Date: 22 January 2011
Source: The New York Times
The Obama administration has become so concerned about the slowing pace
of new drugs coming out of the pharmaceutical industry that officials
have decided to start a billion-dollar government
drug development center to help create medicines.
The new effort comes as many large drug makers, unable to find enough new drugs,
are paring back research. Promising discoveries in illnesses like depression
and Parkinson’s that once would have led to clinical trials are
instead going unexplored because companies have neither the will nor the resources
to undertake the effort.
The initial financing of the government’s new drug center is relatively small compared
with the $45.8 billion that the industry estimates it invested in research in
2009. The cost of bringing a single drug to market can exceed $1billion, according
to some estimates, and drug companies have typically spent twice as much
on marketing as on research, a business model that is
increasingly suspect.
The National Institutes of Health has traditionally
focused on basic research, such as describing the structure of proteins, leaving
industry to create drugs using those compounds. But the drug industry’s
research productivity has been
declining for 15 years, “and it certainly doesn’t show any signs of turning upward,”
said Dr. Francis S. Collins, director of the
institutes.
The job of the new center, to be called the National Center for Advancing Translational
Sciences, is akin to that of a home seller who spruces up properties to attract
buyers in a down market. In this case the center will do
as much research as it needs to do so that it can attract drug company
investment.
That means that in some cases, the center will use one of the institutes’ four new
robotic screeners to find chemicals that affect enzymes and might lead to the
development of a drug or a cure. In other cases, the center may need to not only
discover the right chemicals but also perform animal
tests to ensure that they are safe and even start human trials to see if they work. All of that has
traditionally been done by drug companies, not the government.
“None of this is intended to be competitive with the private sector,” Dr. Collins
said. “The hope would be that any project that reaches the point of commercial
appeal would be moved out of the academic support line and into the private
sector.”
Whether the government can succeed where private industry has failed is uncertain,
officials acknowledge, but they say doing nothing is not an option. The health and human services secretary, Kathleen Sebelius, sent a letter to Congress on
Jan. 14 outlining the plan to open the new drug center by October — an
unusually rapid turnaround for an idea first released with little fanfare
in December.
Creating the center is a signature effort of Dr. Collins, who once directed the
agency’s Human Genome Project. Dr. Collins has been
predicting for years that gene sequencing will lead to a vast array of
new treatments, but years of effort and tens of billions of dollars in
financing by drug makers in gene-related research has largely been a
bust.
As a result, industry has become far less willing to follow the latest genetic advances
with expensive clinical trials. Rather than wait longer, Dr. Collins has
decided that the government can start the work itself.
“I am a little frustrated to see how many of the discoveries that do look
as though they have therapeutic implications are waiting for the pharmaceutical
industry to follow through with them,” he said.
Dr. Collins’s ability to conceive and create such a center in a few short months
would have been impossible for most of his predecessors, who had nice offices
but little power. But Congress in recent years has invested real budgetary
and administrative authority in the director’s office, and Dr. Collins is the
first to fully use these new powers.
Under the plan, more than $700 million in research projects already under
way at various institutes and centers would be brought together at the new
center. But officials hope that the prospect of finding new drugs will lure
Congress into increasing the center’s financing well beyond $1 billion.
Hopes of new money may be optimistic. Republicans in the House have promised to
cut the kind of discretionary domestic spending that supports the health institutes,
and officials are already bracing for significant cuts this year. But Dr.
Collins has hinted that he is willing to cannibalize other parts of the health
institutes to bring more resources to the new center.
“There are some people that would say this is not the time to do something bold
and ambitious because the budget is so tight,” he said. “But we would be irresponsible
not to take advantage of scientific opportunity, even if it means
tightening in other places.”
For the plan to go into effect by October, the administration must by law get rid
of one of the 27 centers and institutes already in existence at the N.I.H.—
something that has never been done before. So the administration plans to downgrade
the National Center for Research Resources, in
part by giving some of its functions to the new drug center.
Researchers and staff members connected to the research resources center have inundated
a complaint blog about the coming change. Mark O. Lively, a professor of
biochemistry at Wake Forest University and a
member of an advisory council to
the research resources center, said that he could not understand why the
administration was moving so quickly with its plans.
“And the N.I.H. is not likely to be very good at drug discovery, so why are
they doing this?” Dr. Lively asked.
But Dr. Garret A. FitzGerald, a professor of medicine and pharmacology at the University of Pennsylvania, said the new center could
inspire universities to train a new generation of investigators who could
straddle the divide between academia and industry.
“It could be a really good idea,” he said.
Both the need for and the risks of this strategy are clear in mental health. There
have been only two major drug discoveries in the
field in the past century; lithium for the treatment of
bipolar disorder in 1949 and Thorazine for the treatment of psychosis in
1950.
Both discoveries were utter strokes of luck, and almost every major psychiatric
drug introduced since has resulted from small changes to Thorazine. Scientists still
do not know why any of these drugs actually work, and hundreds of genes have
been shown to play roles in mental illness — far too many for focused efforts.
So many drug makers have dropped out of the field.
For Dr. Thomas R. Insel, director of the National
Institute of Mental Health, the drug industry’s departure from this vital
research area shows that the government must do something, although he acknowledges
the risk.
“Would we be foolish — we being an agency that has never developed drugs and actually
doesn’t know how to do therapeutics that well — to get into this space?”
Dr. Insel asked.
But Dr. William Potter, who was once a top researcher at the mental health institute
and retired last year as the vice president of translational neuroscience
at the giant drug maker Merck, said that far
more basic research needed to be done on the causes
of mental illness before anyone — industry or government — could
successfully create breakthrough drugs.
“We still don’t even understand how lithium works,” Dr. Potter said. “So how do
people think we can find drugs systematically for mental illness?”
Keywords: Drugs / Health / Clinical
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