KAISER DAILY HIV/AIDS REPORT
A service of kaisernetwork.org
http://www.kaisernetwork.org/dailyreports/hiv

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*** WEBCAST: HOUSE DEBATE ON GLOBAL AIDS***
View a webcast of the House Floor Debate on
H.R. 1298, U.S. Leadership Against HIV/AIDS,
Tuberculosis, and Malaria Act of 2003,
sponsored by Rep. Henry Hyde (R-Ill.).
http://www.kaisernetwork.org/healthcast/bush/28apr03
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Friday, May 2, 2003

POLITICS AND POLICY
========================================
1. House Approves Amended $15B International AIDS Bill With 'More
Conservative Cast'; Bush Urges Quick Passage in Senate


ACROSS THE NATION
========================================
2. Ending Segregation of HIV-Positive Prisoners in Alabama Could Save
Money, Study Says


DRUG ACCESS
========================================
3. Mexican Congress Votes Down Bill To Shorten HIV/AIDS Drug Patent
Protections


SCIENCE & MEDICINE
========================================
4. FDA Approves New Formulation of Protease Inhibitor Viracept; Reduced
Pill Burden May Increase Adherence

5. New HIV Vaccine Set To Begin Phase I Clinical Trials in June


OPINION
========================================
6. Illinois Senate Takes 'Half-Step' Toward Reducing HIV Vertical
Transmission, Chicago Tribune Editorial Says

****************************************

POLITICS AND POLICY

1. House Approves Amended $15B International AIDS Bill With 'More
Conservative Cast'; Bush Urges Quick Passage in Senate

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=17498

The House yesterday approved 375-41 an international HIV/AIDS bill (HR
1298), which would authorize $15 billion over five years to fight AIDS in
Africa and the Caribbean, with amendments that give the bill a "more
conservative cast," the Washington Post reports (Eilperin/Goldstein,
Washington Post, 5/2). The bill, sponsored by Rep. Henry Hyde (R-Ill.),
would authorize $3 billion a year for five years to international HIV/AIDS
programs, with up to $1 billion in fiscal year 2004 going to the Global
Fund to Fight AIDS, Tuberculosis and Malaria. Hyde's bill endorses the
"ABC" HIV prevention model -- abstinence, be faithful, use condoms -- which
has had success in lowering AIDS prevalence rates in Uganda. The bill also
allows international organizations that counsel about abortion to receive
U.S. funding on the condition that family planning and abortion programs be
financed and run separately (Kaiser Daily HIV/AIDS Report, 5/1). The bill
would also establish a new federal task force to act as a shadow for the
Global Fund as part of an effort to allay fears among many Republicans that
the fund is inefficient (Kaiser Daily HIV/AIDS Report, 3/20).

Appropriations Concerns


President Bush lauded the House for "acting quickly to pass historic
legislation that is consistent" with the plan he announced in his January
State of the Union address. He added, "Today's action is an important step
toward providing critically needed treatment and care for millions of
people suffering from AIDS, and proven prevention programs for millions
more who are at risk." Bush called on the Senate to "act quickly so that
we can turn the tide against this disease and give the hope of life to
millions of people in the world's most afflicted countries" (White House
release, 5/1). Some lawmakers said they were concerned that the measure
could "fall short of its goals unless Bush and the Republican leadership"
seek additional funding for the global HIV initiative during the
appropriations process, the Post reports (Washington Post, 5/2). The
amount the bill authorizes is "significantly more than even the White House
requested" in its budget, and "Republicans provided still less room for the
Appropriation Committees in the [fiscal year 2004] spending plan adopted
last month," the Wall Street Journal reports. Rep. Jim Kolbe (R-Ariz.)
said, "The budget resolution doesn't permit fiscal 2004 funding anywhere
near the $1 billion" allocated for the Global Fund. House Minority Leader
Nancy Pelosi (D-Calif.) said, "The proof of the pudding will be when we go
to appropriations and see what the funding is in there," adding, "We have
something dramatic [in this bill], and I applaud it and hope it will be
sustained" (Rogers, Wall Street Journal, 5/2).

