CEO SUMMARY: Here’s the story, with new details, about how a patient sample, cross-contaminated with a “deadly” strain of influenza virus from a proficiency test kit, triggered alarm bells at the highest levels of public health in Canada, the United States, and the World Health Organization. It’s story that has few heroes and reveals the politics of public health. And this story has not been reported…until now!
BY NOW, MOST EVERYONE in the lab industry has heard about the brouhaha which followed the discovery that more than 4,000 laboratories in 18 countries were sent the “deadly” A/H2N2 strain of influenza virus by at least four laboratory proficiency testing programs.
It was an international story. Television and newspaper coverage was extensive. Government health officials acted swiftly to assure the public that there was little chance that a laboratory accident would introduce this virus into the environment and trigger a new influenza pandemic. For several days, the nation’s clinical laboratory industry was in the media spotlight—and not necessarily in a complimentary way.
Yawns in Clinical Labs
But what went unreported in the national news was that, within the clinical laboratory industry, this story was a “yawner.” Outside of the public health community, many individuals working in clinical laboratories considered the hubbub about live H2N2 virus going out in proficiency test kits to be a non-story.
On the surface, it is an inexplicable dichotomy. At one extreme, public health officials—and directors of public health laboratories—were telling reporters that live H2N2 flu virus was “deadly” and a lab accident had the potential to trigger a worldwide influenza pandemic. On the other extreme, individuals who worked in laboratories which received the H2N2 PT kits considered it no big deal.
It was this dichotomy which led THE DARK REPORT to a different story behind the “H2N2 Affair.” Lab administrators and pathologists will find this alternative story instructive. It may explain the politics behind the decisions by various public health agencies to characterize the distribution of PT kits with live H2N2 flu virus as a significant threat with the potential to trigger an influenza pandemic. It also provides early warning about how an accident in a clinical lab with the potential to adversely affect public health might be used by public health officials to shift public attention away from their own past performance.
The basic facts of the story are well- known. The virus was a strain of influenza known as A/H2N2. It had been included in virology proficiency test kits prepared by Meridian Biosciences, Inc., then shipped to laboratories participating in the proficiency testing programs of the College of American Pathologists (CAP), American College of Physicians (ACP), the American Association of Bioanalysts (AAB), and the American Association of Family Practitioners (AAFP).
Strain Last Seen in 1957
A/H2N2 is the strain of virus which sparked a major influenza pandemic in 1957-58 and caused an estimated one million to four million deaths world- wide. In the United States, H2N2 caused about 70,000 deaths. This influenza strain was last seen in 1968. After that, H2N2 vanished with the emergence of influenza A/H3N2 viruses that caused the next pandemic.
Because it has not been seen since 1968, all persons born since that year have no immunity to H2N2. This is one reason why public health officials raised a public alarm upon discovering that live H2N2 flu virus had been distributed to 4,000 laboratories in PT kits. They emphasized, in their public statements, that a lab accident had the possibility of releasing the H2N2 influenza strain into the public, where it had the potential to trigger a serious outbreak of the disease.
But that is not the full story about the “H2N2 Affair.” From a variety of knowledgeable and well-placed sources, THE DARK REPORT has pieced together a tale which revolves around a victimized patient and the possible motives by some public health establishments to use this incident as an opportunity to trumpet their ability to protect global health. Even if there are some inaccuracies in the tale that follows, the collective picture offers alternative motives for different players involved in the “H2N2 Affair.”
Our version of the story picks up in Vancouver, British Columbia in March 2005. A med tech in a hospital lab microbiology department was working with patient specimens and the virology PT kit with the H2N2 flu virus. This med tech cross-contaminated at least one patient specimen with the H2N2 virus.
There was a simple reason why this cross-contamination led to the discovery that H2N2 had been shipped in virology PT kits. The patient was a bone marrow transplant patient. When her specimen tested positive for influenza, protocol was for the patient to immediately start therapy for the influenza. Her specimen was also sent to the National Microbiology Laboratory(NML) in Winnipeg, Manitoba for identification of the influenza subtype.
Results Took Weeks
It took NML several weeks to culture the specimen and identify the subtype. It was Easter weekend when the results were ready. “We found this out in the middle of the night on Good Friday,” recalled Frank Plummer, Scientific Director at NML. His lab had just identified a patient specimen containing a strain of live influenza virus considered virulent and not seen in the population in 37 years. “For several hours, we were very concerned,” said an understated Plummer.
NML notified public health officials in British Columbia and the Canadian capitol on Sunday, March 26, 2005. Notification was sent to the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) on the same day.
