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Friday, August 8, 2003

POLITICS AND POLICY
========================================
1. Bush Administration Uses 'Misleading Statements' To Support Ideology,
Report by House Committee Democrats Says

2. Bush Administration Appoints Edward Green to Presidential Advisory
Council on HIV and AIDS

3. National Journal Uses Global AIDS Initiative as Example of 'Mismatch
Between Rhetoric, Reality' in Appropriations Process


GLOBAL CHALLENGES
========================================
4. Lesotho Parliament President Calls for Country's Chiefs To Undergo
Voluntary HIV Testing

5. Nigerian President Launches New HIV/AIDS Policy Aimed at Reducing Stigma


DRUG ACCESS
========================================
6. About 200 HIV-Positive Venezuelans Protest at Social Security Offices
Over Access to HIV/AIDS Medicines


SCIENCE & MEDICINE
========================================
7. FDA Orders Gilead for Second Time To Stop Downplaying Risks, Inflating
Benefits of Antiretroviral Drug Viread

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

POLITICS AND POLICY


1. Bush Administration Uses 'Misleading Statements' To Support Ideology,
Report by House Committee Democrats Says

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19264

The Bush administration has "manipulated the scientific process and
distorted or suppressed scientific findings" in order to support its
ideology on issues ranging from sex education to the environment, according
to a report released yesterday by the minority staff of the House Committee
on Government Reform, the New York Times reports (Marquis, New York Times,
8/8). The 40-page report, titled "Politics and Science in the Bush
Administration," was prepared for Rep. Henry Waxman (D-Calif.) by the
committee's minority staff special investigations division (Weiss,
Washington Post, 8/8). The report covers more than 20 subject areas, which
"span a broad range" but "share a common attribute: the beneficiaries of
the scientific distortions are important supporters of the president,
including social conservatives and powerful industry groups," according to
the report (House Committee on Government Reform Minority Staff, "Politics
and Science in the Bush Administration," August 2003).

Subjects


The report says that the administration altered "performance measures" used
to establish the effectiveness of abstinence-only sex education programs to
make it easier to claim that the programs are effective, according to the
Washington Post. In addition, the administration removed from the CDC Web
site information about condom use, as well as data showing that
comprehensive sex education does not lead to increased sexual activity
among teenagers. The report also says that the administration changed a
National Cancer Institute Web site to "impl[y]" that scientific evidence
supported a link between abortion and an increased risk of breast cancer,
according to the Post. In addition, the report says that Bush appointed
"numerous people with political, rather than scientific credentials" to
important scientific advisory committees, including the appointment of
Jerry Thacker to the Presidential Advisory Council on HIV and AIDS, the
Post reports (Washington Post, 8/8). Thacker, a Pennsylvania marketing
consultant who has called AIDS a "gay plague" and homosexuality a
"deathstyle," withdrew his name on Jan. 23 after the White House,
Democratic lawmakers and AIDS and gay-rights advocates criticized his
appointment (Kaiser Daily HIV/AIDS Report, 2/5). According to a Waxman
spokesperson, the report will be updated on the Web site as new examples of
the Bush administration's "purported abuses" arise, the Post reports
(Washington Post, 8/8).

Drawing Conclusions


The report concludes that the administration's "political interference with
science has led to misleading statements by the president, inaccurate
responses to Congress, altered Web sites, suppressed agency reports,
erroneous international communications and the gagging of scientists"
(House Committee on Government Reform Minority Staff, "Politics and Science
in the Bush Administration," August 2003). White House spokesperson Scott
McClellan "dismissed" the report, according to the Times. He added, "This
administration looks at the facts and reviews the best available science
based on what's right for the American people. The only one who is playing
politics about science is Congressman Waxman. His report is riddled with
distortion, inaccuracies and omissions" (New York Times, 8/8).

