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The FDA's new app for doctors could spur new uses for old drugs

CNN logo CNN 9/16/2020 By Ryan Prior, CNN
A new app developed by the FDA enables doctors to spend a few minutes submitting case reports about how they've treated unique patients. © Shutterstock A new app developed by the FDA enables doctors to spend a few minutes submitting case reports about how they've treated unique patients.

In the trenches of the fight against coronavirus, Dr. Raghav Tirupathi often has little time to think and no textbook to follow while treating patients with Covid-19.

That's why the infectious disease specialist in Chambersburg, Pennsylvania, finds himself increasingly turning for guidance to Cure ID, an app developed by the US Food and Drug Administration enabling doctors to consult with each other across hospitals, academic disciplines and international borders.

He uses many of the established treatments -- the antiviral drug remdesivir, the corticosteroid dexamethasone and convalescent plasma. But in the minutiae of a patient's given situation and with treatment guidelines regularly updated, the Cure ID app is vital for him to compare notes with other doctors about which drugs to administer, and in what order.

a screenshot of a cell phone: The app is organized by disease and allows doctors to discuss how and why a drug may have worked in a given condition. © FDA The app is organized by disease and allows doctors to discuss how and why a drug may have worked in a given condition.

"Things happen quickly and we can't afford to think about phases," said Tirupathi, who practices in a rural community hospital. "They reassure me that I'm not the only one doing it. We use Cure to justify what we are doing in our institution."

He's one of thousands of doctors sharing information via an app the US government agency hopes will spur new cures for hundreds of difficult-to-treat diseases.

App origins

The app wasn't designed for a pandemic, but it's just in time for one.

Launched by the FDA and the National Center for Advancing Translational Sciences at the National Institutes of Health in December 2019, the app has enabled doctors to write and submit anonymized case reports about their patients in just minutes for 325 distinct diseases.

After downloading it from Apple's App Store or Google Play, users confirm they are licensed health professionals. Then they can view case reports organized by disease, create their own reports and engage with the medical community via the app's community forum.

Cure ID was originally developed to aid in repurposing old drugs for new uses, according to Heather Stone, the app project lead and a health science policy analyst at the FDA.

Drug repurposing is a shortcut around the process to bring a brand-new drug to market, which can take 10 years and an estimated $2.6 billion, according to the Pharmaceutical Research and Manufacturers of America, a trade group.

Cure ID was designed to cut down that time and cost, particularly to focus on rare diseases that perplex doctors and don't always get much attention from major drug companies.

After the pandemic hit, the FDA and NIH created a new section of the app so doctors could input data solely around their Covid-19 findings.

"Time is of the essence to find new therapies for Covid," Stone said. "Cures may already be sitting on a pharmaceutical shelf somewhere as we speak."

With more than 864,000 Covid-19 deaths globally over the last eight months, the standard process of writing up a case study for publication in a medical journal could leave thousands of lives hanging in the balance as potentially lifesaving information finds its way to doctors who can use it. (To be sure, journals are speeding up publication in the face of the pandemic.)

And with many doctors cloistered in academic disciplines such as infectious disease or pulmonology, the FDA and NIH believe the app can break down silos and address the problem of health providers missing new insights discovered by researchers in other disciplines.

"This provides a wider audience," Stone said.

The potential to crack hard-to-treat cases

Stone joined FDA in 2013 after completing a master's degree in public health that included fieldwork at a remote hospital nestled in the foothills of the Himalayas. While there, she met a man with a multidrug-resistant tuberculosis, for whom different 12 drugs had failed.

After searching the academic literature for hours, she and a doctor found a drug combination that had saved the life of a young girl in a similar situation. Those drugs had been approved decades earlier, although not for tuberculosis.

Stone and the doctor believed that the combo would work on the elderly man as well, but by then they were too late to save his life. Stone spoke to dozens of other patients who had been treated with the same drugs and recovered. In her five years of pioneering the Cure ID app, those patients have kept her motivated.

"I would like to hope that if more case reports could be gathered in one place and systematized, then the work to bring them into clinical trials would have occurred earlier," she said.

Though physicians like Tirupathi use Cure ID to consult with colleagues about tuberculosis or coronavirus in real time, the primary goal for the app is to lay the foundation for randomized controlled trials, which are the gold standard for proving whether a particular drug is safe or effective in clinical practice.

"Cure ID is not a substitute for a peer-reviewed trial," Stone said. "Drugs may be good in single use but might not work in a study."

Breaking down walls between doctors

Cure ID is also a repository synthesizing data on all existing Covid-19 clinical trials so far.

"The app is awesome because it is so easy to use. It's empowering for someone who is eager for information," said Dr. David Fajgenbaum, an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine, who runs a database called the Covid-19 Registry of Off-label & New Agents.

For months, he and fellow researchers have been sifting through thousands of papers published on Covid-19 treatment data. Their database powers the Covid-19 section of the Cure ID app, keeping the number crunching up to date so that doctors around the world can easily keep up with emerging best practices as they combat the coronavirus in the trenches.

Over 30,000 papers had been published on 448 different Covid-19 treatments as of August 24.

"It's what you might call exponential medicine," Fajgenbaum said. "You don't have to be the world's expert to have 100 cases right in front of you."

And conversely, if a doctor has a brilliant new insight to share, this is an easy way to immediately push it out.

"By sharing your data with other doctors, it could help many patients you may never see," he continued. "It's a democratization of information."

Sharing data to support rural doctors

Better data sharing is one of the key ways to bring the newest insights to as many people as possible, particularly in settings far removed from big cities, where doctors have better access to resources and examine more unusual patient cases.

"Registries are not talking to each other," Tirupathi said. "Rural hospitals are contributing cases that otherwise go unnoticed in the literature."

There have been over 1,500 coronavirus cases, including 47 deaths in Franklin County, Pennsylvania, where Tirupathi practices, according to Johns Hopkins University.

Some 160 miles west of Philadelphia, rural residents, especially racial and ethnic minorities, can't easily enroll in a clinical trial or seek specialized care at a major research center such as Harvard or Stanford, he noted.

But with the app, rural doctors can harvest intel from those centers at a glance.

"Cure ID can look at hundreds of drugs at a time. That's what really excited me," Tirupathi said.

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