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June 4th, 2012 
FAKE NEWS for the Zionist agenda MONDAY, June 4 (HealthDay News) — John Mahan, a 58-year-old
Nashville firefighter battling a gastrointestinal cancer, couldn’t believe
what he was hearing last July.
His doctor had just told him that his clinic had run out of injectable
fluorouracil (5-FU), the generic chemotherapy Mahan needed to keep his
tumor at bay.
“My initial reaction was, ‘you’ve got to be kidding, right?'” he
said.
Unfortunately, the news was all too real. Mahan was switched to another
drug, capecitabine. Taken in pill form, it had the same anti-cancer
effectiveness as 5-FU but with more onerous side effects.
“It made me feel bad, weak,” Mahan said, “just run down, feeling tired
all of the time, loss of appetite.”
At a Monday news briefing at the annual meeting of the American Society
of Clinical Oncology (ASCO) in Chicago, Mahan spoke on behalf of the
thousands of cancer patients who have been hit hard by the recent
nationwide shortages of generic, injectable cancer drugs.
The crisis peaked earlier this year when children with a leading form
of childhood cancer, acute lymphoblastic leukemia (ALL), were faced with a
looming shortage of a lifesaving drug, methotrexate. Quick action on the
part of the U.S. Food and Drug Administration, the pharmaceutical industry
and others averted that shortage, but deficits in this and other cancer
medicines are still possible, experts warn.
“The good news has been that the frequency of the drug shortages has
begun to decline for a variety of reasons,” Dr. Richard Schilsky, chair of
ASCO’s government relations committee, told reporters. “But there is
still an unpredictable availability of many drugs and we are never sure
exactly when a generic drug is suddenly going to go out of supply. That
creates a tremendous amount of uncertainty — anxiety for our patients and
great difficulty in planning if you’re a physician.”
Overall, 22 crucial oncology therapies have recently been in short
supply, noted ASCO President Dr. Michael Link. Of most concern right now,
he said, are shortages of a handful of medicines:
- Methotrexate — while there is currently an adequate supply of
methotrexate for ALL and other cancers, there is now a shortage of a
compound needed for patients who require high-dose infusions of the drug,
Link said. - 5-FU — gaps in supply remain for this mainstay generic medicine,
used to fight cancers of the colon, pancreas, head-and-neck and other
sites. - Nitrogen mustard — one of the earliest anti-cancer therapies
developed, it remains essential to care of lymphomas and Hodgkin’s
disease. “It has been unavailable for some time,” Link said, and there are
no really good substitutes. - Paclitaxel (Taxol) — periods of short supply continue for this key
treatment for breast cancer and other malignancies.
“Hearing from our members, we are learning that the shortages are most
acute among community practices where the majority of adult patients are
cared for,” Link added. Smaller centers may not have the buying clout that
larger, academic medical centers might have, leaving them more vulnerable
to shortages, he explained.
These drug shortages typically occur among sterile injectable cancer
medications that have gone to cheaper, generic status. The experts
gathered at the meeting noted that the world’s supply of generic
medications is now concentrated in only about six companies that may
produce dozens or hundreds of drugs.
“So, for example if one company makes 30 products and they have a
problem, suddenly 30 products are at risk of a shortage,” explained Dr.
Sandra Kweder, deputy director of the Office of New Drugs at the FDA.
Producing highly sophisticated, sterile injectables is a particularly
complicated process, she said, and quality issues can arise that cause
plants to be temporarily shut down while the issue is resolved.
In many cases, these safety issues are not minor ones, Kweder noted,
and can include “particles of glass or metal shavings” found in vials
that, of course, pose safety issues for patients.
But, why the shortages now? According to Kweder, it’s not that new,
tougher quality-control rules have come into place recently. Instead, a
host of popular drugs have recently gone off-patent and “what we’ve seen
is great growth in the generic world,” she said. As more generics get
produced at more production facilities, “we are just seeing more in terms
of problems in that manufacturing,” Kweder said. Many companies are now
modernizing their production facilities, she said, but that will take
time.
According to Kweder, the FDA, in close consultation with drug
companies, has already prevented about 150 drug shortages since October of
last year, when President Barack Obama signed a special Executive Order
demanding action on the issue. As companies gave FDA early warning of
looming problems, the agency and the pharmaceutical industry worked
together to find alternate sources of supply, including imports from
abroad, Kweder said.
Methotrexate, the drug needed by children with leukemia, “continues to
be very carefully monitored,” Kweder said. “We expect the [shortage of]
the injectable that has been difficult for some practices to obtain to be
resolved within the next month completely.”
Progress is taking place at the Congressional level as well, the
experts said, as a bill makes its way through the House and Senate that
would mandate that generic drug makers give the FDA six months advance
notice of any possible production problems.
The bill, which has the full support of ASCO, also includes a provision
that generics makers would pay the FDA a user fee, aimed at speeding
oversight and approval for new generics.
All of this gives some comfort to Mahan, whose cancer has progressed
but is being held in check by a new course of therapy. Still, he worries
about other patients who may be facing the same dilemmas he did.
“Until this impacts you personally,” he said, “most people aren’t even
aware that there’s even a shortage going on.”
More information
Find out more about the shortage of cancer medications at the U.S. Food and Drug Administration.
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