Chapter One: THE ROAD TO PROPECIA
Discovering the Cause and Treatment of Baldness
Innovation is not a random process. When it works, it works because someone has identified a real need and found a way to bring new ideas or new technologies to bear on that need.
LEWIS W. LEHR
Ask any balding man when he first noticed his hair thinning, and odds are he'll remember. Like any other milestone in his life, he isn't likely to forget the event or its accompanying details, like where he was, what he was doing, and, most important, how he felt.
I was in bed, stretching and getting comfortable on the pillow, just like any other night. What made this one different, though, was that when I ran my fingers through my hair, out came, not one or two, but at least ten strands of hair. I couldn't miss it because my hair was worn well below my collar, so these were long strands; a man with shorter hair might not as easily notice the earliest stages of hair loss. I was "lucky."
My heart sank because when this happened, in February 1987, 1 was only twenty-two. Not that I wouldn't have still been upset had the balding process begun in my thirties or forties, but at twenty-two, with my adult life just beginning, the last thing I wanted to worry about was losing my hair.
The next morning, while in the shower, I noticed that the drain was completely clogged -- with my hair. I had a thick head of finely textured hair, and now I was faced with the possibility of losing it to male pattern baldness.
First I tried the then widely advertised Helsinki Formula, then KeraKare, a lotion that's applied to the scalp every night. Neither worked. In fact, some of the over-the-counter topical treatments that used to be marketed as baldness cures disappeared in the wake of the FDA ruling that a product couldn't advertise itself as a hair-loss treatment unless it had specific FDA approval as a hair drug. Yet many of these useless concoctions are still advertised and flood the market because of ineffective enforcement of the law.
For seven years I unsuccessfully experimented with every treatment on the market. I found that I really had two "careers." While running my video-production company, Spence-Comm, Inc., I was on an equally time-consuming quest to save my hair. Not only did I spend hours rubbing my head with lotions, I also had "top" New York dermatologists inject hormones into my scalp at $175 per very painful injection. I researched the biological effects of pulsed electrostatic-field treatment for hair, which turned out to be one of the biggest disappointments in the industry. Then, like so many other hopeful men, I ended up using minoxidil, which was then available by prescription only but would eventually be marketed over-the counter as Rogaine.
A so-called "prominent hair specialist" in New York City was providing me with his own concoction of minoxidil and Retin-A, and he told me to spray this on my scalp four times a day in order to grow hair. According to him, I was the perfect candidate for his potion: I was in my midtwenties then and my hair loss was not that extensive. My crown was beginning to thin, and my hairline had receded by about half an inch. But I was losing a tremendous amount of hair every day; the balding process was progressing very quickly.
The First Approved Hair Loss Drug
Minoxidil (Ioniten) was the first drug approved by the FDA for treatment of baldness. For many years, minoxidil, in pill form, was widely used to treat high blood pressure. It had one strange side effect, though: It grew hair in an unexpected manner. People grew hair on the backs of their hands, or on their cheeks, and some even grew hair on their foreheads.
Some enterprising researchers had the notion that applying minoxidil topically, directly on the head, might grow hair on balding areas. It did, in varying degrees depending upon the extent of hair loss, and at the time it was revolutionary.
Like all legitimate hair loss treatments, minoxidil works in varying degrees, depending on many hair loss factors. Now marketed over-the-counter under the brand name Rogaine, at the standard 2‰ solution or the extra strength 5‰ solution, the drug's side effects include dry, itching or flaking scalp (which is the most common, but easily reduced or eliminated by using common overthe-counter dandruff shampoos like Neutragena T-Gel, Head and Shoulders or Nizoral), and low blood pressure (which is rare and reversible once you stop using the drug). Minoxidil is not advised, however, for anyone who has heart disease because of the potential for cardiac side effects in those people at risk.
The most recent studies show that Rogaine Extra Strength for men (5‰ solution) regrew 45‰ more hair than regular strength Rogaine (2‰ solution). In the same group of studies, hair regrowth that was shown in month four while using regular strength was visible by month two while using extra strength. This indicates that Rogaine Extra Strength actually speeds up the hair growth process, making treatment that much more effective.
Rogaine is thought to work by stimulating and enlarging miniaturized hair follicles and reversing the miniaturization process. According to Pharmacia & Upjohn, which manufactures and markets Rogaine, regrowth is more likely to occur if you have a large number of only partially miniaturized hair follicles. These kinds of follicles still produce hair, but this hair will be thinner than unaffected strands, and must be at least 3/8 of an inch or more in length for it to favorably respond to Rogaine.
