Washington
Round-Up
March 27, 1998
Introduction of Patient Choice
and Access to Quality Health Care Act
On Wednesday, March 25, 1998, Representatives
Dave Weldon (R-FL) and Sherrod Brown (D-OH) introduced H.R.
3547, the Patient Choice and Access to Quality Health Care
Act. The legislation was referred to the House Commerce Committee
and Education and Workforce Committee. At present, H.R. 3547
has five cosponsors. They are Rep. Sherrod Brown (D-OH), Rep.
Tom Coburn (R-OK), Rep. Ted Strickland (D-OH), Rep. John Cooksey
(R-LA), and Rep. Gene Green (D-TX).
As introduced, H.R. 3547 seeks to
establish:
- Out-of-network access;
- Adequate/timely in-network access
to specialists (as medically necessary) for enrollees in
a managed care plan;
- Grievance process for managed
care enrollees;
- Notice of enrollee rights and
an enrollee information checklist;
- Restriction on health care professional
incentive plans;
- Prohibition of interference with
certain medical communications;
- Report from the Secretary of
Health and Human Services to Congress to study the effectiveness
and results of the legislation's patient protections.
Attached for your review is a summary
of H.R. 3547, the Patient Choice and Access to Quality Health
Care Act.
Varmus Testifies Before
House Labor, HHS Subcommittee
On March 10, 1998, Dr. Harold Varmus,
Director of the National Institutes of Health (NIH), testified
before the House Appropriations Subcommittee on Labor, Health
and Human Services, and Education on its FY 1999 budget. In
his opening statement, Congressman John Porter (R-IL), Chairman
of the Subcommittee, expressed concerns about the FY 1999 budget
for the NIH. The biggest concern the Chairman expressed was
that the Administration is requesting an 8.4 % increase for
the NIH without providing to the Congress an actual funding
source, but instead relying on proposed tobacco legislation.
During his testimony,
Dr. Varmus pointed out the five priority areas for FY 199 for
the NIH.
They are: "1) Research grants, which will be increased
to a record 30,000, with over 8,000 new and competing awards;
2) Development of new and more powerful instruments for research;
3) Recruitment of young investigators by increasing by 25%
the stipends provided to graduate students and post-doctoral
fellows; 4) Improvements in clinical research such as increased
support for clinical investigators and the General Clinical
Research Centers, loan repayment programs for clinical trainers,
and enhancing clinical trials by improving databases; and 5)
Review and improvement in administration including a re-examination
of the peer review panels."
Dr. Varmus' opening statement is
available on the web at www.nih.gov/welcome/director/031098.htm
Press Conference for NIH
Doubling
On Thursday, March 19, 1998, leaders
from both chambers of Congress and celebrities assembled to
promote the doubling of NIH's budget. Those attending the rally
included Christopher Reeve, Mary Tyler Moore, Senator Tom Harkin
(D-IA), Senator Connie Mack (R-FL), and Congressman John Porter
(R-IL). All speakers urged that the NIH budget, which is $13.7
billion for 1998, be doubled over the next five years. They
also explained that current research spending is insignificant
compared to the $1 trillion in indirect costs every year from
major diseases. Billions of dollars could be saved if better
treatments were found for diabetes, cancer, and Alzheimer's,
many stated.
Commerce
Health & Environment
Subcommittee Looks at New Developments in Medical Research
On Thursday, March
26, 1998, the House Commerce Health and Environment Subcommittee
held a hearing
entitled, "New Developments in Medical Research: NIH and
Patient Groups." Witnesses testifing at the hearing included
Muammad Ali, Congressman John Porter, and Congresswoman Nancy
Johnson. The hearing was held to examine the importance of
the National Institutes of Health and the role of patient advocacy
groups regarding funding for biomedical research. For copies
of witness testimony from the hearing, please contact Eric
Byer at (202) 857-1886 ext. 3240, or e-mail him at eric_byer@dc.sba.com.
