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How a New Policy Led to Seven Deadly Drugs
Los Angeles Times
Wednesday, December 20, 2000
How a New Policy Led to Seven Deadly Drugs
Medicine: Once a wary watchdog, the Food and Drug Administration set
out to become a partner of the pharmaceutical industry. Today, the
public has more remedies, but some are proving lethal.
By DAVID WILLMAN, Times Staff Writer
WASHINGTON--For most of its history, the United States Food and
Drug Administration approved new prescription medicines at a grudging
pace, paying daily homage to the physician's creed, First, do no
harm.
Then in the early 1990s, the demand for AIDS drugs changed the
political climate. Congress told the FDA to work closely with
pharmaceutical firms in getting new medicines to market more swiftly.
President Clinton urged FDA leaders to trust industry as partners,
not adversaries.
Dr. Janet Woodcock, director of the FDA's drug-review center, says
the agency depends on doctors to take into account the risks, to
read the label. ... That's why drugs are prescription drugs.
BRIAN WALSKI / Los Angeles Times
The FDA achieved its new goals, but now the human cost is becoming clear.
Seven drugs approved since 1993 have been withdrawn after
reports of deaths and severe side effects. A two-year Los Angeles
Times investigation has found that the FDA approved each of those
drugs while disregarding danger signs or blunt warnings from its own
specialists. Then, after receiving reports of significant harm to
patients, the agency was slow to seek withdrawals.
According to adverse-event reports filed with the FDA, the
seven drugs were cited as suspects in 1,002 deaths. Because the
deaths are reported by doctors, hospitals and others on a voluntary
basis, the true number of fatalities could be far higher, according
to epidemiologists.
An adverse-event report does not prove that a drug caused a
death; other factors, such as preexisting disease, could play a role.
But the reports are regarded by public health officials as the most
reliable early warnings of danger.
The FDA's performance was tracked through an examination of
thousands of pages of government documents, other data obtained under
the Freedom of Information Act and interviews with more than 60
present and former agency officials.
The seven drugs were not needed to save lives. One was for
heartburn. Another was a diet pill. A third was a painkiller. All
told, six of the medicines were never proved to offer lifesaving
benefits, and the seventh, an antibiotic, was ultimately judged
unnecessary because other, safer antibiotics were available.
The seven are among hundreds of new drugs approved since 1993, a
period during which the FDA has become known more for its speed than
its caution. In 1988, only 4% of new drugs introduced into the world
market were approved first by the FDA. In 1998, the FDA's
first-in-the-world approvals spiked to 66%.
Video: Willman reacts to receiving the Pulitzer Prize for this report.
Real | Quicktime
The drug companies' batting average in getting new drugs
approved also climbed. By the end of the 1990s, the FDA was approving
more than 80% of the industry's applications for new products,
compared with about 60% at the beginning of the decade.
And the companies have prospered: The seven unsuccessful drugs
alone generated U.S. sales exceeding $5 billion before they were
withdrawn.
Once the world's unrivaled safety leader, the FDA was the last
to withdraw several new drugs in the late 1990s that were banned by
health authorities in Europe.
This track record is totally unacceptable, said Dr. Curt D.
Furberg, a professor of public health sciences at Wake Forest
University. The patients are the ones paying the price. They're the
ones developing all the side effects, fatal and non-fatal. Someone
has to speak up for them.
The FDA's faster and more lenient approach helped supply
pharmacy shelves with scores of new remedies. But it has also yielded
these fatal missteps, according to the documents and interviews:
* Only 10 months ago, FDA administrators dismissed one of its
medical officer's emphatic warnings and approved Lotronex, a drug for
treating irritable bowel syndrome. Lotronex has been linked to five
deaths, the removal of a patient's colon and other bowel surgeries.
It was pulled off the market on Nov. 28.
* The diet pill Redux, approved in April 1996 despite an
advisory committee's vote against it, was withdrawn in September 1997
after heart-valve damage was detected in patients put on the drug.
The FDA later received reports identifying Redux as a suspect in 123
deaths.
* The antibiotic Raxar was approved in November 1997 in the face
of evidence that it may have caused several fatal heart-rhythm
disruptions in clinical studies. FDA officials chose to exclude any
