Black patients are about four times as likely to have kidney failure as white Americans, and who make up more than 35% of people on dialysis but just 13% of the U.S. population.
This article was published on Tuesday, June 8, 2021 in Kaiser Health News.
Alphonso Harried recently came across a newspaper clipping about his grandfather receiving his 1,000th dialysis treatment. His grandfather later died — at a dialysis center — as did his uncle, both from kidney disease.
"And that comes in my mind, on my weak days: 'Are you going to pass away just like they did?'" said Harried, 46, who also has the disease.
He doesn't like to dwell on that. He has gigs to play as a musician, a ministry to run with his wife and kids to protect as a school security guard.
Yet he must juggle all that around three trips each week to a dialysis center in Alton, Illinois, about 20 miles from his home in St. Louis, to clean his blood of the impurities his kidneys can no longer flush out. He's waiting for a transplant, just as his uncle did before him.
"It's just frustrating," Harried said. "I'm stuck in the same pattern."
Thousands of other Americans with failing kidneys are also stuck, going to dialysis as they await new kidneys that may never come. That's especially true of Black patients, like Harried, who are about four times as likely to have kidney failure as white Americans, and who make up more than 35% of people on dialysis but just 13% of the U.S. population. They're also less likely to get on the waitlist for a kidney transplant, and less likely to receive a transplant once on the list.
An algorithm doctors use may help perpetuate such disparities. It uses race as a factor in evaluating all stages of kidney disease care: diagnosis, dialysis and transplantation.
It's a simple metric that uses a blood test, plus the patient's age and sex and whether they're Black. It makes Black patients appear to have healthier kidneys than non-Black patients, even when their blood measurements are identical.
"It is as close to stereotyping a particular group of people as it can be," said Dr. Rajnish Mehrotra, a nephrologist with the University of Washington School of Medicine.
This race coefficient has recently come under fire for being imprecise, leading to potentially worse outcomes for Black patients and less chance of receiving a new kidney. A national task force of kidney experts and patients is studying how to replace it. Some institutions have already stopped using it.
But how best to assess a patient's kidney function remains uncertain, and some medical experts say fixing this equation is only one step in creating more equitable care, a process complicated by factors far deeper than a math problem.
"There are so many inequities in kidney disease that stem from broader structural racism," said Dr. Deidra Crews, a nephrologist and the associate director for research development at the Johns Hopkins Center for Health Equity. "It is just a sliver of what the broader set of issues are when it comes to both disparities and inequities in who gets kidney disease in the first place, and then in the care processes."
Why Race Has Been Part of the Equation
Kidneys filter about 40 gallons of blood a day, like a Brita filter for the body. They keep in the good stuff and send out the bad through urine. But unlike other organs, kidneys don't easily repair themselves.
Furthermore, it's hard to gauge whether kidneys are working properly. Gold-standard tests involve a chemical infusion and hours of collecting blood and urine to see how quickly the kidneys flush the chemical out. An algorithm is much more efficient.
Buoyed by activism around structural racism, those seeking equity in healthcare have recently been calling out the algorithm as an example of the racism baked into American medicine. Researchers writing in the New England Journal of Medicine last year included kidney equations in a laundry list of race-adjusted algorithms used to evaluate parts of the body — from heart and lungs to bones and breasts. Such equations, they wrote, can "perpetuate or even amplify race-based health inequities."
In March, ahead of the national task force's upcoming formal recommendation, leaders in kidney care said race modifiers should be removed. And Fresenius Medical Care, one of the two largest U.S. dialysis companies, said the race component is "problematic."
Until the late 1990s, doctors primarily used the Cockcroft-Gault equation. It didn't ask for race, but used age, weight and the blood level of creatinine — a chemical that's basically the trash left after muscles move. A high level of creatinine in the blood signals that kidneys are not doing their job of disposing of it. But the equation was based on a study of just 249 white men.
Then, researchers wrapping up a study on how to slow down kidney disease realized they were sitting on a mother lode of data that could rewrite that equation: gold-standard kidney function measurements from about 1,600 patients, 12% of whom were Black. They evaluated 16 variables, including age, sex, diabetes diagnosis and blood pressure.
They landed on something that accurately predicted the kidney function of patients better than the old equation. Except it made the kidneys of Black participants appear to be sicker than the gold-standard test showed they were.
The authors reasoned it might be caused by muscle mass. Participants with more muscle mass would likely have more creatinine in their blood, not because their kidneys were failing to remove it, but because they just had more muscles producing more waste. So they "corrected" Black patients' results for that difference.
Dr. Andrew S. Levey, a professor at Tufts University School of Medicine who led the study, said it doesn't make intuitive sense to include race — now widely considered a social construct — in an equation about biology.
Still, in 1999, he and others published the race equation, then updated it a decade later. Though other equations exist that don't involve race, Levey's latest version, often referred to as the "CKD-EPI" equation, is recommended for clinical use. It shows a Black patient's kidneys functioning 16% better than those of a non-Black patient with the same blood work.
Removing the Race Number
Many patients don't know about this equation and how their race has factored into their care.
"I really wish someone would have mentioned it," Harried said.
He said it burned him up "knowing that this one little test that I didn't know anything about could keep me from — or prolong me — getting a kidney."
Glenda V. Roberts curbed her kidney disease with a vegan diet and by conducting meetings as an IT executive while walking. But after more than 40 years of slow decline, her kidney function finally reached the cutoff required to get on the transplant waitlist. When it did, the decline was swift — a pattern researchers have noted in Black patients. "It really makes you wonder what the benefit is of having an equation that will cause people who look like me — Black people — to get referrals later, to have to wait longer before you can get on the transplant list, but then have your disease progress more rapidly," she said.
Roberts, who is now the director of external relations at the University of Washington's Kidney Research Institute in Seattle and on the national task force, said a genetic test added to her feeling that a "Black/non-Black" option in an equation was a charade.
"In fact, I am not predominantly of African ancestry. I'm 25% Native American. I'm Swedish and English and French," said Roberts. "But I am also 48% from countries that are on the continent of Africa."
The Black/non-Black question also doesn't make sense to Delgado, the University of California nephrologist. "I would probably for some people qualify as being non-Black," said Delgado, who is Puerto Rican. "But for others, I would qualify as Black."
So, theoretically, if Delgado were to visit two doctors on the same day, and they guessed her race instead of asking, she could come away with two different readings of how well her kidneys are working.
Researchers found that the race factor doesn't work for Black Europeans or patients in West Africa. Australian researchers found using the race coefficient led them to overestimate the kidney function of Indigenous Australians.
But in the U.S., Levey and other researchers seeking to replace the race option with physical measurements, such as height and weight, hit a dead end.
To Crews, the Johns Hopkins nephrologist who is also on the national taskforce, the focus on one equation is myopic. The algorithm suggests that something about Black people's bodies affects their kidneys. Crews thinks that's the wrong approach to addressing disparities: The issue is not what's unique about the inner workings of Black bodies, but instead what's going on around them.
"I really wish we could measure that instead of using race as a variable in the estimating equations," she said on the "Freely Filtered" podcast. "I don't think it's ancestry. I don't think it's muscle mass."
It might not be that Black bodies are more likely to have more creatinine in the blood, but that Americans who experience housing insecurity and barriers to healthy food, quality medical care and timely referrals are more likely to have creatinine in their blood — and that many of them happen to be Black.
Systemic health disparities help explain why Black patients have unusually high rates of kidney failure, since communities of color have less access to regular primary care. One of the most serious consequences of poorly controlled diabetes and hypertension is failure of the organ.
Direct discrimination — intentional or not — from providers may also affect outcomes, said Roberts. She recalled a social worker categorizing her as unable to afford the post-transplant drugs required to keep a transplanted organ healthy, which could have delayed her getting a new organ. Roberts has held executive roles at several multimillion-dollar companies.
Delgado and Levey agree that removing race from the formula might feel better on the surface, but it isn't clear the move would actually help people.
Studies recently published in the Journal of the American Medical Association and the Journal of the American Society of Nephrology noted that removing the race factor could lead to some Black patients being disqualified from using beneficial medications because their kidneys might appear unable to handle them. It could also disqualify some Black people from donating a kidney.
"Fiddling with the algorithms is an imperfect way to achieve equity," Levey said.
As researchers debate the math problem and broader societal ones, patients such as Harried, the St. Louis minister and security guard, are still stuck navigating dialysis.
"One of things that keeps me going is knowing that soon they may call me for a kidney," Harried said.
