Many more people than previously acknowledged may be living lives
divorced from a happy and healthy relationship with food and eating.
Long-term dieters are like drug addicts - their next go is definitely
going to be their last but somehow it never is. Increasing amounts of
research indicate that dieting is more often a contributor to
long-term eating and weight issues than it is a passport to lasting
and relaxed weight control. Whilst repeated dieting does not
automatically lead on to the very serious eating disorders of anorexia
and bulimia, constant unhappiness with eating and self-image can
certainly be harmful to self-esteem and, indeed, physical and mental
health. Yale University's Prof. Kelly Brownell coined the notion of
Yo-Yo Dieting 20 years ago. The research was a major breakthrough into
realizing the limitations of interfering too much with a natural
relationship with food and eating. Yo-Yo Dieting is the widely
understood notion of periods of crash weight reduction being followed
by periods of weight regain once the artificial eating regime is
relaxed. Subsequent studies have indicated that major health risks,
particularly of heart disease, are associated with these dieting
cycles. Now, new research by a weight-control charity suggests that
many more people than previously recognized are living their lives
dominated by anxieties over eating and dieting. The Weight Foundation
says that obsessive dieting is to blame for great misery and that too
little help is on offer for individuals who spend their lives locked
into depressing and often unhealthy dieting regimes. For many women,
the panicky run-up to peak holiday time - and also the Thanksgiving
period - are triggers for fresh cycles of self-starvation, with the
lost weight often creeping back on. However, The Weight Foundation is
discovering that the extent of the worldwide dieting misery is much
wider than these weight-loss and regain rituals. The research being
conducted by the charity's founder through the UK's Manchester
Metropolitan University is shedding light on the millions of dieters
worldwide who suffer long-term distress but do not undergo any
dramatic swings in weight. "The accepted pattern of dieting is what
has been called Yo-Yo-ing," explains Evans, a 46 year old Cambridge
University social sciences graduate, professional motivational trainer
and private therapist. "Instead, we call this Swinger dieting because
we find whether and how quickly weight returns depends on many factors
and is not automatic like a Yo-Yo. However, the more you look at what
is actually going on in the privacy of people's own homes, this is
just the tip of the dieting iceberg." Flatliner dieting is identified
as being a constant battle between "good" and "bad" foods, with people
varying between treating and punishing themselves with food. These
mini-dieting cycles can be packed within as short a time as a single
day. The term Flatliner refers both to the lack of any jagged peaks of
weight gain and loss and also to the emotional flatness and misery
usually experienced with this lifestyle. There is constant tension
between overeating and self-denial. Lifer dieting refers to people who
never really come off a diet at all, even though they may swap diets
now and then. Lifers fear that breaking their strict eating regime for
just a single day might spell disaster. Occasions such as weddings and
family gatherings are times of high anxiety. Evans says, "The majority
of research to date on eating and dieting problems has tended to
concentrate on the extreme areas of Anorexia and Bulimia. What we are
finding, particularly horrible as these conditions are, is that there
are potentially huge numbers of dieters experiencing great distress."
As with all unrecognized conditions, many of these people suffer in
silence, without understanding or support. The Weight Foundation is
referring to all types of dieting which tend to dominate an
individuals' lifestyles as Hardcore Dieting. The charity is seeking to
understand what pressures and motivations hold obsessive dieting
behavior in place and is finding in both the U.S and the UK that there
is a widespread cultural acceptance that a dieting lifestyle is the
morally correct lifestyle. It is Evans' goal to develop an
international network of committed individuals who can mentor dieters
to move away from depressing and destructive habits. The philosophy is
that by treating food and eating as mainly just a necessity of life,
weight will find its natural – normally lighter – level. "The key
difference between happily slim people and unhappily overweight
individuals is that, for the former, food plays a very small part in
their lives." "Dieting can often make people overweight and it will
always make them unhappy. The key to lasting weight control is to
enjoy a healthy and natural relationship with food. It is only by
developing a thorough understanding of Hardcore Dieting that this
message will stop falling on deaf ears," says Evans. The Weight
Foundation's website features The Hardcore Dieting Index, a
self-diagnostic questionnaire for dieters.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 7:12 PM 0 Comments Links to this post

Criminal organizations have found yet another way to make money:
counterfeit prescription drugs, a growing problem that is concerning
drug companies and policymakers alike.

In 2003, 10 percent of all medications sold worldwide were
counterfeit, Rep. Mike Rogers, R-Mich., said at a briefing this week.
That's equal to $32 billion of the drug industry.

"Technology has allowed criminals to counterfeit drugs and work them
into the system here in America," Rogers said.

He added that the Food and Drug Administration was originally created
to help prevent counterfeiting, and the United States has one of the
safest drug systems in the world.

"(Counterfeiting) used to be a problem that was confined to developing
countries. We're now seeing it in one of the safest and most regulated
countries in the world," John Theriault, vice president of security at
Pfizer Inc., told United Press International. "It's clearly much worse
than it was five years ago."

