P A A C T , I N C .
P R O S T A T E C A N C E R C O M M U N I C A T I O N N E W S L E T T E R • V O L U M E 2 2 , N U M B E R 1 • M a r c h 2 0 0 6
FOUNDER: LLOYD J. NEY, SR. – FOUNDED 1984
VACCINE FOR PROSTATE CANCER President and Chairperson: Board of Directors: Shortcomings of current prostate cancer treatment
Roughly 30-40% of patients who initially present with prostate cancer con-fined to the prostate gland will experience cancer recurrence. Many of
these patients will receive drugs that suppress the release of testosterone
and other male hormones, since starving prostate cancer cells of circulating
Peter Noor Jr. Richard H. Profit Jr.
male hormones can delay the growth and spread of prostate cancer. Hor-
monal therapy is often begun when an increase in prostate specific antigen(PSA) is observed after therapy for cancer confined to the prostate. How-ever, hormone suppression therapy does not cure prostate cancer. Prostate
Honorary Board Members:
cancers become resistant to this therapy within 1-2 years, and there is no
effective therapy for patients who have failed hormone suppression therapy
following a return of prostate cancer after primary therapy. There is a needfor additional therapies that improve the control of prostate cancer that re-mains confined to the prostate region, and for cancer that metastasizes be-
Medical Advisory Board:
Richard J. Ablin, Ph.D. V. Elayne Arterbery, M.D. Background of vaccine therapy for cancer
The immune system is the body's natural defense system against disease.
Immune system manipulation as a therapeutic approach for cancerous tu-
mors was first considered when it was observed that some human tumors
Michael J. Dattoli, M.D. Fernand Labrie, M.D. Fred Lee Sr. M.D.
All cells have unique proteins or protein components on their surface called
antigens. Many cancer cells produce cancer-specific antigens. The goal of
using cancer antigens as a vaccine is to teach the immune system to recog-
nize the cancer-specific antigens and to reject any cells with those antigens.
Gary M. Onik, M.D. Haakon Ragde, M.D.
The antigens activate white blood cells called B lymphocytes (B cells) and
T lymphocytes (T cells). B cells produce antibodies that recognize and bind
to a specific antigen to destroy the cancer cell. T cells that recognize a par-
ticular antigen can attack and kill cancer cells. Vaccines can also use the
patient's own dendritic cells (white blood cells that activate the immune
system) to connect antigens to the body's killer cells (T-cells). Let’s Conquer Cancer in OUR Lifetime
Cancer involves uncontrolled abnormal cell growth.
cer, is appealing as a therapeutic direction because
The immune system is mostly unable to differentiate
the prostate gland is not essential for survival, which
between cancer cells and normal cells. The inability
makes the proteins expressed in normal and cancer-
to recognize cancer cells as foreign, stems from the
ous prostate gland cells suitable targets for immune
fact that cancer cells are cells that were at one time
response. Additionally, a large number of genes and
normal. Cancer vaccines facilitate the immune sys-
proteins with specific or preferential expression in the
tem to overcome its tolerance of cancer cells so that it
prostate gland and in prostate cancer have been iden-
can recognize them as invading antigens and attack
tified. Agents called promoters that control the ex-
them. This is accomplished by injecting a preparation
pression of these genes have been identified and
of inactivated cancer cells, or proteins unique to the
cloned. Another reason prostate cancer is well-suited
as a target for vaccine therapy is the availability ofserum PSA as a marker of therapy effectiveness. Prostate cancer vaccine Background
PSA is normally present in small amounts in men
Therapeutic vaccines, which include prostate cancer
who are free of prostate cancer, and PSA levels rise
vaccines, are used to treat conditions that have al-
when prostate cancer develops. Patients have been
ready occurred. The premise of prostate cancer vac-
shown to mount T-cell responses to PSA. Some
cine is to induce the immune system to recognize tu-
prostate cancer vaccines use genetically modified vi-
mor-associated antigens displayed on human malig-
ruses that contain PSA. The patient is injected with
nancies and to direct cytotoxic responses to these tar-
the virus, the immune system responds to the virus
and becomes sensitized to cancer cells containingPSA, and the sensitized immune system then destroys
Immunotherapy, or vaccine therapy for prostate can-
Page1. Vaccine for Prostate Cancer (V Elayne Arterbery,CANCER COMMUNICATON Published Quarterly by: PAACT, Inc.
Patient Advocates for Advanced Cancer Treatments
5. Maximum Surveillance with Minimal Interven-
Director…Richard Profit
tion: Who to Treat, When to Treat, How to Treat. Editor….Richard Profit/Molly Meyers
The Role of Monitoring Tools (Israel Barken, M.D.)Assistant….Molly Meyers Webmaster….Art Schlefstein
8. Prostate Cancer and Diet (Charles E Myers Jr.,Postmaster: Send address changes to: Prostate Cancer Communication P.O. Box 141695 Grand Rapids, MI 49514
10. Complete Remissions are Important (Charles EMyers Jr., M.D.)Phone: 616/453-1477 Fax: 616/453-1846
11. Prostate Cancer and BPH (Dr. Bruce West)E-Mail: [email protected] PAACT Web Page: http://www.paactusa.org Newsletter: http://www.paactusa.org
14. Get Treatment for Cancer-Related Depression
15. LAC-PAACT Update (Gregory H Teufel, Esq.)Articles authored by other than the editor may not fully reflect the views of the corporation but are printed with the under- standing that the patient has the right to make his own interpretation
15. What the Heck Has Been Going on in My World
of the efficacy of the information provided.
– Part X (Mark A Moyad, M.D., M.P.H.)In an effort to conserve space and be able to insert as much material as possible in the newsletter, references from various articles are intentionally omitted. If you would like to obtain those references, please contact PAACT, we keep all of the original articles and the references used on file.
22. Prostate & Kidney Cancer Symposium
Types of prostate cancer vaccines
sensitized to the protein, and then reinfused into the
Whole cell vaccines
Whole-cell vaccines potentially use all the antigensfound on the tumor cells. The cancer cells come
Prostvac
from the patient or from laboratory-derived human
Other prostate cancer vaccines use genetically modi-
tumor cell lines. The cells are inactivated and then re-
fied viruses that contain PSA. The patient is injected
injected back into the patient. Whole-cell vaccines
with the virus, which sensitizes the immune system to
modify the tumor cells to express an immune-
cancer cells containing PSA, and then the immune
activating agent. GVAX (Cell Genysys) is an exam-
system destroys the cancerous cells. In addition to
PSA, PROSTVAC-VF also incorporates TRICOM,Therion Biologics proprietary compound of
Antigen-specific vaccines
costimulatory molecules designed to enhance the an-
Invading viruses or bacteria produce protein frag-
tigen presentation and activation of immune re-
ments, or antigens that trigger immune system attacks
sponses essential for the tumor destruction.
and antigen-specific vaccines are designed to targettissue-specific proteins such as the antigen. Several
The two components of Prostvac vaccine are the
prostate-specific proteins have been used as targets
"priming vaccine," made from vaccinia virus, and the
for prostate cancer vaccines, including prostate-
“booster,” made from fowlpox virus.
specific antigen (PSA), prostatic acid phosphatase(PAP), and prostate-specific membrane antigen
(PSMA). Other delivery approaches include cancer-
GVAX® (Cell Genesys) immunotherapy is com-
associated carbohydrate vaccines, which target car-
prised of two prostate cancer cell lines genetically
bohydrates preferentially expressed in prostate can-
modified to secrete granulocyte-macrophage colony
cer; viral vaccines, which elicit powerful T cell re-
stimulating factor (GM-CSF), a hormone that stimu-
sponses and include the vaccine Prostvac; peptide-
lates immune response to cancer cells, and then irra-
based vaccines; and plasmid DNA-based vaccines.
diated for safety. The goal of GVAX is to stimulate asystemic immune response against the patient's pros-
Tumors are skillful at suppressing immune response
tate cancer, destroying prostate cancer cells that per-
and evading recognition, but dendritic cells represent
sist or recur following surgery, hormone or radiation
a way to bypass a tumor’s natural defenses. Den-
therapy. GVAX uses inactivated prostate cancer cell
dritic cells activate T cells by locating antigens and
directing T cells to them. One strategy used in anti-gen-specific vaccines is to increase the number of
What patients are candidates for prostate cancer
dendritic cells in a vaccine, to trigger a correspond-
vaccine?
ingly robust T-cell response. Dendritic cells can be
Most prostate cancer vaccines are currently tested on
removed from the patient, and then infused back into
patients whose cancers are growing or spreading, and
the patient to induce a specific antitumor response
are no longer responsive to hormone therapy (some-
after being loaded with tumor antigens.
