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FDA: Safety Problems Prompted Review of Homeopathic Remedies

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This June 16, 2009 file photo shows Zicam Cold Remedy nasal gel in Boston.  A top federal drug regulator says that increased safety problems with homeopathic remedies contributed to the government’s decision to revisit its oversight of the products at a public hearing this week. The Food and Drug Administration on Tuesday, April 21, 2015,  wrapped up a two-day meeting to hear from supporters and critics of products like Zicam Allergy Relief and Cold-Eeze, alternative remedies that are protected by federal law, but not accepted by mainstream medicine. (AP Photo/Eric Shelton)

This June 16, 2009 file photo shows Zicam Cold Remedy nasal gel in Boston. A top federal drug regulator says that increased safety problems with homeopathic remedies contributed to the government’s decision to revisit its oversight of the products at a public hearing this week. The Food and Drug Administration on Tuesday, April 21, 2015, wrapped up a two-day meeting to hear from supporters and critics of products like Zicam Allergy Relief and Cold-Eeze, alternative remedies that are protected by federal law, but not accepted by mainstream medicine. (AP Photo/Eric Shelton)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — A top federal drug regulator says increased safety problems with homeopathic remedies contributed to the government’s decision to revisit its oversight of the products this week.

The Food and Drug Administration on Tuesday wrapped up a two-day meeting to hear from supporters and critics of products like Zicam Allergy Relief and Cold-Eeze, alternative remedies that are protected by federal law, but not accepted by mainstream medicine.

Similar to dietary supplements, the FDA does not review the safety or effectiveness of homeopathic remedies before they are sold. But unlike supplements, homeopathic medicines can state that they are intended for specific medical symptoms and conditions.

The FDA’s Cynthia Schnedar, a director of drug compliance, said the agency has issued 40 warning letters to homeopathic product makers since 2009 amid increasing U.S. sales.

In perhaps the most serious case, in 2009 the FDA ordered the maker of Zicam to stop marketing three products that contained zinc gluconate. The agency linked those products to 130 reports from consumers who said they lost their sense of smell.

In 2010, the FDA warned about reports of toxicity in children taking Hyland Homeopathic’s teething tablets, which contained a berry-derived toxin called belladonna that can be poisonous in larger doses.

And last month the agency warned U.S. patients with asthma not to rely on homeopathic products claiming to treat the respiratory condition, which can cause fatal complications if not properly managed.

Despite such problems Schnedar stressed that this week’s FDA meeting was a “listening session,” and that the agency has not reached any decision about whether to alter its regulations.

“We’re gathering information to allow us to consider whether to adjust the current enforcement policies we have in place,” Schnedar said in an interview.

The FDA hasn’t revisited its oversight of homeopathic products since 1988, when it essentially exempted the industry from basic production standards that are mandatory for traditional drugs, like listing ingredients and dosibizng levels on product labels.

Zicam and hundreds of other homeopathic remedies are often sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. But homeopathic medicine is based on a 200-year old theory unsupported by modern science: that ingredients which create certain symptoms in healthy people are effective in treating the disease that causes the same symptoms.

A key principle of traditional homeopathy holds that the more diluted a remedy is, the better it works. Today, many remedies marketed as homeopathic contain heavily diluted drugs, vitamins and minerals. For instance, Zicam contains a heavily diluted dose of zinc as its “active ingredient.”

On Monday, industry executives and lobbyists argued that the current FDA framework works well for homeopathy. Representatives from the Consumer HealthCare Products Association, which represents homeopathic manufacturers, emphasized that consumers like having easy access to alternative treatments.

But industry critics argued that many consumers do not understand how homeopathic products differ from conventional medicines.

“Stocking homeopathic remedies labeled for specific symptoms or conditions alongside conventional over-the-counter drugs on the pharmacy or supermarket shelves is innately misleading,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center.

She and others want the FDA to require homeopathic remedies to undergo the same safety and effectiveness reviews as conventional drugs. But failing that, Fugh-Berman said that the products should carry a disclaimer warning that they have not been shown to treat or prevent any disease or condition.

Copyright 2015 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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City Government

Gov. Newsom Proposes New Office of Community Partnerships and Strategic Communications as part of California Blueprint 

Established within the Governor’s Office of Planning and Research (OPR), the new office will formalize and build on the work the state carried out as part of the 2020 Census and COVID-19 public awareness and community engagement campaigns. The new office’s first campaigns will include COVID-19 and climate justice. 

