No surprise here. Just put together a bunch of data and make up the statistics. No one's the wiser. "Now hurry and let me sell Oxycontin to children" -FDA
The FDA requires a lot more than a few medical papers. They have their own guidelines for studies, and you have to follow them to the letter. They also have investigators present to make sure data isn't mislabeled or incorrect.
The Oxycontin issue wasn't that the medicine wasn't safe, is that it was deemed safe by the FDA for its intended use, then it was pushed to doctors to go beyond its intended use.
The FDA was too late to respond to this, but it was undetected by the majority of the medical field because people went to the streets for re-ups, and doctors didn't want to admit fault. This is mostly due to improper regulation in how drug companies are allowed to interact with doctors, and the lack of healthcare resources.
1. Failure to Properly Enforce Marketing Regulations
2. Failure to Obtain Evidence of Long-term Safety and Effectiveness
3. Failure to Manage Conflicts of Interest
And my personal favorite:
> An FDA official who led the approval of OxyContin got a $400,000 gig at Purdue Pharma a year later
Special mention:
> A former senior U.S. Drug Enforcement Administration official who spent three decades at the DEA, specializing in preventing the diversion of prescription drugs like OxyContin, is now paid to advise one of the largest opioid manufacturers in the country, Purdue Pharma
Yes, I read that part. It doesn't counter any of my points, they actually enforce them.
Oxycontin was safe to use for their intended purposes, but they were not used that way. It wasn't the approval process that was problematic, just the follow-up.
