Balding Blog

Dear Dr. Rassman:

I am a bit concerned about continuing with Propecia in light of the recent finding on the risk of high grade prostate cancer. At the FDA hearing in June of last year, the FDA statistician estimated that the risk of getting high grade prostate cancer using 5mg of Finasteride over a 7 year period was 1 in 200. I realize that Propecia is one fifth that, but even a 1 in 1,000 risk when it comes to an aggressive cancer seems, well, risky. If you told me that there was a 1 in 200 or 1 in 1,000 chance the plane I was about to board would crash, I would not board. So, my question is this: is there anything in the study you see that makes you think it’s safe to keep going with this drug?

I believe you are reading things out of context. The FDA site states:

“The labels of all 5-alpha reductase inhibitors (5-ARIs) are being revised based on FDA’s review of two large studies examining whether these drug products (Proscar, Avodart) reduce the risk of prostate cancer. The studies did find an overall reduction in the risk of lower-grade forms of prostate cancer, but both studies also showed an increased risk of high-grade prostate cancer.

As a result of these two studies, the labels of all FDA-approved 5-ARIs will be revised to include new information that these drug products may increase the risk of high-grade prostate cancer. The product labeling will also state that 5-ARIs are not approved for the prevention of prostate cancer.” [Source]

I did a quick Google search and found prostate cancer statistics, unrelated to finasteride use. “Based on rates from 2006-2008, 16.48% of men born today will be diagnosed with cancer of the prostate at some time during their lifetime.” That is about 16 in a 100 or 1 in 6 men.

My point is: Propecia does not cause cancer. The studies that the FDA quotes and the media has latched on to point to how those men who ended up with prostate cancer while on finasteride had a higher grade prostate cancer than men who did not take finasteride… but the controversy of why this is, was not clear from the studies.

A final point is that if you are concerned about the medication, you do not have to take it. It is an option I give to all my patients. This is one of the many reasons why a doctor should prescribe you the medication, because each and every patient is different and the prescribing doctor should be there to address all of these issues one on one with the patient.

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.”

Hello Dr. Rassman,

Just wanted to start out by thanking you for this site. It seems like every time I get concerned about hairs falling out in the shower or sink, I check out your responses. LOL! Anyway, I am a 20 year old male who started taking Propecia 23 days ago (yes, I know, very precise). I noticed that the success rates of the medication are about 80% for preventing further loss and about 60% for actually growing back missing hair. Would these percentages increase for me since I am so young and just recently starting losing hair (1-2 years)? I am just so worried all the time that I might be in that 20% who gets the rotten end of the deal. I don’t want to be that 21 year old with a ring of hair around the sides and back. Just me worrying the weeks before Propecia is supposed to “kick in”…

Thanks!

Without seeing you or at least your photos, it would be impossible to address your concerns. It is true that young men (your age) will more likely get a reversal of some or most of the miniaturization, but that depends upon your balding pattern. You should get your hair mapped and from that, we can make the types of judgments you are asking about. What I can tell you is that in someone of your age, the success rate for reducing the rate of hair loss (or reducing miniaturization) is very high.

I don’t know if your numbers are correct, and though I’m sure I’ve seen actual percentages before, I can’t seem to find them at the moment. Where did your statistics come from? If anyone has a link, I’d love to see it.

The writer of the piece below researched the value of Propecia for our review. If you choose not to go to the source, at least read what is written here.

Dr Rassman

Brilliant site. In response to a post dated April 16 (Propecia Success Rates), you asked your readers for a link related to the success rate of Propecia use. While the clinical studies supporting drug approval (links below) involved many endpoints and durations of observation (from 12 months to 5 years), the most dramatic evidence is at the 5-year assessment for men with vertex baldness:

“ An independent analysis of photographs (of the entire head)….. showed that at 5 years, 48% of men using Propecia had increased hair growth, 42% of men had no change (from pre-Propecia baseline photos), and 10% were rated as having lost hair. For placebo, 6% of men had increased hair growth, 19% of men had no change (from baseline photos), and 75% were rated as having lost hair.”

For your readers, the best link to summarize the clinical studies supporting regulatory approval in the US for any drug is at the FDA’s web site and will contain both the “Product Label” or “Summary Basis of Approval”. The Product Label is a brief summary similar to what is found in the package insert that comes with the medication, and the “Summary Basis of Approval” (also termed “Review”) is a detailed submission often involving thousands of pages. However, the “Medical Review” in the Summary Basis of Approval is a document that is well indexed and usually contains the clinical studies supporting safety and efficacy.

