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Thumbs up Veteran Issues Digest Number 1700

1. Regs, Froms & web sites to help with claims From: Colonel Dan 2. Ruling could clear way for resumption of funeral protests From: Colonel Dan 3. New anthrax vaccine doomed by lobbying From: Colonel Dan
Messages

1. Regs, Forms & web sites to help with claims

Posted by: "Colonel Dan" colonel-dan@sbcglobal.net coloneldan1

Fri Dec 7, 2007 9:44 am (PST)

Save this message for future use, pass it on to other veterans and families.

Three things that will help a veteran with his claim, is to know the
process, and how to find info about your illness or injury.
The first reference below is a web site where you can see the C&P Exam the
VA uses, and print it out... can even show it to your
private doctor. Of Course you can also search for info about your illness at
Google

2nd reference below is a web site you can search, review and print out
various pages of regulations, etc about the VA system & claims.

3rd reference is a web site where you can search Veteran Board of Appeals to
see how the VA has handled your illness or injury, and what they were
looking for, and what paragraphs in VA regs apply


1.
http://www.vba. va.gov/bln/ 21/Benefits/ exams/index. htm

These 57 Disability Examination Worksheets are in use both by the doctors of
VHA (Veterans Health Administration) who do the disability examinations and
by the rating specialists, hearing officers, and Decision Review Officers of
VBA (Veterans Benefits Administration) who do the disability evaluations.
************ ********* ********* *

2.
http://www.warms. vba.va.gov/ TOCindex. htm

especially:
<http://www.warms. vba.va.gov/ TOCindex. htm#b> Compensation and Pension - 21

<http://www.warms. vba.va.gov/ TOCindex. htm#k> 38 Code of Federal Regulations
- REGS

38 Code of Federal Regulations - REGS

<http://www.warms. vba.va.gov/ booka.html> Book A - General

<http://www.warms. vba.va.gov/ bookb.html> Book B - Adjudication

<http://www.warms. vba.va.gov/ bookc.html> Book C - Schedule for
Rating Disabilities

************ ********* ********

3.
an on-line search of BVA's decisions, enter the word or group of words you
are looking for in the block below. From the resulting list, you can connect
directly to individual decision texts or you can return to this page to
conduct additional searches. Decisions are current through August 31, 2007.

http://www.index. va.gov/search/ va/bva.html



2.


Ruling could clear way for resumption of funeral protests

Posted by: "Colonel Dan" colonel-dan@sbcglobal.net coloneldan1

Fri Dec 7, 2007 10:21 am (PST)

http://www.kansasci ty.com/news/ local/story/ 393344.html
Posted on Thu, Dec. 06, 2007

Ruling could clear way for resumption of funeral protests

By MARK MORRIS
The Kansas City Star

A Topeka church could soon resume picketing at soldiers' funerals in
Missouri because of a federal appeals court ruling Thursday.

A three-judge panel ruled that a Kansas City judge erred last year when he
refused to give the Westboro Baptist Church a preliminary injunction while
considering whether two Missouri laws banning funeral pickets were
unconstitutional.

Writing for the panel, Circuit Judge Kermit E. Bye stressed that the appeals
court was not ruling on the laws' constitutionality. However, Bye said that
because the church had shown a "fair" chance of ultimately winning, it
deserved a preliminary injunction barring the state from enforcing the laws
while litigation continued.

"The injunction will not cause substantial harm to others, and the public is
served by the preservation of constitutional rights," Bye wrote.

Church members have complained that the Missouri laws violate their freedom
of speech as guaranteed by the First Amendment. Shirley Phelps-Roper,
daughter of church founder Fred Phelps, filed the suit and said Thursday
that she was "thrilled" with the ruling.

"We see here that there is someone left in this country with their
constitutional head on straight," Phelps-Roper said.

Missouri Attorney General Jay Nixon announced plans to appeal to the full
8th Circuit Court of Appeals.

"Missouri has the right to protect the families of our fallen military
members from these intrusive and disgusting protests," Nixon said in a
written statement.

Westboro church members believe that God is punishing America for tolerating
homosexuality, abortion, divorce and other issues, Phelps-Roper said.