He doesn't know how long his name will be on the transplant waitlist — or whether the race coefficient has prolonged the wait — but he keeps a hospital bag under his bed to be ready.
Aerospace giant Boeing tested two kinds of ionization technologies — like those widely adopted in schools hoping to combat COVID — to determine how well each killed germs on surfaces and decided that neither was effective enough to install on its commercial planes.
Boeing noted in its conclusion that "air ionization has not shown significant disinfection effectiveness."
Companies that make the air purifiers say they emit charged ions, or "activated oxygen," that are said to inactivate bacteria and viruses in the air. Boeing did not test the technology's effectiveness in the air, only on surfaces. It also used a "surrogate" for the virus that causes COVID-19.
The Boeing study has been cited in a federal lawsuit filed by a Maryland consumer against Global Plasma Solutions, maker of the "needlepoint bipolar ionization" technology that a Boeing spokesperson said its engineers tested.
The proposed class-action lawsuit says GPS makes "deceptive, misleading, and false" claims about its products based on company-funded studies that are "not applicable to real world conditions."
A GPS spokesperson said the lawsuit is "baseless and misleading" and that the company will aggressively defend against it. He added that Boeing "researchers deemed the study 'inconclusive.'"
"Plaintiff's Complaint throws the proverbial kitchen sink at GPS in the hopes that something might stick," the air purifier company says in court documents filed May 24 as part of its motion to dismiss the proposed class action. "But it is devoid of any concrete, specific allegations plausibly alleging that GPS made even a single false or deceptive statement about its products."
The plaintiff's case cites a KHN investigation that found that more than 2,000 U.S. schools had bought air-purifying technology, including ionizers. Many schools used federal funds to purchase the products. In April, a COVID-19 commission task force from The Lancet, a leading medical journal, composed of top international health, education and air-quality experts, called various air-cleaning technologies — ionization, plasma and dry hydrogen peroxide — "often unproven."
Boeing said in its report that with ionization there is "very little external peer reviewed research in comparison to other traditional disinfection technologies" such as chemical, UV and thermal disinfection and HEPA filters, all of which it relies on to sanitize its planes.
The controversy is getting the attention of school officials from coast to coast. They include one California superintendent who cited the lawsuit and switched off that district's more than 400 GPS devices.
For worried parents and academic air-quality experts who regard industry-backed studies with skepticism, the Boeing report heightens their concerns.
"This [study] is totally damning," said Delphine Farmer, a Colorado State University associate professor who specializes in atmospheric and indoor chemistry who reviewed the Boeing report. "It should just raise flags for absolutely everyone."
'No Reduction' in Bacteria
GPS pointed to another study, one conducted in the weeks before Boeing began its study in September, by a third-party lab. It completed a study of twodevices — powered by GPS technology — that another aviation company now markets to clean the air and surfaces in planes.
That study looked at the effect of the ionizers on the virus that causes COVID-19 when used on aluminum, a type of plastic called Kydex and leather. The test report shows it was conducted in a sealed, 20-by-8-foot chamber, with airflow speeds of 2,133 feet per minute — or about 24 mph. At the end of 30 minutes, "the overall average decrease in active virus" was more than 99%.
"Given the specific environment this was tested in, the quality of the materials, and the method in which the virus was dispersed, it is safe to say that the bipolar ionization system used in this experiment has the ability to deactivate SARS-CoV-2 with the given ion counts," the Aug. 7 report from the third-party lab says.
The following month, Boeing began its own testing of GPS devices and another kind of ionization technology.
The Boeing study cites a GPS white paper that says its device killed 99.68% of E. coli bacteria in one test in 15 minutes. GPS records show the test was done on bacteria suspended in the air. The Boeing engineers used the company's technology to try to kill E. coli on surfaces in a lab but found "no observable reduction in viability" after an hour.
The Boeing study notes it "was unable to replicate supplier results in terms of antimicrobial effectiveness."
GPS cautioned that the Boeing tests examined disinfection of surfaces, not the air: "While GPS products do have the ability to help reduce pathogens in air and on surfaces, GPS products are not chemical surface disinfectants."
Yet surface tests comprise half of the test results the company lists on its "pathogen reduction" webpage, a GPS spokesperson confirmed.
Boeing researchers found another lab result they could not replicate: While the GPS white paper reported a 96.24% reduction in Staphylococcus aureus in 30 minutes, Boeing engineers found "no reductions" in the bacteria in an hourlong test.
Boeing found minimal or no reduction on surfaces in four other pathogens it tested with GPS ionizers for an hour in a Huntsville, Alabama, lab.
Notably, Boeing's tests in Huntsville detected no hazardous ozone gas from the GPS unit, the report says. The "corona discharge" ionization technology from another vendor that Boeing also studied did emit ozone at levels that "exceeded regulatory standards."
A University of Arizona lab test described in the Boeing study found that the GPS device showed a 66.7% inactivation of a common cold coronavirus on a surface after an hour of exposure at up to 62,000 negative ions per cubic centimeter. That ion level is far higher than the amount of ions company leaders have said the devices tend to deliver to a typical room. Those levels have ranged from 2,000 to 10,000 and even up to 30,000 ions per cubic centimeter when an HVAC system is running, according to records provided to KHN and statements made by companyrepresentatives.
In a presentation during a Berkeley Unified School District meeting in California, a physicist who appeared with executives said a level of more than 60,000 ions per cubic centimeter "has been shown to be not healthy."
GPS noted that Boeing deemed the 66.7% effectiveness rate in killing the common cold virus "statistically significant." A GPS spokesperson said the result validates needlepoint bipolar ionization's "effectiveness against certain pathogens." In its report, Boeing called the test results "inconclusive" due to "lack of experimental confirmation."
A GPS spokesperson also highlighted a passage in the Boeing report's conclusion that said: "There remains significant interest in air ionization due to lack of byproduct production, minimal risk to human health, minimum risk to airplane materials and systems, and the potential for persistent disinfection of air and surfaces under specific flow conditions."
The Boeing study concluded in January. In April, GPS published the results of additional tests it funded at a third-party lab showing its technology "is highly effective in neutralizing the SARS-CoV-2 pathogen."
Boeing engineers said their study highlights the need for those in the ionization business to standardize the evaluation of the technology "to allow comparison to other proven methods of disinfection."
Ripple Effects of the Boeing Study
On May 7, law firms representing a man who spent over $750 on a GPS air cleaner in Texas filed the "fraudulent concealment" lawsuit against GPS in U.S. District Court in Delaware.
The lawsuit claims that the defendant's "misrepresentations and false statements were woven into an extensive and long-term advertising campaign … accelerating during the COVID-19 pandemic."
"People are being victimized by these companies for profit," said Mickey Mills, a Houston attorney for the plaintiff. "People are scared because of COVID, and they capitalize on it."
In filing a motion to dismiss the case, GPS told the court the lawsuit was an "attempt to distort the facts and assert baseless claims, doing grave damage to GPS's business in the process."
The GPS court document also says the disclaimers on its website "make it unreasonable for any consumers to believe that the efficacy demonstrated in GPS studies will necessarily be the same for their particular application."
It asserts that most of the GPS statements identified in the plaintiff's lawsuit — such as "safe to use" and "cleaner air" — amount to "non-actionable puffery" as they are "vague generalities and statements of opinion."
The lawsuit spurred a Newark, California, school district to turn off its GPS devices, according to a May 18 memo from Superintendent Mark Triplett to district families. The district spent nearly $360,000 on the devices, an April board presentation shows.
The roughly 5,500-student district bought GPS units for every school HVAC system, Triplett said in a March school board meeting in which he noted the technology "arguably is much better than any filter." By May, he said in the memo the district had become aware of the lawsuit "alleging the misrepresentation" of the devices and would continue to monitor the situation.
A company spokesperson noted GPS appreciates Newark's concerns and has reached out to share additional data and answer questions, as well as extended "an offer to conduct onsite testing to verify the safety of this technology and the added benefits."
Megan McMillen, vice president of the Newark Teachers Association and a special education preschool teacher, said it was disheartening to know the cash-strapped district in the Bay Area spent so much on the devices instead of other safety measures or services to mitigate learning loss after the chaotic pandemic year.
"For such a big chunk of that [money] going to something potentially ineffective … is really frustrating," she said.
States that were slow to use health centers in the vaccine rollout made a mistake that has made it difficult to get a handle on COVID in the most vulnerable communities.
This article was published on Tuesday, June 8, 2021 in Kaiser Health News.
