Sawaya: The truth about Dutasteride & Clinical Trials
Article by HairlossTalk.com
February 9, 2004
An editorial by Dr. Marty Sawaya on the truth behind why Dutasteride trials were never finished despite its effectiveness, and why a new hair loss treatment with sufficient testing may be a long way off...
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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. |
The truth about Dutasteride
People keep asking about Dutasteride, from Glaxo. You have no idea how many questions
I keep hearing, from “Why didn’t they go forward with it?” to
“What is wrong with the company?” to “How can we use it off-label?”
or “Does it really work better then finasteride?”, etc. Well, the
answer to these questions, as usual, centers around corporate politics. Glaxo
merged with Burroughs-Wellcome, and was then called Glaxo-Wellcome. This merger
was fine, because the clinical studies for Dutasteride had already been completed
through phase II. The results analyzed by the company showed that it really was
an effective agent for hair growth in men; however, the company underwent another
merger with Smith-Kline, in 1999. Phase III is the final leg of the study process,
and if the ball had already been rolling, the company may have proceeded to complete
the approval process. However, when the new top officials took over, they concluded
something unsavory about the profitability of Dutasteride. After some analysis,
they decided that Dutasteride would not make profits of over 500 million per year
as a hair loss treatment, so it was placed to the side for other new drug development
projects.
To date there are only two clinically proven products on the market. Sales of
these products, Minoxidil (also known as Rogaine) and finasteride (also known
as Propecia) were not making Wall Street projections, barely grossing $100 million
per year. This was clearly disappointing, and companies realized that unless you
really have a “blockbuster” (meaning, it will make over $500 million
per year) don’t bother with the hair growth industry.
This doesn’t mean that Dutasteride wasn’t a blockbuster drug, but
with the media hype about the sexual side effects of Finasteride/Propecia so inflated,
it was hard to repair the damage. As huge and powerful as Merck, the manufacturer
of Propecia was and still is, it didn’t matter. The media prevailed, and
men were very cautious of using Propecia. Glaxo probably realized that Dutasteride
would face even more challenges, since it was a more potent drug than Propecia,
being a dual 5a-Reductase Enzyme Inhibitor, with a longer half-life
(stays in the body a long, long time). Would anyone buy a once a week, or once
a month pill for an outrageous price like $20 per pill? You say that you would,
but would you really?
People are also the problem. Everyone wants “something” for “nothing”
and the powers that be at Glaxo were fully aware of all the complaining men are
doing about the cost of Propecia at $50 per month. They were also fully aware
that people had figured out how to get it for cheaper by purchasing 5mg proscar
and splitting the tabs into 1mg equivalent of Propecia. Glaxo took all of this
into consideration. If you look at Dutasteride, now called Avodart (by Glaxo-Smith/Kline
Co.), which is approved and only indicated for men with benign prostatic hypertrophy,
it is a soft-gel capsule that cannot be cut up into portions. It is also a different
dose, and not the one that would have probably been used for hair growth.
The Difficulty of an effective Clinical Trial
In any case, conducting clinical trials to prove hair growth in men and women
can be a challenge. As simple as all of this might seem, it really is a tedious
task to plan, organize, set-up and conduct clinical trials, costing millions and
millions of dollars. These days, finding suitable subjects for the study is also
a challenge, as so many people have used the currently available products, or
have had hair transplants, weaves, or other procedures done to mask hair loss.
The industry demands naive patients with no use of current or previous treatments,
even herbal agents (which is another article for another day).
After Upjohn received so much criticism from their poorly designed Rogaine studies,
it was no wonder when the next company, Merck, came to bat, that they had a burden
on their back to improve the methods and technology for really proving hair growth.
People demanded real hair, not the fuzz that Minoxidil was showing to grow. Although
Merck pulled out the “red-carpet” for their studies, sparing no expense,
the one that really came to their rescue was the Canfield Scientific Co., a family
photography and imaging company based out of New Jersey. It was the ingenuity
of Doug Canfield that inspired the set-angled camera with standard lighting, filters,
using the same quality of film, and developing methods. Yes, this standardized
the process of taking macro and microphotographs to assess hair growth on the
scalp of patients in the clinical trials. It got to be that if you weren’t
using these latest methods, you were “out of the game” and not considered
an up-to-date player.
Merck also went the “whole-hog” and added taking 4 mm-punch scalp
biopsies to their studies. To me, these biopsies were unnecessary, but were used
to assess hair follicle numbers, as a back up to the photography. Nowadays, this
is probably on the way-side, as I have always thought, if it truly grows cosmetically
acceptable hair, you don’t need to do a biopsy, you should be able to see
it with the proper photography methods in place, which nowadays, is available
with digital photography.
The next player that came along was just a few years ago. The Bristol Myers-Squibb
company proclaimed a “similar to minoxidil” topical hair growth product
that was supposed to be a “thousand times stronger” than Minoxidil.
I wonder what happened to that? I guess they finally realized that “the
thousand times stronger” was for contraction of cardiac tissue, since it
was another vascular-blood pressure effecting agent, and not 1000-times stronger
for growing hair.
The Value (and cost) of a real Clinical Trial on a hair loss treatment
So, we really haven’t seen many other companies come to the “plate”
for starting hair growth studies. As I stated earlier, the bar of profit has been
raised so high, and if you can’t reach market projections of over $500 million
in sales per year, then it really does not come under serious consideration by
the pharmaceutical industry. If you consider Biotech on the other hand, they would
gladly take a product, if they had one, for these kind of market shares, but in
the Biotech world, (a shaky world at that), I have not heard of any hair growth
products coming to the forefront anytime soon.
Of course, every company thinks they “have something really BIG”,
and they try to keep it under wraps because they really don’t have the background
to assess what they have. So you end up hearing a lot of chatter on the various
websites about this new "treatment". I never take any of it seriously,
and you shouldn't either, until you see the clinical studies starting. If they
go to large-scale clinical studies, that must mean they have something, or they
wouldn’t spend the millions to conduct them, and believe me, they do cost
a lot.
Once in a while, you may see a physician at a University/academic based center
offer a clinical study for “hair” where they are able to apply for
grant funds from a company to test their product on a small-scale basis. I wouldn’t
get too excited about something like this either, because usually the physician
is just “trying anything” they can to get grant funds from the company.
This is what it’s all about in the University/academic setting. If you can’t
get extramural funding from the National Institutes of Health or other agencies,
then get it from industry. Sad.
For many companies, hair growth is just too risky of a business to venture into,
and not widely held in high enough esteem, in comparison to heart disease, cancer
and other more life-threatening areas of medicine. While everyone wants a “quick
fix” and runs for the latest cosmetic laser therapies being offered to combat
wrinkles and aging, the hair growth therapy arena is still in its primitive stages
and has a long road to travel before anything earth-shattering comes to market.
As frustrating as all this sounds, for now, I still recommend hair transplants.
Those seeking hair transplants should know that they do work, and rather well,
so it is an option to consider, and I am always amazed at the dedication many
of the hair transplant doctors have for wanting to improve and perfect their craft
to get the most amazing end-results. Go shopping for the “good” hair-transplant
docs; they are out there!
Marty Sawaya MD, PhD
Physician/medical writer
HLT
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