By Helen Branswell

TORONTO (CP) - Canadian researchers are launching a large, multi-year international study to try to find a way to help the hundreds of thousands of men diagnosed with prostate cancer every year decide whether to opt for potentially life-altering treatments or choose a watch-and-wait approach.

The Canadian Cancer Society and the National Cancer Institute of Canada announced the study Thursday, saying it is hoped the START trial - the acronym stands for Man erectile dysfunction
Therapy Against Radical Treatment - will resolve one of the thorniest dilemmas in prostate cancer care.

“It’s answering some questions that we really need some answers to. Does active treatment at the time of diagnosis really make a difference in terms of long-term survival from prostate cancer?” explained Heather Logan, director of cancer control policy with the Canadian Cancer Society.

Prostate cancer is the most commonly diagnosed cancer in Canadian men and the third most fatal form of the disease. The cancer society estimates that this year 22,300 Canadian men will be diagnosed with prostate cancer and 4,300 will die from it.

The study is designed to follow 2,100 newly diagnosed volunteers in Canada, the United States and Britain, randomly assigning them to receive either treatment or to undergo active surveillance. Men in the surveillance group whose cancer progresses or who later decide they want to have treatment can do so.

It’s expected it will take four to five years to enrol all the patients who will then be followed for between 10 to 15 years. It could be 20 years before this trial produces the answer so many men and their physicians would like to see.

The principal investigator is Dr. Laurence Klotz, who daily sits across from men faced with the decision of whether to agree to a watch-and-wait approach - called active surveillance or watchful waiting - or to instead have their prostate removed or undergo radiation treatment.

On the one hand is the stress of not trying to eradicate the cancer. On the other is the real chance of long-term side-effects that can have a serious impact on the man’s quality of life.

“You elect to avoid risk of prostate cancer death by having treatment, you incur very major risk of erectile dysfunction, urinary incontinence, rectal problems if you have radiation and so on,” said Klotz, chief urologist at Toronto’s Sunnybrook Health Sciences Centre.

“The idea is we’re trying to kind of drive a middle road between treating everybody, which will result in impotence viagra, and treating nobody which will result in under-treatment and just identify the ones who look like the bad actors.”

He said choosing to take no immediate action is a particularly difficult one, running counter to what he calls society’s “cancer hysteria” - the equation of a cancer diagnosis with a death sentence.

Tom LePoidevin, 73, had to make that tough choice in Klotz’s office 16 years ago, when a PSA (prostate specific antigen) screening test revealed he had prostate cancer.

“As soon as you hear the news I think the majority of people would say: ‘Oh, when are you going to be operated on,”‘ said LePoidevin, a retired marketing executive from Collingwood, Ont.

While he admits he erectile dysfunction solutions
frets about the fact he has a cancer he hasn’t tried to excise, LePoidevin believes he has made the right choice for himself. But he hopes men in his position in future will be armed with science, not best guesses, when they have to make the same decision.

Many men with prostate cancer need to undergo treatment to stop the advance of the disease. But in many others - perhaps as many as half the cases that come to light - doctors know the cancer is unlikely to break out of the prostate and spread to other parts of the body.

Since the advent of PSA testing, large numbers of men who were seemingly healthy have been told they have cancer cells in their prostates and have faced this difficult choice. Experts say a significant portion of these men will die from other causes and would never require any prostate cancer care if the screening test hadn’t signalled the presence of malignant cells.

“With a disease like this which typically is diagnosed in either late middle age or more, death from other causes is by far the commonest cause of death in men with prostate cancer. Heart disease is the commonest cause of death in men with prostate cancer,” Klotz said.

He noted that at age 50, about one out of every two men will have some cancer cells in their prostate. By age 80, the number is 80 per cent.

The problem is, doctors don’t know how to determine with certainty which are the cancers that will progress (and therefore should be treated) and which are the types that won’t. As as result, many men receive treatment they would never have needed if their cancer hadn’t been picked up by a PSA test.

