Gene editing. Therapeutic drugs. Reconstructive surgery. In this article, you will get to know why does it take so long for new hearing loss remedies to become publicly available.
We’ve seen some incredibly exciting research into deafness and hearing loss over the past several years — some of which have the potential to make even congenital deafness a thing of the past. Yet, for all the potential they display, we must take each with a grain of salt.
And for all that they point to a future without hearing impairment, it will be a long time before we see tangible benefits from these studies. As noted by the US National Institute of Health’s National Library of Medicine, there is a significant time lag between medical research and medical interventions — an average of 17 years, to be exact. To understand why this is the case, one must first understand the processes and principles underlying health research.
Before we dive in, however, it’s important to note that the COVID-19 vaccine is not as much of an anomaly in this regard as one might expect. As reported by Medical News Today, much of the research underlying the vaccine’s development was based on prior research into other viruses from the same family. This previous body of work combined with international collaboration and no shortage of funding effectively supercharged the vaccine’s development.
Most health research does not have the benefit of a global pandemic to drive urgency and secure funding. Instead, it is an extensive, deliberate process. Funding must be secured, research must be tested and verified, and — if and when that research leads to a treatment — clinical trials must be carried out.
The process by which a new drug is developed, for instance, looks a little something like this:
- Initial research. This can take years, sometimes even as long as a decade. And that’s assuming there are no setbacks in the research.
- Preclinical testing. Per the Food and Drug Administration (FDA), drugs must be tested for an average period of three and a half years before being allowed to enter human trials.
- Investigational New Drug (IND) Application. Essentially, this details the results of preclinical testing and is used to determine whether or not a drug is approved for human testing.
- Clinical Trials. Testing on human beings. Divided into three phases, clinical trials are typically carried out over an average of six years.
- Phase 1 (1 Year). Healthy volunteers.
- Phase 2 (2 years). Patients for which the treatment or drug is intended.
- Phase 3 (3 years). Large-scale, randomized trials involving several thousand patients. Each patient is provided with a list of possible side effects from previous trials.
- New Drug Application. Once all data from the clinical trials has been collected, the manufacturer collects it and submits it as part of a New Drug Application. These documents are comprehensive, often 100,000 pages or longer. It takes an average of two and a half years for such an application to be approved.
It may seem frustrating that so many promising treatments are locked away behind so much red tape. But it’s important to remember that these checks and balances exist for a reason. Modern medicine is a far cry from the slapdash techniques of a century ago, and it’s far better to have to wait a bit longer for treatment than to risk undergoing a procedure whose side effects may be worse than the condition it was developed to treat.
About the Author:
Dr. Renee Flanagan is the Director of Audiological Care at HearingPlanet. She works with the training and development of Hearing Care staff so they may help the hearing impaired population by following best in class hearing healthcare practices.