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At first it sounded like a break.
"It does not work and it will not work in the future," said Dr. Janet Woodcock, the lead drug regulator in the United States.
She was speaking to an audience of about 150 researchers who were striving to discover new drugs that would save lives. The room was silent.
"I do not want to put everyone out," she said. "Science is fabulous, but that's not enough."
Certainly, Woodcock did not seek to sever ties with researchers working in universities, research institutes and pharmaceutical companies. But she called for major reforms in the relationship of scientists with regulators, doctors and each other. Without a complete overhaul, she said, their success in the lab will not reach the patients who need it most.
"The goal is not just to improve knowledge. The goal is not FDA approval. The goal is to improve human health, "she said Friday at the conference on medical breakthroughs at Rancho Palos Verdes. (The Los Angeles Times is the main sponsor of the event.)
"Is the guy living under the bridge going to benefit from a $ 2 million cure for CAR-T cells?" She asked, referring to a revolutionary treatment for cancer. "If this guy can not get the drugs, then we have failed."
Woodcock has drawn attention to various causes of the discrepancy between laboratory discoveries and drugs that reach the clinic. The current structure of university research discourages collaboration: grant review processes, promotion criteria and even the concept of tenure should be re-examined, she said.
In addition, the process of creating and marketing a drug has been hampered by corporate secrecy. When science is valuable and "not to share," drug trials are fragmented and expensive. In the meantime, important clinical questions remain unanswered when they have no obvious commercial gain, she said.
And above all, the access of patients from other industries seek to make their products cheaper. But this is not the case in the pharmaceutical industry, where high failure rates and expensive clinical trials have led to drugs far beyond the financial means of those who need them.
"I never thought in the 90s that if hepatitis C treatment was offered, it could not be treated. It was inconceivable, "she said. "But fast forward to now, and that's the reality we see."
Some changes in drug development have positively disrupted the ecosystem. For example, as researchers seek to defeat rare diseases, patients and advocacy groups are no longer just innovation leaders, they are actively involved in finding solutions.
But even this fervor has caused collateral damage, said Woodcock. Health problems such as
Cardiovascular disease, addiction and antimicrobial resistance are now less attractive candidates for research, even though they affect many more people.
Woodcock urged researchers to exploit Big Data – such as electronic health records – to study these diseases with effective and universal protocols. She also encouraged her audience to include practicing physicians in the research process.
"You can not just develop breakthroughs before throwing them over the wall to practitioners," she said. "We need the whole system to evolve and change if we want to do what we have decided to do: help each patient feel better and live longer."
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