PORTLAND, Ore. (AP) — Tom Childers drove up the hill to
Oregon Health & Science University one morning last January for his monthly
chemotherapy — only to be told to come back tomorrow. The drug his life
depended on was in short supply.
His doctor, Michael Mauro, assured Childers the clinic was
doing all it could to get more leukemia medicine. “I accepted that at face
value,” recalls Childers, 67.
Mauro, however, was frustrated that a lifesaving treatment
relied on a drug shipment for which there was no guarantee. “If we didn’t
get the drug for this gentleman — as days passed, or maybe if it went longer
than that, if weeks passed — he would relapse,” says Mauro. “What are
we, a Third World country?”
Childers, from Dufur, stayed at a friend’s house in Portland that night. He
returned to the clinic in the morning only to be told more supplies had not
arrived. He returned home. After a week of worry for his family, Childers
received a call to return for his medicine. In April, after three more
chemotherapy sessions, his leukemia was declared in remission.
While things worked out for Childers, the incident jolted
He hadn’t realized the extent to which OHSU pharmacists
wrestled with shortages. The last-minute decision to delay treatment for
Childers and several other relatively healthy patients reflects a national
The number of individual drugs in short supply nationwide
has climbed from 70 in 2006 to a record 211 last year — and more than 150
already this year.
Shortages are hitting every aspect of health care in rural
and urban areas alike. As a result, patients are getting late treatments,
substitute medications or decreased drug doses for illnesses in which survival
rests on getting the best medicine available.
“It was pretty bad to have to look someone in the eye
and say, ‘Look, we can’t treat you right now,'<” Mauro says. “In
the United States
in 2011, that seemed like a pretty ridiculous thing.”
The problem boils down to profits, quality, and supply and
Supplies of Childers’ drug dwindled when several
manufacturers shut down production of cytarabine — a popular chemotherapy drug
that is irreplaceable in fighting certain types of leukemia — due to quality
problems or a shortage of raw materials.
Overall, about half of pharmaceutical shortages stem from
quality problems, according to the nonprofit Institute for Safe Medication
Practices. Other shortages concern production issues, such as when companies
consolidate and close factories.
Many common generic medications also can be hard to find.
When drug patents expire, it opens the door to other manufacturers but lower
That’s why supplies of generic leucovorin, a B vitamin
proven to make cancer treatments more successful, have been short since late
2008. A patented, more expensive version remains plentiful. Many observers say
shortages are exacerbated by hoarding and speculation by third parties who purchase
large quantities of drugs and sell them at a premium like scalpers outside a
“In the industry, we call them the pirates,” says
Mike Brownlee, OHSU pharmacy director.
Cancer doctors like Gerald Segal have become vocal critics.
Segal, who works at Northwest Cancer Specialists in Northeast
Portland, has had to tell patients that because of shortages,
they’re receiving reduced doses of leucovorin that may not be as effective.
“I never in my life thought something like this would
happen in the United States,”
Perhaps most disturbing to him is that even though the
medical establishment has sounded alarms, no one sees a way out.
“The shortages are growing worse at such an exponential
rate,” says Erin Fox of the University
of Utah’s Drug Information
Service. She works with the American Society of Health System Pharmacists to
document shortages. “I feel that we’re at a tipping point of a health care
Besides shortages of key cancer drugs, sedatives crucial to
emergency rooms and intravenous nutrients have been crimped. So have certain
antibiotics, ADHD drugs and even drugs to put inmates to death.
In the United
States, no deaths have been directly
attributed to lack of medicine. However, surveys of pharmacists and other
health care professionals attribute hundreds of near misses and treatment
errors to drug shortages, and that’s probably underestimated, according to the
Two bills in Congress would require manufacturers to give
more notice of impending shortages so health care providers and the government
can adjust. When the Food and Drug Administration learns of the shortages in
advance, it often is able to boost foreign imports, according to FDA
spokeswoman Tamara Ward.
However, the bills’ fates are unclear, and even some
senators with a strong reputation in health care, such as Oregon Sen. Ron
Wyden, are not signing on. Wyden “has questions as to whether or not the
legislation as introduced gets at the root problem of why there are shortages
to begin with,” says his spokesman, Tom Caiazza.
With no solutions on the horizon, doctors and pharmacists
OHSU’s Mauro pushed for a cancer-drug shortage committee to
improve shortage response times.
“Usually, it’s a mad scramble,” says Majid Tanas,
an OHSU pharmacy manager. He says the committee evaluates each patient to
determine minimum drug dose or a possible substitution.
“It’s day-to-day micromanaging of a precious stock to
make sure our patients are well taken care of,” he says.
OHSU drug buyers use social media to soak up the latest
scuttlebutt, and the pharmacy has a “clean room” where a
remote-controlled robot divides large vials of drugs when smaller doses are
Like most of the health care community, OHSU frowns on
hoarding scarce drugs. But pharmacists there are considering increasing
reserves of certain medications.
Most doctors and hospitals try not to buy from third-party
suppliers because the drugs’ origin and quality are unknown. But, in some
cases, shortages can mean choosing between denying necessary treatment or
buying drugs of unknown quality.
“You don’t know where the product is coming from,”
said Kathy Stoner, pharmacy director of Legacy Health Systems. In an email, she
added, “We have, very rarely, used them when in dire need.”
Other times, providers make difficult choices on rationing,
as with the long-running leucovorin shortage.
Dr. Samuel Taylor, an oncologist with Celilo
in The Dalles,
says his group has rationed leucovorin. Colon
cancer patients considered curable receive full doses. Patients considered
terminal, but who could have years to live with full treatment, instead receive
a partial dose, he says.
“I’m not sure that there would be a measurable
detriment to patients with that, but it is a modification that is not recommended,”
says. “These are issues that at least do compromise our standard of
Segal, the Portland
oncologist, says the free market is no longer taking care of patients’ needs.
He thinks the country may need a drug czar to ensure supplies.
“Somebody’s got to grab this situation,” he says,
“and do something about it.”