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Column: Right-wing judges are on a mission to stop the FDA from warning consumers about snake oil



Column: Right-wing judges are on a mission to stop the FDA from warning consumers about snake oil

To anyone who has paid even a modicum of serious attention to COVID-19 and its treatment, ivermectin is the zombiest of zombie drugs.

Used to treat parasitic diseases in animals and humans, the drug became a darling of anti-vaccination activists and conspiracy-mongers, who pushed it as a treatment for the pandemic disease and claimed it was being suppressed by Big Pharma, among other sinister forces.

Contrary to its continued promotion by quacks such as Florida Surgeon General Joseph Ladapo, the drug has been conclusively shown to be utterly useless against COVID.

You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.

— Food and Drug Administration counsels against a useless COVID treatment


One would have hoped that hard scientific evidence and a stern advisory by the Food and Drug Administration against its use would have been enough to kill the ivermectin craze, but it lives on. Last year, three doctors sued the FDA, claiming that its public warning harmed their practices and cost them their jobs at hospitals and medical schools.

A few months later, a federal judge in Galveston threw out their case, ruling in effect that they didn’t come close to having a leg to stand on. That should have been an end to it. But earlier this month, the case was revived by the U.S. 5th Circuit Court of Appeals, which takes cases from Texas, Louisiana and Mississippi and is, by many measures, the hackiest of hack-ridden federal courts.

The three judges hearing this appeal — two appointed by George W. Bush and one (the opinion’s author) by Donald Trump — found that the FDA had exceeded its authority in advising against the use of ivermectin against COVID. “The FDA can inform,” the court said, “but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” (Emphasis in the original.)

That’s absurd, says Dorit Rubinstein Reiss, an expert on vaccine policy at University of California College of the Law, San Francisco, and the author of a withering analysis of the 5th Circuit opinion.

The FDA’s job, Reiss told me, is to “balance the need for treatment with safety concerns. If the FDA can’t translate what it’s finding into plain language — ‘do this, don’t do that’ — then it can’t do its job. That undermines the whole regulatory scheme.”


More on that in a moment. First, some context.

Undermining the FDA’s authority has been a right-wing project for years. That’s because the agency’s duty is to stand in the way of businesses desiring to push unsafe and ineffective nostrums at unwary consumers, and also in the way of a perverse idea that personal freedom includes the freedom to be gulled by charlatans.

This campaign got pumped up during the Trump administration. Trump in 2018 signed a federal “right-to-try” law that masqueraded as a compassionate path giving sufferers of intractable, incurable diseases access to experimental treatments. In fact, as I wrote, it was a cynical ploy backed by the Koch brothers’ network aimed at emasculating the FDA in a way that would undermine public health.

Trump subsequently browbeat his maladroit FDA chairman, Stephen Hahn, into issuing an emergency authorization for the use of convalescent plasma to treat COVID-19 patients. Like ivermectin, that was another utterly ineffective treatment.

In announcing his decision while Trump stood glaring at him, Hahn grossly misrepresented the results of a medical trial conducted by the Mayo Clinic, which failed to demonstrate any effectiveness for the treatment. In the run-up to the announcement, Trump issued a tweet accusing “the deep state … at the FDA” of deliberately delaying effective COVID treatments until after the upcoming Nov. 3, 2020, election, which Trump lost. Hahn didn’t respond to that frontal attack on his agency’s integrity.


The FDA is under more solid management now, but the malign influence of judges Trump installed in the federal judiciary lives on. That brings us to the 5th Circuit, on which 12 of the 16 currently active judges were appointed by Republican presidents — six by Trump.

The court has received appeals of some of the loopiest district court rulings of recent memory, largely because conservative litigants in Texas have the ability to hand-pick judges who see things their way.

Among the recent rulings those judges have issued that swear at precedent and common sense are those outlawing the use of the medication mifepristone for abortion (another case aimed at undermining FDA authority) and barring agencies of the federal government from communicating with social media companies, which was brought by right-wing litigants hoping to hobble the government’s battle against medical misinformation.

The 5th Circuit judges have frequently matched the district court rulings they’re reviewing with loopy opinions of their own.

Trump appointee James Ho issued a partial concurrence in the mifepristone case in which he asserted that an “unborn child” was “killed by mifepristone,” and justified outlawing use of the drug by stating that “unborn babies are a source of profound joy for those who view them. Expectant parents eagerly share ultrasound photos with loved ones. Friends and family cheer at the sight of an unborn child. Doctors delight in working with their unborn patients — and experience an aesthetic injury when they are aborted.”


