http://prostatecancerinfolink.net/2010/12/29/second-study-confirms-data-on-p
sadt-and-survival-post-surgery/

* Only PSA doubling time (™9.0 months vs 3.0-8.9 months vs < 3.0
months) remained independently predictive of overall and/or metastasis-free
survival in multivariate analysis.

The authors note that - based on this data set - overall and metastasis-free
survival "can be extensive for men with PSA-recurrent prostate cancer, even
in the absence of further therapy before metastasis."

In other words, men with a PSA doubling time > 9 months after initial
biochemical failure have a high probability of long-term metastasis-free
survival, which may call into question the value of any form of second-line
therapy until there is clear evidence of the presence of metastatic disease.

Link is also available on the VPCC Facebook page.

Abiraterone Acetate Update

Marketing application also submitted to European Health Authorities
HORSHAM, Pa., Dec. 20, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate. Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.

Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.

Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.

Data from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.

"These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company," said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. "We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients."

If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.

About Metastatic Advanced Prostate Cancer

Prostate cancer is considered to be advanced when metastases beyond the prostate occur and when resistance emerges to conventional hormonal therapies. Metastatic advanced prostate cancer is also referred to as castration-resistant prostate cancer, or CRPC, when disease progresses despite conventional hormone therapies or appearance of new metastases.

Prostate cancer occurs when cancer cells form in the tissues of the prostate. The prostate is a gland located around the urethra (under the bladder) in men that produces part of the seminal fluid. In some cases, cancer of the prostate can grow slowly compared with other cancers. However, depending on factors including characteristics specific to the patient and the tumor, prostate cancer can also grow very quickly and spread widely.

Prostate cancer is the second most common type of cancer in American men. One in six men will be diagnosed with prostate cancer, and in the United States in 2009, nearly 200,000 men were diagnosed with the disease. In 2010, an estimated 217,000 new cases of prostate cancer and 32,000 related deaths are expected to be reported in the United States.

About Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care. For more information about Centocor Ortho Biotech, visit www.centocororthobiotech.com.

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.

More information can be found at www.janssen-emea.com.

About Johnson & Johnson Pharmaceutical Research & Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com.

About Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.

Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., partners with affiliated units and companies in the Janssen Pharmaceutical Companies of Johnson & Johnson, such as Centocor Ortho Biotech Inc. and J&JPRD, in the research and development of oncology and supportive care treatments.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International or Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

*Editor's Note: J&JPRD has initiated an early access program (EAP) for abiraterone acetate in metastatic advanced prostate cancer patients who have exhausted currently approved treatment options including docetaxel and are likely to benefit from the therapy. For information about early access to abiraterone acetate, please call 1-800-457-6399.

Aspirin Therapy and Seniors'\Sexual Activity

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Physician's First Watch for December 7, 2010
David G. Fairchild, MD, MPH, Editor-in-Chief


physician's first watch
Poll results are in!




Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis

Sex Remains Important to Many Elderly Men

NIH Issues Guidelines on Managing Food Allergies

Featured in Journal Watch: Suicide Attempts in the Population — What Counts?


Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis


Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.


Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)


Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).


In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation.


Lancet article (Free abstract)

Physician's First Watch coverage of study showing link between low-dose aspirin and reduced colorectal cancer risk (Free)





Sex Remains Important to Many Elderly Men


Roughly half of elderly men consider sex to be at least somewhat important to them, according to an Annals of Internal Medicine study.


Some 3000 community-dwelling men aged 75 to 95 in Australia completed questionnaires about sexual activity and health conditions. (The men also underwent sex-hormone measurement several years earlier.)


Among the findings:


Overall, 30% reported having sex in the previous year; the prevalence was highest among the youngest men (40% among 70- to 79-year-olds vs. 11% among 90- to 95-year-olds).
Of those who reported being sexually active, more than half were satisfied with the frequency.
Independent predictors of not being active included a diagnosis of prostate cancer, osteoporosis, or diabetes; antidepressant or beta-blocker use; and lack of interest or physical limitations of one's partner.
Higher free testosterone levels were associated with increased odds of activity.

Annals of Internal Medicine article (Free abstract)

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Prostate Cancer Roundtable Optimistic that ODAC will Recommend Approval of
Dutasteride for Prostate Cancer Prevention

Washington, DC, November 30, 2010 – On Wednesday, December 1, the U.S. Food
and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
will hear presentations about the effectiveness and safety of dutasteride in
reduction of the risk for prostate cancer in men at greater than average
risk of such a diagnosis – and then decide whether to recommend approval of
dutasteride for this new indication.

Speaking on behalf of the entire Prostate Cancer Roundtable, Dan Zenka, a
vice president of the Santa Monica-based Prostate Cancer Foundation, said,
“We are optimistic that ODAC will send a strong signal to the FDA that the
benefits of dutasteride as an agent for the prevention of prostate cancer
far outweigh the known side effects of this agent. Dutasteride is a drug
that has been widely used for many years by hundreds and thousands of men as
a treatment for benign prostatic hyperplasia.”

The ability to significantly reduce lifetime risk for selected forms of
cancer is dependent, in part, on our ability to develop and bring to market
agents that can clearly reduce that risk -- in the same way that
cholesterol-lowering agents have been able to reduce risk for certain types
of cardiovascular disease. To date, only two drugs have ever been approved
for the prevention of any form of cancer -- tamoxifen and raloxifene -- each
of which is approved for the reduction of risk from invasive forms of breast
cancer in well-defined patient types.

“It is important to note that prostate cancer can have a devastating effect
on entire families,” said Theresa Morrow of Women Against Prostate Cancer.
“Just a little encouragement from a spouse or another family member can get
a man to his healthcare provider for regular health checks, including
prostate cancer testing when appropriate. The approval of a drug that can
help to reduce risk for prostate cancer would be another positive message in
the continuing battle to improve men’s health.”

The 8,200-patient REDUCE trial was a double-blind, randomized,
placebo-controlled, multi-center study that evaluated whether dutasteride --
at a daily dose of 0.5 mg -- decreased risk of biopsy-detectable prostate
cancer by comparison with a placebo. The patients tested in the REDUCE trial
were men between the ages of 50 and 75 who were at increased risk for
prostate cancer because of prostate specific antigen (PSA) levels between
2.5 and 10 ng/ml (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL
(in men aged greater than 60 years).

Results from the REDUCE trial were initially presented at the annual meeting
of the American Urological Association in April 2009 and subsequently
reported in the New England Journal of Medicine. They showed that
dutasteride lowered the relative risk of developing prostate cancer by 23
percent in men with an increased risk of the disease. The absolute reduction
in risk for a diagnosis of prostate cancer associated with dutasteride as
compared to a placebo was 5.2 percent.

The REDUCE trial clearly achieved its primary endpoint and demonstrated that
dutasteride significantly reduced the risk of biopsy-detectable prostate
cancers over a period of just 4 years. A total of 1,516 cancers were
identified among the 6,729 men who underwent a biopsy or prostate surgery,
with 659 in the dutasteride arm and 857 in the placebo arm.

“The approval of dutasteride for the prevention of prostate cancer
represents an important opportunity for men known to be at elevated risk for
this disorder,” said Tom Kirk, president of Us TOO International, the
world’s largest, patient-focused, prostate cancer education and support
network. “It may only be a first step toward the development of more
effective and even safer agents for the prevention of this disease, but it
would further validate the concept of chemoprevention for men at risk of one
of the most common forms of cancer, thereby encouraging continued research
into newer and potentially better agents for the future.”

As prostate cancer continues to strike one in six American men, and with
African American men having an incidence rate up to 60% higher than white
men, it is important that patients and their physicians engage in a
meaningful conversation about prostate cancer, about individual risk for
this disease, and about the value of prevention, early detection, and
appropriate management.

Wendy Poage, president of the Prostate Conditions Education Council stated,
“I cannot over-emphasize the importance for men to engage in an ongoing
dialogue with their healthcare providers about their individual risk for
prostate cancer and the need for appropriate baseline and follow-up testing.
It could mean the difference between living with or dying from this
disease.”

About Prostate Cancer

Prostate cancer is the most prevalent form of cancer among American males.
Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about
32,000 will die from this disease. Risk factors for prostate cancer are
known to include race, family history, elevated PSA levels, positive
findings on a digital rectal examination, and selected pathological findings
on prior biopsies.

About Dutasteride

Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under
the brand name Avodart. Dutasteride has previously been approved in the USA
and other countries around the world for the treatment of moderate-to-severe
symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged
prostate. When used in the management of BPH, dutasteride has been shown to
improve urinary tract symptoms, to reduce the risk of acute urinary
retention, and to lower risk for surgical intervention to resolve symptoms
of BPH.

