Unlicensed lab case shows difficulty of enforcement
ALAMEDA, California––The Physicians Committee for Responsible Medicine and other animal advocates may be celebrating an April 16, 2024 victory of sorts in Alameda, California, but only if they did not read the fine print in the ordinance sparking the cheers, and did not think deeply about the consequences of the ordinance, even if it could be enforced.
“On Tuesday, April 16, City Council narrowly approved a ban on animal testing or experimentation on property owned or controlled by the City of Alameda,” reported Karin K. Jensen for the Alameda Post, “except where such testing or experimentation is performed as part of research related to regulatory filings related to human or animal therapeutics, vaccines, devices, and parasiticides.
“Critics contend this mostly maintains the status quo,” Jensen acknowledged.
True enough, but that is not even the half of it.
Comparable Cambridge ordinance may not have been enforced in 37 years
Comparable ordinances date back at least to a 1987 ban on use of the LD50 acute toxicity test, which requires the death of half of the animal test subjects, and the Draize eye irritancy test, which painfully blinds rabbits, adopted in Cambridge, Massachusetts, home of Harvard University.
Two years later, in 1989, Cambridge also passed an ordinance extending the federal Animal Welfare Act requirement that experiments on ten regulated species categories be overseen by Institutional Animal Care & Use Committees, to cover all vertebrates, giving the committees the authority to stop experiments.
But if the Cambridge ordinances have ever been enforced, there appears to be little if any public record of it.
“Why isn’t laboratory transparent?”
Even if the Alameda and Cambridge ordinances could be enforced, if ever brought to court, cities have limited ability to monitor what businesses, academia, and government agencies do behind closed doors.
This problem came up during the Alameda city council debate.
Council member Trish Herrera Spencer, the Alameda mayor from 2014 to 2018, “said that until a Science Corp lease application [for city property] came to light, she was unaware that animal testing was happening in Alameda,” Jensen wrote.
Herrera Spencer “decried being denied access to see the Science Corp vivarium, rhetorically asking if the industry is providing appropriate animal care, why not be transparent?”
(City of Alameda photo)
Standard operating procedure
Not being transparent is, however, central to doing business for any privately owned for-profit research and development corporation, competing against a world of well-funded and aggressive rivals.
Not being transparent is also easily rationalized by companies and institutions needing to maintain tight biosecurity, since they work with potentially hazardous pathogens.
And of course not being transparent is standard operating procedure for vivisectionists, whose experiments, when disclosed, have often outraged the public for several hundred years.
If it makes money, it will be done
Beyond that, there is the reality that biomedical research is sufficiently lucrative that if it is stopped in one place, it will be done in another.
Biomedical research history since the 1980s has been more-or-less one long record of biotech and pharmaceutical companies exporting their research and development laboratories from the U.S. and European Union, where regulation, inspection, and disclosure requirements may be weak, but at least exist, to poor nations where almost anything goes, and if it does not, can be done with a bribe.
Outsourcing
The White Coat Waste Project, the youngest and fastest growing U.S. anti-vivisection society, founded in 2013, has in recent years focused almost entirely on U.S. government-funded animal research projects that have been outsourced abroad, largely to evade scrutiny––and to evade the expense of evading scrutiny––if the work was done closer to home.
But the White Coat Waste Project currently raises and spends “only” $5 million a year.
The Physicians Committee for Responsible Medicine [PCRM] raises and spends $18 million to $19 million a year.
The risk of outsourcing removing animal experiments from U.S. regulatory jurisdiction does not appear to be among the PCRM concerns.
Associate of Elon Musk?
The Alameda fracas, posted PCRM director of research advocacy Ryan Merkley in January 2024, as debate over the recently passed ordinance heated up, “all started in October 2023. At the time, the [Alameda] council was considering awarding a lease on public property,” specifically the former Alameda Naval Air Station, “to Science Corp, a medical device company run by a co-founder of Elon Musk’s notorious Neuralink that planned to experiment on rabbits and monkeys.”
PCRM, Merkley said, “worked with local residents and our dedicated members to voice concern and outrage, and the council rejected the contract!
“That inspired Councilmembers Trish Herrera Spencer and Malia Vella to go one step further and [try to] ban any animal experiments on public property in Alameda.”
