CVIndependent

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Last updateMon, 20 Apr 2020 1pm

Blood tests for antibodies to the novel coronavirus will be “foundational, fundamental,” to sending Californians back to work, California Gov. Gavin Newsom said on Monday—but medical experts caution that there’s still a lot we don’t know about whether the tests are reliable enough to ensure people’s safety.

Testing people’s blood for antibodies may help determine who has already had the disease and recovered. But just because someone tests positive for antibodies doesn’t necessarily mean they are immune to the virus—or that they will remain that way over time.

Antibodies are immune proteins that attack viruses and other pathogens. Unlike the diagnostic tests that are backlogged across the country, antibody tests—sometimes called serologic tests—don’t sniff out the virus itself. Instead, they search the blood for these proteins, teasing out who has been infected, and who hasn’t.

“We really need the antibody test. The whole country is waiting for a good antibody test,” said Philip Norris, a professor of laboratory medicine at the University of California, San Francisco, and vice president of research at Vitalant Research Institute. “It will change how we can address this epidemic so dramatically. We’re operating with blinders on now.”

Newsom said that figuring out whether people have antibodies to the virus “will allow us to process new protocols in order to get people back into the workforce, or least back into society in more traditional ways.”

Charity Dean, assistant director at the California Department of Public Health, congratulated Stanford University about its development of an antibody test on Saturday. “We’re very excited that this is a California home-grown test that is going to be rolled out in the next week for actual use on Californians,” Dean said.

Stanford spokeswoman Lisa Kim said that the university has developed two antibody tests—one for use in research, and the other for use in the lab. But she declined to discuss the timeframe or make any experts available for an interview.


Some People Already Are Being Tested

Antibody testing of some people already is occurring. The Centers for Disease Control and Prevention is using the tests to survey hotspots for viral spread. A team at Vitalant is testing blood donors from across the country with multiple antibody screens.

Stanford has rolled out a community-wide antibody surveillance effort, The Mercury News reported. And the Food and Drug Administration recently granted emergency use authorization to one antibody test developed by a company called Cellex.

But even when a reliable test is developed, its production and use has to be scaled up to reach millions of people. 

There’s a balance to navigate, said David Pride, associate director of University of California, San Diego’s, clinical microbiology lab—between waiting until scientists fully understand immunity to the novel coronavirus, or allowing people to go out in public again.

“We can know the answers eventually,” he said. “But what are we going to do three months from now? What are we going to tell people—stay at home, or go out? So there’s the strict science, ‘We have to go with the data,’ and then there’s the, ‘What is practical to get life back to normal?’ And those two things are almost in direct opposition.”

Norris expects to see the test prioritized for healthcare workers—for whom every extra bit of protection helps.

“At the medical centers, everybody would love to get an antibody test so that we can apportion those on the front line, and give those jobs to folks who already have antibodies,” he said. “So in theory, I do think it’s a great idea.”


Does Immunity Last?

Relying on antibody tests to determine who can avoid the shelter-in-place order means answering a big question: Can you get the new coronavirus twice?

Right now, reports are mixed. But preliminary findings in monkeys suggest that once infected with the virus, reinfection was unlikely a month later. The evidence hasn’t yet been published in an academic journal, but a team of infectious disease experts called the results reassuring in the Journal of the American Medical Association.

“I think it’s probably a good assumption that if you had (the virus), and you developed an antibody response, you’re unlikely to get it again in the short term,” Pride said.

Researchers around the world are racing to find out for certain—and whether protection persists long-term.

“It won’t be tomorrow,” Norris said. “But people are working hard to make it happen.”

The epidemic started only a few months ago, so there have been no long-term investigations into immunity, according to an article published Monday in the Journal of the American Medical Association. There are also no biological markers yet to separate those who are still vulnerable from those who are immune, such as the levels of antibodies that are protective.

“We don’t know what the correlation is between the antibody levels that we measure and the protection that’s conferred by that antibody,” said Philip Felgner, director of the vaccine research and development center at the UC Irvine School of Medicine. “That’s the link that we don’t have yet.”

Early research suggests that most people infected start producing antibodies against the novel coronavirus between one and two weeks after showing symptoms. And preliminary studies hint that these antibodies can neutralize the virus. Μore research is needed to bear that out.

