Lipitor, Thief of Memory - New Book
Steve Harris sbharris@ROMAN9.netcom.com
> The new book, "Lipitor, Thief of Memory", is now available. The release is
> timely, as Wall Street Journal reported last week that the cognitive damage
> from statin drugs is seen in ~ 15% of the patients. Many of these people
> are told
> they have "early Alzheimer's" when in fact the drug is affecting their
> memory.
Comment:
Well, since you have to have more things than memory problems to
diagnose "early Alzheimer's" all this means is that the doctors
involved were fools.
If Lipitor causes memory problems in some patients, it would still not
be wise to tar all the statins with same brush. Nobody believes that
it's the fall in cholesterol per se that causes the problem, and
indeed you quote reports of people having brain problems with Lipitor
who had them resolve in Pravachol. Which is not too surprising in
light of the fact that Lipitor gets into the brain very well among
this category of drugs, while Pravachol probably is at the other end
of scale in ability to penetrate the blood brain barrier.
SBH
Bruce Bowen
> "Sharon Hope" <sh...@anet.net> wrote in message news:<tBFTb.213993$na.351460@attbi_s04>...
> > The new book, "Lipitor, Thief of Memory", is now available. The release is
>
>
> If Lipitor causes memory problems in some patients, it would still not
> be wise to tar all the statins with same brush. Nobody believes that
> it's the fall in cholesterol per se that causes the problem, and
> indeed you quote reports of people having brain problems with Lipitor
> who had them resolve in Pravachol. Which is not too surprising in
> light of the fact that Lipitor gets into the brain very well among
> this category of drugs, while Pravachol probably is at the other end
> of scale in ability to penetrate the blood brain barrier.
Is it true that Lipitor crosses the blood-brain barrier? Previously,
in response to the book I did a Google search on Lipitor +
"blood-brain barrier" and most if not all of the info I could find
claimed that it didn't, for example:
http://hdlighthouse.org/see/drugs/lipitor.htm (an artcle on Lipitor
and Alzheimers).
``This is an investigator-initiated study. I chose Lipitor because it
doesn't cross the blood-brain barrier,'' Sparks said, noting that
Pfizer decided to partly fund the study after being contacted.
In anycase, the anecdotes the author relates in the promo are sudden
acute lapses in memory and/or amnesia. Not any sort of gradual
degredation in memory, as one might expect with the hypothetical
complaint.
-Bruce
Sharon Hope
short-term memory loss, cognitive decline, and multiple episodes of
transient global amnesia may be entertaining, as is your 'nobody believes it
is fall in cholesterol per se that causes the problem..."
You miss the point entirely: 15% of patients are disabled by the statin
drugs. Over 106 million people take statin drugs world wide.
Why is this significant? Well, to the families of these patients, there is
the tragic loss of the person they have known and loved - sometimes they are
not even recognized by the patient. The patient with memory loss often has
also developed the other common adverse effects, such as myopathy (up to and
including so much apoptosis that deadly rhabdomyolysis results), peripheral
neuropathy and polyneuropathy, and profound fatigue and exhaustion to the
point of collapse when standing for more than a few moments. Financial
status? Devastated, no ability to earn income and massive medical bills for
tests, consultation with experts, cognitive rehabilitation therapy, etc.
From a societal standpoint, the early adopters of statin drugs were the
movers and shakers of industry - job creators, gross national product
boosters, now on early retirement and disability and medicare 10 to 15 years
early, missing their most productive years.
Worse, there is no treatment beyond halting the drug and waiting. It
typically takes as long or longer to recover as it did to develop the
problem. Four years on the drug can mean 6 years or more of weekly
cognitive rehabilitation to recover to the point of continuing a normal
life. Losing the inability to interact, for example, with a 4 year old
grandson for a period of 6 years is a time that can never be recovered.
Losing a job and a home at the same time the children are going to college
damages more than the life of the Lipitor-ravaged patient.
So, while it may make your day to call doctors fools, the fact remains that
there are up to 15 million people who have been disabled by a drug that, had
there been proper warnings and monitoring, would have been preventable.
Quick dismissive pronouncements do not change the damage done to the
patients. Nor to the spouses of these patients, myself included.
This book is a chance to spotlight a significant problem that clearly needs
to be better understood.
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04020...@posting.google.com...
Bill
Sharon,
Is there a published study one can examine to understand the "15%"?
Thanks.
Bill
Steve Harris sbharris@ROMAN9.netcom.com
> sbha...@ix.netcom.com (Steve Harris sbha...@ROMAN9.netcom.com) wrote in message news:<79cf0a8.04020...@posting.google.com>...
> > "Sharon Hope" <sh...@anet.net> wrote in message news:<tBFTb.213993$na.351460@attbi_s04>...
> > > The new book, "Lipitor, Thief of Memory", is now available. The release is
> >
> > Comment:
> >
> > If Lipitor causes memory problems in some patients, it would still not
> > be wise to tar all the statins with same brush. Nobody believes that
> > it's the fall in cholesterol per se that causes the problem, and
> > indeed you quote reports of people having brain problems with Lipitor
> > who had them resolve in Pravachol. Which is not too surprising in
> > light of the fact that Lipitor gets into the brain very well among
> > this category of drugs, while Pravachol probably is at the other end
> > of scale in ability to penetrate the blood brain barrier.
>
> Is it true that Lipitor crosses the blood-brain barrier? Previously,
> in response to the book I did a Google search on Lipitor +
> "blood-brain barrier" and most if not all of the info I could find
> claimed that it didn't, for example:
>
> http://hdlighthouse.org/see/drugs/lipitor.htm (an artcle on Lipitor
> and Alzheimers).
>
> ``This is an investigator-initiated study. I chose Lipitor because it
> doesn't cross the blood-brain barrier,'' Sparks said, noting that
> Pfizer decided to partly fund the study after being contacted.
COMMENT:
Yeah, I did the same and you're right. My recollection was wrong about
Lipitor penetrating the BBB. I did a search on statins and cognative
dysfunction and find that it while it has been reported (wow 60
cases), the case reports distribute nothing like the market share of
statins. Most of the reports involve Lipitor/atorvastatin and
Zocor/simvastatin, and one out of 60 was Pravachol; yet the market
share of Pravachol/pravastatin is much higher than that.
Statins have been looked at in a number of studies of cognative
function, since there is epidemiological suggestion (not proof) that
they might *prevent* Alzheimer's. Incidentally, this evidence is much
better than a bunch of case reports, so the statistical evidence that
statins lessen risk of cognative impairment is far more impressive
than the opposite. The 15% figure given earlier in this thread is
hogwash.
More careful prospective studies have failed to find any effect either
way. While that means we don't know yet whether or not statins will
prevent or slow Alzheimer's, it's excellent evidence that they can't
be causing cognative dysfunction in 15% of people treated, because if
they did, this should show up like a red light with bells and whistles
in any prospective controlled study where careful cognative assessment
is being done. A number of studies have been launched with reports
from two of them, and the claimed large (15%) effect just isn't there.
This doesn't rule out some drug specific effect (paricularly for Zocor
and Lipitor) in some (very) small numbers of users. But no such effect
has been proven in a placebo controlled study. How small the effect
might be cannot even be determined from the data we have, except that
it's too low to show up as a statistically significant effect in at
least 3 controlled studies, which means it's very low. When the below
article says the literature is conflicting regarding statins and
memory loss, it means one study showed a *trend* toward memory
impairment, but the study was so small it wasn't statistically
significant. Two larger placebo controlled studies failed to find the
effect. We don't yet understand what the discrepancy is, but a
nonsignificant trend in one small study plus 60 uncontrolled case
reports, does not an epidemic make.
Pharmacotherapy. 2003 Jul;23(7):871-80. Related Articles, Links
Statin-associated memory loss: analysis of 60 case reports and review
of the literature.
Wagstaff LR, Mitton MW, Arvik BM, Doraiswamy PM.
Drug Information Service, Duke University Medical Center, Durham,
North Carolina 27710, USA.
OBJECTIVE: To review case reports of statin-associated memory loss as
well as the available published evidence for and against such a link.
METHODS: We searched the MedWatch drug surveillance system of the Food
and Drug Administration (FDA) from November 1997-February 2002 for
reports of statin-associated memory loss. We also reviewed the
published literature (using MEDLINE) and prescribing information for
these drugs. RESULTS: Of the 60 patients identified who had memory
loss associated with statins, 36 received simvastatin, 23
atorvastatin, and 1 pravastatin. About 50% of the patients noted
cognitive adverse effects within 2 months of therapy. Fourteen (56%)
of 25 patients noted improvement when the statin was discontinued.
Memory loss recurred in four patients who were rechallenged with the
drug. None of the 60 reported cognitive test results. Two
placebo-controlled trials found no benefits for statins on cognition
or disability. One randomized controlled trial of simvastatin found no
effects on cerebrospinal amyloid levels. In one small, randomized
study, patients receiving statins showed a trend toward lower
cognitive performance than those receiving placebo. Five observational
studies found a lower risk of dementia among patients receiving
statins. CONCLUSION: Current literature is conflicting with regard to
the effects of statins on memory loss. Experimental studies support
links between cholesterol intake and amyloid synthesis; observational
studies indicate that patients receiving statins have a reduced risk
of dementia. However, available prospective studies show no cognitive
or antiamyloid benefits for any statin. In addition, case reports
raise the possibility that statins, in rare cases, may be associated
with cognitive impairment, though causality is not certain.
Publication Types:
Review
Review, Multicase
Review, Tutorial
PMID: 12885101 [PubMed - indexed for MEDLINE]
Sharon Hope
The 15% figure is a Wall Street Journal quote from the principal
investigator of a placebo-controlled 5 year NIH study, not yet published.
The references to statins and Alzheimer's prevention are all speculative
prefaces to funding a trial (most have a "?" in the title, as in Can
statins...?). The one placebo-controlled trial going on right now is having
great difficulties, because - per a published report by some of the
physicians conducting the trial - they cannot keep the elderly participants
on the statin drug portion of the population - they keep developing serious
adverse effects and have to be washed out of the study.
One of the studies eliminated "unrelated mortality" and included
hemorrhagic stroke in the "unrelated" category, despite the Lipitor
Physician's Reference stating:
CNS Toxicity
Brain hemorrhage was seen in a female dog treated for 3 months at 120
mg/kg/day. Brain hemorrhage and optic nerve vacuolation were seen in another
female dog that was sacrificed in moribund condition after 11 weeks of
escalating doses up to 280 mg/kg/day. The 120 mg/kg dose resulted in a
systemic exposure approximately 16 times the human plasma
area-under-the-curve (AUC, 0-24 hours) based on the maximum human dose of 80
mg/day. A single tonic convulsion was seen in each of 2 male dogs (one
treated at 10 mg/kg/day and one at 120 mg/kg/day) in a 2-year study. No CNS
lesions have been observed in mice after chronic treatment for up to 2 years
at doses up to 400 mg/kg/day or in rats at doses up to 100 mg/kg/day. These
doses were 6 to 11 times (mouse) and 8 to 16 times (rat) the human AUC
(0-24) based on the maximum recommended human dose of 80 mg/day.
CNS vascular lesions, characterized by perivascular hemorrhages, edema, and
mononuclear cell infiltration of perivascular spaces, have been observed in
dogs treated with other members of this class. A chemically similar drug in
this class produced optic nerve degeneration (Wallerian degeneration of
retinogeniculate fibers) in clinically normal dogs in a dose-dependent
fashion at a dose that produced plasma drug levels about 30 times higher
than the mean drug level in humans taking the highest recommended dose.
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04020...@posting.google.com...
Sharon Hope
statins and non-cardiac endpoints. The quote in the Wall Street Journal was
from the principal investigator.
If you read the full study - not the abstract - of the published Muldoon
study you will be shocked at the statin scores in comparison with the
placebo group - and that was just a 6 month study.
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TDC-406793X-2&_coverDate=05%2F31%2F2000&_alid=145634983&_rdoc=1&_fmt=&_orig=search&_qd=1&_cdi=5195&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=e3e9eb1c8fe4a5d8c4079791ee99c073
Then read the full text version of the conclusion (not the abstract) of the
"STATIN-ASSOCIATED MEMORY LOSS: ANALYSIS OF 60 CASE REPORTS AND REVIEW OF
THE LITERATURE"
"Because cholesterol synthesis is essential for neuronal function, greater
attention to
cognitive outcomes in patients receiving statins is warranted, especially in
populations
already at risk for memory loss. Although the evidence does not yet support
routine
administration of serial bedside memory tests in otherwise healthy patients
receiving
statins, clinicians must be able to detect memory changes among their
patients and
routinely inquire about mental status. Given the high background rate of
memory loss in
the population receiving statins, prospective controlled studies comparing
the short- and
long-term effects of various statins on cognitive function are warranted."
"Bill" <x...@yy.zz> wrote in message
news:2ClUb.3837$8r4....@newssvr31.news.prodigy.com...
Steve Harris sbharris@ROMAN9.netcom.com
> Check your facts.
>
> The 15% figure is a Wall Street Journal quote from the principal
> investigator of a placebo-controlled 5 year NIH study, not yet published.
COMMENT:
Ahem. Check YOUR facts. First of all, if it's something an
investigator told a news journalist about unpublished data one time,
it's not a fact, it's hearsay.
Second, if you're referring to the UCSD Statin trial (the only long
NIH trial I know about) and if the investigator being quoted is Ms.
Golumb, she can't possibly know any figures, because the codes for
placebo vs. active drug in this trial won't be broken until the end of
the trial, and the trial hasn't quite ended yet. So either she didn't
say what you say she said, or else they aren't running the trial as
they promised, or else you're just wrong in many of a dozen possible
ways.
Please quote the exact WSJ text.
> The references to statins and Alzheimer's prevention are all speculative
> prefaces to funding a trial (most have a "?" in the title, as in Can
> statins...?). The one placebo-controlled trial going on right now is having
> great difficulties, because - per a published report by some of the
> physicians conducting the trial - they cannot keep the elderly participants
> on the statin drug portion of the population - they keep developing serious
> adverse effects and have to be washed out of the study.
Reference for this published report? If the trial is
placebo-controlled and double-blind, as the UCSD trial is, how do the
investigators know if the people "washing out" due to side effects are
taking active drug, or placebo?
>
> One of the studies eliminated "unrelated mortality" and included
> hemorrhagic stroke in the "unrelated" category, despite the Lipitor
> Physician's Reference stating:
> CNS Toxicity
>
>
> Brain hemorrhage was seen in a female dog treated for 3 months at 120
> mg/kg/day. Brain hemorrhage and optic nerve vacuolation were seen in another
> female dog that was sacrificed in moribund condition after 11 weeks of
> escalating doses up to 280 mg/kg/day. The 120 mg/kg dose resulted in a
> systemic exposure approximately 16 times the human plasma
> area-under-the-curve (AUC, 0-24 hours) based on the maximum human dose of 80
> mg/day. A single tonic convulsion was seen in each of 2 male dogs (one
> treated at 10 mg/kg/day and one at 120 mg/kg/day) in a 2-year study. No CNS
> lesions have been observed in mice after chronic treatment for up to 2 years
> at doses up to 400 mg/kg/day or in rats at doses up to 100 mg/kg/day. These
> doses were 6 to 11 times (mouse) and 8 to 16 times (rat) the human AUC
> (0-24) based on the maximum recommended human dose of 80 mg/day.
>
> CNS vascular lesions, characterized by perivascular hemorrhages, edema, and
> mononuclear cell infiltration of perivascular spaces, have been observed in
> dogs treated with other members of this class. A chemically similar drug in
> this class produced optic nerve degeneration (Wallerian degeneration of
> retinogeniculate fibers) in clinically normal dogs in a dose-dependent
> fashion at a dose that produced plasma drug levels about 30 times higher
> than the mean drug level in humans taking the highest recommended dose.
COMMENT:
Things that happen in dogs at blood levels 30 times higher than are
seen in humans on the drug, for long periods of time, are hardly
relevent to anything. For example, there is no animal alive which
could tolerate blood levels of aspirin 30 times those which are
therapeutic in humans, even for a few hours. But the machanisms of
salicylate toxicity in animals killed with overdoses of aspirin
(seizure, heart failure) are not relevent to human trials of
therapeutic doses of aspirin. They are simply data that are useless
for that purpose, even used inferentially. They might be helpful in
trying to evaluate suicide attempts in people taking bottles of
aspirin, but that's about it. Since I know of nobody who has tried to
kill themselves by taking a whole bottle of statin pills everyday for
three months, such a thing being done to an animal is nearly junk
science. It's an advertisement for PETA if it is used to interpret any
human data at all.
SBH
Don Kirkman
<DelUb.178929$5V2.884399@attbi_s53>:
>How glib your opinion of doctors who do not intervene when patients develop
>short-term memory loss, cognitive decline, and multiple episodes of
>transient global amnesia may be entertaining, as is your 'nobody believes it
>is fall in cholesterol per se that causes the problem..."
>You miss the point entirely: 15% of patients are disabled by the statin
>drugs. Over 106 million people take statin drugs world wide.
You DO realize that 15% of 106 million is 15.9 million? I think the
media might have noticed, if the medical community did not, if nearly 16
million people world-wide were debilitated by the statins.
[...]
--
Don
don...@covad.net
Steve Harris sbharris@ROMAN9.netcom.com
> Study is to be published, a 5 year NIH funded placebo controlled study of
> statins and non-cardiac endpoints. The quote in the Wall Street Journal was
> from the principal investigator.
>
> If you read the full study - not the abstract - of the published Muldoon
> study you will be shocked at the statin scores in comparison with the
> placebo group - and that was just a 6 month study.
> http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TDC-406793X-2&_coverDate=05%2F31%2F2000&_alid=145634983&_rdoc=1&_fmt=&_orig=search&_qd=1&_cdi=5195&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=e3e9eb1c8fe4a5d8c4079791ee99c073
COMMENT:
Actually, there's not much that is shocking in this study. Treated
subjects failed to improve as much as expected, due to practice
effect. They didn't become blithering mentally crippled idiots, and
actually, nobody really did worse. Differences between treated and
placebo groups amount to 0.2 standard deviation in performance, which
is about like an IQ change of 2 points even if it extended to all
categories of performance, which it didn't. Statistically significant
but not clinically so. It had NO effect on quality of life, and caused
NO psychological distress. And why should it, since we're talking
about mental performance changes far smaller than are regularly
produced by a cup of coffee, or a meal?
Here's your text. And let me note that even the results below have NOT
been reproduced in other studies looking for them, so they aren't
written in stone.
SUBJECTS AND METHODS: In this double-blind investigation, 209
generally healthy adults with a serum low-density-lipoprotein (LDL)
cholesterol level of 160 mg/dL or higher were randomly assigned to
6-month treatment with lovastatin (20 mg) or placebo. Assessments of
neuropsychological performance, depression, hostility, and quality of
life were conducted at baseline and at the end of the treatment
period. Summary effect sizes were estimated as z scores on a standard
deviation (SD) scale.
RESULTS: Placebo-treated subjects improved between baseline and
posttreatment periods on neuropsychological tests in all five
performance domains, consistent with the effects of practice on test
performance (all P <0.04), whereas those treated with lovastatin
improved only on tests of memory recall (P = 0.03). Comparisons of the
changes in performance between placebo- and lovastatin-treated
subjects revealed small, but statistically significant, differences
for tests of attention (z score = 0.18; 95% confidence interval (CI),
0.06 to 0.31; P = 0.005) and psychomotor speed (z score = 0.17; 95%
CI, 0.05 to 0.28; P = 0.004) that were consistent with greater
improvement in the placebo group. Psychological well-being, as
measured several ways, was not affected by lovastatin.
CONCLUSION: Treatment of hypercholesterolemia with lovastatin did not
cause psychological distress or substantially alter cognitive
function. Treatment did result in small performance decrements on
neuropsychological tests of attention and psychomotor speed, the
clinical importance of which is uncertain.
COMMENT: The above is the study author's conclusion, remember, not
mine.
SBH
Dr. Andrew B. Chung, MD/PhD
Well said, Steve :-)
Servant to the humblest person in the universe,
Andrew
--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/
--
Who is the humblest person in the universe?
Sharon Hope
difference. Statin drugs are prescribed for ongoing usage, not just for 6
months.
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04020...@posting.google.com...
Sharon Hope
"Dr. Andrew B. Chung, MD/PhD" <nos...@heartmdphd.com> wrote in message
news:dca6fb39.04020...@posting.google.com...
Sharon Hope
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04020...@posting.google.com...
news:<hBEUb.189538$nt4.800549@attbi_s51>...
> > Check your facts.
> >
> > The 15% figure is a Wall Street Journal quote from the principal
> > investigator of a placebo-controlled 5 year NIH study, not yet
published.
>
> Please quote the exact WSJ text.
>
The article is copyrighted. See:
Breakthrough! By Tara Parker-Pope
Several topics covered in the article, see "A Statin Backlash"
>
> > The references to statins and Alzheimer's prevention are all speculative
> > prefaces to funding a trial (most have a "?" in the title, as in Can
> > statins...?). The one placebo-controlled trial going on right now is
having
> > great difficulties, because - per a published report by some of the
> > physicians conducting the trial - they cannot keep the elderly
participants
> > on the statin drug portion of the population - they keep developing
serious
> > adverse effects and have to be washed out of the study.
>
>
> Reference for this published report? If the trial is
> placebo-controlled and double-blind, as the UCSD trial is, how do the
> investigators know if the people "washing out" due to side effects are
> taking active drug, or placebo?
>
>
For all of us who experienced statin-caused cognitive effects, short-term
memory loss, confusion, inability to concentrate, temporal global amnesia
episodes, blackouts, etc. (in themselves or in a family member), this will
come as absolutely no surprise:
A Position Paper: Based on Observational Data Indicating an Increased Rate
of Altered Blood Chemistry Requiring Withdrawal from the Alzheimer's Disease
Cholesterol-Lowering Treatment Trial (ADCLT)
Authors are 6 clinical researchers from Sun City, AZ.
The doctors point out that the people taking the statins for the trial have
to be pulled from the study due to adverse effects.
Unfortunately, this does not address the next issue they will encounter:
How will they be able to distinguish between Alzheimer's memory loss and
statin-caused memory loss? Given that Dr. Muldoon's study proved that
measurable cognitive deficits occur in 100% of the people taking statins,
and given that fewer than 100% of the population suffers from Alzheimer's,
it is inevitable they will have to deal with this issue - if they can keep
enough people on the statins without adverse effects - something they are
not experiencing success at now.
Interesting you are unconcerned but Bayer most certainly was not. Perhaps
you are unfamiliar with the sworn testimony in the transcript of the Corpus
Christi Baycol trial, when Lawrence Posner, head of all pharmaceutical
testing for Bayer, including Baycol, testified:
From the transcript of the AM Session on 03-05-03, in the case Hollis Haltom
Vs. Bayer Corporation. Testifying under oath,., in response to the plaintiff
's attorney's question, "What is your current position at Bayer?", LAWRENCE
POSNER, M.D of BAYER stated: "I'm the -- currently I'm the head of worldwide
regulatory affairs for our prescription drug business, which means I have
responsibility in somewhere between 60 and 100 countries where we sell
products for registrations, compliance, things of that nature." Excerpts
from the trial transcript follow, with the Q indicating counsel's Question,
and the A indicating Dr. Posner's Answer:
Q. So there are some concerns addressed here back in 1995 about testing up
to .8. And do you know what the nature of the concern was?
A. Yes. It was related to a side effect that occurred in the brain.
Q. Of what kind of animal?
A. It occurred in the brain of dogs.
Q. Okay. So there was a side effect that occurred in dogs, and then there
was a concern about whether you wanted to go forward and test at this higher
dose level in human beings, given what you had learned about the dogs,
right?
A. That's correct.
Q. Okay. Now, did you just say, well, let's forget about these concerns and
we'll go ahead and put .8 on the market anyway, or did you do some further
analysis that was not mentioned the other day?
A. Yes. The authors of this had -- they had two concerns. One concern was
the toxicity that they found in the brain of dogs. But the other was that
they had no way to identify this and who might be at risk before it
happened. So there was no way to detect that someone was at risk for this
side effect.
[skip some testimony on other topics]
Q. Do you remember in one kind of animal there had been some studies done
that there could be a particular kind of problem with one kind of animal?
A. Oh, yeah. Yes, from the -- that's correct, from the toxicology studies.
> SBH
Sharon Hope
know.
Wall Street Journal has run several articles by Tara Parker-Pope.
Smart Money Magazine ran a 6 page story in the November 2003 issue.
15 million is 3 times the number of Alzheimer's sufferers in the US.
1 in my family is more than enough to illustrate the devastating effects.
"Don Kirkman" <don...@covad.net> wrote in message
news:ih682093kfnb3nb17...@4ax.com...
talkback
> 1 in my family is more than enough to illustrate the devastating effects.
>
No it isn't you moron. With a statement like that you obviously are too
stupid to understand even the most basic principles of causality.
Sharon Hope
Effect is what I can observe - particularly with a 38 year history of daily
observation of the patient. These observations included the rise to
corporate CEO of two different corporations, exemplary hand-eye
coordination, tremendous strength and stamina, leadership in all aspects of
life, sharp memory, shrewd negotiating, keen understanding of complex
issues, multiple US patents for items found in any office, and an
internationally recognized who's who in manufacturing. Four years of
Lipitor 10mg resulted in a slow progression of side effects starting with
muscle pain until, at 54 years of age, he was diagnosed with: short-term
memory below the 1 percentile, multiple episodes of witnessed Transient
Global Amnesia, including several in the course of one week, muscle wasting,
chronic muscle pain, peripheral neuropathy and constant chronic burning
nerve pain, CPK elevation that continued on an upward trajectory for a full
year after halting the Lipitor despite chronic fatigue and extremely limited
physical movement, frequent collapse after expending the energy required to
stand erect for under 7 minutes, the need for up to 4 days bedrest after
walking as much as 100 yards in a day, inability to recall events of 12
hours previous, inability to recall more than 1 item in a list of 3, 2 with
coaching, inability to process sentences beyond 7 words, and progressive
primary aphasia to the degree that 1 sentence could not be reliably
completed in any 4 attempts.
Causality was established by a team of over a dozen physicians, published
world experts in their fields - over 52 appointments in one year alone.