Rejected Science Corp as tenant “over animal ethical concerns”
Picked up Karin K. Jensen in her Alameda Post account, “In January 2024, after rejecting leasing Building 11,” a former Navy airplane hangar, “to Science Corp over animal ethical concerns, the Alameda city council directed staff to draft an ordinance prohibiting animal testing and experimentation on city-owned or controlled property.
“The city does not lease to tenants conducting animal testing,” Jensen reported. “However, the municipal code is silent on the topic. Therefore, such uses could occur. No other California municipality bans animal testing,” Jensen said, though a search of all 482 California municipal codes would be necessary to be sure.
Long history of anti-vivisection ordinances in California
Zoning prohibiting all animal use industries may be in effect in some residential communities, even if none still have unenforced anti-vivisection ordinances passed in the 20th century.
California city councils are known to have considered anti-vivisection ordinances of varying scope, backed by William Randolph Hearst (1863-1951) and his Hearst newspaper syndicate, in Oxnard (1917), San Francisco (1917-1919, 1938), Berkeley (1920-1922), Corona (1930), Stanford (1938), Los Angeles (1950, 1974), Van Nuys (1950), Ventura (1962, 1973), Huntington Beach (1974), and Pasadena (1974).
None of these proposed ordinances passed, but many gained considerable momentum before failing, and similar ordinances might have passed with much less public debate in smaller cities within the Hearst newspaper circulation radius.
Economic Development Strategic Plan
The Alameda 2018 Economic Development Strategic Plan, developed during Trish Herrera Spencer’s mayoral tenure, “identified life science as one of six priority economic sectors,” wrote Jensen.
“Since then, the life science sector has more than tripled, adding over 3,300 jobs to the local economy. Approximately 35 life science companies employ approximately 4,600 people, including some of the city’s largest employers, such as Penumbra, Abbott Diabetes Care, and Exelixis.
“Senti Bioscience and Azzur recently engaged in major commercial construction,” recounted Jensen.
Three professors
Opposing the Alameda animal testing ordinance, Jensen mentioned, were “Three professors representing the University of California at Irvine, the University of Southern California (USC), and San Jose State University.”
Favoring the ordinance were “37 [survey] responses, of which 23 were from Alameda residents,” and 275 letters from individuals supporting a ban,” Jensen wrote.
“Of these, only nine were from residents of Alameda, with 269 resulting from an organized letter-writing campaign,” apparently generated by the Physicians Committee for Responsible Medicine.
No formaldehyde in the alcohol district
Speaking in support of the ordinance, Trish Herrera Spencer argued, Jensen paraphrased, “that the life science industry, spurred by powerful profit motives, was misrepresenting what it would do. No life science companies are [currently] on city property,” Herrera Spencer pointed out, “so existing businesses wouldn’t be affected. However, the ban would affect city properties at Alameda Point, where [Herrera Spencer] didn’t want businesses involved in animal experimentation near Spirits Alley,” a neighborhood of beer pubs touted as a visitor attraction, “and the planned performing arts center.”
(U.S. Food and Drug Administration photo)
Man of many names charged
The enforcement question, meanwhile, is underscored by a currently pending federal case against an individual using the names Jia Bei Zhu, Jesse Zhu, Qiang He, and David He, arrested on October 19, 2023.
Zhu, 62, a citizen of China who formerly resided in Clovis, California, was on November 16, 2023 indicted by a federal grand jury on charges of “distributing adulterated and misbranded medical devices in violation of the federal Food, Drug, and Cosmetic Act and for making false statements to the Food & Drug Administration,” announced Phillip A. Talbert, U.S. attorney for the Eastern District of California.
“According to court documents,” a U.S. Attorney’s Office media release detailed, “between January 2020 and March 2023, through the companies Universal Meditech Incorporated and Prestige Biotech Incorporated, Zhu sold hundreds of thousands of COVID-19 test kits to companies throughout the United States.
Made millions
Zhu’s companies “were based in Fresno and Reedley, California, “and did not obtain pre-market approval, pre-market clearance, emergency use authorization, or other applicable exemption from the Food & Drug Administration as was required,” but “received millions of dollars for the sales of the test kits,” the U.S. Attorney’s Office stipulated.
“If convicted,” the U.S. Attorney’s Office said, “Zhu faces a maximum statutory penalty of three years in prison and a $250,000 fine for the adulterated and misbranding of medical devices charges, and five years in prison and a $250,000 fine for the false statements charge.”