2. Bush Administration Appoints Edward Green to Presidential Advisory
Council on HIV and AIDS

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19265

The Bush administration has appointed Edward Green, a senior research
scientist at the Harvard School of Public Health who supports the "ABC" HIV
prevention model, to the Presidential Advisory Council on HIV and AIDS, the
Washington Times reports (McCaslin, Washington Times, 8/8). Green supports
a comprehensive approach to HIV prevention that includes abstinence, condom
use and faithfulness to sexual partners, with the latter likely being the
most important, according to Green (Kaiser Daily HIV/AIDS Report, 6/23).
According to the Times, Green has said that "it is not 'abstinence only' or
'condoms only.' Both are needed. There is a need for condoms if A and B
fail. Some people will never change their behavior," including some
high-risk groups such as sex workers and their customers. After being sworn
in this week by HHS Deputy Secretary Claude Allen, Green said in a letter,
"I hope to have some influence on how we conduct AIDS prevention in the
future (effective prevention remains my primary focus)" (Washington Times,
8/8).

3. National Journal Uses Global AIDS Initiative as Example of 'Mismatch
Between Rhetoric, Reality' in Appropriations Process

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19266

The real success of a federal program, such as President Bush's five-year,
$15 billion global AIDS initiative (HR 1298), "is not its creation, but
whether it receives the money it needs," National Journal reports in a
cover story in its Aug. 2 issue on the congressional appropriations
process. When the House in May passed the bill authorizing $3 billion a
year for five years to fight AIDS in Africa and the Caribbean,
International Relations Committee Chair Henry Hyde (R-Ill.) said that
Congress "rarely" acts with such "decisiveness for the benefit of so many
suffering in the developing world," according to National Journal. "[I]t
turns out that Hyde was right," the article says, adding that in the case
of the AIDS bill, "[d]espite all the talk," appropriations bills moving
through Congress would allocate "only" $2 billion for the first year of the
program -- "not the $3 billion promised." In addition, "to provide cover
for congressional Republicans," Joseph O'Neill, director of the White House
Office of AIDS Policy, sent the committees letters calling the amount
"sufficient." National Journal concludes that the AIDS initiative is "just
one example of the mismatch between rhetoric and reality in Washington,"
which is "unlikely to change anytime soon ... [since] [a]uthorizers love
their power to create programs, while appropriators relish their power to
decide how much money those programs should receive" (Baumann, National
Journal, 8/2).

GLOBAL CHALLENGES


4. Lesotho Parliament President Calls for Country's Chiefs To Undergo
Voluntary HIV Testing

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19267

The President of Lesotho's Upper House of Parliament Chief Sempe Lejaha on
Wednesday called for chiefs in the country to be tested voluntarily for HIV
to help reduce the stigma associated with the disease, the Associated Press
reports. He said that the chiefs could use their "high cultural stature"
to fight the epidemic facing the small country, where approximately 31% of
the nation's 2.1 million people are HIV-positive, according to the
Associated Press. Lejaha said during a press conference, "HIV voluntary
counseling and testing will help reduce stigmatization in the communities"
(Molefe, Associated Press, 8/6).

5. Nigerian President Launches New HIV/AIDS Policy Aimed at Reducing Stigma

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19268

Nigerian President Olusegun Obasanjo on Monday announced a new national
HIV/AIDS policy to address the stigma associated with the disease and
"promote a sense of collective responsibility" for fighting the AIDS
epidemic, U.N. IRIN/AllAfrica.com reports. He said that the new policy
addresses the "vulnerability" of women and children to the disease and aims
to create a new law to protect the civil rights of people living with
HIV/AIDS. The policy also calls for increased "support and care" for
people living with the disease, according to U.N. IRIN/AllAfrica.com.
Obasanjo said that Nigeria will "intensify" its education projects to help
reduce HIV/AIDS stigma. "Stigmatization is largely a communication issue,
which is based on insufficient information flow and in turn breeds rumor
mongering," Obasanjo said, adding, "Our policy identifies the importance of
upholding and protecting the rights of all Nigerians, including people
living with or affected by HIV/AIDS." Babatunde Osotimehin, chair of the
country's National Action Committee on AIDS, said that the new policy will
address HIV/AIDS as a "development problem rather than just a health issue,
as was the case with the previous policy," according to U.N
IRIN/AllAfrica.com. He added, "It also seeks to provide a platform for us
to do a lot of prevention and provide ... care and support for those
infected and affected" (U.N. IRIN/AllAfrica.com, 8/5).

