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While in Washington in July for an FDA advisory committee
meeting on viral load, and a National Institutes of Health
meeting of the AIDS Clinical Trials Group, we also checked on
some of the Federal HIV/AIDS policy issues developing in
Congress and in the Clinton Administration -- especially
those concerning AIDS treatment. Much is happening; and while
timely information about Federal activities usually does
reach some of the major AIDS organizations around the
country, the background seldom gets through to the general
public. By the time an emotional issue becomes a political
football and gets media coverage, it is usually too late for
the public to be involved except as supporters or opponents
of pre-determined positions. Washington would suffer less of
its famous isolation from how most people think and live, if
non-specialists could learn earlier what was going on, and
become involved in what matters to them while there is still
flexibility in shaping the objectives, strategies, and
decisions.
Today in Washington AIDS funding is doing better than we
would have expected -- thanks more to Republicans as well as
Democrats in Congress, than to the Clinton Administration.
But there are many reasons to be concerned. It is clear that
modern treatment is saving many but not all lives, that those
with the best access to medical care are most likely to live,
and also that treatment is cost-effective, keeping people
productive and working instead of disabled and requiring
hospitalization or other expensive care. But while many
cannot get good care for economic reasons, institutions are
often competing not to help solve the access problems, but to
avoid being the payer of last resort. And there have been
some serious divisions and questionable strategies within
AIDS political organizations.
This article attempts to outline some (not all) current
Federal AIDS issues, especially those which are treatment and
access related, so that our readers can understand what they
are. Sometimes there are bitter fights behind the scenes
within or between AIDS organizations, and here we have tried
to avoid taking sides -- which is made easier by the fact
that we are usually too far from these inside-the-Beltway
battles to have aligned with a side or developed a firm
position. But we could not banish our views entirely, since
some of the material would be difficult to communicate or
understand without the perspective provided by some viewpoint
or other.
New information that treatment is saving lives.
On June 14, the U.S. Centers for Disease Control released updated
information showing a 19% decline in AIDS deaths in the U.S.
The decline among different groups clearly reflected
inequalities in treatment access: a 22% decline in deaths
among men vs. 7% among women; and 28% among whites vs. 10%
among African Americans and 16% among Latinos. (Where medical
care is more widely available -- as in British Columbia, with
the Canadian health system -- deaths have dropped 50%. In
some leading medical practices in the U.S. and elsewhere, the
recent drop may be much larger than 50%. While exact
comparisons between different situations may be difficult or
impossible, the pattern is clear that access to medical care
for HIV disease is now a life-and-death issue.)
We must also remember that the new combination
antiretrovirals do not work for everybody, and it is not
clear how long they will work when they do. What we know
today suggests that usually, the first antiretroviral
treatments a person uses may be most likely to work, since it
is harder to treat those who have already had extensive
antiretroviral treatment which failed. Therefore, it is
important to do everything possible to improve the chances
that the first treatment will be successful. However, there
are many individual cases of persons who have had very good
results with new regimens after prior treatment failure.
Also, some antivirals have much less of a problem with viral
resistance than others. And there seem to be emerging hints
that certain treatments may have some benefit even after they
have lost much of their ability to keep a person's virus
under control. Much more needs to be learned about how to use
even the existing drugs for patients who have had treatment
"failure" (that is, failure to keep the viral load
suppressed).
And much more attention is needed to developing new
approaches -- from new classes of antiretrovirals such as
integrase inhibitors, to different kinds of treatments such
as immune-based (or even immune-suppressive) therapy, to more
attention to occasional accidental hints that some treatment
may be working through a completely unknown mechanism. (Today
such observations usually are quickly abandoned, since they
are considered unreliable if there is no known mechanism.
Instead, such accidental discoveries should be perhaps the
highest priority for research, because of the possibility of
developing new classes of treatments -- which already have
shown proof of principle in humans, even before organized
research and development begins).
The policy bottom line is that AIDS research remains as
necessary as ever for saving lives in the future.
