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Thursday, July 3, 2003

SPECIAL NOTICE
========================================
1. Kaiser Daily Reports Will Not Publish Friday, July 4


POLITICS AND POLICY
========================================
2. Bush's Nomination of Tobias as Global AIDS Coordinator Draws Mixed
Reaction From AIDS Advocates

3. HHS Announces 45 Ryan White CARE Act Grants To Serve Low-Income
HIV-Positive Individuals


GLOBAL CHALLENGES
========================================
4. China, India Facing AIDS 'Catastrophe,' CDC Head Says

5. HIV/AIDS Rates in Caribbean Rising Because of Expensive Treatment, Sex
Tourism, Stigma


SCIENCE & MEDICINE
========================================
6. FDA Approves New Gilead Antiretroviral Drug Emtriva

7. Poor Adherence to HIV/AIDS, Other Disease Treatment Regimens
'Increasing, World-Wide Problem,' WHO Report Says

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

SPECIAL NOTICE


1. Kaiser Daily Reports Will Not Publish Friday, July 4

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18624

The Kaiser Daily HIV/AIDS Report will not publish Friday, July 4, in
observance of Independence Day. The report will resume publishing Monday,
July 7.


POLITICS AND POLICY


2. Bush's Nomination of Tobias as Global AIDS Coordinator Draws Mixed
Reaction From AIDS Advocates

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18625

As expected, President Bush yesterday named Randall Tobias, former chair
and CEO of drug maker Eli Lilly, as head of a new State Department office
assigned to oversee the global AIDS initiative, the Indianapolis Star
reports (Penner, Indianapolis Star, 7/3). U.S. officials from several
government departments and agencies have been working since February to
develop a global AIDS bureau in the State Department to oversee the
initiative (HR 1298), which authorizes $3 billion a year over five years
for HIV/AIDS programs in Africa and the Caribbean, with up to $1 billion in
fiscal year 2004 going to the Global Fund to Fight AIDS, Tuberculosis and
Malaria. However, work has been delayed by the lack of a coordinator. As
the global AIDS czar, Tobias would work under the secretary of state, and
he would be able to distribute funds directly to nongovernmental
organizations and transfer funds between government agencies. The position
will carry the rank of ambassador (Kaiser Daily HIV/AIDS Report, 7/2).

Delivering Drugs


Bush said, "I have chosen a superb leader who knows a great deal about
lifesaving medicines and who knows how to get results" (Indianapolis Star,
7/3). "Randy Tobias has a mandate directly from me to get our AIDS
initiative up and running as soon as possible," Bush added (Bumiller, New
York Times, 7/3). Bush also said that the administration would work with
Tobias to "get help to the people who need it most by purchasing low-cost
antiretroviral medications and other drugs that are needed to save lives."
Bush added, "We will set up a broad and efficient network to deliver drugs
to the furthest reaches of Africa, even by motorcycle or bicycle" (Epstein,
San Francisco Chronicle, 7/3). Tobias said, "AIDS has already killed
almost 20 million people in sub-Saharan Africa, where it is the number one
cause of death. And without intervention, it will claim the lives of
one-quarter of the population in the next decade," which is "nearly
incomprehensible" (Washington Times, 7/3). Tobias added that he would meet
his new position "with enthusiasm and with optimism" (New York Times, 7/3).
The Senate Foreign Relations Committee, chaired by Sen. Richard Lugar
(R-Ind.), will consider Tobias' nomination before it is debated on the
Senate floor (Indianapolis Star, 7/3). Senate Majority Leader Bill Frist
(R-Tenn.) said that Tobias' nomination should "move quickly" through the
Senate (Washington Times, 7/3).

