The day after his inauguration, President Joe Biden signed an order creating a Pandemic Testing Board, which he said would be modeled on FDR's hugely successful Wartime Production Board. A year later, there's little sign of Biden's initiative.
This article was published on Wednesday, February 16, 2022 in ProPublica.
When President Joe Biden was campaigning for office, he said that to beat the coronavirus, the U.S. needed the testing equivalent of President Franklin D. Roosevelt's War Production Board.
"It's how we produced tanks, planes, uniforms, and supplies in record time," the Biden campaign website said. "And it's how we can produce and distribute tens of millions of tests."
A year later, though, it's remarkably hard to tell what the board has done.
As far as we can find, the group has put out no press releases, held no hearings and made no announcements. Biden's executive order states that the head of the board would be, or be chosen by, the White House's head of COVID-19 response. That's Jeffrey Zients, but when we contacted him, he didn't respond.
When we asked White House officials about the Pandemic Testing Board — who was on it and what actions it had taken — they declined to answer our questions and pointed us to the Department of Health and Human Services.
That agency did respond to our inquiries about the board, but its answers offered few details about the board's work. It did not say who is on the panel or what decisions it has made.
"The Pandemic Testing Board serves as the forum where agencies across the federal government which are involved in testing can describe emerging challenges and what they are learning," the agency said. "It provides a mechanism for addressing policy and implementation issues regarding the supply and distribution of tests, as well as increasing access to and affordability of tests in the community."
The agency's full statement also notes that the board has met regularly and has been split into two groups, one focused on test supply and the other on testing policies.
Public health experts told us they, too, hadn't heard much about the board.
"I had assumed that they jettisoned these plans," said Jennifer Nuzzo, an epidemiologist and professor at Johns Hopkins University. "If it still exists, it is certainly very low profile," said Lawrence Gostin, a professor of global health law at Georgetown University. The country's first coronavirus testing czar, Adm. Brett Giroir, said he knew little about it as well. "It is rumored to have met, but I did not see public disclosure or reports from the meetings."
Of course, the inner workings of a board are less important than whether the government is getting the job done. But as ProPublica detailed in November, the Biden administration has been slow to roll out wider testing — just what the board was created to do.
In October, White House officials reportedly disregarded a proposal from testing experts to send rapid tests directly to Americans in anticipation of a COVID-19 spike during the holidays. Press secretary Jen Psaki also infamously dismissed the idea in a December briefing.
Later that month, the Biden administration announced it would send tests directly to Americans. But the tests are arriving just as the omicron wave is receding, and critics have argued that the effort shortchanges communities of color.
"I think it's damn well about time," said David Paltiel, a professor of public health at Yale University. "It's never too late, but some of us have been screaming and yelling about the idea for more than 18 months."
There was no shortage of money for expanding testing. As part of last year's stimulus package, Congress appropriated nearly $48 billion for testing, contact tracing and other efforts to prevent the spread of COVID-19. That is in addition to $48 billion set aside for testing in 2020.
But just like with the board's activities, details about where exactly the money has gone have been hard to come by. Since the Biden administration hadn't released a breakdown, we submitted a request for specifics more than two months ago.
The allocations thus far include: $10 billion for testing in schools, $9 billion for manufacturing testing supplies, nearly $5 billion for testing uninsured individuals, and more than $4 billion for testing and mitigation measures for high-risk populations. Nearly $3.9 billion went toward free community testing at pharmacies and federally qualified health centers, and $2.9 billion went to the Centers for Disease Control and Prevention for expanding labs and testing capacity. More than $1.9 billion has gone toward COVID-19 testing of unaccompanied minors at the U.S.-Mexico border. About $3.6 billion is listed as simply "activities previously planned for PPPHCEA," a reference to the 2020 Paycheck Protection Program and Healthcare Enhancement Act. The Indian Health Service received an additional $1.5 billion. Another $4.4 billion is still pending allocation.
Mara Aspinall, an Arizona State University professor and an adviser to the Rockefeller Foundation on the subject of COVID-19 testing, has been tracking HHS press releases to figure out how the stimulus funds have been spent, since the numbers are not publicly disclosed. She said testing should have been more of a focus since the beginning of the pandemic, but there's still plenty left to do.
"There are a lot of indications that the federal government and state governments are understanding the power of the information that tests bring," she said. "But what we can't repeat is the error of last spring thinking it was over and therefore not continuing to focus."
Living organ donors are never supposed to be billed for transplant-related care. NorthStar Anesthesia charged one donor over $13,000 and nearly sent his bill to collections.
This article was published on Friday, February 11, 2022 by ProPublica.
The email arrived in Elliot Malin's inbox from his cousin's mom.
"Scott needs a kidney," the subject line read.
The message matter-of-factly described Scott's situation: At 28 years old, Scott Kline was in end-stage renal failure. He wasn't on dialysis yet. But he probably should have been.
His mom was reaching out to as many people as she could, asking them to be screened as a potential donation match.
"Thank you for considering it, but please don't feel any pressure to do it," she wrote. "Sorry I have to share this burden, but the best potential match is family."
Malin didn't need to be pressured. For him, the decision was easy.
"There was no other thought besides trying to help Scott," Malin later said.
He clicked on a link in the email to begin the screening process.
If he turned out to be a match, Malin knew the surgery could put his health at risk. The recovery would be physically painful. What he didn't anticipate was that it would put his finances in jeopardy. That just as he would have to trust the skilled hands of the surgeon to make sure the operation went well, he'd have to trust in the expertise of billing coders and financial coordinators to navigate the increasingly complex system that covers the costs of transplant surgeries.
Living organ donors are never supposed to receive a bill for care related to a transplant surgery. The recipient's insurance covers all of those costs. This rule is key to a system built on encouraging such a selfless act. And for most uninsured patients in end-stage kidney failure, Medicare would pick up the tab. But in Malin's case, he would end up facing a $13,000 billing mistake and the threat of having his bill sent to collections.
Donors like Malin play a critical role in the nation's transplant system. According to data from the United Network for Organ Sharing, in the last three years more than 30% of kidney donations came from living donors. Neither UNOS nor other national advocacy organizations track how often billing problems like those encountered by Malin occur. But advocates say they do happen and can deter donors from coming forward.
"Living donors should not be receiving any bills at all whatsoever regarding any part of the living donation process," said Morgan Reid, director of transplant policy and strategy for the National Kidney Foundation.
Malin and Kline describe themselves as cousins, but their blood relationship is distant. Their great-grandfathers were brothers, making them third cousins. Still, they're the same age and grew up as friends, sometimes traveling and spending holidays together. Kline attended Malin's wedding in 2019.
Exactly what went wrong with Kline's kidneys is a mystery. In the summer of 2020 he had just moved to Fort Worth, Texas, for work. He went in for routine blood work to monitor a medication he was taking. When the results came in, the doctor called to ask if he was on dialysis.
"You're in end-stage renal failure," the doctor told him.
"Oh, no I'm not," Kline responded.
The bloodwork wasn't wrong. He had just 17% kidney function. Thus began his search for a new organ. Kline was told his wait for a kidney could be three to five years if a friend or family member didn't step forward. In February 2021, Kline and his family began reaching out to everyone they knew. Volunteers signed up for medical screening, but insurance would only pay to test one at a time. Waiting for one potential donor to be ruled out before testing another drew out an already lengthy process.
Four months after Malin signed up to be screened, he got final confirmation he was a match.
By June, the two cousins were deep in the byzantine organ transplant bureaucracy: screeners, financial counselors, doctors, specialists, laboratories and, the most difficult, insurance companies.
"The amount of hoops you have to jump through to do this is pretty extraordinary," Malin said, describing rounds of medical tests, mountains of paperwork and preauthorizations for procedures. A multidisciplinary team of professionals assembled to assist the two patients through the process.
"The hospital was amazing on trying to make everything as easy as possible," he said of the team.
Malin said they gave him one assurance: He wouldn't have to contend with any bills or be responsible for a dime of the surgery's estimated $160,000 cost. The team had received preauthorization from Kline's insurance plan, which would pick up all of Malin's medical costs.
That assurance, however well-intentioned, fell flat.
In July, Malin traveled from his home in Reno, Nevada, to Fort Worth, where the cousins underwent the transplant surgery at Baylor Scott & White All Saints Medical Center. The surgery was successful.
Malin spent three days in the hospital recovering, Kline a day or two longer — a painful experience made bearable by their companionship.
"We would do our little walks around the hospital floor," Kline said. "We would be suffering together. It was really nice to have that. Usually you're there alone, especially during COVID."
By early August, Malin was back in Reno to finish recuperating. The next week, he started law school. Life was getting back to normal.
When the first bill arrived, it was more annoying than stressful. It totalled just $19.15 for blood work done before the surgery. The hospital said it would take care of it, Malin said. Then he got a notice that an old insurance plan he was no longer a member of had been billed $934 for lab work. Again, he notified the hospital.
In late September, Malin got a bill for a stomach-dropping amount: $13,064. While he was startled by the cost, it didn't worry him too much. He knew Kline's insurance was responsible for paying it. He notified the hospital and forgot about it.
A month later, a second notice arrived. Then, on Dec. 6, Malin received a document that scared him.
"Final Notice! Your account is now considered delinquent," the notice read. If he didn't take action, the billing company warned, it would attempt "further collection activity."
The bill was from NorthStar Anesthesia, a firm that provides anesthesia services to hospitals across the country, including Baylor Scott & White All Saints.
Now, Malin wasn't only irritated that the bills just kept coming, he was worried about his credit.
"I did call them and kind of chewed them out a little bit," Malin said. "I walked through what this was for, that it was a kidney donation and I'm not the responsible party."
Malin complained on Twitter about the aggressive billing practice, eliciting an array of responses, from jokes about asking for his kidney back to outrage that he'd be in this position after such a gift.
After he called the billing company and the hospital, there was nothing else he could do.
"I'm just waiting to see if I go to collections or not," Malin told ProPublica two weeks later.
He did his best to leave Kline out of it entirely.
"He's had a lot on his plate," Malin said of his cousin. "His recovery has been harder than mine. He's the one accepting the organ, so he'll be on immunosuppressants the rest of his life. Because of COVID, he's largely stuck indoors. I don't tell him a lot of it. I don't want to stress him out."
Still, it troubled Kline that Malin was facing such problems.
"At the end of the day, I want everything to go as smoothly as possible for Elliot," Kline said. "He was doing me an unbelievable kindness. I owe my life to him."
A stack of bills for Malin's transplant surgery Credit: Andri Tambunan, special to ProPublica
Malin heard nothing until Jan. 19, one day after ProPublica reached out to NorthStar for comment.
"The CFO of NorthStar just called me and told me she's taken care of the bill," Malin texted a reporter.
The next day, the company emailed Malin, confirming he would not be responsible for the bill, that he was never sent to collections and that his credit wouldn't be affected.
"On behalf of NorthStar, I apologize for causing any confusion or concern for you regarding this matter and assure you that it has been resolved," wrote Kate Stets, the company's chief financial officer.
Fact-based, independent journalism is needed now more than ever.
She said that after his call on Dec. 7, the bill had been rerouted to "the correct parties," but that the company had failed to communicate that to him. The letter explained that NorthStar had received incorrect insurance information at the time of the surgery. (A spokesperson later said NorthStar received no insurance information at the time of the surgery.) In such cases, bills are automatically sent to the patient.
The company has since adjusted its policy to prevent that from happening in future transplant cases, Stets wrote.
"To be clear, it is not NorthStar's policy to bill transplant donors for bills related to their donation surgeries," Stets wrote. "We recognize the well-established public policy standard and practice that transplant donors should not be billed for such services — that we and the nation's healthcare system have a responsibility to foster and encourage such acts of selflessness and generosity."
In a statement, a NorthStar spokesperson said no other organ donors owe "out of pocket payments."
"NorthStar did not hear from Baylor on this matter previously and was first notified of the billing error on December 7, 2021 after insurance information was not provided to NorthStar by the transplant center at the point of care," a spokesperson said. "NorthStar resolved the error immediately and closed the account that same day, prior to any inquiry from ProPublica."
Both Malin and Kline commended the team at Baylor Scott & White All Saints that guided them through the process. The hospital, however, declined to grant an interview to ProPublica about what went wrong with the billing.
A spokesperson provided a short statement: "We are pleased this has been resolved for our patient by NorthStar. Although billing can be complicated, these occurrences are rare. We have also been in touch with the patient and we don't have anything further to report."
Financing such surgeries is so complex that transplant centers employ coordinators to help both patients with the process.
"I tell donors, I can't guarantee you won't get a bill, but if you do, call me," said Deidra Simano, president of the Transplant Financial Coordinators Association.
In one case, after trying everything to get a provider to bill the proper insurance, Simano resorted to paying a patient's $200 bill with the transplant center's credit card.
"That's what we had to do to make it go away," she said.
Malin said he feels fortunate to be equipped to fight the billing issues. He worries about others with fewer means facing a similar situation, recognizing it could be a barrier to those selfless enough to donate an organ.
"It sucks but I wouldn't have changed any of it," he said. "I like my cousin. I want him to be healthy."
A salmonella outbreak sickened more than 60 people at a funeral reception in Texas. Two years later, some of them are still coping with the financial and medical consequences.
This article was published on Wednesday, January 19, 2022 in ProPublica.
On a cloudy day in November 2019, family and friends gathered in Austin, Texas, to mourn the passing of Lovey Jean Carter.
Carter, who had heart trouble and other ailments, had died at 67.
After the burial, many of the mourners returned to Rising Star Baptist Church to share a meal. The brisket was home cooked, but everything else — rotisserie chicken, potato salad and fried chicken — was bought ready to eat from local grocery stores. One of Carter's brothers, James Monroe, had picked up 15 rotisserie chickens ordered from the Sam's Club on the south end of Austin. It was all simple. And it was all supposed to be safe.
But that night dozens of the attendees were stricken by illness, overcome by nausea, cramping, vomiting and diarrhea, according to an investigation by Austin Public Health, which found that at least 61 people reported symptoms of food poisoning after the reception.
"Seemed like a dream that everyone was calling saying, 'I'm sick, I'm sick, I'm going to the hospital,'" Joyce McDowell, one of Carter's younger sisters, recalled.
Hundreds of people die every year in the United States after eating food tainted with salmonella, listeria and other dangerous pathogens. As wrenching as those deaths are, though, they are only the tip of the toll that food poisoning takes on the United States, where millions more people are sickened each year.
Salmonella is a leading culprit, with an estimated 1.35 million infections a year, resulting in thousands of hospitalizations, according to the Centers for Disease Control and Prevention.
For many of those victims, the effects can be life-altering. There can be kidney or gastrointestinal troubles that persist for years. There can be staggering hospital bills that for some patients, especially those without health insurance, seem to never let up.
And long after the worst of the illness has passed, anxiety about eating and the frustrating, often futile, search for answers can linger.
The rate of illnesses caused by salmonella hasn't lessened in 25 years in the U.S., which continues to lag many countries in curbing the spread of the pathogen.
A ProPublica investigation of the U.S. food safety system found that federal regulators don't have the power to stop meat and poultry contaminated with risky strains of salmonella from being sold to consumers. When the U.S. Department of Agriculture, which oversees meat and poultry, detects the pathogen, the agency can't issue recalls or halt plant operations. It can only act if it is able to tie a case or cluster of cases of foodborne illness to a particular product. Inhibiting oversight further, a total of 15 federal agencies have a hand in food safety, with much of the responsibility split between the USDA and the Food and Drug Administration, a fragmented structure that critics say has impeded progress.
Nationally, the price tag in costs of treatment, lost work hours and premature deaths is estimated at $4.1 billion a year, according to the USDA.
"Salmonella is a very expensive pathogen, partially because it causes a lot of illnesses and partially because it can cause pretty severe disease as well," said Sandra Hoffmann, a senior economist at the USDA. "You think, 'Oh, foodborne illness is just a bellyache,' but it is quite costly."
The experience of Carter's loved ones would end up a testament to the toll salmonella can take and to the obstacles to holding anyone accountable when illness strikes.
Austin Public Health opened an investigation into the outbreak shortly after it began, but investigators couldn't pinpoint the source of the illness — a fate that befalls most such inquiries.
McDowell, now 68, hoped to fight through her illness at home. But the next day, she still felt sick. And that night, her watch sounded off with warnings that her heart rate had reached 130 beats per minute.
