Lipitor, Jarvik and Statin Drugs by Jeffrey Dach MD

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Mar 19, 2008, 7:44:03 PM3/19/08
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Original Article can be found here:

http://jeffreydach.com/2007/05/14/lipitor-and-the-dracula-of-modern-technology-by-jeffrey-dach-md.aspx

Perhaps you have seen the Direct-to-Consumer TV and print
advertisements with Robert Jarvik, the inventor of the Jarvik Heart,
speaking on behalf of the Pfizer's anti-cholesterol drug, Lipitor.
With 13 billion dollars in sales last year, Lipitor was the best
selling statin drug, the best selling drug in the world, and most
prescribed drug in the U.S.

Jarvik is best known from the media circus surrounding the 1982
implantation of his Jarvik-7 into the Seattle dentist, Barney Clark.
Although the artificial heart continued to beat, Barney died of multi-
organ failure 112 days after the operation, tethered to a dishwasher
sized air compressor. The heart device acted as a blender which
chewed up the blood cells. Recipients of the Jarvik-7 suffered
horribly for months, finally succumbing to infections, strokes,
convulsions and immune system failure with progressive decline in T
cells, thus making the Jarvik-7 another cause of HIV negative AIDS. (1)
(2)

During the ensuing media coverage, the New York Times dubbed the
Jarvik Heart the "Dracula of Medical Technology" (link). (3)(4)
Jarvik-7 patients had the Kevorkian option of assisted suicide, a
small on-off button which allowed the mechanical heart to be stopped
when too unbearable. About 90 people received the Jarvik heart before
it was banned. The FDA recently approved a revised mechanical heart
September 5, 2006 for heart transplant candidates, intended for
temporary humanitarian use to prolong the terminal patient while
awaiting a suitable donor.(5)

Why would Pfizer select an MD like Jarvik as spokesman for their
Direct to Consumer (DTC) campaign? Jarvik himself doesn't have the
strongest of professional credentials, and apparently had difficulty
gaining admission to a US medical school. Instead, he enrolled for
the first two years at the University of Bologna in Italy, later
returning for the MD degree at the University of Utah.(6) Jarvik never
did an internship or residency, and never actually practiced
medicine. And the heart device had been invented by somebody else,
Paul Winchell, the ventriloquist, who assigned the patent to the
University.(7) Why does Jarvik's "Dracula of Medical Technology" make
him an expert on statin drugs? Eight controlled clinical trials have
shown that statin drugs cause Coenzyme Q10 depletion by inhibition of
HMG-CoA reductase, which is the rate limiting step in cholesterol and
Coenzyme Q-10 biosynthesis.(8) Coenzyme Q10 serves in the
mitochondria as an electron carrier to cytochrome oxidase, the major
system for cellular energy production. Heart muscle requires high
levels of Co-Q10. Side effects of Co-Q10 deficiency include muscle
wasting, muscle pain, heart failure, neuropathy, amnesia, and
cognitive dysfunction.(9) Deaths from heart failure have doubled
nationwide since the introduction of statin drugs in 1987. (10) Statin
induced heart failure can be prevented by supplementing with Co Enzyme
Q10, a form of intervention considerably less expensive and less
traumatic than an artificial heart operation followed by cardiac
transplantation.

Perhaps Jarvik is not the best choice for the Lipitor campaign which
has had mixed reviews.(11) Instead of Jarvik, a more convincing yet
unlikely spokesman would be the popular Duane Graveline MD MPH, a
former NASA astronaut, and author who was started on Lipitor during an
annual astronaut physical at the Johnson Space Center, and 6 weeks
later had an episode of transient global amnesia, a sudden form of
total memory loss described in his book.(12)(13) Graveline points
out that 50 percent of the dry weight of the cerebral cortex is made
of cholesterol, an important substance for memory and cerebral
function.

