CANNABIS AND THE RULE OF LAW

138 intercourse

as

the result, rather than the cause, of the

early

delivery. Goodlin et al. 3,6 thought that orgasm might initiate premature labour by causing strong uterine contractions, z though Masters and Johnson 12 and Solberg et al.l’ be Goodlin et a1.6 showed data considered this to unlikely. which they interpreted as pointin to an association between intercourse and premature labour. They questioned 50 women delivering before thirty-seven weeks and 50 delivering at thirty-nine weeks or later, matched for age, social class, parity, and race. They did not, however, match for previous premature deliveries, diminished weight gain, and use of lysergic acid diethylamide (LSD)-characteristics which were distributed unfavourably in the premature group-which makes it impossible to interpret the results of their study. Wagner et al.s tried to reduce bias by concealing from the interviewers the true purpose of their retrospective study. They state that orgasm was reported more frequently by 19 mothers of "prematures" than by 19 control mothers, though paradoxically the frequency of intercourse was higher among the controls. These differences were not significant and the exclusion of non-viable infants and the mixing of low birthweight with preterm infants in the analysis make it difficult to draw any conclusions from this report. Perkins7 retrospectively asked 155 women with preterm and low birthweight babies about sexual behaviour during pregnancy, and found a worse outcome in women who reported having no orgasms. The women in his study thought that orgasm was associated with uterine contractions, and he concluded that his data did not show any convincing connection between sexual activity, with or without orgasm, and an adverse outcome. A recent study by Naeye,4 based on prospective data from the Collaborative Perinatal Project, found an association between coitus and amniotic fluid infection. This finding has been challenged. Herbst13 noted that some authorities would not accept Naeye’s assumption that neutrophilic infiltration of the placenta indicates amniotic fluid infection. Van den Berg 14 uncovered several methodological shortcomings, including the omission of total death rates in the two groups. Such information would be crucial in determining whether coitus is a risk factor for deaths related to amniotic fluid infection. Our study overcomes some of the limitations of previous investigations. The sample size is large and, since it embraces a large percentage of deliveries in the area, is likely to be truly representative. We reduce the problem of interviewer bias by using a partly blind technique. Except for stillbirths, the interviewers did not know the outcome of the pregnancy. A major drawback was that we were unable to determine whether a woman stopped having intercourse because she was at high risk for a preterm birth. We have allowed for this in the analysis by excluding high risk women. Our findings dispute the hypothesis that intercourse is harmful in pregnancy. Because of its design our study cannot, on its own, be taken as conclusive, but, together with previous studies which showed no deleterious effect, it challenges the view that intercourse during the later part of pregnancy is harmful.

Point of View CANNABIS AND THE RULE OF LAW One year ago (June 16, 1980) a licence was issued by the Home Office to specified members of our department at St James’ Hospital, under the conditions of the Misuse of Drugs Act, 1971, "to supply, offer to supply and have in (our) possession not more than 30 g of cannabis". The intention was to have this substance available as an anti-emetic during combined cytotoxic chemotherapy, on the grounds described earlier.The licence was issued after almost six months’ wrangling, pursued by florid attention in the press. Having issued the licence, apparently under duress, the Home Office disclaimed authority to provide the cannabis, indicating officials at the Department of Health as a source of supply. They, in turn, put it blandly that, following the publication of the proceedings of the Rheims conference,2 release of cannabis for therapeutic purposes in the U.K. was more or less out of the question. I was advised in a letter (July 11, 1980) from the Department of Health and Social Security, that "the whole question of the therapeutic use of cannabis has raised important issues, both within the Home Office and the D.H.S.S., which are currently under consideration. I regret therefore that I am not able to reply in any detail at this moment but will write as soon as I am able to do so." Since then I have received no further information or even the courtesy of replies to correspondence. What seems to be at issue is neither the therapeutic value nor the detrimental reputation of cannabis, which have been disputed since 1839,3 and show no signs of resolution. It is the state of public affairs which is awry. Anyway, the Home Office licence, issued for one year, has now expired. The law, in the Misuse of Drugs Act, 1871, makes provision for the clinical administration of cannabis under defined and agreed conditions. The Department of Health, meanwhile, without authority, implicitly repudiates the published evidence of clinical potential, supported no doubt by such ex cathedra sources as the British National Formulary of March, 1981, in which cannabis is dismissed as having "no valid medicinal use". Such a statement of doctrine has no regard for the clinical and experimental evidence to the 1. Rose MS. Cannabis. a medical question? Lancet 1980; i-703. 2 Nahas GG, Paton WDM, eds. Marihuana- biological effects. Oxford:

1979. 3 Aitken D, Mikuriya T. The forgotten medicine 4. British National Formulary 1981 London:

Pharmaceutical

Society

Pergamon Press,

10: 269-79 British Medical Association and of Great Britain, 1981; p 16.

