BY BOB EVANS
DAILY PRESS (NEWPORT NEWS, VA.)
The Olympian
12 December 2005
NEWPORT NEWS, Va. — In a two-year span, the nation's only licensed
anthrax vaccine maker went from pleading poverty to announcing $100
million in acquisitions, including other pharmaceutical companies and a
new manufacturing plant near Washington, D.C.
It's a pattern that's worked well for BioPort Corp.: Tell the Pentagon
or Congress that it doesn't have the money to keep going, ne-gotiate a
new deal, then count the extra cash rolling in.
During the past seven years, it's transformed an initial investment of
less than $4.5 million into an international biotech firm, with
contracts worth more than $450 million. During that time, the company
has capitalized on its monopoly over the vaccine and on fears that
opposing armies and terrorists will unleash tiny anthrax spores
somewhere.
BioPort is an example of how a sole-source government contract can
become a gold mine — especially if you spend wisely on the right
lobbyists and public relations professionals.
BioPort counts a former Cabinet member and assistant secretary of
health and human services among those it pays to gain favor with
government agencies.
He says Pentagon officials talked about taking over the anthrax vaccine
plant and operations — especially after the government held the license
for the vaccine as collateral for a series of loans and payments that
kept the company afloat.
“What I never heard in those discussions was why nothing ever came of it,” he says.
The Pentagon isn't telling that story, and neither is BioPort.
Troops and veterans who've been asked to put BioPort's products in
their bodies often point to the company's problems getting a clean bill
of health for its manufacturing plant, as well as to the company's
ability to always get its way with government officials. They wonder
whether BioPort's connections — not its scientific and medical prowess
— are behind the company's success.
BioPort is a privately held company that doesn't make its stock
available for public sale. As a result, most aspects of its finances
and management aren't open to public scrutiny.
The company declined to provide its officers for interviews with the
Daily Press. Six weeks after receiving a list of detailed ques-tions —
and promising answers — it sent a box containing two books and some
news releases. None of the questions was answered.
Until 1998, the nation's only manufacturing plant for anthrax vaccine
was owned and operated by the state of Michigan. The state agency that
ran the plant was losing money, so the state put the operation and its
license for making the anthrax vaccine up for bid.
Fuad El-Hibri, a 40-year-old German businessman with a Yale University
management degree, formed a team of investors to buy the business,
which included a $100 million contract with the Pentagon.
He and his father, Ibrahim El-Hibri, a wealthy international financier
from Lebanon, dominated ownership of the company, which they named
BioPort.
But the U.S. government was not keen on letting a foreign-owned company
control its anthrax vaccine. The only other bidder was also based
overseas.
So Fuad El-Hibri played a trump card: A family friend, former Chairman
of the Joint Chiefs of Staff Adm. William Crowe, was made a director.
Crowe put no money into BioPort but got about 10 percent of the stock,
government records show. El-Hibri says Crowe immedi-ately advised him
to apply for U.S. citizenship.
Crowe's advice was good, El-Hibri said. But Crowe's connections were
better: He was the military's top officer during the Reagan
administration, then endorsed Bill Clinton for president in 1992.
Clinton made him U.S. ambassador to the United Kingdom, and while
serving there, Crowe was close to the El-Hibri family, congressional
testimony shows.
Crowe has persistently declined comment on his investment or role with
the company, except for congressional testimony in 1999, when BioPort
was seeking its second government bailout. During that testimony, he
was asked whether he'd lobbied Pentagon officials for BioPort. Crowe
vehemently denied it.
At that point, BioPort had all the leverage over the Pentagon that it
needed — if the military wanted to continue its year-old pro-gram of
inoculating every service member against anthrax.
Even though the Pentagon gave Michigan more than $20 million for new
equipment and repairs and $100 million in guaranteed con-tracts the
previous decade, the plant had several problems. It was shut for
renovations in March 1998, six months before BioPort bought all
operations and licenses in a $25 million package of cash, loans and
promises of future payments.
Food and Drug Administration inspections found repeated problems before
and after BioPort took over. BioPort brought in more, and better-paid,
consultants and employees to fix things up — even though its minor
partners included managers who had run the plant that provided millions
of doses of vaccine to U.S. troops, congressional records show.
As part of the sale, BioPort assumed the right to sell about $7.9
million of vaccines already made and promised to the U.S. military.