times referred to as androgen independent prostate
Specific Prostate Cancer Vaccines Provenge Provenge (Dendreon) combines a synthetic version of
Generally speaking, patients with weakened or com-
prostatic acid phosphatase (PAP), a protein on the
promised immune systems are not candidates for
surface of most prostate cancer cells, with dendritic
prostate cancer vaccine therapy, because they don’t
cells removed from the patient. This preparation is
have the ability to generate the necessary immune
designed to break the patient's immune tolerance to
system response. Patients who have the following
conditions are not considered suitable candidates forprostate cancer vaccines:
Provenge is designed to stimulate the immune system
to attack the 95% of prostate cancer cells that gener-
ate PAP. A patient's own immune cells are collected,
• Current use of topical or systemic steroids such asprednisone
• Autoimmune disorder such as Grave’s disease or
Future outlook for prostate cancer vaccine:
The growing body of evidence strongly supports on-
• History or current eczema or similar skin condition
going and future research and development of pros-
tate cancer vaccine. New discoveries and refinement
of current practice will increase the effectiveness ofprostate cancer vaccine. An example of this is the
Timing of prostate cancer vaccine:
discovery that mature dendritic cells are more effec-
Vaccine therapy is best administered early in the
tive in stimulating T cell response than the immature
course of recurrent prostate cancer for maximum
ones used until recently. There is evidence that ra-
likelihood of extending survival and improving qual-
diotherapy can elicit an immune response, and re-
ity of life. The ideal time to receive the vaccine is
search combining vaccine therapy with radiation
right after hormonal therapy begins to control tumor
spread, when immune cells outnumber cancerousones. It is believed that vaccines stand a better chance
A major limiting factor in the effectiveness of pros-
of getting T-cells to respond after most of the tumor
tate cancer vaccine is the stubborn immune system
tolerance displayed by many advanced tumors. Cur-rent and future research is expected to make progress
Effectiveness of prostate cancer vaccine:
For the most part, trials of prostate cancer vaccinespublished to date have not been designed to assess
Another possible application of prostate cancer vac-
effectiveness in terms of freedom from cancer pro-
cine is in cancer prevention, which is justified by the
gression and overall length of patient survival. In-
large proportion of cancer that is hereditary.
stead, many have focused on the number of patientswho exhibit a full or partial response to the vaccine
Gale Armstrong 1939-2005
therapy, adding to the growing body of evidence thatprostate cancer is a feasible target for immunologic
A very dear and special friend of PAACT’s, and per-
manipulation. There are many unknown variables
sonally of Rick Profit’s, for the past 35 years has
related to prostate cancer vaccine treatment; re-
passed away from Cancer. This man was very spe-
searchers are still learning about the optimal level of
cial in many ways and deserves mentioning to our
immune response needed to mediate cancerous tumor
There are very few people that I can honestly say
Safety of prostate cancer vaccine:
have held special meaning to me in my life, Gale
Prostate cancer vaccines generate a benign side effect
Armstrong being one of those very special people. I
profile and are generally well tolerated because they
cannot begin to mention the love and affection that
are designed to target only the cancer cells and spare
Gale and his family have bestowed upon my life
healthy ones. Also, no dose-limiting toxicity has
without shedding tears. The reason for delaying the
been observed among the many clinical trials con-
eulogy was because Gale’s family always includes an
update along with their Christmas card. Availability of prostate cancer vaccine:
When I take a moment to stop and think of Gale,
Prostate cancer vaccines are experimental; none have
there are a few special times that stand out to me. I
been licensed for marketing in the U.S. by the Food
have been married for twenty nine years come this
June and I can still remember what Gale and Carolgave us on our wedding day. There is also a little
At this time, vaccines are only available through en-
saying that Gale never let me forget, “You do not
rollment in clinical trials. According to the National
need luck, you make your own.” It is unfortunate
Cancer Institute, less than 3 percent of U.S. adults
with this job that you become so close to cancer pa-
with cancer participate in clinical trials; thus, patients
tients and then they eventually move on to their eter-
should be encouraged to participate in such trials if
If at this time anyone is considering making a dona-
Gale is at peace, the Peace which passes all earthly
tion to PAACT, we would like to encourage you to
understanding. We will miss him, but we rejoice in
do so as a memorial on behalf of Mr. Gale Armstrong
his blessed Eternity. Dr. James Wagenaar
and those who have passed before him.
My father overcame many obstacles in his life; a
Gale Armstrong, 65, passed away on February 16,
birth defect, uncaring parents, and poverty. He was
2005 after a two year battle with cancer. At his fu-
able to overcome them by his intelligence and his
neral, two statements were read; one written by his
drive to succeed, but most importantly by his charm.
son-in-law James Wagenaar, and one by his son,
When he turned it on, he could talk the devil into set-
ting himself on fire. It wasn’t charm that could lightup a room. Instead it was an easy grace that made the
Every one needs a Gale Armstrong in their life. A
recipient feel both important and respected. While
man who was a confidante, advisor, and friend. Gale
achieving great success in life, he never met anyone
learned from his humble beginnings, early hardships,
he considered superior to him; he also never met
and personal struggles how to handle any situation.
anyone he considered inferior. He could talk to kings
Gale was one of the wisest men I have had the pleas-
and convicts; business moguls and busboys with
ure to know. He could discuss philosophy, history,
equal magnanimity. He was also generous of his
religion, politics, or any topic with the command of a
time and money to those causes he saw fit and to
college professor. Gale was a man of vision and
those people who needed it the most. I believe he
dreams. Some of us dream, but Gale acted on his
will be remembered the most for his sage wisdom
dreams. He wasn’t afraid of failure or adversities
and his advice. Blessed with the ability to view all
that may arise while chasing your aspirations. Gale
sides of an issue but with the unerring eye to see the
best possible path that a person should take; his council will be sorely missed. Dean
Gale loved family. As I went through the photo-graphs and memories, I realized that there were few
Maximum Surveillance with Minimum Interven-
photographs that didn’t have five or six of us in them. tion: Who to Treat, When to Treat, How to Treat.
There were photographs of everyone; in the kitchen,
The Role of Monitoring Tools.
taking hikes, out on a boat, on the beach, playing
cards, around the Christmas tree, or somewhere ex-
otic Gale had heard about for families.
Prostate Cancer Research and Education Foundation
Gale worked side by side with his wife and family for
many years. There are not many families that can
work around each other so much without conflict andstrife separating them. Gale kept the peace, made it
If all treatment options offered to a patient with
better, and solved the problems. When we had issues
prostate cancer were easy, most patients perhaps
with wives, children, grandchildren or siblings; Gale
would have chosen one instead of waiting. Most of
could counsel us through our differences.
us prefer to take action because action cures fear.
His love for his wife was the kind that great romantic
The diagnosis of cancer instills immediate and over-
novelists write about. Gale would speak of Carol
whelming fear. What will the cancer do if I don’t do
with misty eyes, like a teenager speaking of his first
anything is one of the first thoughts in the patient’s
love. Carol was Gale’s everything. She made his life
mind. Since most treatment options are not palatable
complete. Carol made Gale the caliber of man that
to the patient and perhaps not everybody needs to be
treated, it’s no wonder strategies were developed toavoid treatment if at all possible.
Gale knew nothing of the designation of father-in-law, stepfather, or grandfather. He was a father to us
When a patient faces the task of making a decision,
all. He loved us with inspiration from the Heavenly
the following factors are weighed: the extent of the
father. The greatness of a man is reflected in the sor-
disease, the aggressiveness of the disease, biological
row of those left behind. Our sorrow is immense.
age - as defined by the patient’s general health, and
the personal preferences of the patient - defined by
Clinical stage, Gleason Grade, and PSA. These ini-
his attitude towards uncertainties in relation to gain
tial nomograms tried to predict the pathological
findings after radical prostatectomy. The nomogramsexpanded into other stages of disease like recurrent
There are three historical eras related to watchful
disease after primary local therapy. Some of them
waiting as a treatment for prostate cancer. These eras
tried to predict success of treatments like the Katan
were shaped by the availability of monitoring tech-
Nomograms predicting recurrent disease after radia-
nology. The newer monitoring tools affected both
tion. The PSA also pushed Watchful Waiting into
the use of watchful waiting as a primary treatment
other stages of disease such as biochemical failure
and the type of secondary treatment that followed.
and hormone refractory disease. In both of thesescenarios, there are no symptoms to alert us, but there
is evidence of progression. Therefore, patients in
these stages can utilize the same monitoring tool of
Watchful Waiting. You can see from this how
3. The Post PSA era (Tumor markers and so-
Watchful Waiting extended its impact on all stages of
disease once the PSA era was in full swing. Pre-PSA Era: Historically, prior to the days of Tumor Markers and the Era of Sophisticated Im-
PSA, “Watchful Waiting” was coined to denote
aging: We were and are overlapping this period with
avoiding any primary local treatment of the prostate.
