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

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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

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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.”

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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.

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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.”

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(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.

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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.

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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)

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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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Opinion: Fentanyl could fuel another cycle of loss in L.A.'s Black communities. It doesn't have to

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Opinion: Fentanyl could fuel another cycle of loss in L.A.'s Black communities. It doesn't have to

The death of a parent is typically a gutting and disorienting experience for adults. For a child, it’s even worse, stoking feelings of frustration and abandonment and sometimes self-destructive behaviors such as drug use that can continue well into adulthood. This has particularly serious implications when the child is Black and therefore more likely to end up in the child welfare system.

A recent report by federal researchers provides the fullest picture yet of the sprawling impact of overdose deaths on Black children in Los Angeles and other cities — and what we can do about it.

From 2011 to 2021, the report found, more than 321,000 American children lost a parent to a drug overdose. Black children experienced the highest increases in the rate of such losses during those years, compounding a long-standing public health crisis across Black America. Like much of the United States, Los Angeles has seen drug overdoses soar in recent years, with disproportionate losses among the city’s Black adults.

Black people are significantly more likely to experience drug-related deaths due to limited access to treatment and resources such as naloxone, which can reverse overdoses. When they’re parents, the toll on their children is both rapid and deep. Parental drug use is highly associated with use among children.

Although Black children make up just 7.4% of the Los Angeles County population, they represented 24% of those who entered the child welfare system in one recent year. One study found that about 47% of Black children in California were the subject of a maltreatment investigation before the age of 18, with substance use accounting for 41% of the state’s child maltreatment cases.

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The disproportionate number of Black children in Los Angeles’ child welfare system has been scrutinized since the late 1980s, the height of Los Angeles’ heroin and crack epidemics. The drugs, then largely addressed as a criminal issue through heavy-handed policing and prosecution, consigned a generation of young and middle-aged Black Angelenos, both users and dealers, to premature death and incarceration. Many of their children wound up in the city’s fragmented child welfare system and, all too often, on a similar path toward addiction and entanglement with the legal system.

When a child’s parent dies, other family members — the child’s other parent, grandparents, aunts or uncles — are the first resort to assume responsibility for their care. But Black children, especially those from low-income communities, often end up in the child welfare system instead.

Why? The child’s surviving family members may lack the resources to fill the breach. But racial biases also predispose child welfare workers to remove Black children from their families and impede reunification efforts.

Research has consistently shown that child welfare workers more readily define Black parents’ behavior as abusive or neglectful even when it’s comparable to the conduct of parents of other races. Child welfare workers are also more likely to regard Black families as less loving of their children and less redeemable.

Children who enter the child welfare system due to parental death already spend twice as much time in the system. Black children tend to remain in the system even longer because of bias.

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The twin depredations of Los Angeles’ opioid epidemic and its child welfare system are daunting but not beyond repair. The first necessity is to revamp the city’s racially biased child removal process. Los Angeles officials have been piloting a “blind removal” approach in which investigations are followed by a decision-making process that excludes demographic details such as the child’s race. This is a step in the right direction.

However, a UCLA study of the pilot program revealed that racial disproportionality persists, demonstrating how deep-seated child welfare biases are. For blind removal to be effective in eliminating racial disparities, it must be supplemented by greater transparency, expanded civilian review boards and training in implicit bias.

Second, we need a better understanding of the consequences of placing Black children in the child welfare system. In general, Black children in the system are highly stigmatized, especially when they come from families with histories of drug abuse. That contributes to making them less likely to be adopted. The trauma of losing a parent also means they’re more likely to experience depression and anxiety.

These experiences frequently devolve into social isolation, poor academic outcomes, limited employment prospects and incarceration. Officials must work to identify these patterns early and provide resources such as mental health care to disrupt this harmful cascade.