In the 1960s, healthcare across the Mississippi Delta was sparse and much of it was segregated. Some hospitals were dedicated to Black patients, but they often struggled to stay afloat. At the height of the civil rights movement, young Black doctors launched a movement of their own to address the care disparity.
"Mississippi was third-world and was so bad and so separated," said Dr. Robert Smith. "The community health center movement was the conduit for physicians all over this country who believed that all people have a right to healthcare."
In 1967, Smith helped start Delta Health Center, the country's first rural community health center. They put the clinic in Mound Bayou, a small town in the heart of the Delta, in northwestern Mississippi. The center became a national model and is now one of nearly 1,400 such clinics across the country. These clinics, called federally qualified health centers, are a key resource in Mississippi, Louisiana and Alabama, where about 2 in 5 people live in rural areas. Throughout the U.S., about 1 in 5 people live in rural areas.
The COVID-19 pandemic has only exacerbated the challenges facing rural healthcare, such as lack of broadband internet access and limited public transportation. For much of the vaccine rollout, those barriers have made it difficult for providers, like community health centers, to get shots into the arms of their patients.
"I just assumed that [the vaccine] would flow like water, but we really had to pry open the door to get access to it," said Smith, who still practices family medicine in Mississippi.
Mound Bayou was founded by formerly enslaved people, many of whom became farmers.
The once-thriving downtown was home to some of the first Black-owned businesses in the state. Today the town is dotted with shuttered or rundown banks, hotels and gas stations.
Mitch Williams grew up on a Mound Bayou farm in the 1930s and '40s and spent long days working the soil.
"If you would cut yourself, they wouldn't put no sutures in, no stitches in it. You wrapped it up and kept going," Williams said.
When Delta Health Center started operations in 1967, it was explicitly for all residents of all races — and free to those who needed financial help.
Williams, 85, was one of its first patients.
"They were seeing patients in the local churches. They had mobile units. I had never seen that kind of comprehensive care," he said.
Residents really needed it. In the 1960s, many people in Mound Bayou and the surrounding area didn't have clean drinking water or indoor plumbing.
At the time, the 12,000 Black residents of northern Bolivar County, which includes Mound Bayou, faced unemployment rates as high as 75% and lived on a median annual income of just $900 (around $7,500 in today's dollars), according to a congressional report. The infant mortality rate was close to 60 for every 1,000 live births — four times the rate for affluent Americans.
Delta Health Center employees helped people insulate their homes. They built outhouses and provided food and sometimes even traveled to patients' homes to offer care, if someone didn't have transportation. Staffers believed these factors affected health outcomes, too.
Williams, who later worked for Delta Health, said he's not sure where the community would be today if the center didn't exist.
"It's frightening to think of it," he said.
Half a century later, the Delta Health Center continues to provide accessible and affordable care in and around Mound Bayou.
Black Southerners still face barriers to health. In April 2020, early in the pandemic, Black residents accounted for nearly half of COVID deaths in Alabama and over 70% in Louisiana and Mississippi.
Public health data from last month shows that Black residents of those states have consistently been more likely to die of COVID than residents of other races.
"We have a lot of chronic health conditions here, particularly concentrated in the Mississippi Delta, that lead to higher rates of complications and death with COVID," said Nadia Bethley, a clinical psychologist at the center. "It's been tough."
Delta Health Center has grown over the decades, from a few trailers in Mound Bayou to a chain of 18 clinics across five counties. It's managed to vaccinate over 5,500 people against COVID. The majority have been Black.
"We don't have the National Guard, you know, lining up out here, running our site. It's the people who work here," Bethley said.
The Mississippi State Department of Health said it has prioritized health centers since the beginning of the rollout. But said the center was receiving only a couple of hundred doses a week in January and February. The supply became more consistent around early March, center officials said.
"Many states would be much further ahead had they utilized community health centers from the very beginning," Fairman said. Fairman said his center saw success with vaccinations because of its long-standing relationships with the local communities.
"Use the infrastructure that's already in place, that has community trust," said Fairman.
That was the entire point of the health center movement in the first place, said Smith. He said states that were slow to use health centers in the vaccine rollout made a mistake that has made it difficult to get a handle on COVID in the most vulnerable communities.
Smith called the slow dispersal of vaccines to rural health centers "an example of systemic racism that continues."
A spokesperson for Mississippi's health department said it is "committed to providing vaccines to rural areas but, given the rurality of Mississippi, it is a real challenge."
Alan Morgan, CEO of the National Rural Health Association, said the low dose allocation to rural health clinics and community health centers early on is "going to cost lives."
"With hospitalizations and mortality much higher in rural communities, these states need to focus on the hot spots, which in many cases are these small towns," Morgan said of the vaccine efforts in Mississippi, Louisiana and Alabama.
A report from KFF found that people of color made up the majority of people vaccinated at community health centers and that the centers seem to be vaccinating people at rates similar to or higher than their share of the population. (The KHN newsroom, which collaborated to produce this story, is an editorially independent program of KFF.)
The report added that "ramping up health centers' involvement in vaccination efforts at the federal, state and local levels" could be a meaningful step in "advancing equity on a larger scale."
Equal access to care in rural communities is necessary to reach the most vulnerable populations and is just as critical during this global health crisis as it was in the 1960s, according to Smith.
"When healthcare improves for Blacks, it will improve for all Americans," Smith said.
This story is from a partnership that includes NPR, KHN and the three stations that make up the Gulf States Newsroom: Mississippi Public Broadcasting; WBHM in Birmingham, Alabama; and WWNO in New Orleans.
State lawmakers are debating a bill to eliminate out-of-pocket expenses like copays and payments toward deductibles for abortions and related services, such as counseling.
This article was published on Monday, June 7, 2021 in Kaiser Health News.
SACRAMENTO, Calif. — Even as most states are trying to make it harder to get an abortion, California could make it free for more people.
State lawmakers are debating a bill to eliminate out-of-pocket expenses like copays and payments toward deductibles for abortions and related services, such as counseling. The measure, approved by the Senate and headed to the Assembly, would apply to most private health plans regulated by the state.
So far this year, 559 abortion restrictions have been introduced in 47 state legislatures, 82 of which have already been enacted, said Elizabeth Nash, a state policy analyst at the Guttmacher Institute, a nonpartisan research institute that studies abortion and reproductive healthcare. That's already the third-highest number of abortion restrictions adopted in a year since the U.S. Supreme Court's landmark Roe v. Wade ruling of 1973, which affirmed the legal right to an abortion, she said.
By comparison, just a handful of bills, including California's, would make it easier or cheaper to terminate a pregnancy, she said.
The state legislature is considering the bill just as the fate of Roe v. Wade has been thrown into question. The conservative-leaning Supreme Court has agreed to review later this year a Mississippi law that bans abortions after 15 weeks, and its ruling could end or weaken Roe.
"It's tough to know your reproductive rights may be in question again after it's been decided for 40 years," said state Sen. Lena Gonzalez (D-Long Beach), author of the California bill, SB 245. "We're taking a stance, not just to make abortions available but to make them free and equitable."
Abortion opponents believe the state should instead make birth and maternity care more affordable, said Wynette Sills, director of Californians for Life. Instead of giving patients more choices in their reproductive healthcare and family planning, this bill promotes just one option, Sills said.
"If we're trying to look out for the economically disadvantaged, I think it's repulsive that the best we can offer is a free abortion," she said.
California already offers broad protection for abortion. It's one of six states that require health insurance plans to cover abortions, and most enrollees in the state's Medicaid program for low-income people, Medi-Cal, pay nothing out-of-pocket for the procedure.
When Bella Calamore decided to seek an abortion in May 2020, she thought the procedure would be free through Medi-Cal. But at the clinic, she learned that her father had recently enrolled her in his Blue Cross Blue Shield plan, which told her she would owe $600 after insurance was applied.
"Financially, it just didn't seem reasonable for me to spend that," said Calamore, 22, of Riverside. A college student, she had lost her job as a waitress during the COVID pandemic and had no income. The abortion cost more than her rent that month, she said.
Calamore sat in her car, surrounded by anti-abortion protesters, and tried to figure out what to do. She decided to pay for the abortion, leaving $200 in her bank account, barely enough for food for the rest of the month.
Calamore later got involved with NARAL Pro-Choice America, a group that promotes abortion rights, and testified before the Senate Health Committee.