Dutasteride, like all other prescription medicines, is known to be
associated with some common and some rare side effects. Common side effects
of dutasteride (occurring in less than 5% of patients) include impotence,
decreased libido, difficulty with ejaculation, and tenderness or enlargement
of the breast. Dutasteride is also known to trigger a rare allergic
reaction. Signs of this allergic reaction include a skin rash, hives, and
swelling of the eyelids, face, lips, arms or legs.

In the REDUCE trial, men receiving dutasteride had an increased incidence of
heart failure (30 events or 0.7 percent) compared to men receiving placebo
(16 events or 0.4 percent).

About the Prostate Cancer Roundtable

The Prostate Cancer Roundtable is a group of independent, not-for-profit
organizations which cooperate to foster the development of policies
supporting the prevention and early detection of clinically significant
prostate cancer, the effective treatment of men with this disease, and the
appropriate education of all men at risk for this disease.

###

The above statement has been issued on behalf of and endorsed by

American Urological Association Foundation

Cancer Survivor Bob Whitesel on Provenge treatment

Commenter: Whitesel, Robert
Date: 07/29/2010
Comment:
Autologous cellular immunotherapy Is it "reasonable and necessary" under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act? My name is Robert Whitesel. [PHI Redacted]

[PHI Redacted] Autologous cellular immunotherapy seems more "reasonable" to me than other Medicare accepted prostate cancer therapies, e.g., radical prostatectomy and chemotherapy. To treat aggressive, advanced cancers, to be sure, it would seem to me at least as "necessary" as the aforementioned therapies already accepted as reasonable.

I wish to make three (3) points in support of my affirmative response to the question above:

[PHI Redacted]
2. It is important to minimize treatments with destructive side effects. Quality of life suffers and the patient's immune system may be weakened and left vulnerable to other diseases. This therapy has been designed to build on the immune- system-boosting-capability of GM-CSF (granulocyte macrophage-colony stimulating factor) agents and doesn't leave one's immune system compromised by the destructive effects of taxane-based chemotherapy agents.

3. Some way must be found to reduce the cost of this out- patient-administered therapy. Long-term costs could be reduced by treating the largest possible number of qualified patients early in their disease progression, thereby putting the cancer cells at least into dormancy and reducing or eliminating the subsequent need of today's similarly costly and less-effective treatments for these men.

Urologist Dr Mark Scholz on Provenge as Treatment

Dear CMS Reviewers,

As an oncologist who specializes in treating
prostate cancer patients, I was extremely pleased
when the U.S. Food and Drug Administration
approved Provenge for the treatment of
metastatic, castrate resistant prostate cancer as
it represents an important advancement not only
in the treatment of prostate cancer, but the
beginning of a new treatment paradigm for the
treatment of all cancers.

I have used Provenge in my practice and continue
to be impressed by the ease of administration
with the treatment, as well as the almost total
lack of side effects experienced by patients. As
someone who has worked with prostate cancer
patients for nearly 20 years, I am all too
familiar with the difficult issues that patients
sometimes face with other treatments. Provenge
marks a new chapter in how I am able to treat my
patients, one that offers an improved survival
benefit, as well as an extremely mild side effect
profile and treatment duration when compared to
other treatments, such as chemotherapy. The
limited toxicity is so critical in maintaining a
good quality of life in these elderly ,
testosterone deprived individuals.

In addition to my clinical work, I am also the co-
founder and executive director of the Prostate
Cancer Research Institute, a non-profit
educational and research institute the focuses on
disseminating state-of-the-art information about
the diagnosis, staging and treatment of prostate
cancer. Provenge’s availability provides
healthcare professionals, as well as the patients
we treat, with a long-awaited and much-needed
alternative therapy for one of the neediest
patient populations in the prostate cancer
community.

There is a great deal of excitement among the
prostate cancer community to have a new and
effective treatment in the form of an
immunotherapy. I firmly believe that CMS has a
duty to both patients and their healthcare
providers to fully reimburse Provenge for the
indication in which it was approved, ensuring
that patients who have long awaited a new
treatment option to help them in their battle
with prostate cancer will have access to it. I
ask you, as a physician and an advocate for the
prostate cancer community, please do not delay or
inhibit access to Provenge.

Mark Scholz, M.D.
Medical Director of Prostate Oncology
Specialists, Inc., Marina Del Ray, CA
Associate clinical professor at the University of
Southern California School of Medicine
Co-Founder and Executive Director of the Prostate
Cancer Research Institute

Medical Phyicist Robert Baker to MEDCAC on Provenge

View Public Comment for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)


Commenter: Baker, Robert
Title: Consultant, CEO
Organization: RJB Consulting
Date: 07/14/2010
Comment:
I am a Medical Physicist (Ph. D., licensed by the
American Board of Radiology), and have worked in
the medical field for more than 35 years. My role
always involves patients being treated with
radiation, e.g. from a linear accelerator treating
a cancer patient, or implanted radioactive seeds;
both of these techniques are often directed at
prostate cancer

I began my career in the early 1970’s, at the
University of California, San Francisco Medical
Center, (now a clinical trial center, with
researchers enthused about Provenge, and a very
long waiting list of patients!). Chemotherapy was
new and experimental then; Radiation Oncologists
began prescribing these new drugs (there were no
Medical Oncologists yet); doctors called them the
“telephone drugs”, because they had names like
Roche 7473. (These doctors also referred to them
as “poison”). Now we have enough of these drugs
to fill a phone book!

Then President Nixon declared the “War on
Cancer”. After several decades, and billions of
dollars had been spent on this “war”, I have heard
many of these same physicians say, in effect, “we
should just admit we have lost the war!” Cancer
incidence was up, not down, survival was not much
affected.

Since that time, we have had improvements in
treatment delivery involving radiation (IMRT,
Gamma Knife, Cyberknife, etc), but radiation’s
effect is explained statistically; radiation never
completely eliminates the tumor cells; it merely
reduces the tumor burden to the level that the
body’s own innate defenses can eradicate it.

The Holy Grail of Cancer research has always been
to activate the body’s natural defenses (the
immune system) to destroy the tumor. Provenge has
finally accomplished just this task, and as such,
it is the FIRST FDA approved product to do so!

Provenge has greatly reduced side effects,
compared to any and all chemotherapies. The
specific clinical trial leading to the final
approval of Provenge, involved patients with very
advanced stage prostate cancer, that had already
failed multiple other existing treatment regimens,
and in the majority of cases had already
metastasized; “compassionate use” allowed these
clinical trial patients in the Standard of Care
arm (Taxotere) to “cross over”, if they were
failing treatment under the standard treatment;
many did so (I believe the majority), and even
these were helped by Provenge, even though they
were provided the drug late, and with a preserved
(frozen) form of Provenge.

This is truly a remarkable accomplishment, a
dramatic result, and supporters of this product
believe (and there is evidence) that Provenge can
be even more effective when applied earlier and in
broader circumstances.

In summary: Provenge is a breakthrough,
disruptive, new, dramatic, life extending, quality
of life preserving, treatment, that should be made
available to all prostate cancer patients whose
doctors determine they will benefit!

New Biomarker for Prostate Cancer

PROTEIN ARRAY ACCURATE
FOR PROSTATE CA
A panel of prostate cancer-derived
autoantibodies distinguished cancer
from benign prostatic hyperplasia and
healthy tissue with greater than 90%
accuracy, according to a preliminary
report from the 2010 American Association
for Cancer Research meeting.
The functional protein microarray had
similar accuracy for detecting cancer
(sensitivity) and for ruling it out when
used to evaluate noncancerous tissue
(specificity).
Prostate specific antigen (PSA) testing
also has a sensitivity of about 90% but a
specificity of less than 50%, John Anson,
PhD, said at a press briefing during
the American Association for Cancer
Research International Conference on
Molecular Diagnostics in Cancer Therapeutic
Development.
“What that means is there are lots of
potential false-positives,” said Anson, of
Oxford Gene Technology in the UK.
“What that translates to in clinical practice
is that a lot of men are going on for
unnecessary diagnostic procedures, such
as needle biopsies, and even radical
prostatectomy, which perhaps are not
required. Biomarker panels offer the
potential to significantly improve detection
of prostate cancer

Preventive Services Update

Oct 26, 2010
The Wall Street Journal Health Blog: "The United States Preventive Services
Task Force has canceled a meeting set for early next month at which the
thorny issue of prostate-cancer screening was due for a vote. ... [W]hen
prostate-cancer screening came up last fall, the USPSTF initially voted to
recommend against screening for men of all ages before opting instead to
re-vote on the issue. . Currently the USPSTF has an 'I' rating for
prostate-cancer screening, which means the current evidence is insufficient
to assess the balance of benefits and harms, for men younger than 75. For
older men, the rating is 'D,' which means the USPSTF recommends against
screening. The group last issued recommendations in August 2008, but in
2009, results from two large screening trials were published. The studies
provided no clear answer of whether the benefits of screening outweighed the
harms" (Hobson, 10/26).

