Mmmmm
There was the time at Duke where Dr anil potti's cancer discovery failed badly in 2011
Pharma & Healthcare
SEP 16, 2015 @ 09:22 AM 4,405 VIEWS
Robert Califf Could Transform The FDA -- The Right Way
Matthew Herper ,FORBES STAFF
I cover science and medicine, and believe this is biology's century.
FOLLOW ON FORBES (2028)
People who care about making sure that medicines and medical devices are safe and effective should be cheering the nomination of Robert Califf to be the new commissioner of the Food and Drug Administration, and any senators who slow his path to the job he deserves should be accused of practicing the basest kind of partisanship.
It’s no shock that Califf is being tapped for the job. His departure from Duke University and the giant clinical trials operation he built there in February was a clear sign that he was being considered for the role. And it wasn’t the first time. Califf’s name was in wide circulation six years ago when Margaret Hamburg was named commissioner in 2009. But Califf was widely seen as too linked to industry. Instead, the Obama administration went with Hamburg, a former commissioner of New York City’s Department of Health and Mental Hygiene. For a time, Joshua Sharfstein, another former public health commissioner who had been focused on drug safety issues, served as the FDA’s associate commissioner.
Hamburg has been a very good FDA commissioner. But instead of being tough on industry, as some might have expected six years ago, she pushed the agency to communicate better with drug and device companies. This has resulted in more approvals and helped lead to the current boom for biotechnology and drug stocks. And Congress is sending clear signals that the FDA should be looking for ways to get medicines to patients more quickly.
Califf’s industry ties run deep. He worked closely with drug companies in the best possible way: convincing them to do large, expensive, and, for Duke, profitable clinical trials that helped prove the effectiveness of major medicines like Sanofi ’s Plavix, Merck ’s Vytorin, and Johnson & Johnson JNJ +0.00%’s Xarelto. But he has not been a pushover, ever, and his goal has always seemed to be to make sure that doctors and patients have the best evidence possible for deciding what drugs to give to patients. He has not always been easy on industry.
In 2008, after Steven Nissen from the Cleveland Clinic had openly criticized Avandia, the GlaxoSmithKline diabetes drug, he proposed a new standard for studying diabetes medicines that would insist they be tested in clinical trials involving thousands of patients to see if they had any effect on heart attack rates. When Nissen mentioned the idea at an open public meeting, Califf was fast to back it.
“I can’t imagine a situation, given what we know now, other than a screening mechanism followed by some sort of trial for the net risk and benefit versus risk,” Califf said at the time.
- Forums
- ASX - By Stock
- BLT
- Maxim raises price target to $23?
Maxim raises price target to $23?, page-22
-
- There are more pages in this discussion • 4 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)