6 Responses to “#SaatchiBill – misguided and potentially dangerous”

  1. Professor Stephen Kennedy April 29, 2014 at 9:39 pm #

    Unfortunately, Dr McCartney has misunderstood the fundamental purpose of this bill, which seeks to offer patients hope when the evidence base is either lacking or uncertain.

    The bill certainly does not seek to prohibit research but simply recognises that research has provided too few answers.

    Lastly, as someone who helped draft the wording of the bill, it was very important to make ‘quackery’ more, not less, difficult to practise than at present.

    That explains why the bill puts in place measures, such as the requirements to involve a multi-disciplinary team and seek approval from a Responsible Officer, so as to ensure that clinicians act responsibly and only offer biologically plausible innovations.

    • Nigel Poole May 1, 2014 at 10:58 pm #

      The draft Bill which has been open to consultation merely provides that in considering whether the process by which a treatment decision was responsible, the fact that it was discussed at an MDT “may” be taken into account. That is not a requirement. There is no definition of an MDT and no requirement as to the seniority, qualifications or number of participants.

      The premise for the Bill is that clinical negligence law is an obstacle to innovation. If you remove that obstacle, as the Bill proposes, then there would be little point in replacing it with an even higher obstacle. The “protections” for patients within the Bill cannot be as strong as the protections given by the law of clinical negligence, otherwise the Bill is self-defeating. If you really want to give increased protection for patients why support a Bill which removes their right of redress when harmed by negligent doctors?

  2. Charlie Chan April 30, 2014 at 12:12 am #

    Dr McCartney’s article suggests that the only way to treat patients is by means of evidence-based medicine and, in those failing conventional treatment, through clinical trials,

    Clinical trials have undoubtedly provided huge advances in the management of diseases. However, the greatest advances have come in common diseases, which have a large pool of patients, who might consider contributing to the future greater good.

    This era of evidence-based medicine has also come with a different cost. There is pressure to conform to guidelines developed from clinical trials, and to shun anything outside the norm. There is pressure from peers, healthcare managers, and commissioners to conform.

    Yet we know full well that many patients do not benefit from treatments devised from randomised trials. How many patients does one have to treat, in order to benefit or save one life. The number to treat is often astonishingly high. Hence, some patients may not need the treatment, and some will not benefit, even if they have it.

    So what does one do, when the evidence has run out – all conventional treatments and clinical trials failed? For that individual patient, the sands of time are also disappearing very rapidly. Is the only evidence, which one might consider, that from a randomised trial?

    As a cancer surgeon with a molecular oncology background, I am fully aware that our scientific knowledge of disease is now marching at an enormous pace. Francis Crick and Jim Watson described the structure of DNA in 1953, the year of our Queen’s Coronation. Their discovery has ushered in an explosion in our knowledge of the molecular nature of disease, and given us the ability to manipulate that knowledge to the benefit of the patient.

    In the cancer world, the new buzz words are “personalised medicine”. These two words describe how we, as doctors and scientists, are now able to interpret the individual molecular changes, which are unique to each person’s cancer. Our understanding of these molecular changes has now been translated into a more enlightened period of targeted treatments, designed to attack a molecular defect in an individual tumour.

    Of course, individual molecular defects can occur in different patients with the same cancer, or even in different patients with different types of cancer. These new targeted therapies are usually designed to treat molecular targets in patients with common cancers. But of course, scientifically, these molecules may also be effective in patients with different cancers, perhaps even rare cancers. Yet, the current paradigm of randomised clinical trials is failing patients with rare cancers.

    How can one recruit enough patients to provide a statistically meaningful analysis for people with a rare disease? It is astonishingly hard. It is hard even to address difficult questions in patients with common cancers. For instance, women aged over 70 with breast cancer are commonly not offered chemotherapy, as our current evidence base is inadequate for older women. Several keen clinical trialists have attempted to perform clinical trials to address this issue in a common cancer. These trials have all closed, due to a failure to recruit.

    So what hope for the young child with the rare brain cancer, or for the 30 year old sportsman with motor neurone disease. There is little or no evidence for us to offer anything to these people. So with no evidence, we do not treat. We are encouraged perhaps, not even to think.

    Is this how our colleagues would have thought before this era of evidence-based medicine? People then would have thought about individual difficult problems, and tried to devise a logical plan, using the knowledge they had at that time. They were innovating. – innovating without fear of litigation.

    This Bill supports responsible innovation, for which the decision to offer innovative treatment is shared amongst a group of doctors, such as in a multidisciplinary team. This shared decision amongst a group of doctors is a more stringent test than that currently required to end life using the Abortion Act, or to incarcerate using the Mental Health Act; only two doctors need to make those decisions.

    There is a proposal to create a Central Data Repository, which will log every innovative treatment resulting from this Bill. Hence we will be able to learn from these treatments in patients, where all standard and trial therapies have been exhausted. This resource may also spawn new hypotheses, which may lead to substantial clinical trials addressing difficult problems, both in rare and common diseases. Hence this Bill would not promote pseudomedical nonsense or quackery.

    The patients want to have this opportunity, when there are other options have run out. We, as their advocates, owe them a duty to innovate in a responsible manner. Otherwise, we condemn all these poor souls to the worse outcome possible – premature death.

  3. lorraine cleaver May 1, 2014 at 1:29 pm #

    I tire of the banging of EBM drum when it’s known that as much as 50% of evidence is never published.

    In the year 2012/13, 225,000 prescriptions were issued for Levothyroxine in Scotland. Hypothyroidism is not the easy to manage, one pill a day disease medicine would have us believe and the evidence there is also questionable.

    Healthcare Improvement Scotland carried out a scoping report as part of my petition for improved thyroid and adrenal diagnosis and treatment. Under the header Evidence Base, they state “UK guidelines for the use of Thyroid Function Tests published in 2006 were based on a non-systematic review of generally poor quality evidence from the American Association of Clinical Biochemists.” and also “A recent review reported an association between variations in TSH and thyroid hormone levels and adverse health outcomes in individuals with test values within the reference range.”

    The fact is, there are no guidelines for treating this very common and debilitating disease and the Policy Statement of the RCP is based primarily on Professional opinion. While medicine argues, patients have little choice but to press ahead for other avenues to regain their health and this bill may just help.

  4. lorraine cleaver May 1, 2014 at 1:31 pm #

    The report I quote from above file:///C:/Users/lorraine/Downloads/Hypothyroidism%20(3).pdf

    My petition which the Scottish Government and Scottish Parliament are thankfully taking seriously. http://www.scottish.parliament.uk/GettingInvolved/Petitions/PE01463

  5. Keith Walker May 2, 2014 at 1:34 pm #

    Whilst admiring the sentiment, I’m not sure what a premature death is, but accepting the notion of it, I think it’s the disease that condemns one to it, not the absence of unsubstantiated and experimental treatment that might make the remainder of life even worse, or indeed shorter. Just another view.