Even If Propecia Doesn’t Cause Permanent Side Effects, Isn’t Propecia to Blame?
Hello Dr. I have often seen you say that those who claim that Propecia has ruined their sex drives in a permanent way are really suffering from something that is all in their heads. Even if this happens to be true, does it really matter? Take a converse example with the placebo effect. I’ve heard some people suggest that if, for example, an anti-depressant makes someone feel better that it doesn’t really matter if it’s just the placebo effect or not. So why not have the same standard for Propecia? If it’s all in someone’s head after they quit the drug, did not the drug still cause it in some way? Thank you
I didn’t definitively say that those claiming side effect persistence were just suffering from something in their own heads, but it’s a possibility. In fact, I don’t think I’ve ever said the claims of persistent side effects from Propecia are completely false. I did say that the medical literature and my own experience hasn’t shown any permanent side effects among my patients. I’ve also said that those with sexual issues should see their doctor and have a proper, complete history and physical exam to make sure that there are no other causes that can be identified, such as testicular tumors. I do not diagnose medical problems on BaldingBlog. I do not medically treat or give medical advice to people here on BaldingBlog. I just give my opinion and write about hair loss issues.
I feel like I’m beating the same drum over and over here, but I do not force medications on people and have always left the decision to my patients, as they are not sheep that are herded into a direction. Most come to me prepared after doing their research via the Internet.
The placebo effect is well documented in the research studies and appears almost as high as the actual reports of sexual side effects. I suspect that many of the negative writings about Propecia contribute to the psychological effect that produces a placebo impact. There is a small group of disgruntled readers that want me to acknowledge a possibility of permanent side effect associated with taking Propecia (even one dose)… and while it’s not likely, perhaps in extremely rare cases it could happen. I just don’t know. The science isn’t there, but anything is possible. Correlation does not equal causation.
Jeremy
Please provide info on what studies you are referring to that show finesteride is associated with permamnet sexual dysfunction. Besides a recently published Journal of Sexual Medicine survey, which was uncontrolled and did not evaluate causative factors involved in the sexual dysfunction, I am aware of no studies that have looked at this issue. Indeed, it is highly unlikely that such studies can be easily done, as the phenomena of irreversible sexual dysfunction due to finesteride – if real – is probably too infrequent to show up in randomized prospective studies (as was required by Merck to show safety and efficacy). Rare events more commonly show up after approval of a drug when taken by thousands and I have yet to see a published analysis of any cases.
Actually, the poster’s question is far more interesting than anyone seems willing to admit. It’s sort of the converse of the often cited example: even if a drug has no medical value, is not a positive placebo effect itself beneficial? I suppose it depends on what you are trying to treat. But, I think most people will answer this by saying the following: that’s not the way science works and, in any event, this can be dangerous as it may cause people to avoid treatments that really work and thus exacerbate the problem. Maybe the poster’s question is, Is a nocebo effect not still a side effect?
Daniel, I have told you before that I will no longer respond to your verbose, off-point rants. Much of what you say is irrelevant and false and you don’t seem to be able to grasp and respond to the stated comments. Please allow others to discuss.
Also, I’d note that this was the method of the study:
“The Proscar Long-term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men, aged 45 to 78 years, with symptomatic benign prostatic hyperplasia, enlarged prostates, and no evidence of prostate cancer. Patients completed a questionnaire at screening regarding their history of sexual dysfunction. During treatment, spontaneously self-reported sexual AEs were recorded.”
Key points here are the study was done with men aged 45 – 78 who had prostate problems. I’m not sure this is even extremely application to men aged 20-40.
Malaclypse – You raise some fair points about the relevance of the study. I previously noted that the dose was higher for the PLESS study and the age of the men were higher. This certainly would provide difficulties for trying to estimate a precise risk for an individual to develop PFS.
I’m currently in the process of attempting to retrieve the study data so i can elaborate more upon the specifics. The study does consolidate all sexual AEs which may include some milder instances, but the point is that the causal relationship for severe side effects exists, even if it is rare. The same size is large enough that the difference from the placebo is statistically significant, meaning the data demonstrates that finasteride can cause persisting side effects in patients. Regardless, Merck’s marketing literature states that all side effects reverse within a mean of 2 weeks which is clearly untrue.
