Washington
Round-Up
American Society of Transplant
Physicians
June 12, 1998 Washington Round-Up
NIH Funding In Tobacco Legislation
Threatened By Senate Amendments
This week, during
consideration of tobacco legislation, the Senate approved amendments
by Senator
Paul Coverdell (R-GA) and Senator Phil Gramm (R-TX) that may
threaten the National Institutes of Health (NIH) research funding
component contained in Senator John McCain’s (R-AZ) tobacco
bill. The approved amendments would divert NIH research funding
from the tobacco legislation to drug interdiction/drug abuse
programs, a tax cut to reduce the "marriage tax" penalty,
and health insurance coverage for the self-employed.
At present, Congressional champions/supporters
of NIH funding and concerned interest groups are working to
restore the NIH funding component in the legislation.
Managed Care Update
At present, Congress is considering a variety of legislative
proposals
that seek to reform managed care health insurance plans. However,
as the "clock-runs-down" on this second session of
the 105th Congress, it is unclear if Congress will
have time to focus and complete action on a managed care reform
package. During a press conference on Monday, June 8, 1998,
House Minority Leader Dick Gephardt (D-MO), called for a grass-roots
effort to pressure the Congressional leadership to bring managed
care reform legislation to a vote this year. Gephardt blamed
the intense lobbying effort in Washington by employers and
insurers as the reason why the bipartisan legislation to protect
patient rights has been kept off the Congressional agenda.
Minority Leader Gephardt stated that, "We’re powerless
to get HMO reform on the agenda," and urged patients and
concerned individuals to, "write to Congress and urge
the leadership to schedule a vote on the legislation." Although
moderate Republicans have joined with Democrats to support
legislative measures that seek to assure patients access to
more doctors and guarantee their right to appeal insurance-company
decisions, some conservatives regard the proposals as too much
of an intrusion by the federal government. Small businesses
and managed care companies have launched advertising campaigns
arguing that such efforts will drive up the price of health
insurance and force many people to lose coverage. ASTP leadership,
the Public Policy Committee, and the entire Society have been
active in working to educate and mobilize key Congressional
leaders to support legislative efforts that seek to protect
patients’ rights by ensuring access to organ transplantation.
Congressman Nethercutt
Addresses Ad Hoc Group for Medical Research Funding On June
11, 1998,
Congressman George Nethercutt (R-WA) addressed the Ad Hoc Group
for Medical Research Funding. Nethercutt, a member of the House
Appropriations Committee and the Chair of a House Task Force
looking into program priority setting at the National Institutes
of Health, discussed what the Task Force’s plans are for the
remainder of 1998 and for 1999. The Congressman started by
explaining that the Task Force’s composition is cross-jurisdictional,
meaning that it overlaps issues taken up by the House Commerce,
Ways & Means, Appropriations, and Science Committees. Nethercutt
explained that he hopes to formalize this Task Force into what
he calls the "House Select Subcommittee on Scientific
Research in Human Health." This subcommittee would receive
its own budget and look into not only programs funded by the
NIH, but also by the National Science Foundation (NSF). In
particular, the group will assess the peer review process at
both institutions and whether or not it is efficient. He also
said that one of the purposes of the Task Force would be to
coordinate activities with research from both the public and
private sectors. Nethercutt said that the Task Force intends
to hold hearings around the country with the goal of issuing
a report on its findings sometime in late 1999.