They have drawn scorn across the country for pickets at the funerals of
servicemen and servicewomen. Jurisdictions in more than 40 states have
enacted funeral picketing bans. And earlier this year a Maryland jury
ordered Westboro to pay nearly $11 million to the father of a fallen soldier
whose funeral was picketed. The church has said it does not have the money
and is appealing.

Should U.S. District Judge Fernando Gaitan issue the preliminary injunction,
the church would resume picketing in Missouri, Phelps-Roper said.

"We've been avoiding the Missouri ones (funerals), but now we have to retool
and get that back on the landscape," Phelps-Roper said.

A schedule of pickets posted on the church's Web site shows events this week
in Minnesota, Nebraska, Illinois, Wisconsin and Indiana.

Missouri enacted its laws after Phelps-Roper and other church members
picketed the August 2005 funeral of a soldier in St. Joseph. The laws bar
protests one hour before a funeral starts until one hour after it ends.
Protests are also barred within 300 feet of funerals.

In declining to give Phelps-Roper an injunction, Gaitan wrote in January
that he agreed with state lawyers that "Missouri's interest in providing
safe, secure and dignified funerals to its citizens far outweighs any
interest the (church) has in protesting and disparaging such events."

The U.S. Supreme Court has not addressed the issue of whether the state has
an interest in protecting both the dignity of funeral services and the
privacy of family and friends during a time of mourning.

In 1999, the 8th Circuit threw out an Omaha, Neb., ordinance that barred
anti-abortion demonstrators from protesting at a church that had appointed a
physician who performed abortions to the posts of deacon and elder.

Bye wrote that because of that precedent, "we conclude Phelps-Roper has a
fair chance of proving any interest the state has in protecting funeral
mourners from unwanted speech is outweighed by the First Amendment right to
free speech."

Not even Phelps' opponents agree on whether the desire for a respectful
funeral atmosphere should trump free speech.

"I think most people in the (Patriot) Guard agree with me that, as
despicable as his group is, we believe in our First Amendment rights," said
Deems Peterson of Lenexa, an assistant state captain of the organization' s
Kansas branch. "To decide what is agreeable speech and what is disagreeable
speech is not the flavor or the meaning of the First Amendment."

The Patriot Guard, a 64,000-strong nationwide group, was formed in 2005 in
response to protests at a Kansas funeral of a soldier who had died in Iraq.
Volunteers on motorcycles and in vehicle convoys hold up U.S. flags at
funerals to counter Phelps' protests.

_____

INSIDE
Kansas justices hear arguments on a law restricting protests at military
services. | B4

The Star's Lee Hill Kavanaugh and Tim Hoover contributed to this report. To
reach Mark Morris, call 816-234-4310 or send e-mail to mmorris@kcstar. com.


3.

New anthrax vaccine doomed by lobbying

Posted by: "Colonel Dan" colonel-dan@sbcglobal.net coloneldan1

Fri Dec 7, 2007 10:46 am (PST)

http://www.latimes. com/news/ nationworld/ nation/la- na-anthrax2dec02 ,1,3942924
,full.story

From the Los Angeles Times

FEAR INC.: A TIMES INVESTIGATION

New anthrax vaccine doomed by lobbying

America's sole supplier faced oblivion if its rival's product was adopted.
It was time to call on political connections.
By David Willman
Los Angeles Times Staff Writer

December 2, 2007

WASHINGTON - Shortly after the Sept. 11, 2001, terrorist attacks and the
subsequent anthrax mailings, top U.S. science advisors said the country
"urgently needed" a new, improved anthrax vaccine.

The existing vaccine often caused swollen arms and muscle and joint pain.
Inoculation required six injections over 18 months, followed by yearly
booster shots. The estimated shelf life was just three years.

The scientists' report, issued by the Institute of Medicine, called for "an
anthrax vaccine free of these drawbacks" -- a vaccine that would require
only two or three injections, achieve protection within 30 days, stay potent
for a long time and cause fewer adverse reactions.

Yet nearly six years later, the old vaccine is still the only one available
-- and the government is buying it in mass quantities for the Strategic
National Stockpile.

The manufacturer, Emergent BioSolutions Inc. of Rockville, Md., prevailed in
a bitter struggle with a rival company that was preparing what federal
health officials expected to be a superior vaccine. The episode illustrates
the clout wielded by well-connected lobbyists over billions in spending for
the Bush administration' s anti-terrorism program.

