Report: Congressional Brinksmanship Doomed Ebola Drug
By Jonathan Springston, Associate Managing Editor, AHC Media
The November issue of Critical Care Alert takes a closer look at the origins and evolution of the Ebola Virus Disease (EVD) and how nations around the world have responded in the wake of the 2014 pandemic and how they are preparing for the next one.
The cover story of the November issue of ED Management examines what happened in late 2014 at Dallas’ Texas Health Presbyterian Hospital, which treated the first U.S. patient diagnosed with EVD and where two nurses eventually contracted the disease. The story focuses on a recently released panel report that broke down the system’s weaknesses during the crisis and made recommendations for improvement.
As researchers learn from past experience and prepare for the future, troubing news emerged this week about a potential EVD drug that could have been useful treating patients last year.
A treatment for EVD that was fast-tracked for FDA review fell victim to congressional politics in October 2012, a year and a half before an EVD outbreak in West Africa that would eventually reach the United States, the PBS program “Nova” reported Wednesday.
The U.S. Department of Defense contracted with Sarepta Therapeutics, a small pharmaceutical company based in Cambridge, MA, that focuses on developing drugs for rare diseases and had made strides in its EVD research, in 2010 to develop a treatment for the deadly disease. In 2012, the company’s therapeutic became the first EVD drug candidate to be given fast-track designation by the FDA, a designation meant to expedite the review of a treatment that addresses a serious condition and fills an unmet medical need. But later that year, as Congress battled over the debt ceiling, development came to a screeching halt. From the “Nova” report:
In September 2012, Sarepta’s drug, AVI-7537, received fast-track designation by the FDA — a major milestone that would expedite the approval process for the drug. Over $89 million federal dollars had already been spent on Sarepta’s Ebola and Marburg [a similar hemorrhagic fever] program.
But federally funded research is vulnerable to political upheaval, and in October progress came to an abrupt stop. With the fiscal cliff looming, the Department of Defense terminated the Ebola portion of its contract with Sarepta. “Ultimately there was a decision made to end the relationship,” Commander Franca Jones, the director of medical programs at the Department of Defense, says. “Not because there was anything wrong with their countermeasure,” she adds. “There were cost constraints that were not rectifiable.”
Unlike many other drugs, it wasn’t the results of clinical trials that killed AVI-7537, but the fallout from a game of political brinksmanship.
Less than two years later, the world was reeling from an EVD outbreak that would eventually reach the United States. But instead of the Sarepta product, the United States would funnel money toward two other drugs developed by companies whose federal contracts survived the 2012 fiscal cliff fiasco. Today, research into a viable, permanent EVD vaccine solution goes on.
Does EVD Linger in Semen?
One year after the EVD crisis, researchers continue to learn new information of concern about the disease.
Scientists have known that EVD can linger in male semen for three months. However, new research shows EVD could remain much longer than first thought, according to papers published Wednesday by The New England Journal of Medicine.
According to the first paper, a male EVD survivor in Liberia was released from a treatment center in October 2014 with no signs of illness. About five months later, he had unprotected sex with a woman, who died of Ebola 20 days later. Genetic analysis of blood from the woman and semen from the man showed that the man sexually transmitted EVD to his partner. A second paper revealed some male EVD survivors from Sierra Leone produced semen that contained traces of EVD nine months after first experiencing symptoms.