Monday April 23, 2018
Aug-15-2016 12:27TweetFollow @OregonNews
FDA Advisory Committee:
Marianne Skolek-Perez, Salem-News.com Investigative Reporter
The FDA approved Arymo ER (a morphine sulfate abuse deterrent tablet).
(MYRTLE BEACH, S.C.) - Recently I attended an FDA Advisory Committee meeting where a new killer opioid called Arymo ER (a morphine sulfate abuse deterrent tablet) submitted by Egalet U.S. Inc. was under consideration to be unleashed in the U.S.
Morphine has typically been administered in hospitals intravenously for terminal illnesses. A morphine extended release tablet is an invitation for an escalation of deaths in this epidemic. And yes by the end of the day, the FDA Advisory Committee gave this dangerous time release opioid the "green light".
Executives of Egalet U.S. gave testimony as to the "attributes" of their morphine tablet being pitched as abuse deterrent -- as did "scientific advisors".
One of the scientific advisors was Lynn R. Webster, MD who is the self-proclaimed pain champion of the U.S. and is the Vice President of Scientific Affairs at PRA International and a pain researcher.
PRA is one of a handful of centers in the North America who do these clinical trials on opioids and arguably the most prominent. Dr. Webster has written extensively on the topic and maintains a website and blog on pain research.
During the "pitch" to the FDA Advisory Committee by Webster as scientific advisor to Egalet U.S., he spoke very knowledgeably about the qualities of the abuse deterrent Arymo ER -- and in fact answered questions from the Advisory Committee about the benefits of the extended release morphine in a tablet.
For those who are not familiar, there is a license called "controlled substance handler". It's requirement for analyzing or conducting research with opioids is as follows:
R156-37-301. License Classifications - Restrictions.
(1) Consistent with the provisions of law, the Division may issue a controlled substance license to manufacture, produce, distribute, dispense, prescribe, obtain, administer, analyze, or conduct research with controlled substances in Schedules I, II, III, IV, or V to qualified persons.
Link to information on controlled substance license requirements: www.rules.utah.gov/publicat/code/r156/r156-37.htm.
The FDA should be aware that Lynn R. Webster, MD does not hold a license as a controlled substance handler:
Lynn Roy Webster
License 161058-8914 - Controlled Substance Handler Individual (EXPIRED)
There is that possibility though that Webster could have been conducting research using another researcher's license, but I'm confused.
Why did the FDA Advisory Committee and FDA personnel allow Webster to give testimony and answer questions regarding the controversial extended release morphine tablet when he had an expired license?
The Advisory Committee may want to reconsider their recommendation of Arymo ER because they appear to have been misled (whether deliberately or not) and this could fall under the category of "unethical" or "criminal".
Pharmaceutical companies may want to take note on the seriousness of their scientific advisors holding appropriate credentials before appearing before the FDA Advisory Committee. The Advisory Committee's function should be to preserve lives -- not put them at risk.
On September 15 and 16, 2016, the FDA Advisory Committee will be holding meetings on appropriate pediatric development plans for prescription opioid drugs.
If the FDA Advisory Committee driving the bus on pediatric development plans for opioids doesn't scare you -- remember it is a "school bus" this time.