These exams were supported by extensive testing, including PET scan of the
brain, MRI of the brain, nerve conduction test, muscle biopsy, mitochondrial
evaluations, mitochondrial DNA analysis, carotid artery scan, angiograms,
myriad blood, neuropsych testing and cognitive rehabilitation therapy with
its evaluative tests.
Anecdotal observation is one form of illustration of effects in the medical
journals - and the type of illustration of effect this one case serves to
represent. Published research, listed on the PUB MED site of the National
Institutes of Health that verifies these adverse effects includes anecdotal
observations equivalent to the one I have described, but also population
studies and placebo controlled trials. (See below for examples)
The reason this book, "Lipitor, Thief of Memory," is so important is that it
may help prevent other
families from going through this PREVENTABLE memory loss, and it might lead
to research into a treatment for those who stayed on the drug too long while
the doctor did not associated the statin with the damage as it progressed.
Evidence from the National Institutes of Health website and other documented
sources:
MEMORY LOSS & STATINS
Frequently Asked Question: What medical research studies have been done on
Statins and Memory Loss, or other mental problems that I can bring to my
doctor's attention?
(Statins: Lipitor, Mevacor, Pravachol, Zocor, Lescol, Crestor, and Baycol,
aka atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin,
rosuvastatin, and simvastatin; )
Australian Adverse Drug Reactions Bulletin (Australia's equivalent to the
FDA)
Volume 17, Number 3, August 1998, section 3, page 3
Simvastatn is listed under "DRUGS THAT MAKE YOU FORGET"
Recognizing the 14 reports of Amnesia under that drug, .8% of the total
adverse effects for that drug.
www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf
Studies & Links in chronological order, with the latest on top:
Statin-associated memory loss: analysis of 60 case reports and review of the
literature.
Wagstaff LR, Mitton MW, Arvik BM, Doraiswamy PM.
Drug Information Service, Duke University Medical Center, Durham, North
Carolina 27710, USA. Pharmacotherapy. 2003 Jul;23(7):871-80.
This study searched the MedWatch drug surveillance system of the Food and
Drug Administration (FDA) from November 1997-February 2002 for reports of
statin-associated memory loss. They also reviewed the published literature.
References from the study are good for follow-up research.
Full Study Text free on Medscape:
http://www.medscape.com/viewarticle/458867
The Role of Lipid-Lowering Drugs in Cognitive Function: A Meta-Analysis of
Observational Studies
from Pharmacotherapy
Posted 06/30/2003
Mahyar Etminan, Pharm.D., Sudeep Gill, M.D., FRCPC, Ali Samii, M.D., FRCPC
Although this study does bring the cognitive issues to light, it is a very
poor study. The authors left out the pivotal study by Dr. Muldoon, that
showed 100% of statin users had a measurable loss of cognitive ability
after 6 months, while 100% of the placebo group improved their scores.
Abstract:
Full Study Text free on Medscape:
http://www.medscape.com/viewarticle/456866
Muldoon MF, Barger SD, Ryan CM, Flory JD, Lehoczky JP, Matthews KA, Manuck
SB.
Effects of lovastatin on cognitive function and psychological well-being.
After 6 months, 100% of the patients on placeboes showed a measurable
increase in cognitive function, and 100% of the statin patients showed a
measurable decrease in cognitive function.
Am J Med. 2000 May;108(7):538-46.
PMID: 10806282 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10806282&dopt=Abstract
Simvastatin-Associated Memory Loss
Amanda Orsi, Pharm.D., Olga Sherman, Pharm.D., and Zegga Woldeselassie,
Pharm.D.,
Abstract: The statins are widely used to treat dyslipidemias. They are
generally associated with mild adverse effects, but rarely, more serious
reactions may occur. A 51-year-old man experienced delayed-onset,
progressive memory loss while receiving simvastatin for
hypercholesterolemia. His therapy was switched to pravastatin, and memory
loss resolved gradually over the next month, with no recurrence of the
adverse effect.
from Pharmacotherapy
Posted 06/01/2001
Page 1 of 3:
http://www.medscape.com/viewarticle/409738?WebLogicSession=PXke2H8h99pyNVSCajAh5clptzOAHJSZuNBobSwWmi9veWjdJ2A3%7C-1468812056489609316/184161392/6/7001/7001/7002/7002/7001/-1
full printable version: http://www.medscape.com/viewarticle/409738_print
ADR of the Month
September 2001 Vol. 6 No. 9
EDITORS
Michelle W. McCarthy, Pharm.D.
Anne E. Hendrick, Pharm.D.
University of Virginia Health System
Department of Pharmacy Services
Drug Information Center
PO Box 800674
Charlottesville, VA 22908-0674
http://hsc.virginia.edu/pharmacy-services/Newsletters/ADR%20of%20the%20Month/ADRMonth%209-01htm.html
The Tablet, a general member benefit published by the British Columbia
Pharmacy Association, September 2001, Volume 10 no 8.
Excerpt:
Do HMG-CoA reductase inhibitors impair memory? After taking simvastatin for
a year, a 51-year-old patient developed short term memory loss, to the
extent of being unable to complete his sentences because he would forget
what he was going to say. The drug was discontinued, replaced by
pravastatin, and within one month his memory returned.14 In a separate case,
a 67-year-old woman developed impaired short-term memory, altered mood, soci
al impairment, cognitive impairment and dementia after one year of
atorvastatin therapy. When atorvastatin was discontinued, her memory, mood
and cognition improved completely.15 Memory impairment in a patient
receiving atorvastatin has been reported to the BC Regional ADR Centre.
REFERENCES:
14. Orsi A, Sherman O, Woldeselassie Z. Simvastatin-associated memory loss.
15. King DS, Jones DW, Wofford MR et al. First report of cognitive
impairment in an elderly patient: case report. Pharmacotherapy 2001 Mar; 21:
371.
http://www.bcpharmacy.ca/publications/thetablet/pdf_version/BCPhA_Tablet-Sep2001.pdf
See page 11 of 16:
See also:
Statins and risk of polyneuropathy, A case-control study
D. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L.A. García
Rodríguez, MD, MSc;
J. Hallas, MD, PhD; and S.H. Sindrup, MD, PhD
http://213.4.18.135/87.pdf full text
Preclinical safety evaluation of cerivastatin, a novel HMG-CoA reductase
inhibitor.
von Keutz E, Schluter G.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9737641&dopt=Abstract
Institute of Toxicology, PH-Product Development, Bayer AG, Wuppertal,
Germany
Am J Cardiol. 1998 Aug 27;82(4B):11J-17J.
PMID: 9737641
"In dogs, the species most sensitive to statins, cerivastatin caused
erosions and hemorrhages in the gastrointestinal tract, bleeding in the
brain stem with fibroid degeneration of vessel walls in the choroid plexus,
and lens opacity."
Subchronic toxicity of atorvastatin, a hydroxymethylglutaryl-coenzyme A
reductase inhibitor, in beagle dogs.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8864188&dopt=Abstract
Walsh KM, Albassam MA, Clarke DE.
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Ann
Arbor, Michigan 48105, USA.
"The toxicity of atorvastatin (AT), an inhibitor of
hydroxymethylglutaryl-coenzyme A reductase (HMG), was evaluated in beagle
dogs. hemorrhage in gallbladder and brain, demyelination of optic nerve, and
skeletal muscle necrosis"
Finally, on memory loss and statins: Sworn testimony from the Baycol trial
in Corpus Christi, Texas. From the transcript of the AM Session on 03-05-03,
Q. Okay. And were you able to demonstrate to your own satisfaction, to
SmithKline's satisfaction, to the FDA's satisfaction, that that particular
problem that showed up with that kind of animal is not something that
happens in human beings?
A. Yes. We did it -- we did it by explaining the toxicology data. We also
explained it on the basis of kinetic data. That actually at the higher
levels of drug, what happens is a certain amount of drug is bound to
proteins in the body that circulate; and therefore, is not -- cannot cause
side effects. And actually, a much smaller proportion of the drug is free.
And that what you corrected for that, you actually found out that the
margins of safety were in fact greater than you would predict just from the
animal data.
Q. And as you move forward then and got approval and sold Baycol from 1997
through 2001, did that problem that had shown up with that one kind of
animal ever become a problem with human beings?
A. It was actually shown with other statins as well. It wasn't unique to
cerivastatin. It was a problem -- it was identified early on with lovastatin
and some of the others.
AMNESIA & STATINS
Frequently Asked Question: Amnesia is one of the Lipitor side effects
reported by Pfizer on the Physician's Information, where can I find out more
about people who have had amnesia episodes while taking the drug?
Dr. Graveline, retired family MD, USAF Flight Surgeon, researcher in space
medicine and US Astronaut, who suffered adverse effects from Lipitor,
maintains several websites and is working on a book about statin-related
memory loss and amnesia at:
www.spacedoc.net (you can start here and read about his life and his books)
http://www.spacedoc.net/lipitor_thief_of_memory.html
http://www.spacedoc.net/lipitor.htm
http://www.spacedoc.net/statin_dialogues.htm
Australian Adverse Drug Reactions Bulletin (Australia's equivalent to the
FDA)
Volume 17, Number 3, August 1998, section 3, page 3
Simvastatn is listed under "DRUGS THAT MAKE YOU FORGET"
Recognizing the 14 reports of Amnesia under that drug, .8% of the total
adverse effects for that drug.
www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf
NERVE DAMAGE & STATINS
Frequently Asked Question: What medical research studies have been done on
Statins and Nerve Damage that I can bring to my doctor's attention?
Studies & Links in chronological order, with the latest on top:
Statins and risk of polyneuropathy, A case-control study
D. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L.A. García
Rodríguez, MD, MSc;
J. Hallas, MD, PhD; and S.H. Sindrup, MD, PhD
http://213.4.18.135/87.pdf full text
Are users of lipid-lowering drugs at increased risk of peripheral
neuropathy?
David Gaist, Luis Alberto García Rodríguez · Consuelo Huerta · Jesper Hallas
· Søren H. Sindrup
http://213.4.18.135/75.pdf full text
abstract
Are users of lipid-lowering drugs at increased risk of peripheral
neuropathy?
David Gaist, Luis Alberto García Rodríguez · Consuelo Huerta · Jesper Hallas
· Søren H.
Sindrup
http://213.4.18.135/76.2.pdf full text
http://213.4.18.135/87.pdf full text
Pharmacodynamics: Statins and peripheral neuropathy
U. Jeppesen (2), D. Gaist (1)(2), T. Smith (1), S. H. Sindrup (1)(2)
(1) Department of Neurology, Odense University Hospital, DK-5000 Odense C,
Denmark Tel.: +45-6541-2474, Fax: +45-6541-3389
(2) Department of Clinical Pharmacology Odense University, Odense, Denmark
Received: 6 July 1998 / Accepted in revised form: 1 October 1998
Abstract Volume 54 Issue 11 (1999) pp 835-838
http://link.springer-ny.com/link/service/journals/00228/bibs/9054011/90540835.htm
Association of HMG-CoA reductase inhibitors with neuropathy.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12549960&dopt=Abstract
Ann Pharmacother. 2003 Feb;37(2):274-8.
Backes JM, Howard PA.
Department of Pharmacy Practice and Lipid, Atherosclerosis, Metabolic and
LDL-Apheresis Clinic, University of Kansas Medical Center, Kansas City, KS
66160-7231, USA. jba...@kumc.edu
"Epidemiologic studies and case reports suggest an increased risk of
peripheral neuropathy with statin drugs. The majority of cases were at least
partially reversible with drug cessation." (emphasis added)
Statin therapy and small fibre neuropathy: a serial electrophysiological
study.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12639733&dopt=Abstract
Lo YL, Leoh TH, Loh LM, Tan CE.
J Neurol Sci. 2003 Apr 15;208(1-2):105-8.
Department of Neurology, Singapore General Hospital, Outram Road, Singapore.
gnr...@sgh.com.sg
Describes 3 patients who developed neuropathy after ONE MONTH of statin
therapy. "One patient redeveloped small and large fibre neuropathy when the
similar drug was readministered."
Peripheral Neuropathy and Lipid-Lowering Therapy
Paul E. Ziajka, MD, PhD, and Tammy Wehmeier, RN, Orlando, Fla.
Abstract: We report a case of peripheral neuropathy induced and excerbated
by several commonly used HMG-CoA reductase inhibitors including lovastatin,
simvastatin, pravastatin, and atorvastatin, and the vitamin niacin. A review
of the literature shows similar cases with individual lipid-lowering drugs,
but this case shows the cross-reactivity of the neuropathic process to
different HMG-CoA reductase inhibitors, and is the first reported case of a
peripheral neuropathy exacerbated by the use of niacin.
http://www.sma.org/smj1998/julysmj98/ziajka.pdf
Phan T, McLeod JG, Pollard JD, Peiris O, Rohan A, Halpern JP.
Peripheral neuropathy associated with simvastatin.
J Neurol Neurosurg Psychiatry. 1995 May;58(5):625-8.
PMID: 7745415 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7745415&dopt=Abstract
Ahmad S.
Lovastatin and peripheral neuropathy.
Am Heart J. 1995 Dec;130(6):1321. No abstract available.
PMID: 7484806 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7484806&dopt=Abstract
Jacobs MB.
HMG-CoA reductase inhibitor therapy and peripheral neuropathy.
Ann Intern Med. 1994 Jun 1;120(11):970. No abstract available.
PMID: 8172444 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8172444&dopt=Abstract
Medication-induced peripheral neuropathy.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12507417&dopt=Abstract
Curr Neurol Neurosci Rep. 2003 Jan;3(1):86-92. Review.
Weimer LH.
Neurological Institute of New York, 710 West 168th Street, Unit 55, New
York, NY 10032, USA. Lh...@columbia.edu
PMID: 12507417 [PubMed - indexed for MEDLINE]
"Although most cases demonstrate acute or subacute onset after exposure,
recent experiences with statin drugs raise the possibility of occult toxic
causes of chronic idiopathic neuropathy."
Le Quesne PM. Neuropathy due to drugs. In: Dyck PJ, Thomas PK, Griffin JW,
et al, eds. Peripheral neuropathy. 3rd ed. Philadelphia: Saunders,
1993:1571-1581.
(Book, no link)
Of interest:
MacDonald BK, Cockerell OC, Sander WAS, Shorvon SD (2000) The incidence and
lifetime prevalence of neurological disorders in a prospective
community-based study in the UK. Brain
123:665-676
General background medical Info from
Related, but also will appear in other FAQs:
Neuromuscular Disease Center
Washington University School of Medicine, St. Louis, MO
Home: http://www.neuro.wustl.edu/neuromuscular/index.html
Under Disorders & Syndromes:
Select:
Myopathy: http://www.neuro.wustl.edu/neuromuscular/maltbrain.html
Neuropathy: http://www.neuro.wustl.edu/neuromuscular/naltbrain.html
Neuromuscular: http://www.neuro.wustl.edu/neuromuscular/syaltbrain.html
CNS (Central Nervous System):
http://www.neuro.wustl.edu/neuromuscular/syaltbrain.html#cns
Specifics,
MYOGLOBINURIA - RHABDOMYOLYSIS
http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html
Then see Lipid Lowering Agent Myopathies
http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html#lipid
Note that this connects to CARDIAC + MYOPATHY
http://www.neuro.wustl.edu/neuromuscular/msys/cardiac.html
And to TOXIC NEUROPATHIES:
http://www.neuro.wustl.edu/neuromuscular/nother/toxic.htm#statin
OR Locally supplied Search on "Statin" leads to:
TOXIC MYOPATHIES http://www.neuro.wustl.edu/neuromuscular/mother/myotox.htm
Note also tht under Mitochondrial Disorders, the list of problems associated
with Coenzyme Q10 Deficiency
http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html#coq10
MITOCHONDRIAL MYOPATHIES
Facts About Mitochondrial Myopathies from the Muscular Dystrophy Association
http://www.mdausa.org/publications/mitochondrial_myopathies.html#whatcauses
"talkback" <tb...@yahoo.com> wrote in message
news:kMNVb.1958$Fp5...@read1.cgocable.net...
talkback
> Cause and effect are two different elements of the same event.
Okay. I'll rephrase it nice and simple for you. Sorry, I just assumed
you weren't a complete idiot.
Your "case study" of ONE person is NOT a broad enough data sample to
illustrate anything except that you are stupid.
If I observed ONE pig being catapulted over a house, I would be mistaken
in saying pigs can fly.
FYI - If you say stupid things people are going to think (know) that you
are stupid.
No more on this. Get some reality assessment help.
Steve Harris sbharris@ROMAN9.netcom.com
> This was a 6 month study, and already there was a statistically significant
> difference. Statin drugs are prescribed for ongoing usage, not just for 6
> months.
COMMENT:
By what right do you use the word "already"? That presumes that which
remains to be proven, namely that the effect described is ongoing and
cumulative over longer periods of time.
Let me show you what happens if you use your style of argument. I give
one group of people a placebo and the other a blood pressure pill. At
six months I measure their blood pressures and find a significant
difference. "Oh, no!", I say. "Already at 6 months their blood
pressures are down by 5 points! At this rate, in 5 years they'll all
be dead!"
The analogy is actually fairly close, because it takes the brain a bit
to adapt to the effects of lots of drugs, including blood pressure
pills. For some months after lowering a person's blood pressure from
high to normal you can find a range of mildly negative mental effects.
But they're not usually clinically significant, and the brain does
adapt to the normal perfusion pressure, eventually. So the short term
effects by no means show that lowering blood pressure to normal is a
bad thing to do.
Very similar things happen, BTW, when you lower the blood sugars of
long uncontrolled diabetics to normal. Mentally they can have problems
for quite some time. But that doesn't mean it lasts forever, or gets
worse. And it doesn't mean you shouldn't do it. On the contrary if you
leave blood sugar (or blood pressure or blood cholesterol) high, bad
things happen to mentation in the end, because the risk of stroke is
greatly increased.
Say, did I tell you about the patient I once tried to cure of smoking?
After a 3 days without cigarettes she was complete mass of nerves,
unable to think or perform. So we had to give them back. At that
rate, in a month we'd have had to put her in a nursing home.
SBH
list...@nospam.net
Wow! And people thought *I* was being impolite when I questioned Mrs.
Hope's overblown assertions.
Don't get me wrong - I don't necessarily think you're wrong in your
assessment, but boy are you blunt!
Mrs. Hope is one of a few serious anti-statinites in this newgroup
(because of her unfortunate situation). There's nothing you can say to
enlighten her. She's on a crusade and won't be swayed.
Just so it's clear: talkback is not ME using a different name - as
others do here. Phew!
(Just popped in to see how things were going - generally the've gone
further down hill...)
Sharon Hope
you.
However, my husband's experience, as well as many others we have first-hand
knowledge of, was slight cognitive impact at 6 months, with the more common
muscle pain being first and foremost concern. The cognitive impacts
gradually progressed to the point where the family insisted the doctor be
consulted because of many remarkable examples of short-term memory loss - we
were gravely concerned that the problem was due to TIA's/mini strokes. The
doctor, when asked, blew it off with a joke - "What, do they think you have
early Alzheimer's? Well, there's no cure anyway, so.... FORGET IT! haha"
(Husband at that point was 52). Months later, as the cognitive decline
continued more and more noticably, we requested - in writing this time -
help from the cardiologist, asking if it were stroke, some bad reaction to
medication, or some other cause.
This led to another stress test, angiogram, and a carotid artery scan - all
came back fine, with the cardiologist furious because he had, "wasted my
time! His arteries look great!" He dismissed the questions at that point,
and the hospital release papers state that the doctor said no matter what
the side-effects, the drug is working for the arteries, so do not
discontinue.
Within a few more months there were multiple witnessed episodes of Transient
Global Amnesia - quite frightening for both the patient and the family.
Inability to remember events of the day before, in some cases within an hour
before, quite obviously affected business. Aphasia then became more and
more troublesome, to the point that he was unable to reliably complete one
sentence in four attempted. By the time 4 years on Lipitor had elapsed,
communication was nearly impossible, Transient Global Amnesia episodes
frequent, and recall for recent (span from previous day to within last few
years) events nonexistent.
This progression is documented over and over again in the literature (PUB
MED) and has been shared with us by many many families. All with the same
gradual progression of cognitive decline on Lipitor and other stronger
statins.
The very lucky folks experienced amnesia in the first month or so of
treatment, and connected the events with the new treatment. For those who
are gradually declining, there is no "new" medication to blame at the time
and doctors were not looking for this set of adverse effects. Tragically
they don't seem to follow up on the memory loss in and of itself, either.
When described anecdotally, they "hear" only a failure to find car keys, and
invariably comment that it happens to everyone, not to worry. By the time
it has progressed so far as to be obvious to the man in the street and clerk
at the store, neuropsych tests show drastic loss of short-term memory.
So, when I say "already" as if it is a progression, that is because I
recognize it as such in my immediate experience, as well as in the reported
experience of many others, both in the medical literature and among new
friends in adversity. How, you will naturally ask, can a post test prove
anything unless compared with a pre-test? By the job the person performed.
The evaluator specifies in the neuropsych evaluation that it is impossible
for the person to continue in the job they had functioned in during the
pre-morbid condition. However, post testing years after discontinuing the
statins shows improvement - also gradual, and taking at least as long as it
took to develop the condition to show any slight but statistically
significant elevation in cognitive scores, but improve they do. The
literature shows that those rechallenged with the statins return to the
cognitive deficit condition.
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04020...@posting.google.com...
talkback
> Very similar things happen, BTW, when you lower the blood sugars of
> long uncontrolled diabetics to normal. Mentally they can have problems
> for quite some time. But that doesn't mean it lasts forever, or gets
> worse. And it doesn't mean you shouldn't do it. On the contrary if you
> leave blood sugar (or blood pressure or blood cholesterol) high, bad
> things happen to mentation in the end, because the risk of stroke is
> greatly increased.
I'm curious if this effect is caused by the blood sugar being "normal"
or below normal. In other words, is it relative to having previously
high blood sugars or maybe it's that when diabetics start getting better
control they experience occasional lows, which, as we know, can cause
confusion, etc.
Sharon Hope
associated with violent outbursts.
If you will review the thread, there were many references to a broad number
of published medical articles, including populational studies as well as
surveys of the literature.
In addition, popular press articles were cited, including references to
articles in the financial press - Wall Street Journal, multiple articles,
and Smart Money Magazine. Add to these previous citations, coverage in the
Graedon's People's Pharmacy, both articles and radio show recordings, and a
recent local newspaper article from Northern California:
http://tw.us.publicus.com/apps/pbcs.dll/article?AID=/20040129/NEWS/401290101
Now the advent of a book, Lipitor, Thief of Memory. Soon more published
results of a trial that looked at cognitive impacts.
In addition, the effects personally observed were mentioned. The posts are
far, far in excess of one observation.
"talkback" <tb...@yahoo.com> wrote in message
news:atQVb.160$oF5....@read2.cgocable.net...
Sharon Hope
Golomb BA, Stattin H, Mednick S.
PMID: 11104842
Department of Medicine, University of California, Los Angeles, CA
92093-0995, USA. bgo...@ucsd.edu
BACKGROUND: Community cohort studies and meta-analyses of randomized trials
have shown a relation between low or lowered cholesterol and death by
violence (homicide, suicide, accident); in primates, cholesterol reduction
has been linked to increased behavioral acts of aggression (Kaplan J, Manuck
S. The effects of fat and cholesterol on aggressive behaviour in monkeys.
Psychosom. Med 1990;52:226-7; Kaplan J, Shively C, Fontenot D, Morgan T,
Howell S, Manuck S et al. Demonstration of an association among dietary
cholesterol, central serotonergic activity, and social behaviour in monkeys.
Psychosom. Med 1994;56:479-84.). In this study we test for the first time
whether cholesterol level is related to commission of violent crimes against
others in a large community cohort.
...
RESULTS: One hundred individuals met criteria for criminal violence. Low
cholesterol (below the median) was strongly associated with criminal
violence in unadjusted analysis (Men: risk ratio 1.94, P=0.002; all subjects
risk ratio 2.32, P<0.001). Age emerged as a strong confounder. Adjusting for
covariates using a matching procedure, violent criminals had significantly
lower cholesterol than others identical in age, sex, alcohol indices and
education, using a nonparametric sign test (P=0.012 all subjects; P=0.035
men). CONCLUSIONS: Adjusting for other factors, low cholesterol is
associated with increased subsequent criminal violence.
"talkback" <tb...@yahoo.com> wrote in message
news:atQVb.160$oF5....@read2.cgocable.net...
talkback
Good Lord - Wall Steet Journal, Smart Money Magazine, radio shows, The
Armpit Daily Bugle!! Your references are truly impeccable.
Enough of you. Too stupid to talk to any more.
Al. Lohse
list...@nospam.net wrote:
>
>>>>>>>snipped >>>>>>>.
> Mrs. Hope is one of a few serious anti-statinites in this newgroup
> (because of her unfortunate situation). There's nothing you can say to
> enlighten her. She's on a crusade and won't be swayed.
>
All right, it was cute, but it is time to
deal with reality.
Listener has picked up on a trend that seems
to give results.
Racist it to race.
Anti-Semitism is to Jew.
Sexist is to feminist.
Male chauvinist pig is to feminist.
Homophobe is to homosexual.
Seinfeld had an episode in which people who
disliked dentists were denigrated as
"anti-dentites."
And now, "anti-statinite" is to statin drugs.
This form of name-calling, of denigrating
anyone who fails to go along with the pack
appears to be successful, but, I would say,
not always honourable, not always desirable.
It may lead to outcomes which are
undesirable, as, in the case of statin drug
consumption, the slight possibility of death
for the prospect of little or no health
benefit.
So, Listener, if you want to present evidence
to this "sci" (for "science") news group, by
all means do so. If you want to instigate
chants and rants against people who have
formed opinions, on facts, not in keeping
with your own, perhaps you can find
"alt.advertising" or "alt.psychology" more to
your liking.
Regards,
A.L.
Al. Lohse
"Steve Harris sbha...@ROMAN9.netcom.com"
wrote:
Just where do you come from Steve Harris? You
are not the actor on "Practice" are you?
Sharon Hope has been informing us on the
plight of her husband for some time now. The
fact is he trusted his doctor and his doctor
trusted the pharmaceutical industry. Now he
suffers and no one, except his wife, is
trying to help him. He is permanently damaged
by what might be called the whimsy of modern
medicine.
