Also reported this week (April 20, 2006) in the New England Journal of Medicine:
The NIH Buget and the Future of Biomedical Research
By Joseph Loscalzo.

"We have recently entered another period of stagnant funding for the NIH. Having doubled between 1998 and 2003, the NIH budget is expected to be $28.6 billion for fiscal year 2007, a 0.1 percent decrease from last year, [1] or a 3.8 percent decrease after adjustment for inflation - the first true budgeted reduction in NIH support since 1970. Whereas national defense spending has reached approximately $1,600 per capita, federal spending for biomedical research now amounts to about $97 per capita - a rather modest investment in "advancing the health, safety, and well-being of our people." [1] This downturn is more severe than any we have faced previously, since it comes on the heels of the doubling of the budget and threatens to erode the benefits of that investment. It takes many years for institutions to develop investigators skilled in modern research techniques and to build the costly, complicated infrastructure necessary for biomedical research. Rebuilding the investigator pool and the infrastructure after a downturn is expensive and time-consuming and weakens the benefits of prior funding. This situation is unlikely to improve anytime soon: the resources required for the war in Iraq and for hurricane relief, along with the erosion of the tax base by the current administration's fiscal policies, are expected to have long-term, far-reaching effects."



-- Greg Wasson <[log in to unmask]> wrote:
U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH
NIH News
National Institute of Neurological Disorders and Stroke (NINDS)
http://www.ninds.nih.gov/

EMBARGOED FOR RELEASE: Thursday, April 20, 2006; 6:30 p.m. ET

CONTACT: Natalie Frazin ([log in to unmask]) or Margo Warren
([log in to unmask]), 301-496-5924

ECONOMIC BENEFIT OF NINDS-SUPPORTED CLINICAL TRIALS ESTIMATED AT MORE
THAN $15 BILLION OVER TEN YEARS

A comprehensive review of all phase III clinical trials supported by
one
Federal agency finds that, estimated conservatively, the economic
benefit in the United States from just eight of these trials exceeded
$15 billion over the course of 10 years. The study also found that new
discoveries from the trials were responsible for an estimated
additional
470,000 healthy years of life. The clinical trials were sponsored by
the
National Institutes of Health's National Institute of Neurological
Disorders and Stroke (NINDS).

The study is one of the first to systematically analyze the impact of a
publicly funded research program on medical care, public health, and
health care costs. The analysis showed that the 10-year return on the
investment in clinical trials research funding was 4600 percent. The
researchers also found that the projected benefits of the clinical
trial
program during the period covered by this study were more than $50
billion -- far greater than the total budget of the NINDS ($29.5
billion) during that period. The investment in most of the trials was
returned through health benefits within 1.2 years after the trial
funding ended.

"The results of this analysis demonstrate the return of the public
investment in NIH research for the American people not only in economic
terms, but in additional healthy years of life," says Elias A.
Zerhouni,
M.D., Director of the NIH. "We are transforming the practice of
medicine
by moving into a era when treatment will increasingly become more
predictive, personalized, and preemptive."

"This study strongly suggests that, for this institute at least, the
economic benefit from clinical trials more than offsets the total
expenditures on clinical and basic research," says Story C. Landis,
Ph.D., director of the NINDS.

The investigators, led by S. Claiborne Johnston, M.D., Ph.D., of the
University of California, San Francisco, evaluated the costs and public
heath benefits of all 28 phase III clinical trials supported by the
NINDS between 1977 and 2000. The total cost of funding these trials was
$335 million. The investigators reviewed publications on treatment
utilization, societal cost, and health impact. When necessary, they
supplemented the published data with other publicly available
information from organizations that pool sales data, the companies that
manufacture the drugs and devices tested, and disease-based non-profit
organizations. Information on the utilization of the tested therapies
and their impact on societal costs and savings or quality of life was
available for just eight of these trials. The costs of the other 20
trials were included in the analysis, but their potential benefits were
not. The study appears in the April 22, 2006, issue of "The Lancet".*

"We tried as best we could to be very systematic and to estimate
conservatively whenever an estimation was required. In spite of all
that, we found that there was a tremendous positive impact from the
program of clinical trials at NINDS," says Dr. Johnston.

All cost and economic impact data were converted to 2004 U.S. dollars
in
order to generate 10-year projections of the impact of the trials,
starting from the point at which the funding for each trial ended. The
investigators used a statistical measure called "quality-adjusted life
years" (QALY) to measure the impact of improvements in health and
survival from changes in medical practice associated with the trials.
Using this measure, a year of life in perfect health is considered
equal
to 1 QALY, and years of sub-optimal health are assigned numerical
values
between 0 and 1 based on the severity of impairment. The value of a
single QALY was estimated at $40,310, which was the average economic
productivity of a U.S. resident in 2004, regardless of employment or
age, according to the U.S. Bureau of Labor Statistics. The total
societal economic impact for the trials was calculated as the total net
health benefit in QALY, multiplied by average economic productivity,
minus the increase in costs related to the tested therapies and the
total cost of the clinical trials.

Among the eight trials with adequate data for analysis are some of
NINDS' best-known successes. One was a trial of tissue plasminogen
activator (t-PA) for ischemic stroke that showed that t-PA could
prevent
brain damage if used within the first three hours after a stroke
begins.
Another was the Randomized Indomethacin Germinal
Matrix/Intraventricular
Hemorrhage Prevention Trial, which showed that using indomethacin in
premature babies can prevent brain hemorrhage. Each of these studies
had
an estimated net benefit of more than $6 billion over 10 years.

In spite of this, the analysis did not include the benefits of many
other trials for which information on impact was incomplete. Many of
these trials have greatly changed clinical practice and have probably
had a major public health impact, such as a study that established the
use of methylprednisolone after spinal cord injury, the researchers
note. Therefore, the total benefits of the research program are likely
underestimated, they say.

The study also did not estimate the potential economic and health
impact
of less obvious results from the clinical studies. For example,
clinical
trial results might change the use of treatments similar to the one(s)
that were tested. The trial results might also lead to new basic
research discoveries. "We made no attempt to value the scientific
discoveries and methodological advances from clinical trials; as some
of
the most highly cited publications in the literature, this impact is
probably substantial," the researchers say.

The research was funded by the NINDS but, to reduce bias, it was
performed independently and the sponsor had no control over the content
of the analysis. Also, an independent panel of health policy experts
audited the analysis and reviewed the manuscript.

The NINDS is a component of the National Institutes of Health (NIH)
within the Department of Health and Human Services and is the nation's
primary supporter of biomedical research on the brain and nervous
system. The NIH is made up of 27 Institutes and Centers. It is the
primary Federal agency for conducting and supporting basic, clinical,
and translational medical research, and investigates the causes,
treatments, and cures for both common and rare diseases.

The National Institutes of Health (NIH) -- "The Nation's Medical
Research Agency" -- includes 27 Institutes and Centers and is a
component of the U.S. Department of Health and Human Services. It is
the
primary federal agency for conducting and supporting basic, clinical
and
translational medical research, and it investigates the causes,
treatments, and cures for both common and rare diseases. For more
information about NIH and its programs, visit http://www.nih.gov.

---------------------------------------------------
*Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS. "The impact
of an NIH program of clinical trials on public health and costs." "The
Lancet", April 22, 2006, Vol. 367, pp. 1319-1327
---------------------------------------------------


                                  "Willy Loman never made a lot of money. His name was never in the paper. He's not the finest character that ever lived. But he's a human being, and a terrible thing is happening to him. So attention must be paid...Attention, attention must finally be paid to such a person." - Arthur Miller - Death of a Salesman



















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