Note: This post comes from one of our favorite readers (he has requested to remain anonymous), who has contributed posts in the past about FDA issues. He provides some insight into clinical trials, and sent this in to answer some of the questions/concerns posted in our comments section about Propecia data.

Finasteride side effects are a hot issue on various forums and on our own site, so hopefully this can clear up some of the hysteria that perpetuates online:

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A recent post impressed me by referring to Propecia data from a FDA hearing (more updated and accurate information is in the U.S. Product Label) but may have been confused by how data is collected and interpreted in clinical trials. I am a veteran of overseeing clinical trials resulting in drug approvals.

1. The poster notes that the “rate of sexual side effects is 3.8 percent with finasteride versus 2.1 percent with placebo.” Actually, following the Advisory Committee hearing and in further review of the data, the US Product Label shows that in Year 1, decreased libido was 1.8% for the 945 men receiving finasteride and 1.3% for the 934 men receiving placebo (placebo-adjusted rate of 0.5% or 1 in 200 cases). Similarly, erectile dysfunction was reported in 1.3% of men receiving finasteride and 0.7% of those receiving placebo (placebo-adjusted rate of 0.5% or 1 in 200 cases). Approximately 1.2% of men receiving finasteride and 0.9% of men receiving placebo discontinue the study drug due to sexual side effects. No cases of irreversibility of sexual dysfunction were reported.

2. The poster asks (given that the reporting was “self-reporting”) whether the results “are scientific”. This latter sentence makes me wonder if the poster wonders if clinical trial data is collected similar to the uncontrolled self-selected questionnaire surveys often cited in other situations. It is not. Unlike self-selected questionnaires, where one does not know the denominator (how many patients are receiving the drug, only those reporting a complaint) or period of observation, a clinical trial is different. In a clinical trial, the physician investigator asks every participating patient at regularly scheduled visits through the entire study (and predetermined) follow-up whether they are having or have had any new or worsened effect in any organ system. By definition, this reporting has to come from the patient. But, it is as scientific as one can get (it is solicited rather than self-selected). In addition, any report of a side effect is attributed to the drug (active vs. placebo) regardless of the causality. That is, if a person gets hit by a car and sustains trauma and is on an active drug, trauma is tabulated under the drug (although an investigator may causally relate it to something else). This conservative approach is taken to capture any possible relationship (i.e., maybe the drug makes someone drowsy and more prone to accidents).
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In a recent blog post you wrote about sexual side effects associated with propecia use, “These side effects are reversible withing one to two weeks after you stop the medication.” You then went on to say that Dr. Irwig’s study in Journal of Sexual Medicine was not a scientific study.

When you read through the FDA hearing on Propecia (FDA link) Keith Kaufman of Merck talks about the 3.8 percent of finasteride users experiencing side effects versus 2.1 percent of the placebo. He then goes onto say that these patients then completed a validated sexual function questionare. I am not a doctor but Merck basically based these figures on self reporting, should those numbers not be considered scientific?

In July the Dr. Irwin Goldstein the Editor-in-Chief of the Journal of Sexual Medicine wrote “I think of the frequent phone calls I receive from distressed men with varying degrees of hair loss who have used 5 alpha reductase inhibitors and now have newly manifested sexual and cognitive complaints that often persist despite discontinuation of the 5 alpha reductase inhibitor. Often such 5 alpha reductase inhibitor users have sought help only to be belittled, betrayed, misdirected, and sometimes misinformed. In general, these patients feel deceived becuase of the lack of information warning them of the potential side effects.”

I am one of the individuals suffering from persistent sexual dysfunction after stopping propecia and it appears pretty certain to me that in a small subset of men the persistent sexual dysfunction is due to the medication.

I am not going to get roped into an anti-Propecia agenda. I will leave that up to those who regularly comment on almost every post where the word “Propecia” appears.

