Jun 19 2008

Scientists cast doubt on value of screening for prostate cancer

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Men’s Health News
Even though deaths from prostate cancer death have fallen in the U.S. since screening became more common, new research is suggesting that this does not justify the need for such tests.
According to a team of scientists from the University of Bristol many other factors could be involved such as different treatment programmes for American men and some discrepancy over how deaths are reported.
Since screening became widespread in the U.S. mortality rates have fallen four times more than in the UK.
It seems that many men over 80 have evidence of prostate cancer when they die, but it is often unclear whether this or other conditions killed them, which leads to different accounts on death certificates.
The researchers say this does not mean that screening by using a blood test to detect what is known as the prostate specific antigen (PSA), is not saving lives.
But they suggest until research pins down the exact role of screening in decreasing prostate cancer mortality, it remains a matter of speculation.
Whereas prostate cancer screening became common in the States in the early 1990s, and nearly 60% of men over 50 were being tested by 2001, in the UK, between 1999 and 2002, an estimated 6% of men aged 45-84 had been tested.
At the start of the 90s, mortality rates for the two countries were similar, but after this period, the rate of decline in the U.S. at 4.17% per year, was almost four times that of the Kaufen cialis soft pillen mastercard UK, at 1.17% per year.
Simon Collin a statistician who led the research says other changes were occurring in the treatment of men with prostate cancer in the U.S. during that time and included the use of a particular hormone treatment in older men and more aggressive treatment of those with an advanced form of the disease.
Prostate cancer accounts for a quarter of cancers in men but the National Health Service (NHS) has resisted offering widespread PSA screening because the test is seen as notoriously inaccurate.
Even though 10-15% of men will have high enough PSA levels to justify carrying out a prostate biopsy, only 2-3% will require any treatment.
This means in fact that the majority will have been subjected to unpleasant, invasive and potentially costly investigations for no reason with possible serious side effects such as impotence and incontinence.
Experts say there is an urgent need for a new diagnostic test which could form part of a national screening programme and which would reliably identify the aggressive prostate cancers that need treatment.
The NHS says all screening programmes are based on an assessment that more good than harm will be achieved through their implementation and until there is clear clinical evidence to show real benefit can be gained from routine prostate screening, the NHS will not be screening men who have no symptoms for prostate cancer.
The authors of the study say while the differing outcomes are worrying, the jury is still out on whether screening is worthwhile.
The research is published in Lancet Oncology.
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Jun 19 2008

Maxi-K Gene Transfer May Prove To Be Safe And Effective Erectile Dysfunction Treatment

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Maxi-K gene therapy may be a safe and effective future option for men whose erectile dysfunction (ED) is not treatable with oral therapy. Two studies presented at the 103rd Annual Scientific Meeting of the American Urological Association (AUA) may give hope to these individuals. Researchers present their findings to reporters in a special press conference on May 20, 2008 at 10 a.m.
Maxi-K therapy is a unique, locally administrated gene-transfer technology to treat erectile dysfunction (ED). The safety and the restorative effects of the treatment have been shown by data from participants in a phase I trial. In some men, the effect lasted up to six months. The gene therapy appears safe as no transfer-related adverse events were reported more than two years after the transfer in some subjects. Unlike conventional oral therapies for men with ED, Maxi-K therapy does not require prior planning, fosters sexual spontaneity and can be used by men taking heart medication.
Researchers not only provided follow-up to previous studies on Maxi-K therapy in men, but also explored whether increased erectile function enhanced other areas of sexual behavior. Male cynomulgus monkeys with ED were observed during their injection period and while in the presence of estrogen-implanted females. Researchers observed and measured the monkeys’ number of ejaculations, time to ejaculation, number of mounts, time to first mount, number of thrusts, number of sexual invitations by the female and number of erections achieved. Researchers observed dramatic changes after gene transfer, including increases in the number of partial and full erections and a two-fold increase in erection duration. An increase in intimacy was also seen. The data imply that increased erectile function per se may lead to increased sexual function.
"This study gives hope to men who experience ED but have not responded to oral therapies," said Arnold Melman, M.D., one of the study’s authors. The importance of these observations in clinical and pre-clinical trials is that it appears that gene transfer with the Maxi-K channel enhances both erectile capacity as well as other important measures of sexual behavior."
Researchers also presented updated data reaffirming that human patients being treated with hMaxi-K therapy for ED were not adversely affected. The trial, conducted with 11 men between the ages of 18 and 65 with moderate to severe ED who received previous unsuccessful treatment, concluded that direct, organ-targeted, naked DNA gene transfer with hMax-K produced no treatment-related adverse events and the treatment is not associated other diseases or conditions. These results open the door to further testing involving Maxi-K gene transfer and could lead to its effective use in treating the human population.
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Christ GJ, Andersson K, Williams K, Zhao W, D’Agostino R, Kaplan J: Restoration of erectile function and sexual behavior in atherosclerotic monkeys following maxi-k gene transfer with a smooth muscle-specific promoter. Kaufen generishe levitra J Urol, suppl., 2008; 179: 425, abstract 1240.
Melman A, Davies KP, McCullough AR, Bar-Chama N, Christ GJ: Long-term safety follow up of a phase I trial for gene transfer therapy of ED with hMaxi-k. J Urol, suppl., 2008; 179: 426, abstract 1241.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs members and their patients, including UrologyHealth.org, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
Source: Lacey Holt
American Urological Association
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Jun 19 2008

