[Ip-health] NYT: US Federal research center to develop medicines
suerie_moon at yahoo.com
Sun Jan 23 14:27:49 PST 2011
The New York Times
January 22, 2011
Federal Research Center Will Help Develop Medicines
By GARDINER HARRIS
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
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 $1
billion, according to some estimates, and drug companies have typically spent
twice as much on marketing as on research, a business model that is
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
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
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
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?”
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