“The Blue Sheet” Vol. 36, no. 8

- 12 -
"The Blue Sheet"

February 24, 1993

When the researchers used a combination of AZT
plus ddl plus nevirapine, they were "unable to select for
viruses triply resistant" to the combination. "The approach used here can be applied to optimize combinations of antiretroviral agents, although extrapolation...to
clinical therapy may be difficult, and MDR may develop
against some convergent combinations," the authors
caution. However, they conclude that the results suggest
"convergent therapy may be beneficial in the treatment
of HIV-1 infections and in post-exposure prophylaxis,
and this will be investigated in clinical trials"....
AIDS is now the third-leading cause of death in
the 26-44 age group, Centers for Disease Control and
Prevention Director William Roper notes in testimony
before the House Appropriations/HHS Subcommittee
Feb. 17. Asked if AIDS-related funding is disproportionate compared to more widespread conditions like cancer
and heart disease, Roper replies that "we have it about
right. AIDS merits a very substantial investment," given
the communicability of the disease. Overall, the nation's
health is generally good, he says, citing positiye trends
in life expectancy and preventive care and decreasing
rates of infant mortality, heart disease and stroke. However, Roper warns of emerging problems related to child
immunizations, the aging of the population and increasing mortality from violence....
Bristol-Myers Squibb's Megace (megestrol acetate)
should be approved for the treatment of anorexia,
cachexia, or weight loss in patients with advanced
AIDS, the Food and Drug Administration's Antiviral
Drugs Advisory Committee recommended by a fiveto-four vote at its Feb. 18 meeting. Two twelve-week
placebo-controlled trials showed a five to seven pound
weight gain in patients who had lost about 30 pounds
when treated with 400 mg to 800 mg of Megace a day
compared to a two pound weight loss in the placebo
groups. There was a total of 20 deaths judged to be
AIDS-related in the 283-patient Megace group, while

two out of 86 placebo-treated patients died. Both Bristol
and FDA reviewers said the mortality difference was not
statistically significant, but did represent a trend. The
company filed an NDA (new drug application) for
Megace oral suspension April 1, 1992, and an NDA for
a tablet formulation in August. The drug has been marketed since the 1970s as a palliative treatment for breast
and endometrial cancers....
Two studies published in the Feb. 17 Journal of the
American Medical Association suggesting a link between vasectomy and prostate cancer are "far too
preliminary to consider vasectomy reversal to reduce the
risk of prostate cancer," according to a same- issue
editorial by Stuart Howards, University of Virginia
Health Sciences Center, et al. Instead, the authors urge
that men who have undergone vasectomy adhere to the
American Urological Association's recommendations on
screening for prostate cancer. Conducted by Edward
Giovannucci, Harvard Medical School, et al., the prospective study of 10,055 men and retrospective study of
14,607 men found that men with vasectomies have a
66% greater chance of developing prostate cancer. That
increased risk rises to 85% for men who had undergone
vasectomy at least 22 years in the past....
The Immunization Now Act (HR 940), introduced
by Rep. Byrne (D-Va.) and seven cosponsors Feb. 17,
proposes immunization vouchers as an alternative to
federal vaccine distribution. The bill would authorize
funding of up to $7 mil. in FY 1994, $12 mil. in FY
1995, and $50 mil. in each subsequent fiscal year to
provide vouchers that could be used for all children
under age two without other health coverage to receive
age-appropriate immunizations for free. The program
would be fully implemented by 1997, including establishment of a registry to track immunizations. Byrne
derived authorization figures based on HHS estimates of
funding needed to cover the target population....

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