Heroin: Legalization for Medical Use

This report discusses the limited legalization of diacetylmorphine (heroin) for use in the medical treatment of intractable pain. The report attempts to present pros and cons on the issue as well as information on pending legislation. The report also provides a comparison of heroin's analgesic qualities to those of currently available and equivalent pharmaceutical alternatives.

-d 7 e ,ongressiona I Research Service The Library of Congress HEROIN: LEGALIZATION FOR MEDICAL USE Blanchard Randall I V A n a l y s t i n S o c i a l Sciences S c i e n c e P o l i c y Research D i v i s i o n March 1 4 , 1984 ABSTRACT The l i m i t e d l e g a l i z a t i o n of d i a c e t y l m o r p h i n e ( h e r o i n ) f o r u s e i n t h e m e d i c a l t r e a t m e n t of i n t r a c t a b l e p a i n i s d i s c u s s e d i n a w h i t e paper which a t t e m p t s t o p r e s e n t p r o s and cons on t h e i s s u e a s w e l l a s i n f o r m a t i o n on pending l e g i s l a t i o n . The paper a l s o p r o v i d e s a c a n p a r i s o n of h e r o i n ' s a n a l g e s i c q u a l i t i e s t o t h o s e of c u r r e n t l y a v a i l a b l e and e q u i v a l e n t p h a r m a c e u t i c a l a l t e r n a t i v e s . HEROIN: LEGALIZATION FOR MEDICAL USE Over t h e p a s t few y e a r s a g r e a t d e a l of a t t e n t i o n h a s focused on t h e emot i o n a l l y c h a r g e d i s s u e i n v o l v i n g t h e l e g a l i z a t i o n of h e r o i n f o r medical p u r p o s e s , e s p e c i a l l y f o r t h e t e r m i n a l l y ill s u f f e r i n g from i n t r a c t a b l e p a i n . Heroin, a n o p i a t e d e r i v a t i v e , i s s u b j e c t t o c o n t r o l under Schedule I of t h e C o n t r o l l e d Subs t a n c e s Act ( T i t l e I1 of t h e Comprehensive Drug Abuse P r e v e n t i o n and C o n t r o l Act of 1970). Drugs placed i n t h i s s c h e d u l e meet t h e f o l l o w i n g c r i t e r i a : (1) t h e drug' o r o t h e r s u b s t a n c e has a high p o t e n t i a l f o r a b u s e ; ( 2 ) t h e d r u g o r o t h e r s u b s t a n c e h a s no c u r r e n t l y accepted medical u s e i n t r e a t m e n t i n t h e United S t a t e s ; and ( 3 ) t h e r e i s a l a c k of a c c e p t e d s a f e t y f o r u s e of t h e d r u g o r subs t a n c e under medical s u p e r v i s i o n . (i.e., P r o p o n e n t s of t h e l e g a l i z a t i o n of h e r o i n h a v i n g h e r o i n r e s c h e d u l e d , p r o b a b l y down t o Schedule 1 1 ) most o f t e n a r g u e t h a t , c o n t r a r y t o t h e second s c h e d u l i n g r e q u i r e m e n t of Schedule I ( n o c u r r e n t l y a c c e p t e d m e d i c a l u s e ) , t h e s u b s t a n c e does have a p l a c e of b e n e f i t i n our armamentarium of d r u g s t o r e l i e v e pain. The p r i n c i p a l argument i n f a v o r of t h e use of h e r o i n a s an ana1gesi.c i s t h a t i t i s more p o t e n t and t h e r e f o r e can be a d m i n i s t e r e d i n s m a l l e r d o s e s t h a n most o t h e r n a r c o t i c a n a l g e s i c s , i n c l u d i n g morphine. T h i s may be t r u e f o r e a r l y e f f e c t s i n t h a t h e r o i n p a s s e s t h e blood-brain b a r r i e r more r a p i d l y t h a n d o e s morphine. However, h e r o i n i s then r a p i d l y hydrolyzed t o rmrphine i n t h e body - and a c t s t h e r e a f t e r a s morphine does i n p a i n c o n t r o l . 1/ F u r t h e r r e s e a r c h may 1/ J a f f e , J e r a n e H . , and William R. Martin. I n Goodman and Gilman, The ~har6cblo~icB a la s i s o f T h e r a p e u t i c s [ 6 t h e d . 