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Impotence Drugs in the Spotlight — for Different Reasons

jweiss123 — Mon, 26 May 2008 10:03:22 +0000

May 2, 2000 (Atlanta) — One of the major concerns about Viagra is whether
the impotence drug is suitable for patients with heart disease. And those
taking drugs known as nitrates for heart conditions already are warned not to
use the distinctive blue pills. Now another treatment for impotence has been
tested on men suffering with impotence and heart disease, and the results are
encouraging.

At the same time, neurologists in California are finding that Viagra gives
patients with Parkinson’s disease substantial relief from movement
symptoms associated with the brain disorder.

The new drug, Uprima, was studied in nearly 1,500 patients, about 225 of
whom had a history of heart disease, over the course of two months. After
trying various doses of the drug, the researchers found that at the recommended
dose, about one in two attempts at intercourse were likely to be successful.
Those not receiving treatment had successful intercourse in less than one out
of four attempts.

The research, paid for by the TAP Holdings, was presented at a
urology conference here this week.

Uprima is taken by placing it under the tongue and allowing it to be
absorbed into the bloodstream. It was recommended for approval by an advisory
panel to the FDA last month, even though there were concerns about Uprima’s
side effects. About one-third of those taking the drug at a high dose suffered
from nausea or dizziness.

It’s still not clear how Uprima may interact with longer-acting nitrates,
although there is some indication that the combination may lead to fainting or
dangerously low blood pressure. That side effect may have proven lethal to some
nitrate patients who tried Viagra.

However, lead investigator for the new study, Eugene Dula, MD, says Uprima
does appear safer for many heart patients. Dula is medical director of the West
Coast Clinical Research in Van Nuys, Calif.

Dula tells WebMD that Viagra or Uprima should be fine for patients not
taking nitrates but who take one or two drugs for high blood pressure. If they
are on nitrates, especially the short-acting variety, Dula thinks Uprima may be
a good option for these patients. He also says the short-acting nitrates
haven’t caused a profound dip in blood pressure, and that the FDA is taking a
hard look at the longer-acting versions. Other doctors feel that Uprima may be
a useful alternative for patients trying to cope with heart disease and
impotence.

“The nitrate studies are very small with Uprima. There’s about a 10%
incidence of blood pressure changes. They’re not of the magnitude that occur
with Viagra and nitrates, but they are somewhat concerning,” John Mulhall,
MD, assistant professor of urology at Loyola University Medical Center, tells
WebMD.

There also are questions about Uprima’s effectiveness since a relatively
high percentage of those getting placebo treatments also were able to achieve
an erection. “The patients that were entered into the study may not have
had severe sexual dysfunction to start out with,” says Patrick Walsh, MD,
chief of urology at Johns Hopkins Medical in Baltimore.

Uprima is thought to work by stimulating that area of the brain responsible
for causing erections. , it’s also been used to treat Parkinson’s
disease.

Now a new study suggests that Viagra may prove beneficial to people with
Parkinson’s disease. Symptoms of Parkinson’s include shaking, poor balance,
muscle rigidity, and dyskinesia, or abnormal, involuntary muscle movements.

In this study, presented at a neurology conference in San Diego, seven of
nine Parkinson’s patients treated with Viagra experienced a significant
improvement in dyskinesia, with three patients reporting a complete resolution.
The benefits lasted for as long as they remained on the drug and returned when
the drug was discontinued. The patients continued taking their other medicines
while on Viagra and experienced no worsening of their symptoms. Flushing of the
face, reported by one person, was the only side effect, and there was no change
in sexual function.

Neurologist David M. Swope, MD, who conducted the trial, tells WebMD he was
intrigued when one of his patients, a 60-year-old man, said his Parkinson’s
symptoms improved after he started taking Viagra for impotence. Swope theorizes
that the drug’s effects may resemble those of dopamine, a chemical in the brain
and nervous system known to be decreased in Parkinson’s patients. Swope is
assistant professor of neurology at Loma Linda University in Loma Linda,
Calif.

“I was surprised it worked in these patients as well as it did,” he
says. “I ? wasn’t expecting it to be effective in these patients.”
Swope warns that these findings are “very, very preliminary. We need more
evidence that it actually works before it is used routinely.” He is now
designing another study to test the effects of Viagra more carefully. “I
think the role of Viagra has yet to be defined, but potentially this might be
a new approach to treatment.”

Vital :

A recent study suggests the drug Uprima may safely treat impotence in
patients who also have heart disease.
A Uprima researcher says the drug seems safer than Viagra for patients who
are taking nitrates for their heart conditions. Doctors still don’t know the
long-term effects of taking Uprima and nitrates together.
Researchers also are testing how Viagra might help people with Parkinson’s
disease control some of their movement problems.

Read another articles about .

Impotence Drugs Duke It Out

jweiss123 — Sat, 24 May 2008 20:53:15 +0000

Nov. 17, 2003 — Start your engines: Of the medications for
erectile dysfunction, more guys say Levitra gives them better performance.

This result — from what the researcher calls the first
head-to-head study of the three drugs — is being presented at the 6th Congress
of the European Society for Sexual Medicine in Istanbul, Turkey this week.

