The Clinical Research Act of 2005

THE CLINICAL RESEARCH ACT OF 2005 -- (House of Representatives - May 05, 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.

What 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.

http://thomas.loc.gov