Lastly, policymakers must continue to explore the benefits of guaranteed basic income to provide a cushion for personal and professional growth. Another California pilot program would provide guaranteed basic income to those who age out of foster care at 21 or older. The state should lower the eligibility age to 18 to account for the steep challenges in housing and employment Black youths face as soon as they become adults. Researchers at Stanford and other institutions have found that such policies support better health, housing security and employment prospects.

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Addressing the deepening overdose epidemic in Los Angeles’ Black communities requires attention not just to the immediate risks to drug users but also to the childhood experiences that often drive them to use. One of our most powerful tools for preventing future overdoses is to take better care of the children most directly affected by today’s losses.

Jerel Ezell is an assistant professor of community health sciences at UC Berkeley who studies the racial politics of substance use.

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NASA JPL team hopes to give greenhouse gas-monitoring satellite 'unprecedented' vision

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NASA JPL team hopes to give greenhouse gas-monitoring satellite 'unprecedented' vision

It was almost 10 years ago when Andrew Thorpe received a text from the crew flying overhead in a small aircraft: They had spotted a new methane hot spot.

Thorpe drove along winding dirt and mountain roads in an unwieldy rental SUV near the Four Corners region of the southwestern U.S. When he arrived at the spot relayed from the plane, he pulled out a thermal camera to scan for the plume. Sure enough, methane was seeping out of the ground, likely from a pipeline leak.

He found a marker sticking out of the desert with the phone number for a gas company, so he gave them a call. “I had the most confused individual on the other side of the phone,” Thorpe said. “I was trying to explain to them why I was calling, but this was back many years ago when there really weren’t any technologies that could do this.”

Over the years, the work has gotten Thorpe some unwanted attention. “I did some driving surveys in California .… A rent-a-cop was very suspicious of me and tried to scare me off,” said Thorpe. “If you set up a thermal camera on a public road and you’re pointing it at a tank beyond the fence, people are going to get nervous. I’ve been heckled by some oil and gas workers, but that’s par for the course.”

Today, Thorpe is part of a group that is at the forefront of greenhouse gas monitoring at NASA’s Jet Propulsion Laboratory in La Cañada Flintridge. For over 40 years, the Microdevices Laboratory at JPL has developed specialized instruments to measure methane and carbon dioxide with extreme precision.

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The instruments, called spectrometers, detect gases based on which colors of sunlight they absorb. Earlier this year, a team of researchers from JPL, Caltech and research nonprofit Carnegie Science was selected as a finalist for a NASA award to put the technology into orbit.

JPL technicians work on an Airborne Visible/Infrared Imaging Spectrometer, or AVIRIS, that will be installed in an airplane to search for methane and other greenhouse gases.

(Myung J. Chun/Los Angeles Times)

If chosen for the satellite mission, the team’s carbon investigation, called Carbon-I, would launch in the early 2030s. Over the course of three years, Carbon-I would continuously map greenhouse gas emissions around the globe and take daily snapshots of areas of interest, allowing scientists to identify sources of climate pollution, such as power plants, pipeline leaks, farms and landfills.

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While there are already multiple satellites monitoring these gases, Carbon-I’s resolution is unprecedented and would eliminate any guesswork in determining where the gas was emitted. “There’s no denying it anymore — once we see a plume, there’s no other potential source,” said Christian Frankenberg, co-principal investigator for Carbon-I and a professor of environmental science and engineering at Caltech.

Caltech professor Christian Frankenberg peers into the AVIRIS-5.

Caltech professor Christian Frankenberg, co-principal investigator for the proposed space-based Carbon-I emission-monitoring system, peers into an AVIRIS monitor under construction in a JPL lab.

(Myung J. Chun/Los Angeles Times)

Carbon-I’s finest, 100-foot resolution “is a very high resolution from space. That’s an incredible resolution to be able to get,” said Debra Wunch, a professor at the University of Toronto who studies Earth’s carbon cycle and is not involved in the Carbon-I proposal. “It would be able to give us much more insight into exactly the source of emissions .… This would be groundbreaking. You would be able to see individual stacks, individual parts of landfills, even.”