This is part of Kaiser Health News' Daily Report - a summary of health
policy coverage from more than 300 news organizations. The full summary of
the day's news can be found here and you can sign up for e-mail
subscriptions to the Daily Report here. In addition, our staff of reporters
and correspondents file original stories each day, which you can find on our
home page.

Important New PSA Research

MONDAY, Oct. 25 (HealthDay News) -- Having a prostate-specific antigen (PSA) test to screen for prostate cancer reduces the risk that if cancer develops it will spread to other parts of the body, new research indicates.


The finding adds to the ongoing debate on whether PSA screenings actually improve survival rates or, by contrast, lead to unnecessary treatment.

"Our study shows that routine screening not only improves the patient's quality of life by stopping metastatic disease, but it also decreases the burden of care for this advanced disease that must be provided by the health-care system," study author Chandana Reddy, a senior biostatistician at the Cleveland Clinic in Ohio, said in a news release from the American Society for Radiation Oncology.

"This demonstrates that the PSA test is extremely valuable in catching the disease earlier and allowing men to live more productive lives after treatment," Reddy said.

Reddy and his colleagues are to report their findings Monday at the American Society for Radiation Oncology annual meeting, in San Diego.

PSA tests are blood tests that have been available and widely used since 1993. They measure levels of the prostate-specific antigen protein produced by the prostate; high levels are thought to be an indication of prostate cancer.

However, critics have cautioned that some patients diagnosed with early prostate cancer are subjected to aggressive treatments -- and their unwelcome side effects, such as incontinence and erectile dysfunction -- for a disease that is often slow-moving and of no real consequence to survival if left untreated among older patients who are likely to die of other, unrelated causes.

However, the researchers pointed out that prostate cancer is not curable when it is caught late and has spread (or metastasized) to other parts of the body. They suggested that assessing to what degree a PSA diagnosis might reduce the risk of metastasis could be the best way to determine the value of the test.

To that end, Reddy and his team analyzed data on more than 1,700 prostate cancer patients who between 1986 and 1996 had been treated with either radiation therapy or surgery to take out their prostate gland and the surrounding tissue.

Noting that in the first half of the study period, PSA tests were not yet available, the authors compared the spread of the disease over the course of 10 years among those who had been diagnosed with a PSA test and those who had not.

Over the 10-year period, metastatic disease took hold among 13 percent of all the patients. However the researchers found that regardless of whether patients were categorized as having high-, medium-, or low-risk disease, those who had been diagnosed as a result of a PSA screening were significantly less likely than those who weren't to have seen their cancer spread during the decade following their original treatment.

Dr. Lionel L. Banez, an assistant professor of urologic surgery at Duke University Medical Center, said that the current study leans toward the relative benefits of prostate cancer screening.

"There is compelling evidence that PSA testing saves lives, especially when performed in an optimized strategy," he said. "For example, getting an initial PSA measurement at age 40 to properly assess baseline prostate cancer risk has been proven to be quite beneficial.

Nevertheless, Banez acknowledged that doctors need to interpret test results judiciously.

"The challenge," he stressed, "lies in ensuring that the risks for over-diagnosis and over-treatment, as well as potential decline in quality of life, are minimized or avoided."

More

United Health Care Program to Cut Individualized Treatmnts

UnitedHealthcare plans to announce on Wednesday a one-year project with five
oncology practices, offering doctors an additional fee. The new fee is meant
to encourage doctors to follow standard treatments rather than opting too
often for individualized and unproven courses of therapy, which can include
the most expensive drug combinations. By proposing a different type of
payment structure, companies hope to lower doctors' dependence on a system
that generates substantial sums for cancer specialists who routinely favor
top-of-the line treatments.

Regional insurers in some states, including California, Washington and
Pennsylvania, are negotiating similar limits with doctors and their clinics.
WellPoint, another large insurer, is developing a way of paying oncologists
to coordinate and manage patient care.

By almost any measure, cancer treatments can be exorbitantly expensive.
Cancer care in the United States costs almost $100 billion a year, and
medical bills for the average patient on chemotherapy can top $100,000 a
year.

http://www.nytimes.com/2010/10/20/health/policy/20cancer.html?_r=1&emc=eta1

What does this mean for forward movement with new treatments once they are
approved? Also are they considering anything other than cost? What about
QOL? Will this have an impact on the development of new treatments?

Kathy



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Vitam Update

Knowing What’s Worth Paying For in Vitamins

CloseLinkedinDiggMixxMySpaceYahoo! BuzzPermalink By LESLEY ALDERMAN
Published: December 4, 2009
WHEN I stock up on ibuprofen (my painkiller of choice), I typically buy a 500-count bottle of a store brand like Kirkland or Rite Aid. After all, ibuprofen is ibuprofen. Each pill costs me about 3 cents — or only one-third the cost of 9-cent Advil.

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Chester Higgins Jr./The New York Times
A Vitamin Shoppe location in Manhattan. ConsumerLab.com found products sold by vitamin chains tended to be more reliable than drugstore brands.


Well
Share your thoughts on this column at the Well blog.

Sales over the last decade had been growing by about 4 percent annually. But this year, as more people are taking their health into their own hands, perhaps hoping to stave off doctor bills, vitamin sales are expected to grow by 8 percent to a total of $9.2 billion, according to Nutrition Business Journal, a market researcher and publisher.

About 42 percent of shoppers purchase their vitamins at natural and specialty retail outlets, like GNC and Whole Foods, according to the journal, while only 23 percent take the discount approach and buy their bottles at supermarkets and club stores. The other 35 percent buy through mail order or from a health care provider.

Of course, it’s controversial whether we should be taking vitamins at all. Recent studies have indicated that taking a multivitamin won’t protect you from heart disease or cancer. And experts maintain that if you eat well, you don’t need vitamin supplements.

“The evidence shows that a healthy diet and exercise are the best way to ward off disease; a vitamin cannot replace those benefits,” says Eric Rimm, associate professor of epidemiology and nutrition at the Harvard School of Public Health.

But what if you don’t eat well or are chronically stressed out? Then, Professor Rimm says, there may be some benefit from taking a multivitamin. “Certain subgroups, including women of child-bearing age attempting to get pregnant, may need specific supplements, like folic acid and omega-3,” he added.

As for the matter of cost: If you take only a daily multivitamin mainly as a medical insurance policy, it certainly won’t hurt your health — as long as you do not already eat a lot of fortified food. And it could help. But it will require spending some money. And if you take a multivitamin and a few individual vitamins and minerals, it’s even more worth your while to make sure you’re not paying more than you need to.

USE ONLY WHAT YOU NEED Popping too many vitamin pills is not only a waste of money but can be bad for your health. Talk to your doctor about what added vitamins or minerals you might require; you can ask for a blood test to learn what you might be lacking.

For example, if you don’t get enough vitamin D — many people who live in the northern states or who wear sunscreen everyday are low on this crucial vitamin — then buy just a D supplement. Standard multivitamins will probably not have the levels of D you require (many doctors suggest taking 1,000 to 2,000 international units a day).

If your doctor recommends a specific supplement, like omega-3, ask in what form you should be taking it.

FIND A REPUTABLE SOURCE Vitamins and minerals are commodity items, and every manufacturer has access to the same ingredients. For that reason, researchers and scientists say paying more for a name brand won’t necessarily buy you better vitamins.

“When we measure levels of vitamins in the blood, we find the levels are the same whether the person was taking a generic brand or a name brand,” says Dr. Rimm, who has been studying the effects of vitamins for 20 years.

That said, don’t be too cheap. Purchase your vitamins from well-known retailers that do a brisk business and restock frequently, whether that’s Costco or Drugstore.com. Vitamins lose their potency over time and must be stored at, or below, room temperature. If bottles are sitting on a shelf in warm room or in direct sunlight, they may degrade even before their expiration date.

PRICE MAY NOT MEAN QUALITY While the Food and Drug Administration regulates vitamins as part of the nutritional supplement industry, it does not test them before they are put on the shelves. The F.D.A. places the responsibility on the manufacturer to ensure that its dietary supplement products are safe before they are marketed. All of which means that no matter what the price, quality is not assured.

ConsumerLab.com, a company based in White Plains that tests hundreds of vitamins each year, finds that 30 percent of multivitamins have a quality problem: the pills might have more or less of a stated ingredient, or they might not dissolve properly.

Taking exception to such assertions is the vitamin industry’s trade group, the Council for Responsible Nutrition. In response to questions, the council released a statement from Andrew Shao, a vice president for scientific and regulatory affairs.

