invariably will follow.
It
is in this spirit that Kienle and collaborators have looked critically at
all papers published on the placebo effect. They have used the same
meticulous and patient procedure that you, Uffe, have used to pick apart
any and all studies linking fat and cholesterol to heart disease. Their
decimation of Beecher's "landmark" 1955 study is admirable -
they show that his data are either constructed, missing of
misinterpretated. Beecher's much quoted "35% placebo effect"
proves to be a fiction of his imagination. Please read the book by Kienle
or her article in Erfahrungsheilkunde 5/1997: 298-307 or (with Helmut
Kiene) in Alternative therapies 1996; 6(2): 39-54. Two other critics of
the placebo effect are Asbjørn Hrobjartsson and Peter Gøtzsche; cf for
instance their article "Is the placebo powerless?" in NEJM 2001;
344: 1594-1602 ("We found little evidence in general that placebos
had powerful clinical effects"...).
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Uffe Ravnskov
Dag - The aim with Skrabanek's and McCormick´s book was not to discuss good
science but to expose follies and fallacies.
I
am not familiar with the placebo literature. However, Hrobjartsson and Gøtzsches
NEJM paper was met with many objections that in my opinion were not
answered convincingly. Below I have quoted some of them. In any case, you
can´t blame the authors for not having read a paper that was published 12
years after the publication of their book!!!
To
the Editor: The main reason we are
skeptical about Hróbjartsson and Gøtzsche's condemnation of
placebos in nontrial settings concerns expectations. A
patient enrolled in a clinical trial with, say, one-to-one
randomization knows that there is only a 50 percent chance of
getting the putative active ingredient and, furthermore, that
there is considerable doubt about the effectiveness of the
active ingredient. This is very different from the use of
placebos in nontrial settings, in which many patients may
believe, 100 percent, that they are receiving a useful active
substance. We hypothesize that the relation between doubt
about the effectiveness of a treatment and its placebo effect
(which we would define as the psychologically mediated effect
of treatment) is nonlinear, with a huge reduction in the
placebo effect once any substantial doubt is present.
Richard
J. Lilford, Ph.D., F.R.C.P.
David A. Braunholtz, B.Sc.
….In
most of the randomized, controlled trials, the no-treatment group
still involved some form of treatment. Examples were contact with
a psychiatrist, maintenance of interpersonal psychotherapy, weekly
60-minute small-group meetings, and additional pharmacotherapy. In
some trials, patients were selected after a response to a specific
treatment (e.g., only those who had a response to amitriptyline were
enrolled in the trial by Klerman et al.,4
and those with a response after placebo in the trial by
Rabkin et al.).5
Therefore, the hypothesis that there is no difference between
placebo and no treatment was not actually tested, and no
definitive conclusions can be drawn.
Thomas E. Einarson, Ph.D., Michiel Hemels, M.Sc.
….Hróbjartsson
and Gøtzsche conclude that there is no justification for the
use of placebos outside the setting of clinical trials. Their
findings are impressive, but is their conclusion too sweeping?
First, they did find some evidence of an effect in the
important subgroup of trials in which the main outcome was
pain. Second, despite the large sample, the statistical power
to examine many subgroups of interest was low. Their data may
have failed to demonstrate a small but clinically useful
benefit of placebo for some patients and for some outcomes other
than pain. Third, they found statistical evidence of heterogeneity of
results in studies with binary outcomes. The results could not
be heterogeneous unless at least one trial differed from the
others, which would require a real (though unidentified) effect.
Fourth, they studied patients in randomized clinical trials,
many of which focused on serious conditions whose clinical consequences
may have overshadowed small but useful effects of placebo.
Fifth, they noted that the low methodologic quality of some
trials might explain a lack of effect, though they found no
association between dimensions of trial quality and significant effects
of placebo…..
John C. Bailar III, M.D., Ph.D.
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Beatrice
Golomb
You might be interested in another perspective on the placebo issue. I
wish I had these in PDF, but I don't. Probably the best single citation is
the original Nature letter (and possibly its follow-up). The point is made
that there are no regulations about what goes into placebos, any
guidelines are at best informal, companies that manufacture the drug under
study often determine the components, the composition of placebos are
rarely named in journal articles and there is no requirement to do so, and
there are no placebos that are known to be truly physiologically inert (including
sugar pills, which for instance led to significant GI effects in persons
who are lactose intolerant in several studies; or substances that are not
absorbed, like methylcellulose which is sufficiently effective at lowering
cholesterol that trials were conducted on this effect). Indeed, in some
cases the outcome of a study can be traced to active effects of the
placebo. A positive, negative or same direction effect of a placebo can
lead to the spurious appearance of a negative, positive, or null effect of
a drug.
1.
Golomb BA. Paradox of placebo effect. Nature 1995; 375:530
2. Golomb BA. Using placebos. Nature 1996;
379:765..