"I never felt so weak like that in my life," she said.
By the time she arrived at Dell Seton Medical Center in Austin, others from the funeral were already at area hospitals. Before long, doctors had identified the source of the spate of illnesses as salmonella.
"You hear it advertised on the TV that so many people die a year of salmonella," McDowell said, "but you never think that it'll hit home. But it did."
After the result of lab tests came back, Austin Public Health was notified on Nov. 5, three days after Carter's funeral.
The health agency would eventually identify 84 people who attended the funeral reception. At least 26 of them were hospitalized, some for more than a week. The youngest person hospitalized was 1, the oldest 92. Servers who tasted the food also ended up sick.
The health agency interviewed 67 of 84 funeral attendees, asking each of them to recall what they had eaten, when they started feeling ill and what the symptoms were. The agency found that the rotisserie chicken was eaten by more of the sick people than any of the other foods served.
But as clear as the cause might have seemed to the victims, determining that the chicken was in fact the source of the salmonella outbreak still wasn't going to be easy. One reason was that so many of the mourners fell ill. Only two of the people who were identified as having eaten at the funeral didn't get sick, which left investigators unable to effectively distinguish between what the sick people ate and what the healthy people ate.
"It's plausible that the chicken was the cause of the illness," Jen Samp, a spokesperson for Austin Public Health, said in an email, "however, we did not have statistical evidence to prove which food was the culprit."
A spokesperson for Sam's Club, Erin Hulliberger, told ProPublica in an email that the company is "committed to providing high-quality products" and noted that the Austin investigators had said they were unable to determine the source of the illness.
The possibility of cross-contamination presented another investigative challenge. The brisket and chicken had been served with the same utensils, so if salmonella was originally present on one but not the other, the bacteria could have spread between them.
Monroe, who had picked up the rotisserie chickens and cut them up before the reception, was among those who ended up sick. He and his son sampled a few bites while prepping the food, and by the time the service was over, he was in such pain that he went home instead of going to the reception. It wasn't until that night, as he heard of others who had become ill, that he realized that the rotisserie chicken might be the cause of all the sickness.
A little over a week later, after he had recovered, Monroe gave the health agency what seemed like a valuable clue: a whole rotisserie chicken that was one of the 15 purchased for the funeral reception but had been sitting, unopened, in Monroe's refrigerator.
For investigators, an unopened package of a suspect food can be a vital, if rare, piece of evidence. Usually, the food suspected of causing illness has already been eaten, opened or discarded by the time illness emerges and an investigation is launched.
The health agency picked up the chicken from Monroe's home, placed it on ice inside a double layer of biohazard bags and took it to a state laboratory in Austin for testing, according to Samp, who said the agency followed state protocols.
The state lab, however, determined the chicken wasn't suitable for testing. A spokesperson for the Texas Department of State Health Services told ProPublica that Austin Public Health had collected two leftover rotisserie chickens from Monroe's house — one in the unopened package and one in an opened package — and transported them in the same bag, creating the potential for cross-contamination. "We have very strict protocols that must be followed to ensure the integrity of the samples collected for testing," the spokesperson, Lara Anton, said.
So what could have been the key to determining what made everyone sick ended up unexamined, underlining one of the challenges inherent in investigating foodborne illnesses.
"That's the nature of the beast," said Jack Guzewich, who for 11 years led the FDA's foodborne disease surveillance and response program. "There's so many other things that can go wrong that you end up inconclusive."
Guzewich, who left the FDA in 2011 and worked as a consultant on foodborne disease investigations before retiring, said that had the leftover chicken been tested, it might have shown whether the chicken from Sam's Club was carrying the same strain of salmonella that made everyone sick. "If the chicken sampling had been done correctly, they might have had the smoking gun and met the gold standard," he said.
Based on samples from 26 of the victims, investigators determined that the funeral goers had been infected by a form of salmonella known as Saintpaul. It's one of a relatively small number of salmonella types that account for most of the salmonella infections documented by the CDC. In 2008, Saintpaul, named for the Minnesota city where a scientist first isolated the strain, caused an outbreak that led to more than 1,400 infections nationwide. In the years since, the CDC has documented about 200 cases a year, about a fifth of them leading to hospitalization. (The CDC estimates that for every confirmed salmonella infection, almost an additional 30 go unreported.)
Even as the Austin health agency was investigating, some of the victims were pressing for answers on other fronts, contacting Sam's Club and enlisting a personal injury lawyer.
Two days after the funeral, one relative reported the outbreak to Sam's Club through a contact form on the company's website. About a week later, another reported the outbreak to Sam's Club by phone. In an email to one of the relatives and a voicemail to the other, representatives of Sam's Club said the company had opened an "investigation."
Patrick Monroe, the relative who filed a complaint online, said a Sam's Club representative called him several weeks later and said because government investigators hadn't tested the chicken, there was "nothing" the store could do.
Keith Carter, the relative who had reported the incident by phone, said he didn't hear anything back from Sam's Club. "I kept calling them, and they never returned my calls," Carter said.
Hulliberger, the spokesperson for Sam's Club, said the company takes safety seriously. "We have policies in place to comply with strict food safety controls, which help ensure the food we provide is safe," she said.
She pointed out that the investigation had not determined what food caused many of the mourners to become ill. "Based on its investigation, Austin Public Health reported it was statistically impossible to implicate any of the food items from the funeral reception in 2019 as the source of illness that ProPublica is attempting to link to Sam's Club," she said.
In its report on the outbreak investigation, the health agency said it visited the store where the rotisserie chickens were purchased. It inspected its "kitchen and process" and did not note any violations.
A few of the relatives had found a firm willing to represent them in filing a lawsuit. It wouldn't be quick or easy, but it might give them some answers and perhaps some compensation for the harm endured by so many of the mourners.
But two months later, the firm, now known as Pastrana & Garcia, backed out. After the health department said it was not going to be able to pinpoint the source of the food poisoning, the lawyer who had agreed to represent the victims, Raul Steven Pastrana, told them the case was all but unwinnable. "Without the health department's willingness to identify one source of the poisoning, there are too many possible sources to meet the 'more likely than not' standard," he wrote in a letter to the relatives. In an email to ProPublica, Pastrana's firm declined to comment.
In Dale, a community about 30 miles south of Austin where many members of Lovey Jean Carter's family live, some in houses right across from one another, memories of the salmonella outbreak are still fresh. Intense pain, diarrhea, nausea and vomiting overtook every household in the family in the hours after the funeral reception. The youngest member of the family, a 1-year-old, was vomiting through the night while her grandfather anxiously looked after her. Several family members were taken to hospitals in ambulances.
It felt as if death was stalking them, Carter's mother, Lola Monroe, 94, said. "I think about that so often. My daughter's funeral, and right after the funeral everybody got sick."
Hattie Tibbs, 74, a family friend who was taken to a hospital in Kyle, said the illness brought her to tears. "Oh my, the pain," she said, "I wouldn't wish that on nobody."
Getting out of the hospital and over their symptoms wouldn't be the end. After the hospital stays and doctor's visits, bills began to arrive. For some, insurance covered nearly everything. Others still owe money to this day.
Keith Monroe, who stayed in the hospital for one week and didn't have health insurance at the time, was billed about $49,000, which he still owes. On top of his medical bills, Monroe, a handyman, lost work in the four months he was recovering.
Keith and Russell Carter, who are brothers and nephews of Lovey Jean's, held out for three days after the funeral, trying their best to avoid seeking care.
"We really didn't want the hospital bills. I knew if we went in, it'd be no telling how much it'd be," Keith Carter, 55, said. "We just tried to tough it out, and the more we tried to tough it out, the worse it got." Carter was vomiting, nauseated and completely dehydrated. His pain level, he said, reached a 10.
After about eight hours in the emergency room, his charges came to about $15,000, of which he was responsible for $1,700. Carter has five daughters and works as an equipment manager for the state's health and human services agency by day and as an airline baggage handler at night. He had to take time off from both jobs when he got sick.
"When you got five girls and you got other bills — you got car payments, house payments — it's money that you're spending that you really don't have," Carter said.
Having to pay for being sickened by the funeral food made the hospital charges all the more frustrating. "I really didn't want to pay anything, especially when you're not at fault," he said.
Today, Carter still suffers from abdominal pain. Tibbs had to change her diet because her stomach can no longer tolerate some of the foods it used to. And Keith Monroe has to use the restroom much more frequently because of lingering kidney problems.
Patrick Monroe said he is troubled that his relatives never got answers about what made them so sick. "I just don't know how something like this got passed over."
He is still paying off medical bills for himself and his two children. He doesn't eat rotisserie chicken anymore. And he gets anxious at doctors' offices, which bring back memories of all the illness the family endured. "I felt like I was going to die."
Michael Grabell, Mollie Simon and Bernice Yeung contributed reporting. Lexi Churchill contributed research.
Maryam Jameel is an engagement reporter working on community-sourced investigations out of ProPublica's Washington, D.C. newsroom.
By the time Cheryl Cosey learned she had COVID-19, she had gone three days without dialysis — a day and a half more than she usually waited between appointments. She worried how much longer she could wait before going without her life-saving treatments would kill her.
The 58-year-old Cosey was a dialysis technician for years before she herself was diagnosed with end-stage renal disease. After that, she usually took a medical transport van to a dialysis facility three days a week. There, she sat with other patients for hours in the same kind of cushioned chairs where she’d prepped her own patients, connected to machines that drew out their blood, filtered it for toxins, then pumped it back into their fatigued bodies.
Her COVID-19 diagnosis in the pandemic’s first weeks, after she’d been turned away from a dialysis facility because of a fever, meant Cosey was battling two potentially fatal diseases. But even she didn’t know how dangerous the novel coronavirus was to her weakened immune system.
Had she realized the risks, she would have had her daughter Shardae Lovelady move in. Just the two of them in Cosey’s red brick home on Chicago’s West Side, looking out at the world through the sliding glass door in the living room, leaving only for her dialysis.
After Cosey’s positive test in April 2020, Lovelady had to take her mother to a facility that treated patients with suspected or confirmed COVID-19. The facility fit her in for one of its last appointments the next day.
At that point, Cosey had gone more than four days without dialysis.
Four hours later, after Cosey completed her treatment, Lovelady returned to the nearly deserted building to bring her mother home, the sun having long disappeared from the sky. Cosey, dressed in a sweater and a green spring jacket, was disoriented, her breathing sporadic.
Alone with her mother on the sidewalk, Lovelady ran inside to ask workers for help getting Cosey out of her wheelchair and into her car.
“They offered no assistance,” Lovelady said. “They treated her as though she was an infection.”
(A spokesperson for the facility said employees aren’t allowed to help patients once they leave, for safety reasons.)
As Lovelady waited for paramedics to arrive, she grabbed a blanket from her car to wrap around her mother.
“My mother has COVID. I know she has COVID, but I didn’t care,” Lovelady said. “I hugged her and just held on until the ambulance came.”
Then she followed the flashing lights to the hospital.
In the three decades before the pandemic, the number of Americans with end-stage renal disease had more than quadrupled, from about 180,000 in 1990 to about 810,000 in 2019, according to the United States Renal Data System, a national data registry. About 70% of these patients relied on dialysis in 2019; the other 30% received kidney transplants.
The Midwest stood out as the region with the highest rate of patients with the disease, and Illinois had the nation’s third highest prevalence after Washington, D.C., and South Dakota, according to the Centers for Disease Control and Prevention.
A rare bright spot was the downturn in the death rate. Although diagnoses have been going up, death rates for patients who are on dialysis have declined since the early 2000s.
Then COVID-19 struck. Nearly 18,000 more dialysis patients died in 2020 than would have been expected based on previous years. That staggering toll represents an increase of nearly 20% from 2019, when more than 96,000 patients on dialysis died, according to federal data released this month.
The loss led to an unprecedented outcome: The nation’s dialysis population shrank, the first decline since the U.S. began keeping detailed numbers nearly a half century ago.
They were COVID-19’s perfect victims.
“It can’t help but feel like a massive failure when we have such a catastrophic loss of patients,” said Dr. Michael Heung, a clinical professor of nephrology at the University of Michigan. “It speaks to just how bad this pandemic has been and how bad this disease is.”
Before most patients reach advanced kidney failure, they are diagnosed with diabetes, hypertension or a host of other underlying conditions. Their immune systems are severely compromised, meaning they are essentially powerless to survive the most dangerous infections.
Many are old and poor. They also are disproportionately Black, as was Cosey. A 2017 study called end-stage renal disease “one of the starkest examples of racial/ethnic disparities in health.” Those inequities carried through to the pandemic. Dialysis patients who were Black or Latino, according to federal data, suffered higher rates of COVID-19 by every metric: infection, hospitalization, death.
Their deaths went largely unnoticed.
To get their treatments, the majority of dialysis patients in the U.S. must leave the relative safety of their homes and travel to a facility, often with strangers on public or medical transportation. Once at the dialysis center, they typically gather together in a large room for three to four hours.
The fear of contracting the virus was enough to keep many from venturing out for medical care, including those already on dialysis and those set to get the treatment for the first time. Exactly how long patients can go without dialysis depends on a number of factors, but doctors generally begin to worry if they miss two of their thrice-weekly sessions.
Dr. Kirsten Johansen, director of the United States Renal Data System, said the rates of people starting dialysis had been relatively stable until the pandemic. “Then the floor fell out,” she said in an interview.
COVID-19’s collateral damage played out in other ways as well. It meant that people delayed going to the hospital for everything from heart disease to cancer. For dialysis patients, whose life expectancy in some cases is three decades shorter than the general population, the results were calamitous. Hospitalizations of dialysis patients for reasons unrelated to COVID-19 dropped 33% between late March and April of 2020, federal data shows.
Dr. Delphine Tuot, a nephrologist and associate professor at University of California San Francisco and Zuckerberg San Francisco General Hospital and Trauma Center who focuses on vulnerable populations, found herself pleading with some of her patients to come in for their regular dialysis appointments.
One of them was a 60-year-old man whose shortness of breath landed him in the hospital in February. Doctors scheduled dialysis three times a week, and though he was initially resistant, Tuot said, he came around once he realized he would die without it.
Still, he missed appointments. When Tuot followed up, he told her he was afraid to leave the house because he was caring for his wife who had cancer, and he didn’t want to contract COVID and bring it home to her. Soon a cycle began. He skipped treatments, fluid built up in his body and an ambulance rushed him to the hospital because he couldn’t breathe. He got dialysis, was sent home and got back on track.
When cases surged and the delta variant took hold this summer, the cycle restarted — until he skipped dialysis for three weeks in a row, so long that his heart couldn’t recover, according to Tuot. He died last month.
Despite early efforts to mask and isolate patients at dialysis facilities, one study found the rate of COVID-19 hospitalizations of dialysis patients from March to April 2020 was 40 times higher than the general population.
Even with skyrocketing hospitalizations, it took three months after vaccines were approved before federal officials provided vaccinations to dialysis clinics, despite advocacy groups urging that this high-risk population be prioritized.
Although dialysis centers were swift to implement safety protocols in the pandemic’s early days, some facilities didn’t follow their own infection control policies, including washing hands properly, keeping workers home when sick or disinfecting equipment, federal inspection records show.
And home dialysis, which has been shown to be safer for patients during the pandemic, is out of reach for many, especially Black and Latino patients. Nephrologists had pushed for greater access to home dialysis before the pandemic; that need is more apparent now than ever, Tuot said.
“The fact that individuals had to go to a center with other individuals who are equally immunocompromised and had to get to that center, whether that was by public transportation or by van transportation, it’s clearly additional risks,” Tuot said. “Bottom line, they are very vulnerable. They’re very sick.”
The ambulance took Cosey to Chicago’s Rush University Medical Center. Lovelady filled in the staff on her mother’s medical history of end-stage renal disease, high blood pressure and asthma. The next day, Cosey called her daughter from her hospital bed. Lovelady noticed marked improvement from the night before.
“She sounded like herself,” Lovelady said. “We joked around a little bit. I asked her what kind of medicine she was on. She said they started her on dialysis.”
One by one, Lovelady added her sister, cousin and brother to the call. They told Cosey she had scared them, but now that she was doing better, they teased that they needed her to come home to bake her famous cheesecake. Her grandchildren hadn’t stopped asking about her either. They missed movie nights at Cosey’s house, when she made them popcorn and covered the floor with blankets.
