Weighing Risks and Benefits on an FDA Advisory Committee

More than 400 pages of medical research, 11 hours of testimony and a blizzard in March. Welcome to my first FDA Advisory hearing!

I am the newly appointed consumer representative on the Drug Safety and Risk Management Advisory Committee for the FDA. On March 13 and 14, our committee was joined with a sister committee. Anesthetic and Analgesic Drug Products, to determine if, based on new postmarketing research, the benefits of Opana ER, an opioid pain med, still outweigh its risks.

About a week before the meeting, 4 CDs arrived at my house so I had to clear my calendar to focus on reading medical reports. This was by far the most difficult part. As a consumer rep, I’m not expected to be trained in the technical scientific aspects, but am expected to be able to understand most of it. Frankly, I started my own cheat sheet of acronyms and key phrases: PMR = Post Marketing Requirements; PROMAQ = Prescription Opioid Misuse and Abuse Questionnaire; ETASU = Elements to Assure Safe Use; PWID = People Who Inject Drugs and too many others!

Opana ER is oxymorphone. It’s indicated for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Opana ER was reformulated in 2012 to add a substance, POI, that made the pill hard to break and, if it was successfully crushed, to turn into a gel. The company’s goal was to stop abusers from crushing and snorting Opana. The postmarketing research indicated that they were successful. Nasal abuse went down dramatically. However, clever drug abusers figured out how to liquefy the gel and shoot up. Instead, intravenous use increased dramatically.

There were many aspects to be considered, not the least of which is the very research upon which we had to make our decision. It was not of great quality.

There were many aspects to be considered, not the least of which is the very research upon which we had to make our decision. It was not of great quality. As one of my co-panelists noted, “This is a hidden population.” They are hard to study and to compare to non-abusing people.

I found the increase in IV use disturbing. Because of the unique properties of Opana ER, those addicted need to shoot up several times a day and multiple skin pricks from needles make sepsis a health hazard. Because of the high street price and the power of the drug, addicts can share one pill with 4 other users. The rate of needle sharing is particularly high with this drug and the rates of HIV and hepatitis correspondingly high.

Counterbalancing the abuse was the fact that Opana is an effective pain killer. Several committee members noted that oxymorphone is not the first choice of pain medication, but when other meds weren’t effective, they were glad to have it as an alternative. There are many patients who are able to use it without abusing it.

The question posed to us, “Do the benefits of Opana ER still outweigh the risks?” was challenging. The discussion with the committee members before the vote brought in multiple points of view which strongly informed my vote.

In my experience, a family with an addict lives in fear that the addiction will kill before the family can get the addict into a program or whatever is needed to restore health. The move from nasal to IV abuse leads to many more complications that might make recovery insurmountable, and certainly more difficult. My vote, that the benefits no longer outweigh the risks, was in the majority. Eighteen members of the panel voted as I did, 8 voted that the benefits outweighed the risks and 1 abstained.

Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.

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