(The court narrowed the FDA’s authority to approve the drug, but its ruling is under review by the Supreme Court.)

In a 2019 case, a three-judge panel voted 2-1 to find that a key provision of the Affordable Care Act, and possibly the entire law, was unconstitutional. In her concurrence, Jennifer Walker Elrod, a George W. Bush appointee in the majority, approvingly repeated a right-wing congressman’s claim that the act was “a fraud on the American people.”

The 5th Circuit judges combine their clownish approach to the law with a clownish confusion over the federal rules of procedure they are bound to apply. As recently as Tuesday, the appeals court had to withdraw an order it had issued the day before, granting red state plaintiffs a rehearing in the case involving government contacts with social media companies.

The court had originally allowed four government agencies to continue interacting with the companies; the red states wanted the judges to withdraw their permission. But the court’s granting of a rehearing so flagrantly violated procedural rules governing cases, like this one, that are already under consideration by the Supreme Court, that it had to immediately backtrack. (The circuit’s clerk of the court obligingly accepted the blame, attributing Monday’s grant to a “clerical error.”

The judges who made this blunder — Elrod, Edith Brown Clement and Don R. Willett — are the same ones who ruled in the ivermectin case. Let’s take another gander at that ruling.


Reiss terms the ruling “problematic on legal and policy grounds” by “undercutting the FDA’s ability to offer expertise-based guidance about products they regulate.”

The judges were particularly exercised by an FDA Twitter campaign that aimed to dissuade consumers from taking the veterinary preparation of ivermectin commonly administered to horses.

“You are not a horse,” the agency tweeted. “Stop it with the #ivermectin. It’s not authorized for treating #COVID.” The agency also issued a general warning headlined “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” explaining that the drug has not been shown to be effective for the purpose and is dangerous in high doses.

The three plaintiff doctors — one from Virginia, one from Texas, and one practicing in Washington and Arizona — had lost their hospital privileges or other professional positions for promoting the drug. The latter plaintiff is under investigation by medical regulators in the two states where he’s licensed. All three blamed the FDA.

The 5th Circuit judges agreed that even though the agency pointed out that it has no power to order patients to do or not do anything and no authority over physicians — who have the legal right to prescribe medications approved by the FDA for “off-label” uses — it had exceeded its authority by using “imperative” language (i.e., “Stop it”) instead of merely declaring that the drug wasn’t approved for COVID.


Yet as Reiss points out, the FDA frequently couches its advisories in such straightforward terms, and has done so virtually since its creation in its present form in 1930. The agency’s warning against unproven stem cell treatments — a dark and dangerous hive of medical charlatans — advises patients, “Don’t believe the hype” and adds that it’s “increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics.”

Carrying the 5th Circuit’s ruling to its logical extreme, the agency’s stem cell warning would exacerbate the vulnerability of disease sufferers to quacks hawking expensive and ineffective treatments.

Thanks to its promotion by anti-vaxxers and conspiracy-mongers, ivermectin prescriptions in the U.S. spiked to 88,000 in mid-August 2021 from 3,600 per week prior to the pandemic, despite a lack of any evidence that it is useful against COVID.

(Centers for Disease Control and Prevention)


Despite the judges’ contention that it has no authority to offer recommendations to the public, Reiss notes that such authority is actually embedded in federal law, which gives the FDA the right to undertake “collecting, reporting, and illustrating the results of [its] investigations.”

“That certainly seems to include conclusions based on the data collected,” Reiss wrote: “Reporting on the result of an investigation that showed ivermectin is not effective for COVID-19 would naturally include a comment that it should not be used.”

In any event, there’s no case to be made that the FDA warnings caused the doctors’ professional troubles. Several professional organizations have warned of the ineffectiveness of ivermectin for COVID, including the American Medical Assn. No medical board needed the FDA to tell it that doctors prescribing this modern snake oil deserved scrutiny.

It’s possible that the appellate judges themselves had an inkling that they were on thin ice in their ruling. They didn’t rule conclusively that the FDA was wrong, but rather sent the case back to the trial court judge for further pondering on technical grounds, such as whether the FDA’s advisories amount to “final agency actions” subject to court review or whether the doctors even had standing to bring the lawsuit in the first case.

“They seem to be trying to hedge,” Reiss says. On the other hand, they didn’t dismiss the case outright, as they should have. The judges cast a shadow over the FDA, at a time when its crucial, lifesaving campaign against medical misinformation doesn’t need any more head winds.