3. Golomb BA. Are placebos bearing false
witness? Chemistry and Industry 1995; 21:900.
4. Golomb
B. When are medication side effects due to the nocebo phenomenon? JAMA
2002; 287:2502-3; discussion 2503-4.
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Dag Viljen Poleszynski
Dear Uffe, I agree with you - S & M could not have read the
criticism of placebo by Gøtzsche et al., but they could have read
Beecher's much quoted paper from 1955, since they did write rather
uncritically about the placebo effect (p. 14: ....placebo response from 25
to 75%). This only goes to show that nobody is perfect, we all have
something to learn.
In
general, criticism is very important (and you are a master at that), but
perhaps equally important is to offer som viable alternatives (at least
som alternative hypotheses) to whatever one is criticizing. Otherwise,
people may be left with nothing to believe in....
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Uffe
Ravnskov
Why
it is so unpleasant/uncomfortable/scary to be without an idea about this
or that, not to be able to explain everything? Isn't it a good
starting point for discovery? I am rather ignorant than being misled
by follies and fallacies.
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Dag Viljen Poleszynski
I am not scared/unconfortable not being able to explain everything, on
the contrary! However, when patients ask, they need some advice as to what
seems to be rational to do, based on the best knowledge at hand. I met the
same objection in 1994 when Norwegian elites tried to make Norway join the
EU. The "no" movement only said "no" and had no
alternatives. I wrote a book outlining a number of alternatives to Norway
joining the EU, but the message drowned in the heated media debate. Since
the EU was rejected, Norway instead got the EEA agreement, which is a much
worse solution (in my mind) than the Swiss alternative (not joining, but
having an alternative affiliation).
Since
I edit a health journal and give a lot of lectures, I get a number of
questions about nutritional supplements, n-3 oils, how much fat one could
eat, etc. If I don't know the answer to a question, I say so, but being
able to give some guidelines is met with many positive reactions. Hence,
we don't need to explain everything, but we should at least be able
to explain why we recommend what we do or live the way we do.
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Malcolm Kendrick
If
I may throw my hat into the ring on this one. The placebo effect is
something that I have been thinking about a great deal recently - I
am not sure why, I just started to question the unquestioned assumption
that the placebo effect actually exists.
Almost
all placebo studies have been done in pain - possibly the most
subjective of all medical 'experiences.' So far as I am aware no-one has
measured placebo effect on objective outcomes e.g. speed of wound healing,
or progression of CHF.
As
with so many things in medicine the 'placebo' effect fits with our rigidly
constructed prejudices i.e. the idea sounds right, so we believe it.
No-one has ever (at least not that I could find) done a study with a
treatment arm, a placebo arm and a 'do nothing at all' arm. Until such
studies are done, we will not know if the placebo effect is real,
means anything, or should continue to be included as part of the so-called 'gold-standard'
clinical trial.
I sometimes
wonder how many billions of dollars (may) have been wasted on
placebo-controlled trials - when the whole concept of the impact of
placebo has never been subjected to any trial?
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Morley Sutter
Malcolm:
Your comments concerning the role of placebos are appropriate.
As illustrated by the attached abstracts I have garnered over the
past few years, however, placebos can be ignored only under certain
circumstances and after due deliberation.
Moyad
MA. Institution M.A. Moyad, Department of Urology, Univ. of Michigan
Medical Center, 1500 East Medical Center Drive, Ann Arbor, MI 48109-0330;
United States. E-Mail: moyad@umich.edu.
The placebo effect and randomized trials: Analysis of alternative
medicine. Urologic Clinics of North America. Vol 29(1) (pp 135-155), 2002.
Randomized controlled trials are generally regarded as the gold standard
of study designs to determine causality. The inclusion of a placebo group
in these trials, when appropriate, is critical to access the efficacy of a
drug or supplement. The placebo response itself has received some attention in the medical literature over
the past fifty years. The recent increasing utilization of dietary
supplements and herbal medications by patients makes it imperative to
reevaluate the placebo response in conventional and alternative medicine.
This article will review some of the negative and positive results from
randomized trials utilizing dietary supplements androstenedione,
beta-carotene, CoQ10, garlic, soy, vitamin C and E...) for a number of
non-urologic and urologic conditions, including cancer.
Moerman,
Daniel E. PhD; Jonas, Wayne
B. MD Deconstructing the Placebo Effect and Finding the Meaning Response.
Annals of Internal Medicine. 136(6):471-476,
March 19, 2002We provide a new perspective with which to understand what
for a half century has been known as the "placebo effect." We
argue that, as currently used, the concept includes much that has nothing
to do with placebos, confusing the most interesting and important aspects
of the phenomenon. We propose a new way to understand those aspects of
medical care, plus a broad range of additional human experiences, by
focusing on the idea of "meaning," to which people, when they
are sick, often respond. We review several of the many areas in medicine
in which meaning affects illness or healing and introduce the idea of the
"meaning response." We suggest that use of this formulation,
rather than the fixation on inert placebos, will probably lead to far
greater insight into how treatment works and perhaps to real improvements
in human well-being.