Unfortunately a serious problem today is that there are few
major new drugs in the pipeline for the next two to three
years -- due in large part, we believe, to deficiencies in
earlier stages of the drug-development process, not just to
the natural difficulty of medical research. This situation
needs much more attention from activists and the public, as
well as from professional researchers and policy specialists.
Progress in ADAP funding
The AIDS Drug Assistance Program
(ADAP), run by the states with Federal funding from the Ryan
White CARE Act and usually state funding as well, is intended
to help persons who are uninsured or underinsured. It is a
major component of access to care for those who may be
employed and who therefore are probably ineligible for
Medicaid, but could not afford treatment otherwise
(antiretroviral combinations which include protease
inhibitors can cost $15,000 a year). ADAP is also paying for
drugs for many who are poor enough for Medicaid, but are not
judged "disabled."
In the last two years a financial crisis has developed in the
ADAP programs of many states, because with better treatments
available today, more people are choosing to get treated, and
to learn their HIV status so that they can get medical care
if necessary. Also, the new drugs are more expensive, and
clearly need to be used in combination with other
antiretrovirals, further increasing the financial demands on
the programs.
During the last year, much work has been done in documenting
how ADAP programs are operating in every state,(1) and in
projecting future needs based on current data on utilization
trends.(2) A conservative estimate is that $132 million in
additional Federal funding will be needed for next year (the
ADAP fiscal year begins in April). Today, only three states
(California, New York and North Carolina) cover all FDA-
approved HIV drugs for everyone who needs them, while three
(Arkansas, Oregon, and South Dakota) do not cover protease
inhibitors at all.(3) (Nevada, also listed in the report as
not covering protease inhibitors, has just decided to
contribute state funds which will allow the program to do so.
California did not cover all of the drugs when the report was
written, but now does.)
In the last year, 35 states imposed at least one emergency
measure, such as waiting lists, reducing the list of drugs
covered, or transferring money from other health programs to
pay for the drugs. Recently we heard that about 10 states are
heading for a crisis this year, in which treatment will be
refused to many who need it and who qualify for the programs
set up by those states.
On July 15 the House of Representatives Labor-HHS
Appropriations Subcommittee approved a funding increase for
the full $132 million conservatively projected to provide
doctor-prescribed treatments for those who are eligible for
the ADAP program and likely to use it next year -- despite
the fact that the White House had failed to send Congress a
request for the money, which Congress had asked for. On July
22, however, a Senate subcommittee approved only $50 million.
The difference will probably be resolved in a conference
committee -- meaning that a lot of work -- and political
unity -- from AIDS organizations will be required.
It is also important to know that states vary greatly in how
they fund and run their ADAP programs. While intended as a
Federal partnership with the states, about 20 states put in
no money of their own, and rely on Federal funds entirely.
This is a big part of the reason why some states have much
more restrictive programs, or have run out of money and had
to impose emergency restrictions.
Another difference between states is that, while ADAP is
funded primarily from Title II of the Ryan White CARE Act
(which provides money to the states depending on their number
of AIDS cases), some states (for example, New York) also use
some of their Title I money for ADAP, while others (for
example, California) do not (although some cities use Title I
money to fund treatment in other ways than by direct transfer
to the state ADAP program). Title I is for relief to
metropolitan areas heavily impacted by the epidemic;
therefore, states with no such cities do not receive Title I.
ADAP and the "FASA" Dispute
A political conflict has
developed within the ADAP Working Group, one of the
organizations which was instrumental in getting favorable
consideration from Congress for the ADAP program. The dispute
concerns a provision in a law called FASA (the Federal
Acquisition Streamlining Act). This provision, which is part
of existing U.S. law but has never been used due to industry
opposition, would expand a Federal discount pricing schedule
currently used by the Veterans Administration, the military,
and some other government agencies, so that state governments
and some public clinics could use it as well; it would apply
to purchases of furniture, equipment, and much else besides
drugs. The pharmaceutical industry is strongly opposed -- as
are many suppliers who would lose business if state
governments and public agencies could buy supplies at the
Federal discount instead of buying from them. (This FASA
provision should not be confused with the deep discount "PHS
pricing" of pharmaceuticals, which is already in use by some
but not all ADAP programs.)