Mr. Shao said that the F.D.A. allowed for “a reasonable amount of variation” — which he characterized as up to 15 percent more of an ingredient than the label might indicate. Mr. Shao said that manufacturers frequently add slightly more of an ingredient to ensure that the amount is at least at the level claimed on the label as the product nears the end of its shelf life.

In any case, ConsumerLab.com says it has found a few patterns that consumers may find helpful. Products sold by vitamin chains tend to be more reliable than drugstore brands, and Wal-Mart and Costco’s vitamin lines are usually worth considering. In a recent test of multivitamins, ConsumerLab.com found that Equate-Mature Multivitamin 50+ sold by Wal-Mart was just as good as the name brand Centrum Silver, but at less than a nickel a day is half the price.

Puritan’s Pride, a catalog and online retailer, also has very good prices, and Dr. Cooperman says that its products are generally good.

Curious consumers can subscribe to ConsumerLab.com for $30 a year and learn how other supplement brands fare in the lab’s tests.

CERTIFICATION SYMBOLS One quality check you can make, although it is not a perfect screening, is to see whether a product is certified by one of several nonprofit organizations that check supplements for purity and quality.

The two most commonly used groups are the United States Pharmacopeia (www.usp.org) and NSF International (www.nsf.org), according to Mr. Shao. Manufacturers voluntarily submit a product for review and, if it passes, the product can bear an approval seal, such as USP or NSF. Because the process is voluntary, Mr. Shao points out, the absence of the seal does not necessarily mean the product is of poor quality.

But at least the seal should mean you know what you’re getting. And with vitamins, anything beyond that simple assurance may not be worth paying for.

Nanoparticle PSA Test Improves Detection

Prostate Cancer Resources

Managing Bone Metastases and Pain

Side Effects of Prostate Cancer Treatment

Nanoparticle PSA Test Predicts If Prostate Cancer Will Return; Ultrasensitive Test Gives First Accurate Answer After Surgery
by Alton Parrish | BeforeItsNews.com | 06.02.2010
Men who have just had their cancerous prostate gland removed have one pressing question for their doctors: Am I cured? But conventional tests haven't been sensitive enough to provide a concrete answer.

Current tests that measure the level of protein called PSA (prostate-specific antigen), which signals the presence of cancer, often detect no PSA, only to have cancer return in up to 40 percent of the cases.

New research from Northwestern University Feinberg School of Medicine and the University International Institute for Nanotechnology shows that an ultrasensitive PSA test using nanoparticle-based technology (VeriSens™ PSA, Nanosphere, Inc., research-use-only) may be able to definitively predict after surgery if the cancer is cured long-term or if it will recur.

The new test, which is based upon assays invented at Northwestern in the laboratories of co-principal investigator Chad A. Mirkin, is 300 times more sensitive than currently available commercial tests and can detect a very low level of PSA that indicates the cancer has spread beyond the prostate. The test also may pick up cancer recurrence at a much earlier stage, when secondary treatment is most effective for a patient's survival.

"This test may provide early and more accurate answers," said co-principal investigator C. Shad Thaxton, M.D., an assistant professor of urology at Feinberg and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

"It detects PSA at levels in the blood that cannot be detected by conventional tests. It may allow physicians to act at the earliest and most sensitive time, which we know will provide the patient with the best chance of long-term survival."

This ability to quickly detect very low levels of PSA may enable doctors to diagnose men with prostate cancer recurrence years earlier than is currently possible. Prostate cancer is the second leading cause of cancer death for men in the United States.

Not only may the new test more accurately predict the course of the disease; it also gives an early indication of whether secondary treatments, such as radiation and hormone therapy, are working. If not, then doctors can quickly begin alternative treatment and refer patients to clinical trials.

The study results will be presented at the American Urological Association 2010 Annual Meeting. These and the results of other Northwestern PSA studies will be presented at the meeting by Lee Zhao, Dae Kim and Hannah Alphs, urology residents at Feinberg.

"These studies suggest that the nanotechnology PSA test might become the preferred postoperative PSA test for men who have been treated with radical prostatectomy," said William Catalona, M.D., professor of urology at Feinberg, a physician at Northwestern Memorial Hospital and director of the clinical prostate cancer program at the Lurie Cancer Center.

"It should be especially useful in the early identification of men who would benefit from adjuvant postoperative radiation therapy and those who need postoperative salvage radiation therapy for recurrence."

Catalona, a senior investigator on the study, was the first to demonstrate that the PSA test could be used as a screening test for prostate cancer.

The study confirms and builds on the previous findings of a 2009 pilot study Thaxton conducted with Mirkin, the George B. Rathmann Professor of Chemistry in the Weinberg College of Arts and Sciences, and other colleagues.

PSA is a protein normally secreted out of the prostate cells into the semen in high concentrations. Usually, very little diffuses into the blood stream, and the normal PSA value for men without prostate disease is less than 2 nanograms per milliliter.

When the prostate gland has a disease process, such as inflammation, benign enlargement or cancer, the barriers to PSA diffusion into the blood stream are breached, and PSA levels rise.

In a man who has his cancerous prostate removed, there should be no PSA in the blood except for a minute amount produced by the periurethral glands. However, any PSA produced by cancer recurrence ends up in the blood stream and can be detected earlier with the more sensitive nanotechnology PSA assay.

For the new study, researchers obtained blood serum retrospectively from men whose PSA serum samples had been frozen after surgery and whose assays (blood analysis) showed an undetectable PSA level based on the conventional test.

Northwestern researchers then tested those serum samples using the more sensitive nanotechnology-based test. They wanted to see if they could detect PSA at levels below the limit of the conventional test, and if those results could predict the cancer outcome for those patients, who were followed for up to 10 years.

Using the new test, Thaxton and colleagues found that the low and non-rising PSA levels (presumably produced by the normal periurethral glands) of patients meant that the prostate cancer was effectively cured and did not return over a period of at least 10 years. Scientists also found a PSA level higher than that expected from the periurethral glands based on the new test meant the patients would have their disease recur.

As result of the study, researchers were able to assign a PSA level number to a cure for the first time as well as a number that indicated the disease would recur and if it would recur aggressively.

These newly identified levels were below what could have been detected with the conventional PSA test. The researchers were able to quantify PSA values at less than 0.1 nanograms per milliliter, the clinical limit of detection for commercial assays.

Thaxton said the next step for scientists is a prospective clinical trial to compare the nanoparticle-enhanced PSA assay to traditional PSA assays and determine if earlier detection and treatment can save lives.

CMS Payment Coverage Debate over Provenge

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Dendreon vs CMS: Why the Provenge Coverage Controversy Is Bigger Than Just One Product
by Ramsey Baghdadi | CancerNetwork.com | 09.22.2010
It appeared that the controversy surrounding the prostate cancer immunotherapy Provenge ended with FDA approval in April. But now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
Is $93,000 beyond the upper limit of what a drug company can charge for a non-curative cancer therapy when the government is the primary payer? That may be one interpretation of a recent action by the Centers for Medicare & Medicaid Services (CMS) to review its coverage policy for Dendreon’s prostate cancer cell-based immunotherapy Provenge.

Although the looming fight between Dendreon and CMS appears to be specific to the product in question, there is a larger lesson for other biopharmaceutical companies, particularly those operating in cancer drug development: as the government becomes an increasingly large payer, it is paying closer attention to what officials may see as exorbitant pricing practices.

And CMS has the tools at its disposal to force a de facto price negotiation—or go down fighting.

At the very least, the case of Provenge serves as another reminder that there are two regulators in Washington—not one—that are critical in determining a product’s commercial success. Approval by the Food & Drug Administration (FDA) remains, of course, a defining milestone for biotech companies and their investors, but satisfying CMS can be just as critical, especially in the field of oncology where Medicare is the dominant payer.

CMS may end up covering Provenge without limitation, or it may end up putting restrictions on coverage that have no real impact on a product that is going to be in relatively tight supply for the near future. But simply by initiating the review, the agency is encouraging public conversation about the value of the therapy.

That certainly has the attention of investors—and may be a sign of things to come for the biopharma sector overall.

Provenge Clears One Regulatory Hurdle, Faces Another

It’s almost never a good thing when your drug is the topic of daily conversations at CMS. That’s exactly the situation Dendreon found itself in with Provenge.

Investors cheered when Provenge was approved by FDA on April 29. The stock price rose as the days grew closer to Dendreon’s user fee date for Provenge as investors correctly anticipated that the product would complete its turnaround from a devastating “complete response” letter sent three years earlier. Even after the run-up, the stock increased by almost 35% the day the approval letter was disclosed, bringing its year-to-date increase to 100%. All that on top of a 10-fold price increase in 2009.