This information can be accessed without charge. For any drug, the link is Drugs@FDA. One can then choose the drug as listings are by alphabetical order and trade (brand) name. Once the drug is chosen, then choose the link with “Label Information.” For Propecia, therefore, the link that takes the reader to the “Review” from 1997 Drug Approval Package #020788.

For Propecia, three double-blind, placebo-controlled randomized studies of 12 months duration were conducted with 1879 men. The two main endpoints were hair count by photography of selected areas and patient self-assessment. Secondary endpoints were investigator ratings and ratings of photographs (by independent counters). Main results were as follows:

Combined data from Study 1 and 2 in men with vertex baldness (number of men = 1533): At 12 months, there was a 107-hair difference within a 1-inch diameter circle compared with those in the placebo group. An extension study showed that the hair count was maintained for up to 2 years in men taking Propecia, compared with the placebo group (38-hair placebo-adjusted difference at 2 years). Related to the figures your poster of April 17 noted, at 12 months, the investigators rated 65% of men treated with Propecia as having increase growth compared with 37% in the placebo group. At 2 years, the same investigators rated 80% of men using Propecia (compared with 47% of men using placebo) as having increased growth. These figures were 77% (Propecia) and 15% (placebo) at 5 years.

An independent analysis of photographs of the entire head (without reader knowledge of treatment assignment of person is photo) showed that at 12 months approximately 50% of men treated with Propecia (compared with 7% using placebo) had increased growth. At 5 years, 48% of men using Propecia had increased hair growth, 42% of men had no change (from pre-Propecia baseline photos), and 10% were rated as having lost hair. For placebo, 6% of men had increased hair growth, 19% of men had no change (from baseline photos), and 75% were rated as having lost hair.

Additional data including info on Study 3 (hair loss in anterior mid-scalp with or without vertex baldness) can also be evaluated.

This is a scholar’s view of the long term studies on Propecia, as published. This writer’s review from a practical view shows that the drug Propecia works for hair retention. I have never understood the focus on unproven alternatives by much of the balding male population who read this blog and write to me. Rather than get predictable hair retention, men seem to be willing to take ‘things’ that have not been shown to have hair retention value and during the period that they take these compounds, they are losing hair that will never grow back.

So where Propecia seems to hold the ‘status quo’ for years, too many men seem to be willing to accept progressive balding when psychologically, they obsess over their hair loss. And far too many men believe what they see on television or the Internet and don’t think that pictures of hair growth they’re shown may be fraudulent.

I have been on propecia for 3 years, now I am 24 and the effects seem to be wearing off. It has worked well to stop loss up until now. What would cause it to stop working and how can I combat this? Is there something else I can take? What about avodart?

Thanks a million!

Unfortunately, Propecia (and probably Avodart) will eventually stop working in men with an aggressive genetic hair loss predisposition. In these men, you need to have a Master Plan to determine what you might do when the drugs stop working. In many young men taking Propecia, the effects over time will decrease, but when it does, you should not stop taking it because then you will experience what I call ‘catch-up hair loss’, which means that you will lose all of the benefits of the drug over the previous years within months upon stopping it.

Some doctors who prescribe Avodart are reporting better results in men like you, but this is still no miracle cure. Even if the Avodart works where Propecia fails, the Avodart will eventually fail as well.

Hi Doc. Thanks for a great website.

37 year old male, been on Propecia for three months now. Prior to Propecia, hair was falling out of vertex at a steady rate. Started Propecia and loss stopped immediately and completely within three days. One month later after continued Propecia use, hair begins falling out at same rate as before Propecia and continues falling out now.

I know that I can’t “build up a tolerance” to Propecia, so am I in a shedding phase? If so, how long will that last approximately? And is it a good sign that my loss stopped so dramatically at the outset of my treatment? Is that a sign of things to come after this shedding?

Any information would be appreciated. Thanks!

If this is not a short term shedding process, you could be in for trouble. I don’t have any idea if it’s a temporary thing or how long it’ll even last. Stick to the treatment and then work with your prescribing doctor. You might start to ask yourself if its time to consider adding minoxidil to the treatment plan.