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The OCPSC will work directly with respective State departments to develop priority public awareness and community outreach initiatives, facilitate coordination and collaboration across State government to maximize impact in California’s communities, provide grant funding to CBOs and other partner organizations, and share community insights with relevant State and external stakeholders. 
The OCPSC will work directly with respective State departments to develop priority public awareness and community outreach initiatives, facilitate coordination and collaboration across State government to maximize impact in California’s communities, provide grant funding to CBOs and other partner organizations, and share community insights with relevant State and external stakeholders. 

By Emily Breslin

As part of the California Blueprint released Monday, Governor Gavin Newsom has proposed $65 million in ongoing General Fund monies to create the new Office of Community Partnerships and Strategic Communications (OCPSC) to take on the critical role of managing priority public education and community engagement efforts and provide ongoing support to community-based organizations (CBOs).

“Throughout the COVID-19 pandemic and during the 2020 Census, our community partners on the ground have played a major role in reaching Californians – especially our most marginalized communities,” said Newsom. “These organizations are committed to creating more resilient, healthy, and safe communities, and the new Office of Community Partnerships and Strategic Communications will formalize support for these partners and catalyze the social infrastructure necessary to build a California for All.”

Established within the Governor’s Office of Planning and Research (OPR), the new office will formalize and build on the work the state carried out as part of the 2020 Census and COVID-19 public awareness and community engagement campaigns. The new office’s first campaigns will include COVID-19 and climate justice.

“Addressing climate change and building thriving communities in California requires not only an all-of-government approach but depends on the critical contributions of California’s frontline communities and the organizations that activate and organize them, said Samuel Assefa, director of the Governor’s Office of Planning and Research. “As the state’s land use and planning agency, the Office of Planning and Research understands the unique value of public awareness and education and the singular role that community-based organizations play as trusted sources of information and in organizing local people power.”

The OCPSC will work directly with respective State departments to develop priority public awareness and community outreach initiatives, facilitate coordination and collaboration across State government to maximize impact in California’s communities, provide grant funding to CBOs and other partner organizations, and share community insights with relevant State and external stakeholders.

“Our partnerships with diverse, trusted community-based organizations strengthened the State’s ability to engage Californians during the COVID-19 pandemic and 2020 Census,” said Maricela Rodriguez, director of Civic Engagement and Strategic Partnerships in Governor Newsom’s Office. “We learned valuable lessons during these campaigns and the Office of Community Partnerships and Strategic Communications will build upon them for future community outreach and engagement efforts.”

Emily Breslin is the deputy director of Communications and External Affairs, Governor’s Office of Planning and Research.

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Activism

City’s Environmental Report on Oakland A’s Project Fails to Protect Health and Safety of Local Residents, Says Community Coalition

“The City has rushed the Final EIR in order to meet the arbitrary end of the year deadline set by the Oakland A’s,” according to a factsheet released by the East Oakland Stadium Alliance (EOSA). “The City Council and Planning Commission should not be bullied by the Oakland A’s into certifying an EIR that fails to adequately consider the project’s full impact on the neighboring community and Port operations.” The public can attend and participate in the Final EIR vote at the City of Oakland Planning Commission Zoom meeting, Wednesday, Jan. 19, 3 p.m. at: https://us06web.zoom.us/j/82519936593

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The public can attend and participate in the Final EIR vote at the City of Oakland Planning Commission Zoom meeting, Wednesday, Jan. 19, 3 p.m. at: https://us06web.zoom.us/j/82519936593
The public can attend and participate in the Final EIR vote at the City of Oakland Planning Commission Zoom meeting, Wednesday, Jan. 19, 3 p.m. at: https://us06web.zoom.us/j/82519936593

Oakland Port Commission Zoom hearing on Final EIR set for Jan. 19 at 3 p.m.

By Ken Epstein

The real estate development at Howard Terminal proposed by billionaire developer John Fisher, the owner of the Oakland A’s, and backed by Oakland Mayor Libby Schaaf “will result in numerous significant and unavoidable impacts in critical areas of concern such as toxics, traffic, air quality, and public safety,” according to a factsheet released by the East Oakland Stadium Alliance (EOSA).

An examination of the 3,500-page Final Environmental Impact Report (FEIR) produced by city staff found that the Final EIR did not adopt any of the recommendations from the over 400 comments that were submitted by community members who pointed out numerous deficiencies with the Draft EIR, according to the factsheet released by EOSA.

“By refusing to substantively improve the Draft EIR in response to these hundreds of comments, and instead simply defending the previous analysis, the City and the A’s (in the Final EIR) are ignoring the majority of community stakeholders,” the factsheet said.

The EOSA is a coalition of local businesses, workers, labor organizations, and Oakland community members who are concerned about the Oakland A’s’ proposal to leave behind their current Coliseum location in East Oakland and build a new stadium in the middle of Oakland’s thriving working waterfront. Coalition partners include the ILWU, California Trucking Association, Acts Full Gospel Church, Pacific Merchant Shipping Association, SSA Marine, Schnitzer Steel and the Oakland East Bay Democratic Club.