Budget Committee Chairman
Releases His Mark
On March 17, 1998,
Senate Budget Committee Chairman Pete Dominici (R-NM), released
his version
of the FY 1999 budget resolution. His draft, more commonly
know as the "chairman's mark," will be the starting
point for the Senate Budget Committee's consideration of the
resolution. The following is the langauage within the text
of the resolution on NIH:
"The Chairman's Mark assumes
for the National Institutes of Health in 1999 $15.1 billion
in BA (budget authority) and $13,9 billion in outlays. This
funding level represents an 11% increase in 1999, on top of
the 7% increase provided in 1998. Over the period 1999 to 2003,
the Mark assumes providing NIH with $15.5 billion in BA and
$11.2 billion in outlays above a freeze baseline." The
complete version of the Chairman's Mark can be found on the
web at www.senate.gov/~budget/republican/major%20documents/mark98/markcntnts.htm.
Harkin/Chafee/Graham Tobacco
Legislation
On Thursday, March
12, 1998, Senators Tom Harkin (D-IA), John Chafee (R-RI), and
Bob Graham (D-FL),
held a press conference to present an overview on their tobacco
legislation, called the Kids Deserve Freedom From Tobacco Act,
or "KIDs Act." The legislation, which will be introduced
in the next few weeks, would reduce youth tobacco use through
a set of comprehensive policy changes. The bill would create
a National Fund for Health Research to "strengthen our
national commitment to finding preventive measures and cures
for diseases - especially those related to tobacco use, including
cancer, heart disease, emphysema, and stroke."
ASTP Signs onto Support
Letter for Increased Funding at NIH
On March 17, 1998,
the ASTP endorsed a letter supporting an increase in funding
for the NIH for
FY 1999. The letter, which will be sent to all Senate and House
Budget Committee Members, asks that Members on these committees "provide
sufficient budget authority and outlays to provide a $2 billion
increase (15%) for the National Institutes of Health for FY
1999."
NIAID Tesifies Before House
Labor, HHS, Subcommittee
On March 18, 1998, Anthony S. Fauci,
M.D., Director of the National Institute of Allergy and Infectious
Diseases (NIAID), tesified before the House Appropriations
Subcommittee on Labor, Health and Human Services, and Education.
Attached is Dr. Fauci's written testimony before the Subcommittee.
AMA Holds Annual Leadership
Meeting
On March 8-11, 1998, the American
Medical Association held their 1998 National Leadership Conference
at the Sheraton Washington Hotel in Washington, D.C. Guest
speakers included President Bill Clinton, House Speaker Newt
Gingrich, and Health Care Financing Administrator Nancy-Ann
Min DeParle. Copies of these speeches can be found on the web
at www.ama-assn.org/mar98nlc/nlclive.htm.
Below, please find
an article from Senator Connie Mack (R-FL) on tobacco money
helping to fund
medical research…
DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Democrats to Offer Managed Care
Legislation Next Week
National Institutes of Health
Statement by
Anthony S. Fauci, M.D.
Director, National Institute of Allergy and Infectious Diseases
Mr. Chairman and Members of the
Committee:
I am pleased to present the President's
budget request for the National Institute of Allergy and Infectious
Diseases (NIAID) for Fiscal Year 1999. The President proposes
that the NIAID receive $702 million, an increase of 8.0 percent
for NIAID non-AIDS research activities. Including the estimated
allocation for AIDS research activities, total support proposed
for the NIAID is $1.47 billion, an increase of 8.6 percent
over the comparable FY 1998 appropriation. Funds for NIAID
AIDS research efforts are included in the Office of AIDS Research
budget request.
The activities of the NIAID are
covered by the NIH-wide Annual Performance Plan required under
the Government Performance and Results Act (GPRA). The FY 1999
performance goals and measures for NIH are detailed in this
performance plan and are linked to the HHS GPRA Strategic Plan
which was transmitted to Congress on September 30, 1997. The
NIAID is anxious to meet the challenges set forth in this plan
and we look forward to continued support from Congress that
will facilitate our achieving these goals.