With Mrs. Hope's extensive research, it is
enormously clear, certainly beyond a
reasonable doubt, that her husband was
victimised by the system.
I see her use of the word "already" to mean
you do not have to wait a decade to determine
the negative cognitive effects of that drug.
Adverse effects show up early.
You have presented no evidence to the
contrary, nor have you any evidence the
negative cognitive effects are temporary or
transient. You have tried to change the
subject. What might your motives be?
Because Mr. Hope trusted his doctor to end up
in his state, his wife has told us what to
look for regarding adverse effects that
doctors are not told about and, are,
apparently, not even interested in.
Had Mr. Hope had the benefit of hindsight, he
could have availed himself of the information
in the following link and decided not to
continue with the therapy. (But it is very
difficult for all of us to tell our doctors
to "take a hike.")
http://www.ti.ubc.ca/PDF/48.pdf
This information was released last summer.
Their conclusion is: "Therefore, statins have
not been shown to
provide an overall health benefit in primary
prevention trials."
Had Mr. Hope known that, and his doctor
certainly should have known that, he would
not be a drug-damaged individual today.
By not continuing therapy, he could have
saved himself and his family a great deal of
grief. They have been destroyed by the drug
therapy applied by an apparently well-meaning
physician. Some of the best minds, including
Dr. Chung's, have been unable to help him.
You are certainly encouraged to give contrary
evidence, but simply trying to change the
subject should not be encouraged here.
I have no problem with the word, "already."
Have you still a problem with it?
A.L.
list...@nospam.net
<lo...@cc.umanitoba.ca> wrote:
>
>And now, "anti-statinite" is to statin drugs.
>
>This form of name-calling, of denigrating
>anyone who fails to go along with the pack
>appears to be successful, but, I would say,
>not always honourable, not always desirable.
>It may lead to outcomes which are
>undesirable, as, in the case of statin drug
>consumption, the slight possibility of death
>for the prospect of little or no health
>benefit.
>
>So, Listener, if you want to present evidence
>to this "sci" (for "science") news group, by
>all means do so. If you want to instigate
>chants and rants against people who have
>formed opinions, on facts, not in keeping
>with your own, perhaps you can find
>"alt.advertising" or "alt.psychology" more to
>your liking.
>
>Regards,
>A.L.
Sorry I ruffled your feathers a bit. Name-calling? - did your even
READ talkback's responses? THAT was rough stuff, IMO.
I certainly meant no underlying racial (or otherwise) connotation. I
will discontinue using it, if it makes you happy, even though I do
feel it is an appropriate moniker.
How about "crusader against the use of statins". That lends a more
herioc tone, ok?
Steve Harris sbharris@ROMAN9.netcom.com
COMMENT:
Ms. Golumb seems to be on an anticholesterol campaign. Alas, there are
a couple of obvious confounders other than age, sex, education, and
alcohol use. After all, we need to wonder about WHY it's important to
adjust for age and sex when looking at cholesterol and violence. One
reason is that testosterone has bad effects on cholesterol,
particularly HDL. And so does age, but much of the age effect is due
to obesity. Young fat men with low testosterone aren't as violent as
young skinny men with high testosterones. But they also have higher
cholesterols, and if you don't control for body mass index and
testosterone levels, it looks like cholesterol is the culpret.
Let me put it another way: cholesterol levels are a proxy for whether
or not you're being starved, which tends to make people cranky and
violent (monkeys too). Anybody who's had to live with somebody on a
crash diet knows this effect. It's not new, either. "Yond Cassius has
a lean and hungry look; He thinks too much: such men are dangerous."
Shakespeare's Ceasar may have been on to something, but it wasn't
necessarily the effect of cholesterol.
SBH
Don Kirkman
>They have, particularly the financial press - because investors need to
>know.
>Wall Street Journal has run several articles by Tara Parker-Pope.
Parker-Pope wrote on August 5, 2003, about CRP and cholesterol *testing*
(she supports CRP); statins were only mentioned in passing.
On January 26, 2004, Parker-Pope wrote of a number of "medical
breakthroughs" expected in 2004. Regarding the NIH study of statins,
she cited Beatrice Golomb, director of the study thus: "Although the
patient data in the NIH study is still secret, Dr. Golomb says that
among other patients she has seen, about 15% have developed some
cognitive problem related to statin use. Even so, notes Dr. Golomb,
'there are still people who are persuaded ... that there are no
cognitive effects from statins.'
Note that the 15% is not from the NIH study but is Dr. Golomb's estimate
from her own practice. Also note that 15% could be three patients out
of twenty, and that Dr. Golomb's clientele may not be typical, since she
is associated with a university.
As far as I can see there are NO numbers for sufferers from statins in
your references; I see names, including yours, and I see anecdotal
stories about specific doctors, but nothing clinical and nothing
supporting *any* morbidity rate, much less 15% Do you have credible
evidence supporting your statements?
>Smart Money Magazine ran a 6 page story in the November 2003 issue.
Smart Money is under the same corporate umbrella as WSJ. One of your
mailing group companions, though, wrote "Sorry to hear about your
problem with Lipitor. Your story has happened over and over again
everyday by someone taking Lipitor. That's why some of us helped get
that smartmoney article written."
>15 million is 3 times the number of Alzheimer's sufferers in the US.
Please point us to any media actually reporting 15 or 16 million
debilitated by statins. That's how many there would have to be for the
15% bad side effects you posted about. ISTM numbers like that would be
everywhere in the media. As I wrote above, I see NO figures except Dr.
Golomb's estimate of 15%.
>1 in my family is more than enough to illustrate the devastating effects.
. . . effects which, with a p of one, could be totally coincidental or
caused by other unrecognized factors.
>"Don Kirkman" <don...@covad.net> wrote in message
>news:ih682093kfnb3nb17...@4ax.com...
>> It seems to me I heard somewhere that Sharon Hope wrote in article
>> <DelUb.178929$5V2.884399@attbi_s53>:
>> >How glib your opinion of doctors who do not intervene when patients
>develop
>> >short-term memory loss, cognitive decline, and multiple episodes of
>> >transient global amnesia may be entertaining, as is your 'nobody believes
>it
>> >is fall in cholesterol per se that causes the problem..."
>> >You miss the point entirely: 15% of patients are disabled by the statin
>> >drugs. Over 106 million people take statin drugs world wide.
>> You DO realize that 15% of 106 million is 15.9 million? I think the
>> media might have noticed, if the medical community did not, if nearly 16
>> million people world-wide were debilitated by the statins.
--
Don
don...@covad.net
Don Kirkman
<402920B5...@cc.umanitoba.ca>:
>"Steve Harris sbha...@ROMAN9.netcom.com"
>wrote:
[Re: Mr. Hope's problems]
>Sharon Hope has been informing us on the
>plight of her husband for some time now. The
>fact is he trusted his doctor and his doctor
>trusted the pharmaceutical industry. Now he
>suffers and no one, except his wife, is
>trying to help him. He is permanently damaged
>by what might be called the whimsy of modern
>medicine.
>Had Mr. Hope had the benefit of hindsight, he
>could have availed himself of the information
>in the following link and decided not to
>continue with the therapy. (But it is very
>difficult for all of us to tell our doctors
>to "take a hike.")
>http://www.ti.ubc.ca/PDF/48.pdf
>This information was released last summer.
>Their conclusion is: "Therefore, statins have
>not been shown to
>provide an overall health benefit in primary
>prevention trials."
But you seem to be overlooking
1> PROSPER study
"Measures of overall health impact in the combined populations, total
mortality and total serious adverse events, were unchanged by
pravastatin as compared to placebo,"
2> (ALLHAT-LLT)2 study
"Total serious adverse events were not reported."
3> (ASCOT-LLA) study
"The trial report stated that total serious adverse events *did not
differ between patients assigned atorvastatin or placebo*, but the
actual numbers of serious adverse events were not given."
In the metastudy of pooled data, "In the 2 trials where serious adverse
events are reported, the 1.8% absolute reduction in myocardial
infarction and stroke should be reflected by a similar absolute
reduction in total serious adverse events; myocardial infarction and
stroke are, by definition, serious adverse events. However, this is not
the case; serious adverse events are similar in the statin group,
44.2%, and the control group, 43.9% (Table 2). This is consistent with
the possibility that unrecognized serious adverse events are increased
by statin therapy and that the magnitude of the increase is similar to
the magnitude of the reduction in cardiovascular serious adverse events
in these populations. This hypothesis needs to be tested by analysis of
total serious adverse event data in both past and future statin trials.
Serious adverse event data is available to trial authors, drug companies
and drug regulators. The other measure of overall impact, total
mortality, is available in all 5 trials and is not reduced by statin
therapy (Table 2)"
Since the absolute reduction in MI and stroke was 1.8%, and since the
SAEs in the statin group and the control group were similar, the other
(unnamed) adverse effects in the statin group may be offsetting the 1.8%
treatment-related reduction; i.e., the other adverse effects are likely
in the range of 1.5% to 2.0%. Note that these adverse effects are
neither specified nor characterized.
--
Don
don...@covad.net
list...@nospam.net
wrote:
>>http://www.ti.ubc.ca/PDF/48.pdf
>
>>This information was released last summer.
>>Their conclusion is: "Therefore, statins have
>>not been shown to
>>provide an overall health benefit in primary
>>prevention trials."
>
>But you seem to be overlooking
>
>1> PROSPER study
>"Measures of overall health impact in the combined populations, total
>mortality and total serious adverse events, were unchanged by
>pravastatin as compared to placebo,"
>
>2> (ALLHAT-LLT)2 study
>
>"Total serious adverse events were not reported."
>
>3> (ASCOT-LLA) study
>
>"The trial report stated that total serious adverse events *did not
>differ between patients assigned atorvastatin or placebo*, but the
>actual numbers of serious adverse events were not given."
I also posted information directly from the studies or those directly
involved in the studies [see: "Re: Cholestrol: opinions please" (not
my spelling!] which tempers if not contradicts what the crusaders
against the use of statins proclaim. As you can see when ever anyone
questions what they post they respond with attacks and MORE
questionable links
So, what is *really* going on here? How can there be these two
opposing views regarding the dangers/safety of statin use? Studies
have been done. Conclusions have been posited. Who is misreading or
misinterpreting the data? and Why??
Sharon Hope
news:b40j205kkaviqeqme...@4ax.com...
snip>
> I also posted information directly from the studies or those directly
> involved in the studies [see: "Re: Cholestrol: opinions please" (not
> my spelling!] which tempers if not contradicts what the crusaders
> against the use of statins proclaim. As you can see when ever anyone
> questions what they post they respond with attacks and MORE
> questionable links
The crusade is against unrecognized adverse effects, proven in published PUB
MED articles, which are consistently ignored and destroy quality of life for
a subset of people.
TWO YEARS after the many many rhabdo deaths caused Bayer, of its own
volition, to remove Baycol from the market, while all other statins also had
rhabdo deaths, there was a physicians joint advisory issued by NHLBI, ACC
and AHA advising physicians to monitor for muscle, kidney and liver damage,
and to halt the drug if these were identified in the patient. That advisory
mentioned, in one single sentence, the nerve damage associated with statins,
proven in three published populational trials.
The subset of patients who suffer cognitive damage - admitted by Pfizer on
the physician's insert at a rate of 2% but estimated at 15% by the NIH
investigator if Wall Street Journal quoted correctly - deserve to have their
doctors monitor for cognitive damage. It is not unreasonable to discontinue
medication for a particular patient when that patient develops adverse
effects that eliminate that person's ability to earn a living or recall the
events of the previous day.
>
> So, what is *really* going on here? How can there be these two
> opposing views regarding the dangers/safety of statin use? Studies
> have been done. Conclusions have been posited. Who is misreading or
> misinterpreting the data? and Why??
Stimulants work as stimulants in most people. For children with ADD,
stimulants have the inverse effect. No one becomes hysterical or
belligerant when this simple observation of fact is posited. Why is it so
threatening to the statins-at-all-costs defenders to contemplate the
possibility that for some patients, statins are associated with adverse
effects that are sufficiently serious to merit discontinuing the drug? Do
these same people scream at their television screens when a direct-marketing
commercial for a prescription drug lists the major adverse effects? Is
there some reason statin patients should be kept ignorant of these adverse
effects, when the approach to all other pharmaceuticals is to warn patients
of adverse effects?
So, what IS *really* going on here?
Are the following citations not sufficient to show that some people
experience some adverse effects from statins? Are statins the only
prescription medication that is purported to be absolutely free of adverse
effects to the degree that anyone developing what appears to be an adverse
effect is denigrated, and anyone reporting it is ostracized, and anyone
concerned is the subject of ad hominem attacks?
What are the Lipitor Adverse Events in Placebo-Controlled Studies listed by
Pfizer in the Physician's information?
For a full introduction to the list, view
http://www.lipitor.com/pi/default.asp, the information below is from the
version updated as of April 2002:
Body as a whole: Infection, Headache, Accidental Injury, Flu Syndrome,
Abdominal Pain, Back Pain, Allergic Reaction, Asthenia;
Digestive system: Constipation, Diarrhea, Dyspepsia, Flatulence;
Respiratory system: Sinusitis, Pharyngitis;
Skin and Appendages: Rash;
Musculoskeletal system: Arthralgia, Myalgia.
What are the Lipitor Averse Events reported in patients treated with Lipitor
in clinical trials listed by Pfizer in the Physician's information?
For a full introduction to the list, view
http://www.lipitor.com/pi/default.asp, the information below is from the
version updated as of April 2002:
Body as a Whole: Chest pain, face edema, fever, neck rigidity, malaise,
photosensitivity reaction, generalized edema.
Digestive System: Nausea, gastroenteritis, liver function tests abnormal,
colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis,
eructation, glossitis, mouth ulceration, anorexia, increased appetite,
stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis,
melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis,
hepatitis, pancreatitis, cholestatic jaundice.
Respiratory System: Bronchitis, rhinitis, pneumonia, dyspnea, asthma,
epistaxis.
Nervous System: Insomnia, dizziness, paresthesia, somnolence, amnesia,
abnormal dreams, libido decreased, emotional lability, incoordination,
peripheral neuropathy, torticollis, facial paralysis, hyperkinesia,
depression, hypesthesia, hypertonia.
Musculoskeletal System: Arthritis, leg cramps, bursitis, tenosynovitis,
myasthenia, tendinous contracture, myositis.
Skin and Appendages: Pruritus, contact dermatitis, alopecia, dry skin,
sweating, acne, urticaria, eczema, seborrhea, skin ulcer.
Urogenital System: Urinary tract infection, urinary frequency, cystitis,
hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis,
fibrocystic breast, vaginal hemorrhage, albuminuria, breast enlargement,
metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary
urgency, abnormal ejaculation, uterine hemorrhage.
Special Senses: Amblyopia, tinnitus, dry eyes, refraction disorder, eye
hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion.
Cardiovascular System: Palpitation, vasodilatation, syncope, migraine,
postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension.
Metabolic and Nutritional Disorders: Peripheral edema, hyperglycemia,
creatine phosphokinase increased, gout, weight gain, hypoglycemia.
Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy,
thrombocytopenia, petechia.
What are the Lipitor Adverse events associated with Lipitor therapy reported
since market introduction, that are not listed above, listed by Pfizer in
the Physician's information?
For a full introduction to the list, view
http://www.lipitor.com/pi/default.asp, the information below is from the
version updated as of April 2002:
anaphylaxis, angioneurotic edema, bullous rashes (including erythema
multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and
rhabdomyolysis.
REPORTING ADVERSE EFFECTS FROM STATINS
Where should I report adverse effects from statins?
Report to the FDA, http://www.fda.gov/medwatch/how.htm
Also, it is important to report side-effects to the Statin Study, funded by
the National Institutes of Health and conducted at the University of
California, San Diego.
Statin Study website: http://medicine.ucsd.edu/statin/
with contact info at:
http://medicine.ucsd.edu/statin/contactinfo.html
UCSD STATIN STUDY E-MAIL ADDRESS: stati...@ucsd.edu
MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995
PHONE NUMBER: (858 558-4950
Dr. Golomb, the principal investigator of the Statin Study, is an incredibly
intelligent and active woman. Take a look at her Curriculum Vitae at:
http://www.medicine.ucsd.edu/faculty/golomb/
Of interest:
MEMORY LOSS & STATINS
Frequently Asked Question: What medical research studies have been done on
Statins and Memory Loss, or other mental problems that I can bring to my
doctor's attention?
(Statins: Lipitor, Mevacor, Pravachol, Zocor, Lescol, and Baycol, aka
atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, and
simvastatin; Nerve Damage: Neuropathy, peripheral neuropathy,
polyneuropathy; See separate FAQ for memory loss, cognitive damage, amnesia
and aphasia, i.e., central nervous system (CNS) damage)
http://www.medscape.com/viewarticle/458867
from Pharmacotherapy
Posted 06/30/2003
Abstract:
http://www.medscape.com/viewarticle/456866
social impairment, cognitive impairment and dementia after one year of
See also:
and some of the others. In fact, for none of the statins did it ever predict
for any clinical problem or toxicity.
Q. So these animals would have that same problem regardless of which
statin -- or at least with other statins?
A. Certainly with lovastatin it was true.
Q. But when it came time to human beings, that just wasn't something that
happened to human beings?
A. And I think today no one pays much attention to it.
AMNESIA & STATINS
Frequently Asked Question: Amnesia is one of the Lipitor side effects
reported by Pfizer on the Physician's Information, where can I find out more
about people who have had amnesia episodes while taking the drug?
Dr. Graveline, retired family MD, USAF Flight Surgeon, researcher in space
medicine and US Astronaut, who suffered adverse effects from Lipitor,
maintains several websites and is working on a book about statin-related
memory loss and amnesia at:
www.spacedoc.net (you can start here and read about his life and his books)
http://www.spacedoc.net/lipitor_thief_of_memory.html
http://www.spacedoc.net/lipitor.htm
http://www.spacedoc.net/statin_dialogues.htm
Australian Adverse Drug Reactions Bulletin (Australia's equivalent to the
FDA)
Volume 17, Number 3, August 1998, section 3, page 3
Simvastatn is listed under "DRUGS THAT MAKE YOU FORGET"
Recognizing the 14 reports of Amnesia under that drug, .8% of the total
adverse effects for that drug.
www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf
CHEST PAIN & STATINS
Frequently Asked Question: Chest pain, that my cardiologist cannot explain
via angiogram, stress test, EEG or EKG, is one of the side-effects I see is
reported by many people. Is there any information on chest pain associated
with statins?
Naturally, chest pain should be first evaluated by a cardiologist. If the
usual explanations for chest pain do not apply to you, and you believe that
statin adverse-effect may be the cause, here are some articles that may give
you some background, or may be useful to give to your doctor. Some are
specific to statins and cardiomyopathy, some are background on how statins
affect CoQ10 production and how a CoQ10 deficiency affects the cells.
Most of these research articles have been found via a search of the National
Institutes of Health website
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=&DB=PubMed , a repository
for hundreds of medical journals. In most cases, only the abstract is
available and the full article must be purchased. Many of the others can be
found via a Google or other net search, or were discovered via posts on the
Lipitor message boards.
See:
http://www.lipitor.com/pi/default.asp Pfizer's Physician's Info for
prescribing Lipitor, includes documented known adverse effects. Note "Body
as a Whole: Chest pain," the italics indicate that the incidence was > 2% in
original trials.
COENZYME Q10 (UBIQUINONE) DEFICIENCY CAUSED BY STATINS
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12353945&dopt=Abstract
Study report: http://www.annals.org/issues/v137n7/nts/200210010-00004.html
Dr. Phillips study mentioned in a Wall Street Journal article (This is
smooth muscle, not cardiac muscle.) Conclusion "statin therapy may be
associated with increased oxidation injury.mild adverse effects of statins
that are difficult to assess might be much more prevalent than widely
considered "
http://www.impostertrial.com Is Myopathy Part Of Statin Therapy? Dr.
Phillips study website, with info for Patient and Physician
Cohen & Gold, Mitochondrial Cytopathy in Adults: What we know so far
http://www.ccjm.org/pdffiles/COHEN701.PDF
(See "Heart" in table page 4, and section on page 7) CoQ10 If statins cause
CoQ10 deficiency, and CoQ10 deficiency causes mitochondrial disease, what
are the symptoms of mitochondrial disease? Heart pain is one of them.
Oxidation Injury in Patients Receiving HMG-CoA Reductase Inhibitors:
Occurrence in Patients without Enzyme Elevation or Myopathy.
US Patents: # 4,933,165
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1&f=G&l=50&s1=4933165.WKU.&OS=PN/4933165&RS=PN/4933165
see also subsequent related patents: Do a search by patent number at:
http://patft.uspto.gov/netahtml/srchnum.htm
for the following:
United States Patent 5,082,650
United States Patent 5,849,777
United States Patent 6,264,960
Merck Patent application stating that statins interfere with CoQ10 and that
deficiency causes problems. They documented that they knew this about
statins in 1989, 10 years before the 100+ deaths by Rhabdomyolysis!
http://sites.huji.ac.il/malaria/maps/ubiquinonemetpath.html
Malaria Parasite Metabolic Pathways Ubiquinone Metabolism
another version:
http://www.stdgen.lanl.gov/stdgen/images/KEGG/00130.html
DEFINITION Ubiquinone biosynthesis - Reference pathway. Diagram of the
Ubiquinone (aka CoQ10) metabolic pathway, highlighting exactly where the
Statins interrupt it. All of the 17 or so steps have to happen correctly for
the body to produce CoQ10, but statins interrupt (or retard) this in step
#2.
Introduction to the Citizen's petition to the FDA:
http://www.vaccinationnews.com/DailyNews/July2002/StatinInduced8.htm by Dr.
Peter Langsjoen This is the introduction to the petition. (It is aimed at
getting attention, and the wording may be more alarming than necessary.)
To the FDA: "Citizen Petition To Change The Labeling For All Statin Drugs
(Mevacor, Lescol, Pravachol, Zocor, Lipitor, And Advicor) Recommending Use
Of 100-200mg Per Day Of Supplemental Co-Enzyme Ql0 To Reduce The Risk Of
Statin-Induced Myopathies (Including Cardiomyopathy And Congestive Heart
Failure)," by Dr. Julian Whitaker, MD:
http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf
or as html:
http://216.239.33.100/search?q=cache:4qAiX-YbZLYC:www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf+Statin-Induced+Cardiomyopathy+Introduction+To+The+Citizen%27s+Petition+On+Statins&hl=en&ie=UTF-8
Statin Depletion of CoQ10 is linked to heart problems.
Exhibit A of FDA Petition: "The clinical use of HMG CoA-reductase inhibitors
(statins) and the associated depletion of the essential co-factor coenzyme
Ql0; a review of pertinent human and animal data." by Dr. Peter Langsjoen
MD:
http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-02-Exhibit_A-vol1.pdf
Examples of the heart problems associated with statin depletion of CoQ10.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2247468&dopt=Abstract
Lovastatin decreases coenzyme Q levels in humans.
Proc Natl Acad Sci U S A. 1990 Nov;87(22):8931-4.
PMID: 2247468 [PubMed - indexed for MEDLINE] A 1990 study showing depletion
of CoQ10 by Lovastatin - includes descriptions of cardiac patients.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11479481&dopt=Abstract A
2001 discussion on "The effect of pravastatin and atorvastatin on coenzyme
Q10"
http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/C/CellularRespiration.html
Primer on how cells breathe normally (Note the role of CoQ10, called
"Ubiquinone" in "The Respiratory Chain" section.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11505177&dopt=Abstract
(abstract)
http://213.4.18.135/70.pdf
http://216.239.33.100/search?q=cache:IGxCBJ3vs1kC:213.4.18.135/70.pdf+gaist+statin+myopathy+risk+greater&hl=en&ie=UTF-8
view as html
Lipid-lowering drugs and risk of myopathy: a population-based follow-up
study. Dr. Gaist is in Denmark and studies populations of entire countries
for epidemiology information.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12011277&dopt=Abstract
Dr. Gaist's study, Statins and risk of polyneuropathy: a case-control study.
(more serious than peripheral neuropathy)
http://213.4.18.135/87.pdf Dr. Gaist's studies on Statin-induced nerve
damage (full text)
Others:
Watts GF, Castelluccio C, Rice-Evans C, Taub NA, Baum H, Quinn PJ. Plasma
coenzyme Q (ubiquinone) concentrations in patients treated with simvastatin.
J Clin Pathol. 1993;46:1055-7. [PMID: 8254097]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=PMID:
8254097
Mortensen SA, Leth A, Agner E, Rohde M. Dose-related decrease of serum
coenzyme Q10 during treatment with HMG-CoA reductase inhibitors. Mol Aspects
Med. 1997;18 Suppl:S137-44. [PMID: 9266515]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=9266515
Bargossi AM, Grossi G, Fiorella PL, Gaddi A, Di Giulio R, Battino M.
Exogenous CoQ10 supplementation prevents plasma ubiquinone reduction induced
by HMG-CoA reductase inhibitors. Mol Aspects Med. 1994;15 Suppl:s187-93.
[PMID: 7752830]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=7752830
Ogasahara S, Engel AG, Frens D, Mack D. Muscle coenzyme Q deficiency in
familial mitochondrial encephalomyopathy. Proc Natl Acad Sci U S A.
1989;86:2379-82. [PMID: 2928337]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=2928337
Baker SK, Tarnopolsky MA. Statin myopathies: pathophysiologic and clinical
perspectives. Clin Invest Med. 2001;24:258-72. [PMID: 11603510]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=11603510
Rosenfeldt FL, Pepe S, Ou R, Mariani JA, Rowland MA, Nagley P, et al.
Coenzyme Q10 improves the tolerance of the senescent myocardium to aerobic
and ischemic stress: studies in rats and in human atrial tissue. Biofactors.
1999;9:291-9. [PMID: 10416043]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=10416043
Reust CS, Curry SC, Guidry JR. Lovastatin use and muscle damage in healthy
volunteers undergoing eccentric muscle exercise. West J Med.
1991;154:198-200. [PMID: 2006566]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=2006566
Statin-associated myopathy.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12672737&dopt=Abstract
Thompson PD, Clarkson P, Karas RH.
