Breast Cancer Clinical Trial Insights – Rebuilding a Foundation of Trust in Minoritized Communities

Clinical trials help us learn more about the body, diseases that impact it, and medications to help it heal. Sounds great, right? Then why are so many people so skeptical of them? That’s complicated, but the short answer is history, which includes many examples of how minority communities have suffered at the hands of research and science. Researchers haven’t always been as heavily regulated as they are today, and there have been many instances of researchers and organizations acting unethically. While governments and research organizations around the globe have created laws, regulations, and best practice guidelines, there’s still a lot of mistrust. We get it, and we know that patients want the truth, and deserve full transparency in order to build trust, so let’s talk about it.

A Dark Past

Although clinical research has helped shape the present and future of lifesaving treatment interventions, the path of success is also littered with a past of unethical and exploitative experiments, a couple of which are listed below.

Tuskegee Syphilis Experiment

Many of us are familiar with the infamous Tuskegee Syphilis Experiment, in which many serious ethical issues came to light as details of the experiment were revealed through investigations and Congressional hearings.   As part of this experiment, Black men (some who were diagnosed with syphilis and some who were not) were told that they would be undergoing treatments for  “bad blood” which was a common term at that time to describe a variety of conditions. The experiment began in 1932, and at that time there were no treatments for syphilis. Men in the trial were offered free medical care along with some other benefits in exchange for taking part in the trial which was designed to study the full course of the disease. By 1943 Penicillin was widely available and well known as the standard treatment for syphilis, but researchers urged health professionals in the area not to provide it to study participants and instead gave them aspirin or supplements. . This was done without the patients’ knowledge or consent and is one of the reasons the informed consent document is required and heavily reviewed and monitored for every clinical trial and every participant.  

Clearly, this violated the basic human rights of the patients involved. It also breaks one of the three basic principals that guide clinical trials and researchers today: respect for patient autonomy.  These violations became grounds to pursue compensation, both monetary reparations and medical benefits for the victims of the Tuskegee Syphilis Experiment and their families. Victims of the study received a formal presidential apology from President Clinton in 1997 as well.  This historical event marked a newfound push for higher quality in clinical research and ethical standards to be used around the world.

The Power of One: We want to take a moment to celebrate the researcher who found out what this team was doing and reported them-Peter Buxton. When study leadership wouldn’t pay attention and shut down the trial, he went to the press to leak the story which spurred national outrage leading to the termination of the trial. Good people who care about other people can and DO make a difference. We thank Peter and all others who have stood up and spoken out against the exploitation of our brothers and sisters.

HeLa Cell Experiment

Henrietta Lacks, a 31-year-old mother of five,  was experiencing concerning vaginal bleeding outside of her menstrual cycle. She went to The Johns Hopkins Hospital, one of the only hospitals at the time that would provide care to Black patients, and during her exam, the doctor found a large cancerous tumor on her cervix. She began radium treatments which were the standard of care for cervical cancer at the time. So far, so good right?  A patient comes in with a concern, has a thorough evaluation, begins the best treatment available. That sounds like an ideal scenario!

Enter Dr. George Gey, a cancer and virus researcher at Hopkins. Tissue samples from Henrietta and many other patients were sent to Dr. Gey’s lab for analysis. He noticed that Henrietta’s cells, today referred to as HeLa cells, were different than other patients. Most of the samples he received died quickly, but the cells in Henrietta’s sample continued to live and replicate, doubling every 20-24 hours. Today, federal law would require Dr. Gey to get Henrietta’s full consent before using her cells for his tests, which have contributed to medical breakthroughs for decades. In 1951, no such law existed, so Henrietta wasn’t told that her cells were being used in research. Again, just like with Tuskegee, there was no transparency, and Henrietta wasn’t given the chance to give consent. Unlike Tuskegee, there is a bit of grey area here. What Dr. Gey was doing in his lab was very much the norm during that period of time, and while Henrietta wasn’t aware of the research being done with cells from her tissue samples, she did receive the very best care available at that time for her cancer. Despite this, Henrietta died in October of 1951. She is often referred to as immortal though as her cells continue to contribute to medical breakthroughs and her life and memory have heavily influenced the regulations surrounding consent for tissue samples. Henrietta’s genetics led to key developments in areas like vaccines, cancer, and fertility treatment, contributing to nearly 75,000 studies.  In recent years, much has been done to rectify the way Henrietta Lacks’ cells were used without her consent.  The National Institutes of Health granted some control to her family over scientists’ access to the cells’ DNA code and agreed that they would receive acknowledgment in the resulting studies.  A book has been written about how this Black woman unknowingly transformed biomedicine, this best-seller is called The Immortal Life of Henrietta Lacks. In 2021, the “Henrietta Lacks Enhancing Cancer Research Act of 2019 was enacted into law, which requires the U.S. Government Accountability Office to complete a study on barriers to participation in federally funded cancer clinical trials by populations that have been underrepresented in such trials.  In addition, several foundations have made significant donations to the family’s foundation, but not until much legal pushback from the family.

Tiger Trials Truth: We believe that when we know better, we can (and should) do better. Unfortunately, Henrietta’s family wasn’t asked for their consent to share her name, cells, or details about her genetic profile for decades. They also didn’t receive any compensation of any kind for many years even though her cells played an important role in the development of countless new drugs. Her cells continue to be used to develop lifesaving new therapies, including the COVID-19 vaccine, but many researchers question the ethics of continuing to use her cells. Because they were obtained without her consent, despite it being legal at the time, we know better now. Researchers who believe we should reduce or discontinue the use of her cells in the future argue that continuing research with these cells perpetuates injustice. Others argue that terminating the use of HeLa cells goes against her family’s wishes. Her granddaughter, Jeri Lacks-Whye said “I want scientists to acknowledge that HeLa cells came from an African American woman who was flesh and blood, who had a family and who had a story,” in an interview with Nature.

The Future of Clinical Trials

 Being transparent about the history of research and how that has shaped laws and guidelines about care, consent, and safety today is a good first step.   With that said, it is common for people to have anxiety when they hear the words “research” or “clinical trials.” Many people know about what has happened, but few know about the changes brought about because of these tragedies.

Today, there are many systems in place to prevent unethical practices, protect patient safety, and ease the barriers we know contribute to health inequity. Some examples of these are institutional review boards and ethics committees, strict informed consent regulations, and the research participant bill of rights.

Some other protections for participants in clinical trials are: 

• Data & Safety Monitoring Boards: This is a group of experts who regularly review data collected during the trial while the trial is going on. Their job is to evaluate the results as they are collected, and they’re looking for two things: is this drug working, and are the patients who are participating safely?
• GCP: GCP is otherwise known as “Good Clinical Practice” which is an international research standard for another layer of protection for study participants. The goal of this standard is to protect the rights, safety, and welfare of people participating in trials. It also works to ensure data that is collected is complete, accurate, and credible.

There is still much work to be done, but with these regulations and best practices in place to protect patients, medicine has become safer, more inclusive, and more accessible. If you or a loved one are considering participating in a clinical trial, you likely have many questions. We’ve included a few common ones below. When you’re done, check out our FAQ page here.

Frequently Asked Questions