the PSA period because some of the new monitoring
In reality, however, many patients chose Watchful
tools were available at the same time that the PSA
Waiting because of their fear of making a decision
became available. We are now developing a better
and the desire to avoid distressing side effects. Given
understanding of the molecular basis of diseases.
the paucity of monitoring tools to follow the patient,
Because of that, more attention is given to the mole-
Watchful Waiting was a very passive approach.
cules related to prostate cancer and these are the tu-
What the follow up consisted of was the reporting of
mor markers. There are many new tumor markers.
symptoms by the patient, periodic physical examina-
Most of them are used as research tools, but some of
tions and minimal blood testing by the physician.
them are available commercially which means they
These tools were very limited compared to the new
have been used “off the shelf” for patients who
monitoring tools we have today. The treatment of
wanted more aggressive monitoring. Here are some
choice when progression of disease became apparent
of the names of the new tumor markers in the blood
was hormonal blockade. Primary treatment was not
and in the pathological tissue: CGA, NSE, CEA,
available as a choice since the tools of monitoring
IGF-1, BCL-2, P53 TGF-B1 & Il6SR, Thymosin B-
were not sophisticated enough to catch the disease
while it was local only. The Pre-PSA era was typi-cally a “cat is out of the bag” story; by the time we
Other developments based on molecular understand-
realized the disease was progressing, it was no longer
ing have enriched our monitoring capabilities. Func-
tional imaging such as spectroscopic MRI is a primeexample. PSA Era: The PSA was introduced in the mid 1980s and used to monitor patients who elected to delay
The availability of these tumor markers and new im-
treatment after initial diagnosis. New definitions
aging is starting to change the paradigm related to
sprung up to replace the traditional Watchful Waiting
whom to treat, when to treat and how to treat. The
(see table below). The utility of the PSA created a
new monitoring tools are now applied not only at the
different approach to deal with progression of dis-
time of diagnosis but also to the more advanced
ease. It gave information early enough to still enable
stages of disease such as biochemical failure after
local primary treatment with curative intent. During
treatment and hormone refractory disease.
the same period of time, nomograms appeared on thescene. Nomograms are derived statistically from
Here are some of the definitions related to Watchful
grouping historical data on large groups of patients.
Waiting as they have appeared in the scientific medi-
The items looked at in these nomograms included
cal literature over the past 10 years.
These are just some of the publications and views of
Definition Paradigm Reference Maximum Surveillance and Minimum Interven- tion: Choo and Kloz were the first to report on a pro-
spective active surveillance protocol. The table
above gives the historical review of shaping and re-
shaping the new paradigms of Watchful Waiting.
Out of my own long career devoted to prostate can-
cer, I came to a personal conclusion to apply the dic-
tum: Maximum Surveillance and Minimum Inter-
vention. Maximum Surveillance is always active and
always objectified by the doctor. The Minimal Inter-
vention is a decision that has to be taken by the pa-
tient in choosing the least aggressive treatment. My
dictum has stood the test of time with countless pa-
tients whom I was and still am in contact with, now
The Future: With the advent of gene-molecular fin-
gerprinting, our suspected cancer cells will be able to
receive correct, individualized treatment. These ap-
proaches will take away the guess work and the
waiting periods. Each individual will receive his
treatment according to his private, personal and spe-cific fingerprinting of his tumor. No more relying on
statistics formed by groups as published in medical
lect the most prudent diet for general health while
journals. I believe that this future is quickly ap-
also preventing prostate cancer relapse.
proaching. I am proud to tell you, the reader, thatPC-REF is an active player in realizing this future.
This drive led me to focus on a Mediterranean diet.
Through patient donations and support, we have
The literature supporting the Mediterranean diet is
given a seed money grant in 2005 to a researcher at
vast. Among the clinical trials that support the diet,
Johns Hopkins to investigate the genetic fingerprint-
I’ve found two particularly persuasive in terms of
ing of prostate cancer cells in metastatic disease.
general health. The Lyon Diet Health study looked at
Let’s continue to open the door to a better era as we
605 people in the intensive care unit with their first
heart attack. Half followed a version of the NorthernEuropean diet with modest cholesterol restriction.
To learn more about surveillance and interventions
The other half followed a Mediterranean diet pat-
with the new paradigms described in this article, the
terned after that found on Crete. After four years the
following PC-REF services are available. “ASK DR.
number of new heart attacks decreased by 50%, while
BARKEN” a free, weekly telephone call in show,
the number of new cancers decreased by 60%. The
every Tuesday evening at 6 pm Pacific, 9 pm Eastern,
second study is the HOPE trial. In this study, re-
toll free 1-877-727-3301. Also available is individ-
searchers followed close to 2,300 subjects between
ual Coaching with Dr. Israel Barken for which a do-
the ages of 70-90 for more than 10 years. Researchers
nation to PC-REF based on time is expected. Money
also looked at four life-style issues and the risk of
raised through Coaching goes toward funding new
death from various causes. The four life-style issues
research for prostate cancer. In helping yourself, you
were: not smoking, exercise, moderate alcohol con-
sumption, and the Mediterranean diet. Overall, thosewho incorporated all four positive life-style habits
Prostate Cancer and Diet
had close to a 70% reduction in death rate compared
with those who had none of these. The Mediterranean
American Institute for Diseases of the Prostate
diet accounted for about a 25% reduction in overall
deaths as well as deaths from cancer and heart dis-
As many of you know, I was diagnosed with poor
There is less extensive information on prostate cancer
prognosis prostate cancer in February of 1999. Fortu-
and the Mediterranean diet, but I find it quite persua-
nately, I remain in remission. In part this is due to the
sive. Saxe and his colleagues took a group of patients
aggressive initial treatment I received and in part I
who had recurred following radical prostatectomy
think it is due to the program I’ve developed to sup-
and placed them on the Mediterranean diet. Their
press cancer recurrence. An important part of that
PSA doubling time was 6.4 months before the diet
program is diet and I’ve naturally been very inter-
change and 17.7 months afterward. This is nearly a
ested in updating it as research on prostate cancer de-
2/3 reduction in the growth rate of the cancer. This
velops. If you want to get a sense of this literature, go
alone has the potential to triple the lifespan of these
to PubMed (www.pubmedcentral.nih.gov/) or Goo-
gle Scholar (http://scholar.google.com/. One of the
Another factor I find persuasive is that laboratory
first things you’ll notice is that there are more than
data on how food components control prostate cancer
1,000 papers on the broad issue of the impact of diet
growth show that it is plausible that the Mediterra-
and nutrition on prostate cancer. The next thing
nean diet will suppress prostate cancer growth and
you’ll notice is that there are almost as many contro-
spread. For example, there are now over 120 papers
versies as there are articles. Of course, there is an-
that link the fatty acid arachidonic acid to the growth
other complication: most men with prostate cancer
and spread of prostate cancer. Aspirin, ibuprofen, and
are also at risk for high blood pressure, diabetes, and
other nonsteroidal anti-inflammatory drugs work by
heart disease as a result of elevated cholesterol. In my
blocking arachidonic acid and also appear to have a
own family, there is a strong history of high blood
favorable impact on prostate cancer progression.
pressure. With these issues in mind, I’ve tried to se-
Arachidonic acid is found in large amounts in meat.
The Mediterranean diet as practiced on Crete limits
tils you find in the stores may take up to an hour to
red meat to once a month and white poultry to once a
cook, and while tasty, they are not really special. But
week. The major daily sources of protein are beans,
there are gourmet lentils that are much smaller and
nuts, and grains. This diet is quite low in arachidonic
have their own unique flavor. Because of their small
acid content, but not low in fat. In fact, there’s a rela-
size, these often cook very rapidly. I have found
tively high fat content in the form of olive oil and
http://chefshop.com one of the best internet sites to
nuts, such as almonds, pistachios, and hazelnuts. All
learn about these special lentils and get samples to
of these are sources of monounsaturated fat: a form
try. You can also find these on Amazon.com. Some
of fat that markedly reduces “bad” or LDL choles-
unusual lentina include: beluga lentils, which are tiny
terol. In the laboratory and in clinical studies, this
black beans that cook in 20 minutes or less and have
type of fat doesn’t stimulate prostate cancer growth
a rich, smoky flavor. Pardina browns are another
and spread. While it is now popular to recommend a
great small lentil with a rich nutty flavor and again
low fat diet to men with prostate cancer, there’s no
cook in 20 minutes or less. You are more likely to
basis for excluding olive oil or these nuts from your
find small French green lentils in local gourmet
diet and they actually have a dramatically favorable
stores. You can get fancy in how you cook these, but
I love to sauté diced celery and onion, add the beansand water and cook. While the beans are cooking, I
The Mediterranean diet is also rich in fish and the fat
crush garlic into olive oil—my current favorite is
found in fish—DHA and EPA—blocks the adverse
rosemary-flavored oil—and let sit until the beans are
effects of arachidonic acid. Adding fatty fish repre-
cooked. At that point, I add garlic and olive oil and
sents another step away from a low fat diet that actu-
salt to taste. (As I explained, this isn’t a low fat diet!)
