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tion’s enormous de�cit will certainly mean greater fr ugality,
legislators need to strengthen, even if only modestly, funding for
NSF and NIH. A good starting point would be to hold President
Bush and Congress accountable for reneging on 2002 legislation
that authorized a doubling of NSF’s budget by 2007. That dou -
bling won’t happen now: that’s clear. But �nancial leaders who
are dependent, one way or another, on government funding of re -
search should ask why not. There should be outrage over the ero -
sion of U.S. research institutions. ■
Get Well Soon
What’s wrong with the regulatory
agency and how to cure it.
Last December, the U.S. Food and Drug Administration warned
doctors that a drug widely prescribed to children for attention
de�cit hyperactivity disorder carried with it “the potential for se -
vere liver injury.” The FDA demanded that the manufacturer, Eli
Lilly, relabel the product with a new bold-letter warning. Since
the drug was introduced in 2002, some two million people have
taken it. The FDA discovered that two of these patients had suf -
fered subsequent liver problems.
So far, so good. Perhaps a little overzealous. But the FDA had
been less vigilant about more serious safety concerns related to
the pain relievers Vioxx, Bextra, and Celebrex. An FDA whistle -
blower told the U.S. Congress that tens of thousands of patients
may have died needlessly because of the FDA’s misjudgments
about Viox x alone. Perhaps the whistleblower overstated the in -
�uence of drug manufacturers on the FDA’s hesitation to warn
the public about these drugs. Nevertheless, a thorough exami -
nation is in order.
As Stephan Herrera explains in a review of Philip J. Hilts’s
book Protecting America’s Health: The FDA, Business, and One
Hundred Years of Regulation, there is talk in Washington of
overhauling the FDA to ensure that
such mistakes don’t recur (see “Who
Needs the FDA?” p. 70). Some are ask-
ing for the creation of an independent
product-safety review board to over -
see the FDA’s own product-safety re -
view board. The FDA itself has asked
the National Academies’ Institute of
Medicine to conduct a review and
vows to act on its recommendations.
Other critics, particularly those on
the right who are ideologically antago-
nistic to all regulation, argue the
agency must be destroyed altogether.
They say it is a kind of tyranny to tell
sick citizens they cannot use risky
therapies, so long as the risks are
clearly explained. They believe a U.S. dr ugs agency should limit
itself to describing the e�cacy of medicines.
In this rush to review and restructure the agency, the root
cause of all that ails the FDA is being overlooked. Despite being
responsible for the health and well-being of 300 million Ameri -
cans—and the proper working order of close to $1.5 trillion worth
of products and ser vices—the agency must make do with an an -
nual budget of $1.5 billion. No other government agency is re -
quired to do so much with so little. The FDA needs more money
and more guidance in how to spend it for the greater good. It
won’t be easy for a Republican-dominated Congress to give the
FDA more money and power, but the public and media will
surely back those who lead the charge.
If something must be scrapped, let it be the “user fee” system.
Hundreds of millions of dollars in product-review fees paid by
drug companies go to the FDA. Congress and the FDA will say
that they can’t a�ord to ditch the user fee system, but it creates in -
tolerable con�icts of interest.
Failing all of this, surely the FDA at least deser ves a real com -
missioner. We recommend the White House look at Stanford
University’s president emeritus, Donald Kennedy. Now the edi -
tor in chief of Science, Kennedy served as FDA commissioner
from 1977 to 1979. There is some precedent for rehiring com -
missioners. Kennedy is wiser now and even more highly re -
garded by scientists and the biopharmaceutical industry. Another
good choice would be David Kessler, dean of the University of
California, San Francisco, School of Medicine, who was an e�ec -
tive and powerful commissioner of the FDA under both Presi -
dent George H. W. Bush and President Bill Clinton. The FDA
again needs this type of expertise and strong leadership.
With the proper remedy and the right physician, the FDA can
be healed. ■
Translating promising science
into new therapies.
Amid the national debate over stem cells and therapeutic cloning,
there’s another biomedical technology that is showing increas -
ing promise without the ethical conundrums. RNA interference
(RNAi) is a natural regulatory process in which small, double-
stranded RNA molecules turn o� speci�c genes in a cell. Because
RNAi is highly targeted and e�cient, it has become a widely used
tool for understanding what genes do and how they work. But its
real payo� lies in new therapies—and developing them will re -
quire a renewed commitment to funding and research.
Exploiting the properties of RNA molecules could yield more-
e�ective dr ugs to �ght cancer, HIV, in�uenza, and other diseases.
Rather than blocking the e�ects of speci�c proteins, which is
what conventional drugs do, an RNAi-based therapy could in
theory stop the proteins from being made in the �rst place. Mark
In this rush
to review and
the root cause
of all that ails
the FDA is
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