Appropriations Season Begins The
appropriation season started the week of June 8th with
the first two measures, the Agriculture and VA-HUD appropriation
spending measures being marked-up by the Senate on Tuesday,
June 9, 1998. However, not all of the 13 appropriation bills
will have an easy path to passage. One of the more contentious
appropriation bills will likely be the Labor, Health and Human
Services, and Education spending measure. In the Senate, the
Budget Committee has allocated $82,319 billion to the Appropriations
Labor, HHS and Education Subcommittee for FY 1999. The Subcommittee
will now decide what funding will be distributing to the programs
in the Departments of Labor, Health and Human Services, and
Education. Senator Arlen Specter (R-PA), Chairman of the Senate
Subcommittee, and Senator Tom Harkin (D-IA), Ranking Minority
Member on the Senate Subcommittee, have been steadfast supporters
of increasing the NIH budget. However, because of the spending
levels for FY 1999, it will be extremely difficult to give
the NIH a significant increase. Also, Senator Specter underwent
heart bypass surgery on June 1st. Reports indicate
the Senator’s condition has improved, but are unclear as to
when the Senator might return to work. According to staff,
the Senate Subcommittee is expected to mark up in mid to late
July. In the House, the Budget Committee has allocated $82,052
to the Appropriations Labor, HHS, and Education Subcommittee
for FY 1999. Congressman John Porter (R-IL), Chairman of the
Subcommittee, had also been extremely optimistic in giving
the NIH a significant increase for FY 1999, but due to the
spending level allocated, he and Congressman David Obey (D-WI),
Ranking Minority Member of the Subcommittee, fear that this
will be very difficult. One of the biggest dilemmas facing
both Chairmen will be cutting popular education programs to
fund increases for the NIH. According to Chairman Porter, "At
this point, with the numbers we’re looking at, we’re going
to have a situation that will more closely parallel 1995 than
what we did in 1997." In 1995, a partial government shutdown
occurred because of disagreement between the Republican-led
Congress and the White House on certain appropriation spending
measures. Also, it is still unclear as to the outcome of the
legislation and whether the Labor, HHS spending measure will
receive money from a tobacco settlement.
Groups Offers 12 Principles Towards
Enhancing Pace of Biomedical Research Investment In response
to the overwhelming support among lawmakers and the President
for a significant increase in medical research funded by
the National Institutes of Health, a group of individuals
from the scientific, institutional, and patient advocacy
communities began a dialogue about the opportunities to quicken
the pace of investments towards biomedical research at the
NIH. The group, consisting of the following individuals:
William R. Brinkley, Federation of American Societies for
Experimental Biology; Purnell W. Choppin, Howard Hughes Medical
Institute; Myron Genel, Council on Scientific Affairs, American
Medical Association; David Korn, Association of American
Medical Colleges; Cornelius J. Pings, Association of American
Universitoies; Leon Rosenberg, Funding First; Myrl Weinberg,
National Health Council; and Ralph G. Yount, Federation of
American Societies for Experimental Biology, felt strongly
that efforts to achieve a doubling of the NIH budget would
be considerably enhanced by consideration of how these increased
resources would best be spent. Over the course of Spring
1998, this group met and developed a set of principles that
will go to decision makers in Washington as they consider
accelerating the pace of investment in biomedical research.
The twelve principles are attached.
ASTP Leadership Testifies on
OPTN Regulation Before a Joint Hearing of Congress Dr.
William Harmon, a member on the ASTP Board of Directors and
the ASTP Public Policy Committee from the Children’s Hospital
in Boston, MA, will testify as a witness on June 18, 1998.
The joint hearing will be convened by the Senate Labor and
Human Resources Committee and the House Commerce Committee.
The purpose of the hearing is to review the Organ Procurement
and Transplant Network (OPTN) regulation released by Health
and Human Services Secretary Donna Shalala earlier this year.
The ASTP worked closely with the staff of both House and
Senate committees in securing a witness testimony slot for
the hearing. The ASTP Public Policy Committee was also successful
in obtaining Marc Wheat, the House Commerce Committee staffer
coordinating the hearing, as a guest during the Public Policy
Meeting being held in Washington, D.C. on June 16th and
17th.
Hearing on Sale of Body Parts
Held On June 4, 1998, the House Government Reform and
Oversight Committee and the House International Relations
Committee held a joint hearing on the sale of body parts
by the People’s Republic of China. A copy of Congressman
Benjamin Gilman’s (R-NY), Chairman of the House International
Relations Committee, opening statement is attached.