No Animal Welfare Act charges
The federal case against Zhu, however, appears to make no mention of charges of multiple violations of the Animal Welfare Act, possibly because he was indicted under other charges carrying stronger penalties.
“If it were not for an errant hose sticking out of the back of a warehouse last spring, city officials would not have known that a shady biotech company with links to China had set up shop there, filling it with industrial freezers, hundreds of vials of pathogens, and about 1,000 dead and dying lab mice,” recounted Daily Mail senior health reporter Cassidy Morrison on July 31, 2023.
“Inhumanely stored white lab mice”
“Government investigators also found COVID diagnostic and pregnancy tests at the underground testing facility that they believed were being developed there, in addition to at least 20 stored infectious agents, including coronavirus, HIV, hepatitis, and herpes,” Morrison wrote.
“The nondescript warehouse,” in Reedley, California, “was identified by a code enforcement officer,” Jesalyn Harper, “who happened to notice a garden hose located where it should not have been,” Morrison explained.
“A search warrant issued less than three weeks later revealed hundreds of vials of improperly labeled chemicals and biohazards.
“In one room were about 1,000 inhumanely stored white lab mice, roughly 200 of whom were already dead.”
“Genetically engineered”
Joe Prado, assistant director of the Fresno County Department of Public Health, told media that the laboratory “utilizing laboratory mice to see whether or not the Covid test kits were actually testing for COVID.”
The San Joaquin Valley Sun reported that according to one Wang Zhaolin, said to be a spokesman for Prestige Biotech, the mice “were genetically engineered to catch and carry the COVID-19 virus.”
“The mice were found not to carry COVID-19,” updated Noah Goldberg of the Los Angeles Times after Zhu was taken into custody. “They were actually bred to grow the COVID-19 antibody cells used for test kits.
Bull semen
“Officials investigated, shut down the lab and ordered the mice euthanized. But baseless rumors started flying online that the lab was connected to the Chinese government and could be part of preparations for a biological attack,” Goldberg said.
“The Reedley lab was not the first time Zhu’s companies courted trouble,” Goldberg added.
“In 2016, he was the owner of a Canadian company, IND Diagnostic Inc., that was ordered to pay $300 million ‘for misappropriating technology related to the separation of sex chromosomes from bull semen,’ according to American federal agents.”
Jia Bei Zhu apparently managed to operate for several years with no permits and no biosecurity to speak of, only to be tripped by a garden hose.
Well-funded, well-connected companies operating in Alameda are unlikely to be so sloppy.
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We can’t control the abuse or ignorance of the law as used, abused and overlooked by those in power. We can try to live our lives, to the best of our ability, in such a manner as to avoid harm to others. For me, that means avoiding the entities that are in any way involved in these diabolical things, educating myself and hopefully others as to who they are and what they do, and practicing preventive care to protect myself and avoid having to utilize these corrupt entities.
Sharing with gratitude, and all the rest.
Ever more evidence of taxpayer waste, government mismanagement, and ineffective laws being passed with no hope of alleviating the suffering of animals. I also would have hoped that PCRM was doing more with all those millions and was better informed about that ordinance. We should be prioritizing the welfare of animals during these efforts before using them to announce “victories.”
I am aware that animal research is not popular however, developing an illness that has basically taken away about 1/2 of my life for the past 30 years I have to be honest and say if I can get a medication that relieves my constant daily pain or makes me better so my quality of life is not so horrible that I am only alive because my death would be devastating to my family; if a few thousand rats were going to need to be killed to make life easier for the millions of people who are suffering from chronic pain conditions but because of the stupidity of our government and the drug addicts they like me are no longer allowed relief from opioid medications despite the fact that less than 1% of people who are using them under the guidance of a doctor have ever actually become addicted to them. But as I say if thousands of people with autoimmune diseases are able to get better or millions of people who are going to develop them can get a vaccine and then not develop the disease because they killed rodents I don’t think that sacrifice is too great. If a new type of pain treatment is developed that would help the millions in chronic pain and reduce the amount of people who are genetically prone to addiction of opioids then those rats lives would be well worth it. It’s not like rats aren’t killed every single day simply because of where they are living and their deaths don’t contribute to the world being a better place. People are committing suicide every day to escape their painful lives and they all deserve better! If rats’ lives are the price then until you get to walk in my shoes you like me would probably change your mind about the value of a rodent. I am not in favor of dogs, cats, rabbit and other animals being used for testing especially primate testing. I doubt it has much more value than the rats do!