Clinical freedom died around 1983.1 A number of factors dealt the final blow. Among the most important were, first of all, the undeniable results of randomized controlled trials. Many of them were in the cardiovascular field – for example, coronary artery bypass graft transplantation for patients with angina pectoris and serious diseases, thrombolysis and β blockade for myocardial infarction, and aspirin for acute coronary syndromes. These, along with previous studies showing the effectiveness of antihypertensive therapy and subsequent studies showing the benefits of statins and angiotensin-converting enzyme inhibitors, have fundamentally changed medical practice. Physicians must have good reasons to deny patients the potential benefits of these treatments. The impact of this law on the practice of cardiology is uncertain. The law is likely to have an impact on practice in several respects. A fundamental principle is that people have an absolute right to life. This may be contrary to reasonable cardiological advice – for example, a decision not to resuscitate. Consent to treatment protocols may need to be strengthened. The allocation of limited NHS resources can be subject to judicial review – for example, a patient who dies while waiting for coronary artery bypass surgery could be denied the fundamental right to life that would have been granted if they had lived in another country. Social security law has set precedents that apply to insurance medicine. Heart disease sufferers often discuss the option of retirement for health reasons and may even be encouraged to do so by their medical advisors and human resource managers.
However, most permanent health insurance plans stipulate that a worker would have to be “completely unable to continue their previous job” in order to claim benefits. This is a difficult argument for the cardiologist if, for example, the person has fully recovered after coronary artery bypass surgery. These measures were originally developed to compensate victims of accidents at work, not those whose illness is due to natural causes. As a result, there is insufficient funding to meet all requests, and each is reviewed at the time of application and at a later date. Patients may be financially disadvantaged if they retire for medical reasons without first checking the terms of their policy. The first development is the “European cardiologist”. It is a degree that recognizes clinical competence and is awarded upon completion of basic training in the specialty, which includes two years of a common medical core, three years of cardiology and one flexible year in a related discipline. Currently, candidates can also be accepted if they can demonstrate that their training and experience are equivalent to those set out in the recommendations.2 Most of the hundreds of degrees awarded to cardiologists in Southern and Eastern European countries went to cardiologists.
The legal status of the degree has yet to be verified, but under EU law, a holder can apply for a job in any EU country and their application must be duly examined. However, every country has the right to impose higher employment standards in its healthcare system, as would almost certainly be the case in the UK at present. The second European project is the creation of a European Cardiology Accreditation Council (EBAC). This body, like the one awarding the diploma – the European Cardiology Specialty Council (EBSC) – is a descendant of two parent organisations, the ESC and the Cardiology Section of the European Union of Monospecialists (UEMS), which is the official communication channel for cardiologists with Brussels. EBAC became operational in September 2001 and provides a European framework for the approval of postgraduate meetings and courses. To find these and other JAMA patient sites, go to the Patient Page link on the JAMA website under www.jama.com. Many are available in English and Spanish. A patient page on coronary artery bypass grafting was published in the April 21, 2004 issue; A percutaneous coronary intervention was published in the 11. It was released in February 2004; and one on electrocardiograms was published in the 23/30 August 2003 issue. There are three problems with implementing policies: cost, complications, and the fact that the majority of patients receive treatment they do not need.
No country can afford universal health coverage. Some form of rationing is therefore inevitable, and this is, of course, a major reason for the development of guidelines. In states and countries where treatment criteria have been established – for example, Oregon in the United States and New Zealand in the case of coronary artery bypass grafting – the experience has not been happy. In theory, guidelines for expensive treatments should allow equitable access based on clinical need. This is what all governments expect from this profession. In practice, each patient has a unique set of problems, and many, if not most, do not correspond to the agreed indications for treatment, especially if they become emergencies. Where rationing is achieved by waiting, as in the United Kingdom, the seemingly random allocation of scarce resources is not manifestly less unfair. Implementing policies in a country like the United Kingdom, where the provision of cardiology services lags far behind most developed countries, will be extremely costly. The costs of NICE recommendations, for example, cannot be borne by healthcare purchasers. These steps in the litigation process explain why so few cases continue. Most cardiologists should have little to worry about.
But the threat of litigation is also a very disturbing experience. Some doctors find it difficult to keep going, but with help, most do, and most find that patients still have enormous confidence in the profession. The flood of litigation may ease somewhat, as plaintiffs are now subject to further scrutiny before receiving legal aid, and the register of lawyers authorized to perform forensic work reduces the availability of the opportunistic lawyer. Traditionally, the practice of medicine has been based on experience, not “evidence.” From the beginning, it was clear that coronary angioplasty and bypass surgery can reliably eliminate angina. No trial has ever been conducted. Our advice to symptomatic patients to have a permanent heart valve or pacemaker replaced is also based on experience. Guidelines for the management of many cardiovascular diseases are therefore produced by expert groups without the benefit of an “evidence base”. These are called “consensus statements.” There is a danger that these expert groups will contain enthusiasts whose influence can lead to recommendations that go beyond the evidence. The regulation on pacemakers in the UK guidelines for pacemakers and electrophysiology, for example, strongly favours two-chamber devices, which seems quite reasonable given their physiological performance. However, the Council would be more persuasive if it were supported by the results of ongoing randomized trials. The complainant`s second option is to seek legal advice and then take action.
Nowadays, the first indication that such an action is being considered is a request for the publication of patient notes. To succeed, the plaintiff must first prove that there was damage – “but I would now be fine for the cardiologist`s actions.” Death is usually undeniable. However, chronic leg pain and immobility after a femoral hematoma are more difficult to assess unless there are convincing neurological signs that could convince a judge. Second, the complainant must prove that the physician “failed to exercise due diligence” and that his act or negligence caused damage (liability). To succeed, a plaintiff does not have to prove causation beyond a doubt, as in criminal law, but only to prove that it was “more likely than not” (causation).