Commenter: Schellhammer, Paul
Title: professor of urology
Organization: urology of virginia/eastern virginia medical school
Date: 07/26/2010
Comment:
I have had experience with delivery of ACI
(Provenge) over the past 10 years in their
multiple trials. I am very favorably impressed
by the clinical trial survival benefit and the
lack of toxicity. I am interested in offering
this to patients with far-advanced prostate
cancer. Please make it possible for me to do so
at the completion of review, and in the interim,
please provide a directive for current coverage.
Men who have to wait one year for a review may
indeed die or become too ill before this
treatment is available. The majority of the men
who participated in clinical trials with active
cellular immunotherapy were over the age of 65,
were found to benefit significantly from therapy,
and should not be denied the opportunity for this
therapy now and over the next year due to
reimbursement issues
The treatment is reasonable because it is not
associated with significant toxicity ( Much less
than chemotherapy (docetaxel) and it is necessary
because it provides better survival outcomes than
chemotherapy (docetaxel). Currently docetaxel is
FDA approved and reimbursed for this group of
patients. ACI is safer and more effective and
likely will be proven to be more cost-effective
as well absent the management of toxicities.
Paul Schellhammer MD
Thursday, July 29, 2010
From: J Manarite
Subject: Re: [Prostatecanceraction] Trailblazers (Medicare) & Provenge
To: "ProstateCancer Action"
Date: Thursday, July 29, 2010, 12:01 PM
I've been trying to do my homework on this, so here's what I know about Trailblazers - Correct me if I'm Wrong -
First of all, remember there are 2 separate Medicare/Provenge issues happening right now. One is the CMS (national Medicare) which the Public Comment is part of. This process is called an NCA or an NCD, and onces it is started, will take close to a year to be complete. This is not the Traiblazer issue.
- - - - - - - - - -
So, here's the Trailblazers issue. While CMS is conducting their NCA, the local/state Medicare Carriers (MAC's) can pay for Provenge. It looks like this:
10 different MAC's, (only 3 have written policies covering Provenge - 7 do not. Traiblazers is one of the 7.)
15 different jurisdictions covering (only 5 have written policies covering Provenge - 10 do not.)
50 states + D.C. + 5 US territories (only 12 states + 2 US territories have written policies covering Provenge)
plus a little bit of arm wrestling in the court system over which MAC has which jurisdiction
So, here is what Traiblazers' jurisdiction currently looks like (to the best of my knowledge)
* Jurisdiction 4 (J4)- Trailblazers Health Enterprises - Colorado, New Mexico, Oklahoma, Texas
* Jurisdiction 11 (J11) - North Carolina, Virginia - Currently Trailblazers Health Enterprises, but Awarded to Palmetto GBA? - (dependent on expected Sept court ruling)
I think the take-home message is that advocates in CO, NM, OK, TX, NC, SC, VA, and WV might get together and start communications with Trailblazers.
correction (from Scott Riccio@ Dendreon) - SC and WV are NOT Trailbalzers for Medicare part B. They are Palmetto, so they are getting Provenge paid for. Good news.
At this point, we are not only advocating for the patients, we are advocating for and with the physicians. Think about the key physicians in the Trailblazer states that have their hands tied re: Provenge reimbursement. Here's one - E David Crawford posted today on Public Comment. Plus - Provenge PI's - Dr Logothetis, Dr Schellhammer - somebody add names, because I know there's more.
I am working on Florida.
Jan Manarite
PCRI Florida Educational Facilitator
(239) 395-0995
--------------------------------------------------------------------------------
From: kmeadelist@aec225.com
To: prostatecanceraction@malecare.com
Date: Wed, 28 Jul 2010 23:12:49 -0400
Subject: Re: [Prostatecanceraction] Medicare & Provenge - an update or 2
I was just told by the wife of a patient in New Mexico that Trailblazer has said they will not pay for Provenge and they were told by the doctor today that he can’t get Medicare/Trailblazer to pay for Jevtana for prostate cancer. She is very upset because these were his last treatment options.
Kathy
From: prostatecanceraction-bounces@malecare.com [mailto:prostatecanceraction-bounces@malecare.com] On Behalf Of J Manarite
Sent: Thursday, July 22, 2010 6:40 PM
To: ProstateCancer Action
Subject: [Prostatecanceraction] Medicare & Provenge - an update or 2
First of all, the CMS public comment (part of a national process that will take almost a year) is a separate issue than the individual Medicare Carrier decisions (which can happen now). So, here's what I've learned.