The bill would not apply to the millions of Californians whose health insurance plans are regulated by the federal government. Out of approximately 23,000 women who get abortions in California each year, roughly 9,650 would be affected by this bill, according to an analysis by the California Health Benefits Review Board.
The board estimates the bill would lead to a 1% increase in abortions among those whose cost sharing would be eliminated, or the equivalent of about 100 additional abortions per year.
While the measure likely would not significantly increase abortions, waiving costs would help those who would otherwise have to make financial sacrifices, like falling behind on rent or cutting back on groceries, said Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.
"We've noticed a lot of callers who had private insurance plans and really restrictive copays or high deductibles," Pinckney said. "They're really creating a barrier."
The cost of an abortion rises as a pregnancy progresses. A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to the board's analysis, but isn't available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California. As a pregnancy advances, the cost goes up and fewer providers are willing to perform an abortion.
"The moment that a person finds out that they're pregnant, the clock is ticking, as well as the meter," said Fabiola Carrión, a senior attorney with the National Health Law Program.
Several other states expanded abortion access this year. New Mexico repealed its pre-Roe law that banned abortion in case Roe is overturned, and Virginia repealed a ban on abortion coverage in plans sold through the state's marketplace. Hawaii expanded the category of medical professionals who can provide abortions, and Washington now requires student health plans that cover maternity care to cover abortions as well.
New Jersey lawmakers are considering a comprehensive abortion-rights bill that would eliminate cost sharing for abortions, but advocates aren't optimistic about its chances.
Meanwhile, total abortion bans have been passed in Oklahoma and Arkansas this year, as have bans on abortion after six weeks in Texas, Idaho, South Carolina and Oklahoma (Oklahoma has passed three different bans on abortion this year). None have gone into effect, leaving time for court challenges, said Nash, from the Guttmacher Institute.
Eliminating abortion costs for patients has been tried in other states, including Oregon, which adopted a comprehensive abortion rights law in 2017 that included language similar to California's. A handful of other states have provisions to reduce out-of-pocket costs.
States have learned — from contraception coverage and from California's experience requiring health plans to cover abortions — that simply requiring something doesn't ensure patients can get it, Nash said. "Cost sharing is a huge barrier to accessing services that you need to remove so people can actually get the care they need," she said.
Most essential healthcare, like routine immunizations, preventive services and contraception, is already covered at no cost to the patient. Advocates of SB 245 say abortion is just as essential and should be treated the same way.
The California Association of Health Plans disagrees. This measure is one of several this year that would eliminate out-of-pocket costs for treatments or medicines, including insulin and other drugs for chronic diseases, said Mary Ellen Grant, a spokesperson for the association.
"We find this concerning as these bills would cumulatively increase premiums for all health plan enrollees," Grant wrote in an email.
Questions arise about how doctors will be trained, how that training will be paid for and whether a rural, sparsely populated state can sustain either a nonprofit or for-profit medical school, let alone both.
This article was published on Monday, June 7, 2021 in Kaiser Health News.
Two universities are eyeing the chance to be the first to build a medical school in one of the few states without one. The jockeying of the two schools — one a nonprofit, the other for-profit — to open campuses in Montana highlights the rapid spread of for-profit medical learning centers despite their once-blemished reputation.
Montana is one of only four states without a medical school, making it fertile ground for one.
What's happening in this Western state triggers questions about how future doctors will be trained, how that training will be paid for and whether a rural, sparsely populated state can sustain either a nonprofit or for-profit medical school, let alone both.
For more than 100 years, for-profit medical schools were banned in the U.S. because of the early 20th-century schools' low educational standards and a reputation of accepting anyone who could pay tuition.
Then, a 1996 court ruling forced accrediting agencies to take another look at for-profit medical schools, prompting a resurgence over the past dozen years. Their advocates argue that these institutions meet the same standards and requirements as every other medical school and often are established in communities that otherwise couldn't fund such institutions.
But those assurances don't quiet the concerns of skeptics, who warn that the problems of the past will inevitably return.
For years "there has been a sense that we should not risk going back to where the supply of doctors and the quality of doctors is in the hand of for-profit providers," said Robert Shireman, director of higher education excellence and a senior fellow at the Century Foundation, a progressive think tank that released a report in 2020 critical of for-profit medical schools. "But now essentially we have investment vehicles that are owning for-profit medical schools. That is a recipe for predatory behavior."
The debate landed on Dr. Paul Dolan's turf when he read in the Billings Gazette on Feb. 23 that a for-profit institution, Rocky Vista University College of Osteopathic Medicine, planned to open a satellite campus in Billings. Dolan, the chief medical information officer at Benefis Health System in Great Falls, had been working for at least a year to bring a nonprofit medical school to Montana and its population of just over 1 million people.
"There was some irritation locally here because it felt like this was our opportunity and these guys were trying to edge us out," he said.
Dolan responded quickly, and that same day, the Billings Gazette posted news about another possible med school moving to the state. This time the story featured Dolan's health system and its efforts to bring a satellite nonprofit medical school to Great Falls, 220 miles from Billings. It would be anchored by the Touro College and University System, a not-for-profit private institution with campuses across the U.S. and abroad, including multiple medical schools.
Rocky Vista University declined an interview request for this story. But Dr. Alan Kadish, president of the Touro College and University System, said the question of whether Montana can handle multiple medical schools isn't the issue. "The real thing is that the area needs more physicians and there is an opportunity to train them."
A Long History
Over a century ago, the U.S. banned for-profit medical schools over criticism that large numbers of commercial medical schools were proliferating and overproducing "under-educated and ill-trained medical practitioners," according to a Carnegie Foundation report first published in 1910.
In the 1970s, though, for-profit medical schools started to pop up in the Caribbean and were often attended by U.S. students who were rejected for admission by traditional, domestic schools. Then, that 1996 lawsuit regarding accreditation of a for-profit law school opened the door for other for-profit, postsecondary training institutions like Rocky Vista to reenter the U.S. market.
Yife Tien, son of a Caribbean for-profit medical school founder, used this model to establish Rocky Vista and accepted the school's first class in 2008 in Parker, Colorado. The school gained full accreditation in 2012 from the Commission on Osteopathic College Accreditation. In 2013, the Liaison Committee on Medical Education, which accredits allopathic medical schools, eliminated the accreditation standard that schools be not-for-profit.
Osteopathic and allopathic medical students study the same curriculum and participate in the same clinical training but take different licensing exams.
Rocky Vista remained the only for-profit school in the U.S. for seven years until another opened in California in 2015. Since 2015, five more for-profit medical schools have opened, and a sixth is scheduled to open in Utah later this year. All but one are osteopathic.
For-profit medical schools have also been proposed in Missouri and Maryland.
The Pros and Cons of a For-Profit Model
Even as for-profit schools become more common, critics predict problems. They warn that the private investors who fund the medical schools are not being transparent about where tuition funds go. They also argue that ownership can be unstable and that students may be taking out enormous loans for a lower-quality education.
The Century Foundation's 2020 report detailed Shireman's efforts to identify the investors, board of directors and owners of several of the for-profit medical schools. His findings were murky.
"It's a web of interconnected [limited liability corporations] where it is difficult to figure out who at the end of the day are the real decision-makers," he said.
Rocky Vista, for instance, initially owned by Yife Tien, was sold in 2018 to Medforth Global Healthcare Education, a private equity firm that also owns a Caribbean medical school. Most of the other for-profit schools appear to be funded by various individual investors or private equity groups involved in multiple other ventures, such as real estate and mining.
While nonprofit schools reinvest excess funds into their institutions, it's unclear where for-profits put their excess funds and how much investors may be profiting. Unlike other schools, even private ones such as Harvard Medical School, which post annual revenue and expenses reports, these for-profit schools do not share financial reports publicly on their websites.
KHN asked the existing U.S. for-profit medical schools to share their investors and financial reports. Only two responded, but both declined to comment.
When schools don't exhibit financial transparency, it can lead to problems, said Shireman; it makes institutions less accountable to their students and can result in lower-quality education.
"That can create a situation where you invest less in excellence and you spend less on actually educating students," Shireman said. "You charge more to the students themselves and you end up focusing almost exclusively on the easily measurable outcomes — like training people to pass the medical exams, rather than training people to be excellent doctors."
But Dr. George Mychaskiw, one of the founding deans of Burrell College of Osteopathic Medicine, a for-profit osteopathic medical school that opened in New Mexico in 2016, dismissed these concerns, saying that if a school meets the necessary standards then its business model should be irrelevant.
