Science
Kaiser accused of violations months after state fine on mental healthcare
Months after Kaiser Permanente reached a sweeping agreement with state regulators to improve its mental health services, the healthcare giant is facing allegations that patients could be improperly losing such care.
The National Union of Healthcare Workers, which represents thousands of Kaiser mental health professionals, complained earlier this year to state regulators that Kaiser appeared to be inappropriately handing off decisions about whether therapy is still medically necessary.
The union alleged that Rula Health, a contracted network of therapists that Kaiser uses to provide virtual care to its members, had been directed by Kaiser to use “illegal criteria” to make those decisions during regular reviews.
California requires such decisions about mental health care to be based on criteria developed by professional groups, but the union said there was no evidence that was happening. Instead, the union complained that documents indicated Rula was relying on questions answered by Kaiser patients about their own symptoms.
The risk is that patients “have a psychological disorder that requires additional treatment and Kaiser is unfairly and improperly terminating their access to care,” said Fred Seavey, a researcher for the union.
The union also alleged that regularly requiring such “clinical care reviews” violated laws barring insurers from putting up barriers to mental healthcare that don’t exist for other health conditions. Kaiser does not subject other outpatient care to such reviews, “let alone at such frequencies,” the union said in its complaint.
The union called on the California Department of Managed Health Care to order Kaiser to immediately halt that review process and notify any Kaiser patients whose treatment was “illegally terminated” by Rula.
Kaiser said in a statement that it does not set limits on the number of therapy sessions, and that “the level of therapy needed and the frequency and number of sessions for any patient is a decision made by our mental health care providers in consultation with patients and as appropriate based on the patient’s clinical needs.”
It added that “the self-assessment tools do not determine whether treatment remains medically necessary. … Patient self-assessment tools may be used as one aspect of gathering information from the patient but are never the only factor.”
A Department of Managed Health Care spokesperson said its enforcement office was looking into the issues raised by the union under its recent settlement with Kaiser. That agreement, reached last fall, required Kaiser to pay a $50-million penalty and invest $150 million over five years into improving its mental healthcare.
The state agency said it had found shortcomings at Kaiser related to failures to provide timely appointments, insufficient oversight of medical groups in determining “appropriate care,” and inadequate handling of patient grievances, among other issues.
Among the problems that DMHC noted: Medical records for patients did not show the use of legally required guidelines for making decisions about mental health treatment. Patient records instead showed “self-assessment scores” from questionnaires, according to the settlement agrement.
Kaiser Permanente chief executive Greg A. Adams said last year that the organization had seen demand for mental healthcare surge amid the pandemic, which collided with an “ongoing shortage of qualified mental health professionals, clinician burnout and turnover,” as well as a 10-day strike by mental health clinicians.
In a recent statement, Kaiser said it was “in the process of implementing transformational changes contemplated by the settlement agreement,” including a “dramatic increase in the number of providers available to see our members — both newly-hired therapists and contracted therapists.”
A Rula spokesperson said in a statement that its therapists, “in collaboration with their patients, make all clinical decisions around the course of care.”
In Chino, Jaklynn Fuentes-Soto said she was told by her therapist earlier this year that her sessions with the Rula provider would soon stop, even though “my therapist thought that I should continue treatment.” The 25-year-old said that if she wanted to keep seeing the therapist, she would have to pay out of pocket.
As a student working part time, “I don’t think that financially I’m able to.”
Fuentes-Soto said she has been diagnosed with major depressive disorder and other mental health conditions. She said she had been regularly seeing her therapist after one episode led her mother to take her to the emergency room.
“If I’m not having the help that I need for my mental health,” she said, “it has me regress to a very dark place.”
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Science
Opinion: Wait times go down. Patient satisfaction goes up. What's the matter with letting apps and AI run the ER?
![Opinion: Wait times go down. Patient satisfaction goes up. What's the matter with letting apps and AI run the ER?](https://ca-times.brightspotcdn.com/dims4/default/3f08d55/2147483647/strip/true/crop/5000x2625+0+563/resize/1200x630!/quality/75/?url=https%3A%2F%2Fcalifornia-times-brightspot.s3.amazonaws.com%2Fd9%2Fbe%2F711429f84ea0a1d2b553f725778c%2Fgettyimages-182712891.jpg)
My resident describes our next emergency room patient — a 32-year-old female with severe, crampy mid-abdominal pain, vomiting and occasional loose stools. The symptoms have been present for nearly a week, and there is tenderness to both sides of the upper abdomen. It could be a gallbladder problem, the resident says, hepatitis, pancreatitis, diverticulitis or an atypical appendicitis. She proposes routine blood tests along with an ultrasound and an abdominal CT scan.
