[ RadSafe ] Critics Question Federal Purchase of Drugs to Remove Radiation From People

[LNMolino at aol.com]

http://homeland.cq.com/hs/display.do?docid=2065112&sourcetype=31

Critics  Question Federal Purchase of Drugs to Remove Radiation From People
By Zack  Phillips, CQ Staff

The federal government's purchase last month of two  drugs to remove
radiation from the bodies of those exposed to a dirty bomb or  other
large-scale nuclear release is raising questions about the wisdom of  the
decision.

The Department of Health and Human Services (HHS)  announced in February it
would pay nearly $22 million for more than 400,000  doses of two
anti-radiation agents from Buffalo Grove, Ill.-based Akorn  Inc.

That purchase was separate from the department's high-profile  procurement of
a countermeasure to radiation sickness - the subject of heated  criticism
from some congressional leaders and interested industry parties -  for which
one or more contracts are scheduled to be awarded in  June.

HHS officials frame the contract with Akorn as part of a series of  efforts
to protect American citizens against the fallout from a  catastrophic
accident or terrorist attack; critics say it is further evidence  of an
ambiguous strategy in preparing for the fallout from a nuclear  or
radiological attack.

Like A Claw
The five-year contract with  Akorn - the American distributor for German
manufacturer Hameln  Pharmaceuticals - calls for 390,000 doses of a
calcium-based compound and  60,000 doses of a zinc-based solution, and
includes an option for an  additional 500,000 doses of each.

The so-called chelating agents attach  themselves to radiation particles
"like a claw" and then help remove them  from the body, said Noreen Hynes,
director of HHS' Office of Research and  Development Coordination, in an
interview last week.

"You want a  [radiation] particulate out of the body as quickly as possible
so it doesn't  install itself and then [become] not removable," she said.

HHS officials  have said the agents are part of a collection of
pharmaceuticals the  department is stockpiling to treat victims of a
large-scale  incident.

Some critics are questioning the merit of the purchase. The  agents are "not
useful" for a nuclear detonation, according to a 2002 article  in the New
England Journal of Medicine. And the types of radiation they work  against -
plutonium, americium and curium - are present in some, but not  all
radiological bombs.

Others have questioned why the department has  agreed to buy 450,000 doses,
or more, of Akorn's agents while the procurement  for radiation sickness - or
Acute Radiation Syndrome (ARS), as it is known  officially - calls for only
100,000 doses, with a possibility of another  100,000 doses later.

ARS is a collection of illnesses that can befall  someone exposed to high
levels of radiation, such as the fallout from a  nuclear detonation. The
Akorn agents would remove radiation but not treat the  potentially lethal
symptoms of ARS - high susceptibility to infection and  internal bleeding,
for example - as the ARS countermeasure presumably  would.

Hynes said in the interview that the desire for chelating agents  came from a
rigorous examination of various issues - such as what drugs are  needed now
and how best to use taxpayer money - by the inter-agency  commission of
experts that set the department's biodefense  requirements.

Any product that wins the ARS procurement, she said, would  be "an
experimental drug," compared to the Akorn agents, which were approved  by the
Food and Drug Administration in 2004.

"That's another reason  why you'd buy a fully approved product - if you think
it will take a long  time [to develop a new one]," she said.

"The earlier something is in  development, the harder it is to justify a
very, very big-ticket item if we  don't have any idea if it is going to
work."

At least one firm says  that explanation is inconsistent with Project
Bioshield, the $5.6 billion  program of incentives created to lure
pharmaceutical and biotechnology  companies to the traditionally less
lucrative biodefense  market.

"Bioshield is supposed to incentivize companies to build  experimental drugs;
it's not supposed to be used for drugs that are already  approved," said
Robert Marsella, senior vice president of Hollis-Eden  Pharmaceuticals, a San
Diego-based firm responding to the ARS solicitation  that has been a vocal
critic of HHS' procurement policies. "If you don't set  the market, they will
not get built."

In the case of anthrax, HHS  agreed to purchase 75 million doses of a
next-generation vaccine, compared to  between 5 million and 10 million doses
of an existing vaccine.

Louis N.  Molino, Sr., CET
FF/NREMT-B/FSI/EMSI
LNMolino at aol.com
979-690-7559  (Office)
979-690-7562 (Office Fax)
979-412-0890 (Cell Phone)

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