Preventive Cardiology and Cardiovascular Research, Division of Cardiology,
Hartford Hospital, Hartford, Conn 06102, USA. pth...@harthosp.org
"recent evidence suggests that statins reduce the production of small
regulatory proteins that are important for myocyte maintenance"
Statins and myotoxicity.
Curr Atheroscler Rep. 2003 Mar;5(2):96-100. Review.
PMID: 12573193 Farmer JA.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12573193&dopt=Abstract
Baylor College of Medicine, One Baylor Plaza, Room 525D, Houston, TX 77030,
USA. jfa...@bcm.tmc.edu
CARNITINE DEFICIENCY CAUSED BY STATINS
Bhuiyan J, Seccombe DW. The effects of 3-hydroxy-3-methylglutaryl-CoA
reductase inhibition on tissue levels of carnitine and carnitine
acyltransferase activity in the rabbit. Lipids. 1996;31:867-70. [PMID:
8869889]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=8869889
JOINT PAIN AND STATINS
Frequently Asked Question: Can statins have something to do with my joint
pain?
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11707010&dopt=Abstract
Four cases of tendinopathy in patients on statin therapy.
Joint Bone Spine. 2001 Oct;68(5):430-3. PMID: 11707010 [PubMed - indexed for
MEDLINE]
Abstract on a report of 4 cases of people with painful tendons & statins.
Included to show that the pain and damage shows up in a variety of areas.
QUITTING STATINS
Frequently Asked Question: Can it be dangerous to just stop taking statins?
One study indicates that there are more coronary events when people stop
taking statins (Definitely talk with your doctor on this):
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11914253&dopt=Abstract
Withdrawal of statins increases event rates in patients with acute coronary
syndromes. The dangers of getting off statins. See also:
http://www.lipidsonline.org/commentaries/al_abstract.cfm?abs_id=Abs030
VIOLENCE AND LOW CHOLESTEROL
Frequently Asked Questions: Can it be the statins making me so irritable and
prone to angry outbursts?
It may be that the angry outbursts are caused by the Low Cholesterol, the
result of taking Lipitor or other statins.
Dr. Beatrice Golomb, who is now conducting the NIH funded Statin Study,
published 2 articles/studies on the connection between violence and low
cholesterol levels.
See:
Low cholesterol and violent crime. Golomb BA, Stattin H, Mednick S.
Department of Medicine, University of California, Los Angeles, CA
92093-0995, USA. J Psychiatr Res 2000 Jul-Oct;34(4-5):301-9
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11104842&dopt=Abstract
and
Cholesterol and violence: is there a connection? Golomb BA. Ann Intern Med
1998 Mar 15;128(6):478-87
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9499332&dopt=Abstract
IMMUNE SYSTEM AND STATINS
Frequently Asked Question: Can statins depress my immune system?
It is a tribute to the imaginations of the drug marketers to see how
successfully they have put positive "spin" on a very alarming proposition,
that statins depress the immune system (or is it just arrogance?). If the
known side effect of statins is to depress your immune system, and it is so
beneficial to transplant recipients and others with autoimmune disease, what
about people with pre-statin 'normal' immune systems?
I'm not the only one astonished and disgusted with this, check out Dr.
Mercola's comment (scroll down for his response to the article) on
http://www.mercola.com/2000/dec/24/statins.htm
Excerpts: "This is an amazing example of positive "spin" put on a very
negative result. People with high cholesterol certainly don't need their
immune systems suppressed...If suppressing the helper T cells is considered
such great benefit then there is a disease going around that does this quite
well - AIDS...if the mechanism of action of the drug is not understood, how
can the manufacturer or the FDA claim that it is safe"
It sounds like he is talking about this article
http://pub.ucsf.edu/today/print.php?news_id=200211062 , but actually he is
describing the last time the drug companies tried to feed us a myth about
how great it is that statins depress immune systems: (available for online
purchase from Nature Medicine:
http://www.nature.com/dynasearch/app/dynasearch.taf?sp-w=Exact&_action=search&search_fulltext=&sp-p=All&search_volume=&search_startpage=&search_title=&s
earch_author=&search_abstract=statins+as+immunosuppressors&issue_start_month
=12&issue_start_year=2000&issue_end_month=01&issue_end_year=2001&pickerCount
=You+have+selected+1+journal+to+search.&rolloverMessage=&sp_k=NM
Atorvastatin suppresses interferon-gamma -induced neopterin formation and
tryptophan degradation in human peripheral blood mononuclear cells and in
monocytic cell lines.
Neurauter G, Wirleitner B, Laich A, Schennach H, Weiss G, Fuchs D.
Summary: Recent findings indicate that statins also have anti-inflammatory
properties and can modulate the immune response.statins inhibit T cell
activation within the cellular immune response.atorvastatin directly
inhibits IFN-gamma-mediated pathways in monocytic cells, suggesting that
both immunoreactivity of T cells and of monocyte-derived macrophages are
down-regulated by this statin.
Clin Exp Immunol 2003 Feb;131(2):264-7
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12562386&dopt=Abstract
A novel anti-inflammatory role for simvastatin in inflammatory arthritis.
Leung BP, Sattar N, Crilly A, Prach M, McCarey DW, Payne H, Madhok R,
Campbell C, Gracie JA, Liew FY, McInnes IB.
J Immunol. 2003 Feb 1;170(3):1524-30.
PMID: 12538717 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12538717&dopt=Abstract
Immunomodulation: a new role for statins?
Wulf Palinski
SUMMARY: Statins reduce the expression of the class II major
histocompatibility complex (MHCII) by arterial cells, leading to a decreased
T-cell response. This indicates that statins...
Nature Medicine6, 1311 - 1312 (01 Dec 2000) News and Views
HMG-CoA reductase inhibitors as immunomodulators: potential use in
transplant rejection.
Raggatt LJ, Partridge NC.
These findings suggest that statins have the potential to regulate an immune
response in vivo and that more investigation is essential in order to
explain the opposing clinical data.
Drugs. 2002;62(15):2185-91.
PMID: 12381218 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12381218&dopt=Abstract
Statins as a newly recognized type of immunomodulator
Brenda Kwak, Flore Mulhaupt, Samir Myit, François Mach
SUMMARY: Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)
reductase, or statins, are effective lipid-lowering agents, extensively used
in medical practice. Statins have never been shown to...
Nature Medicine 6, 1399 - 1402 (01 Dec 2000) Article
and could a depressed immune system lead to infection? See:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11936540&dopt=Abstract
Statin-induced fibrotic nonspecific interstitial pneumonia.
Eur Respir J. 2002 Mar;19(3):577-80.
PMID: 11936540 [PubMed - indexed for MEDLINE]
STATINS AND CANCER
Frequently Asked Question: What are the cancer rates for people on statins?
Despite the infomercial-type hype in recent press releases under titles
like, "Does Lipitor prevent cancer?" (note it is a question, not an
assertion), the numbers from recent studies tell the opposite story:
Statin use and the risk of breast cancer.
Beck P, Wysowski DK, Downey W, Butler-Jones D.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12725884&dopt=Abstract
J Clin Epidemiol. 2003 Mar;56(3):280-5.
PMID: 12725884 [PubMed - in process]
"Stratified analyses revealed increases in risk in short-term statin users
and statin users with long-term hormone replacement therapy (HRT) exposure."
The PROSPER Study (PROspective study of pravastatin in the elderly at risk)
[Article in French]
Kulbertus H, Scheen AJ.
Service de Diabetologie, Nutrition et Maladies metaboliques et deMedecine
Interne Generale, CHU Liege.
Rev Med Liege. 2002 Dec;57(12):809-13.
"New cancers were more frequent amongst pravastatin-treated individuals
(+25%; p = 0.020)."
Major Outcomes in Moderately Hypercholesterolemic, Hypertensive Patients
Randomized to Pravastatin vs Usual Care
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack
Trial (ALLHAT-LLT)
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12479764&dopt=Abstract
ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research
Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart
Attack Trial.
Deaths by cancer during the ALLHAT study: Pravastatin= 163; Usual Care= 148
6-year rate per 100 Participants: Pravastatin= 4.1; Usual Care= 3.7
ERECTILE DYSFUNCTION (ED) AND STATINS
Frequently Asked Question: Can statins interfere with my sex life?
Do lipid-lowering drugs cause erectile dysfunction? A systematic review.
Rizvi K, Hampson JP, Harvey JN.
University of Wales College of Medicine, Wrexham Academic Unit, Wrexham, UK.
Fam Pract. 2002 Feb;19(1):95-8. PMID: 11818357
BACKGROUND: Erectile dysfunction (ED) is common although under-reported by
patients. Along with the better known causes of ED, drug-induced impotence
needs to be considered as a cause of this symptom. Lipid-lowering drugs have
been prescribed increasingly. Their relationship to ED is controversial.
OBJECTIVES: Our aim was to clarify the relationship between lipid-lowering
therapy and ED. A secondary aim was to assess the value of the systematic
review procedure in the area of adverse drug reactions. METHODS: A
systematic review was carried out using computerized biomedical databases
and Internet sources. Terms denoting ED were linked with terms referring to
lipid-lowering drugs. Information was also sought from regulatory agencies.
RESULTS: A significant literature was identified, much from obscure sources,
which included case reports, review articles, and information from clinical
trials and from regulatory agencies. Information from all of these sources
identified fibrates as a source of ED. A substantial number of cases of ED
associated with statin usage have been reported to regulatory agencies. Case
reports and clinical trial evidence supported the suggestion that statins
can also cause ED. Some information on possible mechanisms was obtained, but
the mechanism remains uncertain. CONCLUSIONS: The systematic review
procedure was applied successfully to collect evidence suggesting that both
statins and fibrates may cause ED. More numerous reports to regulatory
agencies complemented more detailed information from case reports to provide
a new perspective on a common area of prescribing.
ERECTILE DYSFUNCTION AND STATIN THERAPY: INTERACTION WITH CARDIOVASCULAR
RISK FACTORS AND DRUG THERAPIES
H. Solomon1, J. Man1, Y.P. Samarasinghe2, M.D. Feher2, A.S. Wierzbicki3, G.
Jackson1
1Department of Cardiology, St. Thomas' Hospital, 2Beta Cell Diabetes Centre,
Chelsea & Westminster Hospital, 3Department of Chemical Pathology, St.
Thomas' Hospital, London UK
Erectile dysfunction has been associated with atherosclerotic risk factors
and drugs used in their treatment. This study investigated the relationship
of erectile function with cardiovascular risk factors and specific drug
therapies. International Index of Erectile Function (IIEF) scores measured
in 100 men attending cardiovascular risk clinics. Cardiovascular risk
factors and drug therapies were assessed prior to initation and after 6
months of statin therapy. Before statin therapy no correlation was observed
between IIEF score and any individual cardiovascular risk factor though
better scores were observed in patients on warfarin or angiotensin-II
receptor blocker therapy (r=0.42; p <0.001). After 6 months of statin
therapy, significant correlations were observed between lower IIEF scores
(r=0.62; P<0.001) and age, smoking, diabetes and usage of warfarin or
angiotensin-2 type 1 receptor blocker (ARB) therapy. Differences in dose,
relative efficacy or relative lipophilicity of statin prescribed showed no
correlation with change in IIEF score. This study suggests impotence
following statin therapy is likelier in patients with more severe
endothelial dysfunction due to established cardiovascular risk factors
including age, and smoking and diabetes. This is complicated by adverse
interactions between statin therapy and concomitant treatment with warfarin
or angiotensin-II type I receptor blockers.
http://www.kenes.com/73eas/program/abstracts/126.doc
Drug Information Center: Information on Statin Drugs
"On March 7, 2002, Colorado HealthSite interviewed Beatrice A. Golomb, MD,
PhD, principal investigator of a study on Statin Drugs by the National
Institutes of Health. Dr. Golomb noted that the most common problems
reported about statin drugs pertain to muscle pain or weakness, fatigue,
memory and cognitive problems, sleep problems, and neuropathy. Erectile
dysfunction, problems with temperature regulation (feeling hot or cold, or
having sweats) are among the other problems reported. "
http://www.coloradohealthsite.org/pharmacology/statins.html
"Question: What are the common complaints of patients who take statins?
Dr. Golomb: The most common problems we hear reported pertain to muscle pain
or weakness, fatigue, memory and cognitive problems, sleep problems, and
neuropathy. Erectile dysfunction, problems with temperature regulation
(feeling hot or cold, or having sweats), are among the other problems
reported. "
http://www.coloradohealthsite.org/topics/interviews/golomb.html
BBC News: Wednesday, 15 March, 2000, 19:02 GMT
Heart drug impotence warning
"Statins prevent heart attacks by reducing the levels of dangerous
cholesterol in the bloodstream.
However, a small number of men prescribed the life-saving drug have
complained that they are unable to achieve an erection."
"Dr John Harvey, from the Wrexham Maelor Hospital in Wales, identified 220
men who appeared to have lost their "virility" after starting to take
statins. "
http://news.bbc.co.uk/1/hi/health/678811.stm
LUPUS-LIKE SYMPTOMS AND STATINS
Frequently Asked Question: Can statins cause Lupus symptoms?
Drug-induced lupus-like syndrome associated with severe autoimmune
hepatitis.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12765306&dopt=Abstract
Graziadei IW, Obermoser GE, Sepp NT, Erhart KH, Vogel W.
Lupus. 2003;12(5):409-12.
PMID: 12765306 [PubMed - in process]
RHABDOMYOLYSIS AND STATINS
Frequently Asked Question: Which statins cause deadly Rhabdomyolysis?
All of them. See :
FDA adverse event reports on statin-associated rhabdomyolysis.
Omar MA, Wilson JP.
Ann Pharmacother. 2002 Feb;36(2):288-95. Review.
PMID: 11847951
Of 871 reports detailing 601 cases in a 29 month time frame, the list of
statin, number of cases, and percentage of the whole follows:
simvastatin, 215 (35.8%);
cerivastatin, 192 (31.9%);
atorvastatin, 73 (12.2%);
pravastatin, 71 (11.8%);
lovastatin, 40 (6.7%);
fluvastatin, 10 (1.7%)
As of August, 2001, there were at least 81rhabdomyolysis deaths associated
with Non-Baycol statins.
http://www.essentialdrugs.org/edrug/archive/200108/msg00064.php
The Public Citizen petition to the FDA, August 20,2001:
http://www.citizen.org/publications/release.cfm?ID=7051
At that time the count of deaths by statin-induced rhabdomyolysis:
Outcome
Number of Cases
Percent of Total Deaths
Deaths
Atorvastatin
13
18.1%
Cerivastatin
20
27.8%
Fluvastatin
1
1.4%
Lovastatin
5
6.9%
Pravastatin
9
12.5%
Simvastatin
24
33.3%
ELDERLY AND STATINS
Frequently Asked Question: Should people over 70 take statins?
Lack of association between cholesterol and coronary heart disease mortality
and morbidity and all-cause mortality in persons older than 70 years.
JAMA. 1994 Nov 2;272(17):1335-40.
Krumholz HM, Seeman TE, Merrill SS, Mendes de Leon CF, Vaccarino V,
Silverman DI, Tsukahara R, Ostfeld AM, Berkman LF.
Department of Internal Medicine, Yale University School of Medicine, New
Haven, CT 06520-8017.
"CONCLUSIONS--Our findings do not support the hypothesis that
hypercholesterolemia or low HDL-C are important risk factors for all-cause
mortality, coronary heart disease mortality, or hospitalization for
myocardial infarction or unstable angina in this cohort of persons older
than 70 years."
Another study showing people over 65 do not benefit from cholesterol
reduction:
Long-Term Prognostic Importance of Total Cholesterol in Elderly Survivors of
an Acute Myocardial Infarction: The Cooperative Cardiovascular Pilot
Project.
Foody JM, Wang Y, Kiefe CI, Ellerbeck EF, Gold J, Radford MJ, Krumholz HM.
Section of Cardiovascular Medicine, Department of Medicine, and Section of
Chronic Disease Epidemiology, Department of Epidemiology and Public Health,
Yale School of Medicine, New Haven, Connecticut; Qualidigm, Middletown,
Connecticut; Yale-New Haven Hospital Center for Outcomes Research and
Evaluation, New Haven, Connecticut; Center for Outcome and Effectiveness
Research and Education, University ofAlabama at Birmingham and Birmingham
Veterans Affairs Medical Center, Birmingham, Alabama; Department of
Preventive Medicine, University of Kansas School of Medicine, Kansas City,
Kansas; and Metastar, Madison, Wisconsin.
J Am Geriatr Soc. 2003 Jul;51(7):930-936. PMID: 12834512
"PARTICIPANTS: Four thousand nine hundred twenty-three Medicare
beneficiaries from four states aged 65 and older"
"CONCLUSION: Among elderly survivors of AMI, elevated total serum
cholesterol measured postinfarction is not associated with an increased risk
of all-cause mortality in the 6 years after discharge. Furthermore, this
study found no evidence of an increased risk of all-cause mortality in
patients with low total cholesterol. Further studies are needed to determine
the relationship of postinfarction lipid subfractions and mortality in older
patients with coronary artery disease (CAD)."
High-density vs low-density lipoprotein cholesterol as the risk factor for
coronary artery disease and stroke in old age.
Weverling-Rijnsburger AW, Jonkers IJ, van Exel E, Gussekloo J, Westendorp
RG.
Section of Gerontology and Geriatrics, Department of General Internal
Medicine, Leiden University Medical Center, Leiden, The Netherlands.
a.w.e.weverli...@lumc.edu
Arch Intern Med. 2003 Jul 14;163(13):1549-54.
"In contrast to high LDL cholesterol level, low HDL cholesterol level is a
risk factor for mortality from coronary artery disease and stroke in old
age."
Total cholesterol and risk of mortality in the oldest old.
Weverling-Rijnsburger AW, Blauw GJ, Lagaay AM, Knook DL, Meinders AE,
Westendorp RG.
Department of General Internal Medicine, Leiden University Medical Center,
The Netherlands.
Lancet. 1997 Oct 18;350(9085):1119-23.
" In people older than 85 years, high total cholesterol concentrations are
associated with longevity owing to lower mortality from cancer and
infection. The effects of cholesterol-lowering therapy have yet to be
assessed."
Steve Harris sbharris@ROMAN9.netcom.com
> >Wall Street Journal has run several articles by Tara Parker-Pope.
>
> Parker-Pope wrote on August 5, 2003, about CRP and cholesterol *testing*
> (she supports CRP); statins were only mentioned in passing.
>
> On January 26, 2004, Parker-Pope wrote of a number of "medical
> breakthroughs" expected in 2004. Regarding the NIH study of statins,
> she cited Beatrice Golomb, director of the study thus: "Although the
> patient data in the NIH study is still secret, Dr. Golomb says that
> cognitive problem related to statin use.
Italics added by me. This is *not* the study result, which is still
sealed exactly as I said, but personal estimation of the axe-to-grind
Ms. Golumb from her private practise. Figures from her own practice,
but which she hasn't published.
From my private practice, I estimate significant mental problems with
statins are closer to zero. Take that, Dr. Golumb. Of course, I will
admit that I use Pravachol first, and that I think I've seen a lot
more rheumatic problems from the other statins than most studies will
admit. But take anecdotal evidence for what it's worth. Which is not a
lot.
> Note that the 15% is not from the NIH study but is Dr. Golomb's estimate
> from her own practice. Also note that 15% could be three patients out
> of twenty, and that Dr. Golomb's clientele may not be typical, since she
> is associated with a university.
Exactly.
> Please point us to any media actually reporting 15 or 16 million
> debilitated by statins. That's how many there would have to be for the
> 15% bad side effects you posted about. ISTM numbers like that would be
> everywhere in the media. As I wrote above, I see NO figures except Dr.
> Golomb's estimate of 15%.
Which isn't from the NIH study. Which Shirley said it was. Golly,
we're so surprised. She was wrong. It's hearsay.
SBH
Sharon Hope
not see. I absolutely believe that you do not see these adverse effects in
any of your patients. No surprises here. Who could contest such
assuredness?
(My husband's doctor didn't see anyone with these adverse effects, either -
but the Neuropsych testing results were drastic: below the 1 percentile in
short-term memory)
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04021...@posting.google.com...
Sharon Hope
ran neuropsych tests on all participants, both prior to the treatment and at
the end of the trial, and compared the scores between placebo and statin
groups, as well as the individual deltas between the two groups.
Then again, if they did not do that, they were not looking for the type of
cognitive impacts raised in this thread.
You don't find what you don't look for.
"Don Kirkman" <don...@covad.net> wrote in message
news:p8qi20t3ing0rd3rm...@4ax.com...
Sharon Hope
snip
>
> >> You DO realize that 15% of 106 million is 15.9 million? I think the
> >> media might have noticed, if the medical community did not, if nearly
16
> >> million people world-wide were debilitated by the statins.
> --
> Don
> don...@covad.net
Exactly - 5 million Alzheimer's patients estimated in US. 15 million world
wide with preventable loss of cognitive ability due to statins.
I'm waiting for CNN's Paging Dr. Gupta to discuss it...(that's the show
sponsored entirely by Pfizer).
In this post-Enron financial world, WSJ is to be congratulated in alerting
savvy investors to potential downside for their investment in pharmaceutical
companies that are heavily dependent on statins. If for no other reason
than, short of adding statins to the water, the market share growth may have
nowhere further to go. A 15% reduction in patients taking statins is a
major hit, if a significant portion of the entire company's income is due to
sales of that product.
talkback
> Odd,
For the last time, why don't you start by doing some research on how to
present a case.
THEN...you can try to present a point of view that will stimulate
discussion, rather than attacks on your methodology. Surely you can see
that many take strong exception to your views. That alone should
indicate that maybe you need to go back to the drawing board.
If you just want babble from your soapbox then, ok, you are on the right
track.
list...@nospam.net
wrote:
>What you refuse to look for, entertain, or recognize you will undoubtedly
>not see. I absolutely believe that you do not see these adverse effects in
>any of your patients. No surprises here. Who could contest such
>assuredness?
>
This is one of the ways Mrs. Hope responds to those who contradict
her. If you're a doctor, you're either a pharma-whore or just lack the
ability to properly diagnose!
talkback
Exactly. I think the logical progression in HER treatment plan would be
extensive therapy with the possibility of help from an SSRI (one that
doesn't kill 15% of the world population of course.).
list...@nospam.net
wrote:
> Why is it so
>threatening to the statins-at-all-costs defenders to contemplate the
>possibility that for some patients, statins are associated with adverse
>effects that are sufficiently serious to merit discontinuing the drug? Do
>these same people scream at their television screens when a direct-marketing
>commercial for a prescription drug lists the major adverse effects? Is
>there some reason statin patients should be kept ignorant of these adverse
>effects, when the approach to all other pharmaceuticals is to warn patients
>of adverse effects?
I have never been a statin-at-no-cost defender. I see statins as a
relatively safe, efficacious alternative for those in whom lifestyle
change, diet, age..etc are too difficult to effect or change. For
primary prevention it might very well be an effective prophylatic. I'm
all for more studies. I'm not keen on putting it in drinking water for
that matter but I do believe in choice.
(And, no, I don't yell at my tv...)
>So, what IS *really* going on here?
>
>Are the following citations not sufficient to show that some people
>experience some adverse effects from statins? Are statins the only
>prescription medication that is purported to be absolutely free of adverse
>effects to the degree that anyone developing what appears to be an adverse
>effect is denigrated, and anyone reporting it is ostracized, and anyone
>concerned is the subject of ad hominem attacks?
I have never believed or stated that statins are side-effect free. The
point is this: NOTHING is side-effect free. I have always acknowledged
your unfortunate situation, but for you to ignore/discount out of hand
contradictory citations, facts and statements is not helpful to you or
others.
Dr. Andrew B. Chung, MD/PhD
I have contradicted her without getting that moniker. Perhaps God is protecting
me :-)
Servant to the humblest person in the universe,
Andrew
--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/
--
Who is the humblest person in the universe?
http://makeashorterlink.com/?W1F522557
What is all this about?
http://makeashorterlink.com/?N13D32F57
list...@nospam.net
<and...@heartmdphd.com> wrote:
>list...@nospam.net wrote:
>
>> On Wed, 11 Feb 2004 05:02:38 GMT, "Sharon Hope" <sh...@anet.net>
>> wrote:
>>
>> >What you refuse to look for, entertain, or recognize you will undoubtedly
>> >not see. I absolutely believe that you do not see these adverse effects in
>> >any of your patients. No surprises here. Who could contest such
>> >assuredness?
>> >
>>
>> This is one of the ways Mrs. Hope responds to those who contradict
>> her. If you're a doctor, you're either a pharma-whore or just lack the
>> ability to properly diagnose!
>
>I have contradicted her without getting that moniker. Perhaps God is protecting
>me :-)
Actually, I don't think *anyone* really knows what to make of you! :-)
Dr. Andrew B. Chung, MD/PhD
> On Wed, 11 Feb 2004 20:17:20 GMT, "Dr. Andrew B. Chung, MD/PhD"
> <and...@heartmdphd.com> wrote:
>
> >list...@nospam.net wrote:
> >
> >> On Wed, 11 Feb 2004 05:02:38 GMT, "Sharon Hope" <sh...@anet.net>
> >> wrote:
> >>
> >> >What you refuse to look for, entertain, or recognize you will undoubtedly
> >> >not see. I absolutely believe that you do not see these adverse effects in
> >> >any of your patients. No surprises here. Who could contest such
> >> >assuredness?
> >> >
> >>
> >> This is one of the ways Mrs. Hope responds to those who contradict
> >> her. If you're a doctor, you're either a pharma-whore or just lack the
> >> ability to properly diagnose!
> >
> >I have contradicted her without getting that moniker. Perhaps God is protecting
> >me :-)
>
> Actually, I don't think *anyone* really knows what to make of you! :-)
I'll take that as a compliment, I think ;-)
Servant to the humblest person in the universe,
Andrew
--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/
--
Don Kirkman
>"Don Kirkman" <don...@covad.net> wrote in message
>news:g7mi201p8fhfv44g8...@4ax.com...
>snip
>> >> You DO realize that 15% of 106 million is 15.9 million? I think the
>> >> media might have noticed, if the medical community did not, if nearly
>16
>> >> million people world-wide were debilitated by the statins.
