96 Percent of Men on Propecia Have Persistent Side Effects?!
Hello Doc,
Please go through this ridiculous article in Yahoo.
Link: For Some Men, Propecia’s Sexual Side Effects May Be Long-lasting
Please tell me what you think.
Thanks
There are a great deal of claims that may accurately reflect the patient example, however, the documentation and balance of the presentation is poor and heavily biased. Read it accordingly.
It’s worth pointing out that this recent hysteria is just based on interviews with 54 men, where the participants reported their own issues after stopping the medication. Even more important is to note that these men were recruited from PropeciaHelp.com, an anonymous web forum where men post about problems (real or otherwise) they have from the medication.
The surprising 96% figure gives the media a good, scary headline to get people interested in watching or reading their report. For example, I just saw a quick 20 second segment on my local morning news that said “96% of men have persistent side effects”, but provided nothing else beyond that. It’s very alarmist and misleading.
The link by the poster only goes to a magazine article discussing the scientific paper. But, I am now including the abstract of the scientific paper, which was published in the Journal of Sexual Medicine, July 2012 issue (see https://onlinelibrary.wiley.com/doi/10.1111/j.1743-6109.2012.02846.x/abstract). Due to copyright issues, I am copying the abstract only (which is public) but not the entire article (which I read but requires a subscription or availability through a medical library).
I encourage readers to read the entire publication. For me, the sample size (n=54) was highly selected (those from PropeciaHelp.com) but confirmed that in some men they experience persistent sexual side effects even after cessation of Propecia. What is missing from this paper – and other reports in the literature – are detailed analyses of these men (hormonal, biologic, and psychological including concomitant medications and history) to further support (or lessen) the possibility that these irreversible problems are directly related to Propecia.
INTRODUCTION. Finasteride has been associated with sexual side effects that may persist despite discontinuation of the medication. In a clinical series, 20% of subjects with male pattern hair loss reported persistent sexual dysfunction for > 6 years, suggesting the possibility that the dysfunction may be permanent. These subjects also reported a wide range of symptoms including changes in cognition, ejaculate quality, and genital sensation. Other medications have been associated with irreversible neurological effects, such as phenothiazines with tardive dyskinesias.
AIM. To prospectively study whether the persistent sexual side effects associated with finasteride resolve or endure over time.
METHODS. Subjects (N = 54) with persistent sexual side effects associated with finasteride were reassessed after 9–16 months (mean 14 months). All subjects were otherwise healthy young men without any baseline sexual dysfunction, medical conditions, psychiatric conditions, or use of oral prescription medications prior to taking finasteride for male pattern hair loss.
MAIN OUTCOME MEASURE. Scores from the Arizona Sexual Experience Scale (ASEX).
RESULTS. The participation rate was 81%. At reassessment persistent sexual side effects continued to be present in 96% of subjects. According to the ASEX scores, 89% of subjects met the definition of sexual dysfunction. Neither the length of finasteride use nor the duration of the sexual side effects correlated to changes in scores of sexual dysfunction.
CONCLUSION. In most men who developed persistent sexual side effects (>3 months) despite the discontinuation of finasteride, the sexual dysfunction continued for many months or years. Although several rat studies have shown detrimental changes to erectile function caused by 5 alpha reductase inhibitors, the persistent nature of these changes
is an area of active research. Prescribers of finasteride and men contemplating its use should be made aware of the potential adverse medication effects
The abstract you posted preempts some of your own criticisms, unsurprisingly.
” All subjects were otherwise healthy young men without any baseline sexual dysfunction, medical conditions, psychiatric conditions, or use of oral prescription medications prior to taking finasteride for male pattern hair loss.”
The article also says testosterone therapy does not seem biologically plausible as the subjects generally have normal hormone levels. The follow-up involved an investigation into at least two separate hormone tests and the results did not show any interesting results. Before the first study was released, Dr. Irwig spoke with many more men than was reported and intentionally excluded any men with other ‘biologic, psychiatric, and pharmaceutical’ factors that could have confounded the study.
