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One of my favorite BaldingBlog contributors (who shall remain nameless) sent in some great insights about FDA advisory committees. We’ve previously posted his thoughts on the LaserComb, clinical trials, and FDA trials. This post will be used in the future as a point of reference:

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Dr Rassman,
Given the many questions related to consideration of FDA expansion of the finasteride label for prevention of prostate cancer, your readers may wish to access the data themselves and better understand the process (which becomes more transparent and less “conspiratorial”).

 
The recent finasteride and dutasteride opinions noted in the Dec 3 Balding Blog posting are not from the FDA, but are from an independent group termed the Oncologic Drugs Advisory Committee. The committee is composed of 18 voting members (and several non-voting members) – mainly oncologists, with some statisticians, epidemiologists, and a patient representative, the former mainly from academic institutions.

The FDA eventually considers the committees opinion in approval or withdrawal of drugs (or “expansion” of a drug label for a new indication). The FDA usually follows the recommendations of advisory committees, as the committees’ recommendations are presumably “data-driven” and the FDA typically comes to similar conclusions. However, as in the case of many decisions that are split or where significant differences in interpretation of risk-benefit exist, the FDA has occasionally approved or rejected a drug against the recommendation of an advisory panel. Examples of split Advisory decisions (where a majority vote did occur) are the opinions this year related to several weight loss drugs.

The Oncologic Drugs Advisory Committee voted 17-0 against expanding the label for finasteride to include prevention of prostate cancer. A unanimous vote by FDA Advisory Committees is rare. I have no special knowledge of the meeting. This decision was based in part on data from the 19,000 patient Prostate Cancer Prevention Trial and the belief that the data did not support the risk benefit profile (i.e. possibility of increased aggressiveness of tumor did not outweigh reduced risk of low-grade tumors). As with all such committee meetings, which are open to the public (including listening via live webcasts), the transcript will be published and available within a few weeks at the FDA’s web site.

However, interested readers can go to the FDA web site now and access the Briefing Document and presentations given to Committee members from the drug company seeking approval. This information is public and typically posted several days before the meeting. The meeting was held on Dec 1, but the date of posting was Nov 26 (see under Oncologic Drugs Advisory Committee). The info can be found at the following links [note - all are PDF files]:

1. Draft Agenda for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
2. Briefing Information for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
3. Draft Questions for the November 30, 2010 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
4. Merck Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
5. FDA Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
6. GlaxoSmithKline Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
7. Draft Questions for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
8. Draft Meeting Roster for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
9. Webcast Information for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee

Hi. I am from Europe in Slovenia. In 5 months i’m gonna move to Canada for studying. So I wanna know, is “different” water gonna hurt my hair and started to make me bald? I am 18 years-old. And if water is bad there (in Canada) or if there’s “hard water” there or filled with chlorine… so if I don’t wash my hair with that water and I wash it with bottled water from stores, will that be OK, will the water be good for my hair, prevent baldness because of the “bad water”?

Thank you in advance for your answer.

When you go to Canada, look around to see if the people there are all bald. If the people’s hair in Canada look like they do in Slovenia, I wouldn’t worry too much.

Hard water (with a high mineral content) won’t make you go bald, though you might notice your hair lacking body or shine. If you are still worried and don’t want to even chance it, I suppose you will be spending lots of money on bottle water… or you could invest in a water filter.

Hello Doctor, I am 46, I’ve been on Proscar (cut in quarters, every second day) for 3 yrs now with good results in halting further loss & slight only thickening in the crown. The usual side effects I experience such as no morning erections anymore & only occasional unpredictable ED.I also use generic 5% Minoxidil every night. In Sept 08 I had 3,476 grafts which have grown pretty good with decent coverage as I have only very fine hair. Because of my fine hair I still use Couvre & Toppik with excellent results.

My question is prior to taking Finasteride I took a herbal over the counter tablet called Trinovin (containing Isoflavines) with good results for my since age 35 ish weak urine flow & in later yrs symptoms of BPH. I stopped Trinovin when I started Proscar as I wasn’t sure of the combo use but would like to try it again for the previous stronger results it gave me for urine flow. Will the Trinovin work in sync with the Finasteride or work against it causing bad results all around? Trinovin’s has a comprehensive website & it’s info seems to give the same sort of explanations in it’s workings as Finasteride, but I wanted to ask your opinion first before I try it as a combo. Thanks.

