Microsoft word - cc_vol_22-1.doc

P A A C T , I N C .
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

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:
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 (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
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 ( or Goo- gle Scholar ( 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 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 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 ( 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 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-
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.
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 ( 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 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.
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.
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

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 ( 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.


Microsoft word - as140_abct462 medicinal chemistry_tye_9 jan 2013

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