The ADAP Working Group is a coalition of AIDS community
organizations and pharmaceutical companies. It is funded by
membership contributions by all of the organizations, with
industry paying higher dues; but the community organizers may
have more day-to-day influence on its operation, because the
industry people are more constrained by the rules and
policies of their companies. On the whole, this structure has
worked well, greatly contributing to the success of
increasing ADAP funding by bringing together two very
different groups which each has its own interest in getting
the drugs paid for.
The pharmaceutical industry strongly wants Congress to repeal
the FASA provision that would extend discount Federal pricing
to state governments and some other public agencies. Many
companies will not discuss the issue in the ADAP Working
Group, on the grounds that company employees could be
violating antitrust laws if there is any discussion of drug
prices or pricing programs when representatives from more
than one company are in the room; they say these discussions
must be with individual companies outside of the Working
Group. Most but not all AIDS organization which are involved
with this issue strongly support the FASA provision -- or at
least want to hold hearings on it before it is repealed --
since it might lead to lower drug prices to ADAP programs,
and therefore access to care for more patients (some dispute
this, saying that companies will raise prices to compensate
for expansion of the Federal price schedule, and that there
are other technical reasons the program might not work well).
They are also concerned that the White House and some members
of Congress are unlikely to support the ADAP Working Group's
future requests for money, if the pharmaceutical industry,
which receives the money which is spent through ADAP, refuses
to help make the Federal funds go as far as possible in a
time of budget cuts.
Our main concern is that this dispute has become a partisan
one, threatening the unity which is necessary if AIDS
organizations are to be effective in supporting treatment
access. AIDS should be nonpartisan; but over the years most
AIDS political organizations have unfortunately been much
closer to one political party, the Democrats. Since the
Republicans now control both houses of Congress, their
support is critical; we are fortunate that the ADAP Working
Group is nonpartisan, that the Log Cabin Republicans (a group
focused primarily on gay issues) and others have helped
organize the Republican support it needed. But the Log Cabin
Republicans also strongly support industry in its efforts to
repeal the FASA provision, and this has led to conflict
between it and other AIDS organizations in the ADAP Working
Group. The conflict could become a serious threat to the
effectiveness of AIDS work in Congress, especially since the
AIDS community in Washington has too little representation on
the Republican side.
On July 11 a Senate subcommittee voted to repeal the FASA
expansion provision. It did not consider a government-
proposed compromise to retain the discount pricing for states
and public agencies for drugs for life-threatening
conditions, since one member of the subcommittee, who had
been expected to introduce that compromise, decided not to do
so. (The compromise did have one harmful element, in that for
two years it would have singled out HIV for the lower prices,
as a kind of trial run -- which could have created
understandable resentment by other disease advocates, since
all life-threatening diseases should have the lower prices
equally.)
Comment: What is most likely to happen now is that Congress,
apparently paid off by industry, will repeal the FASA
provision before the public even knows about it; hearings
which were supposed to happen this year did not take place.
But if this issue does have a future, we would hope that the
AIDS community would keep it out of the ADAP Working Group,
which is an effective but fragile coalition of two interests
which are irrevocably split on this issue. FASA should be
used to help build vitally necessary coalitions with other
disease groups, whose interests here are identical to those
of the AIDS community -- not to split apart a productive
coalition which we already have.
On the larger politics around ADAP, we have asked
participants why the Republican-controlled Congress has been
much more helpful on ADAP funding than the Democratic
Administration. The four answers we have heard are (1) many
people in both parties have had personal contact with someone
with AIDS, and this is more influential than party
affiliation; (2) ADAP is strongly supported by industry, with
which Republicans are usually aligned; (3) the ADAP Working
Group and the Log Cabin Republicans have done their homework
well and kept the issue prominent; and (4) the rules of
Congress are such that the (Democratic) Administration would
have had to find an "offset" -- take money away from some
other program in the Health and Human Services budget, to pay
for the ADAP funding increase -- while the (Republican
controlled) Congressional subcommittee had somewhat different
constraints.
