FDA -- Don't Insult Me!!!

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

Image: joeforamerica.com

(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

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
www.salem-news.com/articles/july072016/fda-opioid-partydrugstudy-ms.php

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
sarah.peddicord@fda.hhs.gov

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 Salem-News.com and Global News Centre: www.salem-news.com/articles/july072016/fda-opioid-partydrugstudy-ms.php
http://www.globalnewscentre.com/fda-approves-a-dangerous-opioid-based-on-cheap-party-study-disturbing-and-true/#sthash.NhpNuEsn.dpbs