Post Finasteride Syndrome Studies Have Serious Problems – They Are Essentially Case Reports – With Significant Methodological Problems
Curr Opin Endocrinol Diabetes Obes, 2014 vol. 21(6) pp. 493-8 5?-Reductase inhibitors in androgenetic alopecia Yim, E; Nole, KL; Tosti, A
PURPOSE OF REVIEW: The authors will review the current literature on efficacy and safety of 5-alpha reductase inhibitors (5?RIs) for androgenetic alopecia (AGA).RECENT FINDINGS: The 5?RI finasteride and dutasteride are effective in treating AGA and promoting hair regrowth. 5?RI can be given orally, topically and more recently through mesotherapy. However, there has been an increasing concern about permanent sexual adverse events such as impotence and infertility. Most of these reports are published as case reports, and two studies reporting persistent sexual side-effects after discontinuation of finasteride had serious method limitations, as patients were recruited from a website. To our knowledge, permanent sexual adverse events have yet to be published in higher quality studies, such as randomized controlled trials. Although patients treated with 5?RIs have an increased incidence of sexual adverse events, these events decrease if discontinued or over time with continued therapy.
SUMMARY: Sexual side-effects are uncommon and resolve spontaneously in most patients even without discontinuing therapy. Significant effort is underway to find delivery systems that optimize delivery and reduce systemic absorption of topical 5?Rs including hydroxypropyl chitosan and liposomal and nanoparticulate systems.
The following is a comment from one of our readers:
…”I think the following recent review in a respected, high-impact journal night be of interest to your readers. It underscores some of the points previously made by your reputable bloggers related to an issue of continuous concern: that sexual side effects from finasteride are uncommon and that reports of permanent effects after discontinuation are essentially case reports (or letters to editors) with significant methodologic problems.“
This opinion does not hold much significance. The contributors ignore or are unaware of some of the studies that have investigated physiological differences in post finasteride syndrome patients. Many of the reports that this opinion references are case series that were published several years ago. There are no methodological problems with case series but they are often published in the early stages of discovered new consequences of drugs before more thorough evidence is collected, analyzed, and published.
It is also worth noting that at least one of the contributors has a significant conflict of interest. If you google Antonella Tosti and Merck, you will see she received tens of thousands of dollars from Merck over the past 2 or 3 years for various activities. Merck has a track record of aggressively interfering with the medical research process so this really should not be overlooked. It happened earlier this year when they threatened legal action against a doctor who wanted to publish a negative opinion on one of their drugs and is one of the main reasons why I have to remain anonymous on this blog.
Interestingly, I also just discovered Dr. Rassman has a conflict of interest he has not yet disclosed. Google Dr. Rassman and Merck and you will see for yourself. Just last month or so he said he has never seen a patient that complained of irreversible side effects after taking Propecia. Regardless of whether or not Propecia caused the side effects in this particular case, his previous claim appears to be clearly untrue.
Once again, “researcher’ – who is unlikely to be a true researcher – resorts to personal attacks when the evidence does not support his view. The notion that Dr Rassman has a conflict of interest because he has spoken at a scientific conference funded by a drug company is naive. Such meetings are typically sponsored by pharmaceutucal companies to facilitate discussion, and speaker agendas are not approved in advance. The Sunshine Law requires public discloure of payments to physicians, some who act as consultsnts to contribute to the design of future biopharma studies (the horror!) Nothing new or nefarious here. If researcher would devote a small amount of this energy to supporting research (rather than case histories or letters to the editor by the same Wash-DC. based physician), then maybe the field would advance. Nothing Dr R has said about the ” post-finasteride” syndrome has ever been controversial -it is poorly described, something he has not seen, and the phenomena has been supported by case histories of individuals with confounding factors rather than well-controlled prospective studies. Add the internet conspirators and lawyers and you dont get avery good mix.
I am a true researcher and didn’t resort to personal attacks. There was no evidence provided in the opinion and was a mostly misinformed opinion piece.
You are right, speaking at a conference does not pose a conflict of interest but that was what not I was referencing. I suggest you have another look because it looks like Dr. Rassman is now a party to litigation on the same side as Merck. I don’t know anything beyond you see on Google but being in such a precarious situation would certainly taint one’s objectivity.
I do personally support research on post-finasteride-syndrome but as you know it is highly confidential and the details cannot be shared before articles are published. Things are moving ahead but there are many doctors in the hair transplant industry that are very backwards in their thinking for a variety of reasons. An informed person would know at least half a dozen separate researchers have published on post-finasteride-syndrome to date and there are more to come. The published case series is a small piece of the puzzle. I and others have posted some of the other PFS related articles on here so I suggest you take a look if you are interested in learning more. I assure you, a Harvard teaching hospital would not take up such a study only based on the evidence of a single case series.
Meh, ambulance chasers. Highly skilled ones though, I must say. They’ve got all the research methods lingo down and all that : )
It’s too bad this is all beyond the reach of the general public so they just respond emotionally instead of thoughtfully. They become scared by it all. I have looked at some of the other papers about PFS. They are theoretical papers that posit different sorts of causal dynamics, sometimes supported with small scale studies, studies on animals, etc. But in the end, they are just conjecture. You can do this with any drug. You can write some theoretically interesting papers about how chlorine in water is the cause of much of our cancer, obesity, autism… You can probably get those papers published too in some decent outlets, as long as they provide something “new” and “interesting” for academic debates.
But they are no replacement for large-scale placebo controlled research studies. The best information we can get is from the large scale placebo controlled research studies that have been conducted time and time again and show that finasteride is safe for 99% of the population and effective for 85% of the population. That is the best information we have. You can think otherwise, but you would be depending on the guidance of lesser quality information.
Of course, you are free to do so, to think and make decisions based on this lesser quality information. It is a free country and we choose to do as we wish. People, many people, believe that MMR vaccines cause autism in children. MANY people. These people should not be jailed or anything…it is ok that they believe this.
That still doesn’t make it true.