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EXAMINING IMPACT OF RACE IN STAGING CHRONIC KIDNEY DISEASE

Source: Brigham and Women's Hospital
Date: 11/12/2020
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An equation used for over a decade to estimate kidney function and stage chronic kidney disease (CKD) can underestimate kidney function and lead to gaps in care delivery in African-American patients, according to research led by investigators at Brigham and Women’s Hospital.

The researchers say the “race multiplier factor,” which is used as part of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Modification of Diet in Renal Disease (MDRD) equations to estimate kidney function, can contribute to health disparities in African Americans with CKD. This is particularly important because African-American patients with CKD are known to have worse clinical outcomes with respect to hypertension control, timely nephrology referral, dialysis fistula or graft placement, adequate dialysis treatment and transplantation access.

“The race multiplier is something that all of us were taught to use during medical school and residency training,” said Mallika L. Mendu, MD, MBA, a Brigham nephrologist and senior author of the study, published in October in the Journal of General Internal Medicine (JGIM). “I was surprised to learn how many patients are impacted by the use of the race multiplier and its potential implications on care delivery, particularly referral to kidney transplantation.”

Changing the Math Results in Reclassification of CKD

The calculation in question uses serum creatinine levels to obtain the estimated glomerular filtration rate (eGFR). To account for differences among individuals, the equation includes factors for age, sex, weight and race to improve statistical precision.

Earlier research suggested African Americans had higher measured glomerular filtration rate with the same creatinine levels, leading to the adjustment. But there was no clear biological explanation for why it would be different, Dr. Mendu said.

The new JGIM study led by Dr. Mendu analyzed data and electronic health records from 56,845 patients who were in the Partners HealthCare system’s CKD registry as of June 2019; 2,225 of them self-identified as African American. The researchers recalculated eGFR for these patients, removing the race multiplier of 1.159, and classified the severity of the patients’ disease based on the revised eGFR numbers.

They found the race multiplier essentially designated African-American patients as being healthier than people of other races who had the same clinical findings. Overall, one in three African-American patients was reclassified to a more severe stage of disease when the multiplier was removed. One-quarter of them were moved from Stage 3 to Stage 4.

Differences in staging of patients with more advanced disease ultimately could affect whether they were considered for transplant surgery, the researchers said. Notably, 64 African-American patients were reclassified to an eGFR less than or equal to 20 (a common threshold for kidney transplant referral), but none had a referral. This indicated to Dr. Mendu and the co-authors that there were real, potential adverse consequences to using the race multiplier that could exacerbate disparities.

A Focus on Reducing Health Disparities

Leaders at the Brigham stopped using the race multiplier in June based on preliminary findings from the JGIM study. The team’s research has caught the attention of policymakers, and other hospital systems have said they will refrain from using the race multiplier as well.

Dr. Mendu said the findings from this study may help advance the use of cystatin C as a marker for CKD instead of creatinine. She considers cystatin C to be another acceptable measure of eGFR, as this test does not use a race adjustment factor. The Brigham has always been a leading institution when it comes to CKD treatment, she noted, adding that changing the way patients with CKD are staged and ensuring health equity are other key areas in which the institution can play a pivotal role.

“There are so many complicated issues related to race in medicine and health disparities, something that the COVID-19 pandemic has made very clear,” Dr. Mendu concluded. “But this is one problem we think is quite solvable.”

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Examining ethical issues surrounding wearable brain devices marketed to consumers

Source: Cell Press
Date: 05/22/2019
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Wearable brain devices are now being marketed directly to consumers and often claim to confer benefits like boosting memory and modulating symptoms of depression. But despite the size of this market, little is known about the validity of these claims and, substantiated or not, the related ethical consequences or repercussions.

In a perspective being published in the journal Neuron on May 22, a team of neuroethicists looked at the range of products being sold online and questioned the claims made by companies about these products. They identified 41 devices for sale, including 22 recording devices and 19 stimulating devices. The goal of the project was to look at issues of transparency, rights, and responsibility in the way these products are marketed and sold.

“When it comes to biotechnology, and in particular brain technology, there is a heightened level of responsibility around ethical innovation,” says senior author Judy Illes, a professor of Neurology and Canada Research Chair in Neuroethics at the University of British Columbia (@NeuroethicsUBC). “The great news is that it doesn’t cost a lot of money to innovate ethically: it just takes some more thought, good messaging, and consideration of potential consequences. There are many experts who are poised to help this industry in a practical, solution-oriented way. It’s worth it for companies to take the time to do it right.”

