Hardly.  The post is from the wife of a man who went from corporate CEO to
totally disabled on Lipitor 10mg for 4 years.  At 54 he was scoring below
the 1 percentile in short term memory.  This book represents an opportunity
for getting the word out to prevent this in others' loved ones.  (His story,
along with other patients who were damaged, was detailed in Smart Money
Magazine last November.)

Two years off the drug he is still in constant pain.  Over fifty two tests
and appointments the first year. Two years of weekly cognitive
rehabilitation therapy with very small but promising gains - enough to rule
out every other cause.

For the families of the patients experiencing these side effects, their
world is destroyed - personally, as well as financially.  Worse, they find
out, as we did, that there is no research into finding a treatment for
recovery.  Not to mention the fact that it could have been prevented, if
only the doctors were to associate the memory loss with the Lipitor earlier
in the decline.  Australia's drug administration published in 1998 that
statins are associated with memory loss.  The FDA has yet to issue a
warning, despite many published studies showing neurotoxicity and memory
loss:

Check the facts:

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.

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

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=1
0806282&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=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

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. 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.

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. 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

Are users of lipid-lowering drugs at increased risk of peripheral
neuropathy?
David Gaist, Luis Alberto Garc?a Rodr?guez ? Consuelo Huerta ? Jesper Hallas
? S?ren 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 Garc?a Rodr?guez ? Consuelo Huerta ? Jesper Hallas
? S?ren 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=1
2549960&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. jbackes@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=1
2639733&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.
gnrlyl@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=7
745415&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=7
484806&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=8
172444&dopt=Abstract

Medication-induced peripheral neuropathy.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
2507417&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. Lhw1@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