The Medical Innovation Bill tabled by Lord Saatchi and currently making its way through the UK's House of Lords "strikes at the heart of evidence-based medicine" and risks "opening the door to the use of less proven, or unproven, approaches such as complementary or alternative medicine", according to a new Editorial published in The Lancet Oncology.
According to the Editorial, "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."
The Editorial goes on to explain why the Bill could ultimately cause harm to patients, adding that, "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."