The authors established four general categories for the claims about wearable brain devices:

  • Wellness: benefits like stress reduction, improved sleep, and weight loss
  • Enhancement: including improved cognition and productivity and greater physical performance
  • Practical applications: uses like research and enhanced worker safety
  • Health: improvement of conditions such as those affecting behavior and attention, as well as certain neurodegenerative diseases

Despite wide-ranging claims, there have been few studies evaluating the scientific validity of any of them. The authors didn’t seek to evaluate the products’ effectiveness in this review. Instead, they looked at how manufacturers could communicate the potential outcomes from using these devices–both positive and negative–in a more ethically responsible way.

The neuroscience wearables market has parallels to other direct-to-consumer medical products. This includes herbs and supplements, home genetic testing kits, so-called wellness CT scans, and “keepsake” 3D ultrasounds offered to pregnant women. By marketing them for wellness or recreation rather than health, companies that sell these products and services are able to avoid regulatory oversight from agencies such as the Food and Drug Administration.

“We have concerns, however, that people could turn to these devices rather than seeking medical help when they might actually need it,” Illes notes. “They may also choose these devices over conventional medical treatments that they have been offered. There are a lot of potential effects that we don’t know much about.”

Symptoms and side effects that could result from use of these products include redness or other irritation where the devices contact the skin, headaches, pain, tingling, and nausea. Some of the products mention the possibility of side effects in their packaging, but there haven’t been any studies looking at how common or serious the effects may be.

The researchers note that warning labels advising consumers about risk are largely lacking. “I would consider this an important, responsible message to consumers, but as far as I know, few of these products have it,” Illes says.

Illes and her team believe that because some of these products are marketed for children, who may be particularly vulnerable to their effects on the brain, extra caution is needed. “Their bodies and brains are still developing,” she says. “What are the claims for these products and how do we manage and appreciate them both for their potential benefits and possible risks?” Additional caution may also be needed for use of neuroscience wearables in the elderly, another population that may have a higher risk of potential harm.

There are also issues related to neuroscience wearable products that record brain activity. “How are these data used, and who has access to them?” Illes asks. “These are things we don’t know. We should be asking these questions.”

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This work was supported by Technical Safety BC, an independent, self-funded organization mandated to oversee the safe installation and operation of technical systems and equipment.

Neuron, Coates McCall et al.: “Owning Ethical Innovation: Claims about Commercial Wearable Brain Technologies” https://www.cell.com/neuron/fulltext/S0896-6273(19)30289-2

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Study examines direct-to-consumer stem cell clinics in 6 Southwestern states

Source: Cell Press
Date: 08/01/2019
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This direct-to-consumer stem cell marketplace has come under increasing scrutiny, but relatively little is known about the clinics that deliver these treatments or how the treatments they offer align with the expertise of the practitioners providing them. In a paper published August 1 in the journal Stem Cell Reports, investigators offer a detailed characterization of nearly 170 stem cell businesses across six southwestern states. The study focused on Arizona, California, Colorado, Nevada, New Mexico, and Utah, where the researchers estimate that about one-third of all stem cell clinics in the US are located.

“Previous studies have built up a broad picture of the direct-to-consumer stem cell industry,” says Emma Frow, an assistant professor in the School for the Future of Innovation in Society and the School of Biological and Health Systems Engineering at Arizona State University, co-first author on the paper along with David Brafman, also an assistant professor of bioengineering at Arizona State University.

“We took a deeper dive into a smaller number of clinics and found that there’s a lot of variation among the businesses offering these services,” she says. “About 25% focus exclusively on stem cells, but many others are facilities like orthopedic and sports medicine clinics that have added stem cells to their roster of services on offer. For these clinics, it’s very difficult to know how much of their business comes from stem cell treatments.”

The researchers conducted extensive online searches for stem cell clinics in the six states. “There’s no exhaustive list of all the clinics that exist,” Frow says. “This is a lively marketplace, with businesses opening and closing and changing their names.” For the 169 businesses they identified, they catalogued the treatments being offered, the medical conditions these clinics purported to treat, and the types of cells they claimed to use. For the 25% of clinics focused solely on stem cells, they also looked at the stated expertise of the care providers at these clinics in relation to the medical conditions they offer to treat with stem cells.

The researchers found that orthopedic, inflammatory, and pain conditions were the main types of medical conditions treated with stem cells at direct-to-consumer stem cell clinics in the Southwest. Frow notes that these types of conditions “tend to be chronic problems that often are not curable. The market has really capitalized on targeting conditions that are hard to manage with existing therapies.”

Earlier studies have shown a lower percentage of clinics treating inflammatory conditions. “This could mean that the number of clinics treating inflammatory conditions is on the rise or that, in the Southwest, there is more focus on treating inflammatory conditions than in other parts of the US,” Frow suggests.

