The History of Minoxidil
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.)
Developed by the Upjohn Company 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 in the growth of new hair.(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 with 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. After all, 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 and Aristotle developed around 400 BC. (see History of Hair Loss Treatments).
However, 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 endured 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 its 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 an article that 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 and it fell 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, Michigan 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 marketplace 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 be $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 its time. Instead of marketing Rogaine to doctors, they marketed directly to the consumer. Ads in sports and men’s magazines began appearing and commercials, with bald men contemplating their own baldness, were encouraged to see their doctor. Within a year or two, this retooled approach was still seen as too “soft” and “vague.” Men, Upjohn decided, needed to be pushed to harder. They ran more aggressive television ads, calling for action immediately, and offered a $10 coupon off their next 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 its 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 its 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 became clear to that rival Merck Pharmaceuticals would receive FDA clearance for its anti-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)
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Treatment Bibliography
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