Minoxidil Falls Short as Miracle Baldness Cure

At 7:15 on a cold Monday morning in March, a long line of well-dressed men and women snaked around a subterranean hallway of the Food and Drug Administration building in Rockville, Md. By 8:30 a.m., when the meeting of the Dermatologic Drugs Advisory Committee was to convene, the more than 100 seats in Conference Room C had been claimed, a press section was filled, seven TV camera crews had staked claim to adequate sight lines and dozens of people were trying to get in.

Unpublicized except in obscure drug-trade publications and business journals, the meeting was destined to monopolize local evening-news broadcasts, produce front-page stories in newspapers, cause palpitations on Wall Street and fan the hopes of millions of American males.

The advisory panel--made up of physicians from New York, California, Massachusetts, Florida and elsewhere--was there to decide whether the drug Minoxidil was a safe and effective cure for baldness. They sat dispassionately as Upjohn trumpeted statistics of success--40% of those using the product on an experimental basis had moderate to dense hair growth. Then came reports of side effects--nothing serious. Of the 10 patient deaths during the experimental program, none could be linked to the medication.

Two thousand volunteers had participated in the testing program and 1,800 had completed it: Their success or failure was now being scrutinized. One sitting in the room wrote this story.

I am a Minoxidil failure.

My involvement began in 1983. In the spring of that year, Upjohn had begun funding a year-long research project at 27 medical centers across the country. At issue was the safety and effectiveness of Minoxidil, a drug found in an oral blood-pressure medicine being marketed under the trade name Loniten.

Loniten was found to have several side effects: on the bad side, edema, reduced blood pressure and anemia; on the good, regenerative hair growth in the temple area. Upjohn hoped to refine the hair-growing and eliminate the negative side effects by administering the medication topically rather than orally.

I got invited to be one of the 100 people selected by the Washington Hospital Center out of the 5,000 or more volunteers in the Minoxidil test. When a lab assistant called to invite me, I laughed and declined. When my wife heard about the opportunity, she didn’t laugh, so I decided to try it.

Beginning in July 1983, 100 of us began reporting each month to the Washington Hospital Center, as did almost 2,000 others to 26 locations nationwide. There wasn’t a lot of chitchat in the waiting room during those visits, but we all knew why we were there. We glanced at each others’ heads while awaiting our turn for a checkup and a new supply.

Every morning and every night I carefully squeezed a few drops of a solution from a brown bottle and vigorously rubbed it on my head. It was a month before I could do this without shaking. I was so full of hope for hair and so afraid of wasting a drop. I had to weigh myself every morning and record fluctuations.

Once a month I reported for inspection. My ankles were measured for swelling; my blood pressure, heart rate and chest were checked. Then I was ushered into the hair counting room. A lab technician would draw a one-inch-diameter circle at the back of my head and count the hairs within the circle, using an old-fashioned adding machine. It was a tedious process. The technician had to classify the hairs as terminal (long, colored and luxurious), vellus (unpigmented peach fuzz), or indeterminate. There was a changing array of technicians, as this was exacting but not rewarding work.

Always Pessimistic

Finally I would be asked if I thought I had grown any hair that month. I was always dubious about such self-diagnosis and I was always pessimistic. It didn’t seem as if much was happening, although occasionally the hair counter would announce that I seemed to be experiencing a little action on top.

For the first four months, I experienced a nagging feeling: What if I was being given a placebo? One-third of all patients were being given a solution that was 2% Minoxidil, one-third a 3% solution, and one-third a solution with no Minoxidil.

We were assured that after four months, the placebo group would be switched to the 3% Minoxidil group. Placebo-testing may be a necessary fact of research, but it is frustrating for those to whom time is of the essence.

The experiment lasted a year, and the people who knew I was a participant became increasingly curious about the top of my head. My wife exclaimed once that there was new stubble around my bald spot, but it was a false alarm--merely the residue from clippings taken by the hair counter. Co-workers said my hair looked fuller and neater; the solution acted as a form of hair spray. The technicians hinted of great progress in others, though my waiting-room companions looked no bushier than before.

Upjohn had promised that after the end of the test period and before Minoxidil was approved by the FDA, patients would continue to receive the medication at no charge. However, in the summer of 1984, the 75 or so patients who were still participating in the program faced a dilemma, partly economic and partly psychological. Funding for the physical examinations ended after one year, and in order to continue receiving the medication free, patients had to begin paying about $600 a year for medical services.

What price vanity? Free hair tonic is one thing, and being the focus of so much attention was kind of fun, but paying good money to continue using a product with no demonstrable result would have turned a lark into an obsession. I quit the program. Fifty patients elected to continue, and 22 of those are still receiving the treatment.

Then more of my hair fell out.