But I guess you have YET to read any case studies detailing irreversible conditions in post-finasteride patients?
Grant
There is nothing inconsistent about my blog comment. I mention a case series (and provide the abstract) from a publication – not just referencing a magazine article – that notes that a large number of men had persistent and real sexual dysfunction after use of finasetride. What I am also pointing out is that the article lacks quite a few details (which is why it is not published in a top-flight journal).
In the realm of scientific publications, DATA is king and opinions/hypotheses of authors are less valuable. I am less interested in general “baseline” conditions and more in a detailed biochemical/hormonal analysis, and listing of more info perhaps in a table?) for each patient – which was lacking. It doesn’t mean the phenomenon is not real. Your comment “The abstract you posted preempts some of your own criticisms, unsurprisingly” is just the typical and personal type of response so common on these blogs. If you are aware of published, detailed case histories in scientific journals (not magazine articles) you are aware of, why don’t YOU provide the reference?
and let the cheap shots begin……..
Dr L is right on and also echoes the cautiousness of Dr R. This J Sexual Medicine paper is valuable but at the end of the day a retrospective series obtained from men who advertise from a Propecia.help website (I have read the full paper). Thus, at the time that are contacted for this paper, they probably have not had detailed evaluations during their period of sexual dysfunction (at least it is not reported in the full article)- and can only report historically report “baseline†information to the author. How about a nice case study detailing (in depth) such an individual – or a prospective series of men who have extensive evaluations during their sexual dysfunction (and not just responses to questionnaires)
I just read an article this morning with a reasonable take on the issue. The title is also mildly amusing- “Calm Down: Propecia Probably Isn’t Causing Your Erectile Dysfunction”
https://www.theatlantic.com/health/archive/2012/07/calm-down-propecia-probably-isnt-causing-your-erectile-dysfunction/259803/
As far as I know, there’s no outcry about permanent sexual side effects from men taking finasteride for BPH at much higher dosages. Unless something unique is happening in younger patients, I find it hard to believe there is a direct biological connection.
Does anyone know the median age of subjects in this study? It would be interesting to know how it compares to the median age of men taking proscar.
According to the clinical trials:
“Integrated analysis of clinical adverse experiences showed that during treatment with Propecia, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with Propecia due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ≤0.3% by the fifth year of treatment with Propecia.”
Source: https://www.drugs.com/sfx/propecia-side-effects.html
Sounds like a safe drug to me.
I don’t have to do more than skim through the abstract to determine that this is another poorly conducted study done by Dr. Irwig. The selection of the sample group was quite flawed even in the first study, and any data obtained from the follow-up will be equally useless. It’s basically confirming that the flawed data obtained from the first study is still relevant a year later.
I don’t want to speak harshly of Dr. Irwig, as I have respect for what he is doing. However, the poor quality of these studies leaves me a little skeptical, and I will remain critical of his work. I am curious if these studies are just being published with the sole intent of making headlines. If this is the intent, the strategy is working extremely well as it seems like every news outlet is picking up this story.
I suppose due to the complete lack of any medical data that can causally associate symptoms to the drug finasteride, there isn’t much any other way to go about getting some public traction, so I can’t exactly blame anyone here.
I have not read the study, but Dr. L mentions that no hormonal testing was conducted. I can’t say I am at all surprised, because hormone levels in supposed sufferers of this condition always appear to be well within normal levels. Many finatics (get it, fin? pun.) claim their hormone levels are completely out of whack after taking this drug, but fail to provide any sort of tangible evidence. If everyone’s hormonal profile is so out of whack, Dr. Irwig’s study would most certainly have identified this as an issue, and undoubtedly implicated finasteride years ago.
If I were conducting a similar study, hormonal testing would be the absolute first thing I would do. The fact that it isn’t even mentioned tells me that Dr. Irwig knows hormones look fine, and reporting this fact would lessen the impact of the study. Clearly, Dr. Irwig is convinced finasteride is dangerous and wants his studies to reflect this.
