By Valerie Ulene,
Special to the Los Angeles Times

October 10,
2011






It's getting harder for me to deny that I've reached
middle age, and the most obvious sign is that the men in my life are losing
their hair. Many men struggle to come to terms with hair loss and
yearn for a way to turn back the clock. Although I'm no expert on the subject,
I've suggested they look into Propecia, a medication used to treat male pattern
hair loss.

Invariably, they're intrigued. It works by preventing testosterone
from turning into another hormone that causes hair loss. Over five years, the
majority of men who take the drug report that their hair loss slows, their bald
spot gets smaller and the appearance of their hair improves. However, the threat
of drug-related side effects such as impotence,
male breast
cancer and perhaps prostate
cancer has caused many of my friends to seriously reconsider the importance
of a full head of hair.

This scenario is hardly unique to Propecia. Every
medication on the market offers potential benefits and also carries risks.
Deciding whether to take a drug requires a close evaluation of both.
Unfortunately, the information necessary to make that decision isn't always
readily available, particularly when it comes to side effects.

Although
manufacturers are required to inform consumers about side effects, these
disclosures are often made in a way that render them incomprehensible and
largely meaningless. On television commercials, for example, side effects are
usually rattled off in quick succession toward the end of an ad. Potentially
life-threatening problems such as liver failure, blood clots and stroke are
presented alongside comparatively innocuous ones like nausea, dry mouth and
constipation. And the likelihood that any of them will actually occur is
ambiguous.

The U.S. Food
and Drug Administration tries to ensure that pharmaceutical companies
present the pros and cons of their products in a way that's accurate and
balanced, says Thomas Abrams, director of the FDA's Office of Prescription
Drug Promotion.

"We want people to get good information so that they
can make good decisions," Abrams says. "But that's not an easy thing sometimes,
given the complexity and technical nature of prescription drugs."

Drug
companies tend to do a better job with print advertisements — in large part
because the FDA requires it. Print ads must contain a "brief summary" that
includes a list of all possible side effects. When an ad is intended for
consumers (as opposed to physicians), the FDA encourages drug companies to use
language that's easy to understand.

Package inserts serve as the most
complete source of information about medications. These inserts include just
about everything that's known about a drug — from how it works to how to treat
an overdose — and the FDA requires that consumers receive one each time they
fill a prescription.

But just as too little information can leave people
guessing, too much information can be overwhelming. For the average consumer,
package inserts frequently add to the confusion.

Propecia's package
insert is a good example. It describes the results of several clinical trials,
including the fact that 1.2 % of men discontinued taking the drug because of
sexual side effects such as decreased libido and erectile dysfunction. That's an
important piece of information for potential users. But it's also important for
them to read on and see that in those same studies, nearly 1% of the men who
took the placebo
experienced sexual side effects and stopped treatment too.

Statistical
information provided in package inserts isn't only difficult to understand, it's
often frightening. People tend to pay more attention and give more weight to
negative information than they do to positive information. And when it comes to
medications even the tiniest increased risk of cancer is
enough to scare away some potential users.

The FDA is aware of the need
to improve the way drug information is presented to the public and has its
experts on the case. Last month, researchers at the agency published the results
of three studies in the journal Medical Decision Making that tested various ways
of conveying information in print ads. It turned out that the format currently
being used wasn't the most effective. Instead, consumers were better able to
recall information on a drug's risks when it was displayed in a format that
resembles the "Drug Facts" box on over-the-counter medications. What's more,
consumers liked this format better.

"We want people to understand,
comprehend and retain the information they're given," Abrams says.

Hair
loss treatment isn't a matter of life and death. For men who take a pass, the
worst possible outcome is baldness. Things can get complicated — and decisions
more difficult — when more serious medical conditions are being addressed. If
the need for treatment is urgent, a drug's risks may be easy to accept. But if
the benefits of treatment aren't so clear-cut, the need for complete and
accurate information about a drug's risks is even more important.

My
friends have put serious thought into the decision about whether to start taking
Propecia. One of them was extremely concerned about the drug's sexual side
effects but opted to give it a try. Months later, his hair has regrown and his
sex life is intact. Another friend is still struggling with what to do. He's
most worried about the possibility of cancer. For him, a full head of hair just
doesn't seem worth it.

I understand where both are coming from. But I
have to admit, if there were a drug that could make wrinkles disappear, the side
effects would have to be pretty severe to stop me from taking
it.

Ulene is a board-certified specialist in preventive medicine in
Los Angeles. themd@att.net