Viagra and Levitra are to treat erectile
dysfunction. Cialis is currently under review by the FDA to treat erectile
dysfunction and a final word is expected later this year. Levitra is
by Bayer Pharmaceuticals and GlaxoSmithKline, a WebMD sponsor.
Cialis is manufactured by Eli Lilly and Company, a WebMD sponsor. Viagra’s
manufacturer is Pfizer.

Even though Cialis’ effects may last longer, nearly 50% of all
patients preferred Levitra at the recommended starting dose at 10 mg,
researcher Frank Sommer, MD, PhD, a urology specialist at the University
Medical Centre in Cologne, Germany, tells WebMD.

“What they really liked was the quick onset of action, it
was very reliable, and it produced satisfactory hardness of the erection,”
Sommer explains.

In Sommer’s study, 47 men received each of the drugs for six
weeks with a one-week drug-free period in between. Sommer also tested different
dosages of the medications. Each drug was taken prior to sexual activity.

All three of the drugs were effective in men with erectile
dysfunction. Compared to the placebo all of these drugs produced a significant
improvement in erections for vaginal penetration and completion of
intercourse.

At the maximum dose — 20 mg of Cialis, 20 mg of Levitra, 100
mg of Viagra — 43% preferred Levitra, 40% liked Cialis best, and 17% preferred
Viagra.

In the half-maximum dose group, 47% preferred Levitra, 34%
preferred Viagra, and 19% rated Cialis best.

Men who preferred Cialis did so because they felt their
erections lasted longer. And the men who preferred Levitra and Viagra listed
their main reasons as ease of getting erections and hardness of erections.

Two men taking Cialis had such severe back pain that they went
to the hospital emergency room, reports Sommer. Since no spinal problems were
evident, the pain was linked with Cialis.

Other studies have shown that between 4% to 6% of all men
taking Cialis complain about back pain, and for some people it’s very severe
back pain, says Sommer.

Another Viewpoint

The study “shows the potency of Levitra,” says Myron
Murdock, MD, who sits on the national medical advisory boards for Cialis and
Levitra.

But there’s one problem that could skew results: “These
patients knew which drug they were taking, and that makes a very big
difference,” he tells WebMD.

Also, all three drugs work through the same mechanism — and
over time, the effect becomes cumulative, he says. “The longer you take any
of these drugs, the more effective the drug becomes.” Therefore, whatever
drug a guy was taking at the study’s end may show the best results.

Another problem: There have been the reports of back pain with
Cialis. “But that typically occurs within the first 24 hours of taking the
pill, and it’s usually mild, and tends to occur in more muscular males.
Physical activity and nonsteroidal anti-inflammatory drugs (NSAIDs, like
ibuprofen) make it go away. For most men, it’s not a serious side affect, but
it can be an annoyance,” says Murdock.

Bottom line on all these erectile dysfunction drugs: “If
Viagra works well for you, and you have one or two sexual episodes a month,
stay on Viagra,” Murdock tells WebMD. If you’ve been disappointed with
Viagra, and don’t have sex frequently, if you’re a diabetic, or have had
prostate surgery — or if you don’t like the lifestyle limitations of Viagra –
then you should be on Levitra, he says.

Cialis is great for very sexually active guys — sex one or
more times a week — and who aren’t in any of the hard-to-treat categories. Of
all the erectile dysfunction drugs, “Cialis will be more
,” Murdock says.

The Doctor Will Email You Now: Internet Decried as Rx Source

jweiss123 — Fri, 23 May 2008 18:23:51 +0000

March 9, 2000 (Washington) — A split-second ride fueled by a powerful
Internet search engine reveals the extent of the problem: type in
“Viagra” and nearly 60,000 results come flying back. But those
flashing, dancing, web sites that proclaim, “No prescription? No
problem,” are best avoided, says an Ohio physician who analyzed the risks
of buying the impotence drug via the World Wide Web.

“There are no regulations now, and the government is moving very slowly
to corral the practice of online prescribing,” says Steven E. Kahan, MD,
the lead author of the article in the March issue of the Journal of
Urology. “This is obviously something that is very tough to get your
arms around. Then, after everything is said and done, you have the
international sites, and I don’t know who is going to regulate them.” Kahan
is an attorney and urologist-in-training at Case Western Reserve University in
Cleveland.

However, in a letter published in the March 8 issue of TheJournal
of the American Medical Association, Jane Henney, MD, commissioner of the
FDA, acknowledges that laws need to be updated and writes that the agency is
working with state pharmacy and medicine boards to “investigate illegal
online selling and prescribing.”

Viagra (sildenafil) has been available since March 1998 for the treatment of
impotence, or erectile dysfunction (ED). It has been hawked in television
commercials by Bob Dole, the former senator and presidential candidate. The
most common side effects of Viagra are facial flushing, nausea, dizziness and
blue-tinged vision, but it can also cause a potentially deadly drop in blood
pressure, when combined with certain medications, including
nitroglycerin.

