[Congressional Record (Bound Edition), Volume 151 (2005), Part 6]
[House]
[Page 8743]
[From the U.S. Government Publishing Office, www.gpo.gov]




                   THE CLINICAL RESEARCH ACT OF 2005

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Florida (Mr. Weldon) is recognized for 5 minutes.
  Mr. WELDON of Florida. Mr. Speaker, I am very pleased to join with my 
colleague today, the gentleman from Pennsylvania (Mr. Doyle), to 
introduce the Clinical Research Act of 2005. This bill might be better 
referred to as the ``Curing Humans Rather Than Rats Act of 2005.''
  This bill will address many of the problems confronting academic 
health centers as they attempt to leverage enormous biomedical research 
gains made in the past century and, in particular, in the last decade, 
by the vast investment of the U.S. taxpayers in the National Institutes 
of Health.
  In 1994, when I was first elected, the NIH budget was just $10 
billion, but today, they get $29 billion. This is a significant 
expansion of biomedical research funding. It is resulting in 
significant breakthroughs in a host of areas to include human genomics, 
biomedical engineering, molecular biology, and immunology. These have 
provided an unprecedented supply of information for improving human 
health.
  Research often does not produce results overnight, but as stewards of 
the taxpayer dollars, we have every right to expect that the fruits of 
that research will result in better treatments for patients. Reaping 
the benefits of this bench research requires a Federal commitment to 
clinical research, including a commitment to ensuring that the 
infrastructure is capable of translating, in a systematic and rational 
way, the fruits of basic science research into improved patient care.
  Unfortunately, while we have seen this dramatic increase in NIH 
funding, the Federal commitment to clinical research has not kept pace 
with rising costs.
  Just what is clinical research? A great example has been the great 
breakthroughs in the treatment of AIDS in recent years. These new 
compounds are often developed in a laboratory, tested on laboratory 
animals, but then, at some point, academic research centers have to 
start giving these products, these compounds to humans. They interface 
with the lab and the patients. They bring these new interventions from 
the bench to the doctors and clinics all over this country.
  That has happened to the clinical researchers and why? From 1970 to 
today, the percentage of clinical researchers and NIH study committees 
has dropped dramatically. These NIH study groups are the committees 
that score research proposals and make recommendations on which 
proposals will be funded. The costs of clinical research have increased 
dramatically as, obviously, we are working with humans. To many 
researchers, working with rats and tissues is just much easier. With 
rats, they show up to work every day, they follow the protocols and, if 
they die, they will not sue you. You just buy some more rats.
  Also, academic health centers, under increased pressure to costs and 
the need to generate income, are putting increased pressure on the 
clinical researchers to spend more of their time seeing billable 
patients and less of their time on their clinical research projects. 
All of this hinders clinical research and makes it less likely that the 
cures will move from the lab to the bedside. This is a growing 
frustration, not just for the clinical researchers that work in this 
field, but for the patient advocacy groups.
  I hear repeatedly from people who advocate for those suffering from 
kidney disease, heart disease, Parkinson's Disease that we are not 
moving the scientific information quickly enough into patient care. We 
have been too slow in getting improved patient therapies and 
interventions from the enormous investment we have made in basic 
research. It is important that this Congress step in now and address 
this challenge.
  I believe we can and should do a better job in moving bench research 
to the bedside. That is what this bill is aimed at doing.
  In addition to concerns about how NIH dollars are allocated, we must 
recognize the significant financial burdens that academic health 
centers are facing today associated with rising costs, inadequate 
funding, mounting regulatory burdens, fragmented infrastructure, 
incompatible databases, and a shortage of both qualified investigators 
and willing study participants.
  Let me add that some of my colleagues have suggested that NIH should 
focus on basic research and that private industry will focus on 
clinical applications. Those suggesting this lack a full understanding 
of the issues at hand. Industry is much less likely to dedicate tens of 
millions of dollars to research clinical applications to address the 
needs of millions of Americans who suffer from one of the hosts of 
small and less profitable to treat diseases. Industry does not, nor 
will it, spend tens of millions of dollars on nonpatentable therapies 
and interventions. If you cannot patent it and you will not make a 
profit, industry just will not fund it.
  Of note, however, is that the NIH will and does devote significant 
taxpayer funding in partnerships with industry to develop patentable 
compounds and interventions. Absent the resources provided in this 
bill, patients will continue to suffer, I believe needlessly, from 
diseases for which we could and should develop definitive treatments.
  The bill that the gentleman from Pennsylvania (Mr. Doyle) and I are 
introducing today, and that Senator Santorum is preparing to introduce 
in the Senate, will provide our Nation's academic health centers with 
the crucial resources they need and the opportunity to meet the 
public's expectation.
  If we are going to reap the full benefit of the enormous investment 
of taxpayer dollars in biomedical research, it is important that we 
move this legislation forward. I would say to my colleagues, if you 
think that we have cured enough rats and believe it is time that we 
look to cure a few more humans, join me and the gentleman from 
Pennsylvania (Mr. Doyle) in the bipartisan Clinical Research Act of 
2005.

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