- - - - - - - -
*Current Status -
Individual Medicare Carriers & their states (Jurisdictions)
Provenge Policy IN WRITING? (when)
Jurisdiction 1 (J1) Palmetto GBA- American Samoa, California, Guam, Hawaii, Nevada, Northern Mariana Islands - YES (May '10)Jurisdiction 2 (J2)- Alaska, Idaho, Oregon, Washington - Awarded to National Heritage Insurance Company - ? (Jim Kiefert may know more)
Jurisdiction 3 (J3)- Noridian Administrative Services -Arizona, Montana, North Dakota, South Dakota, Utah, Wyoming - NO
Jurisdiction 4 (J4)- Trailblazers Health Enterprises - Colorado, New Mexico, Oklahoma, Texas - NO
Jurisdiction 5 (J5)-Wisconsin Physician Services Health Insurance Corporation- Iowa, Kansas, Missouri, Nebraska - NO
Jurisdiction 6 (J6) - Illinois, Minnesota, Wisconsin- Awarded to Noridian Administrative Services * -NO
Jurisdiction 7 (J7) - Arkansas, Louisiana, Mississippi - Awarded to Pinnacle Business Solutions Inc.* -NO
Jurisdiction 8 (J8) - Indiana, Michigan - Awarded to National Government Servces * - NO
Jurisdiction 9 (J9)-First Coast Service Options-Florida, Puerto Rico, United States Virgin Islands - NO
Jurisdiction 10 (J10) -Cahaba Government Services -Alabama, Georgia, Tennessee - NO
Jurisdiction 11 (J11)-North Carolina, South Carolina, Virginia, West Virginia - Awarded to Palmetto GBA? - not yet, but YES (dependent on expected Sept court ruling)
Jurisdiction 12 (J12)-Highmark Medicare Services -Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania -NO
Jurisdiction 13 (J13)-National Government Services -Connecticut, New York - YES (July '10)
LINK: http://www.ngsmedicare.com/sia/ARTICLE%20%20Sipuleucel_T_ProvengeRelatedtoLCDL25820_A50060.htm
Jurisdiction 14 (J14) - National Heritage Insurance Company - Maine, Massachusetts, New Hampshire - NO
Jurisdiction 15 (J15) -Kentucky, Ohio- Awarded to Highmark Medicare Services * - NO
Subject: Re: [Prostatecanceraction] Trailblazers (Medicare) & Provenge
To: "ProstateCancer Action"
Date: Thursday, July 29, 2010, 12:01 PM
I've been trying to do my homework on this, so here's what I know about Trailblazers - Correct me if I'm Wrong -
First of all, remember there are 2 separate Medicare/Provenge issues happening right now. One is the CMS (national Medicare) which the Public Comment is part of. This process is called an NCA or an NCD, and onces it is started, will take close to a year to be complete. This is not the Traiblazer issue.
- - - - - - - - - -
So, here's the Trailblazers issue. While CMS is conducting their NCA, the local/state Medicare Carriers (MAC's) can pay for Provenge. It looks like this:
10 different MAC's, (only 3 have written policies covering Provenge - 7 do not. Traiblazers is one of the 7.)
15 different jurisdictions covering (only 5 have written policies covering Provenge - 10 do not.)
50 states + D.C. + 5 US territories (only 12 states + 2 US territories have written policies covering Provenge)
plus a little bit of arm wrestling in the court system over which MAC has which jurisdiction
So, here is what Traiblazers' jurisdiction currently looks like (to the best of my knowledge)
* Jurisdiction 4 (J4)- Trailblazers Health Enterprises - Colorado, New Mexico, Oklahoma, Texas
* Jurisdiction 11 (J11) - North Carolina, Virginia - Currently Trailblazers Health Enterprises, but Awarded to Palmetto GBA? - (dependent on expected Sept court ruling)
I think the take-home message is that advocates in CO, NM, OK, TX, NC, SC, VA, and WV might get together and start communications with Trailblazers.
correction (from Scott Riccio@ Dendreon) - SC and WV are NOT Trailbalzers for Medicare part B. They are Palmetto, so they are getting Provenge paid for. Good news.
