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Truvada and politics

Timothy Kincaid

July 16th, 2012

The Food and Drug Administration has now just approved the use of Truvada, an AIDS drug, as a preventative medication for some high-risk HIV-negative people. To my way of thinking, this is WONDERFUL, yet another tool in our arsenal for slowing and preventing the spread of the virus.

Not everyone agrees. (Wall Street Journal)

In a media call after the decision was announced, the AIDS Healthcare Foundation called the FDA decision “a catastrophe in the fight against HIV in America” and said it was likely to lead to more, not fewer, HIV infections.

The organization has opposed FDA approval for Truvada’s use in preventing HIV in healthy people. Gilead Sciences is the maker of Truvada, which was already approved to treat people who are infected with HIV.

Michael Weinstein, co-founder and president of the AIDS Healthcare Foundation, later told the Health Blog that healthy people should be required to show proof of a negative HIV test before getting Truvada as a prevention medicine.

[UPDATE: Sorry, I left out essential information] However, Weinstein is not just demanding testing, a condition that was announced a month ago. He and AHF have led a campaign against this step altogether.

Weinstein and AHF are a bit, well, peculiar. I don’t want to trash an organization that works hard to encourage testing, but sometimes I think that Weinstein’s brand of politics is based more in micromanaging the lives of others than in utilizing tools to prevent the spread of AIDS. (He has collected enough signatures to put a proposition on the city ballot to ban the production of all porn in the city of Los Angeles that does not feature condoms. He thinks this will reduce non-condom porn – gay or straight – from being produced and marketed; I know it will simply cause a multi-billion dollar industry to move somewhere else at a time in which our city is in financial panic mode. Porn producers will provide for demand.)

Here’s what I know: some people will behave irresponsibly for a time. Here’s what I believe: that irresponsibility does not deserve sero-conversion as some sort of punishment or moral judgment. If we can limit their transmission rate, that is a good thing EVEN IF they are bad bad boys who don’t have sex the way that Michael Weinstein thinks appropriate.

HIV is not an automatic presumption for unsafe sex. And I get the impression that Weinstein – who has for years sang the mantra that condoms must be worn every time – would prefer that we act out of fear rather than truth. And here is some truth that he surely will not appreciate.

And I firmly believe that too many young gay men have thought “yeah, well I screwed up so I’ve probably become infected by now so why should I even try to protect myself this time”. Truth is a tool that allows us to respond and it has always infuriated me that the AIDS prevention community has been less than forthright.

I am not suggesting, hinting, implying, or advocating for giving up rule number one which is “wear a condom”. And the inclusion of counseling and risk management as a requirement for prescription is, I believe, a wise move. And there are many unanswered questions including cost of the medication, availability, and the extent to which some will see it as a magic shield.

But I also am realistic enough to know that safer sex will not always happen. Sorry, that’s just the truth. And I also know that some serodiscordant couples negotiate the risks they are willing to take so as to allow some measure of spontaneity and enhanced intimacy and I’m not going to stand in their bedroom with a clipboard and a bureaucratic tone. If this gives them an additional tool to decrease the odds of infection, then by all means allow them the tool.

I agree with AHF that everyone really needs to be tested. I would love to see a massive governmental effort (yeah, I said it) to test every single person in the country above the age of 13, regardless of who they are (preferably using the nucleic acid test twice over a two month period). I believe that people are basically decent and that knowledge of one’s status would go a long way to avoiding infecting others.

And I want to praise that organization for being on Santa Monica Boulevard in a ‘testing bus’ during the evenings when the bars are packed while the institutional (and increasingly pointless) Gay and Lesbian Center offers testing in West Hollywood from noon to 7 PM four days a week for up to 20 people per day. I also appreciate Weinstein’s support of the newly approved at-home HIV simple swab test that requires only 20 minutes and no outside participation.

