Just started finasteride and have a couple of questions.

[Wuffer]

Doctors do perform penile nerve function tests, penile ultrasounds, hormonal assays, and nocturnal erection tests. Whether or not these are "standard tests" for the diagnosis of "PFS" I've no idea. But as doctors are becoming more aware of the problem, they are coming up with criteria to determine if one is suffering from finasteride related problems.

This I agree with. There is definitely ongoing research about this phenomenon, and that's a good thing.

These trials were conducted in the late 80's early 90's. I'm not going to spend any time searching the for the trials. They might be there, they might not be. But the Proscar clinical trials did pick up persistent side effects, otherwise Merck would not have warned patients. http://ebookbrowsee.net/proscar-Doctor-d382231097 There it is, in black in white. Merck warning men finasteride side effects do not always go away as early as the 90's.

Just to be clear, are you referring to this? "If symptoms persist, they usually resolve upon discontinuing 'Proscar'."

Just to paraphrase, this is saying that if symptoms persist during Proscar treatment, they will usually resolve upon discontinuation. I assume the word "usually" is what you are focusing on. While I can't verify this without finding specifics about what they are talking about, couldn't this simply be referring to gynecomastia, which is usually persistent? What's more likely is it's simply the terminology they chose to use, and it doesn't mean anything at all.

I find it a pretty big stretch to conclude that Merck knew all about persistent symptoms based on the word "usually". Of course, you could be entirely right, but I don't know how you could assume anything without first verifying the data.

Realistically though, I'm guessing a lot of men had persistent sexual dysfunction after the Proscar trials. Since sexual dysfunction is incredibly common in the study age group (probably 45 - 70), many men will end up with dysfunction due to other causes, both in the Proscar and placebo groups. However, if the Proscar group had a statistically significant incidence of persistent dysfunction, then that would be a different story.

It has to say "Not [statistically] signifcant" .... at what level. If it doesn't give the p value, then it's worthless. No reputable journal would ever allow an omission of p when determining statistical signifcance. Especially since most studies, including Merck's, found a statistically significant difference (p < .01) between the finsteride group and control group in the sexual dysfunction AE. Sorry, the Journal of Dermatology Treatment is not reputable, if they allow that to be published. The Lancet or NEJM would never allow that.

Well, just so you realize, this is a very high level abstract, not the entire study. P-values aren't always in abstracts. But the point is, almost every study done on the drug reaches the same conclusion: that finasteride is effective has a low incidence of reversible side effects.

There's certainly been a placebo-controlled study that noted men experienced unresolved sexual dysfunction i nthe Finasteride group. And not all studies screen for long term side effects. No offence, but I think some of this might be over your head.

You will probably understand why I can't take your word on this. If you are certain there has been a study that noticed this, why don't you share it? If you simply can't find it, I understand, but you're just saying it's over my head and don't really present a good argument for your case. I've debated this with dozens of people before, and I always end up with the same run-around; either I'm essentially told I'm too dumb to understand, or I'm not worth the person's time.

Just to be clear, I'm not arguing that PFS definitively has not been proven (you're right, study parameters aren't usually set up to find something like this) but on the same token, you seem very confident that studies have definitely proven it's existence, which is simply not the case. Where it's at right now is we simply don't know. Hopefully further study will clarify what's happening.

 

[dutchdude]

Just to be clear, are you referring to this? "If symptoms persist, they usually resolve upon discontinuing 'Proscar'."

y

While I can't verif this without finding specifics about what they are talking about, couldn't this simply be referring to gynecomastia, which is usually persistent?

No. Perhaps you missed the s in symptoms. Merck was referring to symptoms, including but not limited to sexual dysfunction. .

What's more likely is it's simply the terminology they chose to use, and it doesn't mean anything at all.

Definitely not true. It means what it means. Side effects usually resolve upon discontinuing Proscar. This is a clear warning side effects (including but not limited to sexual dysfunction) are not always resolveable. I consider this indisputable.

