IVIG shortage: does this shortage present opportunity for Nabi?
Sunday, April 26
While thousands of patients, many of them children, are wondering why a drug their lives depend on mysteriously became so scarce and
expensive, officials are questioning whether the shortage is real or a
cruel ploy by someone in the supply chain to increase profits. 60
Minutes investigated the shortage in a report which aired last Sunday.
The shortage of immune globulin (IG), a drug made from blood plasma
that fights off potentially fatal illnesses in people whose immune
systems cannot fight them on their own, has Dr. Arthur Caplan
incensed. "I think there are vultures out there in the blood
supply....people who are making money off the lives of American kids,"
said Caplan, who heads the government's Advisory Committee on Blood
Safety and Availability. "It is beyond my understanding that we
haven't had Congressional outrage, and indeed, international outrage,"
he told co-editor Mike Wallace.
Dr. Caplan's advisory committee will meet April 27-28 in Washington to
discuss the shortage and its causes. The U.S. Congress will also be
examining the shortage next month in hearings conducted by
Representative Christopher Shays (R-Conn.) who heads its Subcommittee
on Human Resources and Intragovernmental Relations.
"The shortage is critical, but we're not convinced that it is not
being manufactured by the companies themselves," Shays tells Wallace.
He is concerned that the manufacturers might be able to produce more
IG, but are instead blaming aggressive FDA regulation of the industry
for the shortage. "One of the things we are very concerned about is
that you don't have shortage blackmail," continues Shays. "The FDA is
coming to [the IG makers] and saying 'we need you to produce more.'
They in turn say, 'You just aren't allowing us the ability to produce
the amount that we need to.'"
The shortage has already prompted the FDA to approve the emergency
release of IG that had been originally withdrawn for fear that it may
be infected with Creutzfeldt Jakob Disease (CJD). CJD is a fatal brain
disease similar to "mad cow" disease. Although there have been no
documented cases of CJD transmission from blood or plasma products,
scientists still have no clear understanding of how the disease is
spread.
According to an internal FDA memo found by 60 Minutes, "very large
inventories of intravenous immune globulin" have been identified but
are "not reaching U.S. consumers." 60 Minutes' investigation also
discovered that 20 percent of IG is exported overseas where, in some
cases, it fetches a much higher price.
In another memo, the FDA says that "supply disruptions also may have
occurred due to stockpiling or other market phenomena."
Jan Bult, who runs the blood plasma industry's trade group, was the
only industry figure who would speak to Wallace. Bult said he couldn't
comment on the FDA memo but denies that the industry is stockpiling
the drug. He tells Wallace that the shortage is due to IG's increasing
popularity -- too many doctors prescribing it for too many illnesses
-- and because it is a difficult drug to produce in sufficient
quantity. The FDA told Wallace it has no authority over the export or
pricing of a drug like immune globulin.
Meanwhile, some drug brokers are selling IG at exorbitant prices. A
hospital in Greenville, North Carolina, was used to paying $15 per
gram but was recently offered IG at $125 per gram by Taylor
Pharmaceuticals of San Clemente, California. People who need IG but
cannot buy it have resorted to asking the relatives of deceased
patients for their leftover IG.
Hospitals must cope with the shortage the best they can and
life-and-death decisions are apt to present themselves as the shortage
continues. "At any given time in the United States, in a children's
hospital, someone is trying to make a decision about which child is
going to get immune globulin in that hospital....They're going to be
making triage decisions about this vital substance," Caplan tells
Wallace.
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