>Exactly - 5 million Alzheimer's patients estimated in US. 15 million world
>wide with preventable loss of cognitive ability due to statins.
No, no, no. We are talking about 15 million **debilitated statin
victims** based on your own statements of 106,000,000 statin users and
15% showing debilitating side effect. I did the math for you.
>I'm waiting for CNN's Paging Dr. Gupta to discuss it...(that's the show
>sponsored entirely by Pfizer).
>In this post-Enron financial world, WSJ is to be congratulated in alerting
>savvy investors to potential downside for their investment in pharmaceutical
>companies that are heavily dependent on statins. If for no other reason
>than, short of adding statins to the water, the market share growth may have
>nowhere further to go. A 15% reduction in patients taking statins is a
>major hit, if a significant portion of the entire company's income is due to
>sales of that product.
Here's another mysterious 15% that has no relation to anything that's
been mentioned so far in the thread.
--
Don
don...@covad.net
Sharon Hope
> It seems to me I heard somewhere that Sharon Hope wrote in article
> <p4jWb.3437$uV3.11583@attbi_s51>:
>
> >"Don Kirkman" <don...@covad.net> wrote in message
> >Exactly - 5 million Alzheimer's patients estimated in US. 15 million
world
> >wide with preventable loss of cognitive ability due to statins.
>
> No, no, no. We are talking about 15 million **debilitated statin
> victims** based on your own statements of 106,000,000 statin users and
> 15% showing debilitating side effect. I did the math for you.
>
Yes, if the Wall Street Journal got the quotation correct, we are talking
about 15 million **COGNITIVELY debilitated statin victims** world-wide. The
debilitated statin victims from myopathy, myositis, peripheral neuropathy,
polyneuropathy, chronic fatigue and cardiomyopathy are IN ADDITION TO the 15
million cognitively damaged statin patients.
By comparison, that is 3 times the number of Alzheimer's patients in the US.
>> A 15% reduction in patients taking statins is a
> >major hit, if a significant portion of the entire company's income is due
to
> >sales of that product.
>
> Here's another mysterious 15% that has no relation to anything that's
> been mentioned so far in the thread.
>
It is based upon the assumption that, now that there are published studies
and a book out on the topic, perhaps doctors recognizing the patients who
have adverse effects to the point of debilitating cognitive damage will
actually stop prescribing statins for those damaged patients. Same affected
15%, if the patient has a perceptive doctor. There is one benefit that the
statin-induced memory loss offers for the patient : irregardless of the
doctor's halting the prescription, the patient tends to forget to take the
medication - effectively discontinuing the treatment himself.
> --
> Don
> don...@covad.net
Al. Lohse
23% in 6 years.
Why did so many participants drop out of
ALLHAT-LLT? Presumably they were being paid
and given the drug for free.
I do not know the answer, but I can speculate
on why a person would drop out. That
speculation would lead one to conclude the
drug made them sufficiently UNwell that it
was not worth the money to continue.
A.L.
Don Kirkman
>"Don Kirkman" <don...@covad.net> wrote in message
>news:76fm20530mkf7s9m4...@4ax.com...
>> It seems to me I heard somewhere that Sharon Hope wrote in article
>> <p4jWb.3437$uV3.11583@attbi_s51>:
>> >"Don Kirkman" <don...@covad.net> wrote in message
>> >Exactly - 5 million Alzheimer's patients estimated in US. 15 million
>world
>> >wide with preventable loss of cognitive ability due to statins.
>> No, no, no. We are talking about 15 million **debilitated statin
>> victims** based on your own statements of 106,000,000 statin users and
>> 15% showing debilitating side effect. I did the math for you.
>Yes, if the Wall Street Journal got the quotation correct, we are talking
>about 15 million **COGNITIVELY debilitated statin victims** world-wide. The
>debilitated statin victims from myopathy, myositis, peripheral neuropathy,
>polyneuropathy, chronic fatigue and cardiomyopathy are IN ADDITION TO the 15
>million cognitively damaged statin patients.
Which once again raises the question: where are the media reports on
these 15,000,000 victims of statins? Is there a cover up by all the
world media except WSJ/Smart Money?
--
Don
don...@covad.net
Don Kirkman
>Don Kirkman wrote:
>>
>> It seems to me I heard somewhere that Sharon Hope wrote in article
>> <p4jWb.3437$uV3.11583@attbi_s51>:
>> >"Don Kirkman" <don...@covad.net> wrote in message
>> >news:g7mi201p8fhfv44g8...@4ax.com...
>> >snip
>> >> >> You DO realize that 15% of 106 million is 15.9 million? I think the
>> >> >> media might have noticed, if the medical community did not, if nearly
>> >16
>> >> >> million people world-wide were debilitated by the statins.
[...]
>23% in 6 years.
I don't know what this relates to.
>Why did so many participants drop out of
>ALLHAT-LLT? Presumably they were being paid
>and given the drug for free.
>I do not know the answer, but I can speculate
>on why a person would drop out. That
>speculation would lead one to conclude the
>drug made them sufficiently UNwell that it
>was not worth the money to continue.
I counter-speculate that some of them moved away.
Speculation is no substitute for verifiable evidence.
--
Don
don...@covad.net
Nigel
> It seems to me I heard somewhere that Al. Lohse wrote in article
> <402D1450...@cc.umanitoba.ca>:
>
>
>>Why did so many participants drop out of
>>ALLHAT-LLT? Presumably they were being paid
>>and given the drug for free.
>
>>I do not know the answer, but I can speculate
>>on why a person would drop out. That
>>speculation would lead one to conclude the
>>drug made them sufficiently UNwell that it
>>was not worth the money to continue.
>
> I counter-speculate that some of them moved away.
>
> Speculation is no substitute for verifiable evidence.
One of the greatest challenges in long term studies is managing to keep
people enrolled. Many patients are dropped from the study because they
stop going to the clinic, move, etc. Losing a third or more of patients
would not be unusual in a multi-year study.
Sharon Hope
it is to find a statin population that will make it through the term of the
trial, due to so many washing out from serious adverse effects. I accept
your general statement, but this is specific to statins:
J Mol Neurosci. 2003;20(3):407-10.
A position paper: based on observational data indicating an increased rate
of altered blood chemistry requiring withdrawal from the Alzheimer's Disease
Cholesterol-Lowering Treatment Trial (ADCLT).
Sparks DL, Lopez J, Connor D, Sabbagh M, Seward J, Browne P; Alzheimer's
Disease Cholesterol-Lowering Treatment Team.
Ralph and Murial Roberts Laboratory for Neurodegenerative Disease Research,
Sun Health Research Institute, Sun City, AZ 95351, USA.
Larry....@sunhealth.org
Recruitment for the inaugural double-blind placebo-controlled trial
investigating a cholesterol-lowering treatment for benefit in Alzheimer's
disease (AD) (ADCLT) ended after obtaining 98 informed consents. Suspension
of recruitment of the ADCLT occurred in concert with initiation of two
separate multicenter trials testing similar hypotheses. Although occurring
at very low rates (<2%), altered-chemistry adverse events requiring
discontinuation of therapy (withdrawal AEs) are not unexpected with use of
cholesterol-lowering statins. We suggest that exceptionally close monitoring
for altered chemistry among individuals with AD should be undertaken in
future statin treatment trials, as limited data from the ADCLT indicate that
chemically based withdrawal AEs could be more prevalent among female AD
patients. There was no apparent correlation between the occurrence of
withdrawal-AE incidence and lower body mass among the female AD trial
subjects and, therefore, probably was not a dose-related resultant. This
might indicate that cognitively intact elderly women at risk for heart
disease and those with clinically documented AD should not be presumed to be
pharmocodynamically equivalent. Lipid profiles obtained at screening in the
ADCLT are consistent with a possible difference between patients with
current AD and those at risk for heart disease. Elevated cholesterol,
increased cholesterol/high-density lipid (HDL) ratios, and elevated
triglycerides are routinely observed among those at risk for heart disease;
however, among ADCLT study participants, only cholesterol levels were
increased while cholesterol/HDL ratio and triglyceride levels remained
within normal limits.
Publication Types:
a.. Clinical Trial
b.. Randomized Controlled Trial
PMID: 14501025 [PubMed - indexed for MEDLINE]
"Nigel" <I.don't...@like.spam.com> wrote in message
news:Xns948F460B1FE3...@206.172.150.13...
Steve Harris sbharris@ROMAN9.netcom.com
> However, specific to statins, there is a published article on how difficult
> it is to find a statin population that will make it through the term of the
> trial, due to so many washing out from serious adverse effects.
COMMENT:
You didn't even read your own posted abstract, apparently. The adverse
effects noted could not have made it "difficult" since the washout
rate was less than 2%, which the authors note is "not unexpected."
Furthermore, the "adverse effects" which caused these were due to
altered blood chemistries, presumably CPK or liver enzyme elevation.
Look at the title. There's no suggestion that they were due to mental
status problems.
Sharon Hope
due to adverse effects of the statins in the statin population of
placebo-controlled statin trials.
The supposition in a preceding post was that such attrition was merely due
to population migration. In this case it is documented that attrition is due
to statin adverse effects. That was the point of my post.
I do, however, continue to wonder how, as the trial wears on, statin memory
loss will be distinguished from early Alzheimer's. (I spoke to the
personnel conducting part of the larger study in a different center, and
they had no answer the question.)
In this trial, unlike other statin trials, the researchers are specifically
looking for cognitive loss. It is highly likely that they will find what
they are looking for, given:
1) the percentage adversely affected in the Muldoon study (with both
cognitive loss in some areas and failure to improve at a normal rate
comparable with the placebo group in other areas)
2) the fact that this population is significantly older
3) the fact that more than one study shows that such an older population is
more likely to experience statin adverse effects than others
Interesting that you had no comment on the statement that the number of
withdrawal AEs "probably was not a dose-related resultant"
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04021...@posting.google.com...
Bill
> I believe you missed the point. The citation shows that there are drop-outs
> due to adverse effects of the statins in the statin population of
> placebo-controlled statin trials.
>
> The supposition in a preceding post was that such attrition was merely due
> to population migration. In this case it is documented that attrition is due
> to statin adverse effects. That was the point of my post.
>
> I do, however, continue to wonder how, as the trial wears on, statin memory
> loss will be distinguished from early Alzheimer's. (I spoke to the
> personnel conducting part of the larger study in a different center, and
> they had no answer the question.)
I'm not sure I understand this. If this is a placebo controlled trial, no
matter what you call it, any significantly increased memory loss in the statin
arm should be apparent. Unless you are referring to the possibility that
statins could improve memory in one way and hurt it in another? Also do you
know when this study is supposed to be completed?
Bill
Sharon Hope
> seen in humans on the drug, for long periods of time, are hardly
> relevent to anything.
The FDA considered it relevant that brain hemorrhages were seen in early
testing of Lipitor with dogs, and therefore required Pfizer to list it in
the Lipitor physician's insert.
The point is not what the dosage was for the dog.
When a subsequent study of statins lists "hemorrhagic stroke" under the
"unrelated mortality" section, when "hemorrhagic stroke" is included by
Pfizer as a relevant adverse effect that showed up in early testing of
Lipitor, the authors of the study are either ignorant of the very drugs they
are testing, or are unethical, irresponsible, untruthful, and, yes, immoral.
There is no reason to believe it is not a specific outcome of the trial. If
the researchers cannot deal with the inconvenience of documenting the death
as related, despite it not being a part of the conclusion they would like to
draw, then they should not be doing the research in the first place.
Every drug has adverse effects. Pharmaceudical prescriptions are made on a
risk analysis of harm/benefit tradeoffs. Why is it that there is such
denial that statin adverse effects exist? Why is there such a visceral
outcry and attack against anyone who points out the adverse effects?
There is absolute evidence that some people have cognitive adverse effects
under Lipitor and the other statins. The Australian drug administration
listed statins under "drugs that make you forget" in the last century. How
many physicians order pre-testing of cognitive abilities of their statin
patients prior to prescribing, with follow-up testing at 6 months, a year,
and annually thereafter? How many physicians even take the few minutes to
administer the MMSE (Mini Mental State Exam) at that same frequency with
their statin patients?
How can physicians say they have no cognitive adverse effects in their
practice if they don't check? I am now talking about running a full study,
just following up on their patients. The patient with memory loss is the
last to be aware of it - family and friends see it first. The Transient
Global Amnesia effects are a little more obvious to the patient, but often
only if the TGA episode is witnessed.
Only when there are more physicians understanding that these adverse effects
do occur will the next step be available: research into treatment of those
who have lost their memory to Lipitor or other statins. Simply stopping the
drug does not result in recovery, unless the patient waits for years. There
needs to be something that will offer the hope of recovery for these
patients and their families. AND there need to be fewer people suffering
massive loss, because of monitoring by their physician, and cessation of the
drug at the earliest sign of cognitive decline.
context:
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04020...@posting.google.com...
> "Sharon Hope" <sh...@anet.net> wrote in message
news:<hBEUb.189538$nt4.800549@attbi_s51>...
snip
> > One of the studies eliminated "unrelated mortality" and included
> > hemorrhagic stroke in the "unrelated" category, despite the Lipitor
> > Physician's Reference stating:
> > CNS Toxicity
> >
> >
> > Brain hemorrhage was seen in a female dog treated for 3 months at 120
> > mg/kg/day. Brain hemorrhage and optic nerve vacuolation were seen in
another
> > female dog that was sacrificed in moribund condition after 11 weeks of
> > escalating doses up to 280 mg/kg/day. The 120 mg/kg dose resulted in a
> > systemic exposure approximately 16 times the human plasma
> > area-under-the-curve (AUC, 0-24 hours) based on the maximum human dose
of 80
> > mg/day. A single tonic convulsion was seen in each of 2 male dogs (one
> > treated at 10 mg/kg/day and one at 120 mg/kg/day) in a 2-year study. No
CNS
> > lesions have been observed in mice after chronic treatment for up to 2
years
> > at doses up to 400 mg/kg/day or in rats at doses up to 100 mg/kg/day.
These
> > doses were 6 to 11 times (mouse) and 8 to 16 times (rat) the human AUC
> > (0-24) based on the maximum recommended human dose of 80 mg/day.
> >
> > CNS vascular lesions, characterized by perivascular hemorrhages, edema,
and
> > mononuclear cell infiltration of perivascular spaces, have been observed
in
> > dogs treated with other members of this class. A chemically similar drug
in
> > this class produced optic nerve degeneration (Wallerian degeneration of
> > retinogeniculate fibers) in clinically normal dogs in a dose-dependent
> > fashion at a dose that produced plasma drug levels about 30 times higher
> > than the mean drug level in humans taking the highest recommended dose.
>
>
>
> COMMENT:
>
> Things that happen in dogs at blood levels 30 times higher than are
> seen in humans on the drug, for long periods of time, are hardly
> relevent to anything. For example, there is no animal alive which
> could tolerate blood levels of aspirin 30 times those which are
> therapeutic in humans, even for a few hours. But the machanisms of
> salicylate toxicity in animals killed with overdoses of aspirin
> (seizure, heart failure) are not relevent to human trials of
> therapeutic doses of aspirin. They are simply data that are useless
> for that purpose, even used inferentially. They might be helpful in
> trying to evaluate suicide attempts in people taking bottles of
> aspirin, but that's about it. Since I know of nobody who has tried to
> kill themselves by taking a whole bottle of statin pills everyday for
> three months, such a thing being done to an animal is nearly junk
> science. It's an advertisement for PETA if it is used to interpret any
> human data at all.
>
> SBH
Sharon Hope
news:%XBXb.36085$EP2....@newssvr33.news.prodigy.com...
> >
> > I do, however, continue to wonder how, as the trial wears on, statin
memory
> > loss will be distinguished from early Alzheimer's. (I spoke to the
> > personnel conducting part of the larger study in a different center, and
> > they had no answer the question.)
>
> I'm not sure I understand this. If this is a placebo controlled trial, no
> matter what you call it, any significantly increased memory loss in the
statin
> arm should be apparent. Unless you are referring to the possibility that
> statins could improve memory in one way and hurt it in another? Also do
you
> know when this study is supposed to be completed?
>
> Bill
> >
Bill,
The study is looking into whether or not Statins prevent Alzheimer's. Not
sure that is an improvement of memory, but prevention of loss.
My husband's experience, as well as many others' documented in PUB MED, is
that Statins cause loss of short-term memory.
Could both outcomes result from the study? Sure. May affect different
people in different ways. Again, the example of stimulants that work as
'uppers' for most people, but 'downers' for ADD children - same drug,
different effects. (BUT in this case, it is the primary outcome of the drug,
not an adverse effect)
But, if the people on the statin side of the study do get memory loss, is it
early Alzheimer's or is it statin-induced cognitive damage? How will they
determine which? This analysis is apparently not part of the proposal or
plan for the study, or the researchers would have had an answer when asked.
Not sure of the length, would be listed on the FDA site somewhere, but it
just started last year.
Bill
> Bill,
> The study is looking into whether or not Statins prevent Alzheimer's. Not
> sure that is an improvement of memory, but prevention of loss.
>
> My husband's experience, as well as many others' documented in PUB MED, is
> that Statins cause loss of short-term memory.
>
> Could both outcomes result from the study? Sure. May affect different
> people in different ways. Again, the example of stimulants that work as
> 'uppers' for most people, but 'downers' for ADD children - same drug,
> different effects. (BUT in this case, it is the primary outcome of the drug,
> not an adverse effect)
>
> But, if the people on the statin side of the study do get memory loss, is it
> early Alzheimer's or is it statin-induced cognitive damage? How will they
> determine which? This analysis is apparently not part of the proposal or
> plan for the study, or the researchers would have had an answer when asked.
>
> Not sure of the length, would be listed on the FDA site somewhere, but it
> just started last year.
>
>
If statins, on average, impair memory it should show up - though you may not
be able to identify the mechanism. Until recently, as best I recall, the only
definitive test for Alzheimer's was an autopsy. However, I do remember reading
recently that significant progress has been made in this area, though I can't
give you a source.
Bill
Dr Chaos
> Which once again raises the question: where are the media reports on
> these 15,000,000 victims of statins? Is there a cover up by all the
> world media except WSJ/Smart Money?
Where are all the huge number of new neurology consultations
from 15,000,000 victims of statins?
Sharon Hope
Statins and risk of polyneuropathy: a case-control study.
Gaist D, Jeppesen U, Andersen M, Garcia Rodriguez LA, Hallas J, Sindrup SH.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12011277&dopt=Abstract
Department of Neurology, Odense University Hospital, Denmark.
dga...@health.sdu.dk
Neurology. 2002 May 14;58(9):1333-7.
Statins and risk of polyneuropathy: a case-control study.
Neurology. 2002 May 14;58(9):1333-7.
PMID: 12011277 [PubMed - indexed for MEDLINE]
Are users of lipid-lowering drugs at increased risk of peripheral
neuropathy?
Gaist D, Garcia Rodriguez LA, Huerta C, Hallas J, Sindrup SH.
Institute of Public Health, University of Southern Denmark, Odense
University, Sdr Boulevard 23A, DK-5000 Odense, Denmark. dga...@health.sdu.dk
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11317483&dopt=Abstract
Eur J Clin Pharmacol. 2001 Mar;56(12):931-3.
Are users of lipid-lowering drugs at increased risk of peripheral
neuropathy?
Eur J Clin Pharmacol. 2001 Mar;56(12):931-3.
PMID: 11317483 [PubMed - indexed for MEDLINE]
Statins and peripheral neuropathy.
Jeppesen U, Gaist D, Smith T, Sindrup SH.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10027656&dopt=Abstract
Department of Neurology, Odense University Hospital, Denmark.
Eur J Clin Pharmacol. 1999 Jan;54(11):835-8.
Statins and peripheral neuropathy.
Eur J Clin Pharmacol. 1999 Jan;54(11):835-8.
PMID: 10027656 [PubMed - indexed for MEDLINE]
"Dr Chaos" <mbkennelS...@NOSPAMyahoo.com> wrote in message
news:slrnc30mbv.ro7.m...@lyapunov.ucsd.edu...
Sharon Hope
not news - one was published in 1998:
Statin therapy and small fibre neuropathy: a serial electrophysiological
study.
Lo YL, Leoh TH, Loh LM, Tan CE.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12639733&dopt=Abstract
Department of Neurology, Singapore General Hospital, Outram Road, Singapore.
gnr...@sgh.com.sg
J Neurol Sci. 2003 Apr 15;208(1-2):105-8.
PMID: 12639733 [PubMed - indexed for MEDLINE]
'We describe three patients who developed small fibre neuropathy after 1
month of statin therapy with clinical resolution upon prompt drug
withdrawal. All patients showed abnormal sympathetic skin responses (SSR) in
comparison with controls. SSRs returned to normal in tandem with clinical
improvement. One patient redeveloped small and large fibre neuropathy when
the similar drug was readministered. The SSR is of value in the
electrophysiological assessment and follow-up of statin-related small fibre
neuropathy.'
Association of HMG-CoA reductase inhibitors with neuropathy.
Backes JM, Howard PA.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12549960&dopt=Abstract
Department of Pharmacy Practice and Lipid, Atherosclerosis, Metabolic and
LDL-Apheresis Clinic, University of Kansas Medical Center, Kansas City, KS
66160-7231, USA. jba...@kumc.edu
Ann Pharmacother. 2003 Feb;37(2):274-8.
Link confirmed, risk portrayed as small - but for those with the neuropathy
risk is 100%
Medication-induced peripheral neuropathy.
Weimer LH.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12507417&dopt=Abstract
Neurological Institute of New York, 710 West 168th Street, Unit 55, New
York, NY 10032, USA. Lh...@columbia.edu
Curr Neurol Neurosci Rep. 2003 Jan;3(1):86-92.
"The underlying pathomechanisms remain incompletely elucidated; however,
apoptosis is emerging as an important final pathway in some forms of toxic
neuropathy. Although most cases demonstrate acute or subacute onset after
exposure, recent experiences with statin drugs raise the possibility of
occult toxic causes of chronic idiopathic neuropathy."
Peripheral neuropathy and lipid-lowering therapy.
Ziajka PE, Wehmeier T.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9671841&dopt=Abstract
Florida Lipid Associates, Orlando 32806, USA.
South Med J. 1998 Jul;91(7):667-8.
We report a case of a peripheral neuropathy induced and exacerbated by
several commonly used HMG-CoA reductase inhibitors including lovastatin,
simvastatin, pravastatin, and atorvastatin, and the vitamin niacin. A review
of the literature shows similar cases with individual lipid-lowering drugs,
but this case shows the cross-reactivity of the neuropathic process to
different HMG-CoA reductase inhibitors, and it is the first reported case of
a peripheral neuropathy exacerbated by the use of niacin.
PMID: 9671841 [PubMed - indexed for MEDLINE]
"Dr Chaos" <mbkennelS...@NOSPAMyahoo.com> wrote in message
news:slrnc30mbv.ro7.m...@lyapunov.ucsd.edu...
Sharon Hope
describe the study.
They started with criminally violent population. Presumably the
incarcerating institution would feed all in the same way. So, would you
then say all the violent criminals with low cholesterol were on a hunger
strike? Highly unlikely.
Also, check your facts. Testosterone sits on a platform of cholesterol.
Lipitor is notorious for lowering Testosterone levels, particularly in
younger men. The lower the cholesterol, the lower the testosterone level.
Inverse of what you speculate.
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04021...@posting.google.com...
> "Sharon Hope" <sh...@anet.net> wrote in message
news:<d1YVb.214613$nt4.1033451@attbi_s51>...
> > Low cholesterol and violent crime.
> >
> > Golomb BA, Stattin H, Mednick S.
> > PMID: 11104842
> > Department of Medicine, University of California, Los Angeles, CA
> > 92093-0995, USA. bgo...@ucsd.edu
> >
> > BACKGROUND: Community cohort studies and meta-analyses of randomized
trials
> > have shown a relation between low or lowered cholesterol and death by
> > violence (homicide, suicide, accident); in primates, cholesterol
reduction
> > has been linked to increased behavioral acts of aggression (Kaplan J,
Manuck
> > S. The effects of fat and cholesterol on aggressive behaviour in
monkeys.
> > Psychosom. Med 1990;52:226-7; Kaplan J, Shively C, Fontenot D, Morgan T,
> > Howell S, Manuck S et al. Demonstration of an association among dietary
> > cholesterol, central serotonergic activity, and social behaviour in
monkeys.
> > Psychosom. Med 1994;56:479-84.). In this study we test for the first
time
> > whether cholesterol level is related to commission of violent crimes
against
> > others in a large community cohort.
> > ...
> > RESULTS: One hundred individuals met criteria for criminal violence. Low
> > cholesterol (below the median) was strongly associated with criminal
> > violence in unadjusted analysis (Men: risk ratio 1.94, P=0.002; all
subjects
> > risk ratio 2.32, P<0.001). Age emerged as a strong confounder. Adjusting
for
> > covariates using a matching procedure, violent criminals had
significantly
> > lower cholesterol than others identical in age, sex, alcohol indices and
> > education, using a nonparametric sign test (P=0.012 all subjects;
P=0.035
> > men). CONCLUSIONS: Adjusting for other factors, low cholesterol is
> > associated with increased subsequent criminal violence.
>
>
>
> COMMENT:
>
> Ms. Golumb seems to be on an anticholesterol campaign. Alas, there are
> a couple of obvious confounders other than age, sex, education, and
> alcohol use. After all, we need to wonder about WHY it's important to
> adjust for age and sex when looking at cholesterol and violence. One
> reason is that testosterone has bad effects on cholesterol,
> particularly HDL. And so does age, but much of the age effect is due
> to obesity. Young fat men with low testosterone aren't as violent as
> young skinny men with high testosterones. But they also have higher
> cholesterols, and if you don't control for body mass index and
> testosterone levels, it looks like cholesterol is the culpret.
>
> Let me put it another way: cholesterol levels are a proxy for whether
> or not you're being starved, which tends to make people cranky and
> violent (monkeys too). Anybody who's had to live with somebody on a
> crash diet knows this effect. It's not new, either. "Yond Cassius has
> a lean and hungry look; He thinks too much: such men are dangerous."
> Shakespeare's Ceasar may have been on to something, but it wasn't
> necessarily the effect of cholesterol.
>
> SBH
talkback
> Your philosophical and literary analysis is interesting, but does not
> describe the study.