“The City has rushed the Final EIR in order to meet the arbitrary end of the year deadline set by the Oakland A’s,” the fact sheet said. “The City Council and Planning Commission should not be bullied by the Oakland A’s into certifying an EIR that fails to adequately consider the project’s full impact on the neighboring community and Port operations.”

Below are some of the “significant and unavoidable impacts of the Oakland A’s Howard Terminal project that the Final EIR fails to mitigate and address”:

Rail Safety – The EIR found that the project “would expose roadway users (e.g., motorists, pedestrians, bus riders, bicyclists) to a permanent or substantial transportation hazard.”

According to the factsheet, the EIR fails to provide any scenario where the project has adequate rail crossings for cars, pedestrians, and bicyclists.

“The A’s and City should not expose more people to potentially fatal safety hazards while traveling across these at-grade railroad crossings,” said the factsheet.

Air Quality – “Demolition and construction associated with the Howard Terminal development would result in daily emissions that exceed the City’s thresholds,” said the factsheet. “Significant and unavoidable air pollution impacts of the A’s Howard Terminal project also include contributing to cumulative regional air quality impacts and to cumulative health risk impacts on sensitive receptors.”

Truck Displacement -The EIR does not analyze the impacts resulting from the displaced trucks using the Howard Terminal site. This is a major impact of using Howard Terminal, but the EIR calls this analysis too “speculative” to analyze. “The project will likely result in more idling, more miles traveled, and more congestion on local roads for trucks trying to get to and from the Port,” said the factsheet

Toxic Remediation – “The EIR provides few details on the project’s required Remedial Action Plan because it still has not been drafted. This means that the City Council is being asked to approve the project before it knows the actual level of toxic remediation and the remaining toxic hazards,” according to the factsheet.

What information is in the EIR makes it clear that “the A’s don’t intend to clean up most of the site, but just to pave over and pile on the existing toxic pollution,” the factsheet said.

Maritime Compatibility – “The Draft EIR provided few comprehensive Seaport Compatibility Measures despite receiving dozens of suggestions from the maritime industry and waterfront labor that would minimize impacts on the Port,” the factsheet said.

To find out more about the East Oakland Stadium Alliance, go to www.eastoaklandstadiumalliance.com

The public can attend and participate in the Final EIR vote at the City of Oakland Planning Commission Zoom meeting, Wednesday, Jan. 19, 3 p.m. at: https://us06web.zoom.us/j/82519936593

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Bay Area

Oakland Healthcare Unions Denounce CDC and California’s New Guidelines

While federal and California state guidelines now allow healthcare workers who test positive for COVID-19 to return to work without quarantining as long as they are asymptomatic until at least February 1, it’s unclear what this will mean for several Oakland healthcare facilities.

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Oakland Highland Hospital screening tent at the emergency entrance on July 5, 2021. Photo by Zack Haber.
Oakland Highland Hospital screening tent at the emergency entrance on July 5, 2021. Photo by Zack Haber.

By Zack Haber

Two unions representing healthcare professionals have denounced recent moves by the Center for Disease Control (CDC) and The California Department of Public Health that have eased, or in some cases temporarily eliminated, quarantining guidelines for those who have tested positive for COVID-19 or been directly exposed to the virus.

“Part of why there’s this rise in transmission is that people aren’t quite well and they’re able to come out and mingle with the public,” said Zenei Triunfo-Cortez in an interview. Triunfo-Cortez has worked as a registered nurse for 42 years, and she’s the president of National Nurses United (NNU), a registered nurses’ union with over 175,000 members.

On December 22 of last year, as news that the CDC was considering shortening their COVID-19 quarantine duration guidelines from 10 days to five days was spreading, the NNU published an open letter to the director of the CDC, Dr. Rochelle Walensky, that urged her to maintain the 10-day quarantine period.

“Weakening COVID-19 guidance now, in the face of what could be the most devastating COVID-19 surge yet,” the letter reads, “will only result in further transmission, illness and death.”

On December 23, the CDC changed their guidelines for healthcare workers. To address staffing shortages, the new guidelines stated that medical facilities could have both vaccinated and unvaccinated healthcare workers who test positive for the virus return to their jobs immediately without quarantining in certain crisis situations as long as they were either asymptomatic or mildly symptomatic.

On December 27, the CDC changed their guidelines for the rest of the population, shortening the quarantining period from 10 to five days. The new guidelines stated that as long as a COVID-positive person has no symptoms or their symptoms are resolving and they don’t have a fever, they can end their quarantine on the sixth day.