Unfortunately, according to Pharmacia & Upjohn, any area of your scalp with no hair or where only vellus (peach fuzz) hair remains is less likely to respond to treatment. Rogaine is the most effective for the earliest stages of hair loss. The manufacturer also cautions that Rogaine should not be used by those under 18 years of age; those using a topical prescription product on the scalp; those experiencing sunburned, inflamed, infected, irritated or painful scalp; or those whose hair loss was sudden, indicating that it is not male pattern baldness, but some other form of hair loss.
Rogaine's effectiveness can be enhanced by simultaneously using other treatments, including Propecia, herbal, and nutritional approaches. Some men with sensitive scalps do not make good candidates for treatment with Rogaine, and once those men stop using the drug, their scalp irritation will go away.
The DHT Connection and Finastefide
By late 1994, 1 had amassed quite an amount of information on baldness, so when I read in the New York Times that a number of drug companies had committed to putting the next baldness breakthrough on pharmacy shelves, I was intrigued that among the drugs that were being studied was finasteride, the prescription prostate drug that Merck & Co., the pharmaceutical company, manufactured and marketed in a 5 mg. dose under the brand name Proscar. Finasteride prevents testosterone from converting into DHT (dihydrotestosterone), the androgen that can cause not only prostate problems but the demise of hair follicles. I knew from my reading about testosterone that Merck was on to something. Only a product that changes the body's chemistry, introduced internally (with a pill, for instance), could combat the hormonal assault on hair follicles.
Doctors and patients discovered that Proscar, originally prescribed to treat benign prostate enlargement, had an exciting, positive side effect: It grew hair on bald men's heads -- "regular" (called terminal) hair, not peach fuzz. The stage was finally set for a truly effective balding treatment.
To understand why this is the case, here's a crash course on how testosterone causes hair loss: For many years, the scientific community and the rest of us were under the impression that androgenetic alopecia (male pattern baldness) was caused by the predominance of the male sex hormone, testosterone. While testosterone does play a role in the balding process, the accumulation of scientific study over the course of decades has revealed that dihydrotestosterone (DHT), a derivative of testosterone, is actually the main culprit.
Testosterone converts to DHT with the aid of the enzyme Type II 5-alpha-reductase, which is held in a hair follicle's oil glands. Scientists now believe that it is not the amount of circulating testosterone but the level of DHT binding to receptors in scalp follicles that determines hair loss. DHT shrinks hair follicles, making it impossible for healthy hair to survive.
The first evidence of the relationship between male pattern baldness and testosterone was discovered by a psychiatrist early in the twentieth century. At the time, castration was commonly performed on some of the more uncontrollable psychiatric patients in sanatoriums. Castrating these patients not only eliminated their sex drive, it also produced a calming effect, much like a sedative.
This particular doctor noted that one of his castrated patients had a full head of hair, while the patient's uninstitutionalized twin brother who came to visit was very bald. The doctor then noted that the mentally ill twin had been castrated before the onset of puberty. The doctor was curious: If a pure form of testosterone was injected into the castrated twin, would it affect his full head of hair? Within weeks of the injection, the twin began to lose his hair.
In 1942 James B. Hamilton of Yale published a report in the American Journal of Anatomy detailing his studies of men whose testes had been removed before puberty for medical reasons and noting the fact that these men never went bald, even if they had bald relatives. When these castrated men were given testosterone injections, however, their hair began to fall out, and they were soon almost as bald as some of their relatives. If the testosterone injections stopped, their hair loss stopped progressing. Interestingly, if the men came from families with few bald men, the testosterone injections didn't cause much baldness. This was the first time science had noted that baldness was linked to both hormones and genes.
These studies revealed that if testosterone has never been introduced into the hormonal pool, then hair loss will not occur. But once testosterone is activated (at puberty, for those who have not had the misfortune of being castrated), it creates a biochemical reaction in people who have a genetic predisposition to androgenetic alopecia, male pattern baldness.
In the case of the twin at the sanatorium who grew bald once testosterone was introduced into his body, it's important to note that when the doctor stopped giving him testosterone, the twin did regrow some of his hair, but not all of it, since many of his hair follicles had died.
Only decades later would scientists discover that follicles die not from the testosterone itself but from its follicle-killing derivative, DHT, and that hair will not grow from dead follicles.