Graveline also points out that statins are useful for secondary
prevention of heart disease in patients with significant pre-existing
coronary artery disease (link), however the benefit is independent of
cholesterol response during statin use. (14) Contrary to the secondary
prevention findings, no statin primary prevention study has ever shown
a benefit in terms of all cause mortality in healthy men and women
with only an elevated serum cholesterol, and no known coronary artery
disease (link). Patients with known heart disease are customarily
placed on statin drugs by the medical system with no need for direct
to consumer (DTC) advertising to this group. DTC ads for Lipitor are
clearly directed at the larger group of untreated primary prevention
patients, for which there is no benefit in terms of all cause
mortality.(15)

The J-Lit study actually showed higher mortality at the lowest serum
cholesterol (both total and LDL-C), a paradox called the J-Shaped
Curve.(16) The highest mortality was found at the lowest total
cholesterol of 160 mg/dl, and lowest mortality at serum cholesterol
around 240 mg /ml, exactly the opposite one would expect if
cholesterol lowering was beneficial for health. The authors state
that the increased mortality at the lower cholesterol levels was due
to increased cancer. Another statin trial, CARE (Cholesterol And
Recurrent Events), showed 1500 % increase in breast cancer among women
in the statin treated group, explained as merely a statistical
aberration.(17) This is disputed by Uffe Ravnskov who feels that the
difference is significant, and points to rodent studies showing statin
drugs cause cancer in animals.(18)(19)

The Honolulu Heart Study of elderly patients showed the lowest serum
cholesterol predicted the highest mortality.(20) A study by Krumholz
found lack of association between cholesterol and coronary heart
disease mortality and morbidity in persons older than 70 years.(21)
Jenkins (BMJ) states that no statin drug study has ever shown an all
cause mortality benefit for women.(22)

The Jarvik-Lipitor ad campaign is a perfect example of why
prescription drug ads are dishonest, do not promote public health,
increase unnecessary prescriptions, increase costs to taxpayers, and
can be harmful or deadly to patients. New Zealand and the US are the
only two industrialized nations to allow direct-to-consumer
advertising for prescription drugs. Here in the USA, thirty nine
public interest groups have proposed congressional legislation to ban
DTC prescription drug ads.(23)(24)

Two more unlikely spokesmen for the Lipitor ad campaign include Mary
Enig and Uffe Ravnskov. Should either one be selected as Lipitor
spokesman, I myself would run down to the corner drug store to buy up
the drug. It seems unlikey that even Pfizer's deep pockets could ever
induce them to recant their opposing position on the cholesterol
theory of heart disease. Mary G. Enig writes, "hypercholesterolemia
is the health issue of the 21st century. It is actually an invented
disease, a problem that emerged when health professionals learned how
to measure cholesterol levels in the blood.(25) Uffe Ravnskov MD PhD,
who can easily be regarded as the "Duesberg" of the Lipid Hypothesis,
is spokesman for Thincs, The International Network of Cholesterol
Skeptics, and author of "The Cholesterol Myths, Exposing the Fallacy
That Saturated Fat and Cholesterol Cause Heart Disease". His
controversial ideas have angered loyal cholesterol theory supporters
in Finland who demonstrated by burning his book on live television.
(26)

Last week I paid a condolence call to a dear friend who just lost her
mom to Alzheimer's. Our kids have grown up together and we shared
family events for the last 15 years. A few months ago, during one
such occasion, the conversation touched on her mom's mental decline in
a nursing home, and I mentioned that sometimes treatment for B12
deficiency or hypothyroidism can help. They had already tried that to
no avail. During the condolence call, we chatted about her mom's life
and the reason for the cognitive decline. Apparently, her mom had
been taking Lipitor for 15 years, and her daughter recalled in painful
detail the initial episodes of transient global amnesia, followed by
progressive dementia, and death attributed in retrospect to the drug.
How many demented nursing home patients will suffer from the adverse
side effects of statin drugs? We will never know. People
experiencing adverse side effects from statin drugs may share their
experiences in discussion groups. (27) One such group has 3800
messages.(28)

regards from,

Jeffrey Dach MD
4700 Sheridan Suite T
Holywood Florida 33021
954-983-1443

disclaimer http://www.drdach.com/wst_page20.html


References

(1) http://www.ncbi.nlm.nih.gov/pubmed/3261735?dopt=Abstract
Wellhausen SR, Ward RA, Johnson GS, DeVries WC.
Immunologic complications of long-term implantation of a total
artificial heart.
J Clin Immunol. 1988 Jul;8(4):307-18. PMID: 3261735