To test whether antibodies can block the virus from penetrating cells, Norris’ colleague at Vitalant created a safer stand-in for the virus by equipping the more benign vesicular stomatitis virus with a key coronavirus protein. Then he mixed his declawed virus with cells, and added serum from two patients who had recovered.

The antibodies blocked the virus from getting inside the cells, preventing a successful infection. That’s the rationale behind treating sick patients with plasma filled with antibodies from people who have recovered. However, clinical trials are needed to determine if it works. 

There’s another open question: How long does immunity last?Long-term follow-ups of people who survived the first SARS epidemic in 2002 and 2003 suggest that their antibodies lasted for about two years, before disappearing in about a quarter of the study participants after three years

Studies of milder coronaviruses indicate that reinfection is possible, but that the symptoms tend to be less severe the second time around. 

In the 1990s, a team of scientists in the United Kingdom spritzed “nasal washings” containing a mild coronavirus up the noses of 15 volunteers. Ten became infected; eight came down with colds; and a year later, most of the infected volunteers had slightly higher levels f antibodies in their blood than the volunteers who weren’t infected. 

When the volunteers were re-exposed a year later, all five who hadn’t been infected the first time became infected, and one showed symptoms. Of the ones who had been infected the previous year, two-thirds became re-infected—but none developed symptoms. 

Again, it’s hard to draw conclusions from such a small study. But that, and the possibility that the virus itself might change over time, is why Felgner cautions against pinning hopes on the idea that antibodies mean imperviousness to the virus. Instead, he proposed a more measured view:

“They’re going to have to say this immune response that’s being measured here doesn’t necessarily protect me entirely from this infection. But it may reduce the severity if I do get another exposure,” he said.


The Worst-Case Scenario: False Security

It’s one thing to use an antibody test academically to investigate the virus—where it spreads and how people’s bodies fight it off. It’s another thing to rely on it to shape public policy and determine who should take on greater risks of exposure—which is what Newsom has hinted at. 

Newsom said last week that testing for antibodies “is all part of our strategy to get people … back into some semblance of normalcy.”

But it’s still too early for Felgner to be completely comfortable with that idea. Antibody responses vary from person to person. Some may not make enough or send the right kinds to the lungs to fight off the virus.

“That’s what gives everybody who works on the science a queasy feeling of insecurity—because there are so many obvious things that need to be checked, to get confidence in this,” Felgner said. “And we don’t have those answers yet.”

Still, those answers are coming. Felgner’s team is planning to survey healthcare workers over time for a constellation of antibodies. The goal is to compare these antibody fingerprints to symptoms to understand why some get severe disease, and others escape relatively symptoms-free. 

Inaccurate tests could put people at risk if the results indicate that someone has antibodies, when in fact, they don’t—a result known as a false positive. That could happen if a test detects antibodies against other coronaviruses, like the ones that cause colds, and misinterprets them as antibodies against the novel coronavirus.

“So suddenly you’re getting a lot of positives where you shouldn’t, and people falsely think they’re protected,” Norris said. “That would be the worst-case scenario.”

That’s why researchers around the state are carefully vetting which tests to use. Nam Tran, associate professor and senior director of clinical pathology at University of California, Davis, said his team is working with a Southern California company called Diazyme to develop an in-house antibody test.

“I’ve received over 100 emails from numerous manufacturers—some I’ve never even heard of before,” Tran said. “You don’t want to jump on it out of desperation and have a bad test. Can you imagine I tell a patient or an employee ‘Oh, you’re immune to COIVID-19,’ and it turns out they weren’t weren’t? We can’t do that.”

CalMatters.org is a nonprofit, nonpartisan media venture explaining California policies and politics.

Published in Local Issues

When the novel coronavirus hit California, Jamille Cabacungan, a registered nurse at UCSF Medical Center, rushed to sign up as a volunteer to treat infected patients.

She hesitated to answer, however, when asked about her preparation for that job.

The hospital is providing the necessary gear, she said, and more heightened training for some nurses. But not for all—and much of her training is coming from videos forwarded to her by the hospital, as opposed to hands-on learning-by-doing. Her colleagues are depending on her—“we don’t want to put our pregnant co-workers or those who live with elderly people at risk,” she added—but the preparation is less intense than she expected, considering the risk involved.

As California’s coronavirus strategy has moved from containment to mitigation, the health-care workers on the first line of response to the epidemic are also finding themselves on the front line of potential infection. From internal conversations to calls for action from their unions, nurses, first responders and hospital staffers have sounded the alarm, raising questions about the safety protocols and spotlighting flaws and lags in response, both in California and nationally.

