Series: The Killer Cure (10 Of 11)

METHADONE: STRENGTHEN THE FDA

GIVEN the dangers of the drug methadone recently outlined in the
Gazette, you would think that the U.S. Food and Drug Administration
-- charged with protecting the public health -- could at least
require more specific and cautionary labeling on the packages.

Not so. While FDA officials say they're working on it, Congress
requires the FDA to cooperate with drug companies in deciding how
drugs should be labeled. Drug company lawyers can veto any warnings
they don't like. The unwary public is just out of luck.

At the same time, Congress has refused FDA requests for funding and
authority to do its job. Larry Sasich, a Pennsylvania pharmacist and
consultant for the consumer group Public Citizen, told reporters
Scott Finn and Tara Tuckwiller that most of FDA's money is spent on
approving new drugs. The budget for keeping an eye on existing drugs
hasn't changed in a decade. - advertisement -

Perhaps that's why the number of methadone deaths shot up in recent
years, and no one at the federal level has done anything about it.
This happened despite the fact that methadone is an old drug --
created by the Germans during World War II -- and that its deadly
potential is well-documented.

This is just the latest example of a vital government agency that has
been crippled by budget cuts and neglect. Remember the Federal
Emergency Management Agency, then the U.S. Mine Safety and Health
Administration. When such protective agencies fail to do their job, people die.

Methadone had been used mostly to help recovering heroin addicts
control their cravings. In recent years, doctors have prescribed it
more often for pain. Insurance companies like it because it is cheap.

As Finn and Tuckwiller found, methadone contributed to the deaths of
2,992 Americans in 2003, up from 790 in 1999. Sometimes it was taken
improperly or furtively, but not always. West Virginia's methadone
death rate was four times the national rate. A Utah study showed that
42 percent of overdose victims had valid prescriptions for the drug.
This is not just a problem of criminals and addicts.

Senate Finance Chairman Chuck Grassley, R-Iowa, convened hearings in
2004 after the FDA was slow to react to deaths blamed on the
painkiller Vioxx. More than a year ago, Grassley and Sen. Christopher
Dodd, D-Conn., introduced a bill that would give the FDA more
independence and power. Sen. Jay Rockefeller plans to join as a
co-sponsor. That's a good start. But laws take time. That bill has
been stalled in the Senate Committee on Health, Education, Labor and
Pensions, a committee chaired by Republican Sen. Michael Enzi of Wyoming.

Not waiting for Congress, the FDA or drug manufacturers, the state
Board of Pharmacy and the West Virginia Medical Association are
responding to news of the mounting death toll.

In response to Gazette reports, the pharmacy board will provide
information to druggists to help them explain to patients the need
for caution when taking methadone. The medical association will
educate doctors about the drug's risks and will publish an article on
the drug in its medical journal.

We applaud their prompt attention, and urge Congress to give
Americans a tough and meaningful FDA, quickly.