“The change is motivated by science demonstrating that the majority of [COVID-19] transmission occurs early in the course of the illness,” reads a statement from the CDC about the reduced quarantine guideline, “generally in the 1-2 days prior to onset of symptoms and 2-3 days after.”

In their letter, the NNU pointed to the extremely contagious Omicron variant, and warned “Now is not the time to relax protections.” They mentioned pressure from businesses to maintain profits “without regard for science or the health of employees or the public” as the primary motivation for shortening the quarantine time. The letter included a link to a story about Delta Airlines CEO Ed Bastian asking the CDC to consider such a change.

Data from Alameda County, and California show that after the Omicron variant of COVID-19 began to become widespread in mid-December, local and statewide cases surged. By late December, average daily case rates were higher than they ever had been before.

Hospitalizations also rose sharply. Then cases and hospitalizations continued to rise through early January and have continued to rise. At the time of publication, information on recent COVID-19 deaths is unclear as the county and the state are updating that data.

“It’s stressful because some of our co-workers might be coming into work sick,” said Sonya Allen-Smith in an interview on January 7 about working under the new guidelines. She’s been an X-ray technologist at a Kaiser Permanente facility in Oakland for 13 years and is a member of the SEIU UHW union for healthcare workers.

“We think about if we’re going to take it home to our families,” she said. “My husband’s immune system is compromised. If I bring it home to him, he definitely will not make it.”

The Oakland Post obtained a flow chart Kaiser e-mailed to their employees on January 7 that guided them through the quarantine process the company required them to enter into if they tested positive for COVID-19.

It showed Kaiser employees had to quarantine for five days and could return on the sixth day if they tested negative for the virus with an antigen test. Allen-Smith said she felt the quarantine period was too short.

“We’re not giving people enough time to heal or recover,” Allen-Smith said. “Weakening the guidelines is not going to stop the staff shortage. It may increase it because people will spread it.”

In an e-mail, Kaiser Permanente’s media team wrote that they’re “implementing CDC and CDHP guidance and isolation with considerations to vaccination status and staffing levels.” It also stated that “all employees coming back or continuing to work, wear the appropriate PPE and follow all infection prevention measures.”

On January 8, the California Department of Public Health (CDPH) decided to temporarily adopt the guidance for healthcare workers the CDC had released on December 23 to address staffing shortages at healthcare facilities.

“From January 8, 2022 until February 1, 2022, healthcare professionals who test positive for [COVID-19] and are asymptomatic,” reads their statement announcing the new guidelines, ”may return to work immediately without isolation and without testing.”

The statement also said such returning employees would have to wear N95 masks while working and that these new guidelines could again change as information becomes available.

Both the NNU and the SEIU-UHW unions immediately denounced CDHP’s decision.

“For healthcare workers on the frontline it is very disappointing to see the State of California bypass common sense safety measures,” said Gabe Montoya, an emergency room technician, in a statement SEIU-UHW released. “No patient wants to be cared for by someone who has COVID-19 or was just exposed to it.”

While federal and California state guidelines now allow healthcare workers who test positive for COVID-19 to return to work without quarantining as long as they are asymptomatic until at least February 1, it’s unclear what this will mean for several Oakland healthcare facilities.

When asked for a statement about their Bay Area healthcare facilities, Sutter Health’s media team wrote an email stating: “Consistent with CDC contingency tiered guidelines released in late December, and in response to critical staffing conditions, we have revised our process for how employees who work at patient care sites return after they have been sick with symptoms consistent with COVID-19. It’s important to note that symptomatic employees are not returning to work until their symptoms improve.”

When asked directly if asymptomatic COVID positive employees were currently returning to work, Sutter Health’s media team did not respond.

When asked about their current COVID-19 quarantine policies, Alameda Health System’s media and communications manager Eleanor Ajala wrote “Alameda Health System is reviewing guidance” and that they planned to attend a meeting with the state to discuss the issue.

On January 11, Allen-Smith said she hadn’t heard of any change to Kaiser Permanente’s quarantine policy, but that she knows three co-workers sick with COVID-19 who had just returned after five-day quarantines.

In an e-mail, Kaiser Permanente’s media team wrote that to address staffing shortages they were “employing traveling nurses, adjusting elective and non-urgent surgeries and procedures as needed, and offering our industry-leading telehealth capabilities in addition to in-person care.”

The media team did not directly answer when asked if Kaiser was allowing asymptomatic COVID positive employees to return to the job at Bay Area healthcare facilities.

Allen-Smith is unhappy about the guidelines changing and is unsure if Kaiser’s policy will further change in the near future due to CDHP’s recent announcement.

“A lot of us are confused and sad and just don’t feel safe in the workplace,” she said.

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