Within weeks, it signed a new contract with the Pentagon providing for
$45.1 million more, including $16 million in immediate cash for plant
renovations. The deal required the government to pay for vaccine even
if the drugs weren't licensed for use.
That wasn't enough for BioPort: Nine months later, in June 1999, it was
still struggling to get FDA approval of its manufacturing plant. The
company said it was running out of money and needed more help.
Pentagon auditors looked at BioPort's books and concluded that millions
of dollars were unaccounted for. BioPort didn't even know the cost of
making a dose of vaccine, the auditors reported.
It was clear that $1 million had been spent to renovate and furnish
offices, as well as $1.28 million more on bonuses for “senior
man-agement.”
One unnamed former manager got $10,000 a month for as much as 40 months — whether he worked or not, records show.
And $1 million more had been spent on items unrelated to anthrax production, the auditors said.
They concluded that BioPort's request for extra money didn't meet legal requirements.
But Pentagon contract officers, citing “the interests of national
security,” overruled them and approved a $24.1 million bailout in
September 1999.
The contract addition that they blessed paid all the company's debts
and provided a 144 percent increase in payment for each an-thrax
vaccine dose, from $4.36 to $10.64.
It was $2 million less than BioPort sought. Pentagon officers wrote
that by chopping the amount, they didn't have to notify Congress about
the new deal.
Congress found out anyway, but did nothing to stop the deal.
Hearings were held, including one by Sen. John Warner, R-Va., chairman
of the Senate Armed Services Committee. His session in-volved only
BioPort officials and others who supported the bailout.
A second hearing involving critics of the company and the renegotiated contract was promised but never held.
More aggressive questioning took place in the House of Representatives.
It was determined that El-Hibri and his partners had in-vested only
$4.5 million of their own money, in cash and loan guarantees.
All that money and the cash the Pentagon had chipped in was gone, spent
on renovations, consultants' fees and physical improve-ments,
congressional investigators found.
Further, the original $25 million deal with Michigan had become $14.45 million.
“The message seems clear: If a company wants to make millions without
providing a product or service, enter into a sole-source contract with
the Department of Defense to produce vaccines,” Rep. Walter Jones,
R-N.C., said in a written statement. “BioPort ap-pears to have the
government over a barrel.”
Louis J. Rodrigues of the Government Accountability Office — a
congressional oversight agency that's frequently criticized BioPort and
the Pentagon's management of the vaccine program — told Congress that
it “had no option” but to pay up if it wanted anthrax vaccine.
The Pentagon contractors who made the original deal with BioPort should
have known there was no way that the company could stay in business,
Rodrigues said.
“We did nothing to force BioPort's hand and make them come up with a cost-control system,” he said.
Or, he added, a realistic business model.
Pentagon officials promised Congress that they'd do a better job — in
part by assigning government employees to oversee the com-pany's
bookkeeping and quality-control systems.
They denied that they'd been patsies for the well-connected company.
“All I am trying to say is that this is not a sweetheart deal,” David
R. Oliver, then principal deputy undersecretary of defense for
ac-quisition technologies, told Congress.
BioPort struggled for more than three years to get licensing for its
plant and product. Meanwhile, batches of vaccine were made and the
Pentagon paid for each — including money for storage of unusable
vaccine.
Vaccine made before the plant renovation kept going into the arms of
thousands of troops. Dozens of them came to Congress, com-plaining that
the drug made them permanently ill, giving them headaches, joint pain,
loss of memory and more severe symptoms.
By 2000, even the Pentagon had lost patience and told BioPort to stop
making vaccine until the plant regained its license. But the military
agreed to keep making payments anyway, to keep the company afloat.
Those payments meant that BioPort's owners didn't have to borrow money
elsewhere and didn't have to risk their personal fi-nances, a
congressional auditor testified in 2000.
By January 2002 — when federal drug regulators finally agreed that the
plant and company could resume licensed operations — the Pentagon had
paid BioPort $126 million for drugs that were stored and unlicensed,
congressional records show. It also paid $33.5 mil-lion during that
time for vaccine given to 525,000 troops.
The months before the licensing approval were tumultuous for the company and the nation.
In August 2001, Congress and the Pentagon publicly said they were
considering giving up on BioPort and its failures in getting
op-erations up to snuff.