I’m still waiting for a real study to be conducted this condition. Dr. Irwig, if you read this, go ahead and re-use your sample of ~100 men from propeciahelp. But then take a sample of 100 men who discontinued the medication without lasting issues. Compare hormone levels, look for trends, and take a more systematic and scientific approach to the problem. I am already confident what the results will be, but it would be nice for the rest of the world the realize this as well. When you conduct studies that try to verify what you believe is the truth, science and medicine takes a step backwards.
I still want to see specifically HOW these Propecia Help guys are different from men who have never taken finasteride, men who take finasteride (with no sides), and men who have discontinued finasteride (with no residual sides). I hope Dr. Irwig will compare the the hormone levels of the aforementioned four groups to give us some answers.
Dr. L
No cheap shots are necessary. You asked a basic question about what the hormone levels were for these men and Dr. Irwig noted in his article that most were in range. Less than two months ago you wrote “Yea, and I’m still waiting for a SINGLE published case history to appear in the peer-reviewed medical literature.” What made you change your mind after you referred to the follow up of the same exact article a case series in the above comment. I think it seems very likely that you are somehow directly or indirectly connected to Merck but this will be uncovered, you will be subpoenaed in a US court and your career will be destroyed. Your contradictory statements simply cannot be trusted.
https://baldingblog.com/2012/05/24/it-seems-everyone-blames-every-bad-thing-on-propecia/
Merck is receiving a lot of terrible press that will continue to snowball as they finally receive the justice they deserve. The flooding of what seem to be Merck PR agents on this blog post seems to be evidence that they feel very threatened and they’re resorting to very desperate measures to defend themselves. These types of actions are very self-destructive in the long run.
Gland9
Recently more and more patients have been reporting problems that they now realize are tied to Propecia due to the recent media press. In older men, it is much easier for them to think it was caused by other concomitant health problems or even old age so they would be much less likely to realize Propecia is the source. These specious explanations are not relevant to young men.
Grant Said: “I think it seems very likely that you are somehow directly or indirectly connected to Merck but this will be uncovered, you will be subpoenaed in a US court and your career will be destroyed.”
Grant, when you say things like this you shoot yourself in the foot and i’m pretty sure no one is going to be able to take you seriously from now on. You should go ahead and change your username again for a 4th or 5th time and try again!!
Just for the record, you insinuated that you believe Dr. L may be directly tied to Merck, and is a ‘shill’ of sorts on their behalf? You honestly believe Merck would pay employees to go post on forums to try to convince one guy who is already dead-set in his beliefs hell or high water that he is wrong?
You also seem convinced that this controversy will precede Merck’s downfall, and that it would result in anything more than a barely noticeable blip in their profits? Just as one good example to illustrate that this is not the case, take a look at Merck’s stocks for the last year. You will see that they have held the same upward trend in spite of the fact that this whole Propecia issue has hit headlines like never before.
Merck deals with lawsuits all the time. They have years of experience and million dollar lawyers to deal with legal issues. They could hire a thousand people to go post on forums and pay off doctors, but it won’t change the fact they will still get sued. Even if Merck lost every single lawsuit to people suing for damages from taking Propecia or Proscar, it still probably wouldn’t even equal what they bring in from a signle month from these drugs. I can’t imagine finasteride brings in even close to 1% of their anual income.
Try to put things back into perspective. The fact that you believe Merck feels threatened or are in any desperate situation shows that you are quite out of touch with reality. Companies this huge know exactly how to deal with situations like this in a way that will result in the minimum amount of fallout. They aren’t desperate; they know exactly what they are doing and are taking the necessary steps to mitigate the situation.