Kaptchuk,
Ted J. OMD Institution From Harvard Medical School, Boston, Massachusetts.
The Placebo Effect in Alternative Medicine: Can the Performance of a
Healing Ritual Have Clinical Significance?[Miscellaneous] Annals of
Internal Medicine. 136(11):817-825,
June 4, 2002.
In alternative medicine, the main question regarding placebo has been
whether a given therapy has more than a placebo effect. Just as mainstream
medicine ignores the clinical significance of its own placebo effect, the
placebo effect of unconventional medicine is disregarded except for
polemics. This essay looks at the placebo effect of alternative medicine
as a distinct entity. This is done by reviewing current knowledge about
the placebo effect and how it may pertain to alternative medicine. The
term placebo effect is taken to mean not only the narrow effect of a dummy
intervention but also the broad array of nonspecific effects in the
patient-physician relationship, including attention; compassionate care;
and the modulation of expectations, anxiety, and self-awareness. Five
components of the placebo effect-patient, practitioner,
patient-practitioner interaction, nature of the illness, and treatment and
setting-are examined. Therapeutic
patterns that heighten placebo effects are especially prominent in
unconventional healing, and it seems possible that the unique drama of
this realm may have "enhanced" placebo effects in particular
conditions. Ultimately, only prospective trials directly comparing the
placebo effects of unconventional and mainstream medicine can provide
reliable evidence to support such claims. Nonetheless, the possibility of
enhanced placebo effects raises complex conundrums. Can an alternative
ritual with only nonspecific psychosocial effects have more positive
health outcomes than a proven, specific conventional treatment? What makes
therapy legitimate, positive clinical outcomes or culturally acceptable
methods of attainment? Who decides?
Grandjean
P. Guldager B. Larsen IB. Jorgensen
PJ. Holmstrup P.PLACEBO
RESPONSE IN ENVIRONMENTAL DISEASE - CHELATION THERAPY OF PATIENTS WITH
SYMPTOMS ATTRIBUTED TO AMALGAM FILLINGS.
Journal of Occupational &
Environmental Medicine. 39(8):707-714,
1997 Treatment of patients who attribute their environmental illness to
mercury from amalgam fillings is largely experimental. On the Symptom
Check List, overall distress, and somatization, obsessive-compulsive,
depression, and anxiety symptom dimensions, were increased in 50
consecutive patients examined and Eysenck Personality Questionnaire scores suggested less extroversion and
increased degree of emotional lability. Succimer (meso-2,
3-dimercaptosuccinic acid) was given at a daily dose of 30 mg/kg for five
days in a double-blind, randomized placebo-controlled trial, Urinary
excretion of mercury and lead was considerably increased in the patients
who received the chelator: Immediately after the treatment and 5 to 6
weeks later, most distress dimensions had improved considerably, but there
was no difference between the succimer and placebo groups. These findings
suggest that some patients with environmental illness may substantially
benefit from placebo.
Weihrauch TR.
Gauler
TC.Placebo - Efficacy and adverse effects in controlled clinical trials
[Review] Arzneimittel-Forschung.
49(5):385-393, 1999 May.
The therapeutic efficacy of placebo in a series of diseases has long been
known. It is less well known, however, that treatment with placebo can
also produce significant adverse drug reactions. Therefore, the placebo
drug reactions from controlled trials were studied for the first time
systematically Method:
The efficacy and the safety of placebos were investigated using patient
and drug data pooled from randomized, placebo-controlled, multicentre
studies in five different groups of indications covering the therapeutic
areas of cardiology (nisoldipine), neurology/psychiatry (nimodipine/
ipsapirone), metabolism (acarbose) and gastroenterology (hydrotalcite).
Results: The efficacy of placebo was clear, and varied
not only between the five indication groups but also within them. Whereas
placebo, unlike active treatment, produced hardly any improvement in
symptoms in patients with severe stroke, it was as effective as active
treatment in patients with mild neurological deficits, producing an
improvement of about 50 %. In patients with angina pectoris, placebo
produced an increase in exercise tolerance (treadmill
walking time to onset of ST-segment depression and angina attacks) of
about 10 % on average, compared with about 22 % under active treatment (nisoldipine).
