Prompt: 

One of the biggest problems in phage therapy has been in the approval process.   Describe the trouble surrounding FDA approval and recommend some suggestions to improve the process of phage therapy approval.

The FDA approval process is long and daunting for any new drug or therapy treatment. Only about 18% of medicines make it to Phase I of clinical trials, according to the Forgotten Cure. Because of the rigorous tests the drugs must pass, it is hard for them to advance past this phase. Another problem is the cost and time of development and FDA approval. On average, it costs $800 million for development and approval of new treatments. This makes the large pharmaceutical companies not want to invest in this research themselves, leaving it for others to do.

The researchers who want to conduct an FDA trial must first submit an application for their trial to be approved. In the case represented in the Forgotten Cure, the researchers submitted an application and then had to undergo a series of questions relating to the trial, to show they were serious and to help prove that their trial would be beneficial, and would not cause further problems. In phage therapy, some of the concerns for FDA trials were lytic phages and the scientist’s ability to identify different phages. The FDA was concerned that temperate phages, that undergo the lysogenic cycle, could exchange genes with other organisms and cause problems during and after testing.

Because phage therapy is to be used on humans, it is much more regulated by the FDA than other animals, and therefore harder to gain approval. The FDA was worried about transduction and that it would cause harm to humans who used the therapy if toxins were to be released. The companies described in the Forgotten Cure had more success in using phage therapy for animals such as chickens. Starting with cows and chickens, however, is one way to help gain public approval.

There are many ways that scientists can help improve the process of phage therapy approval. The work done by Ramachandran in the Forgotten Cure is an example of ways scientists can try to make phage therapy safer for humans. Ramachandran was able to inactivate endolysin, which allows phage to escape from the bacterial cell by weakening the cell wall. In his tests, all of the mice treated with this engineered vaccine survived, while 80% of those untreated did not (Forgotten Cure). Designing methods and techniques like Ramachandran will help the FDA to be more comfortable with giving bacteriophage to humans and will help speed and improve the approval process for scientists and doctors interested in the subject.

Scientific researchers are not the only ones needed for clinical trials. Physicians will need to be involved and collaborate with the researchers to have a successful phage research trial. If physicians do not think that phage therapy will work, or that it is not safe, it will be hard to conduct clinical trials. Helping to educate physicians on phage therapy will improve the approval process.

Another way to help improve phage therapy approval is to increase the understanding of phages general population and convince them of their safety and effectiveness. While gaining FDA approval can be hard, another step is getting patients to accept phage therapy as an acceptable treatment. This can be done by teaching individuals about bacteriophage, and then about phage therapy, making it seem like a common treatment, as it was for the Georgians, who even had vials of phage in first aid kits in the war. Another way to increase the public’s feelings of safety with bacteriophages is to continue to discover more about them, researching phage not only for their potential therapeutic uses but also to learn more about them so that scientists and others can better understand what they are researching and using.