Cosey’s boisterous laugh reassured them.
When Lovelady sensed her mother tiring, she told her she’d call her back the next day.
“Go ahead and get some rest,” she said.
While the arrival of the pandemic rocked the health care system as a whole, the effect on dialysis facilities has received little attention.
The Centers for Medicare & Medicaid Services typically monitor the facilities through routine inspections and surprise visits to investigate specific complaints. But federal officials are two years overdue on more than 5,000 inspections at dialysis facilities across the country, Medicare data shows, and three years behind on more than 3,000 of them. Since the start of 2020, the number of inspections to dialysis facilities by government officials fell by more than 30% from the previous two years, ProPublica found. Complaints made up a larger portion of investigations. In 2019, 35% of total visits were in response to complaints. Last year, it jumped to 51%.
A spokesperson for the Centers for Medicare & Medicaid Services said in a statement that the pandemic forced the agency to temporarily suspend or delay inspections for non-urgent complaints and routine inspections to focus on infection control and critical concerns that placed patients in immediate jeopardy. The agency is working with states, which act on behalf of federal officials, to address the resulting backlog, the spokesperson said, but “nearly all state agencies report insufficient resources to complete the required, ongoing federal workload.”
The spokesperson said “the COVID-19 pandemic has presented a unique challenge unlike any other in history and has impacted our routine oversight work,” adding that “complaint investigations remain our first priority to ensure we address the immediate needs of patients receiving care in dialysis facilities.”
Insufficient funding has compounded those challenges. The budget for inspections has “been flatlined” since fiscal year 2015, while the number of dialysis facilities has increased by 21% to nearly 8,000 today, according to the agency. After several years of requesting more money, the centers were approved to receive an increase for fiscal year 2022.
When investigators did inspect dialysis facilities, they found some violations specific to COVID-19 and others that involved general safety lapses, according to federal records from March 2020 to July 2021.
A dialysis patient who started treatment just before the pandemic died after a nurse at a Kentucky facility failed to properly dilute an antibiotic, according to inspection reports. Minutes after the medicine began dripping through an IV, the patient said: “My body is on fire! It’s going through my whole body,” records show.
At a New York facility, another patient died after losing more than 1 1/2 pints of blood when their catheter became disconnected, according to federal records. That same facility underreported its number of deaths in the first 11 months of the pandemic by 16 people.
Federal officials issued their most serious citation to an Indiana facility for refusing to provide dialysis to a patient suspected of having COVID-19. The patient’s previous dialysis had also been cut short because their assisted living facility did not provide them transportation after 9:15 p.m. So they did not receive a complete treatment.
An estimated 5% to 10% of end-stage renal patients live in congregate settings, such as nursing homes or assisted living facilities. The same factors that led to nursing home populations being decimated — age, health, difficulty isolating — applied to those dialysis patients. In the first months of the pandemic, they contracted the virus at a rate more than 17 times higher than those who lived independently, according to one study.
Workers at those facilities weren’t immune either. Oluwayemisi Ogunnubi, 59, worked as a nurse administering dialysis to patients inside a nursing home on Chicago’s South Side. A Nigerian immigrant, she had sent money home to pay for her children’s schooling until she was able to bring them to the U.S. Her smile and supportive nature made her popular among her coworkers, according to an official at Concerto Renal Services, the dialysis company where she worked.
On April 21, 2020, Ogunnubi’s body began to ache, and she was sent home early from work. She was later taken to a hospital, where she tested positive for COVID-19. She died three days later, federal and county records show.
Occupational Safety and Health Administration officials cited Concerto, and levied a penalty of $12,145. The company provided employees who performed dialysis on patients with N95 respirators, but investigators found that Concerto’s written procedures weren’t complete and that the company had failed to provide medical evaluations that ensured employees knew how to use the respirators.
Two other Concerto employees, including one who fell ill the same day as Ogunnubi, contracted COVID-19 at the time but survived. Within two weeks of Ogunnubi’s death, 10 residents at the nursing home died of complications related to COVID-19, according to Cook County Medical Examiner records. Half had kidney failure.
Kyle Stone, Concerto’s executive vice president and general counsel, said the first and only COVID-related death of an employee shook the company. Stone said Concerto “made a difficult choice” to use respirator masks without providing medical evaluations to employees, but it “was clearly the correct choice under the circumstances.”
If Concerto had been required to fulfill every aspect of OSHA requirements for a written policy that early in the pandemic, he said, the company would not have been able to provide the respirator masks, “almost certainly resulting in greater risk of harm and death.”
OSHA’s failure to “see and appreciate” the trying circumstances at the time, Stone said, was “baffling and disappointing.” Concerto eventually settled with OSHA, which downgraded the violation and reduced the penalty to $9,000.
“We are quite proud of our work in 2020 during the eye of the COVID storm,” Stone said.
As devastating as the pandemic has been, many experts say it could have been worse. Dr. Alan Kliger, a clinical professor of medicine at Yale School of Medicine, co-chaired the American Society of Nephrology COVID-19 Response Team that held weekly calls with chief medical officers from 30 or so dialysis companies, including the largest two, DaVita and Fresenius. The facilities, Kliger said, implemented universal masking and patient screenings before the CDC recommended them. They also treated COVID-19 patients in separate shifts or at specifically designated isolation clinics.
“There’s been a tremendous amount of collaboration and sharing of information and uptake of best practices in this group of competitive companies,” Kliger said. “They really rallied together to protect patients.”
Epidemiologist Eric Weinhandl said that there’s another battle on the horizon with the omicron variant spreading rapidly, which he finds especially worrisome given how federal officials failed by not distributing vaccines to dialysis facilities in December 2020.
“It’s heartbreaking because you look at this, and much like nursing home residents, these patients are completely vulnerable. But they still have to go to a dialysis facility three times a week,” Weinhandl said. “Why wouldn’t you prioritize this population?”
The CDC said in a statement that “demand exceeded supply” when vaccines were first authorized and “as supply increased and states adopted CDC’s recommendations, older adults and those with underlying health conditions began being prioritized.”
It wasn’t until March 25 that the Biden administration announced it was partnering with dialysis facilities to send vaccines to patients at the centers.
Now, Weinhandl wonders if dialysis patients will be a priority if the federal government approves a second round of boosters for high-risk patients.
“Is there a plan? Because I think that there should be,” he said. “I think this is getting pretty predictable. Every time COVID surges, you see the dialysis population’s excess mortality surge with it.”
Sometimes the frailty of dialysis patients is no match for COVID-19’s brutality.
Oscar and Donna Perez were the kind of siblings who loved each other without judgment or condition. After Oscar began dialysis in 2018, Donna picked him up from his appointments three nights a week. She cut his toenails when his feet were too swollen for him to reach and massaged them when the pain woke him up at night.
He was her son’s godfather, her best friend who shared his love of music with her — especially the 1960s R&B singer Billy Stewart — and annoyed her in the way only brothers can, swatting her feet off chairs just as she got comfortable and pestering her with questions when she was deep into Instagram.
But Oscar Perez was sick. In addition to his failing kidneys, the 38-year-old Latino father struggled with hypertension, diabetes and congestive heart failure. In early January, doctors performed coronary bypass surgery. He was not yet eligible for the vaccine, but the hospital tested him for COVID-19 when he was admitted. He was negative.
He went home on Jan. 18, the same day as the wake for his uncle, who, his family said, died after he missed too many dialysis appointments. But the next day, Oscar collapsed at home, confused and mumbling in pain, with signs that the coronavirus was flourishing in his lungs. He was rushed back to the hospital. A doctor called to tell Donna Perez that her brother had tested positive and needed to be intubated.
On Jan. 31, doctors called Donna again and told her that her brother’s condition was declining fast. She picked up her parents, another brother and his girlfriend, and headed to the hospital to visit Oscar from outside the glass door of his room. They told doctors to try to resuscitate him if his heart stopped.
That night, after they returned home, Donna Perez’s phone rang one more time. Oscar’s doctor said he probably wasn’t going to make it through the night. This time, they could visit him in his hospital room in PPE.
Seeing her brother up close, swollen and helpless, she leaned in, hugged him, and said, “I can tell you’re tired. You can go.” Donna promised to take care of his daughter.
Her family pushed back and said she had to tell him to be strong.
Donna told them they needed to let Oscar go. He died a few hours later.
“This disaster is one that befalls dialysis patients, with diabetes especially, regularly,” Dr. David Goldfarb, clinical director of the nephrology division at NYU Langone Health in New York City, who reviewed Oscar Perez’s medical records for ProPublica.
“Of course, it’s possible to do better,” he continued. “Given his age, it’s really tragic.”
The advent of technology to filter a patient’s blood revolutionized kidney care in the 1950s, and people lined up to get access to the limited number of machines. In 1960, one hospital created its own admissions panel, later nicknamed the “God committee,” to review cases to decide who would receive the groundbreaking treatment.
Twelve years later, Congress approved legislation that created the Medicare End Stage Renal Disease program, which guaranteed coverage of medical care, including dialysis and kidney transplants. It remains the only disease-specific Medicare entitlement program, credited by some as possibly saving more lives than any other federal government program. Generally, Medicare only covers those over age 65 and the disabled, but this program is available to people of all ages with end-stage renal disease.
Total Medicare-related spending in 2019 on end-stage renal disease patients topped $50 billion. Even with that budget, the agency hasn’t been able to fix persistent health disparities. That year, Black patients were more than four times more likely than their white counterparts to have the disease.
Black patients also progressed from chronic kidney disease to end-stage renal disease three times as often as white patients. Yet they are less likely to start off their dialysis treatments on a waiting list for a transplant — or eventually receive one from a living donor — than white patients.
In a statement, Medicare said it is working to address the disparities and said it is “committed to ensuring the health and safety” of all its dialysis patients.
Another area of concern is home dialysis, which research has shown is cheaper than in-center dialysis and offers similar or better survival rates, enhanced quality of life and greater flexibility. Barriers to home dialysis affect all patients, but the percentages of Black and Hispanic patients receiving home dialysis in 2019 were 10% and 11% respectively, compared with white and Asian patients at 17% each.
The push for closing that gap has gained traction, bolstered by federal data that found COVID-19 hospitalizations rates of patients who underwent home dialysis from late March to June 2020 were between one-quarter and one-third those of patients traveling to dialysis facilities.
“We do have to figure out a way to do better because we’re really, in essence, causing harm, when we’re not able to divert proper resources to patients who most require them,” said Dr. Kirk Campbell, a nephrology professor and vice chair of medicine for diversity, equity and inclusion at the Icahn School of Medicine at Mount Sinai in New York City.
Some patients don’t have the space to store the supplies needed for home dialysis. Others are overwhelmed by the prospect of having to keep the area around the catheter clean to prevent infection. But, Campbell said, that’s where patient education comes in. The most common type of home dialysis, called peritoneal dialysis, often is done at night while the patient is sleeping and does not involve blood flowing outside the body.
While home dialysis isn’t possible for all patients, some doctors are hesitant to recommend it at all, in part because the clinicians lack the training, experience or a certain comfort level with it. That’s especially true, Campbell said, for patients of color and those from disadvantaged backgrounds. There’s often an unconscious bias that those patients won’t be able to handle it, he said.
Campbell and others said it’s critical that clinicians receive additional training in home dialysis. He leads one of the few nephrology fellowship programs in the country where doctors can spend an extra year specializing in home dialysis. The results have been so promising, he said, that they hope to expand.
In July 2019, the Trump administration issued an executive order aimed at revamping kidney care in the United States through the Department of Health and Human Services’ Advancing American Kidney Health initiative. The goals of the initiative were lofty — some say unrealistic — and included having 80% of new end-stage renal disease patients in the U.S. receive in-home dialysis or transplants by 2025. In 1972, the year the Medicare program passed, 40% of patients were on home dialysis. Currently, about 13% of patients are receiving dialysis at home.
Starting January, the Centers for Medicare & Medicaid Services will offer facilities greater reimbursement for improving their home dialysis rates for low-income patients.
Some observers say the change doesn’t go far enough. In September, U.S. Rep. Bobby Rush, an Illinois Democrat, and Rep. Jason Smith, a Republican from Missouri, proposed legislation that would require Medicare to pay for workers to assist patients who need additional help with home dialysis. The measure, which was introduced without much fanfare, also calls for greater patient education around the treatment and a federal study analyzing racial disparities.
Hong Kong, where about three in four patients are on peritoneal dialysis, is a global leader in home treatment. Patients there receive peritoneal dialysis first unless there is a medical reason that would preclude it.
Dr. Isaac Teitelbaum, a nephrologist who has been the medical director of the home dialysis unit at the University of Colorado School of Medicine since 1986, said expanded training for clinicians and incentives for patients, including a reduced co-pay or a tax credit, could encourage more patients to dialyze at home.
“You don’t live just so you can do dialysis. You do dialysis so that you can enjoy life,” he said. “You do dialysis so that you can watch your children and grandchildren grow up and so that you can participate in family events and go on vacations.”
Cheryl Cosey was not offered home dialysis, her family said. Shardae Lovelady said it might have made all the difference for her mother.
Cosey’s health deteriorated quickly after the call from her hospital bed. Doctors transferred Cosey to the intensive care unit, put her on a ventilator and gave her medication to push the oxygen from her lungs into her bloodstream, according to hospital records.
The family braced themselves. Lovelady drove to Minnesota to pick up her sister. She gathered everyone for a big dinner the way her mother used to do.
Lovelady and her sister stayed up late talking, finally dozing off when the house quieted.
When the phone rang at three in the morning, Lovelady recognized the hospital’s 312 area code.
Everything she had done to prepare for that moment suddenly vanished, and she allowed herself to hope.
The call was short. She never even flipped on the bedroom light. She turned to her sister, who was asleep next to her, and nudged her awake.
Irene Bosch developed a quick, inexpensive COVID-19 test in early 2020. The Harvard-trained scientist already had a factory set up. But she was stymied by an FDA process experts say made no sense.
This article was published on Tuesday, December 21, 2021 in ProPublica.
When COVID-19 started sweeping across America in the spring of 2020, Irene Bosch knew she was in a unique position to help.
The Harvard-trained scientist had just developed quick, inexpensive tests for several tropical diseases, and her method could be adapted for the novel coronavirus. So Bosch and the company she had co-founded two years earlier seemed well-suited to address an enormous testing shortage.
E25Bio — named after the massive red brick building at MIT that houses the lab where Bosch worked — already had support from the National Institutes of Health, along with a consortium of investors led by MIT.
Within a few weeks, Bosch and her colleagues had a test that would detect coronavirus in 15 minutes and produce a red line on a little chemical strip. The factory where they were planning to make tests for dengue fever could quickly retool to produce at least 100,000 COVID-19 tests per week, she said, priced at less than $10 apiece, or cheaper at a higher scale.
Bosch’s prototype attracted a top Silicon Valley venture capital firm, which pitched in $2 million.
“We are excited about what E25Bio is capable of shipping in a short amount of time: a test that is significantly cheaper, more affordable, and available at-home,” said firm founder Vinod Khosla. (Disclosure: Khosla’s daughter Anu Khosla is on ProPublica’s board.)
On March 21 — when the U.S. had recorded only a few hundred COVID-19 deaths — Bosch submitted the test for emergency authorization, a process the Food and Drug Administration uses to expedite tests and treatments.
A green light from the FDA could have made a big difference for the many Americans who were then frantically trying to find doctors to swab their noses, with results, if they were lucky, coming back only days later.
But the go-ahead never came.
In the months that followed, Bosch responded to repeated requests from FDA reviewers for data and studies. When the agency finally put out guidance that summer about the performance over-the-counter home tests needed to meet, officials required that such tests be nearly as sensitive as the lab tests used to definitively determine whether a patient has COVID-19.
That standard proved difficult to meet. Rapid tests are usually sensitive enough to detect viral antigens when someone has enough of them to be able to spread the disease. Such tests are not as good at picking up cases in either earlier or later stages of infection, when viral loads are lower.
Bosch’s tests missed the FDA’s high bar. It wasn’t until the spring of 2021 that much larger companies were able to design similar tests — relatively inexpensive, over-the-counter rapid tests — that the agency found acceptable.
“You could have antigen tests saving lives since the beginning of the pandemic,” said Bosch, sitting in her lab at MIT. “That’s the sad story.”
