Lack of Equality
The healthcare industry thrives on innovation, but has hardly budged in terms of equity in clinical trials, where first-in-class medicines are typically brought to market based on data from majority white, male patients.
Particularly as the healthcare industry zeroes in on precision medicine, therapies tailored to patients' genetic makeup, a better understanding of different populations' biological differences is vital in drug testing.
Women and minorities have demanded and achieved greater representation in government, pop culture and industry, but year after year, researchers have flagged a lack of diverse inclusion in drug trials. The result is medications that simply do not work the same way in women as they do in men, or prove more harmful to certain races than to the white participants in whom the drugs were tested.
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Barriers to entry in clinical trials start right from the beginning: a database that only reports in English despite the fact that 66 million U.S. residents speak a language other than English at home, according to U.S. Census Bureau figures.
Clinicaltrials.gov, the government's official database for all clinical trials, is not searchable by language, nor can it identify trials that recruit in languages other than English.
Even if a Non-English speaking person were able to navigate the website and get enrolled in a medical study, the patient would likely not have a translator, therefore running into issues of consent — which is crucial to the integrity of a clinical trial.
- Many trials do not provide the essential informed consent documents in any language besides English.
- Even if technological developments fill some of the gaps in document translation, a clinician with an understanding of different cultures may be required to facilitate communication during a clinical trial.
- A lack of multilingual ability is evident "across the board," another result of a homogeneous healthcare professional workforce that excludes minorities.
Alzheimer's Part 1
No new drugs have been approved for Alzheimer's disease in 15 years, and as pharmaceutical companies struggle to make progress against the devastating disease, minorities have been left out of the conversation.
The prevalence of Alzheimer's disease is only expected to grow, according to the Alzheimer's Association's annual report. Most research efforts are focused on early detection and risk prevention, but minorities may not directly benefit from pharmaceutical companies' drug development, experts have observed, pointing to majority-white clinical trials.
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Alzheimer's Part 2
In the 1,169-patient A4 study on memory loss in Alzheimer's disease, Harvard University neurology professor and study lead Reisa Sperling set a goal of one person of color for every five screened candidates — and ended up with single-digit percentage enrollment among minorities.
"She tried everything," Global Alzheimer's Platform Foundation President John Dwyer said. "But that study suffered from [a] sine curve. ... No matter how hard the doctors try, the community won't respond at the rate you want if you haven't built long-standing relations of trust.
Dwyer said outreach to potential clinical trial participants "goes up and then it comes down," like a sine curve: Researchers — or "the guys in the suits," as one African American primary care physician put it to Dwyer — tend to parachute in to an underserved community to recruit for clinical trials and pack up and leave after.
- Clinical trials are carefully designed to examine a particular condition, and since Alzheimer's often comes with comorbidities, or co-occurring diseases, patients are often found to be ineligible under traditional entry requirements.
- Dwyer's organization, the GAP, Global Alzheimer's Platform, Foundation, is aiming for a 5% to 8% range of African American and Latino enrollment in clinical trials for Alzheimer's while building an infrastructure focused on high-density underrepresented populations.
Digital Health Type
Wearable technology is being touted by industry leaders and researchers as a potential tool for expanding underserved communities' access to clinical trials and treatment — so long as users remember to flip their watches to the underside of their wrists.
According to Elektra Labs CEO Andrea Coravos, some wrist-worn wearables, particularly clinical-grade devices equipped with sensors to measure heart rate, are trained on a certain type of skin, meaning that if an individual has darker skin or a wrist tattoo, the connected tool may not be able to detect heart rate.
- Apple Inc.'s Apple Watch was found in 2015 to have issues when worn by users with wrist tattoos. The watch, like many other wearable devices, uses a type of light sensor — a green light photoplethysmography, or PPG — that is affected by pigmentation in tattoos and sometimes skin tone.
- The foundational algorithms can contain human developers' beliefs and prejudices and emphasized that diversity among developers needs to be addressed — not unlike the issue of lack of diversity among healthcare professionals that impacts clinical trials.
Scientists began to realize in the 1990s that cardiovascular disease — the most prevalent cause of death worldwide — manifests differently in women than men, as women's hearts are about two-thirds the size of men's. While women and minorities are getting more attention around this disease, drug trials are still not addressing their physiological differences.
Cardiovascular disease was historically thought of as a man's disease, and women have made up just 20% to 30% of drug and device trials for the condition, according to American Heart Association, or AHA, board member Stacey Rosen, a cardiologist and vice president of women's health at the Katz Institute for Women's Health at North Shore-LIJ Health System in New York. But women experience different symptoms than men, a fact that not all physicians recognize, the Women's Heart Alliance said.
- While cardiovascular disease trial enrollment rates for women have increased to around 40% to 45%, which is "still not great, honestly," Rosen said, minorities continue to be underrepresented in drug trials. Appropriate analyses of each demographic group are needed to parse the unique effects of the drug or device on a population.
- Cardiovascular disease drug development has slowed in recent years, due in part to the hefty costs associated with the larger trials that are necessary, and the complex disease population. But some companies are still forging ahead.
- Computer power and big data can be advantageous for evaluating cardiovascular disease patients who have more than one condition — an issue that would traditionally exclude them from clinical trials.
Essential Healthcare is a weekly collection of critical developments across the pharmaceutical, biotechnology, healthcare provider, healthcare technology and medical equipment industries that draws on exclusive analysis and value-added content from the Healthcare News team at S&P Global Market Intelligence.Subscribe to Essential Healthcare