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Medicine Science

Merck's Drug Propecia Linked To Sexual Dysfunction 235

zaxios writes "Merck — the pharmaceutical giant previously featured on Slashdot for drawing up a 'hit list' of doctors that criticized its drug Vioxx, and creating a fake medical journal to endorse its products — is embroiled in a new scandal. USA Today is reporting on two new studies that show Propecia, Merck's $250 million prescription medication for baldness, can make men irreversibly impotent. Lawsuits have been filed in the United States and Canada from men claiming to have permanently lost their sexual function after taking the drug. All this is reminiscent of Merck's difficulties with Vioxx, a once $2.5-billion-a-year drug, which was withdrawn from the market in 2004 after a study showed it doubled the risk of heart attack and stroke in users."
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Merck's Drug Propecia Linked To Sexual Dysfunction

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  • by Anonymous Coward on Saturday April 09, 2011 @01:20AM (#35765742)
    ...Propecia is an anti-androgen! Duh.
    • Re: (Score:3, Insightful)

      by Khyber ( 864651 )

      This is the correct answer.

      Anyone that doesn't understand this shit should be suing their doctor for not telling them, not the drug company.

      • Comment removed (Score:4, Interesting)

        by account_deleted ( 4530225 ) on Saturday April 09, 2011 @04:06AM (#35766210)
        Comment removed based on user account deletion
        • by zaxios ( 776027 ) <zaxios@gmail.com> on Saturday April 09, 2011 @05:17AM (#35766422) Journal

          Whether a drug is worth the risk for the benefits should be up to the PATIENT, not some damned ambulance chaser!

          Right, and in this case the patients weren't warned of the risk of irreversible impotence, only reversible impotence that was supposed to go away after they stopped taking the drug. They weren't in any position to weigh up the real risks and benefits, and have every right to sue the pharmaceutical company for that.

        • Informed Consent (Score:5, Insightful)

          by ShakaUVM ( 157947 ) on Saturday April 09, 2011 @05:23AM (#35766434) Homepage Journal

          Really needs to DIAF. I mean sure, if the drug company lies? Bust their asses, shut them down. but too many drugs, drugs that can save lives and make folks lives better, are being taken off the market not by lies but by douches that don't follow directions and that is total bullshit! If my doc explains the pros and cons of a drug and I agree to take it it should be between my doc and myself not some ambulance chasing scumbag!

          Your story is an excellent case for the policy of informed consent. As long as everyone knows what the risks are, people should be free to take the drugs.

          Who cares if Vioxx increased your chance of a heart attack by a small amount? ("Doubling" the risk is much scarier than saying it raises your risk by 1% or whatever.) If the patient UNDERSTANDS the risk, and no better drugs exist, he should be able to take his Vioxx or whatever. It's called a black-label warning, and the FDA does it all the time. But nothing helps if the drug gets pulled off the market.

          I know about this, because my landlord at the time (an old Korean war vet) suffered excruciating pain from arthritis in his spine. He started on Vioxx and became a functional individual again. When they pulled it from the market, it was like literally chopping his legs off. Not one other painkiller really worked for him, except morphine. So he was put on morphine, and spent 17 hours a day sleeping. I asked him if he'd trade a 1% chance of a heart attack in exchange for getting his life back, and his response was something along the lines of "Yes, in a second. I spend all day sleeping now - I'd like to have my life back, even if it means a slight risk."

          Naderites love to claim that their lawsuits keep the evil big corporations in line, not thinking about the harm they cause to the little guys.

          Of course, after the whole Vioxx debacle played out, they found that all COX-blockers increase the risk of heart problems (due to shared receptors, IIRC, on the heart). But other companies just slapped a black-label warning on their Celebrex or whatever, and kept selling it.

          • by ColdWetDog ( 752185 ) on Saturday April 09, 2011 @08:14AM (#35766852) Homepage
            The problem wasn't so much that Vioxx slightly increased one's risk of heart attacks - it was that Merck hid data, went on an insane advertising campaign calling it a 'super aspirin' and tried to sell it to everyone and their dog. We have much more dangerous medications that we use all of the time but are (supposedly) treated with more respect. We did throw the baby out with the bath on this one. But remember it wasn't the FDA that banned Vioxx - Merck pulled it from the market.

            In that mythical pony-and-unicorn world of Steve Jobs and our dreams, the FDA would have forced Merck to sell rights to the drug to someone else who could act in a more responsible fashion.

            And yes, Celebrex is just about as bad for cardiac risk and doesn't work as well. Newsflash: Drugs are dangerous.
            • >>But remember it wasn't the FDA that banned Vioxx - Merck pulled it from the market.

