May 5, 2020 - Health

Antibiotic pipeline in peril from coronavirus and incentives system

Data: Axios research; Chart: Naema Ahmed/Axios

This pandemic may be caused by a virus, but desperate measures to save patients often include overprescribing antibiotics, which is raising concerns about furthering antibiotic resistance.

Why it matters: Antimicrobial resistance (AMR) forces clinicians to look for other drugs to treat patients but the antibiotic pipeline is in dire straits. The COVID-19 pandemic is exposing how few options there are and the need for investment to be prepared for more antibiotic resistant infections to emerge, industry experts tell Axios.

Driving the news: The Government Accountability Office last week publicly released a report with eight recommendations for the federal government on how to better determine and address the problem.

  • It included the possible need for the Department of Health and Human Services to request authority and appropriations to create and implement postmarket financial incentives because until "such incentives are developed, more drug companies may exit the antibiotic development sector, and the pipeline of new treatments may continue to decrease." (HHS did not concur with the recommendation on postmarket incentives.)
  • "Because of the way that evolution affects bacteria and viruses, these are areas in which preparedness requires us to have ready, or almost ready, a drug we don't actually need yet," says Kevin Outterson, co-director of Boston University's health law program and executive director of the nonprofit CARB-X.
  • Case in point: If a company had made a COVID-19 vaccine in 2018, there would have been zero value at that time, Outterson pointed out. But, right now, "What would that be worth? It's almost incalculable, how much money that would be worth right now. It has trillions of dollar of value today."

By the numbers: 15 antibiotics have been approved by the FDA in the past decade, almost all brought to the market by small companies, Outterson says.

  • "But over the past 13 months, one-third of them have either fallen into bankruptcy or [have been] sold in a transaction in which the value of the drug was essentially zero — and that, I'm telling you, is a catastrophe of epic proportion," Outterson says.
  • Smaller companies were the only ones willing to take the risk as Big Pharma doesn't see the incentive, he said, and now "there's almost nobody left who wants to put their own money at risk."
  • One of the problems is once a new antibiotic is developed, use of it is limited in an effort to protect its effectiveness. Plus some insurance companies balk at covering new, often more expensive antibiotics.
  • In 2019, Achaogen and Melinta Therapeutics declared bankruptcy because of slow sales of their newly approved antibiotics, per CIDRAP. Tetraphase also was forced into sale.

What's happening: Antibiotics are being thrown at COVID-19 patients partly because growing research points to secondary infections, like sepsis, as being responsible for a portion of the deaths.

  • There's not enough data to determine if those were AMR infections, but there's great worry the increased usage of the drugs will lead to greater resistance, says Greg Frank, director of infectious disease policy at the Biotechnology Innovation Organization, a biotech trade organization.
  • Often a virus weakens a body's immune system, making the person susceptible to bacteria. And, some of the methods used to try and save patients — like ventilators — can also expose the person to other germs, Frank says.
  • This has led to growing calls to test patients for bacterial and fungi infections along with COVID-19.
  • Officials are ultimately "failing in their mission" when they focus resources only on the immediate problem, such as finding a treatment and vaccine for COVID-19, only to have people die from secondary infections for which there already should be effective drugs, Frank adds.

The bottom line: "Having a full and effective arsenal of antibiotics, antimicrobials and antifungals is an important component of being prepared for the next pandemic," Frank tells Axios.

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