“Nurses are eager to take care of patients and make sure that our communities are safe, but we need the right staffing, equipment, supplies, communication and training to do this safely,” Deborah Burger, president of the National Nurses United, which represents about 150,000 nurses around the country, said during a public health roundtable earlier this week. 

“Put simply, if we are not protected, our patients are at risk,” Burger said. 

The union has asked the state to notify nurses when patients sickened by the virus are sent to their health-care facilities. They are also petitioning the state to release a full account of the protective gear in stock statewide, including respirators, and information about where these respirators are stored, citing concerns over a shortage of respirators and other personal protective equipment.

The nurses say that some of the workplace safety guidelines for states recommended by the Centers for Disease Control and Prevention are not rigorous enough to sufficiently protect health care workers and their patients.

Earlier this month, the union released a nationwide survey of 6,500 nurses in which only 29 percent said their hospitals had a plan in place to isolate potential coronavirus patients, and only 44 percent said they had gotten information from their employers about how to recognize and handle the virus.

As sick people turn up in emergency rooms, community clinics and school nurses’ offices, the workers who initially treat them run a high risk of infection. After a Vacaville hospital reported the first U.S. instance of community transmission, and the patient was transferred to UC Davis Medical Center in Sacramento, for example, healthcare workers’ unions reported 124 workers were placed under quarantine. (UC Davis Medical Center later said that number was inaccurate but did not provide an estimate.) Concerns have also been raised about health-care workers inadvertently spreading the virus.

Dr. Sonia Angell, director of the California Department of Public Health, said her department is collaborating with all groups involved in response and checking regularly with hospitals and health care facilities to learn where their needs are.

Gov. Gavin Newsom said Tuesday that the collaboration has extended to health-care workers’ unions.

“We certainly can strengthen those lines of communication, but they are open lines of communication, very directly with the governor himself,” Newsom said.

SEIU-United Healthcare Workers West, which represents nearly 150,000 workers across California, is also asking the state to help increase access to coronavirus testing for both workers and the general public. Spokesman Sean Wherley said the union also wants hospitals to make it easier to track workers sent home for possible exposure to the virus, and to provide clearer follow-up.

“They were sent home as a precaution, but not all of them were tested before they were sent home, so what about the risk posed to their families?” Wherley said.

In California and nationally, testing has been an ongoing issue. Though thousands of Californians are self-monitoring and self-quarantining, only 1,075 people have been tested in the state, with a backlog of about 200 tests, Newsom said Tuesday. Commercial labs are supposed to help relieve some of that load.

Workforce shortage is also a concern. “If each positive patient results in five to 10 workers being sent home, how many times can that happen before you have a staffing crisis?” Wherley said.

The California Hospital Association said healthcare staffing hasn’t become an issue at this point, “but it is certainly something everybody has to be cognizant of,” said Jan Emerson-Shea, a spokesperson for the group.

“The discussion has moved from containment to accepting the fact that this virus is here, so there is certainly some concern about how it will affect staff and the ability to continue operating,” she said.

Newsom’s emergency declaration earlier this month on coronavirus allows health-care workers to come from out of state to fill any gaps should California experience a crisis in staffing. Still, state lawmakers—the majority of whom, like Newsom, were elected with the support of organized labor—have been sensitive to health-care workplace concerns.

“Making sure we protect health care workers is extremely critical, because we depend on these very same health-care workers to take care of the patients who may end up in the hospital,” said Sen. Richard Pan, chair of the Senate Health Committee. “If there are any resources (state public-health officials) need, the Legislature would want to make sure they have those resources.”

CalMatters.orgis a nonprofit, nonpartisan media venture explaining California policies and politics.

Published in Local Issues

On July 13, California’s three state cannabis-licensing authorities—the Bureau of Cannabis Control, the California Department of Food and Agriculture, and the California Department of Public Health—announced the publication of proposed “non-emergency” regulations that would replace the rules under which the state’s marijuana industry has been operating.

Voters passed Proposition 64 in November 2016, legalizing the sale and use of recreational cannabis in California as of Jan. 1, 2018—meaning there was only a little more than a year to create an entire state agency, licensing guidelines and regulatory processes.