As I mentioned earlier, persistent is a euphemism for permanent. Because so little is currently known about the mechanism through which the effects are caused, the term that is used is persistent. But since there is no cure, the distinction is irrelevant. Without more research and acknowledgement, these persistent effects will remain permanent without a cure or even treatment. I have spoken with doctors that have treated hundreds of patients and they remain hopeful, but have yet to successfully cure any patients.
You are right, in that at least some of the members of PH are probably suffering from entirely unrelated maladies. This certainly confuses matters, but does not prove that PFS doesn’t exist. Just because there are false claims does not delegitimize the existence of a genuine relationship.
The study does not perfectly correlate with the balding patient body but it is sufficiently close that the study shows finasteride can cause long term sexual dysfunction. If you want to write off the risk because you think you are immune since you are 15 years younger and taking a smaller dose then that is your prerogative, but that reasoning is very myopic in perspective.
oops!. Jeremy I meant to say. Sorry!
Jeremy, I have pointed it out before that you are not the only one that reads this blog. I don’t care if you choose to respond to the points I raise or not. I am writing for the benefit of other readers as well. There are perhaps thousands of people who visit and read this blog. I simply cannot let false or misleading claims go unchallenged, so I will continue to respond to them whenever I see them.
And yes, my posts do tend to be rather verbose. I concede that. They are, however, never off-point.
I guess I feel that the causal reader may not be aware of most of these issues, so I like giving as much detail as possible to inform people. I write with the assumption that every potential reader is hearing these issues for the first time, so sometimes I may go overboard on the details.
I’m not a medical professional or anything remotely approaching one, but I have a few layman comments based on the debate I’ve been reading.
Something that isn’t given enough consideration is that doctors, by default, have a duty to go with the evidence in front of them and the majority effect they see. I would imagine the overwhelming majority of doctors see very few if any finasteride users coming back to them with persistent or permanent sexual side effects of a concerning enough nature. Most doctors will provide finasteride prescriptions for hundreds of even thousands of patients and yet possibly never ever see a negative case reported back to them.
In short, finasteride has made far more many men happy and hairy than impotent. As Dr. Rassman and indeed any good doctor will repeatedly remind you; finasteride is elective. All a good doctor can do is tell you what they see. If they see 99%+ of their patients having a beneficial, side effect free improvement from a drug, then they are obliged to tell you that.
Look at it another way, let’s take an arbitrary medical condition; anemia. Every year thousands of patients will report to their GP with anemia and the vast majority of the time the cause will either be common or trivial and easily reversible. In a small minority of patients that anemia could be due to a malignant tumour or some other serious disease. But a doctor will examine and treat you as they do the majority, even if that means they could potentially miss the rare tumour. Why? Because there are no perfect solutions. Doctors live by their ability to get most things right but never everything right. No doctor will say “I won’t give you iron tablets, I’ll schedule a CT scan/X-Ray/MRI/endoscopy/sigmoidoscopy because last year I had 2000 patients with anemia and 2 of them ended up with serious health conditions”. It’s just impractical and doesn’t offer the best advice or treatment plan for the patient.
What I’m trying to say, in a rather long-winded way, is that prescribing finasteride is still the best thing to do for the overhwelming majority of patients. Most of them will end up with zero or minimal side effects and keeping or gaining hair for anything from 5 years upwards. A tiny minority of them may experience adverse effects and, potentially, long term ones at that.
A doctor, however, cannot stop a clearly beneficial and almost completely safe medicine on hearsay, rumour or small, random studies alone. All they can tell you is to look at the side effects and make your decision – do you want to keep and possibly grow your hair or let it go and deal with it?
It’s not a loaded question; it’s just an honest one. But the frustrating part is you need to ask yourself the same question with any medication, from indigestion tablets to chemotherapy or experimental new drugs; am I willing to accept the risks, no matter how small. If you’re not, then you know the answer to whether finasteride is right for you or not.
