Mar 4, 2019

The FDA is set to classify fecal transplants

Photo: Steve Russell/Toronto Star via Getty Images

There is a new battle brewing among doctors, patient advocates and pharma companies over — believe it or not — human excrement.

Driving the news: The fight is over fecal microbiota transplants, a remarkably effective treatment for the bacterial infection Clostridioides difficile, the New York Times reports. The battle is over whether the treatment — which involves transplanting healthy fecal matter into the bowels of patients suffering from the infection — should be classified as a drug or as a procedure akin to organ, tissue and blood transplants.

The FDA is expected to make a final decision soon, although in 2013 it made a draft decision to regulate the procedure as a drug.

  • The market for drug-based treatments for C. diff is expected to hit $1.7 billion by 2026, according to GlobalData.
  • Following the success of the procedure, scientists are currently trying to come up with similar treatments for disorders like obesity, autism, ulcerative colitis, and Alzheimer’s and Parkinson’s diseases.
  • Investors are pouring money into such endeavors.

One major concern for critics: Treating the therapy as a drug will give it a 12-year monopoly period upon approval.

  • They say this could slow innovation and cause patients who can't afford the procedure to attempt to replicate it at home.
  • And, of course, there's fear that this would lead to high prices for stool transplants.
  • Drug companies say that regulating the procedure as a drug will help ensure its safety and efficacy.

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Sign of the times: A pro-Warren super PAC

Democratic presidential candidate Sen. Elizabeth Warren at a rally in Nevada. Photo: Alex Wong/Getty Images

A group of women progressives who back Sen. Elizabeth Warren has formed Persist PAC, a super PAC airing pro-Warren ads starting Wednesday in an effort to boost her performance ahead of Saturday's crucial Nevada caucuses, a spokesman told Axios.

Why it matters: Warren has spoken adamantly against the influence of unlimited spending and dark money in politics. But these supporters have concluded that before Warren can reform the system, she must win under the rules that exist — and that whether she likes it or not, their uncoordinated help may be needed to keep her viable through this weekend's contest and into South Carolina and Super Tuesday.

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Pentagon policy chief resigns amid reported discord with Trump

John Rood. Photo: Mark Wilson/Getty Images

John Rood, the Pentagon's top policy official, will resign from his post at the end of the month, CNN first reported and President Trump confirmed.

The state of play: CNN said Rood "was perceived as not embracing some of the changes in policy the White House and senior Pentagon officials wanted," such as peace talks in Afghanistan with the Taliban and a decision to cut back on military exercises with South Korea as the president courted North Korea's Kim Jong-un.

Coronavirus cases rise, as warnings of global pandemic grow

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's NHC; Note: China refers to mainland China and the Diamond Princess is the cruise ship offshore Yokohama, Japan. Map: Danielle Alberti/Axios

We may be "at the brink" of a global pandemic, warns a top U.S. public health official, as cases continue to spread despite containment efforts. Meanwhile, the global economy is being affected, including the tech manufacturing industry.

The big picture: COVID-19 has now killed more than 2,000 people and infected over 75,000 others, mostly in mainland China, where the National Health Commission announced 136 new deaths since Tuesday.

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