The orange pills, which are dissolved under the tongue, have been shown to relieve addicts' craving for narcotics and ease the withdrawal sickness that comes on when addicts stop taking them abruptly.
Stabilizing addicts on Suboxone, they say, frees them from the need to seek out street drugs and can greatly assist in their rehabilitation. About 170,000 patients nationwide take the drug and officials expect those numbers to grow substantially in coming years.
While advocates argue that Suboxone's benefits far outweigh any abuse, there's no doubt that abuse is on the rise in parts of the country where the drug is most prescribed. The SAMHSA document is the second in the past month to confirm diversion and abuse by patients who were prescribed the narcotic to take unsupervised. On Jan. 8, Suboxone manufacturer Reckitt Benckiser Pharmaceuticals Inc. reported to the FDA that misuse is growing. That report also noted that overall abuse of Suboxone is far less than for methadone and OxyContin.
The SAMHSA study shows that agency officials knew of emerging diversion problems as they stepped up efforts to persuade more doctors to use the drug to treat addicts. SAMHSA, a division of the Department of Health and Human Services, sets policy for the national buprenorphine initiative. Since Suboxone was first marketed in early 2003, the agency has actively promoted it as a "major breakthrough" for treating people addicted to heroin or prescription pain pills.
In January 2006, a month after receiving abuse reports from Vermont, SAMHSA officials commissioned a study and assembled a panel of experts to investigate. Their report was submitted to the agency Nov. 30, 2006.
Earlier that year, SAMHSA had advised Congress that the buprenorphine program was progressing well with "minimal adverse public health consequences." Congress agreed on Dec. 8, 2006, to expand the treatment, by allowing some doctors to treat up to 100 patients with the addiction drug.
But the panel of experts had identified a number of shortcomings in oversight of the program, including doubts about the amount of training Congress required doctors to undergo before using the drug to treat addicts. The panel suggested that limited training of physicians was partly to blame for misuse of the drug.
