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.
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.