Increased Treatment Access


Taiwo Adewole, head of the AIDS unit at the Nigerian Institute of Medical
Research in Lagos, said that efforts launched last year to control HIV/AIDS
were limited by "several obstacles," including an inability to monitor the
AIDS control program, a lack of coordination among antiretroviral drug
units and no follow-up care for HIV/AIDS patients, Reuters reports. The
program involves the distribution of generic antiretroviral drugs from
India to 10,000 Nigerian HIV/AIDS patients through 25 drug units across the
country. The drugs are obtained for about $90 per person and provided to
patients for $10; however, patients also have to cover additional costs of
approximately $50 for tests performed three to four times annually, Reuters
reports. Adewole said, "Our records show that many of those within the 15
to 30 (age bracket), which forms the highest prevalence rate of infected
people, don't come to the centers for treatment." He added, "The
government has to create a platform for more people to get access to the
antiretrovirals because the number of 200 sufferers budgeted for by each
center is too small" (Ibagere, Reuters, 8/7).

DRUG ACCESS


6. About 200 HIV-Positive Venezuelans Protest at Social Security Offices
Over Access to HIV/AIDS Medicines

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19269

Approximately 200 HIV-positive people in Caracas, Venezuela, on Wednesday
protested at the country's Social Security Institute (IVSS), calling on the
agency to use donations for the importation and domestic production of some
HIV/AIDS medicines, EFE News Service reports. Carlos Quintero, president
of the HIV/AIDS advocacy group Accion Solidaria, said that the agency has
not paid any of the $4 million it originally pledged to use for the
importation and production of HIV/AIDS medicines. In recent weeks, more
than 3,500 HIV-positive individuals have registered with groups in
Venezuala that donate medicines because of a shortage of available
treatments at the IVSS and a "delay in obtaining funds to import them,"
according to EFE News Service. Since a May 2002 Venezuelan Supreme Court
ruling, the IVSS has been required to cover the costs of treatment and
medicines for its members living with HIV/AIDS. IVSS also makes voluntary
donations to nongovernmental organizations treating HIV-positive people who
do not qualify for treatment under the public health system. Quintero
said, "I have had to turn some patients away because we don't have enough
medicines," which he said could negatively affect patients who stop taking
their medications. The Venezuelan Health Ministry, which began registering
HIV-positive individuals in 1987, estimates that there are approximately
100,000 people in the country living with HIV/AIDS (EFE News Service, 8/6).

SCIENCE & MEDICINE


7. FDA Orders Gilead for Second Time To Stop Downplaying Risks, Inflating
Benefits of Antiretroviral Drug Viread

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19270

The FDA for the second time in little more than a year has ordered Gilead
Sciences to stop downplaying the risks and inflating the benefits of its
antiretroviral drug Viread, the Los Angeles Times reports (Douglass, Los
Angeles Times, 8/8). Thomas Abrams, director of the FDA's division of drug
marketing, advertising and communications, wrote in a July 29 letter to
Gilead that the company's representatives at an early April AIDS conference
failed to disclose the risks of acid accumulation and severe liver
enlargement associated with Viread and claimed that the drug could be used
in a broader range of patients than the group of patients for whom it is
approved (Beasley, Reuters, 8/7). Representatives at the conference
exhibit said that Viread is more potent, has fewer side effects and is
safer than similar antiretroviral drugs, claims which Abrams says there are
no "data from head-to-head clinical trials to substantiate." Abrams said
that the representatives' actions are "particularly troubling" because the
company had been issued a similar warning in March 2002 (Los Angeles Times,
8/8). The FDA in a March 14, 2002, letter criticized the company over
statements made by its representatives to physicians attending a scientific
conference in December 2001. The FDA said that Gilead representatives told
doctors that Viread has "no toxicities" and is a "miracle drug" (Kaiser
Daily HIV/AIDS Report, 3/27/2002). The company is required to respond to
the FDA in writing by Aug. 12 with details of its plans to identify and
correct violations and to retrain its sales force. Failure to respond
could result in regulatory action, including seizure and injunction,
according to the letter. Gilead spokesperson Amy Flood said that the
company believes the violations were an "isolated incident," adding that
Gilead takes the FDA's concerns "very seriously." Flood said that the
company will be "working to respond to the FDA" (Reuters, 8/7).

Investor's Business Daily Examines Future Product


Investor's Business Daily today profiles Gilead's efforts to compete in the
antiretroviral drug market, including its efforts to gain approval for its
Viread-Emtriva combination pill, which the company hopes to launch by 2005.
The full article is available online (Lau, Investor's Business Daily, 8/8).

________________________________________

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