Will Lightbourne sees his job as a chance to refocus Medi-Cal on improving health by linking people with behavioral health programs and getting them into housing.

This article was published on Thursday, July 30, 2020 in Kaiser Health News.

By Samantha Young

When Will Lightbourne looked at the statistics behind California's coronavirus cases, the disparities were "blindingly clear": Blacks and Latinos are dying at higher rates than most other Californians.

As of Monday, Latinos account for 45.6% of coronavirus deaths in a state where they make up 38.9% of the population, according to data collected by the California Department of Public Health. Blacks account for 8.5% of the deaths but make up 6% of the population.

Lightbourne, who led California's Department of Social Services under Gov. Jerry Brown, describes this pandemic as one that "rips the bandage off" a healthcare system long riddled with inequity.

So, when Gov. Gavin Newsom asked Lightbourne, 70, to come out of retirement in June to lead the Department of Healthcare Services, he said, he couldn't say no.

"He has committed his whole professional life to public service," said Mike Herald, director of policy advocacy at the Western Center on Law & Poverty. "He's not joking when he talks about the importance of these issues and the important role that government plays in addressing societal inequities."

The Department of Healthcare Services oversees the state's Medicaid program for low-income people, called Medi-Cal, which provides healthcare to some 12.5 million Californians.

Lightbourne said he sees the job as a chance to refocus Medi-Cal on reducing disparities — improving people's health not only by providing better access to doctors, but also by linking them with behavioral health programs and using healthcare dollars to get them into housing.

He said the department also plans to amend contracts with health providers and use routine performance reviews to make sure providers are addressing disparities.

Healthcare advocates say Lightbourne has a track record of getting things done.

At the Department of Social Services, he persuaded Brown, a known penny pincher, to increase cash assistance to low-income families, restoring cuts lawmakers had made in the Great Recession. And he was instrumental behind the scenes in the repeal of the contentious policy that had prohibited Californians from receiving increased welfare income if they had more children while receiving public assistance, Herald said.

"Will is very purpose-driven and has made substantive changes in every role he has ever had," said Graham Knaus, executive director of the California State Association of Counties.

Before embarking on state service, Lightbourne served as director of the Santa Clara County Social Services Agency, the Human Services Agency of the City & County of San Francisco and the Santa Cruz County Human Services Agency.

Lightbourne's local and state experience give him a valuable skill set as state and county officials grapple with providing healthcare to some of California's most vulnerable residents during a pandemic, Knaus and other advocates said.

The task won't be easy. The previous director of the Department of Healthcare Services, Brad Gilbert, left the job after less than four months.

Lightbourne talked to California Healthline about why he returned to state government, how the department is responding to COVID-19 and how he hopes to improve access to healthcare for those who need it. The interview has been edited for length and clarity.

Q: Why did you come out of retirement to take a job that's difficult under normal circumstances — and even tougher during a pandemic?

Events of the past six months have made it blindingly clear that we've got structural inequities that are not just immoral but are, at an existential level, unsurvivable. It's a pandemic that landed on top of a pandemic of inequalities, opportunity and income that's been raging since the 1980s. And that pandemic has been enabled by a pandemic of racism that has rotted in our society for generations.

I think we have to use the moment to insist that our publicly financed healthcare system really partners up with our public health network and with our social safety-net system to address community and population health with a laser focus on reducing disparities.

Q: How has the department responded to COVID-19 to address the most vulnerable Californians?

The growth in telehealth is something that would not have occurred without this experience. There's work still underway to look at how we can come up with some approaches to reduce the number of people in skilled nursing facilities, where the rate of spread is so much more severe and with really mortal results.

I have the suspicion that we're never really going to get to a point where we say the effect of COVID is over. The mere fact that so much healthcare utilization is down now, particularly down in the places where people who start at a disadvantage normally seek care, we're going to find long-term health consequences into the future, even post-vaccine.

Q: In January, Gov. Newsom outlined a proposal to broaden a Medi-Cal program known as CalAIM that addresses physical and behavioral health needs in patients' care, and even pays for their housing with healthcare money. Can your department still move forward with those goals even though there isn't money in the budget for it?

