Sunday, May 15, 2016

UW-Madison Lied to Feds, Misled Public, Put Humanity at Dire Risk

Note: Over the past almost two decades I have learned that when it comes to universities' and university officials' statements about their care and use of animals, about the benefits that have resulted and that will result in the future as a result of the things they do to animals, that they lie easily and repetitively. This lesson has led me to look carefully and with much doubt about every assertion they make, but particularly so when money and animals are involved. This doubt and skepticism and my anger and sorrow over the things they do to the animals they use contributed to my close watch of UW-Madison's promotion and hype about the influenza research conducted by Yoshihiro Kawaoka, particularly his efforts to invent viruses more deadly than any yet encountered and to test their effects on ferrets and monkeys. I have written about it with some regularity.

Estimates of the number of deaths cause by the 1918 Spanish influenza epidemic vary from 20 to 100 million. John M. Barry, in his book The Great Influenza says:
Although the influenza pandemic stretched over two years, perhaps two-thirds of the deaths occurred in a period of twenty-four weeks, and more than half of those deaths occurred in even less time, from mid-September to early December 1918. Influenza killed more people in a year than the Black Death killed in a century; it killed more people in twenty-four weeks than AIDS has killed in twenty-four years.
Over half of those who died in the 1918 pandemic were in their 20s and 30s, in the prime of their lives, not the elderly.

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Two years ago, I again called Madisonians attention to the grave risks associated with Yoshihiro Kawaoka's influenza research at the University of Wisconsin-Madison. ("Flu lab accident could leave millions dead within weeks." Jul 8, 2014.) University officials Tim Yoshino and Susan West fired back with the claim that my "alarmist" letter was "irresponsible," but they provided nothing in rebuttal other than simple ad hominems. ("Tim Yoshino and Susan West: Rick Bogle's flu lab column irresponsible." Tim Yoshino and Susan West. Jul 11, 2014.)

Yoshino and West must have known when they wrote their response that serious accidents had recently occurred in the Kawaoka lab and that federal regulators had ordered a halt. At the time of their letter, Yoshino was the "responsible official" for UW-Madison Select Agent Program, and West was the chair of UW-Madison's Institutional Biosafety Committee.

International concern over influenza research like that occurring in the Kawaoka lab led to the current international moratorium and much continuing international debate.

Following the initiation of the moratorium, the White House Office of Science and Technology Policy and the Department of Health and Human Services instituted their own review citing the grave risks of the research and the serious biosafey errors and accidents with highly infectious agents at top labs across the country. News of these accidents led USA Today to investigate. The resulting report, "Biolabs in Your Backyard," was recently awarded a Scripps Howard Award for public service reporting. That report includes many thousands of pages of documents and correspondence that were obtained through Freedom of Information Act requests. The documents compiled by USA Today include over 400 pages of biosaftey committee minutes, laboratory accident reports, and correspondence between UW-Madison officials and the National Institutes of Health concerning accidents and violations. Local media has not reported on the serious problems in Kawaoka's lab discovered by USA Today.

Kawaoka's influenza research is conducted in a BSL3+ laboratory built for him by the university in 2006 for $11.4 million after the University ran into trouble with the Centers for Disease Control (CDC) over its approval of Kawaoka's Ebola experiments without the required level of biosafety. The BSL3+ lab (sometimes referred to as a Biosafety Level-3Ag lab) has been repeatedly characterized in local media as being only "half a notch below the top level" of biosafety. ["Following controversy, UW researcher's findings on bird flu virus published." Wisconsin State Journal. May 2, 2012; "UW-Madison study: New bird flu in China could cause global outbreak." Wisconsin State Journal. Jul 11, 2013; "UW-Madison flu studies raise risk more than prevent it, biosafety panelist says." Wisconsin State Journal. Jun 29, 2014.]

The very top level of biosafety is provided in BSL4 laboratories. In a BSL4 lab, workers wear space suits. In the documents obtained by USA Today, it is apparent that the "half a notch" difference between a BSL4 lab and Kawaoka's BSL3+ is pretty big.

On November 9, 2013, barely six months before I warned readers about the risks associated with an accident in the Kawaoka lab and Tim Yoshino and Susan West said my alarmist op-ed was irresponsible, a worker in Kawaoka's BSL3+ lab dropped a stack of culture plates infected with two varieties of influenza viruses: HPAI (highly pathogenic avian influenza) and H5Nl. The plates broke and spilled the contents onto the floor and may have splashed the researcher's bare ankles. University officials have said that the mutations of H5N1 studied in Kawaoka's lab are very dangerous. [Susan West and Timothy Yoshino: UW flu research is important and safe. Wisconsin State Journal. Jul 2, 2014.] The university reported the event to the NIH, as they are required to do. In their report, they said that the researcher did not think that the material had come into contact with his or her exposed bare skin, but wiped their legs with disinfectant nevertheless. The doctor on call at the University hospital did not think there was a need for the researcher to take Tamiflu, but the person involved in the incident and others more familiar with the seriousness of the risk insisted.

The NIH chastised UW-Madison for allowing anyone to work in a BSL3+ laboratory with exposed skin. Essentially all biosafety accidents are the result of human error and institutional malaise. The potentially exposed researcher was not quarantined.

Kawaoka's influenza experiments have been of particular concern to public health officials outside Wisconsin due to his manipulations of the viruses' genes to produce new-to-the-world influenza viruses, or what some scientific reports have termed "novel potential pandemic pathogens" or PPPs. These are recombinant viruses; they are laboratory creations and worry many observers. These genetic recombinations can result in what is termed a gain-of-function, and are used in what is termed GOF research.

