VA Psychiatrist Concerned About New
Super-Painkiller's
Availability
By Sid Perkins
Stars and Stripes Medical Correspondent
A Food and Drug Administration advisory panel last month recommended
approval of a new product to treat pain associated with cancer, but not
without considerable debate and expressions of concern from a VA
psychiatrist during the hearings.
The controversy is not about the drug itself, but the means of
administering it: a lozenge on a handle that some critics fear a child
could mistake for a lollipop.
The product, named "Actiq," contains the powerful narcotic fentanyl
citrate, which is a painkiller about 100 times stronger than morphine.
With FDA approval, Actiq would be manufactured by Anesta Corp. of Salt
Lake City. Company officials say the product is designed to treat a
cancer patient's "breakthrough" pain - sudden, severe spasms of pain that
break through the medications a patient is already receiving to control
chronic pain.
Dr. Laura F. McNicholas, a psychiatrist at the Philadelphia VA Medical
Center and a member of the advisory panel, joined others who expressed
concern about "Actiq" during the panel's hearing. McNicholas said she was
not too worried about the lollipop form of the drug, but was concerned
about making it more widely available.
"There are two populations at risk out there," McNicholas said. "A child,
who doesn't know any better, and a substance-abusing adolescent, who can
get hold of the product either by having a cancer patient in the home or
through illicit prescriptions.
"If this were made available to a person who was not already tolerant of
opiates, someone who was already taking significant amounts of opiates for
pain management, it could be extremely dangerous or even deadly," she
said.
Fentanyl citrate, because of its strength, is rarely prescribed for home
use and is most commonly available through injection in a hospital,
although it is also available in a patch form. In addition to its
painkilling effect, the drug also significantly affects breathing. As the
dosage increases, breathing slows and becomes more shallow; at large
doses, breathing may stop. Other side effects include a slowing of the
heartbeat and contraction of the pupils.
Anesta Corp.'s Dr. Steven A. Shoemaker, a specialist in internal
medicine and pulmonary critical care, said the company has taken a number
of steps to minimize the risks. The lozenge is an off-white color,
designed to be unattractive to children, and the manufacturer has designed
a foil pouch that it claims can't be opened by children under the age of
four. Shoemaker said the company has also put together a patient
education program which includes detailed precautions and an instructional
videotape.
"This product is all about giving the cancer patient good pain management
at home," Shoemaker said. "It offers the potential to improve the
patient's quality of life, which is especially important when the
remaining quantity of life may be limited."
Shoemaker also said Actiq provides the benefit of quick pain relief
without the inconvenience or additional pain of needles. He said that
blind studies conducted by the company showed that 50 percent of patients
reported significant pain relief within five minutes, and 80 percent
reported significant relief within 10 minutes.
Although the advisory panel voted unanimously to recommend approval of
Actiq, McNicholas said a number of the panelists would like to see more
effort from the company to minimize the risks involved.
Anesta filed its application with the FDA for Actiq in November 1996.
Shoemaker said he hopes the product will be approved by the end of this
year.
This article appeared on page 10
of the Oct. 6,
1997, edition of The Stars and Stripes.
Copyright 1997 by The National Tribune Corporation.
All rights reserved.