According to an investigation conducted by "Dateline NBC" shown at the
briefing, the counterfeit drug market is incredibly profitable.
Counterfeiters can sell phony prescriptions for $1 in instances where
every real pill would cost $8 at wholesale. A company could import
$1.5 million pills a year, resulting in a $10 million profit.

Even experts who were brought in by the "Dateline" investigation had
trouble distinguishing good counterfeit pills from the real ones.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 9:24 AM 0 Comments Links to this post

Baltimore Mayor Martin O'Malley announced recently in his
gubernatorial campaign that he will consider buying prescription drugs
from Canada and abroad as a way to reduce health care costs for
Marylanders. But that policy can potentially harm both consumers and
the economics of drug creation and sale in the United States.

Those unsolicited and poorly worded offers for Cialis and Viagra in
our e-mail inboxes say it all.

Drug re-importation is one situation where the invisible hand will not
solve the problem. The key prefix is the "re-" in reimportation. The
United States develops, creates and produces the bulk of the world's
drugs. Foreign governments legally purchase drugs from American
companies at discount prices and then set their own prices at home
(translation: price controls). Were Maryland to allow drug
re-importation, American firms would continue to assume the worldwide
burden of drug research and development but at a profit margin that
did not take those efforts into account.

And how does Mayor O'Malley plan to ensure that drugs coming in are
safe? This policy move cannot just be made in isolation. Federal
approval is required. Further, when American-produced prescription
drugs make their way back into this country, they will have passed
through multiple hands, increasing the risk of tampering and
counterfeiting.

To guarantee drug safety, the Food and Drug Administration would have
to investigate (and test) drugs for tampering and counterfeiting,
which would create a heavier government and taxpayer burden and
ultimately a less favorable environment for the creation of effective
medicines. The FDA does not regulate drugs obtained in foreign
markets, and describes the medical and economic drawbacks of using
these drugs on its Web site.

Randall W. Lutter, Ph.D., FDA's associate commissioner for policy and
planning told this to would-be re-importer Steven M. Saxe, director of
the Washington State Board of Pharmacy: "FDA is very concerned about
the safety risks associated with the importation of prescription drugs
from foreign countries. In our experience, many drugs obtained from
foreign sources that are represented as U.S.-approved prescription
drugs are of unknown origin and quality."

By law, if a prescription drug is originally manufactured in this
country and exported, only the United States manufacturer may import
the drug back into the United States.

In order for O'Malley to push through what he proposes, he would need
to obtain a waiver from the FDA, which is unlikely due to the agency's
consistent refusal to approve such applications elsewhere in the
United States.

The FDA is aware of patients' concerns about access to effective,
low-cost medication. Lutter said the FDA is working to change "our
regulations to reduce litigation that unnecessarily delays access to
more affordable generic drugs, and doubling the annual number of
generic drug approvals over the last five years." As an alternative,
in the meantime, numerous direct patient assistance programs exist to
help mitigate costs for consumers, such as those administered by
Lilly, Pfizer and the Partnership for Prescription Assistance in
Maryland.

Living in America is a trade-off where the prescription drug market is
concerned and not necessarily a good one. We have a broad range of
effective, cutting-edge choices, but many essential medications are
pricey because we shoulder the majority of research and development
worldwide. As a result, right or wrong, we aren't just paying for the
pill itself; we also pay for its years of testing and research and for
pills that never reach the market.

But buying medicine from abroad is not the answer. The regulatory
machinery that would be required to ensure the safety of imported
medicine would be expensive, lengthy to create and erase any potential
price benefits. The problem of high drug prices can only begin to be
solved when other countries start to devote more funds to research and
development and pharmaceutical companies here price brand-name
prescriptions more consistently.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 9:23 AM 0 Comments Links to this post

An American nicotine drink being marketed as a cigarette substitute
would only be sold with a prescription if it hit the shelves in
Canada, according to Health Canada.

Health Canada spokeswoman Nathalie Lalonde said it had previously
stated that Nic Lite would fall under the definition of a natural
health product because nicotine is a natural chemical substance
derived from tobacco plants. Products containing nicotine with a dose
equal or lower than four milligrams per serving - equivalent to the
amount found in Nic Lite - are regulated as over the counter natural
health products.

"However, this only applies to certain dosage forms, such as gums and
lozenges, and not products in liquid form (such as Nic Lite)," Lalonde
wrote in an e-mail to The Canadian Press.

Lalonde said all health products must also undergo a thorough
pre-market review by Health Canada before they're approved for sale.

"Only where there is sufficient evidence supporting the safe and
effective use of a product will the product be authorized for sale in
Canada," Lalonde wrote.

Nic Lite is a lemon-flavoured drink that contains organic nicotine
equivalent to the amount found in two cigarettes.

Joseph Knight, CEO of California-based Nico Worldwide Inc., the makers
of Nic Lite, said that his company has filed an application to Health
Canada to bring the product to Canada.

"We're hoping that in the next two to three months we would have our
clearances in place," Knight told The Canadian Press in a phone
interview last week from Oxnard, Calif.

Knight said Nic Lite was designed to be used by smokers to help them
when they can't smoke.

The product is also being touted as a way to cope with smoking bans.

