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.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 11:46 AM