Meanwhile, BioPort brought in more business partners and consultants
from established vaccine companies and government con-tractors to
figure out how to regain its license.
Then came Sept. 11, 2001, followed the next month by deadly
anthrax-laden letters to members of Congress and others in Washing-ton,
D.C.; Connecticut; and Florida.
Instead of asking questions about the vaccine's safety, many members of Congress began asking why more doses weren't available.
Tommy Thompson, then secretary of health and human services and the
Bush administration official responsible for vaccine and drug
licensing, was caught between a Congress that wanted action and critics
who feared political pressure would hasten licensure.
“I can assure you nobody is pressuring FDA to approve this,” he said in October 2001.
Three months later, BioPort had its license back.
A few months after that, it was back to pleading poverty.
This time, BioPort was after a bigger prize: a contract to supply
millions of doses of anthrax vaccine for use by civilians, postal
workers, police, firefighters and others who might encounter domestic
terrorism.
A $1 billion contract was being waved in front of vaccine and pharmaceutical makers, the largest in government history.
BioPort responded as it had in the past.
In a series of interviews, company officials said their business was
“at risk” and in financial jeopardy if the government did not quickly
give it the contract for a domestic vaccine stockpile — or a new
Pentagon deal.
If BioPort was on the ropes financially, its biggest stockholders didn't seem to feel it.
During the same week the president of BioPort pronounced it “at risk,”
the chairman of the board and biggest stockholders — El-Hibri and his
wife, Nancy — were in the news because neighbors were complaining about
their plans to build an 88-acre commercial equestrian and polo center
near their home in Gaithersburg, Md., near Washington, D.C.
The El-Hibris had never moved to Michigan to oversee the daily struggle over licensing at the vaccine plant there.
Washington, D.C., was the focus of much of BioPort's attention anyway.
In 2002, records show, the company increased spending for lobbyists in
Congress, from $30,000 to $110,000. The amount doubled the following
year.
BioPort also hired Ruder Finn and Fleishman-Hillard, high-powered
public relations firms staffed by many former government officials.
BioPort, still the nation's only licensed anthrax vaccine manufacturer,
began sponsoring “public education seminars” and studies to build
support for a bigger government stockpile of the drug.
On the first anniversary of the Sept. 11 attacks, six doctors,
scientists and former military officers — described as a “panel of
bioter-rorism experts” by BioPort — announced the need for
preparedness. Their primary recommendation was to not rely on a new
anthrax vaccine but to purchase millions of doses of BioPort's product.
BioPort paid several of the people on that panel to review and endorse
the report, including former military officers who only a year before
told Congress how safe and effective the company's vaccine was.
They included Marine Maj. Gen. Randy West and Lt. Gen. Ronald Blanck, a former Army surgeon general.
West said he was paid $5,000 for reviewing the report, which was
written by either BioPort or its public relations agent — not the
experts on the panel.
Even though the ghost writing wasn't known at the time, a critic from
the conservative Cato Institute publicly dismissed the panel's work as
“just BioPort trying to make some money.”
After that, the company's efforts became less obvious.
Muhiuddm Haider, an unpaid member of the panel and a professor in the
school of public health at George Washington University, started
operating a Web site for BioPort in support of the anthrax vaccine.
BioPort's name doesn't appear anywhere on the site, but the company
supplies all the money to operate it, $40,000 a year, Haider said.
The Web site says it's sponsored by the Partnership for Anthrax
Vaccination Education, or P.A.V.E., a group of medical organizations
that includes the prestigious American Medical Association.
Earlier this year, Haider and P.A.V.E. petitioned the FDA to license
the anthrax vaccine for use against inhaled spores of the bacteria.
The ties to BioPort were not disclosed then, either.
P.A.V.E.'s Web site and the organization's publications extol the need
for vaccine and say the vaccine is safe. They mention none of the side
effects, even the minor ones that the Pentagon acknowledges are
suffered by a third or more of those who get the shots.
“I am not marketing for BioPort,” Haider says. “I am marketing for public safety.”
P.A.V.E.'s public safety efforts began with a series of forums.
Featured speakers were West, officials from BioPort, Haider and others
connected to BioPort.
People who question the effectiveness and safety of the vaccine aren't on the agenda for those forums.
