PLAN FOR SPEEDIER OK OF NEW DRUGS IN WORKS

Scientists are drafting an ambitious blueprint for evaluating medical
research that could take years off the time it takes to win approval for new
drugs.

While still in its earliest planning stages, the new and sometimes
controversial approach could have profound implications for cardiovascular
disease, rheumatoid arthritis, osteoporosis, multiple sclerosis and certain
cancers, as well as other illnesses.

Dr. Harold Varmus, director of the National Institutes of Health, has
convened a group of scientists to explore the possibilities of this new
direction in research, which he says shows ``real potential.''

Dr. Daniel Hoth, a former AIDS and cancer specialist for the NIH and now a
San Francisco consultant working on the project, agreed that ``this could
transform drug development.''

In recent years, as Americans have been clamoring for faster access to new
medicines, Congress and federal regulators have initiated procedural changes
and bureaucratic streamlining to accelerate drug approval.

Like blood-pressure-lowering medications that ultimately prevent stroke or
drugs that increase a woman's bone density, reducing her risk of later
developing fractures, the new effort identifies early signs of a drug's
eventual effect. Called ``surrogate markers,'' these are harbingers of a
successful treatment or even a cure that scientists and regulatory agencies
can use to predict a health benefit rather than waiting for lengthy studies
to document it.

This surrogate marker approach to drug evaluation differs significantly from
traditional, often years-long clinical trials, which typically involve
studying drugs until their usefulness is proved -- or disproved --
definitively.

The new concept already is producing results. Reducing the level of HIV in
the blood, for example, is a surrogate marker for AIDS.

Only last week, AIDS dropped off the list of the 10 leading killers in the
United States, the result of powerful drugs approved using this new
approach -- drugs that, under traditional trials, might only just now be
coming onto the market.

1998 San Francisco Chronicle Page A7

Checked-by: Don Beck