History
of Minoxidil |
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About the same time hair transplantation was gaining
ground as an acceptable, although pluggy, treatment
for baldness, minoxidil began to appear in the media
as a potential treatment for hair loss. Reports were
cautiously optimistic, with long time gaps, and all
seem to come with some cheesy title like: "Hair
Today, Gone Tomorrow," or "Hair Raising
News," or "Hair All About It," or,
"Hair Raising Effect," or, "Bald Truth
- blah blah. (Author's note: These same type of pun
titles have been repeated to a nauseating degree for
the last 40 years by reporters who thought they were
first to claim them. After reading the first 30, it
got old.) (Article continues
below ad)
Developed by then Upjohn Co. of Kalamazoo, Michigan,
Minoxidil first came on the scene in 1968 when it
was being tested as an oral treatment for hypertension.
Those tests quickly revealed test subjects were sprouting
hair on their "...backs, cheeks and heads."
(14)
A Time Magazine newsbrief entitled "Hair
Today, Gone Tomorrow" from January 26, 1981
reported:
"For brooding baldies who have spent fortunes
on useless hair-growing potions and lotions, hope
seems to recede as steadily as their hairlines.
But now comes word that a respected pharmaceutical
firm, the Upjohn Co. of Kalamazoo, Mich., is investigating
a chemical that could lead to development of the
first successful hair restorer. The drug's name:
minoxidil.
"Upjohn, which developed minoxidil as
a treatment for severe high blood pressure, stumbled
on its potential gold mine when clinical trials
indicated the drug had a peculiar side effect: growth
of hair on the body, face and scalp. Most intriguing,
the hair-raising effect extended to the pates of
men supposedly irreversibly bald." (15)
The very first tests for this new "hair restorer"
were conducted -get ready for this- on "...balding
inmates at the state prison in Jackson, Michigan."
However, those results were inclusive and didn't work
out. Undeterred, the company went out in search of
new male and female subjects with lost hair.
Very little is heard about these tests until a November
1984 press release comes out reporting that 50 percent
of the subjects at 20 different testing locations
were reporting positive results.(16) About a week
later, the Associated Press picks up the story which
is then distributed in newspapers throughout the country.
The AP reported that 2200 subjects were being tested
in 28 different locations. In one, Washington Hospital
Center, 71 patients out of 91 men and 5 women saw
improvement. Of those, 27 saw "cosmetically acceptable"
improvement with hair growth being "doubled."
(17)
According to another Time Magazine article that appeared
in 1986, when this same hospital announced they were
seeking subjects to test this new miracle cure, "...10,000
eager volunteers called in, jamming the switchboard
for three days and forcing the staff to use
disaster control lines." (18)
As news of the results leaked to the media from eager
doctors who led the testing centers, and eager Upjohn
executives who issued press releases, the FDA was
applying the breaks to all the excitement and tried
to shift the focus back on safety.
That same 1986 Time Magazine article reported:
"Despite the clamor, the FDA shows no sign
of giving the nod soon. In the past two months,
agency officials have scolded Upjohn, charging that
a company press release was "overly positive"
and contained " 'misconceptions and false impressions
of safety and efficacy.' "
Upjohn's press release that got them into trouble
from the FDA was released on April 29, 1986 and caused
the company's stock price to rise 9 percent in 48
hours to $174.25 a share. The excitement over the
drug from both investors and bald men was building
to unrealistic levels. As the first hair loss drug
to come from a respected pharmaceutical company, the
excitement and hype that was building around minoxidil
at the time could be - understandable. Afterall, mankind
had waited 5,000 years for something like this and
it was a significant improvement from the pigeon poop
and goat pee concoction Hippocrates developed around
400 BC. (see History
of Hair Loss Treatments)
But even in that 1986 article, Time Magazine was
trying to be cautious about the results. Although
76 percent of patients in that 2200 person study were
showing "new hair growth," the placebo group
also showed some new hair growth and only 40 percent
of the minoxidil group were reporting new hair growth
that was "moderate" or otherwise, noticeable.
"It rarely produces a robust crop."
The article also pointed out that minoxidil was working
best on younger men with recent hair loss, not older
men who had already endure a bald spot for years or
decades. "It works best on the scalps of
men who are just beginning to go bald, especially
those in their early 20s. Only a fraction of the nation's
millions of balding men meet those criteria."
Surrounded by a combination of caution and hype,
the FDA approved Rogaine 2 percent topical solution
as the first hair loss treatment drug in the United
States on August 17, 1988. Unfortunately, the hype
before it's release had been so great, that the results
and cautions by respected dermatologists cooled this
effect once it hit the market. The day after it was
released, the New York Times ran a piece which cautioned
the now widely known points about minoxidil. (19)
- It will never restore hair density to that of
a man's youth.