In the article, Kahan and two colleagues trace the advent of Viagra’s
through the Internet and focus on the ethical, legal, and
regulatory issues that surround online prescribing in general. The authors
write that the physician-patient relationship was under stress before the
popularity of the Internet. The increasingly common practice of phone calls to
patients altered this arrangement, with patients expecting “attention to
medical needs” and a guarantee of privacy during such calls.

At first, physicians turned to the Internet primarily as a means to
communicate with colleagues and conduct research, but now more realize it can
“permit easier patient access to health care and lower transaction costs
with arguably continued consistent health care delivery,” the authors say.
Improved patient compliance may also be achieved.

The authors argue that regulations should recognize a distinction between
Internet pharmacies and online prescribing and point out that a variety of
governmental agencies have a limited hand in such regulation today. While the
FDA ostensibly has oversight of prescription medications, it does not regulate
the actual writing of such medications, but only the “development,
distribution, and promotion” of .

There is little harm in people filling prescriptions written by their
physician through reputable Internet pharmacies. But that’s where the sites’
involvement should begin and end, Kahan says.

“I think Internet pharmacies should not initiate a prescription, and the
prescription that is filled should be based on a doctor-patient relationship,
and that usually involves a physical exam,” says Kahan. In his own
practice, Kahan says he found it “strange” that patients had access to
medications he deemed inappropriate for them and “all I could do was warn
them about what might happen and discourage them for getting it from the
Internet. Hopefully, they would have the sense not to get it.”

State governments have cracked down on physicians who have prescribed
medications online to people who don’t reside in the states where the
physicians are licensed, holding that it constitutes practicing medicine
without a license. The Federal Trade Commission is charged with ensuring that
drug advertising is not false or misleading, although monitoring Internet
claims specifically seems to have gotten little emphasis, Kahan says.

Irwin Goldstein, MD, a professor of urology at Boston University, points out
that patients should have a thorough examination before they are given Viagra
to rule out any possible interaction with other medical conditions they have.
He tells WebMD that a “doctor’s visit” by an online physician could
miss the possible reasons for erectile dysfunction and other medical conditions
that could make Viagra a bad idea, including diabetes, hypertension, high
cholesterol, kidney failure, anemia, prostate and testicular infections, and
depression.

For Robert Sher, MD, a urologist in Maryland, the article reinforces his
belief that prescribing and obtaining Viagra over the Internet are just
wrong.

“Viagra has side effects,” says Sher, who reviewed the article for
WebMD. “People need to be monitored on it. If they aren’t monitored they
can die. You need to see the patient. ED is a medical problem and patients need
to have a thorough evaluation prior to prescribing it. Viagra is not for
patients who are using nitroglycerin products and may be abused by someone who
just wants it as a sex enhancer.”

Though none of his patients have discussed obtaining Viagra through the
Internet, the possibility certainly exists that they could get it this way,
Sher says. “You see these sites everywhere. They advertise in the
newspaper, and I think Viagra is probably the tip of the iceberg of what other
drugs you can get on the Internet.”

In her letter to JAMA, Henney also counsels that patients not obtain
first-time prescriptions from online doctors, and she urges physicians and
pharmacies to “educate their patients about dangerous online
practices.” The agency “also encourages health care professionals and
patients to report any suspicious web sites to the FDA or the National Boards
of Pharmacy. Until fully effective safeguards are in place, patients and health
care providers should be cautious when using or the use of the
Internet for purchase of prescription medications,” she writes.

Vital Information:

Experts are concerned about the ease with which the erectile dysfunction
drug Viagra is obtained over the Internet without a prescription or a visit to
a doctor.
One problem is that regulation of prescribing over the Internet is
fragmented among government agencies, although governing practices may be
changing in the future.
Getting a prescription filled by an online pharmacy should not be a problem
for consumers, as long as the prescription was written based on a sound
doctor-patient relationship that involves a physical exam.

How do yo think, is it true about ?

Covering Birth Control

jweiss123 — Thu, 22 May 2008 17:13:47 +0000

Sept. 4, 2000 — When Seattle pharmacist Jennifer Erickson returned to work
in late July one day after filing a lawsuit against her
employer, the Bartell Drug Co., her female co-workers were ecstatic. “It
was all high fives and ‘You go, girl!’ ” Erickson says with a laugh. Her
customers thanked her. Strangers who recognized her from interviews in the
local and national media stopped her on the street.

So why is this 26-year old suing her own employer — and getting so much
attention and support from her co-workers and customers? Erickson is
challenging one of the longest-standing disparities in medicine. She thinks
it’s wrong that the health insurance plans offered by so many companies across
the country provide coverage for drugs like Viagra for men but don’t cover
birth control pills and other contraceptives. And she thinks changes are long
overdue.

To try to close this gender gap, Erickson volunteered to be the lead
plaintiff in a class action lawsuit filed last month by Planned Parenthood –
the first case ever seeking to force an employer to include contraceptives in
its health plan. While the lawsuit targets only Bartell, it could pave the way
for similar suits against every company in the United States that provides
similar prescription coverage to its employees but fails to cover
contraceptives.