Ecologist 1980;

3. Goodlin RC, Schmidt W, Creevy DC. Uterine tension and fetal heart rate during maternal orgasm. Obstet Gynecol 1972, 39: 125-27. 4. Naeye RL. Coitus and associated amniotic fluid infections. N Engl JMed 1979; 301: 1198-1200 5 Wagner NN, Butler JC, Sanders JP. Prematurity and orgasmic coitus during

pregnancy: data on asmall sample. Fertil Steril 1976; 27: 911-15. 6. Goodlin RC, Keller DW, Raffin M. Orgasm during late pregnancy: possible deleterious effects. Obstet Gynecol 1971; 38: 916-20. 7 Perkins R. Sexual behaviour and response in relation to complications of pregnancy 8

9.

Am J Obstet Gynecol 1979, 134: 498-505. Pugh WE, Fernandez FL. Coitus in late pregnancy. Obstet Gynecol 1953; 2: 636-42 Armitage P. Statistical methods in medical research Oxford: Blackwell Scientific

Publications,

1971

Harlap S, Davies AM. The pill and births: the Jerusalem study. Bethesda, Center for Population Research NIH, 1978. 11 Solberg DA, Butler J, Wagner NN Sexual behaviour in pregnancy. N Engl J Med 1973, 10

REFERENCES 1 Lull CB, Kimbrough RA. Clinical obstetrics. Philadelphia Lippincott, 1953. 2 Speert H, Guttmacher AF Obstetric practice. New York. Landsberger Medical Blakiston Division of McGraw-Hill, 1956.

288: 1098-103.

Books,

12. Masters WH.

Company,

Johnson

VE. Human sexual response. Boston:

13. Herbst AL. Coitus and the fetus. N

14. Van den

Little, Brown and

1966

Engl J Med 1979; 301: 1235-36. Berg BJ. Coitus and amniotic fluid infections N Engl J Med 1980; 302: 632

139

contrary. What is a person to do, meanwhile, who finds relief through cannabis? Mr Robert Randall, equipped with details concerning his glaucoma from the department of ophthalmology, University of California at Los Angeles, won his case of prosecution with a defence of "common law right of necessity".5 It was argued that he would be acting in conflict with his own interests to abide by legal prohibition and so allow his condition to deteriorate. By the end of May, 1981, 30 states have passed laws recognising the medical use of cannabis.6 It is ironic that the United States, formerly the most vigorous proponent of the U.N. Single Convention prohibiting the use of cannabis, is overtly rescinding its position, whilst mediating the distribution of delta-9-

tetrahydrocannabinol (D-9-THC) as an officially preferred alternative, and facilitating pharmaceutical research into synthetic analogues. In the United Kingdom, however, where the Dangerous Drugs Acts, 1971 and 1973, have theoretically preserved the option of administering cannabis, it is, in practice, prohibited. English legal text books suggest that the defence of "necessity" should be available under similar circumstances to that of the defence of "duress".7,s There is, at present, no defence for possession under the Misuse of Drugs Act, 1971, and no certainty that the courts will permit a defence of necessity in answer to charges of possession, merely that such mitigating circumstances could modify the penalty. Proceedings are currently taking place which will lead to the High Court being asked to determine whether the defence of necessity is available as a matter of law. The submission that marihuana has medicinal value originates most forcefully from younger Americans who have used it for recreational purposes. Among them have been patients with leukaemia, lymphoma, and disseminated malignancies, receiving heavy doses of cytotoxics, often in combination. They informed their doctors that marihuana alleviated the attendant nausea and sickness. Subsequently, workers negotiated limited permission to administer D-9-THC, which has been thoroughly documented. Precisely why D-9-THC was released, but not marihuana, remains unclear. It is a potent factor, but not the sole active ingredient of cannabis, which contains a multitude of chemically and pharmacologically distinct constituents. Patients’ experiences have been only partially acknowledged because of the bureaucratic filtering process. The study9 of 15 patients receiving high-dose methotrexate for osteogenic sarcoma, one of the most enthusiastic reports of the antiemetic potency of D-9-THC, characterised the material used in both capsules and cigarettes as D-9-THC. It appears, however, that the details "concerning the type of cigarettes

employed was a misstatement." 10The cigarettes in question were made with Mississippi grown Mexican marihuana from the 1978 crop, in which D-9-THC was the major but not the sole ingredient identified by chromatographic analysis. The agencies concerned to avert any relaxation in the law of total prohibition wish to see no challenge to the doctrine that cannabis has no medicinal value. Meanwhile, condemnation and scorn are heaped upon cannabis-"a thoroughly vicious drug, deserving the odium of civilised people"11-and it 5 United States v Randall, 20 Cr L. Rep. 2299, 104 Daily Washington L. 6 Alliance for Cannabis Therapeutics Newsletter May 31, 1981

Rep.

