Senate bill would promote unapproved drugs

WASHINGTON (AP) The Senate is about to consider letting drug sales
people promote uses for medicines that the government has not approved
and critics are using a scare over unapproved diet drugs to argue the bill is
dangerous.

The legislation comes as the Food and Drug Administration investigates 16
more people whose heart valves may have been damaged by the diet drug
combination fen/phen.

Although doctors haven't proved fen/phen is to blame, the new patients bring
to 49 the total cases of heart damage linked to the diet drugs. Ten patients
needed openheart surgery. The FDA has never approved taking both diet
drugs fenfluramine and phentermine together.

While drug companies may not advertise unapproved uses of drugs, doctors
may legally prescribe medicines in any way they choose; and an estimated 6
million Americans tried fen/phen last year before doctors spotted the possible
heart side effect.

But Sen. Connie Mack, RFla., says doctors can't always keep up with the latest
information on new uses for old drugs so he is preparing legislation to let
drug sales representatives give doctors studies that promote socalled offlabel
uses of medicines.

A drug goes on sale only after the FDA determines it is safe and effective
against a particular disease. But doctors then can prescribe that drug for any
disease, and some 40 percent to 60 percent of all prescriptions are for these
offlabel uses.

Doctors ``should have the ability to receive credible scientific information
from reputable sources in order to make informed treatment decisions,'' Mack
wrote senators last week.

But FDA allies say fen/phen shows offlabel drug promotion is dangerous,
arguing that more Americans would be at risk for the heart damage had drug
companies spurred even wider sales.

``Fen/phen is a prime example of the potential danger from offlabel drug
use,'' said Jim Manley, spokesman for Sen. Edward Kennedy, DMass., who is
leading opposition to Mack's bill. ``Problems like this would only be amplified
by passage of this amendment.''

The bill ``can most accurately be described as the killer fen/phen
amendment,'' Dr. Sidney Wolfe of the consumer advocacy group Public
Citizen wrote senators.

Doctors learn about new uses for old drugs from medical meetings or scientific
journals. Some new uses prove lifesaving drugmakers, for example, knew
aspirin could help prevent heart attacks before the FDA did while others
have killed. But the idea was that doctors are supposed to keep up with the
latest science, not be swayed by a drug representatives.

Mack's bill, to be introduced later this week, is considered the most disputed
element of a plan to revamp the FDA. It would let sales people hand doctors
copies of studies from what are considered the best medical journals.

The companies would have to disclose whether they paid for the study, and
provide a list of all related research so doctors could look up further
information.

The FDA cites concerns:

Timepressed doctors are unlikely to read further studies to ensure the
company didn't push only positive research. However, the bill would give the
FDA 30 days to decide whether to force a company to balance its promotion
with a full copy of a negative study about that drug.

A study on, say, 20 patients might be published in a top journal, but be too
small to catch side effects or prove how well the drug works in largescale use.

The bill would remove a company's incentive to do the more thorough
research FDA demands for approval of the new use.

That worry is especially acute for children's drugs, says the American
Academy of Pediatrics, which opposes letting companies offer offlabel
information that encourages using an adult drug on children. Only 20 percent
of today's drugs have been adequately tested for a child's use, the academy said.

But Mack does have the backing of the influential American Medical
Association, which declared the bill a ``significant step forward in the free flow
of information to benefit patients.''