              Right, that's what I said. And I'm hardly defending Merck here. They behaved irresponsibly, but pulling Vioxx from the market when they could have black-labelled their drug (as everyone else did) was also irresponsible.

              My wife was in pharmacy school while all that was going down. It was an interesting issue to study.

        • Re: (Score:2, Insightful)

          by Anonymous Coward

          When it costs a company nothing to push a liability waiver under your nose before rendering services, pretty soon everyone wants a blank check before they'll sell you groceries. If everyone wants a blank check, the blank check loses it's meaning.

          Meanwhile, it costs politicians and marketers nothing to sell you on a feeling of safety.

          The two combine to form a society of people emotionally incapable of making & keeping contracts. They sign the liability waivers and they probably mean it the first 100 time

      • by zaxios ( 776027 )

        ...Propecia is an anti-androgen! Duh.

        This is the correct answer. Anyone that doesn't understand this

      • by zaxios ( 776027 ) <zaxios@gmail.com> on Saturday April 09, 2011 @06:31AM (#35766568) Journal

        ...Propecia is an anti-androgen! Duh.

        This is the correct answer. Anyone that doesn't understand this shit should be suing their doctor for not telling them, not the drug company.

        Antiandrogens are only supposed to have that effect temporarily, while you're taking them. The significance of these new studies is that they show Propecia is causing permanent impotence - it persists even after you stop the drug. That is not a known behaviour of antiandrogens, and was not disclosed to patients considering Propecia.

        • It's been known for decades that continual ingestion of anti-androgens (for a period of over 6 months) can cause permanent loss of potency. This lawsuit is bogus.
          • by zaxios ( 776027 ) <zaxios@gmail.com> on Saturday April 09, 2011 @09:39AM (#35767338) Journal

            It's been known for decades that continual ingestion of anti-androgens (for a period of over 6 months) can cause permanent loss of potency.

            Simply wrong. They provide a loss of potency while on the medication - which, in the case of prostate cancer, is usually years. And yes, the loss of potency worsens after several months. But it does not persist after treatment. Here is a quote from Merck's page for Propecia [propecia.com]: "A small number of men had sexual side effects, with each occurring in less than 2% of men. These include less desire for sex, difficulty in achieving an erection, and a decrease in the amount of semen. These side effects went away in men who stopped taking PROPECIA because of them." That information has turned out to be wrong. Are you seriously telling me they shouldn't be liable for giving prospective patients wrong information about side effects? If so, why not?

            • Please read again the page you linked to. Nowhere does it say that there cannot be permanent side effects - only that 2% of males experienced the side effects, and that they went away when they stopped taking the drug, in a limited-time trial.

              That is NOT the same as long-term use.

    • If it wasn't Propecia, maybe it was a different anti-baldness pill, but I remember a coworker commenting about it back in the ?late 90s?. I don't remember whether he decided to take the pill or not, though.

    • by zaxios ( 776027 ) <zaxios@gmail.com> on Saturday April 09, 2011 @04:46AM (#35766334) Journal
      Propecia is an antiandrogen, and has always been known to cause sexual dysfunction while the user was on the drug. What's significant about these new studies is that they show that sexual dysfunction can persist AFTER you stop taking Propecia. That contradicts what Merck has always said - their product guidance warns of sexual side effects but expressly states that they always stop after ceasing the drug - and the advice that doctors give to patients considering taking Propecia. That's why there's a lawsuit - no one was ever warned that these sexual side effects might be permanent.

      In fact, it remains a mystery how the drug could have this effect: its half life is only a few days, and it really should be ceasing any effect within that time. At least one doctor (Dr Alan Jacobs, a neuroendocrinologist in NYC) is speculating that Propecia is inducing permanent changes to the expression of genes governing the androgen system. IANAD so I express no view on that.

      If you want to learn more about this issue, go to propeciahelp.com. There are people there who have been suffering from post-Propecia symptoms - not just sexual dysfunction, but other symptoms associated with low testosterone like cognitive impairment, fatigue, etc - for upwards of 10 years after stopping Propecia. If that's not worth a big payout from a pharma company that expressly told that that all side effects would cease after taking the medication, I'm not sure what is.
      • In fact, it remains a mystery how the drug could have this effect: its half life is only a few days, and it really should be ceasing any effect within that time. At least one doctor (Dr Alan Jacobs, a neuroendocrinologist in NYC) is speculating that Propecia is inducing permanent changes to the expression of genes governing the androgen system. IANAD so I express no view on that.