I also pledge that if Weinstein proves right and sero-conversions increase rather than decrease, I will apologize and join him in calling for a reversal of the FDA’s position. But for me, fewer transmittable and fewer infectible people means less virus transmission which makes me want to stand up and dance around the table.

I think that FRC and Weinstein need to let go of the nanny instinct and find ways to utilize new tools to maximize results rather than seek to mold behavior. Because you don’t want to find yourself wondering why you feel sad, angry, and in objection on the day that we finally find an effective vaccine for this vir

Comments

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tim
July 16th, 2012 | LINK

In the infosec community we have this concept called “defense in depth” – while dated its still very much of interest in all corners in life. Basically it means there isn’t just one defense mechanism in place but many – because just one isn’t sufficient.

The right wing wants sex never to happen. And the left wing thinks all sex is protected. The reality is neither are true and that we should have the tools to deal with situations as they happen. I don’t see this drug as a bad thing – but another tool in the toolchest.

David Roberts
July 17th, 2012 | LINK

When you pare this down, it sounds like a basic ideological argument against social engineering on certain levels, specifically as used to effect public health. These types of policies should be evidence driven.

If the data shows that significant numbers of lives will be saved by, for instance, requiring all porn to include condom use, then a reasonable attempt should be made to do so. If it shows little or no effect, then there is no need to waste the time and resources on that.

Likewise, if use of this drug as a preventative will help save lives without significant harm, then we should follow through and allow that — regardless of our lay opinions (or moral objections) on the matter one way or the other. Perhaps if the data exists we could view it and then have a more productive discussion.

As for the ideological end of it, we allow our daily decisions to be powerfully influenced by very effective advertising which constantly bombards us. I personally think a few data-driven messages designed with public health and safety in mind are perfectly acceptable.

Matt in TX
July 17th, 2012 | LINK

Here’s what I know: some people will behave irresponsibly for a time. Here’s what I believe: that irresponsibility does not deserve sero-conversion as some sort of punishment or moral judgment.

Mr. Kincaid, I may be in the minority among the readers of this site, but I quite like that you are generally skeptical of the gay-left/1970s-liberationist/queer-theory mindset, and I wish you were more so, here.

I wish you had written this piece differently. I remember when you tackled the CDC statistic claiming that 1 in 5 gay men in the US are HIV positive, and argued that you believe it’s more like 1 in 10.

But either number is far too high for a disease that’s 100% preventable!

Your attitude seems to be “Well, guys will sow their wild oats, and some number of people will get infected, and while it’d be great if that number were smaller, the wild oats are here to stay, and what’s most important is that we don’t feel any shame about that.”

I disagree. What’s *most important* is not our self-esteem, understood as our freedom from any sort of criticism, even self-criticism, regarding our sexual choices. That’s a 1970s/liberationist/ Me Decade mindset if I ever heard one! It’s *more important* that we try to stop the spread of HIV.

Medications are very effective and many HIV positive people have so low a viral load that they are “undetectable”. It is theorized (and widely rumored) that undetectable people cannot pass on the virus.

There’s no doubt that being diagnosed HIV positive means something very different now from what it used to mean. But lots of these medicines have brutal side effects. Just one example: the facial wasting that one often sees in very gay urban neighborhoods among middle-aged men. Plus, being HIV positive still has extremely serious consequences for one’s life. Losing your health insurance, for example, becomes a very big deal. And if you had hoped to adopt one day, it certainly changes the calculus of that, because the vast majority of adoption agencies will not work with you.

The CDC estimates some 30,000 new HIV infections from gay male consensual sex every year. Again, this is 100% preventable. But it will mean large numbers of us making difficult choices on an individual level, and nobody wants to do that.

Hue-Man
July 17th, 2012 | LINK

My objection is more conservative – powerful drugs that have the potential to cause unknown side effects on major internal organs – especially in combination with other prescription and illegal drugs – should not be dispensed when their efficacy is poorly understood. Save it for treatment of HIV and hold it in store for some future disease.