“This problem affects millions of women all over the country,” says
Sylvia A. Law, a law professor at New York University. “Yet it’s the first
time the issue has ever been addressed in a court — and it’s high time.”
Law was the first to argue in a 1998 Washington Law Review article that
excluding contraceptives from prescription coverage illegally discriminates
against women under Title VII of the federal Civil Rights Act.

Three-quarters of American women of childbearing age rely on
employer-sponsored plans for their health coverage, according to the Alan
Guttmacher Institute, a research group that works to broaden access to family
planning services. Yet half of all large plans do not cover any
form of prescription contraception, and only a third cover the Pill. While most
HMOs do cover oral contraception, only about 40% cover all five of the
FDA-approved prescription birth control methods available in this country.

Erickson’s lawsuit aims to assist working women like herself — those who
are neither rich enough to easily pay for contraceptives themselves nor poor
enough to qualify for help from the government. And while the young newlywed is
new to activism, the role of crusader for women’s rights seems to be coming
quite naturally. “I’m very outgoing and outspoken,” Erickson says.
“It’s easy for me to say, ‘This is wrong, fix it.’”

Bartell has yet to file a response to the suit, but in a press statement the
company defended its policy as “lawful and nondiscriminatory,” noting
that “no medical benefits program covers every possible cost.” Company
officials have not spoken with Erickson about the lawsuit. She says her working
environment has remained friendly.

Erickson, who grew up in Lafayette, Ind., moved to Seattle in 1999. She has
worked for Bartell for 18 months and was recently promoted to pharmacy manager.
She says she loves her job and considers Bartell — which operates a chain of
45 drugstores in Washington — a progressive workplace. But she hates telling
customers that their health plans don’t cover the contraceptives they need.
Even more, she hates watching them turn away angrily.

“One woman recently said to me, ‘I have to make rent this month, I have
five kids to feed, I can’t afford to pay for birth control pills,’ ”
Erickson says. “I want to say to her, ‘Don’t leave without these!’ I feel
so bad.”

But Erickson’s efforts aren’t simply aimed at helping others. The fact that
her own company’s insurance plan doesn’t cover contraceptives forces Erickson
– who says she’s not ready to have children — to pay $360 a year
out-of-pocket for birth control pills.

While she can afford this expense, she thinks it’s unfair that she has to.
And there were times in the past when she couldn’t. Like many women, she turned
to Planned Parenthood, where she was a regular client and a strong supporter.
So when representatives from the local chapter said they would help her file a
complaint against Bartell with the Equal Employment Opportunity Commission last
December, she didn’t hesitate.

The resulting lawsuit has made waves for its landmark legal strategy. It
charges that a company whose insurance plan covers most prescription drugs but
excludes contraceptives violates federal laws because only women
use prescription contraceptives.

Family planning advocates argue that excluding birth control from
prescription coverage is not only discriminatory, it’s also economically
short-sighted. is far cheaper than the cost of either a pregnancy
or an abortion. In 1996, the Health Insurance Association of America estimated
it would cost about $16 per person to provide birth control coverage for
members of group plans. Compare that to the average cost of an abortion:
$316.

“Services for men get covered much quicker than services for women,”
says Judith DeSarno, president and CEO of the National Family Planning and
Reproductive Health Association. It was only 25 years ago that insurance
companies agreed to cover the cost of prenatal care. “There’s a very clear
pattern here,” she says. “It’s the nickel-and-diming of women’s
health.”

A recent nationwide survey found that two-thirds of Americans want insurers
to cover contraception. Currently 13 states have passed laws requiring health
plans to pay for contraceptives if they cover prescription drugs to include
contraceptives, and 21 states are considering such legislation. Federal
legislation has been stalled in Congress since 1997.

The big problem with the state laws, says Roberta Riley, the Planned
Parenthood attorney who filed the lawsuit, is that they generally don’t apply
to self-insured companies like Bartell, which put together their own medical
coverage for their workers. Because self-insured companies account for half of
all employer-sponsored health insurance, that leaves a large gap. And that,
Riley says, was one reason Planned Parenthood decided it was time to go to
court.

But before any lawsuit could be filed, the advocates needed a plaintiff who
was willing to risk taking on her employer. They found one in Jennifer
Erickson.

“Jennifer is a Rosa Parks; she has a sense of idealism and
altruism,” says Riley. “She’s a very intelligent young woman, a
thinking person. No doubt her experiences turning down women raised her
awareness and motivated her to stand up and do something about it.”

What also made her an ideal plaintiff is that “she’s not disgruntled,
she has no ax to grind with her employer about any other issue,” says
Riley. “She wants to pursue her career at Bartell Drugs, but she also wants
this company to cover contraception and wants to change the law so all
companies do so as well.”

“It’s hard to find a woman who will stand up to her boss for $30 a month
– the cost of birth control pills — and risk her job for a principle,”
says Law.

Jennifer Erickson simply shrugs off the deluge of praise. “Stepping
forward is not as hard as I thought it would be,” she says. “When you
really believe in something, it’s easy to do.”

Loren Stein, a journalist based
in Palo Alto, Calif., specializes in health and legal issues. Her work has
appeared in California Lawyer,Hippocrates,L.A. Weekly,
and The Christian Science Monitor, among other publications.