This is the time-honored approach to an undifferentiated patient complaint: Generate a list of possible diagnoses, decide which represent a “reasonable” concern and use the results from further testing to conclude what’s going on. Yet increasingly the second phase of this process — evaluating which diagnoses represent a reasonable concern — is getting short shrift. It is the heavy lift of any patient encounter — weighing disease probabilities, probing for details. It’s often simpler, and faster, to cast a wide net, click the standard order for blood work and imaging, and wait for the results to pop up.
The issue of the “busy doctor ordering too many tests” has plagued medicine for decades. Now, as hospitals inject algorithms and technology into their workflow, it’s much worse. Medicine is moving inexorably away from the deductive arts, becoming more technology- and test-dependent and less patient-centric.
Go to an emergency room today and you will likely be met within minutes by a doctor whose sole role is to perform a “rapid medical evaluation.” The provider asks a few questions, ticks boxes on a computer screen and, shazam, you are in line for the most likely series of tests and scans, all based on typically a less than 60-second encounter.
This strategy seems obvious. When workups are initiated as soon as the patient arrives, wait times go down, patient satisfaction goes up, and fewer patients leave out of frustration before even being seen. These are the metrics that put smiles on administrators’ faces and give hospitals high marks in national surveys.
But is it good doctoring? Without the luxury of time, these gateway providers typically lump patients into broad, generic categories: the middle-aged person with chest pain, the short-of-breath asthmatic, the vomiting pregnant patient, the septuagenarian with cough and fever, and so forth. The diagnosis is then reverse-engineered with tests to cover all possible bases for that particular complaint.
In essence this is flipping the script on traditional doctoring while incentivizing doctors to use testing as a surrogate for critical thinking, dumbing down the practice of medicine and throwing gasoline on the problem of over-testing.
Since rapid evaluation became the norm, use of laboratory, CT and ultrasound services at my hospital has increased nearly 20%. Just the other day, a pregnant woman in my ER went through a full battery of time-consuming, expensive and invasive tests even though she’d been through all of them at another hospital the day before. As far as I can tell, the only reason we did that was because that’s what an algorithm told us to do.
This has real effects on patients. Contrary to popular perception, more tests may not supply more answers. That’s because the accuracy of any test depends on the likelihood that the patient has the disease in question before the test is performed. Testing performed without the appropriate indication or context can produce incidental or even spurious results that may have your doctor looking in entirely the wrong direction.
The basic problem with hospitals’ growing obsession with efficiency is this: Algorithmic systems treat all patients the same, expecting precise, like-for-like responses to every question with just the right amount of detail. Except every patient is unique. And they tend to give up their stories at their own pace, in broken, non-linear fits and starts, sometimes conflating truth and fiction in ways that can be counterproductive and frustrating, but also uniquely human. I am often reminded of Jack Webb in the old TV series “Dragnet” imploring a witness to offer “just the facts, ma’am, just the facts.” In real life, whether from situational stress, self-delusion, superstition, health illiteracy, mental illness, drugs or alcohol, my patients’ initial version of their complaint is rarely “just the facts” or the final word on the subject.
A colleague recently described her role in a clinical encounter as 9 parts translator to 1 part doctor. One question leads to another, and then another, and another until she successfully translates the patient’s lived experience into a language modern medicine and its algorithms might begin to understand. My experience is similar. Properly choreographed, the doctor-patient interaction becomes a pas de deux — two people in sync, jointly trying to solve a puzzle with each sharing their perspective and expertise. In the transition to front-loaded care, I worry health decisions will be made with information that may be incomplete or, at times, totally unreliable.
Algorithmic medicine also seems tailor-made for an AI takeover. The logic is obvious. Use “big data” to assist doctors and nurses struggling to keep up with the demands of modern medicine. AI can ensure a level, consistent floor of care that avoids errors of omission by considering a deliberately broad list of diagnostic possibilities. In an ideal world, a synergy of human and machine intelligence could amplify the patient-doctor encounter. As likely, AI will lead doctors to abdicate judgment and responsibility to the automated response of the machine.
And so, I complimented my resident on her list of concerns but suggested that we spend a little more time with the patient. The story of her symptoms didn’t feel complete. I recommended my resident grab a chair and simply ask the patient about her life. What emerged was the chaotic picture of an exhausted part-time student by day, working two evening waitressing jobs and surviving on pizza, pasta and energy drinks. She had always had a “fragile stomach.”