At this point, we are not only advocating for the patients, we are advocating for and with the physicians. Think about the key physicians in the Trailblazer states that have their hands tied re: Provenge reimbursement. Here's one - E David Crawford posted today on Public Comment. Plus - Provenge PI's - Dr Logothetis, Dr Schellhammer - somebody add names, because I know there's more.
I am working on Florida.
Jan Manarite
PCRI Florida Educational Facilitator
(239) 395-0995
--------------------------------------------------------------------------------
From: kmeadelist@aec225.com
To: prostatecanceraction@malecare.com
Date: Wed, 28 Jul 2010 23:12:49 -0400
Subject: Re: [Prostatecanceraction] Medicare & Provenge - an update or 2
I was just told by the wife of a patient in New Mexico that Trailblazer has said they will not pay for Provenge and they were told by the doctor today that he can’t get Medicare/Trailblazer to pay for Jevtana for prostate cancer. She is very upset because these were his last treatment options.
Kathy
From: prostatecanceraction-bounces@malecare.com [mailto:prostatecanceraction-bounces@malecare.com] On Behalf Of J Manarite
Sent: Thursday, July 22, 2010 6:40 PM
To: ProstateCancer Action
Subject: [Prostatecanceraction] Medicare & Provenge - an update or 2
First of all, the CMS public comment (part of a national process that will take almost a year) is a separate issue than the individual Medicare Carrier decisions (which can happen now). So, here's what I've learned.
- - - - - - - -
*Current Status -
Individual Medicare Carriers & their states (Jurisdictions)
Provenge Policy IN WRITING? (when)
Jurisdiction 1 (J1) Palmetto GBA- American Samoa, California, Guam, Hawaii, Nevada, Northern Mariana Islands - YES (May '10)Jurisdiction 2 (J2)- Alaska, Idaho, Oregon, Washington - Awarded to National Heritage Insurance Company - ? (Jim Kiefert may know more)
Jurisdiction 3 (J3)- Noridian Administrative Services -Arizona, Montana, North Dakota, South Dakota, Utah, Wyoming - NO
Jurisdiction 4 (J4)- Trailblazers Health Enterprises - Colorado, New Mexico, Oklahoma, Texas - NO
Jurisdiction 5 (J5)-Wisconsin Physician Services Health Insurance Corporation- Iowa, Kansas, Missouri, Nebraska - NO
Jurisdiction 6 (J6) - Illinois, Minnesota, Wisconsin- Awarded to Noridian Administrative Services * -NO
Jurisdiction 7 (J7) - Arkansas, Louisiana, Mississippi - Awarded to Pinnacle Business Solutions Inc.* -NO
Jurisdiction 8 (J8) - Indiana, Michigan - Awarded to National Government Servces * - NO
Jurisdiction 9 (J9)-First Coast Service Options-Florida, Puerto Rico, United States Virgin Islands - NO
Jurisdiction 10 (J10) -Cahaba Government Services -Alabama, Georgia, Tennessee - NO
Jurisdiction 11 (J11)-North Carolina, South Carolina, Virginia, West Virginia - Awarded to Palmetto GBA? - not yet, but YES (dependent on expected Sept court ruling)
Jurisdiction 12 (J12)-Highmark Medicare Services -Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania -NO
Jurisdiction 13 (J13)-National Government Services -Connecticut, New York - YES (July '10)
LINK: http://www.ngsmedicare.com/sia/ARTICLE%20%20Sipuleucel_T_ProvengeRelatedtoLCDL25820_A50060.htm
Jurisdiction 14 (J14) - National Heritage Insurance Company - Maine, Massachusetts, New Hampshire - NO
Jurisdiction 15 (J15) -Kentucky, Ohio- Awarded to Highmark Medicare Services * - NO
Thursday, July 8, 2010
Calcium & Vit E Supplements Don't Cause Disease
Daily Health News: Calcium, Vitamin D Supplements OK for Arteries
No evidence of raised stroke or heart risks in those taking moderate doses, researchers say
--------------------------------------------------------------------------------
7/5/2010
(HealthDay News) -- Moderate doses of calcium and vitamin D supplements don't raise women's coronary artery calcium (CAC) levels, a new study finds.
