Duke researcher urges caution on President Trump's call for less FDA regulation

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A Duke cancer researcher hopes patient safety isn't compromised in the quest to speed drugs to market.

A Duke University researcher is sharing his concerns with ABC11 about President Donald Trump's calls to roll back FDA regulations for the approval of new treatments and drugs.

It's a point President Trump brought up in his address to Congress, as he motioned over to a young woman named Megan Crowley, battling Pompe disease, a rare illness that affects a person's cells.

"Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one saved Megan's life, from reaching those in need," the President said in the speech.

Megan Crowley was a guest at President Donald Trump's Feb. 28 address to the joint Congress.



"If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles, just like Megan," Trump added.

Duke Cancer Institute's deputy director, Dr. Steven Patierno, said the process of getting new drugs and treatments to market is something that needs to be handled with care.

"Any approach to speeding up the approval of drugs by the FDA has to balance patient safety with entrepreneurship," he said.

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On top of that, Dr. Patierno points out that the FDA already has a "fast track," and other processes to expedite urgent and promising work.

It's something that's already happening at Duke, as it was awarded breakthrough therapy approval by the FDA for its use of the polio vaccine to treat glioblastoma multiforme, a form of brain cancer.

"Several are still alive today, which is three to five years after the treatment, which is almost unheard of in glioblastoma," Dr. Patierno said.

Though he said the process of developing new medicine can sometimes takes many months and even years -- it's doing so in a way that won't harm patients that is key.

"We want to save patients' lives, we want to minimize delays and getting breakthrough therapies into the clinic, but we also want to balance that with patient safety," Patierno said.

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