In a statement released in June, the makers of Nic Lite said they plan
to roll out the product in more than 50 U.S. airports, targeting
nicotine-addicted airline passengers facing smoke-free flights and
long periods where they may be unable to light up.

But Nico Worldwide Inc. may have been dealt a blow in distributing the
product in the United States. The U.S. Food and Drug Administration
told the company in June that Nic Lite doesn't meet the definition of
a dietary supplement.

"The product is considered an unapproved new drug," FDA spokeswoman
Laura Alvey wrote in an e-mail to The Canadian Press. "The company is
in violation of the (Food Drug and Cosmetic) Act in continuing to
market the product as a dietary supplement."

Nico Worldwide had cited a 1993 New England Journal of Medicine
article which stated that nicotine is a naturally occurring compound
in many vegetables including cauliflower, eggplant and tomatoes, to
support its dietary supplement claim.

Knight has said the FDA originally approved Nic Lite in 2004 and that
his company's lawyers plan to meet with the government agency in
Washington.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 9:22 AM 0 Comments Links to this post

Erectile dysfunction formerly called impotency is not a new subject at
all to discuss. It is a problem, which our first forefather honorable
Mr. Adam might also had faced at some point of time. What I want to
say is that it is not a new problem. I have stayed with the mankind
since the beginning of life on this earth. Now, the point to be
discussed is what erectile dysfunction is and what causes it. Erectile
dysfunction (ED) also recognized as impotence, is the lack of ability
to get or uphold an erected penis for satisfactory sexual activity.
Erectile dysfunction is different from other circumstances that hamper
with successful sexual intercourse, such as lack of sexual desire and
problems with ejaculation and orgasm. It can occur at any age but it
is more common in the men above the age of 65. An occasional episode
of erectile dysfunction happens to most men and is normal. As man's
age increases, just like he experiences changes in his other body
parts, it's also normal to experience changes in his erectile function
also. Erections may take longer to develop, may not be as rigid or may
require more direct stimulation to be achieved. Men may also observe
that his orgasms are less passionate, the quantity of ejaculated semen
is reduced and revival time increases between erections. It is
estimated that that erectile dysfunction affects 30 million men in
United States only. The penis contains two cylindrical, sponge-like
structures that run along its length, parallel to the tube that
carries semen and urine. When a man becomes sexually aroused, nerve
impulses cause the blood flow to the cylinders to enlarge about seven
times the regular amount. This sudden influx of blood expands the
sponge-like structures and produces an erection by straightening and
stiffening the penis. Continued sexual arousal or excitation maintains
the higher rate of blood flow, keeping the erection firm. After
ejaculation, or when the sexual excitation passes, the excess blood
drains out of the spongy tissue, and the penis returns to its
non-erected size and shape. Cialis, or Super Viagra, is used to treat
erectile dysfunction. Cialis (tadalafil) is an oral treatment for
erectile dysfunction. Cialis is offered as film-coated, almond-shaped
tablets for oral usage. Each tablet contains 5, 10, or 20 mg of
tadalafil. Cialis is known as "the weekender pill" for its
long-lasting strength. This is the name given to cialis by the French
people. It works exactly like viagra by inhibiting an enzyme called
phosphodiesterase, which releases Nitric Oxide from nerve endings and
endothelium causing relaxation of smooth muscle and hence penile
erection. This is a product developed by Eli Lilly and ICOS and it was
launched under the trade name of the product called Tadalafil launched
in the market in 2003. Cialis has a power for around 36 hours in
contrast to that of Viagra, which is something like 4 hours that means
that a person can take the medicine and can anticipate having erection
at a time much later than the time of use. In recent trials, it was
discovered that 60.4 percent of men who took Cialis succeeded in
having sex up to 36 hours later. There is no stipulation of empty or
full stomach because this does not affect cialis's performance. Men
with ED due to some arterial disorders will benefit the most. There is
a widely spread myth that a person as soon as taking the drug will
have erection but that is not the case. It starts taking action only
when a person gets some sexual stimulation or in other words, he needs
to be seduced. In this way it can start is action within 16 minutes
for some men and for most within about 30 but not more than that. The
recommended dose of Cialis is 20 mg, taken prior to anticipated sexual
activity. The maximum recommended Cialis dosing frequency is once per
day. Cialis may be taken between 30 minutes and 36 hours prior to
anticipated sexual activity. Patients may initiate sexual activity at
varying time points relative to Cialis dosing in order to determine
their own optimal window of responsiveness. The Cialis dose may be
lowered to 10 mg based on individual response and tolerability. Cialis
may be taken without regard to food. Cialis Dosage adjustments are not
required in elderly patients. Dosage recommendations described in "Use
in adult men" apply to elderly men. However, Cialis should not be
taken in those cases where sexual activity is not advisable because of
their underlying cardiovascular status (heart condition). Patients
should inform their doctors about any heart problems that they have
experienced prior to taking Cialis. The most common side effects with
cialis are headache, indigestion, vision changes, muscle aches,
flushing, and stuffy or runny nose. These side effects usually go away
after a few hours. Patients who get back pain and muscle aches usually
get it 12 to 24 hours after taking cialis. Back pain and muscle aches
usually go away by themselves within 48 hours. Cialis may rarely cause
an erection that won't go away (Priapism). If you get an erection that
lasts more than 4 hours, get medical help right away. Priapism must be
treated as soon as possible or lasting damage can happen to your penis
including the inability to have erections. Cialis is also available
through online Cialis pharmacy stores. Now people don't have to go to
their doctors and answer their embarrassing questions because they can
buy Cialis from an online cialis pharmacy. Cheap Cialis is available
their only on the prescription basis. But some of these cheap cialis
pharmacies may be fraud. He reason is simple; because they sell dugs
cheaper then original rates they might compromise with the quality of
the medicine. So people need to be aware of those online cialis shops,
which sell cheap cialis as an OTC dug i.e. without any prior
consultation or prescription. Any comments and /or suggestions will be
highly appreciated. Please note that this article is not a substitute
for medical advice.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 6:29 AM 0 Comments Links to this post