Deposits of calcium in blood vessels have been linked to blood vessel blockages and increased risk of heart attack and stroke. Because of this, many women have concerns about taking calcium pills to maintain bone strength, according to the authors of a report published in the June 16 issue of the journal Menopause.
For this study, the researchers used cardiac computed tomography imaging to measure CAC levels in 754 women who were aged 50 to 59 at the time of enrollment. CAC scores were similar among women who took calcium (1,000 milligrams of elemental calcium daily) plus vitamin D3 (400 International Units daily) for an average of seven years and women who took a placebo.
"This study provides reassuring evidence that moderate doses of calcium and vitamin D supplements do not increase calcium deposition in the coronary arteries. Thus, women need not avoid these supplements and sacrifice bone health due to concern about such a risk," Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston, said in a hospital news release.
More information
The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about calcium and vitamin D.
SOURCE: Brigham and Women's Hospital, news release, June 15, 2010
Copyright © 2010 HealthDay. All rights reserved.
Add to RSS Feed Back to top Print
You should also consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem.
No evidence of raised stroke or heart risks in those taking moderate doses, researchers say
--------------------------------------------------------------------------------
7/5/2010
(HealthDay News) -- Moderate doses of calcium and vitamin D supplements don't raise women's coronary artery calcium (CAC) levels, a new study finds.
Deposits of calcium in blood vessels have been linked to blood vessel blockages and increased risk of heart attack and stroke. Because of this, many women have concerns about taking calcium pills to maintain bone strength, according to the authors of a report published in the June 16 issue of the journal Menopause.
For this study, the researchers used cardiac computed tomography imaging to measure CAC levels in 754 women who were aged 50 to 59 at the time of enrollment. CAC scores were similar among women who took calcium (1,000 milligrams of elemental calcium daily) plus vitamin D3 (400 International Units daily) for an average of seven years and women who took a placebo.
"This study provides reassuring evidence that moderate doses of calcium and vitamin D supplements do not increase calcium deposition in the coronary arteries. Thus, women need not avoid these supplements and sacrifice bone health due to concern about such a risk," Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston, said in a hospital news release.
More information
The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about calcium and vitamin D.
SOURCE: Brigham and Women's Hospital, news release, June 15, 2010
Copyright © 2010 HealthDay. All rights reserved.
Add to RSS Feed Back to top Print
You should also consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem.
Wednesday, July 7, 2010
Medicare Review of Provenge
ABOUT PROSTATE CANCERGET INVOLVEDPROGRAMSRESEARCHPARTNERSSTOREABOUT US
Risk Factors
Prevention
Detection
Diagnosis
Treatment
New Prostate Cancer Research
Prostate Cancer Resources
Dendreon: Medicare Reviewing Provenge Coverage
by Marley Seaman | The Associated Press | 07.02.2010
Medicare administrators say they will take a full year to review Dendreon Corp.'s prostate cancer therapy Provenge and decide whether to cover the costly treatment.
Provenge, which costs $93,000 for a course of treatment, has been widely expected to bring Dendreon billions in revenue in the coming years. But sales will be slashed if Medicare decides not to cover the cost or offers only limited coverage. Medicare's Coverage and Analysis Group will propose a decision in about nine months and make a final ruling about a year from now. That decision will apply to all Medicare contractors.
Shares of Seattle-based Dendreon fell $2.20, or 6.8 percent, to close at $30.13. The stock fell as much as 13.4 percent earlier in the session.
The Food and Drug Administration approved Provenge in late April for patients who have prostate cancer that has spread and that has not responded to hormone-based treatment. Some Medicare insurance contractors already are paying for the therapy, but there is no national policy. Contractors can continue to cover Provenge during the agency's review, but must adhere to any final decision.
Medicare is evaluating whether or not it is reasonable and necessary to cover Provenge. Company studies have shown that taking Provenge added four months to the lives of men with advanced prostate cancer, about a month-and-a-half longer than that afforded by Sanofi-Aventis SA's Taxotere, the only chemotherapy approved for men in this situation. Doctors hope for even greater benefit if they give the drug earlier in the course of the disease.
The Coverage and Analysis Group is a team of medical officers, managers and analysts. A technical panel and a coverage advisory committee also will take part in the review. The group will be considering whether it makes sense to cover a costly drug that has a relatively narrow approval. But if it decides to cover Provenge treatment for patients with less advanced cancer, that could help sales.
