Connect with us

Science

California communities are banning syringe programs. Now the state is fighting back in court

Published

on

California communities are banning syringe programs. Now the state is fighting back in court

As Indiana officials struggled to contain an outbreak of HIV among people who injected drugs, then-Gov. Mike Pence reluctantly followed the urgings of public health officials and cleared the way for an overwhelmed county to hand out clean syringes.

Pence was far from enthusiastic about launching the program in Scott County, but after it rolled out in 2015, the percentage of injection drug users there who said they shared needles dropped from 74% to 22%. Within a few years, the number of new HIV infections plummeted by 96% and new cases of hepatitis C fell by 76%.

The Sierra Harm Reduction Coalition wanted to keep those same diseases in check in California. The tiny nonprofit got approval from the state to deliver syringes in El Dorado County to prevent the spread of life-threatening illnesses.

Yet when the program was discussed at a December meeting of the county’s Board of Supervisors, the success story in Indiana held little sway. Faced with complaints about discarded needles and overdose deaths, the supervisors voted to prohibit syringe programs in the county’s unincorporated areas.

“These programs may work in other parts of California and throughout the United States, although I have my doubts,” Sheriff Jeff Leikauf said at the meeting. “El Dorado County does not want or need these types of programs.”

Advertisement

El Dorado is among a growing number of California communities that have banned syringe programs, testing the state’s power and political will to defend them as a public health strategy. It is part of a broader pushback against “harm reduction” — the practical philosophy of trying to reduce the negative effects of drug use — as overdose deaths have soared.

Now California is fighting back. In a recently filed lawsuit, the Department of Public Health argued that local ordinances prohibiting syringe programs in El Dorado County were preempted by state law, making them unenforceable.

The state is seeking a court order telling El Dorado County and the city of Placerville, its county seat, to stop enforcing their bans and allow syringe programs to resume.

An El Dorado County spokesperson said Monday that the county does not comment on pending legal issues. Its district attorney, however, said he was outraged to learn of the lawsuit, saying that state leaders were “seeking to impose the normalization of hardcore drug use.”

“Don’t come into our county and double down on your failed policy,” El Dorado County Dist. Atty. Vern Pierson said in a statement. “Allowing addicts to use fentanyl and other hardcore drugs is exactly what has caused other California counties to experience a death rate that is out of control and getting worse.”

Advertisement

Mona Ebrahimi, the city attorney for Placerville, said the city had put a 45-day temporary moratorium in place “to study the ongoing effects of syringe service programs in the city.”

“The city wants to protect the health, safety and welfare of its residents,” Ebrahimi said.

The California Department of Public Health has long endorsed handing out sterile syringes as a proven way to prevent dangerous infections from running rampant when people share contaminated syringes. Researchers have linked syringe programs with a roughly 50% reduction in HIV and hepatitis C.

“It sounds crazy: ‘Wait, you want to give out the tools to people to do this thing that we all agree is a bad idea?’” said Peter Davidson, a medical sociologist at UC San Diego. But it works, said Davidson, who called the programs “probably the best studied public health intervention of the last 70 years.”

Public health officials also see them as a crucial way to reach people who use drugs and link them to addiction and overdose-prevention services. In Seattle, for instance, researchers found that injection drug users who started going to a needle exchange were five times more likely to enter drug treatment than those who never went.

Advertisement

Signs direct visitors to the syringe-exchange program at the Austin Community Outreach Center in Austin, Ind., in 2015. The program was set up to curb an outbreak of HIV among people who injected drugs.

(Darron Cummings / Associated Press)

And in California, harm reduction groups have been particularly effective in getting Narcan — a nasal spray that can reverse opioid overdoses — into the hands of people who need it.

It’s “hugely important to reduce overdose in the community, and these are the programs that do that,” said Barrot Lambdin, a health policy fellow at RTI International who studies the implementation of health interventions.

Advertisement

Yet leaders in some cities and counties have strenuously rejected the health benefits of syringe programs.

In El Dorado County, local leaders asserted that the efforts of the Sierra Harm Reduction Coalition had not “meaningfully reduced” HIV or hepatitis C cases since its syringe program began four years ago and said the free needles were ramping up the risk of deadly overdoses, which they argued were a bigger threat.