Emergent's rival, VaxGen Inc. of South San Francisco, had spent four years
developing a new anthrax vaccine and had won an $877.5-million federal
contract to deliver enough doses for 25 million people. The contract
threatened Emergent's very existence. The old vaccine, its only moneymaker,
would likely be obsolete if VaxGen succeeded.

Emergent responded by mobilizing more than 50 lobbyists, including former
aides to Vice President Dick Cheney, to make the case that relying on the
new vaccine was a gamble and that the nation's safety depended on buying
more of Emergent's product.

The company and its allies in Congress ridiculed VaxGen and impugned the
competence or motives of officials who supported the new vaccine. The
lobbying effort damaged VaxGen's credibility with members of Congress and
the Bush administration, a Los Angeles Times investigation found.

When VaxGen encountered a stubborn scientific problem and needed more time
to deliver its vaccine, the firm found scant support, even among officials
who had earlier backed its efforts. The government then imposed tougher
testing requirements on the struggling company.

A senior federal scientist who oversaw the project said she sought authority
to allow advance payment to VaxGen to help it work through the difficulties.
Top administration officials blocked her requests, she said.

Finally, a year ago, officials canceled VaxGen's contract, all but capsizing
the company.

Emergent, meanwhile, has won federal contracts worth at least $642 million
for the old vaccine and is in line to win many millions more as the
government expands the strategic stockpile.

Kimberly B. Root, a spokeswoman for Emergent (formerly BioPort Corp.), said
the company's lobbying ultimately served the national interest.

"Had we just thrown up our hands, what position would we be in now?" Root
asked. "Where would the government be? There wouldn't be, potentially, a
vaccine in the stockpile."

Bill Hall, a spokesman for the U.S. Department of Health and Human Services,
said VaxGen's "poor performance" sealed its fate. In canceling the contract,
Hall said, officials acted "as effective custodians of government finances."

Yet Dr. Philip K. Russell, a vaccinologist and retired Army general who was
a senior biodefense official in the Bush administration, described the
outcome as "a big, dramatic failure."

"National security took a back seat to politics and the power of lawyers and
lobbyists," said Russell, who supported the decision to award VaxGen the
contract.

If officials had granted the company a bit more time, Russell said, it would
likely have solved its scientific problem and delivered a superior vaccine.
He noted that setbacks are common in developing vaccines and said VaxGen
appeared capable of overcoming this one.

"It wasn't an insurmountable problem," said Russell, who after leaving the
government did not lobby for or advise either of the competing vaccine
companies. "It was a solvable problem."

Effort to contain threats

On the Sunday night after Sept. 11, 2001, Health and Human Services
Secretary Tommy G. Thompson convened an urgent meeting of health officials
and leading scientists.

"Tommy Thompson was really, really concerned that something could happen,"
recalled Dr. Donald A. "D.A." Henderson, a former World Health Organization
physician who led successful efforts to eradicate smallpox. "There was
intelligence information coming through and some chatter coming through,
suggesting there was going to be a second event, that the second event could
very likely be a biologic event.

"And anthrax and smallpox were both raised as possibilities. "

The imperative was clear: Find a way to eliminate both threats.

About 10 p.m., as they filed out of HHS headquarters, Henderson and health
department lawyer Stewart Simonson acknowledged their fears.

"I told D.A., 'We're going to make this work.' And he said, 'I just hope
we're not too late,' " Simonson recalled. "That's how scared we were."

They and other federal officials later scored a victory over one of the two
threats: Working closely with vaccine manufacturers, they assembled 200
million doses of smallpox vaccine.

Countering anthrax quickly proved to be more complicated.

In October 2001, six envelopes containing powdered anthrax were sent through
the mail on the East Coast, killing five people and sickening about 20
others. Authorities closed contaminated buildings in Washington and Florida,
and treated hundreds of congressional employees with antibiotics. No one has
been charged in the attacks.

The anthrax mailings showed that the most reliable way to prevent death is
with an antibiotic such as Cipro or doxycycline, administered quickly and
for up to 60 days. Inhaled anthrax otherwise can kill up to 90% of those
infected. The Strategic National Stockpile now holds enough such antibiotics
to treat more than 40 million people.