It looked to be the successful end of a long, up-and-down journey for the biotech company. During a same-day conference call announcing the Provenge approval, CEO Mitchell Gold declared that Dendreon had found the “Holy Grail of oncology” and that the company would begin a rollout of Provenge the following week.

The price? $93,000 for a three-course cycle; or $31,000 per infusion…

Even though breakthrough oncology therapies typically can garner an attractive premium compared with drugs in other therapeutic areas, the high price surprised even the most bullish Provenge watchers who had been following the progress of the cell-based immunotherapy.

Would reimbursement be a problem at that price, especially considering approximately 75% of patients who will use Provenge are Medicare beneficiaries?

Dendreon anticipated that Medicare and private payors would cover the costs of Provenge, Gold said, and a company official noted that the prostate cancer therapy Taxotere cost roughly $60,000 for a full treatment, making it “very close” to Provenge. The company also highlighted the cost advantage of Provenge as a defined, three-course regimen rather than a more typical open-ended course of therapy.

In the end, the price, Dendreon said, represented and “advantageous cost/value structure.”

Moreover, Dendreon planned to rollout Provenge to only 2,000 patients in the first 12 months, translating to a $110 million cost—not typically a sum that grabs a lot of attention when it comes to the large Medicare program.

CMS Opens a National Coverage Analysis

However, CMS was paying attention.

In a shocking move, CMS announced on June 30th that it had opened a national coverage analysis (NCA) for Provenge to determine whether the therapy is “reasonable and necessary.”

The Medicare agency said specifically: “CMS opens this NCA for autologous cellular immunotherapy treatment of prostate cancer. CMS is requesting public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer…CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review. CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in 2010.” The National Coverage Decision is expected in March 2011.

How big an impact did CMS’ announcement have? For Wall Street, it is simple: CMS’ decision to review coverage of the therapy erased all the gains from the approval of the product; with the stock dropping all the way back to the levels it had in January.

Put another way, investors seem to feel that the uncertainty surrounding the coverage policy means as much to the value of the company as did the uncertainty around FDA’s regulatory decision.

Using an alternative metric, based on Dendreon’s market cap of approximately $7.3 billion the day following FDA approval, Dendreon would have to give Provenge to more than 78,000 men with prostate cancer to meet the cap number. Following the CMS announcement, the number of prostate cancer patients dropped to just over 41,000 needed to meet the $3.9 billion market cap in early July.

And investors wondered: If CMS is taking on Provenge, will it take on other cancer therapies, like Roche AG’s Avastin, Herceptin and Rituxan?

The answer to that question is: it just might.

All indications are that the decision to review Provenge was triggered by specific circumstances surrounding what is, after all, a completely new type of therapy: a cell-based cancer “vaccine.” In that sense, it is probably an over-reaction to read into CMS’ decision a blanket review of coverage of all high-priced cancer therapies currently in use and in the pipeline.

But, having opened up the conversation in this specific context, there is nothing to stop CMS from expanding its reach and looking more broadly at what everyone in the healthcare policy world agrees is a key issue for the future: the exploding cost of cancer treatment in the U.S.

The Wrong Approach

It appears to have been a confluence of four factors that led to the NCA for Provenge: the price, Dendreon’s lack of communication with CMS, noise from private payers, and an agreement between FDA and CMS to facilitate the exchange of information.

First off, there are indications that CMS was unhappy that Dendreon did not talk with agency officials much earlier in the development and review process, given the certainty that Medicare would be the primary payer for the new therapy. During the April 29 conference call, Dendreon essentially admitted it was not focused on CMS early on, saying it planned to meet with agency officials the week of May 3 to discuss reimbursement issues.

The lack of communication is one thing; the pricing decision is another. After hearing the price set by Dendreon for Provenge, some CMS officials became concerned about the high cost. At that point, the immunotherapy began being discussed regularly at the agency.

At the same time, CMS was hearing concerns from medical directors at private insurers who were complaining about the sticker-shock price.

Almost serendipitously from CMS’ point of view, a memorandum of understanding (MoU) was signed between the Medicare agency and FDA “to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the federal partners.”

The MoU provides a framework for CMS medical experts and coverage analysis group to get full access to Dendreon’s study data of Provenge.

CMS’ decision to initiate an NCA may be nothing more than a back-door price negotiation.

It wouldn’t be the first time. Biogen Idec expected to get a payment code soon after launching its diagnostic/radiotherapeutic agent ibritumomab (Zevalin). The code was delayed for several months and then was set at 78% of Average Wholesale Price (AWP) as opposed to the much better rate of AWP-5%. Subsequently, Zevalin took another hit when CMS reclassified it as a procedure rather than a drug, giving it an even lower reimbursement rate.

What happened? CMS leadership became aware that Biogen had set Zevalin’s AWP at about $30,000 and communicated to the company that either there needed to be a price cut or Biogen could keep waiting for a coverage code. Eventually, the agency and Biogen were able to reach a compromise, but Zevalin never reached the commercial success that Biogen had hoped for.

CMS’ Options: Many or Few?

The Zevalin issue, however, took place outside of the “official” coverage process; with Provenge, CMS is going by the books, and that means there really isn’t much room for Dendreon to make an accommodation on price.

Here is how CMS officials see the options for a potential national coverage decision:

(1) Coverage

(2) Coverage with evidence development

(3) Coverage for on-label use only and blanket non-coverage for off-label use

(4) More restrictive coverage affecting even on-label use

(5) Blanket non-coverage

However, under the applicable Medicare statute, it appears as though CMS is relatively boxed in, and will have to cover, at the very least, the labeled uses of the therapy.

Sec. 1861(t)(2)(A) of the Medicare statute defines “drugs” to include “any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.”

The description under the law of a medically accepted indication: “includes any use which has been approved by the Food and Drug Administration for the drug and such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or the carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this sub-clause by the Secretary.”

Still, there is ambiguity about whether CMS could in fact deem an FDA-approved drug to be not “reasonable or necessary” despite the definition, and some officials within CMS believe the therapy should not be covered, citing skepticism over the study data used to support FDA approval.

If CMS were to attempt to move away from routine coverage of cancer drugs, it would indeed have dramatic implications for the biopharma sector and the scientific inquiry and development of novel cancer therapeutics.

Copyright CancerNetwork.com 2010

CMS Payment Coverage Debate over Provenge

ABOUT PROSTATE CANCERGET INVOLVEDPROGRAMSRESEARCHPARTNERSSTOREABOUT US


Risk Factors

Prevention

Detection

Diagnosis

Treatment

New Prostate Cancer Research

Prostate Cancer Resources

Managing Bone Metastases and Pain

Side Effects of Prostate Cancer Treatment






Show All
Interests: -- Select a topic -- 2006 Prostate Cancer SymposiumAdvocacy and PolicyExpertsGeneral Health NewsInternational NewsPress/MediaProstate Cancer - The DiseaseProstate Cancer StoriesSponsors and PartnersVolunteersZERO in the News

Dendreon vs CMS: Why the Provenge Coverage Controversy Is Bigger Than Just One Product
by Ramsey Baghdadi | CancerNetwork.com | 09.22.2010
It appeared that the controversy surrounding the prostate cancer immunotherapy Provenge ended with FDA approval in April. But now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
Is $93,000 beyond the upper limit of what a drug company can charge for a non-curative cancer therapy when the government is the primary payer? That may be one interpretation of a recent action by the Centers for Medicare & Medicaid Services (CMS) to review its coverage policy for Dendreon’s prostate cancer cell-based immunotherapy Provenge.

Although the looming fight between Dendreon and CMS appears to be specific to the product in question, there is a larger lesson for other biopharmaceutical companies, particularly those operating in cancer drug development: as the government becomes an increasingly large payer, it is paying closer attention to what officials may see as exorbitant pricing practices.

And CMS has the tools at its disposal to force a de facto price negotiation—or go down fighting.

At the very least, the case of Provenge serves as another reminder that there are two regulators in Washington—not one—that are critical in determining a product’s commercial success. Approval by the Food & Drug Administration (FDA) remains, of course, a defining milestone for biotech companies and their investors, but satisfying CMS can be just as critical, especially in the field of oncology where Medicare is the dominant payer.

CMS may end up covering Provenge without limitation, or it may end up putting restrictions on coverage that have no real impact on a product that is going to be in relatively tight supply for the near future. But simply by initiating the review, the agency is encouraging public conversation about the value of the therapy.

That certainly has the attention of investors—and may be a sign of things to come for the biopharma sector overall.

Provenge Clears One Regulatory Hurdle, Faces Another

It’s almost never a good thing when your drug is the topic of daily conversations at CMS. That’s exactly the situation Dendreon found itself in with Provenge.