“I think there’s a strong consensus, not only in the United States but around the world, that there is over-treatment,” said Dr. Barnett Kramer, associate director for disease prevention at the U.S. National Institutes of Health in Bethesda, Md.

“The magnitude of over-treatment is probably debated, but not the fact that some men are over-treated.”

Finding a way to be able to determine at the time of diagnosis which is which would be a valuable contribution to the field of cancer care, Kramer suggested.

“Absolutely. Because day in and day out the decision is being made with regard to therapy of screen-detected prostate cancer whether to treat or how aggressively to treat,” he said.

“And it affects over 100,000 men a year just in the United States, and around the world it affects that many more. And so it’s not an unusual question that a patient faces and their physicians face.”

To: FOREIGN EDITORS

Contact: UNITED STATES, Lori Yeghiayan, +1-323-860-5227, +1-323-377-4312 - mobile, lori.yeghiayan@aidshealth.org; or INDIA, Dr. Chinkholal Thangsing, +91 11 4174 5541, +91 98 1827 0687 - mobile, chinkholal.thangsing@aidshealth.org

NEW DELHI, India, Sept. 6 /PRNewswire-USNewswire/ — As part of its
ongoing global campaign to lower drug prices and improve access to lifesaving
HIV/AIDS treatments worldwide, AIDS Healthcare Foundation (AHF) has published
a print advertisement in the form of an open letter that will appear in
several prominent Indian newspapers today.

Headlined ‘Cipla, Tell the Truth’ this latest ad is scheduled to appear in
the Mumbai editions of The Indian Express and The Financial Express today and
in the Delhi editions within a few days and follows a month-long public
dialogue regarding higher prices offered by Cipla for its generic HIV/AIDS
drugs in India vs. Africa. The controversy was sparked by an earlier drug-
pricing advocacy ad placed by AHF in Indian newspapers in August. Headlined
‘Profit at What Cost? AIDS Drugs for All’ the ad questioned a 150% price
difference between what Cipla has offered African and Indian purchasers for
the same lifesaving cause of erectile dysfunction
medication. Spurred by AHF’s allegations,
the Monopolies and Restrictive Trade Practices Commission (MRTPC), India’s
anti-trust commission that probes monopolistic, restrictive and unfair trade
practices, recently began an investigation into Cipla’s pricing practices.

“With this advertisement, we hope to put an end to the recent storm of
controversy pitting AHF and Cipla against each other and to re-focus the
public dialogue on what is most important: the fact that Cipla’s HIV/AID drug
prices are simply too high in India,” said Chinkholal Thangsing, M.D., Asia
Pacific Bureau Chief for the AIDS Healthcare Foundation and a medical provider
based in New Delhi. “We also hope to refute baseless claims recently leveled
at AHF regarding the motives behind our efforts to lower HIV/AIDS drug prices
in India and to increase access to lifesaving medicines. As a non-profit
organization with a twenty-year history of providing free medical care and
advocacy to people living with HIV/AIDS our commitment has been, is, and
always will be to the people we serve. We urge Cipla to end its attempts to
divert attention away from the facts so that we can get down to the important
work of saving lives.”

AHF begins its open letter to Cipla by reiterating its original claim-
which Cipla has yet to refute-that the generic manufacturer is offering many
of its HIV/AIDS medicines at significantly lower prices in African than in
India: “The simple truth is that Cipla is charging too much for its drugs in
India and its pricing is depriving Indians living with HIV/AIDS of access to
lifesaving treatment … Cipla is charging much more for anti-retroviral (ARV)
drugs in India than they do in Africa.”