Given the size of this task—and the size of this state—it’s no surprise that California has gotten off to a bumpy start. High taxes, both on the state and local level, are a major problem. In Washington, Oregon and Colorado, marijuana consumers saw a drop in the price of cannabis for the recreational user as soon as the supply chain was able to catch up to demand—so much so, in fact, that the black and gray markets were largely put out of business.

In California, this has not been the case. Because of both the incredibly high taxes on legal weed and the big production costs California’s state regulations have created, legal marijuana has remained expensive—so the illegal cannabis market has been able to maintain lower prices and, therefore, flourish. Non-licensed retailers have also thrived, providing customers with much lower prices than the licensed competition. (In some parts of the state, I have heard of regulators not realizing that a shop is unlicensed until they asked to see permits.) On the Bureau of Cannabis Control’s own Facebook page, the day the new regulations were announced, people were bragging and/or complaining that they have returned to the black market. 

Medical-marijuana patients are also suffering under these taxes, and many have had to return to the illegal market in order afford the medicine they need to control their very serious medical issues. Small growers who have been in the cannabis industry for decades have suffered and been driven out of business because of the onerous regulations placed on them—and as of July 1, a number of dispensaries were stuck with inventory that was all of a sudden illegal for them to sell, because it did not meet state standards.

Thankfully, it seems like Lori Ajax, the chief of the California Bureau of Cannabis Control (BCC), recognizes that there have been problems, and she seems to be interested in fixing them. The proposed regulations, which can be viewed here, are now open to a 45-day public-comment period. State law stipulates that the non-emergency regulations must be in place by the end of the year.

I find some portions of the new regulations to be very encouraging. I am still in the process of digesting the information that the BCC wants to be able to award research funding. One of my biggest beefs with the medical-cannabis industry is its promotion of cannabis as a cure-all for many ailments, when there are so few peer-reviewed studies regarding the medical benefits of marijuana. This is not necessarily the industry’s fault—federal law has essentially prohibited the use of marijuana for all purposes, including scientific ones—so the state’s possible foray into scientific research funding is a step in the right direction.

The new regulations also get rid of the necessity for establishments to have two sets of licenses; as of now, dispensaries need one for medical marijuana, and one for recreational adult use. With only a few differences in the requirements, it seems unnecessary to require businesses to apply for two types of licenses to sell the same product.

I also find the proposed codification of enforcement to be encouraging. Under the emergency regulations, there was no significant list of grounds for disciplinary action, meaning each licensing authority had the ability to discipline on a case-by-case basis—a system that is open to abuses. The proposed regulations will create a framework for licensing authorities to use when initiating or undertaking enforcement.

Unfortunately, the BCC is proposing to keep in place its requirements around packaging. Retailers would still not be able to package product onsite, and would still be required to place cannabis products in a resealable child-resistant opaque package before customers leave the store. This requirement has always seemed rather ridiculous: If the goal is to protect children, why do we not see these same sorts of requirements around tobacco and liquor? Given California’s push for a greener future, adding a new type of plastic waste feels counterproductive.

While I believe the Legislature still needs to step in to make some legal changes to ensure California’s cannabis industry—particularly small and minority-owned businesses—can thrive, these new regulations are a start.

Any interested party is encouraged to participate in the public-comment process—although consider yourself warned that reading through the proposed rule changes is not an easy process. (The Initial Statement of Reasons from the BCC is 567 pages long!) Comments on the proposed regulations are being accepted in both writing (via email or snail mail) and at public hearings throughout the state, comments cannot be made by phone. The closest hearings will be held in Los Angeles and Riverside (find a list here), so written comments may be a Coachella Valley resident’s best bet. Regarding BCC regulations, comments can be sent to This email address is being protected from spambots. You need JavaScript enabled to view it.; in the subject line, type in the subject of the proposed regulation to which the comments apply. You can make your comment either in the body of the email or as an attached document. Physical mail can be sent to: Lori Ajax, Chief, Bureau of Cannabis Control, P.O. Box 419106, Rancho Cordova, CA, 95741. All information submitted becomes public information—so don’t include anything you want to remain confidential.

Published in Cannabis in the CV

On June 27, the California Department of Public Health issued its first data report on residents’ participation in the new End of Life Option Act.

The law was signed by the governor in 2015 and took effect on June 9, 2016. The report reveals that 258 terminally ill California patients—diagnosed as having less than 6 months to live—started the process as called for under the law, as of Dec. 31, 2016.

