818
appropriate to the degree of disability by means of personal accident and illness policy rather than by an extension of an Employers Liability or Public Liability Policy. This ensures that in the event of an illness or death, a claim would be met without question, whereas with an Employers Liability Policy, the insurance company may expect the injured party to prove the employer’s negligence. cover
Ethical Review
Protocols must be reviewed from a purely scientific standpoint. At Searle an international system reviews all protocols for their scientific merit. In addition, a local ethical committee reviews proposed in-house studies. Committee meetings are attended by the clinical monitors whose protocols are under review for them to answer technical questions. The frequently used term, "independent ethical
review", suggests that the committee members should be connected with or chosen by anyone connected with the volunteer studies. This ideal is difficult to achieve since it is important that the members should be suitable as well as independent. Our committee chairman is a senior consultant physician at the local hospital and the other members are a consultant haematologist, a group pharmacist, a schoolteacher with a chemistry degree, and a personnel manager. The committee members accept the responsibility and demands on their time without financial or other material reward. It could be argued that this committee is not truly independent since its membership was partly determined by Searle employees. It is however probably as independent as any appropriate and effective ethical committee can be and its degree of independence compares favourably with equivalent committees in hospitals. not
CONCLUSION
I believe that the arguments for and against conducting drug studies involving normal volunteers within a pharmaceutical company show that such studies can, and perhaps even should, be done, provided their organisation and conduct are approached in a scientific and ethical mariner and provided the limitations of carrying out studies in pharmaceutical companies are recognised. The following helped to make arrangements for planning and conducting volunteer studies at G. D. Searle & Co.: Dr M. J. Asbury, Dr J. M. Clarke, Mr I. R. Harrision, Mrs M. Porteous, Dr L. E. Ramsay (now at the Gardiner Institute of Medicine, Western Infirmary, Glasgow), Dr M. J. Tidd, and Dr G. R. Venning. I also thank the members of the Ethical Committee for their help. REFERENCES 1. Wld Hlth Org. Chron. 1976, 30, 360. 2. Laurence, D. R. in Evaluation of Drug Activities: Pharmacometrics (edited by D. R. Laurence and A. L. Bacharach); p.3. London and New York, 1964. 3. Hassar, M., Pocelinko, R., Weintraub, M., Nelson, D., Thomas, G., Lasagna L. Clin. Pharmac. Ther. 1977, 21, 515. 4. The Report of the Committee to Investigate Medical Experiments on Staff Volunteers. Association of the British Pharmaceutical Industry. London, 1970. 5. Stuart-Harris, C. in International Aspects of Drug Evaluation and Usage (edited by A. J. Jouhar and M. F. Grayson); p.205. Edinburgh and Lon-
don, 1973. 6. Tyrrell, D. A. J. ibid. p.211. 7. Br. med. J. 1973, ii, 220. 8. Hassar, M., Wemtraub, M. Clin. Pharmac. Ther.
1976, 20, 379.
