FDA approves rapid COVID test, Trump touts plasma treatment for COVID, CDC alters testing guideline

Steven Loeb · August 28, 2020 · Short URL: https://vator.tv/n/50d0

Healthcare in politics, week 8

Healthcare has been hot button a political issue for decades, with fights over Medicare going back to the mid-60s. The issue has been especially fractious over the last decade with the implementation of the Affordable Care Act, which passed without a single Republican voting for it.

It's with that backdrop that we now find ourselves in the midst of what HHS declared on January 31, 2020 to be a public health emergency. COVID-19 has upended the healthcare system in ways that nobody could have foreseen; thanks, in part, to CMS waiving telehealth regulations in April, combined with the necessity of using virtual care to see a doctor, that sector has been explosive growth in just a few months. 

As this is an election year, the delineations between what the two sides believe in, and their vision for how healthcare should work, will be made clear. That is what will be discussed at the Healthcare in Politics salon, hosted by Vator, HP and UCSF Healthhub, on October 7. Every week until then we will be doing a roundup of some of the biggest healthcare news and what Trump, Biden and the biggest healthcare agencies are up to:   FDA approves rapid COVID test

The Food and Drug Administration (FDA) authorized emergency use of a coronavirus test from Abbott, which costs $5 and can produce results in 15 minutes.

The test, which can be administered without any lab equipment, is meant to be used within seven days of the onset of symptoms. Results are produced on a card: if one line appears then the patient is negative for the coronavirus, but two lines means they have the virus.

Data from Abbott, which was submitted to the FDA, showed that the test had a 97.1 percent accuracy rate with positive samples, and a 98.5 percent accuracy rate for negative samples.

The company says it plans to start shipping the tests in September, it could soon manufacture 50 million of the tests per month by October.

Along with rapid test, Abbott is also releasing a smartphone app that could allow people to display test results from their health care provider via a QR code.

FDA Sign & Bldg 21 at Entrance | FDA Building 21 stands behi… | FlickrTrump touts plasma treatment for COVID, FDA apologizes

President Donald Trump announced emergency authorization to treat COVID-19 patients with convalescent plasma taken from patients who have recovered from the coronavirus,, calling it “a breakthrough.” 

However, so far, the evidence as to whether or not it works has not been conclusive, including when to administer it and what dose is needed.

“COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months,” Denise Hinton, the chief scientist for the FDA, wrote in a letter describing the emergency authorization.

The announcement, which came on the eve of the Republican National Convention, was quickly accused of being politically motivated, and received pushback from medical experts. 

FDA Commissioner Stephen Hahn also apologized for overstating the potential benefits of the treatment after saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma, which is not what the initial results had shown.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” Hahn tweeted.

Random COVID-19 testing helps Eighth Army protect the force | Article | The  United States ArmyCDC changes testing guideline, but states push back

The Centers for Disease Control and Prevention changed its guidance on COVID-19 testing, stating that healthy people who have been exposed to COVID-19 "do not necessarily need a test" if they don't have any symptoms of the virus. Vulnerable individuals, including as older people and those with chronic medical conditions, are still recommended to get tested. 

The CDC had previously recommended that anyone in close contact with someone who is infected get tested. An exposure is considered spending more than 15 minutes with an infected person at a range closer than 6 feet.

The change was met with criticism from infectious disease experts. 

"It's like they're saying we don't have enough tests," Dr. Michael Saag, an infectious disease physician and associate dean for global health at the University of Alabama, Birmingham, said.

"If a community or municipality has sufficient testing, they should continue to use the testing and ignore this recent update."

Numerous states, including Florida, Texas, Arizona, Illinois, California, New York, New Jersey and Connecticut, have rejected the new guideline, stating that they will continue recommending that those who come into contact with infected individuals get tested.

CDC's director Dr. Robert Redfield also walked back some of the changes, stating that "all close contacts of confirmed or probable COVID-19 patients" may consider testing. 

IMG_7136 | Robin Marty | Flickr
Trump asks Supreme Court to ban abortion medication through the mail

The Trump administration asked the U.S. Supreme Court to reverse a lower court ruling that allowed for the use of mifepristone, which is used in medication abortion, through the mail. 

In July, a U.S. District Judge in Maryland blocked a requirement from the FDA that required mifepristone to only be dispensed at a clinic, hospital or medical office. Acting Solicitor General Jeffrey B. Wall applied for a stay the injunction.

"The safety requirements here concern only medication abortions using Mifeprex, which is approved for use only during the first ten weeks of pregnancy. They have no effect on the availability of surgical abortions, a method that this Court has treated as safe for women," wrote Wall.  

As a result of the ruling, some abortion providers began delivering mifepristone by mail, though some still faced state laws that restricted their ability to do so. 

Telemedicine useage has exploded during the COVID epidemic. In March, CMS announced it was telehealth regulations temporarily, which was followed by more regulatory relief in April, including the ability to easily hire healthcare workers across states and expand at-home treatments.
(Image source: healthworkscollective.com)

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