The Pill for HIV: A bad idea, actually

Conceptually, having something like The Pill anyone could take every day to prevent HIV-1 infections would be a good idea. Take some kind of preventative antretrovirals when you are sexually active and feel you are ‘at risk’, maybe prevent some new HIV-1 infections.

We had hopes that an antiretroviral drug Tenofovir would work in precisely that manner. It kinda worked as a microbicide for women. And then it kinda worked as a pill in homosexual men.

And then it turned out that in other larger clinical trials, Tenofovir didnt work well at all, in pill or microbicide form.

Tenofovirs failures arent news, at this point.

So everyone was rather surprised to learn that the FDA was granting expedited approval for Tenofovir/Truvada ‘broader use’, ie use in non-HIV+ people. There is *no* experimental evidence to suggest that is a good idea right now.

Furthermore, it recently came to light that Tenofovir might be involved in permanent kidney damage. That is, it causes damage, and that damage does *not* resolve itself after one stops the medication (file this under ‘Why antiretrovirals are a bad idea for ‘XMRV positive’ people‘. Yes, ‘XMRV positive’ patients are reporting that they are taking Tenofovir, even though XMRV does not exist as a human pathogen).

I find myself agreeing with representatives from AIDS Healthcare Foundation:

“The more we learn about Truvada as an idea for preventing HIV, the worse the idea is.”

“The FDA should not be trafficking in willful ignorance.”

AHF has long been critical that PrEP will not work on a large-scale basis because, consistent with poor medication adherence rates for most diseases, people will not be able to take Truvada as directed. Because of this, there will be little or no preventative effect, and drug resistance and drug resistant strains of HIV will develop. In addition, people who falsely believe they are fully protected against HIV very likely may engage in riskier behavior, thereby increasing their risk of HIV infection.

“The idea of giving healthy people a toxic drug that will damage their kidneys in order to possibly prevent HIV – when simple condom use is 95% effective – is the height of irresponsibility and corporate greed,” said Michael Weinstein, AHF’s President. “Widespread use of PrEP has all the makings of a public health disaster – increased HIV infections, drug resistant strains of HIV, and tens of thousands of damaged kidneys. And the FDA, in expediting its review and limiting further research, appears hell-bent on bringing this about as quickly as possible.”

Comments

  1. #1 mo (one of Abbies's elk)
    February 16, 2012

    How the hell do those CFS patients get arvs? don’t they need perscriptions?
    obviously, any drug that works worse than condoms should not be sold, because people will use them instead of condoms.

  2. #2 Tum
    February 16, 2012

    This is truly stuff for a dystopian future.

    The problem as I see it, is that HIV/AIDS is as much a medical problem, as it is a social problem – if not more a social problem. Religions like the catholic church and their zealots with their “every sperm is sacred” policy are in a considerable part responsible that the spread of HIV has not been curbed more.

    I am getting misanthropic. Humanism is dead. Everybody for themselves.

    If we don’t handle the spread of HIV, then evilution will do that for us. If we are lucky, Darwin will be busy handing out awards and people with cognitive biases not suited for the judgement of these kinds of risk will die out. Maybe people taking advise from imaginary friends will die out too (if the advise is bad).

    But then again, maybe only the people who can handle anti-retrovirals better will survive.

    As I said, it is dystopian.

    On a related note: If someone wants to investigate our research friends in Frederick, MD, I have prepared a FOIA request at the link above. I can not see it through, sorry. If someone is in the US, can see it through, can do the appeals (if necessary) and maybe even has the ability to litigate if the good people in Frederick refuse to cooperate, then that would be the chance to bring some light into the behavior of the fine researchers in Frederick and in Reno. Please check if it is complete, not too broad and not to narrow, if the wording is OK and so on. This is as far as I can get. Girls and boys, now is the time to nut up or shut up. I’ll shut up (a bit).