We may be delayed to some extent. It was never intended initially as a big-bang system change. It was always going to be a degree of iterative development, and that remains true — whether some things have to go a little slower because of money reasons.

Q: You have talked about access to healthcare and how COVID-19 has really highlighted systemic disparities. In Medi-Cal, lack of access to care has long been a problem, especially in rural areas. So has inadequate care for children. Are those issues you intend to address?

One of the things we need is an adequate network of providers that really covers the medically underserved areas of the state. We need to work effectively with our rural health clinics, as well as our urban Federally Qualified Health Centers to expand access, particularly to the populations that historically haven't had that access.

In terms of services for children, that's a big part of that agenda both in physical and behavioral health and also the dental health system. There's a big focus on how to improve access and preventive services for children.

Q: In the Great Recession, California lawmakers made many deep cuts to safety-net programs, some of which have been restored only recently. The governor proposed a number of healthcare-related cuts this year that were ultimately rejected by the legislature. How will you ensure that Medi-Cal enrollees won't see their benefits scaled back in the future?

It's going to be my job to make the case not to reduce services that poor people rely on. That said, we live in the real world and if we ever have to reduce things, my approach would be to try to say, "How can we reduce things we can readily rebuild rather than destroy things that are foundational?"

Goal No. 1 at this point is to work very closely with our congressional delegation to really encourage the federal government to support the core services and activities so that we can meet the needs of the people of the state.

This KHN story first published on California Healthline, a service of the California Healthcare Foundation.

Samantha Young: syoung@kff.org, @youngsamantha

Early evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the FDA.

This article was published on Wednesday, July 29, 2020 in Kaiser Health News.

By Arthur Allen

The vaccine trial that Vice President Mike Pence kicked off in Miami on Monday gives the United States the tiniest chance of being ready to vaccinate millions of Americans just before Election Day.

It's a possibility that fills many public health experts with dread.

Among their concerns: Early evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the Food and Drug Administration. That conflict between science and politics might cause some people to not trust the vaccine and refuse to take it, which would undermine the global campaign to stop the pandemic. Or it could lead to a product that is not fully protective. Confidence in routine childhood vaccinations, already shaken, could decline further.

"The fear is that you wind up doing to a vaccine what [Trump has] already done with [opening] school," said Dr. Joshua Sharfstein, a former FDA deputy commissioner and a professor at Johns Hopkins University in Baltimore. "Take an important, difficult question and politicize it. That's what you want to avoid."

On Monday at 6:45 a.m., the first volunteer in the landmark phase 3 trial for the Moderna Therapeutics vaccine received a shot at a clinic in Savannah, Georgia. Clinicians at 88 other sites, stretching from Miami to Seattle, also administered the experimental shot in a trial that aims to enroll 30,000 people.

Dr. Anthony Fauci, the country's leading infectious disease expert, told reporters he hoped 15,000 could be vaccinated by the end of the week, although he provided no information about progress toward that goal. All volunteers would receive a second shot 29 days after their first inoculation. (Half will receive a placebo containing saline solution.)

Another vaccine, produced by Pfizer with the German company BioNTech, also entered a large phase 3 U.S. trial this week. It's being tested independently of the National Institutes of Health, which is partially funding the Moderna trial as well as tests for an Oxford University/AstraZeneca vaccine trial, and others in the future. AstraZeneca has said some doses of its vaccine might be ready as early as September.

Fauci said he expects the Moderna trial to provide an answer about whether that vaccine works by the end of the year — and it's "conceivable" an answer could come in October. "I doubt that, but we are leaving an open mind that it is a possibility."

Such a fast pace worries some experts.

"I don't see how that's remotely possible unless the thing I most fear happens, a truncated phase 3 trial with just an idea of efficacy, an idea of common side effects, and then it rolls out," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

Pence downplayed such fears Monday, telling reporters: "There will be no shortcuts. There will be no cutting corners."

Officials are pressing for an open and transparent process.

Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, is preparing to release a bill requiring the FDA to have an expert panel review any COVID vaccine and issue a recommendation before FDA Commissioner Stephen Hahn makes a decision.

With past vaccines, the FDA has generally relied on such a committee, made up mostly of vaccine experts and appointed by the FDA commissioner. They typically conduct a painstaking examination of all evidence before voting on whether the FDA should approve a vaccine. The commissioner has rarely, if ever, gone against the committee's decisions.

