PCR

THIS SCAM HAS BEEN GOING ON FOR A WHILE

https://web.archive.org/web/20030328011217/http://www.os.dhhs.gov:80/ophp/presentations/Ascher.ppt

Update on Biodetection:

Problems and Prospects

Russian roulette

Though all of the recent anthrax attacks against abortion clinics have turned out to be hoaxes, emergency crews responding to them

have discovered a new problem.

BY JEFF STEIN

When an abortion clinic in Milwaukee received an anonymous letter purportedly containing the deadly toxin anthrax two weeks ago, the city's downtown was tied up in knots for several hours. Blocks surrounding the building were cordoned off while ambulances, fire trucks and special emergency teams flooded the area. The Summit Women's Center was evacuated and hundreds of workers in nearby businesses were ordered to stay inside their offices for several hours -- an exercise that probably cost the city $100,000.

The letter was eventually determined to be a hoax, like scores of similar cases over the past few months.

The test used to evaluate the threat letters was in the field is supposed to be "99.9 percent accurate."

Members of Milwaukee's Hazardous Materials Team, however, tell a different story.

They say the field test they used to determine whether anthrax was really in the envelope was, in fact, a bust.

The problem, according to Jim Martins, Milwaukee's Special Teams Coordinator, was that the hand-held device reacted as positively to the suspected anthrax as it did to a non-infected control substance -- a false positive.

"What we got from that didn't help us decide which way to go," Martins said.

The HAZMAT team has since learned that they weren't the only ones having problems with the test.

"The Army told us it was useless," explained one team member.

A government biologist, who asked not to be identified, agreed: "It works only 50 percent of the time, and that's not good enough."

Milwaukee Sentinel - 1999

Executive Office Of The President

Office of Science and Technology Policy

Washington, D.C. 20502

July 19, 2002

MEMORANDUM FOR FEDERAL MAIL MANAGERS AND FIRST RESPONDERS TO FEDERAL MAIL CENTERS

FROM: John H. Marburger, III, Director (Signature)

SUBJECT: Purchase of Anthrax Detection Technologies

Since October 11, 2001, when the U.S. mail was contaminated with Bacillus anthracis, federal, state and local agencies and first responders

have used commercially available Bacillus anthracis detection equipment to identify unknown substances resembling anthrax powder.

However, recent scientific evaluation of these commercially available detection systems concludes that this equipment does not pass acceptable standards for effectiveness.

Specifically, Bacillus anthracis

detection thresholds for these devices are well above the minimum level that can infect personnel, and are not suitable for determining biological contamination of personnel, rooms, or pieces of equipment.

Many devices also have been shown to give a significant number of false positives, which could cause unnecessary medical intervention with its own risk.

the Office of Science and Technology Policy, in collaboration with the Office of Homeland Security and 14 federal agencies, is coordinating the preparation of Guidelines for Federal Mail Centers in Washington, DC Metropolitan Area for Managing Possible Anthrax Contamination. This guidance will provide the standard operating procedures for federal mail centers to use in handling, identifying, and delivering a suspect article to the appropriate authorities for analysis. The Guidelines are available on the GSA website, at www.gsa.gov/mailpolicy.

The response of a facility to a threat or suspect article should be an integrated effort involving threat assessment protocols with law enforcement, testing by a Centers for Disease Control and Prevention (CDC) validated facility, and medical evaluation and response with the public health department. Microbiological culture in a CDC-validated laboratory is the “Gold Standard” for determining the presence of anthrax spores.

Field testing solely using commercially available polymerase chain reaction or handheld immunoassays for the detection of Bacillus anthracis IS NOT recommended and should not be used for the purposes described in the following paragraph.

Until further notice, the Office of Science and Technology Policy advises that federal agencies cease issuing any new procurement requests, task orders, purchase orders, or contracts for the purchase of new equipment or services that may detect, sample, test or filter air for Bacillus anthracis as the method for assaying suspicious mail, or for routine environmental sampling of mail rooms.