A chart included in the ad compares the private price Cipla offers in
India to the government or man impotence
organization price offered in
Africa and the private price offered in Uganda (where AHF operates free
treatment clinics). The results are startling: Cipla offers Duovir-N, a
combination of three generic anti-retroviral drugs, for two times as much in
India as it does in Africa and almost one-and-a-half times as much than in
Uganda. The price Cipla offers for Triomune, a combination of three generic
anti-retroviral drugs, is three times as much in India as offered in Africa
and two-and-a-half times as much as Cipla charges for the same drug in Uganda.
Finally, the price Cipla offers for Efavir, a two-in-one anti-retroviral
combination, is three times as much in India as offered in Africa or twice as
much than Cipla charges in Uganda. Bottom line: All three of these potential
lifesaving generic ARV combinations by Cipla are priced (or offered) at an
average of two to three times less in Africa than they are priced (or offered)
in India; as such, the steeper prices offered in India mean that fewer Indians
can partake in the lifesaving benefits of these Indian-made AIDS medicines.

The letter also answers baseless assertions about AHF’s connections to
pharmaceutical companies: “Cipla has accused AIDS Healthcare Foundation (AHF)
of working for the multi-national drug companies … AHF, a non-government
organization, vigorously opposed high drug pricing from all pharmaceutical
companies. In fact, AHF has sued several drug companies over the years to
lower prices … Gilead is one company that has worked closely with AHF and is
one of many supporting our free ARV programs in the developing world.
Nevertheless, we are strongly opposed to Gilead’s application for patents in
India … It should be clear: AHF is not for sale to anyone, at any price.”

In both public news articles in India and private correspondence with AHF
over the past two weeks, Cipla officials have demanded a published public
apology over the advocacy advertisement. With the demand, Cipla has also
informed AHF that if no apology is published within seven (7) days, then it
intends to sue AHF, an international non-governmental organization (NGO) that
provides direct medical care and services to over 46,000 people with HIV/AIDS
in 12 countries, for USD $25 million over the ad.

In response, AHF states: “Cipla is diverting attention away from its
pricing in India and smearing AHF’s good name in the process. Cipla wants to
intimidate the one organization that has publicly criticized it by threatening
to bankrupt us by demanding a billion rupees from AHF for supposed defamation
… We will not be silenced by threats. We will continue to fight for the
lives of our 60,000 patients worldwide, including those in India.

Of the 2.5 million people now estimated to be living with HIV/AIDS in
India, approximately 85,000 are receiving lifesaving antiretroviral treatment.
Cipla, the world’s largest manufacturer of antiretroviral drugs to fight
HIV/AIDS (as measured by units produced, distributed and sold-not overall
revenue), is best-known for manufacturing economical generic anti-AIDS drugs
used throughout Africa.

Detailing its extensive history of advocacy targeted at drug companies
with the goal of lowering drug prices and increasing access to affordable
HIV/AIDS medications, the letter ends with a challenge to Cipla to demonstrate
the same sort of commitment to affordable drug access in for Indians in need
as it does for Africa: “AHF is prepared to meet with Cipla anywhere, at any
time to find a solution. The rest is up to Cipla.”

To view the open letter print ad in its entirety, please visit:
http://www.aidshealth.org/images/pdfs/ciplaad2thehinduweb2.pdf

History of AIDS Healthcare Foundation’s Drug Pricing and Access Advocacy

Over the years AHF has had a long, outspoken and successful history of
advocacy and outreach regarding AIDS drug pricing and access issues around the
globe. This advocacy has often occurred via direct meetings and correspondence
with drug company officials; through press conferences and press statements;
via the filing of lawsuits; through lobbying government officials; via the
mounting of protests and awareness campaigns; and through the placement of
advertisements and calls to action, such as the current, “Profits at What
Costs? AIDS Drugs for All,” in India.

