Accountability, audit, and standards of practice in the UK

In the wake of the judgments set out by the General Medical Council of the United Kingdom and the likely further investigation of the Wisheart case involving a series of neonatal and infant deaths during cardiac surgery, the profession has had to produce a swift response in its attempts to retain some level of self regulation. At the British Medical Association conference in June this year, an almost unanimous vote was obtained in support of the notion of regular appraisal of current medical practice. The government decision to publish league tables of hospital mortality rates for England and Wales, bringing these parts of the UK into line with the position in Scotland, has helped to focus attention on the need for setting and monitoring standards of good clinical practice (GCP). The profession has already begun to feel the pressure for external evaluation, for instance in the declaration of intent by the government to introduce a scheme of inspection of hospital trusts by an independent watchdog, similar to that which has been introduced by the Office for Standards in Education to police high school education.

Many in the profession think that schemes of this nature will be difficult to set up and control and will require careful planning. However, they are to be welcomed and indeed the Royal College of Ophthalmologists has during the past few years been gradually introducing correspondence based audits of success rates for surgical procedures such as cataract extraction and retinal detachment. In addition, a series of guidelines for GCP applied to several aspects of ophthalmic care such as management of diabetic retinopathy, glaucoma, and refractive surgery have been published. However, whereas compliance with these guidelines has heretofore been on a voluntary basis, now the profession may be seeing a more statutory element being introduced to the application of recommendations for GCP. After all, in the education sphere some high schools which have not met the required standard have been closed.

Education is a major problem in diabetes care

The results of a recently conducted MORI poll in the UK confirms the widespread ignorance in the general population concerning many aspects of diabetes. Of particular concern to the British Diabetic Association is the public belief that diabetes is mostly a mild disease. While the chronic, non-urgent nature of the disease in the elderly is well recognised, the morbidity associated with duration of the disease is startling and the BDA points to the high economic impact of the disease for instance from blindness and lower limb amputations. According to the BDA, diabetes currently affects 1.4 million people in the UK and this figure is set to double by the year 2010. The disease or its complications consumes at least 5% of healthcare resources, estimated in the UK to be around £4000 per minute.

Call for drug trials protocol procedure

Further changes in clinical research practice, which will affect ophthalmologists in the UK, are recommendations made by an independent inquiry into the Randomised Asphyxia Study Trial (RAST) as a result of a simple prescribing error which caused a fatal accident and led to the cessation of the trial. The recommendations are that the Medicines Control Agency adopts a more proactive stance in ensuring that the medical profession and the pharmaceutical industry use the same terminology for drug prescription. More importantly, however, the inquiry recommended that the Medical Research Council initiates moves to draw up comprehensive and systematic guidelines for the conduct and monitoring of drug trials on patients. In principle these recommendations are laudable and take the medical profession some way towards the situation in other countries such as the USA where the Food and Drug Administration imposes very strict procedural requirements on new drug trials. This has had in some cases a significant delaying effect on the introduction of new drugs and even, in some cases, the rejection of certain medications for use in the USA which in other countries have been shown to be beneficial. In addition, the bureaucratic elements of FDA regulated drug trials impose a significant additional burden on clinical researchers. It is possible therefore that these new moves will see the development of ophthalmic pharmacotherapeutics as a distinct sub-branch of pharmacology units.

Patent rights to the human genome sequence

The announcement by a commercial firm recently that it intended to produce partial sequence data of the human genome which it would delay publishing in order to have exclusive rights to patent some of the sequences has generated a vigorous response in several quarters. For instance, the Wellcome Trust has clearly adopted the stance that the human genome sequence should be produced only through international collaboration and as speedily as possible with the information placed immediately in the public domain. To back this approach, the trust has increased its committed funding of the sequence from one sixth to one third of the total sequence, the work to be performed at the Sanger Centre, Cambridge. The trust’s total investment in the Human Genome Project thus amounts now to £205m. The trust is also concerned about previous patents granted solely on the basis of DNA sequence information and has initiated a review of all such patents to investigate their credibility. Some companies also support the stance taken by the Wellcome Trust: Perkin-Elmer has combined with the Institute for Genomic Research of Maryland and promised to sequence the entire human genome by 2001 when it will make the sequence data freely available. This is four years earlier than the proposed date set by the Human Genome Project.

Binocular eye movement control

A recent paper (Nature1998;393:692–4) has revisited the Helmhotz–Hering difference in viewpoint regarding control of eye movements. According to the authors of the new work, Helmholz held the view that control of movement of each eye was independent and that binocular movements were learned. In contrast, Hering maintained that both eyes were innervated by common command signals which yoke eye movements (Hering’s law). The authors have produced evidence which suggests that Hering’s law is unlikely to be correct. Instead they show that premotor neurons in the paramedian pontine reticular formation which were previously believed to regulate conjugate rapid eye movements in fact selectively control either right or left saccade movements. However, they also show that the distribution of neurons firing for ipsilateral movements in the abducent nerve are distributed 2:1 in response to input from movement in either eye. They suggest that “sensitivity to ipsilateral and contralateral eye movements across the abducens motor neurone pool may provide a basis for learning binocular co-ordination in infancy”. Thus, they come down on the side of Helmholz.