, and more another.

Gene Therapy Offers Hope of New Lease on Sex Life

jweiss123 — Wed, 21 May 2008 12:00:57 +0000

April 1, 2001 — Move over, Viagra: A team of researchers has found that an form of gene therapy can restore over-the-hill male rats to the sexual potency — as measured by their ability to have erections — of studly young rats just a third their age. The therapy was described at the annual Biology meeting in Orlando, Fla.

Although the therapy is far from being ready for prime time in humans, it has potential as a long-acting treatment that could help to restore youthful vigor to men with erectile dysfunction, report Trinity Bivalacqua and colleagues from Tulane University in New Orleans and Johns Hopkins University in Baltimore.

In their study, the researchers injected into the penises of aged rats a cold virus modified to carry a gene that helps blood vessels in the penis to expand and fill with blood, one of the key steps necessary to creating and sustaining an erection.

“We looked at the physiology, asking is this going to help these animals get better erections, which it did,” Bivalacqua, a medical student at Tulane University, tells WebMD.

Erections are controlled by a complex series of events involving nerves and the signals they carry, as well as hormones and other substances that control the expansion of blood vessels, so it’s not surprising that any one of several defects or disruptions of one of the mechanisms involved in sexual performance in men can result in erectile dysfunction.

One method for treating erectile dysfunction has been through direct injection into the penis of substances that stimulate the release of chemicals within the penis that control the relaxation of smooth muscle. When smooth muscles surrounding the blood vessels in the penis relax, they allow more blood to enter, thereby causing an erection. Drugs like Viagra work by interfering with an enzyme that would otherwise prevent relaxation of smooth muscle.

Unfortunately, penile injections and Viagra are one-shot deals and need to be repeated every time a man with erectile dysfunction wishes to have sexual intercourse.

To see whether they could create a longer-lasting treatment for erectile dysfunction, Bivalacqua and colleagues injected into the penises of aged male rats a harmless cold virus, called an adenovirus, that had been modified to carry a gene for an important , or chemical messenger, involved in erections.

Five days after the injections, the rats underwent nerve stimulation to simulate a normal erection, and their responses were compared with those of other rats one-third their age. The researchers found that older animals that received the adenovirus had erectile responses comparable to those of young rats. In contrast, older rats injected with a different gene not associated with erectile function had no significant improvements in function.

The researchers also found evidence that the virus continued to be present in penile tissue for up to 30 days, suggesting that the therapy, if found to be safe and effective in humans, could be delivered once a month rather than before every episode of sexual intercourse — no doubt a welcome prospect to men who are squeamish about the idea of penile injections.

But a urologist who studies gene therapy for erectile dysfunction tells WebMD that there are several drawbacks to using adenoviruses as carriers for genes.

“As a strategy in humans, I think adenovirus has some drawbacks in that it’s inflammatory, and usually repeated doses will cause an immune system reaction. I think we need to keep trying different genes, and we also need to start looking at long-term strategies for gene expression, because these are temporary and won’t be permanently incorporated into the penis,” says Hunter Wessells, MD, associate professor of urology at the University of Washington School of Medicine in Seattle.

Craig F. Donatucci, MD, a urologist who specializes in research and treatment of erectile dysfunction at Duke University Medical Center in Chapel Hill, N.C., tells WebMD that ” it makes sense, because you fix the problem, but then you have the issue about the dangers of adenoviruses.”

Donatucci points to the 1999 death of a patient at the University of who was undergoing experimental gene therapy with an adenovirus for correcting a lifelong metabolic disorder. “If you’re talking just about erectile failure, what’s your safety level? Where do you set that?” he asks. “From a general philosophical viewpoint, it’s very attractive to think of gene therapy in the future, putting in some form of gene therapy, but realistically, it’s a long way from happening.”

Erectile Dysfunction 2003: More Choices

jweiss123 — Tue, 20 May 2008 00:14:29 +0000

First there was the little blue pill. This year it has two
companions: The little orange pill, and the , yellow pill.

Men with erectile dysfunction now have three drugs to choose
from — Viagra, Levitra, and Cialis. If that’s news to you, you must not have
turned on a television set or opened a magazine in the last few months.
Everywhere you look, it seems, there are famous athletes singing the praises of
their drug-restored virility. It’s hard to remember the no-so-long-ago time
when “erectile dysfunction” were words no man dared speak.

Does one drug work better than another? That depends on the
man.

All three drugs work the same way, says urologist Gerald Brock,
MD, associate professor at St. Joseph’s Health Center in London, Ontario,
Canada. Brock is past chair of the Canadian Male Sexual Health Council. He’s
treated many patients with Viagra and, in clinical trials, with Cialis and
Levitra.

“The big difference is length of action,” Brock tells
WebMD. “All are very safe and have proven in tens of thousands of men to be
a valuable treatment for erectile dysfunction.”

Viagra starts working in about half an hour — although an
effect has been seen in as little as 12 minutes — and its effect lasts for
about four hours. Levitra has about the same window of effect at lower doses.
Cialis gets to work a bit faster — one-third of men respond in 15 minutes –
but lasts for 36 to 48 hours in some men.

