Agency sat on 'bupe' study (Baltimore Sun)

Officials waited to reveal findings on misuse of drug

By Fred Schulte and Doug Donovan

Sun reporters

The federal agency that oversees buprenorphine treatment for narcotics addicts learned more than two years ago of illegal sales and abuse of the pills but did not reveal the findings as officials campaigned to expand use of the drug.

U.S. Substance Abuse and Mental Health Services Administration records show that in December 2005, Vermont health officials advised the federal agency of some patients crushing and injecting the pills called Suboxone, trading or peddling them on the street - even smuggling them into the state's prisons.

Agency officials hired consultants who confirmed those problems and others. Yet the agency didn't tell Congress or the U.S. Food and Drug Administration, which has the power to order tighter controls over prescription drugs. Agency officials waited until Jan. 28 of this year to disclose the findings, which were posted on the SAMHSA Web site as "new" and a "comprehensive report" of buprenorphine abuse nationwide.

The report, which characterizes abuse of the drug as a "small but persistent problem," is the first by the agency to provide detailed evidence of misuse as well as weaknesses in systems set up by Congress to guard against it.

The lengthy delay in releasing the study drew a stern rebuke from Sen. Bernard Sanders, a Vermont independent who called for an investigation by the Committee on Health, Education, Labor and Pensions.

Sanders, in a letter Thursday to his committee's chairman, Sen. Edward M. Kennedy, asked the panel to "look into concerns about buprenorphine and investigate the failure of the FDA and SAMHSA to collaborate and to share and release reports in a timely manner."

SAMHSA spokeswoman Kay Springer conceded that her agency "took quite a while" to release its findings. The study was "originally developed for internal purposes" and "not intended for public release," and agency officials only recently decided the information "might be beneficial to the public," she wrote in an e-mail exchange.

FDA spokesman Christopher C. Kelly said his agency "will evaluate the new information and determine what, if any, regulatory action is warranted."

An investigation by The Sun in December documented abuse of the drug, including illegal street sales in New England and in Baltimore, where buprenorphine enjoys wide political support. City health commissioner Dr. Joshua M. Sharfstein is a strong proponent and is seeking $5 million from the state legislature to expand use of buprenorphine as a treatment for heroin addicts.

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.

The panel also noted that federal agencies were failing to share data that would help them identify patterns of abuse. Findings from the FDA-mandated "post marketing surveillance" system set up in 2003 by Reckitt Benckiser to detect abuse of the drug, for instance, weren't made available to SAMHSA officials who were supposed to monitor its misuse.

Deaths and injuries related to misuse of buprenorphine were likely to be under-reported, the panel suggested, because medical examiners and emergency rooms weren't routinely testing for the presence of the drug in overdose cases. The experts advised SAMHSA to develop a monitoring system so that "early intervention can be taken to interrupt and minimize any non medical use."

The consultants also uncovered a number of shortcomings in the buprenorphine program run in Vermont, the state with the highest levels of use with the drug. The report found that the state's Medicaid program was being billed for prescriptions for the drug from doctors not authorized to prescribe it. In one case, a gynecologist was listed as prescribing Suboxone to male patients.

Prison inmates were among those misusing the drug, the report said. Jay Simons, superintendent of the Chittenden Regional Correctional Facility in South Burlington, Vt., said buprenorphine is the drug most often smuggled in. "Bupe is consistently a problem," he said.

In an interview yesterday, Simons said public safety officials would have benefited from knowing what the federal government knew of abuse and illegal sales. "It certainly would have given us a heads up," he said.

Sanders said that Congress needs to take action quickly before generic versions of the drug become available.