The Mediterranean diet is also rich in tomatoes and
Sardines are rich in heart healthy fats, are very low in
other vegetables, especially dark green leafy vegeta-
the contaminations found in many fish, and are a key
bles like broccoli, kale, and spinach. Among other
part of the Mediterranean diet. Unfortunately, com-
things, these provide lycopene and lutein, two natural
mercially available sardines range greatly in quality.
compounds that appear to suppress prostate cancer.
The brand I’ve found consistently good is King Os-car. My favorite is the double layer sardines packed
Evidence in favor of the Mediterranean diet is eve-
rywhere in the medical literature. For example, therehave been a number of recent studies suggesting that
pomegranates may be beneficial for men who have
The taste alone makes avocado oil a special treat.
prostate cancer. This fruit is one of the classics of the
There are practical advantages to the oil, though,
Mediterranean diet, both as a fresh fruit and as syrup
such as the fact that it is very stable at high cooking
you can use when the fruit is out of season.
temperatures: it doesn’t break down until tempera-tures exceed 600 degrees F. But what I really love is
The Mediterranean diet itself encompasses a wide
the flavor of the best Avocado oils: they have a rich
variety of foods, but there are some products that
golden hue and an almost buttery aftertaste. The best
make the diet a tasty and attractive alternative for me.
brand I have sampled so far is the Elysian Isle Gour-
(Note that I have no financial link of any kind with
met Avocado from New Zealand. The oil is produced
by cold pressing and is clearly made with care. Youcan find the product at several sites on the internet,
but I suggest you use Google to find the best deal.
Beans and other legumes are great for your healthand offer protein free of cholesterol and arachidonic
acid. But beans are not without problems. First, they
Among alternative medical practitioners, there’s a
can take a lot of time to cook from scratch. Also,
wide-spread myth that sugar feeds prostate cancer.
there is the problem of intestinal gas—as I’m sure
Many men therefore eliminate fruits and other sweets
your wife can attest to! Lentils, on the other hand,
from their diet. But in truth, there isn’t one shred of
don’t cause gas and are quick to cook. Now, the len-
scientific evidence to support this idea. Studies by
Dr. Giovannuci and colleagues at the Harvard School
of Public Health show that the greater the intake of
When I tell patients that they will need to do without
fruits and sugar, the lower the risk of metastatic
butter, many ask in astonishment: “What do you
prostate cancer. And it appears that diabetics, with
spread on toast, then? Luckily, there are many op-
their high blood sugar levels, are at a reduced risk of
tions. Almond butter is a great tasting yet healthy al-
dying of prostate cancer. One argument I’ve heard in
ternative. I also love garlic crushed in olive oil plus a
response to all this is that the PET scan is successful
little salt. But my real favorite is home-made hum-
in visualizing cancers because cancers take up the
mus. Nothing could be easier to make. I place cooked
radioactive sugar used. Well, PET scans are useless
chickpeas (garbanzo beans) in a blender with ground
in visualizing prostate cancer in all but the most ag-
up sesame seed butter (tahini) and olive oil. Some-
gressive cases because this is one cancer that does not
times I use olive oil and a bit of water instead of
take up sugar in any great quantity.
tahini. This base can then be flavored in many ways. One of my favorites is to add hot pepper, but the
Now, a key element of the Mediterranean diet is that
variations are endless. Finally, when only the flavor
it is rich in fruits like dates, figs, pomegranate,
of butter will do, I use one of the butter-flavored salts
grapes, and oranges. My favorite fruit is an apple that
has been grown in our part of Virginia since pre-Revolutionary times: the Albemarle Pippin. The Al-
bemarle Pippin was a favorite of Thomas Jefferson
This is a wonderful monthly magazine, written in
and Benjamin Franklin and was a major export item
English, but devoted to Italian food. While many of
from America to Europe in that time. Even today, the
the recipes contain meat or dairy fat, each issue has at
website devoted to Montecello describes this apple
least several new ideas you can use. It’s also a great
(http://www.monticello.org/gardens/inbloom/). Un-
way to find out about internet and mail order sources
fortunately, the Albemarle Pippin has largely disap-
of Mediterranean food items. You can even find out
peared from American commerce. It bears only every
how to rent a villa in Italy if you want and can afford
other year, the trees take their own sweet time ma-
turing and the fruit is a dull green color mottled with
www.italiancookingandliving.com or call toll-free at
brown. But each fall, here in Albemarle County, Vir-
ginia, a few local orchards have the apples for sale. My wife and I make sure to buy them by the bushel.
I hope these products and ideas show you that
Fortunately, they store very well and actually taste
adopting a Mediterranean diet need not be a burden
better after months of storage. In fact, I think they are
but an adventure that has the side effect of improving
reaching their peak right now. The flavor is rich,
your overall health while helping keep your prostate
complex, and aromatic with a perfect balance be-
Complete Remissions Are Important
You’ve heard of frozen raspberries, but what about
freeze-dried? Freeze-dried fruits are fantastic: you
American Institute for Diseases of the Prostate
can just pop them in your mouth like candy and the
flavor gradually emerges as you chew. The drying
concentrates the flavor. I’ve never tasted anythinglike this with the fresh berries. You can also quickly
(Note: this is excerpted and somewhat modified from
crush these berries into a powder that can be added to
a recent issue of the Prostate Forum devoted to the
tea or put on top of other fruits. One of my favorites
treatment of young men with prostate cancer)
is to take Concord grape juice or pomegranate juice,add the raspberry powder and heat until it steams. We
We can now cure a number of cancers even if they
buy cans of 3.5 pounds of raspberries freeze-dried at
are metastatic. This is true for acute lymphocytic
t h e p e a k o f f r e s h n e s s f r o m
leukemia in children, Hodgkin’s disease, nonHodg-
http://www.store.honeyvillegrain.com.
kin's lymphoma, and testicular cancer. In each ofthese diseases, cure is most likely if the patient rap-
idly enters a complete remission, typically within 4
mittent hormonal therapy supports the contention that
months of starting treatment. If we can’t create a
drugs that prevent the synthesis of dyhydrotestoster-
complete remission, cure simply isn’t possible. For
one (DHT), like Proscar or Avodart, do what Dr.
each of these cancers I just mentioned, complete re-
Leibowitz claims – they help maintain complete re-
mission means that we can find no evidence of cancer
mission. One of the first patients I treated in this
after treatment. Among individuals who attain a
fashion started hormonal therapy in April 1996 and
complete remission, some have microscopic deposits
stopped in April 1997. Since then, we’ve used
of cancer that will re-grow over time. Thus, the ulti-
Proscar to maintain his disease; his PSA has re-
mate measure of successful treatment is when the
mained undetectable for more than 8 years despite
person remains in complete remission for years after
having a normal testosterone for more than 6. Thus,
treatment is over. This is called a durable, un-
while it is possible to attain a complete remission in
maintained complete remission. As you’ll see, it’s
metastatic prostate cancer, these remissions are not
possible to attain complete remission in men with
metastatic prostate cancer, but these remissions arenot durable if they aren’t maintained. Nevertheless,
Based on these experiences, I divide prostate cancer
my approach to men with metastatic disease is gov-
treatment into two phases. The first phase focuses on
erned by the knowledge that it’s now possible to
attaining a complete remission. The second phase is
place many into complete remission. Based on what
designed to delay or prevent disease recurrence. In
we know about treating cancers with drugs, this ap-
large part, all of my efforts are focused on either ob-
proach is likely to give any man the best chance of
taining as complete a response as possible or in
looking for better agents to maintain a remission.
So, complete remission in men with metastatic pros-
My current program for newly diagnosed men with
tate cancer means that no evidence of the cancer can
metastatic cancer is to first try to induce a complete
be found. By this I mean that the PSA is less than
remission with triple hormone blockade® using
0.05 ng/ml. Furthermore, bone scan and CT scan re-
LHRH agonists, such as Lupron, Trelstar, Eligard or
sults show no evidence of remaining cancer. My cur-
Zoladex, combined with Casodex and either Proscar
rent views on this subject were formed following a
or Avodart. If the patient does not enter a complete
provocative discussion with David Crawford, the
remission with this program, I use second line hor-
head of Urology at the University of Colorado. In
monal therapy with agents such as ketoconazole,
1989, he published a major randomized controlled
transdermal estrogen, or aminoglutethimide.
trial comparing Lupron alone with Lupron + Eulexin.
