Oct 9, 2019

The struggle to evaluate drugs

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

Updates: George Floyd protests enter 12th day

Protesters in Washington, D.C. on June 6. Photo: Samuel Corum/Getty Images

Tens of thousands of demonstrators are rallying in cities across the U.S. and around the world to protest the killing of George Floyd. Huge crowds have assembled in Washington, D.C., Philadelphia and Chicago for full-day events.

Why it matters: Twelve days of nationwide protest in the U.S. has built pressure for states to make new changes on what kind of force law enforcement can use on civilians and prompted officials to review police conduct.

Updated 1 hour ago - World

In photos: People around the world rally against racism

Despite a ban on large gatherings implemented in response to the coronavirus pandemic, protesters rally against racism in front of the American Embassy in Paris on June 6. Photo: Julien Mattia/Anadolu Agency via Getty Images

Tens of thousands of people have continued to rally in cities across the world against racism and show their support this week for U.S. demonstrators protesting the death in police custody of George Floyd.

Why it matters: The tense situation in the U.S. has brought the discussion of racism and discrimination onto the global stage at a time when most of the world is consumed by the novel coronavirus.

Updated 2 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 7:30 p.m. ET: 6,852,810 — Total deaths: 398,211 — Total recoveries — 3,071,142Map.
  2. U.S.: Total confirmed cases as of 7:30 p.m. ET: 1,917,080 — Total deaths: 109,702 — Total recoveries: 500,849 — Total tested: 19,778,873Map.
  3. Public health: Why the pandemic is hitting minorities harder — Coronavirus curve rises in FloridaHow racism threatens the response to the pandemic Some people are drinking and inhaling cleaning products in attempt to fight the virus.
  4. Tech: The pandemic is accelerating next-generation disease diagnostics — Robotics looks to copy software-as-a-service model.
  5. Business: Budgets busted by coronavirus make it harder for cities to address inequality Sports, film production in California to resume June 12 after 3-month hiatus.
  6. Education: Students and teachers flunked remote learning.