Drugs and ABCs


Some AIDS advocates are concerned that Tobias' link to the drug industry
could "undercut th[e] goal" of making inexpensive antiretroviral drugs
available to countries hardest-hit by the pandemic, the Chronicle reports
(San Francisco Chronicle, 7/3). Nathan Geffen, national manager of South
Africa's Treatment Action Campaign, said that Tobias' nomination
"demonstrates incredible lack of tact and respect for people with HIV
living in the developing world who frequently cannot access life-saving
medicines," adding, "He's certainly not someone who's known for being at
the forefront of AIDS" and his nomination has the "potential to be quite
detrimental" (Indianapolis Star, 7/3). Family Research Council's vice
president for government affairs Connie Mackey said, "We are concerned that
Mr. Tobias does not have a proven track record of supporting the effective
strategies to combat AIDS," adding, "The White House must ensure that Mr.
Tobias follows the A-B-C model to combating AIDS." Michael Schwartz, vice
president for government relations at Concerned Women for America, said,
"CWA applauds Mr. Tobias for sharing the philosophies of this president and
accepting the nomination to carry out this historic initiative to implement
the Ugandan model" (Washington Times, 7/3). Dr. Joe McIlhaney, president
and founder of the Medical Institute for Sexual Health and a member of the
Presidential Advisory Council on HIV and AIDS, said that he has "no doubt"
that Tobias will advocate the ABC model of AIDS prevention (Medical
Institute for Sexual Health release, 7/2).

Management Experience


Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS
Foundation, said that Tobias "needs to coordinate the efforts of all
relevant federal agencies, work hard to avoid unnecessary bureaucracy, and
move resources quickly into the field where they are urgently needed"
(Riechmann, AP/Long Island Newsday, 7/2). He added that Tobias "does seem
to [have] some management acumen and the ability to pull a lot of levers"
(New York Times, 7/3). HHS Secretary Tommy Thompson said that Tobias will
"bring a wealth of valuable experience to this mission, and his appointment
signals once again the president's high commitment to fighting HIV/AIDS
worldwide" (HHS release, 7/2). AIDS Healthcare Foundation President
Michael Weinstein said, "Given the enormity of the stakes in terms of human
life and the difficult waters he'll have to navigate, we wish Mr. Tobias
well in this new role" (AHF release, 7/2).

Global AIDS Alliance Report


Paul Zeitz, executive director of the Global AIDS Alliance, said, "This
decision [to nominate Tobias] is another troubling sign that the president
may not be prepared to fulfill his pledge to take emergency action on AIDS.
This raises serious questions of conflict of interest and the priorities of
the White House. Both the people of Africa and the people of the United
States will lose if the president's AIDS initiative fails to use the
lowest-cost, generic medications" (San Francisco Chronicle, 7/3). GAA last
week released a report examining the president's "unfulfilled promises"
related to the AIDS pandemic (GAA release, 7/2). The report, titled "The
Truth about President Bush's $15 Billion 'Emergency' AIDS Pledge... Is it
all Spin and Broken Promises?," is a briefing note on the president's
upcoming trip to Africa, which "should not be a victory lap around the
continent; in fact, it is his last chance to deliver on his pledge" to
fight AIDS in Africa, according to the report (GAA report, 7/2). Zeitz
said, "We call on the Senate to carefully scrutinize this nomination.
Senators from both sides of the aisle should fully investigate the
continuing relationship between Mr. Tobias and the pharmaceutical industry"
(GAA release, 7/2).

Looking to Africa


The Tobias announcement comes less than a week before Bush is scheduled to
visit five African nations -- Senegal, South Africa, Botswana, Uganda and
Nigeria -- to promote economic development and the fight against HIV/AIDS
(Kaiser Daily HIV/AIDS Report, 7/2). During his trip, Bush will "stee[r]
clear" of "hotspots" and instead visit countries that have already "made
headway in democratic development," such as Uganda, which has also shown
success in curbing HIV/AIDS, the Associated Press reports (Gedda,
Associated Press, 7/3). Some advocates are concerned that Bush's Africa
trip and the AIDS initiative could be a "premature ... credit ... for an
effort [that] will move too slowly," Reuters reports (Richwine, Reuters,
7/2). Jeffrey Sachs, director of the Columbia University Earth Institute,
said, "I don't think that this administration understands the magnitude of
the calamity" of HIV/AIDS, tuberculosis and malaria in Africa. Sachs added
that the administration is "cutting programs in other areas of health to
make way for the meager first installment on the AIDS program. The
president should take the opportunity of this trip to open his eyes and get
a little education about the realities ... Africa faces" (Borst, Associated
Press, 7/2). Jamie Drummond, executive director of DATA, said, "Whether
this trip is ... a real change for Africa will be debated in [Washington]
D.C." during the appropriations process. Drummond added that Congress
should fulfill Bush's budget requests but that "the president needs to
fight ... to make that happen" (Reuters, 7/2). The White House yesterday
released a fact sheet detailing the President's "Emergency Plan for AIDS
Relief" (White House fact sheet, 7/2).

