Earlier this year the Food and Drug Administration (FDA) approved Pizensy (lactitol), an osmotic laxative for treating chronic idiopathic constipation and IBS-C. The new medication is great news, but what took so long?
The process of getting a drug tested, reviewed, and approved in the US can take an average of 12 years. This is because the FDA has strict safety protocols that new drugs must go through before they’re actually prescribed or sold to patients. Most new molecules must go through clinical trials before the results of the studies are presented to the FDA. Lactitol, the active ingredient in Pizensy, went through three phases of trials with 1,400 patients.
A clinical trial is research designed to evaluate a new medical treatment, drug, or device. They’re conducted in phases, to find out specific information about the new molecule. One phase may focus on safety, another on effectiveness, and a third may center on comparing the drug with other products.
One of the greatest challenges most clinical research studies face when accelerating new drugs is the clinical investigator’s ability to recruit individuals for trials. It’s one of the major reasons why it takes so long for new therapies to enter the market.
According to the National Center for Biotechnology Information (NCBI), a national repository for molecular biology information, consumers don’t participate in trials because some are skeptical and don’t trust healthcare institutions. Others may be afraid that the side effects from the new drug might make them sicker. But more commonly, people are just simply not aware about the studies occurring in their communities.
Without more drug studies, new therapies like Pizensy could take even longer to enter the market. But there are things the IBS community can do to ensure that scientists continue to focus on uncovering new molecules for treating digestive disorders. Here are three:
1. Increase awareness by asking physicians to inform patients about new trials. Advocacy groups, such as the IBS Support Group, are also great sources of information on upcoming studies.
2. Remind people that participating in a trial gives them access to the latest therapies. During the study, patients will also receive free care from a medical team who carefully monitors their overall health. In some cases, transportation and a small stipend are also included.
3. Give hope to others. Many health conditions or diseases are passed down through families. Participating in a trial helps scientists get one step closer to a breakthrough, helping patients in the future.
Why people of color don’t trust clinical trials
One outcome of institutional racism within healthcare is a deep distrust of clinical trials by minority groups. Clinical trials have, on average, less than 8% minority representation. This means there is not enough data on how medications affect people of color.
Encouraging minorities to participate in investigational studies requires a different approach than just saying the trials must diversify its participants. There is a depressing history of abuse and exploitation of Black people for medical research throughout the slavery and post-slavery years, culminating in the 40-year Tuskegee Syphilis Study, which only ended in 1972.
“That’s the last thing on their minds,” said Kwaku Owusu, co-founder and CEO of Drugviu. “One of the underlying root causes for lack of minority participation in clinical trials is trust. For minorities, the pitch to participate should be to give them free access to promising therapies that aren’t yet available.”
Drugviu is a registry of nonwhite patients and their personal health experiences. Drugviu offers an online patient community where persons of color can share their medication experiences and side effects. At the same time, it is building a nonwhite patient registry for clinical trial patient recruitment. To learn more, visit www.drugviu.com.