Bleeding

AJ and I attended an investigator meeting last Saturday. During coffee break, he mentioned how the recent NovoSeven incident might affect their department policy in the future.

The story goes like this. Two weeks ago, there was a road traffic accident. A young lady suffered from pelvic trauma and was sent to a major hospital in town. Because of severe internal bleeding, the attending doctor suggested to use a drug called NovoSeven. However, this drug was not provided by public hospitals for this indication, and the family members had to pay for it. The family members paid but were unhappy with the arrangement. On second thought, they filed a complaint to the Hospital Authority.

At this time, the news has already been spread by the media. The Hospital Authority did not support the doctor either. The administrators quickly refunded the family members. According to the news, his behavior was commented as inflexible and inappropriate.

In the following days, politicians and columnists were quick to demonize the attending doctor. He was portrayed as apathetic and unkind. In addition, he was compared to physicians in Mainland China who refused to save patients if they had no money.

I can understand the reaction of the public. After all, it is scary if healthcare providers may not do their best during life-saving situations because of monetary reasons. However, fundamental questions were largely ignored. Did the emergency doctors withhold life-saving procedures at the time of discussion? Does NovoSeven work?

To my horror, whether the drug works was never the focus of discussion. Even politicians with medical background thought drugs with potential benefit (but not supported by evidence) should be given liberally during emergencies. In the era of evidence-based medicine, all medical treatment should be based on the best available evidence. The medical literature is full of examples of therapies with theoretical benefits that turn out to do more harm than good.

So, does NovoSeven work?

NovoSeven is recombinant factor VIIa. It serves the function of coagulation factor and makes the blood clot. It has been registered at the US Food and Drug Administration for the treatment and prevention of bleeding in patients with hemophilia (I left out the technical descriptions for simplicity). Apart from hemophilia, studies have shown improved functional outcomes among patients with intracranial hemorrhage treated with NovoSeven. In a randomized controlled trial of 301 patients with trauma and severe bleeding, the administration of NovoSeven, as compared to placebo, reduced the need for blood transfusion, but the difference in deaths and critical complications was not statistically significant.[J Trauma 2005;59:8-18] The absence of survival benefit was confirmed by a few other retrospective series. In other words, you probably can spare trauma patients from the drug by providing adequate blood transfusion and yet still achieve the same outcome.

At the end of the discussion, AJ was still worried that his patients with gastrointestinal bleeding would force him to provide the drug.

“Don’t worry,” I answered. “Level one evidence failed to show that the drug improves outcomes in patients with variceal bleeding.”[Gastroenterology 2004;127:1123-1130]