In
England
THE ROYAL
Now
FREE’S 150TH
ANNIVERSARY
young surgeon returning home one December upon a destitute dying girl on the steps of St Andrew’s Church, Holborn. He was unable to secure her admission to hospital and the incident distressed him so much that he immediately enlisted the help of his friends to found a medical charity to provide accommodation for the sick poor regardless of their means and without the necessity of a governor’s letter of introduction. Such was the beginning of what IN 1828
night
a
came
is now a teaching hospital of international repute, The Royal Free. And on April 17, 1978, at St. Andrew’s Church, where it all began, the hospital celebrates its 150 years of existence with a Thanksgiving Service in the presence of its Patron, Princess Alice, Duchess of Gloucester; and it will also honour the memory of the young surgeon, William Marsden. The Lancet is particularly pleased to add its congratulations, for Thomas Wakley, founder of the journal, and Marsden were contemporaries with similar ideals and humanitarian principles ; and Wakley’s son was later to be on the consultant surgical staff of the hospital and also chairman of the management committee. The hospital was first opened in Hatton Garden. There is no record of the number of beds, but it seems probable that only the homeless or the dying were actually taken into the wards and that the majority who came to the hospital were treated as outpatients. But such were the idealistic yet practical principles at its heart that in 1832 when all other hospitals refused to admit patients suffering from cholera, 700 cases were treated at The Free Hospital. In 1842 when premises formerly used as the barracks of the Light Horse Volunteers in Gray’s Inn Road fell vacant the committee of management bought the lease and in 1863 the freehold was purchased. This was the parent hospital until a few years ago; although all the original buildings were rebuilt and others added, the barrack structure of the hospital was plainly recognisable. Queen Victoria was Patron of the hospital on her accession to the throne and granted a Royal Charter in 1892, so the full derivation of its name emerges. Medical and social history was made in 1874. A small band of women, led by Sophia Jex-Blake and Elizabeth Garrett Anderson, were determined to found a medical school for women, for the Apothecaries’ Society had altered its rules to prevent women qualifying as doctors and no university would admit them; thus, the London School of Medicine for Women was founded. The pioneers were reduced almost to despair when they found that no hospital would admit women students and, unless the school was able to provide clinical instructions for its students, it was doomed. Once more the hospital gave the lead to medical and public opinion by opening its wards to women students, thereby securing the entry of women into the medical profession. In 1947 the school became coeducational by revision of its charter. As time progressed, additional hospitals became associated with Gray’s Inn Road to form the Royal Free Group. In 1974, the 850-bed new Royal Free District General and Teaching Hospital opened in Hampstead, a triumph of planning and cooperation, for the new building was actually built and commissioned while the nearby Lawn Road branch was in full use. Another event this year will be the opening of the clinical sciences building and the School of Medicine, making up the total complex of the Hospital. None can have a more favourable prospect for any aspect of service to the community, and the local population are fortunate, despite its size, in having the Free in its midst. During 1978 there will be many celebrations, some highly original (the Art Gallery exhibitions are already widely acclaimed); and the 3000 staff and 300 undergraduate students who work there each day have every right to take pride in their history and their future.
appropriate to the degree of disability by means of personal accident and illness policy rather than by an extension of an Employers Liability or Public Liability Policy. This ensures that in the event of an illness or death, a claim would be met without question, whereas with an Employers Liability Policy, the insurance company may expect the injured party to prove the employer’s negligence. cover
Ethical Review
Protocols must be reviewed from a purely scientific standpoint. At Searle an international system reviews all protocols for their scientific merit. In addition, a local ethical committee reviews proposed in-house studies. Committee meetings are attended by the clinical monitors whose protocols are under review for them to answer technical questions. The frequently used term, "independent ethical
review", suggests that the committee members should be connected with or chosen by anyone connected with the volunteer studies. This ideal is difficult to achieve since it is important that the members should be suitable as well as independent. Our committee chairman is a senior consultant physician at the local hospital and the other members are a consultant haematologist, a group pharmacist, a schoolteacher with a chemistry degree, and a personnel manager. The committee members accept the responsibility and demands on their time without financial or other material reward. It could be argued that this committee is not truly independent since its membership was partly determined by Searle employees. It is however probably as independent as any appropriate and effective ethical committee can be and its degree of independence compares favourably with equivalent committees in hospitals. not
CONCLUSION
I believe that the arguments for and against conducting drug studies involving normal volunteers within a pharmaceutical company show that such studies can, and perhaps even should, be done, provided their organisation and conduct are approached in a scientific and ethical mariner and provided the limitations of carrying out studies in pharmaceutical companies are recognised. The following helped to make arrangements for planning and conducting volunteer studies at G. D. Searle & Co.: Dr M. J. Asbury, Dr J. M. Clarke, Mr I. R. Harrision, Mrs M. Porteous, Dr L. E. Ramsay (now at the Gardiner Institute of Medicine, Western Infirmary, Glasgow), Dr M. J. Tidd, and Dr G. R. Venning. I also thank the members of the Ethical Committee for their help. REFERENCES 1. Wld Hlth Org. Chron. 1976, 30, 360. 2. Laurence, D. R. in Evaluation of Drug Activities: Pharmacometrics (edited by D. R. Laurence and A. L. Bacharach); p.3. London and New York, 1964. 3. Hassar, M., Pocelinko, R., Weintraub, M., Nelson, D., Thomas, G., Lasagna L. Clin. Pharmac. Ther. 1977, 21, 515. 4. The Report of the Committee to Investigate Medical Experiments on Staff Volunteers. Association of the British Pharmaceutical Industry. London, 1970. 5. Stuart-Harris, C. in International Aspects of Drug Evaluation and Usage (edited by A. J. Jouhar and M. F. Grayson); p.205. Edinburgh and Lon-
don, 1973. 6. Tyrrell, D. A. J. ibid. p.211. 7. Br. med. J. 1973, ii, 220. 8. Hassar, M., Wemtraub, M. Clin. Pharmac. Ther.