While E25Bio’s test didn’t catch quite as many cases as those now on the market, it could have been used to catch superspreaders, with warnings that a negative result wouldn’t rule out infection. Experts told us that the test could have been a vital public health tool had it been produced in the millions in 2020 just as COVID-19 was racing across the country undetected.
“Since we didn’t have other options, it would have been a very good test,” said Michael Mina, an epidemiologist who followed E25Bio’s early progress. “If we were going to war, and somebody was invading us, and we had a bunch of revolver pistols, and we didn’t yet have the shipment of machine guns, hell yeah, you’re going to pick up the revolver pistol. You do what you can when you need to in an emergency.”
Three other experts reviewed Bosch’s submissions at ProPublica’s request and agreed that her test approached what is now considered acceptable for over-the-counter tests.
Mina and others have been calling for an embrace of rapid testing since the pandemic’s early days, saying that tests should be ubiquitous and cheap enough that people could stock them in their medicine cabinet, like aspirin or Band-Aids. Although not a panacea, rapid tests can slow the spread of COVID-19 when used repeatedly and when the infected follow instructions to isolate, manystudiessuggest.
After not showing urgency on the issue for much of the past year, the Biden administration has moved recently to boost production and lower prices. Facing a huge new wave of cases and an increasing outcry about shortages of tests, Biden announced Tuesday that 500 million more at-home tests would be distributed by mail, starting in January.
David Paltiel, a professor at the Yale School of Public Health, said a significant part of the problem is that the FDA created a detailed roadmap for tests that give patients a close-to-definitive answer on whether they have COVID-19, but never created a separate framework for rapid tests that serve a different purpose: helping people get frequent, fast evidence of whether they may be contagious.
“The former are tests of infection; the latter are tests of infectiousness,” Paltiel said. “They both share the same regulatory pathway — a pathway that was designed with diagnostic testing in mind and is littered with requirements that make no sense for the purpose they serve.”
He added, “It’s an outrage that rapid tests aren’t dirt cheap and plentiful on grocery store shelves.”
The FDA declined to comment on individual test submissions, but said in a statement that it has worked to authorize “accurate and reliable” home tests since the beginning of the pandemic.
“Unfortunately, many submissions the FDA has received for home tests include incomplete or poor data, and it is the FDA’s responsibility to protect the public health by declining to authorize poorly performing tests or those without complete data,” the agency said. “We have also worked interactively with many developers to resolve concerns when data was incomplete or unclear, or to find solutions to issues that arose during review. If the FDA received a home test that the data and science supported in early-to-mid 2020, we would have quickly authorized it.”
Bosch has since moved on to start a new venture focused on helping other test developers conduct trials that meet the FDA’s standards. This winter, she’s working with the housing authority in the high-poverty Boston suburb of Chelsea to conduct a trial using several tests that have been authorized in other countries, but not America. The goal: to demonstrate that such tests can be effective when deployed for free, in conjunction with education and outreach.
“The next thing is frequent testing for communities that need it,” Bosch said. “How do we flood the market with a $2 test that is as good as a $20? We’re doing it in Chelsea. We should be an example for the whole country.”
American medical device regulators have never been enthusiastic about letting people test themselves.
In the 1980s, the FDA banned home tests for HIV on the grounds that people who tested positive might do harm to themselves if they did not receive simultaneous counseling. In the 2010s, the agency cracked down on home genetic testing kits, concerned that people might make rash medical decisions as a result.
But the FDA wasn’t an obstacle to Bosch’s work on tropical diseases, since the tests were mostly needed in places like the Brazilian Amazon, where infected mosquitoes are hard to escape. The National Institutes of Health thought Bosch’s tests had enough potential to give E25Bio $1.8 million for the project.
So when the pandemic struck, the small company decided to use its expertise for the new threat. Within a few weeks, Bosch and her colleagues developed antibodies that could detect the presence of proteins attached to the new coronavirus.
In her previous work, Bosch had found that tests of this type could be validated in the lab, so she ordered up some samples of the SARS-CoV-2 virus and ran two different types of antigen tests on them. She found that both worked fairly well, and packaged up all her evidence and sent it to the FDA, with little guidance on what would pass muster.
Shortly after, an FDA reviewer told her she’d need to conduct a clinical trial, which would take months. “My first huge surprise was when they said, ‘Nope, none of your validations are going to pass for an EUA,’” Bosch said.
The next challenge was that the accuracy of antigen tests would be measured by how they compared to a different type of diagnostic: the polymerase chain reaction, or PCR, test, which is considered the “gold standard” for finding coronaviruses. Many see that as an unproductive comparison, given the fact that PCR detects remnants of the virus, which may persist for many days after the infection ceases to be a threat.
“When you’re PCR testing, you’re testing for the presence of viral genetic material,” said Hannah Mamuszka, the CEO of Alva10, a company that helps diagnostics manufacturers prove their value for insurers. “When you’re antigen testing you’re testing for presence of a protein on the surface of the virus,” she said. “Those are obviously not the same thing. So it’s really confounding that the FDA has had such a hard time communicating what they need, and defining what a test would need to look like to be used at home.”
Nevertheless, by April 2020, E25Bio had lined up a trial with three hospitals in Florida. They found the test identified 80% of the swabs that a PCR test had shown to be positive (known as sensitivity) and 94% of the negatives (known as specificity).
The FDA wanted to see fewer false positives, even though people who test positive on an antigen test are usually advised to confirm it with a PCR. And while the overall sensitivity of E25Bio’s test was lower than other tests would later demonstrate, it measured 100% for people with higher viral loads — those most likely to be infectious.
Bosch was in frequent contact with her assigned reviewer at the FDA, and even talked to Tim Stenzel, the head of the agency’s office that vets diagnostic tests. The Bill & Melinda Gates Foundation gave E25Bio another $500,000 to continue research and development.
But at the end of July 2020, the FDA came out with a template that laid out the expectation that tests available for home use without a prescription would reach 90% overall sensitivity — that is, antigen tests would pick up nine out of ten positive tests that a PCR identified. Bosch knew her tests couldn’t meet that standard. And without an EUA for home use, they wouldn’t be able to serve their intended function.
Already, plenty of models had illustrated the importance of frequent testing, including one co-authored last year by Yale’s Paltiel with Rochelle Walensky, now head of the Centers for Disease Control and Prevention. In September 2020, as chief of infectious diseases at Massachusetts General Hospital, Walensky argued that antigen tests were actually most useful for pinpointing people at their most infectious.
In fact, the utility of that approach was being tested at Bosch’s own former workplace. Beginning in the late summer of 2020, a coworking lab space in Cambridge where E25Bio had launched started a trial with 257 of its users who agreed to take both the antigen rapid test at home and a PCR test twice a week. (This was also closer to a home use scenario than the Florida hospitals study, in which COVID-19 was more prevalent and tests were administered by medical professionals.)
A peer-reviewed paper based on the results showed overall sensitivity of 79%, and that the rapid test picked up nearly all of the positives later detected by a PCR in the first few days after symptoms appeared, allowing infected people to stay out of the office as soon as they knew.
But the FDA does not consider test performance data broken out by how much virus the subjects have in their systems, saying the typical method for measuring it is inconsistent. Nor did the agency initially authorize tests on the condition that they be sold in packs of more than one, with instructions to use them sequentially to catch any fast-moving infections.
Bosch wasn’t the only one to be tripped up by the new standard. In mid-September 2020, Stenzel said on his weekly town hall call with test developers that his office had received zero applications for home use tests, a month and a half after putting out the template, despite his insistence that the agency was willing to be “flexible.”
Meanwhile, a $666 million NIH program to accelerate the approval and production of new COVID-19 tests funded mostly PCR tests in 2020.
The antigen tests that did make it into the NIH program in the first threefundingrounds — including one made by Quidel, a public company that multiplied its profits by tenfold in 2020 over the previous year — generally had to be processed in labs or required expensive analyzers.
One of few simple antigen tests to win government support, made by Maxim Biomedical, still hasn’t submitted an EUA application, according to chief operating officer Jonathan Maa. Another grantee, Ellume, was authorized for nonprescription home use in December 2020. But it took months to go into widespread production, and still costs $39, if you can find it.
Toward the end of October 2020, Bosch received a 48-hour ultimatum from the FDA for a response to a request for additional data. She had answers to the agency’s questions, but didn’t quite make that deadline.
By the time she replied, the FDA had already closed her application. “You call and they say, ‘Oh sorry, the clock started and we can’t stop it,’” she said.
Soon after, the company’s leadership asked her to resign. The company continues to operate, but hasn’t obtained FDA authorization for any tests. “As we commercialize our COVID-19 rapid tests internationally, we are also focused on developing the next generation of rapid tests for consumer diagnostics,” an E25Bio spokesperson said, while declining to comment on Bosch’s departure or its current product pipeline.
“All our life, day in and day out, went to make antigen tests,” Bosch said. “It was tragic, because it was all because the FDA decided to be so harsh in their responses that investors said, ‘Oh, there’s no way she will pull it out.’”
E25Bio’s travails with the FDA didn’t stop Bosch from putting her expertise to use.
In early 2021, she started talking to the city of Chelsea about running a trial that could show how rapid antigen testing — even with the types of tests that the FDA had rejected — could be rolled out in a high-risk community. In the spring, when infection rates in Chelsea were among the highest in the nation, many residents had had a difficult time accessing PCR tests, because the places administering them often dissuaded immigrants by requiring identification.
Chelsea officials agreed, and Bosch secured donations of tests from five manufacturers that had been authorized in Britain, Germany, India or Korea, but none yet in the U.S. (They can still be used here for research purposes.) She said she has validated them in her lab and found them to be about as accurate as BinaxNOW, the FDA-authorized home test made by medical device giant Abbott Laboratories.
“If they have a budget for next year to do frequent testing, this will be an accomplishment,” Bosch said. “I wanted to show to the world that an experimental device is just as good as any other already-approved FDA test.”
So for the past few months, Bosch has canvassed three buildings owned by the local housing authority. Bosch, who is from Venezuela, puts on salsa music and explains in Spanish how the program will work.
The trial began in earnest last week, with study administrators walking newly enrolled subjects through using the tests. In a building reserved for elderly and disabled people, residents entered with walkers and in flip-flops to learn how to swab their noses, put the swabs in a vial of solution, squeeze a few drops onto a pad and wait anxiously for the single line to appear that would indicate a negative result.
Most were able to take a picture of the results with their phones and upload them using a special app, which they’ll continue to do in their homes each week.
The FDA frowns upon this kind of instruction in trials for at-home tests — users are supposed to be able to execute the test without training. But in reality, many need support.
For the nonprofit that helped launch the effort, the Center of Complex Interventions, the important part is demonstrating that rapid tests can work when used as part of a coordinated testing regime to address specific situations: right before people gather indoors or after an exposure to an infected person, for anyone in a high-risk job, for people in crowded living situations, or for those who have health risk factors. People in all of those situations are concentrated in Chelsea’s housing authority buildings.
“It’s a lot different than saying, ‘Let’s roll it out to everybody,’” said Karthik Dinakar, who is leading the project. “It all has to be connected in a way that makes people feel like they’re participating. The goal for us is to make the community safer, and also shift the mindset to a new equilibrium.”
Joshua Sharfstein, a vice dean at Johns Hopkins University’s Bloomberg School of Public Health who used to be principal deputy commissioner of the FDA, said that rapid tests could have been authorized earlier with these kinds of protocols in mind.
“There was no testing strategy,” Sharfstein said, outlining the opportunity that America missed to use a variety of tests for the purposes to which they were best suited. “What they could have done is to say, ‘Here are the six uses of tests. You’re sick, you’re exposed, you’re trying to maintain people on a campus. What’s the performance of test that you would need?’
“Just think how amazingly helpful that would be,” he finished, wistfully.
Meanwhile, the CDC and NIH have been studying similar programs in a handful of communities using Quidel’s at-home test. Governors have been catching on to the utility of rapid tests too. Last week, the state of Massachusetts bought millions of rapid test kits made by iHealth laboratories. The company’s chief operating officer, Jack Feng, told National Public Radio that the price was higher in the U.S. because of the expense of clinical trials that aren’t required elsewhere.
And since rejecting Bosch’s submissions, the FDA has been coming around to her way of thinking. In March, the agency published a template for tests that would be used serially and sold in packages of two or more, allowing the kind of frequent testing she had advocated for. And last month, it published a new template that lowered the sensitivity standard for single-use over-the-counter tests to 80%.
Bosch had tests a year and a half ago that missed that bar by 1%.
In reporting on the rising number of newborns needlessly dying of syphilis, ProPublica reporter Caroline Chen identified a contributing factor: the CDC's funding structure, which is influenced by both politics and shifts in public attention.
This article was published on Tuesday, November 16, 2021 in ProPublica.
In public health, a “sentinel event” is a case of preventable harm so significant that it serves as a warning that the system is failing. The alarms are now blaring.
A growing number of babies are being born with syphilis after their mothers contract the sexually transmitted disease and the bacteria crosses the placenta. These cases are 100% preventable: When mothers who have syphilis are treated with penicillin while pregnant, babies are often born without a trace of the disease. But when mothers go untreated, there is a 40% chance their babies will be miscarried, be stillborn or die shortly after birth. Those who survive can be born with deformed bones or damaged brains, or can suffer from severe anemia, hearing loss or blindness.
I’ve spent the past few months trying to understand why countries including Belarus, Cuba, Malaysia and Sri Lanka have managed to wipe out congenital syphilis while the United States faces its highest incidence in nearly three decades: Last year, 2,022 cases were reported, including 139 deaths. That’s a shocking reversal from 1999, when the Centers for Disease Control and Prevention declared that the United States was on the verge of eliminating the centuries-old scourge for adults as well as babies.
What went wrong here?
My reporting led me to one major factor: the unusual and — according to various experts I spoke with, problematic — way that the CDC is funded, which has not only hampered the response to a rise in sexually transmitted diseases, but also has left us ill-prepared for the COVID-19 pandemic.
State and local health departments get much of their money from the federal agency, which has the best birds-eye view of all of the bugs, viruses and illnesses circulating in America. But CDC scientists don’t have the power to decide how much money to spend fighting each one.
Instead, Congress dictates to the CDC, in an uncommonly specific manner not seen with many other agencies, exactly how much money, by line item, it can spend to combat any single public health threat, from broad categories like emerging infectious diseases and Alzheimer’s disease, to more niche conditions like interstitial cystitis, neonatal abstinence syndrome and Tourette syndrome. Though prevention tactics for HIV and other STDs significantly overlap, HIV prevention has a separate line item and is allocated about six times as much money as the category for sexually transmitted infections.
The decisions can be politically driven and detached from bigger-picture health needs, as lobbyists and patient advocates descend on Washington to make the case to lawmakers that their specific disease of interest should get a bigger piece of the pie. Causes that don’t have large armies of compelling spokespeople can get ignored. Sexually transmitted diseases, which have an extra layer of stigma to contend with, have few dedicated advocacy groups. The small number of lobbyists focused on STDs sometimes can’t even get a meeting with lawmakers.
“The CDC needs to have more money and more flexible money,” former CDC director Dr. Tom Frieden told me. The political nature of the agency’s funding is part of what led the country to neglect virus surveillance before the coronavirus pandemic. The 2014 Ebola epidemic was supposed to be a “global wakeup call,” yet in 2018, the CDC scaled back its epidemic prevention work as money ran out.
That means public health in the U.S. is constantly in what Frieden calls “a deadly cycle of panic and neglect” — scrambling to throw money at the latest emergency, then losing the attention and motivation to finish the task once fear ebbs. In May, President Joe Biden’s administration announced it would set aside $7.4 billion over the next five years to hire and train public health workers. But some officials worry about what will happen when those five years are up. “We’ve seen this movie before, right?” Frieden said. “Everyone gets concerned when there’s an outbreak, and when that outbreak stops, the headlines stop, and an economic downturn happens, the budget gets cut.”
Jo Valentine, former program coordinator for the CDC’s 1999 push to eliminate syphilis, says one of the reasons the campaign failed is because public health is usually working “in rescue mode, parachuting in and fixing things.” That’s effective in acute situations, like stopping a new outbreak from exploding, but it doesn’t address long-term structural issues like economic stability, safe housing and transportation, which are all key factors in chronic and preventive care. The last fraction of cases in any public health effort can be the hardest to solve because they often involve vulnerable populations experiencing these barriers to accessing care. They are also the easiest populations to ignore.
