Announcements

** Survey Asks Needs of People with AIDS

The National Association of People With AIDS is distributing
35,000 copies of a "Survey of Needs" to map out the major
problems facing people with AIDS. Fifteen questions take up
issues such as type and quality of health care, insurance
coverage, financial security, emotional support and
discrimination. Other questions deal with respondents'
demographic characteristics.

According to Paul Sathrum of NAPWA, "Until now, no one has
documented what people with AIDS think their greatest needs are.
This survey is kind of a run-through that will give us an idea of
what to target in follow-up questionnaires."

Survey results will establish priorities for public policy
lobbying efforts.

Community based AIDS organizations throughout the country
are giving out the questionnaire, which should be sent back by
June 1. If copies of the "Survey of Needs" are not available to
you, they may be obtained by calling NAPWA at (202) 898- 0414.

**Accelerated Approval: Public Comment Period Ends June 15

The U. S. Food and Drug Administration has formalized and
published in the Federal Register a proposal for accelerated
approval of drugs for serious or life-threatening illnesses.
Written comments can be submitted through June 15. These
comments will be considered in drafting the final rule.

The published document combines elements of several
proposals which have been made during the last two years -- by
the Lasagna Committee, by FDA Commissioner David Kessler, M. D.,
and by the Council on Competitiveness. The procedures it
formalizes are essentially those already used in the approval of
ddI, and in the recent recommendation for the approval of ddC
plus AZT combination therapy. The document also includes a
separate provision allowing for approval of certain dangerous
drugs only under restrictions specified by the FDA; examples of
such restrictions include distribution only to specialized
facilities or to physicians with specialized training or
experience, or requiring that certain medical tests be used to
monitor for dangerous reactions.

The proposal specifies that "Drugs or biological products
approved under this proposal will have met the requisite
standards for safety and effectiveness under the Federal Food,
Drug, and Cosmetic Act...and thus will have full approval for
marketing." The purpose of this statement appears to be to put
the FDA on record as opposing discrimination by public or private
health-insurance systems against reimbursing drugs approved under
this provision.

There are also provisions which affect pharmaceutical
companies: for requiring postmarketing studies; for FDA
monitoring of promotional materials used with accelerated-
approval drugs; and for streamlined withdrawal procedures in case
later research does not confirm drug efficacy.

Comment

We strongly support accelerated approval for drugs for
serious and life-threatening illnesses. This proposal has enough
momentum that it will probably be accepted without major
weakening.

There is some danger, however, since the pharmaceutical
industry is likely to object to some of the provisions,
especially for streamlined withdrawal of drugs for other than
safety reasons. This could lead to industry pressures which
would make the rule less usable, as happened with the "treatment
IND" proposal of several years ago. Or some provisions might be
considered so onerous that companies might not to seek
accelerated approval even when they could obtain it. We do not
know whether such problems were effectively worked out in
advance.

For More Information

The accelerated-approval proposal was published in the
Federal Register April 15, 1992, pages 13234-13242. Written
comments should be sent to the Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn
Dr., Rockville, Maryland 20857. For more information, contact
Marilyn L. Watson, Center for Drug Evaluation and Research, FDA,
301/295-8038.

** California: Prisoner Demonstration Rescheduled

The Sacramento demonstration by ACT UP/CHAIN (California HIV
Activist & Inmate Network), originally scheduled for May 4 and
announced in AIDS TREATMENT NEWS issue #149, has been rescheduled
for June 1. The rally begins at 11 a.m. at the State Capitol,
10th St. and Capitol Mall.

For more information, contact your local ACT UP chapter, or
ACT UP/Los Angeles (213/669-7301; P. O. Box 26601, Los Angeles,
CA 90026), ACT UP/San Francisco (415/563-0724; P. O. box 14844,
San Francisco, CA 94114), or ACT UP/Santa Barbara (805/569-3299;
P. O. Box 4899, Santa Barbara, CA 93140).

Comment

The date was changed because organizers felt the issue might
be lost among the events and media coverage stemming from the
verdict in the Rodney King police-brutality case. Also, many
activists were arrested at a May 1 protest in San Francisco and
jailed for much of the weekend preceding the Monday planned for
the prison demonstration. On May 1 and again on May 8, hundreds
of people were arrested in San Francisco when they attended
peaceful, legal rallies (against the Rodney King verdict) and
obeyed all police orders.

Although the May 1 and May 8 events were not AIDS related,
the new tactic of police traps and mass arrests against legal
demonstrators who did not intend to be arrested threatens AIDS
protests as well, and raises concern about other AIDS services in
San Francisco. The arrests stem from the election of a new
mayor, who took office in January 1992, and his recent
appointment of a new police chief. It is widely believed that
the purpose of the arrests was to please the mayor's conservative
supporters, who are hostile to protests in general and seldom
supportive on AIDS.

** Berkeley: Primary Care Conference June 3

"AIDS Update for Primary Care: Maximizing Quality and
Length of Life," a one-day conference for physicians, nurses,
emergency personnel and others involved in primary care of HIV
positive patients, will by held Wednesday, June 3, 12: 30 p.m.
to 8: 30 p. m., at Alta Bates Medical Center, 2450 Ashby Avenue,
in Berkeley, California. The fee is $120 for physicians, $70 for
nurses and residents.

For more information, call Mary Grim, Medical Education
Program Manager, 510/204-1420.

*****

AIDS TREATMENT NEWS
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AIDS TREATMENT NEWS reports on experimental and
standard treatments, especially those available now. We
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collect information from meetings and conferences,
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survivors have usually tried many different treatments,
and found combinations which work for them. AIDS
Treatment News does not recommend particular
therapies, but seeks to increase the options available.

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ISSN # 1052-4207

Copyright 1992 by John S. James. Permission granted for
noncommercial reproduction, provided that our address
and phone number are included if more than short
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