Of those 258 patients, 191 were prescribed the life-ending medications, by 173 unique physicians. The report states: “111 patients, or 58.1 percent, were reported by their physician to have died following ingestion of aid-in-dying drugs prescribed under EOLA, while 21 individuals, or 11 percent, died without ingestion of the prescribed aid-in-dying drug(s). The outcome of the remaining 59 individuals, or 30.9 percent, who have been prescribed aid-in-dying drugs, is currently undetermined, as there has been no outcome reported for these individuals within the time period covered by this report.” (Full disclosure: One of the 111 patients who passed away using the new law was my mother-in-law; see “Annette’s Story,” posted at CVIndependent.com on Dec. 20, 2016.)

Kat West is the national director of policy and programs at Compassion and Choices, a national support organization for medical aid-in-dying patients and their cause. The organization just released its own, independent report on the law, covering activity through May 31 of this year.

“We were actually very encouraged by the data that came out of the state, because it showed that (the participation rate) was in keeping with our previous experience in the other authorized states,” West said. “The one piece of data we were very happy to see was the ratio of the number of different doctors prescribing the drugs compared to the group of patients requesting. That was a really good indicator that medical aid-in-dying is being what we call “normalized” and basically mainstreamed into end-of-life care.”

According to the Compassion and Choices report, the organization knows of 313 prescriptions that were written for medical aid in dying in the first five months of 2017. Meanwhile, 498 health-care facilities and 104 hospice locations have adopted policies supportive of patient choice, while about 80 percent of private insurance companies have covered the cost of the medications, including Blue Cross Blue Shield, Kaiser Permanente, Sutter and all Medi-Cal plans.

“The additional 313 prescriptions issued (thus far in 2017) were only the ones that we know about,” West said. “There are plenty of doctors who did not reach out to our organization, and there are plenty of terminally ill people who did not reach out to us. As a result, we don’t know of all of the prescriptions that may have been written in the state of California.”

Not all of the news is good for proponents of medical aid-in-dying protocols. The federal House Appropriations Committee recently voted to block funding to implement a new medical aid-in-dying law in Washington, D.C.

In California, a Riverside County Superior Court judge allowed the Ahn vs. Hestrin lawsuit, which challenges the End of Life Option Act, to move ahead into the courts, although an injunction request to put the law on hold was rejected by the judge.

John Kappos, a partner at the O’Melveny and Myers law firm, is representing proponents of the law. He said he is not too concerned about the lawsuit.

“What I find most concerning is the fact that a purely voluntary procedure like medical aid in dying causes some people to try to impose their will on others,” he said. “People can decide that they want to do it, or they can decide that they’d prefer not to do it and just die of natural causes. There’s no one here who is telling the people who do not want to participate in medical aid in dying that they need to, or have any obligation to do so. It’s very concerning to me that there are people in California who feel that they need to tell others … they have to suffer at the end of life, and potentially die an excruciating death.”

Kappos said it could take a year or longer for the case to be resolved. “It’s hard to guess at these kinds of things, but in my view, these are purely legal issues, and eventually, that will come to light, and the case should be resolved on a motion (in the defendant’s favor).”

Here in the Coachella Valley, Eisenhower Medical Center continues to deny its staff and doctors permission to write medical-aid-in-dying prescriptions for its terminally ill patients.

“I try to take the long view, and that is that change is hard,” said West, of Compassion and Choices. “But look back 20 years as an example. If you were to bring up the subject of hospice care with a group of medical professionals, it would clear the room. That’s how taboo the topic of death and end-of-life care was then. Now, of course, hospice is completely mainstream, and everyone thinks it’s great. So it’ll be the same trajectory for medical aid in dying, especially now that California has authorized it.

“Eisenhower is just going to find itself out of step with the community’s needs and desires. It’s going to find itself out of step with its own doctors’ feelings about the issue, and eventually, it will change its policy. The community clearly wants it, so it’s just the administrators. The community is already stepping up their demands, and internal champions within Eisenhower are also calling us and letting us know what they think.”

West predicted change will come to Eisenhower sooner rather than later.

“I’d say they will change their policy within a year. I do believe that,” West said. “The administrators have to pay attention to what their community is asking for.”

West suggested that everyone engage in an end-of-life-treatment discussion with their own health-care professionals.

“Our big ask of everyone is to ask your own doctor now if they would provide the protocol legalized in the End of Life Option Act—whether she or he will support you if and when the time comes,” West said.

Published in Local Issues