I hadn’t heard of Trinovin before (it’s made and promoted primarily in Australia), but upon looking at the product’s website it almost looks like it could be a medication in the way that it is marketed. As you point out, it’s actually an herbal product (red clover) that is said to treat prostate issues. Regular readers of this site know how I feel about most herbal treatments, and while in general there is nothing wrong with herbals, my motto has always been “buyer beware”. If it works for you, that’s great. I am not here to promote or discredit anything.

The US FDA lists red clover as “generally recognized as safe” but with that being said, I also cannot give you medical advice. I don’t think it would be an issue to take Trinovin with finasteride, but again, I’m really not familiar with this herb and I don’t want to guide you in the wrong direction. If you’re taking prescription finasteride and have had a history of prostate issues, you should be under the care of a doctor already. You need to tell your physician about your desire to get back on the Trinovin and see what he/she says. As an aside, I am a bit worried that you have been having these prostate problems since 35 years old, and even now you are still too young to be having these types of issues.

Hi, I was reading an article yesterday that mentions Propecia and Avodart and tumor growth. I’ll put the link below. I’m currently taking Propecia and I want to know if I have anything to be concerned about? Thanks!

Article: Avodart may promote some tumor growth

Sometimes its hard to decipher research and its conclusions especially when there is controversy. The news you are referring to is from a recently published study in the April 2010 New England Journal of Medicine (a respected medical journal). Its conclusion was, “Over the course of the 4-year study period, dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia.” This is good.

The confusion is in the news article spin-off you found of other doctors giving their opinions and commentaries. The significance of this article is that now Avodart (dutasteride) has been shown to reduce the risk of incident prostate cancer similar to what was shown in the Proscar (finasteride 5mg) study, which was published in the New England Journal of Medicine in 2003.

Despite the apparent positive findings, there were controversies due to interpretation of the studies where some thought Proscar may be delaying aggressive prostate cancer from being detected. To address this, the National Cancer Institute published a bulletin in 2006 which stated, “We’ve now shown that the cancers prevented by finasteride are often clinically significant, the same kind of cancers that lead to surgery. In addition, we showed a 28 percent reduction of high-grade cancer with finasteride.”

Remember, these are positive findings for Proscar and now Avodart. Also note that these studies are not about Propecia (finasteride 1mg), and while the inference is there, you cannot make a claim that taking the 1mg dose will have the same impact on the reduction of prostate cancer risk.

So to answer your question more simply — no, I do not think you have anything to be concerned about based on this information.

First off i just want to congratulate you on your blog. You’re doing a splendid job. It helped me tons in these two years of my battle with MPB.

My question relates to thickness of the hairs. You had mentioned previously in several posts that the thickness of hairs is standard for each hair in the non balding areas (the horse shoe pattern hair remaining that will probably outlive us). However i did a test and plucked some of these hairs in this region and not all of them have the same thickness. I didn’t use a microscope or anything but it it is quite clear to the naked eye. I am also sure that i am not thinning in these areas because my MPB is very very early and just in the corners of the hairline and none of my family members went past NW 3-4.

So to sum it up is it possible that some hairs on the head might be thinner than others? Is this normal? thank you

Yes, you are correct! Hair thickness varies all over the head as each hair is going through its cycle of growth/rest/fall (anagen/catagen/telogen). For non-balding men and women, you should have about 90% of hairs in a growth phase with relatively thicker hair and about 10% should be in a relatively thinner state. Then there are vellus hairs which are found in the follicular units. These vellus hairs are always thin and that is normal. So it is perfectly natural to have thinner hair in the back of the scalp (permanent, non-balding zone). If you are balding, this ratio will be dramatically different. Keep in mind this is a relative comparison with respect to your own hair at different areas of your scalp. This is in essence the miniaturization study that we have been advocating.

