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The Wall Street Journal Interactive Edition -- September 24, 1997
Review & Outlook
Fen-Ted
What would you call a politician who privately urges the federal
government to ease controls on one controversial drug even as he
publicly blocks the streamlining of all federal drug approvals?
A hypocrite? A room-temperature IQ? A Republican "extremist?"
We'd call him Ted Kennedy, who has single-handedly tried to block reform
of the Food and Drug Administration even though he lobbied the
government in a January 16 letter to ease controls on fenfluramine, the diet drug that has since been withdrawn from the market because of
concern over side effects. The Earl of Hyannis was joined in his letter by other famous New England liberals, Senator John Kerry and
Representatives Barney Frank, James McGovern, Joe Kennedy and Sam
Gejdenson.
Their purpose, in writing to Drug Enforcement Administrator Thomas
Constantine, was to request that the feds "deschedule" fenfluramine,
which is the "fen" in the fen-phen diet drug combo linked to leaky heart valves. The feds monitor controlled substances under five different schedules depending on their capacity for addiction and medical risk. Fenfluramine is a Schedule IV drug, which means it can be issued only with a prescription and can be refilled no more than five times over six months. "Descheduling" would free the drug from many rules and record-keeping. In May, DEA opened a public comment period on descheduling the drug, but had made no decision by the time it was withdrawn.
Sen. Kennedy didn't respond to our queries about the letter. But our
guess is that it had something to do with a small biotechnology company called Interneuron Pharmaceuticals Inc., based in Lexington, Mass. Interneuron developed Redux, a diet drug chemically similar to
fenfluramine. We called Interneuron for comment but didn't hear back.
Now, we aren't about to join a public lynch mob over fen-phen or any
other drug caught in the media-trial lawyer vortex. That's the game
Senator Kennedy and his pals at the Naderite lobby, Public Citizen,
play. As Henry Miller wrote on this page yesterday, the FDA had choices short of the huge disruption of withdrawal to cope with the reported fen-phen side effects.
Our concern has long been that pols and "public-interest" know-nothings use tragic anecdotes to frighten both the public and the bureaucrats at FDA to slow down approvals for all drugs and medical devices. Thepeople who pay for this are patients with urgent, often life-threatening needs.
Which is precisely why FDA reform has been debated in Congress for
nearly 20 years. The latest version now moving through the Senate is a
watered-down bill favored by everybody but the Naderites. One of its
better provisions would allow more terminally ill patients to have
access to experimental drugs not yet approved by the FDA. We'd prefer
something far more deregulatory so some future bureaucratic kingpin like
David Kessler can't keep drugs away from whichever patients come after
AIDS. But it's the best we're going to get with this timid Congress.
The bill passed the Senate Labor and Human Resources Committee in June
by 14-4, with even liberals Paul Wellstone and Barbara Mikulski in
support. Yet Mr. Kennedy has used excuse after excuse to delay Senate
passage, hoping to run out the clock this year. His colleagues have had to roll over three of his filibusters so far, all by huge majorities, the most recent just yesterday. When his eminence held forth with his latest phony concern, even his old friend, Chris Dodd, stood up to say he was wrong.
Mr. Kennedy is happy to lobby regulators on behalf of a diet drug made
by a constituent. But he'll lay his substantial figure across the tracks to prevent other drugs from getting to patients more quickly. If Jesse Helms were doing this, imagine what the press corps would write. |
