You are correct in that people should not put so much blind faith in
doctors; but, they do and too few know better.

Pantethine doesn't.

 In Susan's

That was my point. Yet more than one doc continues to insist on treating
her LDL.

 (I'm not sure what she means by an atoxic

I posted the abstracts from Medline.  The term "atoxic" was used in one
of them.  I guess a supplement that works better than a statin with no
harm to those on dialysis or those with hepatitis qualifies for the term.

She never would've in her earlier years.  The elderly often become sadly
compliant and substitute their doc's judgment for their own.  From a
distance, I hadn't realized how much she'd slipped til she mentioned she
'd been put on Crestor after all of this trouble, and took it!  She was
peeing blood and feeling very weak at the time.

Yes, you've been fortunate.  It happens more the other way, IME first as
a health program operator, then as a chronically ill patient.  I think
docs are mostly ignorant about the drugs they rx, and dismissive of what
pharma reps tell them to be.

Susan

listener <listener@nospam.net> wrote in part:

By "right on the money" I didn't mean that Susan was necessarily
right in everything she said, or that you and she would agree. I
meant that she wrote an anti-statin post that was constructive and
entirely appropriate for this group. Zee and Sharon write such
posts as well.

(I do think she was right on the money in her comments, too, with
one possible quibble.)
--
Jim Chinnis   Warrenton, Virginia, USA

The effects all drugs (not just statins) have on seniors is very
poorly understood my most physicians.  First of all most if not all
seniors taker much more medication than youger people.  So there is a
much greater chance and probability of combinations of drugs that
should not be taken together due to interactions, vitamins and over
the counter stuff included.  Add to that is the fact that regular
adult doses are usually too high or much too high for most seniors who
metabolize more slowly and thus have higher concentrations of these
drugs in their blood and for longer periods of time.  Then there is
the likelyhood that seniors are being treated by several specialists
and that they may not know the complete drug consumption profile of
their patients and also may not be that well versed in interactions of
all of the drugs their patients take, especially the ones they didn't
prescribe.

Also is is highly unlikely that most seniors are followed by geriatric
specialists  as their primary physician, doctors who may actually be
able to sort through a complicated drug profile and modify it to the
senior's needs.  

I firmly believe that in today's health care environment you
practically have to be your own doctor or your
parent's/friend's/children's doctor and research the hell out of
everything that is being tested for, prescribed, diagnosed, etc.
Don't hesitate to get 2nd and even 3rd opinions.

The one good thing about the information revolution is that now you
have access to sophisticated medical information that was previously
unavailable to the layman.  

Conversly there is as much disinformation as there is vaild
information so it is all to easy to be misled.

You still need to rely on a physician for their experience, knowledge,
training, etc. It gets really tough when you are trying to look after
a parent and they live in another city or you just do not have the
time to go to all their appointments with them, etc.  Plus a lot of
parent's don't want to be micro managed by their children even if it
might be of significant help.

We went through plenty with both my parents and even though my sister
is a doctor, in many aspects I was able to advance their care more
than her.  She had the knowledge, contacts and experience, but I could
push and prod more than she could.  Plus she had almost no spare time
due to her heavy work load.

My 2 cents.

I meant how long ago did it start? If it was 3 years ago, the Drs. involved
should be sued for malpractice. At that time the need for CK testing and
muscle problems associated with statins were very well known. I think it was
even in public news by then. Drs. have an obligation to keep up by going to
conferences etc.

If they seriously harm a patient by 1. not knowing the side effects of a drug
they prescribe and 2. not doing the appropriate blood tests after prescribing
that drug, they should be held accountable.

Bill

Susan, please be aware that the statins are proven to cause measurable
cognitive damage, detectable by NP testing after only 6 months of use.  Left
to continue, the result can be short-term memory loss, confusion, and
transient global amnesia.

Also, the doctor should be formally requested to make statin adverse effects
reports to both the FDA and the UCSD Statin study.  (sample request at the
end of this message)  References below that.

To my physician,

I believe that my symptoms may be due to the adverse effects associated with
cholesterol-lowering statin drugs.  I need your help to understand the cause
of my symptoms, treatment options, and the prognosis for my recovery.

Please review the references below, published medical studies that show
similar problems associated with statin drugs.  These are made available via
the National Institutes of Health (NIH, http://www.ncbi.nlm.nih.gov/Entrez/)
library of biomedical journal citations and other major repositories of
medical research.

