Animal abuse and infectious disease oversight failures have common roots.

CDC scientists' adherence to biosafety protocols and the agency's oversight of research underway in its own labs have been subjects of concern recently voiced by infectious disease and public health researchers and members of Congress.

Officials at the University of Wisconsin, Madison say they know their labs are safe because they are inspected by the CDC. That appeal to authority suggests an absence of independent thought -- not a good trait in people charged with protecting the public from ridiculously dangerous germs.

The university has its own Institutional Biosafety Committee, the IBC, and a biosafety task force, though evidence of the latter hasn't been easy to fine. It's probably not a real thing. University spokespersons say that emergency plans are in place, and that they will spring into action in the unlikely event of a release of an insanely dangerous virus. After the fact. Like the response to the man infected with Ebola who was allowed to get on a plane and disembark in the most densely populated city in Africa.

The biosafety problems at the CDC's and UW-Madison's infectious disease labs have close and informative parallels with the problems associated with the use of animals in laboratories across the U.S.

The agency responsible for oversight of the use of animals in most situations is APHIS, the Animal and Plant Health Inspection Service, a part of the USDA. APHIS oversight of animal welfare -- in both laboratory settings and commercial dog breeding -- has been found to be woefully ineffective by the USDA's Office of the Inspector General. The NIH also has a nominal oversight role. It's Office of Laboratory Welfare (OLAW) relies on universities self-reporting their regulatory deviations, a recipe for slipshod operations, limited reporting, and frequent violations. On-site inspections by OLAW are rare. University spokespersons say that their Animal Care and Use Committees, or ACUCs, guarantee that the animals under their control are cared for and used humanely. There is an emergency plan in place to deal with some animal health problems.

It is the nature of much research at the university that some projects are subject to both biosafety and animal use oversight. Theoretically, a project like Yoshihiro Kawaoka's influenza experiments using ferrets are subject to oversight by the NIH, CDC, USDA, and the IBC and an ACUC. If pushed, the university could probably name even a few more nominal watchdogs.

That sounds great. Except that the NIH acted only after UW-Madison researcher Gary Splitter's students had violated it's Major Action rules.

Under the NIH Guidelines, the term "Major Action" means that NIH Director approval is required. Only one type of experiment requires NIH Director approval -- the deliberate transfer of a drug resistance trait to a microorganism when such resistance could compromise the ability to control the disease agent in humans, veterinary medicine, or agriculture (see Section III-A-l-a of the NIH Guidelines).

The CDC's culture of disregard for biosafety rules and its multiple mistakes and accidents have been the subject of much recent reporting. The CDC's animal care problems are less well known but no less troubling, at least to people like me who think that hurting animals ought to be recognized as a serious crime. The USDA promotes the use and consumption of animals; its problems enforcing the minimal restraints on abusive practices in labs shouldn't come as a surprise to anyone.

The university's IBC and its ACUCs aren't genuine oversight bodies. Their very practiced role is to make sure that the minimal federal rules are more or less adhered to. The members of the committees are participants in the activities they are charged with overseeing. This is one of the systemic problems identified as one of the causes of the CDC's dangerous mistakes and accidents: insiders being relied on to regulate themselves. That hasn't worked well for prisons or nursing homes either. One university biosafety committee member has said that the IBC is more of an advocate of the research than it is a critical evaluator of the safety procedures. Cheerleading for the very thing the oversight committee members are supposed to be evaluating is rife within the ACUCs membership and the senior officials charged with oversight duties.

The misleadingly named little group "Speaking of Research" is an extremist U.S. spin-off of a pro-animal experimentation fringe group founded by a fifteen year-old boy in England. The British group aptly called themselves "Pro-Test." To get a feel for who these people are, watch this video. UCLA monkey vivisector Dario Ringatch, the principal behind the group, can be seen a few times on the edge of screen, but he stays pretty much out of sight. His odd and loud pot-bellied side-kick, monkey vivisector David Jentsch, is one of the video's main characters. I mention this only because it may inform your response to me telling you that Eric Sandgren, director of the of UW-Madison's Research Animal Resource Center (RARC) and go-to spokesperson for issues involving the university's use of animals, is also a quasi-(full dues paying?) member of the group. He has contributed to the group's website and was instrumental in bringing Ringatch to UW-Madison to publicly spew his elitist and deranged world view.

Oversight of animal use at the university is strongly influenced, maybe even somewhat controlled by Eric Sandgren. He is a callous liar.

