by Kevin Rands | May 15, 2016 10:06 pm
Dr. Marty Sawaya speaks on everything from whats really going on in the pharmaceutical companies, in relation to hair loss research, and why it may be awhile before we see any new treatments…
She’s been there. She’s attended the meetings with the bigwigs of the pharmaceutical industry. She’s sat next to those in power while they discuss whether to fund more research. She’s seen both the good and bad going on behind closed doors. She can provide an eye into the world most of us just wonder about, but never get to see. This article is one of many Dr. Sawaya will be writing exclusively for HairlossTalk’s Newsletter. Make sure you’re subscribed, and feel free to post your comments and questions below.
I guess many people wonder, “Why don’t we have more effective therapies to treat hair loss? We’ve gone to the Moon and now, Mars, but why don’t we have a cure for hair loss? Why aren’t there more companies working on hair growth treatments? After all, millions of men and women worldwide have hair loss, and a fortune could be made growing hair.” Well, I’ve heard all of this before and while it seems like such a “given” that there are billions to be made IF the right hair growth treatment were found, the answer is that “it just isn’t that simple”.
The Lack of Funding
When I look back over 20 years, I never thought I would be involved in hair growth research, but in graduate school I was given a chance to study the biochemistry of hormones and their effects on hair follicles. The male hormones, testosterone and dihydrotestosterone (DHT) affect sebaceous glands (acne) and hair follicle growth. While we know that that these male and even female hormones influence hair growth differently on scalp versus body hair, we don’t exactly know all the other players involved in hair growth regulation. Amazingly, research funds are scarce and not available to explore the area to its fullest potential.
You would think that some big-shot pharmaceutical company would invest millions in research, but they won’t for many reasons. Some reasons may be that they want to keep all the research “in-house” so they don’t have to share the profit, however, despite their size and gross profits, their experience is very narrow in the field of “hair”. The other side of the coin is that the budget for research and development is so small, and the money is instead spent on marketing (how many commercials have you seen for prescription drugs?). Most companies are focused on more disease-oriented problems, such as heart disease, diabetes, cancer, etc. Cosmeceuticals just aren’t high on the radar. If they happen to find a blockbuster “quality of life” product (like Pfizer did for Viagra, which treats impotency) or something else “along the way” that might work for hair loss, then they will assess the marketplace for such a product, and try to plan clinical studies for FDA approval.
Unfortunately, they have to do all of this within the 17-year window period they have for their “exclusive” patent rights. After this time the product can be classed as “generic” and is open for many companies to make and sell. Some companies do nothing but wait for drugs to lose their patent rights so they can manufacture the product, waiting for distribution months before the date of patent expiration. Talk about “vultures”.
Behind the Scenes at the Rogaine Trials
Once a patent has been issued, the clock starts ticking and companies have to gauge their product and run as fast as they can with it. This is why so many companies like Merck take a drug for one indication, such as their drug for prostate health (Proscar) and run with it for hair loss (Propecia). Moral of the story? “Get the most out of an already approved product”. It is easier to get another “indication” for an existing product approved by the FDA. Starting with a new product will take years to complete the phase I-IV studies, not to mention tens of millions of dollars before gaining FDA approval.
If we look back at the only 2 products approved by the FDA in the USA for hair thinning, Minoxidil (Rogaine, originally by the Upjohn Co) and Finasteride (Propecia, by Merck), its important to note that both companies, especially Upjohn Co, had virgin territory they were venturing into. In the mid 1980’s, there had never been clinical trials for a hair growth product, and Upjohn had to “invent the wheel”. At that time, Minoxidil was used to treat severe high blood pressure (hypertension) as the drug was approved for this indication called, in the form of Loniten. As you can probably guess, men were running to their doctors, getting Loniten tablets, crushing and grinding them up, even with all the chalky residue mess, and putting it on their heads before the clinical studies were completed. It was a wild and crazy time back in the mid-late 1980’s, but up to that time, no company had ever had a product to treat male-pattern hair loss. Upjohn ended up losing a significant amount of money because men were using it before it gained FDA approval, and once it was approved, men realized it wasn’t the blockbuster they were hoping for. Consequently, the surge in sales didn’t last too long, disappointing Wall Street projections.
Of course, the Upjohn Company doesn’t exist now, as it merged with the Swedish based company, Pharmacia in the late 1990’s. A few years later, Pharmacia was sold to Pfizer, one of the world’s largest pharmaceutical companies. Whatever there was of Upjohn has now faded to the past. The family-owned pharmaceutical companies are “no longer” and yes, there really was a Dr. Upjohn, in Kalamazoo, Michigan back in the early 1900’s.
The Truth about Rogaine
Getting back to the original clinical trials by Upjohn. You may or may not remember seeing photos of the guys with their heads down on a table where crude cameras took photos of their scalps in the crown/vertex area. These were such primitive and inconsistent methods, that nobody could tell if there really was an increase in hair growth due to the lighting, camera angles, film used, and processing methods. As a result, Upjohn went thru a significant amount of criticism. The blows and remarks were biting, but in the end the studies did show thin, small, lightly colored hairs that grew after 6 months to a year’s use of topical Minoxidil, when used twice a day.
This brings up another point. Why twice per day? Because that is how it was tested in the clinical trials. You can probably do just as well with a once a day dosing, but in order for them to get FDA clearance, they’d have to change the dosing, frequency, and formulation, which puts you literally back to square one as far as the FDA is concerned. The studies have to be done all over again. Besides, twice a day will sell more product, and it is all about profits. Rest assured, it is all about corporate profit.
Why does it say “for vertex/crown thinning only” on the package labeling? Why not also for frontal hair loss? The reason for this is that the clinical studies back then only assessed hair growth in the vertex/crown area, so this is the only approval the FDA gave for its use. Later of course, approval was gained for use in women with hair thinning, but only for 2% formulation, not 5%. Does 5% Minoxidil work in women? Of course, but studies could not show a clear difference in benefit between 2% versus 5% minoxidil, so approval was not gained for 5% minoxidil in women. Many women use it off-label, and it is available over-the-counter in many drug stores in the USA. I even use it once a day, and think it helps.
For now, all we have is minoxidil and finasteride to use for men with hair thinning. Options for women are even fewer, with just minoxidil approved in its 2% formulation, although 5% minoxidil is available, but the packaging is so frightful, that women are confused on what to use. In the next issue, finasteride and dutasteride will be discussed in more detail along with more information on hair loss treatments. Stay tuned.
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