Dr. Anthony S. Fauci, who directs the National Institute of Allergy and
Infectious Diseases and has advised President Bush and Congress on U.S.
preparedness, said: "We already know that we prevented a serious problem on
the Hill by essentially blanket-treating people with [Cipro]. We know that
because when we went back and did surveys, we found that many people who had
absolutely no symptoms were actually exposed."

The success in limiting deaths from the 2001 mailings brought into focus the
lack of expert consensus about the magnitude of the anthrax threat. Some
scientists have said that terrorists could disperse anthrax over a wide
area, inflicting casualties on the scale of a nuclear weapon.

Skeptics, however, note that although anthrax is relatively easy to obtain
and can linger tenaciously on surfaces, it is not contagious and is
difficult to deliver lethally outdoors.

Another attack, Fauci said, "would create massive panic in this country. It
would create economic and other real, logistical problems. But at the end of
the day, you're not going to kill as many people as you would if you blasted
off a couple of car bombs in Times Square."

Nevertheless, fear of a panic-inducing anthrax event generated momentum for
amassing millions of doses of vaccine as a backstop to the antibiotics that
would be the first line of defense.

Bush underscored the threat as he rallied support for the Iraq war. In an
October 2002 speech in Cincinnati, the president told a crowd that Saddam
Hussein's regime had supplies of anthrax and other biological weapons
"capable of killing millions." Such weapons could be easily deployed, Bush
added: "All that might be required are a small container and one terrorist
or Iraqi intelligence operative to deliver it."

The U.S. already had a military stockpile of anthrax vaccine, filled with
Emergent's product. Now, support grew for creating a civilian cache, to
allow mass inoculations immediately after an attack.

The idea was that a new vaccine -- faster-working, with fewer doses and
fewer side effects -- would protect people who couldn't tolerate antibiotics
and would work against anthrax that withstood antibiotic treatment. A
vaccine might also help protect people reentering a building that had been
contaminated.

In February 2002, the Institute of Medicine released its report, calling the
old vaccine "reasonably safe" but "far from optimal" and concluding: "A new
vaccine, developed according to more modern principles of vaccinology, is
urgently needed."

Officials meeting privately in late 2003 -- including Russell, Simonson,
representatives of the vice president's office, the Centers for Disease
Control and Prevention, the Department of Homeland Security and Fauci's
staff -- decided to push for the purchase of 75 million doses of a new,
genetically engineered vaccine.

Dr. Kenneth W. Bernard, then a biodefense advisor to Bush, estimated that
such a stockpile -- providing three doses for 25 million Americans -- would
be enough to respond to simultaneous attacks on New York, Los Angeles and
Washington.

Henderson and Russell said the requirement for 75 million doses was based as
well on a desire to keep a manufacturer operating continuously, so it could
quickly ramp up production in a crisis.

The problem now, both said in recent interviews, is that the nation has not
gotten a newer, better vaccine.

Project BioShield contract

In July 2004, President Bush signed legislation called Project BioShield,
providing $5.6 billion for "next generation" vaccines and drugs to counter
threats of biological terrorism.

VaxGen had been working for two years on its anthrax vaccine, building on
earlier efforts by the Army. VaxGen's early work had impressed Fauci's
staff, which oversaw $100 million in federal research grants to the company.

Now VaxGen wanted to win the first BioShield contract. The company had been
formed in 1995 by scientists from Genentech Inc., which retained an
ownership stake. Lance K. Gordon, inventor of the first vaccine for infant
meningitis, became VaxGen's chief executive in 2001.

But by 2003, the company's survival was in doubt. It had seen an
experimental AIDS vaccine fail in late-stage testing. And in August 2004,
the Nasdaq stock exchange delisted VaxGen for failing to file timely
financial results; the company's stock price sank 35%.

VaxGen sought the BioShield contract by proposing to genetically engineer an
anthrax vaccine with greater purity, more consistent potency and fewer
unwanted side effects than Emergent's old vaccine.

But inside the company's salmon-colored walls facing San Francisco Bay,
technicians were seeing disquieting data: Blood samples drawn from study
patients showed that the vaccine failed to trigger enough anthrax-fighting
antibodies.