Hahn undercut confidence in the FDA's independence earlier in the year, many observers felt, when he issued an Emergency Authorization Use declaration for hydroxychloroquine, a drug used to treat malaria that President Donald Trump and members of his administration have continued to tout, erroneously, as a cure for COVID-19. The FDA later revoked the authorization, which was made without consulting an independent committee.

"FDA's independence has been threatened, no question, by the hydroxychloroquine issue," said Dr. Jesse Goodman, a Georgetown University professor who led the FDA's biologics division and later was chief scientific officer.

The agency must give outside scientists and the public the opportunity to see the data and the FDA's reasoning before coming to such a decision, he said.

Concerns about political interference arose recently when Trump talked excitedly about a vaccine, and Treasury Secretary Steven Mnuchin confidently told reporters there would be a vaccine by the end of the year for emergency use.

To be sure, it's unlikely the FDA would be tempted to issue an emergency release without data that showed a vaccine was working and not causing serious side effects.

The massive coronavirus outbreaks in Texas and other hard-hit areas where the Moderna vaccine is being tested should provide an answer, although exactly when is an open question.

In theory, scientists might get a handle on a vaccine's efficacy before all 30,000 people are enrolled, vaccinated and studied.

In fact, an answer could become clear after only 150 to 160 cases of disease are reported among the trial participants, Fauci said. If roughly two-thirds of those cases occurred in non-vaccinated people, it would show statisticians that the vaccine had above-60% efficacy, he said.

If the vaccine is 80% to 90% effective and the annual rate of infection in the places where it's being tested is above 4%, scientists could get a signal of efficacy in such a trial with just 50 cases, or in as little as three months, said Ira Longini, a University of Florida biostatistician who designs vaccine trials.

The Moderna vaccine trial would hit that three-month threshold on Oct. 27.

The trial's fate is partly in the hands of its 30-member Data and Safety Monitoring Board, whose members can see unblinded data about the participants in real time — pinpointing who was vaccinated with the actual vaccine and got sick, for example. The board will alert the NIH and vaccine maker if it sees surprising data — either dangerous side effects or powerful efficacy. Some fear that if the vaccine seems to work in an early review, the FDA would be pressured to stop the trial.

Offit said NIH should not accept anything less than a completed trial of 30,000 people. Fifty cases "is a very small number" to use as evidence for releasing a vaccine that could be administered to tens of millions, he said.

The public might clamor for the release of any vaccine that seemed to work. Moderna said it has already begun producing millions of doses of vaccine "at risk," banking on the vaccine's success. The FDA could release those under powers provided when the country declared a public health emergency in March.

With more than half the country deeply mistrustful of Trump, according to recent polls, any federal decision could be resisted and lead to widespread rejection of even a promising vaccine. Sharfstein worries about a "knee-jerk" reaction against the vaccine by Democrats if Trump touts it before the election.

Experts also worry about releasing a vaccine that shows some positive effects but isn't robustly protective. A slide presented by FDA deputy director Philip Krause at the World Health Organization earlier this month said a weak vaccine could fail to protect the public adequately, leading to a false sense of security in those who've received it, while making it harder to test future vaccines.

This KHN story first published on California Healthline, a service of the California Healthcare Foundation.

Arthur Allen: ArthurA@kff.org

Historically, racial and ethnic miniorities have been less likely to be included in clinical trials for disease treatment.

This article was first published on Monday, July 27, 2020 in Kaiser Health News.

When U.S. scientists launch the first large-scale clinical trials for COVID-19 vaccines this summer, Antonio Cisneros wants to make sure people like him are included.

Cisneros, who is 34 and Hispanic, is part of the first wave of an expected 1.5 million volunteers willing to get the shots to help determine whether leading vaccine candidates can thwart the virus that sparked a deadly pandemic.

"If I am asked to participate, I will," said Cisneros, a Los Angeles cinematographer who has signed up for two large vaccine trial registries. "It seems part of our duty."

It will take more than duty, however, to ensure that clinical trials to establish vaccine safety and effectiveness actually include representative numbers of African Americans, Latinos and other racial minorities, as well as older people and those with underlying medical conditions, such as kidney disease.