Created in the Amazonian forest, by a Brazilian monk, a new natural
treatment to cure and to prevent cancer, seems to be an interesting
alternative in the fight against cancer. The priest affirms, he has
obtained real results in several types to cancer : cancer of breast,
cancer of uterus, cancer of stomach, cancer of skin, cancer of
prostate, etc. The formula is simple, cheap and easy to prepare it in
house and even though extensive clinical studies do not exist on this
procedure, it seems to be a sensible alternative to try. ALOE Vera One
of the components of the formula is Aloe Vera (sábila) whose medicinal
properties have been investigated for a long time : "It has been
proved that Aloe Vera is effective in cancer in animals. In fact, in
1992, the U.S. Department of Agriculture approved the use of Aloe Vera
for the treatment of soft tissue cancer in animals as well as feline
leukaemia. There is strong scientific proof that, in vitro, Aloe Vera
suppresses the growing of cancer tumour, stimulates immune system
response, raises tumour necrosis levels, and promotes healthy tissue".
"Aloe Vera helps to lower the damage done to the body by treatments
such as radiation and chemotherapy, which destroy healthy immune
system cells that are very important for the body's recovery. With the
use of Aloe Vera, the immune system is boosted, tumors shrink,
metastases are reduced so the cancer does not spread, and new" "In
1997, University of San Antonio researcher Jeremiah Herlihy, Ph.D.,
conducted a study to observe any negative effects of drinking aloe
daily. Rather than exhibiting negative effects, however, test animals
receiving daily aloe showed a remarkable reduction in leukemia, heart
disease, and kidney disease. Dr. Herlihy concluded, "We found no
indication of harm done to the rats even at high levels." In fact, the
aloe-drinking animals actually lived 25 percent longer than those in
the control group" Other components are bee honey and "cañazo" (rum,
or any distilled liqueur). HONEY Medicine may be increasingly
high-tech, but the latest wonder treatment which is being offered to
patients is — honey. Last week, it was announced that bandages soaked
in manuka honey are to be given to mouth cancer patients at the
Christie Hospital in Manchester to reduce their chances of contracting
the MRSA super bug and to lessen wound inflammation following surgery.
This is just the latest study investigating this particular type of
honey's healing powers. It is used routinely at the Manchester Royal
Infirmary for dressing wounds, and other research has found it can
fight gum disease, ease digestive problems and soothe sore throats.
All honey contains hydrogen peroxide, a substance once used as a wound
disinfectant in hospitals — it comes from an enzyme that bees add to
nectar. It also contains the enzyme glucose oxidase, which boosts its
anti-bacterial properties. This was recognised by the ancient
Egyptians and Greeks, who used honey to help heal burns and sores.
Aloe, bee honey and rum are mixed and a syrup is obtained that must be
consumed daily. It is important to use "fresh pulp of the plant Aloe
Vera, including the rind. (to retire the thorns). Not to use
commercial extracts of Aloe Vera. In order to avoid the poisonous
effect of the plant Aloe Vera, the treatment must be alternated : 10
days of treatment, 10 days free or of rest. Never long treatments. The
treatment can be used single or complementing chemotherapy processes.
An ample and detailed description of the treatment can be found at :
"The Miracle of Sharing.Org" Other Diseases This treatment also can be
useful for autoimmune and digestive diseases. (irritable bowl
syndrome, ulcerative colitis, esophagitis, peptic ulcer, rheumatoid
arthritis, osteoarthritis, mouth lesions, sore-throat, lupus, etc.)
Remark All information is general in nature and is not intended to be
used as a substitute for appropriate professional advice and the
reader assumes all risks from the use, non use or misuse of this
information.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 6:29 AM 0 Comments Links to this post

Once again, this year's EXPOPHARM in Munich will be stressing its
importance as a European leading trade fair for the drugs and pharmacy
market. From 21st to 24th September 2006, around 450 exhibitors from
17 nations will be presenting their products and services on approx.
24,000 square metres of exhibition floor.

For the first time in its over 50 years´ existence, EXPOPHARM has been
booked up for weeks. Visitors´ interest has been developing in
parallel to the extremely positive feedback of the exhibitors. Over
20,000 domestic and overseas visitors are expected in halls C1 to C4
of Munich New Fair Ground.