VaxGen hired more vaccine experts, including a new chief scientific officer.

The complication did not deter federal health officials. On Nov. 4, 2004,
HHS Secretary Thompson announced that VaxGen had been awarded the BioShield
contract, worth $877.5 million. The money would start to flow when the
company made its first delivery of vaccine, expected in two years.

"Acquiring a stockpile of this new anthrax vaccine is a key step toward
protecting the American public against another anthrax attack," Thompson
said.

The announcement was bad news for Emergent, whose vaccine remained the only
revenue generator for its BioPort subsidiary.

"We were worried about it," recalled retired Navy Adm. William J. Crowe Jr.,
a former chairman of the Joint Chiefs of Staff who served on the company's
board from 1998 through late 2005. (Crowe was interviewed at a hospital in
Virginia in late August, two months before his death at age 82.)

BioPort was founded in 1998 by Ibrahim El-Hibri, a Lebanese financier. Along
with Fuad, his U.S.-educated son, El-Hibri formed BioPort by purchasing
vaccine-making facilities of the state of Michigan for $24.75 million. The
company's only product was the anthrax vaccine, called BioThrax, which it
sold chiefly to the U.S. military. In mid-2004, the company reorganized as
Emergent BioSolutions.

To counter the challenge posed by VaxGen, Emergent invested where it could
buy immediate impact: lobbying.

"We had 500 employees who were about to lose their jobs, and we went out and
became advocates for them," said Allen Shofe, a company vice president who
managed its lobbyists.

In 2005, Emergent's yearly spending for lobbying nearly quadrupled, to $1.41
million. Last year it reached $2.1 million, federal records show. All told,
from 2004 through June 2007, the company used 52 lobbyists at a cost of
$5.29 million, the records show.

During the same period, VaxGen spent $720,000 on six lobbyists.

Emergent's lobbyists stressed a core message:

* U.S. civilians were at risk of death without an immediately expanded
stockpile of anthrax vaccine;

* Emergent stood ready to supply the civilian stockpile, whereas VaxGen had
yet to prove it could deliver a new product;

* Emergent might stop making the vaccine if the government chose not to buy
its product for the stockpile.

The company enlisted friendly members of Congress and recruited a cadre of
former government officials to press its attack. Among them was Jerome M.
Hauer, a former acting assistant secretary for emergency preparedness at
HHS.

Hauer had been in the thick of decisions to pursue a new anthrax vaccine.
While at HHS, he told Emergent in a February 2003 letter that the department
had concluded a new vaccine was "a better long-range option than investing
in expanding manufacturing capacity" for BioThrax. Hauer wrote that "the
scientific basis" for a genetically engineered vaccine was "very sound and
will result in an improved product."

But after leaving the Bush administration in late 2003, Hauer did an
about-face, delivering Emergent as a client to his new boss, the
Fleishman-Hillard public relations and lobbying firm, according to company
records and people familiar with the matter.

At a December 2004 biotech-industry conference, Hauer said the government
should purchase more of the old vaccine. He also took aim at Simonson, the
HHS lawyer, who had succeeded him as assistant secretary. Hauer said that
Simonson should be stripped of his authority for his handling of the
BioShield contract.

In June 2005, Emergent placed Hauer on its board of directors. In that year
and 2006, Emergent paid $360,000 to Fleishman-Hillard, records show.

In an interview, Hauer said he lobbied members of Congress and advised the
company how to "educate" the administration. He said he changed his mind
about Emergent's vaccine after concluding that he had relied earlier on
"biased information" from his then-colleagues at HHS.

In the spring of 2005, VaxGen became more vulnerable to its rival's
onslaught. VaxGen scientists determined that the problem with the new
vaccine's potency was not the result of a lapse in refrigeration, as they
had first speculated. The difficulty lay with the vaccine's formula. An
aluminum additive, expected to increase potency, had the opposite effect.

"Our vaccine had a stability problem," said Dr. Marc J. Gurwith, a
scientific executive with VaxGen. "The problem was going to take more
testing to figure out what went wrong and how to fix it."

