Pubdate: Wed, 13 Jan 2016
Source: New York Times (NY)
Copyright: 2016 The New York Times Company
Contact: http://www.nytimes.com/ref/membercenter/help/lettertoeditor.html
Website: http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Sabrina Tavernise

IMPLANT FOR OPIOID ADDICTS URGED FOR FEDERAL APPROVAL

SILVER SPRING, Md. - A panel of medical experts recommended Tuesday 
that the Food and Drug Administration approve a new way of treating 
opioid addicts, using a slender rod implanted into the arm that 
delivers medicine for months at a time. Some doctors say it could 
help ease the national epidemic of drug overdoses.

The rod is about the size of a small matchstick and delivers daily 
doses of buprenorphine - one of the most common medical treatments 
for opioid addicts - for six-month periods. In controlled doses, 
buprenorphine can help the body withdraw from opioid addiction, but 
can also itself be addictive. That risk is increased by the fact that 
the medicine can be taken only by mouth, requiring patients, often 
ill from addiction, to manage their daily dosages.

The advisory panel voted 12 to 5 to recommend approval. The panel 
concluded that flaws in the evidence the company presented, including 
missing data in a clinical study, were not fatal, and that the 
product was roughly as effective as the oral form of the drug. They 
agreed it would be a useful tool for doctors in the face of a major 
public health epidemic and could help stem the flow of illicit use of 
buprenorphine.

"I think this will save some folks' lives," said Dr. David Pickar, 
adjunct professor of psychiatry at Johns Hopkins Medical School, who 
voted to recommend approval. "From a safety point of view I think 
we're in good shape."

Dr. Thomas Grieger, a staff psychiatrist at the Maryland Department 
of Health and Mental Hygiene, said: "There is not evidence of 
significant risk using this agent, but there is evidence of 
significant benefit."

Prescription drug abuse has become a major public health problem in 
the United States, with overdose deaths more than quadrupling since 
the late 1990s. In recent years, use of heroin, an opioid, has 
exploded, keeping the numbers of deaths from overdoses high. The 
federal health authorities reported recently that the number of 
opioid overdose deaths in 2014 was the highest on record.

The F.D.A. often takes the advice of its advisory panels but does not have to.

The implant is called Probuphine, and it is made by Braeburn 
Pharmaceuticals, based in Princeton, N.J.

Supporters, who spoke at the meeting said the implant would make it 
easier for addicts to manage their addiction and reduce its stigma by 
eliminating the need to take the medicine every day. Recovered 
addicts said the implant would allow them to feel normal again.

"I'm president of my own company again, I'm not a dirty junkie," said 
Scott Jernigan, one of the presenters. "But I need help. With the 
implant it will be one less hurdle for us as addicts to get over."

People who run treatment centers said it could help stem the illegal 
use and sale of buprenorphine, a problem that has come to plague many 
of the areas worst hit by the prescription drug epidemic. Emergency 
department visits involving illicit use of buprenorphine more than 
tripled from 2006 to 2010, according to federal health officials.

Buprenorphine is a partial synthetic opioid and can help wean the 
body off more powerful opioids like heroin and methadone by offering 
a milder version of their euphoric effects, thereby preventing 
patients from having full-blown withdrawal symptoms.

"The problem is people are using buprenorphine to manage their 
addiction, not to recover from it," said Joe R. Gay, executive 
director of Health Recovery Services Inc., a nonprofit treatment 
agency with clinics in six counties in Ohio. "This is a major problem 
in our area, and it has really undermined the credibility of 
buprenorphine treatment, which is actually very effective."

One criticism experts considered was what would happen when the 
patient with the implant needed to adjust the daily dosage, something 
that doctors on the panel said was common, particularly at early 
stages of treatment, when the doses of the medicine tend to be 
higher. That would require giving additional oral supplies, a 
practice that would defeat the purpose of having an implant and could 
reduce the potential to prevent illicit use.

"I would not want to create the expectation that you can just implant 
this and say 'bye-bye,' " said Dr. Melinda Campopiano, a medical 
officer at the federal Substance Abuse and Mental Health Services 
Administration.

Others worried that the implant would discourage patients from 
returning for other important parts of treatment, like counseling, 
that they say are needed to keep the patient on track.

"The fear is that patients simply will not get the essential part of 
treatment beyond just the medication," said Dr. Carl Sullivan III, 
director of the addictions program at West Virginia University, who 
was not part of the panel.
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MAP posted-by: Jay Bergstrom