Speaking at the Breakthroughs in Medicine conference, Dr. Janet Woodcock of the FDA explains why the drug pipeline isn't doing all it could for patients.
Dr. Janet WoodcockShe was speaking to an audience of about 150 researchers who are toiling to discover new medicines that will save lives. The room was silent.Advertisement
To be sure, Woodcock wasn’t looking to sever ties with the researchers, who work at universities, research institutes and pharmaceutical companies. But she did call for major reforms in the scientists’ relationships with regulators, doctors and one another. Without a wide-ranging overhaul, she said, their successes in the lab won’t make it to the patients who need them most.
“The goal isn’t just improving knowledge. The goal isn’t FDA approval. The goal is to improve human health,” she said Friday at the Breakthroughs in Medicine conference in Rancho Palos Verdes. ?” she asked, referring to a breakthrough cancer treatment. “If that guy can’t get the drug, then we’ve failed.”
Woodcock pointed to various causes for the disconnect between discoveries in the laboratory and medicines that reach the clinic. The current structure of the academic research discourages collaboration: Grant review processes, promotion criteria and even the concept of tenure ought to be reconsidered, she said.In addition, she argued, the process of creating and commercializing a drug has been hindered by corporate secrecy.
And above all other concerns was patient access. Other industries focus on making their products cheaper. But that’s not the case with the pharmaceutical industry, where high failure rates and expensive clinical trials have led to drugs far beyond the financial reach of those in need.
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