Priya Lynn
July 17th, 2012 | LINK

I agree with Weinstein that people should have to provide an HIV negative test before they are given access to Truvada.

Joe Beckmann
July 17th, 2012 | LINK

The Weinstein argument comes from AIDS Service Organizations afraid of losing money. Their venality transcends their ethics.

That said, you might note that PrEP was preceded by PEP (Post-Exposure) also using Truvada, but within 72 hours of exposure. Both work remarkably well WHEN THE PATIENTS COMPLY WITH THE TREATMENT regimen. But nobody knows how long – before or after – that compliance is important. (Probably over 7 days for post; probably 3 to 5 days for pre.)

Finally, I remember a remarkable discussion with a bunch of teenagers who, when they discovered PEP and PrEP online, were shocked that their teacher in health ed had never mentioned either. “Your job to teach the teacher,” said I somewhat naively. When one began to discuss a party he’d been invited to the next week, and asked for how he could get PrEP, I explained it was in clinical trials, and not yet available. He asked what the difference in dosage or medication was between the two. “None,” said I. “Oh, I’ll just lie, I know how to do that already,” said he.

The next week I was in an international webinar on PrEP, and asked if they knew any way to limit lying. Nope. So the kid knows more about treatment than the international panels. That’s what “control” produces.

Mark F.
July 17th, 2012 | LINK

How about letting people make their own decisions about what drugs they will or won’t take? I guess that is too radical for most people.

The nanny state is alive and well.

chiMaxx
July 17th, 2012 | LINK

For once, Timothy, we agree completely.

When we base our policies on people doing the right thing, every time, without fail, those policies are doomed to failure themselves.

AlexH
July 17th, 2012 | LINK

I agree with Matt In TX, but I think we should err on the side of caution; if Truvada can hinder HIV transmission, then it should be readily available to all.

Sandhorse
July 17th, 2012 | LINK

OK, Tim, I am usually so far in your camp that I could be roasting marshmellows over your fire. But in this case I don’t think I could disagree with you more.

If a bottle of Truvada still requires a perscription (not sold OTC), then I see no reason NOT to require testing before the doctor signs that script. Do you not know the dangers of going on monotheropy when one is already HIV positive?

Granted Truvada is already a mix of two drugs, but if you’ve already sero-converted this still needs to be taken with a combination of other drugs. If not, the risk of developing a drug resistant strain is high. Let’s not even mention how many people this person may infect with a virus resistant to two classes of drugs before they even get to start their first line of treatment.

Sorry, this just smacks of ignorence. It is not an invasion of privacy, nor a self-rightious judgment, if your doctor runs a preliminary test before supplying you with a drug. These aren’t M&Ms.

You say you think everyone should be tested; but how do you expect that to happen when you think required testing before even a perscription drug is administered is some kind of governmental overreaching? You contradict yourself.

And in regards to your comment about the banning of bareback porn. YIKES! You seem to think this too is some sort of governmental invasion of privecy at best and an economic disaster at worse. Crazy talk.

If a chemicicals company wanted to start a business in CA and was only willing to do so if they were allowed to pay their employees a little extra to go without a haz-mat suit two days out of their work week, would you be for that too? Exposing someone to an occasional dose of radiation is no big deal, right? The city needs the money.

This is the most moraly corrupt defence of capitalism I’ve ever heared. And I am FAR from a bleeding liberal.

These adult entertainment actors are not in the privacy of their own home, there at work in front of a camera. How many porn companies provide health insurance for their employees? I’m guessing few, if any. With the cost of HIV meds averaging $24,000 a year per person, most of these poor saps that get infected on the job will likly have to go on a state funded pharmacutical program. That shoudn’t tax an already bankrupt governmental agency too much, right? So what if a few of these former actors (and the average career of an adult performer is remarkably short) have to go on a waiting list, while a deadly virus feeds on their immune system; the city coffers will have a few extra bucks to work with.

