Funny how an article about pain medication is posted under Psychiatry and Addictions.
In 2006, in the midst of a growing opioid epidemic, the FDA approved the new narcotic painkiller Opana. It was a familiar drug. Under the name Numorphan, it had been abused in the 1960s and 1970s until it was removed from the market. When injected, the drug is 10 times as potent as morphine.
In 2006, we were in the midst of a growing opioid epidemic? Seems like for some people, there’s always an ongoing opioid “epidemic.”
And since there are plenty of drugs other than pain medications that are abused, should they also be removed from the market? No more Xanax or Valium? I mean, damn, how many people abuse alcohol? Should we try prohibition all over again?
Known generically as oxymorphone, the FDA approved the new version of the drug — made by Endo Pharmaceuticals — in 2006 as both an immediate-release and extended-release pill. Then in December 2011, the agency approved a new abuse-deterrent version — but users have been able to foil the anti-injection mechanism and have been shooting up Opana.
In addition to overdose risk, abuse of Opana by injection has been tied to a recent outbreak of HIV in rural Indiana as well as a surge in hepatitis C infections in several Appalachian states…
Because the recent outbreak of HIV is the drug’s fault, right? Has nothing to do with the drug war or the DEA’s war against pain patients? Lack of access to affordable mental health and addiction treatments? Clean needle exchanges? Poverty?
It also has been associated with a blood-clotting disorder and permanent organ damage — a problem that didn’t occur with injection abuse of generics and the earlier version of the drug.
Well, when you coat pain pills in plastic, or whatever these new abuse-deterrent drugs are covered in, you’re going to have problems, no? Why not also mention problems like how hard these pills are to digest and how the time release mechanism doesn’t appear to work very well?
“There certainly didn’t seem to be a need for it,” said James Roberts, MD, a professor of emergency medicine at Drexel University College of Medicine in Philadelphia. “There are plenty of narcotics around for pain relief.
Gee, you’d think a doctor would know that many patients can’t tolerate a number of the legal narcotics that are “around.” And some opioids work for some people but don’t work very well for others. But why would doctors want more options for their patients? Why, thinking about the needs of patients is just utter nonsense, especially for doctors.
The IMMPACT meetings helped develop a new approach to winning approval of drugs known as enriched enrollment. The approach allows drugs companies to weed out people who don’t respond well to a drug or who can’t tolerate taking it before an actual clinical trial for the drug begins.
Independent doctors say that approach makes it much more likely a drug will be found effective and possibly win FDA approval. It’s also cheaper for drug companies to conduct such trials. Critics say the approach essentially stacks the deck in favor of the drug. More importantly, experts say, drugs tested that way are not likely to reflect what will happen when a medication gets on the market and is prescribed for large numbers of people.
When Endo tried to get Opana approved in 2003, the FDA said the drug didn’t appear effective enough in clinical trials. It also raised safety concerns after several postoperative pain patients overdosed on the drug and had to be revived with naloxone. So Endo conducted new clinical trials using enriched enrollment…
Opana is not the only opioid approved using enriched enrollment. In 2013, drugmaker Zogenix used the strategy to win approval for Zohydro, a high-dose, hydrocodone-only drug that was originally approved without any abuse-deterrent mechanisms.
So, hydrocodone has never been approved before 2013? You know, there aren’t too many people who would say that hydrocodone doesn’t work. In fact, it works best for the largest number of people, with the least amount of side effects — which many other opioids do not.
The article says it was written by John Fauber and Kristina Fiore, and since they’ve reported on PFROP before, I have to wonder how cozy they are with Mr. Kolodny and his group. Perhaps even members? Or maybe this is just a version of Fox News for the war against pain patients?