Taxotere-based chemotherapy is only initiated after
In this trial, Crawford and his colleagues noted that a
second line hormonal therapy is no longer causing
certain proportion of men with advanced metastatic
the PSA to decline. The advantage of this approach
disease entered complete remission on hormonal
is that many of my patients don’t receive chemother-
therapy. In our discussion, that so influenced me, he
apy and thus are spared the side effects of this form
expounded upon this by noting that many of these
men remained disease-free for many years. It is im-portant to note that the men in the trial were on con-
Prostate Cancer and BPH
tinuous hormonal therapy, so these are not un-
As I mentioned in Volume 9 #5 (Prostate Forum-Hormonal Therapy I), I commonly use intermittent
“I thought you would like my recent PSA info! If you
hormonal therapy and what has surprised me most
recall, I started out two years ago with a PSA of 66.6.
about this approach is that there are a proportion of
My blood PSA this week is now 0.4! Who says this
men who remain in complete remission for years af-
Standard Process stuff doesn’t work miracles.”
ter treatment ends. Dr. Robert Leibowitz of Compas-sionate Oncology reports that this is common if we
This is a quote from a friend who was faced with
administer Proscar during the time patients are off
sudden, aggressive prostate cancer at a young age. In
hormonal therapy. My own experience with inter-
fact his doctor told him to go home, get his affairs in
order, and plan for some aggressive surgery and toxic
The most rapidly growing number of prostate cancer
treatments. He opted to ignore his urologist’s rec-
sufferers in the United States are those men who have
ommendation and start on a nutritional protocol, with
already been “cured” with radical surgery and/or ra-
no medical treatment at all. The rest is history – he
diation. These men make up the largest number be-
is cured. Here’s the great news about prostate can-
cause they still have identifiable PSA in their blood –
indicating persistent cancerous cells throughout thebody – despite aggressive, radical therapy. This re-
What happens when you find out you have prostate
currence of rising PSA takes place in the over-
cancer? Your doctor recommends a prostatectomy,
whelming majority of men diagnosed with prostate
radiation, seed therapy (brachytherapy), watchful
cancer and treated with the medical “gold standard.”
waiting, Lupron injections, and/or some other treat-ment. What should you do? That is a question that
No doctor can tell you that your cancer is confined to
tens of thousands of men are faced with each year. In
the gland. The real prostate cancer survivors are
2006 alone, it is expected that over 230,000 men will
those men who have had the cancer cells starved out
be diagnosed with prostate cancer. And not one in
of existence, and/or those men whose immune system
one thousand are prepared with adequate information
is able to eliminate the cancer seeds and cells that are
to make the correct decision. This includes both pa-
released into the bloodstream. These inevitably settle
or nest in the bones, attract a blood supply to them-selves, and grow. This takes place in almost all
Choosing the right kind of therapy has a lot to do
with the aggressiveness of the cancer and your cur-rent age. If you are in your late ‘70s to ‘80s and your
Once you understand this phenomenon, it is easy to
cancer is not aggressive, watchful waiting may be
understand that settling for any local treatment alone
perfect for you. However, if the cancer is aggressive,
is inadequate. Local treatment includes radical
you must take action – and some form of therapy
prostatectomy, radiation therapy, seed therapy, or
cryotherapy. All local therapies are designed to re-move or destroy the prostate gland. Treatment usu-
Alternatively, if you are younger and the cancer is
ally comes with the assurance that “we got it all.” In
not aggressive, you may want to reconsider the medi-
truth, there has never been any study that shows that
cal “gold standard” of radical prostatectomy. Why?
any local (even radical) therapy is both necessary and
Because prostate cancer is overwhelmingly likely to effective in the treatment of prostate cancer. recur after surgery given the many years you have left to live. In almost all cases, the cancer is already
Amazingly, despite aggressive local therapy, men
throughout the body at the time of diagnosis. And if
who receive surgery or radiation are equally likely to
you’re younger and have an aggressive cancer, you
die from prostate cancer as those men who have
must take action. But the gold standard of surgical
taken no action. Or in other words, if you are young
therapy may be wholly inadequate, or even dead
enough, and the cancer is aggressive enough, and you
take no other action, the cancer will come back andtry to kill you. Prostate Cancer is Systemic The first factor for all prostate cancer sufferers to
For men with PSA recurrence, your PSA will slowly
fully understand and accept is that prostate cancer,
rise and unless something else is done (usually hor-
once discovered, is rarely if ever confined to the
mone blocking therapy), the cancer will debilitate
gland or prostate capsule – even though your doctor
and even kill you – despite the quote “we got it all.”
may tell you with certainty that the cancer is confined
So you need to take action – and that action is most
to the prostate gland. The sad fact is that the over-
often a combination of a powerful nutritional proto-
whelming majority of men diagnosed with prostate
col and/or Triple Hormone Blockade® (THB). With
cancer, regardless of age, have had microscopic
this type of therapy there is rarely the need for any
spread of tumor cells long before the diagnosis was local therapy at all. made.
You read that correctly. There is no need for radical
and Immuplex (3/day). This kind of nutritional ther-
prostatectomy or radiation therapy. That means no
apy combined with THB® is powerful indeed. If you
drastic or enduring side effects from surgery: urinary
remember that all prostate cancer is systemic, and
incontinence, fecal incontinence, impotence, diapers,
you use the right kind of therapy, you can beat this
and more. That means no radiation damage to your
bowels. That means no hospital and all the inherentrisks of disease or death that come with a hospital
Benign Prostatic Hypertrophy
visit. In fact, therapy of this type is now considered
If you only have benign prostate hypertrophy (BPH),
remember that this can be helped nutritionally also. We use three to nine Palmettoplex capsules with Triple Hormone Blockade® Therapy (THB)
three to six Cataplex F tablets daily with great re-
This remarkable therapy, started by Robert L. Lei-
sults. If your prostate is just too big to shrink, there
bowitz, M.D., involves 13 months of hormone
is a wonderful medical procedure that is safe and ef-
blocking medications. The hormones eliminate tes-
fective called Green Light PV, which is short for
tosterone (androgens) from the body, starving the
Selective Photo Vaporization of the Prostate.
prostate cancer out of existence. It can be tough –with side effects such as hot flashes, temporary
In this procedure, an 80-watt laser is used to vaporize
change in sexual function, decreased energy, and in
some of the excess tissue in the prostate gland that is
rare instances breast growth. But it is only for 13
blocking the urethra and holding up urine flow. It is
months and there is no other medical therapy that can
done with a catheter and a tiny laser. It takes about a
half hour and usually provides profound and long-term relief without the problems and potent side ef-
Triple Hormone Therapy works best when started
fects of a surgical reaming out of the prostate gland
early – even though lots of men with advanced pros-
tate cancer have had excellent results. So when firstdiagnosed, you would want to consider getting in
There is almost no risk of infection; nothing is cut;
touch with Dr. Leibowitz at Compassionate Oncol-
and problems with impotence, nerve damage, incon-
o g y M e d i c a l G r o u p i n L o s A n g e l e s
tinence, and more are now a thing of the past. About
(www.prostateweb.com or 1-310-229-3555). Ac-
two millimeters of prostate tissue surrounding the
cording to Dr. Bob, virtually all men can tolerate
urethra is vaporized, eliminating the pressure and
these reversible side effects for 13 months.
stricture that causes urinary problems. You can findout about Green Light PV on-line at
In my opinion it is not too high a price to pay for a
www.laserscope.com or call them at 1-800-356-7600
potential prostate cancer cure. Surely it beats having
your prostate removed, then waiting around withyour fingers crossed hoping that “they got it all.” Dr.
But even this seemingly benign technique can carry
Bob has a long list of prostate cancer survivors who
problems if the doctor performing the therapy does
are willing to serve as volunteers to answer questions.
not have the necessary skills. To avoid an urologist
For this type of therapy, information, and counseling,
who may only have a weekend seminar under his
do not hesitate to give his office a call.
belt, I suggest you go to skilled and experienced menwho have performed lots and lots of these proce-
Nutritional Therapy
dures. In the Detroit area call Dr. Mahmood Hai (1-
Always include a powerful nutritional protocol to ac-
734-595-1166). In the Los Angeles area call Dr.
company other therapies. My friend with the PSA of
Thomas Bogaard (1-213-483-6830). I have checked
0.4 opted for a nutritional protocol alone – without
on both these doctors and visited Dr. Bogaard. Be
any local treatment and without Triple Hormone
assured you will get the best procedure at either of
Blockade® Therapy. The basics of a protocol for
men with prostate cancer are the very same basics heused. The products and dosages that can work in-
Even if you have Green Light PV treatment, it is al-
clude Arginex (6/day), Cataplex E (6/day), Cyruta-
ways best to use Palmettoplex and Cataplex F to Plus (9/day), Prostate (3/day), Cataplex F (6/day),
give you the bet odds of superior results. So whether
you have a prostate that is just a nuisance, or one that
cer and its progression make it easier to move for-
can be life threatening, always remember to use a
ward. If the initial sense of hopelessness or helpless-
protocol that really works. And don’t put all your
ness persists and is accompanied by feelings of de-
eggs in one basket with the standard medical ap-
spair, guilt, and worthlessness, the possibility of sig-
proach of local therapy. It could cost you your life.
nificant depression should be considered. It is im-portant that you speak with your doctor, healthcare
Get Treatment for Cancer-Related Depression
team, or your family and friends about these feelings.