Medicare will also deal with a deceptively simple question: what is Provenge? Is it a traditional drug, a biologic drug, or something else? The answer could affect the amount that Medicare will cover because different types of drugs are covered at different rates.
Provenge is designed to train a patient's immune system to attack tumors. It is different from traditional drugs and even biotech drugs because it is made by mixing blood cells from the individual patient with a protein found on cancer cells and an immune system-boosting substance.
Side effects of Provenge are relatively mild, such as chills, fatigue, fever, and headache. By comparison, side effects of chemotherapy typically include hair loss, nausea, anemia and diarrhea.
About 192,000 new cases of prostate cancer were diagnosed in 2009, and 27,000 men died of the disease, according to the FDA. Prostate cancer most often affects older men.
Wednesday [June 30] marked the beginning of a 30-day public comment period on coverage. After the comment period ends, the agency will take about nine months to create a proposal. The public will then have 30 days to comment on the proposal, and Medicare will publish a final decision within 60 days of the end of that comment period. The decision goes into effect as soon as it is published.
Risk Factors
Prevention
Detection
Diagnosis
Treatment
New Prostate Cancer Research
Prostate Cancer Resources
Dendreon: Medicare Reviewing Provenge Coverage
by Marley Seaman | The Associated Press | 07.02.2010
Medicare administrators say they will take a full year to review Dendreon Corp.'s prostate cancer therapy Provenge and decide whether to cover the costly treatment.
Provenge, which costs $93,000 for a course of treatment, has been widely expected to bring Dendreon billions in revenue in the coming years. But sales will be slashed if Medicare decides not to cover the cost or offers only limited coverage. Medicare's Coverage and Analysis Group will propose a decision in about nine months and make a final ruling about a year from now. That decision will apply to all Medicare contractors.
Shares of Seattle-based Dendreon fell $2.20, or 6.8 percent, to close at $30.13. The stock fell as much as 13.4 percent earlier in the session.
The Food and Drug Administration approved Provenge in late April for patients who have prostate cancer that has spread and that has not responded to hormone-based treatment. Some Medicare insurance contractors already are paying for the therapy, but there is no national policy. Contractors can continue to cover Provenge during the agency's review, but must adhere to any final decision.
Medicare is evaluating whether or not it is reasonable and necessary to cover Provenge. Company studies have shown that taking Provenge added four months to the lives of men with advanced prostate cancer, about a month-and-a-half longer than that afforded by Sanofi-Aventis SA's Taxotere, the only chemotherapy approved for men in this situation. Doctors hope for even greater benefit if they give the drug earlier in the course of the disease.
The Coverage and Analysis Group is a team of medical officers, managers and analysts. A technical panel and a coverage advisory committee also will take part in the review. The group will be considering whether it makes sense to cover a costly drug that has a relatively narrow approval. But if it decides to cover Provenge treatment for patients with less advanced cancer, that could help sales.
Medicare will also deal with a deceptively simple question: what is Provenge? Is it a traditional drug, a biologic drug, or something else? The answer could affect the amount that Medicare will cover because different types of drugs are covered at different rates.
Provenge is designed to train a patient's immune system to attack tumors. It is different from traditional drugs and even biotech drugs because it is made by mixing blood cells from the individual patient with a protein found on cancer cells and an immune system-boosting substance.
Side effects of Provenge are relatively mild, such as chills, fatigue, fever, and headache. By comparison, side effects of chemotherapy typically include hair loss, nausea, anemia and diarrhea.
About 192,000 new cases of prostate cancer were diagnosed in 2009, and 27,000 men died of the disease, according to the FDA. Prostate cancer most often affects older men.
Wednesday [June 30] marked the beginning of a 30-day public comment period on coverage. After the comment period ends, the agency will take about nine months to create a proposal. The public will then have 30 days to comment on the proposal, and Medicare will publish a final decision within 60 days of the end of that comment period. The decision goes into effect as soon as it is published.
Swedish Study:PSA Test Saves Lives
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
PSA Test Does Cut Prostate Cancer Deaths, Study Finds
Swedish report adds to controversy over the usefulness of the blood screen
by Steven Reinberg | Bloomberg Businessweek | 07.01.2010
(HealthDay News) Adding to the ongoing debate on the usefulness of the prostate-specific antigen (PSA) blood test for prostate cancer, new research from Sweden finds the screen cuts lives lost to the disease by almost half.