Also, I am respectfully requesting that you file an adverse effects report
with the FDA (http://www.fda.gov/medwatch/how.htm), and that you please send
a copy of the report to the to the NIH-funded Statin Study, attention: Dr.
Beatrice Golomb, Principal Investigator.
Statin Study website: http://medicine.ucsd.edu/statin/
Statin Study contact info: http://medicine.ucsd.edu/statin/contactinfo.html
UCSD STATIN STUDY E-MAIL ADDRESS: statinstudy@ucsd.edu
MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995
PHONE NUMBER: (858) 558-4950

Thank you

MEMORY LOSS & STATINS, AMNESIA & STATINS

References (updated as of  January 7, 2005):

Randomized trial of the effects of simvastatin on cognitive functioning in
hypercholesterolemic adults.Am J Med. 2004 Dec 1;117(11):823-9. Muldoon MF,
Ryan CM, Sereika SM, Flory JD, Manuck SB.Center for Clinical Pharmacology,
University of Pittsburgh, Pennsylvania 15260, USA. mfm10@pitt.edu"This study
provides partial support for minor decrements in cognitive functioning with
statins. Whether such effects have any long-term sequelae or occur with
other cholesterol-lowering interventions is not known." This is the second
of two studies by Muldoon, both showing measurable cognitive decline in
statin groups after only 6 months, using Neuropsychological (NP) testing.
Further, this study identifies the subset of NP tests that are "statin
sensitive" in detecting the cognitive deficits.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra
ct&list_uids=15589485

Effects of lovastatin on cognitive function and psychological well-being.

Muldoon MF, Barger SD, Ryan CM, Flory JD, Lehoczky JP, Matthews KA, Manuck
SB.
After 6 months, 100% of the patients on placeboes showed a measurable
increase in cognitive function, while the statin patients showed a
measurable decrease in cognitive function in some areas.
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=1
0806282&dopt=Abstract

Cognitive impairment associated with atorvastatin and simvastatin.King DS,
Wilburn AJ, Wofford MR, Harrell TK, Lindley BJ, Jones DW.Department of
Medicine, University of Mississippi Medical Center, Jackson, Mississippi
39216, USA. dking@pharmacy.umsmed.eduPharmacotherapy. 2003
Dec;23(12):1663-7. "we report two women who experienced significant
cognitive impairment temporally related to statin therapy. One woman took
atorvastatin, and the other first took atorvastatin, then was rechallenged
with simvastatin. Clinicians should be aware of cognitive impairment and
dementia as potential adverse effects associated with statin therapy."
PMID: 14695047
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra
ct&list_uids=14695047

"DRUGS THAT MAKE YOU FORGET"
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

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.

Abstract:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
2885101&dopt=Abstract

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:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
2820814&dopt=Abstract

Full Study Text free on Medscape:

http://www.medscape.com/viewarticle/456866

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=PXke2H8h99pyNVSCajAh5
clptzOAHJSZuNBobSwWmi9veWjdJ2A3%7C-1468812056489609316/184161392/6/7001/7001/700
2/7002/7001/-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/ADR
Month%209-01htm.html

Do HMG-CoA reductase inhibitors impair memory?
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:

AMNESIA & STATINS

Lipitor, Thief of Memory

Dr. Duane Graveline, retired family MD, USAF Flight Surgeon, researcher in
space medicine and US Astronaut, who suffered adverse effects from Lipitor.
The book is available through Amazon.com.  Dr. Graveline maintains several
websites and is working on a second book about statin drug side effects:
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

===========

Please see also:

Mechanistic and epidemiologic considerations in the evaluation of adverse
birth outcomes following gestational exposure to statins.Am J Med Genet.
2004 Dec 15;131A(3):287-98. Edison RJ, Muenke M.Medical Genetics Branch,
National Human Genome Research Institute, National Institutes of Health,
Department of Health and Human Services, Bethesda,Maryland 20892-3717, USA."The
cholesterol-lowering "statin" drugs are contraindicated in pregnancy, but
few data exist on their safety in human gestation. We reviewed case reports
for patterns suggesting drug-related effects on prenatal development and
considered a variety of mechanisms by which such effects, if confirmed,
might occur. This uncontrolled case series included all FDA reports of
statin exposures during gestation, as well as others from the literature and
from manufacturers. Exposures and outcomes were reviewed and were tabulated
by individual drug. Age-specific rates of exposure to each drug among women
of child-bearing age were estimated. Of 214 ascertained pregnancy exposures,
70 evaluable reports remained after excluding uninformative cases. Among 31
adverse outcomes were 22 cases with structural defects, 4 cases of
intrauterine growth restriction, and 5 cases of fetal demise. There were two
principal categories of recurrent structural defects: cerivastatin and
lovastatin were a_ssociated with four reports of severe midline CNS defects;
simvastatin, lovastatin, and atorvastatin were all a_ssociated with reports
of limb deficiencies, including two similar complex lower limb defects
reported following simvastatin exposure. There were also two cases of
VACTERL a_ssociation among the limb deficiency cases. All adverse outcomes
were reported following exposure to cerivastatin, simvastatin, lovastatin,
or atorvastatin, which are lipophilic and equilibrate between maternal and
embryonic compartments. None were reported following exposure to
pravastatin, which is minimally present in the embryo. Statins reaching the
embryo may down-regulate biosynthesis of cholesterol as well as many
important metabolic intermediates, and may have secondary effects on
sterol-dependent morphogens such as Sonic Hedgehog. The reported cases
display patterns consistent with dysfunction of cholesterol biosynthesis and
Sonic Hedgehog activity. Controlled studies are needed to investigate the
teratogenicity of individual drugs in this cla_ss."PMID: 15546153 [PubMed -
in process]

Statins and risk of polyneuropathy, A case-control study
D. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L.A. Garc?a
Rodr?guez, 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=9
737641&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=8
864188&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.