Wednesday, September 28, 2016

Breaking CDC whistleblower claims agency has been using the wrong Zika test

Breaking: CDC whistleblower claims agency has been using wrong Zika test
By Erin Elizabeth - September 28, 2016


A nurse practitioner in Miami's Wynwood neighborhood gives a pregnant patient information about mosquito protection in August, after she was tested for Zika virus. The area was an active Zika transmission zone and prompted a CDC travel advisory, which has since been lifted. (Lynne Sladky/AP)
Another one bites the dust. Enter CDC whistleblower number two- wonder how many need to come forward before people stop blinding trusting this organization that DOES NOT have our best interests in mind?
As officials fight to control the dreaded Zika (which scientists from around the world say is nothing but a mild virus) the CDC once again finds itself engaged in some internal housekeeping problems, specifically, debate about the best way to test whether someone has been infected with the mosquito-borne virus.
And at the center of this issue is one of the leading experts on the Zika virus, Robert Lanciotti, chief of the CDC lab responsible for developing tests to diagnose viral diseases such as Zika that are transmitted by mosquitoes, ticks, and fleas.
And as if working off a script, once Lanciotti raised concerns both inside and outside the agency about their decision to use a new test for Zika, he was demoted (in May). He argued that the test they wanted to use was less effective than another established test and missed nearly 40 percent of Zika infections. He also claimed the agency was withholding information about testing differences from state and local public health laboratories.
As you might imagine, the CDC didn’t immediately comment but his actions did prompt an internal investigation.
The Washington Post reports that the investigation found that they had acted reasonably (their own investigation, lol) by witholding the conflicting test data from state public health labs; they felt that releasing it could have created “considerable confusion during an ongoing emergency response.”
Obviously, the CDC and Lanciotti feel this testing issue is important because they are aware of how much money they can make by, sorry, because so many people need to be tested- like pregnant women. Even though Zika has never caused microcephaly before it has spontaneously started to do so- getting this test is imperative.
From the article:
“During a 2007 Zika outbreak in Micronesia, Lanciotti’s lab developed a test to detect traces of the Zika virus in a person’s blood. Called the Singleplex, it detects genetic material up to seven days after onset of illness.
When the Zika outbreak hit Brazil, this test, and another one also developed by Lanciotti’s lab to detect antibodies the body makes to fight infections, were used on samples submitted to the CDC for diagnosis.”
Because most people don’t have symptoms, figuring out if someone has become infected with Zika is very difficult. And many countries in South and Central America and the Caribbean also have dengue and chikungunya outbreaks as well. Officials worried there might be confusion.
So:
  • In March, the CDC sought emergency FDA approval to allow the new test to be distributed to state and local public health labs.
  • A day later the FDA approved emergency use of the test, Trioplex.
  • Soon after, the CDC notified public health labs about the test and began shipping it.
  • Lanciotti compared the two tests and found that Trioplex missed 39 percent of Zika infections that were detected by Singleplex.
  • An independent lab came to the same conclusion.
  • A study by the CDC lab in Puerto Rico found no difference in sensitivity.
  • Lanciotti disagreed with the decision and in mid-April, he emailed his contacts at about 30 public health laboratories.
  • The CDC notified the state labs about which tests were recommended but didn’t address the differences in performance directly.
  • In mid-May, Lanciotti emailed senior CDC leaders and asked again that the test’s lesser sensitivity be shared with public health laboratories- accusing them of deliberately withholding information.
  • A week later, Lanciotti was reassigned to a nonsupervisory position.
(He was reinstated to chief of his lab in July after he filed a whistleblower retaliation claim.)
Any of this sound like the CDC’s status quo?
The CDC’s refusal to hear their people and to be honest and transparent with the public makes them a threat to our health. If we cannot trust them to do what’s right, when they are supposedly “the top public health agency in the United States”, then who can we trust?



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