Black and Latino people have been three times as likely as white people to become infected with COVID-19 and twice as likely to die, according to federal data obtained via a lawsuit by The New York Times. Asian Americans appear to account for fewer cases but have higher rates of death. Eight out of 10 COVID deaths reported in the U.S. have been of people ages 65 and older. And the Centers for Disease Control and Prevention warns that chronic kidney disease is among the top risk factors for serious infection.

Historically, however, those groups have been less likely to be included in clinical trials for disease treatment, despite federal rules requiring minority and elder participation and the ongoing efforts of patient advocates to diversify these crucial medical studies.

In a summer dominated by COVID-19 and protests against racial injustice, there are growing demands that drugmakers and investigators ensure that vaccine trials reflect the entire community.

"If Black people have been the victims of COVID-19, we're going to be the key to unlocking the mystery of COVID-19," said the Rev. Anthony Evans, president of the National Black Church Initiative, a coalition of 150,000 African American churches.

Evans and his team met in mid-July with officials from Moderna, the Massachusetts biotech firm that launched the first COVID vaccine trial in the U.S., to discuss a collaboration in which NBCI would supply African American participants. But that was less than two weeks before the start of a phase 3 trial expected to enroll 30,000 people, and Evans said the meeting was his idea.

"It's not that the industry came to me," he said. "I went to the industry."

Blacks make up about 13% of the U.S. population but on average 5% of clinical trial participants, research shows. For Hispanics, trial participation is about 1% on average, though they account for about 18% of the population.

When it comes to trials for drug treatments and vaccines, diversity matters. For reasons not always fully understood, people of different races and ethnicities can respond differently to drugs or therapies, research shows. Immune response wanes with age, so there's a high-dose flu shot for people 65 and older.

Still, the pressure to produce an effective vaccine quickly during a pandemic could sideline efforts to ensure diversity, said Dr. Kathryn Stephenson, director of the clinical trials unit in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.

"One of the questions that has come up is, What do you do if you're a site investigator and you have 250 people banging on your door — and they're all white?" she said.

Do you enroll those people, reasoning that the faster the trial progresses, the faster a vaccine will be available for everyone? Or do you turn away people and slow down the study?

"You're accelerating development of a vaccine, and if you hit a milestone, what is the meaning of that milestone if you don't know if it's very safe or effective in [a given] population? Is that really hitting the milestone for everyone?" she said.

Including people who are elderly or have underlying medical conditions is vital to the science of vaccines and other treatments, even if it's more difficult to recruit patients otherwise healthy enough to participate, advocates said.

"We have to admit that older adults are the ones who are likely to develop side effects" to treatments and vaccines, said Dr. Sharon Inouye, director of the Aging Brain Center and a professor of medicine at Harvard Medical School. "On the other hand, that is the population that will be using it."

People with kidney disease, which affects 1 in 7 U.S. adults, have been left out of clinical research for decades, said Richard Knight, a transplant recipient and president of the American Association of Kidney Patients. Nearly 70% of more than 400 kidney disease patients the organization surveyed in July said they'd never been asked to join a clinical trial.

Excluding from the vaccine trial such a large population vulnerable to COVID doesn't make sense, Knight contended. "If you're trying to manage this from a public health standpoint, you want to make sure you're inoculating your highest-risk populations," he said.

New guidance from the federal Food and Drug Administration, which regulates vaccines, "strongly encourages" the inclusion of diverse populations in clinical vaccine development. That includes racial and ethnic minorities, elderly people and those with underlying medical problems, as well as pregnant women.

But the FDA does not require drugmakers and researchers to meet those goals, and will not refuse trial data that doesn't comply. And while the federal government is rushing billions of dollars to fast-track more than a half-dozen leading candidates for COVID vaccines, the pharmaceutical firms producing them are not required to publicly disclose their demographic goals.

"This is business as usual," said Marjorie Speers, executive director of Clinical Research Pathways, a nonprofit group in Atlanta that works to increase diversity in research. "It's very likely these [COVID] trials will not include minorities because there's not a strong statement to do that."