Our list of reasonable diagnoses was expanding and contracting, replaced with irritable bowel syndrome, food intolerances, gut motility issues, all overlying a stressed individual barely keeping it together. The labs, ultrasound or CT scan initially proposed now seemed irrelevant.
The result: The patient got out of the hospital faster. She received helpful suggestions about stress reduction, diet and sleep habits. She got an appointment with a primary care physician and avoided thousands of dollars in tests. Had we just relied on tests instead of asking a few more questions, there is a good chance we would have missed the best approach to her problem entirely.
ER waiting rooms and wards are bursting at the seams, and the streamlining of care has never felt more essential. But this is not an excuse for doctors to relinquish their humanity or their “method.” We should tweak the process: Allow more time for doctors to get the story right, do less testing until we have weighed the risks and rewards, prioritize asking questions rather than merely looking for answers.
Sociologists coined the term “pre-automation” to describe the transitional phase in which humans lay the groundwork for automation, often by acting in increasingly machine-like ways. As providers, we must not fall in line.
Put another way, with AI primed to take on a substantial role in how doctors deliver care, we should remind ourselves: If we behave like machines, we certainly won’t be missed when machines replace us.
Eric Snoey is an ER doctor at Alameda Health System-Highland Hospital in Oakland.
Science
Column: Democrats show that they're no better than Trump in allowing politics to interfere with science
![Column: Democrats show that they're no better than Trump in allowing politics to interfere with science](https://ca-times.brightspotcdn.com/dims4/default/3527aa7/2147483647/strip/true/crop/2862x1503+0+376/resize/1200x630!/quality/75/?url=https%3A%2F%2Fcalifornia-times-brightspot.s3.amazonaws.com%2F25%2F2f%2F0193bcfb485c8f40972b307b77de%2Fscreenshot-2024-05-16-at-12-55-14-pm.jpg)
Anyone who cares about the importance of science in the making of government policy had to be deeply dispirited by the hearing into the origins of COVID-19 staged by a Republican-led House subcommittee on May 1.
The sole witness at the hearing, and its target, was Peter Daszak, the head of EcoHealth Alliance, a nongovernmental organization tasked with overseeing international virus research funded by federal agencies.
It wasn’t just that the GOP majority used the occasion to promote the ignorant, imbecilic and 100% evidence-free notion that SARS-CoV-2, the virus that caused the COVID pandemic, originated in a Chinese laboratory, through work funded by the U.S. government, and overseen by EcoHealth.
Science is a myth-buster…Because of this, science has become a nuisance, even an enemy to some industries and many of the most powerful actors in the new attention economy.
— Science blogger Philipp Markolin
It was that the Democratic minority showed itself to be complicit with the GOP attack on EcoHealth.
As I wrote at the time, the Democrats threw Daszak and by extension science itself under the bus: “Perhaps they hoped that by allowing Daszak to be drawn and quartered, they might persuade the Republicans to climb down from their evidence-free claims about government complicity in the pandemic’s origins.”
The Democrats’ craven and shameful performance hinted that EcoHealth’s government funding, which had been blocked by the Trump administration and restored, though delayed, under Biden, was pretty much doomed.
On Wednesday, the bell tolled. EcoHealth received a notice from the Department of Health and Human Services, the parent agency of the NIH, that it was immediately suspending all funding to the organization and moving to “debar” it from federal funding going forward.
It’s impossible to overstate what a serious blow this is for EcoHealth and research into the origins of pathogens that could cause illness and death on a global scale — the central purpose of EcoHealth’s work.
The organization, which has operated with a budget of about $16 million, cannot receive a contract from any federal agency or even serve as a subcontractor of another awardee. All organizations with federal contracts that have affiliated with EcoHealth will be “carefully examined.”
EcoHealth says it will appeal the proposed debarment, as is its right. But that process could take years. In the meantime, the organization will be effectively out of money, and very likely out of business. The HHS action effectively turns one of the leading organizations in the quest to protect humankind from the next pandemic into a pariah, completely unjustifiably.
The debarment threat “will mean the demise of EcoHealth, one of the most scientifically productive and internationally respected groups conducting field surveillance for potential pandemic viruses,” says Gerald T. Keusch, a former associate director of international research at the NIH. “And that means our national security will be compromised.”