Local health departments don’t have nearly enough resources to investigate cases of syphilis with contact tracing, which involves tracking down patients, inquiring about sex partners and making sure everyone is treated. One disease intervention specialist I shadowed in Fresno, California, has made six trips to a rural town, driving an hour each way, trying to prevent a single case of congenital syphilis. The patient is unhoused and itinerant, and so far has been hesitant to visit the community clinic for treatment.
With interest in public health now at an all-time high, it is worth reexamining how much money public health gets to take on these unpopular but necessary challenges, and how much authority the CDC gets to set its priorities. I hope that, five or 10 years from now, I’m not still reporting about COVID-19 hot spots left behind after attention wanes, creating places where the disease still flares because testing or treatment is hard to come by. And I also hope I’m not still writing about babies dying from syphilis.
St. Jude Children's Research Hospital promises not to bill families. But the cost of having a child at the hospital for cancer care leaves some families so strapped for money that parents share tips on spending nights in the parking lot.
This article was published on Friday, November 12, 2021 in ProPublica.
A series of sharp knocks on his driver's side window startled Jason Burt awake.
It was the middle of the night on a Saturday in 2016. Burt was sleeping in his pickup truck in the parking lot of St. Jude Children's Research Hospital in downtown Memphis, Tennessee, where his 5-year-old daughter was being treated for brain cancer. He'd driven more than 500 miles from his home in Central Texas to visit her.
A St. Jude security guard peered into the truck and asked Burt what he was doing. Burt explained that his daughter and her mother, his ex-girlfriend, were staying in the hospital's free patient housing. But St. Jude provides housing for only one parent. Burt, a school bus driver making $20,000 a year, told the guard he couldn't afford a hotel. The guard let the exhausted father go back to sleep.
St. Jude would do no more to find him a place to stay.
"They were aware of the situation," Burt said. "I didn't push anything. I was just grateful she was getting treated and I was doing what I needed to do."
St. Jude is the largest and most highly regarded healthcare charity in the country. Each year, the Memphis hospital's fundraisers send out hundreds of millions of letters, many with heart-wrenching photographs of children left bald from battling cancer. Celebrities like Jennifer Aniston and Sofia Vergara sing the hospital's praises in televised advertisements. This year, St. Jude's fundraising reached outer space. The SpaceX Inspiration4 mission in September included a former St. Jude patient as a crew member.
St. Jude's fundraiser mailings heavily rely on patients in the middle of cancer treatment.
Last year, St. Jude raised a record $2 billion. U.S. News & World Report ranked it the country's 10th-best children's cancer hospital, and St. Jude raised roughly as much as the nine hospitals ahead of it put together. It currently has $5.2 billion in reserves, a sum large enough to run the institution at current levels for the next four and a half years without a single additional donation.
St. Jude makes a unique promise as part of its fundraising: "Families never receive a bill from St. Jude for treatment, travel, housing or food — because all a family should worry about is helping their child live."
St. Jude's Raised More Money in 2019 Than the Rest of the Top 10 Children's Hospitals for Cancer — Combined.
But for many families, treatment at St. Jude does not relieve all the financial burdens they incur in getting care for their children, including housing, travel and food costs that fall outside the hospital's strict limits, a ProPublica investigation has found.
While families may not receive a bill from St. Jude, the hospital doesn't cover what's usually the biggest source of financial stress associated with childhood cancer: the loss of income as parents quit or take leave from jobs to be with their child during treatment. For many families, the consequence is missed payments for cars, utilities and cellphones. Others face eviction or foreclosure because they can't keep up with rent and mortgage payments.
Parents at St. Jude have exhausted savings and retirement accounts, borrowed from family and friends or asked other charities for aid. ProPublica identified more than 100 St. Jude families seeking financial help through the online fundraiser GoFundMe, with half of the campaigns started in the past two years. We counted scores of other events like concerts and yard sales organized to help St. Jude families in need.
One family relied on a mixed martial arts fighter to help raise money for expenses like car repairs and cellphone bills, items that St. Jude would not cover. Another spent $10,000, originally saved to purchase a home, on costs related to treatment at St. Jude.
Only about half of the $7.3 billion St. Jude has received in contributions in the past five fiscal years went to the hospital's research and caring for patients, according to its financial filings with the Internal Revenue Service. About 30% covered the cost of its fundraising operations, and the remaining 20%, or $1 of every $5 donated, increased its reserve fund.
Further, ProPublica found, a substantial portion of the cost for treatment is paid not by St. Jude but by families' private insurance or by Medicaid, the government insurance program for low-income families. About 90% of patients are insured, bringing in more than $100 million in reimbursements for treatment a year. If a family shows up at St. Jude without insurance, a company hired by the charity helps them find it. St. Jude does cover copays and deductibles, an unusual benefit.
St. Jude spends about $500 million a year on patient services — a figure that includes all medical care and other assistance. Very little of what St. Jude raises from the public goes to pay for food, travel and housing for families, the investigation found. Last year, it was 2% of the money raised, or nearly $40 million.
In written responses to ProPublica, lawyers for St. Jude and its fundraising arm, the American Lebanese Syrian Associated Charities, or ALSAC, emphasized that countless families have benefited from the charity provided since the hospital opened its doors in 1962.
"ProPublica should be celebrating St. Jude and ALSAC for their commitment to finding cures, saving children's lives, and optimizing patient outcomes," one of their letters said.
It is unquestioned that St. Jude has helped thousands of children and their families over the decades. Patients have offered scores of testimonials about the hospital's generosity and care.
"This often comes as a huge relief to families who often expect to sell all their belongings just so their children can get the medical care and treatment they need to save their lives," the hospital's lawyers wrote. "St. Jude and ALSAC understand that this arrangement cannot cover all financial obligations of all families, nor can St. Jude or ALSAC shield families from all the financial and emotional effects" of a child's illness.
St. Jude said it discloses the limits of its aid to families on its website and in material provided to those whose children are admitted to the hospital. That includes the rule Burt ran into, that the hospital covers the travel and housing costs of only one caregiver and one patient. For many families, the daily food budget is capped at $50. In some cases, hotel stays en route are provided only if families travel more than 500 miles to get to St. Jude.
St. Jude said its assistance is "based on guidelines to ensure fairness and responsible use of donor funds" and on remaining compliant with a federal anti-kickback statute that makes it a criminal offense to offer something of value to induce a medical referral. St. Jude declined to explain how the law affects the amount or type of financial assistance it provides to families.
"St. Jude has never promised anyone — neither patients nor the public in general — that it can solve all financial problems," the letter said.
When parents need additional financial help, St. Jude's social workers often send them to smaller charities or in some cases suggest that they apply for government aid.
They refer many to the Andrew McDonough B+ Foundation, which gives more than $2.5 million a year in grants to thousands of families of pediatric cancer patients at hospitals across the country to help cover rent, utilities and other urgent expenses.
Joe McDonough, the foundation's founder and president, said St. Jude families have the same money problems as families of patients at other children's hospitals, even though he said St. Jude's marketing creates the public perception that it alleviates these burdens.
"People say to me, 'Why are you helping St. Jude families?'" McDonough said. "Well, what happens when a family lives in Augusta, Georgia, and they're being treated at St. Jude? They still have to pay the rent on their apartment back in Augusta, Georgia. They still have to make their car payment. And it's not my position to say whether St. Jude should be paying for all those expenses or not. I'm just explaining that it's not a totally free ride."
The help St. Jude provides to families may soon be increasing.
After ProPublica provided St. Jude with the findings of its reporting, the hospital informed families of a dramatic expansion in the assistance it will give to parents and other relatives during their kids' treatment in Memphis.
Among the most significant changes are increasing travel benefits to two parents instead of one and covering regular trips to Memphis for siblings and other loved ones. St. Jude's letter to parents said the changes take effect Nov. 15.
That would've made a big difference for Burt.
Burt's daughter, whom ProPublica is not identifying at her mother's request, was originally diagnosed with cancer in early 2015, when doctors discovered a tumor pressing against her brain stem. She had successful emergency surgery to remove the mass at Dell Children's Medical Center in Austin, Texas. Medicaid and Dell Children's covered the bill, but the family was still faced with the cost of her ongoing treatment.
"At that point I'm thinking: 'What am I going to do? I guess I'm selling my house, whatever it takes,'" Burt recalled. "Honestly, that was probably a big deciding factor for St. Jude."
St. Jude accepted Burt's daughter into a clinical trial, and the family moved to the hospital's patient housing in Memphis for several months. Both parents stopped working for a time, and people in their hometown raised cash to pay their bills.
Her cancer relapsed the following year with several new, inoperable brain tumors. Burt and his daughter's mom broke up during that round of treatment, and financial problems piled up.
Burt said his credit score dropped so low that utility companies refused to set up service unless he first paid a deposit. One of the family's cars was repossessed, he said. Burt's 2005 Chevrolet Colorado pickup has 300,000 miles on it, many of them logged on trips from Texas to Memphis. When Burt's daughter was at St. Jude for treatment or exams, he'd work all week, then visit on many weekends where he would spend Saturday night sleeping in the hospital parking lot.
He asked hospital officials if he could sleep in St. Jude's housing, but they turned him down, he said.
Burt said he was happy with the care St. Jude provided. His daughter's health is stable, he said, and brain scans taken during her September exam confirmed her two remaining tumors haven't grown. But he's still trying to recover financially.
"It's five years now," Burt said, "and I'm not completely caught up yet."
A Fundraising Giant
St. Jude began with a fledgling entertainer praying for a career break.
When Danny Thomas, a comic and actor best known for the TV sitcom "Make Room for Daddy," was struggling to earn a living in the late 1930s, the devout Roman Catholic went to church and asked for help from the patron saint of desperate cases, St. Jude Thaddeus. If he made it big, Thomas promised to build "a shrine where the poor and the helpless and the hopeless may come for comfort and aid," according to a history published by ALSAC.
Within five years, Thomas became a star and worked to fulfill his promise by building a children's hospital named after St. Jude and a fundraising organization to support it. Thomas, whose parents were Lebanese immigrants, recruited others who shared his Middle Eastern roots to help.
He used his fame to raise the hospital's profile, appearing in ads for St. Jude and hosting fundraising events starring the likes of Elvis Presley and Sammy Davis Jr. Thomas' daughter Marlo, herself a TV star, succeeded him in championing St. Jude.
Today, St. Jude is a specialty treatment and research center with about 5,700 employees and 73 beds. Other top children's hospitals have more staff and beds, and they also treat more conditions.
Though St. Jude raises money across the world, most of its patients come from Tennessee and surrounding states. Patients from elsewhere are usually enrolled in clinical trials.
ALSAC, which handles St. Jude's fundraising and investments, has 2,188 employees in Memphis and in 36 regional offices across the country. More than 400 of the fundraising arm's employees are paid over $100,000, according to IRS filings. The charity takes in so much money each year that it regularly steers hundreds of millions of dollars in donations to reserve accounts, the filings show.
St. Jude's financial holdings, documented in the IRS disclosure filed by ALSAC, the hospital's fundraising arm, for fiscal year 2020.
Overall, St. Jude's reserve has grown by 58% over the past five fiscal years, during which it has added $1.9 billion to its investment accounts and shifted its portfolio toward financial products designed to generate bigger returns than stocks, bonds and mutual funds traditionally deliver. The charity stowed more than a third of the new surplus, $688 million, in riskier private equity investments.
IRS rules do not limit the size of a nonprofit's reserves, and experts on charitable finance differ on best practices.
St. Jude meets Better Business Bureau guidelines, which call for charities to maintain reserves of less than three times total expenses, but other experts expressed alarm that the hospital had accumulated such a large sum of money.
The size of the St. Jude reserve is "staggering," said Laura Otten, the director of LaSalle University's master program in nonprofit leadership. She said a typical reserve for a nonprofit the size of St. Jude is one to two years of expenses. Donors generally want to know their dollars are being put to work, she said.
The hospital said it needs a large reserve because its unique operating model relies on donations to fund annual operating costs. "[W]e are highly donor-dependent and subject to the economic driven vagaries of charitable giving," the hospital said in a written response to ProPublica questions.
But the hospital's reserve is already more than large enough to buffer against recessions and potential drops in donations, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. "They should be spending the money as aggressively as they raise it, but they seem to be hoarding," Bai said.
The hospital said it is also raising billions to fund the construction of new housing and research space, although its plans do not currently include spending any of the reserve on new facilities.
St. Jude's reserves have ballooned at a time when researchers, oncologists, advocates and families complain about a dearth of funding for pediatric cancer studies nationally.
Dozens of other children's hospitals across the country have research divisions devoted to pediatric cancer and enroll their patients in clinical trials for new drugs and procedures. They pay for research staff and studies in part with donations from their local communities, often competing directly against St. Jude. ALSAC has regional offices in several U.S. cities with elite pediatric cancer centers of their own, including Atlanta, Chicago, Denver and Seattle.
Coury Shadyac, an ALSAC vice president and daughter of the organization's CEO, Richard Shadyac Jr., oversees a team of 45 fundraisers along the West Coast "raising $300 million annually" for St. Jude, according to her LinkedIn profile. That's $100 million more in donations than either Children's Hospital Los Angeles or Seattle Children's Hospital, two of the nation's leading pediatric cancer institutions, received in fiscal year 2019, IRS disclosures show. But it's only a small part of St. Jude's fundraising haul.
ALSAC's ubiquitous fundraising has led to concerns that it undercuts other hospitals' campaigns. Some doctors interviewed by ProPublica said they have encouraged donors to give their money to hospitals closer to home.
David Clark, a pediatrician and former longtime chairperson of pediatrics at Albany Medical Center in New York, said St. Jude raises tens of thousands of dollars in his region that does little to benefit the children with cancer in his area since almost all are treated locally. ALSAC has a fundraising office located a few miles from Albany Medical.
"They think of every way they can to make money and the least amount of ways to spend it," Clark said. "They deceive people into supporting something that is totally dishonest."
St. Jude's fundraising appeals often cite the promise that families do not receive a bill from the hospital so that they can focus on helping their child live.
Nearly all St. Jude solicitations feature the hospital's patients — the children usually smiling and bald from treatment — along with the familiar promise that it never sends families a bill.
It's a message that ALSAC has tested and researched to maximize donations. Donors appreciate the promise to never bill families, said Mary Kate Tolan, an ALSAC executive, in a podcast last year. She added that no parent should have to take out a second mortgage or lose their job because their child is being treated at St. Jude.
Alternative messaging to the no-bills promise did not "perform as well," said Tolan, who develops emerging technologies for ALSAC. Tolan did not return requests for comment.
"Borrowing and Begging"
Catherine Rainey thought she would be free of financial worry when her 2-year-old daughter Harlee was admitted to St. Jude last year.
"The first thing my dad said was: 'Catherine, you have nothing to worry about. They raise billions of dollars. Anytime you have a problem, you tell them and they will take care of it,'" she said.
Catherine Rainey with her daughter Harlee, who has cancer, at their home in Appalachia, Virginia, in October. Harlee is being treated at St. Jude. Credit: Greg Kahn, special to ProPublica
But like many families, the Raineys discovered that St. Jude's charity came with limits on payments for expenses such as travel that could be bewildering.
Harlee ended up at St. Jude after first going to nearby Niswonger Children's Hospital in Johnson City, Tennessee, in October 2020. The doctors there discovered a cancerous mass attached to her right kidney. The hospital is a St. Jude affiliate, and the doctors recommended the toddler be treated in Memphis.
Rainey, a single mother of two young girls, had to leave her job as a nurse for months to be with Harlee at St. Jude. The loss of income quickly created problems. "My family, we don't come from money," she said. "We are not doctors and billionaires. We make it. That is it."
St. Jude did provide food and housing on campus. But the hospital said it couldn't help with the items that were causing Rainey to worry, including car payments, insurance and cellphone bills.
Rainey's boss set up a GoFundMe account to help make up some of her lost income. A small local charity, Kari's Heart Foundation, also helped out by paying about $3,000 worth of phone bills and car payments, staving off repossession.
"It was just a bunch of borrowing and begging," Rainey said of her experience while her daughter was treated in Memphis. "They acted like it was coming out of their own pocket."