  3. Can’t even imagine the effects these drugs would have on already weak/failing kidneys.

  4. #4 Mu
    February 16, 2012

    Couldn’t the expedited review backfire on the maker? With little efficacy to show and demonstrated side effects, they might not get a chance to rework their data in the shortened process.

  5. #5 In Vitro Infidelium
    February 16, 2012

    How the hell do those CFS patients get arvs? don’t they need perscriptions?

    No, wonders of the internet = 30 Tenofovir tabs for $280, though who knows what’s actually in the tablets, could be anything http://www.cbsnews.com/8301-504763_162-20042840-10391704.html

    IVI

  6. #6 EvilYeti
    February 16, 2012

    This is what happens when you have an FDA that is owned by Big Pharma.

    Crony Capitalism kind of sucks that way.

  7. #7 Eddie Hamilton
    February 17, 2012

    It is difficult enough to get the ARV’s for people already infected let alone for anyone that’s NOT!

    There are 4,500 people on waiting lists nationwide for assistance through the Ryan White Program. Most of these people are getting their medications through the Pharma’s Patient Assitance Programs. Would you like your life hanging in the balance at Big Pharma’s stockholders meetings?

    Gilead is the worst PaP of them all on top of this antic. The tax breaks for these companies is HUGE!

  8. #8 EvilYeti
    February 18, 2012

    HIV has turned out to be the Goose that laid the Golden Egg for Big Pharma.

    Sexually transmissible, deadly, manageable with a lifetime of expensive meds *and* it targets a demographic with large amounts of disposable income.

    And Tum, the Catholic Church also preaches against premarital sex, adultery and sodomy. If everyone followed their rules we wouldn’t have had the epidemic in the first place.

    Something the anti-theists seem to miss is that all the various “no fun” rules of religion, like not eating shellfish or no casual sex/sticking it in the pooper all originated as a form of early preventative medicine.

  9. #9 David Yikes
    February 18, 2012

    omg guise BIG FARMA iz toadally behind skrewing peple. hiv/aids is a big myth and they are just selling them teh drugz they dont need. No moar triles!

  10. #10 Tum
    February 18, 2012

    And EvilYeti, if the catholic church followed their own rules we wouldn’t have the epidemic of child abusing priests, that we have for at least the last 100 years. People choose to follow some rules and ignore others – why not simply drop the stupid rules?

    And ERV, have you seen the text?

  11. #11 EvilYeti
    February 18, 2012

    I’ve always wondered why child abuse by gay Catholic priests is a ‘Catholic’ issue vs. a ‘gay’ issue.

    Actually, I’m not really wondering at this point. I’m pretty sure of the answer.

  12. #12 WcT
    February 18, 2012

    @EvilYeti

    If you’re still wondering, it’s the same reason that child molesting pediatricians would be seen as a “doctor problem” instead of a “gay problem.”
    a)pedophilia doesn’t equal homosexuality
    b)you put someone in a position of authority and don’t police them, you’re responsible for when they abuse that authority.

  13. #13 EvilYeti
    February 18, 2012

    Sorry, I don’t get it. By that logic gay teens are ‘pedophiles’. I really hope you don’t believe that.

    I also hope its clear that the point I’m making is its a basic human tendency to ascribe the bad behavior of an individual to a social group you don’t approve of.

  14. #14 greg
    February 19, 2012

    ***join occupy**** This is exactly what this is all about. The 1% shafting every one else. Breaking everything and fucking everything up and all we ever seem to do is try to restrain them and then pick up the goddamned pieces after!

    It never ceases to amaze me the way people complain about this shit and then when a massive movement to solve it comes along and sits in their lap the *just keep complaining*. The moment you have bee nwaiting for is here: the uprising to push this shitte way back into the gutter it came from and where it belongs! Join now!

  15. #15 Jason
    February 20, 2012

    EvilYeti – most don’t classify pedophiles as being homo/bi/hetero/etc. They get their own designation. That said, even not classifying it that way, how is it possible for you to get to, “by that logic teens are ‘pedophiles’.”