All of the drugs block an enzyme called PDE-5. PDE-5 is a key
link in the chain of chemical messages that tell a man’s erection to go away.
Brock says that there’s more PDE-5 in the penis than in other muscles, so the
drugs have a pretty specific effect.

Chad Ritenour, MD, teaches urology at Atlanta’s Emory
University. He says lots of patients are trying the newer drugs.

“I tell patients it is going to be like Pepsi versus Coke
– get ready for the blitz,” Ritenour tells WebMD. “But I
don’t think anybody can say one works better than the other. Each drug probably
will work better for some patients than for others.”

More to Sex Than Erections

It’s good to get men talking about their sexuality. But being
sexual is different than having an erection, says Jeanne Shaw, PhD, an
Atlanta-based clinical psychologist and certified sex therapist.

“What I see as a problem is the public has been educated to
believe that good sex requires an erect penis that stays hard through the
entire sexual encounter,” Shaw tells WebMD. “This definition of good
sex changes the basic nature of an encounter from intimacy and pleasure to
achievement and performance.”

This focus on performance, Shaw says, robs men and their
partners of the to deepen their relationships — and their
sexuality. The sexual needs of adolescents, she says, are different that those
of adults. Yet by making erections the be-all and end-all of sex, grown men are
retreating to adolescent sexual values.

“Having an erection does not mean you are being sexual.
Being sexual comes from inside your sense of yourself,” Shaw says. “You
can be sexual, you can feel sexual, you can behave sexually without an
erection. A penis is not the only part of a man’s body that can be used
sexually.”

Shaw makes a distinction between genital behavior and sexual behavior.
Mistaking one for the other, she says, leads to dishonesty and
dissatisfaction.

“You can behave genitally whether you feel sexual or
not,” Shaw notes. “Women and men can fake it. Lots of men get an
erection, penetrate, and lose the erection and pretend they have had an orgasm
because they want to be perfect. They don’t say, ‘Hey, I didn’t have an orgasm
but maybe next time. Being near you is enough.’”

In her practice, Shaw finds that physical problems don’t lie at
the heart of most men’s sexual problems.

“Actually, it is psychological distress associated with not
measuring up rather than physiological problems that causes most sexual
dissatisfaction,” Shaw says. “For many, many men — maybe most –
problems with sex are due to ignorance, anxiety, and inability to communicate
with their partners. I think sexual dysfunction is the inevitable result of the
effort to attain perfection.”

Treatment for Erectile Dysfunction Can Improve Depression

jweiss123 — Sun, 18 May 2008 21:18:34 +0000

Oct. 3, 2001 — Impotence and are closely linked and commonly occur in the same man. But now a new study shows that one little blue pill might actually be able to take care of both problems.

Impotence, also known as erectile dysfunction (ED), affects more than 18 million men in the U.S. As men age, it often becomes more difficult for them to maintain an erection. Diabetes, high blood pressure, and high cholesterol can increase the risks of developing ED.

In some men, depression can cause ED. In others, however, ED may actually cause mild depression. So researchers from the department of psychiatry at Columbia University tried to whether Viagra could improve erections and depression in one fell swoop.

They looked at more than 150 men with ED and mild depression — half were given Viagra and the other half received a placebo but were not aware of which treatment they were taking.

As expected, the men receiving Viagra had a much greater response than those in the placebo group. About 90% of men taking Viagra had in their erections and ability to have sexual intercourse. But only about 12% of men taking placebo had the same results.

The results often showed that whether the men took the drug or placebo, if erections improved, so did their mood.

“Results from the study suggest that successful treatment of ED in depressed men can lead to marked improvement in depression,” write Stuart N. Seidman, MD, and his . However, they are quick to point out that this single study does not reveal how long the improvement in depression will last.

Drugmaker Pulls Impotence Drug out of FDA Approval Process

jweiss123 — Sat, 17 May 2008 14:19:09 +0000

June 30, 2000 (Washington) — Of the 30 million American men suffering from erectile dysfunction, those expecting to have an alternative to Viagra soon will now have to wait. The approval for the erectile dysfunction drug Uprima (apomorphine) was withdrawn by its maker Friday — just days before the FDA was to render a final decision and despite data demonstrating it might prove to be a safer alternative for patients with heart disease.

Apomorphine has been used to treat various disorders since 1869. For the last half of the 20th century, it has been used as a sedative, and since 1967 as a treatment for Parkinson’s disease. In men suffering from erectile dysfunction, the drug stimulates brain centers involved in sexual response and activates spinal nerves to increase blood flow to erectile tissue.

TAP Pharmaceuticals, a joint venture between Abbott Laboratories of Abbott Park, Ill., and Japan’s Takeda Chemical Industries, said it decided to withdraw the application for Uprima so it can complete several ongoing studies to confirm the drug’s safety and . The FDA nod initially was expected in July based on advice from a FDA expert advisory committee, which in April voted 9-3 to recommend that agency officials proceed with its approval.