That's harsh. To be fair, it's not entirely Eric Sandgren's fault that he participates in, promotes, lies about, and defends cruel experiments on animals. It wasn't entirely Adolph Eichmann's fault that he kept the trains running smoothly. (My finger is worn out from pointing to the body of research demonstrating that people will and do generally behave immorally when immersed in a system that supports their poor behavior.)

One of the problems at the CDC labs is that the inevitable, really, genuinely inevitable, consequences of trying to be being careful, or doing much of anything else repetitively and routinely over time, is that we -- you and me, human beings in general, probably all of us with minds -- eventually become enured to the hypothetical risks, become complacent, and make mistakes. This is inevitable. It is a fact of life and of who we are. Here's an interesting study of laboratory accidents and a self-reported explanation for why so many accidents occur.

In both cases -- the failures of the oversight of infectious disease research and the failures of the oversight of the use of animals -- the regulatory problems that plague the systems have quite a few common causes.

There is though, an important difference between the oversight failures involving animal care and use and the oversight failures involving infectious disease research.

In the case of infectious disease research, biased perspectives lead only to an increased risk of billions of humans and other animals being killed in short order.

In the case of animal care and use, oversight failures and biased perspectives lead absolutely and immediately to animals being hurt and killed.

The infectious disease oversight failures have the potential of leading to the deaths of billions of people and animals, but that's a only a potential cost. Animal care and use oversight failures have a demonstrated history of being the direct cause of inhumane treatment, even by the institutions' own self-serving low standards.

Just as defending and sheltering cruelty to the animals being used in the university's research gravy train of tax dollars contributes to a culture of only cursory oversight and moral reliance on the institution's manufactured public relations public image, so too does the defense and promotion of speculative experiments that put us all at such grave risk. Everyone at the university is complicit to some degree in both cases: researchers, lab techs, administrators, cafeteria workers, English professors, music teachers, coaches, students, you name it.

The average German kept her mouth shut when people started being rounded up. But doing so resulted in only 10 to 20 million people being killed over a period of years. The 1918 Spanish flu killed somewhere between three and five percent of the human population, 50 to 100 million out of a population of about 1.8 billion, in a matter of months.

In today's terms, with about 7 billion of us crowded together, flying all over the place, a similar mortality rate would mean that we could expect somewhere between about 200 and 400 million of us dying; perhaps many more given the nature of the germs being invented all because Yoshihiro Kawaoka is hoping to come up with a better and marketable flu vaccine.

This seems like something people ought to be speaking out about as well as asking their legislators to stop.

UW-Madison's Preparedness Plan

An article published on line by the Milwaukee Journal Sentinel [UW puts worst-case-scenario planning for biosafety to the test] reported on the University of Wisconsin, Madison simulating a bombing at Camp Randall in order to gain practice and to test the university's emergency response plans. It reads like a planted article.

Rebecca Moritz, research compliance specialist for UW-Madison's biological safety office, is quoted throughout the article. She was acting as the university spokesperson and as an expert in emergency response planning.

Government anti-terrorism regulations dictate tight security around any biological agent that poses a potentially severe health threat. UW-Madison's labs are subject to regular and unannounced inspections by the CDC's enforcement division, Rebecca Moritz, research compliance specialist for UW-Madison's biological safety office, said Wednesday.

"When inspectors come in, it's their job to find things that are wrong to make us better," Moritz said. "When we have been inspected, we've been told many of our practices and procedures are best practice." ....

.... Moritz will be among more than 100 "victims" participating in Thursday's simulated Boston Marathon-esque terrorist bombing at Camp Randall because participating will benefit her work with biosecurity, she said.

Moritz was part of the planning committee because she works closely on biosecurity issues with the UW-Madison and Madison police departments and the FBI.....

.... UW researchers previously simulated an accidental release of a virus in a lab, Moritz said. That scenario involved a researcher coming down with symptoms at home.

"We come to their home, cover them in (Personal Protective Equipment) and put a respirator and gloves on them," Moritz said. "We transport them to the hospital and have a specific plan for who calls who." UW Hospital was involved in that simulation because the pretend victim was transported by the UW biosafety team and placed in one of several isolation rooms in the ambulance bay of the hospital's Emergency Department.

"I want to see their procedures from a patient's perspective," Moritz said, explaining why she's a pretend bombing victim.