Amendments


The approved bill includes several amendments, including one proposed by
Rep. Joseph Pitts (R-Pa.) that would specifically allocate one-third of the
bill's HIV/AIDS prevention funding for abstinence and monogamy programs.
The amendment was approved 220-197, the New York Times reports. Democrats
argued that requiring funding for abstinence programs could detract from
other prevention methods, such as condom use, which also played a role in
reducing AIDS prevalence rates in Uganda. Pelosi said, "We must support
what works." However, Hyde said that the provisions in Pitts' amendment
would not "stifle other approaches," adding, "It simply says as we move
forward in this war [on HIV/AIDS], don't forget abstinence" (Hulse, New
York Times, 5/2). Another amendment, sponsored by Rep. Christopher Smith
(R-N.J.), would strengthen "conscience" language already in the bill to
ensure that religious groups will receive funding even if they object to
certain aspects of prevention programs, including condom distribution
(Kaiser Daily HIV/AIDS Report, 5/1). The House approved the Smith
amendment on a voice vote, the Los Angeles Times reports. Smith said that
he wanted a "maximum army of volunteers" in the fight against the disease
(Anderson, Los Angeles Times, 5/2). According to the Washington Times, the
amendment was opposed by "most" Democrats, who opposed the prioritized ABC
approach and favored physicians and health officials using "any mixture of
the three options" (Lakely, Washington Times, 5/2). But Rep. Tom Lantos
(D-Calif.) said he was concerned that the Smith amendment could permit some
groups opposed to condom use to "criticize those who do," adding, "No group
should be required to have anything to do with a program to which it has
religious objections, but I'm concerned some groups will use this to
undermine other organizations" (Epstein, San Francisco Chronicle, 5/2).
Lantos added, "We should not use federal funds to tell people in Uganda to
not use condoms because they are morally wrong" (Washington Times, 5/2).
The House also approved an amendment from Rep. Joseph Crowley (D-N.Y.) that
calls for educating men and boys about gender equality, the Long Island
Newsday reports. Crowley said, "In addition to ABC, they should also learn
the big 'R,' respect" (Povich, Long Island Newsday, 5/2). Other amendments
include:

* A measure sponsored by Rep. Sheila Jackson Lee (D-Texas) that calls for
the United States to urge business and private groups to provide to nations
in sub-Saharan Africa assistance to help fight the HIV/AIDS epidemic,
coordinated through a privately subsidized fund.

* A measure sponsored by Rep. Cliff Stearns (R-Fla.) that would require a
deduction from next year's appropriation to the Global Fund that is
equivalent to every dollar paid to any one Global Fund staff member in the
previous year that is over the amount of the U.S. vice president's salary.
The president could waive this provision for national security reasons.

* An amendment proposed by Lantos that calls for a pilot program aimed at
providing assistance to children and families affected by HIV/AIDS,
including assurances of women's inheritance rights.

* An amendment presented by Rep. Betty McCollum (D-Minn.) that would
allocate a minimum of 10% of the bill's proposed funding for FY 2006
through FY 2008 to programs aimed at orphans and "vulnerable children"
affected by HIV/AIDS, including those sponsored by nongovernmental
organizations and faith-based groups.

* A measure sponsored by Rep. Frank Ballance (D-N.C.) that would "expres[s]
the sense of Congress that African nations that object to U.S. food aid on
non-scientific grounds should accept this food assistance to improve
nutrition."

* An amendment sponsored by Rep. Judy Biggert (R-Ill.) that calls for the
president to establish an outreach and awareness campaign about the Global
Fund, encouraging private donations, developing public service
announcements and establishing a Web site.

* A measure sponsored by Rep. Billy Tauzin (R-La.) that calls for
priorities on the "distribution of resources" to specific countries based
on size, demographics and other factors to "ensure the countries that need
assistance the most receive it first." The amendment also commissions the
Institute of Medicine to conduct a report to compare the success of
different HIV/AIDS prevention programs and methods proposed in the bill
(House floor proceedings, 5/1).