Let’s be clear about what has happened here. EcoHealth has been made a scapegoat for the pandemic for partisan reasons. The process started with President Trump. At a news conference on April 17, 2020, a reporter from a right-wing organization mentioned that the NIH had given a $3.7-million grant to the Wuhan Institute of Virology. (Actually, the WIV grant, which was channeled from a larger EcoHealth grant, was only $600,000.)
Trump, sensing an opportunity to show a strong hand against China and advance his effort to blame the Chinese for the pandemic, responded: “We will end that grant very quickly.” The NIH terminated the grant one week later, prompting a backlash from the scientific community, including an open letter signed by 77 Nobel laureates who saw the action as a flagrantly partisan interference in government funding of scientific research.
The HHS inspector general found the termination to be “improper.” The NIH reinstated the grant, but immediately suspended it until EcoHealth met several conditions that were manifestly beyond its capability, as they involved its demanding information from the Chinese government that it had no right to receive. The grant was reinstated last year under Biden, but NIH bureaucrats, perhaps worried about their careers in a new Trump administration, continued to put administrative obstacles in the way of EcoHealth’s work.
The attacks on Daszak and his organization are simply instruments of the GOP project to pin blame for the pandemic on Anthony Fauci, one of the world’s most respected public health figures.
The context is a battle for the minds of uninformed and misinformed Americans over the origin of COVID-19. The hypothesis favored by most qualified virologists and epidemiologists is that the virus reached humans the way most viruses do — as spillovers from wildlife. The alternative hypothesis, for which absolutely not a speck of evidence has ever been presented, is that the virus emerged from a laboratory—specifically the Wuhan Institute of Virology in China, whether deliberately or through sloppy lab practices.
The latter hypothesis was initially promoted by an anti-China cabal in the Trump-era State Department. Although they never produced any grounds for the conspiracy theory, it remains favored by anti-vaccine agitators and in the Republican anti-science camp. It has a certain appeal for uninformed people susceptible to sinister explanations of complicated, troubling events; but it’s not science.
Daszak calls the government actions “fundamentally unfair” and “based on a set of false assumptions about COVID-19 origins and on persistent mischaracterizations and misunderstandings of our research…Our work has been at the forefront of understanding pandemic risk for over two decades, and it’s a very cruel irony that because we knew that China was a potential hotspot for the next coronavirus pandemic, we’re now being targeted in a political backlash caused by exactly the type of pandemic we were concerned about preventing.”
An outgrowth of the lab-leak fantasy is the asinine claim that as head of the National Institute of Allergy and Infectious Diseases, Fauci funded research in China that created the pandemic virus and let it loose on the world, and then concealed his complicity. This is a favorite meme among lab-leak fanatics. Among the research bodies that received NIAID funding to conduct field work in China was EcoHealth. (Fauci retired last year as director of NIAID, which is part of the National Institutes of Health.)
On May 1, the GOP-led Select Subcommittee on the Coronavirus Pandemic brought things to a head with its grilling of Daszak. It was a circus featuring posturing politicians intent on smearing Daszak and EcoHealth on the pretext of getting to the bottom of the pandemic’s cause. The committee Democrats participated fully, hammering Daszak as a “poor steward of the taxpayers’ dollars,” based on transparent trivialities.
During a follow-up subcommittee hearing Thursday, ranking member Raul Ruiz (D-Indio) alluded to the dishonestly of the GOP attack on Fauci. But, perhaps inadvertently, he also exposed the dishonesty of his caucus’ attack on Daszak.
The committee Republicans, Ruiz said, “still have not succeeded in substantiating their allegations that NIH and NIAID through a grant to EcoHealth Alliance created SARS-CoV-2 and conspired to cover it up. … No evidence demonstrates that work performed under the EcoHealth grants, including at the Wuhan Institute of Virology, led to the creation of SARS-CoV-2.”
Does Ruiz ever listen to the words coming out of his mouth? The very goal of the GOP’s dragging Daszak and EcoHealth into this controversy was to fabricate a link in the chain between Fauci and COVID-19; by rejecting the GOP position, Ruiz demolished the case against EcoHealth.
Yet Ruiz didn’t walk the last mile. “EcoHealth has defied its obligations to be a transparent steward of taxpayer dollars,” he said, repeated the lame case against the organization that he first aired, in connivance with the Republicans, during the public interrogation of Daszak on May 1.
Legitimate scientists, such as virology experts uninfected by the conspiratorial fantasy that the virus originated in the lab, are aghast at the suspension of EcoHealth’s funding and the organization’s likely debarment, as well as the Democrats’ supine behavior.
