Wednesday, July 25, 2012

Scientists banned after deadly probiotic treatment

Recently, scientists have begun experiments with bacteria as a new form of treatment. For some diseases it is hypothesized that administering bacteria can improve health, for example by providing patients with probiotic drinks. Despite a lack of conclusive evidence for its efficacy, scientists have been experimenting with probiotics for new patient groups, of which brain cancer is perhaps the most peculiar example. Needless to say, things can go wrong with experimenting. Two scientists that experimented with infecting patients suffering from brain cancer found their results a little off: instead of treating the tumour, the patients died from the supposedly beneficial infection.

In their study, which was conducted at the University of California in Davis, the two scientists experimented with brain cancer patients that were predicted to have only a few weeks to live. Patients reaching that stage of their disease are frequently experimented with, as they do not have much to lose. Additionally, clinicians do not always have to face the extensive regulations set up by the FDA or other regulatory institute for conducting human experiments.

Facing only little regulation for the treatment of the terminally ill, scientists can experiment with a lot of new treatment options. Giving clinicians too much freedom can lead to bad things, as this example illustrates. The two scientists, working as surgeons, thought it would be worthwhile to try infecting terminally ill brain cancer patients with Enterobacter aerogenes, a bacterium that normally lives in our intestines and is harmless there. However, it is known that infections with E. aerogenes can lead to sepsis, an often deadly condition.
Three patients suffering from terminal brain cancer were infected with the bacteria. According to university authorities, that investigated the study, two of those patients died from sepsis, which is basically a blood infection. The university also claims the two surgeons acted without required approval of the ethics board. According to the surgeons, they did not need this permission, because their treatment was not a clinical trial, but instead 'innovative care'. However, treatment with bacterial cultures is similar to using an experimental drug, something that is regulated and needs to be approved. Therefore, the study concluded with the two scientists being banned from conducting further human experiments, something which seems justified.

Role of bacteria
Bacteria are well-known as the cause of various diseases. A little less known is the fact that they play an important role in the artificial production of highly valued substances, such as insulin for diabetes patients. Microbes also dwell in our intestines, where they help with digestion. It is clear that not all bacteria are bad, and some of them are even necessary for our survival. It is therefore not surprising that scientists have come up with the idea of probiotics. The idea of infecting people with bacteria in order to slow down tumour growth was derived from observations that people with infections as a result from surgical operations lived longer. However, the few studies existing that systematically assessed these claims either found no such evidence or were inconclusive. It shows that the two surgeons were irresponsible in the way they set up their hypothesis for treatment.

This example shows that it may be good to apply more rules and regulations to such 'experiments'. Pharmaceutical companies attempting to develop drugs face a mountain of requirements before their drug can find its way to the market, and it seems reasonable that experimenting with human lives would at least require some form of approval. While terminally ill patients often have nothing to lose, it is possible that an highly experimental treatment worsens their suffering. Because such patients are often desperate and grasp onto everything they can get, it is unethical to leave the choice to them. Clinicians should therefore be kept in check when it comes to experimenting with unproven treatment options. 

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