In diabetes therapy, placebo produced no improvement in fasting and
postprandial blood glucose levels compared with active treatment (acarbose),
and also had no effect on HbA(1C) values. Adverse effects of placebo: Adverse drug reactions were observed
under treatment with placebo. The frequency and type of placebo-induced
adverse reactions also varied between indication groups. For example,
typical cardiovascular effects such as tachycardia were observed in the
control group. The placebo side effect profile was largely similar to the
side effect profile of the active treatment. Some adverse drug reactions (such as "dry mouth" in patients with
generalized anxiety syndromes) were observed more frequently under placebo
than under active treatment. Conclusions: Treatment with placebo is frequently effective and
cannot therefore be considered as "non-treatment". Placebo effects can only be quantified by direct
comparison with "non-treatment". Like active treatment, treatment with placebo is frequently
accompanied by adverse drug reactions. Placebo adverse effects are often disease- and active
treatment-specific. The
effects and adverse effects of a placebo need to be known before the
effects of active treatment in controlled clinical trials can be assessed.
The mechanisms of placebo effects are many and varied (e.g.
endorphin release, conditioning). Since the use of drugs without regard to evidence-based medicine (prescription
of drugs without proven efficacy = pseudoplacebos) may clearly also result
in serious adverse effects, such practice may not only be non-beneficial
but may even be harmful.
Hrobjartsson A.
Gotzsche
PC. Is the placebo powerless? An analysis of clinical trials comparing
placebo with no treatment. [Review] New England Journal of
Medicine. 344(21):1594-1602, 2001 May 24.
Background: Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting
this finding has not been rigorously evaluated. Methods: We
conducted a systematic review of clinical trials in which patients were
randomly assigned to either placebo or no treatment. A placebo could be
pharmacologic (e.g., a tablet), physical (e.g., a
manipulation), or psychological (e.g., a conversation). Results: We
identified 130 trials that met our inclusion criteria. After the exclusion
of 16 trials without relevant data on outcomes, there were 32 with binary
outcomes (involving 3795 patients, with a median of 51 patients per trial)
and 82 with continuous outcomes (involving 4730 patients, with a median of
27 patients per trial). As compared with no treatment, placebo had no
significant effect on binary outcomes, regardless of whether these
outcomes were subjective or objective. For the trials with continuous
outcomes, placebo had a beneficial effect, but the effect decreased with
increasing sample size, indicating a possible bias related to the effects
of small trials. The pooled standardized mean difference was significant
for the trials with subjective outcomes but not for those with objective
outcomes. In 27 trials involving the treatment of pain, placebo had a
beneficial effect, as indicated by a reduction in the intensity of pain of
6.5 mm on a 100-mm visual-analogue scale. Conclusions: We found little
evidence in general that placebos had powerful clinical effects. Although
placebos had no significant effects on objective or binary outcomes, they
had possible small benefits in studies with continuous subjective outcomes
and for the treatment of pain. Outside the setting of clinical trials,
there is no justification for the use of placebos
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Malcolm
Kendrick
Thanks for that. As usual, someone on this group has information. It
appears from the abstracts that my natural prejudices in this area
are re-inforced. Placebos have no effect on non-subjective outcomes e.g.
patients with severe stroke. With significant impact on subjective
outcomes - primarily pain.
You
say that placebos can only be ignored under certain circumstances and
after due deliberation. My problem with this statement is that one can
only deliberate when you have data upon which to deliberate. If I said
that there was no need to have a placebo arm in a hypertension trial, then
how could this point be discussed. There is no data on the effect of a
placebo on blood pressure reduction.
The
current 'answer' to the lack of data is always to have a placebo arm
- just to be safe? But in real clinical practice you do not treat some
patients with an active compound and others with a placebo. You either
treat or you do not. So a trial with no placebo arm would give you a more
accurate representation of what would happen to outcomes in real clinical
practice - would it not?
Frankly,
I think the whole idea that trials should be done (wherever possible) with
a placebo arm is completely non-scientific, as there is little or no
evidence to support the hypothesis. Just because a few people report
reduced pain, or increased endurance on a tread-mill test when given
placebo, does not mean that all, or any, clinical outcomes are
affected by placebo (other than subjective reporting). Nor does it mean
that this effect translates in any way into clinical trial results.
Currently,
the need for a placebo control arm in a clinical trial is an unsupported
hypothesis. Or to use Uffe's term - a myth.
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Dag Viljen Poleszynski
Malcolm hit the nail on it's head! If we are looking for real cures, there
is no need for placebo-controls. I just had phone call from a lady who
reduced her weight from 161 kg til 51 kg on a low-carb diet (98 kg down in
8 months). Was it a "placebo effect", and should there have been
a control person??? Placebo-controlled studies were made for drug trials
with small effects. Let them continue using this method for things that
hardly work, as shown by Uffe...
Again: read the German studies previously referred to and be convinced.
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Uffe
Ravnskov
…but
don´t forget to read Follies
and
Fallacies as well.
Finally,
a humorous look at the matter, sent by Herbert
FDA
Approves Sale of Prescription Placebo
WASHINGTON, DC- 9/17/03 -
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 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."
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