The number of visitors attending seminars held at the same time as the
fair should also exceed expectations this year. Last year, providers
recorded over 1,500 participants. Meanwhile, the complete directory of
exhibitors is already online. Visitors and interested parties can not
only get company information, but also prepare for their visit with an
electronic trade fair planner. This personal visit programme can be
stored, updated and called at any time. A large selection of
information, e.g. exhibitor newsletter, travel tips, accommodation
offers, and general information on the Bavarian Land Capital can be
found at www.expopharm.de.

At the same time as EXPOPHARM, the German Pharmacists Day 2006, which
like the fair, is being held against the background of current health
political developments, will be taking place in the International
Congress Centre. On the eve of the opening, a media prize endowed with
a total of 20,000 euros will be granted for the second time.

For further information and pictures, please check out www.expopharm.de

We will be pleased to provide further information as well as pictures for you:

EXPOPHARM Press Office, Carl-Mannich-Straße 26, 65760 Eschborn, Germany

Phone: +49 – 6196 – 928 413, Fax: +49 – 6196 – 928 404, E-mail:
pressestelle@wuv.aponet.de

www.expopharm.de

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 3:13 PM 0 Comments Links to this post

Don't dawdle on the way to your local pharmacy with that Accutane prescription.

That's the hard lesson Lynette Yarnick of Indiana, Pa., learned in May
when she tried to obtain the potent anti-acne drug for her 17-year-old
son Joey at a local CVS drugstore, only to be told it was out of
stock.

When she returned a week later, "they said the prescription had
expired and I'd have to make an appointment with Joey's dermatologist
to start the process all over again," Mrs. Yarnick said.

The Yarnicks are farmers and don't have insurance, so the new doctor's
appointment cost them an extra $300 -- and disrupted her son's
treatment.

"It was such a shame," she added, "because Accutane has just been a
miracle drug for Joey."

That hoop that Mrs. Yarnick and her son had to jump through is just
one of many erected since March to strictly control isotretinoin, the
generic name for Accutane, which has become the gold standard for
people suffering from acne since its approval by the U.S. Food and
Drug Administration 23 years ago.

Accutane was originally formulated for severe acne that is resistant
to over-the-counter and prescription-only remedies: benzoyl peroxide,
salicyclic acid, Retin-A and antibiotics.

Increasingly, though, dermatologists have been prescribing Accutane
for milder forms of acne, which afflicts nearly 85 percent of people
18 to 24 years old.

Because Accutane has severe side effects, including a risk of birth
defects, there always have been restrictions on its use. Monthly blood
tests monitoring liver function, cholesterol and other conditions have
been required for both men and women, as well as pregnancy tests for
women of childbearing potential.

Accutane can cause miscarriages, stillborn babies and severe birth
defects, including heart and central nervous system abnormalities,
deformed limbs and heads, asymmetrical facial features and mental
retardation. Some researchers suspect it may lead to depression or
suicide, although others say the data is inconclusive.

But under the new, federally mandated "iPledge" program, patients must
undergo lengthy counseling about the drug and enroll in an online
registry to answer questions about its use and risks, while medical
staffers must spend increased time online recording lab results and on
the phone with iPledge representatives and pharmacists.

Sometimes, though, staffers have been put on hold for hours, and if
they don't meet certain deadlines, the patient's case is eliminated
from the iPledge system and they must start the process again.

In fact, dermatologists say iPledge has proved to be so cumbersome and
complicated that a number of them -- both nationally and in Pittsburgh
-- no longer prescribe the drug.

Before iPledge went into effect March 1, dermatologists wrote 170,000
prescriptions a month. In the 41/2 months since, according to iPledge,
150,000 Accutane users have been entered into the program.

"The iPledge program is killing us," said Monroeville dermatologist
Lisa Pawelski. "I have stopped prescribing it for women of
childbearing potential until the mess is fixed, but I do not see much
happening toward a fix."

In recent years, some drug safety advocates and a Michigan congressman
whose son committed suicide while taking Accutane have sought to ban
or severely restrict the drug, complaining that it is overprescribed.

The FDA has declined to ban it, but in March, at the agency's urging,
four manufacturers hired Covance Inc., a global biotech company, to
create iPledge to control its distribution and thoroughly educate
patients about possible side effects.

The result seems to have satisfied no one.

While FDA officials have said they hope iPledge will reduce
pregnancies among Accutane users to zero, early indications aren't
encouraging.

Since March, "we've received calls from women on Accutane who have
become pregnant and who were in the iPledge system," said Dr.
Christina Chambers, president of the Organization of Teratology
Information Specialists, a birth defects prevention group.

Meanwhile, the American Academy of Dermatology, which strenuously
lobbied to delay iPledge until flaws in its computer-based program
were worked out, says that startup problems have created numerous
delays in treatment.

Dr. Pawelski's medical assistant was put on hold for four hours before
she could reach an iPledge official to clear up a problem with one
prescription. Since then, iPledge phone waiting times have gone down
to 20 minutes, "but that's still unacceptable," Dr. Pawelski said.

