Transcript If you have 5-10 minutes, you can…

Lubricant Safety Update:
Current Research and Advocacy Efforts
Global Regulatory Issues
IRMA Global Teleconference
January 24, 2011
Marc-André LeBlanc
IRMA Secretary, Lube Wrangler
1
Regulation
2
Regulation
Regulators in various countries classify lubes
differently, depending on claims made by
manufacturers
Application of different sets safety criteria for
exact same product in different countries
IRMA Lube Safety Working Group
3
Regulation
Safety criteria for medical devices usually
stricter than cosmetics criteria
U.S. simply requires data from studies that
test whether lubes irritate rabbit vaginas
IRMA – current criteria insufficient based on
info from lube studies to date
IRMA Lube Safety Working Group
4
Regulation
In some contexts, some lubes are on the
market w/out any regulatory approval
Some regulatory agencies have little to no
power or resources to:
IRMA Lube Safety Working Group
5
Regulation
Even in jurisdictions where :
• Regulatory agencies have very clear and
stringent safety criteria
• Power and resources to enforce rigorously
• May still be no requirement to
demonstrate safety for rectal use
• Manufacturers rarely indicate product
intended for that use
IRMA Lube Safety Working Group
6
Regulation – lack of clarity moment #1
Here’s
the rub
• No clarity around safety
tests to recommend, even if
regulations demanded
them
• Regulators likely to be
hesitant to enforce tests
that would yield limited
safety info
IRMA Lube Safety Working Group
7
Lack of clarity moment #2
Even if/when we know
which lubes are
better than others…
How does that translate
into HIV/STI risk?
IRMA Lube Safety Working Group
8
What is IRMA doing?
• Urge researchers to test lubes for
rectal safety and to share findings
• Facilitate dialogue leading
researchers/advocates in Lube
Safety Working Group (wanna join?)
• Compile articles, studies maintain
background document
9
What is IRMA doing?
• Make IRMA’s list of most widelyused lubes available to anyone
interested in testing lubes
• Monitor how regulatory agencies in
various countries address lube
safety
• Engage with lube manufacturers
• Keep IRMA membership updated
10
Conclusions
• Water-based lubes don’t look great
BASED ON THE TESTS CONDUCTED TO
DATE
• We don’t know how this translates
into real-world use, real-world risk
• Is there a commitment to find out?
• Can we ever imagine advocating for
AI without lubricant?
11
irma-rectalmicrobicides.blogspot.com
oSafety of lubricants for rectal use:
A fact sheet for HIV educators and
advocates
oSafety of lubricants for rectal use:
Questions & Answers for HIV educators
and advocates
rectalmicrobicides.org
12
IRMA Lube Safety Working Group
13
Questions?
14
Thank you
• Marc-André LeBlanc
• [email protected]
15