"It's easy to paint all for-profit institutions with the same paintbrush, and look at them as an ITT Tech, but it just doesn't really apply," said Mychaskiw. "The accreditation standards are so rigorous." ITT Technical Institute was a for-profit institution with 130 campuses that shut down in 2016 after federal sanctions.
That is also the view of Dr. Kevin Klauer, CEO of the American Osteopathic Association, which oversees the accreditation council.
"If the standards are met, and fairness is provided to the students through those standards, we're not questioning their structure and how they're financed if they meet all of the guidelines," said Klauer.
Another issue for for-profit medical schools, though, is that most are awaiting full accreditation, which is not conferred until the first class graduates. That means students are not eligible for federal assistance and instead must take out private loans that usually have high interest rates.
For the most part, tuition costs for for-profit medical schools are in the range of what nonprofit private medical schools charge. Non-profit medical school tuition and fees for the 2020-2021 school year ranged from a low of $19,425 at Baylor to $67,532 at Dartmouth, according to an Association of American Medical Colleges survey. Rocky Vista's tuition and fees for first-year students, by comparison, was $58,530, which is roughly $3,000 more than the average cost of an osteopathic medical school for an out-of-state student, according to the American Association of Colleges of Osteopathic Medicine.
According to 2019 statistics provided by the Century Foundation, the average median amount of program debt for Rocky Vista is $294,780 compared with either the average median program debt for private nonprofit med schools, $201,164, and public medical schools, $177,324. (Rocky Vista is the only for-profit medical school with average median debt listed in the federal government's college comparison tool, College Scorecard, since the other schools are so new.)
The American Medical Association published a report in 2019 that analyzed attrition rates and financial burden of for-profit and nonprofit medical schools. Although the attrition rates were higher at several of the for-profit schools, other statistics were comparable. And since most of these for-profit medical schools are relatively new, data is limited, and it remains to be seen how well their students will perform.
Dr. Nicholaus Mize, a 2015 alumnus of Rocky Vista University and an internal medicine physician at Estes Park Health in Estes Park, Colorado, said he didn't perceive any difference in his medical education because of his school's for-profit model.
"I think it was quite equal," Mize, who is also an adjunct professor at Rocky Vista, wrote us in a LinkedIn message. "I can say that I feel that I received a good medical education. I have stayed friends with many of my classmates and all are doing well in their careers."
However, Mize did take issue with the size of the student loans he had to take out to get that medical education and the loans' high interest rates. One year's charge was especially difficult, he notes — he could only get high-interest private loans because his Rocky Vista campus was not fully accredited at the time.
Meanwhile, the Montana drama continues. Rocky Vista's request to come to Billings isn't the first time a for-profit school eyed Montana. In fact, the Benefis Health System had courted a different for-profit medical school in 2015.
Dolan said that effort fell through when leaders in the state voiced concerns about the school having a for-profit model. That's why his organization shifted its interest to nonprofit institutions.
Still, Rocky Vista announced May 17 that its application for the satellite school in Billings had been given a green light by the Commission on Osteopathic College Accreditation, meaning it can begin building the new campus.
As for Touro, the school's application was submitted in April and a decision on whether to accredit the school will be determined at the commission's August meeting.
There is an emerging consensus that many services that once required an office visit can be provided easily and safely — and often more effectively — through a video chat, a phone call or even an email.
This article was published on Monday, June 7, 2021 in Kaiser Health News.
As the COVID crisis wanes and life approaches normal across the U.S., health industry leaders and many patient advocates are pushing Congress and the Biden administration to preserve the pandemic-fueled expansion of telehealth that has transformed how millions of Americans see the doctor.
The broad effort reaches across the nation's diverse healthcare system, bringing together consumer groups with health insurers, state Medicaid officials, physician organizations and telehealth vendors.
And it represents an emerging consensus that many services that once required an office visit can be provided easily and safely — and often more effectively — through a video chat, a phone call or even an email.
"We've seen that telehealth is an extraordinary tool," said David Holmberg, chief executive of Pittsburgh-based Highmark, a multistate insurer that also operates a major medical system. "It's convenient for the patient, and it's convenient for the doctor. … Now we need to make it sustainable and enduring."
Last fall, a coalition of leading patient groups — including the American Heart Association, the Arthritis Foundation, Susan G. Komen and the advocacy arm of the American Cancer Society — hailed the expansion of telehealth, noting the technology "can and should be used to increase patient access to care."
But the widespread embrace of telemedicine — arguably the most significant healthcare shift wrought by the pandemic — is not without skeptics. Even supporters acknowledge the need for safeguards to prevent fraud, preserve quality and ensure that the digital health revolution doesn't leave behind low-income patients and communities of color with less access to technology — or leave some with only virtual options in place of real physicians.
Some worry that telehealth, like previous medical innovations, may become another billing tool that simply drives up costs, a fear exacerbated by the hundreds of millions of dollars flowing into the burgeoning digital health industry.
Companies offering remote urgent care, virtual primary care and new wearable technologies to monitor patient health are exploding, with the annual global telehealth market expected to top $300 billion by 2026, up nearly fivefold from 2019, according to research company PitchBook.
"I don't think there's any debate that there is a value in better access, but if this is just a one-off service that adds another billing option without fitting into patients' regular care, I don't know if it will do much for patients' health," said Tom Banning, head of the Texas Academy of Family Physicians.
Perhaps the most contentious issue facing politicians, insurers and hospitals is how much a telehealth visit is worth in a system that is already breaking the bank.
While Medicare and other insurers fueled the explosion of telehealth over the past year by paying the same rates as for in-person visits, many are expected to push for lower prices when the federally designated public health crisis ends. At the same time, physicians and hospitals are looking to maintain income.
"Payers are unlikely to give providers carte blanche," said Dr. Hoangmai Pham, a former senior medical official at health insurance giant Anthem. But Pham noted insurers could reward physicians and hospitals that take greater responsibility for their patients' overall health with higher rates for telehealth. "There's an opportunity here," she said.
For now, tens of millions of Americans have gotten used to meeting their doctor on a laptop or smartphone, and pressure is building on the federal and state governments to loosen rules to preserve virtual visits after the health crisis ends.
"I don't want to go back," said Suzy Brantley, a 67-year-old Texan who works at an accounting firm outside Dallas.
Brantley has been going to the same medical practice for more than 15 years. "I love them there," she said. But when the practice closed its doors last spring, requiring virtual visits, Brantley found she enjoyed the more convenient way to do routine business like refill a prescription.
"You don't have to leave work to go to the doctor," she said. "I can just step into the break room for a few minutes and use my phone. … I love it."
She's far from alone. In a nationwide poll last year, 8 in 10 Americans who had used telehealth said they "liked it" or "loved it." Nearly the same share said they were likely to continue using it after the pandemic, according to the survey by the Harris Poll.
Just a year ago, telehealth — or telemedicine, as it's also called — was largely a curiosity. Patient and physician wariness and strict rules about how doctors could bill had squelched widespread use.
Fearing fraud and overuse, the federal government tightly restricted the kind of video and audio visits that could be billed to Medicare, limiting use mainly to rural areas and to visits in which a doctor was in an office or hospital, rather than working remotely.
"There was a fear that if there was the slightest opening in the Medicare payment system, people would find a way to abuse it," said Sean Cavanaugh, who oversaw Medicare during the Obama administration.
That changed suddenly in spring 2020 as pandemic lockdowns shuttered physician offices. Almost overnight, doctors were forced to pivot to virtual care to maintain contact with patients and keep money flowing.
The Trump administration moved quickly to facilitate the shift. The Medicare agency dramatically expanded the kind of services that could be provided virtually. Officials added 140 telehealth services to the list of what Medicare would pay for during the pandemic, including emergency visits, eye exams, speech and hearing therapy, and nursing home care.
Critically, Medicare raised fees for virtual visits to match those for in-office exams, a move followed by state Medicaid programs and many commercial insurers.
The surge was explosive. While fewer than 1% of primary care visits in Medicare occurred virtually in January 2020, by April nearly half did, according to data compiled by the Medicare Payment Advisory Commission.
At UnitedHealth Group, the nation's largest health insurer, the number of covered telehealth visits increased nearly thirtyfold, rising from 1.2 million visits in 2019 to 34 million last year. Other insurers reported as much as an eightyfold increase.
"Very quickly, it became clear that we could deliver very good care to our patients via televisit," said Dr. Manish Naik, chief medical information officer at Austin Regional Clinic in central Texas.