Bacterial infections are a significant complication of long-term total
artificial heart implantation. We evaluated the functional
capabilities of host defense mechanisms in two patients sustained long-
term by a total artificial heart. Although serum complement and
polymorphonuclear leukocyte function remained intact, both patients
became B and T lymphopenic and there was an initial decrease in the
ratio of helper/inducer to suppressor/cytotoxic cells. Histologic
examination of their lymphoidal tissue at autopsy further revealed
reduced numbers of germinal centers and atrophy of the T lymphocyte-
dependent areas. In addition, the reticuloendothelial system was
engorged with degenerate erythrocytes. We hypothesize that blockade of
the reticuloendothelial system was induced by multiple blood
transfusions necessitated by device-associated hemolysis and
coagulopathy. This blockade may have led to a progressive loss of
content of the antigen-specific lymphoidal elements and, perhaps, to a
reduced ability to ingest microbe-antibody complexes.


(2) http://www.ncbi.nlm.nih.gov/pubmed/3566584?dopt=AbstractPlus

Stelzer GT, Ward RA, Wellhausen SR, McLeish KR, Johnson GS, DeVries
WC.
Alterations in select immunologic parameters following total
artificial heart implantation. Artif Organs. 1987 Feb;11(1):52-62.

We examined select immunologic parameters in three recipients of a
total artificial heart and correlated changes with the clinical
course. Two patients remain alive and were studied for 320 and 240
days, respectively; the third died 10 days after implantation. All
patients demonstrated transient complement activation immediately
postoperatively, as indicated by an increase in plasma levels of C3a
des Arg. In the two long-term survivors, C3a des Arg levels again
increased, concomitant with intravascular hemolysis associated with
high blood shear rates imposed by the drive system of the heart. All
three patients had a marked lymphopenia immediately postoperatively,
and the two long-term survivors demonstrated marked fluctuations in
total lymphocyte count. There was a progressive decline in the number
of peripheral blood helper/inducer T cells in the two long-term
survivors. A large number of activated (HLA-DR positive) suppressor/
cytotoxic T cells were also noted in these two patients. A progressive
decrease in B cells was also observed; however, total IgG and IgM
levels were not decreased. No changes in neutrophil phagocytic or
respiratory burst capacities were identified. The cause of these
changes in lymphocyte populations is not clear; however, they may have
impact on the use of this device as a bridge to transplantation and
may lead to decreased immunocompetence during long-term use.

(3) http://query.nytimes.com/gst/fullpage.html?res=940DE7DB143CF935A25756C0A96E948260
The Dracula of Medical Technology Published: May 16, 1988 New York
Times, The Federal project to create an implantable artificial heart
is dead. During its 24-year life this Dracula of a program sucked $240
million out of the National Heart, Lung and Blood Institute. At long
last, the institute has found the resolve to drive a stake through its
voracious creation. ''The human body just couldn't seem to tolerate
it,'' explains Claude


(4) www.time.com/time/magazine/article/0,9171,44039,00.html
Time Magazine, Reviving Artificial Hearts Sunday, Apr. 30, 2000 By
MICHAEL D. LEMONICK

Nobody has talked much about artificial hearts in recent years, and no
wonder. It took Washington dentist Barney Clark 112 miserable days to
die after being fitted with the Jarvik-7 heart back in 1982--four
months of suffering that included convulsions, kidney failure,
respiratory problems, a wandering mind and, finally, multi-organ
system failure. In the aftermath of that debacle, the New York Times
nicknamed artificial-heart research the "Dracula of Medical
Technology."

(5) http://www.fda.gov/bbs/topics/NEWS/2006/NEW01443.html
FDA Approves First Totally Implanted Permanent Artificial Heart for
Humanitarian Uses P06-125 September 5, 2006

(6) http://www.bookrags.com/biography/robert-k-jarvik-woh/
Robert K. Jarvik Biography, Jarvik began premedical course work and
graduated in 1968 with a bachelor's degree in zoology. His immediate
plans were stalled when mediocre grades prevented him from acceptance
into an American medical school. As an alternative, he attended
medical school at the University of Bologna in Italy. After two years
he returned to the United States to pursue a degree in occupational
biomechanics at New York University, receiving an M.A. in 1971.

