The following represents a snapshot of 100 comments that have been appended to the global e-petition. It was considered that this information has a role in helping clinicians to understand why statin therapies are unhelpful to human beings.
Self-reported Findings of 100 signatories to the
Global e-Petition Against Statin Therapy
The Global
e-Petition which can be found at http://www.gopetition.com/online/11757.html
has been
addressed to the World Health Organisation (WHO) in the
hope that they will initiate an impartial investigation
into the risks surrounding statin therapy. The
experiences of one hundred signatories (who had appended
their own commentary in support of their signature) is a
salutary message to clinicians who had made the
assumption that the use of statins, for reducing one’s
total cholesterol in general and LDL cholesterol in
particular, was a good therapeutic measure to initiate.
Self-reported
findings are frequently viewed as limited, when one is
dealing with the science of medicine. Controls can be
difficult to apply effectively to the patient’s
self-reported experiences and so confounding factors may be
able to reduce the usefulness of the information gathered.
Where a patient does not discuss his symptoms with the
family doctor, then the clinician has less insight into the
issues that have caused the patient to arrive for a
consultation in the first instance. It is suggested that
self-reporting is the basis for all medical scientific
enquiry, especially when dealing with any medical condition
that afflicts the patient who is both conscious and able to
speak for themselves.
The
limitations of these findings begins with the unique sample
population. They are a self-selected group of people who
have found the e-petition website either by accident or
they were directed from another self-help website that
provides information about the risks of statin therapy.
Given the known toxicity of statins within the mevalonate
metabolic pathway, it is probable that any group of people
who have taken statins for a considerable period of time
will be likely to complain of conditions, which can then be
ascribed to the toxic effects of statins. The self-selected
sample population will appear to be susceptible to the
damage wrought by statinisation (and therefore more likely
to blame statins?).
The self-reporting of statin-mediated adverse effects is
liable to inaccuracies. The issue of the patient’s state of
knowledge will have an influence on which symptoms the lay
person will ascribe to statin use. Websites purporting to
give the patient sufficient knowledge of statins will not
be able to plan for their literacy, their education and
their ability to grasp the concepts essential to
understanding how symptoms may arise. How are we to know
whether sleep disturbance is caused by the statin or
whether the patient’s own anxiety was responsible for them
not being able to sleep well? Without extensive questioning
and testing, we will never be able to truly understand
where the truth lies, from the analysis of a few data
points that have been self-reported.
The utility of examining and understanding what these
patients have reported, is to find common threads and to
use them to initiate research into the anomalies which the
patients have reported. The author offers the data points
as a first step in this process. The discussion that
follows may be rather wider of the mark than clinicians are
used to discussing but the author’s hope is that it may
stimulate other discussions in an effort to find a way to
stop the madness that is government sponsored
statinisation, here in the UK. The supplied data points and
the commentary which is written, are not offered as
definitive science nor would it be wise to quote this
material as such. The primary purpose behind offering this
work, to the scrutiny of the THINCS membership, is to
provide the clinicians of THINCS with a running commentary
that they may otherwise not be able to review within their
own practices.
Background:
The idea of
initiating a petition was grounded in the author’s brush
with a general practitioner who had demanded that he take
statins to lower his cholesterol. His requests for further
and better information were met with a brusque “because you
fit the profile” and he was then determined to find out
more. He telephoned the charity, Cholesterol UK, and he was
asked to write his questions because of their complexity
and number. The written reply was short and sweet and he
received no answers because of “lack of resources”.
The author started doing his researches and found Spacedoc
and several other websites and the dawn of understanding
finally arrived. He contacted the Department of Public
Health and after months of useless monologue, he gave up
the hope that he could alert them to statin dangers. Along
the way, he has read the occasional book, medical journal
and articles and he has tried to understand the position
with regards to the necessity for statins. His axe is that
he saw no necessity for statins and the e-petition was
born.
Method:
Each signatory
to the petition is permitted to write a commentary of up to
500 words. Only entries that have a commentary were
selected from the 259 signatories that had signed at the
time this snapshot was taken (November 30th 2007). Much of
the commentary was not helpful for assisting understanding
of the patient’s own experiences with statins and these
were discounted. Ultimately, 100 personal accounts were
selected for this analysis.