Also, because iPledge requires that 30 days elapse between doctors'
visits, a patient who can't fill an Accutane prescription within seven
days of receiving it at a doctor's office is "locked out" of iPledge's
computer system, and must wait 23 more days before seeing a doctor for
a new prescription.

"It's infuriating to me that, after 14 years of post-secondary
training and 14 additional years of experience in medical practice,
not to mention a zero percent pregnancy rate, I have to now comply
with this poorly written, time-wasting, confusing, mockery of a
program," Dr. Pawelski said. "It's also thoroughly unjust to the women
whom I cannot now treat."

Even those who still prescribe Accutane are unhappy with iPledge. Dr.
Douglas Kress, a pediatric dermatologist with Children's Hospital of
Pittsburgh who also has a private practice,, said his academic
position gives him access to enough staff to maneuver through
iPledge's requirements, which he nonetheless calls "ridiculous."

The company running iPledge only had "maybe two operators on staff at
the beginning for who knows how many calls. "It's almost as though the
system is being designed to fail so the FDA will ban it," he said.

Not so, said Dr. Peter A. Gross, who chaired the FDA drug safety panel
that mandated iPledge.

"Our job was to do what's best for the patient. If that meant a little
bit more time with the patient to ensure appropriate and safe delivery
of the drug, so be it," said Dr. Gross, who chairs the department of
internal medicine at Hackensack University Medical Center in New
Jersey.

If anything, Dr. Gross said, he would have liked to see the FDA
re-examine the risks versus the benefits of Accutane and a host of
other popular drugs that were approved years ago, because it's
possible that many of the side effects were not known then. That
proposal to FDA officials "didn't go anywhere."

"The FDA is often accused of letting drugs out there that cause all
sorts of serious side effects, but then when they do something,
they're criticized on the other side. They're in a no-win situation,"
he said.

For example, the book that patients are required to read -- about an
hour's worth of material -- before receiving a prescription is "huge,
daunting," said Dr. Melanie Costa, who has a dermatology practice in
Friendship.

"There are amazing things in that book," he said. "There's talk about
possible association with diabetes and all kinds of bizarre things.
They really pile on the overly frightening rhetoric."

Sharon Mohale, a certified physician's assistant in Dr. Kress' office,
questions the age-inappropriateness of some of iPledge's requirements.
Some Accutane patients are as young as 12, she said, "and they have to
go online and answer questions like which form of birth control they
should use and what they should do if a condom breaks."

Another sticking point is making boys and women who can't get pregnant
subject to iPledge's rules. Jackie Funt, who manages her husband's Mt.
Lebanon dermatology practice, said she doesn't understand why teenage
boys are required to read an hours' worth of material about pregnancy
risks before being allowed to receive the drug.

"It doesn't make any sense," she said.

On June 12, after being deluged by complaints from dermatologists,
eight U.S. senators of both parties wrote Dr. Andrew C. von
Eschenbach, the acting head of the FDA, expressing concern about
iPledge and urging him to "address the procedural barriers plaguing
the operation."

An FDA spokeswoman declined to comment on the letter or Dr. von
Eschenbach's response.

Officials at Covance did not respond to requests for an interview,
instead issuing a statement acknowledging "some confusion and delays"
in March and April, when large numbers of prescribers and patients
registered with iPledge.

Staffing has since been increased.

Covance will be required to track how many women registered in the
iPledge system become pregnant while on Accutane, and make that
information public, although no data has been released yet.

It's not clear, in fact, how many women have actually gotten pregnant
over the years while taking the drug before iPledge was instituted;
such reporting has been voluntary.

One study by Roche, one of the drug's manufacturers, found that nearly
2,000 women became pregnant while on the drug since its approval
nearly 24 years ago, and 383 gave birth. Almost half of those babies
had birth defects.

Rep. Bart Stupak, a Democrat from Michigan whose teenage son committed
suicide while on Accutane, remains skeptical that iPledge will lower
those numbers. Mr. Stupak, who held a much-publicized hearing in 2002
on Accutane's dangers, suspects the pregnancy rate among Accutane
users is much higher than that, as well as the suicide rate.

Already, he claims, there have been reports of pregnancies involving
women in the iPledge system. As long as Accutane continues to be
prescribed in such high volume, he said, he doubts these kinds of
serious side effects can be avoided.

"For people who face severe disfigurement from acne, fine. Let those
families weigh the options of whether they want to do it. But
dermatologists are handing it out like it is candy," he said.

It's true that Accutane has become the most widely prescribed acne
medication in the country. But Dr. Diane Thiboutot, professor of
dermatology at Penn State Milton S. Hershey Medical Center, argued
that the FDA is limiting how dermatologists practice medicine.

And it's unfair to penalize hundreds of thousands of patients -- men
as well as women -- who have benefited from Accutane because a small
percentage of women will ignore the warnings.

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# posted by Network @ 11:46 AM 0 Comments Links to this post

Millions of seniors may soon have to pay out of pocket for
prescriptions that used to be covered by Medicare.

The new Medicare prescription plan has a coverage gap.

The gap varies, but here's what it looks like under the standard Medicare plan:

Once drug costs reach $2,250, seniors pay 100 percent of their drug
costs, up to $5,100, when Medicare catastrophic coverage kicks in.