When technology catches up to us, we will have an instrument to accurately map all the hairs and its states on our scalp. As an aside, you should know that this horseshoe rim of hair is often impacted in women and in men who develop DUPA (diffuse unpatterned alopecia).

Dr. Rassman,I have been on finasteride for a little over a year, and it has pretty much stopped my hair loss. Needless to say, I am a pretty big fan.

However, I just came across an article that seems to think that finasteride has some questionable long-term safety concerns that deal with its ability to block allopregnanolone. The article seems to hint that the lack of allopregnanolone in the body could lead to neuro-degenerative diseases like Alzheimer’s in the future. I am not a doctor, so I was hoping that you could give me your thoughts and possibly speculate on the article’s validity.

Thanks.

Here’s the article: Allopregnenolone (synthesized from 5AR) may prevent neurodegeneration

My thoughts are that if you do enough scouring and research on the Internet for any hint of negative effects associated with any medication you will be amply rewarded… and thus spiraling you down the path of confusion, fear, indecision, mistrust of the medical field, and eventually diverting you from your original path of enlightenment and trying to take control of your health.

I am not trying to brush off the article, but I really do not know what the clinical value is with the research (on mice) you found or what it means at hinting of a correlation. But ALL medications have risks and benefits. I personally believe finasteride 1mg is a very safe medication and I prescribe it to my patients. On a positive note, there are actual human studies on 5mg finasteride that was shown to reduce the risk of certain prostate cancer.

A lot of the questions we receive through this site have to do with finasteride (Propecia/Proscar) and its side effects or other various concerns. In the real world grand scheme of things, out of thousands of drugs that people take daily, finasteride is a very safe medication. Furthermore, I highly doubt I am answering all these question from men who ONLY take finasteride (no other drugs) and does not have any medical or psychological issues… plus doesn’t smoke, drink alcohol, or take recreational drugs (such as marijuana). All medications and herbs and even certain foods can have negative effects. My point is that anything is a possibility, but we need to look at the probability of such side effects and think of the risks and benefits of what we do. This mouse study just doesn’t cut it. I do appreciate you sending the article though.

Stepping down from my soap box now…

Dear Dr. Rassman,

I’ve read here that a single dose of Finasteride can stay in one’s body for up to 7 days or more: regrowhair.com

Do you think it’s true?

Thank you! Best Regards

There are many resources for information as well as misinformation. Some sources say finasteride half life is 4-5 hours. Some say it is 8 hours. My Epocrates drug database says it is 6 hours. Half life is the time it takes for 50% of the drug to be out of your bloodstream. So if you assume that the half life is 6 hours, then most of the medication should be out of your bloodstream and excreted out of your body in a day or so (it is excreted in your feces and urine). But being out of the bloodstream does not always correlate with it being out of your body per se, because some form of the medication is left in your tissue. In general, this minute amount is not enough to affect the physiologic goal that was intended, so we have to take the medication at the corresponding interval to keep a consistent level in your body. Propecia (finasteride 1mg) has a recommended dosing of one pill, once a day. This makes sense, because most of the drug is out of the bloodstream in one day.

For the conspiracy theorists…

Now, the confusing part to those who scour the Internet for conspiracy theories and mistrust in the medical and scientific world is that it has been shown that after stopping Propecia there seems to be a suppression of the DHT levels even after one day (when Propecia is out of your bloodstream). There is no clear explanation of why this is. You can also theorize that maybe it takes a while for the DHT to return back to its normal levels in a few days after stopping Propecia. There is no clear answer that I can find, but I suppose some may advocate taking Propecia every other day. I personally would follow the recommended dosing and discuss any changes with your doctor.

For those that still don’t believe…

You want more science? Let’s use the finasteride packaging study as the source: Following an oral dose of 14C-finasteride (radioactive dose) in men, approximately 39% (32-46%) of the dose was excreted in the urine in the form of metabolites. Virtually no unchanged drug was excreted in the urine and 57% (51-64%) of the total dose was excreted in the feces. The elimination rate of finasteride decreases somewhat with age. Mean terminal plasma half-life is approximately 5-6 hours (3-14 hours) and in men more than 70 years of age the half life rises on average to 8 hours (6-15 hours range). These findings are of no clinical significance and hence, a reduction in dosage in the elderly is NOT warranted.