Investors cheered when Provenge was approved by FDA on April 29. The stock price rose as the days grew closer to Dendreon’s user fee date for Provenge as investors correctly anticipated that the product would complete its turnaround from a devastating “complete response” letter sent three years earlier. Even after the run-up, the stock increased by almost 35% the day the approval letter was disclosed, bringing its year-to-date increase to 100%. All that on top of a 10-fold price increase in 2009.

It looked to be the successful end of a long, up-and-down journey for the biotech company. During a same-day conference call announcing the Provenge approval, CEO Mitchell Gold declared that Dendreon had found the “Holy Grail of oncology” and that the company would begin a rollout of Provenge the following week.

The price? $93,000 for a three-course cycle; or $31,000 per infusion…

Even though breakthrough oncology therapies typically can garner an attractive premium compared with drugs in other therapeutic areas, the high price surprised even the most bullish Provenge watchers who had been following the progress of the cell-based immunotherapy.

Would reimbursement be a problem at that price, especially considering approximately 75% of patients who will use Provenge are Medicare beneficiaries?

Dendreon anticipated that Medicare and private payors would cover the costs of Provenge, Gold said, and a company official noted that the prostate cancer therapy Taxotere cost roughly $60,000 for a full treatment, making it “very close” to Provenge. The company also highlighted the cost advantage of Provenge as a defined, three-course regimen rather than a more typical open-ended course of therapy.

In the end, the price, Dendreon said, represented and “advantageous cost/value structure.”

Moreover, Dendreon planned to rollout Provenge to only 2,000 patients in the first 12 months, translating to a $110 million cost—not typically a sum that grabs a lot of attention when it comes to the large Medicare program.

CMS Opens a National Coverage Analysis

However, CMS was paying attention.

In a shocking move, CMS announced on June 30th that it had opened a national coverage analysis (NCA) for Provenge to determine whether the therapy is “reasonable and necessary.”

The Medicare agency said specifically: “CMS opens this NCA for autologous cellular immunotherapy treatment of prostate cancer. CMS is requesting public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer…CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review. CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in 2010.” The National Coverage Decision is expected in March 2011.

How big an impact did CMS’ announcement have? For Wall Street, it is simple: CMS’ decision to review coverage of the therapy erased all the gains from the approval of the product; with the stock dropping all the way back to the levels it had in January.

Put another way, investors seem to feel that the uncertainty surrounding the coverage policy means as much to the value of the company as did the uncertainty around FDA’s regulatory decision.

Using an alternative metric, based on Dendreon’s market cap of approximately $7.3 billion the day following FDA approval, Dendreon would have to give Provenge to more than 78,000 men with prostate cancer to meet the cap number. Following the CMS announcement, the number of prostate cancer patients dropped to just over 41,000 needed to meet the $3.9 billion market cap in early July.

And investors wondered: If CMS is taking on Provenge, will it take on other cancer therapies, like Roche AG’s Avastin, Herceptin and Rituxan?

The answer to that question is: it just might.

All indications are that the decision to review Provenge was triggered by specific circumstances surrounding what is, after all, a completely new type of therapy: a cell-based cancer “vaccine.” In that sense, it is probably an over-reaction to read into CMS’ decision a blanket review of coverage of all high-priced cancer therapies currently in use and in the pipeline.

But, having opened up the conversation in this specific context, there is nothing to stop CMS from expanding its reach and looking more broadly at what everyone in the healthcare policy world agrees is a key issue for the future: the exploding cost of cancer treatment in the U.S.

The Wrong Approach

It appears to have been a confluence of four factors that led to the NCA for Provenge: the price, Dendreon’s lack of communication with CMS, noise from private payers, and an agreement between FDA and CMS to facilitate the exchange of information.

First off, there are indications that CMS was unhappy that Dendreon did not talk with agency officials much earlier in the development and review process, given the certainty that Medicare would be the primary payer for the new therapy. During the April 29 conference call, Dendreon essentially admitted it was not focused on CMS early on, saying it planned to meet with agency officials the week of May 3 to discuss reimbursement issues.

The lack of communication is one thing; the pricing decision is another. After hearing the price set by Dendreon for Provenge, some CMS officials became concerned about the high cost. At that point, the immunotherapy began being discussed regularly at the agency.

At the same time, CMS was hearing concerns from medical directors at private insurers who were complaining about the sticker-shock price.

Almost serendipitously from CMS’ point of view, a memorandum of understanding (MoU) was signed between the Medicare agency and FDA “to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the federal partners.”

The MoU provides a framework for CMS medical experts and coverage analysis group to get full access to Dendreon’s study data of Provenge.

CMS’ decision to initiate an NCA may be nothing more than a back-door price negotiation.

It wouldn’t be the first time. Biogen Idec expected to get a payment code soon after launching its diagnostic/radiotherapeutic agent ibritumomab (Zevalin). The code was delayed for several months and then was set at 78% of Average Wholesale Price (AWP) as opposed to the much better rate of AWP-5%. Subsequently, Zevalin took another hit when CMS reclassified it as a procedure rather than a drug, giving it an even lower reimbursement rate.

What happened? CMS leadership became aware that Biogen had set Zevalin’s AWP at about $30,000 and communicated to the company that either there needed to be a price cut or Biogen could keep waiting for a coverage code. Eventually, the agency and Biogen were able to reach a compromise, but Zevalin never reached the commercial success that Biogen had hoped for.

CMS’ Options: Many or Few?

The Zevalin issue, however, took place outside of the “official” coverage process; with Provenge, CMS is going by the books, and that means there really isn’t much room for Dendreon to make an accommodation on price.

Here is how CMS officials see the options for a potential national coverage decision:

(1) Coverage

(2) Coverage with evidence development

(3) Coverage for on-label use only and blanket non-coverage for off-label use

(4) More restrictive coverage affecting even on-label use

(5) Blanket non-coverage

However, under the applicable Medicare statute, it appears as though CMS is relatively boxed in, and will have to cover, at the very least, the labeled uses of the therapy.

Sec. 1861(t)(2)(A) of the Medicare statute defines “drugs” to include “any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.”

The description under the law of a medically accepted indication: “includes any use which has been approved by the Food and Drug Administration for the drug and such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or the carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this sub-clause by the Secretary.”

Still, there is ambiguity about whether CMS could in fact deem an FDA-approved drug to be not “reasonable or necessary” despite the definition, and some officials within CMS believe the therapy should not be covered, citing skepticism over the study data used to support FDA approval.

If CMS were to attempt to move away from routine coverage of cancer drugs, it would indeed have dramatic implications for the biopharma sector and the scientific inquiry and development of novel cancer therapeutics.

Copyright CancerNetwork.com 2010

Using Finasteride Sor PCa Prevention?

Few Doctors Prescribe Finasteride to Prevent Prostate Cancer, Despite Effectiveness
by Thomas H. Maugh II | Los Angeles Times | 08.11.2010
Most physicians are reluctant to prescribe the drug finasteride to prevent prostate cancer in older men with elevated risk of the disease, despite evidence that the drug can reduce risk by about a quarter, researchers said Tuesday.

"There are no other proven ways of reducing yours risk of prostate cancer -- this is the only one," Dr. Ian M. Thompson of the University of Texas Health Science Center in San Antonio, told Bloomberg. Its use could reduce new diagnoses by "tens of thousands," he said.

Thompson was the lead author of a 2003 report that showed that the drug, sold by Merck under the brand name Proscar, could reduce the risk of prostate cancer among such men from 24% to 18%. Another study earlier this year showed that a second drug, dutasteride, might be even slightly more effective.

About 217,730 men will be diagnosed with prostate cancer this year, according to the National Cancer Institute, and about 32,000 will die from it. That makes it the second-leading cause of cancer death among men, following only lung cancer.

Risk factors for prostate cancer include being over the age of 65, having elevated levels of prostate-specific antigen (PSA), a family history of the disease and being African American.

In the new study, Dr. Linda S. Kinsinger of the Veterans Health Administration National Center for Health Promotion and Disease Prevention and her colleagues surveyed a random sample of 325 VHA urologists and 1,200 VHA primary care physicians to determine how their prescribing practices changed from 2000 through 2005, a period that included the widely heralded finasteride trial.

The researchers reported in the September issue of the journal Cancer Epidemiology, Biomarkers & Prevention that the use of finasteride did increase somewhat during the period, but to treat benign prostatic hyperplasia, not to prevent prostate cancer. Fully 64% of urologists and 80% of primary-care physicians said they never prescribed the drug for prevention, and 52% of the latter group said they did not even know that the drug could be used for that purpose.

One concern among urologists was that the 2003 study suggested that, even though finasteride reduced the risk of prostate cancers, those who did develop the disease might be more likely to develop a highly aggressive form of the disease. Researchers have subsequently shown, however, that that was an artifact of the study and that the drug doesn't increase the risk of such tumors.