The drug finasteride was the result of a long term research project at Merck that began initially in the mid-1950s, according to the company. At that time, Merck scientists were conducting research into the role of androgens (like DHT) in benign prostate enlargement and male pattern baldness. By the 1960s, Merck researchers had learned that Type II 5-alpha-reductase (an enzyme) was necessary to complete the conversion of testosterone to DHT, and this was the basis for the development of finasteride, which inhibits this particular enzyme.
Merck decided to focus first on prostate enlargement, the company says, because the medical need for a treatment of the condition was greater.
The 1970s brought more confirmation of the DHT and Type II 5-alpha-reductase connection to male pattern baldness. Scientists in the Dominican Republic were looking at the cases of male children who, though born with XY chromosomes, grew up looking like females. Only when they went through puberty was it apparent that they were male. Their genitalia were almost nonexistent as children, but they then grew to normal size once the body manufactured testosterone at the onset of puberty.
The researchers noted that these boys never lost their hair as they grew older. Although all of these boys had normal -- and in some cases raised -- levels of male hormones, they all had no trace of Type II 5- alpha- reductase, the enzyme that converts testosterone to DHT, which then kills hair follicles in the male pattern baldness areas of the scalp.
In the mid-1980s, Merck scientists working with their prostate drug finasteride, marketed as Proscar, knew that cases of male pattern baldness were rare in men with low levels of Type II 5alpha-reductase. The company then turned its attention to using finasteride to treat male pattern baldness. They would need separate FDA approval to market finasteride as a hair-loss drug treatment, though, so in 1992 Merck began testing the drug (which they would eventually market under the brand name Propecia) specifically to treat male pattern baldness so they could head down the road to FDA approval.
Remember that it's actually in the hair follicles that testosterone converts to the more powerful DHT, which behaves differently depending upon where on the body those follicles are located. The male pattern baldness areas of the head -- the front, temples, and crown -- are more sensitive to testosterone and therefore quicker to convert it to DHT. As DHT shrinks a hair follicle, shortening a hair's growth cycle, a normal hair's diameter lessens and lessens over time until the hair is tiny and fine. Ultimately, no hair can grow when the follicle dies.
Elsewhere on the body, DHT behaves differently. It actually stimulates hair growth in follicles located on the chest, back, shoulders, eyebrows, and ears, even though it kills hair follicles on the scalp.
Geographical and cultural influences also affect hormones. Compared to Asian men, Americans have more of the enzyme that converts testosterone to DHT and thus have more body hair and more baldness. The role that a culture's food choices may play in the action of our hormones is the subject of ongoing study by scientists (and is discussed in Chapter Two).
Women naturally have far less testosterone than men -- actually just a trace of the hormone. But when a woman has more than the usual amount in her system -- because of medication, a hormoneproducing growth, or another problem -- she can also develop male pattern baldness. Because finasteride can cause birth defects in a male fetus, women of childbearing age who are not sterile should not take finasteride. Although it is not intended for use by women, in certain circumstances a doctor may prescribe it for a woman with androgenetic alopecia.
Apparently baldness leads to more baldness. In balding areas, the oil glands in the hair follicle become larger. Since it's these glands that hold the enzyme that converts testosterone to the follicle killing DHT, there's always a lot of the enzyme in these enlarged glands in balding areas, ready to further weaken the follicles. Oil gland activity is also increased by higher amounts of circulating hormones.
Hormones are not static. Testosterone levels in some men drop by 10 percent each decade after age thirty. Testosterone levels peak in the fall and are lowest in the spring. During the spring low, hair grows the most. As testosterone levels rise, heading toward fall, so does hair loss. By fall, twice as much hair is lost than was lost in the spring. Both men and women have a similar hair growth seasonal cycle. The cyclic nature of both our hair and hormones is one reason why hair loss can increase in the short term even when you are experiencing a long-term slowdown of hair loss (and a long-term increase in hair growth) while on a treatment that controls baldness.
Male pattern baldness is also genetic, and the gene is passed to a child from either parent, not just the mother, as had been previously thought.
Finasteride in Action
When I discovered that Merck was studying their prostate drug Proscar (finasteride) for its baldness prevention and treatment potential, the 1 mg. dose of the drug they would name Propecia was in the second phase of its FDA study. It was 1994, and with the third-phase human trials for efficacy still to come, FDA approval for finasteride's use as Propecia, a drug to prevent and treat hair loss, would be years away.