The researchers also found differences in the degree to which the listed expertise of care providers at stem cell clinics matched the medical conditions they treat with stem cells. For example, they identified that specialists in orthopedics and sports medicine were more likely to restrict stem cell treatments to conditions related to their medical specialties, while care providers listing specialties in cosmetic or alternative medicine were more likely to treat a much wider range of conditions with stem cells.

Public discussions of direct-to-consumer stem cell treatments usually treat clinics as though their business models were all similar, but this study highlights some key differences across these clinics. “We think it makes a difference whether a business is focused solely on stem cells or offers it as one treatment among many,” Frow says. “And we think it’s important to pay attention to the medical qualifications and expertise of the care providers offering stem cell treatments. Just because someone is board certified doesn’t necessarily mean they are qualified to provide stem cell treatments. You really need to ask what they are board certified in and whether their medical expertise is well-matched to the condition you are seeking treatment for.”

Recent moves by the FDA to tighten up its guidelines and restrict the practices of these clinics have generated a lot of attention. The authors of this study see their work as contributing to these discussions. “We want to bring more transparency to discussions of the direct-to-consumer stem cell marketplace and to empower consumers to figure out what kinds of questions to ask when they’re considering treatment,” Frow says. “We also want to help the scientific community get a better understanding of the situation and to help the FDA and state medical boards think through their priorities with regards to regulating the market.”

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This research was funded by the Lincoln Center for Applied Ethics and the Institute for Social Science Research at Arizona State University.

Stem Cell Reports, Frow and Brafman et al.: “Characterizing direct-to-consumer stem cell businesses in the Southwest United States.” https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(19)30253-X

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Bioethicist calls out unproven and unlicensed ‘stem cell treatments’ for COVID-19

Source: Cell Press
Date: 05/07/2020
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As the COVID-19 pandemic enters its third month, businesses in the United States are marketing unlicensed and unproven stem-cell-based “therapies” and exosome products that claim to prevent or treat the disease. In Cell Stem Cell on May 5, bioethicist Leigh Turner describes how these companies are “seizing the pandemic as an opportunity to profit from hope and desperation.”

“I’m concerned that individuals purchasing these supposed ‘therapies’ for COVID-19 will be scammed,” says Turner (@LeighGTurner), an associate professor at the University of Minnesota Center for Bioethics. “I’m also worried that they’ll be injured as a result of being given products that haven’t been adequately tested, or that they’ll forgo measures like social distancing because they’ve paid for a product that they think will protect them from being infected or getting sick.”

Many stem cell clinics have a history of selling unproven and unlicensed interventions for injuries and illnesses ranging from Alzheimer’s disease to pulmonary disorders to spinal cord injuries. Since the COVID-19 pandemic began, some have added claims about “immune-boosting” therapies for treating COVID-19 and acute respiratory distress syndrome (ARDS) caused by infection with SARS CoV-2. These companies advertise stem cell interventions and exosome products derived from such sources as umbilical cords and amniotic fluid. Turner says uncritical news media accounts have compounded some of these claims by reporting on preliminary evidence and case studies.

Yet rigorous clinical trials on these stem cell products have not yet been done. “Randomized controlled trials are needed to establish whether particular stem cell products are safe and efficacious in the treatment of COVID-19-related ARDS,” he explains.

Turner has studied the US direct-to-consumer marketplace for stem cell clinics for nearly a decade. “These businesses have a long history of claiming to treat diseases and injuries for which evidence-based therapies do not yet exist,” he says. To find out what these businesses were promoting, he did Google searches on a variety of terms related to stem cell treatments, COVID-19, and ARDS. He also searched YouTube for promotional videos made by these clinics.

“I found more examples of businesses peddling stem cell products for COVID-19 than I had space to describe in detail,” he notes. “I wasn’t surprised at how quickly some of these companies began making these claims. For them, the COVID-19 pandemic is an opportunity to generate a new revenue stream.”

In the paper, Turner also discusses the role of medical organizations, noting that while most are doing a good job of criticizing deceptive advertising, some have been promoting these interventions despite the lack of scientific evidence supporting their use.

“I want members of the public to know that some companies are trying to take advantage of them by selling supposed treatments that aren’t backed by credible evidence,” Turner concludes. “I’m also hoping that this paper will catch the attention of regulatory bodies like the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), as well as state medical boards and state attorney general offices. The FDA and FTC have issued letters to some businesses, but additional regulatory action is needed.”

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Cell Stem Cell, Turner, L.: “Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed ‘Stem Cell Treatments’ for COVID-19” https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(20)30201-0