1. New York, MacMillian, 1980. p., 506-507. uncover s u b j e c t i v e o r h e r e t o f o r e unknown b e n e f i t s t h a t may a l t e r t h i s e x p l a n a t i o n of h e r o i n ' s mechanism of a c t i o n . The f o l l o w i n g arguments have been made a g a i n s t a change i n F e d e r a l l a w t o p e r m i t t h e u s e of h e r o i n t o c o n t r o l p a i n : 1. On a n i n t e r n a t i o n a l l e v e l , t h e U n i t e d S t a t e s i s p a r t y t o t h e 1961 S i n g l e Convention on N a r c o t i c Drugs, which r e s t r i c t s t h e u s e of opium and i t s d e r i v a t i v e s . 2. The U n i t e d S t a t e s i s a l s o p a r t y t o a World H e a l t h O r g a n i z a t i o n a g r e e m e n t (WHO Assembly R e s o l u t i o n No. 1 4 ) t o d i s c o n t i n u e t h e m e d i c a l u s e of h e r o i n because of i t s a d d i c t i o n producing q u a l i t i e s , and because o t h e r , l e s s harmful d r u g s a r e a v a i l a b l e f o r such m e d i c a l purposes. 3. The a c t i o n of morphine i n l a r g e r d o s e s i s g e n e r a l l y e q u i v a l e n t t o t h a t of h e r o i n and i n e i t h e r c a s e dosage must be below t h a t which would produce r e s p i r a t o r y a r r e s t . 4. N a r c o t i c s c o n t r o l a u t h o r i t i e s do n o t want a d d i c t i v e h e r o i n i n l e g a l u s e i n t h e United S t a t e s a s t h i s would r e q u i r e c a r e f u l s u r v e i l l a n c e i n lockup c a b i n e t s i n American h o s p i t a l s . 5. Drugs many t i m e s more p o t e n t t h a n h e r o i n o r morphine a r e being developed f o r p a i n c o n t r o l , t h e a t t e n t i o n b e i n g focused on dec r e a s e d t o l e r a n c e and on an a c c e p t a b l e l e v e l of s a f e t y and effectiveness. I n 1980, t h e N a t i o n a l Cancer I n s t i t u t e d e v e l o p e d a form of f r e e z e - d r i e d m r p h i n e t h a t i s v e r y s o l u b l e and a s a r e s u l t a l l o w s h i g h d o s e s t o be a d m i n i s t e r e d i n l e s s t h a n one m i l l i l i t e r (one milliliter equals approximately one-quarter teaspoon). 6. U n l i k e morphine, h e r o i n i s u n s t a b l e i n s o l u t i o n and may have t o be mixed d a i l y . 7. I n some c a s e s , t h e b e t t e r s o l u t i o n t o t e r m i n a l i n t r a c t a b l e p a i n i s a cordotomy, a procedure performed by a neurosurgeon i n which t h e a p p r o p r i a t e pain nerve i s s e v e r e d . I n o r d e r t o determine t h e p o s s i b l e v a l u e of h e r o i n compared t o o t h e r powerf u l a n a l g e s i c s , t h e U.S. Government h a s s u p p o r t e d c o n t r o l l e d s t u d i e s conducted by t h e V i n c e n t T. Lombardi Cancer R e s e a r c h Center a t Georgetown U n i v e r s i t y i n Washington, D . C . , and by t h e Memorial S l o a n - K e t t e r i n g Cancer C e n t e r i n New York. The S l o a n - K e t t e r i n g s t u d y was designed t o d e t e r m i n e t h e r e l a t i v e p o t e n c y of i n t r a m u s c u l a r h e r o i n and morphine i n c a n c e r p a t i e n t s w i t h p o s t o p e r a t i v e p a i n . 