It seems
clear, even if it's deplorable, that President Bush and Congress
will not increase funding for medical research. But at the very
least, they ought to make current spending more effective. They
could do so by getting behind bipartisan legislation to create
a Center for Cures at the National Institutes of Health that's
designed to shorten the average 17-year gap between a scientific
discovery and a disease treatment.
And, they
could back House Energy and Commerce Chairman Joe Barton (R-Texas),
who's been trying to enhance the power of NIH's director to strategically
direct funding to the most promising areas of research.
After doubling
NIH's budget from $13.7 billion in 1998 to $27 billion in 2003,
Bush and Congress for the past three fiscal years have imposed
net cuts after inflation is taken into account. Bush's fiscal
2007 budget is expected to call for funding at the 2006 level,
$28.3 billion.
There's a
chance that Bush will finally do right by non-medical research
and increase funding for physics, chemistry, energy, computation
and nanotechnology, all of which have implications for health
research. But for medical research, the NIH cuts mean that only
about 20 percent of peer-reviewed projects submitted for funding
will get money, down from more than 30 percent during the period
of doubling. This means a drastic slowdown in discovery.
It shouldn't
happen. Medical research is not, despite the way it's officially
viewed, "discretionary spending" but rather an investment
in the nation's health. Historically, it has produced dramatic
life- and cost-saving results in the treatment of heart disease,
AIDS, mental illness and cancer, to name a few. And it promises
to do the same in the future for Alzheimer's disease, autism and
diabetes.
But if the
cuts are inevitable, with Bush and the GOP Congress trying to
close the budget deficit, there ought to be an effort to increase
the impact of what is spent, emphasizing the production not just
of scientific papers but of actual cures for diseases.
Cuts or no
cuts, a number of disease groups have become impatient with the
existing medical research system and are backing the Center for
Cures bill sponsored by Sens. Joe Lieberman (D-Conn.), Thad Cochran
(R-Miss.), Tom Carper (D-Del.) and Kay Bailey Hutchison (R-Texas)
as well as Barton's effort to make NIH funding more strategic.
The cures
agency, funded at $5 billion a year, would foster "translational
research" designed to bridge the gap between basic scientific
discoveries and the production of medicines and encourage cooperation
between NIH's 21 disease-specific institutes.
A consortium
of scientists and disease groups, Faster Cures, founded by philanthropist
and cancer survivor Michael Milken, is backing the Lieberman bill
but is also promoting private efforts to cut through the mazes
between discoveries and cures.
Faster Cures'
president, Greg Simon, a former top aide to former Vice President
Al Gore, said in an interview that "NIH has spent the last
40 years doing what we asked it to do - study the biology of disease.
Sometimes it leads to cures, but not often enough. NIH is about
curiosity, not cures.
"Our
basic tenet is that we need what we call research on people that
matters. That's what we mean by translational research. NIH doesn't
do much of it and it doesn't do it very well. I'd estimate that
out of NIH's $28 billion, it spends about $500 million on translational,
mainly in cancer and infectious disease vaccines," Simon
said.
At the other
end of the cures pipeline, the Food and Drug Administration reported
this month that it approved only 20 new drugs last year, down
from 36 in 2004, even though the drug industry reported spending
a record $38 billion on research.
Pharmaceutical
companies say it takes, on average, 15 years and $800 million
to develop a new drug. Much of that is spent on government-mandated
clinical trials to prove safety and effectiveness.
One obvious
clog in the cures process is that drug companies concentrate on
producing "blockbuster" drugs that will provide large
returns on investment. The Bush administration should consider
ways of hastening the approval process, possibly by easing "effectiveness"
testing after safety is guaranteed.
Simon said
that one of the major barriers to curing disease is the research
system's risk-adversity, which is made worse at times when NIH
funding is down. NIH tends to fund well-established researchers
with conventional ideas, not risky projects that might produce
breakthroughs.
He cited
findings by Nobel Prize researcher Thomas Cech showing that the
average age of a scientist getting his or her first NIH grant
is 42, whereas the average age at which Nobel Prize winners produced
their work is 33. "Young people propose ambitious projects
that may not work, so they don't get funded," Simon said.
"Everybody else is proposing something where they've already
done 90 percent of the work. It's one reason why progress is so
incremental."
One aspect
of the cures bill is creation of a Health Advanced Research Programs
Agency, a counterpart to the Defense Advanced Research Programs
Agency that helped develop the Internet, lasers and virtual intelligence
technology.
Simon said
that "systemic problems" in medical research also involve
the refusal of academic researchers to share discoveries in a
timely manner, a crackdown at NIH on cooperation between researchers
and private companies and a lack of collaboration across disease
specialties.
The basic
problem, however, is institutional rigidity - the tendency to
do things as they've always been done, regardless of new opportunities.Simon
cited the example of work on multiple sclerosis, where conventional
researchers are still trying to discover the auto-immune processes
that damage the myelin sheath around nerves, producing paralysis.
"The Myelin Repair Foundation, a small organization out in
California started by a venture capitalist with MS," he said,
"has got a five-year plan to repair the myelin sheath. They
don't need to know how they got MS or why they got MS. They just
want to fix it."
If the Bush
administration and Congress don't want to finance more conventional
medical research, they ought to reform the medical research system.
Mort
Kondracke is the Executive Editor of Roll Call.