One more example for you, I am sure you are well versed in what happened with Vioxx. The drug was directly implicated in over 50 thousand deaths, and countless other injuries. The impact of this was at least a hundred fold what they would experience should finasteride be implicated in these symptoms. Their stocks did plummet, but shortly after they returned and the company has been doing extremely well ever since. Why do you think the finasteride lawsuits would have any affect on them whatsoever?
Merck has a history of shady dealings. They are a heartless corporation. But the same goes for every other massive pharmaceutical company out there.
Also to comment on BiotechMD, it is not ‘cautious’ to ignore potential reports of risk for a medication even if the evidence is very weak and especially not in this case. Ignoring risk signals is actually what I would call ‘reckless’.
And lastly to Harvey Q – the article you posted seems like a prime example of what a PR firm would try to disseminate to counteract a public relations crisis, which Merck is currently facing. Even the first two words are telling readers to ‘calm down’ which is exactly how a crisis manager would approach such a problem. It can be very rewarding to have a healthy sense of skepticism in these types of situations.
My elbow is itchy. I’m taking propecia… that must be the cause!
I have not changed my user name and have posted on this blog a few times. I am a miserable Merck victim that is unlikely to recover my livelihood and health due to the corruption of this vile organization.
Some things to clear up pal: Merck’s stock is LOWER than it was before the Vioxx recall. It was around $60 per share in 2003 and only $45 a share in September 2004 just before Vioxx was recalled. The stock is now even lower at less than $45 per share. The S&P500 index in contrast grew about 60% in value per share since 2003 to now in comparison. Truly pathetic performance when compared to just an average American business.
Secondly, Merck may not pay “Dr. L” directly, but may very well hire a PR agency to take care of the issue for them. These people are not hired to convince a single person that Propecia is safe. It is to convince the thousands of readers who frequent this blog. Merck has done it in the recent past, and will likely continue to do so in the future. I am very likely speaking to a PR-agent at this exact moment. Does the following behavior seem familiar to you at all?!!? This was discovered during the legal process and severely damaged Merck’s reputation. The penalties for this type of behavior are increasing, GSK just paid out the largest criminal penalty in history at $3bn. Merck cannot seem to stop getting in its own and I feel absolutely no pity for it.
https://www.cbsnews.com/8301-505123_162-42841270/new-merck-allegations-a-fake-journal-ghostwritten-studies-vioxx-pop-songs-pr-execs-harass-reporters/
Boy, I’m sure glad I dodged a bullet by never taking Propecia, even though the hair loss docs hand it out like jellybeans.
It’s won’t be long it will be taken off the market. The drug is a complete disaster. A total flop.
“The drug is a complete disaster. A total flop.”
Oh really now?
Propecia has been on the market for some 15 years now, and i’m not precisely sure what the numbers look like but the drug has brought in somewhere around 5-10bn revenue for the Merck. This doesn’t even include whatever is brought in from Proscar, which is probably even higher.
Now the drug was invented around 25 years ago, and in it’s wake brought an extensive amount of research and TWO separate FDA trials in which it passed with flying colors. The safety profile demonstrated by this research shows that finasteride is remarkably well tolerated and safe unlike the majority of other prescription meds.
So after 25 years of use on humans and well over ten million users, the FDA conducts thorough sweep of their records to try to find out why the hell many people are complaining. They found that a grand total of 59 people reported sexual dysfunction lasting more than 3 months after quitting the drug.
59 people out of millions of users over the course of 20+ years.
Yeah. What a complete disaster. Good thing you dodged that bullet. I’m fairly certain you are more likely to die by being struck by lightning than end up with permanent problems from this drug.
How much do you get paid for every post you write praising finasteride? Are you paid a wage or maybe you are on a retainer?
There were only about a hundred submissions to the FDA in that time period and they selected only the perfect matches that seemed indubitably to be linked to finasteride. If you do a little bit of your own thinking, you will see the reports were growing exponentially as the public became aware of the connection between the drug and its risk. And due to the exponential growth of reports, a large portion of the reports in question were omitted since they drew the cut-off in April 2011 rather than present day. Your description is very incomplete and misleading, but seem to be a pretty relentless PR guy so you are doing your job.