Reaction


Rep. Barbara Lee (D-Calif.) said that the bill's passage sends a message to
the world that "the United States will not sit idly by and allow AIDS to
wreak havoc," adding, "Each village, each organization knows what strategy
works best in addressing this problem. ... We have to marshal every way to
fight this pandemic, and we need a balanced approach." Ken Conner,
president of the Family Research Council, said, "Today's vote shows the
efforts of the pro-family lobby paid off. Simply tossing out condoms and
creating the illusion of safe sex does not work. Teaching abstinence ...
does work" (San Francisco Chronicle, 5/2). Irish rock star and AIDS and
debt relief advocate Bono said, "This is the America that put a man on the
moon, that's getting ready to lead the war against AIDS in Africa." He
added, "On to the Senate, where we're hoping for a victory as soon as
possible" (Zuckman, Chicago Tribune, 5/2). Kate Carr, president and CEO of
the Elizabeth Glaser Pediatric AIDS Foundation, said, "We were really
hoping that the Pitts amendment would not be included," adding, "We'd
rather see a more flexible approach" (Washington Times, 5/2). Gloria
Feldt, president of the Planned Parenthood Federation of America, said,
"Tying the hands of health care providers by imposing anti-condom,
abstinence-only restrictions will cause increased suffering and more
deaths" (Chatterjee, Philadelphia Inquirer, 5/2). Nils Daulaire, president
of the Global Health Council, said that the funding requirements included
in the Pitts amendment are "Washington-centric" and could impose "an
enormous amount of bureaucracy and paperwork for people who should be out
there doing the work." However, Daulaire added that the approval of the
bill is "remarkable" and that the United States is "really going to take
the leadership in responding to AIDS around the world" (Washington Post,
5/2).


ACROSS THE NATION

2. Ending Segregation of HIV-Positive Prisoners in Alabama Could Save
Money, Study Says

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=17499

Alabama's prison system could save between $306,000 and $392,000 a year by
ceasing to segregate HIV-positive prisoners from the general prison
population, according to a report released Tuesday by the Alabama Prison
Project and the American Civil Liberties Union's National Prison Project,
the AP/Tuscaloosa News reports (Bryan, AP/Tuscaloosa News, 4/30). The
study, titled "Excluding Alabama State Prisoners with HIV/AIDS from
Community-Based Programs," found that if Alabama ended prison segregation,
44 inmates would be eligible to join state-run community corrections
programs and 12 inmates would be eligible for community-based corrections
programs. Because community corrections programs cost the state $11
dollars a day per person -- $15 a day less than it costs to keep an inmate
in prison -- a change in policy could save the state up to $392,000 each
year. Under the Alabama system, HIV-positive inmates are provided with
basic services but are prohibited from participating in such community
corrections programs such as work release or Supervised Intensive
Restitution programs (Bailey, Birmingham News, 4/30). Alabama, whose
prison system is "cash-strapped" and "overcrowded," is the only state that
still segregates HIV-positive prisoners, according to the AP/News
(AP/Tuscaloosa News, 4/30). The policy was under attack for nearly 16
years until the Supreme Court last year refused to hear an appeal in which
some of HIV-positive inmates accused Alabama of "unconstitutional
discrimination" (Kaiser Daily HIV/AIDS Report, 11/25/2002). Prison
Commissioner Donal Campbell has not yet decided whether to maintain the
policy (AP/Tuscaloosa News, 4/30). Campbell pointed out that the possible
savings could be offset by the cost of treating prisoners who may contract
HIV as a result of ending the policy (Birmingham News, 4/30). "For all the
emotional appeal of this idea that you can keep people protected, the
prisons have never done any study that says Alabama's rate of transmission
is any lower than any other state" as a result of the segregation policy,
Rachel Maddow, lead author of the study said (AP/Tuscaloosa News, 4/30).


DRUG ACCESS

3. Mexican Congress Votes Down Bill To Shorten HIV/AIDS Drug Patent
Protections

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=17500

The Mexican Congress on Monday voted 177-172 to reject a bill that would
shorten patent protections on AIDS and cancer drugs from the current 20
years to 10 years, the AP/Santa Fe New Mexican reports. Intellectual
property rights concerns and worries that the bill sponsor's family would
financially benefit from the change motivated opposition to the
legislation, according to the AP/New Mexican. The defeated bill was
sponsored by the Mexican Environmentalist Green Party. Opponents of the
bill said that the Green Party's head, Jorge Gonzalez Torres, had a
personal stake in the measure's passage because his uncle is a leading
shareholder in the country's largest generic drug store chain, according to
the AP/New Mexican. The lower house of Congress did pass a bill that would
allow the government to temporarily license generic production of patented
drugs to combat "serious diseases that cause a national emergency or
threaten national security." Rep. Silvia Alvarez Bruneliere of the
National Action Party said that the bill passed in the lower house would
both meet social needs and protect patents (Stevenson, AP/Santa Fe New
Mexican, 4/29).