"The prospect of chemoprevention is a difficult one for patients and physicians," Kinsinger said in a statement. She compared using finasteride to ward off prostate cancer to using statins to ward off heart disease.

The primary difference between the two, she added, is that the effects of statins can be monitored by measuring cholesterol levels, but there is no analogous marker to show that finasteride is working. The only marker is not developing cancer.

The primary side effect of finasteride is that it increases hair growth. In fact, the drug is also sold under the brand name Propecia to promote new hair growth in the balding. The amount of drug in Propecia is about 20% of that in Proscar.

Copyright Los Angeles Times 2010




Initial Savings May Hide True Cost of Prostate Cancer Care
U.S. News & World Report | 08.23.2010




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National Cancer Institute's Clinical Trials

Click Here for more information and links to surveys


Multiple trials


Prostate cancer trials at the NIH Clinical Center in Bethesda, MD [080706]


NCI currently conducting trials for patients with prostate cancer -- The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), conducts more than 150 clinical trials at the NIH Clinical Center in Bethesda, MD. NCI is currently conducting clinical trials for patients with prostate cancer.

Visit http://bethesdatrials.cancer.gov/prostate for a listing of prostate cancer clinical trials that are currently enrolling patients at the NIH Clinical Center.

There is no charge for medical care received at the NIH Clinical Center. Study participants will be responsible for travel costs for their initial screening visits. Once participants are enrolled in a trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients.

For more information on clinical trials conducted at NCI, please visit http://bethesdatrials.cancer.gov or call the Clinical Trials Referral Office (formerly Clinical Studies Support Center) at 1-888-NCI-1937 (1-888-624-1937).

The National Cancer Institute also sponsors clinical studies at cancer centers nationwide. To learn more about these studies, call 1-800-4-CANCER (1-800-422-6237).

Hormone refractory/hormone resistant PCa

AFFIRM (A Study Evaluating the EFFicacy and Safety of Investigational DRug MDV3100 in Men with Advanced Prostate Cancer) [012010]

Now enrolling patients, this trial will evaluate the efficacy and safety of the investigational drug MDV3100 as a treatment for advanced prostate cancer – specifically a type known as hormone-resistant prostate cancer. The study will evaluate the impact of MDV3100 on survival and other factors, including quality of life.

The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than the most commonly used anti-androgen, bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone from binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA. Preclinical data published in Science demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

Patients who were previously treated with the chemotherapy drug docetaxel may be eligible for the study. Two-thirds of patients will randomly be assigned to receive MDV3100 while 1/3 will receive placebo (sugar pill), which does not contain active medicine.

For more information on eligibility and enrollment, patients can call the AFFIRM study hotline toll-free at 1-888-782-3256 or visit www.affirmtrial.com

Dr Patriclk Walsh on Selectiing Your Surgeon

Dr. Patrick Walsh, former director of Johns Hopkins's Brady Urological Institute, shares his insights on choosing a doctor for your cancer surgery.

Dr. Patrick Walsh, dean of prostate cancer surgeons, has performed the technically challenging radical prostatectomy procedure thousands of times, and has personally schooled hundreds of surgeons in the finer points of the difficult nerve-sparing cancer operation. He certainly knows what it takes to be an expert in curing a man of cancer, preserving bladder function, and maintaining the nerves responsible for erections. What about the doctor you're considering for your own prostate cancer surgery?

"Your doctor may be nice and personable," says Dr. Walsh, "a practitioner whose empathy for your condition appeals to you, which is great. But what do you know about him? He's got a terrific bedside manner, but is he a board-certified urologist? What training has he had? Does he know and use the nerve-sparing cancer surgery techniques -- the anatomical approach to radical prostatectomy? How many of these cancer surgeries does he perform annually? What success has he had in preserving potency and continence? If he can't or won't give you his rate of success as compared to reports from other surgeons, or to results published in medical journals, this may be a red flag, and perhaps you should look elsewhere for your cancer surgeon.

"You should be able to get a good idea of his success rate in numbers or percentages. In addition, if he hasn't done very many of these cancer operations -- ideally, hundreds -- you might want to find a more experienced surgeon. Look at it this way: Do you want to be one of the patients he's learning on? Do you want to be part of someone's learning curve?


"Remember: You don't want a surgeon who's "pretty good" at removing the prostate. There are no second chances here: This is a one-shot operation. You are looking for the one surgeon who will perform the one radical prostatectomy you will ever receive in your life, the one operation that will cure your cancer.

"You want a surgeon who is going to make sure that no cancer is left behind, and who knows how to minimize trauma to your body during surgery so you don't wind up with incontinence, erectile dysfunction, or both.

"Finding the right surgeon may mean that you must travel to a major medical center in another city. This may mean that you'll be away from home for four days. But after that, even though you may need to wear a catheter for a week or two, the recovery from the operation is usually speedy, and follow-up communication can be carried out over the telephone."

IDing Which of the 24 Types of PCa You Have

Some 218,000 American men will be diagnosed with prostate cancer this year.
An estimated 85% of those
tumors will grow so slowly that they will never cause problems. But the rest
are aggressive and lethal. As of now,
there's no way to tell early on which cancers are which, so tens of
thousands of men undergo surgery or radiation
each year for cancers that never needed treatment, risking impotence or
incontinence in the process.
Several recent genetic discoveries could help doctors evaluate how
aggressive a man's prostate cancer is much
earlier. Scientists at the University of Michigan have identified at least
24 different kinds of prostate cancer of
varying virulence whose DNA signatures can be read like a bar code. Memorial
Sloan-Kettering Cancer Center
researchers have identified other genetic subtypes of prostate cancer that
seem to predict whether the tumor will
be low or high risk. And Harvard Medical School scientists have found a
specific gene that causes prostate
cancers to spread. Some of the discoveries also could lead to new
treatments, tailored specifically for the kind of
prostate tumor a man has.

.

Transdermal Estradiol Therapy for Prostate Cancer

Transdermal Estradiol Therapy for Prostate Cancer
Reverses osteoporosis of androgen suppression, reduces blood clot risk compared with oral estrogen
by Jacqueline Strax

August 11, 2005 -- Can a hormonal therapy for men with advanced prostate cancer move forward by going "back to the future"? As an alternative to standard androgen suppressing drugs like Lupron and Zoladex, some doctors and patients in the US and the UK are looking at estradiol patches.

Tomasz Beer in Oregon and Paul Abel and Jeremy Ockrim in the UK have shown that estradiol patches are effective. Because transdermal estradiol enters the bloodstream through the skin, without passing through the liver, the patches cause fewer cardiovascular side effects than oral estrogen. And compared with Lupron and Zoladex, estradiol patches seem to reduce andropause symptoms and protect against osteoporosis.

Men treated with Lupron and Zoladex experience acute onset andropause ("male menopause"). Most men experience hot flashes, and some report emotional changes and loss of libido, or sex drive.

Osteoporosis, a silent side effect, which can lead to hip or spinal fracture, is another problem with the conventional drugs, especially for white men and men who arenot overweight.

Estradiol dose can be controlled by number of patches used, placement on the body and how often patches are changed. Some men use dispenser-measured doses of estradiol gel. The gel method has not yet been tested in clinical studies, but studies have been done using estradiol patches and results look positive.

Dr. Beer at Oregon Health and Science University and Portland Veterans Affairs Medical Center tested the safety and efficacy of transdermal estradiol (TDE) and the effect on hot flashes, sex hormones, the procoagulant cascade, and bone turnover in patients with androgen independent prostate cancer (AIPC).

In the Oregon study, patients progressing after primary hormonal therapy received transdermal estradiol at a rate of 0.6 mg per 24 hours (administered as six 0.1 mg per 24-hour patches replaced every 7 days). Serum prostate-specific antigen (PSA) and hormone levels, coagulation factors, markers of bone turnover, bone density measurements, and a hot flash diary were collected at regular intervals. Median time to disease progression was 12 weeks.

Three of 24 patients (12.5%) had a confirmed PSA reduction of greater than 50 per cent. Estradiol levels in the blood increased from mean starting level of 17.2 pg.mL to 460.7 pg/mL (range, 334.6-586.7 pg/mL). Total testosterone remained suppressed to castrate levels during treatment, "but the free testosterone level decreased as a result of increased sex hormone binding globulin." Toxicity was "modest" Beer says, "and no thromboembolic complications occurred."

Jeremy Ockrim and Paul Abel At Hammersmith Hospital, London, say transdermal estradiol patches are an effective alternative to current androgen deprivation therapy. In a small pilot study men were given transdermal estradiol patches for 1 year with follow up of 15 months.

The patches produced "an effective tumor response" Abel says. Cardiovascular toxicity was substantially reduced compared with that expected of oral estrogen."The changes in the coagulation parameters suggest down regulation of the hypercoaguable state inherent to advanced prostate cancer," Abel says.