A spreadsheet was opened and a new field was produced for
every symptom mentioned. Each commentary was carefully read
and where a symptom was mentioned, a mark was made against
the comment number within the field mentioned. Some
commentary was not specific to a single symptom and where a
general comment had been made, it too was indicated in its
own field... where there could be any significance attached
to a phrase such as; “I feel older than my years”, for
example.
The author was interested to document the clearly defined
adverse symptoms that were experienced by the statin takers
so that he could plot their frequency and severity and also
to attempt to determine what effect it had exerted over
their lives. This was not really possible because the
signatories were not answering direct questions. They were
free to write whatever they wished and that made for a
chaotic set of responses, which were not amenable to
rigorous methods of control.
The commentaries do not reflect all of information that he
had wanted to analyse for this sample. He recorded drug
type, dosages, where given, duration of statinisation and
gender. Very few signatories gave their age but where it
was noteworthy, he has included that fact in the discussion
that follows each chart. He has loosely grouped the adverse
effects under the heads of muscular problems, neurological
deficit, cognitive problems, mobility problems, affected
site, and pain in general, or pain from nerves or muscles.
The patient may have offered a clinical diagnosis as the
term for their experience and where they have done so, he
has taken this at face value. An example would be where the
commentary had mentioned the word, “myopathy”, he assumed
that it was not a self-ascribed diagnosis. This is also
true for a diagnosis of Amyotrophic Lateral Sclerosis (ALS)
or End-stage Renal Failure.
The author noted where the patients had mentioned a
reduction in the quality of their lives. Where patients had
mentioned symptoms that were not present before they had
started taking statins, or the symptoms appeared to be
typical of the type of effect that is often to be
associated with statin intake, he has assigned a quality of
life score to those who were having problems that appeared
to emanate from statin use. The score was assigned even
where the symptoms were resolving or had resolved because
the author had wanted to highlight any negative effects of
merely taking a statin. The commentaries were written by
the patients or by their carers/spouses/partners or
relatives and this too was noted.
The author had
wanted a measure of resolution, for the patients who had
stopped taking statins and he had assigned a score of 0 to
patients who had not mentioned any form of resolution of
the symptoms of adverse events that had appeared (to them)
to be the result of taking statins. A score of 1 was
ascribed to all commentaries that mentioned some small
improvements in the symptoms of the patient since stopping
taking statins. A score of 2 was assigned to those patients
that had stated that many of their symptoms had resolved on
stopping statins. A score of 3 was assigned to patients who
were almost entirely free of symptoms. A score of 4 was
assigned to patients who had written in their commentary
that they were now fully recovered after the cessation of
statin therapy.
Findings:
The first chart
(fig. 1) shows the frequency of the particular preparation
prescribed. The missing values occurred because not all
patients mentioned which drug they were taking.
fig.
1
Some patients had taken more than one statin and one
patient reported taking “every statin”. Dosages, according
to 19 respondents, had ranged from 10 ~ 80mg. Duration of
statinisation had ranged from 0.03 to 204 months, according
to the 54 people who had commented.
Several patients had decided that statins were not for them
after relatively short periods of time. The shortest time
period was possibly after a single dose of Atorvastatin,
after which the patient was diagnosed with Myalgia. The
patient gave the date of the diagnosis but does not
adequately explain for how long the statin was being taken.
One patient mentioned “long-term leg muscle problems” after
just four 20 mg doses of Simvastatin. Another patient noted
that 30 days of statins left him unable to function without
him taking $200 worth of medications each month, after 3
years. The patient also claimed to have been diagnosed with
statin myopathy and, latterly, mitochondrial myopathy.
One male patient reported 3 months of 10mg of Rosuvastatin
use had left him with global muscle pain after 15 months
cessation of statin therapy. He stated that he now had to
take a lot of medications and suffered with daily pain,
while he had been pain free before the statin therapy
began. He also stated that he was unable to work full time.