>
few reports and studies, analyze the content and make observations based
on the reported facts taking into account the methodologies and assumptions?
This thread is ridiculous. The pervailing arguements seem to be
variations of "Did Not!" and "Did Too!"
Al. Lohse
talkback wrote:
>
> Sharon Hope wrote:
> > Your philosophical and literary analysis is interesting, but does not
> > describe the study.
> >
> Is it really that difficult for reasonably intelligent people to read a
> few reports and studies, analyze the content and make observations based
> on the reported facts taking into account the methodologies and assumptions?
>
Have not been following that thread too
closely.
If what you say is true then it is of utmost
importance to DISCUSS the matter.... not to
shun it as you are attempting.
Talkback appears to have some self-interest
in this matter.
Talkback is too crude for my liking, to
quote, "Enough of you. Too stupid to talk to
any more."
A.L.
talkback
>
> talkback wrote:
>
>>Sharon Hope wrote:
>>
>>>Your philosophical and literary analysis is interesting, but does not
>>>describe the study.
>>>
>>
>>Is it really that difficult for reasonably intelligent people to read a
>>few reports and studies, analyze the content and make observations based
>>on the reported facts taking into account the methodologies and assumptions?
>>
>
>
> Have not been following that thread too
> closely.
>
If you haven't been then you should read it before commenting. The
original poster has a personal interest in this position. Most of the
thread deals with talking ABOUT the study(ies), and not really
discussing the information they contain.
list...@nospam.net
>If statins, on average, impair memory it should show up - though you may not
>be able to identify the mechanism. Until recently, as best I recall, the only
>definitive test for Alzheimer's was an autopsy. However, I do remember reading
>recently that significant progress has been made in this area, though I can't
>give you a source.
>
>
>Bill
>
There has also been research into the connection between Alzheimer's
and amyloidosis. Suggesting a statin-alzheimer's connection at this
point is conjecture.
Sharon Hope
years, destroying his memory, putting him in constant chronic pain, and
depriving him of quality of life, strength, stamina, the ability to
communicate clearly or even stand or walk for more than 20 minutes per day.
Lipitor damage IS personal. As many doctors have told us, the percent of
adverse effects is meaningless if it happens to your family, because then it
is 100%.
Personal? It actually took you this many posts in a thread to figure that
out?
The focus of the thread is on helping prevent it from becoming personal for
someone else. The frightening thing, more so than even the proven side
effects, is the hysterical sky-is-falling reaction by people who refuse to
believe statins are not perfect for everyone. They even refuse to believe
in or acknowledge the adverse effects claimed by Pfizer on the physician's
insert.
Baffling.
"talkback" <tb...@yahoo.com> wrote in message
news:y%tYb.4168$Fp5...@read1.cgocable.net...
Sharon Hope
Meanwhile, the memory loss from Lipitor, a differential diagnosis that rules
out Alzheimer's and other frontotemporal dementias is solidly documented.
<list...@nospam.net> wrote in message
news:fg3530dnkfr640cbv...@4ax.com...
talkback
> Personal? You can't get much more personal than taking a spouse of 35
I've always known that. My point was that I'd like to see some empirical
data to support your position. Data of the type which anyone who reads
if will find it compelling.
From my readings in this thread, there seem to be many who have
questioned the validity of the data you are presentint.
The "personal" element has been know to cloud one's objectivity.
+
talkback
> talkback <tb...@yahoo.com> wrote in message news:<5mLYb.4593$Fp5...@read1.cgocable.net>...
> objectivity"
>
> Yes it certainly has Talkback.
>
> Witness the May 2003 theme issue of the British Medical Journal which
> pointed out how a personal element ($$$) clouds the judgement of so
> many medical researchers who are in the pockets of the drug companies.
>
> Too far back for you? How about the latest issue of the Canadian
> Medical Association Journal. Here. Let me help you...
>
> Time to Untangle Doctors from the Drug Companies
> http://bmj.bmjjournals.com/content/vol326/issue7400/
>
> Pro industry findings in randomized trials:
> Drug company experts advised staff to withhold data about SSRI use in
> children
> http://www.cmaj.ca/cgi/content/full/170/4/441
>
> There's more, but that'll do for starters. Personal element clouding
> one's judgement.
>
> Drug whores I likes to call 'em. It's so succinct. So apt.
>
> So personal.
>
> B'adant
Before jumping into a thread you should take the time to find out what
it's all about. We are all familiar with the problems of drug whores.
What THIS thread is about is one individuals pathetic attempt to deal
with her husband's condition by going on a crusage against a class of
drug. Unfortunatley, the only clinical and objective evidence she has is
neither clinical, objective or compelling. The basis of her position is
her unobjective anectodal experience with a group of one, driven by a
desperate need to find someone or something to blame. About as
convincing as homeopathy.
Sharon Hope
" crusage against a class of drug. " It is an awareness campaign that
patients have informed consent in the prescriptions they receive. If the
drug works for them, fine, if it causes side effects that are so cloaked in
secrecy that the doctors dismiss the adverse effects rather than deal with
them, then that is wrong and they are entitled to know by other means.
Apparently you are under the delusional impression that NIH PUB MED is now a
part of my personal family? That all these authors of the studies cited
below are cousins? That the study subjects are all my husband? That the
book, Lipitor Thief of Memory was written by a relative? How, in your
bizarre version of reality, do you envision my personal involvement in the
production and publication of Pfizer's list of adverse effects on the
Lipitor PI? Do you plan to attack Pfizer for listing adverse effects to
Lipitor? Shoot that messenger, too?
No. Sorry, you are wrong, no relations. Nor am I related to the people who
have posted their problems from statin adverse effects on the following
boards:
Lipitor: http://forum.ditonline.com/viewboard.php?BoardID=38
Zocor: http://forum.ditonline.com/viewboard.php?BoardID=41
Lescol: http://forum.ditonline.com/viewboard.php?BoardID=37
Pravachol: http://forum.ditonline.com/viewboard.php?BoardID=40
Mevacor: http://forum.ditonline.com/viewboard.php?BoardID=39
http://www.rxlist.com/rxboard/lipitor.pl
http://www.rxlist.com/rxboard/lescol.pl
http://www.rxlist.com/rxboard/mevacor.pl
http://www.rxlist.com/rxboard/pravachol.pl
http://www.rxlist.com/rxboard/zocor.pl
NERVE DAMAGE & STATINS
Frequently Asked Question: What medical research studies have been done on
Statins and Nerve Damage that I can bring to my doctor's attention?
Studies & Links in chronological order, with the latest on top:
Statins and risk of polyneuropathy, A case-control study
D. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L.A. García
Rodríguez, MD, MSc;
J. Hallas, MD, PhD; and S.H. Sindrup, MD, PhD
http://213.4.18.135/87.pdf full text
Are users of lipid-lowering drugs at increased risk of peripheral
neuropathy?
David Gaist, Luis Alberto García Rodríguez · Consuelo Huerta · Jesper Hallas
· Søren H. Sindrup
http://213.4.18.135/75.pdf full text
abstract
Are users of lipid-lowering drugs at increased risk of peripheral
neuropathy?
David Gaist, Luis Alberto García Rodríguez · Consuelo Huerta · Jesper Hallas
· Søren H.
Sindrup
http://213.4.18.135/76.2.pdf full text
http://213.4.18.135/87.pdf full text
Pharmacodynamics: Statins and peripheral neuropathy
U. Jeppesen (2), D. Gaist (1)(2), T. Smith (1), S. H. Sindrup (1)(2)
(1) Department of Neurology, Odense University Hospital, DK-5000 Odense C,
Denmark Tel.: +45-6541-2474, Fax: +45-6541-3389
(2) Department of Clinical Pharmacology Odense University, Odense, Denmark
Received: 6 July 1998 / Accepted in revised form: 1 October 1998
Abstract Volume 54 Issue 11 (1999) pp 835-838
http://link.springer-ny.com/link/service/journals/00228/bibs/9054011/90540835.htm
Association of HMG-CoA reductase inhibitors with neuropathy.
Ann Pharmacother. 2003 Feb;37(2):274-8.
Backes JM, Howard PA.
Department of Pharmacy Practice and Lipid, Atherosclerosis, Metabolic and
LDL-Apheresis Clinic, University of Kansas Medical Center, Kansas City, KS
66160-7231, USA. jba...@kumc.edu
"Epidemiologic studies and case reports suggest an increased risk of
peripheral neuropathy with statin drugs. The majority of cases were at least
partially reversible with drug cessation." (emphasis added)
Statin therapy and small fibre neuropathy: a serial electrophysiological
study.
Lo YL, Leoh TH, Loh LM, Tan CE.
J Neurol Sci. 2003 Apr 15;208(1-2):105-8.
Department of Neurology, Singapore General Hospital, Outram Road, Singapore.
gnr...@sgh.com.sg
Describes 3 patients who developed neuropathy after ONE MONTH of statin
therapy. "One patient redeveloped small and large fibre neuropathy when the
similar drug was readministered."
Peripheral Neuropathy and Lipid-Lowering Therapy
Paul E. Ziajka, MD, PhD, and Tammy Wehmeier, RN, Orlando, Fla.
Abstract: We report a case of peripheral neuropathy induced and excerbated
by several commonly used HMG-CoA reductase inhibitors including lovastatin,
simvastatin, pravastatin, and atorvastatin, and the vitamin niacin. A review
of the literature shows similar cases with individual lipid-lowering drugs,
but this case shows the cross-reactivity of the neuropathic process to
different HMG-CoA reductase inhibitors, and is the first reported case of a
peripheral neuropathy exacerbated by the use of niacin.
http://www.sma.org/smj1998/julysmj98/ziajka.pdf
"Increased levels of statin, a marker of cell cycle arrest, in response to
hippocampal neuronal injury." Poirier J, Beffert U, Dea D, Alonso R,
O'Donnell D, Boksa P., Department of Psychiatry, McGill University,
Montreal, Que., Canada. Brain Res Mol Brain Res 1995 Dec 1;34(1):57-64
"It is concluded that, in addition to proliferation related gene products,
neuronal injury induces an increase in levels of statin, a nuclear marker of
cell cycle arrest. Furthermore, statin may be a potentially useful marker of
injurious neuronal stress, even under conditions that do not necessarily
lead to irreversible cell death."
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8750861&dopt=Abstract
Phan T, McLeod JG, Pollard JD, Peiris O, Rohan A, Halpern JP.
Peripheral neuropathy associated with simvastatin.
J Neurol Neurosurg Psychiatry. 1995 May;58(5):625-8.
PMID: 7745415 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7745415&dopt=Abstract
Ahmad S.
Lovastatin and peripheral neuropathy.
Am Heart J. 1995 Dec;130(6):1321. No abstract available.
PMID: 7484806 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7484806&dopt=Abstract
Jacobs MB.
HMG-CoA reductase inhibitor therapy and peripheral neuropathy.
Ann Intern Med. 1994 Jun 1;120(11):970. No abstract available.
PMID: 8172444 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8172444&dopt=Abstract
Medication-induced peripheral neuropathy.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12507417&dopt=Abstract
Curr Neurol Neurosci Rep. 2003 Jan;3(1):86-92. Review.
Weimer LH.
Neurological Institute of New York, 710 West 168th Street, Unit 55, New
York, NY 10032, USA. Lh...@columbia.edu
PMID: 12507417 [PubMed - indexed for MEDLINE]
"Although most cases demonstrate acute or subacute onset after exposure,
recent experiences with statin drugs raise the possibility of occult toxic
causes of chronic idiopathic neuropathy."
Le Quesne PM. Neuropathy due to drugs. In: Dyck PJ, Thomas PK, Griffin JW,
et al, eds. Peripheral neuropathy. 3rd ed. Philadelphia: Saunders,
1993:1571-1581.
(Book, no link)
Of interest:
MacDonald BK, Cockerell OC, Sander WAS, Shorvon SD (2000) The incidence and
lifetime prevalence of neurological disorders in a prospective
community-based study in the UK. Brain
123:665-676
General background medical Info from
Related, but also will appear in other FAQs:
Neuromuscular Disease Center
Washington University School of Medicine, St. Louis, MO
Home: http://www.neuro.wustl.edu/neuromuscular/index.html
Under Disorders & Syndromes:
Select:
Myopathy: http://www.neuro.wustl.edu/neuromuscular/maltbrain.html
Neuropathy: http://www.neuro.wustl.edu/neuromuscular/naltbrain.html
Neuromuscular: http://www.neuro.wustl.edu/neuromuscular/syaltbrain.html
CNS (Central Nervous System):
http://www.neuro.wustl.edu/neuromuscular/syaltbrain.html#cns
Specifics,
MYOGLOBINURIA - RHABDOMYOLYSIS
http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html
Then see Lipid Lowering Agent Myopathies
http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html#lipid
Note that this connects to CARDIAC + MYOPATHY
http://www.neuro.wustl.edu/neuromuscular/msys/cardiac.html
And to TOXIC NEUROPATHIES:
http://www.neuro.wustl.edu/neuromuscular/nother/toxic.htm#statin
OR Locally supplied Search on "Statin" leads to:
TOXIC MYOPATHIES http://www.neuro.wustl.edu/neuromuscular/mother/myotox.htm
Note also tht under Mitochondrial Disorders, the list of problems associated
with Coenzyme Q10 Deficiency
http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html#coq10
MITOCHONDRIAL MYOPATHIES
Facts About Mitochondrial Myopathies from the Muscular Dystrophy Association
http://www.mdausa.org/publications/mitochondrial_myopathies.html#whatcauses
MEMORY LOSS & STATINS
Frequently Asked Question: What medical research studies have been done on
Statins and Memory Loss, or other mental problems that I can bring to my
doctor's attention?
(Statins: Lipitor, Mevacor, Pravachol, Zocor, Lescol, and Baycol, aka
atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, and
simvastatin; Nerve Damage: Neuropathy, peripheral neuropathy,
polyneuropathy; See separate FAQ for memory loss, cognitive damage, amnesia
and aphasia, i.e., central nervous system (CNS) damage)
Australian Adverse Drug Reactions Bulletin (Australia's equivalent to the
FDA)
Volume 17, Number 3, August 1998, section 3, page 3
Simvastatn is listed under "DRUGS THAT MAKE YOU FORGET"
Recognizing the 14 reports of Amnesia under that drug, .8% of the total
adverse effects for that drug.
www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf
Studies & Links in chronological order, with the latest on top:
Statin-associated memory loss: analysis of 60 case reports and review of the
literature.
Wagstaff LR, Mitton MW, Arvik BM, Doraiswamy PM.
Drug Information Service, Duke University Medical Center, Durham, North
Carolina 27710, USA. Pharmacotherapy. 2003 Jul;23(7):871-80.
This study searched the MedWatch drug surveillance system of the Food and
Drug Administration (FDA) from November 1997-February 2002 for reports of
statin-associated memory loss. They also reviewed the published literature.
References from the study are good for follow-up research.
Full Study Text free on Medscape:
http://www.medscape.com/viewarticle/458867
The Role of Lipid-Lowering Drugs in Cognitive Function: A Meta-Analysis of
Observational Studies
from Pharmacotherapy
Posted 06/30/2003
Mahyar Etminan, Pharm.D., Sudeep Gill, M.D., FRCPC, Ali Samii, M.D., FRCPC
Although this study does bring the cognitive issues to light, it is a very
poor study. The authors left out the pivotal study by Dr. Muldoon, that
showed 100% of statin users had a measurable loss of cognitive ability
after 6 months, while 100% of the placebo group improved their scores.
Abstract:
Full Study Text free on Medscape:
http://www.medscape.com/viewarticle/456866
Muldoon MF, Barger SD, Ryan CM, Flory JD, Lehoczky JP, Matthews KA, Manuck
SB.
Effects of lovastatin on cognitive function and psychological well-being.
After 6 months, 100% of the patients on placeboes showed a measurable
increase in cognitive function, and 100% of the statin patients showed a
measurable decrease in cognitive function.
Am J Med. 2000 May;108(7):538-46.
PMID: 10806282 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10806282&dopt=Abstract
Simvastatin-Associated Memory Loss
Amanda Orsi, Pharm.D., Olga Sherman, Pharm.D., and Zegga Woldeselassie,
Pharm.D.,
Abstract: The statins are widely used to treat dyslipidemias. They are
generally associated with mild adverse effects, but rarely, more serious
reactions may occur. A 51-year-old man experienced delayed-onset,
progressive memory loss while receiving simvastatin for
hypercholesterolemia. His therapy was switched to pravastatin, and memory
loss resolved gradually over the next month, with no recurrence of the
adverse effect.
from Pharmacotherapy
Posted 06/01/2001
Page 1 of 3:
http://www.medscape.com/viewarticle/409738?WebLogicSession=PXke2H8h99pyNVSCajAh5clptzOAHJSZuNBobSwWmi9veWjdJ2A3%7C-1468812056489609316/184161392/6/7001/7001/7002/7002/7001/-1
full printable version: http://www.medscape.com/viewarticle/409738_print
ADR of the Month
September 2001 Vol. 6 No. 9
EDITORS
Michelle W. McCarthy, Pharm.D.
Anne E. Hendrick, Pharm.D.
University of Virginia Health System
Department of Pharmacy Services
Drug Information Center
PO Box 800674
Charlottesville, VA 22908-0674
http://hsc.virginia.edu/pharmacy-services/Newsletters/ADR%20of%20the%20Month/ADRMonth%209-01htm.html
The Tablet, a general member benefit published by the British Columbia
Pharmacy Association, September 2001, Volume 10 no 8.
Excerpt:
Do HMG-CoA reductase inhibitors impair memory? After taking simvastatin for
a year, a 51-year-old patient developed short term memory loss, to the
extent of being unable to complete his sentences because he would forget
what he was going to say. The drug was discontinued, replaced by
pravastatin, and within one month his memory returned.14 In a separate case,
a 67-year-old woman developed impaired short-term memory, altered mood,
social impairment, cognitive impairment and dementia after one year of
atorvastatin therapy. When atorvastatin was discontinued, her memory, mood
and cognition improved completely.15 Memory impairment in a patient
receiving atorvastatin has been reported to the BC Regional ADR Centre.
REFERENCES:
14. Orsi A, Sherman O, Woldeselassie Z. Simvastatin-associated memory loss.
15. King DS, Jones DW, Wofford MR et al. First report of cognitive
impairment in an elderly patient: case report. Pharmacotherapy 2001 Mar; 21:
371.
http://www.bcpharmacy.ca/publications/thetablet/pdf_version/BCPhA_Tablet-Sep2001.pdf
See page 11 of 16:
See also:
Statins and risk of polyneuropathy, A case-control study
D. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L.A. García
Rodríguez, MD, MSc;
J. Hallas, MD, PhD; and S.H. Sindrup, MD, PhD
http://213.4.18.135/87.pdf full text
Preclinical safety evaluation of cerivastatin, a novel HMG-CoA reductase
inhibitor.
von Keutz E, Schluter G.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9737641&dopt=Abstract
Institute of Toxicology, PH-Product Development, Bayer AG, Wuppertal,
Germany
Am J Cardiol. 1998 Aug 27;82(4B):11J-17J.
PMID: 9737641
"In dogs, the species most sensitive to statins, cerivastatin caused
erosions and hemorrhages in the gastrointestinal tract, bleeding in the
brain stem with fibroid degeneration of vessel walls in the choroid plexus,
and lens opacity."
Subchronic toxicity of atorvastatin, a hydroxymethylglutaryl-coenzyme A
reductase inhibitor, in beagle dogs.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8864188&dopt=Abstract
Walsh KM, Albassam MA, Clarke DE.
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Ann
Arbor, Michigan 48105, USA.
"The toxicity of atorvastatin (AT), an inhibitor of
hydroxymethylglutaryl-coenzyme A reductase (HMG), was evaluated in beagle
dogs. hemorrhage in gallbladder and brain, demyelination of optic nerve, and
skeletal muscle necrosis"
Finally, on memory loss and statins: Sworn testimony from the Baycol trial
in Corpus Christi, Texas. From the transcript of the AM Session on 03-05-03,
in the case Hollis Haltom Vs. Bayer Corporation. Testifying under oath,., in
response to the plaintiff's attorney's question, "What is your current
position at Bayer?", LAWRENCE POSNER, M.D of BAYER stated: "I'm the --
currently I'm the head of worldwide regulatory affairs for our prescription
drug business, which means I have responsibility in somewhere between 60 and
100 countries where we sell products for registrations, compliance, things
of that nature." Excerpts from the trial transcript follow, with the Q
indicating counsel's Question, and the A indicating Dr. Posner's Answer:
Q. So there are some concerns addressed here back in 1995 about testing up
to .8. And do you know what the nature of the concern was?
A. Yes. It was related to a side effect that occurred in the brain.
Q. Of what kind of animal?
A. It occurred in the brain of dogs.
Q. Okay. So there was a side effect that occurred in dogs, and then there
was a concern about whether you wanted to go forward and test at this higher
dose level in human beings, given what you had learned about the dogs,
right?
A. That's correct.
Q. Okay. Now, did you just say, well, let's forget about these concerns and
we'll go ahead and put .8 on the market anyway, or did you do some further
analysis that was not mentioned the other day?
A. Yes. The authors of this had -- they had two concerns. One concern was
the toxicity that they found in the brain of dogs. But the other was that
they had no way to identify this and who might be at risk before it
happened. So there was no way to detect that someone was at risk for this
side effect.
[skip some testimony on other topics]
Q. Do you remember in one kind of animal there had been some studies done
that there could be a particular kind of problem with one kind of animal?
A. Oh, yeah. Yes, from the -- that's correct, from the toxicology studies.
Q. Okay. And were you able to demonstrate to your own satisfaction, to
SmithKline's satisfaction, to the FDA's satisfaction, that that particular
problem that showed up with that kind of animal is not something that
happens in human beings?
A. Yes. We did it -- we did it by explaining the toxicology data. We also
explained it on the basis of kinetic data. That actually at the higher
levels of drug, what happens is a certain amount of drug is bound to
proteins in the body that circulate; and therefore, is not -- cannot cause
side effects. And actually, a much smaller proportion of the drug is free.
And that what you corrected for that, you actually found out that the
margins of safety were in fact greater than you would predict just from the
animal data.
Q. And as you move forward then and got approval and sold Baycol from 1997
through 2001, did that problem that had shown up with that one kind of
animal ever become a problem with human beings?
A. It was actually shown with other statins as well. It wasn't unique to
cerivastatin. It was a problem -- it was identified early on with lovastatin
and some of the others. In fact, for none of the statins did it ever predict
for any clinical problem or toxicity.
Q. So these animals would have that same problem regardless of which
statin -- or at least with other statins?
A. Certainly with lovastatin it was true.
Q. But when it came time to human beings, that just wasn't something that
happened to human beings?
A. And I think today no one pays much attention to it.
But, I thought I heard statins might cure Alzheimer's, what about that?
So far, there is no proof that statins have an effect on Alzheimers, while
there is proof that statins negatively affect cognition and memory. Is it
possible that the suggestion that statins may help Alzheimer's is just
industry "spin" to divert attention from statin-induced memory loss?
Apparently so, because the adverse effects from the statins are cropping up
so often that they are actually interfering with the ability of the industry
to even run a study on statins and Alzheimers. See:
For all of us who experienced statin-caused cognitive effects, short-term
memory loss, confusion, inability to concentrate, temporal global amnesia
episodes, blackouts, etc. (in themselves or in a family member), this will
come as absolutely no surprise:
A Position Paper: Based on Observational Data Indicating an Increased Rate
of Altered Blood Chemistry Requiring Withdrawal from the Alzheimer's Disease
Cholesterol-Lowering Treatment Trial (ADCLT)
Authors are 6 clinical researchers from Sun City, AZ.
The doctors point out that the people taking the statins for the trial have
to be pulled from the study due to adverse effects.
Unfortunately, this does not address the next issue they will encounter:
How will they be able to distinguish between Alzheimer's memory loss and
statin-caused memory loss? Given that Dr. Muldoon's study proved that
measurable cognitive deficits occur in 100% of the people taking statins,
and given that fewer than 100% of the population suffers from Alzheimer's,
it is inevitable they will have to deal with this issue - if they can keep
enough people on the statins without adverse effects - something they are
not experiencing success at now.
AMNESIA & STATINS
Frequently Asked Question: Amnesia is one of the Lipitor side effects
reported by Pfizer on the Physician's Information, where can I find out more
about people who have had amnesia episodes while taking the drug?
Dr. Graveline, retired family MD, USAF Flight Surgeon, researcher in space
medicine and US Astronaut, who suffered adverse effects from Lipitor,
maintains several websites and is working on a book about statin-related
memory loss and amnesia at:
www.spacedoc.net (you can start here and read about his life and his books)
http://www.spacedoc.net/lipitor_thief_of_memory.html
http://www.spacedoc.net/lipitor.htm
http://www.spacedoc.net/statin_dialogues.htm
Australian Adverse Drug Reactions Bulletin (Australia's equivalent to the
FDA)
Volume 17, Number 3, August 1998, section 3, page 3
Simvastatn is listed under "DRUGS THAT MAKE YOU FORGET"
Recognizing the 14 reports of Amnesia under that drug, .8% of the total
adverse effects for that drug.
www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf
CHEST PAIN & STATINS
Frequently Asked Question: Chest pain, that my cardiologist cannot explain
via angiogram, stress test, EEG or EKG, is one of the side-effects I see is
reported by many people. Is there any information on chest pain associated
with statins?
Naturally, chest pain should be first evaluated by a cardiologist. If the
usual explanations for chest pain do not apply to you, and you believe that
statin adverse-effect may be the cause, here are some articles that may give
you some background, or may be useful to give to your doctor. Some are
specific to statins and cardiomyopathy, some are background on how statins
affect CoQ10 production and how a CoQ10 deficiency affects the cells.
Most of these research articles have been found via a search of the National
Institutes of Health website
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=&DB=PubMed , a repository
for hundreds of medical journals. In most cases, only the abstract is
available and the full article must be purchased. Many of the others can be
found via a Google or other net search, or were discovered via posts on the
Lipitor message boards.
See:
http://www.lipitor.com/pi/default.asp Pfizer's Physician's Info for
prescribing Lipitor, includes documented known adverse effects. Note "Body
as a Whole: Chest pain," the italics indicate that the incidence was > 2% in
original trials.