Although minoxidil had bought me some time (about two years), I was not the best candidate for the drug, so I needed to explore other options, including finasteride, as soon as possible.
I wanted to take finasteride now. But until its approval by the FDA specifically for hair loss, men could only get the drug marketed as Proscar, a 5 mg. pill, for prostate treatment. And if a man didn't have any prostate trouble, he'd have to convince a doctor to prescribe Proscar for him anyway.
I called my hair specialist very excitedly and asked him if he knew about Proscar and its hairsaving side effect. He said that he knew about the drug. When I asked what he thought about it, he told me that if I took the drug at my age (I was almost twenty-nine), I would likely become impotent and eventually take on female characteristics, such as breast enlargement and curvaceous hips. (I discovered later that many physicians were under this misconception and were causing unnecessary worry. It wasn't Proscar but a previous generation of prostate drugs that had these unfortunate "feminizing" side effects among many of the men who took them.)
He affirmed that he provided the only safe and effective antibaldness treatment in the world and that I should stick to his concoction.
Since I enjoyed sex and had no desire to develop a girlish figure, I took his advice. I stuck to his treatment for a few more months. I was still losing my hair. I began to notice that when I went to his office to get my supply of "product" at $90 a pop, there was more and more anti-Proscar literature in his waiting room, photocopied sheets noting only its adverse side effects.
I read some of these and noticed that all of the men who were studied in the original Proscar FDA trials for approval as a prostate drug were over the age of forty. All had enlarged prostates. Chances are that many of them suffered from impotence for reasons having nothing to do with Proscar.
These photocopied sheets listed the possible side effects, and there were only five, including possible lowering of libido, partial impotence, and smaller volume of ejaculant. In about 60 percent of the very few men with these side effects, these symptoms were transient and went away during the course of treatment. (Also, the 5 mg. Proscar pill used in these studies contained five times the amount of finasteride Merck planned to use in its I mg. Propecia pill for the treatment of baldness.) Nothing about the side effects of Proscar mentioned anything about turning into a woman.
The doctor was definitely threatened by the possibility that people could save their hair by popping a pill for far less than the cost of his virtually useless concoction. I stopped using his product and started to research Proscar.
Finasteride is a synthetic compound that specifically inhibits Type II 5-alpha-reductase, the enzyme that converts testosterone into a more potent androgen dihydrotestosterone (DHT). Finasteride, when marketed as a I mg. pill to treat baldness under the brand name Propecia, can decrease DHT concentrations by approximately 60 percent (Proscar's 5 mg. dose decreases DHT by 70 percent).
Contrary to what my hair specialist told me, I discovered that research has shown that in patients being treated with a 5 mg. dose of Proscar during a 12-week period, the hypothalamic pituitary-testicular axis was not affected. In other words, if the patient reacted normally to the drug, he experienced no adverse sexual side effects. Because a balding man now regaining his hair was likely to feel better about his appearance, men taking finasteride might even experience an increase in their libido.
The possibility of experiencing any of the five possible side effects was rare. The antidepressant that my hair specialist wanted me to take (he apparently thought that those not happy about losing their hair should cheer up about it) has sixty-one possible adverse side effects including impotence, ejaculation problems, abnormal bleeding, and, ironically, hair loss. More than 15 percent of the patients treated with this antidepressant drug experienced these adverse side effects. Only 3.7 percent of those taking the 5 mg. Proscar pill experienced any side effects -- and sixty percent of those 3.7 percent experienced the side effects only temporarily, and in time they subsided completely. Aspirin has more documented adverse side effects than Proscar. Aspirin's list of side effects includes nausea, loss of blood in the stool, stomach ulcers and bleeding, hives, liver damage, and visual difficulties.
I couldn't understand why so many medical professionals were so anti-Proscar. Their propaganda also raised the fear of possible birth defects in male fetuses if finasteride was passed through sperm, but according to the research the chances of that were practically nil. And a man could always temporarily stop using the drug if he were inclined to impregnate someone, or he could wear a condom to help prevent pregnancy. Women can also rely on their array of birth control methods to prevent pregnancy if their partner is taking finasteride.
The bottom line is that these hair specialists knew that a drug as affordable, effective, and low risk as Proscar would take some of the lining out of their pockets. It wouldn't be the first time that professionals in health care -- or any other industry -- would be resistant to advances that would jeopardize the economic status quo.
I wanted to start treatment with Proscar. I was not about to let someone else control my destiny. I wanted to keep my hair, and I was willing to do anything that I felt was safe.