People who are keen to prove finasteride as “poison” might as well try and prove the same thing about antidepressants, headache tablets and antibiotics. There will be studies and gossip enough out there to build a case, no doubt. No medication is without its problems, even if that problem is the placebo effect or unfortunate correlation with random medical conditions.
As to whether finasteride can cause permanent side effects, who knows? I agree further testing would be nice to see. But, until then, there are millions of men taking it to great benefit and little deficiency. Medicine is the domain of the majority, and until that trial or test can come along to demonstrate finasteride’s widespread, long term danger, unequivocally, doctors can only go on what they read, discuss and see for themselves. They’re not going to get into the habit of rumour-mongering or listing vast theoretical or potential side effects. They have a duty to please their patients and that’s what they continue to do.
Corda – If you put that philosophy into practice, you would be put out of business by malpractice cases in a matter of 1 to 2 years. Medicine is not the practice of treating the most amount of patients with the least effort. A doctor is required to diagnose and treat the presented problem to the best of his/her abilities.
Additionally, don’t let people like Daniel deceive you into believing there are only ‘small random studies’ and hearsay that are evidence for this problem. There are hundreds to thousands of doctor submitted adverse event reports send to the FDA (not hearsay), a large placebo controlled study, and a couple of other published studies in reputable medical journals that document this situation. This is also in addition to the thousands of ‘internet rumors’ that describe their problems/treatments in full detail.
Jeremy has done a nice job in addressing the two most significant issues that Daniel raised regarding the PLESS study:
On the subject of the drug treated and non-treated groups:
“The whole point of the control group shows that differences in side effects can be attributed to the drug. The comparable population had developed side effects, but the drug treated group developed 250% more side effects. According to basic statistical analysis, it is EXTREMELY unlikely this would have happened by chance.”
That’s what I was wondering. If you follow Daniel’s line of reasoning the entire study would prove nothing even with regard to Proscar.
On the subject of the dosage:
“The 5mg dose only marginally decreases DHT beyond the 1mg dose. Side effects would be slightly higher for an older age range and larger dose, but clearly finasteride does cause long-term side effects in patients according to a DOUBLE BLIND PLACEBO CONTROLLED EXPERIMENT”
While it might be a bit of a leap of faith to compare side effects from 5mg versus 1mg dosages, it still is, after all, the SAME drug. That should be enough to raise the index of suspicion sufficient to justify the kinds of warnings and disclosures that Jeremy is advocating.
Again, I am posting with upmost respect to all involved. I’d rather personal accusations stay out of debate.
I think daniel might be going to far in trying to smash jeremy’s arguments, but I still generally take his side – based on the evidence.
Jeremy,
I do not think it’s fair to use persistent and permanent interchangably (Unless I’ve misunderstood what you said). I broke my leg when I was younger and I had persistent pain for a couple of years after ward. I no longer have any pain. That is a persistent but not permanent effect. This is why I wish you’d address the limitation of the study ending 6 months after use.
Furthermore and I quote:
Another thing to consider is that the fact that Finasteride causes ‘true’ in-use side effects in a statistically significant amount of users could help account for these numbers as well. Who knows; maybe users suffered from ED on fin, got depressed, had problems with their relationships, suffered depression and these problems persisted after the medication was dropped”
I think this point is very valid. I am not sure how the researchers would have accounted for this – being that the study was completely based on surveys of the users (unless I am mistaken about that)
Moreover, the conclusion of the study is this: “Compared with placebo, men treated with finasteride experienced new drug-related sexual AEs with an increased incidence only during the first year of therapy.”
I am not seeing how that equates to persistent sexual sides.
Jeremy, my overall point is that using this study as a the ace in the hole to prove your case is not reasonable.
The truth of your position is really this – and this is what you should be saying:
“We are a bunch of guys who think fin caused our problems. We do have REAL problems. Many of us have been examined by doctors and have ruled out many of the usual causes of our problems. We’ve had an internet message board going on for about 7 years to discuss our problems. We have a few doctors who support us. Our community has been around many years before a lawsuit was discussed. Some claims on our website are probably exaggerated, but that doesn’t mean that fin can’t cause some of our problems. We have some studies and science that indicate more research is needed. However, nothing is conclusive.”
