Biontech has arrived in the reality of the pharmaceutical business. That is probably the way to put it if you mean it benevolently. On Wednesday, the US drug regulator announced that a cancer drug study had been partially stopped due to safety concerns. Three people are dead, and it cannot be ruled out that this is related to the therapy that the Mainz-based company tested on humans for the first time together with its Chinese partner Medilink.
It is normal for patients to die during clinical trials, as cynical as that may sound. Cancer drugs are first tested on seriously ill people. Their chances of surviving longer are poor. The failure of trials is also the rule rather than the exception: only five out of 100 cancer drugs are approved. But in this case, three out of 52 subjects died in an initial clinical trial. Even experts describe this as unusual. But what is even more irritating is how Biontech is reacting to this. They are talking about “safety signals” instead of deaths. Instead of providing information, they are using ambiguities.
The active ingredient co-developed by the Mainz team is intended – if all goes well – to improve the chemotherapy that is commonly used to treat cancer. These work by disrupting cell division. Because tumors usually grow very quickly, they stop the growth. The disadvantage: the active ingredients do not stop at healthy cells. Tissues that generally regenerate more quickly – such as the mucous membranes of the mouth, stomach or intestines – are also affected. Side effects such as inflammation of the mucous membranes, diarrhea, vomiting and hair loss are the result.
Biontech and Medilink’s strategy is to combine such chemotherapy drugs with antibodies that specifically target cancer cells. The hope is that this will make the treatment more tolerable and effective because it will spare healthy tissue. But now three people are dead and the question arises whether at least one of the cases could have been avoided.
The deaths occurred during the dose increases that are usual in this phase. This is how pharmaceutical companies test which amounts of active ingredients achieve the best benefit with acceptable side effects. Two of the test subjects developed blood poisoning, as a result of which they died. Other patients received an even higher dose, and one developed pneumonia, which he did not survive. It is still not clear whether the three patients actually died as a result of the treatment or whether it would have happened anyway, especially since the patient with pneumonia had Covid. This must now be determined.
Did the deaths occur before the new dosage was administered? Were sufficient safety intervals observed before the dose was increased? But instead of explaining, Biontech does not answer questions about the study’s procedure or answers them in a cryptic manner. They resort to the statement that the clinical trials are subject to a “rigorous process” and are “carefully designed and comprehensively monitored.” They say that it is “not unusual” for safety signals to be observed during a “dose escalation phase 1 study.” All of this is true.
And again, not when it comes to how Biontech communicates. In a crisis – and a study that is not extended further due to deaths is nothing else – transparency is needed. Towards the regulatory authorities, the trial participants and also towards investors and the public. The pharmaceutical industry has committed itself to this after the many scandals involving falsified studies and bribed doctors. The question is whether Biontech knows that it is no longer a small start-up, but a pharmaceutical company that has to ask itself questions.