    AHF's advocacy efforts have included:
    -- Earlier this year, AHF mounted a similar print ad and awareness
       campaign on AIDS drug pricing in Mexico. That campaign featured a print
       ad, "AIDS Drug Prices to Die For," which ran in prominent papers in
       Mexico and several US cities and targeted both Bristol Myers-Squibb
       (BMS) and Merck (known as Merck Sharp & Dohme in Mexico). The two drug
       companies are being targeted for charging four times as much in Mexico
       for their key AIDS drugs Reyataz and Stocrin as they do in other Latin
       American and middle-income countries. Mexico, which is classified as an
       'upper middle-income' country, has a gross national income (GNI) of USD
       $6,790 annually, while the average annual per person cost of
       antiretroviral in the country is USD $8,000 (for treatments that can
       cost as little as USD $150 in Africa), making these lifesaving AIDS
       regimens all but unaffordable for nearly all those living with HIV/AIDS
       in Mexico. The Mexico advocacy campaign is ongoing.
    -- Over the past four years, AHF has targeted Abbott Laboratories
       regarding several of its global AIDS drug pricing and access policies.
       AHF is currently targeting Abbott for its recent cold-hearted and
       punitive access policies in Thailand regarding its drug combination,
       Kaletra. In January, the government of Thailand issued a compulsory
       license for the manufacture and import of a generic version of the
       drug; the move prompted Abbott to withdraw all new drugs, including
       Aluvia, a heat-stable tablet formulation of Kaletra, from the official
       governmental approval and registration process in Thailand. In July
       2007, AHF praised the government of Brazil for negotiating a 30%
       discount on Abbott's Kaletra. Brazil had also threatened to issue a
       compulsory license for Kaletra.  Separately, in 2004, AHF had protested
       and filed a lawsuit against Abbott in response to a five-fold price
       hike the company instituted on its AIDS drug, Norvir. The suit was
       later settled.
    -- AHF has repeatedly called on the pharmaceutical industry as a whole to
       cut prices and increase access to AIDS therapies globally. In July
       2006, AHF officials, who had earlier met with Gilead Sciences
       executives, praised the drug company after Gilead announced plans to
       reduce prices for its HIV/AIDS-related medications by two-thirds for
       middle-income countries including Mexico.
    -- AHF has also challenged British drug giant GlaxoSmithKline (GSK) in
       long running campaigns via protests, press conferences and lawsuits.
       Some actions targeted GSK over its patent claim and steep pricing on
       AZT, the first AIDS drug. Other actions focused on GSK's global pricing
       and access, particularly in Africa, and its partnership with Aspencare,
       a generic drug manufacturer in South Africa (where AHF opened its first
       global treatment clinic in 2001), which after several years hadn't
       produced any generic GSK AIDS medications.
    -- AHF also spoke out loudly when the Caffeine and impotence
 Manufacturers
       Association of South Africa and 39 pharmaceutical companies filed a
       lawsuit against the government of South Africa when it approved a law
       that would allow the country to import and manufacture cheaper generic
       AIDS drugs. The drug industry’s move was met with ‘a groundswell of
       public and government opposition,’ which caused some of the ‘largest
       firms’ involved in the case to, ‘rethink their strategy,’ according to
       ‘The Guardian’ newspaper. In April 2001, the drug companies agreed to
       drop their lawsuit, a move that AHF praised.
    — Separately, AHF has targeted Pfizer Inc., the world’s largest drug
       company, over its reckless advertising and marketing for its erectile
       dysfunction drug, Viagra. AHF hosted press conferences; issued press
       statements; wrote and/or met with officials at the FDA and the FCC; and
       filed a lawsuit over one of Pfizer’s Viagra advertising campaigns,
       which AHF believes encourage the non-medical use of the drug as a party
       drug, and which AHF believes can contribute to increased risks for
       exposure to sexually transmitted diseases, including HIV. The campaign
       is ongoing.

AIDS Healthcare Foundation currently provides free anti-retroviral
treatment to people in need in India through its clinics in Mysore, New Delhi
and in Guwahati, Assam under the AHF India Cares banner and in collaboration
with the National AIDS Control Organization. In the Asia-Pacific region, AHF
also operates free treatment clinics in Thailand, Viet Nam, Cambodia and
China.

