OVERPRESCRIPTION COULD STIFLE MEDICAL RESEARCH
From the desk of MD
CLINICAL TRIALS, by their very nature, always assume an element of risk. Whatever computer analyses or laboratory tests on mice or rats might predict, a new drug cannot be licensed or commissioned until its effects have been tested and demonstrated on human beings. In virtually all cases, clinical trials are designed with such precision and accuracy and so closely monitored that patients suffer no adverse reactions: the worst presumption that can made is, generally, there is no improvement in a patient’s condition. Only very rarely do things go terribly and dreadfully wrong, such as happened in 2006 when six volunteers suffered very serious side-effects while trialling a drug for leukaemia and arthritis.
Tight regulation is a common denominator amongst much clinical research to prevent and guard against such disasters. Society’ concerns are not only to ensure the physical and mental safety of patients during trials but also of ethical implications in producing new drugs and procedures which might question, retrospectively, commonly long-held views, morals and medical standards already deemed as sacrosanct. Regulatory bodies such as the Human Embryo and Fertilisation Authority (HFEA) have to ensure that any research and practices carried out are in full compliance with necessary regulatory measures and, specifically, that they do not breach ethical guidelines.
The danger now, however, is not a lack of regulation and oversight but, rather, too much of it. Medical research and the trials that support new developments in medicine have to pass through an avalanche of paperwork with interminable levels of bureaucracy and red-tape before new drugs and research is given the go-ahead. Trials are required in being approved by multiple and interested bodies, including national ethics assessors and committees, the Medicines and Healthcare products Regulatory Agency (MHRA) and other vested groups that have arrogated a right of consultation to themselves under the EU Clinical Trials Directive. The consequential effects include rising costs, a waste of management and research time and additional bottlenecks clogging up a system that requires improved efficiency in how research might be advanced for the common good and wellbeing of some patients suffering intolerable levels of pain and suffering.
The attributive source for this article quotes that three medical academics from the universities of Cambridge and Birmingham have now called for an end to this excessive regulation, which they say is strangling clinical research, does very little in detecting poorly designed or unethical studies and can disadvantage patients by denying them the chance to take part in trials that could be beneficial. They suggest, rightly, that a single, web-based submission could speed up the approval process – which, otherwise, might take up to a year consuming all the time for a research fellowship.
The academics blame the Government, particularly in the areas of time lost and wasted effort. Currently, regulatory enforcements even leads to the absurdity of drug companies having to resubmit tested and approved drugs if these are used in stages of new trials.
Like many drug treatment programmes themselves, the fault, even in this instance, seems to lie within inadequate micromanagement. Implicitly, the Government repeatedly calls for the rapid and swift “translation” of basic research into drug treatments and therapies that benefit patients but it fails to accept that any attempt to prescribe this format has an opposite and negative effect, delaying the approval process by … “opening the door to those jobworths whose only interest is in tinkering so as to demonstrate the need for their input.” The MHRA would do much better to focus on the safety and effectiveness of medicines than on continually controlling the trials of existing drugs.
A key question that stems from the article is why the government is so reluctant to fund anything that does not directly address health issues in the news – cancer, AIDS and multidrug-resistant bacteria? The dangers of overprescription run central to Whitehall’s attitude to advancing clinical and medical research. Yet, this has repeatedly shown to be counter-productive.
Fortuitous scientific providence (or, Serendipity) has, looking back through history, been the key to some of the greatest scientific discoveries: pure research – whether medical or within other branches of science – yields results that cannot be foreseen or predetermined. Sometimes it should be better for the Government to exercise restraint, and not excessive constraint, in areas of prescription and regulation of clinical research.
© Mark Dowe 2008: all rights protected
Attribution:
- The basis of this article has been taken from the Times editorial, entitled “Overprescription” and dated Friday, 17 October 2008 [page 2]
- The wording of the journal stated here is my own and differs significantly to the source quoted but does follow a similar contextual theme.
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Filed under: NHS, medical research | Tagged: clinical trials, commissioning of new drugs, ethics, eu clinical trials directive, HFEA, medical research, MHRA, micromanagement, NHS, regulation
