Cephalon Drug Is Tied to Several Deaths
Off-Label Marketing
Of Cancer Painkiller
Is Focus of Three Probes
From www.wsj.com
By John Carreyrou and Jacob Goldstein, Wall Street Journal
September 14, 2007
Drug maker Cephalon Inc. sent letters to doctors this week warning them
that several deaths have been linked to Fentora, its powerful narcotic to
treat acute cancer pain.
- Fentora and its predecessor, Actiq, are approved
by the Food and Drug Administration only for use in cancer patients, but
they are often prescribed by physicians "off-label" for
such ailments as headaches and back pain.
- The Event: Cephalon alerts doctors to several
deaths linked to Fentora, its powerful painkiller for cancer patients
that is often prescribed "off-label" for
such ailments as headaches and back pain.
- The Background: The company denies marketing Fentora and its predecessor
Actiq for other than its approved use, but its practices are under scrutiny
in three separate probes.
- On the Horizon: The news could give impetus to settlement talks
with authorities that could lead to a large fine and remedial measures.
Cephalon denies marketing the two drugs outside their indication, but its
marketing practices are under scrutiny in three separate probes: investigations
by the U.S. attorney in Philadelphia and the Connecticut attorney general,
and a congressional probe into off-label treatments.
Fentora and Actiq contain fentanyl, a highly addictive substance 80 times
as potent as morphine. Fentanyl is classified as a Schedule II substance
by the Drug Enforcement Administration, which puts it in the same category
as cocaine and methamphetamine. Schedule II drugs have the highest potential
for abuse and an associated risk of fatal overdose.
Cephalon said Fentora has been linked to a total of four deaths. The company
said three of those, which appeared to result from respiratory failure, were
related to inappropriate prescribing of Fentora. Two of the patients were
prescribed the potent drug for headaches even though they weren't on round-the-clock
opiate therapy, the company said. The company said it also received a report
of a fourth death, a person who committed suicide while taking the drug but
wasn't prescribed the drug by a doctor.
Doctors are allowed to prescribe drugs as they see fit, including for off-label
uses. But off-label marketing by drug companies is illegal.
"We have been monitoring this issue," said FDA spokeswoman Susan
Cruzan. "The FDA takes this very seriously, and we are working with
the company to assure the safest possible use of this medication." The
agency didn't address who might be at fault in the deaths.
In 4 p.m. Nasdaq Stock Market composite trading, Cephalon shares fell $3.99,
or 5.2%, to $72.55 on the news.
[Cephalon]
The company said 78,000 prescriptions were written for Fentora between its
launch in October 2006 and September 2007. Fentora is a faster-acting and
more discrete version of Actiq, which is a lozenge on a stick that looks
like a lollipop. Actiq has been associated with more than 120 deaths, including
two involving children who confused the drug for candy. Doctors attributed
some of the deaths to patients' cancer. More than two-thirds of the deaths
occurred during clinical trials before Actiq hit the market in 1999.
In a page-one article in November, The Wall Street Journal reported that
an analysis of prescription data over a 17-month period showed more than
80% of the patients who used Actiq didn't have cancer.
A spokeswoman for Cephalon, Stacey Beckhardt,
said she didn't know what the proportion of off-label use was for Fentora.
But she added: "We
do know that some of the physicians who were prescribing Actiq are prescribing
Fentora in the same way."
Connecticut Attorney General Richard Blumenthal's investigation, which began
in 2004 and is ongoing, has found that Cephalon promoted Actiq off-label
to neurologists to treat headaches, set unrealistically high sales quotas
for its drug representatives and pushed larger prescriptions at higher doses,
according to people familiar with the probe.
"Today's report by Cephalon tragically confirms concerns raised by
our aggressive investigation into Cephalon's off-label marketing of its drugs," the
Connecticut attorney general's office said in a statement.
A person familiar with the matter said Cephalon
is "in active discussions" about
a possible settlement with the Connecticut attorney general and the U.S.
attorney in Philadelphia, though the talks are at a sensitive stage and might
break down. Any settlement would involve a large fine and require that Cephalon
take remedial measures to reform its aggressive marketing practices, this
person said.
Cephalon declined to comment on the various investigations
but said they were ongoing and it continued to cooperate with each one.
Cephalon's Ms. Beckhardt said the company "promotes its medications consistent with
the labeled indication" and added that it was "taking active steps
to re-emphasize the importance of adhering to the labeling information" for
Fentora.
Write to John Carreyrou at john.carreyrou@wsj.com
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