AIDS Healthcare Foundation (AHF) is the nation’s largest non-profit
HIV/AIDS healthcare, research, prevention and education provider. AHF
currently provides medical care and/or services to more than 61,000
individuals in 15 countries worldwide in the US, Africa, Latin
America/Caribbean and Asia. Additional information is available at
www.aidshealth.org

If you have received this news release in error and do not wish to receive
future advisories, or if they should be directed to someone else in your
organization, please call (323) 860-5262. Alternatively, you may fax your
updated information or your request for removal from our list to (323) 962-
8513 or e-mail jennifer.ramirez@aidshealth.org.

SOURCE AIDS Healthcare Foundation

-0-

PRINCE EDWARD ISLAND (CBC) - France is reviewing the way it handles the incarceration of sex offenders after a repeat pedophile secured an early release, obtained a Viagra man erectile dysfunction
from prison doctors, then allegedly raped a erectile dysfunction vacuum device
boy weeks later.

Following the case of three-time convicted pedophile Francis Evrard, French President Nicolas Sarkozy said Monday he was amending prison laws to prevent early release for some sex offenders.

“Drug for impotence levitra must be put in place to make sure this doesn’t happen again,” Sarkozy told reporters Monday, upon returning from a two-week vacation in the U.S.

Evrard, 61, was released from prison in July after serving just 18 of the 27 years he was originally sentenced to.

According to prison officials in the Normandy city of Caen, where Evrard was jailed, a prison physician improve erectile dysfunction
he did not review Evrard’s file before prescribing him Viagra one month before the convicted pedophile walked out a free man.

Last Wednesday, police acting on an Amber Alert for a missing five-year-old boy found Evrard and the boy in a Roubaix garage in northern France, 12 hours after the boy’s disappearance.

Officers also found the erectile-dysfunction drugs issued to Evrard by his prison doctor. The pedophile now faces preliminary charges related to the kidnap and rape of a minor.

Sarkozy said sex offenders who could still be considered dangerous should not benefit from early release.

“What happened? A person who over his career committed several rapes of minors was sentenced to 27 years in prison - he served 18,” Sarkozy said. “I don’t understand why.”

After the Conservative president met with the boy’s father on Monday, he called an emergency cabinet meeting to re-evaluate France’s prison laws. Sarkozy called on the justice minister to include a measure that blocks pedophiles from being granted early release. Medical experts would also have to rule that the offender is not dangerous.

The amended prison laws are to be presented in parliament in November.

With files from the Vacuum device for erectile dysfunction
Press

WEDNESDAY, Aug. 22 (HealthDay News) — Many older Americans
aren't letting age slow down their sex lives, a new study shows.

The first comprehensive national survey of the sexual attitudes,
behaviors and problems of U.S. adults age 57 and older finds many are
having sex often. In fact, the frequency of sexual activity dropped only
slightly between the late 50s up to the early 70s.

And more than half of those in the oldest age group — 75 to 85 — who
were sexually active reported having sex at least two to three times per
month, and 23 percent reported having sex at least once a week.

“This gives us, for the first time, the most comprehensive and
nationally representative data on sexuality for men and women and makes a
particular contribution with regard to knowledge of older women's
sexuality,” study lead author Dr. Stacy Tesser Lindau, assistant professor
of obstetrics and gynecology and of medicine-geriatrics at the University
of Chicago, said at a Monday teleconference.

Lindau is lead researcher on the study, which is published in the Aug.
23 issue of the New England Journal of Medicine.

“This is of extreme importance and a landmark study that hopefully will
get the medical community and society focused on this in a less taboo way.
It's a great start,” said Dr. Barbara Paris, director of geriatrics at Mai
monides Medical Center in New York City. “For most people, it's a shock to
hear that people are having sex in their 70s,” she said.