Harlee has checkups at St. Jude every three months that last about four days. The costs of travel to and from St. Jude put an additional strain on Rainey and Harlee. St. Jude is an eight-hour ride, without stops, from Rainey's home in Appalachia, Virginia, a town of 1,432 people near the Kentucky border.
Rainey said her daughter generally can make it about two-thirds of the way, with frequent stops, before she has had enough. "When she is done, she is really done," Rainey said. "She will scream, cry and kick."
In July, in advance of an August trip to Memphis, Rainey called the patient services department at St. Jude to see whether they could help pay for a hotel to break up the travel day — an expense Rainey said she could not afford.
To qualify for a hotel reimbursement, Rainey said, St. Jude told her she had to live more than 500 miles from Memphis. The ride from her home to the hospital is 530 miles (a measurement ProPublica confirmed with mapping tools). However, Rainey said, St. Jude told her it measured the trip from city limit to city limit and came up with a distance of 491 miles. Even using that metric, the distance is still more than 500 miles, ProPublica found.
When she challenged the hospital's stance, Rainey said she was berated by a patient services representative.
"I was feeling pissed off, and I was crying," Rainey said of the interaction. "You give up your whole life for your child, and they tell you don't worry about anything, we will cover this and then they tell you to just push through the drive."
Rainey did what she could to make the trip go smoothly: She configured a small table to extend across her daughter's car seat, so Harlee could play with the coloring books, markers and Play-Doh bought for the ride. She packed snacks and a cooler full of drinks. Since Harlee was still potty training, she brought extra towels and clothes for accidents. The final step was handing Harlee her Baby Yoda doll once she settled into her car seat. Rainey had sewed a port in the doll's chest to mirror the one Harlee has in hers.
About three hours from Memphis, Harlee was crying inconsolably. Rainey pulled off the interstate and stopped at the first hotel she could find. She later learned it had been described in online reviews as "awful," a "nightmare," "disgusting" and "horrible."
"I didn't know the area," she said. "The hotel was garbage. It just made it worse."
The drive home also required a hotel stop, but this time Rainey was able to find one that was cleaner. A $100 donation from a local charity helped to offset the cost.
Among the changes St. Jude is making is to reimburse families like Rainey's, who live more than 400 miles from the hospital, for an overnight stay at a hotel when making the trip to Memphis.
Rainey said she was called by a St. Jude representative after ProPublica asked about her situation and was told the hospital would pay for her past hotel stays when traveling back and forth to St. Jude. The representative, Rainey said, also told her the hospital discovered the way it had been measuring mileage was inaccurate.
"I am not the only one," Rainey said. "There are others. They should reimburse all the families."
The anxiety of unpaid bills piling up, combined with caring for a child undergoing chemotherapy or radiation, takes a severe toll on parents and guardians, said Christopher Hope, a UPS driver who started a Memphis-based foundation after meeting St. Jude parents who were in financial crisis.
Hope's small charity spent $12,000 last year to help families. Parents in St. Jude social media groups often refer families in need to it. The charity has helped families cover mortgage and car payments.
"I never knew anything about this until hearing about it from families," Hope said. "All we hear is about kids and treatment, not the other side of it."
"It's Not Free"
In addition to charities like Hope's, St. Jude families have repeatedly turned to fundraising sites and networks of their relatives, friends and neighbors to help cover basic expenses while unable to work during their children's treatment. Parents' requests on fundraising sites are sometimes desperate pleas.
In January 2017, one father in North Carolina said he'd had to abandon a business venture to take time for his son to receive care at St. Jude. His income had plummeted. He asked friends to give as little as $10 to "at least make it possible to survive."
This year, a mother in Memphis whose 1-year-old son receives care at St. Jude for sickle cell disorder ran out of medical leave and couldn't work her shifts at a clothing distribution center. After the child had a flare up in July requiring several days of treatment at the hospital, she said she returned home to find her power shut off. Sitting in a dark apartment, unable to pay her utility bills, she set up a GoFundMe campaign. She received less than $20 through the site; her relatives eventually pooled $350 to get her electricity restored.
Even parents with stable jobs and private health insurance often take on debt and need outside help.
When Taylr and Treg Murphy's 17-year-old son Peyton was diagnosed with cancer and needed monthslong treatment at St. Jude in 2017, the entire family — mom, dad, sister and brother — went with him, traveling from their home in Lafayette, Louisiana, to Memphis. Treg took a leave from his job at an oil mining company and Taylr, who works at her mother's bakery, did the same.
"We knew that it was going to be a collective team effort," Treg said. "Without even a discussion, we figured that if Peyton's got to go for the surgery, we're all going."
Peyton had an enormous tumor that had grown out of his right femur and was crowding his knee. Rounds of chemotherapy appeared to have killed osteosarcoma cells elsewhere in his body. But he needed to undergo a procedure called limb-sparing surgery that would require weeks of recovery time at the hospital.
The hospital agreed to allow all five family members to stay for free at St. Jude if they bunked together in a single room. It assigned them a spot in Tri Delta Place, its hotel-like short-term patient residence on the campus. Tri Delta is set up for visits of up to seven days, according to the hospital's guide for volunteers, but the Murphys were there for almost 50.
Taylr said the unit at Tri Delta had no oven or stove and St. Jude provided no grocery money, instead allotting them a $50-per-day credit at the hospital cafeteria, Kay Kafe — not enough to feed the family of five. As the weeks wore on, the Murphys split grilled cheese sandwiches and paid for food out of pocket.
After ProPublica asked about the hospital's food allowances, St. Jude said it would increase them as part of the changes scheduled to go into effect this month. The hospital switched from a $50-a-day cap per family to providing $25 a day to each family member. For a family of four, that would double the food benefit. A weekly stipend given to families in long-term housing was increased to $150 from $125.
For the Murphys, it was the loss of their work income, more than out-of-pocket expenses, that put them into a financial hole as Peyton's treatment went on. Treg's employer couldn't pay him during his long absences.
Fearful of being evicted or having their car repossessed, Taylr said she asked a St. Jude social worker for assistance. The social worker helped her apply for grants from other charities. Taylr said the B+ Foundation paid their rent one month, which ensured they'd have a home to return to.
In the years since his initial treatment, Peyton has gone back to St. Jude repeatedly for exams and surgeries to remove malignant growths in his lungs. Taylr and Treg have missed more work to bring Peyton to Memphis, costing them thousands of dollars more in income.
By the start of this year, Taylr and Treg said they were about $20,000 in debt and panicking. Dustin Poirier, a former UFC champion from their hometown, heard from a friend about Peyton and the family's financial trouble. He donated $10,000 to them from his personal charity and in May hosted a local fundraiser that collected enough to pay off their credit cards.
St. Jude families sometimes commiserate about money problems with each other, Taylr said, but few are aware of the extent of the hospital's unspent resources. The Murphys said they didn't know St. Jude has more than $5 billion in reserve or that it continues to raise hundreds of millions of dollars in surplus donations each year.
St. Jude's Stashes Nearly a Quarter of Its Revenue Each Year.
"That's just insane," Taylr said. "That just blows my mind. When we first started getting treated, people would be like, 'Oh, St. Jude covers everything, that's awesome.' That's not how it works. People don't understand that. I truly didn't understand before I got into St. Jude."
Taylr and Treg said the doctors at St. Jude are "amazing" and they're grateful for their son's care. But they bristled at the assumption that it was covered by the hospital's charity. The family's insurance paid a substantial part of the bills.
"It's not free," Taylr said. "My husband works very hard for the insurance we have — and they are billed." The Murphys pay $12,000 in health insurance premiums each year.
Their struggle continues. Peyton's cancer has relapsed, and he's making regular trips with his mom or dad back to St. Jude for chemotherapy. The family is again applying for help from other charities.
Wiped Out Savings
The costs associated with care at St. Jude caused at least one family to stop going to Memphis altogether.
Last winter, Kelly Edwards was excitedly searching through Tulsa real estate listings after years of diligently saving $10,000 for a down payment on a house. She craved a permanent home for herself and the two young brothers she had taken in five years earlier at the behest of a family friend. She hoped to adopt the boys, now 13 and 9, who call her mom.
In February, the older boy, DJ, was lethargic and uninterested in his schoolwork. After several doctor visits, he was diagnosed with acute lymphoblastic leukemia at a Tulsa hospital. The cancer, referred to as ALL, is the most common type among children, with survival rates that exceed 90%. A day after his diagnosis, DJ and Edwards were driving six hours to Memphis for treatment at St. Jude, which is affiliated with the Oklahoma hospital.
The pair stayed for free at an independently operated Ronald McDonald House near St. Jude, and a weekly stipend from the hospital helped to pay for meals — aid that Edwards said was a blessing. DJ had health insurance through the Oklahoma Medicaid program.
But as with the Murphys, lost income soon put Edwards' family into financial jeopardy. She works as a supervisor for a company that delivers packages for Amazon. After she used up two weeks of paid time off, she stopped getting paychecks. The bills, however, kept coming: rent, car payments, utilities. To that was added the $250 a week she paid a friend to stay with DJ's younger brother and her two dogs in Tulsa.
Within four months, her house savings were wiped out. Edwards said she told her St. Jude social worker about her financial woes but got no additional help.
One of Edwards' adult daughters started a GoFundMe campaign to help, bringing in just over $3,000. Edwards said she appreciated the aid but believes donations were kept low by the widespread perception that St. Jude families don't have financial problems.
"Everyone hears that everything is taken care of by St. Jude," she said. "That is not true, but everyone has that mentality." She said someone she knew asked her "what is that money going for if St. Jude's is paying for everything?"
DJ was scheduled to go back to St. Jude for three weeks of treatment in August, but Edwards decided she simply couldn't afford it. "I don't have the money to go back and forth," she said. She worked with DJ's local doctors and found that the hospital near her home in Tulsa could provide the same treatment he was scheduled to get in Tennessee.
The local treatment allowed her to continue working some shifts and to be at home with both of her boys. DJ is also happier when he is home, Edwards said.
Edwards and the boys are now living in a small house her brother owns just outside Tulsa. Late on a recent weekday afternoon, DJ slowly shuffled into the living room, exhausted from a day of chemotherapy treatment.
He is in the midst of a 20-week regimen where he receives the cancer-killing drugs every other day, just one phase of a nearly three-year treatment plan. He wore an orange knit hat, T-shirt and shorts. He rubbed his eyes before asking a visitor, "How is your day going?" He smiled at the positive response. When he heard the family was eating steak for dinner, he eagerly jumped up to start helping in the kitchen.
After they moved in, Edwards hung family portraits on the walls to make it feel homier. She doesn't expect they will be moving again any time soon.
The dream of buying a home of their own is gone.
ProPublica is continuing to report on the finances, fundraising and operations of St. Jude Children's Research Hospital. Do you know something about this charity? Please reach out to journalists David Armstrong, who can be contacted by phone or Signal at 917-455-1713, or Ryan Gabrielson, who can be contacted by phone or Signal at 718-710-9494.
Former ProPublica reporter Marshall Allen contributed reporting. Kirsten Berg contributed research.
The United States' inability to curb a treatable sexually transmitted disease shows the failures of a cash-strapped public health system. Increasingly, newborns are paying the price.
This article was published on Monday, November 1, 2021 in ProPublica.
By Caroline Chen.
When Mai Yang is looking for a patient, she travels light. She dresses deliberately — not too formal, so she won't be mistaken for a police officer; not too casual, so people will look past her tiny 4-foot-10 stature and youthful face and trust her with sensitive health information. Always, she wears closed-toed shoes, "just in case I need to run."
Yang carries a stack of cards issued by the Centers for Disease Control and Prevention that show what happens when the Treponema pallidum bacteria invades a patient's body. There's a photo of an angry red sore on a penis. There's one of a tongue, marred by mucus-lined lesions. And there's one of a newborn baby, its belly, torso and thighs dotted in a rash, its mouth open, as if caught midcry.Bottom of Form
It was because of the prospect of one such baby that Yang found herself walking through a homeless encampment on a blazing July day in Huron, California, an hour's drive southwest of her office at the Fresno County Department of Public Health. She was looking for a pregnant woman named Angelica, whose visit to a community clinic had triggered a report to the health department's sexually transmitted disease program. Angelica had tested positive for syphilis. If she was not treated, her baby could end up like the one in the picture or worse — there was a 40% chance the baby would die.
Yang knew, though, that if she helped Angelica get treated with three weekly shots of penicillin at least 30 days before she gave birth, it was likely that the infection would be wiped out and her baby would be born without any symptoms at all. Every case of congenital syphilis, when a baby is born with the disease, is avoidable. Each is considered a "sentinel event," a warning that the public health system is failing.
The alarms are now clamoring. In the United States, more than 129,800 syphilis cases were recorded in 2019, double the case count of five years prior. In the same time period, cases of congenital syphilis quadrupled: 1,870 babies were born with the disease; 128 died. Case counts from 2020 are still being finalized, but the CDC has said that reported cases of congenital syphilis have already exceeded the prior year. Black, Hispanic and Native American babies are disproportionately at risk.
There was a time, not too long ago, when CDC officials thought they could eliminate the centuries-old scourge from the United States, for adults and babies. But the effort lost steam and cases soon crept up again. Syphilis is not an outlier. The United States goes through what former CDC director Dr. Tom Frieden calls "a deadly cycle of panic and neglect" in which emergencies propel officials to scramble and throw money at a problem — whether that's Ebola, Zika or COVID-19. Then, as fear ebbs, so does the attention and motivation to finish the task.
The last fraction of cases can be the hardest to solve, whether that's eradicating a bug or getting vaccines into arms, yet too often, that's exactly when political attention gets diverted to the next alarm. The result: The hardest to reach and most vulnerable populations are the ones left suffering, after everyone else looks away.
Yang first received Angelica's lab report on June 17. The address listed was a P.O. box, and the phone number belonged to her sister, who said Angelica was living in Huron. That was a piece of luck: Huron is tiny; the city spans just 1.6 square miles. On her first visit, a worker at the Alamo Motel said she knew Angelica and directed Yang to a nearby homeless encampment. Angelica wasn't there, so Yang returned a second time, bringing one of the health department nurses who could serve as an interpreter.
They made their way to the barren patch of land behind Huron Valley Foods, the local grocery store, where people took shelter in makeshift lean-tos composed of cardboard boxes, scrap wood and scavenged furniture, draped with sheets that served as ceilings and curtains. Yang stopped outside one of the structures, calling a greeting.
"Hi, I'm from the health department, I'm looking for Angelica."
The nurse echoed her in Spanish.
Angelica emerged, squinting in the sunlight. Yang couldn't tell if she was visibly pregnant yet, as her body was obscured by an oversized shirt. The two women were about the same age: Yang 26 and Angelica 27. Yang led her away from the tent, so they could speak privately. Angelica seemed reticent, surprised by the sudden appearance of the two health officers. "You're not in trouble," Yang said, before revealing the results of her blood test.
Angelica had never heard of syphilis.
"Have you been to prenatal care?"
Angelica shook her head. The local clinic had referred her to an obstetrician in Hanford, a 30-minute drive away. She had no car. She also mentioned that she didn't intend to raise her baby; her two oldest children lived with her mother, and this one likely would, too.
Yang pulled out the CDC cards, showing them to Angelica and asking if she had experienced any of the symptoms illustrated. No, Angelica said, her lips pursed with disgust.
"Right now you still feel healthy, but this bacteria is still in your body," Yang pressed. "You need to get the infection treated to prevent further health complications to yourself and your baby."
The community clinic was just across the street. "Can we walk you over to the clinic and make sure you get seen so we can get this taken care of?"
Angelica demurred. She said she hadn't showered for a week and wanted to wash up first. She said she'd go later.
Yang tried once more to extract a promise: "What time do you think you'll go?"
"Today, for sure."
Syphilis is called The Great Imitator: It can look like any number of diseases. In its first stage, the only evidence of infection is a painless sore at the bacteria's point of entry. Weeks later, as the bacteria multiplies, skin rashes bloom on the palms of the hands and bottoms of the feet. Other traits of this stage include fever, headaches, muscle aches, sore throat and fatigue. These symptoms eventually disappear and the patient progresses into the latent phase, which betrays no external signs. But if left untreated, after a decade or more, syphilis will reemerge in up to 30% of patients, capable of wreaking horror on a wide range of organ systems. Dr. Marion Sims, president of the American Medical Association in 1876, called it a "terrible scourge, which begins with lamb-like mildness and ends with lion-like rage that ruthlessly destroys everything in its way."