(7) http://www.paulwinchell.com/artificialheart.htm
Paul Winchell's story, inventing and patenting the first artificial
heart.

(8) http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-02-Exhibit_A-vol1.pdf

The clinical use of HMG CoA-reductase inhibitors (statins) and the
associated depletion of the essential co-factor coenzyme Qlo; a review
of
pertinent human and animal data. BY Peter H. Langsjoen, M.D., F.A.c.c.

(9) http://www.tga.gov.au/adr/aadrb/aadr0504.htm
Australian Adverse Drug Reactions Bulletin Volume 24, Number 2, April
2005, ADRAC has received 281 reports of peripheral neuropathy or
symptoms consistent with this diagnosis attributed to statins (see
Table), and first highlighted this association in 1993.1 Thirteen of
the 281 cases were confirmed by nerve conduction studies. Both sensory
and mixed sensorimotor peripheral neuropathies were reported. The time
to onset ranged from one dose to 4.5 years.

(10) http://library.thinkquest.org/27533/facts.html
September 1996, National Heart, Lung, and Blood Institute, National
Institutes of Health NIH,Data Fact Sheet,

Congestive Heart Failure in the United States: A New Epidemic,

An estimated 4.8 million Americans have congestive heart failure
(CHF). Increasing prevalence, hospitalizations, and deaths have made
CHF a major chronic condition in the United States. It often is the
end stage of cardiac disease. Half of the patients diagnosed with CHF
will be dead within 5 years. Each year, there are an estimated 400,000
new cases. The annual number of deaths directly from CHF increased
from 10,000 in 1968 to 42,000 in 1993 (figure 1), with another 219,000
related to the condition.
CHF is the first-listed diagnosis in 875,000 hospitalizations, and the
most common diagnosis in hospital patients age 65 years and older. In
that age group, one fifth of all hospitalizations have a primary or
secondary diagnosis of heart failure.

(11) http://www.msnbc.msn.com/id/16039753/
Is this celebrity doctor's TV ad right for you?
Despite past failures, Dr. Robert Jarvik succeeds hawking statin drug
Lipitor
By Robert Bazell, Chief science and health correspondent, NBC News,
March. 1, 2007

(12) http://www.spacedoc.net/
Duane Graveline MD SpaceDoc,Statin Drug Side Effects, Transient Global
Amnesia

(13) http://www.spacedoc.net/lipitor_thief_of_memory.html
Lipitor Thief of Memory, the Book by Duane Graveline MD

(14) http://www.ncbi.nlm.nih.gov/pubmed/12446061?dopt=AbstractPlus
Allen Maycock CA, Muhlestein JB, Horne BD, Carlquist JF, Bair TL,
Pearson RR, Li Q, Anderson JL; Intermountain Heart Collaborative
Study.
Statin therapy is associated with reduced mortality across all age
groups of individuals with significant coronary disease, including
very elderly patients.
J Am Coll Cardiol. 2002 Nov 20;40(10):1777-85.

(15) http://www.cmaj.ca/cgi/content/full/173/10/1207-a
CMAJ * November 8, 2005; 173 (10). Letters, Questioning the benefits
of statins, Eddie Vos* and Colin P. Rose, *Sutton, Que.; Cardiologist,
McGill University, Montréal, Que.

(16) http://www.jstage.jst.go.jp/article/circj/66/12/1096/_pdf
J-Lit Study, Large Scale Cohort Study of the Relationship Between
Serum Cholesterol Concentration and Coronary Events With Low-Dose
Simvastatin Therapy
in Japanese Patients With Hypercholesterolemia and Coronary Heart
Disease Secondary Prevention Cohort Study of the Japan Lipid
Intervention Trial (J-LIT)

(17) http://www.annals.org/cgi/content/full/131/2/155-b
Cholesterol Lowering in Older Patients Sandra J. Lewis, MD; Frank
Sacks, MD; and Eugene Braunwald, MD 20 July 1999 | Volume 131 Issue 2
| Pages 155-156

(18) http://www.thincs.org/unpublic.UR3.htm
Uffe Ravnskov, MD, PhD, Letter to the editor of Lancet, sent 10.
December 2002, Evidence that statin treatment causes cancer

(19) http://www.ncbi.nlm.nih.gov/pubmed/8531288?dopt=Abstract
Newman TB, Hulley SB. Carcinogenicity of lipid-lowering drugs. JAMA.
1996 Jan 3;275(1):55-60. Review.

