WASHINGTON-A powerful
illegal opioid is causing
tens of thousands of deaths,
but a standoff between government
researchers and federal
law enforcement is keeping
scientists from finding a
way to stop it from killing.
Overdoses from synthetic
opioids called fentanyl have
surged more than 500 percent
since 2013, killing roughly
20,000 people in the U.S.
in 2016 and outpacing deaths
from heroin. Worryingly,
people who overdose on
such designer drugs, known
collectively as China White,
have been said to be less
responsive to antidotes
now widely carried by first
responders.
Researchers at the National
Institutes of Health want
to understand why current
dosages of the antidotes are
failing in some cases, yet the
nationwide law enforcement
crackdown on opioid abuse
means they're having a hard
time getting permission to
get samples of the illegal
products they need to study.
It's unclear how long NIH
will have to wait for the Drug
Enforcement Administration
to sign off.
"A study that I would
have been able to start two
months ago is now on hold,"
Nora Volkow, director of the
National Institute on Drug
Abuse, said in an interview.
"We are a lab in the middle of
NIH, we will do everything
very, very properly. There's
nothing like being in the middle
of it to realize how hard
these complications are."
The clash is the latest
instance of competing policy
aims and political prerogatives
leading to a stalemate
on studying a pressing public
health issue. Like with fentanyl,
marijuana studies have
been stymied by enforcement
rules. And until recently
deaths linked to gun violence
had been a taboo for
two decades. It took the outrage
following the latest mass
shooting in a Parkland, Fla.,
school to force lawmakers to
clarify that certain research
is allowed.
A spokesman for the DEA
didn't respond to a request
for comment.
"We owe it to the public
to be able to have facts with
respect to these chemicals,"
Volkow said.
Anecdotal reports suggest
that some illegal fentanyl is
so strong-as much as 50 to
100 times more potent than
morphine-that currently
available dosages of the overdose
antidote naloxone aren't
able to revive some victims.
Georgia law enforcement
officials noted in June that
other states had warned
that naloxone might not
work in users who'd ingested
a designer drug called
acrylfentanyl. Naloxone can
be injected and also comes in
a nasal spray called Narcan.
Makers are constantly
tweaking illegal fentanyl
to avoid the DEA's classification
system, which limits
access to certain compounds
based on their medical use
and potential to be abused.
The agency classified a version
of fentanyl called furanyl
fentanyl as a Schedule
1 narcotic, its highest level
of restriction, in November
2016, and in February the
agency added any compound
chemically similar to fentanyl
to Schedule 1 for at least two
years.
Most illegal fentanyl is
made in China and mailed to
the U.S. or smuggled over the
Mexican border. Variations
have popped up in different
areas, making it hard for
researchers and law enforcement
to track.
Big metropolitan areas
recorded the biggest yearover-
year increase in deaths
involving prescription and
synthetic opioids and heroin
in 2016, according to the
Centers for Disease Control
and Prevention. In many,
overdoses are being pushed
up by fentanyl-laced heroin.
Tanya Royster, director of
the Department of Behavioral
Health in Washington, D.C.,
said even longtime heroin
users are succumbing to
overdoses of tainted drugs.
"You purchase this thing
you may not know is laced,
your dealer may not know it's
laced, and you use it like you
have, and then you die," said
Royster.
Concerns that illegal fentanyl
may be too powerful to
be counteracted by naloxone
aren't new. At an FDA advisory
panel meeting in October
2016 to discuss appropriate
naloxone dosing, Seamus
Mulligan, chief executive of
Adapt Pharma Inc., said that
"lower doses of naloxone
may deliver too little naloxone,
too late." In one case
discussed at the meeting, a
patient required 14 doses to
be revived. Adapt sells the
Narcan nasal spray.
Jason Shandell, president of
Amphastar Pharmaceuticals
Inc., which also makes naloxone,
attended the FDA
meeting. He said in an email
that the drugmaker is "taking
the issue into account as we
work on optimizing the volume
and concentration" of
its naloxone spray in development.
The NIH's Volkow wants
to explore how illegal fentanyl
works on the brain's opioid
receptors and whether it
depresses respiration longer
that typical opioids such as
OxyContin. She said the drug
could be strong enough to
stop a person from breathing
even after they've received a
dose of naloxone, by effectively
outlasting the antidote.
But Volkow said that under
current rules gaining access
to illegal fentanyl in a timely
way is extremely difficult.
The DEA tightened its
restrictions right around the
same time that NIH researchers
determined that more
study of the drug's new forms
were needed, Volkow said.
Some U.S. lawmakers
want to end the standoff.
New York Rep. John Katko,
a Republican, has proposed
legislation to create a new
DEA classification to make
it easier for researchers to
access illegal fentanyl. The
bill could be part of a legislative
package the House
Energy and Commerce
Committee plans to put out
for consideration before the
end of May.
Researchers say they welcome
any effort to tame the
bureaucracy. Volkow worried
it could take as long as a year
for NIH to get DEA sign off.
"If they could figure out a
way to streamline, it would
be a lot better," said Kim
Janda, a professor of chemistry
at the Scripps Research
Institute in La Jolla, Calif.,
who leads a team of researchers
developing a vaccine that
would prevent fentanyl overdoses
by keeping the drug
from reaching the brain.
He's been working on the
vaccine a few years and
expects to begin testing
it in monkeys in the next
month. Janda said he remembers
it taking a few months
to get DEA permission for
his research. Scripps has a
DEA license to work with
Schedule 1 drugs, but permissions
were needed for the
specific compounds he wanted
to research, he said.
"It can be very frustrating
for researchers, we want to
do this stuff now," Janda said.