The Root of the Opioid Epidemic has always been at the Top – the FDA. Now let’s do something about it!

The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington

It’s time for “ready, aim, fire” to sweep the FDA and HHS clean and save lives — not enable the pharmaceutical industry to earns billions of dollars while we continue to lose a future generation compliments of agencies failing to protect the American people.

Marianne Skolek Perez, Investigative Reporter

(MYRTLE BEACH) In my 17 years of writing and speaking of the ever worsening prescription opioid epidemic, I have maintained that the root of the epidemic is at the top — the FDA.  Purdue Pharma, maker of the highly addictive and dangerous opioid, OxyContin unleashed a holocaust of deaths and addictions by working with the FDA to win approval for long-term use of opioids — in particular OxyContin.  I have worked with Attorneys General, attorneys, elected officials, physicians and entities who were as determined as me to expose the FDA and Purdue Pharma for their parts in encouraging opioids for long-term use.

This Sunday night, February 24, CBS 60 Minutes (check your local listings) will focus on David Kessler, MD, the former FDA commissioner admitting they erred in allowing pharma to promote opioids for long-term use.

Here is the link to the 60 Minutes press release/preview:https://www.cbsnews.com/news/former-fda-commissioner-says-agency-erred-in-allowing-drug-companies-to-promote-opioids-for-long-term-use-60-minutes/

Today the sealed deposition of Richard Sackler, one of the owners of Purdue Pharma who allowed OxyContin to be criminally marketed, was made available to the public.  Here is a link to that eye-opening deposition that was taken in the State of Kentucky settlement.  https://www.statnews.com/2019/02/21/purdue-pharma-richard-sackler-oxycontin-sealed-deposition/?utm_source=STAT+Newsletters&utm_campaign=20e6c88c42-purdue_alert_22119&utm_medium=email&utm_term=0_8cab1d7961-20e6c88c42-149622473

In 2018, I wrote about a Memorandum of Law in Support of Plaintiff (Pharmaceutical Manufacturing Research Services Inc’s (PMRS) Motion for Summary Judgment filed against the United States Food and Drug Administration (FDA) and the United States Department of Health and Human Services  (HHS).  I encouraged every Attorney General and law firm in the country suing Purdue Pharma, maker of OxyContin to read this filing carefully and apply it to current and future lawsuits.

It had been thought that the FDA and HHS were “untouchable” in the prescription opioid epidemic destroying lives in the tens of thousands.  I have long written and spoken that this epidemic’s roots were at “the top” — the FDA.  PMRS has dispelled the myth that these federal agencies in place to protect the American people could use the approval process of dangerous opioids with the mentality of “fire, aim, ready.”

Here are some highlights of the PMRS filing against the FDA and HHS in italics:

In the past two years, it has come to light that FDA has been approving opioid drug products for treatment  of chronic pain despite a lack of substantial evidence, as is required by 21 U.S.C. 355(b) to support the efficacy of those products in a chronic use setting.

In the past years, it has come to light that FDA’s current methodology for approval of so-called abuse deterrent labeling for opioids does not satisfy the requisite statutory standards, is scientifically flawed, and results in false and misleading labeling.  Such labeling gives a false sense of security as to any meaningful solution to the raging opioid epidemic.

Rather than addressing improper approval processes for opioids with labeling for treatment of chronic pain, FDA pursued abuse deterrent formulation and labeling, an approach that has done nothing but fuel the opioid crisis.

Despite the continued lack of scientific evidence to support the use of opioid products for treatment of chronic pain, on July 18, 2001, FDA changed the labeling for OxyContin and other opioids.

Specifically, FDA supported labeling updates that changed the indication of OxyContin for treatment of acute pain to chronic .  In support of their determination, FDA merely stated that the basis for this change was “to reinforce the appropriate patient population for whom this product is intended.”

More recently, in March 2016, the CDC conducted a comprehensive review of the scientific evidence supporting the effectiveness of long-term opioid therapy for chronic pain, and concluded that “the few randomized trials to evaluate opioid efficacy for longer than 6-weeks had consistently poor results.”

Private law firms may not want to “take on the FDA and HHS” citing not having the resources to hold these agencies accountable in the prescription opioid epidemic.  It is a different scenario with every Attorney General in the country who has an obligation to go to the root of the prescription opioid epidemic and stop the loss of human life in the tens of thousands.

It’s time for “ready, aim, fire” to sweep the FDA and HHS clean and save lives — not enable the pharmaceutical industry to earns billions of dollars while we continue to lose a future generation compliments of agencies failing to protect the American people.

Maybe the personal injury lawsuits to be filed as a result of the FDA’s admission of complacency in the opioid epidemic won’t be far behind.

Marianne Skolek Perez

Consultant to attorneys on opioid lawsuits filed throughout the country
Investigative Reporter covering the opioid epidemic writing for
Global News Centre, Salem-News.com, Sons of Liberty Media, The Washington Standard and Freedom Outpost
https://www.judiciary.senate.gov/imo/media/doc/Skolek%20Testimony%20073107.pdf
http://www.youtube.com/watch?v=tmPG1VjD61U&list=UUWoHUEr4ZAbQOfIqtOArjgg&index=6&feature=plcp
908-285-1232 – cell

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.

http://www.salem-news.com/by_author.php?reporter=Marianne%20Skolek

http://www.youtube.com/watch?v=tmPG1VjD61U&list=UUWoHUEr4ZAbQOfIqtOArjgg&index=6&feature=plcp

https://www.facebook.com/photo.php?v=855537227796352&set=vb.658186307531446&type=2&theater

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