The whole point of incidence response plans is to think about and drill all possible worst-case scenarios ahead of time, Moritz said.

"If something horrible were to happen, we've thought of everything and know exactly what to do."

There are a number of things about this, beside the article's reassuring tone, that give me pause. One is the described response to the accidental virus infection. Someone phones from home that they aren't feeling well and the emergency team rushes to their home, puts a respirator and gloves on them and then rushes them to the hospital.

If the person who was calling in was from Yoshihiro Kawaoka's flu lab, and if they really were sick from some gain-of-function highly virulent mutant strain, the steps needed in a containment plan are well beyond the university's capabilities; they are beyond anyone's.

The Flu Is Contagious

Most healthy adults may be able to infect other people beginning 1 day before symptoms develop and up to 5 to 7 days after becoming sick. Children may pass the virus for longer than 7 days. Symptoms start 1 to 4 days after the virus enters the body. That means that you may be able to pass on the flu to someone else before you know you are sick, as well as while you are sick. Some people can be infected with the flu virus but have no symptoms. During this time, those persons may still spread the virus to others. [bold in original]

If one of Kawaoka's lab workers calls in sick, it means that every person he or she had come in contact with over the preceding day or two at least, would have to be assumed to be a potential carrier of the virus and spreading it to the people they came into contact with; the number of exposures and carriers could cascade out of control. I wonder what the plan is? I wonder if there even is a plan? I hope there's something planned other than rushing to someone's house a few days late.

The article seems to me to have a reassuring tone, beginning and ending with assurances that all is well -- the university is prepared for big emergencies, even the escape of a deadly virus, but, it tells us in the next breath, there could never be such an accident in the first place. I'm comforted.

In past statements, the university has said that we ought not be too concerned because it's risky even to drive a car. But they have said honestly that the risk is never zero. In this article Sarah Van Orman, a physician and executive director of UW-Madison's University Health Services, says that an escape from the Kawaoka lab just isn't a "realistic scenario." This could be a change in their talking point.

I asked the writer of the Sentinel article whether she had actually seen the university's preparedness plan; she hasn't replied.

UW-Madison is Bad for Your Health

The influenza viruses being created and studied in Yoshihiro Kawaoka's lab are dangerous.

I could put a string of adjectives in front of dangerous, words like insanely, irresponsibly, foolishly, greedily, blindly, hugely, ridiculously, you get my drift. I'll just say dangerous, or maybe dangerous and cruel.

Here's what I understand to be the gist of Kawaoka's and UW-Madion's defense of his controversial influenza virus experiments. Because pandemic flu has the potential to kill very large numbers of people, it is prudent to try to be prepared before another pandemic breaks out. We should be prepared for a virus like the one that caused the 1918 Spanish flu. One part of being prepared is understanding the virus as well as we can. By studying the virus's genetics, it is possible to identify genes involved in a virus's various characteristics, like it's transmissibility and its ability to slip past an animal's immune system. Such knowledge could lead to a universal flu vaccine that could make influenza as rare as smallpox. That goal justifies the genetic manipulation of flu viruses to make them more dangerous and justifies the very slight chance of the public being exposed to the virus.

A 1918 Spanish flu infection is frequently fatal in mice, macaques, guinea pigs, ferrets, and humans. It is highly transmissible and is thought to move easily between birds and mammals. If the reconstructed virus or one his mutated more virulent strains were to somehow escape from the Kawaoka lab, the seriousness of the potential resulting pandemic is hard to overstate. A large portion of the human population could be killed as well as many animals of other species.

The effectiveness of flu vaccines is notoriously iffy. Some years, among healthy people, a flu vaccine can be can as much as 70% effective, in other years flu vaccines provide little benefit. This variability is due to the variability of the possible virus strains that can emerge. Researchers note that there are millions of possibilities. Flu vaccine manufacturers predict the strain that will be prevalent year to year; sometime they come fairly close and the vaccine is somewhat effective, other years they get it wrong and the vaccines aren't beneficial. Flu vaccine manufacturing is an odd business. There is a large financial payoff whether or not your product works. The holy grail is a universal vaccine; but the large number of possible strains makes the likelihood of a universal vaccine remote according to experts.

The flu was responsible for 36,000 deaths and over 200,000 hospitalizations in the U.S. annually during the 1990s. For comparison, heart disease and cancer were each responsible for almost 600,000 deaths annually in the U.S. [Molinari, Noelle-Angelique M., et al. "The annual impact of seasonal influenza in the US: measuring disease burden and costs." Vaccine 25.27 (2007): 5086-5096.]

