“The Blue Sheet” Vol. 36, no. 8

February 24, 1993

"The Blue Sheet"

-11 -
Vt.). Schiff is the ranking minority member; Barrett,
Horn and Mica are freshmen.
A former hospital administrator at Beth Israel Center, Towns also serves on two House Energy and Commerce panels: the Commerce, Consumer Protection and
Competitiveness Subcommittee, and the Health and the
Environment subcommittee. In the 102nd Congress,
Towns chaired the Congressional Black Caucus. Towns
was first elected as a Representative of the 11th district
in New York in 1982.
According to staffers, Towns has a strong interest in
health care reform, with an eye toward improving access
to care among underserved populations. Last session,
Towns successfully worked to pass legislation aimed at
expanding Medicaid eligibility for residential treatment
of pregnant women who are substance abusers. Towns
also has an interest in AIDS and food safety issues, as
well as consumer access to alternative therapies.
With regard to oversight of the Food and Drug
Administration, Towns will carefully monitor whether
user fees enacted last year for new drug application
reviews by the agency actually expedite drug approvals,
according to staffers. The first-year impact of the FDA
user fee bill was projected to be $36 mil. in additional
funds for drug and biologic review activities in the bill
that passed the House last October.
Towns succeeds Rep. Ted Weiss, who died last
year, as chairman of the subcommittee. During his
10-year tenure as head of the subcommittee, Weiss
actively monitored government health agencies including
NIH and FDA. For example, he held hearings on such
issues as the pace of NIH research on AIDS-related
opportunistic infections and FDA regulation of breast
implants and other silicone products.
INEWS~ CA ULS
The HIV therapeutic vaccine multi-candidate
trial protocol developed by NIH's gpl60 panel has
been finalized and will be sent to the congressional
appropriations committees in early March. The protocol
will also be sent to members of the advisory committee
to the NIH director within the next week. The final
protocol recommends that the Department of Defense,
with its $20 mil. appropriation to conduct a Phase III
efficacy trial with a gp160 therapeutic vaccine candidate, conduct a multi-candidate trial with a focus on
individuals with CD4 cell counts of 200-500. The large
scale trial would cost an estimated $14-23.5 mil. An
earlier protocol, which will also be included in the recommendation sent to Congress, outlined a larger, more
expensive trial ("The Blue Sheet" Jan. 27, p. 6)....

RU 486 manufacturer Roussel-Uclaf's President
Edouard Sakiz will reportedly meet with Food and
Drug Administration Commissioner David Kessler
Feb. 24 in Washington, D.C. to discuss the possibility
of U.S. distribution of the drug. HHS Secretary Donna
Shalala has directed FDA to review the agency's import
ban on RU 486 (mifepristone), the company's abortifacient drug, following President Clinton's Jan. 22 order
calling for the policy changes ("The Blue Sheet" Feb.
10, p.12). In a Dec. 15 letter to Rep. Ron Wyden (DOre.), FDA said that review of the foreign clinical trials
data on RU 486 could be completed within four to six
months of the company's filing of an NDA (new drug
application) in the U.S. ("The Blue Sheet" Dec. 30, p.
12)....
The first-ever large-scale, simple trial to assess
the timing of anti-HIV treatment will be conducted
pending successful completion of a pilot feasibility
study to be carried out by the Community Partnership
in AIDS/HIV Clinical Trials, in affiliation with San
Francisco General Hospital and the University of San,
Francisco. A Feb. 10 UCSF release describes the study,
known as ComPACT 1, as evaluating "the strategies and
timing of therapy, rather than a specific drug or dosage." The six-month pilot study will aim to enroll 200
local patients. Eligibility criteria are termed "broad"; the
study is open to patients at any CD4 level, without
symptoms, who are uncertain whether to begin HIV
immediately or whether to wait before beginning
therapy....
Patients will be randomized to receive either immediate therapy or to defer therapy, with the choice of
drug "left up to the patient and the health care provider." The larger study would be conducted nationwide
with 10,000 patients over a five-year period. The study
will be directed by the Community Consortium in collaboration with Richard Peto, University of Oxford,
England, and funding will be provided by the American
Foundation for AIDS Research (AmFAR)....
HIV-1 replication and virus breakthrough was
eliminated in vitro in a study conducted by Massachusetts General Hospital and Harvard Medical School
researchers Yung-Kang Chow, et al. In the Feb. 18 issue
of Nature, the team reports that a convergent combination of AZT, ddl and pyridinone was assessed for effectiveness in both prophylaxis and treatment of HIV-1
infection. When the drugs were removed 21 days after
infection of cells, "no viral replication was observed for
the next 30 days," Chow, et al., state. In ongoing infections treated with the convergent combination, p24 was
undetectable 21 days after beginning treatment, and after
drugs were removed at day 56, no viral replication was
observed for the next 45 days....

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