Dr. Francis Collins, NIH Director: "Frankly, if we had not gone through our 10-year slide in research support, we probably would have had a vaccine in time for this that would’ve gone through clinical trials and would have been ready.”

In an interview with Huffington Post, Dr. Francis Collins, NIH Director, has stated "that a decade of stagnant spending has "slowed down" research on all items, including vaccinations for infectious diseases."

The HuffPo article goes on,

Money, or rather the lack of it, is a big part of the problem. NIH's purchasing power is down 23 percent from what it was a decade ago, and its budget has remained almost static. In fiscal year 2004, the agency's budget was $28.03 billion. In FY 2013, it was $29.31 billion -- barely a change, even before adjusting for inflation. The situation is even more pronounced at the National Institute of Allergy and Infectious Diseases, a subdivision of NIH, where the budget has fallen from $4.30 billion in FY 2004 to $4.25 billion in FY 2013. 

Upon further investigation of the National Institute of Health's Office of Budget historical data, reveals that the what is being reported by the HuffPo, or to a point the opinion stated by Dr. Collins, doesn't represent the totality of the facts. The graphics below should provide a clearer picture.

(click on image to enlarge)

For example, the amount of money appropriated to the National Institute of Allergy and Infectious Diseases (NIAID),  taken from the image above, shows a relatively consistent and increasing amount of appropriations fiscal year to fiscal year.

As you can see from 2002-03 annual funding increased around $1.4 bn and then from 2003-04 roughly another $600 million. From 2005-07 was where there was relative "stagnation" in budgetary appropriations. Additionally, the infamous budget cuts, presumably a result of sequestration, can be seen beginning in 2011 and continuing until 2013. Furthermore, the total amount of expenditures from 2003-13 by NIAID has been a resounding $44.3 bn.  But...despite the bleating about stagnation and cuts in appropriations there seems to be another set of problems that may be the genesis of the government's inability to provide the proper viral and bacterial countermeasures required in the event of pandemics. This has less to do with money and more with red tape, contracting blunders, and unnecessary bureaucratic redundancy.

From Bloomberg BusinessWeek,

In the 1990s, after revelations of the Soviet biological and chemical weapons programs and the 1995 sarin gas attack in the Tokyo subway, the U.S. handed its defensive drugmaking to the Pentagon. After 2001, the Pentagon budget for biological and chemical defense rose from $880 million to $1.12 billion. Since then, roughly a third of its total budget, about $3.9 billion, has been designated for a list of “biological threat agents.” The list is classified, but it now numbers 18, according to a 2014 analysis by the U.S. Government Accountability Office. Ebola is almost certainly on this list and likely near the top. The Soviet Union had an Ebola program, and Aum Shinrikyo, the cult that released the sarin gas in Tokyo, sent doctors in 1993 to what’s now the Democratic Republic of the Congo on an unsuccessful mission to get an Ebola sample.

Then, because the 2001 anthrax attacks on the Capitol in Washington were directed at civilians, the Department of Health and Human Services launched a parallel track in biochemical defense. Soon, the HHS began keeping its own list of biological threats. Over the next two years, the budget at the National Institute of Allergy and Infectious Diseases (NIAID), part of the HHS, jumped from $2.04 billion to $3.7 billion. Two separate arms of the federal government, with a $5 billion annual budget between them, now were focused on the same set of problems but not talking to each other well. And neither was accomplishing what was needed most: producing drugs.

By 2006 the White House became aware of an inefficiency. NIAID’s budget went to sponsor basic research at university and commercial labs, but the agency didn’t move its ideas out of the lab, into trials, and through the FDA approval process. The Pentagon’s program also “never got enough money to be a pharmaceutical company,” says Robert Kadlec. A consultant and public health physician who held several high-level posts in biodefense in the George W. Bush administration, Kadlec says the Pentagon had “enough for research and development, but not for licensure.”

 Below is a graphic provided by Bloomberg BusinessWeek, illustrating all of the bureaucratic agencies which  have a stake in serums, vaccines or treatments that relate to "biological and chemical defense."

The presentation describes the agency’s work as it was in 2011. Too much effort was wasted on “knowledge products,” or basic science. Unpromising projects weren’t killed and continued to waste money. Drug development was managed around yearly budgets rather than end goals. Efficacy studies, which determine whether drugs work on animals, weren’t complete, nor were safety studies, which test whether a drug is OK for human use. Samples of Ebola were found in a freezer in a containment lab without patient histories, control samples, or even validation that they contained the virus. The samples were safe but useless for drug development.
None of this is meant to impugn Dr Collins, the good work being done at the NIH by any of the virologists, epidemiologists, and other accompanying scientists, or any of the other involved agencies. However, it can be interpreted that the claims about budgetary shortfalls being the fundamental cause  for the lack of development of an EBOLA vaccine appear to be rather myopic and disingenuous. Perhaps another look at our structure for development and manufacturing of drugs is at hand. Rather than trying to fill a bottomless pit with greenbacks, with prospect on return being the status quo, maybe some thought can be given to streamlining these processes and eliminating the unnecessary redundancy.

More over at memeorandum.


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