ACCELERATING THE PACE OF DISCOVERY
AT THE NATIONAL INSTITUTES OF HEALTH
The President and
the Congress -- encouraged by recent scientific advances in
biomedical research,
but mindful of the continuing burden of disease and disability
on the American people -- have in recent months proposed a
significant acceleration of this country's efforts to use the
tools of science to develop new ways to diagnose, treat, cure,
and prevent disease, as well as to improve the health of our
citizens. President Clinton's fiscal year 1999 budget includes
the largest increase in funding for NIH ever proposed by a
President, and many Congressional leaders have supported a
doubling of funding for the NIH over the next five years. While
the exact pace and extent of the build-up remain to be decided,
the strong support for this goal, bridging different branches
of government and political parties, seems poised to translate
into a significant multi-year expansion of funding for NIH,
an action widely supported by the general public. As these
events unfolded, a group of individuals from the scientific,
institutional, and patient advocacy communities began a dialogue
about the opportunities for an expanded NIH. The participants
in this discussion expressed a high degree of satisfaction
with the existing systems and leadership at NIH. In addition,
they found that they also held substantial agreement over directions
for future departures from the status quo, which increased
funding make possible. A summary of the group's recommendations,
in the form of twelve "principles," are offered to
the NIH for guidance as it undertakes its own planning process.
Twelve Principles:
I. Investment and distribution of
increased funds should be based upon scientific opportunity
within the context of the public's health needs.
II. The investigator-initiated,
competitive, peer-reviewed grant is, and should remain, the
core mechanism for distribution of research support for the
NIH. Budget increases should be used to support more research
grants and to fund proposals at the lengths and levels approved
by study sections. *Artificial constraints generated by previous
instabilities of funding -- including arbitrary limits on the
number, sizes, or lengths of grants -- should be eliminated.
This will increase the productivity of the researchers who
write and review the proposals and enable study sections to
concentrate on scientific merit. * The guiding principle in
awarding grants must continue to be excellence.
III. A significant percentage of
any increase in funds at the NIH should be used for innovative
training and research partnerships involving business and industry,
academia and government agencies.
IV. To maximize returns on the expanded
NIH budget, it is essential that there be robust support for
the fundamental disciplines of physics, chemistry, mathematics,
and bioinformatics, as well as for the several other federal
agencies that support such basic scientific and engineering
research.
V. Individuals from organizations
concerned with the prevention and treatment of disease, who
are familiar with the concerns of patients and their families
-- including those individuals from disease-specific advocacy
groups -- must be active participants in the process for planning
and prioritizing research at the NIH.
VI. To exploit the opportunities
presented by unparalleled advances in fundamental biomedical
knowledge, it is important to revitalize and adequately fund
clinical research and its essential infrastructure. In particular,
this should include support for rigorous clinical research
training programs and for institutional core resources, such
as General Clinical Research Centers.
VII. The critical link between basic
research and clinical research -- currently threatened by the
expansion of managed care in academic health centers -- must
be maintained and strengthened, especially in medical schools.
The connection between the process of patient-oriented clinical
research and patient care should be enhanced, and efforts must
be made to expedite movement of new research findings from
the laboratory and scientific journals to practicing physicians
and their patients.
VIII. A mechanism should be established
to provide flexible funds to research institutions to meet
needs not covered by individual research grants. These funds
would be used for, but not be limited to, purposes such as
recruiting bright young minds to the enterprise, meeting the
needs of start-up support for young investigators, providing
institutional bridge funding for deserving researchers, and
for acquiring essential equipment.
IX. A key element in the mission
of the NIH is to recruit, educate, and prepare the next generation
of scientists. A larger portion of research training should
be supported by competitively awarded training grants and individual
fellowships. Trainees should be adequately compensated in terms
of stipends, tuition, and benefits. While the number of Ph.D.
students in the career pipeline is currently adequate to accommodate
the expanded research opportunities created by an increased
NIH budget, the stipend level for trainees currently is inadequate.
A minimum 25 percent increase in stipends is recommended.
X. NIH needs adequate funding for
the evaluation and administration of science in order to maintain
its exemplary record of stewardship of public resources and
to continue its efforts in innovative management.
XI. New and expanded mechanisms
for early career development are needed to facilitate the transition
of young scientists from the training phase to independent
investigator phase of their careers. Ideally, such programs
would provide portable funding for salaries and research expenses
that senior postdoctoral associates could take with them as
they moved from a mentors' laboratories to independent research
positions.