We also advise that every agency terminate any purchase requests, task orders, purchase orders, or contracts that have been issued for this purpose, and where final acceptance has not occurred.

The Department of Defense will continue to procure military standard biological detection equipment following the current statutory regulations under which the Department operates.

STATEMENT BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

Regarding Hand-Held Assays for Identification of B. Anthracis Spores

Purpose

To provide law enforcement, fire services, emergency managers and other first responders with guidance regarding the purchase and use of hand-held assays used for detecting anthrax spores and other biological agents.

Summary

The U.S. Department of Health and Human Services at this time recommends against use by first responders of hand-held assays to evaluate and respond to an incident involving unknown powders suspected to be anthrax or other biological agents.

Background

In recent months, Federal, State and local first responders have had to evaluate numerous samples of white powdery substances to determine if B. anthracis (anthrax) spores are present.

In some cases, field tests showed an apparent “positive” result and this led to the quarantine, isolation or decontamination of people.

When these samples were referred to a reference lab in the Laboratory Response Network (LRN), they were found to be negative through microbiological culturing and molecular methods. The devices used for the initial field tests included tickets and strips from at least four vendors. Problems resulted from a variety of factors, such as testing of caustic or harsh chemicals or the performance of tests by inadequately trained personnel.

Genetic fingerprinting

“Chip” technology

Print oligonucleotides on a slide

Measure binding of fluorescent PCR products

Can strain type all the orthopoxes at once

https://www.forbes.com/2010/03/10/swine-flu-world-health-organization-pandemic-opinions-contributors-henry-i-miller.html

Last June the WHO boosted the pandemic alert to the highest level, Phase 6.

That meant that, according to the WHO, a pandemic was under way--the first time in 41 years that the organization had made such a declaration.

But the WHO must have been suffering from four decades of amnesia because ordinary seasonal flu, which sweeps the world annually--and which is far more lethal than the currently circulating low-virulence H1N1 swine flu--certainly meets the organization's definition of a pandemic: infections over a wide geographic area that affect a large proportion of the population.

Ironically, one might even consider the emergence of the H1N1 flu during the past year a net public health benefit, since it appears to have suppressed, or at least supplanted, the far more virulent and lethal seasonal flu strains. During the second week of January, 3.7% of Americans tested positive for the seasonal flu, compared with 11.5% during the same week last year.

The death toll in the U.S. from H1N1 is estimated by the Centers for Disease Control and Prevention to be around 3,900, while in an average year seasonal flu kills about 36,000.

The WHO's April 2009 decision to raise the pandemic flu threat to the penultimate level, Phase 5, "Pandemic Imminent," was unwarranted and far outpaced the data accumulated.

Even worse was the June declaration that a pandemic was under way, which exposed the WHO's flawed fundamental paradigm.

A warning system based solely on how widely a virus has spread, but that does not consider the nature, severity and impact of the illness it causes,

is prone to false positives;

it would classify not only seasonal flu but also the frequent but largely inconsequential outbreaks of virus-caused colds and gastroenteritis as "pandemics."

WHO has never offered any explanation for why these examples that seem to fit its definition of a pandemic do not meet its criteria.

False alarms make the "pandemic under way" designation almost meaningless, and they diminish its usefulness, which, in turn, has important consequences. As Dr. Jack Fisher, a professor of surgery at the University of California, San Diego, School of Medicine, observed, "Keep crying 'wolf,' and WHO can expect lower than customary compliance with flu vaccine advisories next fall." Not only next fall, but also at some future time when we encounter a genuinely dangerous new pathogen such as a strain of H5N1 avian flu (which in its present form boasts a mortality rate more than 100 fold higher than the H1N1 swine flu) that is easily transmissible between humans.

The U.N.'s false alarms have had more immediate, negative effects.

Matthew Hingerty, managing director of Australia's Tourism Export Council, lamented that the country lost thousands of tourists because of the WHO's pandemic declaration.

