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AIDS FOCUS
Aerosol Pentamidine Gets
" Treatment IND" Approval
On February 6, the U.S. Food and Drug
Administration gave tentative approval to use
of aerosol pentamidine for prevention of
pneumocystis, under the "treatment IND”
rules for providing early access to new
treatments for life-threatening conditions.
The approval was based on data from a San
Francisco study started by the County
Community Consortium and completed by
San Francisco General Hospital.
Aerosol pentamidine was already in
widespread use before this treatment IND.
Several different doses had been used. The
new approval specifies a recommended dose
(300 milligrams every four weeks), and
nebulizer (Respirgard II). It recommends
aerosol pentamidine for "primary"
prophylaxis (i.e. for those who have never
had pneumocystis) for patients who have a T-
helper count under 200 - as well as for
anyone who has had pneumocystis already.
This criterion for primary prophylaxis is
based on a yet-unpublished epidemiologic
study supported by NIAID (National Institute
of Allergy and Infectious Diseases).
The treatment IND allows the developer
to charge for the drug to recover costs; this is
the first time there has been such a charge.
LyphoMed is charging the same price as for
intravenous use of pentamidine, $99.45 per
300 mg. dose. As a result, physicians have
been slow to sign up for the program, as there
is some paperwork required and no price
break. Also, some have chosen to stay with
the doses they have been using, at least until
they see the full justification for the 300 mg.
recommendation, data which may not be
published for several months.
The new official recognition for aerosol
pentamidine should make it easier to get
insurance companies to pay for the
treatment. (One reason for physicians to sign
up for the program, instead of continuing to
prescribe aerosol pentamidine as they have
done before, is that Medicaid is "likely" to
decide to reimburse for treatment
administered under it, and if so,
reimbursement will be retroactive.) Another
benefit of the treatment IND is that research
protocols will probably be changed to allow
patients to use aerosol pentamidine, if they
do not already do so. And the U.S. approval
may contribute to efforts to make aerosol
pentamidine available in Canada, where lack
of access has been a major problem.
LyphoMed has agreed to continue trials
of aerosol pentamidine for 24 months, even
after full FDA approval, so some patients
will receive free treatment through this study.
Physicians and patients can obtain
prescription and enrollment information by
calling LyphoMed's hotline (800) 727-7003,
Monday through Friday, 9:00 a.m. through
9:00 p.m. Eastern Time. Physicians can
request an enrollment packet with forms and
instructions.
- from AIDS Treatment News
ARING ANSWERS
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Alliance Against AlPS , s designed to offer the physical and
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individually tailored care to those who often have difficulty seeking and
accepting nelp during this confusing and traumatic time
The Alliance“Healing Team" includes the patient, their doctor, nurses,
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Together, we provide an optimum of care, resources, referrals, services and
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All Alliance Against AIDS staff members are trained, experienced
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We are the ONLY alternative to hospitalization.
Please call 24 hours a day, 7 days a week for information
and Caring Answers to your Special Needs.
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Members and supporters of LEGAL (Legislate Equality for Gays And
Lesbians) worked with the SCLC (Southern Christian Leadership
Conference) to provide a meal for Atlanta's homeless population April 3
as part of the annual commemoration of the assasination of Dr. Martin
Luther King, Jr. Pictured is Dick Rhodes, local gay political activist,
serving meals to the over 500 homeless persons who attended the dinner
at the MLK Community Center.
TAD GARDOCKI
Canada Allows Relesase of Experimental Drugs
Toronto-The Canadian government
announced it will allow doctors here to prescribe
experimental AIDS drugs to patients, according
to a report in Chicago Outlines. The decision
will allow Canadian doctors to prescribe any
new or experimental treatment a drug company
will release to them without having to wait for
government approval.
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"We've always said these drugs could be
released with just the stroke of a pen," said Dr.
Michael Hulton in an interview with XTRA!,
Toronto's gay/lesbian newspaper. 'It's just that
now the Health Protection Branch appears to be
exercising their discretionary power in our
favor, rather than against us."
The new Emergency Drug Release Program
was prompted by an "evolution" in thinking,
according to Dr. Michelle Brill-Edwards of the
Bureau of Human Prescription Drugs (BHPD).
She said that complaints by AIDS activists and
embarrassing media reports stimulated the quick
action.
Members of AIDS Action Now! (AAN!), a
direct-action group, say their battle with the
Canadian health service is not over.
'They've unlocked a door but there's still no
proactive government agency facilitating the
wider use of AIDS treatment," said Tim
McCaskell of AAN! "So, (if) you're aware of
something and (if) your doctor understands it,"
McCaskell continued, "then, yes, the
government will no longer block that for you.
But that's a long way from doctors across the
country being aware of what's out there."
McCaskell told Chicago Outlines that he did
not believe PWAs from the U.S. would
experience any Canadian interference in crossing
the border to see a physician. U.S. citizens would
not qualify under Canada's social health care
system, however. The Emergency Drug Release
Program’s telephone number in Ottawa is
(613)993-3105.
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