The Democrats, as Stuart Neil, a professor of virology at Kings College London, wrote on X, “have made some shoddy back room deal to allow them to look tough to the conspiracy theorists.” Neil is right. There is no rational explanation for the Democrats’ behavior than some sort of deal with the Republican majority to give them cover to challenge the lab leak theory.
Put it all together, and it looks like HHS started with a politically driven impulse to cut off EcoHealth’s funding, followed by an effort to assemble every justification for doing so, no matter how trivial. The absurdity of its action drips from the closing words of the notice issued by H. Katrina Brisbon, an HHS “suspension and debarment official.” She wrote that “the immediate suspension of EHA is necessary to protect the public interest and due to a cause of so serious or compelling a nature that it affects EHA’s present responsibility.”
The notice was accompanied by an 11-page bill of particulars, but they all boil down to two key purported offenses — that EcoHealth had missed a 2019 deadline for an annual report of its activities to NIH, and that work EcoHealth had funded in China had produced a recombinant version of a virus that grew fast enough to trigger a safety halt in the work.
The first was tantamount to a traffic violation. EcoHealth maintained that it hadn’t been able to file the report on time because it had been locked out of NIH’s onlline reporting portal, which NIH denies. On the second, there were legitimate disagreements over whether the subject virus’ growth actually did trigger the halt requirement; in any case, the virus wasn’t a threat to human health. The work at issue took place in 2018.
HHS cited several other supposed offenses, including EcoHealth’s failure to submit lab notebooks from the Wuhan institute that NIH has requested in November 2021. But since NIH had ordered EcoHealth to stop funding the institute as of April 2020, those notebooks were plainly out of its reach.
Daszak says EcoHealth will respond to the HHS and the subcommittee “with documentary evidence…refuting every single allegation that’s been levied against us.”
The roots of anti-science slant of Trump and others on the far right isn’t hard to discern. It’s aimed at protecting the economic establishment from new ideas and realities such as global warming, while providing financial and personal opportunities for grifters and charlatans.
Swiss scientist and science blogger Philipp Markolin has put his finger on this phenomenon.
“Science is a myth-buster,” he writes. “Its debunking activity reduces the value of information products that too many media manipulators rely on for their business. Because of this, science has become a nuisance, even an enemy to some industries and many of the most powerful actors in the new attention economy.”
Why did the Democrats agree to participate in this charade? In joining the Daszak smear, they have shredded their credibility as of scientific truth, at the very moment when science is most in need of their protection.
The time has come to ask this question of Ruiz, his Democratic colleagues on the coronavirus subcommittee — Debbie Dingell of Michigan, Kwesi Mfume of Maryland, Deborah Ross of North Carolina, Robert Garcia of Long Beach, Ami Bera of Sacramento and Jill Tokuda of Hawaii — along with Health and Human Services Secretary Xavier Becerra: How can you live with yourselves?
Science
Star USC scientist faces scrutiny — retracted papers and a paused drug trial
![Star USC scientist faces scrutiny — retracted papers and a paused drug trial](https://ca-times.brightspotcdn.com/dims4/default/472a0a5/2147483647/strip/true/crop/6450x3386+0+457/resize/1200x630!/quality/75/?url=https%3A%2F%2Fcalifornia-times-brightspot.s3.amazonaws.com%2Ff4%2Fe2%2F87f400ae4308beb4995602644b30%2F1275465-me-usc-campus-gxc-0365.jpg)
Late last year, a group of whistleblowers submitted a report to the National Institutes of Health that questioned the integrity of a celebrated USC neuroscientist’s research and the safety of an experimental stroke treatment his company was developing.
NIH has since paused clinical trials for 3K3A-APC, a stroke drug sponsored by ZZ Biotech, a Houston-based company co-founded by Berislav V. Zlokovic, professor and chair of the department of physiology and neuroscience at the Keck School of Medicine of USC.
Three of Zlokovic’s research papers have been retracted by the journal that published them because of problems with their data or images. Journals have issued corrections for seven more papers in which Zlokovic is the only common author, with one receiving a second correction after the new supplied data were found to have problems as well.
For an 11th paper co-authored by Zlokovic the journal Nature Medicine issued an expression of concern, a note journals append to articles when they have reason to believe there may be a problem with the paper but have not conclusively proven so. Since Zlokovic and his co-authors no longer had the original data for one of the questioned figures, the editors wrote, “[r]eaders are therefore alerted to interpret these results with caution.”
“It’s quite unusual to see this volume of retractions, corrections and expressions of concern, especially in high-tier influential papers,” said Dr. Matthew Schrag, an assistant professor of neurology at Vanderbilt who co-authored the whistleblower report independently of his work at the university.