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Suicides in U.S. hit historic high in 2022, driven by increase among older adults



Suicides in U.S. hit historic high in 2022, driven by increase among older adults

Rising rates of suicide among older adults drove the number of such deaths to a historic high in the United States last year, even as suicide declined among youth, according to a report released Wednesday by researchers at the Centers for Disease Control and Prevention.

More than 49,000 people died by suicide in 2022 across the country, the highest tally recorded for the nation, according to federal figures. It’s the latest evidence of a troubling trend in the U.S., where suicide has been on the rise for much of the 21st century.

The U.S. suicide rate fell somewhat between 2018 and 2020, but then resumed its upward trend, alarming health officials. After adjusting the raw numbers to account for the age distribution of Americans, CDC researchers found that the nation’s suicide rate last year was 14.3 deaths per 100,000 residents — a level not seen since 1941.

The rate is based on preliminary figures for suicide deaths, which are expected to increase as 2022 deaths continue to be assessed and more of them are classified as suicides.


The growing numbers were propelled by rising rates of suicide among people 35 or older, federal figures indicate. Between 2021 and 2022, rates actually fell among those younger than 25, but rose significantly for many groups of older adults, the report shows.

“It’s somewhat different than what we’ve seen in past years,” said Sally C. Curtin, a statistician at the CDC’s National Center for Health Statistics and one of the authors of the new report. Suicide rates have increased across many demographic groups, but “if there’s a bright spot in the report, it is that decline for some of the younger groups which had been marching steadily up.”

Suicide prevention and crisis counseling resources

If you or someone you know is struggling with suicidal thoughts, seek help from a professional and call 9-8-8. The United States’ first nationwide three-digit mental health crisis hotline 988 will connect callers with trained mental health counselors. Text “HOME” to 741741 in the U.S. and Canada to reach the Crisis Text Line.


The gender gap remained wide in 2022, with 23.1 deaths per 100,000 men and 5.9 deaths per 100,000 women. Elderly men were at especially high risk: Among men ages 75 and older, the suicide rate (43.7 deaths per 100,000) was roughly twice as high as for young males ages 15 to 24 (21.6 deaths per 100,000).

“People don’t realize that depression is not a normal part of aging” and that older people can access treatment for it, said Jill Harkavy-Friedman, senior vice president of research for the American Foundation for Suicide Prevention. Older people often face chronic conditions and pain and may also endure social isolation, which can also be affected by hearing loss, she said. “Connection is really important.”

Though suicide was much less common among women than men, the age-adjusted rate for women rose 4% between 2021 and 2022, compared with 1% for men. Among women, the age range at highest risk of suicide was 45 to 54, with 8.9 such deaths per 100,000, according to the new report.

And there have been marked differences in suicide rates by race and ethnicity, with American Indian and Alaska Native people at highest risk (26.7 deaths per 100,000), followed by non-Hispanic white people (17.6 deaths per 100,000), according to the report.


Suicide rates have been significantly lower among other racial and ethnic groups in the U.S., including Black people, whose rate was 9 such deaths per 100,000. But other studies have questioned whether misclassification of deaths among Black people might affect the accuracy of those numbers.

The U.S. has seen suicides rise even as rates fell in many other countries. Experts have suggested a range of factors that might play a role, including the opioid epidemic, economic uncertainty and access to firearms, but there has been ongoing debate and scant consensus about the causes.

“We don’t know why the rate has been going up,” Harkavy-Friedman said. She stressed, however, that suicide is preventable, and “we do have things that we can do that we know work.”

The new report did not examine the specific manner in which people died, but a KFF analysis this year found that firearm-related suicides continued to rise in the U.S., accounting for 55% of all suicides in 2021 and 2022. Reducing access to such “lethal means” has become one focus for suicide prevention.

For suicide prevention, “firearms are the low-hanging fruit here” in the U.S., said Dr. Gonzalo Martinez-Ales, a psychiatrist and epidemiologist at Harvard University and Mt. Sinai Hospital in New York. Purchasing a firearm greatly increases the risk of death by suicide for anyone living in the same household, Martinez-Ales said.


Many people in crisis are suicidal for only a short period — as brief as five to 10 minutes — which means that if they didn’t have something highly lethal at hand, they would be at much lower risk, he said.

In addition, getting help can be more difficult in the U.S. than in other countries since “it can be challenging to navigate the healthcare system,” Martinez-Ales said. In the throes of a crisis, “making access to care easy in that moment might save your life.”