Street scene shows trees with fall colors, cars and old buildings

The El Dorado County Courthouse in Placerville, Calif.

(Max Whittaker / For The Times)

Alessandra Ross, a harm reduction expert at the California Department of Public Health, disputed such arguments in a letter to county officials. Ross pointed out that in just one year, the coalition handed out more than 2,200 doses of medication to reverse opioid overdoses, saving at least 421 lives. Without the group’s efforts, she wrote, “El Dorado County could have potentially lost more than ten times as many people to overdose.”

Advertisement

Under state law, the California Department of Public Health has the authority to approve syringe programs anywhere that deadly or disabling infections might spread through used needles, “notwithstanding any other law” that might say otherwise.

The agency argued that the “significant state and public interest in curtailing the spread of HIV, hepatitis, and other bloodborne infections extends to every jurisdiction in the state, especially since Californians travel freely throughout the state.”

After El Dorado County prohibited syringe services in unincorporated areas, the state public health department adjusted its authorization for the Sierra Harm Reduction Coalition program, limiting its operations to Placerville. In the court filing, the agency said it made the change out of concern for the coalition’s staff and volunteers, who could be at risk of arrest if they provided syringes in the unincorporated areas.

The nonprofit said when it stopped providing syringes outside of Placerville city limits, roughly 40% of its clients were cut off. In February, Placerville city officials passed their own urgency ordinance banning syringe programs for 45 days, exempting needle provision at health facilities.

Ebrahimi, its city attorney, said officials took that step “after CDPH concentrated their use by authorizing them only in Placerville and nowhere else in the county.”

Advertisement

The Sierra Harm Reduction Coalition stopped providing syringes in Placerville as well, according to the state lawsuit. The coalition did not respond Monday to requests for comment on the suit.

El Dorado County and Placerville are not alone: A wave of local bans went into effect last year in Placer County after a harm reduction group from Sacramento sought state approval to hand out clean syringes. The county’s sheriff and its probation chief said in a letter to the state that the syringe program proposed by Safer Alternatives thru Networking and Education, or SANE, would “promote the use of addicting drugs” and lead to more “dirty needles discarded recklessly in our parks.”

The Placer County Board of Supervisors voted unanimously to ban syringe programs in its unincorporated areas. Cities including Auburn, Loomis and Rocklin banned them too.

“We are the ones who should make these kinds of decisions,” then-Mayor Alice Dowdin Calvillo said at a September meeting of the Auburn City Council, “and not allow the state to just bully us.”

Public health researchers stress that studies have found that free needle programs do not increase crime or drug use, or worsen syringe litter. Yet as much of Placer County became a no-go zone, SANE withdrew its application for a syringe program there.

Advertisement

“Our political processes are not well set up for us to make reasoned, scientifically sound judgments about public health,” said Ricky Bluthenthal, a USC sociologist whose research has documented the effectiveness of syringe programs. It doesn’t help that “the populations at risk are often marginalized or not politically active.”

Our political processes are not well set up for us to make reasoned, scientifically sound judgments about public health.

— Ricky Bluthenthal, a USC sociologist who studies syringe programs

The California Department of Public Health declined to address whether it planned to challenge local bans on syringe programs elsewhere in the state, saying it “cannot comment on active litigation strategy.”

Advertisement

Syringe programs have long faced public skepticism: In a 2017 survey, only 39% of U.S. adults said they supported legalizing them in their communities.

Experts say the programs have faced increasing jeopardy as public concern wanes about the threat of HIV and frustration swells over other problems like soaring numbers of overdose deaths and the spread of homeless encampments. Even in Indiana’s Scott County, local leaders voted three years ago to shutter its needle exchange.

Clashes are also arising because programs are making moves into new parts of California, bolstered in some cases by state funding. California officials also have taken steps to help syringe programs overcome local opposition, including exempting them from review under the California Environmental Quality Act.

“It’s not surprising that cities and counties are motivated to protect the public health and safety of their residents through whatever tools they have at their disposal,” said attorney David J. Terrazas, who represented a group that successfully sued to overturn state approval of a syringe program in Santa Cruz County.