There are more accounts in a similar vein and the reader is
invited to read them at your leisure. What does appear to
be important is the safety margin that ought to be in place
to protect the patient. Where the patients have experienced
devastating adverse reactions, after a very short exposure
of a few doses or a few weeks, it is hoped that the author
will be forgiven for pointing out that the statin
medications, under scrutiny, must have been dangerously
toxic.
The next chart (fig. 2) is a look at the way in which the
self-reported muscle problems were categorised by the
patients.
fig.
2
One symptom that appeared to be mentioned a great deal by
the patients was that of muscle problems. A striking
feature of the muscle related problems was the impact on
the mobility of the patients.
The percentage
of patients who had complained about their mobility
difficulties was 25%. As far as one could tell, from
reading ad-hoc accounts that were restricted to 500 words,
there did not appear to be anyone with a pre-existing
mobility problem. The question which is raised is whether
this type of interference with mobility would be reflected
in any other group of statin takers.
The restrictions of the movements of 25% of the patient
base, who had consumed statins at the behest of their
healthcare professional, cannot possibly be recommended as
a benefit of taking statin therapy. Rather... it is
unnecessary collateral damage to 25% of the patients who
were judged to be at risk from heart disease. Another
commonly perceived risk factor for developing heart disease
is needless inactivity and statins would seem to be to
militating against the patient being active in 25% of the
cases reported by the patients.
The 56% of patients who reported having muscle problems are
having their quality of life reduced by their painful or
limited movements. Unsurprisingly, 9% of the respondents
claimed difficulty with working and several had reported
having to retire early or giving up a career and a
livelihood. This was in the pursuit of what, precisely? The
risk that something may happen to a person in the future?
The prospect of incapacitation (through the agency of
statins) appears to be far more certain for these patients,
who imbibe statins on the advice of their medical
practitioner, than does the relative risk of them having an
unspecified cardiac event at some point in the future.
The chart (fig. 3) shows the variety and frequency of
nervous system disorders, reported by patients.
fig.
3
Many patient reported pain (41%) as a consequence of having
statin therapy and 6% complained of neuralgia in addition
to 19% complaining of myalgia. Pain is a feature that
appears to attend a large proportion of the patients who do
take (or have taken) statin drugs. The neural damage report
is a medical diagnosis and was found in 6% of people within
this sample.
Peripheral neuropathy has become associated with statin use
and it is probably mentioned on the websites that may have
guided patients to the petition website. Nevertheless, 11%
of the patients had reported having peripheral neuropathy.
There were 6 cases of a reported difficulty with speaking
and 2 cases of tinnitus that appeared to be caused by
statins. Parasthesia was complained about by 4% of the
total number who had made a comment relating to their own
experiences with statins.
It should be borne in mind that many people would not have
had the time or the inclination to append a comment to the
petition. Of the people who did write a comment, they may
well have had other symptoms that were not written down.
Under this section, we can see that Neuroma and CIDP
(Chronic Inflammatory Demyelinating Polyneuropathy) are
noted with a single reported frequency for each condition
but both are clearly very serious conditions.
The next section deals with cognitive problems that were
ascribed to statin therapy The chart at (fig.4) shows the
conditions that were reported by the patients.
fig.
4
The largest number of reported cases was the category for
memory problems, with 19% of the respondents claiming to
have suffered with memory loss. Confusion and depression
were also mentioned by 6% of the sample population. The 9%
of patients who reported cognitive impairment had used
words that would convey a sense of being ‘foggy’ or
‘forgetful’, to illustrate the mental state which they were
in. There was also one report of total global amnesia (TGA)
and one report of amnesia. A generic ‘psychological
problem’ tag was used for 6% of the total number of
reports, without further explanation.
A number of medications can be mood altering and 17% of the
total number of reports were made by way of observations
from a friend, close relative or carer. Observed mood
changes were not always supported by observations made by
the patient. Cognitive changes can subject relationships to
a high level of stress that is additional to the physical
manifestations of statinisation.