A video excerpt of CNN's coverage of Bush's announcement is available
online in RealPlayer.

NPR's "All Things Considered" yesterday reported on Tobias' nomination.
The segment includes comments from Bush, Tobias, Zeitz and Africa Action
Executive Director Salih Booker (Wilson, "All Things Considered," NPR,
7/2). The full segment is available online in RealPlayer.

3. HHS Announces 45 Ryan White CARE Act Grants To Serve Low-Income
HIV-Positive Individuals

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18626

HHS Secretary Tommy Thompson on Tuesday announced 45 Ryan White CARE Act
grants totaling $23 million to help communities provide primary care and
outpatient services to low-income individuals who are HIV-positive or who
are at risk for contracting the virus, according to an HHS release. The
grants, awarded under the Title III Early Intervention Services program of
the CARE Act, will go to hospitals, medical centers, community-based
clinics, public health departments and universities in 22 states and the
District of Columbia to provide counseling, testing and referral, medical
evaluation, clinical care, oral health care, adherence counseling,
nutritional counseling, outpatient mental health care, outpatient substance
abuse care and referral for specialty and subspecialty care. The grants
target the "communities that need it most," such as inner cities and
remote, rural areas, according to the release. "These grants help
community-based organizations reach out to those who may be HIV-positive
but don't know it, and get them into care," Thompson said, adding, "Early
and continuous care can help these individuals live longer, more productive
lives." Since fiscal year 1991, when the CARE Act was first funded, almost
$13.7 billion has been allocated for programs that have served
approximately 530,000 uninsured HIV-positive individuals (HHS release,
7/1).

GLOBAL CHALLENGES


4. China, India Facing AIDS 'Catastrophe,' CDC Head Says

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18627

China and India, the world's two most populous nations, are facing an AIDS
"catastrophe," CDC Director Julie Gerberding said today at a briefing in
Singapore, CNN.com reports (CNN.com, 7/3). Gerberding also said that
Cambodia would face a crisis unless additional international efforts to
stem the spread of HIV in Asia are developed. "[I]n some countries, like
Cambodia and China and India, the public health measures have yet to take
hold," Gerberding said. She added that the epidemic "is really in that
phase of scaling up very, very quickly. It looks like Africa did a decade
or so ago. If we don't intervene in those environments we will have a
catastrophe. A very, very profound increase in the number of cases."
Gerberding -- who is touring Asia with U.S. Deputy Assistant Secretary of
State Jack Chow to assess regional infectious diseases and provide
technical advice following the outbreak of severe acute respiratory
syndrome, or SARS -- praised Thailand for its efforts to fight HIV/AIDS.
According to the United Nations, China had between 800,000 and 1.5 million
HIV-positive people by December 2001, and the number could grow to 10
million by 2010. In India, the government estimates that four million
people are living with HIV, but a U.S. study released last year predicted
that there would be between 20 million and 25 million HIV-positive Indians
by 2010 (Agence France-Presse/Yahoo! News, 7/3). An estimated 158,000
HIV-positive people live in Cambodia (CNN.com, 7/3). Chow said that there
would be an additional 80 million HIV/AIDS cases by the end of the decade
in China, India, Russia, Ethiopia and Nigeria alone (Agence
France-Presse/Yahoo! News, 7/3).

5. HIV/AIDS Rates in Caribbean Rising Because of Expensive Treatment, Sex
Tourism, Stigma

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18628

HIV/AIDS rates in the Caribbean, which currently has the second highest
HIV prevalence in the world after sub-Saharan Africa, are rising because of
the high cost of treatment, an increase in sex tourism and societies that
"condone male promiscuity but stigmatize HIV," NPR's "All Things
Considered" reports. According to the United Nations, AIDS is the leading
cause of death of Caribbean men and women ages 15 to 45. Last year, 42,000
people in the Caribbean died of AIDS-related causes, and 440,000 people in
the region currently are living with the disease. Robert Carr of Jamaica
AIDS Support, an umbrella group of 60 AIDS-related outreach programs, said
that Caribbean society "values a certain level of machismo that promotes
multiple partners for men," adding that the culture "sort of sets us up for
the kind of spread of the epidemic that we've been seeing." HIV/AIDS is
"not something openly discussed" in the Caribbean because "the disease is
seen as a death sentence, creating fear around even acknowledging it,"
according to NPR. Nina Ferencic, coordinator of the U.N. Office of AIDS for
Latin America, said that the "reluctance is heightened" by the "reality" of
living in small, island communities. The NPR segment also includes comments
from Verity Rushton of the Jamaican Ministry of Health's AIDS program
(Hadden, "All Things Considered," NPR, 6/2).

