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| "Noncompliance Plays Russian Roulette," 2001 Max Greenberg |
Visual AIDS has asked community members to share their
thoughts on the recent FDA decisions which have recommended the approval of
Truvada as a form of PrEP, and the sale of Oraquick’s over the counter,
take-home HIV tests.Through these blog posts, we hope to encourage
conversation around current events, and inspire artists, writers, and others to
consider what is going on right now in terms of HIV/AIDS. For more information, below are links.
Just a Pill a Day Will Make Your Stigma Go Away…and other thoughts from the mind of already HIV+ man
Charles Ryan Long: The United States Food and
Drug Administration (FDA) have really been improving our lives over the past
few weeks. I for one am ecstatic and overjoyed that they have made these
bold leaps into our future! A few weeks ago they gave the go-ahead for
Truvada (a frontline AIDS medicine) to be used in HIV-negative people. (I
jumped the gun here the FDA has not yet approved its use, a final decision will
be made this fall) the And just a few
days ago they made it easier for the same folks to diagnose themselves as
HIV-positive—the inevitable result of last week’s decision—in the comfort of
their own homes. I’m not sure about you reader, but I am leaping out of
my diseased faggot skin at this development and can’t express how much “safer”
I feel.
Alright, for those who
haven’t caught on by this point, I am disgusted by this news. I was not a huge
fan of federal regulators to begin with, but this just killed it (pun
intended.)
I guess I will start with the news of the rapid HIV diagnosis home test, as it makes me less sick to my stomach. On the surface I see less harm in this decision, as it seems trivial and counter productive not to encourage testing. Generally I am a fan of the recent shift to “Test and Treat” and think it is a strategy that will help reduce community viral loads, the overall prevalence of HIV in any given sub-population. Therefore, more people knowing their status, and being treated is a grand idea indeed. An at-home test also seems like a correct response to the tremendous can of AIDS that the Feds opened up when they approved Truvada for use by HIV-negative folk.
I guess I will start with the news of the rapid HIV diagnosis home test, as it makes me less sick to my stomach. On the surface I see less harm in this decision, as it seems trivial and counter productive not to encourage testing. Generally I am a fan of the recent shift to “Test and Treat” and think it is a strategy that will help reduce community viral loads, the overall prevalence of HIV in any given sub-population. Therefore, more people knowing their status, and being treated is a grand idea indeed. An at-home test also seems like a correct response to the tremendous can of AIDS that the Feds opened up when they approved Truvada for use by HIV-negative folk.
Where to start with this clusterfuck of a regulatory screw up?
Hmm,
Well it only seems right to start at the population it’s aimed at, right? HIV-negative, heterosexual people. Oh wait you say, but aren’t the largest numbers of new infections in gay men of all colors, followed by heterosexual black women, then intravenous drug users? If you did say this, you are right (and more than likely someone I would like if we met in person.) The trick here is that Truvada has only been proven to be effective in stopping the spread of HIV in vaginal intercourse. Well, how does this help gay men you ask? How indeed?Unlike the Centers for Disease Control I will not engage in pitting one population against another, as I think all of our lives are worth saving.(I retracted this statement as it was pointed out to me that Truvada has been proven effective in multiple populations and in individuals who were adherent.)
- Another rub here is that it was
only proven effective when taken as prescribed. Easy enough right? Oh but
wait, most people—by their own admission—don’t take medications as prescribed.
We also know that taking HIV meds is just like taking any other
treatment for a chronic disease. Nope also FALSE. All of my
experience tells me it’s difficult to achieve 100% adherence and the side
effects can put you off of it in the first place.
- Oh, then there is that little thing about HAART (the class of drugs used to treat HIV/AIDS) and it’s being less than twenty years old. In other words, any guess as to the long-term effects of using the meds is unknown to anyone (particularly in non-poz populations.) If you meet someone who says different tell them to sit down when grown folks are talking, like my aunt used to. The idea? Summarily shaming them into not speaking when they are clearly so misinformed that they would endanger themselves and others around them.
So that’s where we sit folks. Now HIV-negative people can go out
and protect themselves from the “POZ menace” with one simple pill a day.
Then when they’ve missed a dose, begin to beat themselves up about it,
and turn to the crutch of using sex as a mode of communication again, they can
use their at rapid HIV diagnosis home test. From the Castro to WeHo to
Capitol Hill to Boystown to Chelsea to DuPont Circle to South Beach, I can see
the headlines now: “Gay Men Found Swinging from Rafters Like Dead Blacks from
the Wretched Willow Trees of the South.” Only this time we won’t have to
act like the killings weren’t government sanctioned. We will know full well who
to blame. Once again, it’s those who tell us that they are just here to help and are doing what’s best for us.
