The Complex Process for Formulating Medical Treatments

When was the last time you heard about someone getting smallpox? Thanks to routine vaccination, the disease is believed to have been eradicated. Now monkeypox is becoming a problem in Africa, and doctors have developed a treatment to help those who get infected.

The development of a new medical treatment is not a fast process, but it is an important one. Medical treatment and vaccines can prevent people from getting serious diseases, can minimize the risk of infection, and can prevent serious complications and even death. It’s important to understand how this process works.

Identifying the Problem

Unfortunately, the process of developing a new medical treatment does not begin until there’s a problem. That means that a lot of people are likely to suffer or die before scientists even know that there is a problem that needs solving. Many more will suffer and die after the problem is identified and before a treatment is developed. Just think about how long it took before scientists understood what was happening in patients who had HIV and AIDS.

The better we can be at identifying a problem and determining the parameters of a disease, the better we can be at getting the research process started.

Research and Testing

Once scientists know exactly what the problem is, they can start researching drugs that will help the body fight the infection, that will kill the virus, that will treat the symptoms, or that will otherwise offer some kind of relief or cure. Researching and developing the drug or treatment is the most extensive part of the process. At this stage, scientists must have all the right tools; must have the right facilities, including the ability to store and transport samples and biospecimens effectively, such as through companies like Pacific BioStorage; and they must have the appropriate funding. Insufficient funding or a sudden loss of funding stalls or thwarts progress in the development of new treatments all the time.

Scientists must test the drug or treatment at every stage of the process. Treatments are often first tested on animals to determine whether they are effective and safe. Depending on the results of that testing, scientists may have to reconfigure the drug. Sometimes, they may have to go right back to the drawing board and start over. If there are numerous setbacks, the process can take many years and millions of dollars.

The final phase of testing for a treatment is human testing. At this point, the treatment must be seen as relatively effective and safe based on animal tests. Human trials require informed consent and strict oversight. Yet this stage can reveal much about the effectiveness of a treatment.

Approval and Regulation

Before any drug can be sold or treatment administered, it must be approved by the appropriate government agency — typically the Food and Drug Administration. This is an intensive process that requires that regulators look at all the data related to the treatment, including the research and testing conducted. Regulators may ask for more information, or they may even try to replicate results for some tests in their own lab.

Once a drug or treatment is approved, it will be subject to a period of follow-up monitoring. The FDA or other government agency watches carefully to make sure that results were what was expected and that the drug maker and the drug administrator adhere to regulations.

The process of developing a new medical treatment, whether it be a drug or another type of treatment, is intensive and complex, but it must be so. Medication and other treatments should save lives and improve health, not cause more harm. It is important that pharmaceutical and healthcare companies are held to the highest standards.