$1 billion would go toward developing bioterror remedies

[Guest guest]

It is very possible that I'm thinking too simplistic here - The below article

has a couple of interesting statements - once again, focusing on needs of more

money, liability protections, speed approval, etc.. If the masks being

developed have a 99% rate of blocking toxic pathogens, which can be used

immediately following a bioterrorist attack (IF one should occur), then wouldn't

it make more sense to issue every American one of these masks/filters and make

them responsible for their own protection? (carrying it, storing it, etc...)

This seems to be the most effective protection that's been seen to date. It

would seem that this would eliminate the complex problem of how to distribute

vaccines/drugs to every American, how to keep up with the mutating or biogenetic

engineered strains that there's no vaccines for, liability protection, money for

adverse event reactions, etc... It would seem that effective protective gear, to

include overgarments (key word: EFFECTIVE), to be

included with an advanced warning system in place would eliminate all the below

woes... $1 billion would go toward developing bioterror remedies

http://www.signonsandiego.com/news/business/20061006-9999-1b6tech.html

By Terri Somers

UNION-TRIBUNE STAFF WRITER

October 6, 2006

Several cash-strapped biotechnology companies in San Diego are embracing

proposed federal legislation that would provide a new funding source for the

development of vaccines, therapies or medical devices that could be used in

response to a bioterrorist attack. That additional cash could help San

Diego-based Aethlon Medical speed up and expand research of its device that

filters toxins out of blood. Safe Life, another San Diego company, would use the

funding to speed up production of face mask technology that the company says

blocks 99.99 percent of toxic pathogens. Invitrogen of Carlsbad could use it to

develop its biosensor technology. With part of the proposed $1 billion

fund, the companies said they could bring their products closer to being

production-ready when the government might buy them for the nation's defense

stockpile. But many biotech companies are apprehensive that the Department

of Health and Human Services would control the spigot to the

money because of the department's performance as a partner in the bio-defense

arena over the past two years. “There's fear that we could see the same

problems as we did with Project BioShield: It won't be implemented the way it is

supposed to be,” said Rapoport, a biotech lawyer with McKenna, Long &

Aldridge, who helped write Project BioShield. Project BioShield was

Congress' response to the anthrax attacks of 2001, which killed five people. The

measure, passed two years ago, gave the government $5.6 billion for the

procurement and stockpiling of treatments in case of another bioterrorist

attack. It was also supposed to create the incentive for the pharmaceutical

industry to invest in the development of products that otherwise would not have

a market – most people aren't going to buy an anthrax treatment until

immediately after an anthrax attack.

Project BioShield was also supposed to allow companies to circumvent some

regulatory requirements because the products cannot be tested on healthy humans.

Biotech executives also contend the government was supposed to take risks,

committing funds to buy drugs that seemed promising, not drugs that were proven

safe and ready for production. The results have been lackluster at best.

The money wasn't big enough enticement to attract interest from Big Pharma.

However, much smaller and often-unproven biotechnology companies, including

Aethlon, Safe Life, Isis, Invitrogen and Hollis-Eden in San Diego wanted to meet

the challenge. “But HHS didn't put out enough procurements fast enough,”

Rapoport said. “During the last two years they've made only 10 or 12

procurements, mostly in the smallpox or anthrax area. They haven't spent all the

money and this money wasn't supposed to last 10 years. You are supposed to spend

it and then go back looking for more.”

As a result, the investor market never really materialized for the biotech

companies in bio-defense.

“Look at the share price of all the companies that were getting involved in

bio-defense two years ago and there's not one that hasn't been hurt by this,”

said Rob Housman, a biodefense consultant to biotechnology companies including

Hollis-Eden and VaxGen, based in the Bay Area. Congress wants to solve some

of these problems with legislation that would make $1 billion of Project

BioShield money available to biotech companies for research, long before they

have a product ready for government procurement. Last week, the House

passed the measure commonly referred to as BARDA, which would create the

Biomedical Advanced Research and Development Authority. It now is being

considered by the Senate and is tentatively scheduled to be brought to the floor

for a vote in November, according to the staff of Sen. Burr, R-N.C., one

of its sponsors. BARDA “recognizes that our nation must do more to ensure

the development of medical countermeasures against

bioterrorism and pandemic diseases,” said Jim Greenwood, who heads the

Biotechnology Industry Organization in Washington D.C. “Currently, many

promising countermeasures are not making it through the advance research and

development necessary to bring products to the point of eligibility for

procurement by the landmark Project BioShield,” Greenwood said. The initial

science behind a product is typically provided by grants from the National

Institutes of Health. At the other end of the product chain is Project

BioShield, which pays for the finished product upon delivery. The gap

between the two is referred to as the “Valley of Death” for biotechnology

companies because it is where a good idea can stall and die for lack of funding.