SCIENCE & MEDICINE

4. FDA Approves New Formulation of Protease Inhibitor Viracept; Reduced
Pill Burden May Increase Adherence

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=17501

The FDA on Wednesday approved a new formulation of Viracept, also known as
nelfinavir, which could reduce the number of pills HIV patients take each
day and increase adherence to treatment regimens, according to an FDA
release. Viracept, a protease inhibitor that is approved for the treatment
of HIV infection in combination with other antiretroviral drugs, is
available in 50 mg oral powder and 250 mg tablets. The new 625 mg
formulation reduces the number of pills a patient has to take from five 250
mg tablets twice a day to two 625 mg tablets twice a day (FDA release,
4/30). "To help improve adherence, we felt a simplified dosing regimen was
a critical next step for this proven therapy," Richard Ogden, senior
director of scientific development for Agouron Pharmaceuticals, a Pfizer
company, which developed the drug, said, adding, "The new tablets were
designed for ease of use, and we hope that both new and current Viracept
users will find the switch effortless" (Agouron release, 4/30). Agouron
has submitted clinical data showing that the higher exposure is not
dangerous; however, diarrhea may be more common in patients who take the
625 mg tablets (FDA release, 4/30).

5. New HIV Vaccine Set To Begin Phase I Clinical Trials in June

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=17502

Phase I clinical trials of a new HIV vaccine are set to start in
Switzerland and the United Kingdom in June, researchers announced on
Tuesday, Reuters Health reports. The study, organized by the European
Vaccine Effort Against HIV/AIDS, or EuroVac, will test the safety of the
vaccine on about 160 healthy volunteers -- half at St. Mary's Hospital in
London and half at the Lausanne University Hospital in Lausanne,
Switzerland. Researchers plan to test the first part of the vaccine --
DNA-C, which contains genetic information for particular proteins that are
present on the HIV cell -- on 40 volunteers at each site. The remaining
trial participants will receive the NYVAC part of the vaccine, which
"boost[s]" the effect of the first vaccine. The researchers hope that the
vaccine will be able to trigger participants' bodies to produce HIV
antibodies that can fight off infection. The second phase of the vaccine
trials, in which researchers will test the safety of DNA-C and NYVAC used
in combination, is slated for 2004. The third phase of the trials,
scheduled for 2005, will test the efficacy of the vaccines on hundreds of
volunteers who are at high risk for HIV infection -- including men who have
sex with men, injection drug users and sex workers -- in Switzerland, the
Netherlands, the United Kingdom, Spain, Italy, Germany and Sweden. The
EuroVac program is a collaboration of more than 30 research teams in eight
European countries, including Hans Wolf of the University of Regensburg in
Germany, who developed the DNA-C vaccine, and French pharmaceutical company
Aventis, which developed the NYVAC booster. If the combination vaccine is
found to be effective, it will be administered to large segments of the
populations of Tanzania, Rwanda, South Africa, China and Russia, according
to Reuters Health (Reuters Health, 4/30).


OPINION

6. Illinois Senate Takes 'Half-Step' Toward Reducing HIV Vertical
Transmission, Chicago Tribune Editorial Says

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=17503

The Illinois Senate has taken a "half-step" toward reducing
mother-to-child HIV transmission by considering a bill (SB 263) that would
require health care professionals to provide pregnant women with HIV
counseling and voluntary testing, a Chicago Tribune editorial says (Chicago
Tribune, 5/1). The bill, which has already passed the Senate and is
expected to be considered in the House soon, would require that any
pregnant woman who decides to be tested for HIV sign an informed consent
form before undergoing the test, a system otherwise known as "opt-in"
testing. However, under the measure, infants born to women whose HIV status
is not known would automatically be tested for the virus, unless the mother
signed a form to "opt-out" of the infant testing (Kaiser Daily HIV/AIDS
Report, 4/22). However, "the impact of the legislation is likely to be
modest" because women can still refuse the test, the editorial says. If
doctors are "too busy or too insensitive" to provide adequate counseling,
the requirements "could turn out to be a complete dud," the editorial
states. However, if properly administered, the counseling provision "is
likely to have the greater impact," as it could change high-risk behavior
and prompt a young woman who became pregnant through unprotected sex from
contracting HIV in the future, the Tribune says. The editorial concludes,
"To make a more serious dent in the spread of HIV/AIDS ... legislators will
have to tackle issues such as teenage sex, condom distribution,
needle-exchange programs -- and in all likelihood, they will have to
revisit the routine testing of newborn babes" (Chicago Tribune, 5/1).


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