Maxi-K Gene Transfer May Prove To Be Safe And Effective Erectile Dysfunction Treatment

Published by poster under Uncategorized

Maxi-K gene therapy may be a safe and effective future option for men whose erectile dysfunction (ED) is not treatable with oral therapy. Two studies presented at the 103rd Annual Scientific Meeting of the American Urological Association (AUA) may give hope to these individuals. Researchers will present their findings to reporters in a special press conference on May 20, 2008 at 10 a.m.
Maxi-K therapy is a unique, locally administrated gene-transfer technology to treat erectile dysfunction (ED). The safety and the restorative effects of the treatment have been shown by data from participants in a phase I trial. In some men, the effect lasted up to six months. The gene therapy appears safe as no transfer-related adverse events were reported more than two years after the transfer in some subjects. Unlike conventional oral therapies for men with ED, Maxi-K therapy does not require prior planning, fosters sexual spontaneity and can be used by men taking heart medication.
Researchers not only provided follow-up to previous studies on Maxi-K therapy in men, but also explored whether increased erectile function enhanced other areas of sexual behavior. Male cynomulgus monkeys with ED were observed during their injection period and while in the presence of estrogen-implanted females. Researchers observed and measured the monkeys’ number of ejaculations, time to ejaculation, number of mounts, time to first mount, number of thrusts, number of sexual invitations by the female and number of erections achieved. Researchers observed dramatic changes after gene transfer, including increases in the number of partial and full erections and a two-fold increase in erection duration. An increase in intimacy was also seen. The data imply that increased erectile function per se may lead to increased sexual function.
"This study gives hope to men who experience ED but have not responded to oral therapies," said Arnold Melman, M.D., one of the study’s authors. The importance of these observations in clinical and pre-clinical trials is that it appears that gene transfer with the Maxi-K channel enhances both erectile capacity as well as other important measures of sexual behavior."
Researchers also presented updated data reaffirming that human patients being treated with hMaxi-K therapy for ED were not adversely affected. comprare levitra mastercard The trial, conducted with 11 men between the ages of 18 and 65 with moderate to severe ED who received previous unsuccessful treatment, concluded that direct, organ-targeted, naked DNA gene transfer with hMax-K produced no treatment-related adverse events and the treatment is not associated other diseases or conditions. These results open the door to further testing involving Maxi-K gene transfer and could lead to its effective use in treating the human population.
In addition to the author, Ira D. Sharlip, M.D., a Member of the AUA Public Media Committee, will be on hand to answer questions and provide third-party perspective on the study.
Christ GJ, Andersson K, Williams K, Zhao W, D’Agostino R, Kaplan J: Restoration of erectile function and sexual behavior in atherosclerotic monkeys following maxi-k gene transfer with a smooth muscle-specific promoter. J Urol, suppl., 2008; 179: 425, abstract 1240.
Melman A, Davies KP, McCullough AR, Bar-Chama N, Christ GJ: Long-term safety follow up of a phase I trial for gene transfer therapy of ED with hMaxi-k. J Urol, suppl., 2008; 179: 426, abstract 1241.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients, including UrologyHealth.org, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
American Urological Association (AUA)
1000 Corporate Blvd.
Linthicum, MD 21040
United States