The argument over whether PSA screening saves men's lives or merely leads to the overdiagnosis of very slow-growing cancers (with attendant worry and overtreatment) has bedeviled the medical world for years.
According to recently revised guidelines from the American Cancer Society, men at average risk for prostate cancer should discuss the PSA test with their doctor, starting at age 50. For men at high risk for the disease -- blacks and men who have a father, brother or son found to have prostate cancer at an early age (before 65) -- that discussion should start at age 45.
"Because prostate cancer grows slowly, those men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit," the society notes on its Web site.
Ambivalence over the test hasn't been confined to the United States.
"In Europe, we have been reluctant to recommend that all men get PSA testing as we have felt that there has been a lack of knowledge," agreed lead researcher Dr. Jonas Hugosson, a professor of urology at the University of Gothenburg.
However, he believes that with the results of the new 14-year study, "it feels ethically difficult not at least to inform all men over the age of 50 about PSA and its possibilities. Personally, I would recommend my friends check their PSA," Hugosson added.
The report is published in the June 30 online edition of The Lancet Oncology.
For the still-ongoing study, Hugosson randomly assigned some 20,000 men to either PSA screening once every two years or no screening. The men were between 50 and 65 at the start of the study.
Men whose PSA levels were above normal were offered more tests, such as a digital rectal exam and prostate biopsies.
Over 14 years of follow-up, deaths from prostate cancer dropped by 44 percent among the screened men, compared with unscreened men, the researchers found. Overall, 44 of the men who had PSA testing died from prostate cancer, compared to 78 men who had not had been screened.
Among screened men, 11.4 percent were diagnosed with prostate cancer, compared with 7.2 percent of unscreened men. Of the men in the screened group diagnosed with prostate cancer, nearly 79 percent were diagnosed because they took part in the study, the researchers noted.
In addition, men in the screened group were more likely to have their cancer diagnosed while it was in an early stage. In the screened group, 46 men were diagnosed with advanced cancer, compared with 87 men in the unscreened group, Hugosson's team found.
"Our study has a longer follow-up than previous studies, but shows that in those men invited [to the study], the risk of dying is only half of that in the control group. In men younger than 60 at study entry, the effect was even more pronounced -- only one-quarter of expected deaths occurred," Hugosson said.
Moreover, the risk of over-diagnosis was less than previously thought, with just 12 men needed to be diagnosed to save one life. However, since the benefit of PSA screening requires at least 10 years to be borne out, it still seems questionable to test PSA for men over 70, the researchers noted.
Dr. David E. Neal, a professor of surgical oncology at the University of Cambridge in the U.K. and author of an accompanying editorial, believes that, "PSA testing detects prostate cancer early in its natural history when it causes no symptoms. By doing so, it can save the lives of some men who would otherwise have died of the disease."
This study adds to previous evidence that PSA testing and screening for prostate cancer saves lives, he said. Still, the PSA test remains "a blunt instrument," when it comes to determining the aggressiveness of a particular tumor, Neal said. "We need better tests that identify more accurately those men destined to develop problems in the future from this disease," he said.
In the United States, PSA testing remains a routine part of most physical exams, according to Dr. Nelson Neal Stone, a professor of urology and radiation oncology at the Mount Sinai School of Medicine in New York City.
"I would say 70 to 80 percent of physicians now order a PSA test," he said. "So it is more or less the standard to care in America to get a PSA done."
Stone noted that screening detects a lot of early cancers, which do not need to be treated. "When we see patients with low-risk disease we don't treat them, we observe them," he said.
"Younger men benefit most from screening, because they have the greatest risk of dying," Stone said. "This study clearly supports PSA screening to prevent prostate cancer deaths."
Another expert, Dr. Anthony D'Amico, chief of radiation oncology at Brigham and Women's Hospital in Boston, added that "people in good health will benefit from [PSA] screening, but people in poor health may not benefit at all." That's because if their prostate tumor is not aggressive, they are more likely to die from the other more serious conditions, he explained.