The full segment is available online in RealPlayer.

SCIENCE & MEDICINE


6. FDA Approves New Gilead Antiretroviral Drug Emtriva

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18629

The FDA yesterday approved Foster City, Calif.-based Gilead Sciences'
experimental drug Emtriva for use in combination with other antiretroviral
medications for the treatment of HIV in adults, the New York Times reports
(Pollack, New York Times, 7/3). The drug, also known as emtricitabine, is
the company's second once-daily antiretroviral to gain FDA approval
(Jacobs, San Jose Mercury News, 7/3). The FDA in October 2001 approved
Gilead's antiretroviral Viread, a nucleotide reverse transcriptase
inhibitor, for the treatment of HIV-positive patients (Kaiser Daily
HIV/AIDS Report, 10/29/01). Emtriva, which Gilead obtained when it
purchased Triangle Pharmaceuticals, is a once-daily nucleoside reverse
transcriptase inhibitor, which blocks an enzyme that is necessary for HIV
replication (Ranii, Raleigh News & Observer, 7/2). Gilead said that it
hopes by 2005 to be able to compete with GlaxoSmithKline's Combivir, which
combines Epivir and Retrovir, by launching a combination pill containing
Emtriva and Viread, which would provide the convenience of once-daily
dosing for two drugs, according to the Wall Street Journal (Hamilton, Wall
Street Journal, 7/3).

Developing Country Sales Not Likely


Gilead in April began to sell Viread at approximately one-tenth of its
retail price to 68 developing countries (Kaiser Daily HIV/AIDS Report,
4/4). However, John Milligan, CFO of Gilead, said that due to the high
cost of production, Emtriva would not be affordable to developing countries
even if it were sold at cost. The company plans to offer the drug to
developing countries after the completion of its efforts to streamline the
manufacturing process and reduce production costs, Milligan said (Gellene,
Los Angeles Times, 7/3). According to Gilead spokesperson James Loduca,
Emtriva should be available in pharmacies next week. The wholesale price
will be $252.83 for a one-month supply (Ranii, Raleigh News & Observer,
7/3).

7. Poor Adherence to HIV/AIDS, Other Disease Treatment Regimens
'Increasing, World-Wide Problem,' WHO Report Says

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18630

Poor adherence to the long-term treatment regimens of chronic diseases
such as HIV/AIDS is an "increasing, world-wide problem," with adherence
rates averaging only 50% in developed countries and lower percentages in
developing countries, according to a report released Tuesday by the World
Health Organization, Xinhua News Agency reports (Xinhua News Agency, 7/1).
The report, titled "Adherence to Long-Term Therapies, Evidence for Action,"
found that in the Gambia, China and the United States, adherence to
HIV/AIDS treatment regimens ranges from 37% to 83% (WHO release, 7/1).
Nonadherence to highly active antiretroviral therapy can have important
public health implications, including the development of drug-resistant HIV
that can be transmitted to others and that can limit patients' therapeutic
options. The main factors that affect adherence to such regimens include
the complexity and potential side effects of the regimen, the beliefs and
psychosocial status of the patient and the relationship between the patient
and care providers. The report suggests that providers should try to
improve their patients' adherence by actively involving them in treatment
decisions; providing appropriate support, counseling and education; and
tailoring treatment regimens to fit patients' lifestyles ("Adherence to
Long-Term Therapies, Evidence for Action," 7/1). The report says that the
adherence problem will grow as the burden of chronic diseases increases;
noncommunicable diseases, mental health disorders, HIV/AIDS and
tuberculosis combined represented 54% of the global burden of illness in
2001 and are expected to account for more than 65% in 2020 (WHO release,
7/1).

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