FDA’s Continuing Arrogance and Indifference to the Opioid Epidemic as Death Toll Rages!

Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at FDA

In my seventeen (17) years of communicating with the FDA regarding the approval of opioids by their agency and the resulting epidemic, this is the first time that I did not receive a reply from them.  Concerning?  You bet it is.

Marianne Skolek Perez, Investigative Reporter

(MYRTLE BEACH) The FDA has announced a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee for October 12.  I am extremely interested in this meeting where a very dangerous opioid named Sufentanil will be discussed by the Advisory Committee and I plan to attend.

Sufentanil (R30730 brand name Sufenta) is a synthetic opioid analgesic drug approximately 5 to 10 times more potent than its parent drug, Fentanyl, and 500 times as potent as morphine — with high risk of addiction.  It will make OxyContin look like a day at the beach if approved.  Sufentanil sublingual will be off-label marketed as dangerous opioids such as OxyContin were allowed to be and could be administered to women in labor with a caution to the attending physician of the risks of respiration failure or death. Sufentanil should never be approved for human use.

I sent an email to eleven (11) high ranking officials at the FDA incorporating the above paragraph and asking their assurance that this very vital Advisory Committee meeting will be web broadcasted in its entirety.  I also asked who will be serving on the Advisory Committee and who their “experts” are giving testimony to the need and safety of Sufentanil.

In my seventeen (17) years of communicating with the FDA regarding the approval of opioids by their agency and the resulting epidemic, this is the first time that I did not receive a reply from them.  Concerning?  You bet it is.

October 12 Agenda

The committee will be asked to discuss new drug application (NDA) 209128, Sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee will also be asked to discuss risk-benefit considerations and whether this product should be approved.

So let me ask the arrogant and indifferent officials at the FDA this question:

Are you aware that we are losing people in the hundreds of thousands to deaths and addictions because of the number of opioids you continue to approve?

A couple of years ago, I asked Douglas Throckmorton, MD Deputy Center Director for Regulatory Programs, CDER, FDA on a telephone conference call “Doug how many opioids will you continue to approve before you realize we have enough?”  I was left with a dial tone in my ear.


Maybe the words “arrogance” and “indifference” are not harsh enough to be used in describing the FDA.  I will be working on stepping things up in describing the callousness the FDA has shown the American people as deaths mount to opioids and the FDA increases approval of opioids.  I repeat “Sufentanil should never be approved for human use” — and the FDA knows it.

Links to previous articles written by me exposing Janet Woodcock, MD for her part in contributing to the opioid epidemic:



Marianne Skolek Perez, Consultant
Prescription Opioid Epidemic
Investigative Reporter for http://www.salem-news.com/by_author.php?reporter=Marianne%20Skolek  www.Globalnewscentre.com and covering the prescription drug/heroin epidemic in the U.S. and Canada for 16 years

skolek-new-photo-700Global News Centre’s Marianne Skolek, is an Investigative Reporter who focuses on the Prescription Opioid/Heroin Epidemic in the U.S. and Canada. In particular, Marianne has covered the criminal marketing of OxyContin going back to 1999 and continuing to the present.

In 2002, Marianne lost her daughter, Jill to prescribed OxyContin which her physician referred to as “mobility in a bottle.” It was, in fact, death in a bottle. After doing extensive research on the maker of OxyContin, Purdue Pharma, Marianne began working with the Department of Justice in Virginia in their criminal investigation into Purdue Pharma and in July 2007 was asked by the U.S. Attorney John Brownlee prosecuting the case to testify against the three CEO’s of Purdue Pharma, Michael Friedman, Paul Goldenheim, MD and Howard Udell, Chief Counsel. The CEO’s pleaded guilty to misleading the medical profession about the dangers of OxyContin. Marianne also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007.

In addition, a dangerous and highly addictive opioid named Zohydro has been approved by the FDA against their Advisory Committee’s advice and Marianne continues to alert Attorneys General, Senators and Congressmen as to the FDA’s irresponsibility in the out of control prescription opioid/heroin epidemic killing and addicting in the tens of thousands each year. Zohydro has been referred to as “heroin in a capsule” and its lowest dosage (10mg) contains twice as much hydrocodone as found in a Vicodin pill. The highest single dose of Zohydro contains as much hydrocodone as 5 to 10 tablets of Vicodin or Lortab. Zohydro mixed with alcohol can be fatal and has no abuse deterrent built in which will make it easy to crush and deliver a fatal dose of the opioid.

Currently Marianne has been instrumental in calling for the termination of Margaret Hamburg, MD, Commissioner of the FDA as well as Bob A. Rappaport, MD and Douglas Throckmorton, MD for their lack of commitment to safeguarding the American public against the prescription opioid/heroin epidemic. Marianne’s research, writing and contact with government agencies and attorneys has also exposed the heavily funded pain foundations set up by the pharmaceutical industry and their paid physician spokespersons who convinced the medical boards in 50 states and Canada that dangerous opioids such as OxyContin were less likely to be addictive. These physicians — in particular Scott Fishman, MD, J. David Haddox, DDS, MD, Perry Fine, MD, Lynn R. Webster, MD, Russell Portenoy, MD also downplayed the risks of addictive opioids in books as authors. These books are still available for sale and promoted to the medical profession.

Here are links to Marianne’s involvement in exposing the national conspiracy of the prescription opioid/heroin epidemic, the FDA, the pharmaceutical industry, their pain foundations and paid physician spokespersons.




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