Sawaya on the *real* story behind hair loss research
Article by HairlossTalk.com
February 8, 2004
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...
 |
Dr. Marty Sawaya
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 in 2004. 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.
In Conclusion
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.
Best wishes for now,
Marty Sawaya MD, PhD
Physician/medical writer
© HairlossTalk.com - All Rights Reserved.
Read the Terms under which this service is provided to you.
For Permission to duplicate any content, Email news@hairlosstalk.com
Make sure you're Subscribed to the Newsletter!
| |
|
|
|