From the start, health investigators suspected that the source of H2N2 in the patient specimen was contamination. The H2N2 specimen was a virtual DNA match for the H2N2 viruses that circulated during the years 1957-58. It was as if it had been frozen in time.
“When we heard that it was virtually a genetic match to this 1957-58 isolate, a strain that might have been frozen down way back then, it seemed like this had to somehow be a contaminant of some sort. And that’s what led to the more detailed analysis,” stated Robert Brunham, MD., Director of the British Columbia Center for Disease Control.
Interview With Patient
Medical investigators first located the female patient. After determining that she was negative for the H2N2 virus, she was asked about recent travels, contacts with birds, and when she first felt sick. It was also determined that her respiratory symptoms were not due to influenza.
Investigators then shifted their attention to the hospital laboratory in Vancouver which had done the lab tests on the woman’s specimen. According to Plummer, these investigators determined that a laboratory technician in that hospital “had somehow contaminated the woman’s specimen while working under a protective flume hood on both her specimen and the proficiency test kit containing the 1957 A/H2N2 strain at the same time.”
Sources inside the public health establishment tell THE DARK REPORT that the med tech who worked with the specimens in question was known to have ‘less than ideal” work habits. It was not difficult to rule out any other way that the patient’s specimen could have become contaminated with H2N2 flu virus.
It took a number of days for this investigation to reach its conclusions. It was April 8 when Canadian health agencies notified the CDC of these findings. In turn, on the same day, the CDC contacted the College of American Pathologists and directed it to issue a “destruct the virus and confirm destruction” alert to the 3,747 laboratories which had received its virology proficiency test kit containing the B/H2N2 strain of influenza virus.
On April 12, 2005, the CDC conducted a press conference which sparked news headlines around the world. The CDC downplayed the risk that the H2N2 virus might get back into the population because of an accident in a laboratory working with the virology PT kits. Despite such assurances, the press interpreted developments to mean that a major error had occurred within the clinical laboratory industry.
Reporters hyped the statements given by public health officials. “I was certainly disturbed that it happened,” said Danuta Skronski, an influenza expert at the British Columbia Center for Disease Control. “H2N2 is one of the top five pandemic candidates. There’s no doubt of that. And this should be a strong warning to labs that you do not mess around with pandemic candidates.”
“H2N2 Affair” Timeline
September 10, 2004:
First virology proficiency kits containing influenza H2N2 virus are prepared for shipment.
Hospital lab in Vancouver, BC has a specimen positive for influenza from a patient showing no flu symptoms. It refers the specimen to the National Microbiology Laboratory (NML) in Winnipeg, Manitoba for identification of subtype.
Easter Weekend 2005:
NML identifies unknown flu virus as subtype A/H2N2, a strain not seen in the population since 1968. NML notifies Public Health Agency (PHA) of Canada.
March 26, 2005:
PHA of Canada notifies the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) of this discovery.
Late March 2005:
Investigation determines that the Vancouver hospital lab contaminated the patient’s specimen with live influenza A/H2N2 virus from a proficiency test kit provided by the College of American Pathologists (CAP).
April 8, 2005:
NML reports the results of this investigation to PHA, the CDC, and WHO. CDC notifies the College of American Pathologists of the H2N2 issue. Directs CAP to alert labs with the virology proficiency test kits to immediately destroy the virus and report/attest to the fact.
April 9, 2005:
CDC, WHO, and PHAC consult on course of action.
April 11, 2005:
CDC sends CAP detailed instructions on how to destroy specimens and a process for reporting the destruction of specimens.
April 12, 2005:
CDC learns at least three additional proficiency testing programs used PT kits with the H2N2 virus. CDC directs these programs to alert labs to the destruct and report requirements.
April 12, 2005:
CDC, WHO, PHAC hold press conferences to alert the public to the situation. News stories begin appearing in the national press.
April 13, 2005:
CAP and Meridian Biosciences both issue press releases on the subject.
April 20, 2005:
Last CAP proficiency test specimen is located in Beirut, Lebanon and is prepared for destruction.
Potential Global Emergency
“I think it’s fair to say that, if many bad-luck things had come together, it could have caused a global health emergency,” declared Klaus Stohr, M.D., who directs the WHO’s global pandemic program, based in Geneva, Switzerland. “We all know that laboratory technicians are very well-trained and take care with what they’re doing. But we have seen SARS slipping out in laboratories which belong to national virologic institutions.”
Stohr was making a reference to the fact that, of the last six cases of SARS known in the world, three were directly caused by accidents in laboratories handling the SARS virus.