The medical group not only helped its primary care physicians pivot to telehealth, but it also built a virtual urgent care system that allows patients to connect by video with on-call doctors 24 hours a day, a model used by large medical systems such as Kaiser Permanente.
Other systems are moving beyond televisits to expand use of remote monitoring tools in people's homes that track vital signs of patients with chronic illnesses such as diabetes.
Perhaps nowhere has telehealth proved more transformational than in mental health services and treatment for patients addicted to drugs.
"Telehealth has been a godsend," said Ellen Bemis, chief executive of AMHC, a network of behavioral health clinics in rural northern Maine. Bemis said the clinics are already seeing patients adhere better to their medications as they remain in better contact virtually.
"I hope we never go back," she said.
In Alaska, health officials feel the same way. "What we've seen through COVID was amazing," said state Medicaid director Albert Wall, noting a major decline in patients missing appointments.
Whether these changes endure depends largely on Congress and the Biden administration, which hasn't indicated whether it will make permanent the looser telehealth rules rolled out last year. The rules will sunset when the public health emergency ends, likely at the end of this year.
The uncertainty is fueling an urgent effort by physicians, hospitals, patient advocates and others to persuade government officials not to reimpose the strict limitations.
Democrats and Republicans in Congress have introduced bills to cement the changes. In statehouses, advocates for expanding telehealth have introduced more than 650 bills, according to the Alliance for Connected Care, a telehealth lobbying coalition.
"We've seen the potential of telehealth," said Dr. Christopher Crow, chief executive of Texas-based Catalyst Health Network, which helps primary care physicians manage their practices. "Now, we have to make sure we realize it before everyone starts shifting back to the exam rooms."
Major physician groups are pushing to maintain equal reimbursement for telehealth and in-person visits.
Dr. Susan Bailey, president of the American Medical Association, said Medicare should continue to allow patients to receive virtual care in their homes and in all areas of the country, not just rural areas.
The association is also pushing for Medicare to keep reimbursing doctors for consulting with patients by phone, a move Bailey said would ensure that patients without broadband internet service aren't left behind.
The push for more billable services has raised concerns about fraud, especially as physicians and hospitals develop more efficient systems to see patients remotely. "Overuse is absolutely a concern," said Dr. Von Nguyen, chief medical officer at Blue Cross Blue Shield of North Carolina. "Once these systems are in place, I suspect, the risk will be greater."
Nevertheless, many insurers and state Medicaid programs, two groups that typically look more skeptically at services that can drive up costs, are backing telehealth expansion.
And despite initial fraud concerns, nearly a dozen Medicaid and insurance industry officials interviewed for this article noted that thus far they've seen little evidence of widespread misuse.
"There is fraud in traditional medical care, too," said Dr. Donna O'Shea, a senior executive at UnitedHealth Group.
Several insurance officials said telehealth could ultimately save money by routing some medical care from high-cost doctors' offices and hospitals to lower-priced virtual visits, particularly for urgent care.
And some insurance companies — including Harvard Pilgrim Healthcare in New England and Priority Health in Michigan — are marketing health plans with lower premiums that steer patients to virtual care.
"We see this being a long-term change," said Dr. Michael Sherman, Harvard Pilgrim's chief medical officer.
Sherman said the health plan is even exploring whether to help low-income patients get internet access to expand telehealth further. "We have proven to ourselves that this works," he said.
KHN correspondent Rachana Pradhan and digital producer Hannah Norman contributed to this report.
The growing political pressure to discover Chinese malfeasance or a lab accident at the root of the pandemic could make a definitive answer less, rather than more, likely.
This article was published on Friday, June 4, 2021 in Kaiser Health News.
President Joe Biden has ordered U.S. intelligence agencies to determine whether the COVID virus, or a near ancestor, emerged from a cave, a live-animal market, a farm — or a secretive Chinese laboratory.
But it's doubtful this probe will yield definitive insights, and it could even backfire.
Some experts hypothesize that global pressure could prompt a Chinese scientific whistleblower to come forward with evidence of a lab leak. After all, it is unlikely such an accident could have occurred without dozens of people finding out about the leak, or an ensuing cover-up.
But the growing political pressure to discover Chinese malfeasance or a lab accident at the root of the pandemic could make a definitive answer less, rather than more, likely, according to virologists and experts on U.S.-China scientific exchanges.
"We have to reduce the political tension and let the scientists do the work, not the politicians," said Dr. Jennifer Huang Bouey, a Chinese-born Rand Corp. researcher.
Yet that seems like a pipe dream. In the United States, the lab leak theory is part of the conservative arsenal of attacks on those in science and the media who criticized President Donald Trump's handling of the pandemic. For the ruling Chinese Communist Party, the political implications of acknowledging a lab leak and subsequent cover-up are a non-starter. It would leave China essentially responsible for starting a global pandemic that has killed 6 million and ground economies to a halt.
As Biden last week announced a 90-day review of evidence on the virus's origin — which could involve a review of documents from U.S. agencies that helped fund Chinese viral research— Chinese officials at a World Health Organization meeting dismissed the review and withdrew a promise to cooperate with scientists examining the full slate of origin possibilities.
During its visit to China in February, a WHO investigative team received agreement from Chinese blood banks to preserve samples of donations that could indicate when and where the virus might have been circulating before it swept over the city of Wuhan in December 2019.
The team wants to go back to China, extending its investigation to markets and farms where animals like civet cats, raccoon dogs and bamboo rats — potential carriers of the virus as it leaped from bats to humans — were raised as part of a $70 billion "wildlife farming" industry. In 2003, China banned the sale of such exotic wildlife at "wet markets" — which mainly sell fish and game like live chickens — after they were implicated as the origin of the SARS epidemic, though such animals have returned to markets over the years.
Further study is impossible without Chinese cooperation, which is mired in politics, the WHO investigators say.
"We're not following all these obvious leads now," Dr. Marion Koopmans, a leading Dutch virologist who was part of the WHO team, said last week. "Everything is stalled."
Her team has been criticized for caving to Chinese pressure by failing to seek a strict audit of the Wuhan Institute of Virology, the center of allegations about a lab leak. But to forcefully demand such an audit would require evidence of a leak, rather than speculation based on classified intelligence reports and theoretical gaps in data, Koopmans said. Besides, the Chinese government won't open its books. It has closed access to the data, claiming there had been thousands of hacking attempts against the Wuhan Institute.
That awkward standoff could harm U.S.-Chinese scientific cooperation, which has gradually expanded over the past 40 years and remained strong despite Trump administration attacks. Whether a lab leak happened or not, it's hard to see how a weakening of scientific exchanges would be a good thing for either country.
Full-tuition-paying Chinese students made up the majority of the international enrollees at U.S. colleges and universities in 2019, though Chinese interest in U.S. schools seems to be ebbing. U.S. laboratories depend on Chinese scholars, many of whom end up remaining in the United States. Scholars from the two countries co-publish scientific papers more often than any other national "dyad," according to research by Caroline Wagner of the Ohio State University.
But those partnerships have had their hiccups, sometimes for political reasons. With AIDS and SARS, the Chinese were either reluctant to allow their scientists to release data or released counts that many Western experts doubted were accurate.
Trump curtailed scientific exchanges as early as 2017, issuing fewer visas and raising FBI vigilance of academics with ties to China. Some interagency agreements were allowed to lapse and, in 2018, a 45-member Centers for Disease Control and Prevention contingent in China was cut to 10. Trump saw this as a punishment of the Chinese, but it effectively blinded the U.S. to the goings-on in Chinese epidemiology.
Otherwise, "maybe we'd have had a quicker leg up on the outbreak," said Ben Corb, spokesperson for the American Society for Biochemistry and Molecular Biology.
Despite his anti-China stance, Trump in 2018 renewed a landmark 1979 agreement authorizing scientific and technological cooperation among the Chinese and U.S. governments. However, that renewal document is secret — presumably, Trump was not happy to have to take the advice of his scientific advisers — and it's impossible to come by a copy, according to Duke University business professor Denis Simon, an expert on the US-China scientific relationship.
The Biden administration is said to favor improving scientific cooperation — for example, by easing limits on visas for Chinese scholars. And while Trump clearly viewed the lab leak hypothesis as an opportunity to blame China for the administration's misfortunate COVID response — an association that tarnished the theory's plausibility during the Trump years — Biden seems to want an answer to the question, at least in part to prevent future pandemics.