21 The i n v e s t i g a t o r s r e p o r t e d t h e f o l l o w i n g c o n c l u s i o n s : (a) h e r o i n was about twice a s p o t e n t a s morphine; (b) h e r o i n provided an a n a l g e s i c peak e f f e c t e a r l i e r t h a n morphine; (c) d o s e s w i t h equal a n a l g e s i c e f f e c t s provided comparable improvements i n v a r i o u s elements of mood; (d) peak mood improvement o c c u r r e d e a r l i e r a f t e r h e r o i n ; (e) b o t h a n a l g e s i c and mood improvement were l e s s s u s t a i n e d a f t e r h e r o i n a t doses providing e q u a l peak a n a l g e s i c e f f e c t s ; (f) s l e e p i n e s s was t h e most f r e q u e n t s i d e e f f e c t a f t e r b o t h d r u g s ; and (g) h e r o i n has no unique a d v a n t a g e s o r d i s a d v a n t a g e s f o r t h e r e l i e f of 31 pain i n p a t i e n t s with cancer. - 2 1 Kaiko, Robert F . , e t al. A n a l g e s i c and Mood E f f e c t s of H e r o i n and ~ o r ~ h ih ne Cancer P a t i e n t s w i t h P o s t o p e r a t i v e Pain. The New England J o u r n a l of M e d i c i n e , v. 304, J u n e 18, 1981. p. 1501-5. -3 1. Ibid., (research a r t i c l e a b s t r a c t ) . The S l o a n - K e t t e r i n g s t u d y h a s been c r i t i c i z e d because i t was c a r r i e d o u t w i t h c a n c e r p a t i e n t s who were e x p e r i e n c i n g p a i n f o l l o w i n g s u r g e r y . 41 BY corn- p a r i s o n , t h e Georgetown U n i v e r s i t y s t u d y was c o n d u c t e d w i t h t e r m i n a l l y ill p a t i e n t s w i t h moderate and s e v e r e p a i n . The m e d i c a l team a t George town a l s o found morphine and h e r o i n t o be e q u a l l y e f f e c t i v e , but t h e y n o t e d t h a t h e r o i n , having g r e a t e r potency and s o l u b i l i t y , would be v e r y u s e f u l i n t r e a t i n g p a t i e n t s who have developed a h i g h l e v e l of t o l e r a n c e t o o t h e r d r u g s . 51 F r a n a pharmacological s t a n d p o i n t , i t a p p e a r s t h a t h e r o i n h a s no a n a l g e s i c s u p e r i o r i t y o v e r morphine o r even some o t h e r powerful n a r c o t i c s s u c h a s hydromorphone ( D i l a u d i d ) o r methadone (Dolophine, e t c . ). I n a d d i t i o n , t h e Food and Drug A d m i n i s t r a t i o n h a s r e c e n t l y ( J a n u a r y 11, 1 9 8 4 ) approved a new h i g h potency f o r m u l a t i o n of hydranorphone named D i l a u d i d UP. FDA noted i n i t s p r e s s r e l e a s e t h a t t h e d r u g " w i l l p r o v i d e p a i n r e l i e f a s g r e a t a s can be o b t a i n e d w i t h a n y o t h e r n a r c o t i c , i n c l u d i n g h e r o i n , and can be d e l i v e r e d i n a v e r y small volume." The p o l i c y q u e s t i o n t h a t remains i s whether o r n o t h e r o i n s h o u l d be r e s c h e d u l e d a s a c o n t r o l l e d s u b s t a n c e , and be made a v a i l a b l e a l o n g w i t h o t h e r o p i a t e a n a l g e s i c s t o t r e a t i n t r a c t a b l e pain, e s p e c i a l l y pain so o f t e n encountered by p a t i e n t s w i t h t e r m i n a l i l l n e s s e s such a s c a n c e r . During t h e 1981 a n n u a l meeting of t h e American Medical A s s o c i a t i o n , t h e AMA House of D e l e g a t e s a d o p t e d t h e following resolution: Resolved , t h a t t h e American Medical A s s o c i a t i o n endorsed t h e p r i n c i p l e t h a t t h e management of p a i n r e l i e f i n t e r m i n a l canc e r p a t i e n t s s h o u l d be a medical d e c i s i o n and s h o u l d t a k e p r i o r i t y over- c o n c e r n s about drug dependence. 61 41 July Q u a t t l e b a u m , J u d i t h U. p. A30. 7,1981. Letter to the Editor. 