VaxGen needed patience and flexibility from its presumed allies in
Washington. But Thompson had resigned as HHS secretary, and Emergent's
lobbying had changed the atmosphere. Officials who had backed VaxGen's drive
to deliver a better vaccine were no longer responsive.

"We had a very productive partnership with the government until we
encountered a problem," said Piers Whitehead, VaxGen's vice president for
corporate and business development. "Things deteriorated very rapidly."

In April 2005, Dr. Noreen A. Hynes took over the HHS office that oversaw
development of new drugs and vaccines under Project BioShield. Hynes,
previously a bioterrorism advisor in the White House, said she was concerned
about whether any small company could shoulder the costs of developing a new
vaccine.

The Project BioShield law allowed advance payments of up to 10% of the value
of a contract. But when she sought permission to grant such payments, Hynes
said, she was turned down.

"I was told that the administration had decided there would be none," Hynes
said in an interview. Asked who made the decision, Hynes said that she did
not know but that it flowed from "the highest level."

Hynes, an infectious-disease specialist now at Johns Hopkins University,
added: "It was not surprising, frankly, that this new type of vaccine would
have been delayed in development. That's just the way vaccine development
is. . . . It's one of the reasons why you would want to have the
advance-payment authority."

VaxGen officials said they sought advance payment three times in 2005 and
2006: twice in discussions with HHS and once in writing. Hall, the health
department spokesman, said any consideration of such payments "became moot"
because of VaxGen's lack of progress.

Emergent executives knew well the problems inherent in developing and
manufacturing vaccines. The state facilities they acquired in Lansing,
Mich., had been beset with problems. In 1999 and 2000, inspectors from the
Food and Drug Administration found deficiencies in the company's vaccine,
including problems with stability, potency and purity.

The company pledged to rectify the inadequacies -- and the government stuck
with it as the sole supplier of anthrax vaccine to the military.

Now, as Emergent sought to neutralize the competitive threat from VaxGen, it
added to its lobbying team John V. Hishta, who had deep ties to the
Republican congressional leadership.

Hishta was chief of staff to Rep. Thomas M. Davis III (R-Va.) and has
continued to serve him as a campaign advisor. Hishta also directed national
efforts to elect Republicans to the House from 2000 through 2002.

In July 2005, he arranged for an Emergent executive to appear before the
House Government Oversight and Reform Committee, which was chaired by Davis.

In his opening statement, Davis voiced "concern" that federal officials had
"made insufficient efforts to stockpile existing countermeasures while new
and improved ones are being developed."

The Emergent executive, Robert G. Kramer, told the committee that health
officials were undermining national security by contracting for VaxGen's
product instead of buying more of Emergent's.

"HHS has staked the nation's protection against the No. 1 biologic threat on
an experimental product," Kramer said.

Kramer emphasized that Emergent would reassess whether to keep making the
anthrax vaccine. The company, he said, "finds itself at a critical juncture
in terms of its ability and willingness to commit resources to a product
that lacks a committed customer."

Representatives of VaxGen were not invited to appear.

Asked about his role, Hishta said, "I don't want to comment on my lobbying
work."

Davis did not respond to questions submitted through an aide.

Another key lobbyist for Emergent was Todd A. Boulanger, who had served as
an aide to Republican members of Congress. Boulanger helped shape a letter
by Sen. Charles E. Grassley (R-Iowa) to Thompson's successor as HHS
secretary, pressing him to explain why his department had not purchased more
anthrax vaccine from Emergent.

The selection of VaxGen, Grassley wrote, was "highly suspect." In his
letter, dated Jan. 28, 2005, Grassley told the new secretary, Mike Leavitt,
about "a number of troubling allegations" regarding the vaccine contract.
Grassley suggested that HHS "acted prematurely" in awarding it to VaxGen.
"Some have questioned the effectiveness" of VaxGen's product, he wrote,
noting that the old vaccine "has been available for use in this country for
several decades."

Nine weeks later, Grassley again wrote to Leavitt: "I remain greatly
concerned that the department is not prepared to protect the American people
from an anthrax attack."

Grassley also questioned the independence of Russell, the vaccine specialist
who backed awarding the BioShield contract to VaxGen. Grassley claimed the
former general had been involved in developing the vaccine years earlier
with the Army.