The U.S. surgeon general issued a call to action in 2021, saying that suicide prevention “requires a comprehensive approach that combines multiple strategies to reduce risk and strengthen protective factors at the individual, relationship, community, and societal levels.” That includes addressing “upstream factors” that affect suicide, increasing the use of mobile crisis teams, and keeping people safe from “lethal means,” the surgeon general’s report says.

Harkavy-Friedman urged people to educate themselves on warning signs. “If you are worried about someone, you can ask them directly if they’re thinking of taking their life, and they will feel better under most circumstances because they don’t have to keep it a secret,” she said.

“It makes a difference if we connect with people when they’re struggling. Run towards them rather than running away from them,” she advised.


“Everybody can play a role and we can make a difference.”

If you or someone you know is struggling with suicidal thoughts, seek help from a professional and call 988. The first nationwide three-digit mental health crisis hotline will connect callers with trained mental health counselors. Or text “HOME” to 741741 in the U.S. and Canada to reach the Crisis Text Line.

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Backlash to affirmative action hits pioneering maternal health program for Black women



Backlash to affirmative action hits pioneering maternal health program for Black women

For Briana Jones, a young Black mother in San Francisco, a city program called the Abundant Birth Project has been a godsend.

Designed to counter the “obstetric racism” that researchers say leads a disproportionate number of African American mothers to die from childbirth, the project has provided 150 pregnant Black and Pacific Islander San Franciscans a $1,000 monthly stipend.

The money enabled Jones, 20, to pay for gas to drive to prenatal clinics, buy fresh fruits and vegetables for her toddler son and herself and remain healthy as she prepared for the birth of her second child last year.

But the future of the Abundant Birth Project is clouded by a lawsuit alleging that the program, the first of its kind in the nation, illegally discriminates by giving the stipend only to people of a specific race. The lawsuit also targets San Francisco guaranteed-income programs serving artists, transgender people and Black young adults.

The litigation is part of a growing national effort by conservative groups to eliminate racial preferences in a range of institutions after a U.S. Supreme Court ruling that found race-conscious admissions to colleges and universities to be unconstitutional.


In healthcare, legal actions threaten efforts to provide scholarships to minority medical school students and other initiatives to create a physician workforce that looks more like the nation.

The lawsuits also endanger other measures designed to reduce documented racial disparities. Black women are three to four times more likely than white women to die in labor or from related complications in the U.S., and Black infants are twice as likely as white infants to be born prematurely and to die before their first birthdays. Racial and ethnic minorities also are more likely to die from diabetes, high blood pressure, asthma and heart disease than their white counterparts, according to the Centers for Disease Control and Prevention.

A handful of activist nonprofit groups and law firms are leading the charge. Do No Harm, a nonprofit formed in 2022, has sued health commissions, pharmaceutical companies and public health journals to try to stop them from choosing applicants based on race. Do No Harm claims more than 6,000 members worldwide and partners with nonprofit legal organizations, most notably the Pacific Legal Foundation, which garnered national attention when it defended California’s same-sex marriage ban.

Another nonprofit, the Californians for Equal Rights Foundation, together with a Dallas-based law firm called the American Civil Rights Project, filed the lawsuit against the city of San Francisco and the state of California over the Abundant Birth Project, alleging the program violates the equal protection clause of the Constitution’s 14th Amendment by granting money exclusively to Black and Pacific Islander women. The 14th Amendment was passed after the Civil War to give rights to formerly enslaved Black people.

The lawsuit calls public money used for the project and the three other guaranteed-income programs “discriminatory giveaways” that are “illegal, wasteful and injurious.”


“The city and county of San Francisco crafted the Abundant Birth Project with the express intention of picking beneficiaries based on race,” Dan Morenoff, executive director of the American Civil Rights Project, said in a phone interview. “It’s unconstitutional. They can’t legally do it, and we are optimistic that the courts will not allow them to continue to do it.”

San Francisco and state officials declined to discuss the case because of the pending litigation, but the city defended the program in its initial response to the lawsuit. The Abundant Birth Project started in June 2021 and plans to make a second round of grants to pregnant mothers this fall, the response says.

The project strives to improve maternal and infant health outcomes by easing the economic stress on pregnant Black and Pacific Islander San Franciscans. People in those groups face some of the worst outcomes in the U.S., where more women die as a result of pregnancy and childbirth than in other high-income nations. The state of California last year awarded $5 million to expand the program to include Black mothers in four other counties.