Since the turn of the century and especially since SARS, China has sent many biologists to train in the United States, and they are now leery of being seen as unreliable partners in disease investigations. The Chinese government has copied many aspects of the U.S. scientific and public health system, Bouey noted. Close collaborations and friendships have resulted. Toward the beginning of the pandemic, Dr. Anthony Fauci, the National Institutes of Health's top infectious disease specialist, was in regular contact by email with George Gao, the Oxford- and Harvard-trained scientist who runs China's equivalent of the CDC.
Even with Chinese government cooperation, we might never know how COVID began. But if the intelligence review suggests or manages to determine that a lab leak did cause the pandemic, and China continues to stonewall, it's hard to predict what might happen.
"I think there will be hell to pay," said Simon. "We haven't figured out the consequences to the answer. I'm very concerned about our ability to manage the emotions loosed if that hypothesis were to be accepted."
Now that mask requirements and other measures to prevent the spread of the virus are easing, efforts to boost vaccination rates in underserved communities are even more urgent.
This article was published on Friday, June 4, 2021 in Kaiser Health News.
Throughout the COVID-19 vaccination effort, public health officials and politicians have insisted that providing shots equitably across racial and ethnic groups is a top priority.
But it's been left up to states to decide how to do that and to collect racial and ethnic data on vaccinated individuals so states can track how well they're doing reaching all groups. The gaps and inconsistencies in the data have made it difficult to understand who's actually getting shots.
Just as an uneven approach to containing the coronavirus led to a greater toll for Black and Latino communities, the inconsistent data guiding vaccination efforts may be leaving the same groups out on vaccines, said Dr. Kirsten Bibbins-Domingo, an epidemiologist at the University of California-San Francisco.
"At the very least, we need the same uniform standards that every state is using, and every location that administers vaccine is using, so that we can have some comparisons and design better strategies to reach the populations we're trying to reach," Bibbins-Domingo said.
Now that federal, state and local governments are easing mask requirements and ending other measures to prevent the spread of the virus, efforts to boost vaccination rates in underserved communities are even more urgent.
At St. James United Methodist Church, a cornerstone for many in the Black community in Kansas City, Missouri, in-person services recently resumed after being online for more than a year. St. James has also been hosting vaccination events designed to reach people in the neighborhood.
"People are really grieving not only the loss of their loved ones, but the loss of a whole year, a loss of being lonely, a loss being at home, not being able to come to church. Not being able to go out into the community," said Yvette Richards, St. James' director of community connection.
Missouri's population is 11% African American, but COVID cases among African Americans accounted for 25% of the total cases for the state, according to an analysis by KFF.
Richards said St. James has lost many congregants to the coronavirus, and the empty pews where they once sat on Sundays serve as stark reminders of all this community has been through during the pandemic.
Missouri's public COVID data appears to show robust data on vaccination rates broken down by race and ethnicity. But several groups are seen lagging far behind on vaccinations, including African Americans, who appear to have a vaccination rate of just 17.6%, nearly half of the 33% rate for the state as a whole.
To Dr. Rex Archer, director of the Kansas City health department, one number is a giveaway that this data isn't right. It shows a completed vaccination rate of 64% for "multiracial" Missourians. Such an exceptionally high rate for one group beggars belief, according to Archer.
"So, there's some huge problem with the way the state is collecting race and ethnicity under COVID vaccination," Archer said.
Missouri state officials have acknowledged since February that this data is wrong, but they haven't managed to fix it or explain exactly what's causing it. Archer suggested the inflated multiracial rate is probably due to different racial data being reported when individuals receive first and second shots.
Other problems have been detected, including missing racial and ethnic data for many people who have been vaccinated, and the use of multiple categories such as "other" and "unknown."
The state also noted it used national racial percentages in the state's vaccination data rather than actual percentages based on the state's population. For example, earlier in the vaccination effort, the state used national racial data, which shows nearly 6% of the population is Asian, even though Missouri's population is 2.2% Asian.
Health officials are working to target vaccination campaigns in communities where rates are low, but Archer said the state's data provides little help.
"I mean, we have to look at it, but it's got too many variables to be something we can count on," Archer said.
Though racial and ethnic categories are clearly defined in national U.S. Census data, the same data is not collected uniformly by states.
For example, South Carolina's vaccination data lumps together Asians, Native Americans and Pacific Islanders in one category. In Utah, residents can pick more than one race. Wyoming doesn't report racial or ethnic data for vaccinations at all.
Bibbins-Domingo said the missing or inconsistent data doesn't necessarily mean tracking equity is a lost cause. Vaccination rates for census tracts where racial and ethnic data is known can be used as a proxy to estimate vaccine allocations.
However, Bibbins-Domingo argued that the pandemic has shined a light on racial data problems that have persisted far too long in U.S. public health.
"What my hope is, is that our lessons from COVID really cause all of us to think about the infrastructure we need within our state and nationally to make sure we are prepared next time," Bibbins-Domingo said. "Data is our friend."
Local leaders and health officials in Missouri are scrambling to boost vaccination rates, especially among vulnerable communities, after Republican Gov. Mike Parson recently announced steps to urge residents back to working in person.
Parson ordered state workers back to the office in May and said he would end additional federal pandemic-related benefits for unemployed workers in June, despite vaccination rates across the state being well below what Missouri health experts had hoped to achieve.
Jackson County, Missouri, which includes most of Kansas City, authorized $5 million in federal CARES funding last month to increase vaccinations in six ZIP codes with large Black populations and low vaccination rates. The project will address problems of both access and hesitancy and focus on reaching out to individuals and neighborhoods.
Although many of the state's vaccination efforts have involved large mass events, St. James Pastor Jackie McCall said she's been talking with many in her church and community who need encouragement to have faith in the vaccines.
"So let's go ahead and let's trust," McCall told congregants. "Let's trust the process. Let's trust God. Let's trust the science."
This story is part of a reporting partnership that includes KCUR, NPR and KHN.
This article was published on Friday, June 4, 2021 in Kaiser Health News.
The Food and Drug Administration's decision next week whether to approve the first treatment for Alzheimer's disease highlights a deep division over the drug's benefits as well as criticism about the integrity of the FDA approval process.
The agency said it will decide by June 7 the fate of Biogen's drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn't reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients' cognitive and functional ability by 22%.
A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company.
The FDA is under pressure because an estimated 6 million Americans are diagnosed with Alzheimer's, a debilitating and ultimately fatal form of dementia, and there are no drugs on the market to treat the underlying disease. Although some drugs slightly mitigate symptoms, patients and their families are desperate for a medication that even modestly slows its progression.
Aducanumab helps the body produce antibodies that remove amyloid plaques from the brain, which has been associated with Alzheimer's. It's designed for patients with mild-to-moderate cognitive decline from Alzheimer's, of which there are an estimated 2 million Americans. But it's not clear whether eliminating the plaque improves brain function in Alzheimer's patients. So far, nearly two dozen drugs based on the so-called amyloid hypothesis have failed in clinical trials.
Besides questions about whether the drug works, there also are safety issues. More than one-third of patients in one of the trials experienced brain swelling and nearly 20% had brain bleeding, though those symptoms generally were mild and controllable. Because of those risks, patients receiving aducanumab have to undergo regular brain monitoring through expensive PET scans and MRI tests.
"There's a lot of hope among my patients that this is going to be a game changer," said Dr. Matthew Schrag, an assistant professor of neurology at Vanderbilt University. "But the cognitive benefits of this drug are quite small, we don't know the long-term safety risks, and there will be a lot of practical issues in deploying this therapy. We have to wait until we're certain we're doing the right thing for patients."
Many aspects of aducanumab's journey through the FDA approval process have been unusual. It's "vanishingly rare" for a drug to continue on toward approval after its clinical trial was halted because unfavorable results showed that further testing was futile, said Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner. And it's "mind-boggling," he added, for the FDA to collaborate with a drugmaker in presenting a joint briefing document to an FDA advisory committee.
"A joint briefing document strikes me as completely inappropriate and an abdication of the FDA's claim to being the best regulatory agency in the world," Lurie said.
Three FDA advisory committee members who voted in November against approving the drug wrote in a recent JAMA commentary that the FDA's "unusual degree of collaboration" with Biogen led to criticism that it "potentially compromised the FDA's objectivity." They cast doubt on both the drug's safety and the revised efficacy data.
The FDA and Biogen declined to comment for this article.