2249.

Archbold JF Pleading, Evidence and Practice (Mitchell S, Huxley-Buzzard J (eds). London Sweet and Maxwell, 1979. 8 RDudley and Stephens (1884) 14 Queen’s Bench Division 273. 9 Chang AE, Shiling DT. Stillman RE, Goldberg NH, Seipp CA, Barofsky I, Surion RM. Rosenberg SA. Delta-9-tetrahydrocannabinol as an anti-emetic in cancer patients receiving high dose methotrexate Ann Int Med 1979; 91: 819-24 10 Chang AE Personal communication to Randall, R. 11 Egyptian Government’s Annual Report on Narcotics, 1944.

prohibited pending the submission of definitive pharmacological evidence to the contrary. The analysis of cannabis has developed, therefore, into a growth industry remains

with its own literature, conventions, and grants, in which the resolution of limited questions is subordinate to the possibility of limitless expansion. The results are, moreover, of importance to pharmacological purists alone, and some of the experiments are questionable.’2 Awaiting definitive conclusions, authorities behave with the conviction that they are already available. Draconian regulations debar patients with intractable vomiting caused by chemotherapy from receiving cannabis as a potential source of relief. That seriously calls into question the claim that officialdom is acting with caution out of concern for the sick. These people are already bedevilled with problems; the calculation of risks and benefits must make allowance for their exceptional circumstances. There is a disparity between the notable absence of danger associated with cannabis;’3 and the behaviour of authority as if the danger were obvious to all. The legions of insane, wrecked by their youthful ingestion of cannabis, are not exactly in evidence. St. George’s Hospital, London SW 17 0RE

MICHAEL ROSE

CA, Ambrosetto G, Peraita-Adrados MR, Gastaut H The neuropsychiatric syndrome of D-9 tetrahydrocannabinol and cannabis intoxication in naive subjects a clinical and polygraphic study during wakefulness and sleep In Pharmacology of marihuana (Braude M, Szara S, eds) Raven Press, 1976, 357-75 Harris LS Marijuana and immunity a discussion In Marijuana and Health Hazards (Tinklenberg JR, ed) New York- Academic Press, 1975; p. 55

12. Tassinari

13.

Round the World United States PREVENTION: ACHIEVEMENTS AND PROSPECTS

Two U.S. Public Health Service publications, Promoting Healthl Preventing Diseasel and Prevention ’802, appeared about the time President Reagan was moving into the White House, and must be viewed, therefore, as products of the old regime. Their authors make no great attempt at narration. They have written excellent compendiums, in outline form, telling factually where the United States stands in its efforts to prevent chronic and infectious diseases and injuries and setting goals for further reductions by the end of the present decade. Probably the most striking impression from all these facts is the dominating impact of environmental influences on health. For people here, and around the world, the impact begins months before they are born. A healthy start in life ranks among the nation’s highest priorities in the prevention of disease among its citizens. This is no simple achievement. The mother’s nutrition may be poor; she may smoke, drink alcohol, or use other drugs; she may lack prenatal care. These influences contribute to the greatest single factor in infant mortality, low birthweight (2500 g or less). Approximately 7% of all U.S. babies are of low birthweight, and the rate is almost twice as high for Black infants. The overall rate has been improving but it is still higher than in many other industrial nations. In Japan, for example, 5’ 3% of infants were of low birthweight; in Sweden, 4-1%. Unintentional injuries-in motor vehicles, at home, at work, in public places-are the leading cause of death in the United States for 1.

Promoting Health/Preventing Disease objectives for the nation U.S Department of Health and Human Services, Public Health Service, Fall, 1980. U.S Government Printing Office no. 017-001-00435-9. In U.S.. $4.50; outside, $5 65. Prevention ’80. U.S. Department of Health and Human Services, Public Health Service. U.S. Government Printing Office no 017-001-00433-2. In U S , $5.50, outside, $6.90. Both available from Superintendent of Documents, U S. Government Printing Office, Washington, DC, 20402