| From: |
Gabriel ADEYEMO [ profile ] |
| Subject: |
Fight over use of HIV drugs
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| Sent: |
Mar 12th, 2012 - 04:45:05 |
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SOURCE:* Wall Street Journal*
AUTHOR: Amy Marcus
http://online.wsj.com/article/SB10001424052970203961204577267813686809798.html
Colleague!
Scientists are scrutinizing a new approach to preventing the spread of HIV
that involves healthy people taking drugs to keep them from being infected
by partners with the virus that causes AIDS... The Food and Drug
Administration (FDA) is reviewing a request by Gilead Sciences Inc., the
maker of one of the drugs, for an expansion of the label to allow the drug
to be marketed as a preventive tool.
But an HIV/AIDS organization filed a petition Wednesday urging the FDA not
to approve Gilead's request for the drug combination known by the brand
name Truvada. The organization, the AIDS Healthcare Foundation, said in its
petition that clinical trials to date had not proven that Truvada is
effective enough to merit approval for uninfected people. The foundation
also said the drug's cost, estimated at $14,340 for a year's supply, might
make it hard to adhere to the regimen... But supporters of the prevention
method, which is known as "pre-exposure prophylaxis," or PrEP, say there's
enou gh evidence for the FDA to consider approval.
"It's important to pursue every lead to get ahead of this epidemic," said
David Ernesto Munar, president and chief executive of the AIDS Foundation
of Chicago, an advocacy and service organization... While other drugs are
also being tested for use in prevention, Truvada is the first drug the FDA
is considering for expanded approval to include its use in healthy, at-risk
individuals.
FDA approval would make clearer how the drug might be used by providers who
are already being asked by HIV-negative patients for the drug, said
Mitchell Warren, executive director of AVAC, a nonprofit organization that
advocates for the development and delivery of HIV prevention methods. The
drug is currently approved by the FDA to treat infected people, and doctors
who believe it will help an HIV-negative patient are allowed to write
off-label prescriptions. As long as Truvada is prescribed off-label,
"there's no one being held accountable for the inform ation that goes out,"
Mr. Warren said.
Thanks for reading through and do have a wonderful week ahead.
--
Many Thanks
Yours' in Prevention Science
Gabriel, ADEYEMO
Regional Focal Point - West Africa
Global Youth Coalition on HIV/AID (GYCA), a program of the Public Health
Institute
+234-80-6798-7317 | gabriel (at) gyca.org
www.gyca.org | www.phi.org
GYCA is a youth-led global network of over 6,500 young leaders and adult
allies working on youth and HIV/AIDS in 173 countries world-wide. GYCA's
mission is to empower young leaders with the skills, knowledge, resources
and opportunities they need to scale up HIV/AIDS interventions amongst
their peers.
*My United Nations Pledge 2011-2012: "To lend my wit and my strength to the
AIDS Response guiding global youth towards one goal: Zero HIV: Zero AIDS
Related Deaths, Zero New Infections, Zero Stigma"*
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