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Jul-26-2016 22:30printcomments

FDA -- Don't Insult Me!!!

Is the death toll from these dangerous opioids just not high enough yet?

oh no you didnt

(MYRTLE BEACH, S.C.) - Last month I wrote an article about the FDA's approval of yet another dangerous extended release opioid to be unleashed on the public as we are fighting addictions and deaths in the tens of thousands.

The FDA based their approval on the opioid Vantrela ER on a "cheap party study" conducted by the infamous and self-proclaimed pain champion of the country, Lynn R. Webster, MD. Webster is the vice president of scientific affairs at PRA Health Sciences in Salt Lake City.

His medical career made a detour as reports surfaced he can no longer prescribe opioids (deaths at his now closed pain clinic) to turning his "expertise" of opioids into research.

I encourage you to read these articles1 and educate yourself on the criminal activity of the FDA in not conducting their own studies on Ventrela ER, but presenting a "cheap party study" to their advisory committee.

Teva Gains Recommendation For Approval From FDA Committees For VANTRELA ER

June 07, 2016, 09:08:00 PM EDT By RTT News

Teva Pharmaceutical Industries Ltd. announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration voted 14 to 3 to recommend approval of VANTRELA ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

VANTRELA ER is an extended-release formulation of hydrocodone bitartrate with Teva's proprietary abuse deterrence technology.
The committees also voted: 14 to 3 that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the oral route of abuse. 14 to 3 that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the nasal route of abuse.

16 to 1 that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.

Adverse events reported in five percent or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included: nausea, constipation, vomiting, headache, somnolence, itching and dizziness.

* * * * *

As a result of my articles about the advisory committee of the FDA approving another extended release opioid -- this one based on a "cheap party study", I received the below email from a "press officer" at the FDA:

Hi Marianne –

I saw your below article and I wanted to chat with you, as this drug has not been approved.

I think there may be some confusion around the recent advisory committee that was held to provide recommendations to the FDA and the distinction between that and actual approval. Let me know if you have time to talk.

Best, Sarah

Sarah Peddicord
Press Officer
Office of Media Affairs
Office of External Affairs
U.S. Food and Drug Administration
Tel: 301-796-2805 / Cell: 202-380-8637

* * * * *

This was my reply to Sarah Peddicord:

I received the email you forwarded to my editor recently. No Sarah there is no confusion about your advisory committee recommendation on Vantrela ER. Just as there was no confusion on Zohydro ER being approved by the FDA against your advisory committee recommendation -- and no advisory committee meeting when OxyContin was approved for children.

So no I do not wish to "chat" with a press officer of the FDA. In fact with the FDA's record of approving so many opioids and contributing to the death toll in this country, I am insulted by your email to me.

Best, Marianne

* * * * *

How many more extended release opioids does the FDA need to have their bogus advisory committee consider for approval based on studies conducted by outside agencies and pharma? Is the death toll to these dangerous opioids not high enough for you?

If you're going to try to insult me again -- don't do it in an email -- do it to my face.

1Links to my article as published by and Global News Centre:


Comments Leave a comment on this story.

All comments and messages are approved by people and self promotional links or unacceptable comments are denied.

missrox August 3, 2016 12:17 pm (Pacific time)

scott michaels August 3, 2016 at 9:08 am hey marianne, lets just say you are ignorant. your knowledge of how addiction works and the difference between Dependence and addiction are 2 different things. People that use medicine recreationally then become hooked or take alot more then prescribed are addicts. they will generally use anything for a high. We are dependent on this medicine for only 1 reason , to relieve pain. We dont get high, we are not knuckleheads that get loaded and then die. people like you have uninformed opinions. Imagine you had a botched surgery that causes pain for life, Harsh Nasty pain. You are denied any pain medication, it gets so bad you search the streets and buy a bootleg illegal pain pill or heroin just to relieve the pain and it back fires on you and you get very sick and become a raging addict. Then you will know the difference.

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