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.
