FDA PANEL BACKS UPJOHN <UPJ> BALDNESS DRUG
The federal Food and Drug
Administration's Dermatologic Drugs Advisory Committee voted
unanimously that Upjohn Co's Rogaine baldness drug was safe and
effective.
    The panel recommended that the FDA approve Rogaine for
marketing in the United States, so long as accompanying
packaging and promotional materials disclose that the product
has only limited effect on male pattern baldness.
    The five outside experts attending today's FDA committee
meeting seemed less concerned about Rogaine's safety after an
outside consultant told them the drug "appears to be quite safe
in the normal male population."
    The consultant, Ohio State University Professor of Medicine
Carl Leier, said Rogaine's side effects were minimal, based on
a study of 10,000 individuals who have been getting the drug in
Canada, where it was approved for marketing last year.
    "The Canadian record is quite a good one in terms of side
effects," Leier said.
    The experts urged the FDA to require a warning in the
drug's packaging that patients be monitored for heart effects
while taking the drug, such as irregular heart beats, changes
in heart rate, palpitations and fluid retention in the body.
    Rogaine, whose chemical name is minoxidil, has already been
approved by the FDA when taken orally as a high blood pressure
drug.
    But Upjohn is now seeking agency approval of it as a male
baldness treatment when put directly on the skin in liquid
form.
    Upjohn has previously claimed that, when applied to the
scalp, too little of Rogaine was absorbed into the bloodstream
to affect the heart.
    But panel members concluded that the amount absorbed
merited physician monitoring of patients taking the drug.
    Under questioning by panel members, Upjohn official Richard
De Villez acknowledged the drug in clinical trials produced
moderate hair growth on the crown of the head in only about 40
pct after 12 months.
    He also acknowledged discontinuing treatment would make the
new hair fall out.
    "The Upjohn problem is that they have a tremendous placebo
effect," panel member Paul Bergstresser of the University of
Texas told the meeting.
    He said patients administered a placebo during clinical
trials typically had about half as much new hair growth as did
individuals treated with Rogaine.
    As a result, it may take patients eight-12 months before
they can tell whether thay are benefiting from the drug, he
said.
    In Canada, a year's treatment costs about 550-640 dlrs
(U.S.).
    An Upjohn official said no price would be set for the drug
in the U.S. market until it was approved for sale.
    During trials, the drug was found to have a bizarre side
effect on some individuals: It caused a state of sexual
dysfunction known as "exagerrated erection."
    Stewart Ehrreich, a former FDA official who conducted a
safety review of Rogaine before leaving the agency, said
researchers had found a number of cases of patients who had
exagerrated erections as a result of the drug.
    He said this was a common effect for drugs of the same
class as Rogaine, called vaso-dilators.
    FDA officials said they could make no prediction on when
Rogaine might be approved for marketing.
    Following the vote, panel member Dr. Robert Stern, a Boston
dermatologist, said Upjohn statistics had exaggerated the
effect of the drug.
    He said "about one in five will have a substantial clinical
effect," which he defined as a significant growth of new hair
that made the patient actually look better.
    He urged insurance companies not to cover the cost of
Rogaine treatment in order to preserve scarce medical fund
resources.
    "I would hope that insurance companies will take a strong
line that this is not a product we will reimburse for," Stern
told reporters.
    "I think this is a drug that has some application for some
people, and I think some people will find it worth the expense,"
he said.
    But he said individuals should be required to pay for the
treatment out of their personal funds.
    Stern estimated more than 100,000 American men are already
using minoxidil on their scalps, outside the law, by grinding
up the blood pressure pill and dissolving in a solvent.
 Reuter