FIFTY YEARS: ADVANCING KNOWLEDGE,
IMPROVING HEALTH
This year, the NIAID celebrates
fifty years of progress in understanding, treating and preventing
infectious and immunologic diseases. During the past five decades,
NIAID-supported research in fields such as microbiology and
immunology has led to new therapies, vaccines and diagnostic
tools that have profoundly benefited global health. Capping
this remarkable half-century are recent advances and initiatives
that promise to further reduce the burden of disease in this
country and around the world. Meanwhile, new challenges to
the public health continue to emerge, underscoring the need
for continued progress in our fight against infectious microbes
and diseases of the immune system.
IMMUNOLOGIC TOLERANCE
A long-standing
goal of NIAID-supported immunology research is the development
of new and better ways
to prevent the rejection of transplanted organs and tissue "grafts" by
the immune system. While current immunosuppressive drugs have
greatly reduced graft rejection, these agents are highly toxic
and increase a patient's risk of infection, cancer and other
complications. In addition, despite major improvements in immunosuppressive
therapy, 10 to 50 percent of transplanted organs and tissues
are rejected by patients' immune systems within the first year.
(1)
Even with the latest immunosuppressive
drugs, approximately 60 percent of transplanted kidneys, the
organ most often transplanted, are rejected within 10 years.
(2)
As we work to improve
this record, we are encouraged by new findings, underpinned
by years of
basic immunology research, that show the feasibility of a totally
new approach to preventing graft rejection. NIAID-supported
researchers have demonstrated that it is possible to induce
immunologic "tolerance" to a graft by turning off
the specific immune responses that would otherwise attack it.
Promising results in animal models have been achieved with
transplanted kidneys and livers; early human studies suggest
that long-term tolerance of transplanted bone marrow may be
achieved with appropriate therapy.
One approach to inducing tolerance
is to block the second of two signals needed by T cells to
become activated and orchestrate an attack on a foreign tissue
or organ. In this regard, several different blocking molecules
have shown considerable promise. Other approaches to inducing
tolerance involve manipulating immune system molecules called
cytokines, or inducing the suicide of the immune cells that
otherwise would attack a graft. The refinement of strategies
for inducing tolerance could revolutionize the field of transplantation
and benefit the tens of thousands of patients whose lives could
be saved or improved by a donated organ. In addition, our growing
knowledge of immune tolerance will help in understanding and
treating other conditions such as cancer, autoimmune conditions,
and allergic and infectious diseases.
THE BURDEN OF INFECTIOUS DISEASES
It is underappreciated that infectious
diseases remain the leading killer of people globally and the
third leading cause of death in the United States.(3) ,(4)
Of the approximately 52 million
deaths worldwide in 1996, more than 17 million were due to
infectious diseases, including approximately 9 million among
children.(5)
In addition, a growing number of
cancers and other chronic conditions have been attributed to
infectious agents. For example, the bacterium Helicobacter
pylori causes ulcers and stomach cancer, and Chlamydia pneumoniae
has been implicated as a cause of artery-clogging plaques.
Both hepatitis B virus and hepatitis C virus (HCV) can lead
to liver cancer, and human papillomavirus is responsible for
most cases of cervical cancer. In addition to their human toll,
the financial burdens of infectious diseases are enormous.
In the United States alone, costs associated with infectious
diseases exceed an estimated $120 billion annually.(6)
In the face of the enormous challenges
posed by infectious diseases, the sustained commitment of NIAID
to basic and applied research has paid enormous dividends against
newly recognized pathogens--such as human immunodeficiency
virus (HIV) and HCV--and scourges which have long plagued humanity,
including malaria, tuberculosis and life-threatening infant
diarrhea.
PROGRESS AGAINST HIV/AIDS
HIV, the cause of the acquired immunodeficiency
syndrome (AIDS), remains one of the greatest threats to global
health. More than 30 million people worldwide are living with
HIV/AIDS, a number expected to reach 40 million by the year
2000. In the 17 years since AIDS was recognized, an estimated
11.7 million people with HIV worldwide have died,(7) including
approximately 380,000 in the United States.(8)
Despite the mounting toll of HIV,
recent developments have provided a measure of optimism. In
the United States, AIDS deaths dropped 44 percent from the
first six months of 1996 to the first six months of 1997; new
AIDS diagnoses declined by 12 percent during the same period.(9)
These encouraging trends are probably
due to several factors, notably the increased use of potent
combinations of anti-HIV drugs, and our growing ability to
prevent and treat the many secondary infections associated
with HIV disease.