I called every hair specialist in the nation, trying to get a prescription for Proscar, and almost everyone thought that I was out of my mind. One well-known hair specialist in New York did say that he was supplying some of his patients with the drug. He told me that he had seen some very impressive results. The catch was that he'd only allow his patients to use it in conjunction with his minoxidil concoction. I only wanted the Proscar. But he wouldn't provide it for me unless I used it his way, which would cost around $200 per month for the Proscar pill-minoxidil topical lotion package.
Finally, I asked a physician friend what he thought about prescribing Proscar for male pattern baldness. He looked it up in his Physician's Desk Reference and said that it was worth trying as long as I had some blood tests done and was willing to be tested a few times a year. I agreed, and he gave me a prescription for Proscar.
As one of the very few men outside of Merck's FDA studies to take finasteride to treat hair loss, I felt like some kind of pioneer when I popped that first pill in December 1994. I had a very strong feeling that this was going to help me, and I knew that when it did I would share this information, as well as everything else I was learning about hair loss, with anyone and everyone who needed it.
By early 1995, within two months of starting Proscar, my excessive hair fall-out had ceased. I had no adverse side effects, sexual or otherwise. I had been literally counting hairs and saving them in plastic bags and labeling them to compare weekly counts (C'mon, we've all been there, right?), so I was very aware of what was happening on my head. Before the third month began, the hair count had not only stabilized -- I only lost a little each day, just like someone who isn't balding -- but hair was growing back, too.
The hair on the sides of my head had become very thin over the years, and I had some recession as well. That hair had now begun to grow back.
Within twelve months, ninety-five percent of my hair was actually growing again. It was still a little thinner than it had been before the onset of male pattern baldness, but I was no longer concerned with losing my hair and the unwanted change in my appearance.
My male pattern baldness had not progressed since I began taking finasteride.
In August 1996, I started the Web site "Major Hair Loss News" (http: Urnernbers. aol. com/ hairman96) in order to share reliable information about the biology of hair loss, treatment options, and other information that consumers may need to stay informed and to protect themselves when dealing with the unregulated hair-loss industry.
The response to the Web site has been both overwhelming and gratifying: During the first year alone, nearly 10,000 men and women contacted me for help, and I supplied them with an information package that included details on finasteride, diet, herbal treatments, hair-transplant surgery, an update on physicians, and other research and practical information, charging only $5.95 to cover printing and postage. I soon realized that this Web site was giving real hope to people who had all but thrown in the towel. I have received calls, letters, and E-mail from people all over the world, and I consult with leading hair-loss experts and researchers.
What began as a personal quest ended up as my life's work: consumer advocacy for the "hair impaired."
I knew what they had been through and were still dealing with. I had been there myself.
Randy from Kansas wrote: "The information that you provided regarding DHT and the substances that can counter it was the first substantive data I've ever received on hair loss and hair growth. I've got to believe that countless other guys around the country, even the world, would benefit greatly from what you have to offer."
I was determined to see to it that those battling hair loss wouldn't have to have that problem compounded by unreliable information, greedy marketers of useless products and damaging procedures, and other abuses.
"My brother is twenty-four years old and has full receding baldness. He is extremely handsome regardless, and yet he has been covering his head with a cap for more than three years," wrote one woman in an E-mail that is representative of the pain and frustration of thousands of others with whom I've been in contact. "He feels so terrible, he doesn't feel like looking at anyone and barely keeps his job because he prefers to miss meetings -- so many people would see his head. We love him, but he tries to evade facial contact. I love him, hair or not. I am worried and sad. I've heard on the Net that you have helped a great many people. Can you please help my brother, he is really suffering. I've been in contact with hundreds of men and women who say that the treatments you recommend are the only thing that's helped them. Please help my brother."
I can identify with the pain every time I read a plea like that. I was relieved that I had helped myself, and in turn had been able to help others, but when some of the E-mails and letters began referring to me as the "Hair Messiah," and when the praise for my information and efforts began pouring in along with reports of success with the treatments I'd recommended, I felt a bit strange.
Andres from Argentina wrote: "I am taking finasteride and I am seeing very encouraging results. I think that what you are doing is very important for people who suffer from this problem."
Ken wrote that he hoped my work would "revolutionize the hair industry and take out all the scams and quacks."
