[ RadSafe ] Article: HHS Criticized -- Bid to Develop Radiation Drug Bogs Down

[John Jacobus]

>From the Washington Post, Sept 28, 2005

http://www.washingtonpost.com/wp-dyn/content/article/2005/09/27/AR2005092701717_pf.html

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Company Criticizes HHS BioShield Effort
Bid to Develop Radiation Drug Bogs Down

By Marc Kaufman
Washington Post Staff Writer
Wednesday, September 28, 2005; A19

When it comes to emergency disaster planning, the
elephant in the room has long been a nuclear attack
or, more recently, the detonating of a "dirty bomb"
designed to spread radiation.

With the potential damage so enormous, the federal and
local governments have struggled in their efforts to
plan for the damage from nuclear explosions, and there
has been limited progress since the fallout shelter
craze of the 1950s and 1960s.

But all that was supposed to change after the Sept. 11
and anthrax attacks in 2001, when Congress and
President Bush pushed through the BioShield Act as a
way to jump-start drug company efforts to find and
manufacture antidotes and vaccines. While protection
from biological and chemical weapons is a major focus
of the bill, the absolute top priority is generally
described as preparing for a possible nuclear attack
by terrorists or a rogue nation such as North Korea.

That effort, however, has by most accounts bogged down
and shown few results. That in turn has led to some
sharp and public questioning of the federal agency in
control of the effort, the Department of Health and
Human Services.

In particular, the company Hollis-Eden
Pharmaceuticals, and many legislators that support the
company's efforts, have been highly critical of the
agency's handling of the radiation sickness drug that
it has been developing for five years.

The company says that the drug, called Neumune and
developed with the support and oversight of the
Defense Department, is the only one that will be ready
to protect Americans exposed to radiation within the
next few years, and yet HHS has moved with little
sense of urgency in its procurement process. In
limited studies involving primates, the company found
that 90 percent of the animals given the drug survived
sustained radiation exposure, while just 55 percent of
the untreated group survived.

Testifying in July before the House Committee on
Government Reform, company CEO Richard Hollis accused
the federal effort of having "a lack of leadership, a
lack of implementation and sense of urgency, and a
huge sense of bureaucracy, that has basically killed
the capital markets and ability to raise money to
develop these drugs."

With very few drug companies still interested in
developing BioShield drugs and vaccines because of
doubts they could make money or, for that matter,
break even, Hollis said, it seems counterproductive to
demoralize those few that remain involved.

During that hearing, lawmakers including Reps. Thomas
M. Davis III (R-Va.), Darrell Issa (R-Calif.) and
Henry A. Waxman (D-Calif.) agreed that HHS needed to
move more quickly.

Stewart Simonson, HHS assistant secretary for public
health emergency preparedness, replied that the agency
was itself not satisfied with its progress, and that a
formal draft request for proposal for a radiation
sickness drug would be out by the end of July. Two
weeks later, however, the agency postponed the
announcement.

HHS spokesman Marc Wolfson said the delay was needed
to "insure that the most appropriate immediate targets
. . . can be more fully defined to protect the
American public." He also said the delay would allow
the agency to provide the best guidance to drugmakers.

HHS has again promised a draft request for proposal,
this time by the end of this month. Legislators, and
companies interested in developing drugs under
BioShield, are watching the long-delayed announcement
closely to see whether it will speed the procurement
process or slow it further.

In the July hearing, National Institute of Allergy and
Infectious Diseases Director Anthony S. Fauci expanded
on the problems he said the government faces.

Fauci seemed to dismiss Neumune as a solution, saying
that "we have to almost start from square one"
regarding a radiation sickness drug. He said that the
changed nature of the nuclear threat -- from a massive
attack by the Soviet Union to a single blast or dirty
bomb from a terrorist -- required new research into
new solutions.

"It was either you blow up the city or not," Fauci
said. "It's a totally different picture now, which is
the reason why the research is taking time."

Fauci's description of a changed nuclear reality is
reflected in a 2002 study by the British Medical
Journal. The study estimated that a bomb the size of
the one that caused the Hiroshima blast -- very small
by current standards -- detonated in New York City
would kill at least 50,000 people instantly; 200,000
would be expected to die later from acute radiation
syndrome; 700,000 more would be sickened from that
condition.

That changed threat -- where radiation sickness would
claim many more lives than the actual blast -- creates
opportunities to save people. Radiation sickness is
the result of bone marrow damage, which in turn leads
to the loss of infection-fighting cells and clotting
factors that limit bleeding. In the event of acute
radiation exposure, scientists say, most casualties
would come from uncontrolled infections and bleeding.

What Neumune's makers say is that their drug, a
steroid, can protect bone marrow from radiation. The
drug, which would be self-injected before or soon
after exposure, could theoretically save many
thousands of people downwind from the nuclear blast.
The drug has its limitations -- it has to be taken
within four hours of exposure -- but it does have a
three-year shelf life that company officials say would
allow it to be stored at government sites or in homes.

The only other radiation treatments in the national
stockpile are potassium iodide, which can protect the
thyroid gland from future cancers, and several
compounds that can help flush some radiation out of
the system. Fauci's institute has been experimenting
as well with Neupogen, a drug used to help restore
bone marrow damaged when cancer patients receive
radiation treatment.

Hollis-Eden officials, and numerous lawmakers,
acknowledge that other drugs might hold promise in the
future, but say that Neumune offers the best chance
for radiation sickness protection in the near term.

"We don't understand the delay here because there is
no other drug that fits the post-nuclear attack
scenario," said Bob Marsella, a vice president of
Hollis-Eden. He called the slow-paced decision-making
"inexcusable, given that the federal government's own
lead agency, [the Armed Forces Radiobiology Research
Institute], has identified our drug as the only drug
that meets the criteria for a BioShield contract for
acute radiation syndrome."

© 2005 The Washington Post Company



+++++++++++++++++++
"Anyone who has never made a mistake has never tired anything new."
-- Albert Einstein

-- John
John Jacobus, MS
Certified Health Physicist
e-mail:  crispy_bird at yahoo.com


		
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