Briana Jones is among 150 San Franciscans who have benefited from the Abundant Birth Project. The program aims to counter risk factors that researchers say result in a disproportionate number of Black women dying in childbirth.

(Brittany Sterling )


Khiara Bridges, a Berkeley law professor and anthropologist who has talked to beneficiaries of the Abundant Birth Project but is not directly involved with it, said the Supreme Court ruling on college affirmative action could actually support the argument that the program is legal.

The court struck down affirmative action in part because the majority said Harvard and the University of North Carolina failed to show measurable outcomes justifying race consciousness in college admissions. While statistics on potential benefits from the Abundant Birth Project are not publicly available, Bridges and others familiar with the program expect researchers to demonstrate it saves and improves lives by comparing the health outcomes of families that received the stipend with those of families that did not. The outcomes could justify employing race to choose program participants, Bridges said.

Bridges also drew another distinction between the role of race in college admissions and the role of race in health disparities.

“If you don’t get into Harvard, there’s always Princeton or Columbia or Cornell,” she said. “Maternal death — the stakes are a little bit higher.”


In California, a voter initiative, Proposition 209, has prohibited race-based selection in public education and employment since 1996. California Assemblymember Mia Bonta (D-Alameda) has co-authored a pending bill that would amend the proposition to allow municipalities to grant benefits to specific groups of vulnerable people if they use research-based measures that can reduce health and other disparities.

Bonta, a law school graduate, said the litigation against the Abundant Birth Project is the result of “conservative groups who want to exist in a world that doesn’t exist, where communities of color have not had to suffer the generational harm that comes from structural racism.”

In the U.S., Black women are far more likely than white women to report that healthcare providers scolded, threatened or shouted at them during childbirth, research shows. They also face other forms of obstetric racism, including barriers to quality care and cumulative stress from lifelong discrimination.

Growing up Black in predominantly white and Asian San Francisco has been a struggle for Jones. But, while carrying her second baby last year, she learned from her mother about the Abundant Birth Project. Within a month, her race and address in Bayview Hunters Point, where some of the city’s poorest residents live, qualified her to receive the $1,000 a month during her pregnancy and for six months postpartum.

“I really did feel like it was God helping me,” she said.


For Morenoff, though, it’s just another form of discrimination, and he says the city must either open the Abundant Birth Project to all pregnant women or close it down. “The whole point of the 14th Amendment is to require America to treat all Americans as Americans with the same equal rights,” he said.

Jones had high blood pressure, leading to swollen ankles and dizziness, during both her pregnancies. In her more recent one, the stipend helped her quit couch surfing and move into an apartment, and she gave birth to a healthy boy named Adonis.

“It’s known that people of color struggle way harder than other races,” Jones said. “Where I live, it’s nothing but struggle here, people trying to make ends meet.

“For them to try to take this program away from us,” she said, “it’s wrong.”

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues.

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USC neuroscientist faces scrutiny following allegations of data manipulation



USC neuroscientist faces scrutiny following allegations of data manipulation

A star neuroscientist at USC is facing allegations of misconduct after whistleblowers submitted a report to the National Institutes of Health that accused the professor of manipulating data in dozens of research papers and sounded alarms about an experimental stroke medication his company is developing.

The accusations against Berislav V. Zlokovic, professor and chair of the department of physiology and neuroscience at the Keck School of Medicine of USC, were made by a small group of independent researchers and reported in the journal Science.

The report identifies allegedly doctored images and data in 35 research papers in which Zlokovic is the sole common author. It also raised questions about findings in Phase II clinical trials of a drug called 3K3A-APC, an experimental stroke treatment sponsored by ZZ Biotech, the Houston-based company Zlokovic co-founded.

Preclinical data appeared to have been manipulated, the report authors allege. In addition, the Phase II results appear to contain errors that would skew interpretation of the data in favor of the drug.


An attorney for Zlokovic said the neuroscientist takes the accusations “extremely seriously” and was “committed to fully cooperating” with a USC inquiry into the matter. However, he said his client could not comment on the allegations while the review was pending.

“Professor Zlokovic would normally welcome addressing every question raised, insofar as allegations are based on information and premises Professor Zlokovic knows to be completely incorrect,” attorney Alfredo X. Jarrin wrote in an email. “And other questions address work not performed at his lab or papers where he was not the senior author or contact author and his role was limited.”