Basic research into the structure
of HIV and how it interacts with the immune system led to the
development of the 12 antiretroviral drugs now licensed in
this country. Various combinations of these drugs, as well
as several investigational drugs now in clinical trials, have
helped restore the health of many patients, dramatically reducing
the amount of HIV in their bodies and lowering their risk of
secondary infections, hospitalizations and death. In addition,
new insights into the pathogens that prey on the weakened immune
systems of HIV-infected individuals have led to improved prophylactic
and curative therapies.
Unfortunately, many HIV-infected
individuals have not benefited from the currently available
drugs, cannot tolerate their side effects, or have difficulty
complying with complex treatment schedules that may require
them to take 30 or more pills a day. In addition, the ability
of HIV to mutate and become resistant to the current drugs
is a persistent threat. Therefore, the development of the next
generation of therapies--well-tolerated, effective drugs that
can be administered with a minimum of doses for prolonged periods--remains
a priority. Together with partners in academia and industry,
NIAID-supported scientists are pursuing many new treatment
strategies and exploring ways to boost an HIV-infected person's
immune system.
HIV VACCINE RESEARCH
In many developing countries, where
health care spending may be only a few dollars per person each
year, such therapies will probably remain beyond the reach
of all but the most privileged. Therefore, continued research
into an HIV vaccine and other means of preventing HIV infection
is crucial to slowing the epidemic in these settings, as well
as in our own country. To speed the pace of discovery, NIAID
has strengthened its efforts in HIV vaccine research. Among
recent initiatives are 58 new grants to foster innovative research
on HIV vaccines and the establishment of a Vaccine Research
Center within the NIH intramural research program.
HEPATITIS C
Another recently recognized pathogen
of great concern is hepatitis C virus (HCV), identified in
1989. HCV is a leading cause of cirrhosis, liver cancer, and
a major reason for liver transplants. Worldwide, more than
170 million people are chronically infected with HCV, including
4 million individuals in the United States.(10)
Annual HCV-related deaths number
approximately 8,000 to 10,000 people in this country,(11) a
figure projected to reach 24,000 deaths/year by 2017 if effective
therapies are not found. To combat this epidemic, NIAID recently
established a network of Hepatitis C Research Centers to study
the virus and how it causes disease. In the past year, researchers
at one of the new centers reported a major breakthrough: the
construction of functional, infectious clones of HCV, using
genetic engineering techniques. This advance has facilitated
HCV studies in cell cultures and animal models.
RESPONSE TO THE THREAT OF H5N1 AVIAN
INFLUENZA
We have come to understand that
the emergence of previously unrecognized pathogens such as
HIV and HCV is a continual process. As further evidence of
this, the first known cases of human influenza caused by a
virulent bird virus known as H5N1 avian influenza were identified
in Hong Kong in 1997. Given the possibility that this avian
virus might combine with a human influenza strain and become
more readily transmissible, possibly resulting in a pandemic,
NIAID moved quickly with our colleagues at the Centers for
Disease Control and Prevention, World Health Organization and
other agencies in addressing research questions and public
health needs associated with the outbreak. Fortuitously, as
part of our long-standing research into respiratory viruses,
we had in our repository the specific antisera needed to quickly
develop test kits for detecting the avian influenza virus.
NIAID has also supported the production of a recombinant vaccine
for use in at-risk laboratory and health care personnel, as
well as a surveillance effort in Hong Kong to identify and
characterize the source of the avian virus.