XII. Laboratories must be built
and equipped for the science of the 21st century. Infrastructure
investments should include renovation of existing space as
well as new construction, where appropriate. This investment
must include costs for care of animals (such as transgenic
mice) in biomedical research and provision of the increasingly
sophisticated research equipment required in the modern laboratory.
Opening Statement by Congressman
Benjamin Gilman
Chairman, House
International Relations Committee In 1996 Amnesty International
reported what it described
as a close liaison between the Chinese courts, health departments
andhospitals over the distribution of transplant organs. Report
stated that, and I quote, "the secrecy surrounding the
process, the fact thatorgan transplantation represents a source
of income for hospitals and the reported practice of giving
gifts to officials involved in the execution of prisoners,
all suggest that in some cases the imposition and the timing
of the death penalty may be influenced by the need for organs
for transplantation," close quote.
Amnesty International went on to
state that Chinese legal system provides no protection against
such abuse, while noting that 90 percent of all organs transplanted
in China are from executed prisoners. As public awareness in
Chinese organ transplantation abuses has grown, governments
around the world have begun to react.
Three weeks ago on May 14th the
European Parliament adopted a resolution calling on Beijing
to hold its trafficking in organs from executed Chinese prisoners.
On October 15th -- (clearing throat.) -- excuse me. On October
15th ,1997, ABC News aired an investigative report entitled,
Blood Money. A hidden camera showed a Chinese doctor and his
wife accepting a down payment of $30,000 for a kidney from
a Chinese prisoner who had been executed.
And on February
20th, 1998, the FBI arrested two other Chinese citizens in
New York on charges
of conspiracy to sell organs including kidneys, corneas, livers,
skin, pancreas and lungs for transplants. Mary Joe White, US
the attorney for the Southern District of New York stated,
that when the defendants met with an undercover agent one of
them discussed how Chinese prisoners are executed and the agent
was offered to corneas for $5,000. White said, the trafficking
and profiteering in human organs is quote, "foolish, criminal
conduct that imperials the most vulnerable," closed quote.
The fundamental rule in the practice
of organ donation is that of free and informed consent. In
the case of a condemned prisoner in solitary confinement who
is shackled by handcuffs and leg irons, as it occurs in Chinese
jails, it is naive to pretend that consent can be fully informed
or freely given. However, according to 1994 report by Human
Rights Watch Asia, a prisoner's prior consent for organ removal
often is not even sought. According to the report, the involvement
of the Chinese doctors and other medical personnel in the process
of removing executed prisoners organs is extensive.
Before the executions
medical workers perform blood tests to determine a prisoners
health and suitability
as an organ donor. Medical personnel are at the place of execution,
so that at the moment of death, they can immediately remove
the organs and rush them to the hospital for transplantation.
Human Rights Watch Asia Report states the widespread involvement
of medical professional in the execution. And the transplantation
process represents quote, "a grave violation of internationally
excepted standards of medical behavior," close quote.
Yet, the Chinese authorities have
not only used the death penalty extensively, they've expanded
its scope. The number of offenses in Chinese subject to the
death penalty rose from 21 in 1980 and 68 in 1996 according
to the Amnesty International Report. Sixty eight offenses in
which Chinese are subject to the death penalty. Chinese citizens
have been executed for such crimes as arson, hooliganism, fraud,
forgery, tax evasion, dealing in cultural relics, and blackmail,
all subject for the death penalty.
Amnesty International states that
in this decade, China has executed more people than all the
other nations of the world combined with over 6,100 death sentences
and 4,367 confirmed executions in 1996 alone. These figures
are based only on public reports and are believed to fall far
short of the actual number. China classifies statistics on
the death penalty as a state secret and has never published
them.
Chinese Government reports state
from the time organ transplants were first performed in China
in the late '70s to the end of '95; there were roughly 20,000
kidney transplants. The sell and transplantation of body parts
by Chinese authorities reflect something so alienate to the
civilized world that it's even difficult to believe.
The corruption in China along with
overwhelming power, the military, and the lack of independent
judicial system combines to make this horrific situation possible.
And unless the international community steps in, it will only
worsen as the market for organs, transplanted from executed
Chinese prisoners, continues to grow.