Egyptian public health authorities overreacted and summarily ordered the slaughter of all the pigs in the country.

In addition to the devastating economic losses, garbage filled the streets of Cairo and the numbers of rodents rose to fearsome levels because the pigs were no longer available to consume much of the garbage produced in the city.

The U.N. indicted by the Law of Unintended Consequences.

The publicity and resulting panic surrounding the WHO's announcement of Phase 5 and 6 alerts--especially since the vaccine was not widely available until December--

also brought out the fraudulent peddling of all sorts of ineffective and possibly dangerous protective gear and nostrums, including gloves, masks, dietary supplements, shampoo, a nasal sanitizer and a spray that supposedly coats the hands with a layer of anti-microbial "ionic silver."

For all these reasons, the declaration of a pandemic cannot be a prognostication but rather should be a real-time snapshot, and it must only be made when science and common sense support it.

WHO's performance has been widely criticized. Most flu experts believe that the

WHO's actions were overly alarmist and precipitous and the Parliamentary Assembly of the Council of Europe announced that it plans to debate "false pandemics, a threat to health."

https://www.nytimes.com/2007/01/22/health/22whoop.html

Before long, Dr. Kathryn Kirkland, an infectious disease specialist at Dartmouth, had a chilling thought: Could she be seeing the start of a whooping cough epidemic? By late April, other health care workers at the hospital were coughing, and severe, intractable coughing is a whooping cough hallmark. And if it was whooping cough, the epidemic had to be contained immediately because the disease could be deadly to babies in the hospital and could lead to pneumonia in the frail and vulnerable adult patients there.

It was the start of a bizarre episode at the medical center: the story of the epidemic that wasn’t.

For months, nearly everyone involved thought the medical center had had a huge whooping cough outbreak, with extensive ramifications.

Nearly 1,000 health care workers at the hospital in Lebanon, N.H., were given a preliminary test and furloughed from work until their results were in; 142 people, including Dr. Herndon, were told they appeared to have the disease; and thousands were given antibiotics and a vaccine for protection.

Hospital beds were taken out of commission, including some in intensive care.

Then, about eight months later, health care workers were dumbfounded to receive an e-mail message from the hospital administration

informing them that the whole thing was a false alarm.

Not a single case of whooping cough was confirmed with the definitive test, growing the bacterium, Bordetella pertussis, in the laboratory. Instead, it appears the health care workers probably were afflicted with ordinary respiratory diseases like the common cold.

Now, as they look back on the episode, epidemiologists and infectious disease specialists say the problem was that they placed too much faith in a quick and highly sensitive molecular test that led them astray.

Infectious disease experts say such tests are coming into increasing use and may be the only way to get a quick answer in diagnosing diseases like whooping cough, Legionnaire’s, bird flu, tuberculosis and SARS, and deciding whether an epidemic is under way.

These tests, called “home brews,” are not commercially available, and there are no good estimates of their error rates. But their very sensitivity makes false positives likely, and when hundreds or thousands of people are tested, as occurred at Dartmouth, false positives can make it seem like there is an epidemic.

At Dartmouth the decision was to use a test, P.C.R., for polymerase chain reaction. It is a molecular test that, until recently, was confined to molecular biology laboratories.

Anyone who had a cough got a P.C.R. test, and so did anyone with a runny nose who worked with high-risk patients like infants. “That’s how we ended up with 134 suspect cases,” Dr. Kirkland said. And that, she added, was why 1,445 health care workers ended up taking antibiotics and 4,524 health care workers at the hospital, or 72 percent of all the health care workers there, were immunized against whooping cough in a matter of days.

“If we had stopped there, I think we all would have agreed that we had had an outbreak of pertussis and that we had controlled it,” Dr. Kirkland said.

“The big message is that every lab is vulnerable to having false positives,” Dr. Petti said.

“No single test result is absolute and that is even more important with a test result based on P.C.R.”

…

CAN WE LEARN FROM THE PAST?