Depression can make all of your symptoms worse.
Another reason it is important to talk to your
Depression is not just sadness or feeling blue. It is a
healthcare team about depression is that some of the
combination of symptoms that often includes a
drugs used to treat cancer may make your depression
change in weight and appetite, in sleep and energy, in
worse. For example, steroids (dexamethasone, pred-
thinking and ability to concentrate, in your desire to
nisone, etc.) may make depression more severe, and
participate in social activities, in your overall mood,
some biologic therapies, like interleukin-2 and inter-
and in your interest in both people and your sur-
Both counseling and medications can make a very
These symptoms are often accompanied by feelings
big difference in how you feel and improve other
of guilt, worthlessness, or helplessness that can esca-
symptoms at the same time. There are many medi-
late into thoughts of taking your life. If you are expe-
cations available to treat depression, some of which
riencing pervasive feelings of guilt, worthlessness, or
begin to have an effect within two to four weeks. In
helplessness, or if you are thinking about taking your
addition to counseling and medications, here are
life, seek help immediately. There are many ap-
proaches to dealing with depression, including medi-
• Talk about feelings and fears that you may be hav-
cations and the help of mental health professionals.
ing – do not keep them inside. • Remember that it is OK to feel sad and frustrated.
Some degree of depression is common in people who
• Try deep breathing and relaxation exercises several
are coping with cancer, and some cancers are more
frequently associated with depression, like those that
• Don’t blame yourself for feelings of fear, anxiety,
arise in the pancreas and lung. About 25 percent of
all people with cancer experience clinical depression,
causing distress, impaired functioning, and decreasedability to follow a treatment schedule. Not surpris-
Depression in the setting of advanced cancer is best
ingly, depression is seen more often in people with
treated by a combination of medication, supportive
advanced stages of cancer, and in those who have
therapies (such as relaxation and distraction), and
more disability from their cancer and/or poor pain
counseling. Your prognosis, and therefore the time
available for treatment of your depression, is an im-portant consideration when choosing the best treat-
It is not uncommon for people with advanced cancer
ment. If you have months of treatment ahead of you,
to experience hopelessness or a sense of helplessness
you have time to wait the two to four weeks some-
when they first learn that their cancer has recurred or
times needed to see the benefit from the majority of
that the treatment has failed, whether or not there are
antidepressants. If the time is very short, stimulants
alternative treatments available for the cancer. A pe-
(which act more quickly) may be of greater benefit to
riod of shock, disbelief, or denial is very common,
often followed by a period of depression.
Many people assume that depression is inevitable if
With time, most people with cancer and their families
you have cancer. This is not true. Treatment for de-
are able to come to terms with what at first seems
pression has proven benefits for anyone living with
impossible to accept. For many, understanding what
to expect and gaining more knowledge about the can-
LAC-PAACT 1UPDATE
ing this issue. If this sounds like an issue that would
interest you and you want to help, please contactGreg Teufel.
Apologies for the long hiatus for this column. Weare glad to have some good news to report.
We want to keep you aware that the LAC-PAACT ishere to help you. We are particularly helpful in ad-
In the middle of 2005, Medicare posted payment
dressing insurance and Medicare coverage issues re-
rates to Hospital Outpatient Departments for 2006
lated to advanced cancer treatments. Please do not
and proposed a 12% decrease in an already low re-
hesitate to contact us regarding any coverage or other
imbursement rate for prostate cryosurgery. This
legal issues related to advanced cancer treatments.
would clearly have limited access to cryosurgery.
We want to help and need your help in identifying
There had already been hospitals that stopped doing
prostate cryo because of the limited reimbursement.
We are also always seeking volunteers to help with
PAACT coordinated efforts with other interests and
LAC-PAACT activities. Even if you are not a law-
LAC-PAACT volunteer Gordon Woodward, Esq., a
yer, you can volunteer if you are inclined to help with
lawyer with Schnader’s Washington, DC office, at-
law related issues. Also, if you know any lawyers
tended a meeting in August with Medicare officials
that would be sympathetic to our cause, please make
to urge against the proposed reimbursement rate re-
us aware of them and them aware of LAC-PAACT.
Just contact Greg Teufel regarding volunteer oppor-tunities with LAC-PAACT.
As a result of that meeting and the efforts of LAC-PAACT combined with numerous other interested
If you have been denied coverage for an advanced
organizations, the reimbursement rates were actually
cancer treatment, be sure to let us know and we will
increased instead of decreased, helping ensure con-
see if there is anything we can do to help.
tinued access to this treatment option. We were veryglad to be able to help in that effort. Contact LAC-PAACT If you have any questions or comments, or any sug-
The next challenge we hope to undertake is approval
gestions about how LAC-PAACT can best serve your
for off-label use of chemo’s for prostate cancer.
needs, please do not hesitate to contact me. The pre-
Thanks to Harry Nowicki for bringing this issue to
ferred method to contact me is via email at
our attention last year. The issue of off-label use of
[email protected]. You can also call me at
chemo's for prostate cancer is a very complex one
work at (412) 577-5289, home (412) 421-7123, or on
because the use of these chemo’s have primarily been
my cell phone (412) 596-6316, or send me a letter at
in phase II trials. Hence, it is very difficult to provide
Schnader Harrison Segal & Lewis LLP, Suite 2700,
peer-reviewed articles that insurance companies re-
Fifth Avenue Place, 120 Fifth Ave., Pittsburgh, PA
quire for "proof of efficacy." It is extremely frus-
15222 or a fax at (412) 765-3858. Please note that
trating and depressing to see off-label use of other
requests for the LAC-PAACT kit should be ad-
drugs allowed and not chemo’s that have shown
dressed to PAACT. Contact information for PAACT
some efficacy for prostate cancer in the smaller trials.
is on page 2 of this Newsletter. Please remember that
We are looking for volunteers to assist with address-
this article is not legal advice and I cannot generallygive you legal advice or become your personal attor-
LAC-PAACT is PAACT’s legal advisory committee. Despite
the name of the committee, for various reasons, we generallycannot give you legal advice or act as your personal attorney. WHAT THE HECK HAS BEEN GOING ON IN
Please do not consider anything in this article as legal advice. If
MY WORLD-PART 10 or In Honor of the Super
you want legal advice, I encourage you to consult a lawyer in
Bowl or Winter Olympics-Part X!!!
your state, so that your specific situation and local laws can beconsidered.
2Gregory H. Teufel, Esq. is a partner in the Litigation Depart-ment of Schnader Harrison Segal & Lewis LLP's Pittsburgh
Michigan lost in the last seconds to Ohio State and all I
office. The views expressed are those of Mr. Teufel personally
can say is after several months of intensive post-game
psychiatric therapy, that cost thousands of dollars and in-
-Current use of blood pressure control drugs
volved numerous medications - it is going to be okay and I
really hope Michigan wins next year (excuse me for a sec-ond - my tongue is bleeding) ……. I think I am going to
This just proves once again that many of the accepted risk
take a vacation after this column and do something relax-
factors for CVD bear some relation to E.D. The bottom
ing like go hunting with the Vice President (what a cheap
line to patients is that heart health seems to be equivalent
shot - no pun intended or that was a fowl joke - pun in-
to penile health and vice versa. What this research also
means is that any man that reports E.D. should also have aCVD risk analysis. E.D. may be an early symptom in pa-
67) The penis, the heart, and overall cardiovascular
tients with CVD. Now, this study may not mean much to
disease (CVD) risk: Are they all related? (This sounds
the men that have experienced erectile dysfunction be-
dirty and x-rated, but it really is not and if it was I
cause of prostate cancer treatment, but it still should ap-
would not admit it because the PAACT editors would
ply. Increasing your risk for heart disease only reduces
take this article out before you read it)!?
the chances of regaining erectile function regardless of the
(Reference: Thompson IM, Tangen CM, Goodman PJ,
prostate cancer treatment you received. If you want to
Probstfield JL, Moinpour CM, Coltman CA. Erectile dys-
increase your chances of having good erectile function
function and subsequent cardiovascular disease. JAMA
then you should reduce your cardiac disease risk to as
Here is a wonderful study, which I think really sends theright message. Men aged 55 years or older randomized to
68) Combining sildenafil (Viagra®) with an L-
the placebo group (n = 9,457 participants) in the Prostate
carnitine dietary supplement may enhance the re-
Cancer Prevention Trial (PCPT) at 221 United States
sponse to Viagra® and help to restore sexual function
(U.S.) locations were given evaluations every 3 months
in men after prostate surgery - are you kidding me!?