COENZYME Q10 (UBIQUINONE) DEFICIENCY CAUSED BY STATINS
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12353945&dopt=Abstract
Study report: http://www.annals.org/issues/v137n7/nts/200210010-00004.html
Dr. Phillips study mentioned in a Wall Street Journal article (This is
smooth muscle, not cardiac muscle.) Conclusion "statin therapy may be
associated with increased oxidation injury.mild adverse effects of statins
that are difficult to assess might be much more prevalent than widely
considered "
http://www.impostertrial.com Is Myopathy Part Of Statin Therapy? Dr.
Phillips study website, with info for Patient and Physician
Cohen & Gold, Mitochondrial Cytopathy in Adults: What we know so far
http://www.ccjm.org/pdffiles/COHEN701.PDF
(See "Heart" in table page 4, and section on page 7) CoQ10 If statins cause
CoQ10 deficiency, and CoQ10 deficiency causes mitochondrial disease, what
are the symptoms of mitochondrial disease? Heart pain is one of them.
Oxidation Injury in Patients Receiving HMG-CoA Reductase Inhibitors:
Occurrence in Patients without Enzyme Elevation or Myopathy.
US Patents: # 4,933,165
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1&f=G&l=50&s1=4933165.WKU.&OS=PN/4933165&RS=PN/4933165
see also subsequent related patents: Do a search by patent number at:
http://patft.uspto.gov/netahtml/srchnum.htm
for the following:
United States Patent 5,082,650
United States Patent 5,849,777
United States Patent 6,264,960
Merck Patent application stating that statins interfere with CoQ10 and that
deficiency causes problems. They documented that they knew this about
statins in 1989, 10 years before the 100+ deaths by Rhabdomyolysis!
http://sites.huji.ac.il/malaria/maps/ubiquinonemetpath.html
Malaria Parasite Metabolic Pathways Ubiquinone Metabolism
another version:
http://www.stdgen.lanl.gov/stdgen/images/KEGG/00130.html
DEFINITION Ubiquinone biosynthesis - Reference pathway. Diagram of the
Ubiquinone (aka CoQ10) metabolic pathway, highlighting exactly where the
Statins interrupt it. All of the 17 or so steps have to happen correctly for
the body to produce CoQ10, but statins interrupt (or retard) this in step
#2.
Introduction to the Citizen's petition to the FDA:
http://www.vaccinationnews.com/DailyNews/July2002/StatinInduced8.htm by Dr.
Peter Langsjoen This is the introduction to the petition. (It is aimed at
getting attention, and the wording may be more alarming than necessary.)
To the FDA: "Citizen Petition To Change The Labeling For All Statin Drugs
(Mevacor, Lescol, Pravachol, Zocor, Lipitor, And Advicor) Recommending Use
Of 100-200mg Per Day Of Supplemental Co-Enzyme Ql0 To Reduce The Risk Of
Statin-Induced Myopathies (Including Cardiomyopathy And Congestive Heart
Failure)," by Dr. Julian Whitaker, MD:
http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf
or as html:
http://216.239.33.100/search?q=cache:4qAiX-YbZLYC:www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf+Statin-Induced+Cardiomyopathy+Introduction+To+The+Citizen%27s+Petition+On+Statins&hl=en&ie=UTF-8
Statin Depletion of CoQ10 is linked to heart problems.
Exhibit A of FDA Petition: "The clinical use of HMG CoA-reductase inhibitors
(statins) and the associated depletion of the essential co-factor coenzyme
Ql0; a review of pertinent human and animal data." by Dr. Peter Langsjoen
MD:
http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-02-Exhibit_A-vol1.pdf
Examples of the heart problems associated with statin depletion of CoQ10.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2247468&dopt=Abstract
Lovastatin decreases coenzyme Q levels in humans.
Proc Natl Acad Sci U S A. 1990 Nov;87(22):8931-4.
PMID: 2247468 [PubMed - indexed for MEDLINE] A 1990 study showing depletion
of CoQ10 by Lovastatin - includes descriptions of cardiac patients.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11479481&dopt=Abstract A
2001 discussion on "The effect of pravastatin and atorvastatin on coenzyme
Q10"
http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/C/CellularRespiration.html
Primer on how cells breathe normally (Note the role of CoQ10, called
"Ubiquinone" in "The Respiratory Chain" section.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11505177&dopt=Abstract
(abstract)
http://213.4.18.135/70.pdf
http://216.239.33.100/search?q=cache:IGxCBJ3vs1kC:213.4.18.135/70.pdf+gaist+statin+myopathy+risk+greater&hl=en&ie=UTF-8 view as html
Lipid-lowering drugs and risk of myopathy: a population-based follow-up
study. Dr. Gaist is in Denmark and studies populations of entire countries
for epidemiology information.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12011277&dopt=Abstract
Dr. Gaist's study, Statins and risk of polyneuropathy: a case-control study.
(more serious than peripheral neuropathy)
http://213.4.18.135/87.pdf Dr. Gaist's studies on Statin-induced nerve
damage (full text)
Others:
Watts GF, Castelluccio C, Rice-Evans C, Taub NA, Baum H, Quinn PJ. Plasma
coenzyme Q (ubiquinone) concentrations in patients treated with simvastatin.
J Clin Pathol. 1993;46:1055-7. [PMID: 8254097]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=PMID:
8254097
Mortensen SA, Leth A, Agner E, Rohde M. Dose-related decrease of serum
coenzyme Q10 during treatment with HMG-CoA reductase inhibitors. Mol Aspects
Med. 1997;18 Suppl:S137-44. [PMID: 9266515]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=9266515
Bargossi AM, Grossi G, Fiorella PL, Gaddi A, Di Giulio R, Battino M.
Exogenous CoQ10 supplementation prevents plasma ubiquinone reduction induced
by HMG-CoA reductase inhibitors. Mol Aspects Med. 1994;15 Suppl:s187-93.
[PMID: 7752830]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=7752830
Ogasahara S, Engel AG, Frens D, Mack D. Muscle coenzyme Q deficiency in
familial mitochondrial encephalomyopathy. Proc Natl Acad Sci U S A.
1989;86:2379-82. [PMID: 2928337]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=2928337
Baker SK, Tarnopolsky MA. Statin myopathies: pathophysiologic and clinical
perspectives. Clin Invest Med. 2001;24:258-72. [PMID: 11603510]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=11603510
Rosenfeldt FL, Pepe S, Ou R, Mariani JA, Rowland MA, Nagley P, et al.
Coenzyme Q10 improves the tolerance of the senescent myocardium to aerobic
and ischemic stress: studies in rats and in human atrial tissue. Biofactors.
1999;9:291-9. [PMID: 10416043]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=10416043
Reust CS, Curry SC, Guidry JR. Lovastatin use and muscle damage in healthy
volunteers undergoing eccentric muscle exercise. West J Med.
1991;154:198-200. [PMID: 2006566]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=2006566
Statin-associated myopathy.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12672737&dopt=Abstract
Thompson PD, Clarkson P, Karas RH.
Preventive Cardiology and Cardiovascular Research, Division of Cardiology,
Hartford Hospital, Hartford, Conn 06102, USA. pth...@harthosp.org
"recent evidence suggests that statins reduce the production of small
regulatory proteins that are important for myocyte maintenance"
Statins and myotoxicity.
Curr Atheroscler Rep. 2003 Mar;5(2):96-100. Review.
PMID: 12573193 Farmer JA.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12573193&dopt=Abstract
Baylor College of Medicine, One Baylor Plaza, Room 525D, Houston, TX 77030,
USA. jfa...@bcm.tmc.edu
CARNITINE DEFICIENCY CAUSED BY STATINS
Bhuiyan J, Seccombe DW. The effects of 3-hydroxy-3-methylglutaryl-CoA
reductase inhibition on tissue levels of carnitine and carnitine
acyltransferase activity in the rabbit. Lipids. 1996;31:867-70. [PMID:
8869889]
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=8869889
JOINT PAIN AND STATINS
Frequently Asked Question: Can statins have something to do with my joint
pain?
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11707010&dopt=Abstract
Four cases of tendinopathy in patients on statin therapy.
Joint Bone Spine. 2001 Oct;68(5):430-3. PMID: 11707010 [PubMed - indexed for
MEDLINE]
Abstract on a report of 4 cases of people with painful tendons & statins.
Included to show that the pain and damage shows up in a variety of areas.
QUITTING STATINS
Frequently Asked Question: Can it be dangerous to just stop taking statins?
One study indicates that there are more coronary events when people stop
taking statins (Definitely talk with your doctor on this):
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11914253&dopt=Abstract
Withdrawal of statins increases event rates in patients with acute coronary
syndromes. The dangers of getting off statins. See also:
http://www.lipidsonline.org/commentaries/al_abstract.cfm?abs_id=Abs030
VIOLENCE AND LOW CHOLESTEROL
Frequently Asked Questions: Can it be the statins making me so irritable and
prone to angry outbursts?
It may be that the angry outbursts are caused by the Low Cholesterol, the
result of taking Lipitor or other statins.
Dr. Beatrice Golomb, who is now conducting the NIH funded Statin Study,
published 2 articles/studies on the connection between violence and low
cholesterol levels.
See:
Low cholesterol and violent crime. Golomb BA, Stattin H, Mednick S.
Department of Medicine, University of California, Los Angeles, CA
92093-0995, USA. J Psychiatr Res 2000 Jul-Oct;34(4-5):301-9
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11104842&dopt=Abstract
and
Cholesterol and violence: is there a connection? Golomb BA. Ann Intern Med
1998 Mar 15;128(6):478-87
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9499332&dopt=Abstract
IMMUNE SYSTEM AND STATINS
Frequently Asked Question: Can statins depress my immune system?
It is a tribute to the imaginations of the drug marketers to see how
successfully they have put positive "spin" on a very alarming proposition,
that statins depress the immune system (or is it just arrogance?). If the
known side effect of statins is to depress your immune system, and it is so
beneficial to transplant recipients and others with autoimmune disease, what
about people with pre-statin 'normal' immune systems?
I'm not the only one astonished and disgusted with this, check out Dr.
Mercola's comment (scroll down for his response to the article) on
http://www.mercola.com/2000/dec/24/statins.htm
Excerpts: "This is an amazing example of positive "spin" put on a very
negative result. People with high cholesterol certainly don't need their
immune systems suppressed...If suppressing the helper T cells is considered
such great benefit then there is a disease going around that does this quite
well - AIDS...if the mechanism of action of the drug is not understood, how
can the manufacturer or the FDA claim that it is safe"
It sounds like he is talking about this article
http://pub.ucsf.edu/today/print.php?news_id=200211062 , but actually he is
describing the last time the drug companies tried to feed us a myth about
how great it is that statins depress immune systems: (available for online
purchase from Nature Medicine:
http://www.nature.com/dynasearch/app/dynasearch.taf?sp-w=Exact&_action=search&search_fulltext=&sp-p=All&search_volume=&search_startpage=&search_title=&search_author=&search_abstract=statins+as+immunosuppressors&issue_start_month=12&issue_start_year=2000&issue_end_month=01&issue_end_year=2001&pickerCount=You+have+selected+1+journal+to+search.&rolloverMessage=&sp_k=NM
Atorvastatin suppresses interferon-gamma -induced neopterin formation and
tryptophan degradation in human peripheral blood mononuclear cells and in
monocytic cell lines.
Neurauter G, Wirleitner B, Laich A, Schennach H, Weiss G, Fuchs D.
Summary: Recent findings indicate that statins also have anti-inflammatory
properties and can modulate the immune response.statins inhibit T cell
activation within the cellular immune response.atorvastatin directly
inhibits IFN-gamma-mediated pathways in monocytic cells, suggesting that
both immunoreactivity of T cells and of monocyte-derived macrophages are
down-regulated by this statin.
Clin Exp Immunol 2003 Feb;131(2):264-7
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12562386&dopt=Abstract
A novel anti-inflammatory role for simvastatin in inflammatory arthritis.
Leung BP, Sattar N, Crilly A, Prach M, McCarey DW, Payne H, Madhok R,
Campbell C, Gracie JA, Liew FY, McInnes IB.
J Immunol. 2003 Feb 1;170(3):1524-30.
PMID: 12538717 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12538717&dopt=Abstract
Immunomodulation: a new role for statins?
Wulf Palinski
SUMMARY: Statins reduce the expression of the class II major
histocompatibility complex (MHCII) by arterial cells, leading to a decreased
T-cell response. This indicates that statins...
Nature Medicine6, 1311 - 1312 (01 Dec 2000) News and Views
HMG-CoA reductase inhibitors as immunomodulators: potential use in
transplant rejection.
Raggatt LJ, Partridge NC.
These findings suggest that statins have the potential to regulate an immune
response in vivo and that more investigation is essential in order to
explain the opposing clinical data.
Drugs. 2002;62(15):2185-91.
PMID: 12381218 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12381218&dopt=Abstract
Statins as a newly recognized type of immunomodulator
Brenda Kwak, Flore Mulhaupt, Samir Myit, François Mach
SUMMARY: Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)
reductase, or statins, are effective lipid-lowering agents, extensively used
in medical practice. Statins have never been shown to...
Nature Medicine 6, 1399 - 1402 (01 Dec 2000) Article
and could a depressed immune system lead to infection? See:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11936540&dopt=Abstract
Statin-induced fibrotic nonspecific interstitial pneumonia.
Eur Respir J. 2002 Mar;19(3):577-80.
PMID: 11936540 [PubMed - indexed for MEDLINE]
STATINS AND CANCER
Frequently Asked Question: What are the cancer rates for people on statins?
Despite the infomercial-type hype in recent press releases under titles
like, "Does Lipitor prevent cancer?" (note it is a question, not an
assertion), the numbers from recent studies tell the opposite story:
Statin use and the risk of breast cancer.
Beck P, Wysowski DK, Downey W, Butler-Jones D.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12725884&dopt=Abstract
J Clin Epidemiol. 2003 Mar;56(3):280-5.
PMID: 12725884 [PubMed - in process]
"Stratified analyses revealed increases in risk in short-term statin users
and statin users with long-term hormone replacement therapy (HRT) exposure."
The PROSPER Study (PROspective study of pravastatin in the elderly at risk)
[Article in French]
Kulbertus H, Scheen AJ.
Service de Diabetologie, Nutrition et Maladies metaboliques et deMedecine
Interne Generale, CHU Liege.
Rev Med Liege. 2002 Dec;57(12):809-13.
"New cancers were more frequent amongst pravastatin-treated individuals
(+25%; p = 0.020)."
Major Outcomes in Moderately Hypercholesterolemic, Hypertensive Patients
Randomized to Pravastatin vs Usual Care
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack
Trial (ALLHAT-LLT)
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12479764&dopt=Abstract
ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research
Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart
Attack Trial.
Deaths by cancer during the ALLHAT study: Pravastatin= 163; Usual Care= 148
6-year rate per 100 Participants: Pravastatin= 4.1; Usual Care= 3.7
ERECTILE DYSFUNCTION (ED) AND STATINS
Frequently Asked Question: Can statins interfere with my sex life?
Do lipid-lowering drugs cause erectile dysfunction? A systematic review.
Rizvi K, Hampson JP, Harvey JN.
University of Wales College of Medicine, Wrexham Academic Unit, Wrexham, UK.
Fam Pract. 2002 Feb;19(1):95-8. PMID: 11818357
BACKGROUND: Erectile dysfunction (ED) is common although under-reported by
patients. Along with the better known causes of ED, drug-induced impotence
needs to be considered as a cause of this symptom. Lipid-lowering drugs have
been prescribed increasingly. Their relationship to ED is controversial.
OBJECTIVES: Our aim was to clarify the relationship between lipid-lowering
therapy and ED. A secondary aim was to assess the value of the systematic
review procedure in the area of adverse drug reactions. METHODS: A
systematic review was carried out using computerized biomedical databases
and Internet sources. Terms denoting ED were linked with terms referring to
lipid-lowering drugs. Information was also sought from regulatory agencies.
RESULTS: A significant literature was identified, much from obscure sources,
which included case reports, review articles, and information from clinical
trials and from regulatory agencies. Information from all of these sources
identified fibrates as a source of ED. A substantial number of cases of ED
associated with statin usage have been reported to regulatory agencies. Case
reports and clinical trial evidence supported the suggestion that statins
can also cause ED. Some information on possible mechanisms was obtained, but
the mechanism remains uncertain. CONCLUSIONS: The systematic review
procedure was applied successfully to collect evidence suggesting that both
statins and fibrates may cause ED. More numerous reports to regulatory
agencies complemented more detailed information from case reports to provide
a new perspective on a common area of prescribing.
ERECTILE DYSFUNCTION AND STATIN THERAPY: INTERACTION WITH CARDIOVASCULAR
RISK FACTORS AND DRUG THERAPIES
H. Solomon1, J. Man1, Y.P. Samarasinghe2, M.D. Feher2, A.S. Wierzbicki3, G.
Jackson1
1Department of Cardiology, St. Thomas' Hospital, 2Beta Cell Diabetes Centre,
Chelsea & Westminster Hospital, 3Department of Chemical Pathology, St.
Thomas' Hospital, London UK
Erectile dysfunction has been associated with atherosclerotic risk factors
and drugs used in their treatment. This study investigated the relationship
of erectile function with cardiovascular risk factors and specific drug
therapies. International Index of Erectile Function (IIEF) scores measured
in 100 men attending cardiovascular risk clinics. Cardiovascular risk
factors and drug therapies were assessed prior to initation and after 6
months of statin therapy. Before statin therapy no correlation was observed
between IIEF score and any individual cardiovascular risk factor though
better scores were observed in patients on warfarin or angiotensin-II
receptor blocker therapy (r=0.42; p <0.001). After 6 months of statin
therapy, significant correlations were observed between lower IIEF scores
(r=0.62; P<0.001) and age, smoking, diabetes and usage of warfarin or
angiotensin-2 type 1 receptor blocker (ARB) therapy. Differences in dose,
relative efficacy or relative lipophilicity of statin prescribed showed no
correlation with change in IIEF score. This study suggests impotence
following statin therapy is likelier in patients with more severe
endothelial dysfunction due to established cardiovascular risk factors
including age, and smoking and diabetes. This is complicated by adverse
interactions between statin therapy and concomitant treatment with warfarin
or angiotensin-II type I receptor blockers.
http://www.kenes.com/73eas/program/abstracts/126.doc
Drug Information Center: Information on Statin Drugs
"On March 7, 2002, Colorado HealthSite interviewed Beatrice A. Golomb, MD,
PhD, principal investigator of a study on Statin Drugs by the National
Institutes of Health. Dr. Golomb noted that the most common problems
reported about statin drugs pertain to muscle pain or weakness, fatigue,
memory and cognitive problems, sleep problems, and neuropathy. Erectile
dysfunction, problems with temperature regulation (feeling hot or cold, or
having sweats) are among the other problems reported. "
http://www.coloradohealthsite.org/pharmacology/statins.html
"Question: What are the common complaints of patients who take statins?
Dr. Golomb: The most common problems we hear reported pertain to muscle pain
or weakness, fatigue, memory and cognitive problems, sleep problems, and
neuropathy. Erectile dysfunction, problems with temperature regulation
(feeling hot or cold, or having sweats), are among the other problems
reported. "
http://www.coloradohealthsite.org/topics/interviews/golomb.html
BBC News: Wednesday, 15 March, 2000, 19:02 GMT
Heart drug impotence warning
"Statins prevent heart attacks by reducing the levels of dangerous
cholesterol in the bloodstream.
However, a small number of men prescribed the life-saving drug have
complained that they are unable to achieve an erection."
"Dr John Harvey, from the Wrexham Maelor Hospital in Wales, identified 220
men who appeared to have lost their "virility" after starting to take
statins. "
http://news.bbc.co.uk/1/hi/health/678811.stm
LUPUS-LIKE SYMPTOMS AND STATINS
Frequently Asked Question: Can statins cause Lupus symptoms?
Drug-induced lupus-like syndrome associated with severe autoimmune
hepatitis.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12765306&dopt=Abstract
Graziadei IW, Obermoser GE, Sepp NT, Erhart KH, Vogel W.
Lupus. 2003;12(5):409-12.
PMID: 12765306 [PubMed - in process]
RHABDOMYOLYSIS AND STATINS
Frequently Asked Question: Which statins cause deadly Rhabdomyolysis?
All of them. See :
FDA adverse event reports on statin-associated rhabdomyolysis.
Omar MA, Wilson JP.
Ann Pharmacother. 2002 Feb;36(2):288-95. Review.
PMID: 11847951
Of 871 reports detailing 601 cases in a 29 month time frame, the list of
statin, number of cases, and percentage of the whole follows:
simvastatin, 215 (35.8%);
cerivastatin, 192 (31.9%);
atorvastatin, 73 (12.2%);
pravastatin, 71 (11.8%);
lovastatin, 40 (6.7%);
fluvastatin, 10 (1.7%)
As of August, 2001, there were at least 81rhabdomyolysis deaths associated
with Non-Baycol statins.
http://www.essentialdrugs.org/edrug/archive/200108/msg00064.php
The Public Citizen petition to the FDA, August 20,2001:
http://www.citizen.org/publications/release.cfm?ID=7051
At that time the count of deaths by statin-induced rhabdomyolysis:
Outcome
Number of Cases
Percent of Total Deaths
Deaths
Atorvastatin
13
18.1%
Cerivastatin
20
27.8%
Fluvastatin
1
1.4%
Lovastatin
5
6.9%
Pravastatin
9
12.5%
Simvastatin
24
33.3%
ELDERLY AND STATINS
Frequently Asked Question: Should people over 70 take statins?
Lack of association between cholesterol and coronary heart disease mortality
and morbidity and all-cause mortality in persons older than 70 years.
JAMA. 1994 Nov 2;272(17):1335-40.
Krumholz HM, Seeman TE, Merrill SS, Mendes de Leon CF, Vaccarino V,
Silverman DI, Tsukahara R, Ostfeld AM, Berkman LF.
Department of Internal Medicine, Yale University School of Medicine, New
Haven, CT 06520-8017.
"CONCLUSIONS--Our findings do not support the hypothesis that
hypercholesterolemia or low HDL-C are important risk factors for all-cause
mortality, coronary heart disease mortality, or hospitalization for
myocardial infarction or unstable angina in this cohort of persons older
than 70 years."
Another study showing people over 65 do not benefit from cholesterol
reduction:
Long-Term Prognostic Importance of Total Cholesterol in Elderly Survivors of
an Acute Myocardial Infarction: The Cooperative Cardiovascular Pilot
Project.
Foody JM, Wang Y, Kiefe CI, Ellerbeck EF, Gold J, Radford MJ, Krumholz HM.
Section of Cardiovascular Medicine, Department of Medicine, and Section of
Chronic Disease Epidemiology, Department of Epidemiology and Public Health,
Yale School of Medicine, New Haven, Connecticut; Qualidigm, Middletown,
Connecticut; Yale-New Haven Hospital Center for Outcomes Research and
Evaluation, New Haven, Connecticut; Center for Outcome and Effectiveness
Research and Education, University ofAlabama at Birmingham and Birmingham
Veterans Affairs Medical Center, Birmingham, Alabama; Department of
Preventive Medicine, University of Kansas School of Medicine, Kansas City,
Kansas; and Metastar, Madison, Wisconsin.
J Am Geriatr Soc. 2003 Jul;51(7):930-936. PMID: 12834512
"PARTICIPANTS: Four thousand nine hundred twenty-three Medicare
beneficiaries from four states aged 65 and older"
"CONCLUSION: Among elderly survivors of AMI, elevated total serum
cholesterol measured postinfarction is not associated with an increased risk
of all-cause mortality in the 6 years after discharge. Furthermore, this
study found no evidence of an increased risk of all-cause mortality in
patients with low total cholesterol. Further studies are needed to determine
the relationship of postinfarction lipid subfractions and mortality in older
patients with coronary artery disease (CAD)."
High-density vs low-density lipoprotein cholesterol as the risk factor for
coronary artery disease and stroke in old age.
Weverling-Rijnsburger AW, Jonkers IJ, van Exel E, Gussekloo J, Westendorp
RG.
Section of Gerontology and Geriatrics, Department of General Internal
Medicine, Leiden University Medical Center, Leiden, The Netherlands.
a.w.e.weverli...@lumc.edu
Arch Intern Med. 2003 Jul 14;163(13):1549-54.
"In contrast to high LDL cholesterol level, low HDL cholesterol level is a
risk factor for mortality from coronary artery disease and stroke in old
age."
Total cholesterol and risk of mortality in the oldest old.
Weverling-Rijnsburger AW, Blauw GJ, Lagaay AM, Knook DL, Meinders AE,
Westendorp RG.
Department of General Internal Medicine, Leiden University Medical Center,
The Netherlands.
Lancet. 1997 Oct 18;350(9085):1119-23.
" In people older than 85 years, high total cholesterol concentrations are
associated with longevity owing to lower mortality from cancer and
infection. The effects of cholesterol-lowering therapy have yet to be
assessed."
Do Medical Journals agree that there is bias in drug-industry funded medical
studies?
Yes, as does an observational study.
Association of Funding and Conclusions in Randomized Drug Trials
A Reflection of Treatment Effect or Adverse Events?
http://jama.ama-assn.org/cgi/content/abstract/290/7/921
Bodil Als-Nielsen, MD; Wendong Chen, MD; Christian Gluud, MD, DMSc; Lise L.
Kjaergard, MD
JAMA. 2003;290:921-928 Vol 290 No 7, August 20, 2003
"The experimental drug was recommended as treatment of choice in 16% of
trials funded by nonprofit organizations, 30% of trials not reporting
funding, 35% of trials funded by both nonprofit and for-profit
organizations, and 51% of trials funded by for-profit organizations (P<.001;
2 test). Logistic regression analyses indicated that funding, treatment
effect, and double blinding were the only significant predictors of
conclusions. Adjusted analyses showed that trials funded by for-profit
organizations were significantly more likely to recommend the experimental
drug as treatment of choice (odds ratio, 5.3; 95% confidence interval,
2.0-14.4) compared with trials funded by nonprofit organizations. This
association did not appear to reflect treatment effect or adverse events. "
"Conclusions Conclusions in trials funded by for-profit organizations may
be more positive due to biased interpretation of trial results. Readers
should carefully evaluate whether conclusions in randomized trials are
supported by data. "
"Author Affiliations: The Copenhagen Trial Unit, Center for Clinical
Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark."