BARDA theoretically would provide some Valley of Death funding. While San

Diego biotech executives said they would seek some of the funds, they wonder how

long the money will last. And there are concerns about it tapping into

Project BioShield, which isn't very big. “It's not a lot of money when you

look at the long list of pathogens that they are worried about protecting

against,” said A. Joyce, chief executive of Aethlon Medical. Rapoport

said the important part of the bill is that it established the mechanism for

funding. Congress can always look for additional funding later, he said.

Bill Folkerts, who runs the environmental diagnostic division of Invitrogen,

recalled an analogy used last week in a meeting of companies and government

stakeholders in biodefense: “What's the cost of one aircraft carrier versus the

amount generated toward this?” “There has to be an opportunity to provide

additional funding and greater opportunity for Big Pharma and small biotechs

here,” Folkerts said. Several medical device companies have already shown

that Congress is willing to work with industry on biodefense. Aethlon Medical,

Invitrogen and others successfully lobbied to

expand the types of biodefense measures Project BioShield and BARDA would fund

by including medical devices. Aethlon's hemopurifier functions similarly to

a dialysis machine, with a patient's blood flowing through a filter to remove

impurities, Joyce said. Aethlon's filter removes larger pathogens when they

stick to affinity agents in the filter, he said. Unlike the dialysis

filter, the hemopurifier filter is a closed cartridge, which means the procedure

can be done at home or locations other than doctors offices and clinics, he

said. The filter is supposed to remove the pathogens and lessen the viral

load in a patient's body to a point that the immune system wards off illness.

“This is something that could be a first line countermeasure . . . and it can be

used in the hours or days when the medical community is still trying to figure

out what the pathogen is,” Joyce said. “It took 90 days to figure out SARS.”

The company completed a small

early-stage trial in India. BARDA funding would help in additional trials and

also development of other applications of the technology, such as HVAC filters

for use in hospitals and schools, he said. Rapoport credited the avian flu

scare with helping to breathe new life into Project BioShield and give fuel to

BARDA. “When have you ever seen Congress go back and revisit a funding bill

after two years? Never,” Rapoport said. “There's a sense of urgency here and a

willingness to be flexible.” And that creates hope for biotech companies

that want several issues addressed. For instance, Jaffe, chief

executive of Safe Life, which makes face masks, wants HHS to disclose why it is

focusing on certain bioterror agents and selecting some products over others.

The government has stockpiled large quantities of face masks by other companies.

Jaffe said those products have not been proven to resist 99.99 percent of

pathogens as Safe Life's masks has been

shown to achieve. Several biotech executives said that HHS must also

fulfill its contract. The industry insiders point to the experience of

struggling Bay Area biotech VaxGen, which had never produced a marketable

product, as a troubling example of why they are wary of working with HHS.

In November 2004, VaxGen received an $877.5 million contract under Project

BioShield to produce 75 million doses of its new anthrax vaccine, enough to

inoculate 25 million Americans. VaxGen later told the government it would

miss its original deadline of November 2005 for delivery of the drug by a year.

In March, the government said it wouldn't pay VaxGen until the company completed

a costly and time-consuming human test to ensure the vaccine was safe. The new

requirement, which was not supposed to be done until after delivery of the drug

and payment to VaxGen, forced the company to sell its stake in another

biotechnology company for $79 million to stay afloat and

finance the new test. With BARDA, Burr sought to address some of the

complaints from both sides of the debate. It requires HHS to develop a

strategic plan, which would be made public and articulate specifically what it

views as bioterror and naturally occurring threats and the type of combative

agents its wants to support. To assist, the measure would create a National

Biodefense Science Board to advise the secretary on threats, challenges and

opportunities presented by advances in biological and life sciences. BARDA

also contains an antitrust exemption to allow the government to have a more

direct dialogue with companies. It would also require a company receiving

research funds to share scientific data with HHS, so that the government can

make real-time decisions about whether the product remains promising and funding

should continue. It also allows the government to provide the research

funding based on milestones being met, which is

different than Project BioShield, which promised most of the funding on

delivery of the product.