I don’t think you would disagree that that paragraph, because it accurately states your position. A lot of the language on PH is very inflammatory and is spun in such a way to scare people. This is understandable, considering what many of you claim to have gone through. But it also isn’t fair or reasonable. And I understand, drug companies do the same thing (exaggerate, manipulate words, etc.). But that doesn’t make it right when PH does it either.
I hope you are having a good weekend Jeremy, Daniel and others in the discussion.
Best,
Malaclypse
Jeremy – I never suggested that doctors treat the most amount of patients with the least effort, I’m just citing the fact that doctors cannot justify giving you the works for every symptom or malady you turn up with. It’s not financially viable, it’s not medically viable.
My point was that prescribing finasteride remains the most logical choice for the majority of patients, given the evidence available. Doctors work with what they see and experience every day and if Dr. Rassman has never seen a case of permanent or sever sexual dysfunction, and the drug is FDA approved and effective, then he has a right and an obligation to go on prescribing it.
I’m well aware of the literature and internet discussions about finasteride. I myself don’t take it and, whilst sexual side effects are not the reason for that, they did play some part. I agree that there are some questions about finasteride that I would like to see answered, although I could say that about most drugs really. The simple, cold truth is though most men take it without a hitch. A pretty big majority of men, in fact. I fully understand that doesn’t make it OK for those who do feel finasteride is to blame for their problems, but I’m not of the opinion there is some big conspiracy around the safety of finasteride that is being hidden. I think there’s stuff we don’t understand and some people don’t tolerate it, but the vast majority do just fine and the rest are not very well understood. Until that situation changes, finasteride will continue to be the best chance to combat hairloss medically.
Jeremy – I wonder if I am the only one who has noticed that you seem to be losing your grip?
Isn’t it supposed to say something about a person’s position when their arguments decay to the point of repeated personal attacks?
From Daniel
“I am, however, saying that the claims of it causing “permanent†erectile dysfunction are bogus. There is absolutely no possible mechanism by which the drug could cause this to occur – especially long after use of the drug has been discontinued.”
I would like to personally thank you for destroying your credibility. You would have been in a better situation if you didn’t use such bombastic words like absolutely, bogus, and impossible but we already know that communication is one of your weaknesses. How does your foot taste?
“Isn’t it supposed to say something about a person’s position when their arguments decay to the point of repeated personal attacks?”
[Sarcasm] Please provide a reputable study since these claims you make are completely unfounded and ‘insane’. [Sarcasm] My arguments did not decay to personal attacks, I am calling attention your bombastic absurdity and having a bit of fun gloating because I find you to be very obnoxious and ignorant. Please don’t deflect conversation and admit you knew nothing about epigenetics, persistent pharmaceutical effects, or offer some kind of reasonable rebuttal.
Steven,
how does that validate your decision? Because he agrees with you? He’s not losing his hair. It’s like talking to a dentist about a foot problem.
Steve,
I think my first statement you quoted was valid. I was simply pointing out the fact that if the FDA started to appease this group of individuals by validating their complaints like that, then it opens the door for any group of people to say anything they want about any drug. How about the companies selling snake oil treatments? As long as they get enough people together, they can say whatever they want about any drug knowing they can have warnings added to them. The FDA won’t ever appease these individuals for that very reason.
Think of it this way. A company could hire a thousand people to fake an illness, and they all claim x-competition-medication caused it. All these people write to the FDA, and the FDA puts a warning on x medication. I’m not saying this is a likely scenario, but do you see what I mean here? The FDA has guidelines for a reason.
I think the PLESS has been argued to death, so I won’t comment on it further.
As for your last sentence, I mostly agree. 2000 individuals all claiming permanent sexual side effects is certainly troubling. I fully support further testing and studies on Finasteride. I don’t discourage that at all. I don’t discount the fact that there is ‘something’ going on here.
It certainly raises suspicion. However, it absolutely does NOT justify adding warnings to the medication. The only thing that justifies warnings are medical studies that prove PFS exists. So far, there are no studies that prove this. Jeremy says that individuals are pushing studies that he claims will prove this fact. When I see these conclusive studies, I will be the first to come out and say I was completely wrong.