http://www.latimes.com/news/nation/reports/fda/lat_redux001220.htm
Wednesday, December 20, 2000 |
REDUX:
Unheeded Warnings on Lethal Diet Pill
Heart damage causes billions of dollars in potential legal liability.
By DAVID WILLMAN, Times Staff Writer
Dr. Leo Lutwak was the lead FDA medical officer reviewing the diet
drug Redux, which in one pill approximated half of the slimming
cocktail known as fen-phen. He said he resisted its approval.
BRIAN WALSKI / Los Angeles Times
Before coming to the FDA as a medical officer in 1989, Dr. Leo
Lutwak had specialized in the fields of obesity and osteoporosis as a
Cornell University professor, as a drug company consultant and as a
practicing physician. He said he hired on at the FDA because he
relished the scientific challenge of new drugs and the call of public
service.
In 1995, Lutwak was the lead FDA medical officer reviewing the
diet drug Redux, which in one pill approximated half of the
now-infamous slimming cocktail known as fen-phen.
Both Lutwak and his boss, Dr. Solomon Sobel, told The Times that
they resisted the approval of Redux.
"I, as the primary reviewer, felt that the drug had low
effectiveness and very high risk for neurotoxicity and pulmonary
hypertension," a disorder that damages the respiratory system, Lutwak
said.
"I was insisting on a black box," he added, referring to the
bold border at the top of a prescription label that alerts doctors
and patients to severe life-threatening risk. "But the management
accepted the company's arguments against the black box. And I don't
know why."
Sobel, director of the FDA's endocrine and metabolic drugs
division throughout the 1990s and who remains at the agency, was
concerned that Redux did not work. He said he refused to sign the
agency's formal letter of approval.
"Well let me tell you," Sobel said. "I was supposed to sign off
on that letter. . . . I told [an FDA administrator, Dr. James]
Bilstad that I would not sign on it. If he wanted to approve it, he
should sign on it. And the record shows, he's the one who signed on
it."
How Redux came to be approved in April 1996 remains a curiosity.
After an FDA advisory committee voted, 5 to 3, that evidence of
Redux's safety was "not sufficient to warrant approval," Bilstad took
the unusual step of scheduling a second meeting, just two months
later. At that meeting, in November 1995, the committee voted, 6 to
5, to recommend approval.
Lutwak said he was "shocked" by the scheduling of the second meeting.
Much was riding on Redux. Analysts at one securities firm,
Rodman & Renshaw, estimated the drug would gross $1.8 billion within
four years.
But Redux was withdrawn on Sept. 15, 1997, after heart valve
damage was detected in patients put on the drug. Civil lawsuits that
are now pending also allege that Redux caused the potentially fatal
respiratory disorder that had worried Lutwak.
American Home Products Corp., which marketed Redux and Pondimin,
a diet pill that was used widely in formulations of fen-phen, agreed
last fall to pay or set aside $4.75 billion to settle lawsuits
related to the drugs' potential to cause heart valve damage. The
company more recently has set aside up to an additional $4.75 billion
to pay other patients who have suffered from the respiratory
condition or heart valve damage.
"We are aggressively settling as many cases as we can," said
Douglas Petkus, a spokesman for Wyeth-Ayerst Laboratories Inc., a
subsidiary of American Home.
In its one year on the market, Redux generated sales of $255.3
million. The FDA received reports before and after the withdrawal
that cited Redux as a suspect in 123 deaths.
Bilstad, who left the FDA in January, declined to be interviewed
this fall when reached at his home.
In a written statement, Woodcock acknowledged that "the
possibility of including a black box warning" on Redux's label was
discussed with Wyeth-Ayerst. But, she said, FDA officials decided "it
was not warranted." She said that the drug's potential respiratory
risk was noted within the labeling in bold type. Before Redux went on
the market, Woodcock said, "there was no hint" that it would cause
heart valve damage.
Lutwak, now 72, said he regrets the approval of Redux--and the
agency's failure to insist on a black box warning.
"It might have saved lives," he said.
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