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| "My Disease," 1998-1999 Frederick Weston |
Charles Ryan Long is an artist. He is a long serving community organizer
and activist with a focus on health and wealth distribution as well as
race, sexuality, class and gender. He is currently working on a
collection of essays about 'gaybies', and a multi media project
exploring legacy, love beyond the grave, and role models.
If you have any questions, comments, or would like to
share your own reactions please email us at info@visualaids.org
Wow, there are many inaccuracies here. To start, the FDA has not approved Truvada for use as prevention - an advisory committee RECOMMENDED approval on May 10 - big difference. The FDA will have a decision on that recommendation in September. Originally, the FDA was to have a decision by June 15, but they decided that Gilead's Gilead’s proposed Risk Evaluation and Mitigation Strategy (REMS)needed work. The May 10 panel was very critical of the REMS - for good reason - so it is a prudent step of the FDA to hold off until this is improved.
ReplyDeleteAnother big mistake here - Truvada as PrEP has been shown to work among gay/MSM in a huge international study called iPrEx - in addition to the trials that show Truvada works among heterosexyals - so the recommendations for approval extend to gay/MSM, serodiscordant heterosexual partners, and others deemed at high risk.
The committee voted 19 to 3 in favor of using it for HIV-uninfected gay/MSM, 19 to 2 (1 abstention) in favor of using it for HIV-uninfected partners of those with HIV, and 12 to 8 (2 abstentions) in favor of using it for other “at risk” individuals.
It is necessary and quite healthy to be critical/skeptical/cautious of PrEP and any other new HIV strategy - but we need to start with the facts.
Unfortunately, the facts are in short supply here.
Feel free to check out this link, which has links to the FDA meeting where the recommendations were made, including all materials presented and the 12 hour webcast of the proceedings, in addition to other handy FACTUAL info. http://mappingpathways.blogspot.com/2012/06/fda-panel-approval-giant-step-for-hiv.html
After a quick review (more later) I did jump without looking on my first point of the populations that PREP had been proven to be effective in. I will also admit my ignorance in the inner workings of approval vs. advisory recommendations, but as the article you shared points out that they typically go hand in hand.
ReplyDeleteMy second two points about adherence and long term effects however are not inaccurate and based in FACT, so saying that truth is in short supply is harsh.
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DeleteWell, no not really.
DeleteThe studies did not show the drugs were only effective when used as directed. They showed partial efficacy over the groups in the trials, and there is data showing that that the high levels of adherence yielded high efficacy and that very low levels of adherence yielded little or none (surprise!) We don't know a lot about adherence in the middle range, but infantilizing potential users by assuming their inability to succeed isn't justified. On the contrary, one very important reason that this product is so popular and effective for treatment is that it is reasonably forgiving to missed doses.
As to long term side effects, I'll simply ask, how many of the top five prescription drugs have safety data past 20 years? I'd bet the majority of them are not as critically needed. Moreover, we actually know a great deal about the side effects of this product (which can be serious for some folks.)
Oh and by the way, Truvada is an already approved drug. In the U.S. that means doctors can legally prescribe it for any use. The CDC issued interim guidelines for using Truvada for PrEP in gay and bi men at substantial, ongoing, high risk over a year ago.
ReplyDeleteA label indication would mean that this new prevention tool would be more accessible and may also spur more willingness for agencies and providers to discuss the pros and cons with individuals.
Charles, thanks for the post and the edits. Jim, thanks for the links. Glad Charles was able to express his reactions and glad Jim was able to provide additional information. This is the second, in a series of ongoing blog posts that will explore the FDA's recent actions around AIDS. At Visual AIDS we are interested in providing a forum in which people can express themselves around the epidemic. As part of the series, diverse responses are encouraged, including: poems, steams of thought, essays segments, visual art, rants, and and other forms.
ReplyDeleteExcited about the idea of conversation. We want to promote online discussion that encourages more voices. This will be always a delicate balance of opinions, different ways of knowing, access to information, ways of communicating feeling and priorities. We are excited at the prospect of being reading the blog posts and then taking the time to learn more, begin discussions, and reconsider what they think they know. We hope that through the process of expression (both creating, witnessing, and interacting with) people's hearts and minds will be altered, changed, moved.
Finished and waiting the wings are responses from Cyd Nova out of San Fran and Queerocracy's Cassidy Gardner. If you have thoughts, feelings, ideas you want to share about the FDA and AIDS please email us at info@visualaids.org. Last week's post: http://visualaids.blogspot.com/2012/06/fda-aids-mark-middle-hubbard.html