“This is a premier study,” added Marcia G. Ory, professor of social and
behavioral health and director of the Aging and Health Promotion Program
at Texas A&M Health Science Center School of Rural Public Health. “It
debunks some myths that sex and old age don't go together, and it places
this in the context of health and health problems.”

According to the study authors, little is known about sexuality among
older people in the United States, despite this group being the fastest
growing segment of the population.

“I'm a gynecologist, and, for me, there was a tremendous void of
information to be able to provide people the information they needed to
make health care decisions and to be prepared for changes,” Lindau said.
“With the right information, people might be able to cope better.”

For this study, the University of Chicago's National Social Life,
Health and Aging Project (NSHAP) researchers interviewed 3,005 U.S. adults
(1,550 women and 1,455 men), aged 57 to 85 in their homes.

Three-quarters of those approached agreed to participate and were
remarkably forthcoming about their sex lives.

Researchers found that the prevalence of sexual activity did decline
with age, with 73 percent of respondents aged 57 to 64 reporting sexual
activity, 53 percent among those aged 65 to 74 and 26 percent among those
aged 75 to 85.

Women were less likely to be sexually active than men in age groups.
More than female impotence (78 percent) of men aged 75 to 85 had a spouse or
other intimate relationship, only 40 percent of women in that age group
had a partner.

Women were also more likely to rate sex as “not at all important” (35
percent versus 13 percent of men).

“There do seem some gender disparities,” Lindau said. “Men overall are
more likely to have partners in later life and are more likely to be
sexually active with their partners.”

“Older ages really are different for men and women,” added Linda Waite,
senior author of the paper and the Lucy Flower Professor in Urban
Sociology at the University of Chicago. “Men tend to be married until they
die, and women tend to spend their final years as widows.” In addition,
men tend to have younger partners and women older partners, which
translates into fewer new erectile dysfunction medication for sexual intimacy for women.

About half of both men and women who were sexually active reported
sexual problems. The most prevalent among women were low desire
(experienced by 43 percent of respondents), vaginal dryness (39 percent)
and inability to climax (34 percent). The most common problem reported by
men was erectile dysfunction (37 percent).

Fourteen percent of all men reported using medication or supplements to
help improve sexual function. “That was a high number,” Lindau said.

Health more than age tended to affect people's sex lives; men and women
who said their health was poor were less likely to be sexually active.

“The linkage with sexual health is closer to other health issues and is
not so tied directly to aging per se,” said Edward Laumann, co-author of
the study and the George Herbert Mead Distinguished Service Professor in
Sociology at the University of Chicago. “Sexual health, when it begins to
deteriorate, may be an important warning sign, because it may be an early
warning sign of more profound health problems.” Lindau was co-director of
the 1992 National Health and Social Life Survey which surveyed persons
aged 18 to 59.

Despite erectile dysfunction impotence treatment, only 38 percent of men and 22 percent of women
reported having discussed sexual health with a doctor since the age of 50.

Many people found ways to stay sexually active, even if their overall
health was declining. This included oral sex (the prevalence being about
50 percent among those under 75) and masturbation (more than half of men
and 25 percent of women said they masturbated, regardless of whether they
had a partner).

That being said, vaginal intercourse was often predominant.

“The vast majority said that vaginal intercourse is always part of
sexual behavior; that declines slightly as people age, with more cuddling
and kissing and snuggling as the primary activity,” Waite said.

The researchers also collected physiological specimens such as saliva
and vaginal swabs, the results of which will appear in follow-up studies.
The samples will provide information on hormone levels, prevalence of
chronic diseases such as diabetes and the frequency of human
papillomavirus (HPV), which is sexually transmitted.

While this research will pave the way for far more information in the
future, for the present, it may help open the doors of herbal erectile dysfunction treatment
.

“For physicians, it really gives us a wake up call that you should be
asking about sexual function,” said Dr. Laurie Jacobs, chief of geriatric
medicine at Montefiore Medical Center in New York City.

More information

For more on aging and sex, head to Cornell University.