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February 15th, 2012 
FAKE NEWS for the Zionist agenda TUESDAY, Feb. 14 (HealthDay News) — The U.S. Food and Drug
Administration said Tuesday that it was cautiously optimistic that a
feared shortage of a life-saving drug used to treat a form of childhood
leukemia will be averted.
The drug, methotrexate, is used in combination with other drugs to
combat acute lymphoblastic leukemia (ALL), which typically strikes
children ages 2 to 5 and is the most common type of cancer in
children.
Methotrexate is a linchpin in the treatment of children battling acute
lymphoblastic leukemia. In high doses, the generic drug has been
successful in curing patients and beneficial in preventing recurrence.
Without the drug, a patient’s chance for a cure is reduced while the risk
of recurrence rises, oncologists report.
“We are seeing the [three] companies [that make methotrexate] respond
to this shortage and they are planning on some very large releases, and we
are planning on having the situation resolved,” said Valerie Jensen,
associate director of the FDA‘s drug shortage program.
“Right now, from what we are understanding from the companies, the
releases will resolve these shortages. So we are watching this very
closely,” Jensen added. “We are expecting some good releases at the end of
this month and continuing into March and beyond.”
Oncologists are worried that supplies of methotrexate could be gone in
as little as two weeks.
One of the three makers of methotrexate, Hospira Inc., based in Lake
Forest, Ill., said Tuesday that it had increased production to “make up
for the supply gap.”
Thomas Moore, president of U.S. Hospira, said in a news release:
“Hospira is doing everything it can to help bring more product to market.
This includes working with the U.S. Food and Drug Administration to
qualify a second supplier of the drug’s active ingredient to enable
increased production. Hospira believes that it can increase its supply to
the market if it can secure additional methotrexate active ingredient
supply.”
The other two manufacturers are Mylan Inc., of Canonsburg, Penn., and
Sandoz US Inc., of Princeton, N.J. Both said they are working to head off
a shortage of the drug.
Mylan, in a Tuesday news release, said it has “ramped up its
production in order to try to meet the resulting increased demand. We are
working both on the manufacturing and regulatory fronts to expedite the
FDA
regulatory approvals necessary to further increase capacity to the extent
possible to support the additional demand.”
Dr. Elizabeth Raetz, an associate professor of pediatric
hematology/oncology at NYU Langone Medical Center in New York City, said
methotrexate is a “critical component of ALL therapy.”
The concern is that there is a 90 percent chance for cure of acute
lymphoblastic leukemia, but that’s based on the total drug regimen
including methotrexate, Raetz said. “There is a deep concern that if that
key component is eliminated there would be a reduced chance for cure,” she
said.
There hasn’t been a shortage of the drug at her hospital, Raetz noted,
but many other hospitals across the country have reached a critical point,
and some centers don’t have any at all, she said.
Acute lymphoblastic leukemia is the most common type of cancer in
children. It’s a disease that affects white blood cells, which help to
fight infections in the body. Blood cells are produced in bone marrow. But
in leukemia patients, the bone marrow produces abnormal white blood cells,
which crowd out healthy blood cells. In acute lymphoblastic leukemia, the
excess white blood cells are called lymphocytes or lymphoblasts, according
to the U.S. National Library of Medicine.
The potential shortage of methotrexate is just the latest in a series
of drug shortages that have existed for several years.
In 2011, prescription drug shortages in the United States hit an
all-time high. Last fall, some 200 drug shortages had been reported,
compared to 178 in all of 2010, the FDA reported.
Many of the scarce drugs are injectables, such as cytarabine and
cisplatin, used to treat serious conditions such as cancer. Some are only
given in hospitals and are “absolutely critical,” Jensen said during a
news conference in late September.
More than half (54 percent) of shortages in 2010 were due to quality
issues, such as sterility or drug impurities. Some were caused by delays
or manufacturing capacity problems, while 11 percent were caused by
discontinuation of a drug and 5 percent resulted from raw material
shortages, Jensen said.
Jensen also said the shortages tend to occur in drugs that aren’t
“economically attractive.” This could mean that only one company produces
the drug, making it harder to find alternatives if the supply dries
up.
A lot of the problems are tied to generic drugs, health experts
explained, because few manufacturers make them and profit margins aren’t
as high as for drugs still under patent protection.
On Oct. 31, 2011, President Barack Obama signed an executive order
designed to help ease the drug shortages. The order directed the FDA to
“take action” to prevent and reduce the worsening prescription drug
shortages.
Specifically, the order directed the FDA to take steps to require drug
manufacturers to report any impending shortages or discontinuances six
months ahead of the shortage. The agency should also speed up its review
of new manufacturing sites, new suppliers and new manufacturing protocols,
and also add more staff to its drug-shortage office, the order stated.
More information
For more on drug shortages, visit the U.S. Food and Drug Administration.
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