Historically, monitoring the release of greenhouse gases from individual emitters has been challenging — both carbon dioxide and methane are colorless and odorless. So scientists have often had to rely on adding up self-reported values from companies and estimates from research. For example, to estimate the amount of methane cows produce, scientists would have to determine how much methane one cow releases and multiply it by the total number of cows on Earth.

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“If you look at international policies … currently they’re all based on these bottom-up inventories,” said Anna Michalak, co-principal investigator for Carbon-I and the founding director of the Carnegie Climate and Resilience Hub at Carnegie Science. “We need to get to a point where … we actually have an independent way of tracking what the emissions are.”

Carbon-I’s resolution will also give scientists new access to the atmosphere of the tropics, where clouds currently obscure most forms of satellite surveillance. “It’s their Achilles’ heel,” said Frankenberg.

Since tropical and subtropical forests absorb roughly a quarter of the CO2 humanity produces by burning fossil fuels, accurate data from this region of the globe is badly needed.

Satellites currently orbiting Earth with lower resolution can’t see through small gaps in the cloud coverage. They only see a blurred average of the cloudy and clear spots in the sky for each pixel. Carbon-I, with each pixel’s area almost 50 times smaller than that of most other satellites, can see the clearings and take measurements through them. In an April 2024 paper, Frankenberg, Michalak and their collaborators estimated that Carbon-I would be able to see past the clouds in the tropics anywhere from 10 to 100 times more frequently than its predecessors.

Carbon-I “is going to see things where people don’t know what’s going on,” said Thorpe, who has moved on from his graduate school days pointing thermal cameras at gas leaks and now works as a research technologist with the Microdevices Laboratory. “It’s going to open a whole new realm of science.”

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JPL’s airborne greenhouse gas-monitoring program goes back decades, but the field of space monitoring is still fairly new. Near the start of 2016, NASA headquarters contacted the JPL team. There was an ongoing massive blowout at the Aliso Canyon gas storage facility near Porter Ranch, and NASA wanted the team to check it out.

The team flew over the site in a variant of a 1960s-era spy plane on three days over the course of a month while the Southern California Gas Co. fought to contain the blowout. At the same time, NASA’s Goddard Flight Center in Maryland pointed the NASA Earth Observing spacecraft’s Hyperion spectrometer at the leak.

Hyperion was designed to make observations of the Earth’s surface and filter out noise from the atmosphere. Now, they were trying to observe the atmosphere and filter out the surface, and for the first time, scientists observed a human-made point source of methane from orbit.

“The Hyperion result was pretty noisy, but you could still see the plume,” said Thorpe. “This was really a proof of concept that we could do it from space.”

Even if Carbon-I launches, it doesn’t mean the team will stop putting instruments on planes. From aircraft, the team is able to monitor areas of interest in even sharper resolution and for consecutive days at a time. Right now, a leaner, meaner version of the spectrometers that observed the Four Corners leak and Aliso Canyon blowout is flying a series of missions to monitor the emissions of offshore oil rigs in the Gulf of Mexico.

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A twin-propeller King Air airplane in a hangar.

The twin-engine King Air plane used by JPL to conduct greenhouse gas-monitoring flights in its hangar at Hollywood Burbank Airport.

(Noah Haggerty/Los Angeles Times)

Plane missions also give the team an opportunity to try out new and improve spectrometers. “You can fix them, and you can upgrade them,” said JPL engineer Michael Eastwood, who’s worked with the spectrometers for over three decades and regularly flies with them. “You can take more risks, as opposed to spacecraft that need really mature, really well-known, high reliability — we’re not constrained like that.”

The air team is nimble, too. Typically, two crew members sit in the second row of a King Air twin-propeller aircraft looking at a stack of laptops and instruments with enough buttons to rival the plane’s cockpit. On the screens, they can look at real-time GPS data and spectrometer results and coordinate a flight plan with the pilots. The spectrometer — called AVIRIS, short for Airborne Visible/Infrared Imaging Spectrometer — sits in the third row, looking down through a window cut out in the floor.