The vaccine trials are being coordinated through the COVID-19 Prevention Network, or CoVPN, based at the Fred Hutchinson Cancer Research Center in Seattle. It draws on four long-standing federally funded clinical trial networks, including three that target HIV and AIDS.

Those trial networks were chosen in large part because they have rich relationships in Black, Latino and other minority communities, said Stephaun Wallace, director of external relations for CoVPN. The hope is to leverage existing connections based on trust and collaboration.

"Our clinical trial sites are prepped and ready to engage diverse people," Wallace said.

Wallace acknowledged, however, that attracting a diverse population requires investigators to be flexible and innovative. There can be practical problems. Clinic hours may be limited or transportation may be an issue. Older people may have problems with sight or hearing and require extra help to follow protocols.

Distrust of the medical establishment also can be a barrier. African Americans, for instance, have a well-founded wariness of medical experiments after the infamous Tuskegee Study and the exploitation of Henrietta Lacks. That extends to suspicion about recommended vaccines, said Wallace.

"Part of the consideration for many groups is not wanting to feel like a guinea pig or feel like they're being experimented on," he said.

Moderna, which plans to launch its phase 3 trial Monday, said the company is working to ensure participants "are representative of the communities at highest risk for COVID-19 and of our diverse society."

However, results of the company's phase 1 trial, released in mid-July, showed that of 45 people included in that safety test, six were Hispanic, two were Black, one was Asian and one was Native American. Forty were white.

Phase 1 and phase 2 clinical trials aim to test the best dose and safety of vaccines in small groups of people. Phase 3 trials assess the efficacy of the drug in tens of thousands of people.

Investigators at nearly 90 sites across the U.S. are preparing now to recruit participants for Moderna's phase 3 trial. Dr. Carlos del Rio, executive associate dean at the Emory University School of Medicine, will seek 750 volunteers at three Atlanta-area sites. Half will receive the vaccine; half, placebo injections.

Del Rio has had marked success recruiting minorities for HIV trials and expects similar results with the vaccine trial. "We're trying to do our best to get out to the communities that are most at risk," he said.

Meanwhile, vaccine volunteers like Cisneros just want the advanced trials to start. He signed up for the CoVPN trials. But earlier, he also signed up for 1 Day Sooner, an effort to launch human challenge trials, which aim to speed up vaccine development by deliberately infecting participants with the virus. Such trials can be completed in weeks rather than months but risk exposing volunteers to severe illness or death, and federal officials remain leery.

Cisneros is willing to take that risk to help halt COVID-19, which has killed 143,000 Americans. He said it's a way to take action at a time when the U.S. government has failed to protect minorities, the elderly and other vulnerable people.

"Government is supposed to help those who can't protect themselves," he said. "It appears to me the only thing they want to protect is people with money, people with guns — and not brown people like me."

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

Trump could enact a policy, even one judged illegal by the courts, and the person who follows him into office would need to jump through a number of hoops to undo it.

This article was first published on Friday, July 24, 2020 in Kaiser Health News.

By Jon Greenberg, PolitiFact  

President Donald Trump came into office vowing to repeal and replace Obamacare. While he successfully neutralized the healthcare law's requirement that everyone carry insurance, the law remains in effect.

When Fox News host Chris Wallace noted that Trump has yet to put forward a replacement plan, Trump told him to stay tuned.

"We're signing a healthcare plan within two weeks, a full and complete healthcare plan that the Supreme Court decision on DACA gave me the right to do," Trump said July 19 on "Fox News Sunday."

"The Supreme Court gave the president of the United States powers that nobody thought the president had."

Trump said he would "do things on immigration, on healthcare, on other things that we've never done before."

We wanted to know if the Supreme Court really did that. So we ran the president's words by a number of people who study constitutional and administrative law. We heard several reasons why the Supreme Court might not have said what Trump thinks it said.

The Likely Source

We asked the White House press office for the basis of Trump's assertion and never heard back. Several law professors pointed to a National Review article by University of California-Berkeley law professor John Yoo, best known as authoring a legal justification that led to waterboarding enemy combatants during the George W. Bush administration.

In the article, Yoo argues that when the Supreme Court ruled against the administration's rollback of Deferred Action for Childhood Arrivals, or DACA, the court made it more difficult for new presidents to unwind the policies of their predecessors.