The potential costs and potential benefits should be weighed against each other in order to come to a rational fact-based decision. We can make a list of the pros and cons.

The Pros:

1. A universal flu vaccine; influenza defeated.
2. Comfortable sometimes lavish incomes for flu researchers.
3. Large financial benefits for the institutions they work in.
4. Immense profits if a universal vaccine is invented.

The Cons:

1. No universal flu vaccine in spite of endless millions of tax dollars being spent.
2. The proliferation of labs around the world working on mutated potentially even more dangerous versions of the 1918 Spanish flu.
3. A bio-warfare influenza virus race.
4. A lab accident or mistake that allows the virus to escape.
5. Millions of people and other animals dead in a matter of weeks.
6. Human and other mammalian extinctions.

Both the pros and the cons include elements of both certainty and only slight possibility.

On the side of those who defend the experiments, I suspect that the certainty of items 2 and 3 on the Pro list are the main motivators behind the silly, dangerous, and self-serving statements from the University of Wisconsin about Kawaoka's research and their petulant reaction to criticism. It appears to me that the University of Wisconsin has determined that the certainty of large amounts of money outweighs the slight possibility of an unprecedented catastrophe.

Above, I noted that the research is dangerous and cruel. The animals used by Kawaoka suffer terribly. The animals he uses are said to drown "from within as their lungs filled with blood and fluid."

There are other factors that contribute to what I take to be the widespread ethical blindness afflicting the University. I've written about some of them here.

This just in: "Bio-Unsafety Level 3: Could the Next Lab Accident Result in a Pandemic? So-called gain-of-function pathogen research will likely receive closer scrutiny after three U.S. biolab incidents." Scientific American. Helen Branswell. July 14, 2014.

Dangerous seems hardly adequate to describe what's going on in the Kawaoka lab at UW-Madison.

Where are UW-Madison's bioethicists? Hunkered down no doubt.

When you are drowning on the blood leaking into your lungs, don't say you weren't warned.

The influenza viruses being created and studied in Yoshihiro Kawaoka's lab are dangerous.

I could put a string of adjectives in front of dangerous, words like insanely, irresponsibly, foolishly, greedily, blindly, hugely, ridiculously, you get my drift. I'll just say dangerous, or maybe dangerous and cruel.

Here's what I understand to be the gist of Kawaoka's justification for his most controversial work. Because pandemic flu has the potential to kill very large numbers of people, it is prudent to try to be prepared before another pandemic breaks out. We should be prepared for a virus like the one that caused the 1918 Spanish flu. One part of being prepared is to understand the virus as well as we can. By studying the virus's genetics, it is possible to identify genes involved in a virus's various characteristics, like it's transmissibility and its ability to slip past an animal's immune system. Such knowledge could lead to a universal flu vaccine that could make influenza as rare as smallpox. That goal justifies the experimental genetic manipulation of the virus and justifies the very slight chance of the public being exposed to a much more dangerous strain of the already very dangerous virus.

The 1918 Spanish flu was the most deadly disease in human history.

A 1918 Spanish flu infection is frequently fatal in mice, macaques, guinea pigs, ferrets, and humans. It is highly transmissible and is thought to move easily between birds and mammals. If the reconstructed virus or one of Kawaok's mutated more virulent versions were to somehow escape from the lab, the seriousness of the potential resulting pandemic are hard to overstate. A large portion of the human population could be killed as well as many animals of other species.

The effectiveness of flu vaccines is notoriously iffy. Some years, among healthy people, a flu vaccine can be can as high as 70% effective, in other years flu vaccines provide little benefit. This variability is due to the variability of the possible virus strains that can emerge. Experts note that there are millions of possibilities. Flu vaccine manufacturers predict the strain that will be prevalent year to year; sometime they come fairly close and the vaccine is somewhat effective, other years they get it wrong and the vaccines aren't beneficial. Flu vaccine manufacturing is an odd business. There is a large financial payoff whether or not your product works. The holy grail is a universal vaccine; but the large number of possible strains makes the likelihood of a universal vaccine remote according to experts.

The flu was responsible for 36,000 deaths and over 200,000 hospitalizations in the U.S. annually during the 1990s. [Molinari, Noelle-Angelique M., et al. "The annual impact of seasonal influenza in the US: measuring disease burden and costs." Vaccine 25.27 (2007): 5086-5096.] For comparison, heart disease and cancer are each responsible for almost 600,000 deaths annually in the U.S.