I’m sorry if I come accross as harsh, Tim. I almost always admire and enjoy your posts. Of all the contributors to this blog, I feel the most affinity with you. But in this case, I can hardly believe you wrote it.

I’m franky, appalled.

Timothy Kincaid
July 17th, 2012 | LINK

Oh, goodness. I think I left out an important sentence.

AHF is not just demanding testing. I have no objection to requiring testing as part of the risk management. From the best I can tell, AHF and Weinstein oppose the use of Truvada as a preventative medication altogether and have led a campaign to oppose it being made available as such.

Reed Boyer
July 18th, 2012 | LINK

Truvada’s efficacy in this was what? 44%?

And, as its patent as a treatment is about to finish, the new use as a prophylactic will allow the manufacturer (and/or the drug company that bought the previous drug company) to eke out a little further profit.

beachcomberT
July 18th, 2012 | LINK

This prevention method might help a few rich yuppies but it is ridiculously expensive as a long-term prevention strategy for the general population. Browsing Internet ads, I find the typical discounted price for Truvada is $40 a pill. Even if the government someday uses its muscle to drive down prices, we’re probably still talking about $10 to $20 a pill until a generic version is allowed. Does anyone honestly think health insurance companies, Medicare or Medicaid will cover this cost when condom use is much cheaper? The major categories accounting for new infections are African-Americans, Latinos and youth of all races — i.e., generally speaking, low-income people. How will they buy this drug?

Timothy Kincaid
July 18th, 2012 | LINK

Reed,

If I read secondary sources correctly, the efficacy was tied to the compliance rate. I believe (though could be mistaken) that those who used the drug properly had a 100% rate of non-convergence.

trog
July 18th, 2012 | LINK

Timothy,

I enjoyed and agreed with your breakdown of the issues. Yes, efficacy is indeed tied to compliance rates.

Here’s an article on POZ.com that breaks down the science and real-world application for Truvada as PrEP.

Dr. Mayer of Callen-Lorde does and excellent job of laying out the type of person who might benefit from this PrEP.

http://www.poz.com/articles/hiv_prep_questions_401_22701.shtml

I include the relevant grafs here:

QUESTION: But what about condoms? Won’t guys on PrEP forget about safe sex and start barebacking—and won’t that increase their HIV risk, especially if they’re missing daily PrEP doses?

ANSWERS: In the PrEP trials, participants actually reduced their risk-taking actions, but they also received free condoms and lube as well as counseling and screenings for sexually transmitted infections—and they didn’t know whether they were taking an effective medicine or a placebo. Additional studies are now needed, Liu says, to look for changes in risky behavior when PrEP is implemented in the real world.

But some critics are also saying that men who can’t use condoms regularly will not succeed in taking PrEP daily. “I think that will turn out to be wrong,” Mayer says. “Adherence to medication that has almost no side effects can be achieved by incorporating [Truvada] into life’s other rituals. Brush your teeth every morning? Leave your PrEP by your toothbrush and you’ll be less likely to skip doses.

“In contrast,” he says, “using a condom is a complex social interaction. For those who haven’t found a way to incorporate it seamlessly into their sex lives, it may involve two people interrupting a pleasurable experience to remind themselves of an unpleasant reality. You may also have to convince a partner to use it or let you use it, stay hard while putting it on, and then find a way to resume the sex where you left off.

“Despite all that, every day thousands of people use condoms successfully to prevent HIV infection. Because it’s so effective, has no side effects and is so cheap, a condom is still the best way to prevent HIV infection. But I reject the idea that people who can’t use condoms consistently will categorically be unable to adhere to taking PrEP daily. I would even say that those who struggle with condoms and feel bad or anxious about failing to use them correctly, may have tremendous motivation to use PrEP correctly.”

