Summary: Breast Cancer is a personal diagnosis, requiring a personal treatment plan. Clinical trials can offer new opportunities for patients facing a breast cancer diagnosis, globally – and but trust between the medical community, industry, clinical trial stakeholders, and under-represented communities – specifically Black and brown ones – must first be rebuilt before a trial is considered, trusted and adhered to.
A Note From Our Founder:
There is much trust to be built with the healthcare and scientific community and that’s why we have launched our Tiger Trials program – built for and with patients of color to ensure we eliminate barriers to care – and integrate trust and transparency in order to achieve transformation. As a patient of color, I was never offered a trial. I was never talked to about trials. I only learned about them when my friends began to die of metastatic breast cancer and learned that they were being offered as a last resort. As a patient diagnosed with triple-negative breast cancer, for which there was no targeted treatment at the time – 15 years ago, and the type of breast cancer that is most aggressive and that Black women die from at high rates, as part of my living legacy, I am committed to ensuring that I do all that I can with my Power of One to ensure diversity, equity, and inclusion in clinical trials. Lives depend on it, and the power to transform outcomes for millions of women across the world lies with us all using whatever privilege and power we have for the better. Tigerlily Foundation is working with patients, community-based and global partners to amplify and integrate the voices of populations that need representation and must be included. That is my promise to the patients I serve.
Maimah S. Karmo
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
Q: Is participating in a clinical trial considered a dangerous “last resort”?
A: No, not at all! While the clinical trial process may feel more uncertain than conventional treatment, this is often because the studies required for drugs to become approved are still in progress. Nothing is without risk, not even supplements you might pick up at the grocery store, but any risks to participating in a trial are thoroughly reviewed with each participant prior to any trial-related activities or procedures are done. It’s also important to know that the drugs, tools, and other treatments that are commonly used in Emergency Rooms or your doctor’s office exist because of clinical trials. By participating in a trial you are helping researchers learn important information that could transform the way patients are cared for in the future.
Q: I’m concerned I’ll get the placebo, or it won’t help me.
A: Placebos are not used in oncology trials unless there is an adjunctive treatment along with conventional. That means, if a cancer study has a placebo included, the placebo would likely be added to the standard of care.
Q: I’m worried the treatment will be painful or that I’ll feel like a guinea pig. What if I start a trial and don’t like it?
A: You always have the full right to withdraw from a clinical trial at any time for any reason and without any consequences from the study team.
Q: Aren’t clinical trials always associated with a big-name university?
A: No, that isn’t always true! Clinical trials can be (and often are) conducted at universities, but they’re also done at smaller local research practices as well. Regardless of where the research center is or how large they are, they are all held to the same quality research standards. Just because you don’t live close to a major cancer center doesn’t mean trials aren’t an option for you! Check out our list of trusted trial matching services here (hyperlink trial match page) and search for trials close to you!