The NASA program for which Carbon-I was selected as a finalist aims to fund space-based Earth science that will benefit society. The team was awarded $5 million to sharpen its project proposal before a final NASA review in 2025. There are three other finalists, and two will be selected for the launch.

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This two-step process for selecting missions is new for NASA’s Earth science programs and requires JPL to compete with the rest of the scientific community, independent of their association with the space agency.

“If we’re talking about grocery money, [$5 million] seems like a lot of money, but it’s really a bargain,” said Michalak. “If you think about the fact that you’re committing $300 million toward a mission, spending 1.5% of that to really make sure it’s going to be fabulous and successful is extremely smart.”

In the meantime, the Carbon-I team is focused on showing NASA that it has the technical know-how to execute the project on time and under budget.

“I think all four of the missions in the current phase are absolutely worthwhile scientific missions,” said Michalak, “and 50% odds are not bad odds for a satellite mission.”

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Signs of avian flu found in San Francisco wastewater

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Signs of avian flu found in San Francisco wastewater

Signs of H5N1 bird flu virus have been detected at three wastewater sites in California’s Bay Area, according to sampling data.

While positive wastewater samples have been found in seven other states, California is the only one that has yet to report a bird flu outbreak in a herd of dairy cows.

Genetic evidence of bird flu was detected in San Francisco wastewater on June 18 and June 26. Additional H5 “hits” were seen at a site in Palo Alto on June 19, and another on June 10 from the West County Wastewater facility in Richmond.

According to the San Francisco Department of Public Health, officials have been closely monitoring H5N1 along with federal, state and local partners, and are “aware of the recent detections of fragments of H5N1 in San Francisco’s wastewater.”

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“As with the previous detections reported from before mid-May 2024, it is unclear what the source of H5N1 is, and an investigation is ongoing,” wrote department officials in a statement. “It is possible that it originated from bird waste or waste from other animals due to San Francisco’s sewer system that collects and treats both wastewater and stormwater in the same network of pipes.”

Health officials said the risk remains low for the general public.

The virus has not been identified in California cows, but it has been found in wild birds and domestic poultry in the state.

The finding “is concerning” because of their urban origin, said Devabhaktuni Srikrishna, an entrepreneur who is developing techniques for disease detection, and the chief executive and founder of PatientKnowHow.com. “There are not many dairy or animal farms in San Francisco.”

There are also no dairy farms in Palo Alto or Richmond.

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The plant manager from Palo Alto was out of the office Friday, so could not comment. A spokesperson for the Richmond site directed questions to the state.

A request for comment from the state’s Wastewater Surveillance Program had not yet been returned.

Although the samples from the Bay Area wastewater sites tested positive for H5, the testing was not specific to H5N1.

However, researchers say a positive genetic identification for H5 is suggestive of bird flu — whether H5N1, the virus that has been found in U.S. dairy cattle (and which has infected three dairy workers ) or H5N2, the subtype implicated in the death of a man from Mexico City this month.

Most human influenza A viruses are of the H1 and H3 variety.

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The virus has been detected in 133 dairy herds across 12 states. It has also been found in wild birds and domestic poultry flocks throughout the United States.

In recent weeks, H5 was also detected in wastewater samples in Idaho. among other states.

While there is “no threat to the general public from the H5 detection in wastewater” at this time, said Christine Hahn, Idaho state epidemiologist, “we have determined that it is important that we work to understand these recent findings as much as possible.”

The state is working in conjunction with the Centers for Disease Control and Prevention to investigate the issue.

WastewaterSCAN, the research organization that detected the virus, is an infectious disease monitoring network run by researchers at Stanford, Emory University and Verily, Alphabet Inc.’s life sciences organization.

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A review of their data — which samples from 194 locations across the country — suggests H5 has also been detected at sites in Michigan, Texas, Minnesota, South Dakota and Iowa.

California is the only one of these states that has not reported H5N1-infected cattle.

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