US hits 200k COVID deaths, Trump offers seniors $200 for drugs, FDA to set COVID vaccine standards

Steven Loeb · September 25, 2020 · Short URL:

Healthcare in politics, week 12

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:  Corona Pink Virus Sad - Free image on PixabayU.S. reaches 200,000 COVID deaths

The U.S. death toll from COVID-19 surpassed 200,000, and some experts believe the number could double by the end of the year to 380,000. The number could go as high as 445,000 if health and safety measures as relaxed, said the Institute for Health Metrics and Evaluation

While having less than 5 percent of the global population, the U.S. has more than 20 percent of the 965,000 COVID-19 deaths, and the disease is now one of the leading causes of death. In total, the U.S. has reported more than 6.8 million cases, out of the 31 million reported worldwide. 

Meanwhile, COVID cases have been rising in 22 states over the past week, with seven states, Arizona, Colorado, Minnesota, Montana, Texas, Utah and Wyoming, seeing their daily infections rise by at least 60 percent in that time period. The biggest increases are largely concentrated in the West and Midwest. Rates fell in six states: Washington, Michigan, Indiana, Ohio, Delaware and Louisiana. Trump pledges $200 to seniors to help pay for drugs

President Trump announced that he intends to send $200 drug discount cards to 33 million seniors to help them pay for prescription drugs. The plan would cost $6.6 billion and could be used as part of a Medicare program called the 402 demonstration, which tests innovations that could save money or improve the quality of care in Medicare.

“Nobody’s seen this before, these cards are incredible,” Trump said in a speech. “The cards will be mailed out in coming weeks, I will always take care of our wonderful senior citizens. Joe Biden won’t be doing this.”

The announcement was part of a larger effort, which also includes executive orders which will  protect people with preexisting conditions, as well as prevent surprise medical bills.

It is unclear when these executive orders would be signed and when the cards would be sent out. 

FDA set to make it tougher to authorize COVID vaccine

The Food and Drug Administration is expected to make the standard for an emergency authorization of a coronavirus vaccine tougher, meaning that it is unlikely a vaccine will be cleared before Election Day. That includes a guidance to boost transparency and public trust, in order to increase confidence in the vaccine, which has become increasingly politicized.

Under the guidance, the FDA would ask manufacturers who are seeking an emergency authorization to follow participants in late-stage clinical trials for a median of at least two months. That would start after they receive a second vaccine shot.

These new standards are being reviewed by the White House Office of Management and Budget, and the President has already stated that he might reject them.

"That has to be approved by the White House," Trump said. "We may or may not approve it."

He also suggested that it "was a political move more than anything else."

HHS Secretary Alex Azar, however, sided with the FDA, saying in an interview that "If science and data and the legal constructs say slow down, then we slow down.”

"[The FDA] will not compromise on safety and efficacy standards and there’s many checks built into the system, [including] an independent data and safety monitoring board,” Azar said. "The FDA will call the balls and strikes by career officials according to the safety and efficacy centers that they have released publicly."

Warning! The Difference Between Good GSXR Fairings and Bad Fairings |  gsxrfairings.orgScientists say they are worried about political interference in COVID

The National Academy of Sciences and the National Academy of Medicine released a joint statement warning of "alarming" political interference in the government's coronavirus response.

"We find ongoing reports and incidents of the politicization of science, particularly the overriding of evidence and advice from public health officials and derision of government scientists, to be alarming," NAS President Marcia McNutt and NAM President Victor Dzau wrote.

"It undermines the credibility of public health agencies and the public’s confidence in them when we need it most."

The statement came after numerous reports of government officials inserting themselves into the COVID-19 response, including HHS officials interfering with weekly scientific reports from the CDC, as well as attempts to stop Dr. Anthony Fauci from speaking. The White House also ordered the CDC to stop recommending testing for people who have been exposed to the virus but aren't showing symptoms, which was eventually reversed.

"Our nation is at a critical time in the course of the COVID-19 pandemic with important decisions ahead of us, especially concerning the efficacy and safety of vaccines. Policymaking must be informed by the best available evidence without it being distorted, concealed, or otherwise deliberately miscommunicated," McNutt and Dzau wrote.

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