    ?!?

    Whose logic are you using for that one? I think you’re taking a few too many steps from what anyone has said, because I don’t think taking what anyone said here, and applying it, rationally gets you to that conclusion.

  16. #16 Yetti Culler
    February 20, 2012

    @Jason #15
    You are attempting to reason with some one who is either playing dumb semantic games or is operating purely out of prejudice, or maybe both ! The observation re: teens was probably intended as ‘all teens are ephebophiles’ which would sort of work as an argumentum absurdum, if it was actually relevant, which it wasn’t anyway (no logic to the lack of logic). Anyway teenage sexual abuse of younger children is an issue, and the cast of teenager – 13-20 – year old clearly does not describe a coherent age group within which issues of consent can apply without gradation. For a sensible take http://www.scientificamerican.com/article.cfm?id=pedophiles-erotic-age-orientation

  17. #17 Calli Arcale
    February 20, 2012

    Yikes! Yes, this pill is a bad idea. Preventative medicine has to be very low risk or it is not worthwhile, in general, and also very effective. This appears to be neither low risk nor highly effective. Bad all around. What we need is something on the order of a vaccine in terms of risk/benefit ratios before anyone should be routinely recommending it.

  18. #18 EvilYeti
    February 20, 2012

    I love it when people post citations that prove my point. From the article:

    “Although Michael Jackson might have suffered more disgrace from his hebephilic orientation than most, and his name will probably forever be entangled darkly with the sinister phrase “little boys,” he wasn’t the first celebrity or famous figure that could be seen as falling into this hebephilic category.”

    (hebephile, a newly proposed diagnostic classification in which people display a sexual preference for children at the cusp of puberty, between the ages of, roughly, 11 to 14 years of age.)

    Michael Jackson was also, if you were not aware, a gay man. And among the various ‘hebephillic’ entertainers I’m aware of, their gender preference was consistent regardless of age group.

    And as long as they are entertainers and not catholic priests, its apparently not an ‘epidemic’ as far as the anti-theists are concerned.

  19. #19 dustbubble
    February 20, 2012

    Evil @ 18:
    “Michael Jackson was also, if you were not aware, a gay man.” Right again. You’re on a roll.
    I was not aware that MJ was a Gay Man.

    As far as I knew (insofar as I was aware of his existence at all) he was a twice-married father of three. (one by AI in a near-stranger, it appears). If he was guilty of any paedophilic activities at all, I’d sooner cite his suit of Lisa Marie, who he’d met when he was aged seventeen and she seven. Although he had the good taste to wait nearly twenty years to get hitched. And there are various unsubstantiated accusations of male kiddy-fiddling too.
    Sounds like any other good ol’ fundamentalist preacherman, to my alien ears.

    Frankly, if he had been a bearer of Teh Ghey, life would have been a good deal easier (and cheaper) for him, working in the industry that he did and all.
    Or is your considered opinion “man enabled by power and wealth do nasty&illegal, therefore gay” ?

  20. #20 cynical1
    February 20, 2012

    Few points to make:

    1. Gilead is NOT Big Pharma. It is a medium sized pharma company targeting a niche market.
    2. Big Pharma hates the FDA. They curse their existence and they certainly don’t own them.
    3. Big Pharma doesn’t work on HIV any longer. Very, very little. They have systematically dismantled all of their anti-infective R&D over the past 10 yrs. For instance, Pfizer and GSK spun off their HIV drugs to a new company (ViiV).