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Jun 18 2008

Slough Man Sentenced To Community Service For Peddling Counterfeit Medicines, UK

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Mohammed Azim Dad (30) of 116 Chippenham Lane, Slough, SL1 5BA was sentenced to 250 hours community service on three counts under the Trade Marks Act 1994 relating to counterfeit erectile dysfunction medication, namely Viagra, Cialis and Levitra. Mr Dad appeared at Reading Crown Court following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA).
Mr Dad was charged on 4 November 2005 after he was caught selling the counterfeit products to undercover agents from the drug manufacturer, Eli Lilly. The undercover agents purchased some of the products over the internet. When tested, the prescription only medicines did not contain the correct amount of the active ingredients. When Mr. Dad was interviewed by the MHRA, Mr Dad admitted to buying Viagra and Cialis from China and selling them on eBay for ??4.00. generishe cialis online kaufen mastercard Whilst being actively investigated by the MHRA Mr. Dad continued to sell the counterfeit medicines over the Internet. Mr Dad’s home was raided in July 2005, where the counterfeits were seized, with the estimated value of ??45,000 - ??50,000. He pleaded guilty to the offences in July 2006.
Notes:
The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem.
If an individual is convicted of offences under the Medicines Act 1968, they can be sentenced to a maximum of two years imprisonment and/or an unlimited fine. Where appropriate the MHRA will use the Proceeds of Crime Act 2002 to determine whether or not benefits were accrued through criminal activity and will recoup illicit earnings if the individual is found guilty.

View drug information on Cialis; Levitra; Viagra.
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Jun 18 2008

Monitoring blood flow helps improve prostate biopsies

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Men’s Health News
Using
a special ultrasound technique to spot areas of blood flow in the prostate gland may substantially reduce the number of unnecessary biopsies, according to a new study by urologists and radiologists at the Jefferson Prostate Diagnostic Center and the Kimmel Cancer Center at Jefferson in Philadelphia.
The researchers found that biopsies targeted to areas of increased blood flow in the prostate were twice as likely to be positive for cancer compared with conventional prostate biopsy techniques.
They reported their initial results from a clinical trial this week at the annual meeting of the American Urological Association in Orlando.
According to Prostate Diagnostic Center co-director Edouard Trabulsi, M.D., assistant professor of Urology at Jefferson Medical College of Thomas Jefferson University, finding the best areas to perform biopsies in the prostate has always been difficult. Standard methods entail simply dividing the prostate into a dozen regions within the gland, almost randomly. Center co-director Ethan Halpern, M.D., who is principal investigator on the four-year, National Cancer Institute-supported trial, has been developing and refining techniques to enhance targeted biopsy of the prostate for more than a decade.
Dr. Trabulsi, Ethan Halpern, M.D., professor of Radiology and Urology at Jefferson Medical College, and their co-workers randomly divided 63 prostate biopsy patients into two groups. One group was given the drug dutasteride, which can reduce the blood flow in benign prostate tissue, while the other half received a placebo. They then compared the results from biopsies targeted by blood flow changes using contrast-enhanced ultrasound to those that were done the standard way. The study involved 979 biopsies.
"We’ve previously shown that a two-week course of the drug Avodart (dutasteride) before biopsy reduces the benign blood flow, or background noise," Dr. Trabulsi explains, "allowing us to see subtle flow changes to target for biopsy. When we did this, we found that targeted biopsies based on the contrast-enhanced ultrasound are much more likely to detect prostate cancer. That’s the exciting part about this."
Dr. Halpern explains that standard procedures fail to diagnose prostate cancer in approximately 30 percent of men with the disease, even though the biopsy protocol may sample 12 to 18 tissue cores from the prostate. "comprare il viagra senza ricetta In the future, our goal is to perform a limited number of targeted biopsies and leave the rest of the prostate alone," he says. "This will provide a safer, more cost-effective approach to diagnosing prostate cancer."
The doctors say that the current study involves a novel ultrasound algorithm called flash replenishment imaging to show fine vascular flow differences. "The novelty is using the dutasteride before biopsy, using contrast-enhanced ultrasound and using the latest ultrasound technology to look for blood flow changes associated with prostate cancer."
"We are beginning to have patients who were operated on come back in," Dr. Trabulsi notes. "If we can show that we reliably hit the areas of cancer based on the ultrasound results and didn’t miss any, it’s a home run."

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