My heart goes out to you if you actually have long-lasting sexual side effects, but the questions of validity ring true to your cause of sexual dysfunction. I am not in a position to judge your problem or to put the pieces together for you. That must be between you and your doctors. I am a doctor, but the posts here are just my opinions on my blog. Some may not agree with me, but that is OK! As the disclaimer on every page says, BaldingBlog is not a place for treatment advice or diagnosis. If the readers want to discuss their issues on a professional basis, they can always make an appointment and see me.

I will post an interesting excerpt from the 1997 FDA Drug Evaluation Hearing that you quote (the last sentence particularly worth noting):

“We attempted to obtain followup on all patients reporting sexually-related adverse experiences. Of the 36 patients on finasteride reporting these adverse experiences, 21 reported resolution of the adverse event while continuing finasteride therapy. Seven reported resolution following discontinuation from the study, and seven had persistence of the adverse event while continuing in the study on finasteride therapy. The pattern for patients on placebo was essentially similar, with most patients resolving either on or off drug, four patients reported persistence of the adverse event while remaining on placebo therapy.”

I, like another member on here recently, was prescribed Finasteride in the 5mg tablet once a week by my dermatologist. I’ve researched here that it’s better to take it daily for the most effective treatment, however, the pills that I picked up at the pharmacy are very, very small. They are circular shaped, blue in color and have an ‘H’ on one side, and a ’37’ stamped into the other side. Are you guys familiar with this pill and is this the size that I am expected to cut into fifth’s?

I need to know if I should try and get a larger size, go ahead and cut them (into at least thirds?), or just stick with the once a week treatment. Thank you!

This is a problem that I’ve heard about before, depending on the generic maker. I’m not familiar with that exact pill you’re describing though. Some generic makers use various excipients to size the pill larger, making it easier to cut. Some may even add scores into the tablet to make it easier to break. You can either go back to your pharmacist and see if they have a different generic size available or try to cut the pill carefully.

It really makes no difference if the 5mg pill breaks apart, provided that the entire 5mg pill is consumed over a 4 day period. I am assuming that even with some crumbs lost in the cutting process, it will still amount to 4mg consumed. Taking 1mg every day is better than taking 5mg once every 5 days, but I’m not your prescribing doctor.

Could you tell me more about Laminins-511 please and whether you think it is a promising ‘solution’ to hair loss? I had never heard of it before reading this article, but i’m now very intrigued.

Link: Mens Health

I do not know much about laminin-511 besides this press release from 2008. These are studies performed on mice and the research is disseminated to the popular media, grabbing the interest of readers such as yourself. I don’t see a date on that article, but I’m guessing it was from back when the laminin-511 mouse findings were first announced. It says they’ll have trials in 2 years… so I’d assume there should be info already if it was successful, but I can’t find anything new.

These news stories create a definite interest, but the implications on hair loss treatment remains to be seen. We get these types of stories sent to us almost on a weekly basis.

First of all thank you for what you do with this site it is a tremendous resource. I am twenty and began to recede at the hairline about a year ago. I started taking one fourth of a proscar daily in April without a prescription and got a prescription for it in June after seeing a dermatologist. I have since been taking the generic version daily. The medication does not seem to be working as I have continued to lose much hair from my crown to the point where my scalp is visible in harsh lighting.

I have long hair but i have noticed in the last week that I am losing the very short (terminal?) hairs again after not noticing them for the past few months. Could this be due to the switch to the generic version? The proscar pills were individually sealed while the generic are together in a pill bottle could this air contact affect their potency? As it has been seven months and I have lost noticeably more hair should I discontinue the medication?

Thank you, my dermatologist is pretty clueless when it comes to hair loss, so I appreciate your knowledge.

Generic finasteride 5mg is the same drug as Propecia, which is just finasteride in 1mg strength, so there should be no difference in efficacy. I don’t think bottle vs individually sealed has any bearing on the potency.

Finasteride does not work that well for frontal hairline, so what you may be experiencing is just your normal course of hair loss that the drug cannot address. Harsh lighting will make the hair appear thinner. Do you have comparison photos to look at from before you started? You’ll need to discuss changes to your medication with your prescribing doctor.