Other AIDS funding
Many other AIDS programs were increased
about 5 percent in the House subcommittee; a Senate
subcommittee followed the House levels in some cases, and
proposed different funding in others. For NIH AIDS research,
the House proposed an increase of 4.8% --considerably more
than proposed in President Clinton's budget of February 6; we
do not have a Senate figure for NIH research. For housing,
the president and the House and Senate subcommittees have all
agreed on an 8 million dollar increase in HOPWA (Housing
Opportunities for People with AIDS), about 4%. For AIDS
prevention at the Centers for Disease Control, the House
proposed only a 0.8% increase (far below the president's
request), while the Senate proposed 4.8%.
The next step for the public to be involved will be talking
to their members of Congress during the August recess, which
lasts for the entire month; during the recess it will be
important to urge Senators to raise the $50 million ADAP
increase to the $132 million appropriated by the House, as
otherwise as many as 8,000 people may go without the
treatment they need. After the full Senate and House have
voted, the legislation will go to a Conference Committee to
work out differences between the two versions. It is not yet
known who will be on the Conference Committee, but they will
probably be members of the Senate and House Appropriations
Committees. Members of the public should contact their
Senators and Representative at that time, to support the
highest AIDS funding levels, whether those are from the House
or the Senate (see "How to Be Involved," below).
FDA reform
Since the Republicans gained control of
Congress in January 1995, there have been a number of
proposed laws to greatly change how the FDA evaluates new
drugs and medical devices (here we will focus on drugs; the
devices situation is often different). Supporters usually
describe these proposals as ways to make the FDA more
efficient and get new drugs to patients faster; opponents are
likely to describe them as giveaways to industry which weaken
standards and endanger the public health. No law to change
the FDA emerged from the last Congress (1995 and 1996); this
year, less extreme bills are moving more rapidly, and it is
likely that some law will be passed this year or next. (An
example of an extreme measure -- which was considered last
year but not included in the bills this year -- provided for
automatic drug approval in some cases if the FDA missed
deadlines written into the bill by Congress.)
Complicating the legislation around FDA reform is one issue
on which everyone agrees -- the renewal of the Prescription
Drug User Fee Act of 1992 (PDUFA), which allows the
government to bill pharmaceutical companies for evaluating
their drugs, and use the money to hire extra reviewers and
make other improvements so that the evaluations can be
faster. Companies are happy to pay, because the money they
save by a faster review is far greater than the fees. Patient
advocates are also supportive, because the drugs can be
evaluated faster without any lowering of standards. However,
PDUFA must be reauthorized by the end of September, or
reviewers may soon have to be laid off -- which could
seriously delay new AIDS drugs like 1592 and DMP 266 when
they go for FDA review.
The problem now is that the PDUFA renewal legislation has
other provisions attached, to change the operation of the
FDA. Some of these provisions have wide agreement and are not
an issue; but others have been added to the bill although
consensus has not been reached.
What are some of the FDA reform provisions now in dispute? A
June 11 letter from Health and Human Services Secretary Donna
Shalala to Senator James Jeffords of Vermont (who is Chairman
of the Committee on Labor and Human Resources) discussed the
areas of agreement and disagreement in S. 830, the Food and
Drug Administration Modernization and Accountability Act of
1997. She noted that the bill then contained "approximately
20 provisions that represent significant consensus reforms.
Among the provisions that we all agree on are those that set
forth the Agency's mission, codify reforms to the regulation
of biotechnology products, provide expedited authority for
the adoption of third party performance standards for device
review and for the classification of devices, and streamline
submission requirements for manufacturing changes and
marketing applications for drugs and biologics."
But the letter also listed five non-consensus provisions:
"(1) lowering the review standard for marketing approval; (2)
allowing distribution of experimental therapies without
adequate safeguards to assure patient safety or completion of
research on efficacy; (3) allowing health claims for foods
and economic claims for drugs and biologic products without
adequate scientific proof; (4) requiring third party review
even for devices that require clinical data; and (5)
burdening the Agency with extensive new regulatory
requirements that will detract resources from critical Agency
functions without commensurate enhancement of the public
health."