"Transdermal estradiol therapy prevented andropause symptoms" and "improved quality of life scores and increased bone density," Ockrim and Abel say. A common side effect of androgen suppression, gynecomastia (breast enlargement and soreness) was "negligible."

Estradiol levels above 1,000 pmol./l. were achieved using 2 patches and higher levels were obtained by increasing the number of patches. All patients achieved castrate levels of testosterone within 3 weeks and had biochemical evidence of disease regression. However, one patient died of disease at 14 months and 1 cardiovascular complication occurred.

The patches avoided the clotting problem (hypercoaguable state) associated with estrogen therapy (This is especially important because blood clots are associated with prostate cancer as such). Vascular flow improved. Bone mineral density was significantly increased. Mild or moderate gynecomastia occurred in 80% of patients but no patient had hot flushes. All other functional and symptomatic quality of life domains improved.

The effect on bone mineral density looks especially impressive. Ockrim measured patients for bone bone mineral density of the lumbar spine and the proximal femur with dual-energy x-ray absorptiometry, and correlated with computerized tomography and isotope bone scan findings at 6-month intervals. He found that transdermal estradiol patches improved bone mineral density of men with prostate cancer.

In 20 patients treated with transdermal estradiol patches, in all measured regions bone mineral density increased with time. By 1 year mean bone mineral density had increased by 3.60% +/- 1.6% in the lumbar spine, 2.19% +/- 1.03% in the femoral neck, 3.76% +/- 1.35% in the Ward's region and 1.90% +/- 0.85% in the total hip, respectively. Of 12 osteoporotic sites 4 had improvement based on World Health Organization grading. All other sites improved toward a better classification.

Signs of osteoporosis have been seen in some men's bone density scans within 6 months of their first shot of Lupron, although not all men develop it.

"Patients with prostate cancer treated with androgen suppression are at risk for skeletal fracture," Martin Resnick at Case Western Reserve reported in 2001, "and risk increases with the duration of therapy. Slender white men are at greatest risk. Conversely, black men and those with body mass indexes greater than normal (greater than 25 kg/m(2)) are at minimal risk despite a prolonged duration (10 years) of androgen suppression."

Bone density loss can be delayed and even reversed by biphosphonates (also called bisphosphonates and diphosphonates) , notably Zometa, a powerful drug given by rapid intravenous injection. (Less potent drugs in this class include Aredia, Actonel and Fosomax). Biphosphinates may also prevent prostate (and breast) cancer lesions from breaking down bone. Unfortunately, these drugs can cause osteonecrosis, a rare but incurable, painful condition. Some cancer patients and women with osteoporosis taking biphophonates have developed osteonecrosis (patches of dead, crumbling bone) in the jaw or elsewhere after dental extraction, trauma or fever.

Lupron was first approved by the FDA in 1985 for palliative treatment of men with advanced prostate cancer. The drug is made by Deerfield, Ill.-based TAP Pharmaceuticals Inc., which is a joint venture of Abbott Laboratories and Takeda Chemical Industries, Japan's largest drug company. The Food and Drug Administration approved Lupron and Zoladex without requiring research into their long term effects on mens' quality of life. Studies done for FDA approval purposes lasted for six weeks.

Standard treatments for advanced prostate cancer at the time were limited to surgical castration or relatively high-dose oral estrogen. The high doses of estrogen increased mens' risks of blood clots, deep vein thrombosis, pulmonary embolism and heart attacks. Lupron and Zoladex carry no increased risk of blood clot or heart attack.

In the USA Medicare covers most of the cost of Lupron, Zoladex and other drugs in that class. Younger men are not eligible for coverage, though, unless they are Veterans. Drugs like Casodex and Flutamide, which allow testosterone to circulate in the man's body while preventing it from docking in androgen receptors, are not covered by Medicare.

Cost should never be a prime motive for choosing one cancer therapy over another. But this is an undeniable factor. As Dr. Ockrim says, estradiol is available for " a tenth of current therapy cost, with the potential for considerable economic savings over conventional hormone therapies."

L

Introduction to the New ProstRcision Surgery

The Highest Documented Cure Rate for Prostate Cancer

The two methods with the highest proven cure rate for prostate cancer are ProstRcision and radical prostatectomy. No other method offers the same cure rates. However, there are significant differences between these two procedures. With ProstRcision, we remove the cancer without damaging urinary muscles, so your existing level of urinary control does not change. And equally important, because nothing is cut with ProstRcision, sex nerves are spared, thus the vast majority of men maintain their sexual function.

As with any cancer, you and your family members are faced with a challenging road ahead, and no doubt, countless questions and concerns. We believe the single most important thing you can do is to perform your own personal research on prostate cancer, including knowing all your treatment options, before making a decision

Neoadjuvant Treat ent with Taxotere

Neoadjuvant treatment with Taxotere® (docetaxel) and Emcyt® (estramustine) for high-risk localized prostate cancer appears to be safe and produces promising responses compared with standard treatment, according to the results of a Phase III randomized study presented at the 2010 Genitourinary Cancers Symposium in San Francisco

Prostate Cancer & Blood Clots

Prostate Cancer and the Increased Risk of Blood Clots (4/23/2010)
Men with prostate cancer are at a higher risk for several types of thromboembolic diseases (blood clots), with men undergoing endocrine therapy having the highest risk, according to the results of a study published in the Lancet Oncology

Radiation Hip fractueres, and New Statins Information

Men treated with external beam radiation therapy for prostate cancer may have an increased risk of hip fracture, according to data presented at the 2010 Annual Scientific Meeting of the American Urological Association.

Statin Use May Lower Risk of Prostate Cancer Recurrence (6/3/2010)
It appears that, among men who have undergone radiation therapy for early prostate cancer, use of statins may lower risk of recurrence, according to a study published in the Journal of Clinical Oncology.

Provenge's Successful Phase III Test

PROVENGE® FOR HORMONE-REFRACTORY PROSTATE CANCER
CancerConsultants.com, 08/11/2010

Among men with metastatic, hormone-refractory prostate cancer, the immunotherapy agent Provenge® (sipuleucel-T) improves survival by roughly four months. The findings from this Phase III study were recently published in The New England Journal of Medicine

Duodart Treats E larged Prostate

March 31, 2010
LONDON - Pharmaceutical company GlaxoSmithKline PLC said Wednesday it has received European approval for Duodart, a two-in-one drug for the treatment of the symptoms of an enlarged prostate. The drug is a combination of dutasteride, currently marketed as Avodart, and tamsulosin, a generic drug marketed by Astellas Pharma as Flomax. Glaxo received backing for the drug from Germany under the European Union's decentralized approval procedure, meaning it is applicable across the 27-member bloc. The company said national licenses are expected to be granted throughout the year

Canines May Smell Prostate Cancer

Dogs May Be Able to Smell Prostate Cancer

Dogs may be able to smell the presence of prostate cancer in patient urine samples, according to data presented at the 2010 Annual Scientific Meeting of the American Urological Association (AUA).

Volatile organic compounds (VOCs) are organic chemical compounds that are derived from a number of man-made and biologic sources, including cancer cells. Data have indicated that concentrations of VOCs differ according to age and produce a scent to which animals may be particularly sensitive. Researchers have been evaluating the capability among dogs to detect cancer by scent; previous research has focused on breast, lung, and bladder cancers.

To investigate whether prostate cancer tumors may excrete certain VOCs through urine that dogs can detect by scent, researchers in Paris trained dogs to recognize the scent of VOCs from prostate cancer cells. The dogs were then trained to distinguish between urine from prostate cancer patients and urine from individuals without cancer. Following this training, the dogs were presented with five urine samples, only one of which came from a patient with confirmed cancer. The animals were instructed to identify the samples from cancer patients.

A total of 66 urine samples were used in the study; of these, the dogs correctly classified 63—meaning in 63 of the 66 samples, they accurately identified which samples were from prostate cancer patients and which were not. The dogs correctly identified 100% of urine samples from cancer patients and correctly classified 91% of samples from people without cancer.

According to the AUA Public Media Committee Chair Anthony Y. Smith, MD, “These data suggest that prostate cancer tumors may excrete certain VOCs that turn up in a patient’s urine and that this ‘scent’ may be specific to prostate cancer.” The next step will be to determine what those VOCs are and to develop a test that can identify them. Further development of accurate screening tests for prostate cancer is an important area of research, as the accuracy of the current primary screening method—the prostate-specific antigen (PSA) test—remains suboptimal.

Reference: Cornu J-N, Girardet C, Cancel-Tassin G et al. The use of canines for prostate cancer detection: towards a non-invasive alternative screening tool. Presented at the 2010 annual meeting of the American Urological Association. May 29-June 3, 2010. San Francisco, CA. Abstract 2159.