Russell, who left the health department in late 2004, said he had no
financial stake in the vaccine and no role in developing it.

"How do you confront a whisper campaign?" Russell asked. "The lobbyists have
to earn their pay."

Boulanger's role in providing material to Grassley -- including language for
the senator's January 2005 letter -- was described by people who said they
had direct knowledge of his actions. Asked for comment, Boulanger said, "I'm
not going to say anything about my private conversations with his
[Grassley's] staff."

Emergent paid Boulanger's firm, Cassidy & Associates, $300,000 from 2004 to
2006.

A spokeswoman for Grassley, Jill Kozeny, said the senator's letters were
"based on information from a number of sources."

Grassley's intervention hurt VaxGen on two fronts, company executives said:

Because of his reputation as a fiscal watchdog, his criticism sowed
reticence about VaxGen within Congress and the administration. And the
prospect of overcoming potent political opposition while trying to solve a
tough scientific challenge weakened the resolve of VaxGen's major investors.

Emergent, meanwhile, broadened its connections to the White House by hiring
Cesar V. Conda and Ron Christie as lobbyists. Both had been policy aides to
Vice President Cheney, who championed Project BioShield.

According to people familiar with the lobbyists' conversations with
lawmakers, Conda and Christie raised doubts about Simonson's handling of the
vaccine contract, just as Hauer had.

As assistant secretary for emergency preparedness, Simonson could have made
the case within the Bush administration for giving VaxGen an advance on its
contract. But that prospect was dimmed after the lobbyists' attacks, said
Russell.

"Simonson was neutralized, " he said.

Simonson, who left the government in mid-2006, declined to comment on
Emergent's lobbying effort.

Neither Conda nor Christie responded to messages seeking comment. Emergent
paid their firm, DC Navigators, $340,000 from 2006 through June of this
year.

One of Emergent's other lobbying firms, McKenna Long & Aldrich, has taken
credit for helping write the Project BioShield law. Seven members of the
McKenna firm subsequently registered to lobby for Emergent.

From 2005 through June 2007, Emergent paid the firm $380,000.

Government changes rules

VaxGen's contract called for delivery of the first 25 million doses of
vaccine by November 2006.

In May of that year, government health officials extended the deadline three
years.

But they also erected new hurdles: They required VaxGen to complete, at the
company's expense, new testing of the vaccine in animals, plus an additional
study in humans. The original contract had allowed VaxGen to defer such
studies until after the company began receiving payments.

VaxGen fought without success for better terms, notably partial payment
before delivering the vaccine. It objected to the new regulatory
requirements. It kept at work on the stability problem.

After reviewing VaxGen's progress, the FDA on Nov. 2, 2006, denied approval
to begin the new study in humans, citing concern about whether the vaccine
was stable enough.

On Dec. 19, 2006, the health department canceled VaxGen's contract. By this
fall, VaxGen had laid off 90% of its workforce, which peaked two years ago
at 295 employees, a spokesman said. The company plans to merge with another
Bay Area biotech firm.

In an October report, the Government Accountability Office said that health
officials and VaxGen had been "unrealistic" in believing the company could
deliver its vaccine on schedule. The GAO also said VaxGen was hindered by
regulatory requirements that "were not known" to the company when the
contract was awarded.

VaxGen's Gurwith said in an interview that based on lab results, he was
convinced as of July that the company had figured out how to maintain the
vaccine's stability. Chief executive James P. Panek said that if the
government had stood by VaxGen, it probably would have delivered a better
vaccine "well ahead" of any other manufacturer and at far lower cost.

Emergent, meanwhile, has continued to win contracts to deliver more of the
old vaccine to the civilian stockpile. In a recent interview, two senior
federal health officials, Gerald W. Parker and Carol D. Linden, said they
remained determined to buy enough vaccine to inoculate 25 million Americans.

Henderson, the Bush administration advisor and former World Health
Organization official, said he was uncertain how much of the old vaccine
should be stockpiled for civilians, considering its shortcomings.

"All of us were quite persuaded that once you got the [new] vaccine, you
wouldn't be buying the old stuff," he said.

david.willman@ latimes.com

Times researchers Janet Lundblad in Los Angeles and Sunny Kaplan in
Washington contributed to this report.

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