To conclude…

To all who are utterly confused by now, I say this: Propecia is a medication to help men who have androgenic alopecia. Propecia does not cure androgenic alopecia, but it does slow it down. Propecia has its side effects, but as with all drugs you have to consider the risks as well as benefits and after discussing all the options with your physician you have a choice! Finally, the recommended dose of Propecia is once a day. If you want to take it any other way, that’s between you and your doctor. This is not rocket science and there should not be confusion in this matter. It is a simple drug to take with clear instructions. The rest are just mental masturbation, hypotheticals, and Internet hype.

Have you encountered the Hairy Ball Theorem of Topology. Seems to me it is germane to your field. Quote: “you can’t comb a hairy ball flat without creating a cowlick”

See: Hairy ball theorem, also: Cowlick

Enjoy.

Thank you for the information, but what my patients do with their balls is none of my business.

In all seriousness, aside from the word “hairy” in the name of the theorem, I don’t see a case where I could’ve possibly encountered this in surgery.

Hello Doctor

Are you familiar with the “Hair So Real” hair building fibers ? It is just like toppik , but much much cheaper. Which is what concerns me . Could it be cheaper because of inferior quality? I have tried H.S.R. and it does a very decent job .But what about its ingredients ? Are they safe to use ?

HairSoReal.com

Hair So Real looks like it is similar to Toppik. I don’t know about the ingredients, so I can’t comment on that. Really, I am not endorsing or disapproving of these products. In general they all work pretty well in concealing thinning hair. Many of my patients often use these type of products and most of our experience is with Toppik or DermMatch.

I remembered that one of my staff members here in Los Angeles has mentioned that he tried Hair So Real, so I got his take on it. He said, “I used Hair So Real for over a year and know people who are still using it, and never had any problems. The price is great, but I switched to DermMatch recently because it seems to work better for my crown and back of the head.”

So there you go.

Hello Dr. Rassman,

Thank you so much for the service you provide the public with this site. It must be alot of extra uncompensated work for you, I appreciate it.

I got a 1300 hair graft about 9 months ago to the area that I roughly outlined in red (on both sides of my head of course, I am only showing one side). As you can see it is growing at nearly a 90 degree angle on my head whereas my natural hair falls forward. Even though I cut my hair at the same length, the transplanted area looks twice as long because it is growing directly ‘up’. My two questions are this: 1. Is this a lack of skill on the doctors part that it is growing at an unnatural angle? and 2) if I keep trying to comb it forward can you gradually adjust the natural angle of the hair so that it matches with the rest of my hair as to the angle that it grows (or will the transplanted area permanently be at odds with my natural hair growth angle)?

My doctor recommends a second procedure because as you can see the transplanted area looks quite thin. I am 26, do you see any concerns with having a second procedure done with this doctor, or do you sense a lack of skill and I should look elsewhere? I have minor thinning in the crown area as well, but I do not plan on transplanting anything to that area. I have been on propecia for 9 months, and while it has not totally regrown the crown area, I am hoping that it will prevent further loss in that area.

Many thanks, and feel free to post the picture.

Thank you for permission to post your photo. Please click the photo to enlarge.

You are correct. It seems your hair was transplanted at different angle than your native hair. The surgeon planning for the correct angle and direction of hair is a very important factor in a hair transplant procedure. Unfortunately, this is very difficult to correct and relatively impossible to reverse. Your transplanted hair will always grow in that unnatural direction. One of your options is to have another transplant procedure and make sure that the new transplants are in the correct direction to “blend” in with your hair.

With respect to a second surgery with the same doctor, you need to be able to trust the doctor before having any procedure. Doctors are human beings and they can make mistakes or misjudge the many decisions that are before them in a treatment plan. If you and your doctor have a good trusting relationship, I am sure he/she will see the difference in angle and your concerns and will be more than happy to accommodate accordingly. The key here is to directly discuss this with your doctor first, and then make decisions on the value of the doctor/patient relationship.