The people at Medicare suggested seniors keep using their Medicare
insurance program, but for some seniors, that is just not an option.

Sol Salkovitz said that lately he has come to depend on Medicare to
pay for costly medications.

Salkovitz's wife had a stroke. Medical expenses pushed her into the
Medicare prescription drug coverage gap. So, instead of a co-pay,
Salkovitz had to pick up the entire cost of the drug.

"How do you say no? How do you skip? You can't skip. You wake up every
day and say, 'Thank God I'm here," Salkovitz said.

Salkovitz went in search of cheaper drugs and he ended up at Adams
Discount Pharmacy. Adams is a cash pharmacy, meaning it accepts no
insurance.

"We buy it cheaply and only mark it up a few dollars. We keep it at a
lower price, a discounted price. The most savings are for generics --
deep discounts," said Adam Shubbar of Adams Discount Pharmacy.

But the centers for Medicare and Medicaid services say seniors should
not go looking for cheaper drugs, but stick with their Medicare drug
card.

"You're getting those deep discounts the plan's negotiated. In
addition, the plan is tracking what you're spending out of pocket so
the plan will notify you when you reach that catastrophic limit," said
Nancy O'Conner of the Philadelphia Regional Office for the Centers for
Medicare and Medicaid Services.

Without using a card, seniors must track the drug expenses themselves
and then send copies of the receipts to their Medicare drug plan.

But some say that buying pills on the plan is just too expensive.

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# posted by Network @ 9:10 PM 0 Comments Links to this post

New drugs used to treat leukemia, including Gleevec, may cause serious
heart damage, according to U.S. researchers. The researchers say that
people taking the medication should continue to take it, but should
also be closely monitored for heart damage.

The researchers from Jefferson Medical College in Philadelphia, Tufts
University School of Medicine in Boston, University of Texas released
the caution of Sunday, after they found evidence that treatment caused
heart failure in 10 patients. They say that people taking other drugs
in the same class, called tyrosine kinase inhibitors, may also be at
risk for heart damage.

The drugs have been very successful in treating chronic myelogenous
leukemia or CML, in most patients. They have found that 80 to 90
percent of the patients taking the drug were cancer free for at least
five years. The drugs have also been successful in treating a rare
form of stomach cancer called gastrointestinal stromal tumors or GIST.

Thomas Force, who led the investigation, said ""Gleevec is a wonderful
drug and patients with these diseases need to be on it. We're trying
to call attention to the fact that Gleevec and other similar drugs
coming along could have significant side effects on the heart and
clinicians need to be aware of this. It's a potential problem because
the number of targeted agents is growing rapidly."

The researchers tested the drug in lab dishes and found that it
appears to be toxic to heart cells. Also, mice treated with Gleevec
developed left ventricular dysfunction. This is a key symptom for
heart failure. Novartis, the maker of Gleevec said the cases of heart
failure were rare.

Force said "While the cancer is treated effectively, there will be
some percentage of patients who could experience significant left
ventricular dysfunction and even heart failure from this." Heart
failure will kill half of the patients within 5 years.

Novartis said that patients can be successfully treated with two drugs
that can help treat the heart failure. These drugs, called ACE
inhibitors and carvedilol, can be used as a treatment, but the
prognosis for heart failure remains poor.

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# posted by Network @ 8:29 PM 0 Comments Links to this post

You have a sore back and are prescribed an anti-depressant? Don't
laugh, it happens more often than you'd think. It's called off-label
use, a practice which refers to the use of an approved drug to treat
anything outside the scope of the drug's labelling. A friend's mother,
for instance, is taking an anti-seizure medication for her chronic
pain.

As I understand it, anti-depressants may be prescribed to help people
quit smoking. And I'm told that in cancer therapy, a drug effective in
treating one kind of cancer may be used to treat another even though
it wasn't approved for that purpose.

Even over-the-counter drugs are used for reasons that are not
indicated. Can't sleep? Pop a Gravol at bedtime.

According to the Journal of Head and Face Pain, off-label prescribing
is not uncommon in treating headaches and is within the current
standard of care.

Anti-epileptics and newer anti-depressants are treatments that
apparently help control chronic headaches -- and they're not even
related to painkillers.

This past May, an article in the Archives of Internal Medicine shed
further light on the practice by reporting an enormous study of 725
million prescriptions written in the U.S. in 2001 (this represented
about half of the total number of prescriptions written that year).
The authors found that 21% of the total were for off-label usage, the
majority of which lacked strong scientific evidence.

Looked at more closely, of the 18 million prescriptions for
psychiatric drugs in this study, 17 million apparently looked pretty
thin evidence-wise. Only 11% of the off-label uses of allergy
prescriptions were backed by solid evidence. The three types of drugs
most likely to be prescribed off-label are anticonvulsants, tricyclic
anti-depressants, and anti-inflammatory pills. Who knew?