Tony kept me posted about his battle with hair loss. After receiving my information package, which included information on finasteride, he said, "I immediately called my doctor. Luckily, she had been my physician for many years, because at first she was rather hesitant to give me a prescription. After thumbing through her [drug] book, she decided that it probably wouldn't hurt to give it a try. She prescribed 5 mg. Proscar with the stipulation that I return for checkups. I am happy to report that I have had NO side effects or adverse reactions as a result of taking Proscar. This sounds kind of over the top, but I would have to say that life has really changed for me. In the past, because of my hair loss, time was my enemy. Every day marked the gradual decline in my looks. As a result of Proscar, I now look forward to the next day, and the day after. After three months I already noticed hair regrowth. The word tomorrow has a much more promising ring to it."
Kevin wrote: "Knowing you're losing your hair is frustrating and heartbreaking. Especially for me because I'm only twenty-three. I noticed my loss when I was about twenty and I thought that there was no way this could be happening to me this young. I used to have nice, thick, wavy hair that I used to think was troublesome. I wish I still had hair like I did back then. I guess you really don't appreciate what you're blessed with until it gradually disappears. Being so young, and still in college, looks are important to me. Unfortunately, I believe my hair loss is affecting my looks and it hurts me very much. I probably wouldn't care if I was sixty years old, but I'm only one-third of that age. I think I've spent way too much time worrying about my condition."
Letters and E-mails like these continue to pour in. You'll read about more of these in our discussion of herbal treatments in Chapter Three.
But before we continue with finasteride's road to FDA approval for marketing as Propecia, here's the story of Brian, whose own road led him to finasteride and herbal treatments after he'd seen my Web site.
"After reading the information you sent me, I wondered how you dealt with the stress over all those years of trying everything. It can really get to you. Now that I'm taking Proscar I have hope," he wrote. "My story started about nine years ago. I know this because I found an old prescription bottle of lotion from my dermatologist. My hair was very slowly thinning, so slowly that I didn't notice it too much."
Brian's doctor had given him this lotion to help treat the tingling and itching he often felt as his hair loss gradually progressed. Of course, it did nothing to stop the hair loss.
"About a year and a half ago, I noticed it looked a little thinner again and I decided to try Rogaine. It was over-the-counter now, so what the heck. Seven months later, it hadn't done much of anything at all for me. I stopped the Rogaine," he continued. "Then my seven-year-old daughter was sitting across the living room from me and said, 'I can see right through your head.' I knew what she meant. If I sit in the car and look in the rear-view mirror, looking at the front of my head, I can see light through the back! I stood in front of the mirror one day and put another mirror in the back of my head. What I saw was the typical upside-down horeshoe pattern starting. The only way I can describe that kind of shock is to imagine being asleep in the middle of the night and waking up and seeing a stranger at the foot of your bed. Kind of like watching a horror movie or something. The shock just hits you. You start to notice people talking to you, but looking at your head."
After learning about finasteride, Brian went back to his dermatologist.
"I asked him what kind of treatments were new since I saw him years ago, and he said I should try Rogaine. I told him, 'That won't work for me and my level of hair loss. How about Proscar?' He said he would be going to a conference in the fall and would let me know let me know what he thought after that. But what if I waited that few months, and then he still wouldn't let me try it? Then I've wasted a few more months. Doctors don't look at this as a real medical problem. They shrug it off. That is, of course, the ones who aren't making money off of it. I recently got an E-mail from one of the Rogaine/Retin-A doctors. He strongly suggests not using Proscar. Of course he does. He's trying to sell his product. So many people just take this problem for granted and accept it. I don't accept things easily. I am amazed at all the sites on the Internet that sell hair-promoting shampoos, vitamins, herbal liquids, and they aren't cheap. I've used some really bad-smelling brown herbal liquid stuff on my head that came in a small, cheap, plastic bottle with a label glued to it made on a copy machine. I've paid for information telling me about Thymu-Skin. I've seen videos advertised on the Internet for two hundred bucks that will teach you how to massage your head back to healthy hair. Of course, in my search, I read a lot about 5-alpha-reductase and DHT, and so I started to research this more because it made sense. I finally came to your Web site, which was describing what I was going through. After getting all of your information, and talking to you on the phone, I realized that I had found someone out there who really wants to help."
Now taking finasteride and herbs, Brian is experiencing less hair fall-out and gradual hair regrowth.
Propecia's Road to FDA Approval
On December 19, 1996, Merck & Co. filed with the FDA for approval the results of their thirdphase study of their hair-loss drug Propecia (I mg. finasteride).