for CVD risk and erectile dysfunction (E.D.) between
(Reference: Cavallini G, Modenini F, Vitali G, Koverech
1994 and 2003. Researchers also adjusted their results for
A. Acetyl-L-carnitine plus propionyl-L-carnitine improve
potential confounders such as age, body mass index
efficacy of sildenafil in treatment of erectile dysfunction
(BMI), blood pressure, cholesterol, diabetes, a family
after bilateral nerve-sparing radical retropubic prostatec-
history of heart attack, race, smoking status, exercise
level, and quality of life. A total of 85% of these patients
Researchers from Italy that have a history of working with
had no CVD at the beginning of the study, and 47% of
the dietary supplement L-carnitine decided to perform a
these men had E.D. The men that reported E.D. during
unique and small preliminary clinical study. Men, average
the study or had E.D. when the study started had a signifi-
age 60-63 years, less than 10% were obese, approximately
cant 25-45% increased risk of having a CVD event (like a
50% had high cholesterol, most (55%) were past smokers,
heart attack or a stroke for example). The correlation of
and had prostate removal surgery 1-year earlier, were
E.D. and CVD events was in the range of risk associated
with smoking or a family history of heart attack. The
smaller arteries and vessels in the penis are most likely
2) sildenafil (Viagra®) 100 mg on demand + acetyl-L-
reflecting what is going on in the larger or coronary artery
carnitine (ALC) 2 grams/day + propionyl-L-carnitine
circulation. This is not a new thought because past studies
of patients with diabetes not only demonstrate a higher
3) 100 mg of sildenafil (Viagra®) on demand (35 patients)
risk of E.D. but also CVD. It is also important to mentionin this current study of men in the PCPT that other things
It should also be kept in mind that the prostate removal
were significantly associated with CVD events and not
surgery received by these patients was the bilateral nerve
just E.D. Other risk factors for Cardiovascular Disease
sparing type. Both (bilateral) nerve connections to the
penis were left intact during the surgery making it easier
-AGE (just getting older increases your risk of heart dis-
to have a spontaneous erection after surgery compared to
ease - that sucks man - I just had a birthday - feel free to
men that have only one (unilateral) nerve bundle of the
send me a gift, but please keep it under a 1,000 dollars)
two removed, or both removed, which in either case
makes it more difficult to have a spontaneous erection
compared to bilateral sparing. Men were followed for 4
months then evaluated. Men from group 2 taking the die-
-HDL or “good cholesterol” (every 5 mg/dL decrease)
tary supplement L-carnitine + Viagra® had a better re-
sponse than those who just took Viagra® for 4 months.
Men from group 2 had a significantly greater impact on
erectile function, sexual intercourse satisfaction, orgasm,
and general sexual well-being. However, men did not
have an improvement in the area of sexual desire. L-
after a heart attack could actually improve heart health.
carnitine did not decrease or increase the side effects of
This study was a single-center, randomized, double-blind,
Viagra® (headache, flushing, dizziness, nasal congestion,
placebo-controlled trial for 6-months. A total of 153 pa-
and nausea). Researchers from this study concluded “PLC
tients following a first heart attack were enrolled, and 77
and ALC proved to be safe and reliable in improving the
patients were 60 years or older (68% were men). Ejection
efficacy of sildenafil in restoring sexual potency after bi-
fraction changes (a measurement of how well the heart is
lateral nerve-sparing radical retropubic prostatectomy.”
working where higher ejection fractions mean better func-
This is an interesting small study because anything that
tion), non-invasive measures of vascular stiffness, and
can enhance sexual function beyond what is already given
clinical events were recorded over 6 months. Patients
should be encouraging. L-carnitine supplements do have
were randomly assigned to receive L-arginine supple-
a good safety record and they are receiving a lot of atten-
ments with a goal dose of 3 grams, 3 times a day (3,000
tion in several different areas. L-carnitine supplements
mg/day) or matching placebo for 6 months. No significant
may reduce fatigue in older individuals or those receiving
change from baseline to 6 months in left ventricular ejec-
treatments that increase the risk of fatigue such as che-
tion fraction or vascular stiffness measurements were
motherapy or hormone suppression for breast and prostate
found in either group, including those patients age 60
cancer. Carnitine is a compound found in every cell of the
years or older. In other words, the L-arginine supplements
human body and carries other compounds (fatty acids) to
did not improve heart health. However, 8.6% of the par-
be used for energy production and antioxidant activity.
ticipants (6 individuals) died during the 6-month study in
One of the side effects of L-carnitine is euphoria or in-
the L-arginine group compared to none in the placebo
creased energy levels and it is this side effect that may
group. Due to safety issues, the safety monitoring com-
help patients reduce fatigue. Two of the patients (6.2%)
mittee closed enrollment and stopped the study. L-arginine
from group 2 experienced euphoria and none from group
supplements when included as part of standard therapy
3. One of the biggest side effects with L-carnitine in my
after a heart attack does not improve ejection fraction or
experience is simply price - these are generally expensive
vascular stiffness measurements, and may be associated
dietary supplements and for patients that need to take 4
with a higher rate of death. L-arginine should not be taken
grams or 4000 mg a day this will definitely be costly (so if
in individuals with heart disease. L-arginine is an amino
you are interested you should talk to your doctor about
acid dietary supplement, which functions as a precursor
starting with a low dose - about 500 mg daily). Viagra®
for nitric oxide synthase, and a potential producer of nitric
is also expensive. One concern I have with this study is
oxide (NO). It has become a popular supplement for men
the need to have other independent researchers confirm
experiencing erectile dysfunction with or without the use
these findings, because this one research group from Italy
of proven standard erectile dysfunction prescription medi-
has found numerous benefits with L-carnitine and have
cations. Previous long-term studies of this supplement
completed most of this research. Another concern in this
have not been conducted in high-risk individuals at risk
study was that men took the Viagra® as needed or “on
for a cardiovascular event (like a heart attack). This sup-
demand” instead of every day as was the case with the
plement is being used by individuals experiencing erectile
carnitine supplements. In order to truly evaluate how well
dysfunction, female sexual dysfunction, interstitial cysti-
the L-carnitine supplements were enhancing the impact of
tis, those attempting to enhance overall physical function,
Viagra® the men needed to take the Viagra® daily, or at
and perhaps for many other reasons. However, based on
least take it on a regular schedule. Regardless, I still be-
this single trial, L-arginine supplements should be dis-
lieve that L-carnitine has enough interesting preliminary
couraged in any high-risk cardiovascular patients and per-
data that some patients can use it at a variety of dosages
haps anyone else until more safety and efficacy issues are
from 500 mg – 4,000 mg a day, but compare prices of the
different brands before you buy, and keep in mind thatalthough it has a good safety record in preliminary studies
70) Can a statin drug improve the prognosis in men
that doesn’t mean it won’t come with a catch somewhere
treated for localized prostate cancer?
down the road (If you do not believe me then just read the
(Reference: Moyad MA, Merrick GS, Butler WM, et al.
next article.). In other words, everything comes with a
catch so get your doctor’s approval before using this stuff
We decided to conduct a preliminary study on statin use
and its impact on clinical presentation and biochemicalprogression-free survival after brachytherapy. This was a
69) L-arginine dietary supplements for erectile dys-
retrospective analysis of consecutive patients treated with
function or exercise enhancement may come with a
brachytherapy at one institution. A total of 512 patients
BIG CATCH in individuals with heart disease.
consecutively treated with permanent brachytherapy for
(Reference: Schulman SP, et al. JAMA 2006;295:58-64)
clinical stage T1c-T3aNxM0 prostate cancer were in-
Researchers were trying to determine whether L-arginine
cluded in this study. Biochemical progression-free sur-
dietary supplements given in addition to standard therapy
vival (bPFS) was defined as a prostate-specific antigen
(PSA) level of 0.4 ng/ml or less. Median follow-up was
silicon intake in this study consumed greater than 40 mg
5.3 years. Adjustments for a variety of confounding vari-
Si/day, and lowest was less than 14 mg Si/day. Major
ables included: statins, age, body mass index (BMI), PSA
sources of dietary silicon in the diet are cereals/grains and
level, Gleason score, percentage of positive biopsies, per-
their products such as breakfast cereals, bread, and beer.
ineural invasion, prostate volume, planning volume, do-
Other sources are fruits and vegetables (bananas, raisins,
simetric quality, supplemental external beam radiation,
beans, lentils), and unfiltered drinking water.
tobacco use, hypertension, and diabetes. The 8-year bio-chemical progression-free survival rate was 94.6% for the
TOP FOOD/BEVERAGE SOURCES OF TOTAL
entire group. Pretreatment PSA level and percentage of
positive biopsies were statistically significant predictors of
outcome - in other words a lower PSA and prostates with
less cancer increased the chances of success overall.