A frequent speaker is Jerome Hauer, former assistant secretary of
health and human services for emergency preparedness. He was a leading
proponent of stockpiling anthrax vaccine for civilian use while he was
on the government payroll.
In his first few appearances at P.A.V.E. events, Hauer's connections to
BioPort weren't disclosed. He'd become a paid consultant.
Later, he took over a new bioterrorism institute at Haider's university.
He was named to BioPort's board of directors in June and has been lobbying for the company's products.
As BioPort's board expanded, so did its business.
By September 2003, the Pentagon was paying $22 a dose — more than double the price negotiated in the 1999 bailout.
Cash was coming in fast. The company could make a million more doses a
year than the military demanded, El-Hibri told TWST, a Web site that
runs verbatim interviews with business leaders.
“We are debt-free and profitable,” he said.
BioPort was now a subsidiary of Emergent BioSolutions, led by El-Hibri and his business partners.
By the end of 2003, Emergent announced the purchase of a Maryland drug
maker for more than $3 million and signed a new contract with the
Pentagon, worth from $29.7 million to $245 million, depending on the
doses sold.
The following year, it began building a second, $95 million, anthrax vaccine plant in Frederick, Md.
In January of this year, Emergent signed a deal with the British
government to work cooperatively on toxoid and botulism vaccines,
including a pledge to spend at least $2 million during the next two
years. Purchase of a British company working on five vaccines,
including an oral anthrax vaccine, followed weeks later.
But BioPort and its parent still hadn't landed the big prize: supplying anthrax vaccine for the U.S. domestic stockpile.
BioPort and other companies received seed money to research a
new-generation anthrax vaccine. But when the $1 billion contract was
awarded in November 2004, it went to VaxGen Inc., a California company
without a licensed product and in trouble for misre-porting financial
results to Wall Street.
VaxGen's vaccine isn't ready for use yet and is in early trials, years
away from licensing. Government grants finance at least 11 other
efforts to provide alternatives to BioPort's vaccine, aiming for a
safer, more effective product.
When BioPort couldn't win in the lab, it doubled its efforts in
Congress and other branches of government, adding more and better
lobbyists.
It had hired Louis Sullivan, secretary of health and human services
under President George H.W. Bush — the current president's father. But
higher-powered help was needed.
McKenna Long & Aldridge, a powerful Washington, D.C., law and
lobbying firm also known as “MLA,” was hired Jan. 1 of this year, U.S.
Senate lobbying records show.
Within six months, it reported $140,000 in lobbying fees and helped
bring BioPort a $122.7 million contract to supply 5 million doses of
the vaccine to the Department of Health and Human Services, the
second-largest award under BioShield, the federal law that cre-ated a
domestic stockpile of antiterror vaccines.
The lobbyist's news release was headlined, “MLA Helps Client Secure BioShield Contract for AVA Anthrax Vaccine.”
MLA had supplied several lawyers, including one who'd helped write the
Homeland Security Act of 2002 and two who'd been tapped by Congress for
help in creating the BioShield law. But they couldn't do it alone.
Four days before the big contract award, BioPort added lobbyist John
Hishta to the team. A few weeks later, he filed a U.S. Senate lobbyist
report saying BioPort had paid him $30,000 for “procuring a government
contract for anthrax vaccine.”
Hishta was executive director of the National Republican Congressional
Campaign Committee during its successful 2002 election campaign. The
committee is the main strategy and fund-raising organization for
Republican candidates in the House of Representa-tives.
Hishta also managed a re-election campaign for Virginia Sen. John
Warner. Warner is an important ally of the Pentagon in the an-thrax
vaccination program.
BioPort is still delivering those 5 million doses for the BioShield contract.
But the company didn't wait to resume its well-practiced, well-rewarded
strategy for success: threatening to stop vaccine produc-tion, then
reaping a new contract.
On July 14, BioPort President Robert Kramer told Congress that if the
government didn't promise to buy even more vaccine for the domestic
stockpile, the company might have to stop producing anthrax vaccine
altogether.
“We'll have to make a very simple business decision,” he testified.
Whether it was the renewed threat — or just coincidence — BioPort once again got the desired result.
Last month, Health and Human Services posted a notice that it would
enter private negotiations with BioPort to supply an addi-tional 5
million doses of anthrax vaccine for the domestic stockpile.
The price to taxpayers hasn't been determined yet.
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