Hello, All:

I thought this article is worthy of posting (sorry about the length).
Specifically, check out paragraph #8 (my #s). I wonder where Bruce Agnew,
author of article, is getting his info, and would he be interested in a
follow up story from the parky side? Anybody interested in contacting him?
The website for this article and NIH info is:
http://www.enews.com/magazines/nih/current/960701-002.html

The Journal of NIH Research
07/01/96
Clinical Research: Looking For Help In Unusual Places
Bruce Agnew

1.The rhetoric this spring from NIH and other research advocates didn't
sound like a particularly effective way to persuade managed-care health
insurers to pick up more of the costs of clinical research. It sounded more
like confrontational name-calling.

2.Managed-care operators are "efficiency-driven" and "not particularly
receptive" to academic health centers seeking additional funds for education
and research, NIH Director Harold Varmus told the Senate Labor and Human
Resources Committee in March, as it began hearings on a new NIH
Revitalization Act.

3."Financial pressures and the growth of managed care threaten the very
existence of [academic health] centers," Sen.Edward Kennedy, D-Mass.,
declared on May 7, at a follow-up hearing of the committee. "Clinical
research is in crisis today."

4."It is the managed-care industry that is seriously lagging behind," David
Nathan, president of the Dana-Farber Cancer Institute in Boston--and chair
of a special NIH Director's Panel on Clinical  Research--told the May 7
hearing. "We will not be able to do very much for the state of clinical
research unless insurance carriers and for-profit providers are forced to
contribute to the research and teaching missions in a significant way."

5.But now, Nathan's 14-member study panel and the Senate committee both
appear to be renouncing the use of force. Nathan's panel* instead has begun
holding private talks with leading managed-care firms--and is finding that
some companies, at least, are less obdurate than their reputation suggests.
Nathan even sees a possibility of forging a new clinical-research
partnership with them. "There are some issues that we may be at loggerheads
over, but there's room for working it out," he said in an interview on June
11, although he added, "I'm not sure there's room for working it out with
those who just dig in their heels and say, 'We're not going to talk.'"

6.Senate Labor Committee Chair Nancy Kassebaum, R-Kan., also apparently
wants to work things out privately. In legislation she was preparing to
introduce to reauthorize NIH, she was expected to abandon any idea of
ordering insurers and managed-care operators to pay the ordinary medical
costs of clinical-research patients (see April issue, page 22). After health
insurers helped crush President Clinton's health reform program in 1994, and
threatened to stymie a more modest effort co-sponsored by Kassebaum and
Kennedy this year, Congress is hardly anxious to take on the industry once
again.

7. Both the Nathan panel and Kassebaum's committee, however, will offer a
smorgasbord of other ideas for easing pressures on U.S. clinical research,
ranging from student-loan forgiveness for young clinical researchers to
changes in peer review study sections to eliminate bias against
clinical-research grant applications. Kassebaum's bill, which she was
circulating in draft form to potential co-sponsors last month, may not
become law this year because so little time is left in this congressional
session. But even though Kassebaum is retiring at the end of this Congress,
her bill will be the starting point when the new Congress turns to the
question next year.

8, Among its other provisions, Kassebaum's bill was expected to elevate the
National Center for Human Genome Research to full institute status. But, in
response to pleas from NIH officials, the expected bill would impose no new
disease-specific spending mandates on NIH. (It may pick up some specific
mandates before becoming law; a new program for Parkinson's disease research
is the leading contender.)

9.The Nathan panel plans to make formal recommendations to Varmus in
November, although some of its proposals have already reached his desk
informally. When the Nathan panel started its work on July 7, 1995, one of
its first problems was that no one is quite sure how much clinical research
NIH actually supports. According to Wendy Baldwin, deputy director for
extramural research, NIH devoted $1.2 billion to conventional, multi-patient
clinical trials in fiscal year 1995 and $4.7 billion to "human-subjects
research" that required approval by Institutional Review Boards (IRBs). But
the panel decided that neither of those categories of NIH spending defines
clinical research: "Clinical trials" is too narrow and "human-subjects
research" is too broad. For example, pure laboratory research using human
tissue can require IRB approval, if the tissue donor is identifiable, but is
by no means "clinical" research.

Since then, the panel has defined its own area of interest as covering
everything from single-patient "translational" research to large trials and
outcomes research--or, as Nathan explains it, "research that is directly
patient-oriented, in which an investigator actually makes contact with his
or her human subject, a  patient, or a large group of people." Baldwin has
been analyzing new grant applications to determine how much NIH funding goes
to such "patient-oriented" research, but she does not have an answer yet.

However defined, clinical research is suffering today from a complex of
ailments, members of Nathan's panel believe. Money,of course, is the root of

all trouble. Efforts to cut the federal-government deficit have restrained
the growth of NIH's budget,although NIH continues to get favored treatment
from Congress, and the accelerating spread of managed-care plans is
draining patients and revenues from the academic health centers.

The Association of American Medical Colleges (AAMC) in Washington, D.C.,
estimates that one-third of the revenues from faculty members' clinical
practices, which totaled $9 billion in 1993, is at risk to managed-care
competition. From San Francisco to Boston, academic health centers have been

merging, or discussing mergers, with other academic institutions
or private hospitals to cut overhead and equipment costs. The percentage of
medical students interested in research careers has been declining since
1989, while their average student-loan debt burden has been increasing,
according to AAMC. Nearly one-third of 1995 medical-school graduates had
debts of $75,000 or more, AAMC reported in its annual Trends MDRVMDNM survey

in April.

