1 January 2008

Buprenorphine "abuse" reported to be rare, despite reportedly commonplace on some American streets.

Abuse of Buprenorphine in the United States: 2003-2005. Smith MY, Bailey JE, Woody GE, Kleber HD. Journal of Addictive Diseases 2007 26;3:107-111 [Editorial on same subject: Buprenorphine Misuse, Abuse, and Diversion: When Will We Ever Learn’ Stimmel B.]

Dear Colleagues,

This report finds that across 20 states in America over a 2 year period only 77 individual cases of buprenorphine abuse occurred based on toxico-surveillance data.

The paper goes into detail about how much ‘abuse’ was of the combination product (Suboxone) and how much the pure (Subutex) finding about two per 10,000 prescriptions for the former and one per 10,000 prescriptions for the latter. Yet it is hard to take any of this data seriously with such small numbers. From street reports it is clear that buprenorphine ‘abuse’ (at least diversion) is happening wholesale in some American cities and such abuse is unlikely to be detected in a study of this nature.

These authors have overlooked the gravity of their subject by taking a narrow and unrealistic definition of ‘abuse’, finding data which is (1) favourable to the drug manufacturer, (2) well out of line with common knowledge in the field and (3) of limited benefit in assessing the utility of buprenorphine in the community. Two of the authors are experienced addiction authorities and so it is surprising to find such patently inferior science under their names. The first author is a PhD who works for Purdue Pharmaceuticals and I assume that the ‘study‘, such as it was, complies with part of the manufacturer‘s conditions of post-marketing surveillance.

These authors take as their ‘abuse’ yardstick formal toxicity reports to a Poisons Bureau. Yet they know full well that buprenorphine intrinsically has one of the lowest acute toxic profiles of any drug in the pharmaceutical repertoire. Both combination and pure forms of buprenorphine have a wide scope for “abuse” which was not reported here. These would include taking more/less than the prescribed dose, injecting after spitting, combining with other drugs, on-selling, smoking, giving to minors, prison diversions, cross-border trade, etc. Clinical toxicity is extremely rare when buprenorphine is taken alone, even at very high doses. The standard analgesic dose is 0.2mg where doses up to 32mg daily are commonplace. So even 160 times the starting dose may cause no toxicity at all in some subjects.

The term “abuse” in the title may mean different things to different people, but the average person would probably understand it to mean use outside of doctor’s prescription instructions under accepted treatment guidelines. Health workers in detox services, addiction clinics or emergency rooms in the Boston area attest to this drug being used by a large proportion of addicts coming to notice. For unknown reasons, such use still appears to be rare in New York City. Whether these addicts are ‘drug-seeking’ or ‘treatment-seeking’ is not really the point of this investigation. Nor indeed can it determine any positive aspects of such drug consumption. “Thirteen years ago in France buprenorphine was also introduced for unsupervised prescription. Yet the big difference was that under their health system it was freely available to most who needed it, so there was no place for a black market (except at the borders). There were substantial benefits to both drug users and the wider community.

I believe that this finding of only 77 reports of inappropriate use in a large part of the USA must be one of the most irrelevant findings ever published in a peer reviewed journal. It gives no confidence about this drug’s scope for abuse, nor about its expected benefits in the American context. And it is this context which is being touted in other countries for its introduction, despite no substantial evidence of safety and effectiveness when unsupervised from a doctor‘s office.

‘Street’ buprenorphine has been reported as a drug of choice in many places in the past eg. Wellington, New Zealand in 1991 (where both pure and combination products were banned); Perth; Melbourne; Dublin; Finland; France; Vermont, USA. In his related editorial, Stimmel puts the abuse of opiates and casual attitude of some drug companies into historical perspective, although he takes this study more seriously than I did.

Comments by Andrew Byrne .. (whose practice prescribes maintenance buprenorphine successfully to 30 out of 160 dependency patients). http://www.redfernclinic.com/

Stimmel B. Buprenorphine Misuse, Abuse, and Diversion: When Will We Ever Learn. Journal of Addictive Diseases 2007 26;3:

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