“We are very concerned that this particular strain of virus was used for proficiency testing,” stated Julie Gerberding, answering a question at a press briefing as to why the A/H2N2 strain of virus had been included in PT kits. Gerberding, Director of the CDC, said, “It’s impossible to believe that they [CAP, Meridian, etc.] did not know they were dealing with H2N2.”
4,271 Labs Got H2N2 Kits
Four proficiency testing programs sent PT kits with H2N2 to participating laboratories. CAP sent out 3,747 kits. The American Association of Bioanalysts sent PT kits to 343 laboratories and the American Association of Family Practitioners sent kits to 144 physician office labs (POLs). The American College of Physicians sent out PT kits to 173 POLs. Meridian Biosciences produced the virology PT kits with H2N2 virus for each of these programs.
The quotes above, pulled from various news sources, provide good exam- ples of how various public health communities beat their drums. A potential pandemic had been averted. It was a close call, and the world was lucky because a blunder in choosing the “wrong bug” for a laboratory proficiency test program had not led to the inadvertent introduction of a virulent virus into the environment.
Several sources helped THE DARK REPORT understand why clinical laboratories which had received the virology PT kits with H2N2 virus were not concerned, but that the story still made international news.
Their informed speculation is that certain public health agencies had a motive to improve their public image by the way they characterized this event—and their response to it. First is the National Microbiology Laboratory in Winnipeg. It was observed to THE DARK REPORT that, following the outbreak of SARS in Toronto in the winter of 2003, NML had come under some criticism for not being fast enough to identify the new disease and to institute procedures to control its transmission.
Under this scenario, NML, upon discovering H2N2, a virulent influenza virus not seen since 1967, could go public with news that it had discovered the virus was floating around in some clinical laboratories and it was now taking proactive steps to prevent the possibility of lab accidents involving proficiency kits from introducing H2N2 virus into the environment.
Sources speculate that the Centers for Disease Control and Prevention also had some recent “egg on the face” and thus found the “H2N2 Affair” a convenient opportunity to get favorable publicity. After all, during the past 12 months, the CDC was criticized for not having selected the “right” strains of influenza for this season’s vaccines. Then, a few months later, a major manufacturer of influenza vaccines was shut down for quality control issues. This left the United States critically short of flu vaccines just as the flu season was building.
Way To Increase Credibility
One pathologist working in a public health agency, suggested to THE DARK REPORT that some individuals within the CDC would thus have a motive to consider the “H2N2 Affair” as a way to restore some luster and credibility with the public and government officials. It was a flu-related issue that could demonstrate how the agency was alert, effective, and pro-active in protecting the public health from the threat of an inadvertent introduction of H2N2 into the environment.
Thus, the “H2N2 Affair” may be a story of the public health establishment seizing an opportunity to generate favorable public—and political attention—on an issue that was considered much less of a threat by professionals working inside clinical laboratories handling virology PT kits with live H2N2 Virus.
That may also help explain why there was no mention, by either public health officials or the international media, that POLs, lacking bio-safety level 2 protections, had received live H2N2 virus in their PT kits.
Thus, it is likely that the real victim in this affair has yet to be recognized. That is the female transplant patient in a Vancouver hospital who received therapy for an influenza infection she didn’t have, because a med tech cross-contaminated her specimen with live H2N2 virus. That seems to be the only lab accident involving H2N2 virus which has harmed a patient.
H2N2 in POL PT Kits? Why It Was No Problem
CONCERNS THAT H2N2 INFLUENZA VIRUS in bio-safely level two (BSL-2) labs might escape into the environment and trigger an influenza pandemic eclipsed the fact that hundreds of physician office laboratories (POLs) got H2N2 in their proficiency test kits.
This is another dichotomy in the story about the “H2N2 Affair.” THE DARK REPORT can find no newspaper or major media story that addresses the fact that POLs, lacking BSL-2 protections, received PT kits with H2N2. This may be evidence that that publicity about the threat of a global pandemic was overblown.
One reason might be that the difference in the threat would be recognized quickly by reporters. VR1 kits, which test proficiency for live culture of the virus in laboratories running at BSL-2, actually increase the quantity of live virus over the course of the procedure. In contrast, PT kits like VR4 and M21, which test proficiency in antigen detection and are more commonly used in POLs, start with a finite quantity of live virus which diminishes as the test is conducted.
Several hundred POLs got live H2N2 virus in their virology PT kits. Yet none of the officials at agencies like the CDC and WHO mentioned POLs in their press briefings. Nor did reporters pick up this facet of the story.