How might this give Trump new power?

In theory, Trump could enact a policy, even one judged illegal by the courts, and the person who follows him into office would need to jump through a number of hoops to undo it.

Yoo wasn't sure if Trump could use the argument to make sweeping changes in healthcare, saying it "depends on what the administration policy actually says."

But as Yoo sees it, should Trump establish a new program, the ruling "requires his successor to follow a burdensome process, which could take a year or more, to repeal it."

Many legal experts disagree with Yoo's interpretation. Before we go there, we need to recap the court's DACA decision.

Court Sends DHS Back to the Drawing Table

President Barack Obama created DACA on the grounds that every administration has to allocate limited prosecution resources. Obama argued that it was more important to deport violent criminals, drug dealers and thieves than people who had come into the country illegally when they were little. So long as they had committed no serious offenses and met other criteria, they could apply to avoid deportation.

Under Trump, the Department of Homeland Security moved to end DACA. Supporters of the program sued, saying that under the Administrative Procedure Act, that action was arbitrary. In its June 18 ruling, a 5-4 majority on the Supreme Court agreed.

The ruling describes how Homeland Security Secretary Kirstjen Nielsen got in a procedural bind when she inherited the decision of her predecessor (Acting Secretary Elaine Duke) to end the program. She erred, Chief Justice John Roberts wrote, because instead of making the case for ending DACA as her own decision, she came up with new reasons to justify the earlier move.

"Because Nielsen chose not to take new action, she was limited to elaborating on the agency's original reasons," Roberts wrote. "But her reasoning bears little relationship to that of her predecessor and consists primarily of impermissible 'post hoc rationalization.'"

The court didn't say Homeland Security couldn't change the policy. It said the Administrative Procedure Act requires an agency to consider the key options it faces and explain why it chose the one it picked. With DACA, it said the change needed to show a fuller vetting of its choices.

No New Power Created

So while Trump technically lost that case, he is using the ruling (and Yoo's theory) to voice confidence that he can do things no one thought possible.

Legal scholars give several reasons that might be off the mark. Broadly, they say the court's ruling changed nothing.

"It's a straightforward application of long-standing administrative law doctrine that dates back at least to President Ronald Reagan," said Cary Coglianese, director of the Penn Program on Regulation and a professor of law at the University of Pennsylvania. "Agencies have to explain why they are doing something. They have to look at the plausible alternatives and give a reason for the one they selected."

Justice Brett Kavanaugh also did not see a new take on an old law. In his dissenting opinion, he called the ruling on the Administrative Procedure Act "narrow."

In a similar vein, the court left intact the specific power behind DACA of selective enforcement of the law.

"That's an ordinary part of executive branch practice, and nothing in the Supreme Court's DACA decision should be read to authorize anything beyond that simple practice," said Yale University law professor Cristina Rodríguez.

The path to undoing this sort of executive action may not be as long as Yoo described. The court spelled out how Nielsen could have ended DACA without much delay, said Eric Freedman, professor of constitutional law at Hofstra University Law School.

"If she had considered other possible solutions, what she did would have been fine," Freedman said. "She would have complied with the Administrative Procedure Act and no one would have enjoined her."

There is also something unusual about DACA itself that makes it less of a model for other steps Trump might take.

The program was in place for quite a while before Trump tried to end it. As a result, about 700,000 people ultimately counted on it. The court said that reliance on the program should have factored into the decision to end it.

A new policy from Trump wouldn't have time to accumulate that critical mass.

"Anything Trump does now will be enjoined tomorrow," said Josh Blackman at the South Texas College of Law. "So there will be no reliance, and the next administration could do what it wanted."

Blackman said the court's ruling did create some murkiness around challenging the legality of an unwanted policy. But he said an agency could justify a change strictly for reasons of policy, not law.

Lastly, the DACA decision was about a policy not to enforce the law in certain circumstances. Robert Chesney at the University of Texas Law School said that focus also limits the scope of the ruling.

"If Trump wants to create new rules, the example does not fit in the first place," Chesney said.

A "full and complete healthcare plan" and major immigration changes would likely require new government actions. Without new laws from Congress, that would be out of reach.