(20) http://www.ncbi.nlm.nih.gov/pubmed/11502313?dopt=AbstractPlus
Schatz IJ, Masaki K, Yano K, Chen R, Rodriguez BL, Curb JD.
Cholesterol and all-cause mortality in elderly people from the
Honolulu Heart Program: a cohort study. Lancet. 2001 Aug 4;358(9279):
351-5.

BACKGROUND: A generally held belief is that cholesterol concentrations
should be kept low to lessen the risk of cardiovascular disease.
However, studies of the relation between serum cholesterol and all-
cause mortality in elderly people have shown contrasting results. To
investigate these discrepancies, we did a longitudinal assessment of
changes in both lipid and serum cholesterol concentrations over 20
years, and compared them with mortality.

METHODS: Lipid and serum cholesterol concentrations were measured in
3572 Japanese/American men (aged 71-93 years) as part of the Honolulu
Heart Program. We compared changes in these concentrations over 20
years with all-cause mortality using three different Cox proportional
hazards models.

FINDINGS: Mean cholesterol fell significantly with increasing age. Age-
adjusted mortality rates were 68.3, 48.9, 41.1, and 43.3 for the first
to fourth quartiles of cholesterol concentrations, respectively.
Relative risks for mortality were 0.72 (95% CI 0.60-0.87), 0.60
(0.49-0.74), and 0.65 (0.53-0.80), in the second, third, and fourth
quartiles, respectively, with quartile 1 as reference. A Cox
proportional hazard model assessed changes in cholesterol
concentrations between examinations three and four. Only the group
with low cholesterol concentration at both examinations had a
significant association with mortality (risk ratio 1.64, 95% CI
1.13-2.36).

INTERPRETATION: We have been unable to explain our results. These data
cast doubt on the scientific justification for lowering cholesterol to
very low concentrations (<4.65 mmol/L) in elderly people.


(21) http://jama.ama-assn.org/cgi/content/abstract/272/17/1335?ijkey=d2fe4b0874ba7917

Lack of association between cholesterol and coronary heart disease
mortality and morbidity and all-cause mortality in persons older than
70 years
H. M. Krumholz, T. E. Seeman, S. S. Merrill, C. F. Mendes de Leon, V.
Vaccarino, D. I. Silverman, R. Tsukahara, A. M. Ostfeld and L. F.
Berkman
Department of Internal Medicine, Yale University School of Medicine,
New Haven, CT 06520-8017.

OBJECTIVES--To determine whether elevated serum cholesterol level is
associated with all-cause mortality, mortality from coronary heart
disease, or hospitalization for acute myocardial infarction and
unstable angina in persons older than 70 years. Also, to evaluate the
association between low levels of high-density lipoprotein cholesterol
(HDL-C) and elevated ratio of serum cholesterol to HDL-C with these
outcomes.
DESIGN--Prospective, community-based cohort study with yearly
interviews.
PARTICIPANTS--A total of 997 subjects who were interviewed in 1988 as
part of the New Haven, Conn, cohort of the Established Population for
the Epidemiologic Study of the Elderly (EPESE) and consented to have
blood drawn. MAIN OUTCOME MEASURES--The risk factor-adjusted odds
ratios of the 4-year incidence of all-cause mortality, mortality from
coronary heart disease, and hospitalization for myocardial infarction
or unstable angina were calculated for the following: subjects with
total serum cholesterol levels greater than or equal to 6.20 mmol/L (>
or = 240 mg/dL) compared with subjects with cholesterol levels less
than 5.20 mmol/L (< 200 mg/dL); subjects in the lowest tertile of HDL-
C level compared with those in the highest tertile; and subjects in
the highest tertile of the ratio of total serum cholesterol to HDL-C
level compared with those in the lowest tertile.

