Illustration: Aïda Amer/Axios

The Institute for Clinical and Economic Review and the pharmaceutical industry don’t even agree on what should be considered relevant evidence when deciding if a drug is safe and effective.

Why it matters: "This debate on what constitutes high-quality, 'real-world' evidence is not going away," said Walid Gellad, a pharmaceutical expert at the University of Pittsburgh.

Driving the news: Pharmaceutical companies that were singled out in ICER’s report yesterday on "unjustified" price hikes sent along hundreds of studies for ICER to consider in its analysis. ICER rejected almost all of them.

  • Many of the drug company studies were observational and funded by the companies, and ICER made it clear from the outset that it would only consider observational studies "that were high quality and comparative."

What we're watching: The FDA wants to use more simple trials and observational data in drug evaluations, similar to what drug companies submitted to ICER. 

  • But as Joseph Ross, a professor of medicine at Yale, wrote several years ago, it’s important to assess "the methodological rigor of observational studies before interpreting real-world effects."

Our thought bubble, via Bob: ICER's report is transparent, telling readers that none of the funding for its report came from any part of the industry and outlining clearly what it considered to be acceptable research.

Go deeper: Concerns rise about generic drugs from over

Go deeper

Updated 7 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 9:45 p.m. ET: 19,282,972 — Total deaths: 718,851 — Total recoveries — 11,671,491Map.
  2. U.S.: Total confirmed cases as of 9:45 p.m. ET: 4,937,441 — Total deaths: 161,248 — Total recoveries: 1,623,870 — Total tests: 60,415,558Map.
  3. Politics: Trump says he's prepared to sign executive orders on coronavirus aid.
  4. Education: Cuomo says all New York schools can reopen for in-person learning.
  5. Public health: Surgeon general urges flu shots to prevent "double whammy" with coronavirus — Massachusetts pauses reopening after uptick in coronavirus cases.
  6. World: Africa records over 1 million coronavirus cases — Gates Foundation puts $150 million behind coronavirus vaccine production.

Warren and Clinton to speak on same night of Democratic convention

(Photos: Abdulhamid Hosbas/Anadolu Agency via Getty Images, Sean Rayford/Getty Images)

Sen. Elizabeth Warren and Hillary Clinton both are slated to speak on the Wednesday of the Democratic convention — Aug. 19 — four sources familiar with the planning told Axios.

Why it matters: That's the same night Joe Biden's running mate (to be revealed next week) will address the nation. Clinton and Warren represent two of the most influential wise-women of Democratic politics with the potential to turn out millions of establishment and progressive voters in November.

Trump considering order on pre-existing condition protections, which already exist

Photo: Jim Watson/AFP via Getty Images

President Trump announced on Friday he will pursue an executive order requiring insurance companies to cover pre-existing conditions, something that is already law.

Why it matters: The Affordable Care Act already requires insurers to cover pre-existing conditions. The Trump administration is currently arguing in a case before the Supreme Court to strike down that very law — including its pre-existing condition protections.