Our powerful mind and hope.
One
of the main arguments for continuing drug treatment for depression, psychosis
and bipolar disorder is that you will get worse from stopping the drugs, especially
if they are stopped abruptly. These are findings from mainstream psychiatry.
However,
if we combine this information with the methodology of the randomized
controlled trial, we may see that these drug trials do not show efficacy of
drugs, and may not be usable to show safety. The positive side to this is that
the trials may actually demonstrate the healing power of our own minds.
When drugs
are tested, patients are given a placebo for 4 to 14 days in order to wash out
the drug that they have been taking before the trial. Patients do not know that
they are getting a placebo, and many of them may think that they are lucky and
have been given the new wonder drug.
During this
washout period, many individuals react very well, so well that they do not have
enough psychological problems to enter the real drug trial. These are so-called
placebo responders. They are removed from the trial, since they are not
depressed or psychotic enough to take part in the research project.
This seems
like it is going to give the drug and unfair advantage. However, if the drug
group and the placebo group are of the same size, this does not actually
provide an advantage for the drug. But something much more significant is
happening.
The placebo
washout period is used to ensure that all participants have brains free from
the previous drug they were taking before they start treatment with the new drug.
That means
that at the end of the placebo washout period, all the patients are in acute
withdrawal. One would reasonably expect these patients to do quite poorly, to
be quite disturbed. Some of them are , but many who had a problem when they
were on the drug, actually get well from stopping the drug cold turkey.
However,
those who react badly to the cold turkey withdrawal get to continue. Half of
them then get a drug very similar to the one they had abruptly stopped, and the
rest, the placebo group, get to continue on cold turkey withdrawal.
So this is
what we are testing: Difference between continuing cold turkey withdrawal and
getting back a drug very similar to the one you were dependent on.
So the
classic RCT is not at all testing the difference between drug and no-drug
This may
actually explain some strange effects seen in drug trials:
-The
positive effects of the SSRIs start immediately, even if doctors tell their
patients that the drugs have to be taken from 4 to 8 weeks to feel better
-Patients in
the placebo group get a lot of negative effects such as sleeplessness, and
inner turmoil (akathisia). One would not expect such negative placebo effects (nocebo)
from a pill that patients think will actually relieve their problems.
-Effect only
in the severely depressed. Many doctors seem to accept that SSRIs don’t have an
impressive effect on the moderately depressed, but justify their use on the
severely depressed because of a larger difference between placebo and drug for
this group. We know that patients in this severely depressed group must have
taken larger doses of their previous drug for longer times. It is then quite obvious there will be more severe withdrawal reactions in the placebo
group. The group getting back a similar drug will be even more relieved, since
they were very addicted to the previous drug.
-Drugs not
working in children and adolescents. This may be the only case where
participants have not been on a similar drug before they start the trial, and
here we don’t see a difference between drug and placebo.
So what is
being tested in RCT is not at all the difference between a drug and an inactive
pill, we are testing how good it feels to get back something very similar to
the drug you were dependent on, compared to going cold turkey! Anybody who has
had a serious hangover and then “repaired” by taking a few drinks knows this
difference. The relieving drug doesn’t have to be the same: Acute alcohol
delirium can be cured with benzodiazepines since they are similar to alcohol in
effect on the nervous system.
So the first
conclusion may then be that none of these RCTs prove that the drugs work.
The second
conclusion may even be more startling: We cannot say anything about the safety
when we compare a drug to abrupt withdrawal.
One of the
reasons drug companies give for not leaving depression untreated, is the the untreated
patient may die from suicide. One could then think that taking the drug away
from a patient would increase the risk for suicide. So according to drug
company logic, a patient who has abruptly stopped the life-saving drug, would
have a higher risk for suicide than the medicated patient.
This is
confirmed in a veryh large study reported in Journal of Clinical Psychiatry in
2009. The abstract states: “Antidepressant discontinuation showed a significant
risk for suicide attempt as did the period of an abbreviated trial, that is,
stopping before a therapeutic regimen of 56 days had been reached. The highest
risk was associated with initiation, a finding consistent with other studies,
closely followed by periods of dosing changes and discontinuation”. Slowly increasing dose (titration up)
increased the risk to 262% of normal risk. Decreasing dose gradually lead to a
219% increased risk according to the article.1
This means that
patients on placebo have at least doubled suicide risk after 2 weeks in
withdrawal. The 219% risk was on gradual withdrawal, not abrupt, which would
possibly be much worse.
RCTs compare
suicidal ideation on the drug to placebo. Many studies find a doubled risk. One
study found a 6 fold risk for Paxil2. Since the risk in the placebo
group is already doubled, the increased risk from the drug may be 4 to 12 times
the risk of unmedicated depression. The conclusion is difficult to avoid: antidepressants
are extremely hazardous to our health.
However, the
flipside of this problem is quite positive: avoiding medication for depression
is associated with much less suicide!
And now we
come to the truly amazing power of hope in the form of a placebo. Let us take a
typical antidepressant trial with some simple numbers: 100 participants in the
placebo group and 100 in the drug group. Let us be optimistic for the drug and
assume that 60% get well. 50% typically get well on the placebo. This means that
100 out of 200 patients actually would get
well from the placebo, since 50 patients in the drug group also are expected to
get well from just popping a pill whether it is sugar or drug. This means that
only 10% got anything out of the drug. The rest get well on a placebo. The
results are thus that placebo is 5 times more effective than the drug.
If we
combine this with our first observation that placebo treatment is actually
abrupt withdrawal, it becomes really amazing. Going cold turkey off the
previous medication makes 50% of patients well, often instantly in the case of
those who respond in the washout phase. This is very bad advertising for the
makers of the previous drugs. And the new drug is only one fifth as effective
as cold turkey.
There are so
many other things wrong with RCT’s, such as publishing only the positive
trials, that we cannot even be sure of this 10% drug effect.
In addition
to this, even the very pro-drug Dr. Gibbon’s meta-analysis of industry
sponsored trials showed that the placebo reached the exact same level as the
drug just four days later. All this
shows that we can trust our own minds to heal themselves as long as we don’t
add chemicals.
To conclude:
From this analysis it becomes clear that we don’t have ANY research showing the
effects or safety of SSRIs since we are testing cold turkey withdrawal against
getting back a me-too drug. The research shows the opposite of what the drug
makers hoped to find: placebo is extremely effective and has no side effects.
Hope is curing us.
References
1. Valuck RJ1,
Orton HD, Libby AM. Antidepressant discontinuation and risk of suicide attempt:
a retrospective, nested case-control study. J Clin Psychiatry. 2009
Aug;70(8):1069-77. doi: 10.4088/JCP.08m04943.
2. http://www.breggin.com/index.php?option=com_content&task=view&id=60