Risk Factors
Prevention
Detection
Diagnosis
Treatment
New Prostate Cancer Research
Prostate Cancer Resources
Managing Bone Metastases and Pain
Side Effects of Prostate Cancer Treatment
PSA Test Does Cut Prostate Cancer Deaths, Study Finds
Swedish report adds to controversy over the usefulness of the blood screen
by Steven Reinberg | Bloomberg Businessweek | 07.01.2010
(HealthDay News) Adding to the ongoing debate on the usefulness of the prostate-specific antigen (PSA) blood test for prostate cancer, new research from Sweden finds the screen cuts lives lost to the disease by almost half.
The argument over whether PSA screening saves men's lives or merely leads to the overdiagnosis of very slow-growing cancers (with attendant worry and overtreatment) has bedeviled the medical world for years.
According to recently revised guidelines from the American Cancer Society, men at average risk for prostate cancer should discuss the PSA test with their doctor, starting at age 50. For men at high risk for the disease -- blacks and men who have a father, brother or son found to have prostate cancer at an early age (before 65) -- that discussion should start at age 45.
"Because prostate cancer grows slowly, those men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit," the society notes on its Web site.
Ambivalence over the test hasn't been confined to the United States.
"In Europe, we have been reluctant to recommend that all men get PSA testing as we have felt that there has been a lack of knowledge," agreed lead researcher Dr. Jonas Hugosson, a professor of urology at the University of Gothenburg.
However, he believes that with the results of the new 14-year study, "it feels ethically difficult not at least to inform all men over the age of 50 about PSA and its possibilities. Personally, I would recommend my friends check their PSA," Hugosson added.
The report is published in the June 30 online edition of The Lancet Oncology.
For the still-ongoing study, Hugosson randomly assigned some 20,000 men to either PSA screening once every two years or no screening. The men were between 50 and 65 at the start of the study.
Men whose PSA levels were above normal were offered more tests, such as a digital rectal exam and prostate biopsies.
Over 14 years of follow-up, deaths from prostate cancer dropped by 44 percent among the screened men, compared with unscreened men, the researchers found. Overall, 44 of the men who had PSA testing died from prostate cancer, compared to 78 men who had not had been screened.
Among screened men, 11.4 percent were diagnosed with prostate cancer, compared with 7.2 percent of unscreened men. Of the men in the screened group diagnosed with prostate cancer, nearly 79 percent were diagnosed because they took part in the study, the researchers noted.
In addition, men in the screened group were more likely to have their cancer diagnosed while it was in an early stage. In the screened group, 46 men were diagnosed with advanced cancer, compared with 87 men in the unscreened group, Hugosson's team found.
"Our study has a longer follow-up than previous studies, but shows that in those men invited [to the study], the risk of dying is only half of that in the control group. In men younger than 60 at study entry, the effect was even more pronounced -- only one-quarter of expected deaths occurred," Hugosson said.
Moreover, the risk of over-diagnosis was less than previously thought, with just 12 men needed to be diagnosed to save one life. However, since the benefit of PSA screening requires at least 10 years to be borne out, it still seems questionable to test PSA for men over 70, the researchers noted.
Dr. David E. Neal, a professor of surgical oncology at the University of Cambridge in the U.K. and author of an accompanying editorial, believes that, "PSA testing detects prostate cancer early in its natural history when it causes no symptoms. By doing so, it can save the lives of some men who would otherwise have died of the disease."
This study adds to previous evidence that PSA testing and screening for prostate cancer saves lives, he said. Still, the PSA test remains "a blunt instrument," when it comes to determining the aggressiveness of a particular tumor, Neal said. "We need better tests that identify more accurately those men destined to develop problems in the future from this disease," he said.
In the United States, PSA testing remains a routine part of most physical exams, according to Dr. Nelson Neal Stone, a professor of urology and radiation oncology at the Mount Sinai School of Medicine in New York City.
"I would say 70 to 80 percent of physicians now order a PSA test," he said. "So it is more or less the standard to care in America to get a PSA done."
Stone noted that screening detects a lot of early cancers, which do not need to be treated. "When we see patients with low-risk disease we don't treat them, we observe them," he said.
"Younger men benefit most from screening, because they have the greatest risk of dying," Stone said. "This study clearly supports PSA screening to prevent prostate cancer deaths."
Another expert, Dr. Anthony D'Amico, chief of radiation oncology at Brigham and Women's Hospital in Boston, added that "people in good health will benefit from [PSA] screening, but people in poor health may not benefit at all." That's because if their prostate tumor is not aggressive, they are more likely to die from the other more serious conditions, he explained.