Both Zlokovic and representatives for USC declined to comment, citing an ongoing review initiated in the wake of the allegations, which were first reported in the journal Science.
“USC takes any allegations of research integrity very seriously,” the university said in a statement. “Consistent with federal regulations and USC policies, this review must be kept confidential.”
Zlokovic “remains committed to cooperating with and respecting that process, although it is unfortunately required due to allegations that are based on incorrect information and faulty premises,” his attorney Alfredo X. Jarrin wrote in an email.
Regarding the articles, “corrections and retractions are a normal and necessary part of the scientific post-publication process,” Jarrin wrote.
Authors of the whistleblower report and academic integrity experts challenged that assertion.
“If these are honest errors, then the authors should be able to show the actual original data,” said Elisabeth Bik, a microbiologist and scientific integrity consultant who co-wrote the whistleblower report. “It is totally human to make errors, but there are a lot of errors found in these papers. And some of the findings are suggestive of image manipulation.”
Given the staid pace of academic publishing, publishing this many corrections and retractions only a few months after the initial concerns were raised “is, bizarrely, pretty quick,” said Ivan Oransky, co-founder of Retraction Watch.
The whistleblower report submitted to NIH identified allegedly doctored images and data in 35 research papers in which Zlokovic was the sole common author.
“There had been rumblings about things not being reproducible [in Zlokovic’s research] for quite some time,” Schrag said. “The real motivation to speak publicly is that some of his work reached a stage where it was being used to justify clinical trials. And I think that when you have data that may be unreliable as the foundation for that kind of an experiment, the stakes are just so much higher. You’re talking about patients who are often at the most vulnerable medical moment of their life.”
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.
The drug is intended to minimize the bleeding and subsequent brain damage that can occur after an ischemic stroke, in which a blood clot forms in an artery leading to the brain.
In 2022, 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.
In Phase II of the trial, which was published in 2018 and called Rhapsody, six of the 66 patients who received 3K3A-APC died in the first week after their stroke, compared to one person among the 44 patients who got a placebo. Patients who received the drug also tended to report more disability 90 days after their stroke than those who got the placebo. The differences between the two groups were not statistically significant and could have been due to chance, and the death rate for patients in both groups evened out one month after the initial stroke.
“The statements that there is a risk in this trial is false,” said Patrick Lyden, a USC neurologist and stroke expert who was employed by Cedars-Sinai at the time of the trial. Zlokovic worked with Lyden as a co-investigator on the study.
One correction has been issued to the paper describing the Phase II results, fixing an extra line in a data table that shifted some numbers to the wrong columns. “This mistake is mine. It’s not anybody else’s. I didn’t catch it in multiple readings,” Lyden said, adding that he noticed the error and was already working on the correction when the journal contacted him about it.
He disputed that the trial represented any undue risk to patients.
“I believe it’s safe, especially when you consider that the purpose of Rhapsody was to find a dose — the maximum dose — that was tolerated by the patients without risk, and the Rhapsody trial succeeded in doing that. We did not find any dose that was too high to limit proceeding to Phase III. It’s time to proceed with Phase III.”
Schrag stressed that the whistleblowers did not find evidence of manipulated data in the report from the Phase II trial. But given the errors and alleged data manipulation in Zlokovic’s earlier work, he said, it’s appropriate to scrutinize a clinical trial that would administer the product of his research to people in life-threatening situations.
In the Phase II data, “there’s a coherent pattern of [patient] outcomes trending in the wrong direction. There’s a signal in early mortality … there’s a trend toward worse disability numbers” for patients who received the drug instead of a placebo, he said.
None are “conclusive proof of harm,” he said. But “when you’re seeing a red flag or a trend in the clinical trial, I would tend to give that more weight in the setting of serious ethical concerns around the pre-clinical data.”
The NIH paused the clinical trial in November, and it remains on hold, said Dr. Pooja Khatr, principal investigator of the NIH StrokeNet National Coordinating Center. Khatr declined to comment on the pause or the trial’s future, referring further questions to USC and NIH.
The NIH Office of Extramural Research declined to discuss Rhapsody or Zlokovic, citing confidentiality regarding grant deliberations.
ZZ Biotech Chief Executive Kent Pryor, who in 2022 called the drug “a potential game-changer,” said he had no comment or information on the halted trial.
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.
A USC spokesperson confirmed that Zlokovic has retained his titles as department chair and director of the Zilkha institute.
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