The corkscrew-shaped bacteria can infiltrate the nervous system at any stage of the infection. Yang is haunted by her memory of interviewing a young man whose dementia was so severe that he didn't know why he was in the hospital or how old he was. And regardless of symptoms or stage, the bacteria can penetrate the placenta to infect a fetus. Even in these cases the infection is unpredictable: Many babies are born with normal physical features, but others can have deformed bones or damaged brains, and they can struggle to hear, see or breathe.
From its earliest days, syphilis has been shrouded in stigma. The first recorded outbreak was in the late 15th century, when Charles VIII led the French army to invade Naples. Italian physicians described French soldiers covered with pustules, dying from a sexually transmitted disease. As the affliction spread, Italians called it the French Disease. The French blamed the Neopolitans. It was also called the German, Polish or Spanish disease, depending on which neighbor one wanted to blame. Even its name bears the taint of divine judgement: It comes from a 16th-century poem that tells of a shepherd, Syphilus, who offended the god Apollo and was punished with a hideous disease.
By 1937 in America, when former Surgeon General Thomas Parran wrote the book "Shadow on the Land," he estimated some 680,000 people were under treatment for syphilis; about 60,000 babies were being born annually with congenital syphilis. There was no cure, and the stigma was so strong that public health officials feared even properly documenting cases.
Thanks to Parran's ardent advocacy, Congress in 1938 passed the National Venereal Disease Control Act, which created grants for states to set up clinics and support testing and treatment. Other than a short-lived funding effort during World War I, this was the first coordinated federal push to respond to the disease.
Around the same time, the Public Health Service launched an effort to record the natural history of syphilis. Situated in Tuskegee, Alabama, the infamous study recruited 600 black men. By the early 1940s, penicillin became widely available and was found to be a reliable cure, but the treatment was withheld from the study participants. Outrage over the ethical violations would cast a stain across syphilis research for decades to come and fuel generations of mistrust in the medical system among Black Americans that continues to this day.
With the introduction of penicillin, cases began to plummet. Twice, the CDC has announced efforts to wipe out the disease — once in the 1960s and again in 1999.
In the latest effort, the CDC announced that the United States had "a unique opportunity to eliminate syphilis within its borders," thanks to historically low rates, with 80% of counties reporting zero cases. The concentration of cases in the South "identifies communities in which there is a fundamental failure of public health capacity," the agency noted, adding that elimination — which it defined as fewer than 1,000 cases a year — would "decrease one of our most glaring racial disparities in health."
Two years after the campaign began, cases started climbing, first among gay men and later, heterosexuals. Cases in women started accelerating in 2013, followed shortly by increasing numbers of babies born with syphilis.The reasons for failure are complex; people relaxed safer sex practices after the advent of potent HIV combination therapies, increased methamphetamine use drove riskier behavior and an explosion of online dating made it hard to track and test sexual partners, according to Dr. Ina Park, medical director of the California Prevention Training Center at the University of California San Francisco.
But federal and state public health efforts were hamstrung from the get-go. In 1999, the CDC said it would need about $35 million to $39 million in new federal funds annually for at least five years to eliminate syphilis. The agency got less than half of what it asked for, according to Jo Valentine, former program coordinator of the CDC's Syphilis Elimination Effort. As cases rose, the CDC modified its goals in 2006 from 0.4 primary and secondary syphilis cases per 100,000 in population to 2.2 cases per 100,000. By 2013, as elimination seemed less and less viable, the CDC changed its focus to ending congenital syphilis only.
Since then, funding has remained anemic. From 2015 to 2020, the CDC's budget for preventing sexually transmitted infections grew by 2.2%. Taking inflation into account, that's a 7.4% reduction in purchasing power. In the same period, cases of syphilis, gonorrhea and chlamydia — the three STDs that have federally funded control programs — increased by nearly 30%.
"We have a long history of nearly eradicating something, then changing our attention, and seeing a resurgence in numbers," said David Harvey, executive director of the National Coalition of STD Directors. "We have more congenital syphilis cases today in America than we ever had pediatric AIDS at the height of the AIDS epidemic. It's heartbreaking."
Adriane Casalotti, chief of government and public affairs at the National Association of County and City Health Officials, warns that the U.S. should not be surprised to see case counts continue to climb. "The bugs don't go away," she said. "They're just waiting for the next opportunity, when you're not paying attention."
Yang waited until the end of the day, then called the clinic to see if Angelica had gone for her shot. She had not. Yang would have to block off another half day to visit Huron again, but she had three dozen other cases to deal with.
States in the South and West have seen the highest syphilis rates in recent years. In 2017, 64 babies in Fresno County were born with syphilis at a rate of 440 babies per 100,000 live births — about 19 times the national rate. While the county had managed to lower case counts in the two years that followed, the pandemic threatened to unravel that progress, forcing STD staffers to do COVID-19 contact tracing, pausing field visits to find infected people and scaring patients from seeking care. Yang's colleague handled three cases of stillbirth in 2020; in each, the woman was never diagnosed with syphilis because she feared catching the coronavirus and skipped prenatal care.
Yang, whose caseload peaked at 70 during a COVID-19 surge, knew she would not be able handle them all as thoroughly as she'd like to. "When I was being mentored by another investigator, he said: 'You're not a superhero. You can't save everybody,'" she said. She prioritizes men who have sex with men, because there's a higher prevalence of syphilis in that population, and pregnant people, because of the horrific consequences for babies.
The job of a disease intervention specialist isn't for everyone: It means meeting patients whenever and wherever they are available — in the mop closet of a bus station, in a quiet parking lot — to inform them about the disease, to extract names of sex partners and to encourage treatment. Patients are often reluctant to talk. They can get belligerent, upset that "the government" has their personal information or shattered at the thought that a partner is likely cheating on them. Salaries typically start in the low $40,000s.
Jena Adams, Yang's supervisor, has eight investigators working on HIV and syphilis. In the middle of 2020, she lost two and replaced them only recently. "It's been exhausting," Adams said. She has only one specialist who is trained to take blood samples in the field, crucial for guaranteeing that the partners of those who test positive for syphilis also get tested. Adams wants to get phlebotomy training for the rest of her staff, but it's $2,000 per person. The department also doesn't have anyone who can administer penicillin injections in the field; that would have been key when Yang met Angelica. For a while, a nurse who worked in the tuberculosis program would ride along to give penicillin shots on a volunteer basis. Then he, too, left the health department.
Much of the resources in public health trickle down from the CDC, which distributes money to states, which then parcel it out to counties. The CDC gets its budget from Congress, which tells the agency, by line item, exactly how much money it can spend to fight a disease or virus, in an uncommonly specific manner not seen in many other agencies. The decisions are often politically driven and can be detached from actual health needs.
When the House and Senate appropriations committees meet to decide how much the CDC will get for each line item, they are barraged by lobbyists for individual disease interests. Stephanie Arnold Pang, senior director of policy and government relations at the National Coalition of STD Directors, can pick out the groups by sight: breast cancer wears pink, Alzheimer's goes in purple, multiple sclerosis comes in orange, HIV in red. STD prevention advocates, like herself, don a green ribbon, but they're far outnumbered.
And unlike diseases that might already be familiar to lawmakers, or have patient and family spokespeople who can tell their own powerful stories, syphilis doesn't have many willing poster children. "Congressmen don't wake up one day and say, 'Oh hey, there's congenital syphilis in my jurisdiction.' You have to raise awareness," Arnold Pang said. It can be hard jockeying for a meeting. "Some offices might say, 'I don't have time for you because we've just seen HIV.' ... Sometimes, it feels like you're talking into a void."
The consequences of the political nature of public health funding have become more obvious during the coronavirus pandemic. The 2014 Ebola epidemic was seen as a "global wakeup call" that the world wasn't prepared for a major pandemic, yet in 2018, the CDC scaled back its epidemic prevention work as money ran out. "If you've got to choose between Alzheimer's research and stopping an outbreak that may not happen? Stopping an outbreak that might not happen doesn't do well," said Frieden, the former CDC director. "The CDC needs to have more money and more flexible money. Otherwise, we're going to be in this situation long term."
In May 2021, President Joe Biden's administration announced it would set aside $7.4 billion over the next five years to hire and train public health workers, including $1.1 billion for more disease intervention specialists like Yang. Public health officials are thrilled to have the chance to expand their workforce, but some worry the time horizon may be too short. "We've seen this movie before, right?" Frieden said. "Everyone gets concerned when there's an outbreak, and when that outbreak stops, the headlines stop, and an economic downturn happens, the budget gets cut."
Fresno's STD clinic was shuttered in 2010 amid the Great Recession. Many others have vanished since the passage of the Affordable Care Act. Health leaders thought "by magically beefing up the primary care system, that we would do a better job of catching STIs and treating them," said Harvey, the executive director of the National Coalition of STD Directors. That hasn't worked out; people want access to anonymous services, and primary care doctors often don't have STDs top of mind. The coalition is lobbying Congress for funding to support STD clinical services, proposing a three-year demonstration project funded at $600 million.
It's one of Adams' dreams to see Fresno's STD clinic restored as it was. "You could come in for an HIV test and get other STDs checked," she said. "And if a patient is positive, you can give a first injection on the spot."
On Aug. 12, Yang set out for Huron again, speeding past groves of almond trees and fields of grapes in the department's white Chevy Cruze. She brought along a colleague, Jorge Sevilla, who had recently transferred to the STD program from COVID-19 contact tracing. Yang was anxious to find Angelica again. "She's probably in her second trimester now," she said.
They found her outside of a pale yellow house a few blocks from the homeless encampment; the owner was letting her stay in a shed tucked in the corner of the dirt yard. This time, it was evident that she was pregnant. Yang noted that Angelica was wearing a wig; hair loss is a symptom of syphilis.
"Do you remember me?" Yang asked.
Angelica nodded. She didn't seem surprised to see Yang again. (I came along, and Sevilla explained who I was and that I was writing about syphilis and the people affected by it. Angelica signed a release for me to report about her case, and she said she had no problem with me writing about her or even using her full name. ProPublica chose to only print her first name.)
"How are you doing? How's the baby?"
"Bien."
"So the last time we talked, we were going to have you go to United Healthcare Center to get treatment. Have you gone since?"
Angelica shook her head.
"We brought some gift cards..." Sevilla started in Spanish. The department uses them as incentives for completing injections. But Angelica was already shaking her head. The nearest Walmart was the next town over.
Yang turned to her partner. "Tell her: So the reason why we're coming out here again is because we really need her to go in for treatment. ... We really are concerned for the baby's health especially since she's had the infection for quite a while."
Yang and colleague Jorge Sevilla looking for Angelica, who sometimes stays in a shack in the yard behind this house.
Angelica listened while Sevilla interpreted, her eyes on the ground. Then she looked up. "Orita?" she asked. Right now?
"I'll walk with you," Yang offered. Angelica shook her head. "She said she wants to shower first before she goes over there," Sevilla said.
Yang made a face. "She said that to me last time." Yang offered to wait, but Angelica didn't want the health officers to linger by the house. She said she would meet them by the clinic in 15 minutes.
Yang was reluctant to let her go but again had no other option. She and Sevilla drove to the clinic, then stood on the corner of the parking lot, staring down the road.
Talk to the pediatricians, obstetricians and families on the front lines of the congenital syphilis surge and it becomes clear why Yang and others are trying so desperately to prevent cases. Dr. J. B. Cantey, associate professor in pediatrics at UT Health San Antonio, remembers a baby girl born at 25 weeks gestation who weighed a pound and a half. Syphilis had spread through her bones and lungs. She spent five months in the neonatal intensive care unit, breathing through a ventilator, and was still eating through a tube when she was discharged.
Then, there are the miscarriages, the stillbirths and the inconsolable parents. Dr. Irene Stafford, an associate professor and maternal-fetal medicine specialist at UT Health in Houston, cannot forget a patient who came in at 36 weeks for a routine checkup, pregnant with her first child. Stafford realized that there was no heartbeat. "She could see on my face that something was really wrong," Stafford recalled. She had to let the patient know that syphilis had killed her baby. "She was hysterical, just bawling," Stafford said. "I've seen people's families ripped apart and I've seen beautiful babies die." Fewer than 10% of patients who experience a stillbirth are tested for syphilis, suggesting that cases are underdiagnosed.
A Texas grandmother named Solidad Odunuga offers a glimpse into what the future could hold for Angelica's mother, who may wind up raising her baby.
In February of last year, Odunuga got a call from the Lyndon B. Johnson Hospital in Houston. A nurse told her that her daughter was about to give birth and that child protective services had been called. Odunuga had lost contact with her daughter, who struggled with homelessness and substance abuse. She arrived in time to see her grandson delivered, premature at 30 weeks old, weighing 2.7 pounds. He tested positive for syphilis.
When a child protective worker asked Odunuga to take custody of the infant, she felt a wave of dread. "I was in denial," she recalled. "I did not plan to be a mom again." The baby's medical problems were daunting: "Global developmental delays ... concerns for visual impairments ... high risk of cerebral palsy," read a note from the doctor at the time.
Still, Odunuga visited her grandson every day for three months, driving to the NICU from her job at the University of Houston. "I'd put him in my shirt to keep him warm and hold him there." She fell in love. She named him Emmanuel.
Once Emmanuel was discharged, Odunuga realized she had no choice but to quit her job. While Medicaid covered the costs of Emmanuel's treatment, it was on her to care for him. From infancy, Emmanuel's life has been a whirlwind of constant therapy. Today, at 20 months old, Odunuga brings him to physical, occupational, speech and developmental therapy, each a different appointment on a different day of the week.
Emmanuel has thrived beyond what his doctors predicted, toddling so fast that Odunuga can't look away for a minute and beaming as he waves his favorite toy phone. Yet he still suffers from gagging issues, which means Odunuga can't feed him any solid foods. Liquid gets into his lungs when he aspirates; it has led to pneumonia three times. Emmanuel has a special stroller that helps keep his head in a position that won't aggravate his persistent reflux, but Odunuga said she still has to pull over on the side of the road sometimes when she hears him projectile vomiting from the backseat.
The days are endless. Once she puts Emmanuel to bed, Odunuga starts planning the next day's appointments. "I've had to cry alone, scream out alone," she said. "Sometimes I wake up and think, Is this real? And then I hear him in the next room."
Putting aside the challenge of eliminating syphilis entirely, everyone agrees it's both doable and necessary to prevent newborn cases. "There was a crisis in perinatal HIV almost 30 years ago and people stood up and said this is not OK — it's not acceptable for babies to be born in that condition. ... [We] brought it down from 1,700 babies born each year with perinatal HIV to less than 40 per year today," said Virginia Bowen, an epidemiologist at the CDC. "Now here we are with a slightly different condition. We can also stand up and say, 'This is not acceptable.'" Belarus, Bermuda, Cuba, Malaysia, Thailand and Sri Lanka are among countries recognized by the World Health Organization for eliminating congenital syphilis.
Success starts with filling gaps across the healthcare system.
For almost a century, public health experts have advocated for testing pregnant patients more than once for syphilis in order to catch the infection. But policies nationwide still don't reflect this best practice. Six states have no prenatal screening requirement at all. Even in states that require three tests, public health officials say that many physicians aren't aware of the requirements. Stafford, the maternal-fetal medicine specialist in Houston, says she's tired of hearing her own peers in medicine tell her, "Oh, syphilis is a problem?"
It costs public health departments less than 25 cents a dose to buy penicillin, but for a private practice, it's more than $1,000, according to Park of the University of California San Francisco. "There's no incentive for a private physician to stock a dose that could expire before it's used, so they often don't have it. So a woman comes in, they say, 'We'll send you to the emergency department or health department to get it,' then [the patients] don't show up."
A vaccine would be invaluable for preventing spread among people at high risk for reinfection. But there is none. Scientists only recently figured out how to grow the bacteria in the lab, prompting grants from the National Institutes of Health to fund research into a vaccine. Dr. Justin Radolf, a researcher at the University of Connecticut School of Medicine, said he hopes his team will have a vaccine candidate by the end of its five-year grant. But it'll likely take years more to find a manufacturer and run human trials.
Public health agencies also need to recognize that many of the hurdles to getting pregnant people treated involve access to care, economic stability, safe housing and transportation. In Fresno, Adams has been working on ways her department can collaborate with mental health services. Recently, one of her disease intervention specialists managed to get a pregnant woman treated with penicillin shots and, at the patient's request, connected her with an addiction treatment center.
