Undermining the Hippocratic Oath: the Medical Innovation Bill

Editorial

PA Wire

Undermining the Hippocratic Oath: the Medical Innovation Bill

On Nov 13, 2014, 100 prominent UK oncologists signed a letter to The Times stating they "neither want nor need" the Medical Innovation Bill tabled by Lord Saatchi--an unelected individual with no professional medical or scientific training--that is currently making its way through the House of Lords. These oncologists join almost every prominent British medical association in condemning the Bill. In about 600 words, the Bill tables a series of sweeping indemnities, which would see medical professionals exonerated for not following "the existing...accepted medical treatments...if the decision to do so is taken responsibly". As defined by the Bill, acting responsibly includes having "obtain[ed] the views of one or more appropriately qualified doctors in relation to the proposed treatment", and taking full account of these views as "any responsible doctor would". A doctor may only depart from accepted medical treatment if it is with the patient's consent, and certainly not "for the purposes of research, or for any purpose other than the best interests of the patient".

The Bill is presented as offering patients with terminal disease potentially curative options. Its proponents argue that, by allowing doctors to depart from conventional medical treatment without fear of litigation and outside of clinical trials, patients' lives could be saved by use of innovative medical practice. This would be laudable were this the case. However, it is untrue: doctors are already able to innovate outside the context of trials. Many oncology drugs are used off-label (especially towards the end of life), and equally, many medicines are only approved for adults and must be used off-label for children.

Alarmingly non-specific in its wording, the Bill opens up several potential means of causing harm to patients without recourse to protective litigation. While terminal, rare cancers are the medical condition most frequently invoked by the Bill's proponents, there is no clause stipulating that patients need be untreatable by accepted medicine, nor that they be terminally ill. Thus, the Bill might allow a doctor to depart from accepted practice for no reason other than that he or she, and at least one colleague, does not accept it as best. As Baroness Masham noted in the Bill's second reading, this legislation "would affect all forms of medical treatment, not only in exceptional circumstances...when all evidence-based treatment options have been exhausted", opening the

door to the use of less proven, or unproven, approaches such as complementary or alternative medicine.

There are many ways in which doctors can access drugs that are in early-stage clinical trials but not yet widely available. However, provision of these agents on a desperate whim, in an unmonitored environment, could lead to patient harm. For example, the maximum tolerated dose may be unknown, leading to the dose being subtherapeutic or causing unexpected adverse events. Even if the drug had advanced to later testing, but is not yet licensed, pharmaceutical companies would be required to disclose data about toxicities to national licensing agencies only. This information may not stop pharmaceutical companies from promoting their treatment to medical professionals. Doctors could end up prescribing drugs that hurt their patients, only to find later that the toxicities were known, but undisclosed. Not only would this cause otherwise preventable harm to patients (clearly at odds with the founding tenet of medicine to "do no harm"), but could cause immeasurable psychological pain for doctors who believed they were providing the best care for their patients. And who would pay for these drugs outside a specially designated funding mechanism?

The Medical Innovation Bill strikes at the heart of evidence-based medicine. Saatchi and colleagues have often quoted Sir Austin Bradford Hill, pioneer of the randomised trial, who wrote that "Any belief that the control trial is the only way [to study therapeutic efficacy] would mean not only the pendulum had swung too far, but that it had come right off its hook". To pretend that the alternative is the provision of untested evidence on one or two individuals' potentially biased judgement is not only disingenuous, it is harmful. Evidence-based medicine is a pragmatic approach to an emotive topic that aims to balance advances in medicine with an appropriate degree of caution. In attacking the signatories of The Times letter as complacent and self-satisfied in his commentary in The Guardian on Nov 14, 2014, Saatchi gave in to precisely the type of emotional response that evidence-based practice seeks to avoid. We are all human; evidence-based medicine provides safeguards against paternalistic, impetuous decisions that may be made with the best of intentions, but without due diligence. The Medical Innovation Bill seeks to undermine this, and should not be enshrined in law. The Lancet Oncology

Published Online November 28, 2014 S1470-2045(14)71139-8

For the Medical Innovation Bill see . uk/bills/2014-15/ medicalinnovation.html

For the Bill's second reading in the House of Lords see http:// publications.parliament. uk/pa/ld201415/ldhansrd/ text/140627-0001. htm#14062743000565

oncology Vol 16 January 2015

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