A COMMITMENT TO MALARIA RESEARCH
More than 40 percent of the world's
population lives in areas at risk for malaria transmission.(12)
Approximately 300 to 500 million
cases of malaria occur worldwide each year; every 20 seconds,
a child dies of the disease.(13)
In the past year, the National Institutes
of Health, together with research organizations and donor agencies
from around the world, has worked to mobilize the scientific
resources and political will needed to control this dread disease.
The extraordinary interest among scientists, political leaders,
the media and the general public in this new partnership, called
the Multilateral Initiative on Malaria, is strong evidence
that the global community has recognized the magnitude of the
malaria problem.
At NIAID, we have strengthened our
long-term commitment to malaria research. NIAID-supported malaria
projects--many in collaboration with other government and international
agencies--include a new repository of malaria research materials
that are available to researchers worldwide; basic, field-based
and clinical research on all phases of malaria research; and
projects to determine the genetic sequences of important malaria
species. In addition, new collaborations between intramural
and extramural scientists on malaria vaccine research, production
and evaluation are underway.
DIARRHEAL DISEASES
Like malaria, diarrheal diseases
are leading killers of children, resulting in about 2.5 million
childhood deaths each year.(14)
At least a third of these deaths
are probably due to rotavirus, a disease for which NIAID researchers
have developed an effective, orally administered vaccine. As
recently reported in The New England Journal of Medicine, this
vaccine, the culmination of more than 20 years of research,
reduced severe diarrheal illness by 88 percent in a study of
infants in Venezuela, a country where rotavirus circulates
year round.(15)
The vaccine is nearing licensure
in the United States and other countries, and promises to have
a major impact on the health of children worldwide. In the
United States alone, widespread use of the NIAID-developed
rotavirus vaccine could greatly reduce the 500,000 doctor visits(16)
and 100,000 hospitalizations related to rotavirus each year,(17)
as well as the $1.4 billion in direct and indirect costs associated
with the illness.(18)
THE PROMISE OF NEW TECHNOLOGIES
Many of the advances I have described
have been facilitated by rapid advances in molecular biology,
notably the development of fast and accurate methods for sequencing
the genomes of disease-causing microbes. Sequence information
can be used in many ways, such as finding targets for therapies,
identifying antigens to incorporate into vaccines, detecting
mutations that cause drug resistance, and determining the factors
that influence the virulence of a microbe.
The success of the first microbe
sequencing project--the delineation of the complete Haemophilus
influenzae genome in 1995--encouraged the Institute's current
efforts to sequence the full genomes of eight other medically
important bacteria. NIAID also supports projects to provide
complete or partial genome sequences of large parasitic protozoa.
MAINTAINING A RESEARCH BASE
The burden of infectious and immunologic
diseases, in human and economic terms, is enormous. It is critical
that we maintain a strong scientific infrastructure in core
disciplines such as infectious diseases, immunology and microbiology
to meet the challenges of these diseases. With skillful use
of the increasingly powerful tools of molecular biology, by
identifying research opportunities and priorities and vigorously
pursuing them, and by sustaining a strong research base, we
will be well-positioned to make further progress against current
disease threats as well as the new diseases that will inevitably
emerge.
Tobacco Money Must Help Fund
Medical Research
By Sen. Connie Mack
In recent weeks there has been a
considerable effort to develop a consensual, bipartisan tobacco
agreement. I have been very encouraged by these outstanding
efforts. A consensual agreement is realistically the most effective
way to win the war on teen smoking and improve the health of
our citizens.
Believe me, it has taken some time
for me to come to this conclusion. I first had to get over
my personal disgust with the conduct of tobacco company executives,
and I'm sure many of my colleagues feel the same way.
Internal tobacco
company documents show an industry that actively sought to
hook Americans, and
children in particular, to a product it knew caused life-threatening
diseases and even death among tabacco users. A 1962 document
states: "The amount of evidence accumulated to indict
cigarette smoke as a health hazard is overwhelming, while the
evidence challenging the indictment is scant."
Another document
quotes an industry official as saying, "stopping smoking,
all the research indicates, is quite as difficult as giving
up alcohol or even
heroin."