Mayer continues: “Someone who is using condoms consistently and has good safer-sex practices does not need PrEP with Truvada. However, let’s consider the person—call him Joe—who is struggling with condom use, which is true for many men in the gay community. Joe doesn’t want to become infected with HIV but only succeeds at using condoms 50 percent of the time, whether because of drug use, depression, peer pressure or whatever. Currently, Joe is risking HIV infection the other 50 percent of the time. Joe is probably very anxious about acquiring HIV [and is] an excellent candidate for PrEP. Once on daily PrEP, [provided that he uses it daily as prescribed,] he is going to be over 90 percent protected against HIV even when he doesn’t use condoms. So even if his condom use drops to 20 percent because he feels protected by PrEP, there is still a far lower HIV infection risk for him, and in turn, for all Joe’s partners, than without PrEP. But the key is consistent use, which is why it’s important to discuss adherence with Joe and to follow him closely.

“Importantly,” Mayer says, “we should also explore the reasons Joe is having trouble with condoms. If it’s depression, we should also treat Joe’s depression. If it’s drug or alcohol use, we should provide Joe with substance use treatment. We should be aiming to help Joe with the problems he’s having using condoms and working toward the day when Joe won’t need PrEP anymore.

“But I also know that many gay men are having unprotected sex as a personal choice, and not because they’re depressed or have a drug problem. Those men are generally trying to avoid HIV by other strategies: having unprotected sex only with partners who claim to be negative (serosorting), having unprotected sex only when they’re the top (seropositioning), having unprotected sex only with partners they trust, and so on. All those strategies have been proven time and again to be far from fail-proof, and that’s why we see so many gay men becoming infected with HIV. For those men, PrEP could be enormously helpful.

“Do I think a person on PrEP will use condoms less frequently? The studies don’t show that they do, but real life might be very different, and I think some will inevitably use condoms less. But I also think that using PrEP correctly will still be more protective, even with less condom use. Only time will tell.”

Timothy Kincaid
July 18th, 2012 | LINK

Despite all that, every day thousands of people use condoms successfully to prevent HIV infection. Because it’s so effective, has no side effects and is so cheap, a condom is still the best way to prevent HIV infection.

I don’t think that it is entirely correct that a condom has no side effects.

For most men (I believe) there is a loss of sensation in use of most condoms. While there is some “it’s not sexy” or “it’s not convenient” causes for inconsistent use, I suspect that for most men who do not adhere to a strict condom usage regimen, it is the decrease in sexual pleasure that is the reason. That is not some insignificant reason.

To complicate matters, in some men, there is great difficulty in finding condoms that fit properly. This is less a problem than it once was, but still many men cannot stop in to their local CVS to pick up a condom that is big enough – or, alternately, snug enough – to work as intended.

Taken together, these two problems with condom use can result in erectile disfunction in some men. In any other circumstances, ED would be considered a medical condition and a side effect.

Jim Burroway
July 18th, 2012 | LINK

There is also the issue of latex sensitivity or allergies for some people.

liquid
July 19th, 2012 | LINK

@Jim Burroway
Are non-latex condoms not equally available? Not sarcasm or snark, an honest question. Since I’ve been sexually active,I’ve lived/spent significant time in 5 cities in as many states, and I’ve not yet encountered a drug store or grocery store that didn’t have them, and most of the local LGBT and health organisations that have free condoms available also have them. Anecdotes aren’t evidence, I know, so i’m asking

Jim Burroway
July 19th, 2012 | LINK

liquid,

i’m not sure how widespread non-latex condoms are. There are two kinds: Polyurethane, as far as I know, are not approved for preventing STD’s. Polyisoprene, as I understand it, are. They are fairly new, introduced in 2008.

To be honest, I haven’t looked into this. It had always been drilled into my head to use only latex condoms for so many years. I have my “favorite” brand, and like most consumers, once you pick a brand of anything, you tend to stick with it. Which is why I actually wasn’t aware of the non-latex option. So thanks for the learning opportunity.

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