[Ip-health] NYT: US Federal research center to develop medicines

Suerie Moon 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 
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 $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 
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?” 



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