Grant,
You are as rude as you are paranoid. So anyone who points out the empirical fact that tens of millions of men have benefited from finasteride vs. a tiny percentage who claim damage is a paid Merck PR agent? That is laughable, and demolishes any credibility you might have had. Then I must be another Merck employee, as are my 2 brothers and nephew, who all have successfully used Propecia for decades.
Oh boy, you caught me! Foiled by my own web of lies and deceit! Merck will not be pleased about my poor performance… Nice detective work there, gumshoe.
Seriously, I start to think some of you guys are pretty bright and really know your stuff, but then inevitably the conspiracy theories start to roll in. I guess it makes sense though, when science doesn’t support any of your theories, conspiracies are a great fallback plan.
What are you talking about? I can go to the FDA website right now and submit a report to their AERS database, say finasteride caused the symptoms and I’m all done.
You’re also saying that the reports from April 2011 until now would tell a completely different tale? The last 20 years doesn’t count without that?
The fact that this whole fiasco is more public just means more people can blame whatever symptoms they are currently experiencing on the drug, and potentially cash out from the lawsuits. The symptom list for this post finasteride syndrome is so huge, anyone who has ever taken finasteride and quit would be able to blame the drug for something. Anyone could say “my libido isn’t what it used to be, I blame finasteride”.
Believe me – there is a huge difference between ‘my libido isn’t what it used to be’ and the side effects of finasteride. Consider yourself lucky that you don’t know the difference. Some men who have anxious predispositions sometimes think they are victims but they are unsure and their symptoms diminish fairly quickly. Those who actually have suffered significant consequences due to taking Propecia have no uncertainty that there is something wrong with their body.
Derrysf: These are not conspiracy theories. Do a little bit of research on Merck’s legal history and you will see they engaged in a wide range of corrupt practices to conceal the dangers of some of their previous drugs. Naturally, this would be likely to continue for finasteride and as they have in the past they will be discovered. Unfortunately, their often continue to operate with impunity despite being discovered, but things are beginning to change.
The science comports with the notion that Propecia has the potential to inflict long-term irreversible damage. More and more evidence is being released and those who are in denial will find themselves on the wrong side of history.
Guys,
first off, being cautious and looking for indicators even when the evidence is lacking is a big part of what life is about. Look at the stock market, if everything was clear and present we’d never loose a cent, and always get in (and out) at the right time. we have over paid harvard analysts staying up 24/7 and at the end of the day it is still guess work.
you take a drug that changes your hormones enough to stop a physiological event as apparent as hair loss, and think it wont do anything else to your body? “my endocrine system shut down, im sure it has nothing to do with hormone manipulators im taking!”.
all the believers IMHO have disillusioned themselves, and hey i get it, its completely understandable… I want to believe in a cure to. But id go as far to parallel the notion that drinking makes a night really fun, and the hangover is just a coincidence… right?
Not to mention you all are reacting to this medical journal the same way the vatican reacted to the discovery of Lucy.
for those that dont know who Lucy is, here is a link:
https://en.wikipedia.org/wiki/Lucy_%28Australopithecus%29
Hey all i.can say is im 23. I dont need a study to tell me my sex life was ruined by my short bout with propecia. Literally took it for less than two weeks. Im now on cialis three months later with little help from that. I dont see why these guys get so much criticism? All we are asking for is awareness. Just because you cant see a mechanism biologically doesnt mean it didnt happen to us. And personally the mental and other physical sides outweigh my sexual sides. I literally watched my health fall apart in the last three months. Never in my life have i been through something like this. And i may be the minority, but im meeting so many young guys devastated from this medicine. We dont have an agenda, we just want our lives back. And all we get is that we are hypochondriacs etc. I wish i would never see that site PH.com again! But im glad its there because I personally would not know why my health/sex life/mental state has done a 180 in just 3 months.