A major FDA reform issue -- not addressed in the non-
consensus item list above because it was not yet in the bill
-- concerns whether pharmaceutical companies should be
allowed to promote to doctors uses of approved drugs which
are based on scientific studies, but have not been approved
by the FDA. We consider this a difficult issue, because it is
impossible to know in advance whether or not the benefit will
outweigh the harm. Most AIDS organizations which have a
position on the matter have come from the consumer-protection
camp, and therefore oppose letting companies promote such
"off label" uses of their products.
Those opposed to off-label promotion argue that the system
should be and has been changed to make it easier for a
company which has a legitimate new use for its product to
bring the data to the FDA and get the drug officially
approved for that use. Otherwise, drug sales persons could
use scientific studies that might not have been well reviewed
and may be erroneous, to increase their income and advance
their career by selling drugs which do more harm to the
patient than good. Also, companies may have little incentive
to do the research to thoroughly test the new use, if they
could promote it anyway. And the current proposals do not
address reimbursement problems, which will often leave
patients to pay by themselves for the drug their doctor
prescribed, if their health plan says it is not convinced by
the available evidence.
On the other hand, drug companies usually know more about
their drugs than anyone else; and there are probably many
cases where they know about uses which would be very
important to some people, but under the current system never
come to widespread attention. Overworked doctors keep giving
standard remedies, and when these do not work the patients
are out of luck. Professional medical associations have
unfortunately not filled this breach, and they do not seem
ready to do so; perhaps the problem is that medicine is (and
generally should be) a conservative profession, and while
doctors do write many prescriptions off-label, it might not
be a good career move to actively seek out, develop, and
promote new opportunities for doing so. Meanwhile
pharmaceutical companies are far less likely to do anything
with potential off-label uses, if it means spending
considerable money up front for research and a new FDA review
with no assurance of gain, than if it means giving some
reprints to their sales force and seeing their sales and
profits rise immediately. Potential beneficial new uses that
go nowhere must be recognized as a major though largely
unknown cost of the current system.
Note: As this issue went to press, BIOCENTURY newsletter
reported on July 28 that a compromise has been reached to
allow a company to disseminate peer-reviewed literature,
provided that it certifies that it will apply for
supplemental FDA approval for that use of the drug, or
submits a plan to do so. The approval could be revoked if the
company fails to follow through. Also, the FDA could insert a
statement into the literature package distributed by the
company.
Medicaid
We cannot cover Medicaid issues here in detail,
but want our readers to realize their importance. Medicaid is
by far the largest source of public funding for AIDS care.
According to a briefing paper from the Gay Men's Health
Crisis in New York, it accounts for about two thirds of the
total -- compared to only 15% from the Ryan White CARE Act,
13% from Medicare, and less than 2% from other programs.
Many states are now experimenting with restructuring Medicaid
(called Medi-Cal in California) in various ways. Some of
these changes could improve the program -- but other changes
could strip away protections and make it impossible for
persons with serious illnesses and low income to obtain
adequate care. The central concerns for activists in Medicaid
relate to the state-by-state specifics of program changes,
which are usually implemented under Federal waivers which
release states from certain legal requirements, with the
intent of allowing the states flexibility so that they can
develop more efficient programs. It is critically important
that Federal oversight of these state experiments be
maintained.
A very important proposal, suggested by the AIDS Action
Council and supported by Vice President Al Gore, would be to
change the Medicaid rules so that people do not need to
become disabled by HIV disease before they can receive
treatment for it. (Today, only a few people with HIV qualify
for Medicaid without disability, through other programs.)
Such an approach might save as much as it costs, or even
more, by keeping people healthy and avoiding expensive
remedial care; however, it is difficult to predict government
funding implications. The U.S. Department of Health and Human
Services is currently doing a feasibility study requested by
Vice President Gore.
The "HIV Prevention Act of 1997"
We have not reviewed this
legislation in detail. According to an analysis by the Gay
Men's Health Crisis, it would require states to implement and
pay for many testing and reporting changes which have long
been rejected by public health authorities. States which did
not pass the laws required would be punished by losing
Medicaid funds. Unfortunately this bill is supported by the
American Medical Association.