Genetic manipulations can make viruses more pathogenic and more easily transmitted. In GOF research, viruses with only limited virulence can be altered to be more dangerous. Kawaoka was making already very dangerous viruses even more dangerous. His work is a big part of what led to the current, perhaps temporary, international moratorium on this line of research. Kawaoka was one of only two researchers pursuing this supercharging of influenza viruses; the other was a scientist in The Netherlands. Kawaoka et al have reported that infected monkeys were euthanized after developing a high fever, were huddled in a corner of their cage, their hands and toes clenched, and were bleeding from the skin. [Itoh, Yasushi, et al. "Protective efficacy of passive immunization with monoclonal antibodies in animal models of H5N1 highly pathogenic avian influenza virus infection." PLoS Pathog 10.6 (2014): e1004192.]

On November 16, 2013, a worker in Kawaoka's BSL3+ laboratory stuck him- or herself with a hypodermic needle containing recombinant H5N1 containing genes from a strain of H1N1. It was an H1N1 strain that was responsible for the 1918 Spanish flu, the most deadly disease yet encountered. The seriousness of the exposure was recognized by university doctors, but the university's response put the public at risk. The use of the needle in and of itself was apparently a violation of University policy concerning activities in the BSL3+ laboratory.

But more troubling and much more worrisome from a public heath perspective is that the University appears to have misled federal regulators in order to get approval for these experiments.

In a December 16, 2013, letter to the University, included in the US Today documents, the NIH writes to Daniel Uhlrich, Ph.D., Associate Vice Chancellor for Research Policy, UW-Madison:
In follow-up conversations with you and Rebecca Moritz regarding your occupational health plans, you state that all exposures, including high risk exposures, would follow the same protocol, i.e. home isolation after removing the family from the house. Your decision was based upon consultation with your infectious disease experts and the state health department. You had rejected using a hospital room for quarantine because of the stress on the laboratory worker. This policy is not what was communicated to us in Dr. Kawaoka's application to perform research with mammalian transmissible strains of H5N1 that was provided to the Department of Health and Human Services. In a May 6, 2013, plan provided to NIH, Dr. Kawaoka indicated that he had access to a "designated quarantine apartment" in which researchers could be placed for 10-14 days in the event of an accidental exposure.

The University must find a dedicated facility outside of the individual's permanent residence in which (1) an individual can be safely isolated for up to 10 days, and (2) that can be decontaminated easily after the individual's departure. [This requirement and emphasis was contained in two separate letters from the NIH in response to the University's explanation of the accident.] An isolation room in a hospital would be appropriate. An individual's permanent residence is not appropriate due to the fact that many residences are in buildings with high occupancy that share air exchange and other infrastructure. Please provide revised SOPs that reflect an appropriate quarantine arrangement. No research with mammalian transmissible H1Nl stains may be carried out until this plan is operationalized. [Emphasis in original]

Contrary to what they had said they would do, the University simply called the researcher's family and told them to vacate their residence. Then, in an apparently unsecured vehicle, they took the accident victim home -- a potential patient zero for a global pandemic -- with a glove on their hand and wearing a mask without an exhalation vent -- and told him or her to stay there. There is no mention of any additional security.

In their response letter to NIH, dated December 20, 2013, the University promised that in the future, "Sharp needles will only be used for administering drugs to animals and drawing blood from animals. When either of these procedures are being done with reconstructed 1918 influenza or mammalian transmissible influenza viruses, two people will be required for the procedure."

On March 10-11, 2016, the National Academies of Sciences, Engineering, and Medicine held its second symposium on gain of function research. (National Academies of Sciences, Engineering, and Medicine. 2016. Gain of Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press.) Nothing was decided, but it is clear from the report that many scientists and public health officials remain very worried that GOF research with influenza viruses will be allowed to resume.

Tim Yoshino and Susan West called my letter to Madisonian's irresponsible and alarmist, probably because I observed that an accidental (or intentional) release of a modified influenza virus from the Kawaoka lab could result in millions of deaths within a matter of weeks. They claimed that I had not taken the time to learn about that which I was writing.

I believe that they each and together violated the public's trust; I believe that senior University of Wisconsin-Madison officials and local public health officials have violated the public's trust.

Very well informed and senior infectious disease experts have voiced their alarm. Yet, locally, little is reported, much is hidden. I believe that these violations of the public's trust were and are predictable because of the very large sums of money added to the University's coffers as a result of Kawaoka's research and the propensity of people to obey those they deem to be authorities. Added to this is the phenomena of conforming to the norm, which probably led public health officials to remain silent; after all, local media was not doing any significant or investigative reporting on these problems. Media's silence may have encouraged public health officials to get in line and to avoid a close observation of the situation and to go along with whatever the University experts told them to believe. Madisonians have largely been kept in the dark.

"Given historic estimates of influenza’s spread across the globe (∼24–38% of the world’s population), it is estimated that a pandemic of a highly virulent influenza strain, such as those created in GOF/PPP experiments, could cause between 20 million and 1.6 billion deaths." Evans, Nicholas Greig, Marc Lipsitch, and Meira Levinson. "The ethics of biosafety considerations in gain-of-function research resulting in the creation of potential pandemic pathogens." Journal of Medical Ethics 41.11 (2015): 901-908.

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