The stresses which may be generated within a previously
calm and passive personality, who had become withdrawn or
aggressive while taking statins and could not regain
control of their life, are easy to perceive. Any sense of
confusion/foggyness or impending doom is likely to need
outside intervention and support. As with chronic pain, the
debilitating effects overcome all else and soon the patient
has no other subject of conversation. Chronicity and
persistence of symptoms may contribute to pushing the
patient nearer to the edge of a state where they will begin
to contemplate suicide.
The next chart (fig. 5) shows the spread of adverse
reactions that were cited by the patients.
fig.
5
The chart does not list every single reaction that was
described because of the possibility that some ascriptions
could have been just as easily attributed to other causes.
One observer had noted that his father had died because of
statins. While that may have been true, the coroner had
recorded a verdict of misadventure so this report was not
included.
The adverse reactions that have been listed do appear with
some frequency when the subject of adverse reactions to
statins is discussed. The common complaints (10% of the
possible total of reports) of lassitude and fatigue… that
seem to accompany statin use almost as if they were the
hallmarks of statin toxicity seem to be present in the same
way that changes in the strength of one’s muscles and the
corollary of pain on movement, appear to be hallmarks of
statin use. There is likely to be a significant link with
exercise intolerance (4% of the reported instances) when
one feels tired and weak.
Dyspnoea was mentioned by 3 people. Absent any detail as to
whether one can exclude chronic respiratory disease in
these reports, this apparently statin-mediated adverse
reaction must remain a curiosity for the reader. The
reporting of 3 cases of ataxia may have been less than the
actuality. There are also several single reports of the
patient feeling uncoordinated and becoming clumsy or being
more inclined to falling over. It would be interesting to
see whether the literature can support these patient
supplied reports.
In such a small number of reports, such as those which are
provided in this sample population, the two reports of some
visual disturbance, would induce the author to look deeper
at what may be happening, if he was working within this
field of interest. Two other reports would also merit
further examination. The references to amnesia and total
global amnesia are intriguing, especially as the global
amnesia was referred to as TGA. This suggested that it was
either a medically derived diagnosis or that the person
making the report had possibly read too many self-help
websites.
There was one
report of Parkinsonism and it may be credible where no
pre-disposing aetiology is found. More shocking, was the
incidence of ALS that was reported. My understanding was
that ALS affects about 2 in every 100,000 people, all
around the globe. On this figure alone, I would have
expected to see approximately one quarter of a million
signatures before finding 5 case reports. This information
had been reported within just 100 signatures. The onset of
ALS is not likely to be a finding that any of the 159 other
signatories would have suppressed and 5 occurrences within
259 signatories ought to raise some eyebrows.
The five reports breakdown into 3 females and 2 males. The
statin agent involved was Atorvastatin in 3 out of 5 cases,
of which two were female. Simvastatin/Ezetimibe was used in
one case in a male and Rosuvastatin was used in one case in
a female. ALS is thought to occur more frequently in men
than women with a ratio of 1.5:1 so the 5 reports in this
self-selected population of 100 people also appear to be a
special case in that the author would have expected to see
3 males and two females... but felt that these cases should
have been spread over a considerably larger number of data
points.
The incidence of statin-mediated ALS is an area for further
research and it would appear (at first look) that
Atorvastatin has more potential to induce ALS than the
other statins, at least on this showing from such a tiny
sample population. This would be yet another fruitful area
for more research.
Discussion:
It is common
ground that all drugs produce adverse reactions and
unwanted effects. It appears to be the case that statins
are responsible for a panoply of dire effects, that can
have such serious consequences for the patient. The outlook
is very grim, where statins are being prescribed to prevent
serious heart disease so as to reduce the possibility that
the patient will run the risk of having a cardiac event at
some indeterminate time in the future.
The adverse effects, which appear to follow statin usage,
are a veritable nightmare of happenstance and the author
would not want to experience many of the reported effects
that have been ascribed to taking statins, by the
signatories, who have written an explanatory commentary.
The muscle problems, reported by 57 commentators, would
reduce one’s activity and, for some people, the reduction
in their personal mobility, as reported by 25 people, has
proved to be a life-changing and insurmountable obstacle.
