7 March 2023
During World War II the scientific communities for the Allies as well as the Axis powers were each desperately searching for the secrets of the class of drugs we now call antibiotics. At this point we have a full range of antibiotics, antibacterials, and antifungals. Countless conditions were now treatable and lives were and are saved. However, as we all realize, nothing is static. Our bodies continue to develop, as do the various organisms we encounter on a daily basis.
There are now strains of bacteria, viruses, parasites, and fungi that have mutated to become resistant to our current treatment regimens. They are being called superbugs, or antimicrobial resistance. These infections are rapidly taking their place as a top killer along with HIV and tuberculosis.
In fact, as you stumble into your doctor’s office or urgent care and request “something” to help you get over your current ailment, the doctor or physician assistant may be reluctant to prescribe an antibiotic that would fix you right up. In 2016 a study showed that many, if not most, of the prescriptions for respiratory conditions were the result of viruses, which do not respond to antibiotics. The rationale is that our bodies will become so used to the drugs that when we really need them, the medications will not be effective.
The next step is research to find new and better solutions. There is a report that indicates 63 new antibiotics were approved by the FDA between the years 1980 and 2000 with 15 more approved between 2000 and 2018.
Once a company has developed a new drug and it has been initially tested, it contacts the FDA’s Center for Drug Evaluation and Research (CDER). This entity uses a team of physicians, statisticians, chemists, pharmacologists, and others to evaluate the benefits and risks. This team does not do the testing but only reviews findings from other studies. The developer’s tests include laboratory and animal testing before it is approved for human testing.
In the development stage, the FDA has several classifications. A “fast track” is requested for drugs to resolve serious conditions or for those illnesses that have no options. “Breakthrough therapy” is for one of the treatments that have shown a substantial improvement over the current treatment options. Finally “priority review” is when the FDA will review the application within six months instead of the standard ten.
The data is considered and if CDER decides that its benefits are greater than the risks, the approval process starts. The FDA will review the illness or condtion to be treated as well as the current medical options. So, a disease that has no viable treatments at this time will receive a greater chance of moving along the pipeline. The agency will then look at the results from two independent clinical studies to see how things went. All pharmaceuticals have risks. The FDA and the manufacturer may have differing opinions about the risks and benefits. The FDA will use scientific and technological information to base their decisions.
So if you, or someone you know, is anxiously awaiting one of the new antibiotics or pharmaceutical for another illness, this is what the process before they reach your medical team or you see them advertised on television.