WHY IT TAKES A VILLAGE TO AFFORD A PRESCRIPTION

IF YOU'VE filled a prescription recently, you may have had a nasty
surprise. Antibiotics or a tube of steroid cream used to cost a few bucks,
but now the prices are soaring. A few examples of the cost of a week's
supply of drugs: the antibiotic clarithromycin, $75; Rocalcitrol, a vitamin
D derivative, $55-385 (depending on the dosage); and erythropoietin, for
anemia, $324-486.

Why? In large part, it's your tax dollars at work. Government regulation
imposes enormous ``taxes'' on drug development, which decrease the number
of drugs that are developed and which are ultimately passed along to
consumers in higher prices.

The feds were at it again recently when the FDA announced that drug
companies will be required to test in children the medicines they sell for
adults, and to put the pediatric dosages on the label. That might sound
benign, or even desirable, but these new requirements ignore the realities
of drug testing. They may actually be detrimental to kids and could
actually delay the availability of new drugs, if FDA withholds approval for
adult uses while data from pediatric studies are being collected.

Moreover, the regulation is a rigid, centralized governmental solution to a
non-problem, according to many pediatricians. Even the FDA concedes that
physicians commonly and safely prescribe pain relievers, asthma drugs,
antihistamines, antibiotics and other therapeutics millions of times
annually for children, despite the clinical trials of those products having
been performed only in adults. ``Pediatricians routinely tailor dosages for
children by adjusting the dosage according to the patient's weight,''
confirms Kaiser Permanente pediatric allergist Dr. Michael H. Mellon.

Even if additional testing of drugs in children were needed, there are more
imaginative and effective ways to accomplish it. For example, the FDA could
simply require a prominent label or logo on drug preparations whose safety
and efficacy have not yet been determined in children, or the agency could
publish a list of such drugs annually. This would make parents and
physicians aware that such information is not available, and they, in turn,
could exert moral and economic pressure on drug companies to obtain it.
(Consider, too, that it is in drug companies' own interest to expand the
population that will purchase and benefit from their products, and to avoid
harming patients.)

The FDA seems unaware of the nuances of drug development. Creating a dosage
form appropriate for children is often especially challenging, for a number
of reasons. Can the active ingredient be incorporated in a chewable or
syrup form? Will it have special storage requirements and adequate
shelf-life? Does it taste good enough so that kids will actually take it?

A pediatric form of Glaxo Wellcome's antibiotic, Ceftin, required more than
double the cost and man-hours to develop than did its adult formulation.
The same company also experienced serious problems in finding effective
preservatives for its pediatric syrup form of Epivir, an AIDS drug, even
after the adult formulation had been fully developed.

Clinical trials are difficult to perform with children. For ethical
reasons, testing is done in patients, not in healthy volunteers. Study
participants may be scarce because a disease is rare in children, because
the population is geographically diverse, or because parents are reluctant
to enroll their sick children in an ``experiment.''

Finally, for the purposes of drug testing, ``children'' is by no means a
homogenous category. The term implies several groups that are
physiologically and metabolically distinct: newborns, infants,
preschoolers, primary-schoolers and teens. Moreover, children may pass
through two or more age groups during the course of a multi-year clinical
study, confounding statistical analysis.

As regulatory requirements are ratcheted ever upward, drugs are moving more
sluggishly through the clinical testing pipeline. The total time required
for drug development, from synthesis of the molecule to the patient's
bedside, has almost doubled during the past three decades, from 8.1 to 15.2
years. And the United States's $500 million dollar tab for each drug
approved is by far the most expensive in the world.

Why does the FDA impose unnecessary regulations, which are expensive, rigid
and inimical to free-market forces -- at a time of supposed ``reinventing
government'' and regulatory reform?

For one thing, it's in the self-interest of bureaucrats to seek greater
mandates and, thereby, to amass larger empires and budgets. And it's in
their nature -- as former FDA Commissioner Frank E. Young once quipped,
``Dogs bark, cows moo, and regulators regulate.''

When regulation is excessive, everyone is a loser -- except government
regulators themselves. Money spent by the government, industry and
consumers on FDA regulation is money not spent on something else, including
the ability to protect public health in other ways -- for example, by
increasing the rate of vaccination or performing diagnostic testing.
Consider, for example, the potential benefits of spending the
(conservatively) estimated $21 million annual cost of FDA's new regulation
instead on cervical cancer screening -- according to public health
statistics, it would save 14,700-31,500 years of life.

The FDA's new regulation is the latest example of Big Brother deciding
where private sector R&D resources are best spent. In the process, it
increases costs to consumers and puts them at risk as the introduction of
new drugs is delayed. This regulation, the first to appear under new FDA
Commissioner Jane Henney, suggests that she will show a greater commitment
to the rhetoric than to the reality of protecting the public health.

Henry I. Miller, a physician, is a fellow at the Hoover Institution. He was
an FDA official from 1979-1994. E-mail: miller@hoover.stanford.edu.

Checked-by: Joel W. Johnson