Needle exchange
On this notorious issue it is entirely
clear that needle exchange programs can reduce HIV
infections, without increasing drug abuse. The lack of
adequate needle exchange programs has led to thousands of
unnecessary HIV infections, according to a study by
University of California researchers published in June 1996.
Needle exchange has been supported by study after study, and
the American Medical Association, the U.S. Conference of
Mayors, and many others have called for lifting the current
Federal funding ban. A 1996 public opinion survey found two-
to-one public support for distributing clean needles to slow
the spread of HIV. What is holding back wide use of this
public-health tool is politics resulting from the war on
drugs.
Needle exchange is not a solution by itself, but a component
which can work with other programs, including medical and
social services for injection drug users, and drug-treatment
services upon request. It can bring into prevention and
treatment many people who would not be reached in other ways.
Another approach to reducing HIV infection is
decriminalization of needle possession. Many states already
allow hypodermic needles to be sold in pharmacies without a
prescription -- and Connecticut just changed its law to do
likewise. If drug users could carry one needle for their own
use, without fear of prosecution for doing so, then they
could avoid the need to use whatever needle was available at
the place they get the drug. Drug paraphernalia laws probably
also need to be changed for this to work; the American
Medical Association "strongly (encourages) state medical
associations to initiate state legislation modifying drug
paraphernalia laws so that injection drug users can legally
purchase and possess syringes."
A demonstration calling for lifting the ban on Federal
funding for needle exchange has been called for September 17,
at the Department of Health and Human Services in Washington
D.C. For more information, see
http://www.safeworks.org/savelivesnow/.
International AIDS issues.
At this time U.S. funding for
international health and development work is being increased,
and AIDS is sharing in that. There have been large decreases
in recent years, however; the hope is that this year's
Congressional action could bring the AIDS total as high as
$121 million, which is where it was in 1993.
How to Be Involved
If you want to work on Federal issues, you can sign up with
one or more organizations which will send you background
information, and action alerts when it is important to
contact your representatives. Some of these organizations
are:
- Project Inform, 415/558-8669; ask for information about the
Treatment Action Network. Or check the Project Inform web
site, http://projinf.org. The Treatment
Action Network has an
action alert and sample letter on the Federal appropriations
process that people can use to contact their representatives
during the August Congressional recess.
- In Southern California, contact the AIDS Project Los
Angeles Grassroots Hotline, 213/993-1680, or
http://www.apla.org/apla/grass.html.
- In Northern California, contact the San Francisco AIDS
Foundation, 415/487-3080; ask for information about the HIV
Advocacy Network. Or see http://www.sfaf.org.
- Elsewhere in the U.S. there are other regional networks;
for a current list, contact Project Inform's Treatment Action
Network, listed above.
- Mothers' Voices has an Action Alert Network, 212/730-2777,
http://www.mvoices.org.
- Information is also available from the National Association
of People with AIDS, 202/898-0414, http://www.napwa.org.
- Organizations can join the AIDS Action Council, 202/986-
1300; however it does not have a membership program for
individuals. But anyone can use its extensive political
background papers and alerts at
http://www.thebody.com/aac/aacix.html.
References
- STATE AIDS DRUGS ASSISTANCE PROGRAMS: A NATIONAL STATUS REPORT ON ACCESS, by the National Alliance of State and Territorial AIDS Directors, and the AIDS Treatment and Data
Network, funded by the Kaiser Family Foundation. Copies can
be obtained at http://www.aidsnyc.org/adap.
- RYAN WHITE CARE ACT, TITLE II: ANNUAL HEALTH CARE COSTS AND RYAN WHITE CARE ACT ADAP NEEDS, BUDGET PROJECTION #2, April 17, 1997. ADAP Working Group, 202/462-0260; leave your fax number (10 pages).
- GMHC IN BRIEF, July 15, 1997; Gay Men's Health Crisis, New York, New York.
Copyright 1997 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and phone
number are included if more than short quotations are used.
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