In that case, a state appeals court ruled last year that the California Department of Public Health conducted an insufficient review of a program run by the Harm Reduction Coalition of Santa Cruz County. The department didn’t do enough to consult with law enforcement agencies in the area, among other shortcomings, the court said.

Advertisement

Although the state health department had considered some comments from law enforcement, “it never engaged with them directly about their concerns,” the appeals court concluded. Internal records showed department staff had decided not to respond to some of their comments and called one police chief an “imbecile.”

Terrazas said local officials are best poised to know what works for their communities. But Denise Elerick, founder of the Harm Reduction Coalition of Santa Cruz County, argued it made no sense for law enforcement to hold sway in public health decisions.

“We wouldn’t consult with them on what to do about COVID,” Elerick said.

A bag is filled with boxes of Narcan nasal spray for distribution to people living on the street in Los Angeles.

A bag is filled with boxes of Narcan nasal spray, one of several harm-reduction supplies distributed to people living on the street in Los Angeles.

(Francine Orr / Los Angeles Times)

Advertisement

Weeks after the court ruling, the state health department rolled back its approval for a syringe program in Orange County that would have been run by the Santa Ana-based Harm Reduction Institute, saying it wanted to consult more with local officials.

The decision was celebrated by city leaders in Santa Ana, who had banned syringe programs in 2020 and sharply opposed efforts to restart one. At a recent meeting, interim city manager Tom Hatch said a previous program was “an epic failure” that left its downtown littered with used syringes.

Orange County is currently the most populous county in the state without any syringe services programs — to the alarm of health researchers who found that syringe reuse increased after a local program was shut down.

The Santa Cruz court ruling was also invoked by the Santa Monica City Council, which directed city officials to investigate how Los Angeles County came to approve a program run by the Venice Family Clinic. That program sends outreach workers into Santa Monica parks once a week to offer clean syringes, Narcan and other supplies and connect people with healthcare, including for addiction.

A woman hands out Narcan to a man at Tongva Park in Santa Monica

Devon O’Malley, left, a harm reduction case manager with the Venice Family Clinic, hands out Narcan to Ken Newark at Tongva Park in Santa Monica.

(Mel Melcon / Los Angeles Times)

Advertisement

Critics want the program to relocate indoors, which they say would better protect parkgoers from discarded syringes. In addition, “if someone has to walk inside, there’s a chance for counselors to suggest strongly that it’s time for them to get off the drugs,” said Santa Monica Mayor Phil Brock, who wants the city to formally express its opposition to the program. “We can’t just facilitate their demise.”

Last month, a group called the Santa Monica Coalition filed suit to get L.A. County to halt the program it approved, saying it should instead be in a government building.

But Venice Family Clinic staffers said unhoused people can be reluctant to leave behind their belongings to go elsewhere. Even offering services out of a van reduced participation, said Arron Barba, director of the clinic’s Common Ground program.

“Bringing the service directly to the people is what we know works,” Barba said.

Advertisement

Science

Opinion: Wait times go down. Patient satisfaction goes up. What's the matter with letting apps and AI run the ER?

Published

on

Opinion: Wait times go down. Patient satisfaction goes up. What's the matter with letting apps and AI run the ER?

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.

Advertisement

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.

Advertisement

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.

Advertisement

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.

Advertisement
Continue Reading

Science

Column: Democrats show that they're no better than Trump in allowing politics to interfere with science

Published

on

Column: Democrats show that they're no better than Trump in allowing politics to interfere with science

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

Advertisement

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.

Advertisement

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.”

Advertisement

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.

Advertisement

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.

Advertisement

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.

Advertisement

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.”

Advertisement

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?

Advertisement

Continue Reading

Science

Star USC scientist faces scrutiny — retracted papers and a paused drug trial

Published

on

Star USC scientist faces scrutiny — retracted papers and a paused drug trial

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.”

Advertisement

“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.

Advertisement

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.”

Advertisement

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.

Advertisement

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.

Advertisement

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.

Advertisement

A USC spokesperson confirmed that Zlokovic has retained his titles as department chair and director of the Zilkha institute.

Continue Reading
Advertisement

Trending