        Maybe sex is like other sorts of exercise. If you stop, it can be difficult to start again. Or your partner loses interest and its difficult to get her started again.

      • by Synn ( 6288 )

        Finistride has been in use for over 20 years and there still hasn't been any proof that it really causes these issues long term. The science is still really against it.

        Frankly impotence, low sexual desire, fatigue, can all have psychological causes. I think it'd be interesting to give people a placebo, tell them it may cause sexual dysfunction, then point them to a website www.sugarpillscausedmyED.com and see what the carnage was.

  • by FSWKU ( 551325 ) on Saturday April 09, 2011 @01:21AM (#35765746)
    You take a pill to cure baldness, ostensibly because you find your lack of hair hampers your ability to get laid. But after taking the pills you end up with a full head of hair and maybe even a woman because of it, and you're unable to perform?

    Seems like you're damned if you do, damned if you dont...
    • Nah (Score:5, Insightful)

      by MrEricSir ( 398214 ) on Saturday April 09, 2011 @01:23AM (#35765754) Homepage

      Self-confidence, social ability, and how you dress are more important than your hair.

      • Re:Nah (Score:4, Interesting)

        by Anonymous Coward on Saturday April 09, 2011 @01:40AM (#35765808)

        I always think of this whenever the subject of hair loss/baldness comes up:

        As for me, I'm approaching 50, don't have quite as much hair as I used to, and I'm now living with the most womderful (and goddamned gorgeous) woman it's ever been my pleasure to be with.

        ExecSummary: Whenever one of those Hair Club For Men adverts comes on telly, I just laugh all the way to the bedroom. :)

        • I'm in my 40's and have a full head of wavy locks. The chicks really dig my hair, but I chose to shave it off. The chicks dig my bald head to.

          maybe I'm just lucky, but I really think it's the in-between states that don't work. Everyone I know who embraces baldness is a hit with the ladies.
      • by hitmark ( 640295 )

        Hell, is there not a claim that baldness is a signal of genetic strength? At least if one was living back among the trees, living long enough to start balding would indicate some level of disease resistance.

        But then modern advertising have turned all the typical sexual signals topsy turvy...

        • Actually, since Propecia works by disrupting some kind of testosterone-related hormone -- which is presumably why it causes impotence in the long run -- baldness might very well be an indicator of virility.

          • baldness might very well be an indicator of virility

            It is, and this has been proven since the 1970's! Men with less tetesterone usually keep a full head of hair - but they are often more "womanly". A great book on the subject is Why Men Don't Listen and Women Can't Read Maps [amazon.co.uk]. Sounds sexist, but it's very fact-based - women and men don't think alike, and this book explains even teh gay. It all comes down to how much of the 'correct' hormone your particular chomosome pair receives...

          • by hitmark ( 640295 )

            Yep, that was the word i was unable to recall. thanks.

        • Re:Nah (Score:4, Informative)

          by pieterh ( 196118 ) on Saturday April 09, 2011 @04:27AM (#35766270) Homepage

          It's not so much about genetic strength as about power. Here is the explanation in evolutionary psychology terms.

          Male pattern baldness is an evolved feature that relies on hormonal pathways to trigger. Evolved, meaning it gives an advantage in terms of more success with women, more kids, kids who live longer, and do better.

          Why would going prematurely bald give a man success? The reason is, IMO, about power. Men instinctively trust older men (who know more, have survived, are worth listening to). Premature baldness makes a man look older than he really is. That's a sneaky way to grab power. It demands intelligence, because unless you're smarter than your peers you can't fool them into following you. So there's an inherent association between baldness and smartness.

          I once studied the 100 most powerful people in the UK (Economist report). 4 were women, 96 were men. Of the 96, a significant number were bald, but there was no correlation between baldness and age. I.e., as many younger men with power were as bald as older men.

          Now, as to why men worry about losing their hair? I'd guess, insecurity. Going bald is a gambit, a risk. Obviously you lose attractiveness to women who are looking for a long term partner. You're unlikely to find a woman who wants to settle and raise a family. But if you can pull it off, and get men to follow you, you get power, and a lot of women find that irresistible.

          So the anti-baldness industry caters to insecure men, just as the beauty industry caters to insecure women. Another reason for being proudly bald, it shows not only that you're a born leader of men, smarter than average, and the latest in a long line of winners, but also that you're confident.

      • by TheLink ( 130905 )
        The shape of your skull does matter more if you are bald though.

        Some men look fine bald (good even) whereas others would be better off with hair hiding the shape of their skull.
      • Self-confidence, social ability, and how you dress are more important than your hair.