The potential costs and potential benefits should be weighed against each other in order to come to a rational fact-based decision. We can make a list of the pros and cons.

The Pros:

1. A universal flu vaccine; influenza defeated.
2. Comfortable sometimes lavish incomes for experimental flu researchers.
3. Large financial benefits for the institutions hosting experimental flu researchers.
4. Immense profits if a universal vaccine is invented.

The Cons:
1. No universal flu vaccine in spite of endless millions of tax dollars being spent.
2. The proliferation of labs around the world working on mutated potentially even more dangerous versions of the 1918 Spanish flu.
3. A bio-warfare influenza virus race.
4. A lab accident or mistake that allows the virus to escape.
5. Millions of people and other animals dead in a matter of weeks.
6. Human and other mammalian extinctions.

Both the pros and the cons include elements of both certainty and only slight possibility.

On the side of those who defend the experiments, I suspect that the certainty of items 2 and 3 on the Pro list are the main motivators behind the silly, dangerous, and self-serving statements from the University of Wisconsin about Kawaoka's research. It appears to me that the University of Wisconsin has determined that the certainty of large amounts of money outweighs the slight possibility of an unprecedented catastrophe.

Above, I noted that the research is dangerous and cruel. The animals used by Kawaoka suffer terribly. The animals he uses are said to drown "from within as their lungs filled with blood and fluid."

There are other factors that contribute to what I take to be the widespread ethical blindness afflicting the University. I've written about some of them here.

UW-Madison's "Ethicists'" Ethical Failure

According to the University of Wisconsin, Madison, its "Department of Medical History and Bioethics dates back to 1950, when the University of Wisconsin Medical School created a Department of the History of Medicine, the second department of its kind in the country. The Program in Medical Ethics has been an integral part of the department since its founding in 1973."

Ethics deals with moral principles.

Bioethics is the ethics of medical and biological research.

Ethicists try to come up with the things we ought to do in cases that do not seem to have matter-of-fact or obvious moral answers. They wrestle with uncertainty and ambiguity as they try to reason out what the moral or ethical person ought to do.

From my vantage, because they are being paid by tax dollars, the bioethicists at UW-Madison's Department of Medical History and Bioethics are acting unethically because they have proven to be unable or unwilling to voice an opinion about a current issue involving their own institution that is not terribly hard to understand.

Their primary responsibility is to the taxpayers who are forced give some of each dollar they earn toward their salaries and their lavish benefits. When the public is put at grave risk by research underway at their ivory towered institution they have a clear responsibility to speak out, to make their voices heard, individually if not in concert.

But not a single one of them has so much as made a peep about their institution's steadfast defense of research that senior scientists elsewhere are saying puts humanity at grave risk.

This situation tests their claim that they are doing something meaningful or of benefit to society. A problem of immediate import was laid at their feet, it sits there still, and they ignore it. In this case, their silence is a profound ethical failure. They put you and me at risk. The reasons for their spiritless myopia and weak spines are part of the collection of similar regrettable behaviors described by social scientists who have documented the ethical failures so common throughout history in institutions like the University of Wisconsin.

Humane is in the wallets of the beholder

Yoshihiro Kawaoka's influenza research has been much in the news recently.

The university is defending its repeated approval of his experiments. What choice do they have? They have to defend his work because they don't have the gumption to stop it, in spite of the fact that it increases the likelihood of many people being killed.

Their response to the criticism is the normal and predictable behavior of people who operate within well-defined social or political groups when challenged about their behavior. There may be cases that are exceptional, where some large group acknowledges its Groupthink error and fixes things right away, but I'm unable to cite one off the top of my head.

The reason I'm taking the time out to write here at all is to call attention to one specific thing. Kawaoka says that his research is safe. He also says that his use of animals is humane. By understanding what he means by humane, we might get an idea about what he might mean by safe.

The image below is a reproduction of a chart in a recent paper co-authored by Kawaoka. (Sorry about the terrible image quality; Google has done something to Blogger that has resulted in miserable image quality.)

Protective Efficacy of Passive Immunization with Monoclonal Antibodies in Animal Models of H5N1 Highly Pathogenic Avian Influenza Virus Infection. PLoS Pathog. Jun 2014.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4055766/#ppat.1004192.s007
See: Table S1