How were we supposed
to negotiate with an industry that has a corporate philosophy
of lying and
deceiving the American people? Perhaps more importantly, why
should we bother? The answer is simple. In the words of the
attorney general of Mississippi, "If we don't get over
being mad, we'll never get even."
I am proposing that we get even
in the most constructive way possible, by hitting tobacco companies
where it hurts: in the pocketbook. We have a monumental opportunity
to force Big Tobacco to pick up the tab for finding cures for
the very diseases it has caused. One of the main goals of any
tobacco legislation has been to reduce the level of teen smoking
and tobacco addiction in our country. This must remain our
primary goal. Research from the American Cancer Society shows
that one-third of high school students in the United States
are current cigarette smokers, and research has also shown
that 89 percent of adult smokers began using cigarettes by
or at age 18. We must stop our youth before they start this
addictive, destructive habit.
Yet if our emphasis is limited simply
to reducing smoking without finding cures for diseases caused
by smoking, only half our mission will be accomplished. We
will have effectively abandoned those who have been unable
to break the cycle of addiction and who will eventually be
suffering from smoking- related illnesses.
As many people know,
my family has had its share of battles with cancer. Although
lung cancer
has never been diagnosed in my family, we know firsthand the
anxiety felt upon hearing the words "you have cancer." We
also know the fear that upon discovering even the best
treatments available, we are often
a long way from a cure. By focusing a significant portion of
any tobacco agreement revenues on medical research, we will
accomplish two goals at the same time: providing hope for those
suffering from tobacco-related illnesses and their families
while also making an investment in the future health of all
Americans.
Research has repeatedly shown what
happens to habitual smokers. You smoke, and eventually you'll
get sick. Tobacco addiction greatly increases the likelihood
that an individual will suffer from heart disease, emphysema,
chronic bronchitis, and/or cancer of the mouth, lungs, bladder,
or pancreas. Cigarette smoking is directly responsible for
80 percent of lung cancer deaths and 20 percent of all heart
disease deaths. Research has also shown that smokers, on average,
make six more trips to health care facilities per year than
non-smokers.
A recent study published in Public
Health Reports shows the cost of tobacco addiction in 1993
at $12.9 billion for Medicaid; roughly $1 out of $7 spent on
the Medicaid program. The Centers for Disease Control estimated
that in 1993, the direct medical costs for treating smoking-related
illnesses totaled $50 billion.
If there is comprehensive tobacco
legislation without significant medical research, it would
be a tragedy. Big Tobacco should, at the very least, pay for
research into new methods of treatment and the discovery of
cures. After all, they have helped create many of the diseases
and ailments currently plaguing our society.
I want to clarify that these funds
ought to be used for basic medical research. Basic medical
research has led to breakthroughs in many different areas.
Congress must remain firm in its long-standing policy that
scientists, not Congress, continue to decide how these funds
would be directed and to resist the temptation to earmark research
dollars for specific research initiatives. Why? Because you
never know where scientific research will lead.
Less than two years ago, there was
very little indication of a direct link between tobacco use
and glaucoma. Today, because of unrestricted basic medical
research, we know this link exists.
Also, in the 1980s, scientists at
the National Cancer Institute were working to develop a therapy
for the treatment of cancer. Unfortunately, the treatment did
not work. However, this same research later led NCI scientists,
working with the private sector, to develop the drug AZT, the
first Food and Drug Administration-approved therapy which actually
slowed down the progression of HIV.
If Congress had tied the hands of
scientists by limiting the use of research dollars to a specific
disease, it is highly unlikely that these two discoveries would
have been made. There are many other examples of how research
into one disease helps our understanding of other diseases.
Putting together a consensual, bipartisan
tobacco agreement is no easy task. There are many complex and
politically charged issues involved. We have the opportunity
to craft comprehensive legislation and I encourage my colleagues
to seize this moment. We have the knowledge. We have the technology.
And most importantly, we have the support of the American people.
It is time for America to take this
opportunity and win the war on teen smoking, and, at the same
time, win the war against the diseases which plague our society.
Sen. Connie Mack (R-Fla) is the
chairman of the Republican Conference.
