Blockbuster Drugs Are Dead - Steve Nissen
From MedCity News:
CLEVELAND, Ohio — The medical profession should get behind “innovative” federal regulations that will help win back a skeptical public, and better navigate tougher and tenuous drug pipelines, Cleveland Clinic’s Dr. Steven Nissen told his peers Thursday.
Nissen is a bit fire-and-brimstone when speaking to the public about the U.S. Food and Drug Administration. But Thursday afternoon, he was standing in front of fellow cardiologists — as well as drug and medical device companies — during a lunch speech at the Clinic’s three-day symposium on cardiovascular disease.
Nissen proclaimed dead the concept of the blockbuster drug — the statin that would work for tens of millions, for example. The “low-hanging fruit” in drug development is gone, and harder-to-develop, targeted therapies will be part of the next wave in care.
There are too many drugs that incrementally improve on existing drugs, he said. The federal government can turn companies back toward creating novel treatments — and developing them quickly — in areas like Alzheimer’s, obesity and drug-resistant tuberculosis, Nissen said.
The government should create incentives to develop drugs for such treatments, including extended patent rights for innovative medications, as well as FDA approvals that expire after five years if outcome trials have not been performed in that time.
“If we encourage that kind of regulation, then regulation becomes our friend rather than our enemy,” he said.
There were no questions at this talk, and the crowd applauded politely.
So instead of trying to develop blockbuster drugs from low-hanging fruit, perhaps Academic Health Centers should re-focus on the outstanding practice of medicine? You know, the non-glorious stuff, like good maintenance and care of diabetics, and putting the patient first, rather than viewing him or her as a profit center or a research subject.
To a certain extent we do this in Minnesota, especially at Mayo. But there is always room for improvement throughout the rest of the state. We are fortunate to have a good model.