51 P e r s o n a l caumunication w i t h D r . William Beaver. ~ e o r ~ e t o wUnn i v e r s i t y , J u l y 7 , 1981. The Washington P o s t , - Department of Oncology, 61' R e s o l u t i o n i n t r o d u c e d by D r . Roger J. Smith, D e l e g a t e , American p s y c h i a t r i c A s s o c i a t i o n , and adopted by t h e American Medical A s s o c i a t i o n , J u n e 9 , 1981, d u r i n g t h e i r annual meeting. Although t h i s r e s o l u t i o n avoided mentioning any s p e c i f i c d r u g s f o r p a i n r e l i e f , h e r o i n o r otherwise, i t coincided w i t h v a r i o u s l e g i s l a t i v e i n i t i a t i v e s i n t r o d u c e d i n t h e Congress r e l a t e d t o t h e u s e of h e r o i n f o r p a i n . In the 9 6 t h and 9 7 t h C o n g r e s s e s , R e p r e s e n t a t i v e Edward Madigan i n t r o d u c e d l e g i s l a t i o n t o a u t h o r i z e t h e use of h e r o i n f o r t e r m i n a l l y ill c a n c e r p a t i e n t s , and a h e a r i n g was h e l d by t h e House Committee on I n t e r s t a t e and F o r e i g n Commerce, Subcommittee on H e a l t h and t h e Environment on September 4 , 1980. Similar legisla- t i o n was i n t r o d u c e d by R e p r e s e n t a t i v e Henry Waxman i n t h e 9 7 t h Congress and r e f e r r e d t o t h e House Committee on Energy and Commerce. Although t h e language of t h e two b i l l s d i f f e r e d , t h e i n t e n t of each was t o amend t h e a p p r o p r i a t e s t a t u t e s t o p e r m i t t h e d i s p e n s i n g of h e r o i n f o r p a i n r e l i e f o n l y t o i n d i v i d u a l s w i t h terminal cancer. S e n a t o r D a n i e l K. Inouye a l s o i n t r o d u c e d a h e r o i n b i l l i n t h e 9 7 t h Congress t h a t would amend t h e C o n t r o l l e d S u b s t a n c e s Act and d i r e c t t h e S e c r e t a r y of H e a l t h and Human S e r v i c e s t o e s t a b l i s h a temporary h e r o i n program under which c o n f i s c a t e d h e r o i n would be made a v a i l a b l e t o pharmacies of q u a l i f i e d h o s p i t a l s f o r d i s p e n s i n g t o c a n c e r p a t i e n t s f o r t h e r e l i e f of pain. The b i l l was r e f e r r e d t o t h e Committee on Labor and Human R e s o u r c e s , and r e q u e s t s f o r e x e c u t i v e comment e r e sought from t h e Department of H e a l t h and Human S e r v i c e s and t h e O f f i c e o n Management and Budget. Thus f a r , i n t h e 9 8 t h Congress, two b i l l s have been i n t r o d u c e d i n an e f f o r t t o make h e r o i n a v a i l a b l e under l i m i t e d c i r c u m s t a n c e s . On J a n u a r y 2 6 , 1983, S e n a t o r Inouye r e i n t r o d u c e d h i s l e g i s l a t i o n (S. 209) from t h e p r e v i o u s Congress. On February 6 , 1984, R e p r e s e n t a t i v e Waxman i n t r o d u c e d H.R. 4762 which would d i r e c t t h e S e c r e t a r y (DHHS) t o e s t a b l i s h a 6 h o n t h program under which h e r o i n would be made a v a i l a b l e by p r e s c r i p t i o n through q u a l i f i e d pharmacies. Hearings on R e p r e s e n t a t i v e Waxman's p r o p o s a l were h e l d on March 8: 1984, by t h e Committee on Energy and Commerce, Subcommittee on CRS- 6 Health and t h e Environment. By narrowing t h e f i e l d of p o t e n t i a l p a t i e n t s t h a t might r e q u i r e strong p a i n r e l i e f ( i . e . , t h o s e t e r m i n a l l y i l l w i t h c a n c e r ) , t h e s e l e g i s l a t i v e e f f o r t s would a l l o w l i m i t e d u s e of h e r o i n i n medical p r a c t i c e , and a s a r e s u l t reduce the o p p o r t u n i t i e s f o r p o t e n t i a l i l l i c i t d i v e r s i o n .