    The problem with HIV in the developed world from the pharmaceutical industry’s perspective is that the infection rate in the population isn’t rising and there are already 20+ drugs out there that control the virus when used in combinations. Any new drug has to go through many different combination trials to develop and that’s expensive. Unless there’s clearly superior efficacy, all the new drug does is dilute the market. And of course the developed world can’t afford to pay for these drugs so no money there. Big Pharma didn’t see a big enough return on investment in anti-infectives so they got out and worked on fat pills instead not realizing that coming up with a safer alternative to diet and exercise was a pipe dream. Now Big Pharma companies are all circling the drain having come up with jack in the past decade. As for Gilead, if they have the only preventative drug, they get the entire market for the indication. Also, just because the FDA gave it an expedited review doesn’t mean that it will be approved. If I had to bet, I would guess that they will not approve it for the reasons stated above. They’re not stupid you know.

    I have to admit that I am sort of on the fence about this indication that Gilead is pursuing. On the one hand, there are many promiscuous people who will not use condoms. Is something better than nothing? And then there’s the arguments above which are all valid. Just to play devil’s advocate for a moment. What about the use of valiciclovir for reducing the transmission of HSV? It is approved for that indication and it does, albeit rarely, cause kidney toxicity as well. From the logic above should that indication be removed? But yes I know that HSV is not HIV so it’s not really the greatest analogy. Just saying…..

    Finally, I disagree with you Abbie saying there is “*no* experimental evidence”. There was a very large clinical trail funded by the NIH (your tax dollars) and the Gates Foundation. They showed a 44% reduction in transmission that clearly reached statistical significance. Does the risk/benefit warrant this indication? That’s another story all together but they do definitely have efficacy over placebo. You may not feel it’s good enough but it’s irresponsible to say there is no experimental evidence. For a very promiscuous individual who has many sex partners and never uses protection, they may actually think it’s a great idea.

    Disclaimer: I don’t work for Gilead, the NIH, the FDA or the Gates Foundation and I have no horse in this race because I’m married and like most married men, I never have sex so the risk of HIV infection is nil.

  21. #21 rokujolady
    February 20, 2012

    Firstly, you are a homophobe, Yeti. I will not be taking any of your comments at all seriously based on this fact.
    Secondly, I’m thinking that the child abuse scandal isn’t entirely a Catholic problem. I think we’re going to find pedophiles in any sort of position where they work with children and are deemed beyond reproach by the community. The smug evangelicals and atheists probably shouldn’t pat themselves on the back too hard lest it be found to be just as prevalent but less publicised in their communities. The problem with the Catholic church in particular is that the power structure that it has held for centuries is really good at covering up this crap.
    I am still, despite the best efforts of the marketing departments at companies I’ve worked for, unconvinced that corporate interests permeate or pollute everything, so I think the FDA fast-track might have more complicated reasons than Big-pharma paid for it.

  22. #22 EvilYeti
    February 20, 2012

    Oh For Fucks Sake.

    I live in a gay neighborhood. About half of my friends (male and female) are gay. My opinions on this topic are largely influenced by them, so if you don’t like what I have to say you are the homophobe. Sorry to piss in your Wheaties.

    If you bothered to look (and people have, in depth) you would know that incidents of sexual abuse amongst clergy are similar to those of the general public:

    http://www.thedailybeast.com/newsweek/2010/04/07/mean-men.html

    So if there is an “epidemic” of child abuse amongst Catholics, there is also one in the atheist community. Now take a guess which one of these false statements can be posted on an atheist blog and accepted uncritically. Look up for an example if you want.

  23. #23 EvilYeti
    February 20, 2012

    @20: *some* Big Pharma hate the FDA the same way some Big Banks hated (or well, hated before they collapsed) the SEC and Federal Reserve. Meaning they were not their most favorite children.

    While Gilead isn’t as big as Pfizer, they are still listed on the S&P 500. Which is big enough to get their stuff on the FDA Fast Track for something that is pretty clearly not a very good idea.