The university also issued a statement saying it takes allegations of research integrity seriously. “Consistent with federal regulations and USC policies, the university forwards any such allegations to its Office of Research Integrity for careful review,” the university said in a statement. “Under USC policy, this review is required to be confidential. As a result, we are unable to provide any further information.”

Last year, USC’s Keck School of Medicine received from NIH the first $4 million of a planned $30-million grant to conduct Phase III trials of the experimental stroke treatment on 1,400 people.

Given the serious issues outlined in their report, the whistleblowers say those trials should be stopped immediately.


“It should certainly be paused in my opinion,” said Matthew Schrag, an assistant professor of neurology at Vanderbilt and co-author of the whistleblower report. “There are red flags about the safety of that treatment.”

He said that evidence from the USC-led phase II trial of the drug, which was published in 2018 and called RHAPSODY, raised questions of patient safety. Patients in that trial were more likely to die in the week after treatment, and more likely to be disabled 90 days later than those who were given a placebo.

In addition, Schrag said, some patients given the placebo had to wait longer for the standard stroke treatment of the drug tPA or surgery to dissolve the blood clot.

“The faster you’re able to intervene to either restore blood flow with the drug or restore blood flow by removing the clot, the more brain cells survive,” he said.

He added that he did not believe the delay was intentional but that it had the effect of “skewing the results in favor of the drug.”


Schrag previously raised questions about the integrity of other neurological research, work he said was separate from his employment at Vanderbilt.

Scientists have questioned Zlokovic’s research anonymously for years, Schrag said. Many of these concerns were published on PubPeer, a website on which anonymous contributors can examine scientific papers and highlight potential flaws.

Yet scientists working with Zlokovic did not complain publicly, he said, allowing the studies to continue for years and succeed at attracting tens of millions of dollars in taxpayer funding.

“I think people are concerned about the potential for backlash for harm to their own careers,” Schrag said. “And so I think that motivates people to just go along.”

In its report, the journal Science interviewed four former employees of Zlokovic’s lab who said that Zlokovic routinely pressured them to manipulate data. Two said they were told to discard notebooks with results that didn’t fit preferred conclusions he hoped to reach.


“There were clear examples of him instructing people to manipulate data to fit the hypothesis,” one former employee told the journal.

The severity of the data manipulation charges merits a thorough investigation of Zlokovic’s data, said Elisabeth Bik, a microbiologist and scientific integrity consultant who co-wrote the whistleblower report.

“Appropriate steps would be for USC to ask Zlokovic to give them the lab’s notebooks and data,” Bik said. “For example, for images where it appears that certain parts might have been duplicated or erased, the original images as they came off a scanner or microscope need to be compared to the published figure panels.”

Bik is among a subset of the report’s authors who are considering filing a federal whistleblower lawsuit. Should the NIH deem that any federal grant money was used improperly, a successful suit would entitle the plaintiffs to a portion of the money the government can claw back.

Zlokovic has received roughly $93 million in NIH funding, according to Science. A spokesperson for NIH’s Office of Extramural Research would not comment on the specifics of the case.


“We take concerns related to research integrity very seriously, and this may include allegations of research misconduct,” the office said in a statement.

Over the years, Zlokovic has created several biotech companies aimed at commercializing his scientific work. In 2007, he co-founded ZZ Biotech, which has been working to gain federal approval of 3K3A-APC.

Last year, Kent Pryor, ZZ Biotech’s chief executive, called the drug “a potential game-changer.”

“I believe, based on the positive clinical results to date, our 3K3A-APC will potentially create the first new drug class to treat ischemic stroke since 2003,” Pryor said.

On Tuesday, Pryor declined to comment on the details in the whistleblowers’ report. “I don’t want to get into particular explanations right now because of the ongoing investigations,” he said.


He said the Phase III clinical trial had not yet begun.

Zlokovic is a leading researcher on the blood-brain barrier, with particular interest in its role in stroke and dementia. He received his medical degree and doctorate in physiology at the University of Belgrade and joined the faculty at USC’s Keck School of Medicine after several fellowships in London.

A polyglot and amateur opera singer, Zlokovic left USC and spent 11 years at the University of Rochester before returning in 2011. He was appointed director of USC’s Zilkha Neurogenetic Institute the following year.

“My role will be to enhance an already very strong neuroscience base and try to make USC the No. 1 place in the neurosciences in the country and the world,” Zlokovic said upon rejoining the USC faculty. “It’s a big goal, but I think, with what’s going on right now, it’s actually moving in that direction. I think that could be my greatest contribution.”


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