        The Myth is dead. Long live the Myth.

      • Self-confidence, social ability, and how you dress are more important than your hair.

        For many people, losing their hair hurts their self-confidence, which hurts their social ability.
        It shouldn't matter, but it doesn't.

        • by sjames ( 1099 )

          Mostly because of a gadzillion commercials telling them they are complete losers who can never get laid again if they don't have hair. Some claim they should take a pill, others say they should have a wig glued on (but don't say it that plainly), a few suggest surgically moving their hair around and one or two even claim they should spraypaint their scalps hair colored. The only common thread is "you're a total loser, but if you give us eleventy jillion bucks you can resemble an actual human being again".

    • If it wasn't Propecia, maybe it was a different anti-baldness pill, but I remember a coworker commenting about it back in the late 90s. I don't remember whether he decided to take the pill or not, though.

    • by jamesh ( 87723 )

      Seems like you're damned if you do, damned if you dont...

      Unless your girl knows a thing or two about what causes baldness... like Christine Lavin [youtube.com] does...

    • You take a pill to cure baldness, ostensibly because you find your lack of hair hampers your ability to get laid. But after taking the pills you end up with a full head of hair and maybe even a woman because of it, and you're unable to perform? Seems like you're damned if you do, damned if you dont...

      I've got this funny shaped blue pill for you, sir. When you get a headache from that, why here's some aspirin. Got a tummy ache from the aspirin? Here's some Tagamet

      And on and on and on.... It's pharmaceuticals all the way down.

  • by Anonymous Coward on Saturday April 09, 2011 @01:31AM (#35765776)

    20 years ago, I knew a lady who worked at Merck, about the time Propecia was "discovered". In reality, it was developed as a drug for another purpose (something to do with the prostate) and the hair growth was a side effect. She, and no other females, were allowed in the production area, as exposure caused irreversible infertility in females, and it was really bad for pregnant women.

    • by snowgirl ( 978879 ) on Saturday April 09, 2011 @06:33AM (#35766570) Journal

      20 years ago, I knew a lady who worked at Merck, about the time Propecia was "discovered". In reality, it was developed as a drug for another purpose (something to do with the prostate) and the hair growth was a side effect. She, and no other females, were allowed in the production area, as exposure caused irreversible infertility in females, and it was really bad for pregnant women.

      Your story is absolutely bogus. Propecia cannot cause infertility in women, as it causes a breakdown in the development of Dihydrogen-testosterone from Testosterone by blocking the 5-alpha-reductase enzyme. (It is a 5a-reductase inhibitor.) Women do not need testosterone or testosterone-analogs for fertility, thus Propecia has no mechanism whereby it could cause infertility in women. (In men? Yeah, it by definition will cause testosterone-analog "deficiency", which can include sexual dysfunction.)

      Rather, the real reason why pregnancy is so bad is that if you are being exposed to a 5-alpha-reductase inhibitor is that if a child developing in the womb has an XY genotype, then they will develop with 5-alpha-reductase deficiency [wikipedia.org] and if the concentrations are high enough, they will develop female primary sexual characteristics despite having testicles and Wolfian ducts.

    • by JamesP ( 688957 )

      No, it's not that.

      It causes damages to the process of male fetus formation. Because it blocks DHT (derived from testosterone) and that works in the formation of male characteristics.

      If it's a girl in the womb, no problem. But of course you never know, and by the time you know it's too late.

  • hmmm. (Score:2, Insightful)

    by Anonymous Coward

    the moral is, don't mess with your health if you can avoid it. we just don't know enough yet.....

  • Not surprised (Score:5, Interesting)

    by BlueParrot ( 965239 ) on Saturday April 09, 2011 @01:40AM (#35765806)

    I'm transsexual and take testosterone blockers in order to help feminise my body, and changes in sex drive were quite noticeable. Propecia's active substance, finasteride, is essentially a testosterone blocker ( thou admittedly a weaker one than what I am taking ) so I'm not at all surprised it can have such side effects.

    • I'm transsexual and take testosterone blockers in order to help feminise my body, and changes in sex drive were quite noticeable. Propecia's active substance, finasteride, is essentially a testosterone blocker ( thou admittedly a weaker one than what I am taking ) so I'm not at all surprised it can have such side effects.

      Same, though I'm on both finasteride and spironolactone. This is very much a desirable side effect for us. =)

      I just hope that this doesn't result in a massive recall and them stopping making it. Finasteride in higher doses is used as part of a prostate cancer treatment regimen for analogous reasons to this "side effect", so hopefully the drug won't go away completely.