The FDA committee supported approval of Uprima despite the potential for serious side effects when it is taken with nitrates, a common drug for heart disease, and its apparent interaction with alcohol, which could lead to dangerously low blood pressure, a slow heart rate, and fainting. Viagra also can cause adverse reactions when taken with nitrates. The committee also voted for approval despite questions regarding the overall effectiveness of Uprima. These questions center on whether the clinical trials of the drug truly included men with severe sexual dysfunction.

In those clinical trials, more than half of the treatment group achieved an erection compared with 35% of those patients on placebo. The relatively high rate of responders in the placebo group suggests that the patients included in the studies may not have suffered from severe sexual dysfunction, a number of committee members noted.

Eugene Dula, MD, a urologist and director of West Coast Clinical Research in Van Nuys, Calif., tells WebMD that erectile dysfunction is associated with a high placebo response, and as a result, concerns regarding whether it was tested in the right patient population are probably unfounded.

When asked why the committee voted to support approval in spite of the potential for serious side effects and questions about effectiveness, FDA Committee Chair Ricardo Azziz, MD, MPH, told WebMD, “Erectile dysfunction is a major quality of life issue.”

Now experts speculate the company withdrew its application because of chances that the FDA might not follow its committee’s recommendations to approve the drug. Whatever the outcome, Uprima’s with nitrates and alcohol are risks that need serious consideration, Marianne Mann, MD, a deputy director for the FDA, told committee members at the April meeting.

But the delay does not necessarily mean Uprima will not eventually be approved. “We are still very confident that Uprima is a safe and effective drug. We hope by taking this extra time we will have a much a stronger product,” Kim Modroy, a spokesperson for TAP Pharmaceuticals, tells WebMD.

The additional trials now underway include a large, study to determine safety and effectiveness in doses ranging from 2 mg to 4 mg, and a smaller placebo-controlled trial to study 3 mg and 4 mg doses. Earlier trials tested a 5 mg dose. The additional trials also include studies to assess how the drug interacts with alcohol and nitrates.

These new studies should answer any of the agency’s concerns, notes Dula, who has participated in a number of studies of Uprima.

Modroy says that the company expects to finish these studies sometime this summer and that over the next few weeks, TAP also plans to discuss with FDA officials a new timetable for Uprima’s review.

Uprima does appear to be safer than Viagra for patients with heart disease, based on studies that show its side effects are much milder than those seen with Viagra, notes Dula.

“It is important with Uprima, as with any other drug, that the patient be counseled. It’s not candy,” he tells WebMD. However, with appropriate follow-up, “I think both Uprima and Viagra are safe and effective first-line treatments.”

In previous clinical trials submitted for Uprima’s approval, commons side effects included nausea (32%), dizziness (15%), and sweating. About 60% of the participants dropped out due to these side effects, but the majority of these patients were taking a 5 mg dose, which is a dosing regimen that TAP says it has no plans to pursue. If it is eventually approved, Uprima will be sold in doses ranging from 2 mg to 4 mg, the company says.

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New Drug for Male Impotence Backed by FDA Experts

jweiss123 — Fri, 16 May 2008 13:06:24 +0000

April 10, 2000 (Washington) — If Viagra fails to do the trick, you may soon
be able to try Uprima, a proposed new treatment for erectile . That
is because a committee of experts recommended Monday that the FDA proceed with
Uprima’s approval. The final decision will be made sometime in July.

Placed under the tongue, Uprima is a medication that encourages erections by
stimulating the area of the brain responsible for sexual arousal. Although
Uprima is new, its active ingredient, apomorphine, has been used for various
disorders since 1869. For the last half of the 20th century, it has been used
as a sedative, and since 1967, as a treatment for Parkinson’s disease.

In medical studies, almost 60% of men taking Uprima had an erection, whereas
only 35% of men taking a placebo were able to successfully achieve an
erection.

But the major area of concern with regard to Uprima was its safety profile,
not its . Nausea was seen in 32% of the men, with dizziness and
sweating occurring in about 15%. In the studies, 60% of the men had to drop out
due to side effects. But most of these occurred in men taking at least 5 mg of
the drug. If approved, Uprima will be sold in doses of 2 mg to 4 mg.

Uprima also appeared to interact with nitrates, the common heart drug that
is forbidden in men taking Viagra, and alcohol, leading to concerns about the
potential for more serious side effects, such as passing out, dangerously low
blood pressure, and slow heart rate.

These risks need serious consideration, Marianne Mann, MD, deputy director
of the FDA’s Division of and Urologic Drug Products, told
committee members.

Panel members agreed. But despite the drug’s interaction with alcohol and
nitrates, the committee noted that its benefits still outweighed the risks,
eventually voting 9-3 in support of approval. “Erectile dysfunction is a
major quality-of-life issue,” committee chair Ricardo Azziz, MD, MPH, tells
WebMD. Although this drug may need to be used only in certain men, there is no
question that it had a definite benefit, he says.

At the proposed doses, the occurrence of side effects was also limited, says
Timothy Fagan, MD, FACP, who helped analyze the safety data. “I think it is
reasonable to require that nitrates and alcohol intakes be monitored,” says
the professor of medicine at the University of Arizona. However, “I also
think its safety profile is much better than several other current
therapies,” he tells WebMD.

