10 November 2022: Roberts - A

Professor Roberts is an epidemiologist. This involves the study of disease occurrence, including research on the causes and counter measures to deal with diseases. He has been involved in a number of studies, particularly on the use of tranexamic acid. The example of a randomised control trial was used as an example involving tranexamic acid for non-cardiac surgery. Tranexamic acid reduces bleeding, and it seems to not have underlying side-effects, so it is considered safe. The study confirmed what was already known, that after surgery there was less bleeding for the patients who had received tranexamic acid. A blood leak situation – a cut – starts two processes. One is the clotting process, and one is the process to break down the clot. Tranexamic acid helps to stabilise the clot by controlling the breakdown process. There is, of course, the need to not allow clots to become a thrombosis while still being successful in closing the blood loss breach.

Bleeding after childbirth, for example, is a leading cause of death worldwide. A study showed the benefits of reducing post-partum bleeding without unwanted clot problems. The treatment has a licenced use for people with bleeding disorders for these reasons. Overall, 40% of all blood transfusions are used to control bleeding after surgery. There is a lack of available transfusion blood worldwide. Tranexamic acid reduces the need for a transfusion by between a third or a quarter, so it was seen to have the ability to cut down the need for transfusions, which results in clinical and financial resource benefits.

Guidelines from 2015 were displayed related to the use of tranexamic acid. One of these suitable uses was as an alternative to blood transfusion. It was suggested that moderate blood loss after surgery could be treated with tranexamic acid without the need for a transfusion. The guidelines indicate that only 10% to 20% of possible uses in this way actually happens. An audit resulted in a figure of 67.5% of uses being made, when actually 100% of the patients should have been eligible. The witness said, “Changing clinical practice is really hard” in response to the displayed proposals in the guidelines to encourage greater use of tranexamic acid. He felt more needed to be done – everything possible. By saying what he did, he had also opened again that window on the world of healthcare which demonstrates how resistant to change clinicians tend to be. In the case of contaminated blood, if only that resistance was limited to the use of tranexamic acid, but sadly it clearly was not. “If I had surgery and woke up to find I had been given blood and not tranexamic acid first, I’d be really annoyed,” he said to illustrate what should happen in his view.

An implementation group had been established and its work is ongoing. It includes webinars with surgeons and anaesthetists. There are checklists before operations happen, like, “is this the correct leg to operate on”, and they wanted to get the option of tranexamic acid on that checklist. There would be a financial incentive too to using tranexamic acid more. The option of sanctions for not considering the tranexamic acid route to control bleeding was discussed. There was also the possibility of publishing league tables to embarrass non-users to do better. However, the group is basically ad hoc, so it relies on convincing agencies such as NHS-BT to provide resources to support an education programme. These have so far not led to funding.

It was highlighted that tranexamic acid is cheap to produce, and this is a problem (but shouldn’t be). Because there is no money to be made, it is not promoted. Pharmaceutical companies work hard to make sure their costly products are highlighted to everyone who might have a role in purchasing or using them. This includes flying experts around the world to attend conferences to push their products. The witness tried to get tranexamic acid on the agenda, but this went nowhere. He had written to Pfizer to add the suitability for use in surgery to the listed uses that come with the drug and in reference books, but they did not pursue this. It was assumed that the costs of making the change for a drug that does not generate much money was just not worth the effort. The witness even wrote to the US President.

The ”CQUIN” approach had previously not produced any progress, but the recent yellow alert about blood supply did allow some level of opportunity to go back to the Department of Health/NHS to advocate again the use of tranexamic acid as a solution to the lack of blood supply. The witness believed that if asked, patients would welcome an alternative to receiving someone else’s blood into their veins if one was available.