1261 and 4 then died.) The remaining 131 who formed group 2 were those who despite treatment had a positive smear after two years. It is hardly surprising then that this group were 24’ times more likely to acquire invasive cancer. Judge Cartwright said "I have concluded that some women were offered unconventional treatment and some no treatment at all". Of the 131 group 2 patients who showed a positive smear at two years, the initial treatment had been hysterectomy in 33, cone biopsies in 88, and punch biopsy in 10. At the inquiry it was claimed that of the 25 women treated by punch biopsy alone 8 went on to show invasive cancer, but subsequent investigation showed that only 2 had further disease, which was successfully treated. Green’s views may have been unorthodox but he was by no means alone in his doubt about the efficacy of cervical screening for predicting invasive disease. 2-4 In 1966 he proposed a trial looking into the natural history of CIS. Professor Bonham agreed to this. He has now been found guilty of disgraceful misconduct.7 Maybe this verdict is correct, but another view would be that instead of believing dogma he allowed a trial to ascertain whether CIS inevitably leads to cancer. As Green said at the time "I merely wanted to find out the truth. I simply wanted to save women from unnecessary surgery, but I did not have a mission to save women from any type of surgery, nor did I set out to prove CIS harmless". He may have been wrong, but is there no place for someone to test what were at the time of the initiation of his clinical trial assumptions masquerading as facts? The Mill House, South Tawton, Okehampton, Devon EX20 2LN, UK TOM BELL 1. Mclndoe WA, McLean MR, Jones RW, Mullins PR. The invasive potential of carcinoma in situ of the cervix. Obstet Gynecol 1984, 64: 451-58. 2. Skrabanek P. Cervical cancer screening: time for reappraisal. Can J Publ Hlth 1988; April: 86-88. 3. McCormack JS. Cervical smears: a questionable practice? Lancet 1989; ii: 207-09. 4. Smith A. Cervical cytology screening. Br Med J 1988; 296: 1670. 5. Roberts CJ, Farrow SC, Charley ML. Cost of saving a life by cervical screening. Lancet 1985, ii: 950. 6. Green H. Cervical cancer in New Zealand: a failure in screening. Asis-Oceana J Obstet Gynaecol 1981; 7: 303-13. 7. Anon. Treatment of CIS at National Women’s Hospital, Auckland, still an issue. Lancet 1990; 336: 801-02. SIR,-Your Round-the-World correspondent (Oct 20, p 996) reports that finding Professor Bonham guilty of professional misconduct by the Medical Council of New Zealand completely vindicates the Cartwright inquiry into the treatment of cervical cancer at National Women’s Hospital. Your correspondent continues, "[the finding] should effectively silence critics who deemed the affair a feminist witch-hunt". It will do neither. The affair was especially useful to a government trying to subjugate the medical profession (and British doctors contemplating a move to New Zealand would do well to discuss the medical climate here with doctors working in New Zealand). A substantial body of medical opinion in New Zealand objects to the way the inquiry was set up, to the way it was conducted, to many of its recommendations, and to the subsequent fraternisation of Judge Cartwright with participants in the inquiry. The Cartwright inquiry will long continue to be a source of controversy in New Zealand. 13 Marion Street, Dunedin, New Zealand MICHAEL J. MACKAY Ethics and clinical research MR,—A Lancet editorial (Oct 6, p 846) picks a tight with those who work in medical ethics, charging them with impeding clinical research, especially randomised clinical trials. Since you haul me onto the carpet by name to receive a thrashing for inappropriate flippancy about the obstacles faced by those who wish to do well-designed clinical research, it is appropriate for me to draw your readers’ attention to the vapidity of the premises on which your call to arms is based. The supposition that medical ethics stands in the path of progress via controlled clinical trials is absurd. I cannot speak with confidence about medical ethicists in the UK-a tiny number, yet apparently, from the tone of the editorial, quite capable of paralysing the British medical research establishment-but the obstacles standing in the way of controlled clinical trials and other clinical research in the USA have nothing to do with the writings or actions of obstreperous ethicists. Most of the regulations governing US medical research do not have their origins in the work of medical ethicists. They are the product of the writings of the Harvard anaesthesiologist, Dr Henry K. Beecher.1,2 It was Beecher who first drew the attention of his medical colleagues and, later, of government officials and the press to unethical practices in US research. The primary hindrance to controlled clinical trials in the USA today is not the regulations that emerged in the 1970s. Nor is it the rantings of ethicists about the immorality of such trials. The morality of randomised trials is being questioned by patient advocacy groups and by many pharmaceutical and device companies. Patients with AIDS, cancer, or Alzheimer’s disease (and their families and friends) have been especially critical. Clinical research is also suffering because of a decline in Federal funding. Many manufacturers and some patients believe that the access afforded to new drugs and devices by controlled trials is too restrictive and too slow, especially for those with terminal illnesses. They also argue that such trials unduly drive up the cost of drugs and devices. In American newspapers, magazines, and medical journals calls for "fast tracking", "streamlining", and "community-based trials" have been much in evidence. Ironically, many American medical ethicists have entered this debate on the side of those who stress the importance of carefully designed randomised trials. The other vaporous premise you use to support the notion that it is time for the medical research elephant to swat the medical ethics gnat is "ethical and juridical interference with medical reseach". US courts have shown no inclination to interfere with medical research. Ethicists have offered opinions about the morality of research proposals and generally support bodies such as institutional review boards to oversee clinical research-but can anyone seriously argue that medical ethics has hindered clinical research in a nation whose researchers have undertaken, in the past decade, a cardiac xenograft on a newborn baby, total artificial heart implants with the Jarvik 7 device, the first multiple organ transplants in children, the use of total parenteral nutrition and extracorporeal membrane oxygenation in premature infants, the procurement of lobes of liver, lung, and pancreas from living donors for transplantation, and the first clinical trial of gene therapy? The number of experiments, pilot studies, controlled trials, retrospective studies, epidemiological surveys, or randomised trials that have foundered on the rocks of objections by medical ethicists is, if not zero, then tiny. You say that I am wrong to have "haughtily dismissed" the concerns of medical researchers about restraint upon their research activities. I make no such dismissal in my paper,3 as anyone who got past the obvious sarcasm in the paper’s opening paragraphs toward those who dismiss clinical researchers’ concerns about the burden of existing regulations would know. The whole point of my paper is that most of the ethical norms and regulations now in place issued from a time of outright scandal and abuse in medical research, of which Nuremberg and Tuskegee are the paradigmatic watchwords. I argue that the time has come to move away from the "strongly protectionist character" of human experimentation ethics to the recognition that perhaps medical research ought to proceed with less restraint. I go on to argue that everyone who uses health care has an obligation to participate in the research necessary to permit progress, and that is as zealous a pro-research position as has appeared in print. It is disconcerting to see that a paper which argues for a view similar to that expressed in The Lancet’s editorial has been placed at the centre of a tirade calling for war with medical ethicists. I have no quarrel with the sentiment that clinical researchers do not have to take it any more but it might be wise to carefully establish who is slapping clinical research before refusing to "turn the other cheek". Center for Biomedical Ethics, Univesity of Minnesota, Minneapolis, Minnesota 55455, USA ARTHUR L. CAPLAN 1. Beecher HK. Ethics and clinical research. N Engl J Med 1966; 274: 1354-60. 2. Beecher HK. Research and the individual. Boston: Little Brown, 1970. 3. Caplan AL. Is there an obligation to participate in biomedical research? In: Spicker SF, Alon I, de Vnes A, Engelhardt HT, eds. The use of human beings in research. Dordrecht: Kluwer, 1988: 229-48.