At present, Viagra is the only treatment option taken by mouth.
Schering-Plough Corp. and Eli Lilly and Co. are researching other potential
options, but those are still being studied. Uprima is made by Tap
Pharmaceuticals, a joint venture between Illinois-based Abbott Laboratories and
Takeda Pharmaceuticals, of Japan.

Vital Information:

An expert panel has recommended that the FDA approve Uprima, a new pill to
treat impotence.
The drug has a 60% success rate, compared to a 35% success rate for
placebo.
Side effects reported by patients taking Uprima included nausea, dizziness,
and sweating, and the drug may have interactions with nitrates and
alcohol.

, and more another.

Levitra: New Impotence Drug Christened

jweiss123 — Thu, 15 May 2008 10:03:36 +0000

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Sept. 23, 2002 — The long-awaited competitor to Viagra — christened Levitra today — inches its way to final FDA approval. Two early studies suggest it’s longer lasting, has fewer side effects, and is safe for virtually everyone, including those with heart problems. Similar drugs approved in this class of medication carry warnings for men with heart disease.

However, one urologist advises men not to get their hopes up. “That’s not to say new drugs won’t be exciting and wonderfully worthwhile,” Larry Lipshultz, MD, professor of urology at Baylor College of Medicine in Houston. “The data is interesting. Let’s see if the drug holds up to the claims.”

Levitra was developed by Bayer and and is scheduled for U.S. launch in 2003.

Viagra, produced by Pfizer Inc., the treatment of male sexual dysfunction, allowing men for the first time to pop a pill to get an erection — rather than trying various devices, having a drug injected into the penis, or having a pellet inserted into it.

By some estimates, some degree of ED affects more than 50% of men over the age of 40. In the U.S., alone 30 million men are affected.

However, statistics show that only about 10% of men seek help. So 90% of men out there still aren’t getting treated for impotence, says Irwin Goldstein, MD, director of the Institute for Sexual Medicine at the Boston University Medical Center and a leader of the Massachusetts Male Aging Study.

“In the early days of Viagra, many men got turned off — largely because reports of heart attacks that were shown later not to be related to the drug,” Goldstein tells WebMD. Today, Viagra carries only an advisory for people with high blood pressure who are taking particular types of blood pressure-lowering medication, and patients with angina or heart disease who take nitrates.

The data on Levitra:

A phase III clinical trial enrolled 440 men with erectile dysfunction between 44 and 77 years old, most of whom had undergone nerve sparing prostatectomies six or more months before entering the study. (About a third of men who have had a prostatectomy — removal of the prostate gland — develop ED.) After 12 weeks of Levitra, 71% of the men had improved erections. And a subset of men experiencing depression related to their impotence reported fewer symptoms of depression after taking Levitra.

In a 26-week phase III trial of 805 men, about 74%-77% of men taking 10-20 mg of Levitra reported successful penetration on their first attempt, compared with 46% of men taking placebo. Also, the men who were successful the first time reported successful penetration in about 85%-91% of subsequent attempts, compared with 77% of those taking placebo. Side effects were mild to moderate headache, flushing, and nasal congestion — “mild stuff,” says Goldstein.

Both Viagra and Levitra work by inhibiting the PDE5 enzyme. “That means that if you take a pill, then have sexual stimulation, the drug can magnify the natural erectile response. It allows the reaction to be more like sex should be.”

The biochemical differences between the two drugs mark the difference, he says. “Levitra contains a more efficient enzyme inhibitor, so only a very small amount of the drug is necessary,” Goldstein tells WebMD. “That’s the thing that’s cool about Levitra — it’s biochemical potency is distinctly different from Viagra and Cialis another impotence treatment drug being developed by Lilly.”

All three drugs — plus several more still in development — have their place in a physician’s armamentarium, says Goldstein. “Several other companies are also working on drugs with PDE5 inhibitors.”

When it starts to work and how long it lasts are big issues in impotence medicine: Viagra takes effect in about 30 minutes and the effects last about 4 hours. Cialis reaches maximum concentration in 24 hours, and the effects last for about 3 days, says Goldstein. Levitra is faster-acting, reaching maximum concentration in 30 to 40 minutes, with the effects lasting about 16 hours.

Also, Levitra doesn’t carry one disconcerting visual problem that many men report with Viagra: “If you take Viagra, you get a weird blue vision,” he says.

Just don’t expect miracles with Levitra, says Lipshultz.

“The strength of the drugs will probably be comparable — they’re all supposed to inhibit the enzyme PDE5,” Lipshultz tells WebMD. “Whatever dose you take inhibits it completely. So I don’t think we’re going to be seeing a whole lot of advertising based on ‘take this drug because it’s stronger.’”

Also, if you didn’t have success with Viagra, it’s doubtful that Levitra will work any better, says Lipshultz. “I don’t think we’re going to see people who fail one drug do a whole lot better on another drug. I think where the difference will be — if any — is onset of action, duration of action, and side effects.”

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