Nathan's panel thinks it can do something about that. At the panel's most
recent meeting in May, a subcommittee headed by Jean Wilson of the
University of Texas Southwestern Medical Center in Dallas offered a series
of ideas for making clinical-research careers more attractive to
medical-school graduates. They include a student-loan debt-forgiveness
arrangement modeled on NIH's current debt-forgiveness program for minority
researchers; a scholarship program patterned after the Howard Hughes Medical

Institute's Resident Scholar program that brings graduate medical students
to the NIH campus for a year of intensive research training; a career award
program for more experienced clinical researchers that is designed to
stabilize their salaries; and an earlier, formal introduction of medical
students to clinical research.

In Congress, Sens. Kennedy and Mark Hatfield, R-Ore., introduced legislation
in January that included many of these ideas, including increasing the
debt-forgiveness program to $35,000 a year and offering it to extramural
clinical researchers. Kassebaum was expected to include much of the
Hatfield-Kennedy bill in her proposed bill.

Another subcommittee of the Nathan panel, headed by Guy McKhann, director of
the Zanvyl Krieger Mind/Brain Institute at Johns Hopkins University in
Baltimore, suggested a reshaping of the NIH-funded General Clinical Research

Centers (GCRCs) that could have a significant impact on the way U.S.
clinical research is conducted. Currently, NIH's National Center for
Research Resources (NCRR) spends more than $140 million a year to support 75


GCRCs at 61 institutions throughout the country; more than 7,000 researchers

use the GCRCs each year to conduct nearly 5,000 clinical-research projects
funded by other grants, according to NCRR.

But McKhann's subcommittee believes the GCRCs are hemmed in by NIH
rules--such as a requirement that GCRC directors must be funded by NIH, not
by other biomedical-research sponsors--that reduce their flexibility and
restrict their influence in the academic health centers that house them. The

subcommittee urged Varmus to strip down these rules and give GCRCs
more flexibility. "We want the GCRC to become the central focus of clinical
research--to be the site at which protocols are reviewed for the whole
center to see whether or not they are scientifically valid," Nathan says.

Members of Nathan's panel also appear to believe that NIH's peer review
system is stacked against clinical-research grant proposals. Study sections
generally score clinical-research applications lower than
laboratory-research proposals the first time they review them (although
study sections score revised clinical and lab-oriented proposals about the
same). Study sections with few patient-oriented researchers among their
members score clinical-research proposals particularly poorly.
McKhann's subcommittee recommended that at least half the members of study
sections that review clinical-research proposals should be patient-oriented
researchers.

The Division of Research Grants (DRG), which runs NIH's study-section
system, isn't convinced that re-configuring study sections is the answer.
But DRG officials are encouraging the scientific review administrators
(SRAs) who manage individual study sections to group clinical applications
together and to keep clinical researchers in mind when they assemble their
panels. DRG also is closely monitoring applications in the area of clinical
oncology as a test bed. "We're looking to see whether we need to make
changes in certain areas," says Donna Dean, acting chief of DRG's referral
and review branch.

Of course, as in other areas of biomedical research, funding remains the
major problem--and particularly, in the case of clinical research, funding
from managed-care companies and insurers. Mandating that managed-care
operators pick up a share of clinical-research costs is a political long
shot, at least for now. But Nathan was encouraged after last month's
meeting with managed-care officials about the prospects for voluntary
support--perhaps even partnerships in supporting specific clinical trials.

"There are two choices in this," Nathan says. "We either negotiate this, or
we try to get laws passed. And the former is better than the latter."

If Nathan's panel manages to achieve a negotiated solution, the earlier
industry-bashing rhetoric may prove to have been a pretty good opening move
after all. Apparently, the rules for jawboning an industry are very much
like the old story about how to train a mule: First, you hit it between the
eyes with a two-by-four--to get its attention. --bruce agnew

*Members of the NIH Director's Panel on Clinical Research are: David Nathan,
Dana-Farber Cancer Institute, Boston (chair);
J. Claude Bennett, University of Alabama, Birmingham; Ezra Davidson Jr.,
King-Drew Medical Center, Los Angeles; Haile
DeBas, University of California at San Francisco School of Medicine; William
Friedewald, Metropolitan Life, New York City;
Guy McKhann, Zanvyl Krieger Mind/Brain Institute, Johns Hopkins University,
Baltimore; Herbert Pardes, Columbia
University, New York City; William Peck, Washington University Medical
School, St. Louis; Philip Pizzo, National Cancer
Institute, Bethesda, Md.; Mary Polan, Stanford University School of
Medicine, Stanford, Calif.; Leon Rosenberg, Bristol-Myers
Squibb Pharmaceutical Research Institute, Princeton, N.J.; Judith Swain,
University of Pennsylvania Hospital, Philadelphia;
Samuel Thier, Massachusetts General Hospital, Boston; Jean Wilson,
University of Texas Southwestern Medical Center,
Dallas.
Margaret Tuchan
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