Three months later, on March 23, 1997, they presented data from these phase-three (human trials) studies to the American Academy of Dermatology meeting in San Francisco.
The protocol for all of the studies within these human trials included the following:
* A total of 1,879 men participated.
* The men ranged in age from eighteen to forty-one, and they participated at a number of centers in the United States and worldwide.
* For twelve months each man daily received either a 1 mg. oral dose of Propecia or a placebo.
* The studies were double-blind, meaning that neither the patient nor the clinician administering the dose knew whether the patient was receiving Propecia or the placebo.
* Improvement was assessed by research investigators who examined each patient, by an expert panel of dermatologists who reviewed patient photos, and by the patients themselves, who filled out questionnaires at each visit.
* Each of the men participating had mild to moderate, but not complete, hair loss.
* Safety was evaluated through clinical and laboratory monitoring and analysis, and an analysis of adverse events.
The data presented at this March meeting was from studies of 1,553 men with predominant thinning of hair in the vertex area (top of the head). Overall improvement was seen as early as three months, with continued improvement over the course of the twelve-month trial period.
After twelve months, the results from the vertex studies were as follows:
* 86 percent of the men taking Propecia maintained or showed an increase in the amount of hair based on hair counts during the course of the studies, compared to 42 percent of the men receiving the placebo.
* 14 percent of the men taking Propecia lost hair (measuring any decrease in hair count from the baseline established at the start of the study), while 5 8 percent of the men in the placebo group continued to lose hair.
The difference between the men taking Propecia and the men taking the placebo is most dramatic in these two sets of results because they are based on actual hair counts, the most objective form of result assessment.
*Clinical investigators rated 65 percent of men treated with Propecia as having substantial increased hair growth, compared to 37 percent of the men taking the placebo.
* An expert panel of dermatologists evaluating patient photos rated 48 percent of patients treated with Propecia as having increased hair growth, while only 7 percent of patients taking the placebo were reported to show improvement.
* In the patient questionnaires, 68 percent of men taking Propecia reported that their hair loss had slowed, compared to 45 percent of those taking the placebo. Improvement was noted as early as the third month, when those percentages were 54 and 44 respectively.
"The clinical relevance of the increased hair growth measured by hair counts was substantiated by the significant improvements perceived by patients and through complementary measures such as the investigator and expert panel assessments," said Keith Kaufman, M.D., director of clinical research at Merck & Co., based in Rahway, New Jersey.
Three months later, on June 17, 1997, Merck presented data to the World Congress of Dermatology, meeting in Sydney, Australia, this time from their phase-three human trials studies of 326 men with frontal hair thinning.
As in the vertex studies, men with frontal thinning also benefited from Propecia, which prevented further hair loss and increased hair growth.
*Clinical investigators rated 52 percent of men treated with Propecia as having substantial hair growth, compared to 31 percent of men treated with the placebo.
* An expert panel of dermatologists evaluating patient photos rated 37 percent of patients treated with Propecia as having increased hair growth, while only 7 percent of patients taking the placebo were reported to show improvement.
* In the patient questionnaires, 53 percent of men taking Propecia reported an improvement in the appearance of their hair, while 30 percent of the men taking the placebo reported improvement. In addition, 65 percent of men taking Propecia, compared to 45 percent of men taking the placebo, reported that their hair loss had slowed.
Slightly lower effectiveness rates in the frontal studies are due to the fact that frontal hair is generally harder to regrow than hair at the vertex.
Investigators also reported a significant improvement for men treated with Propecia compared to those taking the placebo in hair density
and pattern in three sections of the scalp-frontal, mid area, and vertex-throughout the studies.
Regarding the data reported in the frontal study, Merck's Keith Kaufman, M.D., said, "The frontal study is unique because hair-loss studies in men typically evaluate hair growth at the vertex. Frontal thinning is commonly seen in men, and it is what they may first notice when they look in the mirror."
Finasteride lowers the numbers in the PSA test (the prostate cancer screening test given as part of your general physical exam), and may therefore give you a false low-numbered status, thus masking levels of Prostate Specific Antigen that are actually higher. Tell your doctor if you are taking finasteride so that he will be able to properly interpret your PSA tests and order other screening tests that are not affected by the use of finasteride.
Regarding side effects, Merck's phase three studies of all the men participating show that "for the overwhelming majority of the men -- 96 percent -- these side effects were not reported," said Dr. Kaufman.
When side effects did occur, they "were reversible in men who discontinued therapy, and even resolved in many of these patients who preferred to continue treatment," Dr. Kaufman noted.