    • by Synn ( 6288 )

      It's not a "testosterone blocker", it blocks some of the conversion of testosterone to DHT.

      You end up with more testosterone, but less DHT. I'm sure that can have effects, but it's going to vary wildly from person to person.

      • by amper ( 33785 )

        Yes, but it's DHT that's primarily responsible for the androgenic effects in your body. Blocking the 5-alpha-reductase enzyme which causes testosterone to be converted to dihydrotestosterone *does* leave more free testosterone in the body, but it get shunted to another metabolic pathway due to lack of 5-alpha-reductase, and is metabolized into estradiol, which is the primary estrogen in post-pubescent and pre-menopausal females.

        Small wonder that long term usage of finasteride might cause permanent sterility

  • by seifried ( 12921 ) on Saturday April 09, 2011 @01:55AM (#35765852) Homepage
    With all the side effects these newer drugs seem to have (rushed warning at the end of the commercials, full page ads with a full page warning on the opposite side) and their cost and dubious effectiveness I really have to wonder how sane people are.
    • by xnpu ( 963139 )

      More scary warnings sell better. Cigarette companies figure that out a while ago, so has big pharma.

  • by countertrolling ( 1585477 ) * on Saturday April 09, 2011 @02:07AM (#35765898) Journal

    Put him in charge of the FDA

  • I had shoulder length hair as a teenager, then around my mid 20's I noticed it had thinned out a bit on top, and the long hair thing was starting to look a bit sad, so I cut it all off and now sport a #1 clipper cut. I know a bit about the sorts of hormone interaction that causes baldness and it seems kind of obvious that unless you can find something that specifically affects the hair folicle's(sp?) sensitivity to those hormones, the only other way is to tinker with the hormones themselves, and i'm not hav

  • by Johnny Mnemonic ( 176043 ) <mdinsmore.gmail@com> on Saturday April 09, 2011 @02:32AM (#35765998) Homepage Journal

    I think it's pretty unreasonable to expect that a pharma be able to test for all possible side affects of a given medication. Some of them don't seem to have side affects related to their main effect, so the scope of the test to look for all possible effects would have to be so broad it'd result in subject fatigue.

    However, I present that in the hypothetical context of pharma operating in good faith. That is, I wouldn't want to hold up a potentially life saving drug just cause I had to test for every possible side effect, including very subjective ones.

    In the current state, pharma isn't acting in good faith. They aggressively push drugs onto patients and doctors that don't really need them, their drugs may not work as claimed, and they don't seem to be acting out of medical principle so much as a "throw it against the wall" method of benefit discovery.

    So therefore, I don't believe they should have the benefit of operating in good faith, and should be held accountable for everything that they do. If they want to have the license to operate in a free market, they should have to accept the liability of their aggressive risk taking too. If they weren't so aggressive in taking risk, I'd cut them more slack for the rare screwup. But I don't think they deserve that latitude any more.

  • Most antidepressants will do that. It took me 4 hrs to empty my sack after taking that crap over a 3 month period.
    I had no sexual desire. This was medical, prostate health.,
    I stopped and finally got back my functionality, personality and reality. Don't take that shit! prosac, effexor and all the other SSRI crap will turn you into a pink cloud zombie.
  • Okay, why is this story "news for nerds?"

    (rolls eyes upward to see own hairline)

    Oh. Nevermind.

    (sobs)

  • Every drug has to be a miracle cure, with no ill effects or risks (discovered or undiscovered)

    Or someone's going to get sued.

    Seems to me the deck's stacked against the drug companies... now...

    Is it worth it to continue work on cancer curing drugs, when you're just going to get sued over them -- because they're less than 100% effective, or because they make people look fat or reduce sexual performance and people hate looking fat and hate lower sexual performance?

    If the treatment of the drug is im

  • This wasn't a new clinical trial as far as I can tell, but it was mining past trials for data and applying them to new hypothesis. A recent xkcd showed some of the problems with this kind of argument. If the data didn't support permanent loss of sexual function, perhaps it would support heart attacks, cancer, blindness, or perhaps cures for any of the above.

    If you think this is a possible side-effect, then hypothesize that, conduct a large trial, and see what the results are.

    Sure, mining past data can gen

  • Whenever it comes to light that some new drug has caused harm to a lot of people, the response is that they are evil and should have known better. Blah. Blah. I'm not saying I disagree, but it's important to put things into perspective.

    Pharmaceutical companies are businesses dedicated to making a profit. That is all. It just happens to be that the products they are pedaling are chemicals that affect the body. While it may be that some individuals working there care about the potential negative effects

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