Tag Archives: inequality

How the Coronavirus Pandemic May Affect Cancer Clinical Trials

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Agata Boxe, Cancer Therapy Advisor: September 23, 2020

The health risks posed by SARS-CoV-2 to cancer patients have spurred changes in how cancer clinical trials are being conducted. Some of the alterations introduced by the National Cancer Institute (NCI) include using telemedicine visits, switching to electronic signatures for signing patient consent forms, shipping of oral medications to patients, and allowing researchers to skip collecting certain data. While the modifications may help to expand access to trials and lead to greater economic and geographic diversity of trial populations, they may also limit the amount of key information about the patient experience. Meanwhile, the pandemic itself may dissuade some groups of patients from enrolling in new trials altogether, thus negatively impacting the make-up of trial populations.

Like all other experts interviewed for this story, Hala Borno, MD, assistant clinical professor in the genitourinary oncology program at the University of California, San Francisco, was in favor of the changes that improved patient access to trials, such as the greater use of telemedicine. “In the context of a pandemic, there’s an opportunity to rethink the burdens that we place on patients and an opportunity to redesign the way in which we deliver cancer treatment in the context of the clinical trial,” Dr Borno said.

Dr Borno’s previous research showed that access to clinical trials was particularly challenging for disadvantaged social groups. Her 2018 study found that patients from lower‐income areas had to travel longer distances compared with patients from higher‐income areas to participate in cancer clinical trials. “What I observed is that patients coming from low-income neighborhoods are shouldering the largest burden of travel in order to participate in clinical research,” she said.

But the new measures may also lead to missing key information that is normally recorded during trials when they are conducted in person. Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C., noted potential complications with capturing the patient experience via videoconferencing compared to in-person visits. For example, it might be more difficult for researchers to notice potentially concerning symptoms that would otherwise be easy to see. “For example, if, as a doctor or researcher, I’m meeting with a patient in person, I might notice that they’re slumping in their chair or they look pale or they seem uncomfortable,” she said. “I might notice a lot of things about them that won’t necessarily be so obvious in a telehealth visit.”

Problems like bad lighting in a patient’s home may contribute to visibility issues. Children bursting into the room or a dog jumping on a patient’s lap may distract the patient from the purpose of the virtual visit. Finally, Dr Zuckerman wondered whether patients might not be as candid during online appointments as they would be during face-to-face visits about how they really feel while receiving treatment.

Jonathan Kimmelman, PhD, a professor and director of the biomedical ethics unit at McGill University in Montreal, said he wondered whether the decreased frequency of in-person interactions between patients and investigators might affect detection of adverse events.

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We can’t ever go to the doctor with our guard down’: Why Black women are 40% more likely to die of breast cancer

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Maria Aspan: Fortune Magazine June 30, 2020

Racism kills Black Americans, and has long before COVID-19. But its toxic combination with sexism has particularly vast and disastrous consequences for the health of Black women.

While Black people in the U.S. are dying from the COVID-19 pandemic at a disproportionately high rate, this national health crisis underlines an even grimmer status quo: Black Americans are also much more likely to die from far more common and longstanding health problems every day. Black women are at particularly high risk of heart disease and strokes, and are at least three times as likely to die as a result of childbirth as white women, contributing to the overall alarmingly high maternal mortality rate in the United States.

Then there are the shocking statistics around breast cancer, which affects one in every eight women and is the most common non-skin cancer affecting women. Black women are less likely to develop it—but 40% more likely to die from it than white women, according to the U.S. Centers for Disease Control and Prevention.

The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it. Now the disproportionately high toll of COVID-19 on the Black population in the U.S. and the simultaneous national reckoning over racism are drawing new attention to the racial inequities hurting Black women—and amplifying the voices of doctors, scientists, and public health experts who have long sounded the alarm.

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Women of all races could be legally omitted from government-funded clinical trials before 1993, and are still often under-represented in most research studies of conditions that affect them. Pregnancy and menstrual cycles are thought to “complicate” the results of trials that are mostly conducted on white men, who are seen as the “norm.”

This can obviously backfire. In 2013, the U.S. Food and Drug Administration sharply cut its recommended dosages of Ambien for women, after years of complaints about grogginess and falling asleep while driving, when followup tests showed that women metabolized the active ingredient in sleeping aids much more slowly than men.

When it comes to clinical trials funded by pharmaceutical companies, “the FDA encourages but does not require diversity in clinical trials,” says Diana Zuckerman, a scientist and president of the National Center for Health Research. “Worse, the agency frequently approves drugs and devices for all adults, even if they were primarily studied on white adults.”

One treatment that the FDA approved in April, for the “triple-negative” type of breast cancer that disproportionately affects Black women, was approved after being tested on 108 patients. Eight of them, or 7%, were Black. Another breast-cancer treatment was approved last year after being tested on 234 patients; seven of them, or 3%, were Black.

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