Despite the uncertainties, the Alzheimer's Association, the nation's largest Alzheimer's patient advocacy group, has pushed hard for FDA approval of aducanumab, mounting a major print and online ad campaign last month. The "More Time" campaign featured personal stories from patients and family members. In one ad, actor Samuel L. Jackson posted on Twitter, "If a drug could slow Alzheimer's, giving me more time with my mom, I would have read to her more."
But the association has drawn criticism for having its representatives testify before the FDA in support of the drug without disclosing that it received $525,000 in contributions last year from Biogen and its partner company, Eisai, and hundreds of thousands of dollars more in previous years. Other people who testified stated upfront whether or not they had financial conflicts.
Dr. Leslie Norins, founder of a group called Alzheimer's Germ Quest that supports research, said the lack of disclosure hurts the Alzheimer's Association's credibility. "When the association asks the FDA to approve a drug, shouldn't it have to reveal that it received millions of dollars from the drug company?" he asked.
But Joanne Pike, the Alzheimer's Association's chief strategy officer, who testified before the FDA advisory committee about aducanumab without disclosing the contributions, denied that the association was hiding anything or that it supported the drug's approval because of the drugmakers' money. Anyone can search the association's website to find all corporate contributions, she said in an interview.
Pike said her association backs the drug's approval because its potential to slow patients' cognitive and functional decline offers substantial benefits to patients and their caregivers, its side effects are "manageable," and it will spur the development of other, more effective Alzheimer's treatments.
"History has shown that approvals of first drugs in a category benefit people because they invigorate the pipeline," she said. "The first drug is a start, and the second and third and fourth treatment could do even better."
Lurie disputed that. He said lowering the FDA's standards and approving an ineffective or marginally effective drug merely encourages other manufacturers to develop similar, "me too" drugs that also don't work well.
The Public Citizen Health Research Group, which opposes approval of aducanumab, has called for an investigation of the FDA's "unprecedented and inappropriate close collaboration" with Biogen. It asked the inspector general of the Department of Health and Human Services to probe the approval process, which that office said it would consider.
The group also urged the acting FDA commissioner, Dr. Janet Woodcock, to remove Dr. Billy Dunn, an aducanumab advocate who testified about it to the advisory committee, from his position as director of the FDA's Office of Neuroscience and hand over review of the drug to staffers who weren't involved in the Biogen collaboration.
Woodcock refused, saying in a letter that FDA "interactions" with drugmakers make drug development "more efficient and more effective" and "do not interfere with the FDA's independent perspective."
Although it would be unusual for the FDA to approve a drug after rejection by an FDA advisory committee, it's not unprecedented, Lurie said. Alternatively, the agency could approve it on a restricted basis, limiting it to a segment of the Alzheimer's patient population and/or requiring Biogen to monitor patients.
"That will be tempting but shouldn't be the way the problem is solved," he said. "If the product doesn't work, it doesn't work. Once it's on the market, it's very difficult to get it off."
If the drug is approved, Alzheimer's patients and their families will have to make a difficult calculation, balancing the limited potential benefits with proven safety issues.
Anne Saint, whose husband, Mike, had Alzheimer's for a decade and died in September at age 71, said that based on what she's read about aducanumab, she wouldn't have put him on the drug.
"Mike was having brain bleeds anyway, and I wouldn't have risked him having any more side effects, with no sure positive outcome," said Saint, who lives in Franklin, Tennessee. "It sounds like maybe that drug's not going to work, for a lot of money."
Their adult daughter, Sarah Riley Saint, feels differently. "If this is the only hope, why not try it and see if it helps?" she said.
Newsom, a self-described feminist and the father of four young children, has long advocated family-friendly health and economic policies. Flush with a projected budget surplus of $75.7 billion, state politicians have come up with myriad legislative and budget proposals to make poorer families healthier and wealthier.
They include ending sales taxes on menstrual products and diapers; adding benefits such as doulas and early childhood trauma screenings to Medi-Cal, the state's Medicaid program; allowing pregnant women to retain Medi-Cal coverage for a year after giving birth; and a pilot program to provide a universal basic income to low-income new parents.
"COVID-19 laid inequity bare for all to see," Assembly member Wendy Carrillo (D-Los Angeles) said in a written statement. She is the co-author of Senate Bill 65, led by Sen. Nancy Skinner (D-Berkeley), which would pour hundreds of millions of dollars into family and healthcare programs annually, focusing on minority groups that Carrillo said were "pushed out of the social safety net by the prior White House."
Newsom and the Democratic-controlled legislature are unified on major healthcare and social safety-net expansions, which would direct billions in health benefits and cash assistance to the state's most vulnerable residents and low-income parents. Legislative Democrats for years have pushed a progressive agenda to help struggling parents and families, featuring proposals like those to permanently end taxes on menstrual products and diapers — expected to cost the state millions.
"We don't need to balance the budget on half of the population that has a uterus," said Assembly member Cristina Garcia (D-Bell Gardens), who has for years sought an end to the "pink tax" on diapers and menstrual products.
Skinner, chair of the Senate budget committee, is among the powerful lawmakers who've put forward legislation to make childbirth safer and parenthood more affordable. Her bill, which cleared the Senate and was up for consideration this week in the state Assembly, has several features that would dramatically expand maternal healthcare (transgender men also get pregnant and give birth).
Before the pandemic, Medi-Cal covered mothers only up to 60 days after their pregnancies ended unless their income fell below a certain line or they had a mental health diagnosis. Skinner's bill, part of a broader national push to improve birth outcomes, would expand full Medi-Cal coverage to 12 months after the end of a pregnancy. Other parts of the bill would intensify state reporting and reviews of fetal and pregnancy-related deaths and severe maternal morbidity, expand housing benefits for families that have a pregnant member, and increase training programs for midwives.
Newsom's $268 billion budget blueprint includes about $200 million a year to fully implement the expansion of Medi-Cal coverage for new mothers, with matching dollars from the federal government until those funds expire in 2027. If the expansion were not renewed, the state would revert to previous Medi-Cal qualifications.
"Not all postpartum issues end at 60 days, and when patients lose insurance, we can't address them in the usual way," said Dr. Yen Truong, an OB-GYN who works with the American College of Obstetricians and Gynecologists on legislative issues in California.
About half of pregnancy-related deaths occur during the pregnancy or on the day of delivery, but about 12% take place between seven weeks and a year after giving birth, according to the Centers for Disease Control and Prevention.
The U.S. had 17.4 early maternal deaths per 100,000 live births in 2018, according to the most recent CDC data with state figures. California's rate, 11.7 per 100,000, was among the lowest in the nation, but the state collects data on maternal deaths in a way that could result in underestimates.
California's overall numbers also obscure stark racial disparities. Statewide, Black infants averaged 7.8 deaths per 1,000 live births, compared with an average of three deaths among white babies. Data from 2013 from Los Angeles County showed Black women had pregnancy-related deaths at rates more than four times as high as the overall rate in the state's largest county.
"Given our state's wealth and medical advancements, this is unacceptable," Skinner, vice chair of the Legislative Women's Caucus, said in a news release.
Democrats also appear unified on another aspect of Skinner's bill: a pilot program to test a universal basic income program for struggling families. The bill would give $1,000 a month to low-income expectant and new parents with kids under 2 years old in counties that decide to participate. Newsom has also proposed $35 million over five years for pilot programs for universal basic income.
These issues could play well, especially among women, and improve Newsom's standing going into a recall election later this year, said Rose Kapolczynski, a longtime campaign consultant to former U.S. Sen. Barbara Boxer who has worked on reproductive healthcare issues in Sacramento.
Indefinitely rescinding sales taxes on diapers and menstrual products — the taxes have been temporarily lifted since early last year — is a particular no-brainer because of its bipartisan appeal, she said.
"It's hard for Republicans to attack something that is a tax cut, and sales taxes are regressive, so progressives would like it," Kapolczynski said.
As for Medi-Cal expansions, Kapolczynski said that even though it wouldn't affect most Californians, the pandemic has made healthcare even more important to voters. "The budget surplus is allowing many things that were called impossible to be possible, and that includes healthcare bills," she said.
Investing in California's young families could help close the racial gap in maternal and infant mortality, said Nourbese Flint, executive director of the Black Women for Wellness Action Project, which endorsed Skinner's bill.
California's would become the first Medicaid program to include "full spectrum" doula coverage, meaning it would include care for women who have abortions, miscarriages and stillbirths, said Amy Chen, a senior attorney at the National Health Law Program.
"California has always led the country and been a little bit in front of where our federal government is when it comes to covering folks," Flint said.
California Healthline correspondent Angela Hart contributed to this report.