When President Bush told drug companies he planned to spend $5.6
billion over 10 years to build a medical arsenal against biological
terrorism, the program's backers promised it would radically alter
the economics of biodefense.
Companies, they said, would no longer be able to complain that no
reliable buyer exists for complex treatments to counter agents such
as anthrax, botulism, ebola and plague. By promising to buy finished
products, rather than just funding early research as it had in the
past, the government would create a guaranteed market for
bioterror-fighting medicines.
But three months later, many biotechnology and pharmaceutical
companies say the plan known as Project Bioshield may not be radical
enough. Enthusiasm for the concept of a government-driven market is
nearly unanimous within the industry, and dozens of companies have
pledged their support. But executives say that, given the financial
and legal hazards of developing drugs, vaccines and diagnostic tests
for deadly pathogens, they want a higher guaranteed profit and fewer
restrictions than the current proposal would offer.
Some industry representatives are lobbying Congress to sweeten
the Bioshield legislation with liability protection for companies if
products developed under government contract harm people. Others are
pushing for more favorable rules about ownership of the rights to
new discoveries made under the program.
Bioshield, announced during the State of the Union address in
January, is the linchpin of the administration's plan to protect
Americans against biological, chemical and radiological attacks, and
its implementation is regarded as a crucial step in creating a
sustainable biodefense industry.
Unlike most commercial drug-development efforts, which mostly
focus on treatments for chronic diseases that could create a steady
stream of customers, biodefense is viewed as a far more risky
market. An effective drug could sit unsold in a warehouse if the
need for it never arises.
But the early skepticism from the industry illustrates the
difficulty the government faces in enlisting drug companies --
particularly the largest and most battle tested -- in the search for
biological countermeasures, even if they are assured of a steady
buyer.
"There needs to be venture-capital type returns if we want
venture-type results," said J. Leighton Read, a California venture
capitalist and founder of vaccine company Aviron, who calls the
program a good first step.
If approved by Congress, Project Bioshield would create a
permanent pot of money -- immune to annual budget cycles -- for
federal health officials to tap whenever they find a promising
medicine. It would also grant agencies wide latitude to expedite
projects in the event of a bioterror attack, including streamlining
product reviews, contracting and staff hiring procedures.
It is too early to tell what provisions the final legislation
will contain. The Senate Health, Education, Labor and Pensions
Committee unanimously passed the bill but it may undergo substantial
revisions before it is approved by both houses of Congress.
Support for the bill is running high in Congress, and observers
predict that the sudden need for drugs and vaccines to contain the
latest public health crisis, severe acute respiratory syndrome, or
SARS, may bring many holdouts on board.
Several lawmakers say the program is already favorable to
industry, giving the president what one House member called a blank
check to entice drug companies to participate. Rep. Henry A. Waxman
(D-Calif.) is pressing for stronger congressional and judicial
oversight of Bioshield, arguing that it could weaken safeguards
against waste and fraud in federal contracts.
Anthony S. Fauci, director of the National Institute of Allergy
and Infectious Diseases, said that by ensuring a permanent
appropriation for biodefense products, Bioshield would remove the
greatest obstacle to industry investment: fears of budget cuts that
could make the government an unreliable buyer. Once federal health
officials engage companies in a contract, he said, "no matter what,
if they come through with a deliverable product, even if we never
use it, we will buy it."
The industry likes much of the proposal.
"Bioshield will streamline the entire process," said James H.
Davis, general counsel at Human Genome Sciences Inc. in Rockville,
which has indicated it is likely to seek funding under the program
to manufacture an experimental antidote to anthrax.
Still, some executives contend that the legislation would impose
cumbersome restrictions on funding. The bill stipulates that a
company must produce and deliver a medicine within five years. In
addition, a contract can be terminated -- and payment denied -- for
failure to deliver sufficient quantity of a product within three
years. In an industry in which the average new drug takes 10 years
to bring to market, both of those time requirements are relatively
short, executives said.
Further, to prevent government subsidization of money-making
drugs, the legislation requires that there be little or no
commercial market for a Bioshield-funded treatment, a rule that
industry experts say could exclude products already in use -- a drug
for cancer, for example, that could be tweaked to treat people
exposed to a radiological attack.
Existing medicines that can be repositioned for biodefense "are
the lowest hanging fruit," said Gillian R. Woollett, vice president
of science and regulatory affairs at the Biotechnology Industry
Organization. "It's not an appropriate exclusion."
Then there is what executives say is missing from the bill:
protection from liability if medicines developed under federal
contract have adverse side affects. "One only has to look at the
experience with smallpox vaccinations," Gail H. Cassell, vice
president for scientific affairs at Eli Lilly & Co., said of recent
deaths tied to the vaccine. "Liability has to be addressed."
Frank M. Rapoport, a lawyer for French vaccine maker Aventis
Pasteur SA, has encouraged lawmakers to make production of a
medicine, not just research, part of a Bioshield contract. He said
large drug manufacturers fear the government will split those tasks,
minimizing the financial incentive for the industry's biggest
companies.
Without these assurances, experts say, the work of developing
critical treatments will fall to small and generally untested
biotechnology companies hungry for government funding. The
government is increasingly finding willing partners among such firms
at a time when they are having trouble raising money from venture
capitalists and the stock market.
A year ago, the Department of Health and Human Services passed
over huge drug companies, including Merck & Co. and GlaxoSmithKline
PLC as potential smallpox contractors in favor of Acambis PLC, a
small British biotechnology company with offices in Cambridge, Mass.
The Defense Department has ordered anthrax vaccine from BioPort
Corp. of Lansing, Mich. The National Institute of Allergy and
Infectious Diseases has awarded contracts for a next-generation
vaccine to VaxGen Inc. of Brisbane, Calif., and the Avecia Group PLC
of Britain.
The Defense Department has also asked Frederick, Md.-based
DynPort Vaccine Co., a joint venture between Computer Science Corp.
and Porton International Inc., to develop several vaccines,
including an improved smallpox vaccine.
The provisions in the Bioshield legislation are aimed at
overcoming the qualms of the large drug companies that have long
regarded the government as a risky business partner. Many point to
the experience of Bayer Corp. with anthrax. Two years ago, when the
government decided to stockpile 1.2 billion doses of the
anthrax-fighting medicine Cipro, Health and Human Services Secretary
Tommy G. Thompson demanded a price of not more than $1 a pill, about
half of Bayer Corp.'s already discounted offer. When the company
protested, Thompson threatened to circumvent patent laws and order a
cheaper genetic version.
"The idea that we are asking this industry to put its capital at
risk for the government is obviously a very steep hill to climb,"
said a Democratic aide familiar with the legislation, speaking on
the condition of anonymity. "These are industries that are
suspicious [of] government to begin with."
Bioshield's supporters say the promise of a guaranteed market and
accelerated purchasing process could do much to change the uneasy
relationship.
"There is no perfect incentive mechanism," said NIH's Fauci. But
with Bioshield, "the government is acting in good faith to embrace
industry."