Gaining a patient's cooperation means seeing them as complex humans instead of just a case to solve. "There may be past traumas with the healthcare system," said Cynthia Deverson, project manager of the Houston Fetal Infant Morbidity Review. "There's the fear of being discovered if she's doing something illegal to survive. ... She may need to be in a certain place at a certain time so she can get something to eat, or maybe it's the only time of the day that's safe for her to sleep. They're not going to tell you that. Yes, they understand there's a problem, but it's not an immediate threat, maybe they don't feel bad yet, so obviously this is not urgent…"
"What helps to gain trust is consistency," she said. "Literally, it's seeing that [disease specialist] constantly, daily. ... The woman can see that you're not going to harm her, you're saying, 'I'm here at this time if you need me.'"
Yang stood outside the clinic, waiting for Angelica to show up, baking in the 90-degree heat. Her feelings ranged from irritation — Why didn't she just go? I'd have more energy for other cases — to an appreciation for the parts of Angelica's story that she didn't know — She's in survival mode. I need to be more patient.
Fifteen minutes ticked by, then 20.
"OK," Yang announced. "We're going back."
She asked Sevilla if he would be OK if they drove Angelica to the clinic; they technically weren't supposed to because of coronavirus precautions, but Yang wasn't sure she could convince Angelica to walk. Sevilla gave her the thumbs up.
When they pulled up, they saw Angelica sitting in the backyard, chatting with a friend. She now wore a fresh T-shirt and had shoes on her feet. Angelica sat silently in the back seat as Yang drove to the clinic. A few minutes later, they pulled up to the parking lot.
Finally, Yang thought. We got her here.
The clinic was packed with people waiting for COVID-19 tests and vaccinations. A worker there had previously told Yang that a walk-in would be fine, but a receptionist now said they were too busy to treat Angelica. She would have to return.
Yang felt a surge of frustration, sensing that her hard-fought opportunity was slipping away. She tried to talk to the nurse supervisor, but he wasn't available. She tried to leave the gift cards at the office to reward Angelica if she came, but the receptionist said she couldn't hold them. While Yang negotiated, Sevilla sat with Angelica in the car, waiting.
Finally, Yang accepted this was yet another thing she couldn't control.
She drove Angelica back to the yellow house. As they arrived, she tried once more to impress on her just how important it was to get treated, asking Sevilla to interpret. "We don't want it to get any more serious, because she can go blind, she could go deaf, she could lose her baby."
Angelica already had the door halfway open.
"So on a scale from one to 10, how important is this to get treated?" Yang asked.
"Ten," Angelica said. Yang reminded her of the appointment that afternoon. Then Angelica stepped out and returned to the dusty yard.
Yang lingered for a moment, watching Angelica go. Then she turned the car back onto the highway and set off toward Fresno, knowing, already, that she'd be back.
Postscript: A reporter visited Huron twice more in the months that followed, including once independently to try to interview Angelica, but she wasn't in town. Yang has visited Huron twice more as well — six times in total thus far. In October, a couple of men at the yellow house said Angelica was still in town, still pregnant. Yang and Sevilla spent an hour driving around, talking to residents, hoping to catch Angelica. But she was nowhere to be found.
In a decade-plus span McKinsey counted among its clients many of the country's biggest drug companies.
This article was published on Monday, October 4, 2021 in ProPublica.
Since 2008, McKinsey & Company has regularly advised the Food and Drug Administration's drug-regulation division, according to agency records. The consulting giant has had its hand in a range of important FDA projects, from revamping drug-approval processes to implementing new tools for monitoring the pharmaceutical industry.
During that same decade-plus span, as emerged in 2019, McKinsey counted among its clients many of the country's biggest drug companies — not least those responsible for making, distributing and selling the opioids that have ravaged communities across the United States, such as Purdue Pharma and Johnson & Johnson. At times, McKinsey consultants helped those drugmaker clients fend off costly FDA oversight — even as McKinsey colleagues assigned to the FDA were working to bolster the agency's regulation of the pharmaceutical market. In one instance, for example, McKinsey consultants helped Purdue and other opioid producers push the FDA to water down a proposed opioid-safety program. The opioid producer ultimately succeeded in weakening the program, even as overdose deaths mounted nationwide.
Yet McKinsey, which is famously secretive about its clientele, never disclosed its pharmaceutical company clients to the FDA, according to the agency. This year ProPublica submitted a Freedom of Information Act request to the FDA seeking records showing that McKensey had disclosed possible conflicts of interest to the agency's drug-regulation division as part of contracts spanning more than a decade and worth tens of millions of dollars. The agency responded recently that "after a diligent search of our files, we were unable to locate any records responsive to your request."
Federal procurement rules require U.S. government agencies to determine whether a contractor has any conflicts of interest. If serious enough, a conflict can disqualify the contractor from working on a given project. McKinsey's contracts with the FDA, which ProPublica obtained after filing a FOIA lawsuit, contained a standard provision obligating the firm to disclose to agency officials any possible organizational conflicts. One passage reads: "the Contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias."
Agency officials rely on disclosure to ensure that they have the information they need to consider whether a contractor's other business relationships risk slanting its judgment. "Contractors have the obligation to disclose potential conflicts, and then the government has an obligation to figure out how to deal with it," said Jessica Tillipman, an assistant dean and government procurement law expert at George Washington University Law School.
Asked for comment, McKinsey did not assert that it disclosed potential conflicts to the FDA. But a spokesperson for the firm, Neil Grace, nonetheless maintained that "across more than a decade of service to the FDA, we have been fully transparent that we serve pharmaceutical and medical device companies. McKinsey's work with the FDA helped improve the agency's effectiveness through organizational, resourcing, business process, operational, digital, and technology improvements. To achieve its mission, the government regularly seeks support from additional experts who understand both the government's mission and the industries' practices. We take seriously our commitment to avoid conflicts and to serve the best interests of the FDA." (McKinsey is a sponsor of ProPublica's local virtual events programming.)
McKinsey's failure to disclose its industry engagements deprived the FDA of the opportunity to consider whether, for example, the overlap between McKinsey's government and pharmaceutical industry projects and the potential financial incentives at play constituted a conflict, experts said.
"For a contractor like McKinsey not to disclose the companies it is working for has all the appeal of the Addams Family on Halloween hiding Uncle Fester in the basement so as not to scare the neighborhood," said Charles Tiefer, a professor of government contracting at the University of Baltimore Law School.
A spokesperson for the FDA did not respond to requests for comment.
McKinsey's extensive opioid company consulting eventually began coming to light, starting with a 2019 ProPublica report. The firm's opioid work has provoked widespread criticism, spawned a welter of lawsuits and led the firm to pay nearly $600 million this year to settle legal claims made by all 50 states, as well as five U.S. territories and the District of Columbia. It also prompted McKinsey to issue a statement in which the firm acknowledged that it "fell short" of its standards in advising opioid makers while also denying that it "sought to increase overdoses or misuse and worsen a public health crisis." The firm pledged not to work on opioid-related projects going forward.
The lawsuits and public outrage have focused on the consulting firm's efforts to help increase (or "turbocharge," in McKinsey's parlance) sales of Purdue Pharma's highly addictive flagship opioid, OxyContin. But lately, concerns have begun to emerge about McKinsey's parallel assignments, which were worth upward of $50 million over about 12 years, for the nation's primary drug regulator. In a letter to the FDA in August, a bipartisan group of senators led by Sen. Maggie Hassan, D-N.H., asked the regulator to address "potential conflicts of interest that may have arisen" from McKinsey's work for both the agency and "a wide range of actors in the opioid industry, including many of the companies that played a pivotal role in fueling the opioid epidemic that our country now faces."
McKinsey, which has focused on counseling the CEOs of leading corporations for much of its nearly 100-year history, began expanding its public-sector practice in the United States around the time of its earliest FDA projects. McKinsey prides itself on its ability to act quickly and with discretion, and in its largely unregulated engagements for corporate clients, there are few impediments to the firm doing so.
In government consulting, however, the rules are far more stringent, and on several recent occasions, the firm has been caught refusing to abide by such strictures, including disclosure rules. Over the past couple of years, for example, McKinsey's bankruptcy-advisory practice has paid more than $30 million to the Justice Department and one client's creditors to settle allegations that it failed to disclose potential conflicts, as required by the federal bankruptcy rules. Those allegations also prompted a federal criminal investigation of the firm. McKinsey has denied wrongdoing, and the investigation, which came to light in 2019, has not led to charges.
There are signs of overlap between McKinsey's government and industry engagements, though publicly available information about the firm's work for drug companies is limited. In one instance in 2008, which surfaced in a lawsuit against Purdue, the FDA told Purdue that it planned to require the company to submit a drug-safety plan for its bestselling drug, OxyContin. The company recognized that regulation of this sort threatened to cut into its sales margins, and according to McKinsey documents filed in federal court, top Purdue executives tasked the consultancy with devising a response to the FDA.
According to McKinsey PowerPoint slides, the firm proposed four options, among them suing the FDA to "delay" the imposition of a safety plan and to "band together" with other opioid producers to "formulate arguments to defend against strict treatment by the FDA." Purdue selected the latter, with McKinsey helping to implement the strategy. In 2009, McKinsey emails and slides show, its consultants prepared Purdue executives for at least two meetings with FDA officials. (One suggested answer to questions about who at Purdue would take personal responsibility for OxyContin overdoses: "We all feel responsible.")
In the meantime, according to a 2011 FDA contract, the agency's drug-regulation division hired McKinsey to develop a "new operating model" for the office responsible for developing drug-safety plans of the sort Purdue and its allies were fighting against, with the consultancy's help. Among McKinsey's tasks were defining the office's "strategic goals and objectives," including its "role in monitoring drug safety."
In 2012, the FDA issued a substantially watered-down version of the opioid-safety plan.
There's no evidence to suggest McKinsey's consultants at the FDA influenced the opioid-safety plan. But this apparent overlap between a government contract and an assignment for a commercial client reflects the type of issue an agency would want to consider when assessing whether a potential conflict of interest exists. Agencies are likeliest to identify a conflict "where an outside business venture is related directly to the subject matter of the procurement and structured such that there is a real economic incentive for biased performance," Keith Szeliga, a partner at the law firm Sheppard Mullin, wrote in a 2006 article in the Public Contract Law Journal.
A number of other McKinsey projects at the FDA, contracting records show, were also likely to have a financial impact on its pharmaceutical industry clients. In 2010, for example, the FDA hired the firm to help it develop a system to track and trace the distribution of potentially harmful prescription drugs. The contract required the firm to consult with "supply chain stakeholders," a category that potentially included a number of long-standing McKinsey clients. Hassan and her fellow senators, in their recent letter to the FDA, called this "an obvious conflict of interest."
Another contract, from 2014, tasked McKinsey with assessing the "strengths, limitations and appropriate use" of Sentinel, a system meant to monitor the safety of drugs once they're on the market. That project likewise called for McKinsey to interview "external stakeholders," including "industry organizations" and "drug and device industry leaders."
The news of McKinsey's opioid work apparently did little to dampen the FDA's enthusiasm for the consultancy. In March 2019, just after the news broke, the agency signed a new contract with McKinsey — extending the firm's multiyear effort to help the FDA "modernize" the process by which it regulates new drugs.
Ian MacDougall is a contributing reporter at ProPublica.
A congressional investigation prompted by ProPublica's reporting found Trump's "Mar-a-Lago crowd," wealthy civilians with no U.S. government or military experience.
This article was published on Monday, September 27, 2021 in ProPublica.
Former President Donald Trump empowered associates from his private club to pursue a plan for the VA to monetize patient data, according to documents newly released by congressional investigators.As ProPublica first reported in 2018, a trio based at Trump's Mar-a-Lago resort weighed in on policy and personnel decisions for the federal government's second-largest agency, despite lacking any experience in the U.S. government or military.
While previous reporting showed the trio had a hand in budgeting and contracting, their interest in turning patient data into a revenue stream was not previously known. The VA provides medical care to more than 9 million veterans at more than 1,000 facilities across the country.
"Patient data is, in my opinion, the most valuable assets [sic] the VA has," a consultant said in a June 2017 email released Monday by Democrats on the House Oversight Committee. "It can be leveraged into hundreds of millions in revenue" by selling access to major companies, he said.
The consultant, Terry Fadem, ran a private nonprofit for Bruce Moskowitz, a West Palm Beach, Florida, physician who was one of the three Trump associates given sweeping influence over the VA, known to officials as "the Mar-a-Lago crowd."
In response to Fadem's email, Moskowitz told then-VA Secretary David Shulkin that he had discussed the plan with interested companies including Johnson & Johnson, CVS and Apple. Shulkin replied that he liked the idea, according to the documents.
Senior officials scrambled to hire Fadem as a contractor, the emails show, but it's not clear whether his contract was awarded. "I am working on trying to understand why and where [h]is contract is stuck," Poonam Alaigh, then the agency's top health official, said in a June 2017 email. "I agree, having him on board as soon as possible will be critical."
The documents do not show what became of the plan or whether the VA ever sold access to patient data. Nor do the records include evidence that Moskowitz or the other Mar-a-Lago associates were in a position to profit personally.
A spokesman for the trio said as far as they know Fadem was not hired and the VA never acted on the licensing idea. "We were asked repeatedly by former Secretary Shulkin and his senior staff, as well as by the President, to assist the VA and that is what we sought to do, period," the three said in a statement.
Shulkin, Alaigh, Trump's office, the VA, Johnson & Johnson, CVS and Apple did not immediately respond to requests for comment. Fadem died in 2019.
The latest revelation helps complete the picture of the Mar-a-Lago triumvirate's extensive influence over Trump's agenda for veterans, a signature issue in his 2016 campaign. ProPublica's revelations about the men's day-to-day involvement prompted investigations by congressional committees and the Government Accountability Office, as well as a court challenge.
House Oversight Committee chairwoman Carolyn Maloney, D-N.Y., and House Veterans Affairs Committee chairman Mark Takano, D-Calif., said in a statement on Monday that the documents show "the secret role the trio played in developing VA initiatives and programs, including a 'hugely profitable' plan to monetize veterans' medical records."
"Ike Perlmutter, Marc Sherman, and Dr. Bruce Moskowitz, bolstered by their connection to President Trump's private Mar-a-Lago club, violated the law and sought to exert improper influence over government officials to further their own personal interests," the chairs said.
Perlmutter, Sherman and Moskowitz have previously said that they obtained no personal benefits, had no official role and exercised no formal authority.
But the newly released documents show that they did view themselves as an official advisory committee — and disregarded repeated warnings that they needed to comply with a Watergate-era transparency law.
"As the President asked, we can now formally create an official committee," Perlmutter, the group's leader and chairman of Marvel Entertainment, wrote in a February 2017 email after a meeting with Trump. Perlmutter is a Mar-a-Lago member and one of Trump's biggest political donors.
Perlmutter went so far as to rebuke White House staff for holding discussions without him.
"I am shocked and extremely disappointed with the manner in which you have engaged in individual communications with Apple — and intentionally excluded our broader team of subject matter experts," Perlmutter said in a March 2017 email to White House aides. "I understand that these backdoor discussions have apparently been occurring almost daily for weeks, and you have not told anyone and refuse to return phone calls and emails."
Official advisory committees are governed by the Federal Advisory Committee Act. The 1972 law, known as FACA, requires federal agencies to inform the public when they consult outside experts.
Administration officials repeatedly told the Mar-a-Lago trio that they would have to comply with the law. The law compels advisory committees to represent a range of views and disclose their activities to the public.
"It appears FACA may be implicated," a VA lawyer said in a January 2017 email that Shulkin shared with Moskowitz.
That April, White House aide Reed Cordish told Perlmutter directly, "You will need to form a FACA group."
But Perlmutter demurred, replying, "We have been advised that FACA does not apply because we are not a formal group in any way."
Instead, the group took efforts to conceal its activities, documents show. "We are still unsure what can be put in emails and what to discuss verbally," Moskowitz wrote to Shulkin in February 2017.
The group's spokesman maintained they weren't a formal committee and said complying with FACA was the agency's responsibility.
In March 2021, a federal appeals court in Washington held that a liberal veterans group could proceed with a lawsuit to enforce FACA's disclosure requirements around the Mar-a-Lago trio.