No birth defects were reported when several patients who were using finasteride impregnated someone.
The tolerability of Propecia was reinforced by the data from these human trials. The drug was very well tolerated, with most patients reporting no significant side effects. The overall safety profile for Propecia and the placebo was similar. Side effects were infrequent and occurred in a small number of men. The only side effects occurring in more than I percent of patients were the following:
* Decreased libido: 1.8 percent of men treated with Propecia vs. 1.3 percent on placebo.
* Erectile dysfunction: 1.3 percent of men treated with Propecia vs. 0.7 percent on placebo.
* Decreased volume of ejaculate: 0.8 percent of men treated with Propecia vs. 0.4 percent on placebo.
* Discontinuation of therapy due to adverse side effects occurred in 1.7 percent of 945 men on Propecia and 2.1 percent of 934 men on a placebo.
Propecia is for use by men only. Women "who are or may be pregnant must not use Propecia, since it may cause a specific birth defect in a male fetus," warned the company.
In their report of these FDA trial studies, Merck explained that "Propecia works by treating an underlying cause of male pattern hair loss by inhibiting the production of DHT, which is believed to be a major cause of hair loss. The enzyme Type II 5-alpha-reductase is involved in the production of DHT. Propecia inhibits the action of Type II 5-alpha-reductase, thereby decreasing DHT concentrations in treated men by approximately 60 percent."
Although male pattern baldness is genetically linked, its onset is triggered by the presence of DHT in the hair follicles of susceptible scalp areas, so "the ability to increase hair growth and prevent further hair loss by specifically lowering DHT with finasteride I mg. provides a potential new oral therapeutic option with an excellent riskbenefit ratio for the treatment of men with male pattern hair loss," Dr. Kaufman noted in Merck's report of their data. "This approach represents an important advance in our understanding of the science of hair loss. An important step in the development of Propecia was understanding the biology of male pattern hair loss and DHT's role in it. This knowledge has led to a new paradigm in treating men with this condition."
The positive results I have experienced while taking finasteride were confirmed by Merck's studies.
Merck submitted their application and study results to the FDA for clearance to market finasteride in I mg. pills under the brand name Propecia as the first oral treatment taken once a day for the prevention of further hair loss and for regrowth in the most common sites of hair thinning in men.
On December 22, 1997, the FDA approved Merck's application to market Propecia, and the prescription drug was shipped to pharmacies only weeks later, in January 1998.
With the introduction of Propecia and the many drugs that are sure to jump on the hair-loss treatment bandwagon in the coming years, treating male pattern baldness will be like treating any other chronic manageable disorder, such as hypertension or diabetes. Once the onset of the disorder makes itself apparent, the patient can go to the doctor and get a prescription for the problem.
Propecia can be used alone or in conjunction with herbs and/or a specific nutritional program that enhances hair retention and regrowth. Propecia is also a very effective adjunct treatment to hairreplacement surgery.
Baldness treatment pioneer O'Tar Norwood, M.D., who set the standard of pattern hair-loss classification with the Norwood Scale, has been following the ongoing hair-loss research and, like many other specialists, shares in the enthusiasm surrounding the breakthrough that finasteride represents with its ability to combat DHT's major role in male pattern baldness.ar
"The fact that it slows down hair loss," Dr. Norwood says, "is revolutionary. I especially encourage young patients who are too early for transplant surgery to use it, as well as those who can use it as an adjunct to hair-transplant surgery."
Those men with mild to moderate baldness will benefit. For those with more extensive baldness, the drug will reduce further hair loss and will encourage hair regrowth in those follicles that are still alive.
Propecia may be used alone or as an adjunct to other treatments, including nutritional, herbal, and surgical. Although Merck's studies are quite reassuring regarding the extremely low incidences of side effects, and the temporary nature of those side effects, caution should always be used when determining if any drug is right for you.
William R. Rassman, M.D., a leading hair specialist who with his colleague Robert M. Bernstein, M.D., perfected the follicular hair-transplant technique in the United States, believes that Propecia can be used alone or as an adjunct to other treatments, including hair-transplantation surgery, but he reminds us that as with many drugs, even those that have been used for a number of years, "all the long-term risks may not be known yet."
Now that the first treatment that actually acts upon the cause of male pattern baldness is on the market, men have the opportunity, if they so choose, to incorporate this drug into their hair-loss prevention and treatment.
Copyright © 1998 by Spencer David Kobren