- Stopping the twice a day application will result
in a return to hair loss as it would have been before.
- It only works best on newly lost hair, and crown
hair loss.
- It works best on hair that is recently lost, or
thinning and about to be lost.
- Minoxidil only grew hair in 30 to 60 percent of
the subjects tested with the 2 and 3 percent formulas.
Despite the FDA approval, the best days for Upjohn's
stock price were gone as well which had fallen to
$31.75 the day of FDA approval, from $174.25 just
two years before when they issued their overly positive
press release in April of 1986. Sales of the topical
solution went on to be mediocre and the profit margin
never matched expectations. As it turns out, minoxidil
in tablet form was being compounded into a topical
solution for years before FDA approval and being sold
to men too eager to wait on the topical solution to
hit American pharmacies. Plus, 45 other countries
had also approved oral minoxidil and clinics were
illegally importing and modifying the drug as a hair
loss treatment for scalp application.
The Kalamazoo, Mich., company contended last month
(April 1987) that 20 companies were illegally importing
the components of its hair-loss treatment and selling
the finished product in violation of Upjohn patents.
(20)
When the FDA approved Minoxidil, the sudden expansion
onto the market place drove prices down, not up. "Rogaine
began looking like a pharmaceutical Edsel in the first
few months after (it was FDA approved). Upjohn
made it available in November of that year. Sales
that some market analysts had predicted would $200
million a year in the first year totaled less than
a third of that in 1989. (20)
Undeterred, Upjohn changed their marketing strategy
to a tactic that was ahead of it's time. Instead of
marketing Rogaine to doctors, they would market directly
to the consumer. Ads in sports and men's magazines
began appearing and commercials with bald men contemplating
their, baldness, were encouraged to see their doctor.
However, this retooled approach was still seen as
too "soft" and "vague" and men
needed to be pushed to action more so Upjohn began
running more hard hitting ads, calling for action
immediately, and offering $10 coupon's off their doctor's
visit. (21)
The strategy apparently paid off as sales more than
doubled from $67 million in 1989, to $140 to $150
million in 1991. By 1992, Upjohn felt that had learned
some valuable marketing lessons and set out to market
their product to women.
As a New York Times Article put it: "After
all, if, as Woody Allen once said, being bisexual
doubles your chance of getting a date, then expanding
a drug's market to women and men, from only men, would
seem to be a marvelous marketing opportunity."
(21, 22)
Two months after that article appeared, the FDA approved
the marketing of a 2 percent formula for women. Despite
the attempt to increase it's market size by selling
to women, by 1995 sales had drifted back down to $124
million worldwide.(21)
By 1996, Upjohn had moved the 2 percent formula out
from behind the pharmacists' counter to over the counter,
and lost it's bid to market Rogaine exclusively -
opening the door for lower cost generics. But the
1990s saw even more bad news for Upjohn. By 1996,
it becomes obvious that rival Merck will receive FDA
clearance for it's ant-DHT hair loss pill, Propecia,
(finasteride). (22)
[Clarification Note: Upjohn had
already merged with Swedish pharmaceutical company,
Pharmacia AB, in 1995, to become Pharmacia Upjohn.
Pharmacia Upjohn became Pharmacia after a merger
with Monsanto. After an acquisition between Monsanto
and Pfizer, Pfizer merged with Pharmacia in 2002.
Pfizer then sold it's Rogaine brand to McNEIL-PPC,
a healthcare division of Johnson and Johnson in
2006, the same year it came out with Rogaine Foam.
So, to be clear, after a long string of mergers
and acquisitions, Rogaine is now owned by Johnson
and Johnson.] (23)
After a clinical trial and a long wait, Upjohn finally
received permission from the FDA to market their Rogaine
Extra Strength (5 percent minoxidil) in January of
1998. For a time, no new major developments came along
for minoxidil users until 2006 when the Rogaine company
released a new version with a more effective foam
based delivery system. This was an important improvement
for the product which always had a "messy"
application in which the user must endure a sopping
mess of wet hair until the topical solution dried
- an inconvenient approach if you want to apply it
in the morning before heading off to work, with your
head still wet and messy from a topical baldness cure.
The foam version works right in and dries fast, making
it easier for users to incorporate into their daily
use, and to stick with the twice a day regimen.(24
& 25)
And with this new foam based delivery system, the
promise of new hair growth seemed to improve from
the 60 percent Rogaine reported in earlier studies,
to the 85 percent possible with the new foam. The
studies that show this 85 percent "improvement"
rate (improvement is a bit loosely defined) are not
made available on the Rogaine website. However, after
some digging, I believe I located the studies which
back their claim and presented them on our Minoxidil
as a Treatment for Crown Hair Loss.
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