I find it a pretty big stretch to conclude that Merck knew all about persistent symptoms based on the word "usually". Of course, you could be entirely right, but I don't know how you could assume anything without first verifying the data.

Here you are stacking the deck by saying "Merck knew all about." Whatever you mean by "knew all about," I don't know. Merck knew enough to warn patients of persistent side effects and they did. No offence, but they don't need you to interpret, verify or do anything else with their data for them.

Realistically though, I'm guessing a lot of men had persistent sexual dysfunction after the Proscar trials. Since sexual dysfunction is incredibly common in the study age group (probably 45 - 70), many men will end up with dysfunction due to other causes, both in the Proscar and placebo groups.

Again, Merck doesn't need you to write their warning labels for them. Merck saw Finasteride side effects were not always resolveable so they warned about it.

But take note of your point here: "men will end up with dysfunction due to other causes, both in the Proscar and placebo groups." Hold that thought for a second.

However, if the Proscar group had a statistically significant incidence of persistent dysfunction, then that would be a different story.

This is why I think this is over your head. Statistical significance is not "a different story." It's just one method used to determine cause and effects. It is a crude, arbitrary, and outdated method with a poor track record of prediction.

If a study finds no statistically significant difference between the Finasteride group and placebo group, but men in both group reported them, the study should say, "further research is needed to determine if Finasteride causes long-lasting sexual dysfunction." A molecular biology or another "hard" science should take over. Giving men a pill and asking them to check off general, vague, subjective symptoms can only tell us so much about a drug.

Well, just so you realize, this is a very high level abstract, not the entire study. P-values aren't always in abstracts.

I understand that was just the abstract. And yes, in the journals I read, yes. P-values are always in abstracts. Whenever the paper mentions statistical significance, the p-value is given. Otherwise, we have no idea at what level. Anything can be "statistically significant" depending on where you put the p-value.

But the point is, almost every study done on the drug reaches the same conclusion: that finasteride is effective has a low incidence of reversible side effects.

My point was that that paper contradicted Merck's trials on Propecia, that there was no statistically significant difference between the two groups in eliciting sexual dysfunction. Merck clearly found a statistically significant difference (p<.01). But let's move to your point:

"that finasteride is effective has a low incidence of reversible side effects."

This is where red flags should be raised. In some studies, both the Finasteride group and Placebo group had long-lasting sexual dysfunction (not statistically significant p<.01). Like this one: http://www.ncbi.nlm.nih.gov/pubmed/12639651

But in Propecia's clinical trials, no one in either group had long lasting sexual dysfunction. Some men should've had long-lasting sexual dysfunction "by chance alone." I can't help but wonder if Merck played fast and loose with the data or didn't properly screen patients for long-lasting side effects.

You will probably understand why I can't take your word on this. If you are certain there has been a study that noticed this, why don't you share it?

See link above.

I've debated this with dozens of people before, and I always end up with the same run-around; either I'm essentially told I'm too dumb to understand, or I'm not worth the person's time.

I never said you were too dumb. I said some of this might be over your head. You don't seem to understand that statistical significance a) is arbitrary, and b) neither scientifically proves nor disproves causation.

Just to be clear, I'm not arguing that PFS definitively has not been proven (you're right, study parameters aren't usually set up to find something like this) but on the same token, you seem very confident that studies have definitely proven it's existence, which is simply not the case. Where it's at right now is we simply don't know. Hopefully further study will clarify what's happening.

I never said that "studies have definitely proven it's existence" I said the evidence is there and a reasonable person should come to the conclusion that long-term Finasteride effects is a real possibility, albeit a small possibility. To say "right now we simply don't know" is intellectually dishonest. Based on Proscar trials, PLESS, and post-marketing reports, scienitsts have a good idea what's going on. The space between definitely not proven and definitely proven isn't some solipistic limbo.