Five people had reported associated joint pains, with knees
occupying the most prominent position, with the muscle
pains they had experienced. Another 4 people had referred
to painful cramps that prevented movement. Myalgia and
myopathy were reported by 19 and 5 people respectively,
with muscle damage being reported by 15 people and muscle
weakness being reported by 21 people. There were also 58
reports of unspecified problems that may have needed far
more space than the 500 word limit would have permitted.
Neurological effects were also evident. The people who
reported nerve damage were 6% of the possible total. A loss
of coordination was mentioned by two people. Chronic
inflammatory demyelinating polyneuropathy afflicted one
person and neuroma was reported by one person.
General pain was reported by 41% of respondents and
neuralgia was reported by 6% of people. Peripheral
neuropathy was mentioned by 11% of signatories. Parasthesia
was experienced by 4 people and ataxia was reported by 3
people. Dysarthria had affected 6% of those making the
commentaries. Tinnitus had affect two of the reporters, as
had visual disturbances. Bladder infections had affected
16% of the reporting sample population. End-stage renal
failure was reported in one person.
Cognitive affects were attributed to statins and these ran
the gamut from suicidal ideation (1%) through to
psychological problems (2%) cognitive difficulties (9%)
confusion (9%) sexual dysfunction (2%) depression (6%) and
the loss of memory problems which were reported by 19% of
respondents.
In themselves, a small number of people referring to
confusion, following a statin, may not appear to be very
significant. It should be remembered that many of the
respondents listed multiple side-effects which they had
attributed to statins. By adding some confusion to chronic
pain and restricted movement, it will be seen how easily
the quality of life can be reduced. It was established that
97% of the reporting patients had experienced a drop in the
quality of their life. They had reported it specifically or
it had been an ascribed value which was based upon their
reporting of the adverse effects of taking statins, on
their lives.
It is noteworthy that 60% of the reporting population had
chosen to stop taking statins. The figure is probably far
higher but some people had used the commentary space to
denounce statin therapy rather than discussing their own
condition.
The chart (fig. 6) clearly demonstrates the quality of life
for 100 people taking statins.
fig.
6
It is obvious that the patients are not the problem here.
The medical profession can sometimes be a little lazy in
the way that the patient may get the blame for the way a
particular treatment has gone. We have all heard comments
like “you don’t heal very well” or “your body does not
agree with that medication”. The list of effects that have
been experienced by just one hundred people who have taken
statins, and not all of them have reported on every aspect
of statin use, demonstrates that statin use should be
reviewed as a matter of urgency.
The indiscriminate use of statins is damaging far more
people than appears to be apparent to governments,
clinicians or the pharmaceutical companies. The last area
which concerns me is that of illness resolution. It is
prudent to ask how well do people recover from the adverse
effects of statins.
The chart (fig. 7) shows that the largest group of people
fall into the ‘No Recovery’ category. The respondents had
not mentioned any resolution of their symptoms. These are
people who have been left with residual damage to many of
the body’s systems, with little or no hope of repair,
recovery or relief.
One person was assigned to the ‘Fully Recovered’ category
because she was prescribed a statin without seeing her
family medical practitioner. It was awaiting collection
from her doctor on the basis of some blood results. She had
refused to take the statin and so she appears within the
fully recovered category, to ensure that 100% of eligible
signatories were assigned to a category.
fig.
7
The final word on this issue is that despite the sample of
100 people being very skewed and notwithstanding the
consequent bias that favours those people who have taken
statins, something untoward is clearly taking place.
People are suffering substantial and lasting physical
damage in addition to the mental suffering that must follow
a reduction in the quality of life. It is noteworthy that
41% of respondents are female and it is settled ground that
women do not derive any benefit from statin therapy. One
person was aged 23 and the author dreads to think of the
difficulties that will portend. No person should have to
imbibe highly toxic medications under any circumstance.
That people are being forced to take statins, by dint of
government policy, is a despicable and criminal act which
is worthy of the harshest penalty.
That governments can enlist the willing cooperation of the
medical profession in the UK, and elsewhere, on foot of
extra bonus payments or other incentives; beggars belief.
December 2007