1976, 20, 379.
In
England
THE ROYAL
Now
FREE’S 150TH
ANNIVERSARY
young surgeon returning home one December upon a destitute dying girl on the steps of St Andrew’s Church, Holborn. He was unable to secure her admission to hospital and the incident distressed him so much that he immediately enlisted the help of his friends to found a medical charity to provide accommodation for the sick poor regardless of their means and without the necessity of a governor’s letter of introduction. Such was the beginning of what IN 1828
night
a
came
is now a teaching hospital of international repute, The Royal Free. And on April 17, 1978, at St. Andrew’s Church, where it all began, the hospital celebrates its 150 years of existence with a Thanksgiving Service in the presence of its Patron, Princess Alice, Duchess of Gloucester; and it will also honour the memory of the young surgeon, William Marsden. The Lancet is particularly pleased to add its congratulations, for Thomas Wakley, founder of the journal, and Marsden were contemporaries with similar ideals and humanitarian principles ; and Wakley’s son was later to be on the consultant surgical staff of the hospital and also chairman of the management committee. The hospital was first opened in Hatton Garden. There is no record of the number of beds, but it seems probable that only the homeless or the dying were actually taken into the wards and that the majority who came to the hospital were treated as outpatients. But such were the idealistic yet practical principles at its heart that in 1832 when all other hospitals refused to admit patients suffering from cholera, 700 cases were treated at The Free Hospital. In 1842 when premises formerly used as the barracks of the Light Horse Volunteers in Gray’s Inn Road fell vacant the committee of management bought the lease and in 1863 the freehold was purchased. This was the parent hospital until a few years ago; although all the original buildings were rebuilt and others added, the barrack structure of the hospital was plainly recognisable. Queen Victoria was Patron of the hospital on her accession to the throne and granted a Royal Charter in 1892, so the full derivation of its name emerges. Medical and social history was made in 1874. A small band of women, led by Sophia Jex-Blake and Elizabeth Garrett Anderson, were determined to found a medical school for women, for the Apothecaries’ Society had altered its rules to prevent women qualifying as doctors and no university would admit them; thus, the London School of Medicine for Women was founded. The pioneers were reduced almost to despair when they found that no hospital would admit women students and, unless the school was able to provide clinical instructions for its students, it was doomed. Once more the hospital gave the lead to medical and public opinion by opening its wards to women students, thereby securing the entry of women into the medical profession. In 1947 the school became coeducational by revision of its charter. As time progressed, additional hospitals became associated with Gray’s Inn Road to form the Royal Free Group. In 1974, the 850-bed new Royal Free District General and Teaching Hospital opened in Hampstead, a triumph of planning and cooperation, for the new building was actually built and commissioned while the nearby Lawn Road branch was in full use. Another event this year will be the opening of the clinical sciences building and the School of Medicine, making up the total complex of the Hospital. None can have a more favourable prospect for any aspect of service to the community, and the local population are fortunate, despite its size, in having the Free in its midst. During 1978 there will be many celebrations, some highly original (the Art Gallery exhibitions are already widely acclaimed); and the 3000 staff and 300 undergraduate students who work there each day have every right to take pride in their history and their future.