  24. #24 cynical1
    February 20, 2012

    EvilYeti – your statement is just silly. The smallest tiniest Biotech can get Fast Track designation. It’s not based on the size of your company or your ability to bribe the FDA. It’s a review process that is expedited based on whether the disease is 1. serious AND 2. whether there is an unmet medical need. It’s a process to (hopefully) get drugs faster to patients. HIV is a serious disease. There is no drug for HIV prophylaxis. Hence, it got a Fast Track designation. Period. That doesn’t mean it’s going to get approved. Wouldn’t you want a vaccine for HIV fast-tracked? It would be and should be. What if the vaccine only provided 50% efficacy in the patient population? There are many fast track NDAs that are shot down by the FDA. The FDA isn’t in any companies pocket. You don’t work in the pharmaceutical industry, do you?

  25. #25 EvilYeti
    February 20, 2012

    cynical1 – no I do not work in the pharmaceutical industry.

    I work in the public, not-for-profit scientific research industry; meaning I’m more interested in the study, treatment and prevention of disease vs. the creation and maintenance of it via food additives and designer drugs.

    And really, only someone that worked for Big Pharma would have their perspective skewed to the point that they think a Fortune 500 company like Gilead was ‘a medium sized pharma company targeting a niche market’. Or think the game isn’t rigged in favor of Big Pharma:

    http://www.sourcewatch.org/index.php?title=Pharmaceutical_industry#FDA_funding_fees

  26. #26 rokujolady
    February 20, 2012

    Yeah, Yeti. I have black friends too, so that means I can’t possibly be a racist. Derp.
    And according to your post at 25, your view isn’t skewed against the pharmaceutical industry at all. You just think they’re out to poison us all and foster chronic illness so we are all compelled to pay them fat sacks of cash for the rest of our lives.

  27. #27 EvilYeti
    February 20, 2012

    rokujolady; please tell me what I said that was homophobic.

    The observation that most cases of ‘pedophilia’ by clergy should be more accurately described as statutory rape of teenage boys by adult, gay men was courtesy of an ordained minister I know. Who happens to be an adult, gay man himself, btw.

    For the record, I didn’t believe him. But I checked the facts and he’s right. You are using the same logic Twatson does to call anyone that disagrees with her a ‘misogynist’. Calling out bad behavior by a minority of the gay community doesn’t automatically make one a homophobe.

    The observation that most diseases are now lifestyle illnesses predominately caused by eating too much bad food, isn’t entirely mine either:

    http://opinionator.blogs.nytimes.com/2011/04/12/how-to-save-a-trillion-dollars/

    And not only is the government not regulating bad food, they are actually subsidizing it via the SNAP program and farm (particularly corn) subsidies.

  28. #28 cynical1
    February 20, 2012

    StupidYeti- You’re obviously an idiot and I’ll let your responses above stand on their own merit. No further dialog necessary.

  29. #29 EvilYeti
    February 21, 2012

    Reality 1.

    cynical1 0.

  30. #30 cynical1
    February 21, 2012

    Couldn’t agree more………….

  31. #31 Jack
    February 21, 2012

    Another reason why ARVs are ‘bad’ for ‘XMRV+’ people:

    Multiple Sources of Contamination in Samples from Patients Reported to Have XMRV Infection: http://www.plosone.org/article/info:doi/10.1371/journal.pone.0030889 20/02/12

  32. #32 hoary puccoon
    February 21, 2012

    EvilYeti @ 18 “…among the ‘hebephillic’ entertainers I’m aware of, their gender preference was consistent….”

    Roman Pulanski? Errol Flynn? Granted, they’ve both shown a consistent gender preference for women….

  33. #33 hoary puccoon
    February 21, 2012

    Oops, I forgot Jerry Lee Lewis (the rock star, not the comedian.) I think JLL actually married a young teenage girl.

  34. #34 EvilYeti
    February 21, 2012

    Jerry Lee Lewis married his 13 year old first cousin and quite literally caught holy hell for it.

  35. #35 ERV
    May 28, 2012

    WHY IS THIS POST GETTING SO MUCH SPAM??? WHYYY???????? WHYYYYYYYYYYYYYY?????

  36. #36 Lyndon Rencher
    May 31, 2012

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