However, a significantly lower pretreatment PSA value,
percentage of positive biopsy cores, more favorable PSA
density, and earlier clinical stage were found in the pa-
tients taking statins at the time of treatment. When ana-
lyzed by specific statin use, 97.8% of patients taking
atorvastatin (Lipitor®) versus 94.7% taking other statins
were free of biochemical progression. This was the long-
est reported follow-up period to date that suggests that
statins, especially atorvastatin (Lipitor®), may improvemost clinical presentations and may improve bPFS in men
In the Western world one of the major sources of bioavail-
after being treated with permanent brachytherapy for
able and bioactive silicon is beer, especially for men. This
clinically localized prostate cancer. An improvement in
is nice to know for the moderate beer drinkers of the
bPFS favored statin users when stratified by low-risk
world. Dietary silicon may improve bone mineral density
(100% versus 96.5%), or high-risk (90.9% versus 85.3%)
in men and premenopausal women. Estrogen levels may
for recurrence. Therefore, the use of atorvastatin (Lipi-
impact the incorporation of silicon in bone, which is why
tor®) especially may have improved outcomes in patients.
post-menopausal women may not have benefited as much.
This is obviously not proof of cause and effect, but these
Regardless, a variety of simple and pleasurable foods and
results support previous laboratory and epidemiologic
beverages may help to improve bone mineral density at
studies, which suggest that statins may have a greater im-
the hip. Hey - thanks to this study I’m going out to have a
pact on presentation and progression of disease compared
to incidence. Atorvastatin may have been favorable be-cause of several reasons: the ability to enter cancer cells,
72) Hey what is the status of that new weight loss pre-
half-life, overall potency, other effects, or simply because
scription drug known as Acomplia® - when is it going
it represented the largest use of any statin compared to
to get approved by the FDA?
another. We were not able to study the newer cholesterol
Well, it looks like we all need to be a little more patient.
lowering drug known as Crestor® because not enough
Acomplia® taken daily (20 mg a day) versus placebo,
patients were taking this drug at the time of the study.
helped patients reduce weight by as much as 17 poundscompared to placebo over a two-year period. Individuals
71)Dietary silicon consumption may improve bone
also lost over 3 inches in their waist, improved their cho-
mineral density in men and pre-menopausal women,
lesterol and were more likely to quit smoking while taking
especially at the hip.
the drug versus a placebo. So, if this drug works so well
(Reference: Jugdaohsingh R, Tucker KL, Qiao N, Cupples
in so many patients why is the FDA waiting longer to ap-
LA, Kiel DP, Powell JJ. Dietary silicon intake is posi-
prove it? The FDA felt like more safety data was needed
tively associated with bone mineral density in men and
on this drug. There was a slightly higher rate of irritability
premenopausal women of the Framingham Offspring Co-
and depression reported on the drug versus placebo so this
is why they want more safety information. I was really
This was a cross-sectional, population-based study of
surprised over the past few days that the FDA took this
2,847 participants. Dietary silicon (Si) was found to be
position, but what can you do? There was also some con-
significantly associated with higher bone mineral density
cern by the FDA that since this drug works by a mecha-
at the hip in men (average age 59 years) and premeno-
nism of action that has not really received a lot of previous
pausal women (average age 47 years), but not post-
research they wanted to wait a little longer. Acomplia is
menopausal women (average age 61 years). The intake of
an endocannabanoid receptor antagonist, which means it
silicon (about 30 mg/day) is among the highest for a trace
blocks some of the same receptors in the brain that are
element in humans. The group in the highest category of
stimulated by marijuana to give a person the munchies or
the back of the box there are pictures of people and they
increased appetite (Note from Moyad: I do not know this
all look very, very old so I feel like the company is not
fact about marijuana from personal experience, but rather
advertising well to my age group. Fiber powders and fiber
from reading the actual research on this product.) We
wafers or bars work well, but I am not a big fan of those
need to be a little more patient and see what happens, but I
dang new fiber pills because you have to take so many
do believe this drug will get approved eventually and I
each day to equal a bowl of All-Bran that they are not
will keep you up to date. It is also interesting that we do
not yet have really effective medications for weight loss. There are only two prescription drugs approved on the
HAVE A NICE DAY, AND MAY YOUR UPCOMING SPRING VACATION BE FILLED WITH CHEAP
market currently for long-term weight loss. One drug is
DIETARY FIBER, AND NOT EXPENSIVE OVER THE
called “Meridia®” and it works somewhat by controlling
COUNTER WEIGHT LOSS PRODUCTS PROMOTED BY
appetite and impacting some brain receptors, but the over-
MANY BONE-HEADED SO CALLED “HEALTH
all effectiveness has been mixed and there have always
EXPERTS.”
been blood pressure issues with this drug. I think themedication is okay but many people do not experience
Finally, Mark I heard you are the new editor of a medical
significant weight loss on this product. The other drug is
journal by Elsevier called “Seminars in Preventive and
known as “Xenical®” and it is a lipase inhibitor, which
Alternative Medicine.” Is this true? Yes, it is and if you
means it blocks the absorption of fat. So, you have to get
go to the web-site of Elsevier publications
some fat in your diet for it to work well and you have to
(www.elsevier.com or call 1-800-654-2452) you can order
take a multivitamin daily because it also blocks the ab-
the same medical journal that the health professionals can
sorption of the so called “fat-soluble” vitamins (vitamins
use that updates the latest on diet, supplements, and
A, D, E, and K). It can come with some interesting side
drugs… for cardiac disease, different cancers, and any-
effects that are reduced over time, such as loose stools,
thing else that is happening in preventive and alternative
and again, it works okay but not good enough to write
medicine. This is the end of this shameless promotion, but
home to momma about (if you know what I mean). The
for some patients the medical journal should be a good
strange thing about the world of drug approval is that re-
cently the FDA seemed to favor the over the counter saleof “Xenical®” because the patent of the drug is going to
PS. In this column we talked a lot about erectile dysfunc-
expire soon. So, soon individuals will be able to buy a
tion (E.D.). Individuals interested in some recent medical
lower dose of this drug over the counter? What about
reviews on E.D. after localized prostate cancer treatment
over the counter weight loss products? Despite what you
have many articles to choose from, but a nice recent arti-
are hearing from some so called “experts” at 2 A.M. on an
cle is by Raina R, Agarwal A, and Zippe CD. Urology,
infomercial there is little proof that any over the counter
November 2005, volume 66, pages 923-929. They review
dietary supplement or herbal product helps you lose
the nonoral treatments like vacuum constriction devices
weight. Many of these products actually contain stimu-
(VCD), injections, and other methods. They also review
lants, which can raise your heart rate and blood pressure.
some of the oral treatments and some of the future clinical
This is why I have never been a fan of these products.
studies. This review is brief and to the point, but they do a
What happens long-term to a person that takes them be-
good job in my humble opinion. The only strike against
sides the fact that their wallet or purse becomes thinner?
them is that they live in Ohio (just kidding - man am I
Not much in my experience. In a later issue we will talk
asking for hate mail or what - keep in mind that of course
about weight loss products for individuals with and with-
I am joking because I was actually born at the Cleveland
out cancer. In the meantime, one of the more controver-
sial but safer weight loss products that never gets enough
Letter to the Editor
attention are the dietary or dietary supplement sources offiber. These products not only promote colon health, but
Enclosed is a check from my father’s estate. In his will he
give people a feeling of fullness, and as an added bonus
requested that this be given to PAACT.
they help lower cholesterol. You should talk to your
My father believed that the PAACT organization kept him
favorite doctor about the possibility of increasing dietary
alive for many more years than he would have been if he
fiber and/or taking a dietary fiber supplement. It comes
didn’t have the support and information that he received
with so many tangible benefits that I love to discuss fiber
with patients, but because I am lazy and PAACT onlypays me 100,000 dollars a year in monopoly money to
At the age of 90 he performed a sky dive at Sky Dive New
write this column I will talk more about fiber in a later
England to promote awareness of the PAACT organiza-
issue. Personally, I like All-Bran® cereal in the morning.
It has worked well for me and is a large source of dietaryfiber. The only problem I have with All-Bran® is that on
He passed away July 12, 2005 at the age of 93.
Subject Description Form Subject Code Subject Title Credit Value Pre-requisite / Co-requisite/ Exclusion Objectives After taking this subject, students will have a systematic understanding of the basic chemical and biochemical basis of drug research and development in the pharmaceutical industry; the analytical skill in evaluate the benefits and limitations of therap
Solapur University, Solapur B.Sc.III Microbiology Syllabus 2009‐ 2010 SOLAPUR UNIVERSITY, SOLAPUR B.Sc.III MICROBIOLOY SYLLABUS (Paper -V) Microbial Taxonomy and Genetics Section I: Microbial Taxonomy and Bioinformatics Bacterial nomenclature and classification A) Comparative study of Bacteria, Archaea and Eucarya. . B) Classification of prokar