That, at least, is the contention of my wife, and to the naked eye there does seem more shine these days. We had been warned that continued use of Minoxidil was necessary to preserve any results; on the other hand, I am older, and regression is a function of age.

Upjohn hasn’t shared my pessimism. Its official summation of the results was enthusiastic. Looking at our charts, photographs and patient and physician evaluations, Upjohn issued a report in the spring of 1986 saying: “Patients in the 2% and 3% Minoxidil groups continued to exhibit highly significant increases in the non-vellus, terminal and total hair counts.”

Upjohn’s stock went crazy but calmed down when the FDA rapped the company’s knuckles for that report, claiming it exaggerated the effectiveness of the medication.

That’s what the panel felt on that cold Monday last March. At the end of the slide presentation and penetrating questions by the panel members, a vote was taken. A non-binding recommendation for approval was given, but it was arrived at reluctantly. Although no one believed the medication would hurt anyone, no one believed that the cure for baldness had been found.

Despite Upjohn’s assertions that 40% of the patients had experienced moderate or dense hair growth, an analysis of the figures revealed that perhaps one in seven might truly benefit from the medication, which is expensive and requires nonstop use.

To grow new hair, it helps to be young and newly balding. Of those patients for whom Upjohn claimed success, 54% were under 30, 55% had been balding for less than five years and 54% had a bald spot of less than five centimeters.

Some more bad news: Minoxidil won’t help receding hairlines. The drug is effective only on the “monk’s cap” area--the vertex of the scalp.

Upjohn originally intended the trade name of its product to be Regaine, the name under which it is marketed abroad. But the FDA didn’t like that name, rather glitzy and redolent of promises, so Upjohn now plans to sell its product as Rogaine.

If the news about Minoxidil is, for most of us, discouraging in the short run, in the long run there is some cause for optimism.

American Cyanamid, a large pharmaceutical firm, is testing Viprostol at several locations nationwide, including the Washington Hospital Center. Similar to Minoxidil, Viprostol is a vasodilator, expanding blood vessels and facilitating blood flow. Developed in the mid-1970s for hypertension, it was never marketed. Now, working on the same hypothesis as that of Upjohn--that increased blood supply to the scalp aids hair growth--American Cyanamid has geared up for the costly and time-consuming FDA-approved human testing. Preliminary results are expected shortly.

A third big pharmaceutical company has jumped on the bandwagon and is quietly studying the hair-growing properties of Diazoxide, a diuretic used to treat hypertension.

And a smaller Los Angeles company, Chantal Pharmaceutical Corporation, obtained permission from the FDA to begin human testing on Cyoctol in December, 1986. This drug is supposed to block the androgenic hormones that are thought to cause male-pattern baldness.

Steroidal hormone-blockers are in use in Europe but produce feminizing side effects, such as breast growth and loss of facial hair. Cyoctol, a synthetic non-steroidal drug also being tested for the treatment of acne, has shown no such side effects.

Research Going On

Testing for prevention of male-pattern baldness is going on in Los Angeles and Japan. Meanwhile, industry analysts estimate that by 1989, when Cyoctol may hit the U.S. market, Rogaine could be earning $500 million a year.

Piggybacking on the publicity of the pharmaceutical companies, a number of cosmetic companies are putting out products that hint of similar effects. Although marketed under different names, each of the products is based on a natural sugar compound, mucopolysaccharide.

An example is Aramis’ Nutriplexx, touted as a “Thinning Hair Supplement.” Although the fine print admits that it does not cure or prevent baldness, its wonder are proclaimed: “At last there is something you can do about your thinning hair. Something more constructive than watching helplessly day by day as your hair becomes even thinner, sparser, less vital.”

Nutriplexx supposedly “penetrates” the hair to make it look fuller. It, and such other products as Foltene and Flowlin, differentiate themselves from conditioners that merely coat the hair. The packaging often simulates that of prescription drugs.

Are they effective? Cosmetically, they may do some good, though claims that they enlarge the follicle and thus allow each hair shaft to become fatter are dubious. The products are marketed as “hair restorers” in foreign countries without the stringent requirements imposed by our government, but as “hair treatments” in this country. As such, they have so far avoided the FDA approval process.

With or without the use of Nutriplexx, Foltene or Flowlin, the balding process will go on; years of rubbing these products into your hair--at more than $250 a year in some cases--will not stem the tide.

Cosmetic companies and pharmaceutical firms still are pouring out vast amounts of money to tap into baldness remedies, which one analyst predicts will be a multibillion-dollar market within a few years. Full-page color ads in USA Today regularly appear for Foltene. Upjohn has constructed a new factory in Belgium and a $26 million addition to a Michigan plant to start making Rogaine this summer or fall.

Hope, if not hair, springs eternal.