The study's authors found that some of the off-label uses were logical
(an asthma drug prescribed for other lung diseases, for example), but
others were for conditions dramatically different from those for which
the drug was approved. Off-label drug prescribing is common throughout
the world. I read that, in India, pharmacists were concerned that an
anti-ulcer drug was used for terminating pregnancy and that in one
study, 25% of the drugs prescribed in a French surgical unit were
off-label.

According to the authors of the study published last May, prescribing
off-label "brings greater latitude to turn scientific knowledge into
innovative clinical practice." There's nothing legally wrong with it.
I'm sure most docs won't prescribe off-label without having confidence
in a drug's "other" effectiveness -- from either reading studies or
having had experience over the years with a particular treatment.

Drug manufacturers are actually not allowed to market a drug for its
off-label use, though Health Canada allows companies to report
scientific studies in the form of press releases regarding off-label
use. But I bet that drug companies would just love to promote
off-label use because doing so can dramatically drive drug sales. Just
look at how hormone replacement therapy's profits soared in days past
when physicians assumed estrogen (originally to prevent osteoporosis)
offered heart and stroke protection for post-menopausal women: The
"fountain of youth" it promised became a cesspool when studies showed
that HRT increased the risk of diseases, including breast cancer.

Botulin toxin, approved for the treatment of muscle spasms, was only
somewhat profitable before its huge economic success as Botox -- a
popular cosmetic anti-wrinkle treatment. There's certainly a dark side
to off-label use: For example, one breast cancer drug had been used
confidently as a fertility drug until Health Canada warned doctors a
few years ago that the drug tripled the risk of fetal abnormalities.

The bottom line? Be informed. If the drug recommended to you is for an
off-label use, talk frankly to your doctor and address the risks and
benefits of the medication. Explore why the doctor feels that
particular drug may be more effective than the use of an approved
drug. Ask him or her what gives them the confidence to support the
off-label use of that drug. It's your body -- and you should know what
goes into it.

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# posted by Network @ 8:28 PM 0 Comments Links to this post

A study led by a UT Southwestern Medical Center researcher sheds light
on how the brain chemical serotonin, when spurred by diet drugs such
as Fen-phen, works to curb appetite.

That knowledge could aid in the design of safer anti-obesity drugs
nearly a decade after Fen-phen was banned for causing harmful side
effects.

The study, which tested the effect of several drugs that alter
serotonin levels in the brain, found that serotonin activates some
neurons and melanocortin-4 receptors, or MC4Rs, to curb appetite and
at the same time blocks other neurons that normally act to increase
appetite.

The dual effect helps explain how such drugs, including Fen-phen, spur
weight loss.

The finding, available online and in the July 20 issue of Neuron, also
reinforces the role of serotonin - a regulator of emotions, mood and
sleep - in affecting the brain's melanocortin system, a key molecular
pathway that controls body weight.

"The more we understand about the pathways and the way serotonergic
drugs regulate body weight, the more it one day might lead to
harnessing beneficial properties of anti-obesity treatments like
Fen-phen and minimizing the harmful side effects," said Dr. Joel
Elmquist, professor of internal medicine at UT Southwestern and
co-senior author of the study.

In the United States, about 66 percent of adults are obese or
overweight, as are 16 percent of young people aged 6 to 19, according
to the Centers for Disease Control and Prevention. The trend is
significant because being overweight or obese increases the risk of
harmful health consequences, such as heart disease, stroke, diabetes,
non-alcoholic liver disease and death.

Drugs that enhance the brain's release of serotonin have helped people
lose weight. Fen-phen, which paired fenfluramine with phentermine, had
such success. The drug combination, however, also led some patients to
develop cardiac complications, Dr. Elmquist said. The drug was removed
from the market in 1997.

But the mechanisms of how it caused weight loss were never fully
determined, he said.

So a few years ago, Dr. Elmquist and his research team set out to
detail how fenfluramine affected the brain's molecular pathways to
reduce appetite. In 2002, they examined the region of the brain's
hypothalamus containing the arcuate nucleus, or ARC. In the ARC,
drug-induced serotonin activates brain cells called
pro-opiomelanocortin neurons, or POMC, which in turn release a hormone
that acts on the MC4R to reduce appetite.

The team's new study shows how serotonin also simultaneously blocks
other neurons, known as NPY/AgRP, from being able to inhibit activity
of MC4Rs. By blocking this inhibitory activity, serotonin prevents an
increase in appetite.

Researchers studied the effect of Fen-phen and other
serotonin-inciting drugs on both normal and genetically engineered
lean and obese mice. They found that serotonin's dual regulation of
POMC and AgRP neurons is necessary to promote weight loss.

"The finding increases the understanding of the molecular circuitry
that controls body weight in response to changing levels of
serotonin," Dr. Elmquist said. "An overarching goal of this
understanding, for humans, is to design specific, safe drugs to fight
obesity."

Dr. Elmquist, who recently left Harvard Medical School, directs the
newly formed Center for Hypothalamic Research at UT Southwestern. The
center, along with the Taskforce for Obesity Research, a National
Institutes of Health Interdisciplinary Research Center, is part of the
institution's effort to investigate the causes of obesity, metabolic
syndrome and diabetes.

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# posted by Network @ 5:41 AM 0 Comments Links to this post