Clearly JAMA came to the conclusion that funding biases the findings in
2002, when they quite publicly changed their editorial policy to require
funding information for studies they publish.
Further, you are invited to view the British Journal of Medicine, May 31,
2003 (Volume 326, Issue 7400), which has focused attention on bias and spin
in industry-sponsored studies. They carried the following articles at
http://bmj.com/content/vol326/issue7400/#TWIB :
Research sponsored by drug companies is biased
http://bmj.com/content/vol326/issue7400/twib.shtml#326/7400/0
No more free lunches
Kamran Abbasi and Richard Smith
BMJ 2003; 326: 1155-1156.
http://bmj.com/cgi/content/full/326/7400/1155 text
http://bmj.com/cgi/reprint/326/7400/1155 pdf
Drug company sponsorship of education could be replaced at a fraction of its
cost
http://bmj.com/cgi/content/full/326/7400/1163 text
http://bmj.com/cgi/reprint/326/7400/1163 pdf
Drug companies advised to publish unfavourable trial results
http://bmj.com/cgi/content/full/326/7400/1163-a text
http://bmj.com/cgi/reprint/326/7400/1163-a pdf
World body reviews doctors' links to drug industry
http://bmj.com/cgi/content/abridged/326/7400/1165-a abridged text
http://bmj.com/cgi/reprint_abr/326/7400/1165-a abridged pdf
http://bmj.com/cgi/content/full/326/7400/1165-a full text
Pharmaceutical industry sponsorship and research outcome and quality:
systematic review
Joel Lexchin, Lisa A Bero, Benjamin Djulbegovic, and Otavio Clark
BMJ 2003; 326: 1167-1170.
http://bmj.com/cgi/content/full/326/7400/1167 full text
http://bmj.com/cgi/reprint/326/7400/1167 pdf
Evidence b(i)ased medicine-selective reporting from studies sponsored by
pharmaceutical industry: review of studies in new drug applications
Hans Melander, Jane Ahlqvist-Rastad, Gertie Meijer, and Björn Beermann
BMJ 2003; 326: 1171-1173.
http://bmj.com/cgi/content/full/326/7400/1171 full text
http://bmj.com/cgi/reprint/326/7400/1171 pdf
Characteristics of general practitioners who frequently see drug industry
representatives: national cross sectional study
Chris Watkins, Laurence Moore, Ian Harvey, Patricia Carthy, Elizabeth
Robinson, and Richard Brawn
BMJ 2003; 326: 1178-1179.
http://bmj.com/cgi/content/full/326/7400/1178 full text
http://bmj.com/cgi/reprint/326/7400/1178 pdf
Who pays for the pizza? Redefining the relationships between doctors and
drug companies. 1: Entanglement
Ray Moynihan
BMJ 2003; 326: 1189-1192.
http://bmj.com/cgi/content/full/326/7400/1189 full text
http://bmj.com/cgi/reprint/326/7400/1189 pdf
Who pays for the pizza? Redefining the relationships between doctors and
drug companies. 2: Disentanglement
Ray Moynihan
BMJ 2003; 326: 1193-1196.
http://bmj.com/cgi/content/full/326/7400/1193 full text
http://bmj.com/cgi/reprint/326/7400/1193 pdf
How to dance with porcupines: rules and guidelines on doctors' relations
with drug companies
Elizabeth Wager
BMJ 2003; 326: 1196-1198.
http://bmj.com/cgi/content/full/326/7400/1196 full text
http://bmj.com/cgi/reprint/326/7400/1196 pdf
How can research ethics committees protect patients better?
Silvio Garattini, Vittorio Bertele, and Luca Li Bassi
BMJ 2003; 326: 1199-1201.
http://bmj.com/cgi/content/full/326/7400/1199 full text
http://bmj.com/cgi/reprint/326/7400/1199 pdf
Medical journals and pharmaceutical companies: uneasy bedfellows
Richard Smith
BMJ 2003; 326: 1202-1205.
http://bmj.com/cgi/content/full/326/7400/1202 text
http://bmj.com/cgi/reprint/326/7400/1202 pdf
Unhealthy spin
Bob Burton and Andy Rowell
BMJ 2003; 326: 1205-1207.
http://bmj.com/cgi/content/full/326/7400/1205 text
http://bmj.com/cgi/reprint/326/7400/1205 pdf
Relationships between the pharmaceutical industry and patients'
organisations
Andrew Herxheimer
BMJ 2003; 326: 1208-1210.
http://bmj.com/cgi/content/full/326/7400/1208 text
http://bmj.com/cgi/reprint/326/7400/1208 pdf
Journals should select drug advertisements more carefully
James J Oliver and Simon R Maxwell
BMJ 2003; 326: 1211. http://bmj.com/cgi/content/full/326/7400/1211
Charities and patient groups should declare interests
Jenny Hirst
BMJ 2003; 326: 1211.
http://bmj.com/cgi/content/full/326/7400/1211-a
Bioethics are difficult to balance
Asad J Raja
BMJ 2003; 326: 1215.
http://bmj.com/cgi/content/full/326/7400/1215-c
Then check out the astonishing articles on medical ghostwriting, starting at
http://www.cbc.ca/consumers/market/files/health/ghostwriting/index.html
It may inspire you to earn extra income, because it points out that a
Medical Ghostwriter can make $100,000 per year writing favorable drug
reports! YMMV
Difficult to question if there is bias in drug-industry studies after
reading the above.
"talkback" <tb...@yahoo.com> wrote in message
news:sxUYb.3275$9f5.2...@read2.cgocable.net...
Bill
> Muldoon MF, Barger SD, Ryan CM, Flory JD, Lehoczky JP, Matthews KA, Manuck
> SB.
> Effects of lovastatin on cognitive function and psychological well-being.
> After 6 months, 100% of the patients on placeboes showed a measurable
> increase in cognitive function, and 100% of the statin patients showed a
> measurable decrease in cognitive function.
> Am J Med. 2000 May;108(7):538-46.
> PMID: 10806282 [PubMed - indexed for MEDLINE]
>
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10806282&dopt=Abstract
>
>
Sharon, as I've pointed out to you before and which you have not disputed it
is simply untrue that this study showed 100% of statin users had a measurable
loss of cognitive ability.
Bill
talkback
> No. Sorry, you are wrong, no relations. Nor am I related to the people who
> have posted their problems from statin adverse effects on the following
> boards:
>
Isn't your husband suffering from this?
Just to confirm I checked one of the links you quoted, (and PLEASE-trim
your posts-this one runs to 12 pages!), and the key poits in the
abstract were "7 patients over 3 years", and the word MAY.
MAY MAY MAY MAY... not "conclusively provern to cause.
It would be more accurate to say that you MAY be an idiot and missing
the point.
talkback
>
> Sharon, as I've pointed out to you before and which you have not disputed it
> is simply untrue that this study showed 100% of statin users had a measurable
> loss of cognitive ability.
>
> Bill
>
>
Sharon, read Bill's post over and over until you get it!
talkback
>>>Talkback says "the personal element has been known to cloud one's
>>>objectivity"
>>>
>>>Yes it certainly has Talkback.
>>>
>>>Witness the May 2003 theme issue of the British Medical Journal which
>>>pointed out how a personal element ($$$) clouds the judgement of so
>>>many medical researchers who are in the pockets of the drug companies.
So what? I don't disagree with this. Why are you bringing this up in a
debate over the evidence of problems with long term Statin use?
>>>Too far back for you? How about the latest issue of the Canadian
>>>Medical Association Journal. Here. Let me help you...
>>>
>>>Time to Untangle Doctors from the Drug Companies
>>>http://bmj.bmjjournals.com/content/vol326/issue7400/
>>>
>>>Pro industry findings in randomized trials:
>>>Drug company experts advised staff to withhold data about SSRI use in
>>>children
>>>http://www.cmaj.ca/cgi/content/full/170/4/441
>>>
>>>There's more, but that'll do for starters. Personal element clouding
>>>one's judgement.
You are taking the whole thing out of context. The personal element I
was refering to was the posters desire to find cause and lay blame for a
close one's medical problems. THAT is what is clouding her judgement.
We all know that personl elements cloud many peoples judgement about a
myriad of things. You make no salient point with respect to this thread.
>
>>Before jumping into a thread
>
>
> Whoooooa! Where you been livin' man? Some ill-fated star orbiting
> Pluto? I've lived what this thread is about. This thread is about how
> statins cause the life-altering damage that Michael Hope, me, and
> hundreds of thousands of others have experienced. That number,
> incidentally, is by educated estimate of researchers and
> pharmaceutical companies (2 to 5 percent of total using statins) not
> uninformed psychotic internet posters with more time than brains.
Okay, Please show me a study that conclusively makes this connection and
I will read it and shut up. Please note, published papers with a
question mark in the title, or the words "may, seem to, apparently, etc.
do not cut it.
>
> Mrs Hope will stick to the facts. I'll get down and dirty.
All we are looking for is facts and empirical data. There are other
newsgroups and websites for your other interests.
Wanna
> dance....
I want to have a meaningful exchange of information and I'm very much
open to being convinced of your position on this statin issue if the
information out there supports it in a scientific manner.
> B'adant
talkback
Note: CAPITALS are mine, but exact.
When read with even a modicum of objectivity, it is clear that this
position is conjecture based on anecdotal observation.
European Journal of Clinical Pharmacology
Publisher: Springer-Verlag Heidelberg
ISSN: 0031-6970 (Paper) 1432-1041 (Online)
DOI: 10.1007/s002280050562
Issue: Volume 54, Number 11
Date: January 1999
Pages: 835 - 838
Statins and peripheral neuropathy
U. Jeppesen A2, D. Gaist , T. Smith A1, S. H. Sindrup
A1 Department of Neurology, Odense University Hospital, DK-5000 Odense
C, Denmark Tel.: +45-6541-2474, Fax: +45-6541-3389
A2 Department of Clinical Pharmacology Odense University, Odense, Denmark
Abstract:
Abstract Within the past 3 years SEVEN cases of REVERSIBLE peripheral
neuropathy APPARENTLY caused by statins have been reported. Here we
report SEVEN additional cases associated with long-term statin therapy,
in which other causes of neuropathy were thoroughly excluded. The
neuropathy was in all cases axonal and with affection of both thick and
thin nerve fibers. The symptoms of neuropathy persisted during an
observation period lasting from 10 weeks to 1 year in four cases after
statin treatment had been withdrawn. We SUGGEST that long-term statin
treatment MAY be associated with chronic peripheral neuropath
talkback
>
> The science of medical writing dictates that qualifying language be
> used. I don't write for a medical journal, so I don't have to follow
> those rules. You've been given citations: this is a case of leading a
> jackass to water, but not being able to make it drink.
>
> B'adant
I drink it in, but don't swallow it all.
Surely you must appreciate the difference between fact and
conjecture-however compelling the conjecture is? Even Einstiens
theories, while extremely compelling did not get past being just
theories until science was able to CONFIRM and QUANTIFY his ideas.
As for following rules, the less one knows about something the better it
is to stick to the rules that have been set down by people far more
knowedgeable than you or I. That is why the "drug whores" can't just say
that something is safe or works. It has to be proven scientifically to
the best of the ability of others (FDA) who, hopefully, have no interest
except to protect the public.
talkback
> You want to have a meaningful exchange?
>
> Your opening salvo in this topic was to call another poster a MORON,
> then you said "Enough of you. Too {STUPID} to talk to any more."
It wasn't my opening salvo, but yes, that poster appeared to be
intellectually incapable of logical discourse. Stupid and Moron are the
epithets I used when I was worked up about it. If you prefer I shall use
more delicate terminology.
>
> http://groups.google.ca/groups?q=g:thl1669454486d&dq=&hl=en&lr=&ie=UTF-8&oe=UTF-8&selm=kMNVb.1958%24Fp5.507%40read1.cgocable.net
>
> Today, you called Mrs. Hope "Hopeless".
Alas, I think it's true. She is hopelessly blinded by the desire to
shore up her contentions, and so seems to be unwilling to listen to
contrary opinions.
>
> I seriously doubt you want a 'meaningful' exchange. You're exhibiting
> one of the classics symptoms of lipitor toxicity. Read Dr. Beatrice
> Golomb's studies on statins and aggression on www.pubmed.org/toxnet.
> Or better yet, look for them around page four in Mrs. Hope's
> citation's list.
>
I tried to find it, but was redirected to the Entrez page and couldn't
find it there either. Please let me know if you can point me to the study.
> B'adant
talkback
Zee
Keep looking. Your mother doesn't work here.
B'adant
Sharon Hope
>
> >
> That is why the "drug whores" can't just say
> that something is safe or works. It has to be proven scientifically to
> the best of the ability of others (FDA) who, hopefully, have no interest
> except to protect the public.
Apparently you have not noticed the change in FDA's funding from public
funding to User Fees.
http://www.fda.gov/oc/pdufa/default.htm
Anything the FDA does to cut back on a pharmaceutical company's market share
results in a loss of budget for the FDA.
Ever wonder why Bayer voluntarily recalled Baycol? Ever wonder why the FDA
did NOT recall it?
Sharon Hope
"Bill" <x...@yy.zz> wrote in message
news:p8YYb.23428$vU6....@newssvr16.news.prodigy.com...
Bill,
Thanks, I do need to update that FAQ.
However, the full-text version does show ranges for the Statin and Placebo
groups. While I grant you that there are overlaps between the uppermost of
one group and the lowest of the other, the median and the overall group
placements are IN EVERY SINGLE MEASUREMENT lower in the statin group than
the placebo group. In more than one measurement the statin group range is
lower than the pre-statin test for the same group. In the other areas the
statin group thrived at half the rate of the placebo group. (similar to a
child graduating from the 6th grade reading 3rd grade level).
While it is possible to imagine that someone in each group scored on one
side of the group's median on pre test, and the other side on the post test,
the relationship of the statin/placebo score ranges hold true in every
cognitively category measured.
I still feel strongly that this is significant, as did the authors and the
journal publishing the study. That it was soft-pedaled in the abstract does
not detract from the findings.
Thanks again for the reminder that the summary overstates it by representing
the range as individual trends. Should be 100% of the ranges and medians,
not the individuals.
Thanks again,
Sharon
>
> Bill
>
>
Jonathan Smith
> talkback <tb...@yahoo.com> wrote in message news:<5mLYb.4593$Fp5...@read1.cgocable.net>...
> objectivity"
>
> Yes it certainly has Talkback.
>
> Witness the May 2003 theme issue of the British Medical Journal which
> pointed out how a personal element ($$$) clouds the judgement of so
> many medical researchers who are in the pockets of the drug companies.
The BMJ never said that it does. The BMJ arrticle suggests that there
is a possible publication bias - and clearly states that the quality
of the two sets of trials are equal.
> Too far back for you? How about the latest issue of the Canadian
> Medical Association Journal. Here. Let me help you...
>
> Time to Untangle Doctors from the Drug Companies
> http://bmj.bmjjournals.com/content/vol326/issue7400/
That isn't the CMAJ reference.
But, here's an point that the authors make that you should note:
"Our study may be influenced by selection bias, as we elected to
search only high-impact journals for trials."
Think about this from an editors perspective. Your goal is to publish
cutting edge new research. You get a choice between a very well done
large scale positive trial of a new therapy and a marginally done
small scale trial with inconclusive results. Which one do you
publish?
> Pro industry findings in randomized trials:
> Drug company experts advised staff to withhold data about SSRI use in
> children
> http://www.cmaj.ca/cgi/content/full/170/4/441
You might want to read the Hirsch commentary that is included in the
same edition of the journal.
> There's more, but that'll do for starters. Personal element clouding
> one's judgement.
There is no evidence that the preference for positive good data being
published is caused by funding sources. Some of the data suggest
there is an association between industry funding and results - so?
This makes the authors whores? I don't think so - but it makes you
look like an idiot.
> Drug whores I likes to call 'em. It's so succinct. So apt.
So what.
It's a shame you are challenged by data.
> So personal.
You sure made it personal.
> B'adant
Is that short for bad day mate?
js
talkback
> Keep looking. Your mother doesn't work here.
>
> B'adant
Thanks.
Obviously you are more interested in antagonizing me than providing any
help.
I shall reply to any new posts from this session, then no more.
talkback
So if the FDA is in bed with the pharma companies and, by association,
with the drug whores, we are all in big trouble.
Jonathan Smith
> "talkback" <tb...@yahoo.com> wrote in message
> news:EDdZb.4829$Fp5....@read1.cgocable.net...
> >
> > >
> > That is why the "drug whores" can't just say
> > that something is safe or works. It has to be proven scientifically to
> > the best of the ability of others (FDA) who, hopefully, have no interest
> > except to protect the public.
>
> Apparently you have not noticed the change in FDA's funding from public
> funding to User Fees.
>
> http://www.fda.gov/oc/pdufa/default.htm
>
> Anything the FDA does to cut back on a pharmaceutical company's market share
> results in a loss of budget for the FDA.
What a load of crap, Sharon. The user fees are charged to the
applicant. User fees are not paid at approval, they are paid at
application. Review timerlines is the guarantee - not approval.
> Ever wonder why Bayer voluntarily recalled Baycol?
Bayer did not recall Baycol. Bayer discontinued marketing Baycol.
Only FDA can initiate a recall action.
> Ever wonder why the FDA
> did NOT recall it?
There was no need - Bayer exercised it's right to withdraw its
marketing application.
Ever wonder why Sharon posts nonsense?
js
list...@nospam.net
Again, I'm having deja vu all over again.
Ms. Hope is hopeless and this thread is hopeless. Round and round we
go and they refuse to listen to any arguement.
list...@nospam.net
Smith) wrote:
>zwal...@yahoo.com (Zee) wrote in message news:<e5f4a9c2.04021...@posting.google.com>...
>> talkback <tb...@yahoo.com> wrote in message news:<5mLYb.4593$Fp5...@read1.cgocable.net>...
>It's a shame you are challenged by data.
>
How succinct.
list...@nospam.net
wrote:
>
>"Bill" <x...@yy.zz> wrote in message
>news:p8YYb.23428$vU6....@newssvr16.news.prodigy.com...
>>
>> "Sharon Hope" <sh...@anet.net> wrote in message
>> news:z2XYb.9616$Xp.69948@attbi_s54...
>> > Muldoon MF, Barger SD, Ryan CM, Flory JD, Lehoczky JP, Matthews KA,
>Manuck
>> > SB.
>> > Effects of lovastatin on cognitive function and psychological
>well-being.
>> > After 6 months, 100% of the patients on placeboes showed a measurable
>> > increase in cognitive function, and 100% of the statin patients showed a
>> > measurable decrease in cognitive function.
>> > Am J Med. 2000 May;108(7):538-46.
>> > PMID: 10806282 [PubMed - indexed for MEDLINE]
>> >
>>
>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10806282&dopt=Abstract
>> >
>> >
>>
>> Sharon, as I've pointed out to you before and which you have not disputed
>it
>> is simply untrue that this study showed 100% of statin users had a
>measurable
>> loss of cognitive ability.
>
>Bill,
>Thanks, I do need to update that FAQ.
Yea! Finally, a (timid) concession.
>However, the full-text version does show ranges for the Statin and Placebo
>groups. While I grant you that there are overlaps between the uppermost of
>one group and the lowest of the other, the median and the overall group
>placements are IN EVERY SINGLE MEASUREMENT lower in the statin group than
>the placebo group. In more than one measurement the statin group range is
>lower than the pre-statin test for the same group. In the other areas the
>statin group thrived at half the rate of the placebo group. (similar to a
>child graduating from the 6th grade reading 3rd grade level).
>
>While it is possible to imagine that someone in each group scored on one
>side of the group's median on pre test, and the other side on the post test,
>the relationship of the statin/placebo score ranges hold true in every
>cognitively category measured.
>
>I still feel strongly that this is significant, as did the authors and the
>journal publishing the study. That it was soft-pedaled in the abstract does
>not detract from the findings.
>
>Thanks again for the reminder that the summary overstates it by representing
>the range as individual trends. Should be 100% of the ranges and medians,
>not the individuals.
Oh, well. Back to the drawing board.
>Thanks again,
>Sharon
>
>>
>> Bill
>>
>>
>
talkback
>>>Sharon, as I've pointed out to you before and which you have not disputed
>>
>>it
>>
>>>is simply untrue that this study showed 100% of statin users had a
>>
>>measurable
>>
>>>loss of cognitive ability.
>>
>>Bill,
>>Thanks, I do need to update that FAQ.
Never mind updates. Just get your facts straight.
>
>
> Yea! Finally, a (timid) concession.
>
gs.
>>
>>Thanks again for the reminder that the summary overstates it by representing
>>the range as individual trends. Should be 100% of the ranges and medians,
>>not the individuals.
>
>
> Oh, well. Back to the drawing board.
>>>Bill
It's unbelievable. She seems to think that her "handled" presentation of
the informaton and games of symantics are going to overcome the lack of
data, evidence, proof, logic, etc.
Truly pathetic.
Sharon Hope
Direct these comments to the journal that published them.
talkback
>>
>>It's unbelievable. She seems to think that her "handled" presentation of
>>the informaton and games of symantics are going to overcome the lack of
>>data, evidence, proof, logic, etc.
>>Truly pathetic.
>
>
> Direct these comments to the journal that published them.
>
>
Read the post. I said "SHE (you) sem to think HER". These comments are
directed AT YOU not any journal.
If you read the journals like you read these posts it's no wonder you
screw up the facts so badly.
You are clearly, irrefuteably, suffering from some serious mental
problem. YOU NEED HELP. Or just go join the Flat World Society and put
in your 2 cents about how all the images of a round earth are an ongoing
conspiracy.
Jonathan Smith
> jonatha...@yahoo.com (Jonathan Smith) wrote in message news:<fbcaefd.04022...@posting.google.com>...
> > > Talkback says "the personal element has been known to cloud one's
> > > objectivity"
> > >
> > > Yes it certainly has Talkback.
> > >
> > > Witness the May 2003 theme issue of the British Medical Journal which
> > > pointed out how a personal element ($$$) clouds the judgement of so
> > > many medical researchers who are in the pockets of the drug companies.
> >
> > The BMJ never said that it does. The BMJ arrticle suggests that there
> > is a possible publication bias - and clearly states that the quality
> > of the two sets of trials are equal.
> >
> > > Too far back for you? How about the latest issue of the Canadian
> > > Medical Association Journal. Here. Let me help you...
> > >
> > > Time to Untangle Doctors from the Drug Companies
> > > http://bmj.bmjjournals.com/content/vol326/issue7400/
> >
> > That isn't the CMAJ reference.
> >
> > But, here's an point that the authors make that you should note:
> >
> > "Our study may be influenced by selection bias, as we elected to
> > search only high-impact journals for trials."
>
>
> Jonathon Smith said:
> The BMJ never said that it does. The BMJ arrticle suggests that there
> is a possible publication bias - and clearly states that the quality
> of the two sets of trials are equal.
>
> http://bmj.bmjjournals.com/content/vol326/issue7400/#CHOICE
> "Research sponsored by drug companies is biased"
YOU said this:
"Witness the May 2003 theme issue of the British Medical Journal which
pointed out how a personal element ($$$) clouds the judgement of so
many medical researchers who are in the pockets of the drug
companies."
And BMJ didn't say it.
> There is much more
> than one article at this url. It is a THEME issue.
>
> And here is another article on the theme of drug companies influencing
> study outcome--just because it's Le Weekend.
>
> http://bmj.bmjjournals.com/cgi/content/full/327/7429/1442?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=1&author1=sackett&andorexacttitle=and&andorexacttitleabs=and&andorexactfulltext=and&searchid=1077316477406_9894&stored_search=&FIRSTINDEX=0&sortspec=relevance&resourcetype=1,2,3,4
>
> Drug company experts advised staff to withhold data about SSRI use in
> children
> http://www.cmaj.ca/
Have you read these articles? I have.
The authors present associations between content and funding source.
You make the leap that it is nefarious and that the authors sell there
souls. You make the leap that the associations prove that the big bad
drug companies are that - big and bad. You make the leap that these
associations prove that these researchers lack any integrity, have no
ethics, and will do anything for their industry dollars.
That is a bunch of unsupported inflammatory crap. And the worst part
is, you don't get it.
> Salut
> B'adant
Don't put words in peoples mouths. Remember, your statement wasn't
that there is bias in what is and isn't published or that there is an
association between good articles funded by industry - it was that
"...personal element ($$$) clouds the judgement of so many medical
researchers who are in the pockets of the drug companies."
You want to come to these conclusions, that's your prerogative - but
don't post that the BMJ concluded it.
js
list...@nospam.net
I warned you that the Crusaders Against the Use of Statins were not
interested in give-and-take discussion. Not one of them. Their minds
are completely shut to any opposing view, no matter how valid.
Feel free to continue but, sadly, you'd have better luck engaging a
brick wall.
list...@nospam.net
Smith) wrote:
As I've said to "talkback", there's just no way to rationally discuss
the pros and cons of statins with the Crusaders Against the Use of
Statins. Their minds are made up, their positions clear.
Watch how they reply to you. It's become very predictable.
talkback
> I warned you that the Crusaders Against the Use of Statins were not
> interested in give-and-take discussion. Not one of them. Their minds
> are completely shut to any opposing view, no matter how valid.
>
> Feel free to continue but, sadly, you'd have better luck engaging a
> brick wall.
No, I'm done. I wish you had told me this way back. Had I known that
Sharon Hope(less) was a close minded moron I would have disengaged long
ago. What a waste of time. It's like spending half an hour talking to
someone who nods and says yes-then you find out they don't understand
the language you are speaking.
talkback
> As I've said to "talkback", there's just no way to rationally discuss
> the pros and cons of statins with the Crusaders Against the Use of
> Statins. Their minds are made up, their positions clear.
>
> Watch how they reply to you. It's become very predictable.
Reminds me of the Randi expose of homeopathetic "medecine". Video tapes
clearly show them agreeing to the methodology and techniques used by the
independent testers to try and prove that the water had retained some
memory (or whatever the claim is going on). They were present and
observed the tests from begining to end. Then when the results showed
nothing, they maintened (exactly as Randi predicted), that the tests
were not done properly, blah blah blah.