RESULTS--Elevated total serum cholesterol level, low HDL-C, and high
total serum cholesterol to HDL-C ratio were not associated with a
significantly higher rate of all-cause mortality, coronary heart
disease mortality, or hospitalization for myocardial infarction or
unstable angina after adjustment for cardiovascular risk factors. The
risk factor-adjusted odds ratio for all-cause mortality was 0.99 (95%
confidence interval [CI], 0.56 to 2.69) for the group who had
cholesterol levels greater than or equal to 6.20 mmol/L (> or = 240 mg/
dL) compared with the group that had levels less than 5.20 mmol/L (<
200 mg/dL); 1.00 (95% CI, 0.59 to 1.70) for the group in the lowest
tertile of HDL-C compared with those in the highest tertile; and 1.03
(95% CK, 0.62 to 1.71) for subjects in the highest tertile of the
ratio of total serum cholesterol to HDL-C compared with those in the
lowest tertile.

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.

(22) http://www.bmj.com/cgi/content/full/327/7420/933-b
BMJ 2003;327:933 (18 October), Letter Might money spent on statins be
better spent? Arnold J Jenkins

I have yet to find a paper showing a significant reduction in
mortality in women for groups treated with statins. It therefore seems
that any benefit, if found, will be minimal. Yet we are almost
compelled by protocols such as the national service framework for
coronary heart disease4 and local prescribing incentives to prescribe
for this subgroup.

(23)
http://www.commercialalert.org/news/news-releases/2006/05/39-health-seniors-groups-call-on-congress-to-end-to-dtc-prescription-drug-ads

39 Health & Seniors Groups Call on Congress to End to DTC Prescription
Drug Ads Thirty-nine medical, health and seniors' organizations are
urging Congress to stop the advertising of prescription drugs to
consumers, Commercial Alert and the National Women's Health Network
announced today.

"Prescription drug ads are dishonest and dangerous," said Gary Ruskin,
executive director of Commercial Alert. "They hype the benefits and
cloak the risks of prescription drugs."

As Robert A. Schoellhorn, former chairman of Abbott Laboratories
warned more than two decades ago, "We believe direct advertising to
the consumer introduces a very real possibility of causing harm to
patients who may respond to advertisements by pressuring physicians to
prescribe medications that may not be required."

(24) http://www.commercialalert.org/phpa.pdf
Public Health Protection Act. We call on Congress to enact the Public
Health Protection Act to prohibit direct-to-consumer marketing of
prescription drugs. Background: In 2004, pharmaceutical companies
spent more than $4 billion in advertising for prescription drugs. This
advertising does not promote public health. It increases the cost of
drugs and the number of unnecessary prescriptions, which is expensive
to taxpayers, and can be harmful or deadly to patients.Provision 1:
Direct-to-consumer advertisements of prescription drugs are
prohibited, including "reminder advertisements," and "help-seeking
advertisements" that direct people to websites that are intended to
promote the sale of particular prescription drugs.

(25) http://www.westonaprice.org/moderndiseases/statin.html
Dangers of Statin Drugs: What You Haven't Been Told About Popular
Cholesterol-Lowering Medicines By Sally Fallon and Mary G. Enig, PhD
Hypercholesterolemia is the health issue of the 21st century. It is
actually an invented disease, a "problem" that emerged when health
professionals learned how to measure cholesterol levels in the blood.

(26) http://www.ravnskov.nu/uffe.htm
The Cholesterol Myths by Uffe Ravnskov, MD, PhD

(27) http://search.yahoo.com/search?p=lipitor+message+boards&fr=yfp-t-501&toggle=1&cop=mss&ei=UTF-8
Message Boards for Statins

(28) http://mb.rxlist.com/rxboard/lipitor.pl?
Lipitor Message Board, adverse events

(29) qjmed.oxfordjournals.org/cgi/content/full/96/12/927
Q J Med 2003; 96: 927-934; High cholesterol may protect against
infections and atherosclerosis U. Ravnskov I

Original Article can be found here:

http://jeffreydach.com/2007/05/14/lipitor-and-the-dracula-of-modern-technology-by-jeffrey-dach-md.aspx


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